Edesa Biotech Receives Approval from Health Canada for Clinical Study

TORONTO, ON / ACCESSWIRE / September 5, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has received approval from Health Canada to begin a clinical study of its investigational drug, EB02, which the company is developing as a potential treatment for patients with grade I-III internal hemorrhoids.

Health Canada reviewed Edesa’s clinical trial application and approved it by issuing a “no objection letter,” a standard guidance document that allows the company to proceed with its planned study. The exploratory study is designed to assess the safety and efficacy of EB02 among hemorrhoid patients at leading clinical research sites in Canada. The company plans to enroll up to 48 patients in the first stage of the trial. Should the initial results be encouraging, the company plans to transition from a proof of concept study to a Phase 2 study.

“Health Canada’s approval to begin clinical trials represents a significant milestone in our goal of demonstrating the broad potential of our novel non-steroidal anti-inflammatory technology. Based on our analysis of clinical data in dermatitis, there’s good reason to believe that EB02 may be effective in treating the erythema, swelling and exudation associated with hemorrhoids.”
– Dr. Par Nijhawan, Chief Executive Officer, Edesa Biotech Inc.

Formulated as a topical cream, EB02 employs a novel mechanism of action against a common inflammation pathway. Unlike steroids and other anti-inflammatory drugs, the treatment being developed by Edesa is intended to inhibit the inflammatory process at its inception rather than after inflammation has occurred. The molecule has demonstrated highly selective, antagonistic activity against the secretory enzyme family involved in inflammation, pruritus, and fibrosis.

“Despite the high prevalence of this condition, patients have limited treatment options available to them. This product candidate represents a potential novel treatment for an indication where there has been little to no innovation.”
– Michael Brooks, President, Edesa Biotech Inc.

Based on National Institutes of Health reports, hemorrhoids affect approximately 12.5 million adults in the U.S. or approximately 5% of the U.S. adult population; almost half of individuals 50 years and older experience symptomatic hemorrhoids. While there are commonly used products, the company noted that, to its knowledge, none have been subjected to a formal review and/or approved by the FDA because they entered the market prior to 1962.

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 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 plan to enroll up to 48 patients in the first stage of the trial and the company’s plans to transition from a proof of concept study to a Phase 2 study. 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
investors@edesabiotech.com

Satsuma Pharmaceuticals Inc. Proposes Initial Public Offering of Common Stock

SOUTH SAN FRANCISCO, Calif., Sept. 3, 2019 /PRNewswire/ — Satsuma Pharmaceuticals, Inc. (“Satsuma”), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder) for the acute treatment of migraine, today announced that it has commenced an underwritten initial public offering of up to 5,000,000 shares of its common stock. All of the shares to be sold in the offering will be offered by Satsuma. In addition, Satsuma expects to grant the underwriters for the offering a 30-day option to purchase up to an additional 750,000 shares of common stock at the public offering price, less underwriting discounts, and commissions. The offering is subject to market and other conditions, and 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.

Satsuma currently expects to use the net proceeds from this offering to fund its Phase 3 EMERGE efficacy trial for STS101, its Phase 3 safety trial for STS101, manufacturing activities relating to STS101, and any remaining amounts to prepare for the commercial launch of STS101 and for working capital and general corporate purposes.

Credit Suisse, SVB Leerink and Evercore ISI are acting as joint book-running managers for the offering.

A registration statement relating to the securities has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not be sold, nor may offers be accepted, prior to the time the registration statement becomes effective. This press 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 state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction.

The offering of these securities is being made only by means of a prospectus, copies of which may be obtained from: Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, Eleven Madison Avenue, New York, NY, 10010, by telephone at 1-800-221-1037 or by e-mail: usa.prospectus@credit-suisse.com; 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; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at 1-888-474-0200 or by e-mail: ecm.prospectus@evercore.com.

Satsuma has applied to list our common stock on The Nasdaq Global Market under the symbol “STSA.”

Contact:

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

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

Edesa Biotech Reports Quarterly Financial Results

TORONTO, ON / ACCESSWIRE / August 14, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today reported financial results for the three and six months ended June 30, 2019 and provided an update on its business.

During the quarter, Edesa completed its reverse acquisition and NASDAQ listing and announced plans to proceed with its clinical investigation of EB01, a novel sPLA2 inhibitor, which the company is developing as a potential treatment for chronic allergic contact dermatitis (ACD). Edesa is currently performing site initiation visits at investigational centers in the U.S. and expects to proceed with enrolling the first patient into its Phase 2b clinical trial in the current quarter.

“Our first quarter as a public company has been very productive and I am pleased to report that our team has maintained a rapid pace toward the initiation of our Phase 2b clinical study of EB01. The next few quarters will be an exciting time for Edesa as we expect to enroll our first EB01 patient, expand the utility of our sPLA2 anti-inflammatory technology into additional indications and evaluate additional assets that can provide new value creation opportunities.”
– Dr. Par Nijhawan, Chief Executive Officer of Edesa

Edesa’s Chief Financial Officer, Kathi Niffenegger, reported that the combined company’s working capital at the end of the fiscal quarter was higher than projected. “Our working capital benefited from lower than expected acquisition-related costs as well as steps taken by management to conserve cash during the transaction. As a result, we are well-positioned to support our current clinical plans and activities,” she said.

Financial Results

Three months ended June 30, 2019

Total revenues were not material for the three months ended June 30, 2019 and June 30, 2018 as the company continued to focus on developing and obtaining regulatory approval for its product candidates.

Total operating expenses increased by $0.90 million to $1.32 million for the three months ended June 30, 2019, compared to $0.42 million for the same period last year:

Research and development expenses increased by $0.20 million to $0.50 million for the three months ended June 30, 2019 compared to $0.30 million for the same period last year primarily due to an increase in clinical research expenses associated with the Phase 2B clinical study of Edesa’s EB01 product candidate as well as higher personnel expenses.
General and administrative expenses increased by $0.70 million to $0.82 million for the three months ended June 30, 2019 compared to $0.12 million for the same period last year primarily due to increased legal and professional fees related to the company’s reverse acquisition, increased personnel expenses and the initiation of public company expenses, which Edesa did not incur as a privately held company.

Net loss for the three months ended June 30, 2019 was $1.29 million, or $0.30 per basic share, compared to a net loss of $0.41 million, or $0.13 per basic share, for the three months ended June 30, 2018.

Six months ended June 30, 2019

Total revenues were not material for the six months ended June 30, 2019 and June 30, 2018.

Total operating expenses increased by $1.01 million to $1.86 million for the six months ended June 30, 2019 compared to $0.85 million for the same period last year:

Research and development expenses increased by $0.03 million to $0.61 million for the six months ended June 30, 2019 compared to $0.58 million for the same period last year primarily due to an increase in clinical research expenses associated with the Phase 2B clinical study of Edesa’s EB01 product candidate as well as higher patent fees and personnel expenses.

General and administrative expenses increased by $0.97 million to $1.25 million for the six months ended June 30, 2019 compared to $0.28 million for the same period last year primarily due to increased legal and professional fees related to the company’s reverse acquisition, increased personnel expenses and the initiation of public company expenses, which Edesa did not incur as a privately held company.

Net loss for the six months ended June 30, 2019 was $1.82 million, or $0.48 per basic share, compared to a net loss of $0.83 million, or $0.26 per basic share, for the six months ended June 30, 2018.

Edesa changed its year-end from December 31 to September 30 resulting in six months activity during this transitional period through June 30, 2019.

Working Capital

At June 30, 2019, the company had working capital of $6.11 million. Cash and cash equivalents totaled $6.36 million.

Investor Calendar

The company is scheduled to present at the H.C. Wainwright & Co. 21st Annual Global Investment Conference, September 8-10, 2019 in New York, NY. Management will also be attending the BIO Investor Forum in San Francisco, October 22-23, 2019. Investors interested in meetings with management can schedule through the conference meeting systems, or by contacting Edesa investors relations at investors@edesabiotech.com

About Edesa Biotech, Inc.

Bardy Diagnostics™ Selected As 1 of 6 Disruptive MedTech Startups for the HealthTech Arkansas Accelerator Program

SEATTLE, Aug. 9, 2019 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that HealthTech Arkansas, a healthcare accelerator and investment fund that connects early-stage healthcare companies with disruptive technologies to Arkansas healthcare providers, has selected BardyDx to participate in the organization’s 2019 accelerator program. BardyDx was chosen for its innovative advancements in cardiac monitoring by delivering industry-leading diagnostic accuracy with the Carnation Ambulatory Monitor (CAM™), the industry’s only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device.

HealthTech Arkansas is a new and expanded iteration of two previous accelerator programs in the state, Health InnovatAR and HubX-LifeSciences. This year, with more provider partners and increased investment for participating companies, HealthTech Arkansas is focused on bringing the most innovative healthcare technologies to Arkansas. The 2019 cohort selection was announced this week at the Arkansas Heart Hospital with a welcome from CEO Dr. Bruce Murphy, followed by a message from Arkansas Governor Asa Hutchinson and presentations from each of the six chosen companies. Both Dr. Murphy and Governor Hutchinson focused on the importance of working together to bring innovative technologies to Arkansas.

2019 HealthTech Arkansas Accelerator Program Cohort — SOURCE: HealthTech Arkansas
From left to right: Dr. Matt Banet with toSense, Dr. Mitesh Rao with OMNY Health, Ken Nelson with BardyDx, Dr. Mayur Saxena with Droice Labs, Governor Asa Hutchinson, Director of HealthTech Arkansas Jeff Stinson, Dr. Adeel Yang with Medumo, and Dr. Josh Reischer with Health Note.

“It’s an honor to be selected as part of the 2019 accelerator cohort. HealthTech Arkansas presents an invaluable opportunity to perform clinical studies with highly-engaged and pioneering healthcare organizations that are eager to implement the newest innovative technologies, like the CAM™ patch, to advance their clinical care – a clear win for both BardyDx and each partnering institution.”
– Ken Nelson, Chief Commercial Officer, BardyDx

This year’s six companies were selected from hundreds of applicants across 18 different countries. The cohort will participate in a program that provides them the opportunity to partner with and build solutions specifically identified by Arkansas Heart Hospital, Arkansas Children’s, Arkansas Urology, Baptist Health, CHI St. Vincent, Conway Regional, Mercy, the University of Arkansas for Medical Sciences (UAMS), and Washington Regional Medical Center as areas of opportunity within their organizations. Each of the cohort companies will receive seed investment as well as complete and total access to clinicians and administrators at each partnering site.

“We’re delighted to have the participation of BardyDx as one of six companies in our cohort this year. Collectively, they’re among the most accomplished early-stage healthcare companies in the country. BardyDx was specifically chosen because the leadership teams in our partner hospitals believe the company can significantly increase the quality of care through its innovative devices. We can’t wait to begin our work with BardyDx.”
– Jeff Stinson, Director, HealthTech Arkansas

This distinction adds to the growing market recognition of the innovative P-wave centric CAM™ patch. Recently, BardyDx was named both 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. Also, BardyDx was recently named the winner of the Impact Pediatric Health Competition hosted by the nation’s leading pediatric healthcare institutions at SXSW 2019 for the CAM’s unique pediatric-friendly design and potential to address significant unmet needs in pediatric healthcare. In addition, BardyDx was also selected as the winner of the 2018 Fierce Innovation Life Sciences Award for Medical Device Innovation from the leading industry publisher of FierceBiotech & FiercePharma.

About HealthTech Arkansas:

HealthTech Arkansas is a healthcare accelerator and investment fund that connects early-stage healthcare companies bringing disruptive technologies to the market with Arkansas healthcare providers for the purpose of conducting pilot projects. We target the intersection of technology and healthcare in three categories: digital health (software), connected medical devices and diagnostic platforms. Our program is by providers and for providers, so we seek technologies that can improve our providers’ quality of care and increase their efficiency.

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, the female-friendly, hourglass-shaped CAM patch is placed on the center of the chest, directly over the heart. 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 and the determination of appropriate medical or procedural intervention.

MEDIA CONTACT:

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

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

RESEARCH TRIANGLE PARK, N.C., Aug. 07, 2019 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today provided a corporate and financial update for the second quarter ended June 30, 2019.

“Our most advanced investigational therapy, trilaciclib, has demonstrated significant benefits for people being treated with chemotherapy for small cell lung cancer and triple-negative breast cancer. We are pleased that the FDA has granted Breakthrough Therapy Designation based on myelopreservation data in small cell lung cancer, an important step toward making trilaciclib available to these patients. We look forward to working with the FDA during our pre-NDA meeting next month. We have also initiated parallel discussions with the FDA regarding promising data in metastatic triple-negative breast cancer, which showed improved overall survival,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer. “In addition, we continue to make rapid progress across our pipeline, with emerging data suggesting that all three investigational therapies – trilaciclib, lerociclib and G1T48 – have the potential to improve outcomes for women with breast cancer and be used in early stages of their disease.”

“We will present new data on trilaciclib, lerociclib and G1T48 at the upcoming ESMO congress. Of note, we will report the first clinical data from approximately 25 patients in a Phase 1 trial of G1T48, our oral selective estrogen receptor degrader. Based on data from this trial, we are planning to initiate a pivotal trial in 2020 with G1T48 for the treatment of ER+, HER2- breast cancer in combination with a CDK4/6 inhibitor.”
– Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D

Clinical, Regulatory and Corporate Updates

Breakthrough Therapy Designation (BTD) granted for trilaciclib based on myelopreservation data in small cell lung cancer (SCLC) patients; U.S. and European regulatory filings on track for 2020: The company has received BTD from the U.S. Food and Drug Administration (FDA) based on positive myelopreservation data in small cell lung cancer patients from three randomized Phase 2 clinical trials. The BTD program is designed to expedite development and review of drugs intended for serious or life-threatening conditions. The company expects to submit marketing applications in the U.S. and Europe in 2020.

Preliminary overall survival (OS) results from randomized Phase 2 trial demonstrated women with metastatic triple-negative breast cancer (mTNBC) lived significantly longer when receiving trilaciclib and chemotherapy compared with women receiving chemotherapy alone: Myelopreservation results, objective response rate (ORR), progression-free survival (PFS) and safety data from this trial were presented at the 2018 San Antonio Breast Cancer Symposium (SABCS) (Read the press release). In June 2019, the company reported updated anti-tumor efficacy results that showed women receiving trilaciclib and a chemotherapy regimen of gemcitabine/carboplatin had a statistically significant improvement in OS compared with those receiving gemcitabine/carboplatin alone (Review the trial data). Detailed data from this trial will be presented at a medical meeting later this year.

Data on all three clinical-stage programs accepted for presentation at ESMO 2019 Congress: New clinical data on trilaciclib, lerociclib and G1T48 have been accepted for presentation at the European Society for Medical Oncology (ESMO) 2019 Congress, being held Sept. 27-Oct. 1. Presentations include the first clinical data on G1T48, an oral selective estrogen receptor degrader (SERD), myelopreservation and efficacy data from the Phase 2 trilaciclib + chemotherapy + Tecentriq^®(atezolizumab) small cell lung cancer trial, and safety and tolerability data from the Phase 1b/2a lerociclib + Tagrisso^® (osimertinib) non-small cell lung cancer trial. The company will host a webcast on Sunday, Sept. 29 to review the data and provide an overview of development and commercial plans across the pipeline.

Additional data on trilaciclib reported at ASCO and MASCC/ISOO annual meetings: The company reported additional data from trilaciclib SCLC clinical trials at both the American Society of Clinical Oncology (ASCO) and the Multinational Association of Supportive Care in Cancer (MASCC)/International Society of Oral Oncology (ISOO) 2019 annual meetings. Pooled myelopreservation and patient-reported outcomes (PRO) data from all three trilaciclib SCLC trials presented at MASCC 2019 showed significant multilineage benefits across neutrophils, red blood cells and platelets, and significantly improved symptoms and function across multiple parameters over time compared to placebo.

Executive team update: In July, the company announced the appointment of Mark Avagliano as Chief Business Officer. Prior to joining G1, Mr. Avagliano was Vice President, Corporate Development at Pfizer Inc., where he was responsible for the evaluation, planning and execution of significant corporate level transactions and oversaw the Mergers and Acquisitions, Transactions and Valuations, and Out-licensing groups.

Board of Directors update: In June, current board member Garry Nicholson was named board chair, succeeding former chair Seth Rudnick, M.D. Additionally, Dr. Rudnick, Sir Andrew Witty and Fredric Eshelman, Pharm.D. were re-elected to the company’s Board of Directors.

Second Quarter 2019 Financial Highlights

Cash Position: Cash, cash equivalents and short-term investments totaled $324.9 million as of June 30, 2019, compared to $369.3 million as of December 31, 2018.

Operating Expenses: Operating expenses were $32.6 million for the second quarter of 2019, compared to $21.7 million for the second quarter of 2018. GAAP operating expenses include stock-based compensation expense of $3.7 million for the second quarter of 2019, compared to $2.1 million for the second quarter of 2018.

Research and Development Expenses: Research and development (R&D) expenses for the second quarter of 2019 were $23.5 million, compared to $18.4 million for the second quarter of 2018. The increase in R&D expense was primarily due to an increase in clinical program costs and personnel costs due to additional headcount.

General and Administrative Expenses: General and administrative (G&A) expenses for the second quarter of 2019 were $9.1 million, compared to $3.3 million for the second quarter of 2018. The increase in G&A expense was largely due to an increase in compensation due to additional headcount, increase in pre-commercialization activities and an increase in professional fees and other administrative costs necessary to support our operations as a public company.

Net Loss: G1 reported a net loss of $30.7 million for the second quarter of 2019, compared to $20.9 million for the second quarter of 2018.

2019 Guidance: the company expects to end the year with $260-$270 million in cash and cash equivalents.

Anticipated Milestones for 2H 2019

Present new clinical results for trilaciclib, lerociclib and G1T48 at the ESMO 2019 Congress, being held Sept. 27-Oct. 1. The company will host an onsite event/webcast on Sunday, Sept. 29 to review the data.

Complete meetings with the FDA and provide a regulatory update for trilaciclib, including NDA filing timeline.

Present preliminary OS findings from trilaciclib mTNBC trial at a medical meeting in 2H19.

Present additional data from the Phase 1b/2a clinical trial of lerociclib + Faslodex^® (fulvestrant) in ER+, HER2- breast cancer in 4Q19.

In 4Q19, identify the dose and schedule of lerociclib and G1T48 for pivotal trials in breast cancer in 2020.

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 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 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
Head of Investor and Public Relations
919-213-9835
jmacdonald@g1therapeutics.com

Aurinia Releases Q2 2019 Financial Results

Review condensed consolidated financials here: https://ir.auriniapharma.com/press-releases/detail/153

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 six months ended June 30, 2019 and recent operational highlights. Amounts, unless specified otherwise, are expressed in U.S. dollars.

“During the past quarter, the Aurinia team has taken multiple steps forward preparing the organization for the next phase of its evolution into a commercial-stage entity. In anticipation of the AURORA Phase 3 results in lupus nephritis, we are appropriately scaling the organization ahead of data, which if confirmatory, sets the stage for a NDA filing during the first half of next year. If approved, we project a commercial launch of voclosporin in early 2021 as a potentially first-line treatment, in combination with mycophenolate mofetil and low-dose steroids for lupus nephritis,”
– Peter Greenleaf, President and Chief Executive Officer

Michael Martin, Chief Operating Officer stated, “In parallel, we are taking all of the steps necessary to initiate a Phase 2/3 clinical trial with VOS for the potential treatment of DES. This Phase 2/3 trial follows a well-established development path for ophthalmic drugs in this therapeutic area.”

Mr. Greenleaf further said, “With respect to our ongoing proof-of-concept study for FSGS, we have added additional clinical trial sites and have modified the study protocol to broaden the inclusion of patients who have received limited corticosteroids exposure prior to enrollment. We expect that these actions will lead to enhanced enrollment.”

VOS Phase 2/3 AUDREY (“Aurinia Dry Eye Study”) Clinical Study in DES

Based upon the VOS exploratory Phase 2a results, Aurinia has initiated plans for a Phase 2/3 study which is expected to enroll its first patient in the fourth quarter of 2019. This study will include certain critical regulatory requirements that the FDA has traditionally required for DES product approval, which include both dose-optimization along with a comparison to vehicle.

The Phase 2/3 clinical study otherwise known as, “THE AUDREY STUDY” is designed as a randomized, double-masked, vehicle-controlled, dose-ranging study to be conducted in the U.S., AUDREY will evaluate the efficacy and safety of VOS in subjects with DES. Approximately 480 subjects are to be enrolled. The study will consist of four arms and in a 1:1:1:1 randomization schedule to either 0.2% VOS, 0.1% VOS, 0.05% VOS or vehicle, dosed twice daily for 12 weeks. The primary outcome measure for the study is the proportion of subjects with 10mm improvement in Schirmer Tear Test (“STT”) at 4 weeks.

Secondary outcome measures, which will be assessed at multiple time points include, STT, Fluorescein Corneal Staining (“FCS”), change in eye dryness, burning/stinging, itching, photophobia, eye pain, and foreign body sensation, change in Symptom Assessment in Dry Eye (“SANDE”) score and additional safety endpoints.

Voclosporin for Focal Segmental Glomerulosclerosis (“FSGS”)

Aurinia initiated a Phase 2 proof-of-concept, open-label study for FSGS in June 2018. The study was designed to evaluate the role of voclosporin for treatment-naïve patients diagnosed with primary FSGS. In response to slower than anticipated enrollment, Aurinia has recently opened additional clinical trial sites outside of the United States and has amended the study to allow enrollment of FSGS patients who have previously received limited corticosteroid exposure. Up to approximately 20 patients are expected to be enrolled with interim results anticipated in 2020.

Financial Liquidity at June 30, 2019

As at June 30, 2019, Aurinia had cash and cash equivalents of $131.5 million compared to $144.3 million of cash, cash equivalents and short-term investments at March 31, 2019, and $125.9 million at December 31, 2018. Net cash used in operating activities was $13.3 million for the second quarter ended June 30, 2019, compared to $12.3 million for the second quarter ended June 30, 2018.

The Company believes, that based on its current plans that it has sufficient financial resources to fund the existing LN program, including the AURORA trial and the AURORA 2 extension trial, complete the NDA submission to the FDA, conduct the ongoing Phase 2 study for FSGS, initiate the AUDREY Phase 2/3 study, and fund operations into the second half of 2020.

Second Quarter 2019 Financial Results

For the three months ended June 30, 2019, Aurinia reported a consolidated net loss of $15.9 million or $0.17 per common share compared to a consolidated net loss of $15.7 million or $0.19 per common share for the same period in 2018.

Research and development expenses (R&D) increased slightly to $11.2 million for the three months ended June 30, 2019, compared to $10.5 million for the three months ended June 30, 2018. The increase in these expenses reflected higher costs incurred for the AURORA 2 extension trial, the drug-drug interaction (“DDI”) study preparation costs associated with the planned NDA submission for LN and preparation costs for the Phase 2/3 DES clinical study.

Corporate, administration and business development expenses increased to $4.9 million for the three months ended June 30, 2019, compared to $3.5 million for the same period in 2018. The increase was primarily due to an increase in consulting fees related to recruitment fees and pre-commercial activities, such as market and payor research, and higher personnel and sponsorship costs.

Non-cash stock compensation expense was $2.0 million for the second quarter ended June 30, 2019, as compared with $2.0 million for the same period in 2018 and is included in both research and development and corporate, general and business development expenses.

Aurinia incurred other expenses of $720,000 during the three months ended June 30, 2019, associated with the successful defense of a proxy contest in connection with its June 26, 2019 annual general meeting. There was no similar expense in the comparable period.

Aurinia also recorded a non-cash reduction of $625,000 in the estimated fair value of derivative warrant liabilities which reduced the loss for the second quarter ended June 30, 2019 compared to an increase of $1.9 million in the estimated fair value of derivative warrant liabilities which increased the loss for the second quarter ended June 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 Six Months Ended June 30, 2019

For the six months ended June 30, 2019, Aurinia reported a consolidated net loss of $28.3 million or $0.31 per common share compared to a consolidated net loss of $31.2 million or $0.37 per common share for the comparable period in 2018.

R&D expenses were $21.8 million for the six months ended June 30, 2019, compared to $19.4 million for the same period in 2018. The increase in these expenses reflected higher costs incurred for the AURORA 2 extension trial, the DDI study and preparation costs associated with the planned LN NDA submission partially offset by lower AURORA trial costs as this trial nears completion.

Corporate, administration and business development expenses were $8.8 million for the six months ended June 30, 2019, compared to $7.3 million for the same period in 2018. The increase reflects the same items as noted in the second quarter corporate, administration and business development expenses.

Non-cash stock compensation expense totaled $3.6 million for the six months ended June 30, 2019, as compared with $4.1 million for the same period in 2018 and is included in both research and development and corporate, general and business development expenses.

For the six months ended June 30, 2019, Aurinia recorded a decrease of $2.4 million in the estimated fair value of derivative warrant liabilities compared to an increase of $4.6 million for the comparable period in 2018.

Unaudited interim condensed consolidated financial statements and the Management’s Discussion and Analysis are available on Aurinia’s website, SEDAR and EDGAR.

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 the 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 an opportunity for potential improvement in the effectiveness by enhancing tolerability, the 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 having data around the end of this year, 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 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 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.

Zymeworks Releases Q2 2019 Financial Results

Endotronix Receives conditional IDE approval from the US Food & Drug Administration

LISLE, Ill., Aug. 1, 2019 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced it has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin the multi-center PROACTIVE-HF trial of the Cordella™ Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor).

The innovative trial is designed to expedite Pre-Market Approval (PMA) of the Cordella Sensor and provide evidence to inform a national coverage decision from the Centers for Medicare & Medicaid Services (CMS). The company plans to begin enrollment in the trial in the third quarter of 2019.

“We are excited to begin enrollment in this groundbreaking trial that will provide the highest level of clinical evidence to redefine the standard of care for patients suffering from chronic heart failure. The trial design and treatment guidelines aim to proactively lower patient PA pressures and enable physicians to maintain target pressures, which we believe will decrease patient mortality lower the rate of HF-related hospitalizations.”
– Katrin Leadley, MD, Chief Medical Officer, Endotronix

PROACTIVE-HF is a prospective, multi-center, randomized, controlled trial that will evaluate the safety and efficacy of the Cordella Sensor in over 950 patients at up to 60 sites across the U.S. The trial will assess the benefits of PA pressure-guided management with the Cordella Sensor for New York Heart Association (NYHA) Class III heart failure patients. The primary endpoints will assess device safety in addition to the rate of mortality and HF hospitalization or use of IV diuretics at 12 months. Key secondary endpoints of the trial include the change in PA pressure, HF medication changes, device performance, and patient quality of life.

The Cordella Sensor is fully integrated with the Cordella™ Heart Failure System (Cordella System), which provides a comprehensive health status of the patient at home with a remote patient management platform and easy-to-use tools to securely collect and share daily patient data with healthcare providers. Together the Cordella System and Sensor aim to proactively deliver the information necessary to improve patient care between office visits while supporting reimbursement for care delivery activities. The system was designed for remote titration of medication and streamlining patient management to help keep patients out of the hospital.

“This is a pivotal milestone for both the company and patients suffering from heart failure. PROACTIVE-HF is designed to show a definitive benefit for PA pressure-guided management and provide the data required for reimbursement of the implantable Cordella Sensor across the U.S. This study along with our recently initiated CE Mark trial, SIRONA II, will build a solid clinical foundation for market adoption of the Cordella Sensor and Cordella System.”
– Harry Rowland, CEO, Endotronix

The Cordella Sensor is an investigational device and is not available for commercial use in any geography. CAUTION – Investigational Device. Limited by Federal (or United States) law to investigational use.
The Cordella System is available for commercial use in the U.S. and E.U. and is currently in cardiology centers across the U.S.

About Endotronix
Endotronix, Inc., a medical technology company, delivers an integrated platform that provides comprehensive, reimbursable health management innovations for patients suffering from advanced heart failure. Their solution, the Cordella™ Heart Failure System, includes a cloud-based disease management data system and at-home hemodynamic management with a breakthrough implantable wireless pulmonary artery pressure sensor for early detection of worsening heart failure.

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
+1 (847) 951-7430

Former Pfizer VP Joins G1 Therapeutics as Chief Business Officer

Mark Avagliano, Chief Business Officer, G1 Therapeutics

RESEARCH TRIANGLE PARK, N.C., July 30, 2019 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced the appointment of Mark Avagliano as Chief Business Officer. In this role, Mr. Avagliano will serve as a member of the G1 executive team and be responsible for leading the company’s global partnering and corporate development strategy and execution.

“Mark has experience executing a broad range of corporate development deals, including partnerships, joint ventures, and strategic transactions. We are excited for him to lead our corporate development function, with the goal of bringing our investigational therapies to patients around the world while creating value for our shareholders,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer.

“We are approaching important clinical, regulatory and commercial milestones across our pipeline, so this is an ideal time to add Mark’s expertise to our management team.”
– Mark Valleca, M.D., Ph.D., Chief Executive Officer

“All three of G1’s therapeutic candidates have the potential to become new standards of care for women with breast cancer, including in the adjuvant setting, and trilaciclib may improve patient outcomes across a range of tumor types,” said Mr. Avagliano. “I’m excited about the opportunity to lead initiatives focused on making these therapies available globally to patients who need better treatment options.”

Prior to joining G1, Mr. Avagliano was Vice President, Corporate Development at Pfizer Inc., where he was responsible for the evaluation, planning, and execution of significant corporate-level transactions and oversaw the Mergers and Acquisitions, Transactions and Valuations, and Out-licensing groups. During his fifteen years at Pfizer, Mr. Avagliano successfully led the execution of numerous transactions, including acquisitions, divestitures, joint ventures, co-developments, co-promotions, product licenses, research collaborations, and public market separations. Mr. Avagliano has deep expertise in screening, evaluation, financial modeling, due diligence, contract negotiations, and deal closings. Prior to joining Pfizer in 2004, Mr. Avagliano held commercial and operational roles at Aventis Pharmaceuticals.

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 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 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 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
Head of Investor Relations/Public Relations
919-907-1944

Edesa Biotech Completes Manufacturing for Upcoming Dermatitis Study

TORONTO, ON / ACCESSWIRE / July 25, 2019 / Edesa Biotech, Inc. (NASDAQ: EDSA), a clinical-stage biopharmaceutical company, reported today that the company has completed the manufacturing of its lead drug candidate EB01, a novel sPLA2 inhibitor that Edesa is developing as a potential treatment for chronic allergic contact dermatitis (ACD). Edesa is currently evaluating investigational centers in the U.S. and expects to proceed with enrolling the first patient into its Phase 2b clinical trial in the current quarter.

“We have completed the manufacturing of our active pharmaceutical ingredient and have the drug product for the first cohort ready to distribute to our investigational centers in the U.S.,” said Michael Brooks, President of Edesa. “During our site evaluation visits, we have been encouraged by the high level of interest from physicians familiar with the limited treatment options for chronic suffers of ACD.”

The company’s Phase 2b adaptive designed study of EB01 in chronic ACD will primarily evaluate safety and efficacy. Secondary and exploratory measures will evaluate symptom reduction, quality of life and dose-relationships among various strengths of EB01 cream.

“Based on encouraging results from two previous clinical studies, we believe our novel therapy has the potential to be an effective and safe treatment for patients with ACD. Our upcoming Phase 2b study of EB01 supports our goal to develop therapies for patients with serious unmet medical needs, particularly in inflammatory conditions where current treatments have serious limitations or side effects.”
– Dr. Par Nijhawan, Chief Executive Officer of Edesa

The company recently announced the receipt of an FDA “safe to proceed” letter, which formally approved the company’s Phase 2b clinical protocol and authorized Edesa to begin its clinical investigation.

About Allergic Contact Dermatitis (ACD)

Contact dermatitis, which can be either irritant contact dermatitis or ACD, is one of the most common occupational health illnesses in the United States and has been estimated to cost $2 billion annually as a result of lost work, reduced productivity, medical care, and disability payments. Edesa Biotech estimates that there are more than 13.2 million people in the U.S. with contact dermatitis, with between 20% and 60% of all cases diagnosed as ACD. Approximately 1.2 million patients have chronic ACD. There are no treatment options specifically indicated for ACD and physicians must utilize agents approved for other dermatology conditions, such as topical corticosteroids, which are able to manage disease symptoms in less than half of patients and have well-known side-effects.

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, 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 Toronto, 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 expectation that it will enroll the first patient into its Phase 2b clinical trial in the current quarter and the company’s goal to rapidly develop therapies for patients with serious unmet medical needs, particularly in inflammatory conditions where current treatments have serious limitations or side effects. 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.

Aurinia Strengthens Its Senior Management Team with the Appointment of Max Donley & Dr. Glenn Schulman

“It is a pleasure to welcome Max and Glenn to the team at this critical juncture for Aurinia. As we continue to build and expand the organization and prepare for the potential U.S. commercialization of voclosporin, their respective talents complement the team already in place, helping to scale the organization and ensure we maintain open communication with all of our stakeholders.”
– Peter S. Greenleaf, President and Chief Executive Officer of Aurinia.

VICTORIA, British Columbia–(BUSINESS WIRE)– Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH/TSX: AUP) (the “Company”), a late-stage clinical biopharmaceutical company with ongoing research in lupus nephritis (“LN”), today announced the appointments of Mr. Max Donley as Executive Vice President of Internal Operations and Strategy and Dr. Glenn Schulman as Senior Vice President of Corporate Communications and Investor Relations.

Mr. Donley commented, “This is an exciting time for Aurinia, and for the future treatment landscape for lupus nephritis (LN). In parallel to preparing for the clinical and regulatory requirements of filing an NDA to the FDA, I look forward to spearheading infrastructure growth necessary to support the potential commercialization of voclosporin and maturation of Aurinia into a vertically integrated commercial biopharmaceutical company.”

Mr. Max Donley, Head of Human Resources, Senseonics, Inc. — Mr. Max Donley (Above)

Max Donley, MBA
Executive Vice President, Internal Operations and Strategy
Mr. Donley most recently led Human Resources, Information Technology, and Facilities at Senseonics. Prior to that, Mr. Donley was Executive Vice President of Global Human Resources, Information Technology, and Corporate Strategy at Sucampo Pharmaceuticals until its acquisition in February 2018. Prior to that, Mr. Donley served as Executive Vice President, Human Resources and Corporate Affairs at MedImmune, where he provided business-integrated leadership and delivered professional tools, programs and services to optimize MedImmune’s human capital investments worldwide.

Mr. Donley received his BA from the University of Michigan and his MBA from the George Mason University.

Dr. Glenn Schulman, Founder of Z3 Biocommunications, LLC. — Dr. Glenn Schulman (Above)

Glenn Schulman, PharmD, MPH
Senior Vice President, Corporate Communications and Investor Relations
Glenn Schulman is a healthcare professional with nearly twenty years of advising biotech and life science companies. Prior to joining Aurinia, Dr. Schulman led Corporate Communications and Investor Relations at Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN). Prior to Achillion, Dr. Schulman held positions of increasing responsibility at CuraGen Corp. where he was ultimately responsible for all aspects of corporate and medical communications, investor and public relations.

Dr. Schulman received his BS Pharmacy from Philadelphia College of Pharmacy, Doctor of Pharmacy degree from Rutgers, Ernest Mario School of Pharmacy, and completed a post-doctoral fellowship at Memorial Sloan-Kettering Cancer Center. Dr. Schulman received his MPH, Health Management, from Yale University.

About Aurinia

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 Allowance is 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 studied in rabbit and dog models. VOS has IP protection until 2031.

Forward-Looking Statements

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: Aurinia being able to extend and protect its patents on terms acceptable to Aurinia, Aurinia successfully completing its clinical trials, Aurinia receiving regulatory approval on terms acceptable to Aurinia, and Aurinia having sufficient funds on hand to complete its trials and operations as currently planned.

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.

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.

Investors & Media
Glenn Schulman, PharmD, MPH
SVP, Corp Comm & IR
gschulman@auriniapharma.com

Celgene Exercises Commercial Option for Zymeworks’ Azymetric™ Platform Triggering $7.5MM Milestone Payment

VANCOUVER, British Columbia–(BUSINESS WIRE) — Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announced that its global biopharma partner Celgene Corporation has selected a lead therapeutic candidate in oncology for further development and exercised its option to a commercial license under the companies’ 2014 Azymetric^™ collaboration and licensing agreement. Zymeworks’ proprietary Azymetric technology platform enables the rapid development of bispecific and multifunctional therapeutics with broad potential for the treatment of cancer, inflammation, and infectious disease. Zymeworks will receive a US$7.5 million payment as a result of Celgene’s exercise of its option to a commercial license.

“Celgene’s first selection of a lead bispecific antibody candidate using the Azymetric platform underscores their dedication to our partnership and the comprehensive utility of our industry-leading technologies. Celgene’s progress, alongside that of Lilly, Daiichi, and Merck, which we announced earlier this year, advances our goal of enabling innovative medicines for patients around the world.”

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

Celgene is one of five global biopharmaceutical companies that has expanded their collaboration agreements with Zymeworks to increase the number of potential products commercialized based on the Azymetric platform. Under the terms of the original 2014 agreement, Zymeworks granted Celgene a license to research, develop, and commercialize up to eight bispecific antibodies, and in 2018, the companies increased the number of potential products to ten. For each of the up to ten products, Zymeworks is eligible to receive up to US$164 million comprised of a licensing fee and development and commercial milestones in addition to royalties on worldwide sales.

About the Azymetric™ Platform

The Azymetric platform enables the transformation of monospecific antibodies into bispecific antibodies, giving the antibodies the ability to simultaneously bind two different targets. Azymetric bispecific technology enables the development of multifunctional biotherapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering degradation, and increase tumor-specific targeting. These features are intended to enhance efficacy while reducing toxicities and the potential for drug resistance. Azymetric bispecifics have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life, and high stability. In addition, they are compatible with standard manufacturing processes with high yields and purity, potentially significantly reducing drug development costs and timelines.

About Zymeworks Inc.

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics. The Company’s 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. The Company’s 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 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 potential milestone payments, royalties and other revenue, advancement towards Zymeworks’ goal of enabling innovative medicines for patients around the world, Zymeworks’ potential with respect to therapeutic treatment and development of therapeutic candidates, and other information that is not historical information. When used herein, words and phrases such as “will,” “eligible to,” “intended to,” 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 fiscal quarter ended March 31, 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.

Zymeworks Inc. Contacts:

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

Endotronix Enrolls First Patient in SIRONA II CE Mark Trial

Study to support European clearance of Cordella™ Pulmonary Artery Sensor System for treatment of patients with chronic heart failure

LISLE, IL – Endotronix Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced enrollment of the first patient in its prospective, multi-center, SIRONA II trial, in Europe. The 60-patient study will evaluate safety and efficacy of the Cordella™ Pulmonary Artery Pressure Sensor System (Cordella Sensor) in support of its CE Mark submission.

Cardiologist Prof. Dr. Wilfried Mullens enrolled the first SIRONA II trial patient at the Hospital Oost-Limburg in Genk, Belgium. An investigator in the SIRONA I First-in-Human study, Prof. Dr. Mullens commented, “The current treatment model for chronic heart failure is reactive and costly. Clinical data demonstrates that pulmonary artery (PA) pressure is the best indicator for early detection and proactive care of heart failure decompensation,” Prof. Dr. Mullens continues, “In my experience, the Cordella Sensor provides reliable PA pressure measurements that when combined with daily patient data presents a comprehensive clinical picture so I can effectively manage my heart failure patients remotely.”

Enrolling patients at up to eight European sites, the open-label SIRONA II CE Mark trial is designed to show safety and efficacy of the Cordella Sensor for the management of New York Heart Association (NYHA) Class III heart failure patients. Key secondary endpoints of the trial include rate of heart failure hospitalizations, device performance, and patient quality of life.

“SIRONA II builds on the success of our First-in-Human trial and expands our experience with the Cordella Sensor as we progress towards receiving our CE Mark,” stated Katrin Leadley, MD, Chief Medical Officer of Endotronix. “It is the next step in our robust clinical program, which also includes a pivotal IDE trial for the implantable sensor, PROACTIVE-HF, set to begin later this year in the U.S.”

The Cordella Sensor is an integrated component of the comprehensive Cordella™ Heart Failure System (Cordella System), which also includes a remote patient management platform with easy-to-use tools to securely collect and share daily patient data with healthcare providers. Together the Cordella System and Sensor aim to proactively provide healthcare providers with the information they need to improve patient care between office visits while supporting reimbursement for care delivery activities. The system enables remote titration of medication and streamlines patient management to help keep patients out of the hospital.

The Cordella Sensor is an investigational device and is not available for commercial use in any geography. 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 Endotronix

Endotronix, Inc., a medical technology company, delivers an integrated platform that provides comprehensive, reimbursable health management innovations for patients suffering from advanced heart failure. Their solution, the Cordella™ Heart Failure System, includes a cloud-based disease management data system and at home hemodynamic management with a breakthrough implantable wireless pulmonary artery pressure sensor for early detection of worsening heart failure.

Related Article: Endotronix Receives ISO 13485:2016 Certification

Opsens Releases Promising Q3 2019 Financials

QUEBEC CITY, July 11, 2019 /CNW Telbec/ – Opsens Inc. (“Opsens” or the “Company”) (TSX: OPS) (OTCQX: OPSSF) today reported its results for the third quarter of 2019.

HIGHLIGHTS

Consolidated revenues of $7.9 M for the third quarter of 2019 compared with $6.4 M for the third quarter of 2018, an increase of $1.5 M or 23%;
Fractional Flow Reserve (“FFR”) sales of $5.2 M for the third quarter of 2019 compared with $3.5 M for the same period last year, an increase of 49%;
44% increase in FFR revenues in the United States compared with the same quarter in 2018;
Landmark supply agreement signed with Abiomed, Inc. (“Abiomed”).

GROWTH STRATEGY

Opsens’ medical sales reached a record level in the third quarter of 2019. FFR revenues increased by 49% year over year. “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 also pleased with Opsens’ extended collaboration with Abiomed through the signing of a five-year contract to supply a critical portion of their Impella CP® heart pump technology widely used in the United States. The agreement follows a co-development project to integrate Opsens’ miniature optical pressure sensor into the Impella CP®. This partnership highlights the benefits of our optical technology for cardiac applications, as well as the accuracy of our measurement technology and the quality of our manufacturing capabilities,” added Laflamme.

FINANCIAL RESULTS – QUARTER ENDED MAY 31, 2019

Opsens’ product sales reached $7.5 M in the three-month period ended May 31, 2019, compared with $5.7 M in the same period, the previous year. This increase is mainly explained by an increase in FFR revenues compared with the quarter ended May 31, 2018. In addition, the Company recorded non-recurring license revenues of $0.4 M ($0.7 M for the same quarter 2018) for a consolidated total income of $7.9 M ($6.4 M in 2018) for the quarter.

Gross margin increased for the quarter ended May 31, 2019, compared with the same period last year, from $3.6 M to $4.5 M.

Net loss was $1.1 M for the period ended May 31, 2019, compared with $0.8 M for the same period last year.

As of May 31, 2019, the Company had a cash position of $17.1 M compared with $10.9 M as of August 31, 2018.

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 70,000 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:

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

Robin Villeneuve, CPA, CA, Chief Financial Officer, 418.781.0333

Epilepsia Publishes Phase 2a Data for Staccato Alprazolam

– Staccato alprazolam is shown to rapidly suppress seizure activity at two minutes in five patients with epilepsy –
– Staccato alprazolam generally well tolerated; no serious or severe adverse events reported –
– Enrollment in Phase 2b, double-blind, placebo-controlled study ongoing –

SUMMIT, N.J., July 09, 2019 (GLOBE NEWSWIRE) — Engage Therapeutics, Inc., a clinical-stage biopharmaceutical company developing a Rapid Epileptic Seizure Termination (REST) therapy for people with epilepsy who experience a predictable pattern of seizures, today announced that data from a phase 2a study of Staccato® alprazolam to suppress seizures in patients with epilepsy were published in the peer-review journal Epilepsia.

This proof-of-concept study demonstrated that Staccato alprazolam delivered the drug deep into the lung and rapidly suppressed seizure or epileptiform activity in five photosensitive patients with epilepsy. The paper, which is titled, “Inhaled Alprazolam Rapidly Suppresses Epileptic Activity in Photosensitive Participants,” was published online ahead of print on July 7 in Epilepsia, the journal of the International League Against Epilepsy.

“The greater epilepsy community of patients, families and health care providers knows full well that there is an urgent need for acute rescue options to reduce or even halt seizure activity,” said lead author Jaqueline French, MD, the study’s principal investigator and professor in the Department of Neurology at NYU Langone Health’s Comprehensive Epilepsy Center, and founder/director of the Epilepsy Study Consortium. “The encouraging data from this phase 2a study served as the foundation for advancing Staccato alprazolam in the clinic as a potential rescue medication for the acute treatment of seizures.”

Engage Therapeutics is now enrolling up to 123 patients in the multi-center StATES Study (Staccato Alprazolam Terminates Epileptic Seizures – NCT03478982), a phase 2b trial designed to evaluate the safety, efficacy, and usability of Staccato alprazolam in subjects with epilepsy who have a predictable seizure pattern. The StATES study is being conducted at approximately 50 trial sites in the United States, Australia, and Jamaica.

This proof-of-concept study referenced in the Epilepsia paper demonstrated that three doses of Staccato alprazolam (0.5 mg, 1.0 mg, and 2.0 mg) rapidly suppressed epileptic activity in photosensitive participants with epilepsy. The primary endpoint of the study was the change in standardized photosensitivity range (SPR) in participants receiving each dose of Staccato alprazolam. Highlights from the phase 2a study as reported this week in Epilepsia include:

Staccato alprazolam reduced epileptiform activity as measured by SPR at two minutes; the effect was sustained through four hours for the 0.5 mg dose and six hours for the 1.0 and 2.0 mg doses;
Magnitude and duration of sedation and sleepiness were dose-related and more prominent with higher doses;
Peak plasma concentrations following administration were achieved following inhalation within minutes, and the rapid onset of pharmacodynamic effects of somnolence and sedation were observed.

Staccato alprazolam was generally well tolerated with a safety profile similar to what has been reported for oral alprazolam or Staccato alprazolam for other indications. No participants in this study experienced any severe or serious adverse events. Four of five participants experienced at least one adverse event during the study, but all were mild or moderate in intensity.

Staccato alprazolam is a single-use, investigational epileptic seizure rescue therapy that combines Staccato delivery technology with alprazolam, both of which have been approved separately for unrelated indications by the U.S. Food and Drug Administration (FDA). Alprazolam is a well-known and highly characterized benzodiazepine for the treatment of anxiety disorders. The Staccato® system aerosolizes a drug and, via inhalation, delivers it deep into the lung for rapid systemic exposure.

Engage Therapeutics, Inc.
Engage Therapeutics is developing Staccato alprazolam for the immediate cessation of active and acute epileptic seizures. The investigational product is in the Rapid Epileptic Seizure Termination (REST) category of products. Engage Therapeutics is based in Summit, N.J.

Exact Imaging Receives Frost & Sullivan’s 2019 Imaging Technology Innovation Award

Exact Imaging wins Frost & Sullivan 2019 Diagnostic Imaging Technology Innovation Award

TORONTO, CANADA — Exact Imaging, the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, is the proud recipient of Frost & Sullivan’s 2019 Global Prostate Cancer Diagnostic Imaging Technology Innovation Award.

“Exact Imaging’s 29 MHz micro-ultrasound system, ExactVu™, offers a novel approach for targeted real-time biopsies as compared to conventional transrectal ultrasound,” says Durga Chandrupatla, Senior Research Analyst, Transformational Health at Frost & Sullivan. “Moreover, Exact Imaging offers healthcare providers with technical and financial freedom through attributes such as being a bed-side procedure, minimal hands-on experience required, low capital investments, and independence from mpMRI for prostate biopsy, thereby enhancing the overall unique selling proposition of its flagship ExactVuTM micro-ultrasound system.”

“We are proud to have our ExactVu™ micro-ultrasound platform be recognized as a truly transformational technology in the prostate cancer marketplace by Frost & Sullivan,” says Randy AuCoin, Exact Imaging’s President and CEO. “This is further validation of the significant value that our ExactVu™ micro-ultrasound platform is bringing to urologists globally. The ExactVu™ system provides clinicians with the highest real-time resolution for an imaging system that they can utilize in their clinics for performing targeted prostate biopsies quickly, effectively and across the prostate cancer pathway – from the first biopsy to repeat biopsies and through to active surveillance monitoring. The goal is to provide the most powerful and cost-effective imaging platform that enables urologists to ultimately improve both the standard of care and patient outcomes.”

The Frost & Sullivan Innovation Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research to identify best practices in the industry.

This is the second award in less than a year for Exact Imaging, who also received the 2019 Life Science Company of the Year Award from Life Science Ontario (LSO) in November 2018.

“Exact Imaging is redefining the diagnosis of prostate cancer by driving significant benefits for patients, clinicians and the healthcare system globally”, said LSO President and CEO Dr. Jason Field. “They are an excellent example of how Ontario-based innovation, coupled with manufacturing and commercialization expertise is fostering world-class medical device companies. We are proud to have chosen Exact Imaging as our 2019 Life Science Company of the Year and look forward to watching their continued growth in the global marketplace”.

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 at 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).

About Life Sciences Ontario:

Life Sciences Ontario (LSO) is a member-driven organization that represents and promotes the province’s vibrant and diverse life sciences sector. LSO collaborates with governments, academia, industry, and other life science organizations in Ontario and across Canada to promote and encourage commercial success throughout the sector. Membership in Life Sciences Ontario includes individuals, students, emerging companies, investors, service providers, and companies with marketed products. The organization provides a wide range of networking and educational events, and operates a mentorship program that is helping to develop highly-skilled talent and build new business opportunities for the life sciences sector. LSO is an effective conduit for delivering policy options to governments, and is dedicated to promoting Ontario’s life sciences sector internationally.

For further information, please contact:

Randy AuCoin
President & CEO
Exact Imaging
T. +1.705.927.0512
E. raucoin@exactimaging.com

Shareholders Overwhelmingly Support Aurinia & Its Board of Directors

Dissident Withdraws the Consents of its Nominees from Consideration Prior to the AGM

Aurinia Reaffirms its Commitment to Voclosporin and Creating Shareholder Value

VICTORIA, British Columbia–(BUSINESS WIRE)– Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”) is pleased to announce that shareholders of the Company (the “Shareholders”) elected all eight of the Company’s highly qualified director nominees at the Company’s Annual General Meeting held on June 26, 2019 (the “Meeting”).

The Dissident shareholder, ILJIN SNT Co., LTD (“ILJIN”), provided notice to withdraw the consents of its director nominees prior to the Meeting after having witnessed the strong proxy results in favour of management’s nominees to Aurinia’s Board.

“We appreciate the strong and unequivocal support from our shareholders,” said Aurinia’s Chairman of the Board, Dr. George M. Milne, Jr. “The Board and management greatly value the numerous conversations we have had with our shareholders over the last few months regarding our ongoing commitment to drive shareholder value through the advancement of and preparation for commercialization of voclosporin to address the unmet medical needs of patients around the globe. Further, we will continue to maintain an active and productive dialogue with Aurinia’s investor community as we continue to execute on our strategy.”

Aurinia Pharmaceuticals Voting Results for the election of its Board of Directors June 26 2019 — Voting Results for the election of directors (above)

Shareholders also approved the non-binding advisory “say-on-pay” resolution approving the Company’s approach to executive compensation with 64.31% voting in favour and 35.69% voting against. Excluding the 1,920,455 common shares known to be owned or controlled by directors, officers, employees and consultants of the Company and the 13,716,567 common shares known to be owned or controlled by ILJIN from the tally on this resolution, approximately 81.82% of common shares were voted in favour of the advisory resolution on executive compensation.

All other matters voted on at the Meeting, which included confirming the number of directors at eight and approving the reappointment of PricewaterhouseCoopers LLP as auditors, were also approved. Voting results on all matters voted on at the Meeting will be filed on SEDAR and EDGAR.

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 Allowance is 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.

Forward-Looking Statements

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.

Company Contact:
Glenn Schulman, PharmD, MPH
Corporate Communications
gschulman@auriniapharma.com

Shareholder Questions:
Laurel Hill Advisory Group
North American Toll Free: 1-877-452-7184
Collect Calls Outside North America:
1-416-304-0211
assistance@laurelhill.com

Pharmaceutical Industry Executive, Adele M. Gulfo Joins Medexus Pharmaceuticals’ Board of Directors

Medexus Appoints Adele Gulfo to its Board of Directors

MONTREAL, June 25, 2019 (GLOBE NEWSWIRE) — Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP, OTCQB: PDDPF), a leading specialty pharmaceutical company with a strong North American commercial platform, announces that Adele M. Gulfo has joined the Company’s Board of Directors, further enhancing the Board’s commercial and business development expertise.

Ken d’Entremont, Chief Executive Officer of Medexus, commented, “We are thrilled to add Adele to our Board of Directors. She brings deep global experience in both business development and commercialization of multi-billion dollar products. Among her many accomplishments, she was instrumental in the launch and commercial success of LIPITOR, which became the world’s best-selling medicine with peak revenues of $13.7 billion globally. She also oversaw the launch and growth of CRESTOR, which achieved peak sales over $6 billion and ran teams that grew Toprol-XL from $200 million to $2 billion. Her knowledge and experience will be invaluable in helping guide the growth of our existing portfolio, as well as in identifying new products that can be added to our product pipeline as we continue on our rapid growth trajectory across North America.”

Ms. Gulfo currently serves as Chief of Commercial Development at Roivant Sciences Ltd., which has a diverse pipeline of over 35 investigational drugs in 14 therapeutic areas. Previously, Ms. Gulfo served as EVP & Head of Global Commercial Development as well as Chief Strategy Officer of Mylan N.V. (NASDAQ: MYL), a leading global pharmaceutical company engaged in the development, licensing, manufacturing, marketing, and distribution of generic, branded generic, and specialty pharmaceutical products. Prior to joining Mylan, Ms. Gulfo spent a total of 14 years at Pfizer, Inc. and predecessor companies. Among her senior roles at Pfizer, Ms. Gulfo served as President and General Manager of Pfizer’s U.S. Primary Care Business, a $12+ billion unit comprising over 5,000 employees across multiple therapeutic areas. In this role, she was the US Country Chair across all BioPharmaceutical Business Units, as well as US Commercial Operations and Market Access. Ms. Gulfo also served as President and General Manager of Pfizer, Latin America, where she led a team of over 4,000 employees across 24 countries responsible for over $3 billion in sales. Prior to joining Pfizer, she spent 9 years at AstraZeneca where she ran the Cardiovascular and Diabetes Business Unit and held senior leadership roles in business development, strategy, and healthcare innovation.

Ms. Gulfo recently served on the Board of Directors and Audit Committee of Bemis Company, Inc. (NYSE: BMS; S&P 500), a multi-billion-dollar global supplier of industrial packaging used by leading healthcare, food, consumer products, and other companies worldwide. Ms. Gulfo is currently a member of the Board of Directors of EnPro Industries, Inc. (NYSE: NPO), a diversified manufacturer of proprietary engineered products used in critical applications across diverse markets including food and pharma, semiconductor, and aerospace.

Trained as a scientist, Ms. Gulfo has been awarded eight U.S. patents for novel medication packaging adherence tools and an allergy treatment. Ms. Gulfo serves as an advisory board member of Partners Healthcare (founded by Brigham and Women’s Hospital and Massachusetts General Hospital) and Springboard Life Sciences. She also served on the Board of Directors for Volunteers of America (VOA) and the Committee of 200 (C200), an invitation-only membership organization of the world’s most successful women business leaders. She holds a Bachelor of Science degree in biology from Seton Hall University and an M.B.A. with highest honors from Fairleigh Dickinson University. Ms. Gulfo studied post-graduate Molecular Biology and began her career at the University of Medicine and Dentistry of New Jersey.

About Medexus

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.

READER ADVISORIES

Forward Looking Statements

This press release contains “forward-looking information” within the meaning of applicable securities legislation. Forward-looking information includes, but is not limited to, statements with respect to future business operation, including with respect to the expected growth of the Company’s pharmaceutical portfolio and pipeline. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the risk that the Company will not receive regulatory approvals in a timely manner or at all, the results of certain drug therapies and their impact on the Company’s profitability, the Company’s business plans, and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although Company believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because Company can give no assurance that they will prove to be correct. Since forward-looking information addresses future events and conditions, by its very nature they involve inherent risks and uncertainties. The Company’s actual results, performance or achievement could differ materially from those expressed in, or implied by, the forward-looking information and, accordingly, no assurance can be given that any of the events anticipated by the forward-looking information will transpire or occur, or if any of them do so, what benefits that Company will derive therefrom. Management has included the above summary of assumptions and risks related to forward-looking information provided in this press release in order to provide security holders with a more complete perspective on the Company’s future operations and such information may not be appropriate for other purposes. Readers should not place undue reliance on forward-looking statements. Readers are cautioned that the foregoing lists of factors are not exhaustive. Additional information on these and other factors that could affect the Company’s operations or financial results are included in reports on file with applicable securities regulatory authorities and may be accessed through the SEDAR website (www.sedar.com). The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake any obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.

Edesa Biotech Receives Approval to Proceed with U.S. Clinical Study

TORONTO, June 20, 2019 /CNW/ — Edesa Biotech, Inc. (Nasdaq: EDSA), a clinical-stage biopharmaceutical company, reported today that the U.S. Food and Drug Administration has notified the company that it may proceed with its clinical investigation of EB01, a novel sPLA2 inhibitor, which Edesa is developing as a potential treatment for chronic allergic contact dermatitis.

The FDA “safe to proceed” letter formally approves the company’s Phase 2b clinical protocol and authorizes the company to begin its clinical investigation. Edesa expects the first patient to be enrolled in the coming quarter following the manufacturing of its drug candidate.

EB01 employs a novel mechanism of action against a common inflammation pathway. Unlike steroids and other anti-inflammatory drugs, like ibuprofen, the topical treatment being developed by Edesa is intended to inhibit the inflammatory process at its inception rather than after inflammation has occurred. In two previous clinical studies, EB01 has demonstrated significant improvement of multiple symptoms in contact dermatitis patients.

“There are limited options for ACD patients and we have been pleased with the level of interest from physicians in the U.S.,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa. “The company is committed to rapidly advancing our clinical plans and remains on track to initiate our clinical study for EB01.”

In addition to its lead product candidate, Dr. Nijhawan noted that the company plans to selectively target additional indications within the areas of dermatology and gastroenterology. The company also plans to expand its portfolio with assets that can drive long-term growth opportunities.

“This is an active and exciting time for Edesa and we look forward to providing clinical and business updates over the coming quarter,” said Dr. Nijhawan.

Clinical Protocol for Phase 2b Trial of EB01
The protocol evaluates EB01 in a randomized, double-blind, vehicle-controlled, sample size adaptive design. ACD patients in this study will be treated for 28 days with various strengths of EB01 cream. Primary outcome measures will evaluate safety and efficacy. Secondary and exploratory measures will evaluate symptom reduction, quality of life and dose-relationships among various strengths of EB01 cream. The company plans to complete an interim analysis following the enrollment of the first cohort to determine the total sample size in the second part of the study; up to 166 total patients may be enrolled.

About Allergic Contact Dermatitis (ACD)
Contact dermatitis, which can be either irritant contact dermatitis or ACD, is one of the most common occupational health illnesses in the United States, and has been estimated to cost $2 billion annually as a result of lost work, reduced productivity, medical care and disability payments. Edesa Biotech estimates that there are more than 13.2 million people in the U.S. with contact dermatitis, with between 20% and 60% of all cases diagnosed as ACD. Approximately 1.2 million patients have chronic ACD. There are no treatment options specifically indicated for ACD and physicians must utilize agents approved for other dermatology conditions, such as topical corticosteroids, which are able to manage disease symptoms in less than half of patients and have well-known side-effects.

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, 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 Toronto, 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 commitment to rapidly advance its clinical plans and the company’s plans to selectively target additional indications within the areas of dermatology and gastroenterology and expand its portfolio with assets that can drive long term growth opportunities. 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.

For further information: Gary Koppenjan, Edesa Biotech, Inc., (805) 488-2800, investors@edesabiotech.com

Bardy Diagnostics™ Selected as 1 of 50 Leading Startups in the 2019 MedTech Innovator Showcase Program

CAM Patch by Bardy Diagnostics - a cardiac patch monitor engineered to capture low amplitude, low frequency electrical signals that form the P-wave. — BardyDx Carnation Ambulatory Monitor (CAM™) – P-wave centric™ ambulatory cardiac patch monitoring and arrhythmia detection device (Above)

SEATTLE, June 19, 2019 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that MedTech Innovator, the premier nonprofit startup accelerator in the medical technology industry, has selected BardyDx to participate in the organization’s 2019 Showcase program, featuring the most promising medical technologies from around the globe. BardyDx was chosen for its innovative advancements in cardiac monitoring by delivering industry-leading diagnostic accuracy with the Carnation Ambulatory Monitor (“CAM™”), the industry’s only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device.

The program commences June 17, 2019 in San Francisco, where the leadership teams from its 50 startups will gather for the annual MedTech Innovator Summit. During this two-day exclusive event, innovators from early to later-stage startups will collaborate with MedTech Innovator’s corporate partners to find solutions to common challenges and mechanisms to accelerate their technologies. They will be joined by investors, providers, payers, and industry stakeholders such as representatives from federal agencies like National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA).

All 50 companies will then present in a Showcase and partnering meetings with executives and investors on June 21 at the Wilson Sonsini Goodrich & Rosati’s 27th Annual Medical Device Conference in San Francisco. The program culminates September 23-25 in Boston, where all companies will present in Showcase panels and gain access to exclusive partnering and roundtables at The MedTech Conference, powered by AdvaMed.

“We are thrilled to be included in this distinguished cohort of innovating companies developing cutting-edge and disruptive technologies in MedTech,” said Ken Nelson, BardyDx Chief Commercial Officer. “We look forward to working with MedTech Innovator and receiving unparalleled visibility and invaluable access to its network of investors, providers, payers, and industry stakeholders through this highly selective program.”

From an initial applicant pool of over 800 applicants spanning 34 countries, BardyDx was chosen among 150 best-in-class medical device, diagnostic, and digital health companies to participate at one of the six regional qualifying MedTech Innovator Pitch Events held in March. BardyDx was selected as part of the 50 advancing innovators from the qualifying round to the Showcase program.

“We take great pride in bringing the world’s best medtech ecosystem together with standout entrepreneurs to provide them with the resources and connections needed to bring their transformative technologies to patients,” said Paul Grand, CEO of MedTech Innovator.

This distinction adds to the growing market recognition of the innovative P-wave centric CAM patch. Recently, BardyDx was named both 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. Also, BardyDx was recently named the winner of the Impact Pediatric Health Competition hosted by the nation’s leading pediatric healthcare institutions at SXSW 2019 for the CAM’s unique pediatric-friendly design and potential to address significant unmet needs in pediatric healthcare. In addition, BardyDx was also selected as the winner of the 2018 Fierce Innovation Life Sciences Award for Medical Device Innovation from the leading industry publisher of FierceBiotech & FiercePharma.

About MedTech Innovator:

MedTech Innovator is the medical technology industry’s nonprofit global competition and accelerator for innovative medical device, digital health, and diagnostic companies. Its mission is to improve the lives of patients by accelerating the growth of companies that are transforming the healthcare system. MedTech Innovator is the largest platform of its kind, providing participants with broad exposure and mentorship from the leading players in the MedTech industry. Additional information can be found at https://medtechinnovator.org/.

About Wilson Sonsini Goodrich & Rosati’s Medical Device Conference:

Wilson Sonsini Goodrich & Rosati, the premier provider of legal services to technology, life sciences, medical and growth enterprises worldwide, will host its 27th Annual Medical Device Conference on June 21. This year’s Conference will focus on understanding the challenges facing the MedTech start-up today, and the strategies that are emerging to respond to these challenges, presented by industry CEOs, venture capitalists, industry strategists, investment bankers, and market analysts. For more information, please visit https://mdc.wsgrevents.com.

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, the female-friendly, hourglass-shaped CAM patch is placed on the center of the chest, directly over the heart. 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 and the determination of appropriate medical or procedural intervention. For more information, please visit www.bardydx.com.

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

Zymeworks Announces Pricing of $175 million Public Offering

VANCOUVER, British Columbia — Zymeworks Inc. (NYSE/TSX:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics (the “Company”), announced today the pricing of its previously announced underwritten public offering (the “Offering”) of 5,555,556 common shares and, to a certain investor, pre-funded warrants to purchase up to 4,166,690 common shares. The common shares are being offered at a price to the public of US$18.00 per common share and the pre-funded warrants are being offered at a price of US$17.9999 per pre-funded warrant, for aggregate gross proceeds to the Company of approximately US$175.0 million, before deducting the underwriting discounts and commissions and estimated Offering expenses. In addition, the Company has also granted the underwriters of the Offering a 30-day over-allotment option to purchase up to an additional 1,458,336 common shares on the same terms and conditions.

The Company intends to use the net proceeds of the Offering 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, breast and other underserved cancers; to accelerate and expand the clinical development of ZW49 through its ongoing adaptive Phase 1 clinical trial and follow-on global studies; to advance other novel preclinical programs, including those involving non-HER2-expressing tumors; and for general corporate purposes.

J.P. Morgan Securities, LLC is acting as active book-running manager for the Offering. Wells Fargo Securities, LLC and Stifel, Nicolaus & Company, Incorporated are acting as passive book-running managers, Raymond James Ltd. is acting as co-lead manager and Ladenburg Thalmann & Co. Inc. is acting as co-manager.

The securities described above are being offered in Canada pursuant to Zymeworks’ final prospectus supplement, dated June 19, 2019 (the “Canadian Supplement”), to its Canadian final base shelf prospectus, dated March 6, 2019 (the “Base Prospectus”), and in the United States pursuant to Zymeworks’ final prospectus supplement, dated June 19, 2019 (the “U.S. Supplement”, together with the Canadian Supplement, the “Supplements”), to its U.S. shelf registration statement on Form S-3, as amended, including a prospectus dated January 31, 2019 (the “Registration Statement”). The Supplements will be filed in Canada and the United States on June 20, 2019.

The Offering is expected to close on or about June 24, 2019, subject to the satisfaction of customary closing conditions, including the listing of the common shares to be issued and that are issuable under the Offering on the TSX and NYSE and any required approvals of each exchange.

The Supplements and the Registration Statement contain important detailed information about the Offering. A copy of the Canadian Supplement will be filed and 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; Wells Fargo Securities, LLC, Attention; Equity Syndicate Department, 375 Park Avenue, New York, NY 10152, by telephone at (800) 326-5897, or by email at cmclientsupport@wellsfargo.com; or 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. 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.

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, the expected closing of the Offering and other information that is not historical information. When used herein, words such as “advance”, “believe”, “initiate”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” 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 March 31, 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.

Zymeworks Inc. Contacts:

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

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

Media Inquiries:
Angela Bitting
(925) 202-6211
a.bitting@comcast.net

Phase 2 Trial Data Demonstrates Longer Survival Rates for Women with Metastatic Breast Cancer Receiving Trilaciclib & Chemotherapy

– Detailed data from this trial will be presented at a medical meeting later this year –

RESEARCH TRIANGLE PARK, N.C., June 18, 2019 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced preliminary overall survival (OS) results from a randomized Phase 2 trial which demonstrated that women with metastatic triple-negative breast cancer (mTNBC) lived significantly longer when receiving trilaciclib and chemotherapy compared with women receiving chemotherapy alone. Detailed data from this trial will be presented at a medical meeting later this year.

Figure 6. Tumor Response & Progression Free Survival Results from G1 Therapeutics' Phase 2 Randomized Trial

Myelopreservation results, objective response rate (ORR), progression-free survival (PFS) and safety data from this trial were presented at the 2018 San Antonio Breast Cancer Symposium (SABCS). Updated anti-tumor efficacy results demonstrated that women receiving trilaciclib and a chemotherapy regimen of gemcitabine/carboplatin had a statistically significant improvement in OS compared with those receiving gemcitabine/carboplatin alone.

Figure 7. Progression Free Survival from G1 Therapeutics Phase 2 Randomized Trial Results

“Triple-negative breast cancer is the most aggressive type of breast cancer, and women diagnosed with metastatic TNBC need new treatment options. We look forward to sharing these data with regulators, as well as presenting findings from this trial at a medical meeting later this year,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer. “As a company committed to improving the lives, treatment options and outcomes of those living with cancer, we’re proud to have a pipeline that now includes three investigational therapies with the potential to become new standards of care for those with breast cancer and benefit women at the earliest stages of their disease.”

G1 Therapeutics Study Design - Phase 2 Randomized Trial for Trilaciclib + Chemotherapy for Women with Metastatic Breast Cancer

About the Study
This randomized, open-label Phase 2 clinical trial (NCT02978716) enrolled 102 patients with mTNBC who had received 0-2 prior lines of therapy in the recurrent/metastatic setting. In this three-arm trial, all patients received a chemotherapy regimen of gemcitabine/carboplatin (GC). Patients were randomized to receive GC only or GC plus one of two dosing schedules of trilaciclib: trilaciclib administered on the day of chemotherapy or trilaciclib administered the day prior to and the day of chemotherapy. Primary endpoints for the trial included myelopreservation measures; secondary endpoints included additional myelopreservation measures and anti-tumor efficacy measures of ORR, PFS, and OS.

Topline OS improvements were statistically significant in both trilaciclib arms compared with the control arm. ORR and PFS data were consistent with results presented at SABCS 2018. The safety and tolerability of trilaciclib were consistent with previously reported data and there have been no serious adverse events attributed to treatment with trilaciclib in this trial.

About Trilaciclib
Trilaciclib is a first-in-class myelopreservation agent designed to protect the bone marrow from damage by chemotherapy and improve patient outcomes. G1 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. The company plans to initiate additional randomized trials to evaluate the myelopreservation and survival benefits of trilaciclib in other tumor types and chemotherapy regimens.

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 myelopreservation agent designed to improve outcomes for patients being treated with chemotherapy. 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 also has an active discovery program focused on cyclin-dependent kinase targets. G1 is based in Research Triangle Park, N.C.

Contact:
Jeff Macdonald
Head of Investor Relations/Public Relations
919-907-1944
jmacdonald@g1therapeutics.com

G1 Therapeutics Appoints Garry Nicholson to Chair of the Board of Directors

Garry Nicholson, new Chair of the Board of Directors for G1 Therapeutics, a clinical stage biopharmaceutical company focused on the discovery, development & delivery of innovative therapies that improve the lives of those affected by cancer.

– Garry Nicholson to serve as new board chair –
– Sir Andrew Witty, Fredric Eshelman, Pharm.D. and prior chair Seth Rudnick, M.D. re-elected –

RESEARCH TRIANGLE PARK, N.C., June 13, 2019 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced that current board member Garry Nicholson has been named as board chair, succeeding former chair Seth Rudnick, M.D. Dr. Rudnick, Sir Andrew Witty, and Fredric Eshelman, Pharm.D. have been re-elected to the Company’s Board of Directors.

“As the company’s clinical programs advance toward global regulatory submissions, Garry’s extensive experience and strategic approach to global drug commercialization and value-creating partnerships make him an ideal board chair,” said Dr. Rudnick. “I look forward to continuing to serve on the board and working with Garry and the leadership team to deliver innovative therapies that have the potential to benefit people with the most common forms of cancer.”

Mr. Nicholson has served on the G1 Board of Directors since 2018. He led the global oncology franchise at Pfizer from 2008 through 2015. As President, Pfizer Oncology, Mr. Nicholson’s responsibilities included global commercialization and sales, clinical development and regulatory strategy, and business development. Under his leadership, the company developed and executed the global regulatory and launch strategy for Ibrance^® (palbociclib), the first CDK4/6 inhibitor approved in the U.S. and Europe. During his tenure at Pfizer, Mr. Nicholson served on the board of directors of the Pfizer Foundation and was a member of the company’s Portfolio, Strategy and Investment Committee, which set corporate R&D priorities and investment strategy.

Mr. Nicholson noted, “Seth’s vision and scientific and clinical expertise were critical in advancing three oncology therapies with the potential to improve outcomes for cancer patients worldwide. I’m excited about the opportunity we have at G1 to fundamentally change how we treat cancer.”

Dr. Rudnick, who served as board chair since 2014, will continue to serve as chair of the Nominating & Governance Committee and as a member of the Compensation Committee. He is also a member of the company’s clinical advisory board.

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 myelopreservation agent designed to improve outcomes for chemotherapy patients. 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 also has an active discovery program focused on cyclin-dependent kinase targets. G1 is based in Research Triangle Park, N.C.

Contact:
Jeff Macdonald
Head of Investor Relations/Public Relations
919-907-1944
jmacdonald@g1therapeutics.com

HistoSonics Touts First-in-Human Study Results

HistoSonics announced its non-invasive robotics platform and novel sonic beam cancer therapy successfully destroyed 11 tumors in eight patients during its first clinical trial.

The results were presented this week at the 2019 Society of Interventional Oncology (SIO) Annual Meeting in Boston. The meeting also included preclinical presentations of what HistoSonics termed promising histotripsy-induced immune responses in melanoma and liver cancer models, tumor-volume reduction effects in liver cancer, and feasibility and safety in treating thyroid tissue.

The Ann Arbor, Mich.-based company is developing its image-guided, robotically assisted sonic therapy (RAST) platform using non-invasive and non-thermal technologies to liquefy and destroy targeted tissues, including tumors, at sub-cellular levels.

The clinical trial’s eight patients each had one, two or three tumors targeted and treated in a single session. They all had multifocal liver malignancy and metastasis from other organs, including breast and colorectal cancers. The trial’s secondary endpoints included procedural safety, local tumor progression (LTP), involution/healing of treatments, immunologic assessment, quality of life, and pain assessments post-procedure.

As reported, 100% of RAST treatments (11 of 11) achieved technical success in destroying the planned targeted volume of tissue, and no patients reported pain or requested analgesics post-procedure at any time point. All treated areas demonstrated rapid involution/healing at each time interval during follow-up. Treatment volumes contracted by an average of 81% upon 2-month follow-up imaging, the company noted.

“The results of this study are encouraging, particularly that the ability to create a treatment zone and the rapid involution of the treatment zone noted in pre-clinical work was equivalent in patient treatments. In addition, the safety and tolerance of the procedure was excellent. I look forward to continued trials in the near future to confirm these promising early results.”
Dr. Tim Ziemlewicz, presenting author from the University of Wisconsin

One adverse event was reported (ablation syndrome in the patient with three treatments in a single session) and resolved two days post-procedure, and one instance of LTP was identified at two months. The observation of LTP in this study was consistent with other modalities and the rapid involution/healing of RAST treatments may help to identify these instances sooner, according to Ziemlewicz. The trial took place in Barcelona, Spain.

The preclinical trial results revealed:

“Promising” data for the use of histotripsy to stimulate adaptive immune responses to tumor neoantigens in an immunocompetent mouse model. The treatments included sham therapy, radiation, thermal ablation, or histotripsy with or without concurrent anti-CTLA-4 checkpoint inhibition immunotherapy.
Local tumor shrinkage of 93.3% in 14 of 15 rats with liver cancer, with treatment delivered by non-invasive orthotopic ablation using histotripsy.
The potential for RAST with histotripsy to deliver precise treatments in targeted regions of the thyroid and thymus in pigs without damaging intervening tissues.

Bardy Diagnostics™ Selected as Winner of the MedTech Breakthrough Award For Best New Diagnostic Technology

Bardy Diagnostics wins Best New Diagnostic Technology at the 2019 MedTech Breakthrough Awards

SEATTLE, June 6, 2019 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that MedTech Breakthrough, an independent organization that recognizes the top companies and solutions in the global health and medical technology market, has recognized the Carnation Ambulatory Monitor (CAM™) with the “Best New Diagnostic Technology” award in the 2019 MedTech Breakthrough Awards program. BardyDx earned the distinction for its innovative P-wave centric™ ambulatory cardiac patch monitoring and arrhythmia detection technology.

Bardy Diagnostics' Carnation Ambulatory Monitor (CAM) - a lightweight bandage-size cardiac patch to capture low frequency P-Wave for cardiologists and cardiac rhythm specialists to aid in arrhythmia diagnoses. — BardyDx’s Carnation Ambulatory Monitor (CAM™) (above)
SOURCE: Bardy Diagnostics

Reliably detecting and recording the P-wave, a small amplitude signal of the ECG originating in the atrium, is essential to accurate arrhythmia diagnosis and the determination of appropriate medical or procedural intervention. By focusing on the detection and recording of the P-wave, BardyDx advances cardiac monitoring by delivering industry-leading diagnostic accuracy.

“It is an honor to be recognized by the MedTech community as one of the innovating companies and technologies paving the way for the future of cardiac monitoring,” said Gust H. Bardy, MD, Founder and Chief Executive Officer of Bardy Diagnostics. “This award recognizes our collective drive at BardyDx towards transforming clinical care and developing an efficient, effective, and accurate healthcare solution that finally addresses the limitations and challenges of current cardiac monitors faced by clinical decision-makers day-in and day-out.”

The MedTech Breakthrough Awards program is the premier awards and recognition platform founded to recognize the medical and health technology innovators, leaders and visionaries from around the world. The program evaluates and recognizes breakthrough solutions and companies in a range of categories, including Medical Devices, mHealth, Robotics, TeleHealth, Patient Engagement, Electronic Health Records (EHR), Healthcare Security, Medical Data and more. This year’s program attracted more than 3,500 nominations from over 15 different countries throughout the world that were evaluated by an independent panel of experts within the MedTech industry, with the winning products and companies selected based on a variety of considerations, including innovation, design, and user experience.

“BardyDx’s non-invasive P-wave centric CAM ™ patch is disrupting decades of old practice and technology for cardiac diagnostics and monitoring,” said James Johnson, managing director, MedTech Breakthrough. “CAM™ represents a true digital health breakthrough and we are thrilled to recognize the Company with a 2019 MedTech Breakthrough Award in recognition of their outstanding success and innovation in the digital health space.”

This award adds to the growing market recognition of the innovative P-wave centric CAM patch. Last month, BardyDx was named both the winner of the 2019 Frost & Sullivan Award for Technology Innovation in Remote Cardiac Monitoring and the winner of the 2019 GeekWire Award in the Hardware of the Year category. Also, BardyDx was recently named the winner of the Impact Pediatric Health Competition hosted by the nation’s leading pediatric healthcare institutions at SXSW 2019 for the CAM’s™ unique pediatric-friendly design and potential to address significant unmet needs in pediatric healthcare. In addition, BardyDx was also selected as the winner of the 2018 Fierce Innovation Life Sciences Award for Medical Device Innovation from the leading industry publisher of FierceBiotech & FiercePharma.

About MedTech Breakthrough:

Part of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the MedTech Breakthrough Awards program is an independent program devoted to honoring excellence in medical and health-related technology companies, products, services, and people. The MedTech Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough health and medical companies and products in categories that include Patient Engagement, mHealth, Health & Fitness, Clinical Administration, Healthcare IoT, Medical Data, Healthcare Cybersecurity and more.

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 design. Designed to be worn comfortably and discreetly, 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
Director, Marketing
Bardy Diagnostics, Inc.
1-844-422-7393
jwu@bardydx.com

Bellingham Urology Group Acquires First ExactVu™ System in Washington State

Bellingham Urology Group's Dr. Vernon A. Orton & Dr. John M. Pettit pictured with colleagues. — Dr. Vernon A. Orton, II & Dr. John M. Pettit with colleagues (above)
SOURCE: Bellingham Urology Group, PLLC.

TORONTO, CANADA — (June 4, 2019) Exact Imaging, the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, announced that Bellingham Urology Group has acquired the ExactVu™ micro-ultrasound system for real-time targeted prostate biopsies. This is the first of its kind in Washington, Oregon, and Idaho.

Dr. Vernon A. Orton, II of Bellingham Urology Group, one of Washington's most experienced robotic surgeons — Dr. Vernon A. Orton, II (above)
SOURCE: Bellingham Urology Group PLLC.

“At Bellingham Urology Group, we are dedicated to providing the highest level of patient care, and investments in the newest imaging technologies to allow our physicians to achieve these outcomes is essential”, says Dr. Vernon Orton, one of Washington’s most experienced urologic robotic surgeons. “Our acquisition of this ExactVu™ high resolution micro-ultrasound system will allow our urologists to actually visualize suspicious regions with 300% the image resolution of conventional ultrasound systems, and then target their prostate biopsies in real-time. Bellingham Urology Group patients will benefit from this excellent new platform that will allow us to ultimately improve our biopsies with the end goal of allowing our physicians to more accurately diagnose significant prostate cancer.”

Dr. Orton adds “The ExactVu™ micro-ultrasound system is a paradigm shift in real-time imaging striving to get even more accurate biopsies using the highest resolution modalities to enable the fastest, most detailed imaging of the prostate. With the system’s FusionVu™ feature, we can also align the patient’s prostate MRI with the live micro-ultrasound image to either perform Cognitive Assist™ or micro-ultrasound/MRI fusion-guided biopsies, all with the benefit of the 70-micron resolution of micro-ultrasound. This allows us to see lesions that were unseen with our older technologies.”

“We are thrilled to have Bellingham Urology Group as the first practice in Washington, Oregon, and Idaho to adopt our ExactVu™ micro-ultrasound platform,” says Randy AuCoin, Exact Imaging’s President and CEO. “The ExactVu™ micro-ultrasound system provides the highest real-time resolution for targeted prostate biopsies and through this progressive urology practice, patients in the Northwestern U.S. can now have access to micro-ultrasound for their prostate biopsies”.

The ExactVu™ customer base is growing globally as the urological community is recognizing the power of micro-ultrasound for providing excellent resolution for visualizing the prostate and providing real-time targeted guidance of prostate biopsies in a manner that is fast, cost-effective, and convenient for the patient.

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 at 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).

About Bellingham Urology Group

Bellingham Urology Group pledges to a mission to deliver evidence-based, patient-centered, state-of-the-art urological care.

For Further Information Contact:

Randy AuCoin
President & CEO
Exact Imaging
C. +1.705.927.0512
E. raucoin@exactimaging.com

Zymeworks Appoints Accomplished Executives to Board of Directors

SOURCE: Zymeworks

VANCOUVER, British Columbia–(BUSINESS WIRE)– Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced the appointment of two new independent members to its Board of Directors, further enhancing the Board’s commercial expertise. The new board members are Sue Mahony, Ph.D., MBA, a pharmaceutical executive with over 30 years of combined experience with Eli Lilly and Company (Lilly), Schering-Plough, Amgen, and Bristol-Myers Squibb, and Troy Cox, MBA, who has served in numerous senior leadership positions at leading biopharmaceutical companies such as Foundation Medicine, Roche-Genentech, UCB BioPharma, Sanofi-Aventis, and Schering-Plough.

“Sue Mahony and Troy Cox are highly respected biopharmaceutical executives that will provide essential leadership as Zymeworks transitions into a late-stage biotechnology company,” said Ali Tehrani, Ph.D., President and CEO of Zymeworks. “Both bring a wealth of knowledge and expertise in the strategic development and commercialization of therapeutics globally. We look forward to benefiting from their guidance as we continue to advance our robust clinical pipeline towards commercialization.”

Sue Mahony former Senior Vice President of Lilly and President of Lilly Oncology — SOURCE: Forté Foundation | Sue Mahony (above)

Sue Mahony brings extensive operational, clinical, and commercialization experience. Most recently, she served as Senior Vice President of Lilly and President of Lilly Oncology. While at Lilly, she held numerous senior leadership positions and led organizations in Europe, the US, Canada, Japan, and China; successfully developed, launched, and commercialized several global brands; and was a member of Lilly’s Executive Committee for 10 years. Prior to joining Lilly, Dr. Mahony served in sales and marketing roles in Europe for over a decade for Schering-Plough, Amgen, and Bristol-Myers Squibb. She also serves on the Board of Directors of Assembly Biosciences and Vifor Pharma. Dr. Mahony received a B.Sc. and a Ph.D. from Aston University and an MBA from London Business School.

Troy Cox former President & CEO of Foundation Medicine Inc. — SOURCE: Massachusetts Biotechnology Council | Troy Cox (above)

Troy Cox brings extensive biotech business and executive leadership experience to Zymeworks’ Board of Directors. Formerly, he served as President, Chief Executive Officer, and on the Board of Directors of Foundation Medicine, Inc., where he helped to advance oncology molecular science, partnered with biopharma, and secured reimbursement to deliver more advanced oncology care, thus shaping the oncology research, diagnostic, and data industries. Mr. Cox has also served as Senior Vice President, Sales & Marketing at Genentech, leading the oncology portfolio, as President of Central Nervous System (CNS) Operations at UCB BioPharma with responsibility for developing and commercializing therapeutics for complex CNS diseases, and in various senior commercial leadership roles at Sanofi-Aventis and Schering-Plough. Mr. Cox received a B.B.A. in finance from the University of Kentucky and an MBA from the University of Missouri.

About Zymeworks Inc.

Zymeworks 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 the expected leadership to be provided by the new directors, Zymeworks’ anticipated advancement of its clinical pipeline towards commercialization and of its preclinical pipeline, advancements in Zymeworks’ partners therapeutic programs, the speed and outcome of drug development plans, and other information that is not historical information. When used herein, words such as “enable”, “plan”, “expect”, “will”, “may”, “look forward to”, “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 fiscal quarter ended March 31, 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.

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

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

Media Inquiries:
Angela Bitting
(925) 202-6211
a.bitting@comcast.net

New Patient-Reported Outcomes Data Shows Trilaciclib Improves Chemotherapy Experience for Patients

SOURCE: G1 Therapeutics

G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today presented additional findings from a randomized Phase 2 clinical trial demonstrating the myelopreservation benefits of trilaciclib in patients undergoing chemotherapy treatment for 2^nd/3^rd-line small cell lung cancer (SCLC). Trilaciclib is a first-in-class myelopreservation agent designed to protect the bone marrow from damage by chemotherapy and improve patient outcomes.

The abstract titled “Trilaciclib, a CDK 4/6 inhibitor, mitigates myelosuppression in patients with previously treated extensive-stage small cell lung cancer receiving topotecan” (#8505) was selected for oral presentation at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.

In December 2018, the company announced topline data showing that SCLC patients receiving trilaciclib + topotecan (a chemotherapy agent) experienced statistically significant reductions in the duration and occurrence of Grade 4 neutropenia, and that trilaciclib treatment resulted in a reduction in the number of granulocyte colony-stimulating factor (G-CSF) administrations and red blood cell (RBC) transfusions, compared to patients receiving placebo + topotecan. Overall, patients receiving trilaciclib + topotecan showed an improved safety profile compared to those receiving placebo + topotecan.

An analysis of patient-reported outcomes (PRO) data showed clinically meaningful improvements in the treatment experience for patients receiving trilaciclib + topotecan compared to those receiving placebo + topotecan. Patients receiving trilaciclib reported significant improvements in several areas, including: general and physical wellbeing, quality-of-life (QoL) measures specific to lung cancer patients, symptoms and impact of fatigue, and symptoms and effects on physical and functional wellbeing due to anemia.

“Chemotherapy is an effective treatment option for those with cancer. As a treating physician, I regularly see how it also negatively impacts patient health and quality of life. Chemotherapy often causes bone marrow damage that can result in anemia and neutropenia, subsequently leaving patients with severe fatigue and at increased risk of infection,” said Lowell Hart, M.D., Scientific Director of Research, Florida Cancer Specialists and trilaciclib clinical trial investigator. “It was encouraging to observe that in this trial, use of trilaciclib made chemotherapy safer, reducing the rates of chemotherapy-related side effects and the use of rescue interventions commonly used to treat them. Importantly, patient-reported outcomes data showed that the myelopreservation benefits of trilaciclib improved their overall experience on chemotherapy.”

Key findings of the trial included:

Patients receiving trilaciclib + topotecan demonstrated statistically significant reductions in both of the trial’s primary endpoints compared to patients receiving placebo + topotecan: duration of Grade 4 neutropenia in cycle 1 and occurrence of Grade 4 neutropenia.
Trilaciclib treatment reduced the number of G-CSF administrations per cycle and the number of RBC transfusions (on/after week 5) per week compared to placebo.
PRO data showed clinically meaningful improvements in the treatment experience of patients receiving trilaciclib + topotecan compared to those who received placebo + topotecan.
Anti-tumor efficacy measures of overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) were comparable between the trilaciclib + topotecan and placebo + topotecan arms.
Consistent with the three other randomized Phase 2 trials, trilaciclib was well tolerated and there were fewer ≥ Grade 4 treatment-emergent adverse events (TEAEs) in the trilaciclib arm compared to the placebo arm.

Following meetings with U.S and European regulatory authorities to review data from three randomized, placebo-controlled SCLC clinical trials, including data presented at the 2019 ASCO Annual Meeting, the company announced plans to submit marketing applications for trilaciclib for myelopreservation in SCLC. The company expects to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in 2020.

About Chemotherapy and Trilaciclib
Chemotherapy is an effective and important treatment against cancer. However, chemotherapy does not differentiate between healthy cells and cancer cells, killing both, including important stem cells in the bone marrow that produce white blood cells (WBCs), RBCs and platelets. This chemotherapy-induced bone marrow damage is known as myelosuppression. When WBCs, RBCs and platelets become depleted, chemotherapy patients are at increased risk of infection, experience anemia and fatigue, and are at increased risk of bleeding. Myelosuppression often requires the administration of rescue interventions such as growth factors and blood or platelet transfusions, and may also result in chemotherapy dose delays and reductions.

Trilaciclib is a first-in-class myelopreservation agent designed to protect the bone marrow from damage by chemotherapy and improve patient outcomes. G1 expects to submit marketing applications in the U.S. and Europe for trilaciclib for myelopreservation in small cell lung cancer in 2020, and plans to initiate new label expansion trials in 2020.

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 and lerociclib are designed to enable more effective combination treatment strategies and improve patient outcomes across multiple oncology indications. 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.

Contact:
Jeff Macdonald
Head of Investor Relations/Public Relations
919-907-1944
jmacdonald@g1therapeutics.com

Zymeworks Earns Milestone Payment in Merck Collaboration

VANCOUVER, British Columbia–(BUSINESS WIRE)– Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that it has earned a milestone payment from Merck (known as MSD outside the US and Canada) achieved under the companies’ 2014 research and license agreement. Zymeworks will receive US$2.0 million in connection with Merck’s completion of a late-stage preclinical study for a bispecific antibody candidate using Zymeworks’ proprietary Azymetric™ and EFECT™ therapeutic platforms.

“Merck’s completion of this milestone is great news,” said Ali Tehrani, Ph.D., President and CEO of Zymeworks. “We believe this accomplishment from another one of our long-term partners provides additional evidence of the potential of our bispecific antibody technology. We expect similar advancements from our other partners’ therapeutic programs in the years ahead.”

Under the terms of the research and license agreement, Zymeworks has granted Merck a worldwide, royalty-bearing license to research, develop and commercialize certain bispecific therapeutic candidates toward Merck’s therapeutic targets for which Zymeworks is eligible to receive additional development and commercial milestone payments as well as tiered royalties on product sales.

About the Azymetric™ Platform

The Azymetric platform enables the transformation of monospecific antibodies into bispecific antibodies, giving the antibodies the ability to simultaneously bind two different targets. Azymetric bispecific technology enables the development of multifunctional biotherapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering degradation, and increase tumor-specific targeting. These features are intended to enhance efficacy while reducing toxicities and the potential for drug resistance. Azymetric bispecifics have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life and high stability. In addition, they are compatible with standard manufacturing processes with high yields and purity, potentially significantly reducing drug development costs and timelines.

About the EFECT™ Platform

The EFECT platform is a library of antibody Fc modifications engineered to modulate the activity of the antibody-mediated immune response, which includes both the up- and down-regulation of effector functions. This platform, which is compatible with traditional monoclonal as well as Azymetric bispecific antibodies, further enables the customization of therapeutic responses for different diseases.

About Zymeworks Inc.

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics. The Company’s 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. The Company’s 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.

Zymeworks 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 future development activities in accordance with the terms of Zymeworks’ agreements with Merck and other corporate partners, advancements in Zymeworks’ partners therapeutic programs, potential payments and/or royalties payable to Zymeworks under these agreements, the speed and outcome of drug development plans, Zymeworks’ potential global growth, and other information that is not historical information. When used herein, words such as “enable”, “plan”, “expect”, “will”, “may”, “eligible to”, 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 fiscal quarter ended March 31, 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.

Contacts

Zymeworks Inc.

Investor Inquiries:

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

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

Media Inquiries:

Angela Bitting
(925) 202-6211
a.bitting@comcast.net

Zymeworks’ Lead Asset, ZW25 Granted Fast Track Designation from FDA

VANCOUVER, British Columbia — Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZW25, a novel Azymetric^™bispecific antibody, for the first-line treatment of patients with HER2-overexpressing gastroesophageal adenocarcinoma in combination with standard of care chemotherapy.

“Receipt of Fast Track designation from the FDA emphasizes the large unmet need of patients with these types of HER2-expressing cancers,” said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. “This designation is key to our objective of getting important new therapies to patients as quickly as possible. We are pleased with the discussions we’ve had with the FDA thus far and will continue to work together on other opportunities to accelerate the development of ZW25 in additional indications.”

The FDA’s Fast Track designation is designed to facilitate development and expedite the review of therapies to treat a serious diseases where there is a significant unmet medical need. A therapeutic that receives Fast Track designation is eligible for frequent communication with the FDA, accelerated approval and priority review, and rolling submission, which means that a company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be submitted for review. The primary objective of this program is to accelerate patient access to new and potential lifesaving therapies.

About the Trial

The Phase 2 trial is a two-part open-label study. The primary objectives of this trial are to confirm the safety, tolerability, and anti-tumor activity of ZW25 in combination with global standard of care regimens for gastroesophageal adenocarcinoma, including platinum and fluoropyrimidine-based regimens.

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 the Azymetric™ Platform

The Azymetric platform enables the transformation of monospecific antibodies into bispecific antibodies, giving the antibodies the ability to simultaneously bind two different targets. Azymetric bispecific technology enables the development of multifunctional biotherapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering degradation, and increase tumor-specific targeting. These features are intended to enhance efficacy while reducing toxicities and the potential for drug-resistance. Azymetric bispecifics have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life, and high stability. In addition, they are compatible with standard manufacturing processes with high yields and purity, potentially significantly reducing drug development costs and timelines.

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.

Zymeworks 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, the speed and outcome of drug development plans, the speed, frequency and outcome of communications with the FDA, patient access to ZW25, and other information that is not historical information. When used herein, words such as “enable”, “plan”, “expect”, “will”, “may”, “eligible”, “continue to” 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 fiscal quarter ended March 31, 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.

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

Tiffany Tolmie
(604) 678-1388
ir@zymeworks.comMedia Inquiries:
Angela Bitting
(925) 202-6211
a.bitting@comcast.net

Satsuma Pharmaceuticals Appoints Elisabeth Sandoval to Board of Directors

Commercial leader brings recent migraine space experience to Satsuma as it advances lead product candidate STS101 into Phase 3 development

SOUTH SAN FRANCISCO, Calif., May 29, 2019 /PRNewswire/ — Satsuma Pharmaceuticals, Inc. (“Satsuma” or “the Company”), a Phase 3-stage biopharmaceutical company developing STS101, (dihydroergotamine (DHE) nasal powder) for the acute treatment of migraine, today announced that Elisabeth Sandoval has been appointed as a member of Satsuma’s Board of Directors, effective immediately. Ms. Sandoval most recently served as Chief Commercial Officer and Executive Vice President of Corporate Strategy for Alder Biopharmaceuticals, an NDA-stage company focused on developing novel therapeutic antibodies for the treatment of migraine, and previously served as Chief Commercial Officer of KYTHERA Biopharmaceuticals.

“We welcome Elisabeth to the Satsuma Board. Her extensive drug product commercialization experience, including recent work in the migraine field, and her leadership and strategy skills, will greatly benefit Satsuma as the Company advances STS101 through Phase 3 development and toward commercialization,” commented Heath Lukatch, Ph.D., Chairman of the Board of Directors of Satsuma Pharmaceuticals.

As Chief Commercial Officer and Executive Vice President of Corporate Strategy at Alder Biopharmaceuticals, Ms. Sandoval was responsible for developing and leading the company’s commercial, strategy, medical affairs, investor relations, corporate communications, and business development functions. Before joining Alder, she was Chief Commercial Officer for KYTHERA Biopharmaceuticals, where she led the commercial strategy and execution including the hiring and development of all commercial functions and launch of a first-in-class product prior to KYTHERA’s acquisition by Allergan. Before KYTHERA, Ms. Sandoval was Vice President of Marketing for Bausch and Lomb Surgical, leading all marketing strategy and execution globally. Prior to this position, Ms. Sandoval was Vice President of Global Marketing at Allergan with responsibility for developing the global commercial strategy for the Medical Aesthetics division and execution of key product launches. She spent 23 years at Allergan in sales and marketing leadership roles in the specialties of dermatology, neurology, and aesthetics. Ms. Sandoval serves on the board of directors for Menlo Therapeutics and ALASTIN Skincare, a privately held company. Ms. Sandoval began her career in research and development at Johnson & Johnson’s Ethicon division. She holds an MBA from Pepperdine University and a B.S. in Biology from the University of California, Irvine.

About Satsuma Pharmaceuticals
Satsuma Pharmaceuticals is a Phase 3-stage biopharmaceutical company focused on developing STS101 as an important and differentiated therapeutic option for the acute treatment of migraine. STS101 is a novel and proprietary investigational drug-device combination product specifically designed to enable intranasal administration of the anti-migraine drug, dihydroergotamine (DHE), with a pharmacokinetic profile optimized to provide consistent and robust clinical efficacy. 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, self-administered, and non-injectable DHE product. The Company believes STS101 will 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 optimization and recently completed a Phase 1 clinical trial.

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

Corporate Contacts

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

John Kollins, President and Chief Executive Officer
Satsuma Pharmaceuticals, Inc.
john@satsumarx.com

Health Canada Clears Forbius’ AVID100 to Commence Phase 2 Clinical Trials

Austin, TX and Montreal, QC (May 28, 2019) – Forbius, a clinical-stage company that develops novel biologics for the treatment of cancer and fibrosis, announced today that it has obtained approval from Health Canada to conduct Phase 2 clinical trials evaluating AVID100, a novel anti-EGFR antibody-drug conjugate (ADC), in EGFR-overexpressing squamous cell carcinoma of the head and neck (SCCHN), squamous non-small cell lung cancer (sqNSCLC) and triple-negative breast cancer (TNBC).

Expansion of ongoing AVID100 Phase 2 trials in patients with SCCHN, sqNSCLC and TNBC who overexpress EGFR to include clinical sites in Canada
AVID100 is the most advanced and broadly active anti-EGFR ADC in clinical development, targeting both wild-type and mutant forms of EGFR
Recommended Phase 2 dose (RP2D) of 220 mg/m²(~6 mg/kg) q3w, one of the highest amongst ADCs in development and predicted to be in therapeutic range

AVID100-01 (NCT03094169) is a Phase 2, open label, multicenter study to evaluate the safety and efficacy of AVID100 in up to 100 SCCHN, sqNSCLC and TNBC patients with confirmed EGFR-overexpression. The trial is currently enrolling patients at centers in the U.S. and will be expanding to additional clinical sites in Canada.

Preclinical data demonstrated AVID100 to be highly potent and selectively cytotoxic against EGFR-expressing cancer cells while sparing normal keratinocytes. A Phase 1 dose-escalation study in patients with advanced solid tumors of epithelial origin confirmed that AVID100 was well tolerated and established an RP2D of 220 mg/m²(~6 mg/kg), which is expected to be in the therapeutically active range and is one of the highest RP2Ds reported for ADCs with maytansinoid payload.

Approximately 20–25% of patients with SCCHN, sqNSCLC and TNBC have tumors that highly overexpress EGFR. No targeted therapy is approved for these indications with confirmed EGFR-overexpression.

About AVID100 and the AVID100-01 Trial

AVID100 is a highly potent EGFR-targeting antibody-drug conjugate (ADC) engineered to achieve enhanced anti-tumor efficacy without a corresponding increase in toxicity against skin and other EGFR-expressing normal tissues. In preclinical studies, AVID100 demonstrated significant anti-cancer activity in EGFR-overexpressing tumor models resistant to marketed EGFR inhibitors. AVID100 is the most advanced, broadly active anti-EGFR ADC in clinical development and targets both wild-type and mutant forms of EGFR.

AVID100-01 (NCT03094169) is an open-label, multicenter, dose-expansion study to evaluate the efficacy, safety and tolerability of AVID100 in patients with confirmed EGFR-overexpressing sqNSCLC (IHC 3+), SCCHN (IHC 3+) and TNBC (IHC 2+/3+) (more than 50% of cells with EGFR 3+ or more than 75% of cells with EGFR 2+ staining).

About Forbius: Targeting TGF-beta and EGFR Pathways in Fibrosis and Cancer

Forbius is a clinical-stage protein engineering company that designs and develops novel biologics for the treatment of fibrosis and cancer. Our current focus is the development of agents targeting the transforming growth factor-beta (TGF-beta) and epidermal growth factor receptor (EGFR) pathways.

Media Contact

Claudia Resch
info@forbius.com

enGene Appoints José M. Lora, Ph.D. as Chief Scientific Officer

MONTRÉAL and BOSTON, May 29, 2019 — enGene Inc., the high growth biotechnology company developing the Gene Pill™ – a robust, proprietary non-viral vector platform to deliver gene therapies via oral administration – today announced the appointment of José M. Lora, Ph.D., as Chief Scientific Officer. Dr. Lora will join the executive management team and will be responsible for setting the scientific strategy and priorities for enGene, as well as overseeing day-to-day research operations.

“We are thrilled to add José’s deep scientific expertise and talent to enGene’s leadership team,” said Jason Hanson, Chief Executive Officer and President of enGene. “Along with his scientific prowess comes his deep drive to bring forward meaningful medications to impact patients’ lives. He is truly the ideal addition to our team.”

“The potential for enGene’s non-viral vector platform to create transformational medicines is remarkably exciting to me personally,” stated Dr. Lora. “I am honored to help build upon the great successes already achieved by enGene’s talented team and to our advancement of promising programs for the benefit of patients.”

Dr. Lora brings to enGene an extensive track record of leading discovery programs from concept to clinic across various therapeutic areas and modalities. He has been intimately involved in numerous IND-filings, is a co-inventor on 10+ patents and has co-authored 40+ peer-reviewed publications and book chapters. Dr. Lora joins enGene from Synlogic, Inc., where he served as Vice President of Research. In this role, José was responsible for building the Immunomodulation Therapy Area and for immuno-oncology programs from discovery up to human proof-of-mechanism/proof-of-concept. Prior to joining Synlogic, José ascended in positions of increasing responsibility at Constellation Pharmaceuticals, Inc., where he was ultimately responsible for establishing and managing immunomodulatory and immuno-epigenetics functions. Early in his career, José led efforts in immunology, liver fibrosis and respiratory diseases (including COPD and Cystic Fibrosis) at Millennium Pharmaceuticals, Inc., Roche Palo Alto, LLC, and GlaxoSmithKline. Dr. Lora obtained his Ph.D. in Cellular and Molecular Biology at CSIC/University of Sevilla, Spain, and completed his post-doctoral studies at Brown University and the University of Utah in the USA.

“I look forward to working with José as enGene enters its exciting new phase of growth,” said Dr. Cheung, Co-founder, and Chief Technology Officer at enGene. “We are proud that the promise of our platform and the milestones our team has accomplished have attracted an industry veteran of José’s caliber to join our journey.”

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.

For further information:

Jason Hanson, CEO and President, enGene Inc., jhanson@engene.com

Tel: 514-332-4888 ext. 100

Zymeworks Enters its First ZymeLink™ Antibody-Drug Conjugate Platform Licensing Agreement with Iconic Therapeutics

SOURCE: Zymeworks

VANCOUVER, British Columbia–(BUSINESS WIRE)–Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that it has entered into a licensing agreement that grants Iconic Therapeutics, Inc. (Iconic) non-exclusive rights to Zymeworks’ proprietary ZymeLink™ antibody-drug conjugate (ADC) platform for the development of its ICON-2 Tissue Factor ADC for cancer. This is the first collaboration leveraging the ZymeLink platform and represents Zymeworks’ third technology platform licensed to a collaborator.

“We believe this first ZymeLink licensing deal provides further validation of our novel ADC technology, which is already being used in Zymeworks’ own clinical candidate, ZW49.”

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

“We believe this first ZymeLink licensing deal provides further validation of our novel ADC technology, which is already being used in Zymeworks’ own clinical candidate, ZW49,” said Ali Tehrani, Ph.D., President and Chief Executive Officer of Zymeworks. “Historically, traditional ADC development has been plagued by a number of challenges related to toxicity and efficacy. Our research has shown that ZymeLink has the capacity to significantly enhance exposure and tolerability, broadening the therapeutic window and leading to potentially safer and more efficacious therapeutic candidates.”

“Zymeworks’ technology provides properties and capabilities we believe will enhance and leverage Iconic’s Tissue Factor platform,” commented William Greene, M.D., Iconic’s Chief Executive Officer. “Having evaluated several alternatives, we are confident that we can develop a truly differentiated ADC with ZymeLink. Tissue Factor is an important target in solid tumors, and we believe the combination of our best-in-class antibodies with Zymeworks’ next generation payload technology will deliver an ADC with enhanced safety and efficacy with the potential to be an important addition to the cancer armamentarium. We look forward to progressing ICON-2 to the clinic in 2020 and more broadly, to further developing our pipeline of therapeutic approaches to targeting Tissue Factor mediated diseases.”

Under the terms of the agreement, Zymeworks will be eligible to receive development and commercial milestone payments and tiered royalties on worldwide net sales. The agreement also provides Zymeworks co-promotion rights with increased royalties for products developed using the Iconic ADC program. If Iconic outlicenses the program, in lieu of co-promotion rights, Zymeworks will receive a share of the revenue Iconic receives from any partners as well as tiered royalties on worldwide net sales.

About the ZymeLink™ Platform

The ZymeLink platform is a set of proprietary cytotoxic drugs and linkers designed to create stable, polar ADCs for the targeted delivery of therapeutics with significantly enhanced exposure and tolerability leading to increased efficacy against targets that traditionally have been challenging for ADCs. The ZymeLink platform is compatible with monoclonal and bispecific antibodies and is intended to facilitate the development of next-generation antibody-drug conjugates with broad therapeutic windows.

About Iconic Therapeutics

Iconic Therapeutics is a venture-backed biopharmaceutical company dedicated to translating an understanding of the role of Tissue Factor biology to new therapeutics for diseases such as macular degeneration and cancer. The company has developed a portfolio of proprietary molecules, which bind to and antagonize Tissue Factor expressed in disease, both in retina and in solid tumors.

About Zymeworks Inc.

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics. The Company’s 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. The Company’s 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 multiple 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, but are not limited to, statements that relate to potential milestone payments, royalties and other revenue, co-promotion rights, ZymeLink’s effect on the ADC field and its potential with respect to therapeutic treatment and development of therapeutic candidates, and other information that is not historical information. When used herein, words and phrases such as “will,” “eligible to,” “entitled to,” “look forward to,” 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 fiscal quarter ended March 31, 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 Relations:

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

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

Media Inquiries:

Angela Bitting
(925) 202-6211
a.bitting@comcast.net

Iconic Therapeutics, Inc.

Shari Annes
Annes Associates
(650) 888-0902
sannes@anneassociates.com

Aurinia Reports First Quarter 2019 Financial Results and Recent Operational Highlights

SOURCE: Aurinia Pharmaceuticals Inc.

VICTORIA, British Columbia–(BUSINESS WIRE)– Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today reported financial results for the first quarter ended March 31, 2019, and provided an update on recent operational highlights. Amounts, unless specified otherwise, are expressed in U.S. dollars.

First Quarter 2019 Highlights

Fully-enrolled AURORA Phase 3 trial in lupus nephritis (“LN”) continues on track with results anticipated in late 2019.
Reported results from a Phase 2a Dry Eye study with voclosporin ophthalmic solution (“VOS”) that achieved statistically superior efficacy in secondary objective endpoints compared to cyclosporin ophthalmic emulsion 0.05% (Restasis®), the current DES market leader. VOS did not meet the primary endpoint as both drugs were well tolerated and demonstrated less than anticipated drop discomfort.
Received a Notice of Allowance from the United States Patent and Trademark Office (“USPTO”) for claims which have the potential to cover voclosporin’s method of use and dosing protocol for lupus nephritis (“LN’) until December 2037.
Appointed Mr. Peter Greenleaf as Chief Executive Officer and Dr. George Milne to Chairman of the Board of Directors.
Cash, cash equivalents, and short-term investments of $144.3 million as of March 31, 2019.

Recent Director and Officer Appointments

On April 29, 2019, Aurinia appointed Peter Greenleaf as Chief Executive Officer and a Director on the Aurinia Board.

Concurrently, Dr. Richard M. Glickman, who previously announced his plans to retire on November 6, 2018, stepped down from his role as Chairman and CEO. Dr. Glickman remains an advisor to the Company for a period of 12 months.

“It is an honor to join Aurinia at this time and lead the organization through its next phase of growth to advance voclosporin toward commercialization based upon the Phase 3 AURORA results in lupus nephritis anticipated by the end of this year,” commented Mr. Peter Greenleaf, Chief Executive Officer of Aurinia. “After following the Aurinia story and after conducting further due diligence, I am truly impressed with the Aurinia team, their ability to execute and advance voclosporin in a cost-efficient manner, with the ongoing goal of bringing voclosporin to help patients suffering from LN.”

In conjunction with Dr. Glickman’s retirement as the Chairman, the Board elevated George M. Milne, Jr., Ph.D., to the position of Chairman of the Board effective April 29, 2019. In addition, the Board appointed Dr. Daniel Billen to the Board also effective April 29, 2019.

Dr. Milne stated, “With the appointment of Peter and Daniel to the board, combined with our experienced and committed employees and management team, Aurinia is strongly positioned to achieve our milestones and maximize the value of voclosporin for all of our stakeholders.

VOS for Dry Eye Syndrome (“DES”)

Based upon the exploratory Phase 2a results generated with VOS in a head-to-head comparison vs. the current market leader for the treatment of DES, Aurinia plans to initiate a Phase 2/3 study by late 2019. This study will encompass certain critical regulatory requirements that the FDA has traditionally required for DES product approval, these requirements include both dose-optimization requirements along with a comparison versus vehicle.

“I’m confident that the internal Aurinia team along with our key ophthalmology clinical advisors have crafted a framework of a plan that minimizes the clinical and regulatory risk for VOS and maximizes our probability of launching VOS into the multi-billion dollar DES market in due course,” said Michael R. Martin, Chief Operating Officer of Aurinia.

Financial Liquidity at March 31, 2019

As at March 31, 2019, Aurinia had cash, cash equivalents and short-term investments of $144.3 million compared to $125.9 million of cash, cash equivalents and short-term investments as at December 31, 2018. Net cash used in operating activities was $13.1 million for the first quarter ended March 31, 2019, compared to $14.4 million for the first quarter ended March 31, 2018.

The Company believes, that based on its current plans that Aurinia has sufficient financial resources to fund the existing LN program, including the AURORA trial and the AURORA 2 extension trial, complete the NDA submission to the FDA, conduct the ongoing Phase 2 study for FSGS, commence additional DES studies and fund operations into mid-2020.

The increase in our cash position at March 31, 2019, was primarily the result of the following:

At-The-Market (“ATM”) Facility

On November 30, 2018, Aurinia had entered into an open market sale agreement with Jefferies LLC pursuant to which the Company could from time to time sell, through ATM offerings, common shares that would have an aggregate offering amount of up to $30 million. The ATM was fully utilized in the first quarter. Aurinia received gross proceeds of $30 million and issued 4.6 million common shares. The Company incurred share issue costs of $1.2 million including a 3% commission and professional and filing fees related to the ATM offerings.

February 14, 2014 Warrant Exercises

The remaining derivative warrants outstanding from the February 14, 2014, private placement were exercised in the first quarter ended March 31, 2019. Certain holders of these warrants elected the cashless exercise option and the Company issued 687,000 common shares on the cashless exercise of 1.3 million warrants. Three holders of 464,000 warrants exercised these warrants for cash, at a price of $3.2204 per common share. The Company received cash proceeds of $1.5 million and issued 464,000 common shares.

Financial Results for the First Quarter Ended March 31, 2019

The Company reported a consolidated net loss of $12.4 million or $0.14 per common share for the first quarter ended March 31, 2019, as compared to a consolidated net loss of $15.5 million or $0.18 per common share for the first quarter ended March 31, 2018.

The loss for the first quarter ended March 31, 2019, reflected a reduction of $1.7 million in the estimated fair value of derivative warrant liabilities compared to an increase of $2.6 million in the estimated fair value of derivative warrant liabilities for the first quarter ended March 31, 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.

The loss before the change in estimated fair value of derivative warrant liabilities and income tax was $14.1 million for the first quarter ended March 31, 2019, compared to $12.9 million for the same period in 2018.

Research and development (“R&D”) expenses increased to $10.6 million for the first quarter ended March 31, 2019, compared to $8.9 million for the first quarter ended March 31, 2018. The increase in these expenses primarily reflected completion costs for the DES study and higher costs incurred for the AURORA 2 extension trial, the DDI study and the FSGS Phase 2a study as these studies had more activity in the first quarter ended March 31, 2019, compared to the same period in 2018.

Corporate, administration and business development expenses increased slightly to $3.9 million for the first quarter of 2019, compared to $3.8 million for the first quarter of 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 first quarter ended March 31, 2019, which are accessible on Aurinia’s website, on SEDAR or on EDGAR.

Aurinia will host a conference call and webcast to discuss the first quarter ended March 31, 2019, financial results today, Monday, May 13, 2019, at 4:30 p.m. ET. This event can be accessed on the investor section of the Aurinia website.

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 Allowance is 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

About LN

About FSGS

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 having data around the end of this year, completing NDA submissions in a successful and timely manner, voclosporin being potentially a best-in-class CNI with robust intellectual property exclusivity; 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 mid-2020 and that the efficacy endpoint clearly signals that VOS has the potential to have a more rapid onset than Restasis^® as measured by signs of the disease. 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 programs; that another company will not create a substantial competitive product for Aurinia’s LN and 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 LN or DES 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 AURORA clinical trial; difficulties we may experience in completing the development and commercialization of voclosporin; the market for the LN 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 or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website.

Aurinia Pharmaceuticals Inc. Interim Condensed Consolidated Statements of Financial Position (Unaudited)

Aurinia Pharmaceuticals Inc. Interim Condensed Consolidated Statements of Operations (Unaudited)

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

Dennis Bourgeault
Chief Financial Officer
dbourgeault@auriniapharma.com

Medexus Pharmaceuticals Announces Normal Course Issuer Bid

SOURCE: Medexus Pharmaceuticals Inc.

MONTREAL, May 14, 2019 — Medexus Pharmaceuticals Inc. (the “Company”) (TSXV: MDP, OTCQB: PDDPF) announced today it has submitted to the TSX Venture Exchange (the “Exchange”) a notice of its intention to make a normal course issuer bid (the “Bid”). Provided the Company receives the approval of the Exchange, the Company may purchase for cancellation, from time to time, as it considers advisable, up to 1,005,333 of its issued and outstanding common shares (“Shares”), being approximately 6.8% of the Company’s currently outstanding Shares and approximately 10% of the Company’s Public Float (as that term is defined in the policies of the Exchange) under the Bid. The Company may not purchase more than 2% of the issued and outstanding Shares during any 30 day period, which as of the date of this announcement represents 294,925 Shares.

Medexus has entered into an “automatic securities purchase plan” (as defined under applicable securities laws) with Canaccord Genuity Corp. (“Canaccord”) for the purpose of making purchases under the Bid (the “ASPP”). Such purchases will be determined by Canaccord in its sole discretion, without consultation with Medexus, having regard to the price limitation and aggregate purchase limitation and other terms of the ASPP and the rules and policies of the Exchange. Conducting the Bid as an ASPP allows Shares to be purchased at times when the Company would otherwise be prohibited from doing so pursuant to securities laws and its internal trading policies.

The maximum number of Shares to be purchased pursuant to the Bid represents approximately 10% of Public Float on the date hereof. Purchases of Shares will be made on the open market through the facilities of the Exchange or by other means as may be permitted by the Exchange (including through other published markets). The price that Medexus will pay for any Shares purchased by it will be the prevailing market price of the Shares on the Exchange at the time of such purchase. The actual number of Shares that may be purchased for cancellation and the timing of any such purchases will be determined by Canaccord in accordance with the ASPP.

It is anticipated that the Bid will commence on or about May 16, 2019 and will conclude on the earlier of (i) May 15, 2020, (ii) the date on which the Company has purchased the maximum number Shares to be acquired pursuant to the Bid, or (iii) the Company providing a notice of termination of the Bid to the TSX-V.

The Board of Directors of Medexus believes that the market price of the Shares may not fully reflect the underlying value of the Shares and that the proposed purchase of Shares would be in the best interests of the Company and is a desirable use of corporate funds. Such purchases will increase the proportionate interest of and may be advantageous to, all remaining shareholders of Medexus. In addition, the purchases by Medexus may increase liquidity to shareholders wishing to sell their Shares. All Shares purchased by the Company will be canceled.

About Medexus

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 Pharmaceuticals 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 prescription 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 it’s 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.

READER ADVISORIES

Forward-Looking Statements

This press release contains “forward-looking information” within the meaning of applicable securities legislation. Forward-looking information includes, but is not limited to, statements with respect to future business operation, including with respect to the expected growth of the Company’s pharmaceutical portfolio and pipeline. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the risk that the Company will not receive regulatory approvals in a timely manner or at all, the results of certain drug therapies and their impact on the Company’s profitability, the Company’s business plans, and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although Company believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because Company can give no assurance that they will prove to be correct. Since forward-looking information addresses future events and conditions, by its very nature they involve inherent risks and uncertainties. The Company’s actual results, performance or achievement could differ materially from those expressed in, or implied by, the forward-looking information and, accordingly, no assurance can be given that any of the events anticipated by the forward-looking information will transpire or occur, or if any of them do so, what benefits that Company will derive therefrom. Management has included the above summary of assumptions and risks related to forward-looking information provided in this press release in order to provide security holders with a more complete perspective on the Company’s future operations and such information may not be appropriate for other purposes. Readers should not place undue reliance on forward-looking statements. Readers are cautioned that the foregoing lists of factors are not exhaustive. Additional information on these and other factors that could affect the Company’s operations or financial results are included in reports on file with applicable securities regulatory authorities and may be accessed through the SEDAR website (www.sedar.com). The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake any obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.

G1 Therapeutics Provides First Quarter 2019 Corporate and Financial Update

Plans to submit U.S. and European marketing applications for trilaciclib following regulatory feedback
First clinical data on oral SERD G1T48 expected in 3Q19
Management to host webcast and conference call today at 4:30 p.m. ET

RESEARCH TRIANGLE PARK, N.C., May 09, 2019 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today provided a corporate and financial update for the first quarter ended March 31, 2019.

“Following meetings with regulatory authorities, we have clarity on a path to submitting marketing applications in the U.S. and Europe for trilaciclib based on existing data from our three trials in small cell lung cancer patients,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer. “Our goal is to make trilaciclib available to patients across the globe as quickly as possible and we are encouraged with regulators’ understanding of this new approach to protecting patients from the damaging effects of chemotherapy.”

Raj Malik, M.D., Chief Medical Officer added, “Trilaciclib is the first in a deep pipeline of clinical-stage programs with near-term data readouts expected. We anticipate presenting new data on our next two programs – lerociclib and G1T48 – later this year. Based on promising early results in our Phase 1 clinical trial of G1T48 in ER+ breast cancer, we plan to present proof-of-concept data in the third quarter.”

Clinical, Operational and Executive Team Updates

Plan to submit U.S. and European regulatory filings for trilaciclib: The company announced plans to submit marketing applications in the U.S. and Europe for trilaciclib for myelopreservation in small cell lung cancer (SCLC) based on written feedback from its end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and discussions with European regulatory authorities. G1 intends to file a New Drug Application (NDA) with the FDA in 2020 and submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) subsequent to an NDA filing. Full press release available here.
Executive team change: Jennifer Moses, who has been with the company for four years and most recently served as Vice President, Finance, has been appointed Chief Financial Officer. Barclay “Buck” Phillips, who had served as CFO and Senior Vice President, Corporate Development since 2017, departed the company to pursue other interests and opportunities.

First investor day presentation: The G1 management team provided a comprehensive overview of the company’s three clinical development programs and outlined the commercialization strategy for trilaciclib. External experts Jeffrey Crawford, M.D., Co-director, Solid Tumor Therapeutics Program, Duke Cancer Institute, and Lowell Hart, M.D., Scientific Director of Research, Florida Cancer Specialists and trilaciclib clinical trial investigator, discussed chemotherapy-induced myelosuppression and trilaciclib’s potential to protect the bone marrow from damage by chemotherapy and improve patient outcomes. The webcast is available on the G1 website here.

First Quarter 2019 Financial Highlights

Cash Position: Cash, cash equivalents and short-term investments totaled $347.8 million as of March 31, 2019, compared to $369.3 million as of December 31, 2018.
Operating Expenses: Operating expenses were $25.9 million for the first quarter of 2019, compared to $20.7 million for the first quarter of 2018. GAAP operating expenses include stock-based compensation expense of $3.8 million for the first quarter of 2019, compared to $1.6 million for the first quarter of 2018.
Research and Development Expenses: Research and development (R&D) expenses for the first quarter of 2019 were $18.1 million, compared to $17.3 million for the first quarter of 2018. The increase in expense was primarily due to an increase in clinical program costs and personnel costs due to additional headcount.
General and Administrative Expenses: General and administrative (G&A) expenses for the first quarter of 2019 were $7.8 million, compared to $3.4 million for the first quarter of 2018. The increase in expense was largely due to an increase in compensation due to headcount increase, increase in pre-commercialization activities and an increase in professional fees and other administrative costs necessary to support our operations as a public company.
Net Loss: G1 reported a net loss of $24.0 million for the first quarter of 2019, compared to $20.4 million for the first quarter of 2018.

Anticipated Milestones for 2019

Expect to complete pre-NDA meeting with the FDA.
Report additional data from all four randomized Phase 2 trilaciclib clinical trials.
Present proof-of-concept data from the Phase 1 clinical trial of G1T48, an oral selective estrogen receptor degrader (SERD), in ER+ breast cancer in Q3 2019.
Present preliminary dose-escalation data from the Phase 1b clinical trial of lerociclib/Tagrisso^® (osimertinib) in non-small cell lung cancer in Q3 2019.
Present additional data from the Phase 1b clinical trial of lerociclib/Faslodex^® (fulvestrant) in ER+, HER2- breast cancer in Q4 2019.

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 first quarter of 2019 ended March 31, 2019. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code:7988598. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. 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 and lerociclib are designed to enable more effective combination treatment strategies and improve patient outcomes across multiple oncology indications. 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.

G1 is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

Contact:

Jeff Macdonald
Head of Investor and Public Relations
919-213-9835
jmacdonald@g1therapeutics.com

G1 Therapeutics Q1 2019 Balance Sheet Data in the thousands — SOURCE: G1 Therapeutics

A Comparison of Micro-Ultrasound & Multiparametric MRI Imaging for Prostate Cancer: An International Meta-Analysis

This work compares mpMRI with high-resolution 29MHz micro-ultrasound imaging, which maintains the workflow, simplicity and low cost of ultrasound and can be used to target biopsies without the need for MRI.

Comparison of Micro-Ultrasound and Multiparametric MRI Imaging for Prostate Cancer: An International Meta-Analysis — Giovanni Lughezzani (1), Ander Astobieta (2), Frédéric Staerman (3), Eric Klein (4), Robert Abouassaly (4), Ahmed El-Shefai (4), Gregg Eure (5)
(1) Instituto Clinico Humanitas, Rozzano, Italy, (2) Urología Clínica, Clínica IMQ Zorrotzaurre, Spain, (3) Polyclinique Reims-Bezannes, Reims, France, (4) Glickman Urological Institute, Cleveland Clinic, Cleveland, USA, (5) Urology of Virginia, Virginia Beach, USA

Introduction & Objectives

Multi-parametric MRI (mpMRI) is growing as a screening approach for prostate cancer due to high sensitivity and negative predictive value. Unfortunately, implementation is complicated due to additional costs, complexity, learning curve, procedure time, and experience required for adequate interpretation and reproducible results. Many men are also contraindicated due to renal function, claustrophobia, or ferromagnetic implants.

Materials & Methods

280 subjects underwent prostate biopsy using the
ExactVu™ micro-ultrasound system (Exact Imaging, Markham, Canada) at 5 urological centers in the USA and Europe
Samples in all subjects were taken from:
- mpMRI targets (PI-RADS™ > 2, Cognitive fusion at 4 sites,
  software-assisted fusion at 1 site)
- Micro-ultrasound targets (PRI-MUS™, > 2)
- Up to 12 additional systematic samples filled in
Clinically significant cancer was considered any Gleason Sum > 6

Results

Micro-ultrasound provided superior sensitivity to mpMRI for detection
of csPCa (p=0.002).

mpMRI demonstrated strong sensitivity (83%), with slightly weaker NPV
(69%). Micro-ultrasound sensitivity (95%) and NPV (82%) were both
higher. However, micro-ultrasound was less specific (17% vs 25% for
mpMRI) and both modalities showed a relatively poor PPV of 43 and 44%.

Conclusions

Micro-ultrasound’s high sensitivity makes it an attractive option for
guiding targeted biopsy relative to the more widely studied mpMRI
The slightly lower specificity suggests micro-ultrasound is not yet able to exclude biopsy in as many men, though this is expected to improve as more information on benign variants becomes available

References

Ghai S, Eure G, Fradet V, et al: Assessing Cancer Risk on Novel 29 MHz Micro-Ultrasound Images of the Prostate: Creation of the Micro-Ultrasound Protocol for Prostate Risk Identification. J. Urol. 2016; 196: 562–569.
Astobieta et al. Initial results comparing 29 MHz micro-ultrasound with multi-parametric MRI for targeted prostate biopsy: Relative sensitivity to clinically significant prostate cancer. Eur Urol Suppl. 2018;17(2):e901.
Eure, et al. Comparison of Conventional TRUS, MRI and Micro-Ultrasound for Visualizing Prostate Cancer in an Active Surveillance Population. Can Urol Assoc J. 2018 Aug 30
Lughezzani et al. Comparison between the diagnostic accuracy of high resolution micro-ultrasound versus multiparametric MRI in the detection of prostate cancer: Preliminary results from a single-institutional ongoing prospective trial. Eur Urol Suppl. 2018;17(8):179.
Abouassaly, et al. Initial Results Comparing Micro-Ultrasound with MRI for Prostate Cancer Detection. ESUI 2018
Staerman. Initial Clinical Experience with 29 MHz Micro-Ultrasound for Real-Time Targeted Prostate Biopsies. ESUI 2018

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 at those areas. For the minority of cases where MRI might assist (i.e., prior negative biopsies), the FusionVu™ micro-US/MRI fusion application operates on the ExactVu micro-ultrasound platform and facilitates MRI fusion-based targeting. The ExactVu micro-ultrasound system including the FusionVu application have received regulatory approval in the European Union (CE Mark), the United States (FDA 510(k)) and Canada (Health Canada medical device license).

For further information, please contact:

Robert Sandler
SVP, Marketing
Exact Imaging
T. +1.416.274.8166
E. rsandler@exactimaging.com

Engage Therapeutics Presents Data from Part 1, Open-label Run-in of StATES Phase 2b Study of Staccato® Alprazolam at 2019 American Academy of Neurology Annual Meeting

8 patients with predictable generalized or focal epileptic seizures treated with Staccato alprazolam
62.5% of patients respond with the cessation of seizure activity within two minutes of therapy administration and no recurrence of seizure activity within two hours
Feasibility of both self-administration or caregiver-administration demonstrated
Enrollment of additional 115 patients in double-blind, placebo-controlled part 2 of the study underway

SUMMIT, N.J., May 6, 2019 /PRNewswire/ — Engage Therapeutics, Inc., a clinical stage biopharmaceutical company developing a Rapid Epileptic Seizure Termination (REST) therapy for people with epilepsy who experience a predictable pattern of seizures presented data from part 1 of its Phase 2b StATES Study (Staccato Alprazolam Terminates Epileptic Seizures) at the 2019 American Academy of Neurology (AAN) Annual Meeting on Sunday in Philadelphia.

Eight adult patients with either generalized or focal predictable seizures were enrolled and treated with a single dose of Staccato alprazolam, an investigational therapy that combines FDA-approved Staccato delivery technology with alprazolam, an FDA approved benzodiazepine, in the open-label, run-in portion of this two-part study. Outcome measures were safety, efficacy, pharmacokinetics, and feasibility of self- or staff-caregiver-administration. Highlights from the AAN 2019 poster, entitled, “A Two-Part, Double-Blind, Placebo-Controlled, Inpatient, Dose-Ranging Efficacy Study of
Staccato Alprazolam (STAP-001) in Patients with Epilepsy with a Predictable Seizure Pattern: Results from the Initial Open-Label Feasibility Part,” include:

Five of eight (5/8) or 62.5% of patients responded with the cessation of seizure activity within two minutes of treatment administration and no recurrence of seizure activity within two hours;
Responses were observed irrespective of seizure type, BMI or concurrent use of CYP450 inducers;
No serious or severe adverse events reported;
Study procedures for the administration of 1 mg Staccato alprazolam to patients with predictable seizures were deemed feasible;
The double-blind, part 2 portion of the study has initiated and will randomize 115 patients to one of two active arms (1 mg or 2 mg Staccato alprazolam) vs placebo.

“These encouraging data not only illustrate a potential efficacy signal for Staccato alprazolam in rapidly arresting seizures in patients with epilepsy but also support the safety and feasibility of administering this unique therapy to patients just as they begin to experience seizure activity,” said Jaqueline French, MD, the study’s principal investigator and professor in the Department of Neurology at NYU Langone Health’s Comprehensive Epilepsy Center, and founder/director of the Epilepsy Study Consortium. “Currently available seizure therapies are limited to preventing additional seizures, leaving patients with epilepsy in constant fear. A rescue therapy capable of rapidly aborting a seizure could alleviate that fear in many people.”

About the StATES Study
The multi-center StATES Study (Staccato Alprazolam Terminates Epileptic Seizures -NCT03478982) is a two-part phase 2b trial designed to evaluate the safety, efficacy, and usability of Staccato alprazolam in subjects with epilepsy who have a predictable seizure pattern. In addition to the eight patients enrolled in the open-label, part 1 portion of the study, up to 115 patients will be enrolled in part 2 of the study, double-blinded and randomized to one of two active arms (1 mg or 2 mg Staccato Alprazolam) vs placebo. The primary endpoint of the study is cessation of seizure activity within two minutes of treatment administration and no recurrence within two hours based on clinical observation. Additional endpoints include safety and tolerability, the severity of the seizures compared to a subject’s prior seizures, utilization of rescue medication and incidence of adverse events. The StATES study is being conducted at approximately 50 trial sites in the United States, Australia, Canada, and Jamaica. Please visit www.epilepsyhealthstudy.com for more information about the StATES study and www.engagetherapeutics.com/study-locations/ for a list of study locations.

About Staccato Alprazolam

Staccato alprazolam is a single-use, investigational epileptic seizure rescue therapy that combines the Staccato delivery technology, which is currently used in a U.S. Food and Drug Administration (FDA) approved product, with alprazolam, an FDA-approved benzodiazepine. It is a small, easy-to-use, hand-held inhaler that delivers alprazolam with a single breath potentially providing a way for people with epilepsy and their caregivers to stop an ongoing seizure. The Staccato system rapidly vaporizes alprazolam to form an aerosol, with particle size designed for deep lung delivery, producing
a rapid, systemic effect. In a phase 2a proof-of-concept study, Staccato alprazolam demonstrated rapid reduction of seizure-like activity in a photosensitivity model.

About Engage Therapeutics, Inc.

Engage Therapeutics is developing Staccato alprazolam for the immediate cessation of active and acute epileptic seizures. The investigational product is in the Rapid Epileptic Seizure Termination (REST) category of products. Engage Therapeutics is based in Summit, N.J.

Media Contact

Mark Theeuwes – mtheeuwes@engagetherapeutics.com

Related Articles

Engage Therapeutics Successfully Completes Open Label Portion of Phase 2b StATES Study and Begins Enrollment in Double-Blind Placebo-Controlled Portion

Engage Therapeutics Doses First Patient in Phase 2b Trial of Epilepsy Seizure Rescue Therapy Staccato Alprazolam

Zymeworks Announces Election of Directors and Voting Results from Shareholder Meeting

VANCOUVER, Canada–(BUSINESS WIRE)– Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, is pleased to announce the detailed voting results on the items of business considered at its Annual General Meeting of Shareholders held on May 2, 2019 (the “Meeting”).

Shareholder Voting Results

The Shareholders voted on the following matters at this year’s Meeting.

Proposal 1 – Election of Directors

The nominees listed in Zymeworks’ proxy statement dated March 18, 2019 (the “Proxy Statement”) were elected as Directors of the Company. Detailed results of the votes are set out below:

Proposal 1	Outcome of the Vote	Votes by Ballot
Election of Directors	Outcome of the Vote	Votes For	Votes Withheld
Kenneth Hillan	Carried	18,394,190 (99.92%)	14,339 (0.08%)
Natalie Sacks	Carried	18,395,416 (99.93%)	13,113 (0.07%)

Proposal 2 – Appointment of Auditors

The vote was carried for the Appointment of the Auditors, KPMG LLP. Detailed results of the votes are set out below:

Proposal 2	Outcome of the Vote	Votes by Ballot
	Outcome of the Vote	Votes For	Votes Withheld
Appointment of KPMG LLP	Carried	23,430,739 (99.88%)	28,799 (0.12%)

Full details of all proposals are fully described in the Proxy Statement available on the Company’s profile on SEDAR and on EDGAR and the detailed results of voting on each proposal are included in the Report of Voting Results filed on SEDAR and on EDGAR.

About Zymeworks Inc.

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics. The Company’s 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^TMbispecific antibody currently in Phase 2 clinical development. The Company’s 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^TM 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 multiple strategic partnerships with eight global biopharmaceutical companies.

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

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

Media Inquiries:
Angela Bitting
(925) 202-6211
a.bitting@comcast.net

Medexus Pharmaceuticals Launches New Dosage for Treatment of Rheumatoid Arthritis, Psoriasis & Psoriatic Arthritis in Canada

SOURCE: Medexus Pharmaceuticals Inc.

MONTREAL, May 7, 2019 — Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP, OTCQB: PDDPF), today announced the launch of a new Metoject^® Subcutaneous 15mg dose in Canada. Metoject Subcutaneous is a pre-filled syringe of methotrexate with a pre-attached subcutaneous needle that is approved in Canada for the treatment of rheumatoid arthritis, psoriasis, and psoriatic arthritis.

Metoject Subcutaneous 15mg is currently reimbursed by the Provinces of Saskatchewan, New Brunswick, Nova Scotia, and Newfoundland and Labrador through their provincial formularies, as well as the Yukon Non-Insured Health Benefits (NIHB) and Correctional Services Canada. As of May 1, 2019, Metoject Subcutaneous 15 mg is reimbursed in the Province of Ontario by the Ontario Drug Benefit Program (ODB). Metoject Subcutaneous 15 mg dose is in addition to the dosage strengths of 17.5mg, 20mg, 22.5mg, and 25mg currently offered in Canada by Medexus.

Ken d’Entremont, Chief Executive Officer of Medexus, commented, “The new 15mg dose of Metoject Subcutaneous is an important addition to the Metoject line in Canada, as it gives physicians more flexibility to accurately prescribe an appropriate strength for their patients, and offers patients a more convenient and comfortable option. We expect this dose to be a significant portion of our Metoject volume going forward.”

About Medexus

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

READER ADVISORIES

Forward-Looking Statements

This press release contains “forward-looking information” within the meaning of applicable securities legislation. Forward-looking information includes, but is not limited to, statements with respect to future business operation, including with respect to the expected growth of the Company’s pharmaceutical portfolio and pipeline. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the risk that the Company will not receive regulatory approvals in a timely manner or at all, the results of certain drug therapies and their impact on the Company’s profitability, the Company’s business plans, and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although Company believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because Company can give no assurance that they will prove to be correct. Since forward-looking information addresses future events and conditions, by its very nature they involve inherent risks and uncertainties. The Company’s actual results, performance or achievement could differ materially from those expressed in, or implied by, the forward-looking information and, accordingly, no assurance can be given that any of the events anticipated by the forward-looking information will transpire or occur, or if any of them do so, what benefits that Company will derive therefrom. Management has included the above summary of assumptions and risks related to forward-looking information provided in this press release in order to provide securityholders with a more complete perspective on the Company’s future operations and such information may not be appropriate for other purposes. Readers should not place undue reliance on forward-looking statements. Readers are cautioned that the foregoing lists of factors are not exhaustive. Additional information on these and other factors that could affect the Company’s operations or financial results are included in reports on file with applicable securities regulatory authorities and may be accessed through the SEDAR website (www.sedar.com). The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.

Bardy Diagnostics™ Selected as Winner of the Frost & Sullivan Award for Technology Innovation in Remote Cardiac Monitoring

BardyDx wins technology innovation award for North American remote cardiac monitoring

SEATTLE, May 7, 2019 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced it has been selected as the winner of the North American Remote Cardiac Monitoring Technology Innovation Award by Frost & Sullivan, a leader in global research and consulting solutions. BardyDx earned the distinction for its industry-leading advancements in remote cardiac monitoring led by its flagship product, the Carnation Ambulatory Monitor (“CAM™”), the only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device.

“Recognition of the CAM™ patch and our P-wave centric™ platform as a breakthrough in ECG monitoring is a direct reflection of our team’s dedication to developing and marketing inventive solutions that reveal the true message and meaning of a patient’s cardiac rhythm, messages that are frequently ignored or missed using existing technologies,” said Gust H. Bardy, MD, Founder and Chief Executive Officer of Bardy Diagnostics. “This prestigious honor recognizes our experience and our years of clinical and technical research, development, and innovation.”

Frost & Sullivan specifically praised the CAM™ patch’s pioneering advancements in engineering and design that have quickly become the industry standard for high fidelity ECG datasets including accurate and clear P-wave detection and recording. BardyDx was also recognized for its advances in artificial intelligence (AI)’s assistive role in enhancing human capabilities for analyzing and interpreting heart rhythms made possible, in part, by the CAM™ patch’s ECG signal quality. Frost & Sullivan also reported that the evolution towards BardyDx’s “augmented” intelligence is “achievable solely because of the CAM™ patch’s unique ability to accurately detect a broad array of arrhythmias, including those commonly mistaken for atrial fibrillation by commercially-available, R-wave focused automated detectors.”

Frost & Sullivan Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research to identify best practices in the industry.

“Overall, BardyDx’s thought leadership, unparalleled innovation, and disruptive potential have positioned it for greater adoption in the cardiac monitoring market,” said Kamaljit Behera, Industry Analyst at Frost & Sullivan.

This award builds upon the growing market recognition of the innovative P-wave centric CAM™ patch. Most recently, BardyDx was named the winner of the 2019 GeekWire Award in the Hardware of the Year category presented at the 11^th annual GeekWire Awards Ceremony held May 2, 2019. Hosted by GeekWire, a Seattle-based technology news site that provides national breaking news, expert analysis and unique insights into the evolving technology industry to a worldwide tech-savvy audience, the Awards honor stars of the Pacific Northwest startup and tech community each year. Also, BardyDx was recently named the winner of the Impact Pediatric Health Competition hosted by the nation’s leading pediatric healthcare institutions at SXSW 2019 for the CAM™’s unique pediatric-friendly design and potential to address significant unmet needs in pediatric healthcare. In addition, BardyDx was selected as the winner of the 2018 Fierce Innovation Life Sciences Award for Medical Device Innovation from the leading industry publisher of FierceBiotech & FiercePharma.

40^th Annual Heart Rhythm Scientific Sessions

BardyDx will be exhibiting at the 40^th Annual Heart Rhythm Scientific Sessions in San Francisco on May 8-10, 2019. Visit booth #2243 to learn about the CAM™ patch and the innovative P-wave centric platform.

About Frost & Sullivan:

Frost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today’s market participants. For more than 50 years, we have been developing growth strategies for the global 1000, emerging businesses, the public sector, and the investment community.

About Bardy Diagnostics:

Bardy Diagnostics, Inc. is an innovator in digital health and remote patient monitoring, with a focus on providing diagnostically-accurate and patient-friendly cardiac patch and other 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 design. Designed to be worn comfortably and discreetly, 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
Director, Marketing
Bardy Diagnostics, Inc.
1-844-422-7393
jwu@bardydx.com

Exact Imaging’s Abdominal Imaging Release Receives CE Mark Approval

SOURCE: Exact Imaging

New EV5C Abdominal Transducer and Color Flow and Power Doppler capabilities enable the ExactVu™ micro-ultrasound system to provide a complete men’s health urological imaging solution

TORONTO, CANADA — (May 7, 2019) Exact Imaging, the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, announced it has received CE Mark Approval for its Abdominal Imaging Release including its new EV5C Abdominal Transducer and Color Flow and Power Doppler capabilities. Operating on the ExactVu™ micro-ultrasound system, the EV5C Abdominal Transducer and Color Flow and Power Doppler capabilities allow urologists to perform complete urological ultrasound assessments including kidney examinations and biopsies, male pelvic and bladder examinations. The ExactVu™ system, which is the only urological ultrasound platform to operate both conventional as well as high resolution (29 MHz) transducers, now provides the ultimate “total men’s health” imaging solution. It can provide a complete abdominal urological ultrasound assessment of a patient as well as providing the fastest, simplest real-time targeting of prostate biopsies, while providing the highest real-time resolution for guidance for those prostate biopsies.

“We are thrilled to have received our CE mark approval for our Abdominal Imaging Release. The demand is significant for a urological imaging platform that merges the 70-micron resolution of the ExactVu™ micro-ultrasound system for real-time targeted prostate biopsies with the ability to provide a complete urological ultrasound assessment of a patient,” said Randy AuCoin, Exact Imaging’s President and CEO. “The goal is to provide urologists with the most flexible, innovative imaging solution to help urologists better diagnose urological disease. We believe this release helps to further establish the ExactVu™ platform as a most useful, cost-effective men’s health imaging solution.”

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 at 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 have received regulatory approval in the European Union (CE Mark), the United States (FDA 510(k)) and Canada (Health Canada medical device license). Regulatory approval for the EV5C Abdominal transducer and Color Flow and Power Doppler capabilities in the United States and Canada is pending.

Media Relations:

Rob Sandler
SVP, Marketing
Exact Imaging
T. +1.416.274.8166
E. rsandler@exactimaging.com
W. www.exactimaging.com

Aurinia Further Strengthens Its Board of Directors with the Appointment of Dr. Daniel Billen

Press Release: April 30, 2019

VICTORIA, British Columbia–(BUSINESS WIRE) — Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) (“Aurinia” or the “Company”), a clinical stage biopharmaceutical company focused on the global immunology market, today announced it has appointed Dr. Daniel Billen to its Board of Directors. Dr. Billen’s appointment is effective April 29, 2019 concurrent with the previously announced appointment of Mr. Peter Greenleaf as Chief Executive Officer and elevation of Dr. George Milne to Chairman of the Board.

“On behalf of the entire organization, it is a pleasure to welcome Daniel onto Aurinia’s Board of Directors. Throughout his career, Daniel has led the international growth of novel biopharmaceutical treatments for patients with debilitating kidney and inflammatory diseases, and we look forward to his strategic insight and guidance with the ongoing development of voclosporin,” commented Dr. George Milne, Chairman of the Board of Directors.

Dr. Billen has more than four decades of experience leading the commercialization of pharmaceutical and biotech products in North America and Europe. Prior to his retirement, Dr. Billen served as Vice President and General Manager, Inflammation and Nephrology at Amgen, from 2011 until 2018. Prior to that, Dr. Billen was General Manager, Amgen Canada, from 1991 until 2011. Dr. Billen previously served in roles of escalating responsibility at Janssen from 1979 until 1991. Dr. Billen received his Ph.D. in Chemistry from the University of Louvain, Belgium.

“Voclosporin represents a potentially significant advancement for patients with life-threatening kidney diseases, such as lupus nephritis,” commented Dr. Billen. “After years of admiring Aurinia’s development of voclosporin, it is an honour to now be joining the Board of Directors and helping to guide this exciting program toward commercialization.”

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 voclosporin, an investigational drug, for the potential treatment of LN, FSGS, and DES. The Company is headquartered 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 2,400 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

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 AURORA clinical trial; difficulties we may experience in completing the development and commercialization of voclosporin; the market for the LN business may not be as estimated; and regulatory authorities not granting approval for use of voclosporin in a commercial manner, or not granting patents or extensions for patents at all or as Aurinia currently anticipates. 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.

Investors Relations:
Glenn Schulman, PharmD, MPH
Corporate Communications
gschulman@auriniapharma.com

Media Relations:
Christopher Hippolyte, 212-364-0458
Christopher.Hippolyte@syneoshealth.com

Related Articles:

Aurinia Pharmaceuticals Inc. Announces New CEO and Board Director and Appoints New Chairman of the Board

Aurinia Receives Notice of Allowance from the US Patent and Trademark Office for Claims Directed to Its Novel Voclosporin Dosing Protocol for Lupus Nephritis

Zymeworks Reports 2019 First Quarter Financial Results

VANCOUVER, British Columbia–(BUSINESS WIRE) May 2, 2019– Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today reported financial results for the first quarter ended March 31, 2019.

“We are pleased to have advanced both of our lead assets to the next stages of clinical development; recently commencing a Phase 2 study for ZW25 and starting enrollment in the Phase 1 clinical trial for our antibody-drug conjugate, ZW49,” said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. “Accordingly, we have also exp

anded our leadership team, adding experienced executives with critical competencies needed to facilitate the development and approval of our clinical-stage assets. We believe we are now well-positioned to deliver on our ambitious clinical goals throughout 2019 and beyond.”

First Quarter 2019 Business Highlights and Recent Developments

Phase 2 Clinical Trial Begins for ZW25 in First-Line HER2 Expressing Metastatic Gastroesophageal Cancers

The Phase 2 trial is evaluating ZW25 in combination with standard of care (SOC) chemotherapy for the first-line treatment of HER2-positive metastatic gastroesophageal cancers. This trial is intended to support a potential first-line registrational trial and could position ZW25 as a new SOC.

Phase 1 ZW49 Clinical Study Open and Enrolling Patients

Enrollment is underway in the United States for the Phase 1 clinical trial of ZW49, Zymeworks’ novel bispecific HER2-targeted antibody-drug conjugate. The objectives of this study are to evaluate safety and early anti-tumor activity as well as establish a recommended dose for future clinical trials.

Three Experienced Development Executives Added to Management Team

Zymeworks expanded its leadership team and added key functional expertise to support the development of its maturing clinical pipeline. The newly created positions include Neil Josephson, M.D., Vice President, Clinical Research; Bruce Hart, Ph.D., Vice President, Regulatory Affairs; and Mark Hollywood, Senior Vice President, Technical and Manufacturing Operations.

Eli Lilly and Daiichi Sankyo Programs Advance Toward Clinical Testing

Zymeworks’ partner, Eli Lilly, filed an Investigational New Drug Application for its second Azymetric™ program, triggering a US$8.0 million payment to Zymeworks. In addition, Daiichi Sankyo recently exercised its option for a commercial license to an immuno-oncology bispecific built using Zymeworks’ Azymetric and EFECT™ platforms. Zymeworks will receive a US$3.5 million payment.

Financial Results for the Quarter Ended March 31, 2019

Revenue for the three months ended March 31, 2019 was $11.9 million as compared to $0.04 million in the same period of 2018. Revenue for 2019 includes an $8.0 million development milestone payment upon Lilly’s submission of an investigational new drug application, $3.5 million of recognized deferred revenue from our licensing and collaboration agreement with BeiGene, as well as $0.4 million in other research support payments. Revenue for the same period in 2018 was $0.04 million, consisting of research support payments.

For the three months ended March 31, 2019, research and development expenses were $17.5 million as compared to $13.1 million in the first three months of the prior year. The change was primarily due to an increase in clinical trial activity and associated drug manufacturing costs for ZW25, as well as an increase in other research and discovery activities as compared to the same period in 2018. Research and development expenses also included non-cash stock-based compensation expense of $1.1 million from equity classified equity awards and $0.4 million expense related to the non-cash mark-to-market revaluation of certain historical liability classified equity awards.

For the three months ended March 31, 2019, general and administrative expenses were $9.0 million as compared to $7.1 million in the first quarter of 2018. The change was primarily due to an increase in employee compensation expenses from increased head count in 2019 over 2018, including non-cash stock-based compensation, as well as other increases in professional fees associated with year-over-year corporate growth. General and administrative expenses included non-cash stock-based compensation expense of $1.5 million from equity classified equity awards and $1.3 million expense related to the non-cash mark-to-market revaluation of certain historical liability classified equity awards.

The net loss for the three months ended March 31, 2019, was $13.6 million as compared to $21.2 million in the same period of 2018. This was primarily due to increased revenue, interest income and 2018 warrant valuation expense, which was not relevant for 2019, that offset an increase in research and development expenses associated with our lead therapeutic candidates and other programs as well as general and administrative expenses.

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

As of March 31, 2019, Zymeworks had $180.3 million in cash and cash equivalents and short-term investments.

About Zymeworks Inc.

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics. The Company’s 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. The Company’s 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 multiple strategic partnerships with eight global 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, but are not limited to, statements that relate to potential payments and/or royalties payable to Zymeworks under its corporate agreements, the speed and outcome of drug development plans, ZW25’s ability to be approved and become a standard-of-care treatment for certain types of cancer, Zymeworks’ potential global growth, and other information that is not historical information. When used herein, words and phrases such as “enable”, “will”, “may”, “expect”, “anticipate”, “eligible to”, 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 March 31, 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.

Zymeworks Q1 2019 Condensed Interim Consolidated Statements of Loss (expressed in thousands of US dollars except share and per share data)

Zymeworks Q1 2019 selected condensed consolidated balance sheet data (expressed in thousands of US dollars)

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.

Zymeworks Q1 2019 GAAP to Non-GAAP Reconciliations (expressed in thousands of US dollars except share and per share data) - unaudited

Zymeworks Inc.

Investor Inquiries:

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

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

Media Inquiries:

Angela Bitting
(925) 202-6211
a.bitting@comcast.net

Related Articles:

Zymeworks Adds Experienced Executives to Management Team to Support Clinical Development

Investigational New Drug (IND)-Submission Milestone Achieved in Lilly Collaboration

Results from ExactVu™ Micro-Ultrasound Studies Featured Prominently at the American Urological Association’s (AUA) 114th Annual Meeting in Chicago, IL

Micro-Ultrasound and its Significant Clinical Benefits are Featured at the Largest Prostate Cancer Conference in 2 Clinical Talks, 5 Oral Presentations and Clinical Posters and a Skills Symposium

CHICAGO, IL — (May 3, 2019) Exact Imaging, the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, and its ExactVu™ micro-ultrasound system will be featured prominently at the 114^th Annual Meeting of the AUA (American Urological Association) in Chicago, IL from May 3 – 6, 2019. There will be a podium talk on the “High Resolution 29 MHz Micro-Ultrasound in the Diagnosis of Primary and Recurrent Prostate Cancer” (Session PD23-03) by Drs. Klotz and Woon (Sunnybrook Health Sciences Center, Toronto, CA) and a second podium talk on “A Multi-Institutional Randomized Controlled Trial Comparing Novel First Generation High-Resolution Micro-Ultrasound with Conventional Frequency Ultrasound for Transrectal Prostate Biopsy” (Session PD23-04) by Dr. Christian Pavlovich (Johns Hopkins University, Baltimore, USA), both on Saturday, May 4, 2019. A Skills Enhancement Workshop on “Targeted Prostate Biopsies using Micro-Ultrasound” on Sunday, May 5^th will feature the following 3 talks:

ExactVu™ Micro-Ultrasound for Targeted Prostate Biopsies: 2 Years of Clinical Experience and Growing Body of Clinical Evidence (Dr. Gregg Eure, Urology of Virginia, Virginia Beach, VA)
Comparison of Cancer Detection Rate of ExactVu™ Micro-Ultrasound vs. mpMRI/MRI Fusion (Dr. Rafael Sanchez-Salas, L’institut Mutualiste Montsouris (l’IMM), Paris, FR)
Significant Potential of 29 MHz Micro-Ultrasound for Urologic Imaging — and Potential for Personalized Treatment (Dr. Daniel Rukstalis, Wake Forest Baptist Health, Winston-Salem, NC)

In addition, the following 5 posters citing the clinical utility of the ExactVu™ micro-ultrasound system will also be presented at the conference:

Comparison of Cancer Detection Rates in Micro-Ultrasound Biopsies Versus Robotic Ultrasound-Magnetic Resonance Imaging Fusion Biopsies for Prostate Cancer
Oliver R. Claros et al., L’Institut Mutualiste Montsouris (IMM), Paris, FR

Comparison of Micro-Ultrasound and Multiparametric MRI Imaging for Prostate Cancer: An International Meta-Analysis
Giovanni Lughezzani et al., Instituto Clinico Humanitas, Rozzano, Italy

Diagnostic Accuracy of Targeted Prostate Biopsies: Results from a Prospective Trial Comparing Micro-Ultrasound with Multiparametric MRI for the Detection of Prostate Cancer
Davide Maffei et al, Humanitas Clinical and Research Center, Rozzano, Italy

Diagnostic Accuracy of the Novel 29 MHz Micro-Ultrasound “ExactVu™” for the Detection of Clinically Significant Prostate Cancer: A Prospective Single Institutional Study
Francesco Chessa et al, Università di Bologna, Bologna, Italy
A Prospective Validation of the Diagnostic Accuracy of PRI-MUS for Prostate Cancer Risk Identification
Dr. Ferdinand Luger et al., Ordensklinikum Linz, Barmherzige Schwestern Linz, Austria

Exact Imaging will also be exhibiting the ExactVu™ platform, along with the FusionVu™ application during the commercial exhibition in Booth #2111. The conference and exhibit will be held at the McCormick Place, Chicago, IL.

“The growing number of talks, posters and workshops on the ExactVu™ micro-ultrasound system reflects the utility and growing pervasiveness of micro-ultrasound as a leading tool for urologists worldwide to guide their targeted biopsies,” says Randy AuCoin, Exact Imaging’s President and CEO. “The ExactVu™ micro-ultrasound system provides the highest real-time resolution for targeted prostate biopsies. The results being presented from across our extensive network of customers shows the usefulness of the system for improving practitioners’ abilities to visualize and guide their targeted prostate biopsies and then follow treatment pathways”.

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 at 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 have received regulatory approval in the European Union (CE Mark), the United States (FDA 510(k)) and Canada (Health Canada medical device license).

For further information, please contact:

Rob Sandler
SVP, Marketing
Exact Imaging
T. +1.416.274.8166
E. rsandler@exactimaging.com
W. www.exactimaging.com

Related Articles:

Exact Imaging Wins “2019 Life Science Company of the Year” from Life Science Ontario (LSO)

Exact Imaging Announces Health Canada Approval for its FusionVu™ Application for MicroUltrasound/MRI Fusion

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

SOURCE: OPSENS Inc.

QUEBEC CITY, April 30, 2019 /CNW Telbec/ – Opsens Inc. (“Opsens” or the “Company”) (TSX: OPS) (OTCQX: OPSSF) is pleased to announce it has entered into a supply agreement as part of its long-term collaboration with Abiomed, Inc. (“Abiomed”) for the Impella CP® heart pump.

Abiomed has awarded Opsens a five-year agreement to supply a critical component for its heart pump technology. The contract includes mutual renewal clauses. This new agreement between Opsens and Abiomed follows a co-development and license agreement to integrate Opsens’ miniature optical pressure sensor into Impella CP® heart pumps, signed in 2014.

“We are pleased to significantly expand our collaboration with Abiomed and the integration of our optical technology into the widely used Impella CP® in the United States. This partnership clearly highlights the benefits of our optical technology for cardiac applications and demonstrates the accuracy of our measurement technology as well as the quality of our manufacturing capabilities,” said Louis Laflamme, President and CEO of Opsens.

“The continued development of our original equipment manufacturer (OEM) business segment is strategically important for Opsens,” adds Laflamme. It increases the critical mass in manufacturing, further advancing the company’s improvement initiatives. This agreement allows Opsens to capitalize on the work done with Abiomed in recent years and highlights the quality of its offer to the interventional cardiology market globally.

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 60,000 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.

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:

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

Robin Villeneuve, CPA, CA, Chief Financial Officer, 418.781.0333

Related Article: Opsens Q2 2019 Revenues Reach a Record Level

Zymeworks Adds Experienced Executives to Management Team to Support Expanding Clinical Development

VANCOUVER, British Columbia / BUSINESSWIRE/ Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced it has expanded its leadership team with the hiring of three new vice presidents to support the Company’s expanded global clinical development: Mark Hollywood, Senior Vice President, Technical and Manufacturing Operations; Neil Josephson, M.D., Vice President, Clinical Research; and Bruce Hart, Ph.D., Vice President, Regulatory Affairs. Zymeworks has also promoted David Poon, Ph.D., to Vice President, Business Development and Alliance Management.

“Adding these seasoned professionals to our leadership team further expands the critical expertise required to advance our promising therapeutic candidates,” said Ali Tehrani, Ph.D., President and Chief Executive Officer of Zymeworks. “These highly skilled individuals complement the team already in place as we work to bring new medicines to patients. With an expanding portfolio of clinical trials, increasing interaction with regulatory agencies, and scaling-up production of clinical materials, they will be able to make immediate and meaningful contributions to our accelerated development efforts.”

Senior Vice President, Technical and Manufacturing Operations

As Zymeworks’ Senior Vice President, Technical and Manufacturing Operations, Mr. Hollywood will be responsible for the manufacturing, quality, and regulatory compliance of Zymeworks’ lead assets as they advance towards potential commercialization. Mr. Hollywood brings 25 years of experience in the biopharmaceutical industry, most recently as Vice President and Head of ZymoGenetics, Inc. (a Bristol-Myers Squibb company) where he had overall management responsibility and led the business in supporting biologics portfolio deliverables including technical and manufacturing operations for development and commercial-stage programs.

Vice President, Clinical Research

As Vice President, Clinical Research, Dr. Josephson will lead the advancement of Zymeworks’ clinical pipeline as the Company prepares for the expansion of ZW25 into Europe and into the Asia-Pacific region with our recent partner BeiGene, Ltd., as well as the acceleration of clinical activities for ZW49. Before joining Zymeworks, Dr. Josephson was a Vice President of Clinical Development at Seattle Genetics, Inc. where he worked on multiple early and late-stage programs, including leading the front-line approval of ADCETRIS® for the treatment of Hodgkin’s lymphoma.

Vice President, Regulatory Affairs

As Vice President, Regulatory Affairs, Dr. Hart will be responsible for leading Zymeworks’ regulatory activities as the Company progresses into later stages of clinical development and expands development opportunities worldwide. Dr. Hart brings over 20 years of regulatory affairs experience, including 15 years at Seattle Genetics where he led the buildout of the regulatory affairs team and served as the regulatory lead for ADCETRIS® from the initiation of clinical testing through FDA approval.

Vice President, Business Development and Alliance Management

As Vice President, Business Development and Alliance Management, Dr. Poon will continue to be responsible for expanding Zymeworks’ strategic partnerships for therapeutic programs and platform technologies. Dr. Poon has held positions of increasing responsibilities during his 11-year tenure at Zymeworks and has been instrumental in establishing its strategic pharma and academic partnerships and collaborations, as well as overseeing competitive intelligence and alliance management.

For detailed biographies of the Zymeworks management team visit: https://ir.zymeworks.com/Management

About Zymeworks Inc.

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics. The Company’s 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. The Company’s 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 multiple strategic partnerships with eight global biopharmaceutical companies.

Zymeworks 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 the advancement of Zymeworks’ therapeutic candidates and assets through clinical development to commercialization, Zymeworks’ ability to bring new medicines to patients, the geographic expansion of Zymeworks’ activities, the potential for worldwide development opportunities, future contributions by the new Vice Presidents and other information that is not historical information. When used herein, words and phrases such as “advance”, “will,” “work to,” “progresses into” 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’ Annual Report on Form 10-K for its year ended December 31, 2018 (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.

Contacts

Investor Inquiries:

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

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

Media Inquiries:

Angela Bitting
(925) 202-6211
a.bitting@comcast.net

G1 Therapeutics Announces Positive Feedback from Trilaciclib End-of-Phase 2 Meeting with FDA; Expects to File NDA in 2020

Research Triangle Park, N.C., April 29, 2019 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today provided a regulatory update on trilaciclib, a first-in-class myelopreservation agent designed to protect the bone marrow from damage by chemotherapy and improve patient outcomes.

Based on written feedback from its end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and discussions with European regulatory authorities, the company plans to submit marketing applications in the U.S. and Europe for trilaciclib for myelopreservation in small cell lung cancer (SCLC). These submissions will be based on currently available data from three randomized, double-blind, placebo-controlled SCLC clinical trials, as well as safety data collected across all completed and ongoing clinical trials.

“We are pleased with the feedback from our recent meetings with regulatory authorities. We look forward to continuing a collaborative dialogue regarding the marketing applications, as well as discussing further clinical development of trilaciclib,” said Raj Malik, M.D., Chief Medical Officer. “We believe trilaciclib represents an important advance in the care of SCLC patients. We will also move forward with a robust development program to evaluate trilaciclib in multiple tumor types and chemotherapy regimens.”

G1 will request a pre-New Drug Application (NDA) meeting with the FDA and anticipates it will be scheduled later this year. The company will provide further details regarding the NDA submission and timeline following that meeting. The company plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) subsequent to an NDA filing.

Chemotherapy is an effective and important weapon against cancer. However, chemotherapy does not differentiate between healthy cells and cancer cells and kills both, including important stem cells in the bone marrow that produce white blood cells, red blood cells and platelets. This chemotherapy-induced bone marrow damage is known as myelosuppression. When white blood cells, red blood cells and platelets become depleted, chemotherapy patients are at increased risk of infection, experience anemia and fatigue, and are at increased risk of bleeding. Myelosuppression often requires the administration of rescue interventions such as growth factors and blood or platelet transfusions, and may also result in chemotherapy dose delays and reductions.

“In clinical trials, trilaciclib demonstrated the ability to protect bone marrow from chemotherapy damage and meaningfully reduced the need for supportive care interventions, such as G-CSF and transfusions,” said Jared Weiss, M.D., Associate Professor, University of North Carolina Lineberger Comprehensive Cancer Center, and trilaciclib clinical trial investigator. “By providing a proactive approach to reduce myelosuppression, trilaciclib improves the patient experience during chemotherapy treatment, reducing side effects and the need for associated interventions commonly given to treat them.”

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 and lerociclib are designed to enable more effective combination treatment strategies and improve patient outcomes across multiple oncology indications. 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.

Contact:
Jeff Macdonald
Head of Investor Relations/Public Relations
919-907-1944
jmacdonald@g1therapeutics.com

Forbius’ AVID200, a Novel TGF-beta 1 & 3 Inhibitor, Cleared by Health Canada to Commence Phase 1 Clinical Trial in Solid Tumors

SOURCE: Forbius

Expansion of ongoing AVID200 Phase 1 solid tumor trial to include patients at clinical sites in Canada
AVID200 is a rationally designed, highly potent inhibitor of TGF-beta 1 & 3, the principal oncogenic TGF-beta isoforms
Best-in-class efficacy and safety potential by selectively targeting TGF-beta 1 & 3 while sparing TGF-beta 2, the isoform that promotes normal cardiac function

Austin, TX, and Montreal, QC (Apr. 29, 2019) – Forbius, a clinical-stage company that develops novel biologics for the treatment of cancer and fibrosis, announced that it has received a no objection letter from Health Canada for its clinical trial application (CTA) to conduct a Phase 1 trial in solid tumors with immuno-oncology candidate AVID200, a rationally designed and highly potent inhibitor of TGF-beta 1 & 3.

AVID200-03 (NCT03834662) is a Phase I, open-label, dose-escalation trial to establish the recommended phase 2 dose (RP2D) of AVID200 in patients with advanced or metastatic malignancies. The trial is currently enrolling patients at centers in the U.S. and will now be expanded to additional clinical sites in Canada to recruit a total of up to 36 patients.

TGF-beta 1 & 3 are the main oncogenic TGF-beta isoforms expressed by many solid tumors and represent promising immuno-oncology targets. These TGF-beta isoforms are implicated in T-cell suppression, fibrosis in the tumor microenvironment, and resistance to immunotherapeutics such as nivolumab (Opdivo) and pembrolizumab (Keytruda) (Chakravarthy et al., Nature Comm., 2018; Tauriello et al., Nature, 2018; Mariathasan et al., Nature, 2018).

About AVID200 and the AVID200-03 Trial

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 older-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 designs and develops novel biologics for the treatment of fibrosis and cancer. Our current focus is the development of agents targeting the transforming growth factor-beta (TGF-beta) and epidermal growth factor receptor (EGFR) pathways.

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Claudia Resch, info@forbius.com

Edesa Biotech Receives Approval from Health Canada for Clinical Study

Related Article: Zymeworks Reports 2019 First Quarter Results

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About AVID100 and the AVID100-01 Trial

About Forbius: Targeting TGF-beta and EGFR Pathways in Fibrosis and Cancer

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Introduction & Objectives

Materials & Methods

Results

Conclusions

References

New EV5C Abdominal Transducer and Color Flow and Power Doppler capabilities enable the ExactVu™ micro-ultrasound system to provide a complete men’s health urological imaging solution

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