SOUTH SAN FRANCISCO, Calif. (GLOBE NEWSWIRE) — Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company, today reported financial results for the quarter and full-year ended December 31, 2019 and summarized recent business results.

Related Article: Satsuma Pharmaceuticals Appoints Rob Janosky as Chief Commercial Officer

“In 2019, the Satsuma team made significant progress toward its goal of delivering STS101, a compact, simple-to-use, self-administered, and non-injectable DHE (or dihydroergotamine) product, as a differentiated treatment option for people with migraine. We’ve established a strong foundation for our business and in 2020 we plan to advance Phase 3 development of STS101 and begin preparing for an NDA filing by the end of 2021 and subsequent STS101 commercial introduction.”

– John Kollins, Satsuma’s President & CEO

Financial Results for Q4 2019 & FY2019

Net losses for the fourth quarter and full-year 2019 were $10.8 million and $28.2 million, respectively, or $0.62 and $4.80 per common share, respectively. This compared to net losses of $2.3 million and $7.3 million, respectively, or $2.17 and $7.15 per common share, respectively for the same periods in 2018. As of December 31, 2019, the Company had $117.9 million of cash, cash equivalents, and marketable securities. The Company believes it has sufficient financial resources to fund operations through the end of 2021.

Research and development expenses were $9.2 million and $24.2 million for the fourth quarter and full-year 2019, respectively, compared to $2.0 million and $6.4 million for the same periods of 2018, respectively. Fourth-quarter expenses increased by $7.2 million, primarily due to additional expenses for the EMERGE clinical trial and drug supply manufacturing activities, as well as increases in salaries and employee-related expenses.

General and administrative expenses were $2.1 million and $4.7 million for the fourth quarter and full-year 2019, respectively, compared to $0.3 million and $1.1 million for the same periods of 2018, respectively. Fourth-quarter expenses increased by $1.8 million, primarily due to general administrative expenses, as well as increases in salaries and employee-related expenses.   

Business Update & FY 2019 Highlights

STS101 EMERGE Phase 3 Efficacy Trial Update

Satsuma expects to report topline data for the EMERGE trial in the second half of 2020. The EMERGE trial, which Satsuma believes is the largest-ever clinical trial undertaken with any DHE product, is a double-blind, parallel-group, placebo-controlled, multicenter trial in approximately 1,140 patients.  EMERGE is designed to evaluate the efficacy, safety, and tolerability of STS101 in treating a single migraine attack and is highly powered on its two co-primary endpoints:  freedom from pain (>99% power) and freedom from most-bothersome-symptom (from among photophobia, phonophobia or nausea) (>95% power) at two hours after administration of study medication.  In addition, EMERGE is designed to prospectively evaluate a number of secondary endpoints and the performance of STS101 in patient subgroups that could enhance its differentiated clinical profile.

The EMERGE trial is the first of two Phase 3 trials Satsuma plans to complete to support registration of STS101. Satsuma plans to initiate in the third quarter of 2020 an open-label, Phase 3 safety trial of STS101 in at least 150 episodic migraine patients, which will treat their migraines with STS101 on an as-needed basis for six months, with a possible 50 patients treated for an additional six months.

STS101 Phase 1 clinical trial results presented in July at the American Headache Society’s Annual Scientific Meeting and subsequently published in its official peer-reviewed journal, HEADACHE: The Journal of Head and Face Pain

The STS101 Phase 1 trial was an open-label, two-part, active-controlled, three-period crossover study designed to investigate and compare the safety and pharmacokinetics of STS101, DHE liquid nasal spray (Migranal^®), and intramuscular (IM) DHE injection in healthy subjects.

Study authors concluded that STS101 showed a favorable tolerability profile and was rapidly absorbed, achieving DHE plasma concentrations comparable to IM DHE and exceeding Migranal. Based on data from this study and results from other clinical studies with DHE (including injected, liquid nasal spray, and orally inhaled DHE dosage forms), the authors posited that STS101 is anticipated to demonstrate rapid pain relief, improvement in patient function, and excellent 2-hour and sustained pain freedom rates.               

Two STS101 posters presented by Satsuma at the 19th Congress of the International Headache Society comparing the PK of STS101 with other DHE formulations and demonstrating the consistent and robust delivery performance of STS101

These posters are available for download on the Publications section of the Satsuma Pharmaceuticals website.

Financing activities and corporate update

2019 financing activities raised approximately $153 million:

• In April 2019, Satsuma closed a $62 million Series B preferred financing.
• In September and October 2019, Satsuma raised nearly $91 million in aggregate gross proceeds in its initial public offering, which resulted in the Company’s shares being listed on the Nasdaq Global Market.

Expanded leadership team, bolstering financial and commercial management functions and corporate governance:

• In May 2019, Satsuma appointed Elisabeth Sandoval to its Board of Directors.  Ms. Sandoval brings to Satsuma extensive drug product commercialization experience, as well as leadership and strategic skills in the migraine field. Ms. Sandoval most recently served as Chief Commercial Officer and Executive Vice President of Corporate Strategy for Alder Biopharmaceuticals (acquired in 2019 by Lundbeck), which recently received FDA approval for eptinezumab, a novel therapeutic antibody for the preventive treatment of migraine, and previously served as Chief Commercial Officer of KYTHERA Biopharmaceuticals.         
• In February 2019, Tom O’Neil joined Satsuma as its Chief Financial Officer.  Prior to joining Satsuma Pharmaceuticals, Mr. O’Neil was Chief Financial Officer at Protagonist Therapeutics, Inc.  Since entering the biopharmaceutical industry in 1999, Mr. O’Neil has served in C-level and other management roles in multiple public and private biopharmaceutical companies. He brings to Satsuma a wealth of relevant finance and operations experience, including leading successful initial public offering and private equity transaction initiatives.
• In March 2020, Rob Janosky joined the Company as Chief Commercial Officer.  Mr. Janosky’s experience in the biopharmaceutical industry spans more than 25 years and includes successfully creating partnerships, building commercial capabilities and launching products within established and emerging biopharmaceutical companies, including DURECT Corporation, Jazz Pharmaceuticals, Vivus Inc., Johnson & Johnson/Alza Corporation, and Wyeth.

Upcoming 2020 Milestones

• EMERGE Phase 3 efficacy trial top-line data in the second half of 2020
• Initiate STS101 Phase 3 open-label safety trial in the third quarter of 2020
• Present further data on STS101, DHE, and the proprietary dry-powder nasal drug delivery technologies incorporated in STS101 at medical meetings in 2020

About Satsuma Pharmaceuticals and STS101
Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product for the acute treatment of migraine, STS101. STS101 is a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate (DHE), which can be quickly and easily self-administered with a proprietary pre-filled, single-use, nasal delivery device. In developing STS101, Satsuma has applied proprietary nasal drug delivery, dry-powder formulation, and engineered drug particle technologies to create a compact, simple-to-use, non-injectable DHE product that can be rapidly self-administered in a matter of seconds. The Company believes STS101 would, if approved, be an attractive migraine treatment option for many patients and may enable a larger number of people with migraine to realize the long-recognized therapeutic benefits of DHE therapy. STS101 has undergone extensive pre-clinical development, completed a Phase 1 clinical trial, and is currently in Phase 3 development.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements concerning the business, operations and financial performance and condition of Satsuma Pharmaceuticals, Inc. (the “Company”), as well as the Company’s plans, objectives and expectations for its business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about the Company’s expectations regarding the potential safety and efficacy of STS101; the Company’s clinical and regulatory development plans; the Company’s expectations with regard to the initiation and availability of data to be derived from its ongoing and planned Phase 3 clinical trials; the timing and likelihood of regulatory filings and approvals for STS101; and expected cash needs and sufficiency of cash on hand. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of STS101; the results of preclinical and clinical studies may not be predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; the costs of clinical trials may exceed expectations; and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

This press release discusses STS101, a product candidate that is in clinical development, and has not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of STS101 for the therapeutic use for which STS101 is being studied.

INVESTOR AND CORPORATE CONTACTS:            

Corey Davis, PhD
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com

Tom O’Neil, Chief Financial Officer
Satsuma Pharmaceuticals, Inc.
tom@satsumarx.com

KIRKLAND, Wash. /PRNewswire/ — Cardiac Dimensions^®, a leader in the development of innovative, minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure (HF), today announced the hiring of Gretchen Gary as Vice President of Global Therapy Development. Ms. Gary brings more than 17 years of structural heart sales, training and market development experience and will be responsible for implementing the Company’s commercial strategy for the Carillon Mitral Contour System ^®.

“We are extremely excited to have Gretchen join the Cardiac Dimensions team. Her strong track record of commercial success and deep understanding of the structural heart space, our customer’s needs and the competitive landscape is a tremendous asset as we broaden adoption of the Carillon Mitral Contour System and prepare for US commercialization in the not-too-distant future.”  

– Rick Wypych, Chief Operating Officer, Cardiac Dimensions

Ms. Gary joins Cardiac Dimensions from Livanova where she held the position of Senior Director of Global Therapy Development and was responsible for establishing a multi-disciplinary physician advisory board to develop patient management treatment guidelines for a novel transcatheter mitral valve replacement (TMVR) product. Ms. Gary also held executive-level positions at CardioKinetix, where she led market development efforts in five countries across three continents, and Direct Flow Medical where she built a field team and training department to support pivotal trial execution. Ms. Gary’s prior experience includes Market Development Manager, Director of Global Sales Training and Director of Sales/European Country Manager at Abbott. In these roles, Ms. Gary was responsible for market development and commercialization of the MitraClip TMVr System in more than ten countries.

“Because FMR in heart failure is a devastating disease, the development of minimally invasive products for treatment is of critical importance. I am very excited to be joining Cardiac Dimensions and am eager to leverage my structural heart experience and make a valuable contribution to this first-of-a-kind pivotal trial. I believe the Carillon System has the potential to change the lives of many patients by providing relief from their symptoms and slowing the progression of heart failure.”

– Gretchen Gary, VP of Global Therapy Development, Cardiac Dimensions

The hiring of Ms. Gary precedes the announcement of findings of a post hoc analysis of pooled prospectively collected data from three studies of the Carillon Mitral Contour System with a focus on the 5-year survival rate and the determinants of long-term survival. The data was presented in a late-breaking trial session at the Cardiovascular Research Technologies meeting (CRT 2020) in National Harbor, MD and published in Cardiovascular Revascularization Medicine. The results demonstrated a lower three-year mortality rate compared to published outcomes of COAPT and guideline-directed medical therapy (GDMT). Using matched patient populations, all-cause mortality rate of the Carillon was 33.7% for Carillon, 42.8% for MitraClip in COAPT and 55.5% for GDMT. Primary determinants of long-term survival were a decrease in NYHA class, an increase in 6-minute walk test distance and decrease in regurgitant volume during the first year of follow-up.¹

An estimated 26 million people, worldwide, suffer from heart failure² and of those, approximately 70 percent have FMR. Heart failure is a significant clinical and economic burden with direct and indirect costs expected to grow to $70 billion by 2030.³

About the Carillon Mitral Contour System^®
The Carillon System offers a simple right heart approach to transcatheter mitral valve repair (TMVr) designed to reshape the anatomy and function of the mitral apparatus from the coronary sinus. Distal and proximal anchors, connected by a shaping ribbon, utilize the heart’s venous anatomy to cinch the mitral apparatus, without compromising the valve or future treatment options.^4,5  The Carillon System is designed to treat the primary cause of functional mitral regurgitation (FMR) in patients with MR grades 2+, 3+ and 4+ and is the first and only device to demonstrate a reduction in regurgitant volume and favorable left ventricular remodeling in a randomized sham-controlled clinical trial of percutaneous valve therapy. ^6,7,8,9

The Carillon System is CE-marked (0344) and has been implanted in over 1100 patients in the U.S., Europe, Australia, Turkey, and the Middle East. The Carillon System is currently being studied in the CARILLON pivotal trial and limited to investigational use in the United States.

About Cardiac Dimensions
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatments to address heart failure and related cardiovascular conditions. Privately held, the company’s lead investors include Aperture Venture Partners, Arboretum Ventures, HostPlus, Life Sciences Partners, Lumira Ventures and M.H. Carnegie & Co. Cardiac Dimensions is headquartered in Kirkland, Washington and has operations in the United States, Australia, and Germany.

MEDIA CONTACT:
Rick Wypych
rwypych@cardiacdimensions.com 
(425) 605-5910

1. Lipiecki J, Kaye DM, Witte KK, et al. Long-Term Survival Following Transcatheter Mitral Valve Repair: Pooled Analysis of Prospective Trials with the Carillon Device. Cardiovascular Revascularization Medicine. Advance online publication. doi:10.1016/j.carrev.2020.02.012.
2. Ponikowski P, Anker SD, AlHabib KF et al. Heart failure: preventing disease and death worldwide. ESC Heart Failure. 2014;1:4–25.
3. Heidenreich PA, Albert NM, Allen LA, et al. Forecasting the Impact of Heart Failure in the United States. Circ Heart Fail. 2013;6(3):606-19.
4. Hoppe UC, Brandt MC, Degen H, et al. Percutaneous mitral annuloplasty device leaves free access to cardiac veins for resynchronization therapy. Catheter Cardiovasc Interv. 2009;74(3):506-11.
5. Latib, A. “Coronary Sinus Annuloplasty.” New York, Montefiore Medical Center.
6. Lipiecki J, Siminiak T, Sievert H, et al. Coronary sinus-based percutaneous annuloplasty as a treatment for functional mitral regurgitation: the TITAN II trial. BMJ Open Heart. 2016; 3
7. Siminiak T, et. al. Treatment of functional mitral regurgitation by percutaneous annuloplasty: Results of the TITAN Trial. Eur J Heart Fail. 2012;14:931-38.
8. Sievert, H. 2018. REDUCE-FMR: A Sham Controlled Randomized Trial of Transcatheter Indirect Mitral Annuloplasty in Heart Failure Patients with Functional Mitral Regurgitation. Presented at TCT 2018, San Diego, CA.
9. Witte K, et al, A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation: The REDUCE FMR Trial. J Am Coll Cardiol, HF I, DOI: 10.1016/j,jchf.2019.06.011

Cardiac Dimensions, Carillon and Carillon Mitral Contour System are registered U.S. trademarks of Cardiac Dimensions Pty Ltd.

South San Francisco, CA – Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company, today announced the appointment of Rob Janosky to the newly created position of Chief Commercial Officer. As Satsuma’s Chief Commercial Officer, Mr. Janosky will be responsible for all commercial activities, as well as leading business development and corporate partnering.

“Rob’s skills and substantial experience further increase the depth of our seasoned leadership team. His experience will be valuable as we prepare for the successful commercialization of STS101 and continue to grow our company.”

– John Kollins, Satsuma’s President and CEO

Mr. Janosky brings to Satsuma a wealth of commercial experience within the biopharmaceutical industry spanning more than twenty-five years, including business development, marketing, sales, brand development, new product planning, and product launch leadership roles in orphan, specialty, and primary care markets. During the past fifteen years, Mr. Janosky’s career has focused on successfully creating partnerships, building commercialization capabilities, and launching products within emerging companies, including DURECT, Vivus, Inc. and Jazz Pharmaceuticals plc, where he was responsible for re-launching Xyrem®, the company’s blockbuster CNS specialty product.

“I am delighted to join Satsuma. I look forward to working with its dedicated management team to help bring its innovative therapeutic product, STS101, to patients with migraine and make the well-established therapeutic benefits of dihydroergotamine (or DHE) broadly accessible to patients.”

– Rob Janosky

Related Article: Satsuma Pharmaceuticals Publishes Phase 1 Trial Results

About Satsuma Pharmaceuticals and STS101
Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product for the acute treatment of migraine, STS101. STS101 is an investigational drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate (DHE), which can be quickly and easily self-administered with a proprietary pre-filled, single-use, nasal delivery device. In developing STS101, Satsuma has applied proprietary nasal drug delivery, dry-powder formulation, and engineered drug particle technologies to create a compact, simple-to-use, non-injectable DHE product that can be rapidly self-administered in a matter of seconds. The Company believes STS101 would, if approved, be an attractive migraine treatment option for many patients and may enable a larger number of people with migraine to realize the long-recognized therapeutic benefits of DHE therapy. STS101 has undergone extensive pre-clinical development, recently completed a Phase 1 clinical trial, and is currently in Phase 3 development.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements concerning the business, operations and financial performance and condition of Satsuma Pharmaceuticals, Inc. (the “Company”), as well as the Company’s plans, objectives and expectations for its business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about the Company’s expectations regarding the potential safety and efficacy of STS101. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2019, filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of STS101. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

This press release discusses STS101, a product candidate that is in clinical development and has not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of STS101 for the therapeutic use for which STS101 is being studied.

INVESTOR AND CORPORATE CONTACTS:
Corey Davis, Ph.D. LifeSci Advisors, LLC
cdavis@lifesciadvisors.com

Tom O’Neil, Chief Financial Officer
Satsuma Pharmaceuticals, Inc.
tom@satsumarx.com

VICTORIA, British Columbia–(BUSINESS WIRE)– Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX: AUP) (“Aurinia” or the “Company”) today issued its financial results for the fourth quarter and year ended December 31, 2019. Amounts, unless specified otherwise, are expressed in U.S. dollars

“2019 was a truly transformational year for Aurinia, highlighted by the positive results achieved with voclosporin in the Phase 3 AURORA clinical trial for the treatment of LN. As the team works diligently to prepare and file a New Drug Application to the U.S. FDA next quarter, we continue to build out an incredibly talented and experienced commercial team that will be led by Max Colao, Aurinia’s newly appointed Chief Commercial Officer.”

– Peter Greenleaf, President and Chief Executive Officer of Aurinia

Related Article: Aurinia Appoints New Commercial Officer & Expands U.S. Leadership

Recent Operational Highlights

Pre-NDA Meeting with the U.S. Food & Drug Administration (“FDA”)

Aurinia held a positive and successful Pre-NDA meeting with the FDA Division of Pulmonary, Allergy and Rheumatology Products on February 25, 2020. The Company presented information about the safety and efficacy data to be included in the filing, reviewed the format and content of the planned application, and gained agreement on the rolling review plans for filing modules of the NDA. No obstacles were raised by the FDA that would prevent submission of the complete NDA by the end of the second quarter as planned.

Appointment of Max Colao as Chief Commercial Officer and build-out of the commercial team

On February 25, 2020, Aurinia announced the appointment of Max Colao to the newly created position of Chief Commercial Officer. In addition, Aurinia has recruited an experienced team of leaders across key commercial functions including sales, marketing, market access, and commercial operations.

“Beyond the impact voclosporin could bring to those living with LN, we continue to evaluate voclosporin in additional indications, including the rare kidney disease, FSGS, as well as for the potential management of dry eye syndrome. During the second half of 2020, we anticipate reporting new data from both of these development programs, consisting of interim data from the exploratory Phase 2 FSGS study and results from the Phase 2/3 AUDREY DES trial evaluating 3 concentrations of VOS compared to vehicle alone.”

– Neil Solomons, Chief Medical Officer of Aurinia

AURORA Phase 3 LN Trial

On December 4, 2019, Aurinia announced positive efficacy and safety results from its pivotal AURORA Phase 3 trial of voclosporin, in combination with mycophenolate (“MMF”) and low-dose corticosteroids, in the treatment of LN. The global study in which 357 patients with active LN were enrolled, met its primary endpoint of Renal Response rates of 40.8% for voclosporin vs. 22.5% for the control (OR 2.65; p < 0.001). Additionally, all pre-specified hierarchical secondary endpoints achieved statistical significance in favor of voclosporin, which included Renal Response at 24 weeks, Partial Renal Response at 24 and 52 weeks, time to achieve urinary protein-to-creatinine ratio (“UPCR”) ≤ 0.5, and time to 50% reduction in UPCR. The robustness of the data was also supported by all pre-specified subgroup analyses (age, sex, race, biopsy class, region, and prior MMF use) favoring voclosporin.

Voclosporin was well tolerated with no unexpected safety signals. Serious adverse events (“SAEs”) were reported in 20.8% of voclosporin patients vs. 21.3% in the control arm. Infection was the most commonly reported SAE with 10.1% of voclosporin patients versus 11.2% of patients in the control arm. Overall mortality in the trial was low, with six deaths observed; one in the voclosporin arm and five in the control group. Additionally, the voclosporin arm showed no significant decrease at week 52 in estimated glomerular filtration rate (“eGFR”) or increase in blood pressure, lipids or glucose, which are common adverse events associated with legacy calcineurin inhibitors (“CNIs”).

The AURORA Phase 3 clinical trial was initiated in May of 2017 and completed enrollment in September 2018.

AURORA 2 Extension Trial

Eligible patients completing the AURORA trial had the option to roll over into a 104-week blinded extension study (the “AURORA 2 extension study”). A total of 216 patients enrolled in the AURORA 2 extension study. The data from the AURORA 2 extension study will allow the Company to assess the long-term benefit/risk of voclosporin in LN patients, however, this study is not a requirement for potential regulatory approval for voclosporin. Data from the AURORA 2 extension study assessing long-term outcomes in LN patients should be valuable in a post-marketing setting and for future interactions with regulatory authorities.

Voclosporin Drug-Drug Interaction (“DDI”) Study

On November 7, 2019, Aurinia announced the completion of an FDA-requested clinical DDI study in patients with lupus that investigated the potential effect of voclosporin on blood levels of mycophenolate acid (“MPA”), the active metabolite of MMF. MMF, also known as CellCept®, is considered by treating physicians to be part of the current standard of care for lupus nephritis (“LN”) in the United States.

This FDA-requested clinical DDI study aimed to measure, and potentially quantify, the impact voclosporin may have on MPA blood levels when given concomitantly with MMF in patients with lupus. The study results indicate that the coadministration of voclosporin with MMF had no clinically significant impact on MPA blood concentrations. In past studies, it was reported that the legacy calcineurin inhibitors (“CNIs”) inhibit the multidrug-resistance-associated protein 2 (MRP-2) transporter in the biliary tract thereby preventing the excretion of mycophenolic acid glucuronide (MPAG) into the bile leading to the enterohepatic recirculation of MPA1. This adverse impact of cyclosporine on MPA pharmacokinetics has resulted in a 30 – 50% reduction in MPA exposure when used in combination. 1

Voclosporin ‘036 Method-of-Use Patent for Proteinuric Kidney Diseases

On May 14, 2019, Aurinia was granted U.S. Patent 10,286,036 entitled ‘PROTOCOL FOR TREATMENT OF LUPUS NEPHRITIS”) with a term potentially extending to December 2037, for claims directed at our novel voclosporin dosing protocol for LN. The allowed claims broadly cover the novel voclosporin individualized flat-dosed pharmacodynamic treatment protocol adhered to and required in both the previously reported Phase 2 AURA-LV study and our Phase 3 confirmatory AURORA trial. Notably, the allowed claims cover a method of modifying the dose of voclosporin in patients with LN based on patient-specific pharmacodynamic parameters.

If the FDA approves the use of voclosporin for LN and the label for such use follows the dosing protocol under the Notice of Allowance, the issuance of this patent will expand the scope of intellectual property protection for voclosporin until December 2037, supplementing an already robust manufacturing, formulation, synthesis, and composition of matter patents.

AUDREY™ Phase 2/3 Trial for Dry Eye Syndrome (“DES”)

In October 2019, Aurinia announced the initiation of patient dosing in the Phase 2/3 AUDREY™ clinical trial evaluating voclosporin ophthalmic solution (“VOS”) for the potential treatment of DES. The AUDREY trial is a randomized, double-masked, vehicle-controlled, dose-ranging study evaluating the efficacy and safety of VOS in subjects with DES. A total of approximately 480 subjects are expected to be enrolled. The study will consist of four arms with a 1:1:1:1 randomization schedule, in which patients will receive either 0.2% VOS, 0.1% VOS, 0.05% VOS or vehicle, dosed twice daily for 12 weeks. The primary outcome measure for the trial is the proportion of subjects with a 10mm improvement in Schirmer Tear Test (“STT”) at four weeks. Secondary outcome measures will include STT at other time points, Fluorescein Corneal Staining (“FCS”) at multiple time points, change in eye dryness, burning/stinging, itching, photophobia, eye pain and foreign body sensation at multiple time points, and additional safety endpoints. Top-line results from the AUDREY clinical study are anticipated during the second half of 2020.

In January of 2019, Aurinia reported Phase 2 results demonstrating that VOS (voclosporin 0.2%) administered twice daily was superior to cyclosporin A 0.05% (Restasis®) administered twice daily across all objective endpoints including FCS and STT. This statistical superiority was observed after two weeks of dosing. The exploratory study also showed no statistically significant nor clinically meaningful difference in drop discomfort, as measured by drop discomfort scores at one and five minutes after the first application, between VOS 0.2% and cyclosporin A 0.05%.

Financial Liquidity at December 31, 2019

At December 31, 2019, Aurinia had cash and cash equivalents of $306 million at December 31, 2019, compared to $125.9 million of cash and short-term investments at December 31, 2018. Net cash used in operating activities was $63.5 million for the year ended December 31, 2019, compared to $51.6 million for the year ended December 31, 2018.

The Company received net proceeds of $179.9 million pursuant to its December 12, 2019, public offering.

The Company believes that it has sufficient financial resources to fund its current plans, which include conducting its ongoing research and development (“R&D”) programs, completing the NDA submission to the FDA, conducting pre-commercial and launch activities, manufacturing and packaging commercial drug supply required for launch, and fund its supporting corporate and working capital needs through 2021.

Financial Results for the Year Ended December 31, 2019

For the year ended December 31, 2019, Aurinia recorded a consolidated net loss of $123.8 million or $1.33 per common share, which included a non-cash increase of $41.1 million related to the estimated fair value adjustment of derivative warrant liabilities during 2019 and at December 31, 2019.

The net loss before the change in estimated fair value of derivative warrant liabilities and income taxes was $82.6 million or $0.89 per common share for the year ended December 31, 2019. This compared to a consolidated net loss of $64.1 million or $0.76 per common share in 2018, which included a non-cash increase of $10 million in the estimated fair value of derivative warrant liabilities for the year ended December 31, 2018. The net loss before the change in estimated fair value of derivative warrant liabilities income taxes was $54.1 million or $0.63 per common share for the year ended December 31, 2018.

The change in the revaluation of the derivative warrant liabilities is primarily driven by the change in Aurinia’s share price. The Company’s share price was significantly higher in December 2019 when 1.83 million derivative warrants were exercised and at December 31, 2019, when the closing share price was $20.26, compared to the Company’s share price of $6.82 at December 31, 2018. This increase in share price resulted in a large increase in the estimated fair value of the derivative warrants for 2019. The derivative warrant liabilities will ultimately be eliminated on the exercise of the warrants and will not result in any cash outlay by Aurinia. In the fiscal year 2019, 3.6 million derivative warrants were exercised with 1.7 million derivative warrants outstanding as of December 31, 2019.

Aurinia incurred R&D expenses of $52.9 million for the year ended December 31, 2019, as compared to $41.4 million for the year ended December 31, 2018. The increase in R&D expenses in 2019 included $6.6 million to manufacture voclosporin for potential future commercial use and higher costs related to the AURORA 2 extension trial, the DDI study and ongoing dry eye studies, partially offset by a decrease in AURORA trial costs.

Aurinia incurred corporate, administration and business development expenses of $22.2 million for the year ended December 31, 2019, as compared with $13.7 million for the same period in fiscal 2018. The increase in these expenses reflected higher corporate activity levels including pre-commercial and launch readiness activities, higher professional and recruiting fees, insurance costs and personnel compensation costs.

Non-cash stock compensation expense was $7.4 million for the year ended December 31, 2019, compared to $6.9 million for the year ended December 31, 2018, and was included in both R&D and corporate, general and business development expenses.

Financial Results for the Fourth Quarter Ended December 31, 2019

Aurinia reported a consolidated net loss of $76.5 million or $0.78 per common share for the fourth quarter ended December 31, 2019, as compared to a consolidated net loss of $14.6 million, or $0.17 per common share, for the fourth quarter ended December 31, 2018.

The increase in the loss for the fourth quarter ended December 31, 2019, primarily reflected an increase of $48.0 million in the estimated fair value of derivative warrant liabilities compared to an increase of $593,000 in the estimated fair value of derivative warrant liabilities for the fourth quarter ended December 31, 2018. This change in the estimated fair value reflected the significant increase in the Company’s share price in December 2019 when 1.83 million derivative warrants were exercised and at December 31, 2019, when the closing share price was $20.26, compared to the Company’s share price of $6.82 at December 31, 2018.

The net loss before the non-cash change in estimated fair value of derivative warrant liabilities and income taxes was $28.9 million or $0.29 per common share for the fourth quarter ended December 31, 2019, compared to $13.9 million or $0.17 per common share for the same period in 2018.

R&D expenses increased to $13.3 million in the fourth quarter of 2019, compared to $10.8 million in the fourth quarter of 2018. The increase in these expenses reflected costs related to NDA submission preparation costs, higher personnel costs, higher costs incurred for the AURORA 2 extension trial, and the AUDREY DES phase 2/3 study partially offset by lower AURORA trial costs.

Corporate, administration and business development expenses increased to $7.2 million for the fourth quarter of 2019, compared to $3.5 million for the fourth quarter of 2018, reflecting higher pre-commercial and launch readiness activities, higher consulting and professional fees, insurance costs, and personnel compensation costs as the corporate organization build continued to ramp up during the fourth quarter of 2019.

The audited financial statements and the Management’s Discussion and Analysis for the year ended December 31, 2019, are accessible on Aurinia’s website at www.auriniapharma.com, on SEDAR at www.sedar.com or on EDGAR at www.sec.gov/edgar.

Aurinia will host a conference call and webcast to discuss the fourth quarter and year ended December 31, 2019, financial results today, Thursday, March 5, 2020, at 4:30 p.m. ET. This event can be accessed on the investor section of the Aurinia website at www.auriniapharma.com.

About Voclosporin

Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical data in over 2,600 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney. It has been shown to have a more predictable pharmacokinetic and pharmacodynamic relationship (potentially requires no therapeutic drug monitoring), an increase in potency (versus cyclosporine A), and an improved metabolic profile compared to legacy CNIs. Aurinia anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension. Further, a U.S. patent has also been issued covering the voclosporin dosing protocol with a term extending to December 2037, if the FDA incorporates the dosing protocol used in both the AURA and AURORA trials into the product label.

ABOUT AURINIA

Aurinia Pharmaceuticals is a late clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently developing an investigational drug, for the treatment of lupus nephritis, focal segmental glomerulosclerosis, and dry eye syndrome. The Company’s head office is in Victoria, British Columbia and focuses its development efforts globally.

Forward-Looking Statements

Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to completing NDA priority review submissions in a successful and timely manner including the anticipated NDA filing during the first half of 2020; the potential for commercial launch of voclosporin for use in LN in 2021; voclosporin being potentially a best-in-class CNI with robust intellectual property exclusivity; Aurinia’s anticipation that upon regulatory approval, patent protection for voclosporin composition of matter will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension; a US patent has also been issued covering the voclosporin dosing protocol with a term extending to December 2037, if the FDA incorporates the dosing protocol used in both the AURA and the AURORA studies into the product label; that the results of the AURORA clinical study are pivotal and potentially groundbreaking for LN patients; that voclosporin may be positioned to become the standard of care for people living with LN; that Aurinia will present AURORA study results at a future scientific conference during 2020. It is possible that such results or conclusions may change based on further analyses of these data. Words such as “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may” and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the market value for the LN, DES and FSGS programs; that another company will not create a substantial competitive product for Aurinia’s LN, DES and FSGS business without violating Aurinia’s intellectual property rights; the burn rate of Aurinia’s cash for operations; the costs and expenses associated with Aurinia’s clinical trials; the planned studies achieving positive results; Aurinia being able to extend and protect its patents on terms acceptable to Aurinia; and the size of the LN, DES or FSGS markets; Aurinia will be able to obtain all necessary regulatory approvals for commercialization of voclosporin for use in LN on terms that are acceptable to it and that are commercially viable; and that Aurinia’s intellectual property rights are valid and do not infringe the intellectual property rights of other parties. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties, and other factors include, among others, the following: difficulties, delays, or failures we may experience in the conduct of our clinical trial; difficulties we may experience in completing the development and commercialization of voclosporin; the market for the LN, DES and FSGS business may not be as estimated; Aurinia may have to pay unanticipated expenses; estimated costs for clinical trials may be underestimated, resulting in Aurinia having to make additional expenditures to achieve its current goals; Aurinia not being able to extend or fully protect its patent portfolio for voclosporin; competitors may arise with similar products; Aurinia may not be able to obtain necessary regulatory approvals for commercialization of voclosporin in a timely fashion, or at all; and Aurinia may not be able to obtain sufficient supply to meet commercial demand for voclosporin in a timely fashion. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business can be found in Aurinia’s most recent Annual Information Form available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar.

We seek safe harbour.

Aurinia Pharmaceuticals Inc.

TORONTO and CHICAGO and MONTREAL (GLOBE NEWSWIRE) — Medexus Pharmaceuticals Inc. (“Medexus” or the “Company”) (TSXV: MDP, OTCQB: PDDPF) today announced that the Company, through its US-based subsidiary, acquired Aptevo BioTherapeutics LLC, a Delaware limited liability company owning the worldwide rights to the commercial hematology asset, IXINITY^®, from Aptevo Therapeutics, Inc. (NASDAQ: APVO) (the “Vendor”), a biotechnology company focused on developing oncology, autoimmune and hematology therapeutics (the “Acquisition”). IXINITY^® is an intravenous recombinant factor IX therapeutic for use in patients 12 years of age or older with Hemophilia B – a hereditary bleeding disorder characterized by a deficiency of clotting factor IX in the blood, which is necessary to control bleeding.

Related Article: Medexus Reports Increased Revenues of C$16.2M for Q3 2020

Key Highlights

• Medexus Pharma, Inc. (“Medexus US”) acquired Aptevo BioTherapeutics LLC, which owns the worldwide rights to the commercial hematology asset, IXINITY^®, for up-front cash consideration of approximately US$30 million (inclusive of approximately US$9.5 million of working capital acquired)
• For the first nine months of 2019, IXINITY^® generated revenues of US$23.4 million, representing year-over-year growth of approximately 40%
• The U.S. hemophilia B market is approximately US$734 million and growing, with a highly concentrated prescriber base
• Acquisition strengthens Medexus’ specialty product portfolio and represents a strategic fit with other products in the Medexus business development pipeline
• Allows Medexus to leverage its U.S. operations for maximum impact through an expanded U.S. product portfolio
• Expected to be immediately accretive to Adjusted EBITDA¹ before acquisition costs
• Acquisition financed entirely with existing cash and a new US$20 million term loan credit facility with MidCap Financial, an affiliate of Apollo Global Management

“We are very pleased to announce this transformative acquisition. IXINITY^® is an FDA approved product with strong brand equity and a track record of safety, efficacy and growing sales. This acquisition is perfectly aligned with our corporate strategy to license or acquire accretive specialty products that address essential patient needs while allowing us to leverage our established North American sales force and infrastructure. Moreover, our ability to execute this transaction through a combination of cash on hand and a new credit facility further illustrates the strength of our balance sheet and projected cash flows.   We appreciate the support provided by MidCap Financial and believe their participation in this financing was fully aligned with our ultimate goal of delivering strong profitability for our shareholders.”

– Ken d’Entremont, Chief Executive Officer, Medexus

The terms and conditions of the Acquisition are governed by a purchase agreement entered into between Medexus US and the Vendor (the “Purchase Agreement”).  In accordance with and pursuant to the Purchase Agreement, Medexus US delivered up-front cash consideration of approximately US$30 million to the Vendor at closing (inclusive of approximately US$9.5 million of working capital acquired) and is required to make certain deferred payments on net sales of IXINITY^® in an amount equal to (i) 2% of net sales until the earlier of (x) the completion of the ongoing U.S. pediatric trial in respect of IXINITY, and (y) June 30, 2022, and (ii) 5% of net sales thereafter until March 1, 2035. In addition, the Purchase Agreement requires Medexus US to make certain milestone payments upon IXINITY^®’s receipt of Canadian and European regulatory approval in each of Germany, France, Spain, Italy, and the United Kingdom and upon IXINITY^® achieving worldwide annual net sales of US$120 million, if achieved by March 1, 2035.  

New Credit Facility

Concurrently with the closing of the Acquisition, the Company entered into a definitive credit agreement with a syndicate of lenders (the “Lenders”) agented by MidCap Financial, in respect to a US$20 million secured term loan (the “Term Loan”), having a term of 40 months.

The Company and its active subsidiaries (including Aptevo BioTherapeutics LLC) are the borrowers under the Term Loan. Each borrower is jointly and severally liable for all obligations of all borrowers under the Term Loan.  The Term Loan is secured by a first-priority security interest in all existing and after-acquired assets of the Company and each other borrower. Borrowings under the Term Loan bear interest at an annual rate of one-month LIBOR plus 6.5%, subject to a LIBOR floor of 1.50%.  Interest on the outstanding balance of the Term Loan is payable monthly in arrears.

The Term Loan was used by the Company to fund a portion of the purchase price of the Acquisition and to pay transaction fees in connection therewith.

In connection with the Term Loan, subject to receipt of final acceptance by the TSX Venture Exchange (the “TSXV”), the Company will also grant to the Lenders warrants to purchase that number of common shares in the capital of the Company (“Common Shares”) equal to 2.00% of the amount funded under the Term Loan, converted to the CAD equivalent based on the Bank of Canada noon exchange rate divided by the exercise price (the “Exercise Price”). The Exercise Price will be equal to today’s closing price of the Common Shares on the TSXV. The Lender warrants will expire concurrently with maturity of the Term Loan.

About Medexus Pharmaceuticals Inc.

Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform. The Company’s vision is to provide the best healthcare products to healthcare professionals and patients, through our core values of Quality, Innovation, Customer Service and Teamwork. Medexus is focused on the therapeutic areas of auto-immune disease and pediatrics. The leading products are Rasuvo™ and Metoject^®, a unique formulation of methotrexate (auto-pen and pre-filled syringe) designed to treat rheumatoid arthritis and other auto-immune diseases; and Rupall™, an innovative allergy medication with a unique mode of action.

For further information, please contact:
Ken d’Entremont, Chief Executive Officer
Medexus Pharmaceuticals Inc.
Tel: 905-676-0003
E-mail: ken.dentremont@medexus.com  

Roland Boivin, Chief Financial Officer
Medexus Pharmaceuticals Inc.
Tel: 514-762-2626 ext. 202
E-mail: roland.boivin@medexus.com  

Investor Relations (U.S.):
Crescendo Communications, LLC
Tel: +1-212-671-1020
E-mail: mdp@crescendo-ir.com

Investor Relations (Canada):
Frank Candido
Direct Financial Strategies and Communication Inc.
Tel: 514-969-5530
E-mail: frank.candido@medexus.com

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accept responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements

Certain statements made in this press release contain forward-looking information within the meaning of applicable securities laws (“forward-looking statements”). The words “anticipates,” “believes,” “expects,” will,” and similar expressions are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Specific forward-looking statements contained in this press release include, but are not limited to, statements with respect to the expected synergies of the Acquisition and statements regarding expected impact of the Acquisition on the Company’s Adjusted EBITDA.  These statements are based on factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, including assumptions based on historical trends, current conditions and expected future developments. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. The Company cautions that although it is believed that the assumptions are reasonable in the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. Material risk factors include those set out in the Company’s MD&A under the heading “Risk Factors and Risk Management” and elsewhere in the Company’s other disclosure documents filed with the applicable Canadian securities regulatory authorities from time to time. Given these risks, undue reliance should not be placed on these forward-looking statements, which apply only as of the date hereof. Other than as specifically required by law, the Company undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.

_______________________

¹ The Company uses both International Financial Reporting Standards (“IFRS”) and certain non-IFRS measures to assess performance. Non-IFRS measures do not have any standardized meaning prescribed by IFRS and are unlikely to be comparable to any similar measures presented by other companies. Non-IFRS measures, as presented herein include adjusted earnings before interest, tax, depreciation, and amortization (“Adjusted EBITDA”). Please refer to the section entitled “Cautionary Note Regarding Non-IFRS Financial Measures” in the Company’s most recent management discussion and analysis (“MD&A”) filed under the SEDAR profile for the definition and historical reconciliation to the most comparable IFRS measure.  

KIRKLAND, Wash. — Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure (HF), today announced the findings of a post hoc analysis of pooled prospectively collected data from three studies of the Carillon Mitral Contour System® with a focus on 5-year survival rate and the determinants of long-term survival. The data was presented in a late-breaking trial session at the Cardiovascular Research Technologies meeting (CRT 2020) in National Harbor, MD.

Related Article: Cardiac Dimensions Carillon® System Improves FMR & Slows Worsening of Heart Failure

Dr. Janusz Lipiecki, a cardiologist in the Center for Interventional Cardiology of Pôle Santé République in Clermont-Ferrand, France, presented the data on behalf of all TITAN, TITAN II and REDUCE FMR clinical study investigators and commented, “The recent publication of the REDUCE FMR data demonstrated a significant reduction in regurgitant volume and favorable left ventricular remodeling1, confirming the results from prior studies, yet questions remained about the long-term impact of the Carillon device.” He continued, “As an investigator, I am proud to present the results of this analysis demonstrated that patients with heart failure and moderate-to-severe FMR who underwent transcatheter mitral valve repair with the Carillon device, had a favorable 5-year survival rate which was associated with changes in clinical and hemodynamic parameters during the first year of follow-up.”

A total of 74 patients from the TITAN, TITAN II and REDUCE FMR clinical studies who had symptomatic congestive heart failure despite guideline-directed medical therapy, grade 2+ to 4+ FMR, left ventricular enlargement, and reduced ejection fraction was assessed as part of the analysis. For all patients, echocardiographic parameters were available through the 12-month visit and vital status was available through 5 years. The association of patient characteristics and changes in echocardiographic parameters at 6 and 12 months with long-term survival was analyzed using Cox proportional hazards regression. Key findings from the analysis include:

• Over 1 year of follow-up, the New York Heart Association (NYHA) class decreased in 64% of patients, distance on the 6-minute walk test increased, and echocardiographic measures indicated significant decreases in MR grade and favorable left ventricular remodeling.2
• The Kaplan-Meier survival rate was 83.6% at 1 year, 73.1% at 2 years, 67.9% at 3 years and 56.2% at 4 and 5 years of follow-up. 2
• Primary determinants of long-term survival were a decrease in NYHA class, an increase in 6-minute walk test distance, and a decrease in regurgitant volume during the first year of follow-up. 2
• Three-year mortality rate compared to published outcomes of COAPT and guideline-directed medical therapy (GDMT), using matched patient populations, was 33.7% for Carillon, 42.8% for MitraClip in COAPT and 55.5% for GDMT – Figure 1. 2

“Mitral regurgitation in the context of heart failure is strongly associated with increased morbidity and mortality. We continue to see a growing body of evidence demonstrating the consistent effectiveness and safety of the Carillon System. The long-term data presented today suggests the primary clinical benefit of percutaneous mitral valve repair may be enhanced after the ventricle has had some time to remodel. We have consistently seen improvements in left ventricular dimensions, which typically is associated with mortality benefits. One would, therefore, anticipate long-term benefits from a decrease in LV volume overload, and these data are supportive.”

– Steven L. Goldberg, MD, Tyler Heart Institute, Community Hospital of the Monterey Peninsula and Chief Clinical Officer at Cardiac Dimensions

Gregory D. Casciaro, President and CEO of Cardiac Dimensions, commented, “This analysis of three important FMR clinical studies is the first to look at five-year follow-up and brings new insights into the long-term role of percutaneous treatment.” He continued, “We are pleased the results confirm a favorable long-term mortality benefit of the Carillon System, supporting the significant improvement in MR and favorable remodeling of the left ventricle, as shown in REDUCE FMR. This reaffirms the effectiveness and safety of the Carillon System and underlines the value of early treatment to slow the deterioration of heart failure.”

An estimated 26 million people, worldwide, suffer from heart failure3 and of those, approximately 70 percent have FMR. Heart failure is a significant clinical and economic burden with direct and indirect costs expected to grow to $70 billion by 2030.4

About the Carillon Mitral Contour System®
The Carillon System offers a simple right heart approach to transcatheter mitral valve repair (TMVr) designed to reshape the anatomy and function of the mitral apparatus from the coronary sinus. Distal and proximal anchors, connected by a shaping ribbon, utilize the heart’s venous anatomy to cinch the mitral apparatus, without compromising the valve or future treatment options.5,6  The Carillon System is designed to treat the primary cause of functional mitral regurgitation (FMR) in patients with MR grades 2+, 3+ and 4+ and is the first and only device to demonstrate a reduction in regurgitant volume and favorable left ventricular remodeling in a randomized sham-controlled clinical trial of percutaneous valve therapy. 7,8,9

About Cardiac Dimensions
Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatments to address heart failure and related cardiovascular conditions. Privately held, the company’s lead investors include Aperture Venture Partners, Arboretum Ventures, HostPlus, Life Sciences Partners, Lumira Ventures and M.H. Carnegie & Co. Cardiac Dimensions is headquartered in Kirkland, Washington and has operations in the United States, Australia, and Germany.

RESEARCH TRIANGLE PARK, N.C. (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today provided a corporate and financial update for the fourth quarter and full-year ended December 31, 2019.

Related Article: G1 Therapeutics & Quantum Leap Healthcare Collaborate in Breast Cancer Research Study

“We achieved significant clinical and regulatory milestones across our pipeline in 2019. In 2020, our primary focus is the execution of our U.S. and European regulatory filings for trilaciclib for patients with small-cell lung cancer and preparation for its commercial launch in the U.S. We believe trilaciclib has the potential to improve outcomes for patients receiving chemotherapy across a broad range of tumor types. In 2020, we will initiate a Phase 3 trial in colorectal cancer and evaluate trilaciclib in the I-SPY 2 breast cancer trial.”

– Mark Velleca, M.D., Ph.D., Chief Executive Officer, G1 Therapeutics

Fourth Quarter Regulatory, Clinical and Corporate Highlights

• Initiated rolling NDA submission for trilaciclib in small cell lung cancer (SCLC) in 4Q19 and expect to complete the filing in 2Q20. Certain portions of the NDA, including preclinical data, were submitted to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2019. The company plans to complete the filing in the second quarter of 2020.
   
• Trilaciclib included in I-SPY 2 neoadjuvant breast cancer trial based on compelling overall survival (OS) findings in Phase 2 triple-negative breast cancer (TNBC) trial. At the European Society for Medical Oncology (ESMO) 2019 Congress, the company presented preliminary data from its randomized, open-label Phase 2 trial of trilaciclib in TNBC showing that the addition of trilaciclib to chemotherapy resulted in a significant increase in OS compared to chemotherapy alone (press release here). These findings contributed to trilaciclib being selected for inclusion in the ongoing Phase 2 I-SPY 2 TRIAL™. Two new investigational treatment arms of the trial will evaluate trilaciclib in neoadjuvant treatment of locally advanced breast cancer. The study will generate data that will allow the company to evaluate trilaciclib in combination with several broadly-used chemotherapy classes, an anti-PD-1 immunotherapy, and a range of breast cancer subtypes (press release here). 
   
• Findings from Phase 1/2a rintodestrant monotherapy trial in patients with ER+, HER2- breast cancer support initiation of combination trials with CDK4/6 inhibitors. The company announced preliminary safety, tolerability and efficacy data on rintodestrant (formerly G1T48), its oral selective estrogen receptor degrader (SERD), at the 2019 European Society of Medical Oncology Congress in September (press release here). Based on these findings, G1 plans to initiate an additional arm of its ongoing Phase 1/2a trial in the second quarter of 2020 to explore the combination regimen of rintodestrant and the CDK4/6 inhibitor Ibrance^® (palbociclib) as a treatment for ER+, HER2- breast cancer. Palbociclib will be provided by Pfizer Inc. under a non-exclusive clinical supply agreement.
   
• Reported additional data from Phase 1b/2a clinical trial of lerociclib in combination with fulvestrant for the treatment of ER+, HER2- breast cancer. Updated findings presented at the 2019 San Antonio Breast Cancer Symposium showed lerociclib, dosed without a drug holiday, has a differentiated safety and tolerability profile than observed in clinical trials with currently marketed CDK4/6 inhibitors. Preliminary efficacy findings were consistent with other CDK4/6 inhibitors used in combination with fulvestrant. Additional safety and efficacy data are expected in the third quarter of 2020.

Fourth Quarter/Full-Year 2019 Financial Highlights and 2020 Guidance

• Cash Position: Cash and cash equivalents totaled $269.2 million as of December 31, 2019, compared to $369.3 million as of December 31, 2018.
• Operating Expenses: Operating expenses were $36.6 million for the fourth quarter of 2019, compared to $26.1 million for the fourth quarter of 2018. GAAP operating expenses include stock-based compensation expense of $4.5 million for the fourth quarter of 2019, compared to $3.3 million for the fourth quarter of 2018. Operating expenses for the full-year 2019 were $129.0 million, compared to $89.3 million for the prior year. Stock-based compensation expense for the full-year 2019 was $16.4 million, compared to $10.2 million for the prior year.
• Research and Development Expenses: Research and development (R&D) expenses for the fourth quarter of 2019 were $24.5 million, compared to $19.1 million for the fourth quarter of 2018. R&D expenses for the full-year 2019 were $89.0 million, compared to $70.7 million for the prior year. The increase in R&D expenses was primarily due to an increase in clinical program costs, costs for manufacturing pharmaceutical active ingredients, and personnel costs due to additional headcount.
• General and Administrative Expenses: General and administrative (G&A) expenses for the fourth quarter of 2019 were $12.1 million, compared to $7.0 million for the fourth quarter of 2018. G&A expenses for the full-year 2019 were $40.0 million, compared to $18.6 million for the prior year. The increase in G&A expenses was largely due to an increase in compensation due to additional headcount, an increase in pre-commercialization activities, an increase in medical affairs costs, and an increase in professional fees and other administrative costs necessary to support our operations.
• Net Loss: G1 reported a net loss of $35.4 million for the fourth quarter of 2019, compared to $24.1 million for the fourth quarter of 2018. Net loss for the full-year 2019 was $122.4 million, compared to a net loss of $85.3 million for the prior year.
• 2020 Guidance: The company expects to end 2020 with $110-$130 million in cash and cash equivalents, prior to the consideration of potential proceeds from partnerships, collaboration activities, and/or other sources of capital. The company expects year-end 2019 cash and cash equivalents of $269.2 million to be sufficient to fund its operating expenses and capital expenditure requirements into the second half of 2021.

Key Anticipated 2020 Milestones

• Complete NDA submission for trilaciclib in SCLC in 2Q20 and Marketing Authorization Application to the European Medicines Agency in 4Q20.
• Begin enrollment in I-SPY 2 clinical trial of trilaciclib in neoadjuvant breast cancer in 2Q20.
• Initiate additional arm of rintodestrant Phase 1/2a trial to evaluate combination with Ibrance^® (palbociclib) in 2Q20; additional Phase 1/2a monotherapy data expected in 4Q20.
• Initiate Phase 3 clinical trial of trilaciclib in colorectal cancer in 4Q20.

Webcast and Conference Call
The management team will host a webcast and conference call at 4:30 p.m. ET today to provide a corporate and financial update for the fourth quarter and full-year 2019 ended December 31, 2019. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 4188787. A live and archived webcast will be available on the Events & Presentations page on the company website. The webcast will be archived on the same page for 90 days following the event.

About G1 Therapeutics
G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development, and delivery of innovative therapies that improve the lives of those affected by cancer. The company is advancing three clinical-stage programs. Trilaciclib is a first-in-class therapy designed to improve outcomes for patients being treated with chemotherapy. Trilaciclib has received Breakthrough Therapy Designation from the FDA; a rolling NDA submission for small cell lung cancer is expected to be completed in the second quarter of 2020. Rintodestrant (formerly G1T48) is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. Lerociclib is a differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, those relating to the therapeutic potential of trilaciclib, rintodestrant and lerociclib, the timing of marketing applications in the U.S. and Europe for trilaciclib in SCLC, the planned initiation of the additional arm of the rintodestrant trial to evaluate combination with Ibrance^® (palbociclib), and lerociclib’s differentiated safety and tolerability profile over other marketed CDK4/6 inhibitors and are based on the company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the company’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, the company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact:
Jeff Macdonald
Senior Director, Investor Relations & Corporate Communications
919-213-9835
jmacdonald@g1therapeutics.com

VICTORIA, British Columbia–(BUSINESS WIRE)– Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today announced the appointment of Max Colao to the newly created position of Chief Commercial Officer. In addition, Aurinia has recruited an experienced team of leaders across key commercial functions including sales, marketing, market access, and commercial operations.

Related Article: Aurinia Demonstrates Voclosporin’s Superiority over Standard-of-Care in Lupus Nephritis

“This is a very exciting time at Aurinia, and we are laser-focused on executing on our strategy to prepare for a commercial launch next year. Assembling a world-class commercial leadership team in the months following the positive AURORA Phase 3 data is a testament to this commitment and voclosporin’s potential. We believe the confirmatory AURORA data represented a potential breakthrough for people affected by lupus nephritis. The addition of Max’s invaluable experience, combined with the collective capabilities and expertise of our growing commercial organization, will be central to a successful market entry.”

– Peter Greenleaf, President & Chief Executive Officer, Aurinia

In preparing for potential commercialization in 2021, Aurinia is building a distinguished team with proven experience in launching therapies for nephrology and autoimmune indications. The Company expects to file a new drug application (NDA) for voclosporin as a potential treatment for lupus nephritis (“LN”) in the second quarter of 2020. Joining the commercial organization along with Mr. Colao are:

• Chris Hays, Vice President, Marketing;
• Fran Lynch, Vice President, Sales;
• Cara Felish, Vice President, Commercial Operations; and
• Tim Hermes, Vice President, Market Access.

These hires follow the recently reported positive efficacy and safety results from the Company’s AURORA Phase 3 trial in the treatment of LN. Voclosporin was granted Fast Track designation by the FDA in 2016.

Max Colao brings nearly 30 years of world-class commercial operations experience to his role at Aurinia. Prior to leading U.S. commercial operations at Alexion and launching multiple rare disease therapies, Mr. Colao spent nearly 20 years at Amgen, holding roles of increasing responsibility on various marketing and sales teams, most notably leading U.S. launches, commercialization, and pricing strategy in the areas of rheumatology, dermatology, and autoimmune disorders for Enbrel®, Prolia®, and Nplate®. Most recently, he was Chief Commercial Officer and Head of Business Development at Abeona, where he led the company’s commercialization and business development efforts of autologous cell therapy and AAV9-based gene therapy for rare diseases. Mr. Colao received his B.S. in applied mathematics and economics from the University of California, Los Angeles and his MBA from the University of Southern California.

Chris Hays comes to Auriniafrom AstraZeneca, where he served as Senior Director and U.S. Head of the anemia business. While at AstraZeneca, he built out the U.S. launch plan for new products and therapy areas. Prior to AstraZeneca, Mr. Hays held roles of increasing responsibility at Fresenius Medical Care North America, where he developed programs and systems to enhance the effectiveness of the renal business. Before that, he spent nearly 10 years at Amgen, where he led marketing efforts across multiple therapeutic units, including rheumatology and nephrology. Mr. Hays received his B.S. from the University of Nevada, Las Vegas and his MBA from Arizona State University.

Fran Lynch brings a wide range of sales experience across multiple areas of the business to his role at Aurinia. Most recently, Mr. Lynch was responsible for expanding the sales force at UCB to prepare for the launch of bimekizumab. Prior to UCB, he was responsible for building out commercial teams at Sun Pharmaceuticals, Takeda Pharmaceuticals, and Human Genome Sciences (HGS). At HGS, he was responsible for the build-out of sales and leadership for the launch of BENLYSTA (belimumab), for systemic lupus erythematosus (SLE). From 1998 to 2010, Mr. Lynch held roles of increasing responsibility at Centocor Biotech (now Janssen Biotech, a Johnson & Johnson company). While at Centocor, he led teams in the rheumatology, gastroenterology, and dermatology franchises. He has also led the commercial rollout of multiple products, including ILUMYA^TM (tildrakizumab-asmn) and ENTYVIO (vedolizumab). He received his B.S. in business administration from the University of Delaware.

Cara Felish comes to Aurinia from Mallinckrodt Pharmaceuticals, where she led the transition of all commercial operations support (Analytics, Sales Operations, Training, Marketing Operations) to a new NJ based headquarters. While at Mallinckrodt, she also held a dual role as Chief of Staff responsible for several strategic projects and facilitation of the enterprise operating committee. Ms. Felish previously established a global Sales Operations & Training function for Thermo Fisher Scientific’s Clinical Diagnostics Division. She led Sales & Marketing Operations at MedImmune (now AstraZeneca) and held various Sales, Sales leadership and Project Management roles at UnitedHealthcare Dental. She received her B.S. in communication studies, with a minor in healthcare management, from Virginia Tech.

Tim Hermes, a seasoned biotech executive, has held market access leadership roles since 1998, where he has worked in a variety of therapeutic areas including rare disease, CNS, orthopedics, pain, and respiratory. Most recently, he served as Vice President, Market Access at Ablynx (now Sanofi-Genzyme), where he led the buildout from the North American subsidiary. Mr. Hermes also developed Ablynx’s market access launch plan to introduce a new innovative biologic for acquired thrombotic thrombocytopenic purpura (aTTP) by conducting extensive payer and hospital research. Before that, he served as Vice President, Government Affairs at Depomed, Inc. (now Assertio Therapeutics, Inc.) and Collegium Pharmaceutical, Inc., where he led market access launch plans. Mr. Hermes also implemented marketing strategies at Auxilium Pharmaceuticals, Inc. and Strategic Health Care. Mr. Hermes received his B.S. in petroleum geology from Centenary College.

Related Article: Aurinia Closes $191.7M Public Offering of Common Shares

About Voclosporin
Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical data in over 2,600 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney. It has been shown to have a more predictable pharmacokinetic and pharmacodynamic relationship (potentially requires no therapeutic drug monitoring), an increase in potency (versus cyclosporine A), and an improved metabolic profile compared to legacy CNIs. Aurinia anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension. Further, a U.S. patent has also been issued covering the voclosporin dosing protocol with a term extending to December 2037, if the FDA incorporates the dosing protocol used in both the AURA and AURORA trials into the product label.

ABOUT AURINIA
Aurinia Pharmaceuticals is a late clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently developing an investigational drug, for the treatment of lupus nephritis, focal segmental glomerulosclerosis, and dry eye syndrome. The Company’s head office is in Victoria, British Columbia and focuses its development efforts globally.

Forward-Looking Statements
Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to completing NDA priority review submissions in a successful and timely manner including the anticipated NDA filing during the second quarter of 2020; the potential for commercial launch of voclosporin for use in LN in the first half of 2021; voclosporin being potentially a best-in-class CNI with robust intellectual property exclusivity; Aurinia’s anticipation that upon regulatory approval, patent protection for voclosporin composition of matter will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension; a US patent has also been issued covering the voclosporin dosing protocol with a term extending to December 2037, if the FDA incorporates the dosing protocol used in both the AURA and the AURORA studies into the product label; that Aurinia has hired seasoned, distinguished world-class commercial leadership; ; that voclosporin may be positioned to become the standard of care for people living with LN; that Aurinia will present AURORA study results at a future scientific conference during 2020. It is possible that such results or conclusions may change based on further analyses of these data. Words such as “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may” and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the market value for the LN, DES and FSGS programs; that another company will not create a substantial competitive product for Aurinia’s LN, DES and FSGS business without violating Aurinia’s intellectual property rights; the burn rate of Aurinia’s cash for operations; the costs and expenses associated with Aurinia’s clinical trials; the planned studies achieving positive results; Aurinia being able to extend and protect its patents on terms acceptable to Aurinia; and the size of the LN, DES or FSGS markets; Aurinia will be able to obtain all necessary regulatory approvals for commercialization of voclosporin for use in LN on terms that are acceptable to it and that are commercially viable; and that Aurinia’s intellectual property rights are valid and do not infringe the intellectual property rights of other parties. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties, and other factors include, among others, the following: difficulties, delays, or failures we may experience in the conduct of our clinical trial; difficulties we may experience in completing the development and commercialization of voclosporin; the market for the LN, DES and FSGS business may not be as estimated; Aurinia may have to pay unanticipated expenses; estimated costs for clinical trials may be underestimated, resulting in Aurinia having to make additional expenditures to achieve its current goals; Aurinia not being able to extend or fully protect its patent portfolio for voclosporin; competitors may arise with similar products; Aurinia may not be able to obtain necessary regulatory approvals for commercialization of voclosporin in a timely fashion, or at all; and Aurinia may not be able to obtain sufficient supply to meet commercial demand for voclosporin in a timely fashion. Although we have attempted to identify factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business can be found in Aurinia’s most recent Annual Information Form available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar.

We seek safe harbour.

Investor & Corporate Contact:
Glenn Schulman, PharmD, MPH
Corporate Communications, Aurinia
gschulman@auriniapharma.com

Media Contact
Krystle Gibbs
Ten Bridge Communications
krystle@tenbridgecommunications.com

TORONTO and CHICAGO and MONTREAL (GLOBE NEWSWIRE) — Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP, OTCQB: PDDPF) today provided a business update and announced its financial and operating results for the three- and nine-month periods ended December 31, 2019. All dollar amounts below are in Canadian dollars.

Related Article: Medexus Reports Record Revenues of C$16.4M for Q2 2020

Ken d’Entremont, Chief Executive Officer of Medexus, commented, “We achieved revenue of $16.2 million for the three months ended December 31, 2019, compared to $14.4 million for the same period last year. This improvement reflects both the Acquisitions in October 2018, as well as continued unit demand growth across our key products. Specifically, Metoject^® unit market demand increased 88%¹, Rupall™ unit market demand increased 62%², and Rasuvo^® unit market demand increased 8%³ over the same period last year. Rasuvo^® has received strong payor, prescriber and patient acceptance in the United States, which has positioned us as an emerging leader in the methotrexate auto-injector market. As reported last quarter, while gross revenue continues to grow, net revenue in the United States continues to be impacted by the consolidation of the Company’s payors in the United States market.  As a result of this consolidation, we have experienced an increase in the discounts given to payors in the form of rebates, and a corresponding reduction in the net selling price of Rasuvo^®.  We received a substantial rebate invoice from one of our main payors in the United States, which negatively impacted net revenue and gross margin for Rasuvo^® in respect of the three-month period ended December 31, 2019. The late receipt of the invoice in respect of these additional rebates was due to an error in the payor’s internal reporting system. We continue to investigate the cause of the late receipt of this rebate invoice, and to analyze and monitor the impact of the consolidation of the Company’s payors in the United States and the potential impact such consolidation has on the net selling price of Rasuvo^®. Nevertheless, we anticipate sustained growth of our key products going forward.”   

Mr. d’Entremont continued, “During the third quarter, we launched new Metoject^® Subcutaneous doses of 10mg/0.2ml and 12.5mg/0.25ml. The new strengths are important additions to the Metoject^® product line as it enables flexibility for physicians to accurately prescribe an appropriate strength for their patients. We anticipate the majority of provinces will reimburse these new strengths in the near-term, in turn, driving new prescriptions and unit growth. As previously announced, Gliolan^® was granted priority review by Health Canada, which should significantly accelerate our path to approval. Additionally, we reported that Health Quality Ontario, under the guidance of the Ontario Health Technology Advisory Committee, has recommended public funding of Gliolan^®. We believe Gliolan^® will gain much broader distribution in Canada once it becomes a fully registered product.”

Mr. d’Entremont concluded, “Overall, we have built a highly scalable business model and we are actively evaluating additional products and potential accretive acquisitions that would enable us to leverage our North American sales force going forward. Within our existing product lines, we have experienced strong unit sales growth and expect to generate positive cash flow from operations for the remainder of the 2020 fiscal year and beyond. Meanwhile, we continue to maintain strict financial discipline and a solid balance sheet with $22.6 million of cash and cash equivalents as of December 31, 2019. During the nine-month period ended December 31, 2019,  we have repurchased 779,900 shares, further illustrating our confidence in the outlook for the business and our commitment to driving value for our shareholders.”

Operational highlights*:

• Metoject^® Demand Growth – Metoject^® experienced strong unit market demand growth of 88%¹ in Q3 2020 as compared to Q3 2019. This is a continuing trend that has improved as we add additional strengths. Metoject^® is now publicly reimbursed in Canada, which allows access for a large group of patients who previously could not access the product.
   
• Rupall™ Demand Growth – market demand of Rupall™ units have shown very strong growth, increasing by 62%² in Q3 2020 as compared to Q3 2019. This growth was a result of physicians switching patients from either the generic prescription antihistamines or over-the-counter products. The Company expects Rupall™ to be a leading prescription anti-histamine in a total market that is valued at $144.7 million, including $53.5 million from the prescription market, which is growing at an annual rate of 16%⁴.  During the three- and nine months ended December 31, 2019, Rupall™ was one of the fastest-growing anti-histamines in the Canadian prescription market⁵.   
  
• Rasuvo^® Demand Growth – market demand of Rasuvo^® units increased by 8%³ in Q3 2020 as compared to Q3 2019. This growth reflects a strong payer, prescriber and patient acceptance for Rasuvo^® in the United States. Management expects this growth to continue as prescribers adopt the most effective and convenient form of methotrexate for their patients. Management believes the Company is positioned as an emerging leader in the methotrexate auto-injector market.  

Operating and Financial Results Summary*

For the three months ended December 31, 2019, total revenues were $16.2 million, compared to revenue of $14.4 million for the three months ended December 31, 2018.  The increase was mainly due to the Acquisitions; however, the increase also reflects the unit demand growth of the Company’s key products in the market.  While gross revenue continues to grow, net revenue in the United States continues to be impacted by the consolidation of the Company’s payors in the United States market.  As a result of this consolidation, the Company has experienced an increase in the discounts given to payors in the form of rebates and a corresponding reduction in the net selling price of Rasuvo^®.  The Company received a substantial rebate invoice from one of its main payors in the United States, which negatively impacted net revenue and gross margin for Rasuvo^® in respect of the three-month period ended December 31, 2019.  The invoice also included unexpected rebates covering a period of several months prior to the three-month period ended December 31, 2019, which resulted in a further reduction in net revenue for the three-month period ended December 31, 2019.  The late receipt of the invoice in respect of these additional rebates was due to an error in the payor’s internal reporting system. Occasionally, the Company experiences extensive time delays between the recording of the accrual in respect of such rebates and the ultimate settlement of US Medicare Part D, commercial and performance-based contracts.  The Company continues to investigate the cause of the late receipt of this rebate invoice, and to analyze and monitor the impact of the consolidation of the Company’s payors in the United States and the potential impact such consolidation has on the net selling price of Rasuvo^®. 

Gross profit for the three months ended December 31, 2019, was $9.0 million, or 55.4% of sales, compared to $9.0 million, or 62.1% of sales, for the same period last year. The lower gross margin for the third quarter ended December 31, 2019, compared to the same period last year, was mainly due to the consolidation of the Company’s payors in the United States market as well as the aforementioned unexpected rebate invoice the Company received from one of its main payors in the United States, which included a catch-up rebate invoice covering a period of several months prior to the three-month period ended December 31, 2019.

The operating loss for the three months ended December 31, 2019, was $3.3 million compared to $0.1 million for the three months ended December 31, 2018. Operating loss for the three months ended December 31, 2019, included approximately $2.1 million of termination benefits and $1.2 million of business development and regulatory affairs expense, compared to $0 of termination benefits and $0.7 million of business development and regulatory affairs expense for the same period last year. The increase in business development and regulatory affairs expenses was due to accelerated business development activities and an increased volume of transactions under consideration.

Adjusted EBITDA^** was $0.7 million for the three-month period ended December 31, 2019, compared to $2.2 million for the same period last year. Net loss for the three-month period ended December 31, 2019, was $2.6 million compared to net loss of $1.3 million for the three-month period ended December 31, 2018.

Under the Company’s normal course issuer bid (NCIB) it purchased and canceled 361,900 common shares in the market for consideration of $1.4 million during the three-month period ended December 31, 2019, and 779,900 common shares in the market for consideration of $3.2 million during the nine-month period ended December 31, 2019.

For the nine months ended December 31, 2019, total revenues were $48.7 million, compared to revenue of $21.1 million for the nine months ended December 31, 2018. Gross profit for the nine months ended December 31, 2019, was $28.5 million, or 58.4% of sales, compared to $12.5 million, or 59.4% of sales, for the same period last year. The lower gross margin for the nine months ended December 31, 2019, compared to the same period last year, was mainly due to the consolidation of the Company’s payors in the United States market as well as the aforementioned unexpected rebate invoice the Company received from one of its main payors in the United States, which included a catch-up rebate invoice covering a period of several months prior to the three-month period ended December 31, 2019.

The operating loss for the nine months ended December 31, 2019, was $5.8 million compared to $3.8 million for the nine months ended December 31, 2018. Adjusted EBITDA^** for the nine-month period ended December 31, 2019, was $1.8 million compared to $2.3 million for the nine-month period ended December 31, 2018.  Net loss for the nine-month period ended December 31, 2019, was $4.1 million compared to $5.6 million for the nine-month period ended December 31, 2018.

The Company’s financial statements and management discussion and analysis (“MD&A”) for the three and nine months ended December 31, 2019, are available on its website and in its corporate filings on SEDAR.

*      Refer to “Cautionary Note Regarding Comparative Financial Information” at the end of this press release.
**    Refer to “Non-IFRS Financial Measures” at the end of this press release.

Conference Call Details

Medexus will host a conference call at 8:00 AM Eastern Time on Wednesday, February 19, 2020 to discuss the Company’s financial results for the third quarter ended December 31, 2019, as well as the Company’s corporate progress and other developments.

The conference call will be available via telephone by dialing toll-free 844-369-8770 for Canadian and U.S. callers or +1 862-298-0840 for international callers, or on the Company’s Investor Events section of the Company’s website.

A webcast replay will be available on the Company’s Investor Events section of the website through May 19, 2020. A telephone replay of the call will be available approximately one hour following the call, through February 26, 2020, and can be accessed by dialing 877-481-4010 for Canadian and U.S. callers or +1 919-882-2331 for international callers and entering conference ID: 33141.

¹ Source: IQVIA – TSA National units.
² Source: IQVIA – Drugstores and hospital purchases.
³ Source: Symphony Sub National 12/31/2019 Data & Chargebacks, PAP
⁴ Source: IQVIA Data – CDH MAT December 2019
⁵ Source: IQVIA: CDH units – FQTR December 2019.

About Medexus Pharmaceuticals Inc.

Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform. The Company’s vision is to provide the best healthcare products to healthcare professionals and patients, through our core values of Quality, Innovation, Customer Service and Teamwork. Medexus is focused on the therapeutic areas of auto-immune disease and pediatrics. The leading products are Rasuvo and Metoject, a unique formulation of methotrexate (auto-pen and pre-filled syringe) designed to treat rheumatoid arthritis and other auto-immune diseases; and Rupall, an innovative allergy medication with a unique mode of action.

For more information, please contact:

Ken d’Entremont, Chief Executive Officer
Medexus Pharmaceuticals Inc.
Tel.: 905-676-0003
E-mail: ken.dentremont@medexus.com  

Roland Boivin, Chief Financial Officer
Medexus Pharmaceuticals Inc.
Tel.: 514-762-2626 ext. 202
E-mail: roland.boivin@medexus.com

Investor Relations (U.S.):
Crescendo Communications, LLC
Tel: +1-212-671-1020
Email: mdp@crescendo-ir.com

Investor Relations (Canada):
Frank Candido
Direct Financial Strategies and Communication Inc.
Tel: 514-969-5530
E-mail: frank.candido@medexus.com

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accept responsibility for the adequacy or accuracy of this release.

Cautionary Note Regarding Comparative Financial Information

On October 16, 2018, the Company (under its former name, Pediapharm Inc.) completed two transformative acquisitions (the “Acquisitions”) in acquiring of all the issued and outstanding shares of Medexus Inc. (“Medexus Canada”) and Medexus Pharma, Inc. (under its former name, Medac Pharma, Inc.) (“Medexus US”) and, subsequently, on December 12, 2018, changed its name to “Medexus Pharmaceuticals Inc.”.

As the three- and nine-month periods ended December 31, 2019, are within the first full year of operation since the Company completed the Acquisitions, readers are cautioned that while certain financial information included herein for, and comparisons to, prior periods have been presented in this press release, changes from a pre-Acquisitions period to a post-Acquisitions period may, in the opinion of management, be of limited value in understanding changes to the financial condition, financial performance, or business of the Company from period to period given the transformative nature of the Acquisitions. Readers are advised that the comparative information included in this press release for the three- and nine-month periods ended December 31, 2018 includes certain unaudited pre-Acquisitions results for Pediapharm Inc. (i.e., the comparative information for this period consist of results prior to October 16, 2018, which reflect only the unaudited pre-Acquisitions results for Pediapharm Inc. and results subsequent to October 16, 2018, which reflect the unaudited consolidated results of the post-Acquisitions Company, including the acquired entities (Medexus Canada and Medexus US)), whereas information provided as at and for the three- and nine-month periods ended December 31, 2019, reflects the unaudited consolidated results of the post-Acquisitions Company, including the acquired entities (Medexus Canada and Medexus US).

Forward-Looking Statements

Certain statements made in this press release contain forward-looking information within the meaning of applicable securities laws (“forward-looking statements”). The words “anticipates,” “believes,” “expects,” “will,” and similar expressions are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Specific forward-looking statements contained in this press release include, but are not limited to, statements with respect to future business operation and results, including with respect to future earnings and the Company’s evaluation of additional products and accretive acquisitions, the anticipated growth in sales of, the market for and distribution of, certain of the Company’s products, and the Company’s investigation of the consolidation of the Company’s payors in the United States, as well as the anticipated impact such consolidation may have on the Company, including with respect to the net selling price of Rasuvo®. These statements are based on factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, including assumptions based on historical trends, current conditions and expected future developments. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. The Company cautions that although it is believed that the assumptions are reasonable in the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. Material risk factors include those set out in the Company’s MD&A under the heading “Risk Factors and Risk Management” and elsewhere in the Company’s other disclosure documents filed with the applicable Canadian securities regulatory authorities from time to time. Given these risks, undue reliance should not be placed on these forward-looking statements, which apply only as of the date hereof. Other than as specifically required by law, the Company undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.

Non-IFRS Financial Measures

This press release uses the term “Adjusted EBITDA” which is a non-IFRS financial measure, which does not have any standardized meaning under IFRS and therefore may not be comparable to similar measures presented by other companies. Rather, this measure is provided as additional information to complement IFRS measures by providing a further understanding of the Company’s results of operations from management’s perspective. Accordingly, they should not be considered in isolation nor as a substitute for analysis of the Company’s financial information reported under IFRS. In particular, management uses Adjusted EBITDA as a measure of the Company’s performance. The Company defines Adjusted EBITDA as earnings before financing and special transaction costs (including, for greater certainty, fees related to the Acquisitions and financing announced on October 16, 2018), interest expenses, income taxes, interest income, depreciation of property and equipment, amortization of intangible assets, non-cash share-based compensation, income from sale of asset, gain or loss on the convertible debenture embedded derivative, foreign exchange gains or losses, and impairment of intangible assets. The Company considers Adjusted EBITDA as a key metric in assessing business performance and considers Adjusted EBITDA to be an important measure of operating performance and cash flow, providing useful information to investors and analysts. These non-IFRS measures presented are not intended to represent cash provided by operating activities, net earnings or other measures of financial performance calculated in accordance with IFRS. Additional information relating to the use of this non-IFRS measure, including the reconciliation of Adjusted EBITDA to Net Income (Loss), can be found in our MD&A, which is available through the SEDAR website.

LISLE, Ill. /PRNewswire/ — Endotronix, a digital health and medical technology company dedicated to advancing the treatment of chronic heart failure (HF), today announced the enrollment of the first two patients in the PROACTIVE-HF pivotal trial. The trial is a pre-market investigational device exempt (IDE) study evaluating the safety and efficacy of the Cordella™ Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor) for the treatment of HF. The first two patients were successfully implanted with the Cordella Sensor by Drs. Navin Kapur and Michael Kiernan at Tufts Medical Center in Boston, Massachusetts and Dr. Liviu Klein at the University of California San Francisco (UCSF).

“Management of chronic heart failure patients can be challenging. The Cordella Sensor and System provide a unique combination of daily patient PA pressure and vital sign data, enabling me and my team to make smarter, trend-based clinical decisions before decompensation occurs. Based on my early experience, the Cordella System offers an intuitive at-home patient experience, including a seated PA pressure reading, for remote management. I’m excited for the PROACTIVE-HF trial and look forward to clearly demonstrating the benefits of hemodynamic PA-pressure guided therapy and its impact on clinical outcomes.”

– Dr. Klein, Director of the Mechanical Circulatory Support Program at UCSF and National Principal Investigator of the PROACTIVE-HF trial

The prospective, multi-center, randomized, controlled, single-blind trial is expected to enroll over 950 New York Heart Association (NYHA) Class III heart failure patients at up to 60 sites across the U.S. The dual-arm trial design compares HF management using daily patient vital sign data versus daily vital sign plus PA pressure data. Designed to show a definitive benefit for PA pressure-guided management, the landmark trial incorporates protocolized PA pressure therapy guidelines and guideline-directed medical therapy (GDMT) for proactive HF management. Primary endpoints of the study include the reduction of HF hospitalizations and mortality. In addition, the data from this trial will support U.S. market access of the Cordella Sensor and inform a national coverage decision from the Centers for Medicare & Medicaid Services (CMS). The company also announced that last year they received Category B IDE Study approval from CMS, which will allow coverage of the Cordella Sensor and routine care services during the trial.

“PROACTIVE-HF is a groundbreaking trial, designed to provide the highest level of clinical evidence in support of PA pressure-guided therapy. Our national coverage of top implanting centers positions us for successful study enrollment to further demonstrate that the Cordella Sensor and System provides efficient HF management, improves clinical outcomes and has the potential to redefine the standard of care for patients with chronic heart failure.” 

– Harry Rowland, CEO, Endotronix

The Cordella Sensor is not available for commercial use in any geography and is under clinical investigation in Europe (SIRONA II CE Mark Trial) and the U.S. (PROACTIVE-HF IDE Trial). CAUTION – Investigational Device. Limited by Federal (or United States) Law to Investigational Use. Exclusively for clinical investigations. The Cordella System, without the sensor, is available for commercial use in the U.S. and E.U. and is currently in cardiology centers across the U.S.

About the Cordella™ Heart Failure System
The Cordella Heart Failure System (Cordella System) is designed to help patients suffering from chronic heart failure feel better and stay out of the hospital with streamlined care and remote medication titration. The system provides a comprehensive health status of the patient at home with easy-to-use tools that securely collect and share health data with healthcare providers for trend-based management. The Cordella Sensor seamlessly integrates pulmonary artery (PA) pressure data into the Cordella System. Together, they proactively deliver the information necessary to improve patient care between office visits and support reimbursement for care delivery activities.

About Endotronix
Endotronix, Inc., is a medical technology company focused on advancing the treatment of chronic heart failure. Privately held, the company is backed by world-class medtech investors including Aperture Venture Partners, BioVentures Investors, LSP, Lumira Ventures, OSF Ventures, Seroba Life Sciences, Skydeck LLC, SV Health Investors, Wanxiang Healthcare Investments, and two unnamed corporate strategic investors.

Cautionary Statement Regarding Forward-Looking Statements
This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not a guarantee of future performance.

MEDIA CONTACT:
Carla Benigni
SPRIG Consulting LLC (847) 951-7430
Carla@sprigconsulting.com

ATLANTA /PRNewswire/ — Antios Therapeutics, Inc. (“Antios”), a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases, today announced it has initiated its first-in-human Phase 1 clinical trial for ATI-2173, a novel liver-targeted, orally-administered, small molecule against hepatitis B. The Phase 1a study is a randomized, double-blind, placebo-controlled single-ascending dose (“SAD”) study in healthy volunteers to evaluate the compound’s safety, tolerability, and pharmacokinetic profile.

“Dosing the first patients with ATI-2173 is a significant milestone for our company and we are very excited to initiate the first-in-human study of our liver-targeted, non-chain terminating, HBV polymerase inhibitor.”

– Abel De La Rosa, Ph.D., CEO of Antios

This SAD study will be conducted in up to 35 healthy subjects randomized into 5 cohorts of 7 subjects each. A Phase 1b multiple-ascending dose (“MAD”) clinical study in HBV-infected subjects is planned to commence following the completion of the SAD and MAD cohorts for the Phase 1a study.

“We are looking forward to learning more about ATI-2173 in the clinic after obtaining very encouraging preclinical antiviral activity and preclinical safety data for our lead molecule.”

– Douglas Mayers M.D., CMO of Antios

About ATI-2173

ATI-2173 is a novel liver-targeted molecule designed to deliver the 5′-monophosphate of clevudine. This L-nucleoside’s active 5′-triphosphate has unique antiviral properties as a non-competitive, non-chain terminating HBV polymerase inhibitor. By selectively delivering the 5′-monophosphate to the liver, while retaining the unique anti-HBV activity of the active 5′- triphosphate, ATI-2173 could become an integral part of a curative combination regimen for chronic hepatitis B.

About Antios Therapeutics Inc.

Antios Therapeutics is a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases. Antios is currently developing ATI-2173, aiming to provide chronic hepatitis B infected patients with a curative combination regimen.

For Media Inquiries, please contact pr@antiostherapeutics.com

Related Article: Antios Therapeutics Raises $25 Million in Oversubscribed Series A Financing to Pursue Hepatitis B Cure

Published in December 2019, Frontiers in Oncology, one of the world’s top peer-reviewed oncology journals in terms of influence and quality, published a new meta-analysis on the diagnostic value of micro-ultrasound in prostate cancer.

Key findings show that micro-ultrasound is a more convenient and cost-effective method in real-time imaging during biopsy procedure in detecting clinically significant prostate cancer. Although micro-ultrasound has shown promising results, more clinical data and comprehensive analysis are still needed.

A total of 7 studies containing 769 patients were included in this meta-analysis. Micro-ultrasound had a pooled sensitivity, specificity, DOR and an area under the SROC of 0.91, 0.49, 10 and 0.82 respectively. Based on these findings, micro-ultrasound has the superior ability to diagnose clinically significant prostate cancer.

Read the study and article in full.

About Prostate Cancer

Prostate cancer is a frequently diagnosed malignant solid tumor in men. It is the second leading cause of cancer deaths in the United States. In 2019, 174, 650 new prostate cancer incidences were diagnosed and 31,620 deaths were attributed to this disease in the United States. Prostate cancer has now become the third most common type of cancer in China and the morbidity and mortality of this disease have steadily increased.

Diagnosing Prostate Cancer

Prostate cancer screening methods include the prostate-specific antigen (PSA) test and digital rectal examination (DRE), in addition to magnetic resonance imaging (MRI) techniques. However, the conventional ultrasound-based rectal systemic biopsy is insufficient, even with a repeated biopsy every 6-24 months, pathological findings suggest significant differences.

The ExactVu™ micro-ultrasound is a novel high-resolution 29-MHz ultrasound that offers real-time biopsies targeted to suspicious areas and enables the details visualization of related prostate tissue characteristics, with 3x greater resolution as compared with conventional ultrasound resolution. Furthermore, the targeting and entire workflow are controlled by the urologist. Micro-ultrasound also has a PRI-MUS (prostate risk identification using micro-ultrasound), which is a protocol for users to easily learn and quickly apply to help guide targeted biopsies to suspicious regions.

People with suspected prostate cancer, usually need a prostate biopsy first, which can result in morbidities, such as bleeding, infection, and rectal and bladder injury. Increasing the positive rate of suspected prostate lesions can significantly reduce unnecessary biopsies and complications. Previous studies demonstrated that MRI has high sensitivity and specificity, and while it is a usual method, it is not recommended as an alternative for system biopsy at present. Micro-ultrasound’s high sensitivity makes it an attractive option for guiding targeted biopsy.

About Exact Imaging

Exact Imaging is the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and guided biopsies in the urological market for prostate cancer. Exact Imaging’s ExactVu™ micro-ultrasound platform operates at 29 MHz and enables a whole new level of resolution with the benefits of ease of use, affordability, and is an extension of the current urological workflow. Using the Exact Imaging platform, urologists are able to visualize areas of interest in the prostate and specifically target biopsies in those areas. For those cases where MRI might assist, the FusionVu™ micro-US/MRI fusion application operates on the ExactVu™ micro-ultrasound platform and facilitates fast, simple MRI fusion-based targeting with the guidance of the micro-ultrasound system’s 70-micron real-time resolution. The ExactVu™ micro-ultrasound system including the FusionVu™ application has received regulatory approval in the European Union (CE Mark), the United States (FDA 510(k)), and Canada (Health Canada medical device license). 

SOUTH SAN FRANCISCO, California (GLOBE NEWSWIRE) — Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company, today announced that Phase 1 trial results detailing pharmacokinetics (PK), tolerability, and safety with its lead product candidate, STS101 (DHE (or dihydroergotamine) nasal powder for the acute treatment of migraine), have been published online in the official peer-reviewed journal of the American Headache Society, Headache, The Journal of Head and Face Pain.

The publication reports result from a Phase 1, open-label, 2-part, active-controlled, 3-period crossover study sponsored by Satsuma and designed to investigate and compare the safety and PK of STS101, DHE liquid nasal spray (Migranal®), and intramuscular (IM) DHE injection in healthy subjects. 

Study authors concluded that STS101 showed a favorable tolerability profile and resulted in DHE plasma concentrations comparable to IM DHE and exceeding Migranal.  Based on data from this study and the results from other clinical studies with DHE (including injected, liquid nasal spray, and orally inhaled DHE dosage forms), the authors posited that STS101 is anticipated to demonstrate rapid pain relief, improvement in functionality, and excellent 2-hour and sustained pain freedom rates.  STS101 is currently being evaluated as an acute treatment for migraine in an ongoing Phase 3 efficacy trial (the EMERGE™ trial), for which Satsuma expects to report top-line data in the second half of this year.

Related Article: Satsuma Completes $90.8M Initial Public Offering

Key findings described in the American Headache Society, Headache, The Journal of Head and Face Pain publication included the following:

• STS101 showed rapid absorption, achieving within 10 minutes the mean DHE plasma concentration threshold (1 ng/ml) that Satsuma estimates to be minimally necessary for efficacy based on prior clinical studies. 
• Drug exposure was substantially greater than Migranal, comparable to IM DHE, and exceeded exposures previously reported for an orally inhaled DHE product candidate (MAP0004) by approximately 30 minutes post-dose and at all subsequent time points.  MAP0004 previously demonstrated rapid onset of clinical efficacy and robust anti-migraine efficacy in a large, double-blind, placebo-controlled Phase 3 trial.
• STS101 PK variability was lower than Migranal, suggesting STS101 may have more predictable, reliable, and robust clinical performance.
• With STS101, maximum DHE plasma concentrations were sufficiently low so as to avoid nausea or vomiting, which are common side-effects with intravenous DHE.
• STS101 demonstrated a favorable tolerability profile and all treatment-related adverse events were mild, transient, and related to the nasal route of administration or known effects of DHE.

Read the Full Publication: A Phase 1, Randomized, Open-Label, Safety, Tolerability, and Comparative Bioavailability Study of Intranasal Dihydroergotamine Powder (STS101), Intramuscular Dihydroergotamine Mesylate, and Intranasal DHE Mesylate Spray in Healthy Adult Subjects.

About Satsuma Pharmaceuticals and STS101
Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product for the acute treatment of migraine, STS101. STS101 is a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate (DHE), which can be quickly and easily self-administered with a proprietary pre-filled, single-use, nasal delivery device. In developing STS101, Satsuma has applied proprietary nasal drug delivery, dry-powder formulation, and engineered drug particle technologies to create a compact, simple-to-use, non-injectable DHE product that can be rapidly self-administered in a matter of seconds. The Company believes STS101 would, if approved, be an attractive migraine treatment option for many patients and may enable a larger number of people with migraine to realize the long-recognized therapeutic benefits of DHE therapy. STS101 has undergone extensive pre-clinical development, completed a Phase 1 clinical trial, and is currently in Phase 3 development.

Satsuma is headquartered in South San Francisco, California with operations in both California and Research Triangle Park, North Carolina.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements concerning the business, operations and financial performance and condition of Satsuma Pharmaceuticals, Inc. (the “Company”), as well as the Company’s plans, objectives, and expectations for its business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about the Company’s expectations regarding the potential safety and efficacy of STS101, including the comparability to other DHE products; the Company’s clinical and regulatory development plans; the Company’s expectations with regard to the data to be derived from its planned Phase 3 clinical trials and the timing of reporting top-line results therefrom; the likelihood of regulatory filings and approvals for STS101; and the Company’s commercialization plans and expectations. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of STS101; the Company’s ability to select suitable dosing regimens; the results of preclinical and clinical studies may not be predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; the costs of clinical trials may exceed expectations; and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

This press release discusses STS101, a product candidate that is in clinical development and has not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of STS101 for the therapeutic use for which STS101 is being studied.

INVESTOR AND CORPORATE CONTACTS:            

Corey Davis, PhD
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com

Tom O’Neil, Chief Financial Officer
Satsuma Pharmaceuticals, Inc.
tom@satsumarx.com

VANCOUVER, British Columbia–(BUSINESS WIRE)– Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics (“Zymeworks” or the “Company”), announced today the closing of its previously announced underwritten public offering (the “Offering”). The Offering consisted of 5,824,729common shares, including the exercise in full of the underwriters’ over-allotment option to purchase 900,000 additional shares, and, in lieu of common shares, to a certain investor, pre-funded warrants to purchase up to 1,075,271 common shares. The common shares were offered at a price to the public of US$46.50 per common share and the pre-funded warrants were offered at a price of US$46.4999 per pre-funded warrant, for aggregate gross proceeds to the Company of approximately US$320.8 million, before deducting underwriting discounts and commissions and estimated Offering expenses.

Related Article: Zymeworks Inks Collaboration Agreement with Pfizer in Breast Cancer Study

The Company intends to use the net proceeds of the Offering (i) to accelerate and expand the global development of ZW25 both as a single agent and in combination with other anti-cancer agents in a variety of HER2-expressing tumors, including gastroesophageal, biliary tract, breast, and other underserved cancers; (ii) to accelerate and expand the clinical development of ZW49; (iii) to advance other novel preclinical programs, including those involving non-HER2-expressing tumors; and (iv) for general corporate purposes.

J.P. Morgan Securities LLC and Citigroup Global Markets Canada Inc. acted as active book-runners for the Offering. Stifel, Nicolaus & Company, Incorporated and Wells Fargo Securities Canada, Ltd. acted as book-runners and Raymond James Ltd. acted as lead manager.

Related Article: Zymeworks Files Preliminary Prospectus Supplements for Offering of Common Shares and Pre-Funded Warrants

The securities described above were offered in Canada pursuant to Zymeworks’ final prospectus supplement, dated January 22, 2020 (the “Canadian Supplement”), to its Canadian final base shelf prospectus, dated November 18, 2019 (the “Base Prospectus”), and in the United States pursuant to Zymeworks’ final prospectus supplement, dated January 22, 2020 (the “U.S. Supplement”, together with the Canadian Supplement, the “Supplements”), to its U.S. automatic shelf registration statement on Form S-3ASR, including a prospectus dated November 5, 2019 (the “Registration Statement”). The Supplements were filed in Canada and the United States on January 23, 2020.

The Supplements and the Registration Statement contain important detailed information about the Offering. A copy of the Canadian Supplement can be found on SEDAR at www.sedar.com, and a copy of the U.S. Supplement and the related Registration Statement can be found on EDGAR at www.sec.gov. Copies of the Supplements may also be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204; Citigroup Global Markets Canada Inc., Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720, or by email at syndprospectus@stifel.com; or Wells Fargo Securities Canada, Ltd., Attention: Equity Syndicate Department, 30 Hudson Yards, 500 West 33rd Street, New York, NY 10001, by telephone at (800) 326-5897, or by email at cmclientsupport@wellsfargo.com. Prospective investors should read the Supplements and the Registration Statement before making an investment decision.

This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.

About Zymeworks Inc.

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics. Zymeworks’ suite of therapeutic platforms and its fully-integrated drug development engine enable precise engineering of highly differentiated product candidates. Zymeworks’ lead clinical candidate, ZW25, is a novel Azymetric™ bispecific antibody currently in Phase 2 clinical development. Zymeworks’ second clinical candidate, ZW49, is a bispecific antibody-drug conjugate currently in Phase 1 clinical development and combines the unique design and antibody framework of ZW25 with Zymeworks’ proprietary ZymeLink™ cytotoxic payload. Zymeworks is also advancing a deep preclinical pipeline in oncology (including immuno-oncology agents) and other therapeutic areas. In addition, its therapeutic platforms are being leveraged through strategic partnerships with nine biopharmaceutical companies.

Cautionary Note Regarding Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this news release include statements that relate to the Offering, the anticipated use of proceeds from the Offering and other information that is not historical information. When used herein, words such as “advance”, “believe”, “may”, “plan”, “will”, “estimate”, “anticipate”, “intend” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under “Risk Factors” in the Base Prospectus, the Registration Statement, the Supplements and Zymeworks’ Quarterly Report on Form 10-Q for the three month period ended September 30, 2019 (a copy of which may be obtained at www.sec.gov and www.sedar.com). Consequently, forward-looking statements should be regarded solely as Zymeworks’ current plans, estimates, and beliefs. You should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events, except as may be required by law.

Investor Inquiries:  
Ryan Dercho, Ph.D.  
(604) 678-1388  
ir@zymeworks.com

Tiffany Tolmie  
(604) 678-1388  
ir@zymeworks.com   

Media Inquiries:  
Kavita Shah, Ph.D. 
(604) 678-1388  
media@zymeworks.com

SEATTLE /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today the commercial launch of the 14-Day version of the Carnation Ambulatory Monitor (“CAM™”), the industry’s only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device, following recent clearance by the FDA. 

“The 14-Day CAM is the culmination of years of development focused on uncovering the full complexity and meaning of a patient’s cardiac rhythm. We are proud to develop and introduce the most advanced and accurate cardiac monitoring technologies that enable new opportunities to reimagine and redefine patient care.”

– Gust H. Bardy, MD, Founder and Chief Executive Officer, BardyDx

The significance of the CAM Patch’s P-wave centric clinical value was highlighted in the American Heart Journal that published the results of a head-to-head comparison with the iRhythm Zio^® XT patch, concluding that the BardyDx CAM Patch identified 40% more arrhythmias and resulted in better, more informed clinical decision-making in 41% of patients over the iRhythm Zio XT patch. In addition, a preceding study also published in the American Heart Journal comparing the CAM Patch and a traditional Holter monitor, showed a four times increase in arrhythmia detection using the CAM Patch, including arrhythmias missed or incorrectly identified using the Holter monitor, concluding that the CAM Patch offered significantly improved rhythm diagnostics.

Strong market uptake of BardyDx’s P-wave centric solutions has spurred recent expansion of the company’s infrastructure to maintain its rapid pace. A second ECG monitoring center located in New Jersey was established last quarter, which received Medicare enrollment approval by the Centers for Medicare & Medicaid Services effective December 2, 2019. In addition, BardyDx recently announced the addition of medical device industry veteran, Ed Vertatschitsch, as Chief Operating Officer, along with several new vice president appointments to strengthen the Leadership Team.  

“We are extremely proud of the continued momentum of the CAM Patch becoming the cardiac monitor of choice and trusted solution of cardiologists and electrophysiologists across the U.S., U.K., and Canada. It is increasingly clear that customers are realizing the true clinical and market-differentiating value of our P-wave focused detection technology in enabling optimal patient care.”

– Ken Nelson, Chief Commercial Officer, BardyDx

The growing market recognition of the innovative P-wave centric CAM Patch includes recently being selected as winner of the Remote Monitoring in Arrhythmias Digital Health Pitch Session at European Society of Cardiology Congress 2019 and finalist of the UCSF Digital Health Award for Best Cardiovascular Digital Diagnostic. In addition, BardyDx was also named the winner of the 2019 MedTech Breakthrough Award for Best New Diagnostic Technology and the winner of the 2019 Frost & Sullivan Award for Technology Innovation in Remote Cardiac Monitoring. 

About Bardy Diagnostics:

Bardy Diagnostics, Inc. is an innovator in digital health and remote patient monitoring, with a focus on providing the most diagnostically-accurate and patient-friendly cardiac monitors to the industry. The company’s CAM Patch is a non-invasive, P-wave centric™ ambulatory cardiac monitor and arrhythmia detection device that is designed to improve patient compliance for adults and children through its lifestyle-enabling form factor. Designed to be worn comfortably and discreetly for up to 14 days, the female-friendly, hourglass-shaped CAM Patch is placed on the center of the chest, directly over the heart for optimum ECG signal collection. The proprietary technology of the CAM Patch provides optimal detection and clear recording of the often difficult-to-detect P-wave, the signal of the ECG waveform that is essential for accurate arrhythmia diagnosis.

MEDIA CONTACT:
Jonathan Wu
Senior Director, Marketing
Bardy Diagnostics, Inc.
1-844-422-7393
jwu@bardydx.com

On January 15, 2020, HistoSonics’ research on non-thermal histotripsy tumor ablation was published in the Journal for ImmunoTherapy of Cancer (JITC), the premier cancer immunotherapy journal at BMC and the official journal of the Society for Immunotherapy of Cancer (SITC). An excerpt from the report can be found below.

Read the Full Report here.

Original Source: Qu S, Worlikar T, Felsted AE, et al. Non-thermal histotripsy tumor ablation promotes abscopal immune responses that enhance cancer immunotherapy. Journal for ImmunoTherapy of Cancer 2020;8:e000200.doi:10.1136/jitc-2019-000200

The Results

1. Histotripsy promotes local intratumoral innate and adaptive immune responses.
2. Histotripsy mediates stronger intratumoral CD8+ T cell infiltration than other modalities of tumor-directed therapy
3. Non-thermal histotripsy is capable of releasing immunogenic tumor neoantigens
4. Histotripsy is associated with regional and systemic tumor-specific CD8+ T cell responses
5. Histotripsy is associated with the induction of abscopal intratumoral CD8+ T cell responses
6. Histotripsy inhibits the development of distant metastases
7. Histotripsy is associated with the induction of systemic inflammatory changes and local release of HMGB1
8. Histotripsy augments the efficacy of checkpoint inhibition immunotherapy

Background

Recent advances in checkpoint inhibition immunotherapy have renewed investigative interest into the possibility that tumor-directed therapies like thermal ablation and radiation, could stimulate tumor-directed immune responses.

Although immunostimulatory effects have been observed with thermal ablation and radiation, the magnitude of these effects has not yet proven capable of consistently augmenting the effect of immunotherapy. One potential immunostimulatory limitation of tumor-directed therapies may be their inability to induce sufficient tumorous release of immunogenic or inflammatory subcellular components, such as neoantigens or damage-associated molecular patterns (DAMPs) like high mobility group box protein 1 (HMGB1) that are capable of triggering strong tumor-directed adaptive immune responses.

Histotripsy is a novel modality of non-invasive tumor ablation that uses overlapping high-pressure ultrasound pulses to disrupt cellular architecture. At their point of convergence, focused ultrasound waves create precise regions of extreme pressure changes. Histotripsy uses microsecond-length ultrasound pulses to mechanically homogenize tissues through acoustic cavitation; by separating these pulses by milliseconds off-time or longer, heat generation is avoided. When applied to tumors, histotripsy reduces tumor tissue to a liquefied acellular homogenate that is gradually reabsorbed. 11–18

By lysing target cells through a strictly mechanical mechanism that avoids the denaturing effects of heat or ionizing radiation, we hypothesized that histotripsy could promote inflammatory and immunostimulatory effects not possible with other modalities of tumor-directed therapy like thermal ablation or radiation.

For the purposes of this report, a murine model of subcutaneous tumor ablation was used to demonstrate that histotripsy is uniquely capable of promoting local, regional and systemic antitumor adaptive immune responses that can significantly augment the efficacy of checkpoint inhibition immunotherapy.

Conclusions

Our observations suggest that histotripsy is capable of stimulating local, regional and systemic antitumor immune responses that, when further amplified by checkpoint inhibition, may be sufficient to make a clinical impact against previously immunoresistant cancers. If so, the immunomodulatory impact of histotripsy may be key to expanding the impact and promise of cancer immunotherapy.

Related Article: HistoSonics Leads The Observer’s 2020 List of Innovative Healthcare Companies

References

11 Hall TL, Fowlkes JB, Cain CA. A real-time
measure of cavitation
induced tissue disruption by ultrasound imaging Backscatter
reduction. IEEE Trans Ultrason Ferroelectr Freq Control
2007;54:569–75.
12 Wang T-yin,
Xu Z, Winterroth F, et al. Quantitative ultrasound
Backscatter for pulsed cavitational ultrasound therapy- histotripsy.
IEEE Trans Ultrason Ferroelectr Freq Control 2009;56:995–1005.
13 Wang T-Y,
Hall TL, Xu Z, et al. Imaging feedback of histotripsy
treatments using ultrasound shear wave elastography. IEEE Trans
Ultrason Ferroelectr Freq Control 2012;59:1167–81.
14 Xu Z, Ludomirsky A, Eun LY, et al. Controlled ultrasound
tissue erosion. IEEE Trans Ultrason Ferroelectr Freq Control
2004;51:726–36.
15 Parsons JE, Cain CA, Abrams GD, et al. Pulsed cavitational
ultrasound therapy for controlled tissue homogenization. Ultrasound
Med Biol 2006;32:115–29.
16 Xu Z, Owens G, Gordon D, et al. Noninvasive creation of an
atrial septal defect by histotripsy in a canine model. Circulation
2010;121:742–9.
17 Maxwell AD, Wang T-Y,
Cain CA, et al. Cavitation clouds created by
shock scattering from bubbles during histotripsy. J Acoust Soc Am
2011;130:1888–98.
18 Vlaisavljevich E, Maxwell A, Mancia L, et al. Visualizing the
Histotripsy process: bubble Cloud-Cancer
cell interactions
in a Tissue-Mimicking
environment. Ultrasound Med Biol
2016;42:2466–77.

Authors

• Shibin Qu Surgery, University of Michigan, Ann Arbor, Michigan, USADepartment of Hepatobiliary Surgery, Xijing Hospital, Xian, Shaanxi, China PubMed articles | Google scholar articles
• Tejaswi Worlikar Biomedical Engineering, University of Michigan, Ann Arbor, Michigan, USA PubMed articles | Google scholar articles
• Amy E Felsted Surgery, University of Michigan, Ann Arbor, Michigan, USA PubMed articles | Google scholar articles
• Anutosh Ganguly Surgery, University of Michigan, Ann Arbor, Michigan, USASurgery, VA Ann Arbor Healthcare System, Ann Arbor, Michigan, USA PubMed articles | Google scholar articles
• Megan V Beems Surgery, University of Michigan, Ann Arbor, Michigan, USA PubMed articles |Google scholar articles
• Ryan Hubbard Biomedical Engineering, University of Michigan, Ann Arbor, Michigan, USA PubMed articles | Google scholar articles
• Ashley L Pepple Surgery, University of Michigan, Ann Arbor, Michigan, USA PubMed articles | Google scholar articles
• Alicia A Kevelin Surgery, University of Michigan, Ann Arbor, Michigan, USA PubMed articles | Google scholar articles
• Hannah Garavaglia Surgery, University of Michigan, Ann Arbor, Michigan, USA PubMed articles | Google scholar articles
• Joe Dib Surgery, University of Michigan, Ann Arbor, Michigan, USA PubMed articles | Google scholar articles
• Mariam Toma Surgery, University of Michigan, Ann Arbor, Michigan, USA PubMed articles | Google scholar articles
• Hai Huang Surgery, Ohio State University Medical Center, Columbus, Ohio, USA PubMed articles | Google scholar articles
• Allan Tsung Surgery, Ohio State University Medical Center, Columbus, Ohio, USA PubMed articles |Google scholar articles
• Zhen Xu Biomedical Engineering, University of Michigan, Ann Arbor, Michigan, USA PubMed articles | Google scholar articles
• Clifford Suhyun Cho Surgery, University of Michigan, Ann Arbor, Michigan, USASurgery, VA Ann Arbor Healthcare System, Ann Arbor, Michigan, USA PubMed articles | Google scholar articles

Author Affiliations

1 Surgery, University of Michigan, Ann Arbor, Michigan, USA
2 Department of Hepatobiliary Surgery, Xijing Hospital, Xian, Shaanxi, China
3 Biomedical Engineering, University of Michigan, Ann Arbor, Michigan, USA
4 Surgery, VA Ann Arbor Healthcare System, Ann Arbor, Michigan, USA
5 Surgery, Ohio State University Medical Center, Columbus, Ohio, USA

Contributors

SQ, AEF, AG, MVB, ALP, AAK, HG, JD, and MT performed in vivo tumor inoculations and treatments and in vitro assays. TW and RH performed in vivo histotripsy treatments. HH performed HMGB1 assays. SQ, TW, AEF, AG, RH, ALP, AAK, AT, ZX and CSC performed data analysis and interpretation. SQ, TW, AEF, AT, ZX and CSC wrote the manuscript. SQ, TW, AEF, AG, MVB, RH, ALP, AAK, MT, HH, AT, ZX and CSC performed manuscript review, editing, and approval.

Funding

This work was funded by VA Merit Review 1I01BX001619-05 (to CSC), NIH Grant R01-CA211217 (to ZX), University of Michigan Forbes Institute for
Discovery (to CSC and ZX), HistoSonics-Michigan Corporate Relations Network Grant AWD006745 (to CSC), NIH Grant T32-CA009672 (to AEF), and NIH Grant T32-CA090217 (to MVB). This work was supported by NIH Grant P30-CA04659229 to the University of Michigan Rogel Cancer Center. The content is solely the responsibility of the authors and does not represent the views of the Department of Veterans Affairs or the US Government or the National Institutes of Health.

Competing interests

None declared

Patient consent for publication

None required

Ethics approval

The murine experiments were prospectively reviewed and approved by the University of Michigan and VA Ann Arbor Healthcare Animal Care and Use Committees.

Provenance and peer review

Not commissioned; externally peer-reviewed.

Data availability statement

Data are available upon reasonable request

Open access

This is an open-access article distributed in accordance with the
Creative Commons Attribution Non-Commercial (CC BY-NC
4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See http:// creativecommons. org/ licenses/ by- nc/4.0/.

VANCOUVER, British Columbia—(BUSINESS WIRE)– Zymeworks Inc. (NYSE: ZYME) (“Zymeworks” or the “Company”), a clinical‑stage biopharmaceutical company developing multifunctional biotherapeutics, has today filed a preliminary prospectus supplement (the “Canadian Supplement”) to its Canadian short form base shelf prospectus dated November 18, 2019 (the “Base Prospectus”) in connection with an offering of its common shares and, in lieu of common shares to a certain investor, pre-funded warrants to purchase its common shares (the “Offering”). The Canadian Supplement was filed with the securities regulatory authorities in each of the provinces and territories of Canada. A preliminary prospectus supplement (the “U.S. Supplement,” together with the Canadian Supplement, the “Supplements”) was also filed with the U.S. Securities and Exchange Commission (the “SEC”) as part of an automatic shelf registration statement on Form S-3ASR, including a prospectus dated November 5, 2019 (the “Registration Statement”) which has been filed with the SEC and was automatically declared effective, pursuant to which the securities will be offered in the United States.

Related Article: Zymeworks Inks Collaboration Agreement with Pfizer in Breast Cancer Study

The Company also expects to grant to the underwriters a 30-day over-allotment option to purchase up to an additional 15% of the number of common shares offered in the Offering. The Offering is expected to be priced in the context of the market, with the final terms of the Offering to be determined at the time of pricing. There can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering. The closing of the Offering will be subject to customary closing conditions, including the listing of the common shares on the NYSE and any required approvals of the exchange. The pre-funded warrants will not be listed on the NYSE.

The Offering is expected to raise total gross proceeds of approximately US$200.0 million, before deducting underwriting discounts and commissions and estimated offering expenses. The Company intends to use the net proceeds of the Offering (i) to accelerate and expand the global development of ZW25 both as a single agent and in combination with other anti-cancer agents in a variety of HER2-expressing tumors, including gastroesophageal, biliary tract, breast, and other underserved cancers; (ii) to accelerate and expand the clinical development of ZW49; (iii) to advance other novel preclinical programs, including those involving non-HER2-expressing tumors; and (iv) for general corporate purposes.

Related Article: Zymeworks Announces Pricing of $175M Public Offering

J.P. Morgan Securities LLC and Citigroup Global Markets Canada Inc. are acting as active book-runners for the Offering. Stifel, Nicolaus & Company, Incorporated and Wells Fargo Securities Canada, Ltd. are acting as book-runners, and Raymond James Ltd. is acting as lead manager.

The Supplements and the Registration Statement contain important detailed information about the Offering. A copy of the Canadian Supplement can be found on SEDAR at www.sedar.com and www.sec.gov, and a copy of the U.S. Supplement and the related Registration Statement can be found on EDGAR at www.sec.gov. Copies of the Supplements may also be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204; Citigroup Global Markets Canada Inc., Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; Stifel, Nicolaus & Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720, or by email at syndprospectus@stifel.com; or Wells Fargo Securities Canada, Ltd., Attention: Equity Syndicate Department, 30 Hudson Yards, 500 West 33rd Street, New York, NY 10001, by telephone at (800) 326-5897, or by email at cmclientsupport@wellsfargo.com. Prospective investors should read the Supplements and the Registration Statement before making an investment decision.

This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.

About Zymeworks Inc.

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics. Zymeworks’ suite of therapeutic platforms and its fully-integrated drug development engine enable precise engineering of highly differentiated product candidates. Zymeworks’ lead clinical candidate, ZW25, is a novel Azymetric™ bispecific antibody currently in Phase 2 clinical development. Zymeworks’ second clinical candidate, ZW49, is a bispecific antibody-drug conjugate currently in Phase 1 clinical development and combines the unique design and antibody framework of ZW25 with Zymeworks’ proprietary ZymeLink™ cytotoxic payload. Zymeworks is also advancing a deep preclinical pipeline in oncology (including immuno-oncology agents) and other therapeutic areas. In addition, its therapeutic platforms are being leveraged through strategic partnerships with nine biopharmaceutical companies.

Cautionary Note Regarding Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this news release include statements that relate to the Offering, the anticipated size of the Offering, the granting of the over-allotment option, the anticipated use of proceeds from the Offering, and other information that is not historical information. When used herein, words such as “advance”, “believe”, “may”, “plan”, “will”, “estimate”, “anticipate”, “intend” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under “Risk Factors” in the Base Prospectus, the Registration Statement, the Supplements and Zymeworks’ Quarterly Report on Form 10-Q for the three month period ended September 30, 2019 (a copy of which may be obtained at www.sec.gov and www.sedar.com). Consequently, forward-looking statements should be regarded solely as Zymeworks’ current plans, estimates, and beliefs. You should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events, except as may be required by law.

Investor Inquiries:
Ryan Dercho, Ph.D.
(604) 678-1388
ir@zymeworks.com

Tiffany Tolmie
(604) 678-1388
ir@zymeworks.com

Media Inquiries:
Kavita Shah, Ph.D.
(604) 678-1388
media@zymeworks.com

SAN FRANCISCO and RESEARCH TRIANGLE PARK, N.C. (GLOBE NEWSWIRE) — Quantum Leap Healthcare Collaborative™ (QLHC) and G1 Therapeutics, Inc. (Nasdaq: GTHX) announced today a collaboration to evaluate trilaciclib, an investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy, in a new randomized, investigational treatment arm for the ongoing I-SPY 2 TRIAL™ for neoadjuvant treatment of locally advanced breast cancer.

Related Article: Phase 2 Trial Data Demonstrates Longer Survival Rates for Women in Metastatic Breast Cancer Receiving Trilaciclib & Chemotherapy

“The I-SPY 2 TRIAL is designed to evaluate agents with the goal of accelerating the pace of promising effective and potentially less toxic treatments to patients who are most likely to benefit quickly. We are excited to include trilaciclib in I-SPY 2, with the goal of determining whether adding trilaciclib to neoadjuvant chemotherapy-based treatment, either with or without an immune checkpoint inhibitor, increases the probability that the tumor will disappear prior to surgery, signaling a much better outcome and survival. The study will also measure how much chemotherapy lowers red and white blood cell levels (myelosuppression) to assess whether trilaciclib reduces any of these negative side effects, which have a significant impact on patient care and quality of life,” stated Dr. Laura J. Esserman, M.D., MBA, Principal Investigator of I-SPY 2 and Director of the Carol Franc Buck Breast Care Center at the UCSF Helen Diller Family Comprehensive Cancer Center. “As with other arms, the I-SPY 2 TRIAL has the ability to evaluate the drug across an array of biomarker signatures to learn the chance of how it will benefit patients and predict success in a confirmatory phase 3 trial.”

“The I-SPY 2 program is recognized as a leading breast cancer research initiative, and we are excited about the opportunity to evaluate the potential of trilaciclib to improve outcomes for a range of breast cancer subtypes. In our Phase 2 trial of women with triple-negative breast cancer, patients who received trilaciclib plus chemotherapy showed significant improvement in overall survival and reductions in the rate of red blood cell transfusions versus patients treated with chemotherapy alone. The I-SPY 2 study will allow us to evaluate trilaciclib for the first time in combination with several broadly-used chemotherapy classes. It will provide important data regarding which patients may benefit from treatment with trilaciclib and inform our future development plans.”

– Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D, G1 Therapeutics

The I-SPY 2 TRIAL, sponsored by QLHC, is a standing Phase 2 randomized, controlled, multicenter platform with an innovative Bayesian adaptive randomization design aimed to rapidly screen and identify promising new treatments in specific subgroups of adults with newly-diagnosed, high-risk (high likelihood of recurrence), locally-advanced breast cancer (Stage II/III). G1 Therapeutics will provide funding and trilaciclib and QLHC will be responsible for running the trial.

Related Article: Trial Results Show Trilaciclib Decreases Myelosuppression in Extensive-Stage Small Cell Lung Cancer (SCLC) Patients

Trilaciclib will be evaluated across all high-risk, early-stage breast cancer subtypes (including HR+, HER2+, and triple-negative breast cancer). All patients will receive standard neoadjuvant treatment, including chemotherapy (and anti-HER2 Mab for HER2+ disease) prior to surgical resection of breast tissue. Patients in two arms of the study will also receive anti-PD-1 immunotherapy in combination with paclitaxel prior to surgery. Biomarker data to evaluate the impact of trilaciclib on the tumor immune microenvironment, as well as pre-specified endpoints to evaluate anti-tumor efficacy and myelopreservation will be collected.

About Trilaciclib
Trilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy. Based on results from three randomized trials in patients with small-cell lung cancer, trilaciclib has received Breakthrough Therapy Designation, and G1 Therapeutics expects to submit marketing applications in the U.S. and Europe for myelopreservation in small cell lung cancer in 2020. In a randomized trial of women with metastatic triple-negative breast cancer, trilaciclib improved overall survival when administered in combination with chemotherapy compared with chemotherapy alone. In 2020, the company plans to initiate a Phase 3 clinical trial in colorectal cancer and begin a neoadjuvant trial in breast cancer as part of the I-SPY 2 TRIAL.

About the I-SPY TRIALs
The I-SPY 2 TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from more than 20 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations.

About Quantum Leap Healthcare Collaborative
Quantum Leap Healthcare Collaborative (QLHC) is a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at the University of California, San Francisco, and Silicon Valley entrepreneurs. Our mission is to integrate high-impact research with clinical processes and systems technology, resulting in improved data management and information systems, greater access to clinical trial matching and sponsorship, and greater benefit to providers, patients, and researchers. Quantum Leap provides operational, financial, and regulatory oversight to I-SPY.

About G1 Therapeutics
G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of innovative therapies that improve the lives of those affected by cancer. The company is advancing three clinical-stage programs. Trilaciclib is a first-in-class therapy designed to improve outcomes for patients being treated with chemotherapy. Trilaciclib has received Breakthrough Therapy Designation from the FDA; a rolling NDA submission for small cell lung cancer is expected to be completed in the second quarter of 2020. Rintodestrant (formerly G1T48) is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. Lerociclib is a differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies.

Company Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, those relating to lerociclib’s differentiated safety and tolerability profile over other marketed CDK4/6 inhibitors, the therapeutic potential of trilaciclib and the timing of marketing applications in the U.S. and Europe for trilaciclib in SCLC, whether adding trilaciclib to neoadjuvant chemotherapy-based treatment, either with or without a checkpoint inhibitor, will increase the probability of pathologic complete response, and whether the I-SPY 2 TRIAL will provide important data regarding which patients may benefit from treatment with trilaciclib and inform future development plans, and are based on the company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the company’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, the company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact:
Jeff Macdonald
Senior Director, Investor Relations & Corporate Communications
919-907-1944
jmacdonald@g1therapeutics.com

PLYMOUTH, Minn. /PRNewswire/ — HistoSonics, developer of a novel non-invasive sonic beam therapy platform, was named by The Observer as one of the nation’s most influential healthcare companies during the 38^th J.P. Morgan Healthcare Investment Conference in San Francisco, CA. The company’s platform, Edison, integrates robotics, imaging, and proprietary sensing technology, and uses the science of histotripsy and the mechanical properties of focused ultrasound to destroy and liquify targeted tissues at sub-cellular levels while preserving non-target tissue, which The Observer likened to advanced technology from science fiction movies set years in the future.  The Observer’s complete list of top “Flyover Tech” firms released recognizes leading digital health and medical technology start-ups residing in the US heartland and that are transforming their respective fields.

Related Article: HistoSonics Receives 2019 Frost & Sullivan Technology Innovation Award

“We are honored to lead The Observer’s list of innovative healthcare companies. We are equally proud to call Ann Arbor and Minneapolis home as we continue to expand our capabilities at each location.”

– Mike Blue, CEO & President, HistoSonics

The company recently completed its first clinical study in liver tumors, opened a new corporate headquarters, manufacturing and training center in Minnesota, and raised $54M in a Series C financing closed in 2019 which included heavyweight healthcare leaders Varian Medical Systems and Johnson & Johnson Innovation, JJDC, Inc., among others. 

HistoSonics proprietary technology is designed to provide potentially significant advantages to patients, including the non-invasive destruction of tumors without the need for surgery or other invasive procedures, while also providing physicians the unique ability to monitor and control the destruction of target tissue under continuous real-time visualization, unlike any modality that exists today. 

Edison is not yet commercially available.  Final performance specifications are subject to change pending the completion of regulatory market-access activities.

About HistoSonics

HistoSonics is a venture-backed medical device company whose mission is to redefine tumor treatment with a non-invasive, highly precise, cost-effective method of destroying tumors and diseased tissue called Robotically Assisted Sonic Therapy (RAST℠). The team at HistoSonics is currently developing a completely non-invasive platform that has the potential to deliver personalized treatments over a broad range of diseases in an outpatient setting, without the incisions, punctures, pain, scarring, and long recovery times associated with existing methods of treatment. RAST is based on the science of histotripsy, a non-invasive ablation modality that uses the pressure created by focused sound energy to destroy tissue at a sub-cellular level. HistoSonics is represented by a team of experienced specialists and industry leaders with offices in Ann Arbor, MI. and Minneapolis, MN.

HistoSonics, Inc. has raised $87M to date and expects to enter select markets late in 2020.

TEWKSBURY, Mass. /PRNewswire/ — Corvia Medical, Inc., a privately-held company with a first-in-class structural heart device to treat heart failure, today announced the first Japanese patients were randomized in Toyama and Hyogo under a clinical trial authorization from the Pharmaceutical and Medical Device Agency (PMDA) in the REDUCE LAP-HF II trial. The Corvia InterAtrial Shunt Device (IASD®) is the world’s first transcatheter device for treatment of heart failure with preserved (HFpEF) and mid-range (HFmrEF) ejection fraction.

Related Article: Corvia Medical’s Interatrial Shunt Device Receives Breakthrough Device Designation for Heart Failure

“We are very proud to be the first hospital in Japan to randomize patients in the trial. Currently, there are limited treatment options for patients suffering from heart failure with preserved and mid-range ejection fraction and I am encouraged by the positive outcomes the Corvia IASD has provided in previous clinical studies.”

– Professor Koichiro Kinugawa, M.D., University of Toyama Hospital

His heart team randomized the first patient at the University of Toyama Hospital.

Professor Masanori Asakura from the Hospital of Hyogo College of Medicine, also recently randomized their first patient in the trial.

“The Corvia IASD provides a much-needed therapeutic option for my heart failure patients. We are pleased to be a part of this landmark trial and we look forward to incorporating this technology into our heart failure treatment algorithm.”

– Professor Masanori Asakura, the Hospital of Hyogo College of Medicine

REDUCE LAP-HF II is a prospective, double-blind, sham-controlled clinical trial randomizing 608 HFpEF and HFmrEF patients in the US, EU, Australia, Japan, and Canada. The Corvia IASD received USA Food and Drug Administration (FDA) Breakthrough Device designation, underscoring its clinical significance and its potential to improve outcomes for heart failure patients, with the potential for accelerated USA market clearance.

Related Article: Corvia Medical Announces Strong Positive One-Year Data from REDUCE LAP-HF I Randomized, Sham-Controlled Clinical Trial

“The Japanese investigators are pleased to participate in REDUCE LAP-HF II, a global trial of the InterAtrial Shunt Device (IASD) for patients with HFpEF and HFmrEF, for which effective treatment strategies have not been established. We hope this landmark trial will be a great success and provide important clinical evidence regarding the efficacy and safety of this novel therapy,”

– Professor Hiroyuki Tsutsui, Kyushu University and Primary Investigator for Japan

“We recognize the randomization of the first patients in Japan as an important advance in the clinical evaluation of the Corvia IASD. I would like to thank Professor Tsutsui and Professor Yamamoto, who provided clinical perspective and academic understanding to the protocol review by PMDA,” commented George Fazio, President, and CEO of Corvia Medical. “We would also like to thank the many physicians and research staff around the world for their continued support of the REDUCE LAP-HF II trial. Our technology has the potential to reduce recurrent heart failure hospitalizations and improve quality of life for many patients and we are encouraged by the trial’s momentum, bringing us one step closer to providing the Corvia IASD therapy to heart failure patients around the world.”

About Heart Failure
There are two types of heart failure: heart failure with reduced ejection fraction (HFrEF), also called systolic heart failure, and heart failure with preserved or mid‐range ejection fraction (HFpEF/HFmrEF), previously called diastolic heart failure. Ejection fraction (EF) is a measurement of how well blood is pumped out of the heart during a single contraction and is noted as a percentage, with normal range between 50%-75%, and mid-range between 40%-50%. HFpEF and HFmrEF occur when the muscles of the left ventricle become stiff and unable to relax normally. As a result, it cannot fill properly. This means the pressure inside the left heart chambers and the lungs increases. Medicines that are effective for treating the other type of heart failure (HFrEF) frequently do not work well for HFpEF or HFmrEF and treatment options are currently very limited.

About the Corvina InterAtrial Shunt Device (IASD^®)
The Corvia InterAtrial Shunt Device is the world’s first transcatheter device to treat heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF). After creating a small opening in the atrial septum, the Corvia IASD implant is deployed, forming a passage between the left and right atria that enables the left atrium to decompress at rest and during physical activity, with the aim of lowering left atrial pressure. By facilitating continuous and dynamic decompression of the left atrium, the Corvia IASD System aims to improve heart failure symptoms and quality of life, decrease heart failure hospitalization rates, and reduce the overall cost burden of managing heart failure patients. The Corvia IASD System is an investigational device and not available for commercial distribution in the United States.

About Corvia Medical, Inc.
Corvia Medical, Inc. is dedicated to revolutionizing the treatment of heart failure with first-in-class transcatheter structural heart devices. Privately held, the company is backed by Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, Edwards Lifesciences and an undisclosed strategic investor.

¹Hasenfuß G., Hayward C., Burkhoff D. et al. A Transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicenter, open-label, single-arm, phase 1 trial. Lancet 2016; 387;1298-304.
²Kaye D., Hasenfuß G., Neuzil P., et al. One-Year Outcomes After Transcatheter Insertion of an Intratrial Shunt Device for the Management of Heart Failure with Preserved Ejection Fraction. Circ Heart Fail. 2016.

MEDIA CONTACT:
Jennifer Fitzgerald
+1-484-678-5018
jen@sprigconsulting.com

QUEBEC CITY /CNW Telbec/ – Opsens Inc. (“Opsens” or the “Company”) (TSX: OPS) (OTCQX: OPSSF) today announced 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market its OptoWire III, a coronary pressure guidewire for physiological measurements such as Fractional Flow Reserve (“FFR”) and Diastolic Pressure Ratio (“dPR”). The OptoWire III is the latest version of OptoWire.

Related Article: First Clinical Use of the OptoWire III following Health Canada Approval

The OptoWire family of products are used to diagnose and guide the treatment of patients with coronary heart disease.

“Opsens is pleased to receive this important regulatory approval as we continue to optimize both the performance and production of our flagship product family. Physicians will appreciate a design with increased maneuverability, strength and a shorter flexible tip, particularly in challenging and complex cases. In addition to design and mechanical improvements, Opsens has also improved the efficiency of the manufacturing process of its flagship product, which will result in improved gross profit margins going forward.”

– Louis Laflamme, President and CEO, Opsens

Dr. Morton Kern, MD, MSCAI, FACC, FAHA, Chief of Medicine at Long Beach VA Medical Center, California, has extensive experience with the OptoWire II. He was the first interventional cardiologist to use the OptoWire III in the U.S. “I have been using the OptoWire for many years and consider it to be the best pressure guidewire on the market to access, measure, treat and confirm percutaneous coronary interventions (“PCI”) in patients with coronary disease,” said Dr. Kern. “The OptoWire III provides unexpected improvements over the OptoWire II – steerability is on par with workhorse guidewires while providing even more accurate and sustainable measurements. I also appreciate the ability to measure a variety of indices from FFR to Non-Hyperemic Pressure Ratios such as Opsens dPR,” added Dr. Kern. “I am a firm believer in coronary physiology pre- and post-PCI, and although usage has remained limited mostly due to device limitations. This product is unique and further supports what the clinical studies and medical societies recommend,” concluded Dr. Kern.

Related Article: Opsens Expands Medical Device Business into Structural Cardiology Market

Securing 510(k) is an important step in Opsens’ plan to grow revenues in the U.S., as the Company is constantly improving its products to increase penetration in the U.S. and other targeted markets.

In addition to the United States and Canada, Opsens has also filed applications for approval in Japan, and Europe.

About Opsens Inc.

Opsens focuses mainly on physiological measurements, such as FFR and dPR in interventional cardiology. Opsens offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. Its flagship product, the OptoWire, is a second-generation fiber optic pressure guidewire designed to provide the lowest drift in the industry and excellent lesions access. The OptoWire has been used in the diagnosis and treatment of over 80,000 patients in more than 30 countries. It is approved for sale in the United States, European Union, Japan, and Canada.

Opsens is also involved in industrial activities in developing, manufacturing and installing innovative fiber optic sensing solutions for critical applications.

Forward-looking statements contained in this press release involve known and unknown risks, uncertainties and other factors that may cause actual results, performance and achievements of Opsens to be materially different from any future results, performance or achievements expressed or implied by the said forward-looking statements.

Neither TSX nor its Regulation Services Provider (as that term is defined in the policies of the TSX) accept responsibility for the adequacy or accuracy of this release.

SEATTLE / PRNewswire / — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, including the Carnation Ambulatory Monitor (“CAM™”), the only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device, announced today the appointment of Ed Vertatschitsch as Chief Operating Officer effective January 2, 2020. With over 17 years in the medical device industry, Vertatschitsch will be responsible for leading all operations, research & development, and regulatory and quality affairs functions.

“We are pleased to have Ed Vertatschitsch join BardyDx’s executive team. Vertatschitsch brings a wealth of operational and development experience across the spectrum from early-stage to large-sized companies. We are thrilled to have him join our team as we continue to expand our product line and rapidly broaden our customer base.”

Gust Bardy, M.D., Founder & CEO, BardyDx

Prior to joining BardyDx, Vertatschitsch served as VP of Global Portfolio Solutions, VP of Treatment and Imaging Solutions – Delivery Systems, and General Manager at Varian Medical Systems. Vertatschitsch joined Varian Medial Systems following the acquisition of Calypso Medical, where he was President and CEO. Previously, he also served as EVP Operations and R&D and VP of Engineering at Calypso Medical. Vertatschitsch possesses strong cross-industry development experience, including leadership roles at Palm and Boeing.

Related Article: Bardy Diagnostics™ Receives 510(k) Clearance from U.S. FDA for its 14-Day CAM™ Patch

“BardyDx is experiencing accelerating growth with the success of the CAM patch and the development of novel ECG analysis technologies. It is an honor to join Dr. Bardy and the innovative team at BardyDx, and I am excited and eager to help further the company’s success.”

– Ed Vertatschitsch, COO, BardyDx

BardyDx also announced today the following additions to its Leadership Team: 

• Cristina Gutierrez – Gutierrez has been appointed VP of Market Development & Training. She brings cardiac monitoring experience having formerly served as Director of Marketing at iRhythm Technologies. Gutierrez possesses over 19 years of experience and has held senior marketing and sales positions at MedBridge, Athios Health, Velano Vascular, FoxHollow Technologies (acquired by ev3 and Covidien), and Cordis.
• Liz Mynhier – Mynhier has been promoted from Sr. Director to VP of Clinical Services & Customer Experience. With over 17 years of experience in cardiology and electrophysiology, Mynhier has managed and grown BardyDx’s ECG monitoring center located in Houston, Texas. Prior to BardyDx, she served in the Cardiac Rhythm Management division at Medtronic and Biotronik.
• Brit Baird – Baird has been promoted from Sr. Director to VP of Regulatory Affairs & Quality Assurance. He possesses over 23 years of experience with senior regulatory, quality, and manufacturing roles at EKOS Corporation (a BTG International group company), Pathway Medical Technologies (acquired by Bayer Healthcare), and Boston Scientific.

“I’m thrilled to welcome the newest additions to our Leadership Team. I have had the pleasure of working with Vertatschitsch in the past and look forward to working with him again. Our ability to recruit talented people from the outside, while providing opportunities for promotions and career progression within our organization, is a testament to the strength of our products, our management team, and our investors.”

– Mark Handfelt, Chief Administrative Officer, BardyDx

About Bardy Diagnostics:

Bardy Diagnostics, Inc. is an innovator in digital health and remote patient monitoring, with a focus on providing the most diagnostically-accurate and patient-friendly cardiac patch monitors to the industry. The company’s CAM patch is a non-invasive, P-wave centric™ ambulatory cardiac monitor and arrhythmia detection device that is designed to improve patient compliance for adults and children through its lifestyle-enabling form factor. Designed to be worn comfortably and discreetly for up to 14 days, the female-friendly, hourglass-shaped CAM patch is placed on the center of the chest, directly over the heart for optimum ECG signal collection. The proprietary technology of the CAM patch provides optimal detection and clear recording of the often difficult-to-detect P-wave, the signal of the ECG waveform that is essential for accurate arrhythmia diagnosis.

MEDIA CONTACT:
Jonathan Wu
Senior Director, Marketing
Bardy Diagnostics, Inc.
1-844-422-7393
jwu@bardydx.com

VANCOUVER, British Columbia–(BUSINESS WIRE)– Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announced the initiation of a Phase 2 trial evaluating ZW25 combination therapy and an agreement with Pfizer which advances the study. Zymeworks’ HER2-targeted bispecific antibody ZW25 is being evaluated in combination with Pfizer’s Ibrance® (palbociclib), an oral CDK4/6 inhibitor, and the hormone therapy fulvestrant in patients with previously-treated locally advanced and/or metastatic HER2-positive, HR-positive breast cancer. Zymeworks will sponsor the study, and Pfizer will provide palbociclib.

“The initiation of this Phase 2 trial and collaboration with Pfizer mark significant milestones in our progress towards establishing ZW25 as the foundational HER2 therapy in multiple regimens across the breast and other cancers. Together, ZW25 and palbociclib have the potential to improve anti-tumor activity and minimize side effects for people living with advanced HER2‑positive, HR-positive breast cancer.”

– Diana Hausman, M.D., Chief Medical Officer, ZymeWorks

This Phase 2 clinical trial is a multicenter, open-label, two-part study (clinicaltrials.gov: NCT04224272). Part one of the study will evaluate the safety and tolerability of ZW25 in combination with palbociclib and fulvestrant and identify the recommended doses (RD) of ZW25 and palbociclib. Part two of the study will evaluate anti-tumor activity at the RD level. The trial will enroll up to 76 patients at sites in the United States and Canada, and expansion to Spain is planned.

Related Article: Zymeworks Earns Milestone Payment in Merck Collaboration

ZW25 is being evaluated within a broad clinical development program in multiple HER2‑expressing cancers, including biliary tract, gastroesophageal adenocarcinoma (GEA), breast, colorectal, and gynecologic cancers. In an ongoing Phase 1 clinical trial, Zymeworks is evaluating ZW25 as a single agent and in combination with chemotherapy as potential treatments for patients with HER2-expressing cancers (clinicaltrials.gov: NCT02892123). For patients with HER2-positive GEA, ZW25 is being studied in a Phase 2 trial as a first-line treatment in combination with standard of care chemotherapy (clinicaltrials.gov: NCT03929666). Zymeworks plans to initiate a registration-enabling Phase 2 trial in previously-treated or recurrent HER2-positive biliary tract cancer in 2020.

Related Article: Zymeworks Announces Updated Single Agent Data for HER2-Targeted Bispecific Antibody ZW25 at ESMO Congress 2019

About Breast Cancer

Breast cancer occurs when cells of the breast grow uncontrollably. According to the World Health Organization, each year, over 2 million new cases of breast cancer are diagnosed and over 600,000 deaths occur globally. Rates are increasing in nearly every region of the world. For locally advanced or metastatic breast cancer, the American Cancer Society estimates over 271,000 new US cases in men and women this year. About 15 to 20 percent of all breast cancers are positive for human epidermal growth factor receptor 2, or HER2. These cancers make too much HER2 protein, which may cause them to grow more quickly and spread to other parts of the body. Despite the advances with available HER2-targeted therapies, there is still an unmet medical need for people with all HER2-expressing cancers, particularly recurrent or metastatic disease that has progressed after standard of care therapy.

About ZW25

ZW25 is being evaluated in Phase 1 and Phase 2 clinical trials across North America and South Korea. It is a bispecific antibody, based on Zymeworks’ Azymetric™ platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging anti-tumor activity in patients. Zymeworks is developing ZW25 as a HER2-targeted treatment option for patients with solid tumors that express HER2. The FDA has granted Fast Track designation to ZW25 for first-line gastroesophageal adenocarcinoma in combination with standard of care chemotherapy and Orphan Drug designation to ZW25 for the treatment of both gastric and ovarian cancers.

About Zymeworks Inc.

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics. Zymeworks’ suite of therapeutic platforms and its fully-integrated drug development engine enable precise engineering of highly differentiated product candidates. Zymeworks’ lead clinical candidate, ZW25, is a novel Azymetric™ bispecific antibody currently in Phase 2 clinical development. Zymeworks’ second clinical candidate, ZW49, is a bispecific antibody-drug conjugate currently in Phase 1 clinical development and combines the unique design and antibody framework of ZW25 with Zymeworks’ proprietary ZymeLink™ cytotoxic payload. Zymeworks is also advancing a deep preclinical pipeline in oncology (including immuno-oncology agents) and other therapeutic areas. In addition, its therapeutic platforms are being leveraged through strategic partnerships with nine biopharmaceutical companies. For more information, visit www.zymeworks.com.

Cautionary Note Regarding Zymeworks’ Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this news release include statements that relate to ZW25 and its potential as an anti-cancer treatment, Zymeworks’ collaboration with Pfizer and the potential efficacy of ZW25 in combination with palbociclib, Zymeworks’ clinical plans and future results, Zymeworks’ technology platform, and other information that is not historical information. When used herein, words such as “will”, “believe”, “may”, “plan”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under “Risk Factors” in Zymeworks’ Quarterly Report on Form 10-Q for the three month period ended September 30, 2019 (a copy of which may be obtained at www.sec.gov and www.sedar.com). Consequently, forward-looking statements should be regarded solely as Zymeworks’ current plans, estimates, and beliefs. You should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance, or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events, except as may be required by law.

Investor Inquiries:
Ryan Dercho, Ph.D.
(604) 678-1388
ir@zymeworks.com

Tiffany Tolmie 
(604) 678-1388 
ir@zymeworks.com

Media Inquiries: 
Kavita Shah, Ph.D.
(604) 678-1388 
media@zymeworks.com 

BOSTON and MONTRÉAL /PRNewswire/ – enGene Inc., the biotechnology company developing rationally designed gene therapies targeted to mucosal tissues through its proprietary non-viral vector DDX® platform, today announced the appointments of Sharon Tan as Vice President and Head of Program Management, and Lance Dieter as Vice President of CMC and Head of Manufacturing, to further propel the development of the company’s gene therapies.

“As we continue to advance our pipeline of gene therapies for potential treatments and cures, the addition of talented and dedicated people will continue to be crucial to achieving our mission. The addition of Sharon and Lance to our growing team in Boston highlights our drive to bring forward meaningful medications to impact patients’ lives.”

– Jason Hanson, President and CEO, enGene

Related Article: enGene Appoints Veteran Life Sciences Executive Jason. D. Hanson as Chief Executive Officer and President

Ms. Tan brings to enGene extensive experience in preclinical and clinical gene therapy program leadership and management. Prior to joining enGene, she led programs from pre-clinical stage through IND-enabling and into Phase 1/2 human studies as Executive Director at Ultragenyx Gene Therapy. Prior to Ultragenyx, she served as Executive Director at Enzyvant as well as Global Project Head at Sanofi Genzyme where she led early and late-stage clinical development programs in the multiple rare disease areas.

“I am honored to join the growing team at enGene and to be part of fulfilling the company’s vision of becoming the leader of innovative gene therapies that improve patients’ quality of life.”

– Sharon Tan, Vice President and Head of Program Management, enGene

Related Article: enGene Announces Strategic Collaboration with Johnson & Johnson Innovation to Develop Novel Gene Delivery Products for Inflammatory Bowel Disease

Mr. Dieter joins enGene with over 23 years’ experience spanning from bench research to product licensure, including analytical and process development and manufacturing integration. He started his career in vaccines bioprocess development at Merck & Co., where he grew his CMC career for 19 years. Most recently, Mr. Dieter served as the Director of Process Development/Scale-up at Moderna in Cambridge, MA, where he and his team were responsible for development and GMP manufacturing of multiple programs at various stages of clinical development.

“enGene’s DDX® platform represents a new era in gene therapy – one which can potentially transform how we treat and cure diseases. I am thrilled to join such an innovative company at this important inflection point as enGene advances its first wave of genetic medicines,”

– Lance Dieter, Vice President of CMC and Head of Manufacturing, enGene

About enGene Inc.
enGene Inc. is a biotechnology company developing a proprietary non-viral gene therapy platform for localized delivery of nucleic acid payloads to mucosal tissues. The dually derived chitosan (DDX®) platform has a high-degree of payload flexibility including DNA and various forms of RNA (siRNA, shRNA, lncRNA etc.) with broad tissue and disease applications. In addition to developing gene therapies for mucosal tissues such as the bladder, enGene has developed a unique gut-optimized gene delivery formulation into an orally available Gene Pill™ to provide oral delivery of a wide range of protein drugs. Oral gene delivery is a revolutionary improvement over current protein-drug delivery methods which involve injections and represent risks of side effects, high cost, poor patient compliance and systemic problems due to the need to administer higher doses. The company is evolving its technology to enable treatments of all mucosal tissues such as the lung and eye among others.

TORONTO, ON / ACCESSWIRE / Edesa Biotech, Inc. (Nasdaq: EDSA), a clinical-stage biopharmaceutical company, today announced that it has entered into definitive securities purchase agreements with certain institutional and accredited investors as well as company insiders in a registered direct offering of an aggregate of 1,355,380 common shares. The price per share for investors other than investors that are officers, directors, employees or consultants of the company is $3.20 and, for each investor that is an officer, director, employee or consultant of the company, $4.11.

Related Article: Edesa Biotech’s Lead Candidate, EB01, Demonstrates Positive Safety Data

In a concurrent private placement, the company agreed to sell to such investors Class A Purchase Warrants to purchase an aggregate of up to 1,016,553 of the company’s common shares, or 0.75 of a common share for each share purchased in the offering, and Class B Purchase Warrants to purchase an aggregate of up to 677,703 of the company’s common shares, or 0.50 of a common share for each share purchased in the offering. The Class A Purchase Warrants will be exercisable at any time on or after the six month anniversary of their date of issuance, at an exercise price of $4.80 per share and will expire on the third anniversary of the date they initially become exercisable. The Class B Purchase Warrants will be exercisable at any time on or after the six month anniversary of their date of issuance, at an exercise price of $4.00 per share and will expire on the four-month anniversary of the date they initially become exercisable.

Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as Edesa’s U.S. financial adviser and placement agent for the offering in the United States. Non-U.S. investors participated in the offering via a concurrent non-brokered placement. The closing of the offering and concurrent private placement is expected to occur on or about January 8, 2020, subject to the satisfaction of customary closing conditions.

Related Article: Edesa Biotech Enrolls First Patient in Phase 2b Dermatitis Study

The gross proceeds to Edesa are expected to be approximately $4.36 million. Edesa intends to use the net proceeds from the offering primarily for working capital and for general corporate purposes, including research and development.

The common shares are being offered pursuant to an effective shelf registration statement on Form S-3 (File No. 333-233567), which was previously filed with the Securities and Exchange Commission (SEC) and declared effective on September 12, 2019. The warrants to be issued in the concurrent private placement and shares issuable upon exercise of such warrants have not been registered under the Securities Act of 1933, as amended (the Securities Act) or applicable state securities law and are being offered pursuant to Section 4(a)(2) of the Securities Act and Regulation D promulgated thereunder.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

A prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website. The offering is being made only by means of a prospectus and related prospectus supplement, copies of which may be obtained, when available, from Edesa Biotech, Inc. via email at investors@edesabiotech.com or telephone at (805) 488-2800. No Canadian prospectus has been or will be filed in a province or territory of Canada to qualify the securities in connection with the offering.

About Edesa Biotech, Inc.
Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on efficiently developing innovative treatments that address significant unmet medical needs. Edesa’s lead product candidate, EB01, is a novel non-steroidal anti-inflammatory molecule (sPLA2 inhibitor) for the treatment of chronic allergic contact dermatitis which has demonstrated statistically significant improvements in multiple clinical studies. A Phase 2b clinical study of EB01 was initiated in October 2019. Edesa also intends to expand the utility of its sPLA2 inhibitor technology across multiple indications and expand its portfolio with assets that can drive long-term growth opportunities. The company is based in Markham, Ontario, Canada, with U.S. offices in Southern California.

Edesa Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions. Forward-looking statements in this press release include the anticipated closing date of the offering and anticipated proceeds from the offering. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa’s operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa’s product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa’s ability to protect its intellectual property and the timing and success of submission, acceptance, and approval of regulatory filings. Many of these factors that will determine actual results are beyond the company’s ability to control or predict. For a discussion of further risks and uncertainties related to Edesa’s business, please refer to Edesa’s public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

Contacts
Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800 ext. 150
investors@edesabiotech.com

TORONTO, ON / ACCESSWIRE / December 12, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today reported financial results for the nine-month period ended September 30, 2019 and provided an update on its business.

Edesa recently enrolled the first patient in a Phase 2b clinical study of its lead product candidate, EB01. The company is developing EB01 as a monotherapy for patients with chronic allergic contact dermatitis (ACD), a debilitating disease that is frequently caused by allergens present in the workplace. In December, the company reported that based on positive safety data in healthy volunteers, the company would expand the study to include ACD patients with symptoms on the face, a commonly effected area. The experimental drug previously demonstrated positive results in two previous studies in ACD patients.

In 2019, Edesa also advanced plans to expand the utility of its anti-inflammatory technology, which forms the basis of EB01, into additional indications. This included an approval by Health Canada to conduct a proof-of-concept study of the company’s product candidate, EB02, as a treatment for hemorrhoids disease (HD).

“We have maintained a rapid pace this year and I’m pleased to report that our team has delivered on our key clinical and corporate milestones. In addition to the transition we made to the public equity markets, we laid the foundation for a number of value creation opportunities in the coming year. We are looking forward to the interim data readout for our Phase 2b study in ACD as well as initiating a clinical study of our anti-inflammatory technology in HD.”

– Dr. Par Nijhawan, Chief Executive Officer, Edesa Biotech

Edesa’s Chief Financial Officer, Kathi Niffenegger, CPA reported that operating expenses, including expenditures related to increased activities for the EB01 clinical program, were largely in line with management’s expectations for the fiscal year.

“We remain committed to the capital efficient product development model that Edesa adopted as a private company and plan to continue to focus our working capital on the advancement of our clinical pipeline.”

– Kathi Niffenegger, CPA, Chief Financial Officer, Edesa Biotech

Financial Results for the Nine-Month Period Ended September 30, 2019*

The company’s year-end financial results reflect a nine-month period as a result of a change in fiscal year following the company’s reverse acquisition completed in June 2019.

Total revenues for the nine-month period ended September 30, 2019 were $0.41 million, reflecting the initiation of sales of product inventory obtained in the reverse acquisition completed in June 2019. There were no revenues for the year ended December 31, 2018.

Total operating expenses increased by $1.62 million to $3.24 million for the nine-month period ended September 30, 2019 compared to $1.62 million for the prior year ended December 31, 2018:

For the nine-month period ended September 30, 2019, Edesa reported a net loss of $2.78 million, or $0.55 per basic share, compared to a net loss of $1.54 million, or $0.47 per basic share, for the prior year ended December 31, 2018.

Working Capital

At September 30, 2019, the company had working capital of $5.18 million. Cash and cash equivalents totaled $5.03 million.

Calendar

Management will be attending the Dermatology Summit on January 12, 2020 and the Biotech Showcase from January 13-15, 2020. Both events are being held in San Francisco, California. Members of the investment or biopharma communities interested in meetings with management can schedule one-on-ones through the conference online systems or by contacting Edesa at .

*As a result of the acquisition accounting for the business combination completed on June 7, 2019, and the subsequent change in year end of the company’s subsidiary Edesa Biotech Research, Inc., the comparative year-end data represent the nine months period ended September 30, 2019 and the twelve months ended December 31, 2018, which should be taken into account when reviewing comparative results. Financial results for any periods ended prior to June 7, 2019 reflect the financials of Edesa Biotech Research, Inc. on a standalone basis.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on efficiently developing innovative treatments that address significant unmet medical needs. Edesa’s lead product candidate, EB01, is a novel non-steroidal anti-inflammatory molecule (sPLA2 inhibitor) for the treatment of chronic allergic contact dermatitis which has demonstrated statistically significant improvements in multiple clinical studies. A Phase 2b clinical study of EB01 was initiated in October 2019. Edesa also intends to expand the utility of its sPLA2 inhibitor technology, which forms the basis for EB01, across multiple indications and expand its portfolio with assets that can drive long-term growth opportunities. The company is based in Markham, Ontario, Canada, with U.S. offices in Southern California.

Edesa Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions, including statements related to: the company’s plans to expand the utility of its sPLA2 anti-inflammatory technology into additional indications, including HD. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa’s operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa’s product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa’s ability to protect its intellectual property and the timing and success of submission, acceptance and approval of regulatory filings. Many of these factors that will determine actual results are beyond the company’s ability to control or predict. For a discussion of further risks and uncertainties related to Edesa’s business, please refer to Edesa’s public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

Media and Investor Contact
Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800
investors@edesabiotech.com

VICTORIA, British Columbia–(BUSINESS WIRE)– Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today announced the closing of its previously announced underwritten public offering of 12,782,439 common shares, including 1,667,274 common shares pursuant to the full exercise of the underwriters’ option to purchase additional common shares (the “Offering”). The shares were sold at a public offering price of US$15.00 per share. The gross offering proceeds to the Company from this Offering are approximately US$191.7 million, before deducting underwriting discounts and commissions and other estimated offering expenses.

Jefferies LLC and SVB Leerink LLC acted as joint book-running managers for the Offering. H.C. Wainwright & Co. LLC, Oppenheimer & Co. Inc., and Bloom Burton Securities Inc. acted as co-managers for the Offering.

For the purposes of the TSX approval, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible inter-listed issuers on a recognized exchange, such as NASDAQ.

The Company intends to use the net proceeds of the Offering for pre-commercialization and launch activities, as well as working capital and general corporate purposes.

Related Article: Aurinia Prices $166.7M Public Offering of Common Shares

The Offering was made pursuant to a U.S. registration statement on Form F-10, declared effective by the United States Securities and Exchange Commission (the “SEC”) on March 29, 2018 (the “Registration Statement”), and the Company’s existing Canadian short form base shelf prospectus (the “Base Shelf Prospectus”) dated March 26, 2018. The prospectus supplements relating to the Offering (together with the Base Shelf Prospectus and the Registration Statement, the “Offering Documents”) have been filed with the securities commissions in the provinces of British Columbia, Alberta and Ontario in Canada, and with the SEC in the United States. The Offering Documents contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed for more complete information about the Company and the Offering. Copies of the Offering Documents are available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov, as applicable. Alternatively, copies of the prospectus supplement are available upon request by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by e-mail at Prospectus_Department@Jefferies.com; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132, or by email at syndicate@svbleerink.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

About Aurinia Pharmaceuticals

Aurinia Pharmaceuticals is a late clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently developing an investigational drug, for the treatment of lupus nephritis, focal segmental glomerulosclerosis and dry eye syndrome. The Company’s head office is in Victoria, British Columbia and focuses its development efforts globally.

Investors & Media:
Glenn Schulman, PharmD, MPH
SVP, Corporate Communications & IR
gschulman@auriniapharma.com

RESEARCH TRIANGLE PARK, N.C. and SAN ANTONIO (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today reported additional data from the Phase 1b/2a clinical trial investigating its oral CDK4/6 inhibitor lerociclib in combination with fulvestrant for the treatment of estrogen receptor-positive, HER2-negative (ER+, HER2-) breast cancer. Updated findings presented during a poster session (P1-19-17) at the 2019 San Antonio Breast Cancer Symposium (SABCS) showed lerociclib, dosed without a drug holiday, has a differentiated safety and tolerability profile than observed in clinical trials with currently marketed CDK4/6 inhibitors. Preliminary efficacy findings were consistent with other CDK4/6 inhibitors used in combination with fulvestrant.

Related Article: FDA Grants G1 Therapeutics Breakthrough Therapy Designation & Provides Q2 2019 Financial Update

The Phase 1b/2a trial is designed to evaluate the safety, tolerability and efficacy of lerociclib administered continuously in combination with fulvestrant as a treatment for ER+, HER2- breast cancer and identify the dose and schedule for future trials of lerociclib. Further investigation is ongoing, with longer-duration efficacy data required to determine the dose for future study in a Phase 3 clinical trial. The company expects to share an update in 2020.

“We designed lerociclib to improve upon the clinical profiles of currently available CDK4/6 inhibitors. The findings from this trial showed that twice-daily dosing of lerociclib with fulvestrant was well tolerated, with 150 mg demonstrating less neutropenia and gastrointestinal side effects. We look forward to evaluating the mature efficacy data for the 150 mg and 200 mg cohorts as we prepare to advance lerociclib into pivotal development.”

– Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D, G1 Therapeutics

About the Lerociclib Trial
Patients enrolled in the Phase 1a/2b clinical trial are women of any menopausal status with locally advanced or metastatic ER+, HER2- breast cancer who had progressed during or within 12 months after adjuvant therapy or progressed during or within two months after endocrine therapy for advanced or metastatic disease. As of October 7, 2019, 110 trial participants received lerociclib at doses ranging from 200-650 mg once daily (QD) and 100-250 mg twice daily (BID). Fulvestrant 500 mg was administered on Day 1, 15, 29, and then once monthly, per standard of care. Preliminary findings were announced in June 2018.

Updated Findings

• Continuous lerociclib dosing with fulvestrant was well tolerated, with BID dosing having a differentiated safety profile
  — Low rates of Grade 4 neutropenia support continuous lerociclib dosing without a drug holiday
  — BID dosing demonstrated improved safety and tolerability profile compared with QD dosing, with lower rates of gastrointestinal adverse events (AEs)
  — Low rates of lerociclib-related stomatitis and alopecia were observed across all dose levels in both dosing schedules
• Coadministration of fulvestrant had minimal impact on the pharmacokinetics (PK) of lerociclib
• The efficacy data were consistent with those from other CDK4/6 inhibitors used in combination with fulvestrant
  — The combination of lerociclib and fulvestrant was active, with a 65.2% clinical benefit rate and a median progression-free survival (PFS) of 15 months observed across the entire study; median PFS was 12.8 months for all QD dose levels combined and not reached for all BID dose levels combined

The poster presented at SABCS is available on the G1 website.

About Lerociclib
Lerociclib is a differentiated oral CDK4/6 inhibitor being developed for use in combination with other targeted therapies in certain types of breast and lung cancer. Preliminary clinical data in estrogen receptor-positive, HER2-negative (ER+, HER2-) breast cancer have demonstrated proof-of-concept of the differentiated clinical profile of lerociclib versus currently marketed CDK4/6 inhibitors, with improved tolerability and less neutropenia. Neutropenia is one of the main toxicities associated with CDK4/6 inhibition. Current treatments require frequent blood testing for neutropenia. Less monitoring would mean fewer office visits and blood draws, improving the experience for patients and reducing the burden on physician offices and costs to the healthcare system.

About G1 Therapeutics
G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of innovative therapies that improve the lives of those affected by cancer. The company is advancing three clinical-stage programs. Trilaciclib is a first-in-class therapy designed to improve outcomes for patients being treated with chemotherapy. Trilaciclib has received Breakthrough Therapy Designation from the FDA; a rolling NDA submission for small cell lung cancer will begin in 4Q19 and is expected to be completed in the second quarter of 2020. Lerociclib is a differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies. G1T48 is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. G1 Therapeutics also has an active discovery program focused on cyclin-dependent kinase targets.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, those relating to lerociclib’s differentiated safety and tolerability profile over other marketed CDK4/6 inhibitors, whether lerociclib’s preliminary efficacy findings will continue to be consistent with other CDK4/6 inhibitors, lerociclib’s potential advancement into pivotal trials and the therapeutic potential of trilaciclib and the timing of marketing applications in the U.S. and Europe for trilaciclib in SCLC, and are based on the company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the company’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, the company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact:
Jeff Macdonald
Senior Director, Investor Relations & Corporate Communications
919-907-1944
jmacdonald@g1therapeutics.com

VICTORIA, British Columbia–(BUSINESS WIRE)– Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today announced the pricing of its underwritten public offering of 11,115,165 common shares (the “Offering”). The shares are being sold at a public offering price of US$15.00 per share. The gross offering proceeds to the Company from this Offering are expected to be approximately US$166.7 million, before deducting underwriting discounts and commissions and other estimated offering expenses. All of the shares are being offered by the Company. The Offering is expected to close on or about December 12, 2019, subject to the satisfaction of customary closing conditions.

Jefferies LLC and SVB Leerink LLC are acting as joint book-running managers for the Offering. H.C. Wainwright & Co. LLC, Oppenheimer & Co. Inc., and Bloom Burton Securities Inc. are acting as co-managers for the Offering. The Company has granted the underwriters an option exercisable, in whole or in part, in the sole discretion of the underwriters, to purchase 1,667,274 additional shares, for a period of up to 30 days.

The Offering is subject to customary closing conditions, including NASDAQ and TSX approvals. For the purposes of the TSX approval, the Company intends to rely on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as NASDAQ.

The Company intends to use the net proceeds of the Offering for pre-commercialization and launch activities, as well as working capital and general corporate purposes.

Related Article: Aurinia Closes US$173.1 Million Public Offering of Common Shares and Full Exercise of Underwriters’ Option to Purchase Additional Common Shares

The Offering is being made pursuant to a U.S. registration statement on Form F-10, declared effective by the United States Securities and Exchange Commission (the “SEC”) on March 29, 2018 (the “Registration Statement”), and the Company’s existing Canadian short form base shelf prospectus (the “Base Shelf Prospectus”) dated March 26, 2018. A preliminary prospectus supplement relating to the Offering has been filed with the securities commissions in the provinces of British Columbia, Alberta and Ontario in Canada, and with the SEC in the United States (the “Preliminary Prospectus”), and a final prospectus supplement relating to the Offering (together with the Preliminary Prospectus, Base Shelf Prospectus and the Registration Statement, the “Offering Documents”) will be filed with the securities commissions in the provinces of British Columbia, Alberta and Ontario in Canada, and with the SEC in the United States. The Offering Documents will contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed for more complete information about the Company and the Offering. Copies of the Offering Documents will be available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov, as applicable. Alternatively, copies of the prospectus supplement will be available upon request by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by e-mail at Prospectus_Department@Jefferies.com; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132, or by email at syndicate@svbleerink.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

ABOUT AURINIA

Aurinia Pharmaceuticals is a late clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently developing an investigational drug, for the treatment of lupus nephritis, focal segmental glomerulosclerosis and dry eye syndrome. The Company’s head office is in Victoria, British Columbia and focuses its development efforts globally.

Investors & Media:
Glenn Schulman, PharmD, MPH
SVP, Corporate Communications & IR
gschulman@auriniapharma.com

VICTORIA, British Columbia–(BUSINESS WIRE)– Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced positive efficacy and safety results from its pivotal AURORA Phase 3 trial of voclosporin, in combination with mycophenolate (“MMF”) and low-dose corticosteroids, in the treatment of lupus nephritis (“LN”).

“This extraordinary pivotal data confirms voclosporin’s ability to achieve statistically significant improvements in clinically meaningful endpoints for this complex disease, with a comparable safety profile to the current standard of care. This data represents a significant advance for people living with LN, which can lead to irreversible kidney damage, eventual kidney failure and death.”

– Neil Solomons, M.D., Chief Medical Officer, Aurinia

This global study in which 357 patients with active LN were enrolled, met its primary endpoint of Renal Response rates of 40.8% for voclosporin vs. 22.5% for the control (OR 2.65; p < 0.001). Additionally, all pre-specified hierarchical secondary endpoints achieved statistical significance in favor of voclosporin, which included Renal Response at 24 weeks, Partial Renal Response at 24 and 52 weeks, time to achieve urinary protein-to-creatinine ratio (“UPCR”) ≤ 0.5, and time to 50% reduction in UPCR. The robustness of the data was also supported by all pre-specified subgroup analyses (age, sex, race, biopsy class, region, and prior MMF use) favoring voclosporin.

Voclosporin was well tolerated with no unexpected safety signals. Serious adverse events (“SAEs”) were reported in 20.8% of voclosporin patients vs. 21.3% in the control arm. Infection was the most commonly reported SAE with 10.1% of voclosporin patients versus 11.2% of patients in the control arm. Overall mortality in the trial was low, with six deaths observed; one in the voclosporin arm and five in the control group. Additionally, the voclosporin arm showed no significant decrease at week 52 in estimated glomerular filtration rate (“eGFR”) or increase in blood pressure, lipids or glucose, which are common adverse events associated with legacy calcineurin inhibitors (“CNIs”).

“These data represent a potential game changer for patients suffering from this debilitating disease. This confirmatory Phase 3 result represents a clinically meaningful leap forward in the treatment of lupus nephritis. Importantly, the data indicate no excess of adverse events in the voclosporin group compared to patients managed with standard of care alone.”

– Brad Rovin, MD, FASN, Chief, Division of Nephrology and Medical Director of the Clinical Trials Management Organization, the Ohio State University Wexner Medical Center

Voclosporin was granted Fast Track designation by the FDA in 2016. Aurinia plans to submit an NDA to the FDA in the first half of 2020.

“We are thrilled with the outcomes reported today from the AURORA trial, which unequivocally demonstrate the tremendous potential for voclosporin to play an important role in the treatment of the approximately one million people worldwide living with LN. We are aware of the intense need for a clinically impactful therapy for this serious disease and are working with urgency to complete regulatory filings in the U.S. and worldwide. If approved, we look forward to potentially making voclosporin available to patients beginning in 2021.”

– Peter Greenleaf, President and Chief Executive Officer, Aurinia

“The treatment of lupus nephritis has been extremely challenging to date, and people with lupus are in need of innovative treatments for this serious disease. We’re proud to have been part of this important achievement through our work educating people with lupus nephritis about the trial and the importance of clinical trial participation,” said Stevan W. Gibson, President and Chief Executive Officer, Lupus Foundation of America. “Voclosporin is the first novel treatment that has demonstrated therapeutic efficacy for people living with lupus nephritis and today marks an important advance in the treatment of this potentially life-threatening disease.”

Aurinia expects to present further data from this trial at a future scientific conference in 2020.

Related Article: Aurinia Pharmaceuticals Completes Voclosporin Study

About AURORA

The AURORA clinical trial is a global, double-blind, placebo-controlled study to evaluate whether voclosporin when added to background therapy of mycophenolate mofetil (MMF)/CellCept® can increase speed of and overall renal response rates in the presence of low dose steroids. The primary endpoint for the study is complete renal response at 52 weeks, after which patients can choose to enroll into a 104-week blinded extension study. Renal response was defined as UCPR of ≤ 0.5 mg/mg, eGFR ≥ 60 mL/min/1.73 m², or no confirmed decrease from baseline in eGFR of > 20%, presence of sustained, low dose steroids and no administration of rescue medication. The target enrollment of 324 patients was surpassed with a total of 357 lupus nephritis (LN) patients randomized globally across sites in 27 countries.

About AURORA 2 Extension

Eligible patients completing the AURORA trial had the option to roll over into a 104-week blinded extension study (the “AURORA 2 extension study”). A total of 216 patients enrolled into the AURORA 2 extension study. The data from the AURORA 2 extension study will allow the company to assess the long-term benefit/risk of voclosporin in LN patients, however, this study is not a requirement for potential regulatory approval for voclosporin. Data from the AURORA 2 extension study assessing long-term outcomes in LN patients should be valuable in a post-marketing setting and for future interactions with various regulatory authorities.

About Voclosporin

Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical data in over 2,600 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney. It has been shown to have a more predictable pharmacokinetic and pharmacodynamic relationship (potentially requires no therapeutic drug monitoring), an increase in potency (versus cyclosporine A), and an improved metabolic profile compared to legacy CNIs. Aurinia anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension. Further, a U.S. patent has also been issued covering the voclosporin dosing protocol with a term extending to December 2037, if the FDA incorporates the dosing protocol used in both the AURA and AURORA trials into the product label.

About Lupus Nephritis

Lupus nephritis (“LN”) is an inflammation of the kidney caused by Systemic Lupus Erythematosus (“SLE”) and represents a serious progression of SLE. SLE is a chronic, complex and often disabling disorder. The disease is highly heterogeneous, affecting a wide range of organs and tissue systems. Unlike SLE, LN has straightforward disease outcomes (measuring proteinuria) where an early response correlates with long-term outcomes. In patients with LN, renal damage results in proteinuria and/or hematuria and a decrease in renal function as evidenced by reduced eGFR, and increased serum creatinine levels. LN is debilitating and costly and if poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in end-stage renal disease (“ESRD”), thus making LN a serious and potentially life-threatening condition.

About Aurinia

Aurinia Pharmaceuticals is a late clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently developing an investigational drug, for the treatment of lupus nephritis, focal segmental glomerulosclerosis and dry eye syndrome. The Company’s head office is in Victoria, British Columbia and focuses its development efforts globally. For further information, see our website at www.auriniapharma.com.

Forward-Looking Statements

Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: completing NDA priority review submissions in a successful and timely manner including the anticipated NDA filing during the first half of 2020; the potential for commercial launch of voclosporin for use in LN in 2021; voclosporin being potentially a best-in-class CNI with robust intellectual property exclusivity; Aurinia’s anticipation that upon regulatory approval, patent protection for voclosporin composition of matter will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension; a US patent has also been issued covering the voclosporin dosing protocol with a term extending to December 2037, if the FDA incorporates the dosing protocol used in both the AURA and the AURORA studies into the product label; that the results of the AURORA clinical study are pivotal and a potential game changer for LN patients; that voclosporin may be positioned to become the standard of care for people living with LN; that Aurinia will present AURORA study results at a future scientific conference during 2020. It is possible that such results or conclusions may change based on further analyses of these data. Words such as “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may” and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the market value for the LN, DES and FSGS programs; that another company will not create a substantial competitive product for Aurinia’s LN, DES and FSGS business without violating Aurinia’s intellectual property rights; the burn rate of Aurinia’s cash for operations; the costs and expenses associated with Aurinia’s clinical trials; the planned studies achieving positive results; Aurinia being able to extend and protect its patents on terms acceptable to Aurinia; and the size of the LN, DES or FSGS markets; Aurinia will be able to obtain all necessary regulatory approvals for commercialization of voclosporin for use in LN on terms that are acceptable to it and that are commercially viable; and that Aurinia’s intellectual property rights are valid and do not infringe the intellectual property rights of other parties. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: difficulties, delays, or failures we may experience in the conduct of our clinical trial; difficulties we may experience in completing the development and commercialization of voclosporin; the market for the LN, DES and FSGS business may not be as estimated; Aurinia may have to pay unanticipated expenses; estimated costs for clinical trials may be underestimated, resulting in Aurinia having to make additional expenditures to achieve its current goals; Aurinia not being able to extend or fully protect its patent portfolio for voclosporin; competitors may arise with similar products; Aurinia may not be able to obtain necessary regulatory approvals for commercialization of voclosporin in a timely fashion, or at all; and Aurinia may not be able to obtain sufficient supply to meet commercial demand for voclosporin in a timely fashion. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business can be found in Aurinia’s most recent Annual Information Form available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar.

We seek safe harbour.

Investor & Corporate Contact:
Glenn Schulman, PharmD, MPH
Corporate Communications, Aurinia
gschulman@auriniapharma.com

Media Contact
Krystle Gibbs
Ten Bridge Communications
krystle@tenbridgecommunications.com

TORONTO, ON / ACCESSWIRE / December 3, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today reported that the company’s lead product candidate, EB01, has demonstrated positive safety data in healthy volunteers participating in its ongoing Phase 2b clinical study in chronic allergic contact dermatitis (ACD), a debilitating disease that is frequently caused by allergens present in the workplace.

The healthy volunteer cohort at the outset of Edesa’s study is designed to clear the way for using the experimental topical treatment on the face of ACD patients. Due to the high prevalence of symptoms on the face of ACD patients, the expansion of the study to facial symptoms is expected to address a key aspect of the disease, while broadening the potential patient population.

Related Article: Edesa Enrolls First Patient in Phase 2b Dermatitis Study

Dr. Par Nijhawan, Chief Executive Officer of Edesa, said that the face and hands are the most common body parts presenting with ACD because they are typically more open to contact with allergens. “Symptoms on the face have a powerful impact on patients’ quality of life and can be especially problematic for chronic ACD patients. The lesions are highly visible and difficult to treat with steroids due to concerns about skin thinning, dyspigmentation, abnormal hair growth and other common side effects of continuous steroid use.”

The data from the healthy volunteers were consistent with safety data from five previous clinical studies that demonstrated no serious adverse events or discontinuations due to adverse events. Since previous studies were focused solely on symptoms on the hands and arms, the company included the healthy volunteer cohort as a precautionary measure.

Edesa Vice President of Research and Development, Blair Gordon, PhD reported that the healthy volunteers were treated with EB01 cream on one side of the face, while the placebo cream was applied to the other side of the face twice daily for one week. “We are very pleased to see that none of the patients reported burning, stinging or itch associated with either the drug product or the placebo cream. No adverse events attributable to either treatment were observed. These results reaffirm the safety profile of our sPLA2 inhibitor technology and EB01,” said Dr. Gordon.

ACD patients participating in the study are being treated for 28 days with EB01 cream, which contains a non-steroidal anti-inflammatory compound known as an sPLA2 inhibitor. In addition to the safety and efficacy of EB01 in ACD patients, investigators will also evaluate symptom reduction, quality of life and dose-relationships among various strengths of EB01 cream as secondary and exploratory measures. Edesa plans to perform a blinded interim analysis after the first 46 subjects are treated to determine the total number of patients for the second part of the study.

Investigational centers for the EB01 study are located in Baton Rouge, LA; Bexley, OH; Chapel Hill, NC; Fridley, MN; Long Beach, CA; Louisville, KY; New York, NY; Plainfield, IN; and Washington, DC.

Additional details about the Phase 2b trial of EB01 (NCT03680131) can be found at www.clinicaltrials.gov.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on efficiently developing innovative treatments that address significant unmet medical needs. Edesa’s lead product candidate, EB01, is a novel non-steroidal anti-inflammatory molecule (sPLA2 inhibitor) for the treatment of chronic allergic contact dermatitis which has demonstrated statistically significant improvements in multiple clinical studies. Edesa’s investigational new drug (IND) application for EB01 was accepted by the FDA in November 2018. Edesa also intends to expand the utility of its sPLA2 inhibitor technology across multiple indications and expand its portfolio with assets that can drive long-term growth opportunities. The company is based in Markham, Ontario, Canada, with U.S. offices in Southern California.

Edesa Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions, including statements related to: the company’s plans to perform a blinded interim analysis following the completion of the first cohort. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa’s operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa’s product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa’s ability to protect its intellectual property and the timing and success of submission, acceptance and approval of regulatory filings. Many of these factors that will determine actual results are beyond the company’s ability to control or predict. For a discussion of further risks and uncertainties related to Edesa’s business, please refer to Edesa’s public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.

Media Contact:

Gary Koppenjan
Edesa Biotech, Inc.
(805) 488-2800

TORONTO – Bright Angel Therapeutics, a biotechnology company focused on developing novel antifungal drugs, today announced an extension to their seed financing round, adding funding that will enable continued advancement of their lead program targeting invasive and drug-resistant fungal infections.

Lumira Ventures, Canada’s largest and most active healthcare venture capital firm, and Viva BioInnovator, the specialized investment and incubation arm of Shanghai- based Viva Biotech Holdings, participated in the new financing. They join co-founder and partner Schrödinger and seed investors Toronto Innovation Acceleration Partners (formerly MaRS Innovation) and adMare BioInnovations. Both Benjamin Rovinski, PhD, Managing Director of Lumira Ventures, and Matthew Carlyle, CFO of adMare, will join Bright Angel’s Board of Directors.

Due largely to the scarcity of fungal-specific targets, to date there are only a handful of approved drugs to treat invasive fungal infections. To overcome the difficulty associated with designing fungal selective compounds when a human homolog exists, Bright Angel Therapeutics has found a way to address this challenge via the use of the Schrödinger platform to design fungal-specific compounds. The company’s lead program targets the fungal Heat Shock Protein 90 (Hsp90) which has been shown to be central to the emergence and maintenance of fungal drug resistance.

“Bright Angel Therapeutics is committed to developing novel drugs to combat the risk of a public health crisis posed by drug-resistant fungal infections, and we’re delighted to welcome Lumira and Viva to our team as we pursue this urgent mission. The magnitude of the global health threat we’re facing is clear from the fact that the U.S. Centers for Disease Control and Prevention recently added Candida auris and azole-resistant Aspergillus fumigatus to their Antibiotic Resistance Threats Report; they join drug-resistant Candida on the list of urgent public health challenges.”

– Dominic Jaikaran, PhD, MBA, President and Chief Executive Officer, Bright Angel Therapeutics

“We’re proud to team up with Bright Angel to find solutions to drug-resistant fungal infections. It’s vital that we develop new medicines to treat these deadly infections, and this funding will move our partnered programs closer to the clinic — and closer to the patients who need them,” said Ramy Farid, PhD, Chief Executive Officer of Schrödinger. 

“There is a growing urgency to develop desperately needed new antifungal drugs to combat emerging drug-resistant fungal infections, and Bright Angel is addressing that critical unmet medical need through a very innovative and differentiated approach,” said Dr. Benjamin Rovinski, Managing Director of Lumira Ventures. “As a lead investor, we are committed to work with the company and its partners to develop the next generation of antifungal drugs.”

Dr. Zhixiong Ye, Chief Scientific Officer of Viva Biotech, said: “Bright Angel is developing fungal-selective inhibitors of Hsp90 as a new treatment strategy for life-threatening invasive fungal infections. The first-in-class compounds being developed by Bright Angel are designed to enhance the efficacy of all three major classes of current antifungal drugs and thwart resistance to them by targeting a fundamental mechanism in fungi that enables resistance to arise.”

“Congratulations to Bright Angel and its team on achieving this milestone, and for their progress in tackling this global unmet medical need. We are excited to be a partner in advancing this Canadian company by not only providing financial support, but also through past medicinal chemistry support which was critical in the early days of the company,” said Gordon C. McCauley, President and Chief Executive Officer of adMare BioInnovations.  

“It is gratifying to see local startups attract interest and investments from around the world,” added Dr. Rafi Hofstein, CEO of TIAP and Chair of Bright Angel.  “This latest capital infusion from Viva BioInnovator and Lumira Ventures is a very good harbinger of the maturity of the science output from the innovation partnership community in Toronto and shows that local venture building is financially viable and on the global investment map.”

About Bright Angel Therapeutics

Bright Angel Therapeutics is a Toronto-based, pre-clinical company committed to developing new drugs to address the growing global public health crisis of antifungal resistance. The company’s discovery efforts are focused on molecules that inhibit stress response pathways that are believed to be central to the emergence of fungal resistance. Bright Angel was co-founded by Schrödinger and is leveraging the Schrödinger computational platform to design potent and fungal-selective inhibitors. Other co-founders include Toronto Innovation Acceleration Partners (formerly MaRS Innovation), a nonprofit supporting the commercialization of research breakthroughs from Toronto’s leading academic institutions; Dr. Leah Cowen, Professor and Chair, Department of Molecular Genetics, University of Toronto, co-Director CIFAR Fungal Kingdom: Threats & Opportunities Program, and Chief Scientific Officer, Bright Angel Therapeutics; and company consultant Dr. Luke Whitesell.

Media Contact

Dominic Jaikaran, Ph.D., MBA, President & CEO, Bright Angel Therapeutics
djaikaran@brightangeltherapeutics.com

TORONTO and CHICAGO and MONTREAL (GLOBE NEWSWIRE) — Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP, OTCQB: PDDPF) provided a business update and announced its financial and operating results for the three- and six-month periods ended September 30, 2019.  All dollar amounts below are in Canadian dollars.

Related Article: Medexus Pharmaceuticals Revenues Increases 512% Year-over-Year

Q2 2020 Financial highlights^*:

• Revenue was $16.4 million compared to $3.4 million for the fiscal quarter ended September 30, 2018 (Q2 2019)
• Gross profit was $9.6 million compared to $1.9 million for Q2 2019
• Gross margin was 58.6% compared to 53.8% for Q2 2019
• Adjusted EBITDA^** was $0.5 million compared to $0.5 million for Q2 2019
• Net income was $0.7 million compared to net loss of $3.6 million for Q2 2019
• The Company finished the quarter with cash and cash equivalents of $25.4 million
• 282,400 common shares were purchased pursuant to the Company’s normal course issuer bid (NCIB) during the quarter for aggregate consideration of $1.1 million
  
  *  Refer to “Cautionary Note Regarding Comparative Financial Information” at the end of this press release.
  ** Refer to “Non-IFRS Financial Measures” at the end of this press release.

“We achieved record revenue of $16.4 million for the three months ended September 30, 2019, compared to $3.4 million for the same period last year.  This improvement reflects continued unit sales growth, as well as the increased scale of the Company as a result of the acquisitions completed in October 2018.  Specifically, Metoject® unit market demand increased 115%¹, Rasuvo™ unit market demand increased 15%², and Rupall™ unit market demand increased 66%³ over the same period last year. Despite the growing demand and unit sales growth for our products, net revenue for Rasuvo™ was impacted by the consolidation of several payers in the United States market, resulting in increased discounts and a reduction in the net selling price.  We did not anticipate the pricing impact of this consolidation, which is industry-wide and not unique to Medexus.  The Company continues to analyze and monitor the impact of the consolidation and is considering the alternatives available to it to address the price reduction. We nevertheless anticipate sustained growth of Rasuvo™ units going forward, and plan to leverage our strong U.S. sales force by introducing new products through this channel, which we believe has the potential to drive significant value for shareholders going forward.”   

– Ken d’Entremont, Chief Executive Officer, Medexus Pharmaceuticals

Mr. d’Entremont continued, “Within the Canadian market, Metoject® continues to benefit from the initiation of public reimbursement in a number of provinces across Canada.  At the same time, Rupall™ continues to gain market share versus generic anti-histamines.  I am also pleased to report that Gliolan® was recently granted priority review status by Health Canada, which should significantly accelerate our path to approval.  This follows the recent draft recommendation for public reimbursement of Gliolan® in Ontario by Health Quality Ontario.  Once Gliolan® becomes a fully registered product, we expect it to gain much broader distribution in Canada, which represents a sizeable, underserved market opportunity.  In the meantime, feedback from the medical community has been extremely positive.”

Mr. d’Entremont concluded, “Despite the impact on the margins of Rasuvo from the consolidation of payers in the U.S. market, we have experienced strong unit sales growth and continue to generate positive cash flow from operations.  Looking ahead, we have built a highly scalable organization and look forward to leveraging our North American sales force by licensing additional products and through accretive acquisitions. As a result, we remain encouraged by the outlook for fiscal 2020, as illustrated by the fact we have repurchased over 600,000 shares year-to-date under the Company’s normal course issuer bid.  At the same time, we have maintained a solid balance sheet with $25.4 million of cash and cash equivalents, as well as a working capital surplus of approximately $29.4 million as of September 30, 2019.”

Operational highlights:

• Metoject® Demand Growth – Metoject experienced strong unit market demand growth of 115%¹ in Q2 2020 as compared to Q2 2019. This is a continuing trend that has improved as we add additional strengths, like the 15 mg dose. Metoject is now publicly reimbursed in Canada, which allows access for a large group of patients who previously could not access the product. 
• Rasuvo® Demand Growth – market demand of Rasuvo™ units increased by approximately 15%² in Q2 2020 as compared to Q2 2019. This growth reflects strong payer, prescriber and patient acceptance for Rasuvo™ in the United States. Management expects this growth to continue as prescribers adopt the most effective and convenient form of methotrexate for their patients. Management believes the Company is positioned as an emerging leader in the methotrexate auto-injector market.   
• Rupall™ Demand Growth – market demand of Rupall™ units has shown very strong growth, increasing by 66%³ in Q2 2020 as compared to Q2 2019. This growth was a result of physicians switching patients from either the generic prescription antihistamines or over-the-counter products. The Company expects Rupall™ to be a leading prescription anti-histamine in a total market that is valued at $131.4 million, including $42.6 million from the prescription market, which is growing at annual rate of 17%⁴.  During the three and six months ended September 30, 2019, Rupall™ was the fastest-growing anti-histamine in the prescription market⁵.

Operating and Financial Results Summary

For the three months ended September 30, 2019, total revenues were $16.4 million, compared to revenue of $3.4 million for the three months ended September 30, 2018.  Gross profit for the three months ended September 30, 2019 was $9.6 million, or 58.6% of sales, compared to $1.9 million, or 53.8% of sales, for the same period last year. The improvements in second-quarter revenue and gross profit compared to the same period in the prior year are mainly due to the Acquisitions, as well as the increase in gross profit driven by the increase in revenue from the Company’s pre and post-Acquisitions products, which impacts were partially offset by the consolidation of the Company’s payers in the US market, resulting in an increase in discounts given and a reduction in net selling price for Rasuvo.

The operating loss for the three months ended September 30, 2019 was $1.3 million compared to $3.3 million for the three months ended September 30, 2018. In line with our strategy to develop new products that complement our existing product portfolio and deliver true innovation to address unmet patient needs, during the quarter the Company incurred $0.2 million of expenses related to the reformulation of a product for use in the field of rheumatology.

Adjusted EBITDA^** was $0.5 million for the three-month period ended September 30, 2019 and September 30, 2018.  Net income for the three-month period ended September 30, 2019 was $0.7 million for Q2 2020 compared to net loss of $3.6 million for the three-month period ended September 30, 2018. Net income for the three-month period ended September 30, 2019 included a $4.3 million unrealized gain on the fair value of derivatives.

Under the Company’s normal course issuer bid (NCIB) is purchased and cancelled:  (i) 282,400 common shares in the market for consideration of $1.1 million during the three-month period ended September 30, 2019, (ii) 418,000 common shares in the market for consideration of $1.8 million during the six-month period ended September 30, 2019, and (iii) an additional 185,700 common shares in the market for consideration of $0.8 million during the month ended October 31, 2019.

For the six months ended September 30, 2019, total revenues were $32.5 million, compared to revenue of $6.7 million for the six months ended September 30, 2018.  Gross profit for the six months ended September 30, 2019, was $19.5 million, or 60.0% of sales, compared to $3.6 million, or 53.6% of sales, for the same period last year. The improvements in six-month revenue and gross profit compared to the same period in the prior year are mainly due to the Acquisitions, as well as the increase in gross profit driven by the increase in revenue from the Company’s pre and post-Acquisitions products, which impacts were partially offset by the price impact of the payer consolidation described above.

The operating loss for the six months ended September 30, 2019 was $2.4 million compared to $3.7 million for the six months ended September 30, 2018. Adjusted EBITDA^** for the six-month period ended September 30, 2019, was $1.0 million compared to $0.2 million for the six-month period ended September 30, 2018.  Net loss for the six-month period ended September 30, 2019, was $1.5 million compared to $4.3 million for the six-month period ended September 30, 2018.  Net loss for the six-month period ended September 30, 2019, included a $5.0 million unrealized gain on the fair value of derivatives.

The Company’s financial statements and management discussion and analysis (“MD&A”) for the three months and six months ended September 30, 2019 are available on our corporate website at www.medexus.com and in our corporate filings on SEDAR at www.sedar.com.

Conference Call Details

Medexus will host a conference call on Monday, December 2, 2019 at 8:00 AM Eastern Time to discuss the Company’s financial results for the second quarter of fiscal 2020, as well as the Company’s corporate progress and other developments.

The conference call will be available via telephone by dialing toll free 844-369-8770 for Canadian and U.S. callers or +1 862-298-0840 for international callers, or on the Company’s Investor Events section of the website.

A webcast replay will be available on the Company’s Investor Events section of the website through March 2, 2020. A telephone replay of the call will be available approximately one hour following the call, through December 9, 2019, and can be accessed by dialing 877-481-4010 for Canadian and U.S. callers or +1 919-882-2331 for international callers and entering conference ID: 56859.

¹ Source: IQVIA – TSA National units.
² Source: Symphony Sub National 9/30/2019 Data & Chargebacks., PAP.
3 Source: IQVIA – Drugstores and hospitals purchases.
⁴ Source: IMS Data-MAT June 2018.
⁵ Source: IQVIA: CDH units – FQTR September 2019.

About Medexus Pharmaceuticals Inc.

Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform. The Company’s vision is to provide the best healthcare products to healthcare professionals and patients, through our core values of Quality, Innovation, Customer Service and Teamwork.  Medexus is focused on the therapeutic areas of auto-immune disease and pediatrics. The leading products are Rasuvo and Metoject, a unique formulation of methotrexate (auto-pen and pre-filled syringe) designed to treat rheumatoid arthritis and other auto-immune diseases; and Rupall, an innovative allergy medication with a unique mode of action.

For more information, please contact:

Ken d’Entremont, Chief Executive Officer
Medexus Pharmaceuticals Inc.
Tel.: 905-676-0003
E-mail: ken.dentremont@medexus.com

Roland Boivin, Chief Financial Officer
Medexus Pharmaceuticals Inc.
Tel.: 514-762-2626 ext. 202
E-mail: roland.boivin@medexus.com

Investor Relations (U.S.):
Crescendo Communications, LLC
Tel: +1-212-671-1020
Email: mdp@crescendo-ir.com

Investor Relations (Canada):
Frank Candido
Direct Financial Strategies and Communication Inc.
Tel: 514-969-5530
E-mail: frank.candido@medexus.com

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Cautionary Note Regarding Comparative Financial Information

On October 16, 2018, the Company (under its former name, Pediapharm Inc.) completed two transformative acquisitions (the “Acquisitions”) in acquiring of all the issued and outstanding shares of Medexus Inc. (“Medexus Canada”) and Medexus Pharma, Inc. (under its former name, Medac Pharma, Inc.) (“Medexus US”) and, subsequently, on December 12, 2018, changed its name to “Medexus Pharmaceuticals Inc.”.

As the three-month period ended September 30, 2019 is within the first full year of operation since the Company completed the Acquisitions, readers are cautioned that while certain financial information included herein for, and comparisons to, prior periods have been presented in this press release, changes from a pre-Acquisitions period to a post-Acquisitions period may, in the opinion of management, be of limited value in understanding changes to the financial condition, financial performance, or business of the Company from period to period given the transformative nature of the Acquisitions.  Readers are advised that the comparative information included in this press release for the three month period ended September 30, 2018 reflects only the unaudited pre-Acquisitions results for Pediapharm Inc., whereas information provided as at and for the three-month period ended September 30, 2019 reflects the unaudited consolidated results of the post-Acquisitions Company, including the acquired entities (Medexus Canada and Medexus US).

Forward-Looking Statements

Certain statements made in this press release contain forward-looking information within the meaning of applicable securities laws (“forward-looking statements”). The words “anticipates,” “believes,” “expects,” will,” and similar expressions are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Specific forward-looking statements contained in this press release include, but are not limited to, statements with respect to future business operation and results, including with respect to future earnings, the anticipated growth in sales of, and the market for, certain of the Company’s products, and expected purchases pursuant to the Company’s normal course issuer bid. These statements are based on factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, including assumptions based on historical trends, current conditions and expected future developments. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. The Company cautions that although it is believed that the assumptions are reasonable in the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. Material risk factors include those set out in the Company’s MD&A under the heading “Risk Factors and Risk Management” and elsewhere in the Company’s other disclosure documents filed with the applicable Canadian securities regulatory authorities from time to time. Given these risks, undue reliance should not be placed on these forward-looking statements, which apply only as of the date hereof. Other than as specifically required by law, the Company undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.

Non-IFRS Financial Measures

This press release uses the term “Adjusted EBITDA” which is a non-IFRS financial measure, which does not have any standardized meaning under IFRS and therefore may not be comparable to similar measures presented by other companies. Rather, this measure is provided as additional information to complement IFRS measures by providing a further understanding of operations from management’s perspective. The Company defines Adjusted EBITDA as earnings before financing costs, interest expenses, income taxes, interest income, depreciation of property and equipment, amortization of intangible assets, non-cash share-based compensation, income from the sale of an asset, impairment of intangible assets as well as fees related to the Acquisitions and Offering. The Company considers Adjusted EBITDA as a key metric in assessing business performance and considers Adjusted EBITDA to be an important measure of operating performance and cash flow, providing useful information to investors and analysts. These non-IFRS measures presented are not intended to represent cash provided by operating activities, net earnings or other measures of financial performance calculated in accordance with IFRS.  Additional information relating to the use of this non-IFRS measure, including the reconciliation between Net Loss and Adjusted EBITDA, can be found in our MD&A, which is available through the SEDAR website.

SINGAPORE — Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announced updated Phase 1 data for single-agent ZW25 in heavily pretreated patients with HER2‑expressing solid tumors in a mini oral presentation by Dr. Do-Youn Oh, study investigator and Professor at Seoul National University, at the ESMO Asia 2019 Congress, taking place November 22 – 24 in Singapore. Zymeworks and its collaborator BeiGene, Ltd. plan to advance ZW25 into potentially registration-enabling global studies in HER2-expressing biliary tract cancer (BTC) and gastroesophageal adenocarcinoma (GEA), based on these durable and consistent clinical data.

“The promising ZW25 data at ESMO Asia further build momentum for the expanding footprint of our ZW25 clinical development program with BeiGene. Cancer is a global fight, and this strong collaboration helps us to rapidly execute on upcoming late-stage studies for people with HER2-expressing cancers worldwide.”

– Ali Tehrani, Ph.D., President and CEO, Zymeworks

The updated single-agent results of the ongoing Phase 1 trial of ZW25 in patients with HER2‑expressing solid tumors include additional safety and anti-tumor activity data from those presented at the ESMO 2019 Congress.

“The encouraging clinical data on ZW25 supports further evaluation of this bispecific antibody in HER2-expressing solid tumors. We’re enthusiastic about the meaningful progress of ZW25 since we established the collaboration with Zymeworks one year ago and look forward to leveraging our unique strengths and expertise to advance ZW25 clinical development globally.”

– John V. Oyler, Co-Founder, CEO, and Chairman, BeiGene

ZW25 Clinical Results Presented Today

Safety, Anti-Tumor Activity, and Biomarker Results of the HER2-Targeted Bispecific Antibody ZW25 in HER2-Expressing Solid Tumors (Presentation# 61O, Mini Oral on Friday, November 22 at 3:30 pm SGT)

Data were reported from 69 patients diagnosed with HER2-expressing solid tumors other than breast cancer who received ZW25 at the recommended dose of either 10 mg/kg weekly or 20 mg/kg every other week. Overall, patients received a median of three prior systemic therapies. Those with BTC, GEA, and colorectal cancer (CRC) received a median of 4.5, 3, and 5.5 prior systemic therapies, respectively. Forty-one (59%) patients received prior HER2‑targeted therapies, including 93% of GEA patients. Eleven patients were diagnosed with BTC, 28 with GEA, 14 with CRC, and 16 with other HER2‑expressing cancers, including endometrial, ovarian, pancreatic, and salivary gland.

Fifty-seven of 69 patients were response evaluable at the time of data cut-off. Overall, the disease control rate (DCR) was 70%, comprising 25 (44%) partial responses and 15 (26%) with stable disease, and 18 (32%) patients experienced disease control for greater than six months. In the nine evaluable biliary tract cancer patients, the DCR was 78%, and the objective response rate (ORR) was 67%. In the 13 CRC and 23 GEA patients, ORRs were 46% and 39%, respectively. Notably, confirmed responses were seen across additional tumor types, including a 100% decrease in target lesions in a patient with pancreatic cancer. The overall median progression-free survival was 5.5 months and is still evolving.

Among all patients, ZW25 was well tolerated as outpatient therapy. The most common treatment-related adverse events (TRAE) were diarrhea (43%), infusion-related reaction (26%), and nausea (13%). All TRAEs were Grade 1 or 2.

Related Article: Zymeworks Releases Phase 1 Data for ZW25 at International Conference

About the Phase 1 Clinical Trial

Zymeworks’ Phase 1 study has three parts. From part one of the study (the dose-escalation phase), the recommended single-agent dose was determined to be 20 mg/kg once every two weeks or 10 mg/kg weekly. In the second part of the study (the cohort expansion phase), additional patients are being enrolled to further assess ZW25’s single-agent tolerability and anti-tumor activity against a variety of cancer types in different settings. The third part of the study (the combination phase) is underway and evaluating ZW25 in combination with selected chemotherapy agents in gastroesophageal and breast cancer patients with HER2 high or lower HER2 expression levels.

About ZW25

ZW25 is being evaluated in Phase 1 and Phase 2 clinical trials across North America and South Korea. It is a bispecific antibody, based on Zymeworks’ Azymetric™ platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging anti-tumor activity in patients. Zymeworks is developing ZW25 as a HER2-targeted treatment option for patients with any solid tumor that expresses HER2. The FDA has granted Fast Track designation to ZW25 for first-line gastroesophageal adenocarcinoma in combination with standard of care chemotherapy and Orphan Drug designation to ZW25 for the treatment of both gastric and ovarian cancers.

About Zymeworks Inc.

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics. Zymeworks’ suite of therapeutic platforms and its fully-integrated drug development engine enable precise engineering of highly differentiated product candidates. Zymeworks’ lead clinical candidate, ZW25, is a novel Azymetric™ bispecific antibody currently in Phase 2 clinical development. Zymeworks’ second clinical candidate, ZW49, is a bispecific antibody-drug conjugate currently in Phase 1 clinical development and combines the unique design and antibody framework of ZW25 with Zymeworks’ proprietary ZymeLink™ cytotoxic payload. Zymeworks is also advancing a deep preclinical pipeline in immuno-oncology and other therapeutic areas. In addition, its therapeutic platforms are being leveraged through strategic partnerships with nine biopharmaceutical companies.

Cautionary Note Regarding Zymeworks’ Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this news release include statements that relate to ZW25 and its potential as an anti-cancer treatment, Zymeworks’ clinical plans and future results, Zymeworks’ technology platform, and other information that is not historical information. When used herein, words such as “believe”, “may”, “plan”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under “Risk Factors” in Zymeworks’ Quarterly Report on Form 10-Q for the three month period ended September 30, 2019 (a copy of which may be obtained at www.sec.gov and www.sedar.com). Consequently, forward-looking statements should be regarded solely as Zymeworks’ current plans, estimates and beliefs. You should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance, or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events, except as may be required by law.

Investor Inquiries:
Ryan Dercho, Ph.D.
(604) 678-1388
ir@zymeworks.com

Tiffany Tolmie 
(604) 678-1388 
ir@zymeworks.com

Media Inquiries: 
Kavita Shah, Ph.D.
(604) 678-1388 
media@zymeworks.com 

LISLE, Ill., Nov. 18, 2019 /PRNewswire/ — Endotronix Inc., a digital health and medical technology company dedicated to advancing the treatment of chronic heart failure (HF), presented positive first-in-human data of the Cordella™ Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor). Data was presented at the 2019 American Heart Association (AHA) Scientific Sessions in Philadelphia, PA by Prof. Dr. Wilfried Mullens of the Hospital Oost-Limburg in Genk, Belgium.

“Chronic heart failure patients too frequently have cycles of decompensation and hospitalization that negatively impact patient outcomes and drive up treatment costs. Recent data shows that using PA pressure-guided therapy with this population keeps them healthier and out of the hospital. The Cordella System is an elegant solution that integrates a PA pressure sensor and a comprehensive patient management platform in one. The straightforward sensor implant provides reliable pressure data, while the patient management platform enables a comprehensive clinical picture of the patient that allows my team to make informed therapy decisions and improve outcomes.”

– Prof. Dr. Wilfried Mullens, Hospital Oost-Limburg

The 90-day results from the first-in-human trial confirm the device safety and accuracy of pressure measurements in the right pulmonary artery using the implanted Cordella Sensor and handheld patient reader. The study included 15 patients across two European sites: Prof. Dr. Mullens in Belgium and Dr. Faisal Sharif of the National University of Ireland (NUI) in Galway, Ireland.

Highlights include:

• The primary accuracy endpoint was met with no significant difference in measured mean PA pressure for the Cordella Sensor and the reference catheter at 90 days.
• The study demonstrated encouraging safety results with zero Device Related System Complications (DSRC) at 90 days.
• High patient compliance (>98%) with daily remote measurements of vital signs and PA pressure throughout the study.

“The presentation of our first-in-human data at AHA this year is another exciting milestone for the company. This work lays the clinical foundation for our groundbreaking IDE trial, PROACTIVE-HF, which will begin enrollment in the U.S. later this year. Designed to provide the highest level of clinical evidence for PA pressure-guided therapy, PROACTIVE-HF will support U.S. market access of the Cordella Sensor and inform a national coverage decision from the Centers for Medicare & Medicaid Services (CMS).”

– Dr. Katrin Leadley, Chief Medical Officer, Endotronix

The Cordella Sensor is not available for commercial use in any geography and is under clinical investigation in Europe (SIRONA II CE Mark Trial) and the U.S. (PROACTIVE-HF IDE Trial). CAUTION – Investigational Device. Limited by Federal (or United States) Law to Investigational Use. Exclusively for clinical investigations. The Cordella System, without the sensor, is available for commercial use in the U.S. and E.U. and is currently in cardiology centers across the U.S.

Related Article: Endotronix Enrolls First Patient in SIRONA II CE Mark Trial

About the Cordella™ Heart Failure System
The Cordella Heart Failure System (Cordella System) is designed to help patients suffering from chronic heart failure feel better and stay out of the hospital with streamlined care and remote medication titration. The system provides a comprehensive health status of the patient at home with easy-to-use tools to securely collect and share health-related data with healthcare providers for trend-based management. The Cordella Sensor seamlessly integrates pulmonary artery (PA) pressure data into the Cordella System. Together, they proactively deliver the information necessary to improve patient care between office visits and support reimbursement for care delivery activities.

About Endotronix
Endotronix, Inc., is a medical technology company focused on advancing the treatment of chronic heart failure. Privately held, the company is backed by world-class medtech investors including Aperture Venture Partners, BioVentures Investors, LSP, Lumira Ventures, OSF Ventures, Seroba Life Sciences, Skydeck LLC, SV Health Investors, Wanxiang Healthcare Investments, and two unnamed corporate strategic investors.

Cautionary Statement Regarding Forward-Looking Statements
This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not a guarantee of future performance.

MEDIA CONTACT:
Carla Benigni
SPRIG Consulting LLC (847) 951-7430
Carla@sprigconsulting.com

VICTORIA, British Columbia — (BUSINESS WIRE) — Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today reported financial results for the three and nine months ended September 30, 2019 and recent operational highlights. Amounts, unless specified otherwise, are expressed in U.S. dollars.

“As we look forward to results from the AURORA Phase 3 trial for LN by the end of this year, the organization has been preparing for success by continuing to strengthen the Board, making several key strategic hires into our commercial and medical affair groups, and advancing the portfolio of potential indications for voclosporin, including FSGS and dry eye syndrome. Looking ahead to 2020, and assuming positive results, we plan on submitting a NDA to the FDA in the first half of 2020 and project a commercial launch of voclosporin in early 2021 as a potentially first-line treatment, in combination with mycophenolate mofetil, for lupus nephritis.”

– Peter Greenleaf, President and Chief Executive Officer, Aurinia Pharmaceuticals

Voclosporin for Lupus Nephritis (“LN”)

On October 16, Aurinia announced that the last patient study visit had occurred in the AURORA Phase 3 LN trial with efficacy and safety results anticipated by the end of 2019.

The AURORA clinical trial is a global, double-blind, placebo-controlled study to evaluate whether voclosporin, when used in combination with mycophenolate mofetil (“MMF”)/CellCept®, can increase complete renal response rates at 52 weeks in the presence of low dose steroids. A total of 358 patients with LN were randomized into sites across 27 countries.

AURORA 2 is an extension study whereby eligible patients from AURORA have the option of continuing their therapy for an additional two years in a blinded fashion. Results of this study are not required for FDA approval; however, AURORA 2 is expected to provide valuable insights as to the long-term safety and efficacy of voclosporin as a potential new treatment for LN.

Voclosporin Ophthalmic Solution (“VOS”) Phase 2/3 AUDREY™ Clinical Trial in Dry Eye Syndrome (“DES”)

On October 31, Aurinia announced the initiation of patient dosing in the Phase 2/3 AUDREY™ clinical trial evaluating VOS for the potential treatment of DES. The AUDREY trial is a randomized, double-masked, vehicle-controlled, dose-ranging study evaluating the efficacy and safety of VOS in subjects with DES. A total of approximately 480 subjects are expected to be enrolled. The study will consist of four arms with a 1:1:1:1 randomization schedule, in which patients will receive either 0.2% VOS, 0.1% VOS, 0.05% VOS or vehicle, dosed twice daily for 12 weeks.

The primary outcome measure for the trial is the proportion of subjects with a 10mm improvement in Schirmer Tear Test (“STT”) at four weeks. Secondary outcome measures will include STT at other time points, Fluorescein Corneal Staining (“FCS”) at multiple time points, change in eye dryness, burning/stinging, itching, photophobia, eye pain and foreign body sensation at multiple time points, and additional safety endpoints.

Top-line results from AUDREY are anticipated during the second half of 2020.

Financial Liquidity at September 30, 2019

As of September 30, 2019, Aurinia had cash and cash equivalents of $134.5 million compared to $131.5 million at June 30, 2019 and $118.0 million at December 31, 2018.

The Company received net proceeds of $14.3 million upon the sale of 2.35 million common shares at a weighted average price of $6.40 per share pursuant to its September 13, 2019 At-the-market (“ATM”) facility with Jefferies LLC.

Net cash used in operating activities was $11.8 million and $38.2 million respectively for the three and nine months ended September 30, 2019 compared to $11.3 million and $38.0 million respectively for the same periods in 2018.

The Company believes, that based on its current plans, it has sufficient financial resources to fund the existing LN program, including the AURORA trial and the AURORA 2 extension study, complete the New Drug Application (“NDA”) submission to the FDA, conduct the ongoing Phase 2 study for focal segmental glomerulosclerosis (“FSGS”), conduct the AUDREY clinical trial, and fund operations into the fourth quarter of 2020.

Third Quarter 2019 Financial Results

For the three months ended September 30, 2019 Aurinia reported a consolidated net loss of $19.0 million or $0.21 per common share compared to a consolidated net loss of $18.3 million or $0.21 per common share for the same period in 2018.

Research and development expenses (R&D) increased to $17.8 million for the three months ended September 30, 2019, compared to $11.2 million for the three months ended September 30, 2018. The increase in these expenses were primarily related to the manufacturing of voclosporin for commercial and investigational use. In addition, higher costs were incurred for the AURORA 2 extension study, completion of the drug-drug interaction (“DDI”) study, preparation costs associated with the planned NDA submission for LN, and initiation of the Phase 2/3 DES clinical trial, partially offset by lower AURORA clinical trial costs.

Corporate, administration and business development expenses increased to $6.1 million for the three months ended September 30, 2019, compared to $2.9 million for the same period in 2018. The increase reflected overall higher activity levels as the Company scales the organization ahead of AURORA Phase 3 results in LN. The Company incurred higher costs for professional and consulting services, insurance, personnel and information technology and for pre-commercial activities, including market research.

Non-cash stock compensation expense was $2.0 million for the third quarter ended September 30, 2019 as compared with $1.5 million for the same period in 2018 and was included in both R&D and corporate, general and business development expenses.

Aurinia also recorded a non-cash reduction of $4.5 million in the estimated fair value of derivative warrant liabilities which reduced the loss for the third quarter ended September 30, 2019 compared to an increase of $4.8 million in the estimated fair value of derivative warrant liabilities which increased the loss for the third quarter ended September 30, 2018. The derivative warrant liabilities will ultimately be eliminated on the exercise or forfeiture of the warrants and will not result in any cash outlay by the Company.

Financial Results for Nine Months Ended September 30, 2019

For the nine months ended September 30, 2019, Aurinia reported a consolidated net loss of $47.4 million or $0.52 per common share compared to a consolidated net loss of $49.5 million or $0.59 per common share for the comparable period in 2018.

R&D expenses were $39.6 million for the nine months ended September 30, 2019 compared to $30.5 million for the same period in 2018. The increase in these expenses were primarily related to the manufacturing of voclosporin for commercial and investigational use. In addition, higher costs were incurred for the AURORA 2 extension study, completion of the drug-drug interaction study, preparation costs associated with the planned NDA submission for LN, and initiation of the Phase 2/3 DES clinical trial, partially offset by lower AURORA clinical trial costs.

Corporate, administration and business development expenses were $14.9 million for the nine months ended September 30, 2019 compared to $10.2 million for the same period in 2018. The increase reflected overall higher activity levels as the Company scales the organization ahead of AURORA Phase 3 results in LN. The Company incurred higher costs for professional and consulting services, insurance, personnel and information technology and for pre-commercial activities, including market research.

Non-cash stock compensation expense was consistent at $5.6 million for both the nine months ended September 30, 2019 and the nine months ended September 30, 2018 and was included in both R&D and corporate, general and business development expenses.

For the nine months ended September 30, 2019 Aurinia recorded a decrease of $6.9 million in the estimated fair value of derivative warrant liabilities compared to an increase of $9.4 million for the comparable period in 2018.

This press release should be read in conjunction with our unaudited interim condensed consolidated financial statements and the Management’s Discussion and Analysis for the third quarter ended September 30, 2019 which are accessible on Aurinia’s website at www.auriniapharma.com, on SEDAR at www.sedar.com or on EDGAR at www.sec.gov/edgar.

Aurinia will host a conference call and webcast to discuss the third quarter ended September 30, 2019 financial results today, Thursday , November 14, 2019 at 4:30 p.m. ET. This event can be accessed on the investor section of the Aurinia website.

Related Article: Aurinia Releases Q2 2019 Financial Results

About Aurinia

Aurinia Pharmaceuticals is a late clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently developing an investigational drug, for the treatment of Lupus Nephritis, Focal Segmental Glomerulosclerosis and Dry Eye Syndrome. The Company’s head office is in Victoria, British Columbia and focuses its development efforts globally.

About Voclosporin

Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical data in over 2,600 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney. It has been shown to have a more predictable pharmacokinetic and pharmacodynamic relationship (potentially requires no therapeutic drug monitoring), an increase in potency (vs cyclosporin), and an improved metabolic profile compared to legacy CNIs. Aurinia anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension. Further, the new Notice of Allowanceis expected to result in the issuance of a U.S. patent with a term extending to December 2037. If the FDA approves the use of voclosporin for LN and the label for such use follows the dosing protocol under the Notice of Allowance, the issuance of this patent will expand the scope of intellectual property protection for voclosporin to December 2037.

About VOS

Voclosporin ophthalmic solution (“VOS”) is an aqueous, preservative free nanomicellar solution intended for use in the treatment of DES. A Phase 2a study was recently completed with results released in January of 2019. Previously, a Phase 1 study with healthy volunteers and patients with DES was also completed as were studies in rabbit and dog models. VOS has IP protection until 2031.

About LN

Lupus Nephritis (“LN”) in an inflammation of the kidney caused by Systemic Lupus Erythematosus (“SLE”) and represents a serious progression of SLE. SLE is a chronic, complex and often disabling disorder. The disease is highly heterogeneous, affecting a wide range of organs and tissue systems. Unlike SLE, LN has straightforward disease outcomes (measuring proteinuria) where an early response correlates with long-term outcomes. In patients with LN, renal damage results in proteinuria and/or hematuria and a decrease in renal function as evidenced by reduced estimated glomerular filtration rate (“eGFR”), and increased serum creatinine levels. LN is debilitating and costly and if poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in end-stage renal disease (“ESRD”), thus making LN a serious and potentially life-threatening condition.

About FSGS

Focal segmental glomerulosclerosis (“FSGS”) is a rare disease that attacks the kidney’s filtering units (glomeruli) causing serious scarring which leads to permanent kidney damage and even renal failure. FSGS is one of the leading causes of Nephrotic Syndrome (“NS”) and is identified by biopsy and proteinuria. NS is a collection of signs and symptoms that indicate kidney damage, including large amounts of protein in the urine; low levels of albumin and higher than normal fat and cholesterol levels in the blood, and edema. Similar to LN, early clinical response (measured by reduction of proteinuria) is thought to be critical to long-term kidney health in patients with FSGS. Currently, there are no approved therapies for FSGS in the United States and the European Union.

About DES

Dry eye syndrome (“DES”) is characterized by irritation and inflammation that occurs when the eye’s tear film is compromised by reduced tear production, imbalanced tear composition, or excessive tear evaporation. The impact of DES ranges from subtle, yet constant eye irritation to significant inflammation and scarring of the eye’s surface. Discomfort and pain resulting from DES can reduce quality of life and cause difficulty reading, driving, using computers and performing daily activities. DES is a chronic disease. There are currently three FDA approved therapies for the treatment of dry eye; however, there is opportunity for potential improvement in the effectiveness by enhancing tolerability, onset of action and alleviating the need for repetitive dosing.

Forward-Looking Statements

Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: AURORA Phase 3 LN trial efficacy and safety results anticipated by the end of 2019, completing NDA submission in a successful and timely manner including the anticipated NDA filing during the first half of next year and subsequent commercial launch in 2021, voclosporin being potentially a best-in-class CNI with robust intellectual property exclusivity; results from the AUDREY trial in DES during the second half of 2020; the expected timing of FSGS results and patient enrollment; and that Aurinia has sufficient financial resources to fund the existing LN program, including the AURORA trial and the AURORA 2 extension study, complete the NDA submission to the FDA, conduct the ongoing Phase 2 study for FSGS, conduct the AUDREY clinical trial, and fund operations into the fourth quarter of 2020. Aurinia’s anticipation that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension; that the new Notice of Allowance is expected to result in the issuance of a U.S. patent with a term extending to December 2037; that if the FDA approves the use of voclosporin for LN and the label for such use follows the dosing protocol under the Notice of Allowance, the issuance of this patent will expand the scope of intellectual property protection for voclosporin to December 2037. It is possible that such results or conclusions may change based on further analyses of these data. Words such as “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may” and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the market value for the LN, DES and FSGS programs; that another company will not create a substantial competitive product for Aurinia’s LN, DES and FSGS business without violating Aurinia’s intellectual property rights; the burn rate of Aurinia’s cash for operations; the costs and expenses associated with Aurinia’s clinical trials; the planned studies achieving positive results; Aurinia being able to extend and protect its patents on terms acceptable to Aurinia; and the size of the LN, DES or FSGS markets. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: difficulties, delays, or failures we may experience in the conduct of our clinical trial; difficulties we may experience in completing the development and commercialization of voclosporin; the market for the LN, DES and FSGS business may not be as estimated; Aurinia may have to pay unanticipated expenses; estimated costs for clinical trials may be underestimated, resulting in Aurinia having to make additional expenditures to achieve its current goals; Aurinia not being able to extend or fully protect its patent portfolio for voclosporin; and competitors may arise with similar products. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business can be found in Aurinia’s most recent Annual Information Form available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar.

QUEBEC CITY, Quebec – Opsens Inc. (“Opsens” or the “Company”) (TSX:OPS) (OTCQX:OPSSF) today reported its results for 2019.

Highlights For the Quarter and The Year

• Record consolidated revenues at $32.8 M for FY2019 compared with $24.1 M for FY2018, a 36% increase;
• Fractional Flow Reserve (“FFR”) revenues of $20 M for FY2019 compared with $14.2 M for FY2018, a 41% increase;
• Q4 FFR revenues reach $5.3 M compared with $4.1 M for the same quarter 2018, a 29% increase;
• 42% increase in FFR revenues in the United States compared with the same quarter in 2018;
• Opsens expands into structural cardiology;
• Opsens gets OptoWire III Health Canada approval

Growth Strategy

“These results reflect cardiologists’ acceptance of the OptoWire’s distinctive features and the positive evolution of our sales approach deployed in the past year,” said Louis Laflamme, President and Chief Executive Officer of Opsens. ” We are excited by our recently announced development efforts to provide precision measurement technology for structural heart procedures. We are also pleased with Opsens’ extended collaboration with Abiomed through the signing of a five-year contract to supply a critical component of their Impella CP® heart pump technology widely used in the United States. These three applications of our technology – coronary physiology (FFR, dPR), the Abiomed heart pump and structural heart offer a diverse foundation for Opsens and highlight the quality and precision of our optical technology for cardiac applications,” Laflamme concluded.

Financial Results – Year Ended August 31, 2019

Opsens’ consolidated products sales reached $29.5 M for the year ended August 31, 2019 compared with $22.1 M the previous year. This increase is explained by a $7.0 M increase in medical revenues. In addition, the Company recorded non-recurring licensing revenues of $3.3 M compared with $2.0 M the previous year.

Gross margin for the year ended August 31, 2019, compared with the same period last year, increased from 53% to 57%. Excluding non-recurring licensing revenue, the gross margin increased from 49% to 52% ($10.8 M for the year ended August 31, 2018 to $15.4 M for the year ended August 31, 2019). This increase is the result of the optimization of FFR production activities, as well as the increase in other medical income.

Net loss amounted to $2.0 M for the year ended August 31, 2019, compared with a net loss of $4.5 M for the same period last year, a positive change of $2.5 M. This variation is mainly explained by an increase in the gross margin partially offset by an increase in administration, sales and marketing and research and development expenses.

Opsens had a cash position of $14.9 M as at August 31, 2019 compared with $10.9 M as of August 31, 2018.

Financial results for the three-month period ended August 31, 2019

Consolidated revenues reached $7.9 M for the three-month period compared with $5.9 M for the same period last year, an increase of $2.0 M or 34%. This increase is mainly related to the increase in FFR sales, which reached $5.3 M compared with $4.1 M in the 2018 comparative quarter.

For the three-month periods ended August 31, 2019 and 2018, gross margin was $4.0 M and $3.0 M, respectively.

About Opsens Inc.

Opsens focuses mainly on physiological measurements, such as FFR and dPR in interventional cardiology. Opsens offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. Its flagship product, the OptoWire, is a second-generation fiber optic pressure guidewire designed to provide the lowest drift in the industry and excellent lesions access. The OptoWire has been used in the diagnosis and treatment of over 80,000 patients in more than 30 countries. It is approved for sale in the United States, European Union, Japan, and Canada.

Opsens is also involved in industrial activities in developing, manufacturing and installing innovative fiber optic sensing solutions for critical applications.

Forward-looking statements contained in this press release involve known and unknown risks, uncertainties and other factors that may cause actual results, performance and achievements of Opsens to be materially different from any future results, performance or achievements expressed or implied by the said forward-looking statements.

Neither TSX nor its Regulation Services Provider (as that term is defined in the policies of the TSX) accepts responsibility for the adequacy or accuracy of this release.

-30-

For further information, please contact:

Louis Laflamme, CPA, CA, Chief Executive Officer, 418.781.0333

Robin Villeneuve, CPA, CA Chief Financial Officer, 418.781.0333

VICTORIA, British Columbia–(BUSINESS WIRE)– Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced the appointment of Ms. Jill Leversage to its Board of Directors and the resignation of Dr. Hyeuk Joon Lee.

“I am pleased to welcome Jill to the board as we look forward to leveraging her knowledge and strategic counsel to guide the Company’s growth and our preparations for success with voclosporin. In addition, I’d like to thank Joon for his insight over the past five years and wish him the best in his future endeavors.”

– Dr. George Milne, Chairman of Aurinia’s Board of Directors

Ms. Leversage began her finance career at Burns Fry Ltd., and has held senior level positions at BMO Financial Group, RBC Capital Markets, and TD Securities. Ms. Leversage has served on a number of public and not-for-profit corporate boards including MAG Silver Corp, RE Royalty Ltd., Insurance Corporate of BC, CMAIO, and the Vancouver Airport Authority. Ms. Leversage is a Fellow of the Institute of Chartered Professional Accountants of British Columbia and also a Chartered Business Valuator (ret.) of the Canadian Institute of Chartered Business Valuators.

“With her cross-border financial expertise, it is a pleasure to welcome Jill to the Aurinia Board. Jill brings more than 25 years of financial and corporate governance expertise which are critical areas of growth as Aurinia continues its transformation into a commercial-stage biopharmaceutical company.”

– Peter Greenleaf, President and Chief Executive Officer, Aurinia Pharmaceuticals

Related Article: Shareholder Overwhelmingly Support Aurinia & Its Board of Directors

About Aurinia

Aurinia Pharmaceuticals is a late clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently developing an investigational drug, for the treatment of lupus nephritis, focal segmental glomerulosclerosis and dry eye syndrome. The Company’s head office is in Victoria, British Columbia and focuses its development efforts globally.

About Voclosporin

Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical data in over 2,600 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney. It has been shown to have a more predictable pharmacokinetic and pharmacodynamic relationship (potentially requires no therapeutic drug monitoring), an increase in potency (vs cyclosporin), and an improved metabolic profile compared to legacy CNIs. Aurinia anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension. Further, the new Notice of Allowanceis expected to result in the issuance of a U.S. patent with a term extending to December 2037. If the FDA approves the use of voclosporin for LN and the label for such use follows the dosing protocol under the Notice of Allowance, the issuance of this patent will expand the scope of intellectual property protection for voclosporin to December 2037.

Forward-Looking Statements

Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to voclosporin being potentially a best-in-class CNI with robust intellectual property exclusivity; Aurinia’s anticipation that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension; that the new Notice of Allowance is expected to result in the issuance of a U.S. patent with a term extending to December 2037; that if the FDA approves the use of voclosporin for LN and the label for such use follows the dosing protocol under the Notice of Allowance, the issuance of this patent will expand the scope of intellectual property protection for voclosporin to December 2037. It is possible that such results or conclusions may change based on further analyses of these data. Words such as “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may” and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: that another company will not create a substantial competitive product for Aurinia’s business without violating Aurinia’s intellectual property rights; the costs and expenses associated with Aurinia’s clinical trials; the planned studies achieving positive results; and Aurinia being able to extend and protect its patents on terms acceptable to Aurinia. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: difficulties, delays, or failures we may experience in the conduct of our clinical trial; difficulties we may experience in completing the development and commercialization of voclosporin; the market for our business may not be as estimated; Aurinia may have to pay unanticipated expenses; estimated costs for clinical trials may be underestimated, resulting in Aurinia having to make additional expenditures to achieve its current goals; Aurinia not being able to extend or fully protect its patent portfolio for voclosporin; and competitors may arise with similar products. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business can be found in Aurinia’s most recent Annual Information Form available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar.

Investor & Media Contacts:

Glenn Schulman, PharmD, MPH
Corporate Communications, Aurinia
gschulman@auriniapharma.com

SOUTH SAN FRANCISCO, Calif., Nov. 12, 2019 (GLOBE NEWSWIRE) — Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA) a clinical-stage biopharmaceutical company, today reported financial results for the quarter ended September 30, 2019 and provided a business update on recent achievements.

“With the successful completion in September of our initial public offering, gross proceeds to Satsuma from private and public equity financings completed in the past two quarters exceed $150 million. These financial resources position Satsuma to continue aggressively executing on the STS101 development plan. Our goal is to make STS101, a compact, simple-to-use, self-administered, and non-injectable DHE (or dihydroergotamine) product which incorporates proprietary nasal powder formulation and delivery technologies, available as a differentiated treatment option for people with migraine.”

– John Kollins, President & CEO, Satsuma Pharmaceuticals

Third Quarter 2019 Business Highlights:

Completed IPO of approximately $90 million and Nasdaq listing (STSA)

• In September, Satsuma announced that it had closed its initial public offering (IPO) of 5,500,000 common shares at a price to the public of $15.00 per share. On October 1, 2019, the underwriters for the offering exercised their option to purchase an additional 552,000 common shares. Aggregate gross proceeds from the offering were $90.8 million, before deducting underwriting discounts and commissions and offering expenses payable by the Company.  With completion of the IPO, the Company believes it has sufficient financial resources to fund operations through the end of 2021, by which time it anticipates filing a new drug application for STS101 with the U.S. Food and Drug Administration.

Dosed first patient in EMERGE™ Phase 3 efficacy trial of STS101

• In August, Satsuma announced it had dosed the first patient in its EMERGE™ Phase 3 efficacy trial of STS101 for the acute treatment of migraine. EMERGE is a multi-center, double-blind, placebo-controlled parallel group study in approximately 1,140 migraine patients that is being conducted in the United States. Satsuma believes that EMERGE is the largest-ever clinical trial undertaken with any DHE product. The trial is statistically designed with greater than 99% and 95% power, respectively, on the trial’s two co-primary endpoints: freedom from pain and freedom from most bothersome symptom, both assessed at two hours after administration of study medication. In addition, the EMERGE trial design incorporates a number of secondary endpoints and prospective evaluations of the clinical performance of STS101 in a number of patient subgroups that could differentiate the clinical profile of STS101. Satsuma expects to report top-line data from the EMERGE trial in the second half of 2020.

Presented STS101 Phase 1 trial results & STS101 data at key migraine-focused medical conferences:

• In July at the American Headache Society’s Annual Scientific meeting, Satsuma presented STS101 Phase 1 trial results demonstrating:
  — rapid drug absorption, achieving within ten minutes the minimum threshold concentration it estimates is necessary for efficacy,
  — sustained drug plasma levels,
  — low pharmacokinetic variability, and
  — favorable safety and tolerability.

These Phase 1 results support the Company’s belief that STS101 should demonstrate a favorable and differentiated clinical profile in the ongoing EMERGE Phase 3 clinical trial.

• In September at the 19th Congress of the International Headache Society, Satsuma presented two posters on STS101 results
  — comparing the pharmacokinetics of STS101 with other intranasal, injectable and oral inhaled DHE dosage forms; and
  — demonstrating that STS101 achieves consistent and robust delivery performance.

These posters are available for download on the Publications section of the Satsuma Pharmaceuticals website (www.satsumarx.com/publications/).

Financial Results for Third Quarter 2019

Research and development expenses were $7.4 million for the third quarter of 2019, compared to approximately $1.4 million for the same period of 2018, an increase of $6.0 million. The increase was primarily due to additional expenses for the EMERGE clinical trial and drug supply manufacturing activities, as well as increases in salaries and employee-related expenses.

General and administrative expenses were $1.0 million for the third quarter of 2019 compared to $0.2 million for the same period in 2018, an increase of $0.8 million. The increase was primarily due to general administrative expenses, as well as increases in salaries and employee-related expenses.

Net loss for the quarter ended September 30, 2019 was $8.3 million or $2.26 per common share, compared to a net loss of $1.6 million or $1.48 per common share for the same period in 2018. As of September 30, 2019, the Company had approximately $118.9 million of cash and cash equivalents, and short-term investments.

Related Article: Satsuma Pharmaceuticals Inc. Proposes Initial Public Offering of Common Stock

About Satsuma Pharmaceuticals and STS101

Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product for the acute treatment of migraine, STS101. STS101 is a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate (DHE), which can be quickly and easily self-administered with a proprietary pre-filled, single-use, nasal delivery device. In developing STS101, Satsuma has applied proprietary nasal drug delivery, dry-powder formulation, and engineered drug particle technologies to create a compact, simple-to-use, non-injectable DHE product that can be rapidly self-administered in a matter of seconds. The Company believes STS101 would, if approved, be an attractive migraine treatment option for many patients and may enable a larger number of people with migraine to realize the long-recognized therapeutic benefits of DHE therapy. STS101 has undergone extensive pre-clinical development, recently completed a Phase 1 clinical trial, and is currently in Phase 3 development.

Satsuma is headquartered in South San Francisco, California with operations in both California and Research Triangle Park, North Carolina. For further information, please visit www.satsumarx.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements concerning the business, operations and financial performance and condition of Satsuma Pharmaceuticals, Inc. (the “Company”), as well as the Company’s plans, objectives and expectations for its business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about the Company’s expectations regarding the potential safety and efficacy of STS101; the Company’s clinical and regulatory development plans; the Company’s expectations with regard to the data to be derived from its planned Phase 3 clinical trials; the likelihood of regulatory filings and approvals for STS101; and the Company’s commercialization plans and expectations. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, to be filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of STS101; the Company’s ability to select suitable dosing regimens; the results of preclinical and clinical studies may not be predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; the costs of clinical trials may exceed expectations; and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

This press release discusses STS101, a product candidate that is in clinical development, and which has not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of STS101 for the therapeutic use for which STS101 is being studied.

INVESTOR AND CORPORATE CONTACTS:            

Corey Davis, PhD
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com

Tom O’Neil, Chief Financial Officer
Satsuma Pharmaceuticals, Inc.
tom@satsumarx.com

Austin, TX, and Montreal, QC (Nov. 8, 2019) – Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer, today presented the first Phase 1 clinical data from its oncology development program with AVID200, in a late-breaking poster presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2019 in National Harbor, Maryland (Nov. 6-10).

AVID200 is a first-in-class, selective inhibitor of TGF-beta 1 & 3, the main pathogenic TGF-beta isoforms. AVID200 spares TGF-beta 2 for optimal safety.

The AVID200-03 trial (NCT03834662) is an open label, multicenter, dose-escalation study of AVID200 monotherapy following a standard 3 + 3 design in patients with advanced or metastatic solid tumor malignancies and no other treatment options.

Related Article: Forbius Completes Phase 1a Solid Tumor Trial Enrollment & Closes Series C Financing

In the presentation entitled “AVID200, first-in-class TGF-beta 1 and beta 3 selective inhibitor: Results of a Phase 1 monotherapy dose escalation study in solid tumors and evidence of target engagement in patients (Abstract # P856)”, Dr Timothy Yap, Associate Professor, MD Anderson Cancer Center, and a PI in the trial detailed the following:

• A total of 15 patients received AVID200 at 5, 15 and 30 mg/kg once every three weeks, 4 patients remain ongoing at time of data presentation.
• AVID200 achieved dose-proportional exposure and exhibited peripheral target inhibition of TGF-beta 1 & 3 over the entire dosing period at all dose levels tested.
• AVID200 was well-tolerated and the maximum tolerated dose (MTD) was not reached.
  • No patients at either of the two higher dose levels, 15 mg/kg (550 mg/m²) and 30 mg/kg (1100 mg/m²), had any toxicities greater than Grade 2.
  • A single patient with appendiceal carcinoma who had a prior total colectomy and was treated in the lowest dose level cohort (5 mg/kg / 180 mg/m²), experienced grade 3 (G3) events including G3 diarrhea (worsening from G2 diarrhea at enrolment) which was characterized as the only DLT in the trial.
• Several patients experienced stable disease including one patient with the prolonged stable disease of more than 8 months who continues on treatment.

“With this Phase 1a dose-escalation study we have shown that selective inhibition of TGF-beta isoforms 1 & 3 via AVID200 leads to efficient blockade of the TGF-beta pathway with potentially best-in-class tolerability. We look forward to reporting additional clinical data from across the AVID200 program.”

– Ilia Tikhomirov, CEO of Forbius 

About TGF-beta 1 & 3

TGF-beta 1 & 3 are the main oncogenic TGF-beta isoforms expressed by many solid tumors. They are believed to play a major role in T-cell suppression, fibrosis and resistance to anti-PD-(L)1 therapies such as nivolumab (Opdivo®) and pembrolizumab (Keytruda®) (Chakravarthy, Nature Comm., 2018; Tauriello, Nature, 2018; Mariathasan, Nature, 2018).

About AVID200 and the AVID200-03 Trial (NCT03834662)

AVID200 is an isoform-selective and highly potent inhibitor of TGF-beta 1 & 3 undergoing Phase 1 clinical testing in solid tumors and fibrotic diseases. TGF-beta 1 & 3 are the principal disease-driving isoforms, while TGF-beta 2 is responsible for normal cardiac function and hematopoiesis.

AVID200’s selectivity for TGF-beta 1 & 3 was designed to achieve optimal efficacy while circumventing cardiac and other safety issues that have limited the applicability of earlier-generation, non-selective TGF-beta inhibitors. Therefore, AVID200 is positioned to be an effective and well-tolerated therapeutic in a variety of clinical settings, including in combination with anti-PD-(L)1 therapy.

AVID200-03 (NCT03834662) is an open label, multicenter, dose-escalation study to evaluate the safety, pharmacokinetics, pharmacodynamics and antitumor effects of AVID200 in patients with advanced or metastatic solid tumor malignancies.

About Forbius

Forbius is a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer. We are focused on the transforming growth factor-beta (TGF-beta) and epidermal growth factor receptor (EGFR) pathways.

Forbius’ team of TGF-beta biology experts designed a proprietary platform of TGF-beta inhibitors with best-in-class potency and selectivity against the principal disease-driving isoforms 1 & 3. This novel class of TGF-beta inhibitors has proven highly active in preclinical models of fibrosis and cancer and was well-tolerated in long-term toxicology studies. Forbius’ lead TGF-beta 1 & 3 inhibitor, AVID200, is undergoing Phase 1 clinical trials in two fibrotic indications as well as in solid tumors.

Forbius’ lead program targeting EGFR is AVID100. AVID100 is an anti-EGFR antibody-drug conjugate (ADC) with a novel tumor-selective mode of action. This program is undergoing Phase 2a clinical trials in EGFR-overexpressing solid tumors.

Media Contact

Claudia Resch
info@forbius.com

QUEBEC CITY, QUEBEC – Opsens Inc. (“Opsens” or the “Company”) (TSX:OPS) (OTCQX:OPSSF) today announced the world’s first clinical use of the OptoWire III, following the recent Health Canada approval.

“This improved version of OptoWire for physiological measurement offers maneuverability and exceptional reliability that significantly simplify the procedure. Assessment of the most complex lesions is streamlined for precise diagnosis and optimized treatment. The robustness and the quality of the optical connection make it even easier to evaluate the quality of the intervention at the end of the procedure. These are major benefits for cardiologists and their patients. The performance of the OptoWire III is, to date, unmatched.”

– Dr. Olivier F. Bertrand, the first worldwide user of OptoWire III

OptoWire III is a coronary guidewire integrating a second-generation optical sensor for vascular physiological measurement, such as Fractional Flow Reserve (“FFR”). This pressure guidewire is designed to offer the lowest drift in the industry and excellent access to lesions. Health Canada’s approval paved the way for first use of the product by interventional cardiologist Olivier F. Bertrand, from the Quebec Heart and Lung Institute.

“Opsens is pleased to provide cardiologists with an even better version of OptoWire. While the high performance of the OptoWire II is recognized, our team made this product even better by responding to user improvement requests for complex lesions, particularly in the most tortuous and calcified arteries. Doctors will appreciate a design with increased maneuverability, strength and a shorter flexible tip. In addition to mechanical improvements, Opsens has also simplified and optimized the design of its flagship product, giving the Company more control and efficiency in its production line, which will result in improved profit margins.”

– Louis Laflamme, President and Chief Executive Officer, Opsens

In addition to Canada, Opsens has also filed applications for approval in Japan, the United States and Europe.

See Opsens’ PP presentation

About Opsens Inc.

Opsens focuses mainly on physiological measurements, such as FFR and dPR in interventional cardiology. Opsens offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. Its flagship product, the OptoWire, is a second-generation fiber optic pressure guidewire designed to provide the lowest drift in the industry and excellent lesions access. The OptoWire has been used in the diagnosis and treatment of over 80,000 patients in more than 30 countries. It is approved for sale in the United States, European Union, Japan, and Canada.

Opsens is also involved in industrial activities in developing, manufacturing and installing innovative fibre optic sensing solutions for critical applications.

Forward-looking statements contained in this press release involve known and unknown risks, uncertainties and other factors that may cause actual results, performance and achievements of Opsens to be materially different from any future results, performance or achievements expressed or implied by the said forward-looking statements.

Neither TSX nor its Regulation Services Provider (as that term is defined in the policies of the TSX) accepts responsibility for the adequacy or accuracy of this release.

For further information, please contact:

Louis Laflamme, CPA, CA, Chief Executive Officer, 418.781.0333 Robin Villeneuve, CPA, CA Chief Financial Officer, 418.781.0333

Related Article: Opsens Signs Landmark Supplier Agreement – Expands Optical Sensing Technology Impact Within Cardiology Segment

VICTORIA, British Columbia — (BUSINESS WIRE) — Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced the completion of a FDA-requested clinical drug-drug interaction (“DDI”) study in patients with lupus that investigated the potential effect of voclosporin on blood levels of mycophenolate acid (“MPA”), the active metabolite of mycophenolate mofetil (“MMF”). MMF, also known as CellCept®, is considered by treating physicians to be part of the current standard of care for lupus nephritis (“LN”) in the United States.

“These results support our belief that voclosporin has no clinically significant impact on MPA levels. These data give us further confidence that the addition of voclosporin to MMF and corticosteroids for the treatment of LN can lead to predictable immunomodulation therapy and optimal results for people suffering from this devastating autoimmune disorder.”

– Neil Solomons, M.D., Chief Medical Officer, Aurinia Pharmaceuticals

This FDA-requested clinical DDI study aimed to measure, and potentially quantify, the impact voclosporin may have on MPA blood levels when given concomitantly with MMF in patients with lupus. The study results indicate that the coadministration of voclosporin with MMF had no clinically significant impact on MPA blood concentrations. In past studies, it was reported that the legacy calcineurin inhibitors (“CNIs”) inhibit the multidrug-resistance-associated protein 2 (MRP-2) transporter in the biliary tract thereby preventing the excretion of mycophenolic acid glucuronide (MPAG) into the bile leading to the enterohepatic recirculation of MPA¹. This adverse impact of cyclosporine on MPA pharmacokinetics has resulted in a 30 – 50% reduction in MPA exposure when used in combination¹.

“These DDI study results further enhance our understanding of voclosporin’s differentiated profile, and we look forward to submitting these data, along with the results from the AURORA Phase 3 trial next year as part of our NDA submission.”

– Peter Greenleaf, Chief Executive Officer, Aurinia Pharmaceuticals

Aurinia remains on track to report results from the AURORA Phase 3 in LN trial by the end of this year. AURORA is a global, randomized, 52-week double-blind, placebo-controlled Phase 3 study that compares the efficacy of voclosporin versus placebo when added to MMF and corticosteroids in subjects with active LN. The results of AURORA are intended to support marketing approval of voclosporin for patients with LN across multiple regulatory jurisdictions.

1. CellCept® (mycophenolate mofetil) package insert, Genentech USA, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco

Related Article: Aurinia Initiates Patient Dosing in Dry Eye Syndrome Clinical Trial

About Aurinia

Aurinia Pharmaceuticals is a late clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently developing an investigational drug, for the treatment of lupus nephritis, focal segmental glomerulosclerosis and dry eye syndrome. The Company’s head office is in Victoria, British Columbia and focuses its development efforts globally.

About Voclosporin

Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical data in over 2,600 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney. It has been shown to have a more predictable pharmacokinetic and pharmacodynamic relationship (potentially requires no therapeutic drug monitoring), an increase in potency (vs cyclosporin), and an improved metabolic profile compared to legacy CNIs. Aurinia anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension. Further, the new Notice of Allowanceis expected to result in the issuance of a U.S. patent with a term extending to December 2037. If the FDA approves the use of voclosporin for LN and the label for such use follows the dosing protocol under the Notice of Allowance, the issuance of this patent will expand the scope of intellectual property protection for voclosporin to December 2037.

Forward-Looking Statements

Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to the results and impact the DDI study will have with regulators or potential approval of voclosporin for LN, the ability to fully-enroll and report top-line results from the AUDREY clinical trial during the second half of 2019, and the number of subjects expected to be enrolled; completing NDA submissions in a successful and timely manner including the anticipated NDA filing during the first half of next year and subsequent commercial launch in 2021, voclosporin being potentially a best-in-class CNI with robust intellectual property exclusivity; the anticipated AUDREY clinical study including enrolling the first subject in the fourth quarter of 2019 and the number of subjects expected to be enrolled; the expected timing of FSGS results and patient enrollment; and that Aurinia has sufficient financial resources to fund the existing LN program, including the AURORA trial, and the NDA submission to the FDA, conduct the current Phase 2a study for FSGS, commence additional studies for DES and fund operations into the second half of 2020. Aurinia’s expected use of the funds from the ATM offering; Aurinia’s anticipation that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension; that the new Notice of Allowance is expected to result in the issuance of a U.S. patent with a term extending to December 2037; that if the FDA approves the use of voclosporin for LN and the label for such use follows the dosing protocol under the Notice of Allowance, the issuance of this patent will expand the scope of intellectual property protection for voclosporin to December 2037. It is possible that such results or conclusions may change based on further analyses of these data. Words such as “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may” and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the market value for the LN, DES and FSGS programs; that another company will not create a substantial competitive product for Aurinia’s LN, DES and FSGS business without violating Aurinia’s intellectual property rights; the burn rate of Aurinia’s cash for operations; the costs and expenses associated with Aurinia’s clinical trials; the planned studies achieving positive results; Aurinia being able to extend and protect its patents on terms acceptable to Aurinia; and the size of the LN, DES or FSGS markets. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: difficulties, delays, or failures we may experience in the conduct of our clinical trial; difficulties we may experience in completing the development and commercialization of voclosporin; the market for the LN, DES and FSGS business may not be as estimated; Aurinia may have to pay unanticipated expenses; estimated costs for clinical trials may be underestimated, resulting in Aurinia having to make additional expenditures to achieve its current goals; Aurinia not being able to extend or fully protect its patent portfolio for voclosporin; and competitors may arise with similar products. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business can be found in Aurinia’s most recent Annual Information Form available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar.

Investors & Media:
Glenn Schulman, PharmD, MPH
Corporate Communications, Aurinia
gschulman@auriniapharma.com

“We recently presented data on our lead asset, ZW25, at two major medical conferences that pave the way for registration-enabling trials in second-line biliary tract cancer (BTC) with single agent ZW25 and in first-line gastroesophageal adenocarcinoma (GEA) with ZW25 in combination with chemotherapy. These clinical plans support our evaluation of ZW25’s broad potential in earlier lines of therapy with the goal of establishing ZW25 as a therapeutic option for a greater number of people with HER2‑expressing cancers.”

– Ali Tehrani, Ph.D., President & CEO, Zymeworks

Third Quarter 2019 Business Highlights and Recent Developments

1. Zymeworks presents Single Agent Data for ZW25 at European Society for Medical Oncology (ESMO) Congress

Updated Phase 1 clinical data continued to show that ZW25 monotherapy provides anti-tumor activity and durable disease control across multiple tumor types in heavily pretreated patients. Encouraging response rates in BTC support the initiation of a registration-enabling Phase 2 trial evaluating single-agent ZW25 as a second-line treatment for patients with HER2‑expressing BTC.

2. Zymeworks presents ZW25 Chemotherapy Combination Data at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

Phase 1 clinical data demonstrated that the addition of chemotherapy to ZW25 treatment may enhance anti-tumor activity vs. ZW25 alone, and the combination therapy was tolerated in heavily pretreated HER2‑expressing GEA patients. These data further support the ongoing Phase 2 trial of ZW25 in combination with standard of care chemotherapy in first-line GEA.

3. Celgene Advances First Azymetric^™ Bispecific Towards the Clinic
Celgene selected its first lead bispecific antibody candidate built using Zymeworks’ Azymetric platform and exercised its option to a commercial license for which Zymeworks received a US$7.5 million payment.

Financial Results for the Quarter Ended September 30, 2019

Revenue for the three months ended September 30, 2019, was $7.9 million as compared to $2.1 million in the same period of 2018. Revenue for the third quarter of 2019 includes $7.5 million recognized upon Celgene’s exercise of its commercial license option and $0.4 million in research and support payments from our partners. Revenue in the same period in 2018 was primarily due to a $2.0 million development milestone upon Lilly’s submission of an IND application under a licensing agreement with Lilly.

Revenue for the three months ended September 30, 2019, was $7.9 million as compared to $2.1 million in the same period of 2018. Revenue for the third quarter of 2019 includes $7.5 million recognized upon Celgene’s exercise of its commercial license option and $0.4 million in research and support payments from our partners. Revenue in the same period in 2018 was primarily due to a $2.0 million development milestone upon Lilly’s submission of an IND application under a licensing agreement with Lilly.

For the three months ended September 30, 2019, research and development expenses were $29.3 million as compared to $14.2 million in the same period of the prior year. The change was primarily due to an increase in clinical trial activity and associated manufacturing costs for ZW25, as well as an increase in other research and discovery activities compared to the same period in 2018. Research and development expenses included non-cash stock-based compensation expense of $1.7 million from equity-classified stock options and a $0.9 million expense related to the non-cash mark-to-market revaluation of certain historical liability-classified stock options.

For the three months ended September 30, 2019, general and administrative expenses were $12.2 million as compared to $7.5 million in the same period in 2018, primarily due to an increase in employee compensation expenses relating to non-cash stock-based compensation, as well as increased headcount in 2019 over 2018. General and administrative expenses in 2019 included a non-cash stock-based compensation expense of $1.7 million from equity-classified stock options and $2.8 million related to the non-cash mark-to-market revaluation of certain historical liability-classified stock options.

The net loss for the three months ended September 30, 2019, was $30.5 million as compared to $18.8 million in the same period of 2018. This was primarily due to an increase in research and development expenses associated with our lead therapeutic candidates and other programs, as well as an increase in general and administrative expenses in 2019. This increase was partially offset by increased revenue from research and development collaborations, interest and other income in 2019.

Zymeworks expects research and development expenditures to increase over time in line with the advancement and expansion of clinical development of our product candidates, as well as our ongoing preclinical research activities. Additionally, Zymeworks anticipates continuing to receive revenue from our existing and future strategic partnerships, including technology access fees, milestone-based payments and research support payments. However, Zymeworks’ ability to receive these payments is dependent upon either Zymeworks or our collaborators successfully completing specified research and development activities.

As of September 30, 2019, Zymeworks had $335.1 million in cash and cash equivalents and short-term investments.

Related Article: Zymeworks Releases Q2 2019 Financial Results

NON-GAAP FINANCIAL MEASURES

In addition to reporting financial information in accordance with U.S. generally accepted accounting principles (“GAAP”) in this press release, Zymeworks is also reporting normalized expenses and normalized loss per share, which are non-GAAP financial measures. Normalized expenses and normalized loss per share are not defined by GAAP and should not be considered as alternatives to net loss, net loss per share or any other indicator of Zymeworks’ performance required to be reported under GAAP. In addition, Zymeworks’ definitions of normalized expenses and normalized loss per share may not be comparable to similarly titled non-GAAP measures presented by other companies. Investors and others are encouraged to review Zymeworks’ financial information in its entirety and not rely on a single financial measure. As defined by Zymeworks, normalized expenses represent total research and development expenses and general and administrative expenses adjusted for non-cash stock-based compensation expenses for equity and liability-classified equity instruments.

Normalized expenses are a non-GAAP measure that Zymeworks believes is useful because it excludes those items that Zymeworks believes are not representative of Zymeworks’ operating expenses.

About Zymeworks Inc.

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics. Zymeworks’ suite of therapeutic platforms and its fully-integrated drug development engine enable precise engineering of highly differentiated product candidates. Zymeworks’ lead clinical candidate, ZW25, is a novel Azymetric™ bispecific antibody currently in Phase 2 clinical development. Zymeworks’ second clinical candidate, ZW49, is a bispecific antibody-drug conjugate currently in Phase 1 clinical development and combines the unique design and antibody framework of ZW25 with Zymeworks’ proprietary ZymeLink™ cytotoxic payload. Zymeworks is also advancing a deep preclinical pipeline in immuno-oncology and other therapeutic areas. In addition, its therapeutic platforms are being leveraged through strategic partnerships with nine biopharmaceutical companies.

Cautionary Note Regarding Zymeworks’ Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this news release include, but are not limited to, statements that relate to plans to initiate a registration-enabling trial for ZW25, increases in research and development expenditures, planned advancement and expansion of clinical development of Zymeworks’ product candidates, anticipated continued receipt of revenue from existing and future partners, and other information that is not historical information. When used herein, words and phrases such as “enable”, “may”, “expect”, “anticipate”, “advances”, “continue”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under “Risk Factors” in Zymeworks’ Quarterly Report on Form 10-Q for its quarter ended September 30, 2019 (a copy of which may be obtained at www.sec.gov and www.sedar.com). Consequently, forward-looking statements should be regarded solely as Zymeworks’ current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Investor Inquiries: 
Ryan Dercho, Ph.D. 
(604) 678-1388 
ir@zymeworks.com 

Tiffany Tolmie 
(604) 678-1388 
ir@zymeworks.com 

Media Inquiries: 
Kavita Shah, Ph.D.
(604) 678-1388 
info@zymeworks.com 

QUEBEC CITY / CNW Telbec/ –Opsens Inc. (“Opsens” or the “Company”) (TSX: OPS) (OTCQX: OPSSF) announces today it is expanding its medical device business into the structural cardiology space and will accelerate development activities of products that reach beyond its current coronary and peripheral applications.

“Opsens’ technical and commercial capabilities have expanded over the last few years, fueled by our success in the coronary market. Our flagship product, the OptoWire, has been used in more than 80,000 patients in the United States, Europe, Japan, and Canada. We remain excited about our core business outlook and also see a highly synergistic adjacent market to expand our technology.”

– Louis Laflamme, President and Chief Executive Officer

The initial area of focus is aortic stenosis, a common and serious valve disease that is often treated through Trans Aortic Valve Replacement (TAVR). This is the fastest-growing part of structural cardiology, driven by an aging population and advancements in valve technology and technique that are bringing the procedure to a wider patient population.

“The company has recently been successfully working on this structural heart project and has sufficiently advanced the program to warrant further activities and investment to accelerate our time to market. We plan to build on our existing technology, infrastructure and know-how in complementary directions. We expect a number of positive development milestones in the next four to six quarters on our way to a commercially viable product that can have an immediate impact on TAVR procedures.”

– Louis Laflamme, President and Chief Executive Officer

Related Article: Opsens Releases Promising Q3 2019 Financials

About Opsens Inc.

Opsens focuses mainly on physiological measurements, such as FFR and dPR in interventional cardiology. Opsens offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. Its flagship product, the OptoWire, is a second-generation fiber optic pressure guidewire designed to provide the lowest drift in the industry and excellent lesions access. The OptoWire has been used in the diagnosis and treatment of over 80,000 patients in more than 30 countries. It is approved for sale in the United States, European Union, Japan, and Canada.

Opsens is also involved in industrial activities in developing, manufacturing and installing innovative fibre optic sensing solutions for critical applications.

Forward-looking statements contained in this press release involve known and unknown risks, uncertainties and other factors that may cause actual results, performance and achievements of Opsens to be materially different from any future results, performance or achievements expressed or implied by the said forward-looking statements.

Neither TSX nor its Regulation Services Provider (as that term is defined in the policies of the TSX) accept responsibility for the adequacy or accuracy of this release.

For Investor or Media Inquiries, contact:

Louis Laflamme, CPA, CA, Chief Executive Officer, 418.781.0333; Robin Villeneuve, CPA, CA, Chief Financial Officer, 418.781.0333

SOUTH SAN FRANCISCO, Calif. and TORONTO — Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, and Notch Therapeutics Inc., an immune cell therapy company creating universally compatible, allogeneic T cell therapies for the treatment of diseases of high unmet need, today announced an exclusive worldwide collaboration and license agreement to research and develop induced pluripotent stem cell (iPSC) AlloCAR™ therapy products for initial application in non-Hodgkin lymphoma, leukemia and multiple myeloma. Under the partnership, Allogene and Notch will create allogeneic cell therapy candidates from T cells or natural killer (NK) cells using Notch’s Engineered Thymic Niche (ETN) platform.

“This collaboration exemplifies Allogene’s long-term commitment to advancing the field of cancer treatment as we continue to expand and progress our innovative pipeline of off-the-shelf AlloCAR candidates. The scientific founders of Notch Therapeutics are among the most respected experts in the field of stem cell biology and its applications to generating T cells and other functional immune cells. We are confident that their technology and expertise, combined with Allogene’s leadership in AlloCAR therapies, has the potential to unlock future generations of cell therapy treatments for patients.”

– David Chang, M.D., Ph.D., President, CEO & Co-Founder, Allogene Therapeutics

“Renewable-source, off-the-shelf cell therapies that may produce cells with greater consistency and at industrial scale have long been the dream for people working in this field. We are delighted to spring into the research collaboration for iPSC-based AlloCAR therapies with Allogene, a leader in the allogeneic CAR T field, with the goal of expanding options for patients.”

– Ulrik Nielsen, Ph.D., Executive Chairman, Notch Therapeutics

Notch was established in 2018 by Juan Carlos Zúñiga-Pflücker, Ph.D. and Peter Zandstra, Ph.D., recognized pioneers in iPSC and T cell differentiation technology. Notch is developing a next-generation approach to differentiating mature immune cells from iPSCs. The Notch ETN technology platform offers potential flexibility and scalability for the production of stem cell-derived immune cell therapies. iPSCs may provide renewable starting material for AlloCAR T therapies that could allow for improved efficiency of gene editing, greater scalability of supply, product homogeneity and more streamlined manufacturing.

Related Article: Lumira Joins Financing Syndicate for Notch Therapeutics – A New Company with Revolutionary Allogeneic T Cell Technology

Under the terms of the agreement, Notch will be responsible for preclinical research of next-generation iPSC AlloCAR T™ cells. Allogene will clinically develop the product candidates and holds exclusive worldwide rights to commercialize resulting products. Allogene will provide to Notch an upfront payment of $10 million. Notch will be eligible to receive up to $7.25 million upon achieving certain agreed research milestones, up to $4.0 million per exclusive target upon achieving certain pre-clinical development milestones, and up to $283 million per exclusive target and cell type upon achieving certain clinical, regulatory and commercial milestones as well as tiered royalties on net sales in the mid to high single digits. In addition to this collaboration and license agreement, Allogene has acquired a 25 percent equity position in Notch and will assume a seat on Notch’s Board of Directors.

“Master cell banks of genetically modified, induced pluripotent stem cells could provide an inexhaustible source of cell therapies that may improve outcomes and expand applicability to new areas.”

– Juan Carlos Zúñiga-Pflücker, Ph.D., Co-Founder, Notch Therapeutics, senior scientist, Sunnybrook Research Institute & Professor & Chair of the Department of Immunology, University of Toronto

“This work with Allogene may also pave the way for additional off-the-shelf cell therapeutics that are custom-designed to treat other immunity-related diseases such as infectious diseases, autoimmune diseases and aging.”

– Peter Zandstra, Ph.D., Co-Founder, Notch Therapeutics & Professor at the University of British Columbia & University of Toronto

About Notch Therapeutics 
Notch Therapeutics is an immune cell therapy company creating universally compatible, allogeneic (off-the-shelf) T cell therapies for the treatment of diseases of high unmet medical need. Notch’s technology platform uses genetically tailored stem cells as a renewable source for creating allogeneic T cell therapies that expand treatment options and deliver safer, consistently manufactured and more cost-effective cell immunotherapies to patients. At the core of Notch’s technology is the synthetic Engineered Thymic Niche (ETN) platform, which drives the expansion and differentiation of stem cells in scalable, fully defined, feeder-free and serum-free cultures into T cells that can be genetically tailored for any T cell-based immunotherapeutic application. This technology was invented in the laboratories of Juan-Carlos Zúñiga-Pflücker, Ph.D. at Sunnybrook Research Institute and Peter Zandstra, Ph.D., FRSC at the University of Toronto. Notch was founded by these two institutions, in conjunction with MaRS Innovation (now Toronto Innovation Acceleration Partners) and the Center for Commercialization of Regenerative Medicine (CCRM) in Toronto.

About Allogene Therapeutics
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a world-class management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability to progress the research collaboration, Notch’s ability to develop a next-generation approach to differentiating mature immune cells from iPSCs, the ability to develop and manufacture new therapies from Notch technology, and the potential benefits of Notch technology and AlloCAR T therapy. Various factors may cause differences between Allogene’s expectations and actual results as discussed in greater detail in Allogene’s filings with the Securities and Exchange Commission (SEC), including without limitation in its Form 10-Q for the quarter ended June 30, 2019. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Allogene Media/Investor Contact:
Christine Cassiano
Chief Communications Officer
(714) 552-0326
Christine.Cassiano@allogene.com

Notch Media Contact:
Mary Moynihan
M2Friend Biocommunications
802-951-9600
mary@m2friend.com

RESEARCH TRIANGLE PARK, N.C. (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today provided a corporate and financial update for the third quarter ended September 30, 2019. Review the full filling here.

“Based on written feedback from the FDA following our pre-NDA meeting in September, we will submit a New Drug Application for myelopreservation in small cell lung cancer. We expect to complete the submission in the second quarter of 2020. Our vision is for trilaciclib to become a new standard of care to mitigate myelosuppression in patients receiving chemotherapy. We are committed to making trilaciclib available to small cell lung cancer patients as quickly as possible, and are executing on a regulatory and development strategy to evaluate the myelopreservation benefits of trilaciclib in the most commonly used chemotherapy regimens. We expect to initiate a Phase 3 trial in colorectal cancer in the second half of 2020. In addition, we will continue to explore trilaciclib in triple-negative breast cancer, where preliminary data has demonstrated a survival benefit.”

– Mark Velleca, M.D., Ph.D., Chief Executive Officer

Third Quarter Regulatory and Clinical Highlights

• The company plans to submit an NDA for trilaciclib in small cell lung cancer (SCLC) based on written feedback from FDA. Based on written feedback from its pre-NDA meeting with the U.S. Food and Drug Administration (FDA) in September, the company will file an NDA for trilaciclib in SCLC. The company expects to complete the NDA submission in the second quarter of 2020. Earlier this year, trilaciclib received Breakthrough Therapy Designation (BTD) from the FDA based on positive myelopreservation data in SCLC patients from three randomized Phase 2 clinical trials. The BTD program is designed to expedite the development and review of drugs intended for serious or life-threatening conditions. 
   
• ESMO presentations: data from Phase 2 clinical trials of trilaciclib in metastatic triple-negative breast cancer (mTNBC) and SCLC and data from Phase 1 clinical trial of G1T48 in ER+, HER2- breast cancer. In an oral presentation on data from a randomized Phase 2 trial of trilaciclib, preliminary overall survival (OS) results demonstrated that women with mTNBC lived significantly longer when receiving trilaciclib and chemotherapy compared with women receiving chemotherapy alone. Data were published simultaneously in The Lancet Oncology. The company also presented updated Phase 2 results in SCLC patients receiving trilaciclib and chemotherapy in combination with Tecentriq^® (atezolizumab) (press release here) and the first clinical data on its oral selective estrogen receptor degrader (SERD), G1T48. Preliminary results from the ongoing Phase 1/2a dose-escalation trial of G1T48 in patients with estrogen receptor-positive, HER2-negative (ER+, HER2-) breast cancer showed G1T48 was well tolerated and demonstrated evidence of anti-tumor activity in heavily pre-treated patients. Based on safety and tolerability findings in the Phase 1b portion of this trial, the company selected the 600 mg and 1,000 mg doses of G1T48 for evaluation in the ongoing Phase 2a portion.

Third Quarter 2019 Financial Highlights

• Cash Position: Cash, cash equivalents and short-term investments totaled $299.9 million as of September 30, 2019, compared to $369.3 million as of December 31, 2018.
• Operating Expenses: Operating expenses were $34.0 million for the third quarter of 2019, compared to $20.8 million for the third quarter of 2018. GAAP operating expenses include stock-based compensation expense of $4.4 million for the third quarter of 2019, compared to $3.3 million for the third quarter of 2018.
• Research and Development Expenses: Research and development (R&D) expenses for the third quarter of 2019 were $22.9 million, compared to $15.9 million for the third quarter of 2018. The increase in R&D expense was primarily due to an increase in clinical program costs, costs for manufacturing pharmaceutical active ingredients, and personnel costs due to additional headcount.
• General and Administrative Expenses: General and administrative (G&A) expenses for the third quarter of 2019 were $11.1 million, compared to $4.9 million for the third quarter of 2018. The increase in G&A expense was largely due to an increase in compensation due to additional headcount, an increase in pre-commercialization activities, an increase in medical affairs costs, and an increase in professional fees and other administrative costs necessary to support our operations.
• Net Loss: G1 reported a net loss of $32.4 million for the third quarter of 2019, compared to $19.9 million for the third quarter of 2018.
• 2019 Guidance: The company expects to end the year with $265-$270 million in cash and cash equivalents.

Anticipated Milestones

• Begin rolling NDA submission for trilaciclib in SCLC in 4Q19, which the company expects to complete in 2Q20; submit Marketing Authorization Application to the European Medicines Agency in 2H20.
• Initiate clinical trials of trilaciclib in colorectal cancer and TNBC in 2020.
• Present additional data from the Phase 1b/2a clinical trial of lerociclib + Faslodex^® (fulvestrant) at the 2019 San Antonio Breast Cancer Symposium (SABCS) on December 11, 2019.
• Identify dose and schedule of lerociclib and G1T48 for pivotal trials in ER+, HER2- breast cancer.            

Related Article: FDA Grants G1 Therapeutics Breakthrough Therapy Designation in Q2 2019 Corporate and Financial Update

Webcast and Conference Call
The management team will host a webcast and conference call at 4:30 p.m. ET today to provide a corporate and financial update for the third quarter 2019 ended September 30, 2019. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 3374256. A live and archived webcast will be available on the Events & Presentations page of the company’s website. The webcast will be archived on the same page for 90 days following the event.

About G1 Therapeutics
G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of innovative therapies that improve the lives of those affected by cancer. The company is advancing three clinical-stage programs. Trilaciclib is a first-in-class therapy designed to improve outcomes for patients being treated with chemotherapy. Lerociclib is an oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies. G1T48 is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. G1 also has an active discovery program focused on cyclin-dependent kinase targets.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, the therapeutic potential of trilaciclib, lerociclib and G1T48 and the timing for next steps with regard to the trilaciclib marketing applications, and are based on the Company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the Company’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, the Company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the Company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; the Company’s development of a CDK4/6 inhibitor to reduce chemotherapy-induced myelosuppression is novel, unproven and rapidly evolving and may never lead to a marketable product; and market conditions. Except as required by law, the Company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact:
Jeff Macdonald
Senior Director, Investor Relations & Corporate Communications
919-213-9835
jmacdonald@g1therapeutics.com

Toronto, ON, (GLOBE NEWSWIRE) — Notch Therapeutics, a company in the emerging field of gene-modified T cell therapy, has been created to commercialize a revolutionary technology that creates allogeneic (donor) gene-edited T cells from stem cells on an industrial scale, efficiently making T cell therapies that are clinically robust and of a consistently high quality. Notch is actively pursuing industry partnerships.

The founders of Notch – Sunnybrook Health Sciences Centre, University of Toronto (UoT), Toronto Innovation Acceleration Partners (TIAP) and CCRM, with Lumira Ventures as an additional investor – created Notch to provide a vehicle through which to further develop and bring to market the combined pioneering research, nearly ten years underway, from the labs of Dr. Juan Carlos Zúñiga-Pflücker, Senior Scientist in Biological Sciences at Sunnybrook, and Chair of the Department of Immunology at UoT; and Dr. Peter Zandstra, Professor, Institute of Biomaterials and Biomedical Engineering at UoT and Director, School of Biomedical engineering and Michael Smith Laboratories at the University of British Columbia. 

“This technology is very promising and might be used to create therapies to treat some of our greatest medical challenges, like cancer, autoimmune diseases and organ transplant rejection. It’s also the first and only method that can reconstitute immune systems. Finally having options to target these high-impact areas for our patients is what we mean when we say we are inventing the future of health care.”

– Dr. Andy Smith, President and CEO of Sunnybrook Health Sciences Centre

“Dr. Zúñiga-Pflücker’s allogeneic T cell therapy was one of the first projects I worked on when I joined UoT. It’s very gratifying to see the technology move toward the clinic.”

– Jennifer Fraser, Director Innovations at the University of Toronto

Even as the field for these therapies grows rapidly, major challenges have until now prevented wider adoption mainly due to a slow and expensive manufacturing process that yielded variable results. The Notch technology, however, shows promise for surmounting these issues cost-effectively and reliably. Notch, having been incubated at CCRM, will be able to leverage its in-house process development expertise and Good Manufacturing Practices (GMP) facility, located in downtown Toronto. It offers universally enhanced T cell therapies against high-impact diseases, using stem cells as a renewable source to expand treatment options and deliver cost-effective immunotherapies to patients. The aim of Notch is to generate T cells from multiple sources of stem cells and provide a platform for research and development, and a better way of manufacturing T cells and their applications for treating cancers or immune deficiencies.

“TIAP is pleased that, after many years of nurturing this research and investing in the risky early-stages with our co-founders, we are now seeing a truly ground-breaking new health science technology make its way through development in a very encouraging way. This is yet another example of what can be done through TIAP’s unique ability within the community to bundle technologies across multiple institutions. This is a true collaboration which has resulted in development of a technology that will have significant impact.”

– Dr. Rafi Hofstein, President & CEO of TIAP

“Notch Therapeutics is a star pupil in CCRM’s incubation program. By de-risking the technology and designing Proof of Concept studies to appeal to investors, attracting experienced start-up management, and working with our ecosystem partners, we have collectively given Notch every opportunity to succeed.”

– Dr. Michael May, President and CEO of CCRM

“Early on, our team recognized Notch’s novel and differentiated platform and its potential to produce safer, more effective, and scalable allogeneic T cell therapies. We are pleased to be part of the financing syndicate. The quality and breadth of science coming out of Canadian universities is phenomenal, and important innovators like Notch are able to access capital, knowledge and the engaged support of Lumira and other investors, to enable the development and commercialization of their technology. We are excited to work with the entire Notch team.”

– Dr. Benjamin Rovinski, Managing Director of Lumira Ventures

About TIAP

TIAP is a leading provider of venture building services, early-stage funding, and deal-brokering with industry and private investors. As a member-based organization made up of 14 member institutions – including the University of Toronto and affiliated teaching hospitals – TIAP’s mandate is to drive the commercialization of their most promising research breakthroughs. TIAP has an active portfolio of more than 60 companies in sectors such as therapeutics, medical devices, and IT/AI, which have raised in excess of CDN$300M from global investors, and has created more than 1000 direct/indirect jobs.

About the University of Toronto
Founded in 1827, the University of Toronto is Canada’s leading institution of learning, discovery and knowledge creation. U of T is one of the world’s top research-intensive universities, driven to invent and innovate. It is also one of the top five universities in the world for its start-up incubator programs. In the last 10 years, the U of T entrepreneurship community has created over 500 companies and raised over $1.5 billion in investment capital. 

About Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre is inventing the future of healthcare for the 1.3 million patients the hospital cares for each year through the dedication of its more than 10,000 staff and volunteers. An internationally recognized leader in research and education and a full affiliation with the University of Toronto distinguishes Sunnybrook as one of Canada’s premier academic health sciences centres. Sunnybrook specializes in caring for high-risk pregnancies, critically-ill newborns and adults, offering specialized rehabilitation and treating and preventing cancer, cardiovascular disease, neurological and psychiatric disorders, orthopedic and arthritic conditions and traumatic injuries. The Hospital also has a unique and national leading program for the care of Canada’s war veterans.  For more information about how Sunnybrook is inventing the future of health care.

About CCRM
CCRM, a Canadian not-for-profit organization funded by the Government of Canada, the Province of Ontario, and leading academic and industry partners, supports the development of regenerative medicines and associated enabling technologies, with a specific focus on cell and gene therapy. A network of researchers, leading companies, investors and entrepreneurs, CCRM accelerates the translation of scientific discovery into new companies and marketable products for patients, with specialized teams, dedicated funding, and unique infrastructure. CCRM is the commercialization partner of the Ontario Institute for Regenerative Medicine and the University of Toronto’s Medicine by Design. CCRM is hosted by the University of Toronto.

About Lumira Ventures
Lumira Ventures is Canada’s leading and most active healthcare venture capital firm. Lumira invests in best-in-class North American companies developing innovative therapeutics and medical technologies whose products offer transformative improvements to patient health outcomes and provide meaningful reductions to the overall cost of healthcare delivery. Since inception, Lumira’s portfolio companies have brought 50+ new therapies to market, impacting the lives of 1+ billion patients globally, generating $65+ billion in cumulative revenue.

Investment & Media-Related Contacts:

• Susanne Staer, Manager, Corporate Affairs, TIAP, sstaer@tiap.ca

• Craig DuHamel, VP of Communications and Stakeholder Relations, Sunnybrook Health Sciences Centre, craig.duhamel@sunnybrook.ca

• Stacey Johnson, Director Communications and Marketing, CCRM, stacey.johnson@ccrm.ca

• Peter van der Velden, Managing General Partner, Lumira Ventures, plv@lumira.vc

VICTORIA, British Columbia — Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced the initiation of patient dosing in the Phase 2/3 AUDREY™ clinical trial evaluating voclosporin ophthalmic solution (“VOS”) for the potential treatment of dry eye syndrome (“DES”).

“Based upon the impressive results seen with VOS in the head-to-head exploratory Phase 2a study against cyclosporin A, we are focused on rapidly advancing this promising treatment for those who suffer from dry eye syndrome. Through the Phase 2/3 AUDREY™ trial, we will generate important dose-ranging and clinical data aimed at bringing VOS towards registration and commercialization.”

– Peter Greenleaf, President and Chief Executive Officer, Aurinia Pharmaceuticals

The AUDREY™ trial is a randomized, double-masked, vehicle-controlled, dose-ranging study evaluating the efficacy and safety of VOS in subjects with DES. A total of approximately 480 subjects are expected to be enrolled. The study will consist of four arms with a 1:1:1:1 randomization schedule, in which patients will receive either 0.2% VOS, 0.1% VOS, 0.05% VOS or vehicle, dosed twice daily for 12 weeks. The primary outcome measure for the trial is the proportion of subjects with a 10mm improvement in Schirmer Tear Test (“STT”) at four weeks. Secondary outcome measures will include STT at other time points, Fluorescein Corneal Staining (“FCS”) at multiple time points, change in eye dryness, burning/stinging, itching, photophobia, eye pain and foreign body sensation at multiple time points, and additional safety endpoints. Top-line results from the AUDREY™ clinical study are anticipated during the second half of 2020.

“Despite available therapies, DES continues to have a significant impact on individuals affected. We are encouraged by the efficacy data we saw in our exploratory study which demonstrated rapid and statistical superiority versus the current standard of care on objective signs of DES. Based on these data, the Company has gained confidence that VOS represents a potential best-in-class calcineurin inhibitor for DES.”

– Neil Solomons, M.D., Chief Medical Officer, Aurinia Pharmaceuticals

In January of 2019, Aurinia reported Phase 2 results demonstrating that VOS (voclosporin 0.2%) administered twice daily was superior to cyclosporin A 0.05% (Restasis^®) administered twice daily across all objective endpoints including FCS and STT. This statistical superiority was observed after two weeks of dosing. The exploratory study also showed no statistically significant nor clinically meaningful difference in drop discomfort, as measured by drop discomfort scores at one and five minutes after first application, between VOS 0.2% and cyclosporin A 0.05%.

“To the best of my knowledge, the Phase 2 results reported by Aurinia earlier this year represent the first double-masked, randomized, head-to-head study to show objective superiority over an active comparator for DES.”

– Joseph Tauber, M.D., practicing ophthalmologist and Founder of the Tauber Eye Center, Kansas City, MO

Related Article: Aurinia Initiates Phase 2 Clinical Trial for Voclosporin Ophthalmic Solution for the Treatment of Dry Eye Syndrome

About Aurinia

Aurinia Pharmaceuticals is a late clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently developing the investigational drug, voclosporin, for the treatment of lupus nephritis (“LN”), focal segmental glomerulosclerosis (“FSGS”), and DES. The Company’s head office is in Victoria, British Columbia and focuses its development efforts globally.

About Voclosporin

Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor (“CNI”) with clinical data in over 2,600 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney. It has been shown to have a more predictable pharmacokinetic and pharmacodynamic relationship (potentially requires no therapeutic drug monitoring), an increase in potency (vs cyclosporin), and an improved metabolic profile compared to legacy CNIs. Aurinia anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension. Further, the new Notice of Allowanceis expected to result in the issuance of a U.S. patent with a term extending to December 2037. If the FDA approves the use of voclosporin for LN and the label for such use follows the dosing protocol under the Notice of Allowance, the issuance of this patent will expand the scope of intellectual property protection for voclosporin to December 2037.

About Voclosporin ophthalmic solution (VOS)

Voclosporin ophthalmic solution (“VOS”) is an aqueous, preservative free nanomicellar solution intended for use in the treatment of DES. A Phase 2a study was recently completed with results released in January of 2019. Previously, a Phase 1 study with healthy volunteers and patients with DES was also completed as were studies in rabbit and dog models. VOS has IP protection until 2031.

About DES

Dry eye syndrome (“DES”) is characterized by irritation and inflammation that occurs when the eye’s tear film is compromised by reduced tear production, imbalanced tear composition, or excessive tear evaporation. The impact of DES ranges from subtle, yet constant eye irritation to significant inflammation and scarring of the eye’s surface. Discomfort and pain resulting from DES can reduce the quality of life and cause difficulty reading, driving, using computers and performing daily activities. DES is a chronic disease estimated to affect more than 16 million people in the United States. There are multiple FDA approved therapies for the treatment of dry eye; however, there is an opportunity for potential improvements in the effectiveness, tolerability, and onset of action.

Forward-Looking Statements

Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: the ability to fully-enroll and report top-line results from the AUDREY clinical trial during the second half of 2020, and the number of subjects expected to be enrolled; voclosporin being potentially a best-in-class CNI with robust intellectual property exclusivity and that Aurinia has sufficient financial resources to fund existing DES programs, including AUDREY. It is possible that such results or conclusions may change based on further analyses of these data. Words such as “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may” and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the market value for the DES program; that another company will not create a substantial competitive product for Aurinia’s DES business without violating Aurinia’s intellectual property rights; the burn rate of Aurinia’s cash for operations; the costs and expenses associated with Aurinia’s clinical trials; the planned studies achieving positive results; Aurinia being able to extend and protect its patents on terms acceptable to Aurinia; and the size of the DES market. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: difficulties, delays, or failures we may experience in the conduct of our clinical trial; difficulties we may experience in completing the development and commercialization of voclosporin; the market for the DES business may not be as estimated; Aurinia may have to pay unanticipated expenses; estimated costs for clinical trials may be underestimated, resulting in Aurinia having to make additional expenditures to achieve its current goals; Aurinia not being able to extend or fully protect its patent portfolio for voclosporin and voclosporin ophthalmic solution; and competitors may arise with similar products. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business can be found in Aurinia’s most recent Annual Information Form available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar.

Investor & Media Contact:
Glenn Schulman, PharmD, MPH
Corporate Communications, Aurinia
gschulman@auriniapharma.com