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

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

– Jason Hanson, President and CEO, enGene

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Working Capital

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

Calendar

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

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

About Edesa Biotech, Inc.

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

Edesa Forward-Looking Statements

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

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

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

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

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

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

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

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

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

About Aurinia Pharmaceuticals

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

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

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

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

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

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

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

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

Updated Findings

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

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

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

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

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

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

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

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

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

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

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

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

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

ABOUT AURINIA

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

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

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

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

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

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

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

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

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

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

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

– Peter Greenleaf, President and Chief Executive Officer, Aurinia

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

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

Related Article: Aurinia Pharmaceuticals Completes Voclosporin Study

About AURORA

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

About AURORA 2 Extension

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

About Voclosporin

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

About Lupus Nephritis

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

About Aurinia

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

Forward-Looking Statements

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

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

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

We seek safe harbour.

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

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

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

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

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

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

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

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

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

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

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

About Edesa Biotech, Inc.

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

Edesa Forward-Looking Statements

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

Media Contact:

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

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

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

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

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

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

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

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

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

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

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

About Bright Angel Therapeutics

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

Media Contact

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

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

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

Q2 2020 Financial highlights^*:

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

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

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

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

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

Operational highlights:

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

Operating and Financial Results Summary

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

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

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

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

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

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

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

Conference Call Details

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

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

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

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

About Medexus Pharmaceuticals Inc.

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

For more information, please contact:

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

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

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

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

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

Cautionary Note Regarding Comparative Financial Information

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

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

Forward-Looking Statements

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

Non-IFRS Financial Measures

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

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

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

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

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

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

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

ZW25 Clinical Results Presented Today

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

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

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

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

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

About the Phase 1 Clinical Trial

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

About ZW25

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

About Zymeworks Inc.

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

Cautionary Note Regarding Zymeworks’ Forward-Looking Statements

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

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

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

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

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

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

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

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

Highlights include:

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

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

– Dr. Katrin Leadley, Chief Medical Officer, Endotronix

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

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

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

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

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

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

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

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

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

Voclosporin for Lupus Nephritis (“LN”)

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

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

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

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

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

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

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

Financial Liquidity at September 30, 2019

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

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

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

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

Third Quarter 2019 Financial Results

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

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

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

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

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

Financial Results for Nine Months Ended September 30, 2019

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

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

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

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

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

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

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

Related Article: Aurinia Releases Q2 2019 Financial Results

About Aurinia

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

About Voclosporin

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

About VOS

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

About LN

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

About FSGS

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

About DES

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

Forward-Looking Statements

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

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

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

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

Highlights For the Quarter and The Year

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

Growth Strategy

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

Financial Results – Year Ended August 31, 2019

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

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

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

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

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

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

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

About Opsens Inc.

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

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

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

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

-30-

For further information, please contact:

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

Robin Villeneuve, CPA, CA Chief Financial Officer, 418.781.0333

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

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

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

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

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

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

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

About Aurinia

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

About Voclosporin

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

Forward-Looking Statements

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

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

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

Investor & Media Contacts:

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

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

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

– John Kollins, President & CEO, Satsuma Pharmaceuticals

Third Quarter 2019 Business Highlights:

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

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

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

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

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

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

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

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

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

Financial Results for Third Quarter 2019

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

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

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

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

About Satsuma Pharmaceuticals and STS101

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

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

Cautionary Note on Forward-Looking Statements

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

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

INVESTOR AND CORPORATE CONTACTS:            

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

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

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

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

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

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

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

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

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

– Ilia Tikhomirov, CEO of Forbius 

About TGF-beta 1 & 3

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

About AVID200 and the AVID200-03 Trial (NCT03834662)

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

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

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

About Forbius

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

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

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

Media Contact

Claudia Resch
info@forbius.com

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

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

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

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

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

– Louis Laflamme, President and Chief Executive Officer, Opsens

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

See Opsens’ PP presentation

About Opsens Inc.

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

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

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

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

For further information, please contact:

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

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

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

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

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

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

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

– Peter Greenleaf, Chief Executive Officer, Aurinia Pharmaceuticals

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

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

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

About Aurinia

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

About Voclosporin

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

Forward-Looking Statements

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

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

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

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

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

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

Third Quarter 2019 Business Highlights and Recent Developments

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

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

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

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

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

Financial Results for the Quarter Ended September 30, 2019

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

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

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

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

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

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

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

Related Article: Zymeworks Releases Q2 2019 Financial Results

NON-GAAP FINANCIAL MEASURES

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

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

About Zymeworks Inc.

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

Cautionary Note Regarding Zymeworks’ Forward-Looking Statements

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

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

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

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

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

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

– Louis Laflamme, President and Chief Executive Officer

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

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

– Louis Laflamme, President and Chief Executive Officer

Related Article: Opsens Releases Promising Q3 2019 Financials

About Opsens Inc.

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

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

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

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

For Investor or Media Inquiries, contact:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Third Quarter Regulatory and Clinical Highlights

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

Third Quarter 2019 Financial Highlights

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

Anticipated Milestones

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

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

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

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

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

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

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

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

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

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

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

– Jennifer Fraser, Director Innovations at the University of Toronto

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

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

– Dr. Rafi Hofstein, President & CEO of TIAP

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

– Dr. Michael May, President and CEO of CCRM

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

– Dr. Benjamin Rovinski, Managing Director of Lumira Ventures

About TIAP

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

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

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

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

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

Investment & Media-Related Contacts:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

About Aurinia

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

About Voclosporin

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

About Voclosporin ophthalmic solution (VOS)

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

About DES

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

Forward-Looking Statements

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

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

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

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

BOSTON — Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announces the first data from its Phase 1 study evaluating novel bispecific antibody ZW25 in combination with chemotherapy in HER2-expressing gastroesophageal adenocarcinoma (GEA) in a poster presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 26 – 30 in Boston.

“Today we report the promising anti-tumor activity of ZW25 in combination with chemotherapy for people with HER2-expressing GEA. These results compare favorably with the current standard of care treatments for patients who have progressed after first-line therapies, including trastuzumab and chemotherapy. The data further support the prioritization of our ongoing Phase 2 trial of ZW25 plus chemotherapy as a first-line treatment for GEA and our goal of establishing ZW25 as the new best-in-class therapy for people with HER2‑expressing cancers.”

– Diana Hausman, M.D., Chief Medical Officer at Zymeworks

The FDA has granted Fast Track designation to ZW25 for first-line HER2-positive GEA in combination with standard of care chemotherapy, and a Phase 2 trial evaluating combination treatment in this setting is actively enrolling patients (NCT03929666).

“The patients in this Phase 1 study have a difficult-to-treat, advanced stage of cancer, which has progressed despite multiple prior therapies. The preliminary activity and tolerability of ZW25 combination treatment with paclitaxel or capecitabine brings hope to these patients and warrants further investigation in a first-line setting.”

– Funda Meric-Bernstam, M.D., Professor and Chair of the Department of Investigational Cancer Therapeutics and Medical Director of the Institute for Personalized Cancer Therapy at The University of Texas MD Anderson Cancer Center

Clinical Data Presented Today

The results from part three of an ongoing Phase 1 study present the safety and efficacy of ZW25, at the recommended dose of 20 mg/kg every other week, in combination with paclitaxel or capecitabine as a treatment for 14 patients with heavily pretreated HER2-expressing GEA. Patients received a median of 2.5 prior systemic therapies, and 93% had progressed following trastuzumab treatment.

Nine of 14 patients were response-evaluable. Overall, the majority of patients experienced a decrease in their target lesions with a disease control rate of 78%, comprising five (56%) partial responses and two (22%) stable disease. These responses were observed in both low and high HER2-expressing GEA. At the time of the data cut-off, four of the five partial responses had been confirmed, and five (56%) response-evaluable patients were still on study.

The overall safety profile of ZW25 plus chemotherapy was similar to that seen with chemotherapy alone. The most common treatment-related adverse events (TRAE) occurring in two or more patients were primarily Grade 1 or 2 and manageable with symptomatic treatment. Of the TRAE occurring in two or more patients, Grade 3 or higher events attributed to ZW25 and/or chemotherapy were fatigue and neutropenia (2 patients each) and stomatitis, peripheral neuropathy, and hypokalaemia (1 patient each). Five patients had chemotherapy dose reductions due to TRAEs, but no patients needed ZW25 dose reductions due to adverse events.

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

About the Phase 1 Clinical Trial

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

About ZW25

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

About Zymeworks Inc.

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

Cautionary Note Regarding Zymeworks’ Forward-Looking Statements

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

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

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

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

SEATTLE /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that it was selected as winner of the “Remote Monitoring in Arrhythmias” Technology and Innovation Pitch Session held as part of the Digital Health program at the European Society of Cardiology (ESC) Congress 2019. BardyDx earned this distinction for its Carnation Ambulatory Monitor (CAM™), the only P-wave centric™ ambulatory cardiac patch monitoring and arrhythmia detection device.

The pitch event was held on the Digital Health Stage as part of ESC’s focus on highlighting innovative technological applications in the field of e-cardiology and how they are impacting research and clinical practice, including wearable devices, mobile apps, electronic health records, and big data. Over a dozen pitch session events provided selected applicants the opportunity to present on their digital health technology, including categories in artificial intelligence, m-health, wearables, and remote monitoring.

“It is an honor for the CAM patch to be chosen and recognized as one of the best remote cardiac monitoring solutions from among those presenting by an audience of pioneering cardiac physicians and industry thought leaders. We are committed to providing optimal P-wave focused digital health solutions that inform the modern-day cardiology practice.” 

– Ken Nelson, BardyDx Chief Commercial Officer

In addition, BardyDx Founder and Chief Executive Officer, Gust H. Bardy, MD was invited to speak at Heart Rhythm Congress (HRC) 2019 held at The International Convention Centre in Birmingham, UK. As part of the AF Association Symposia’s “Management of Atrial Fibrillation” Session, Dr. Bardy’s presentation, “The importance of P-Wave centric ECG monitoring analysis,” highlighted the significance of high-fidelity ECG tracings in accurate arrhythmia diagnosis and treatment decisions.

The CAM patch has experienced strong commercial demand due to its proprietary and innovative P-wave centric digital health platform, which provides clinicians diagnostically-accurate data recognized as superior to other patch and Holter monitoring technologies. Also, the CAM patch recently received 510(k) clearance by the U.S. Federal Drug and Administration to extend monitoring duration up to 14 days. The growing market recognition of the innovative P-wave centric CAM patch includes recently being named finalists for the UCSF Digital Health Awards for Best Cardiovascular Digital Diagnostic and the Medtech Insight Awards for Best Technological Diagnostic Innovation & Best Proof-of-Value of an Innovation. Earlier this year, BardyDx was also named the winner of the 2019 MedTech Breakthrough Award for Best New Diagnostic Technology and the winner of the 2019 Frost & Sullivan Award for Technology Innovation in Remote Cardiac Monitoring.

About Heart Rhythm Congress

The Heart Rhythm Congress (HRC) 2019 was held in Birmingham, UK during October 6-9^th. Organized by Arrhythmia Alliance, HRC provides unrivaled opportunity for health care professionals interested in the management of arrhythmias to share effective practice, showcase innovation, learn about the latest developments and network with UK & international delegates.

About European Society of Cardiology Congress

The European Society of Cardiology (ESC) Congress 2019 was held in Paris during August 31st to September 4th. This year’s special edition of ESC Congress was held in conjunction with the World Congress of Cardiology with a spotlight on Global Cardiovascular Health, highlighting differences in prevalence, clinical manifestations, prevention strategies, diagnostic modalities and management of cardiovascular diseases around the world. The congress focuses on the best and latest science with renowned leaders in cardiovascular medicine. The five-day conference showcased over 500 sessions with an estimated 30,000 delegates – the largest such gathering in the world.

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

TORONTO / Accesswire / – Edesa Biotech, Inc. (Nasdaq: EDSA), a clinical-stage biopharmaceutical company, today announced that the first patient has been enrolled in a Phase 2b clinical trial evaluating the Company’s lead product candidate, EB01, as a monotherapy for patients with moderate to severe chronic allergic contact dermatitis (ACD). The U.S. Food and Drug Administration recently approved Edesa’s clinical protocol and provided a “safe to proceed” letter, which formally authorized the company to begin its clinical investigation.

In the first cohort, ACD patients will be treated for 28 days with EB01 cream, an investigational medicine that contains a non-steroidal anti-inflammatory compound known as a sPLA2 inhibitor. The adaptive-designed study will primarily evaluate the safety and efficacy of EB01 in ACD patients. Investigators will also evaluate symptom reduction, quality of life and dose-relationships among various strengths of EB01 cream as secondary and exploratory measures. Edesa plans to perform a blinded interim analysis following the completion of the first cohort to determine the total number of patients for the second part of the study.

“Initiating this study brings us one step closer to providing new options for patients with ACD, especially for those patients coping with side effects and limitations of current treatments. We believe that addressing the inflammation cascade at its inception represents a potentially innovative approach to treating ACD and other inflammatory diseases and we look forward to sharing our progress.”

– Dr. Par Nijhawan, Chief Executive Officer of Edesa

Contact dermatitis, which can be either irritant contact dermatitis or ACD, is one of the most common occupational health illnesses in the United States. The disease has been estimated to cost up to $2 billion annually as a result of lost work, reduced productivity, medical care and disability payments. Edesa estimates that there are more than 2.5 million people in the U.S. with allergic contact dermatitis, with academic literature pointing to a potentially larger undiagnosed population. More than one million patients are estimated to have chronic ACD. There are currently no treatment options specifically indicated for ACD.

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

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

Related Article: Edesa Biotech Receives Approval from Health Canada for Clinical Study

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 expands its portfolio with assets that can drive long-term growth opportunities. The company is based in Markham, Ontario, Canada, with U.S. offices in Southern California.

Edesa Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions, including statements related to: the company’s plans to perform a blinded interim analysis following the completion of the first cohort and its belief that the study brings it closer to providing new options for patients with ACD. 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.

VANCOUVER, British Columbia — Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announced the appointment of Kathryn O’Driscoll to the executive team as Chief People Officer (CPO).

Ms. O’Driscoll brings over 20 years of experience as an executive-level human resources leader across large global organizations in the technology and non-profit sectors. In her new role as Zymeworks’ CPO, she will be responsible for growing and developing its highly diverse and skilled workforce.

“As Zymeworks becomes a later stage biotechnology company and expands its operations across the United States and Canada, Kathy will be instrumental in recruiting and supporting the very best talent to further strengthen our innovative, patient-centric culture. She brings a wealth of experience building and managing innovative teams rooted in a strong corporate culture at high-growth organizations like Microsoft, PATH, and Snowflake, which will serve our growing demands as we move closer to commercialization.”

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

Ms. O’Driscoll has held various senior people-centric roles at Microsoft, including within the Server and Tools Business, which consisted of more than 11,000 employees and generated $13 billion in revenue. Most recently, she served as Vice President of People at Snowflake, a top cloud computing company where she led the development and implementation of people growth strategies and operations worldwide. Formerly she was the Vice President and Chief Human Resources Officer at PATH, an international leader in global health innovation, where she led a human resources team that had an impact in over 50 countries.

Related Article: Lota Zoth Succeeds Nick Bedford as Zymeworks’ Board of Directors

About Zymeworks Inc.

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

Cautionary Note Regarding Zymeworks’ Forward-Looking Statements

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

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

VICTORIA, British Columbia–(BUSINESS WIRE) — Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today reported that the last patient study visit has occurred in the AURORA Phase 3 lupus nephritis (“LN”) study. Efficacy and safety results from AURORA remain on track to be reported by the end of the fourth quarter 2019.

“With the completion of patient visits in the AURORA study, we now look forward to reporting out the efficacy and safety results by the end of this year. I am extremely grateful for the team’s dedication and commitment as we now work towards database lock, data review, disclosure of the results, followed by the necessary preparations to submit an NDA for voclosporin during the first half of 2020.”

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

The Company also reported today that, further to its Open Market Sale Agreement with Jefferies LLC previously announced on September 13, 2019, in relation to at-the-market (“ATM”) offerings of common shares, the Company has completed the sale of 2,343,750 common shares at a weighted average price of US$6.40 for aggregate gross proceeds of approximately US$15 million. The Company does not intend to conduct further sales pursuant to the ATM at this time.

“This is an extraordinarily exciting time at Aurinia as we await the results from AURORA, and in parallel, build and prepare the organization by ensuring that we are strategically, operationally, and financially prepared for positive results and the planned NDA submission for voclosporin as a first-line treatment in combination with standard of care for LN.”

– Peter Greenleaf, President and Chief Executive Officer, Aurinia

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

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

Related Article: Aurinia Pharmaceuticals Enters into Agreement with Jeffereies LLC.

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 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: results from AURORA being available in the fourth quarter of 2019; the Company’s intention not to conduct further sales pursuant to the ATM at this time; AURORA II providing valuable insights into the long‑term efficacy and safety of voclosporin as a potential new treatment for lupus nephritis; VOS having IP protections until 2031; voclosporin being potentially a best-in-class CNI with robust intellectual property exclusivity; Aurinia’s anticipation that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension; that the new Notice of Allowance is expected to result in the issuance of a U.S. patent with a term extending to December 2037; that if the FDA approves the use of voclosporin for LN and the label for such use follows the dosing protocol under the Notice of Allowance, the issuance of this patent will expand the scope of intellectual property protection for voclosporin to December 2037. It is possible that such results or conclusions may change based on further analyses of these data. Words such as “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may” and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: another company will not create a substantial competitive product for Aurinia’s LN, DES and FSGS business without violating Aurinia’s intellectual property rights; and Aurinia being able to extend and protect its patents on terms acceptable to Aurinia. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: difficulties, delays, or failures we may experience in the conduct of our clinical trial; 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.

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

TORONTO, CANADA — Exact Imaging, the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, announces it has received FDA 510(k) clearance for its Sterile Transperineal Needle Guide for use with Exact Imaging EV29L transducer. Operating on the ExactVu micro-ultrasound system, the Sterile Transperineal Needle Guide now allows urologists to perform targeted prostate biopsies leveraging the near microscopic resolution of the micro-ultrasound for transperineal-based biopsies.  The ExactVu system provides the highest real-time resolution for guidance of prostate biopsies and may now be used in procedures that use transperineal approaches for prostate biopsies.

Related Article: Exact Imaging Receives CE Mark Approval

“There is increasing movement towards transperineal-based prostate biopsies as an option to reduce the risk of infection. With FDA 510(k) clearance for our new Sterile Transperineal Needle Guide, the ExactVu micro-ultrasound system can now be used in all clinical settings for targeted prostate biopsies, including FusionVu™ and cognitive fusion biopsies.”

– Randy AuCoin, Exact Imaging’s President and CEO

ExactVu micro-ultrasound system, its FusionVu application along with the newly released Sterile Transperineal Needle Guide will be showcased live at the LUGPA 2019 Annual Meeting in Chicago, Illinois from November 7-9, 2019 and the 28th Annual Perspectives in Urology: Point Counterpoint in Scottsdale, Arizona from November 14-16, 2019.

“The ExactVu technology broadens my prostate biopsy options and can be performed in the clinic or in an outpatient surgery center. As transperineal biopsy strategies evolve, potentially for enhanced tissue procurement, and therefore, enhanced histopathologic evaluation as well as the likelihood for decreased infectious complication risk, performing targeted transperineal biopsies using the ExactVu 29 MHz micro-ultrasound system optimizes the performance of prostate biopsy.”

– Neal D. Shore, MD, FACS, Medical Director for the Carolina Urologic Research Center and the National Urology Research Director for 21st Century Oncology

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). 

For further information, please contact:

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

PRNewswire — Endotronix Ireland Limited, a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), announced today an Enterprise Ireland Industry Partnership project is a collaboration with Tyndall National Institute, a leading European Deep Tech research center in integrated ICT (Information and Communications Technology) hardware and software. The 12-month project between the wholly-owned subsidiary of U.S.-based Endotronix, Inc., and Tyndall will explore the application of novel electronics technologies to wireless, implantable sensors for chronic disease management, such as the Cordella™ Pulmonary Artery Pressure Sensor System (Cordella Sensor).

“Together our Cordella Sensor and Cordella System provide a robust platform for data-guided chronic disease management based on changes in pulmonary artery (PA) pressure, an early indicator of worsening heart failure. This partnership helps us develop our next generation sensor capabilities and ensures our ongoing leadership in proactive, patient-centered disease management. We look forward to integrating Tyndall’s electronics expertise into our long-term technology roadmap.”

– Michael Nagy, Chief Technology Officer, Endotronix

The Cordella Sensor is fully integrated with the Cordella™ Heart Failure System (Cordella System), which provides 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 provide clinicians the information necessary to improve patient care between office visits. The system was designed for remote titration of medication and streamlining patient management to help keep patients out of the hospital.

“Endotronix is an established medtech innovator that combines the power of wireless, implantable sensors with remote patient management to improve patient care and outcomes for heart failure patients. Our strength in data processing and electronics design creates a powerful synergy that aligns with our combined long-term Deep Tech and ICT for health vision that will lay a foundation for future generations of implantable sensors.”

– Carlo Webster, Senior Strategic Business Development Executive, Tyndall National Institute

Endotronix Ireland Limited is supported by the Irish Government through IDA Ireland.

Endotronix recently received FDA approval to begin PROACTIVE-HF, their U.S. pivotal trial, and began enrollment in their European CE Mark Trial, SIRONA II, for the Cordella Sensor. The Cordella Sensor is an investigational device and is not available for commercial use in any geography. Exclusively for clinical investigations. The Cordella System, without the sensor, is available for commercial use in the U.S. and E.U. and is currently in cardiology centers across the U.S.

About Tyndall National Institute
Tyndall is a leading European research centre in integrated ICT (Information and Communications Technology) materials, devices and systems. It is one of Ireland’s 5 National Labs, specializing in both electronics and photonics. Tyndall works with industry and academia to transform research into products in its core market areas of electronics, communications, energy, health, agri-tech & the environment. With a network of over 200 industry partners and customers worldwide, they are focused on delivering human and economic impact from excellence in research. A research flagship of University College Cork, Tyndall employs over 500 researchers, engineers and support staff across 52 nationalities, including a cohort of 120 full-time graduate students.

About Endotronix
Endotronix, Inc., a medical technology company, delivers an integrated platform that provides comprehensive, reimbursable health management innovations for chronic heart failure. Their solution, the Cordella™ Heart Failure System, includes a cloud-based disease management data system and at home hemodynamic management via 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:

For information on Endotronix, please contact:
Carla Benigni
SPRIG Consulting LLC
(847) 951-7430
Carla@sprigconsulting.com

For more information on Tyndall, please contact:
Ursula Morrish, Marketing and Communications Manager,
Tyndall National Institute,
+353 (0) 852372189
ursula.morrish@tyndall.ie

Austin, TX, and Montreal, QC – Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer, announced today that the Phase 1a solid tumor trial exploring the safety and tolerability of AVID200, a first-in-class TGF-beta 1 & 3 selective inhibitor, administered as a monotherapy has fully enrolled. Simultaneously, the company completed a Series C financing led by HBM Healthcare Investments with participation from new and existing investors.

• AVID200 is a first-in-class, selective inhibitor of TGF-beta 1 & 3, the main pathogenic TGF-beta isoforms; AVID200 spares TGF-beta 2 for optimal safety
• Phase 1a results in oncology demonstrate target engagement and potentially best-in-class tolerability of AVID200; results will be presented at an upcoming immune oncology congress
• Series C Round secures financing into 2021, led by HBM Healthcare Investments

AVID200 is rationally designed to selectively and potently inhibit the main pathogenic TGF-beta isoforms 1 and 3. AVID200 spares TGF-beta 2 for optimal safety. Inhibition of TGF-beta 2 is undesirable as this isoform is important for normal cardiac functioning and hematopoiesis. These and other toxicities have curtailed the development of earlier generation, non-selective TGF-beta inhibitors.

The AVID200-03 trial (NCT03834662) is an open label, multicenter, dose-escalation study focused on demonstrating safety of AVID200 monotherapy in patients with advanced or metastatic solid tumor malignancies and no other treatment options. Following a standard 3 + 3 design, a total of 15 patients received AVID200 at 5, 15 and 30 mg/kg once every three weeks. Pharmacokinetics and target engagement were also evaluated.

The recently completed financing funds the company into 2021 which will allow advancement of AVID200 through its clinical proof-of-principle program. HBM Healthcare Investments led the round, with a number of new and existing investors also participating.

“This Phase 1a dose-escalation study delivers important data that selective inhibition of TGF-beta isoforms 1 & 3 via AVID200 efficiently blocks the TGF-beta pathway with potentially best-in-class tolerability. Together these data position AVID200 as an attractive agent for development in a variety of clinical settings and compelling combinations. We look forward to reporting details of this trial at upcoming immune oncology congresses.”

– Ilia Tikhomirov, CEO of Forbius

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

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

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

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

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

About TGF-beta 1 & 3

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

Media Contact

Claudia Resch
info@forbius.com

MONTREAL — Medexus Pharmaceuticals Inc. (the “Company”) (TSXV: MDP, OTCQB: PDDPF) today announced changes to the Company’s senior management team. Effective immediately, Mr. Sylvain Chrétien will no longer serve as the Company’s President, Canadian Operations. In accordance with his employment agreement, Mr. Chrétien is also required to resign from the Board of Directors of the Company. Also effective immediately, Mr. Benoît Hébert will be departing from his role as the Company’s Vice President, Business Development & Licensing.

Ken d’Entremont, Chief Executive Officer of the Company, commented: “On behalf of the Board of Directors and management team, we would like to thank Mr. Chrétien and Mr. Hébert for their invaluable work, contributions and stewardship over the years and we wish them both much success in their future endeavours. Mr. Chrétien founded Pediapharm Inc., our predecessor entity, and loyally served as President and Chief Executive Officer of Pediapharm Inc. from 2008 until 2018. We are very grateful for his many years of guidance and leadership.”

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

About Medexus Pharmaceuticals Inc.

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

For more information, please contact:

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

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

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

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

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

Forward Looking Statements

Certain statements made in this press release contain forward-looking information within the meaning of applicable securities laws (“forward-looking statements”). The words “anticipates,” “believes,” “expects,” will,” and similar expressions are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Specific forward-looking statements contained in this news release include, but are not limited to, statements with respect to our belief that the Company’s common shares being DTC eligible will simplify the process to trade such common shares in the United States, and that the liquidity and trading volumes of the Company’s common shares will be positively impacted by the DTC eligibility, as well as the future benefits provided to the Company and its shareholders, including with respect to future improvements to overall liquidity. These statements are based on factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, including assumptions based on historical trends, current conditions and expected future developments. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. The Company cautions that although it is believed that the assumptions are reasonable in the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. Material risk factors include those set out in the Company’s most recent MD&A, future capital requirements and dilution; intellectual property protection and infringement risks; competition (including potential for generic competition); reliance on key management personnel; the Company’s ability to implement its business plan; the Company’s ability to leverage its United States and Canadian infrastructure to promote additional growth, including with respect to the infrastructure of Medexus Inc. and Medac Pharma, Inc. and the potential benefits the Company expects to derive therefrom, regulatory approval by the Canadian health authorities; product reimbursement by third party payers; patent litigation or patent expiry; litigation risk; stock price volatility; government regulation; potential third party claims. Given these risks, undue reliance should not be placed on these forward-looking statements, which apply only as of the date hereof. Other than as specifically required by law, the Company undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.

TEWKSBURY, MA – Corvia Medical, Inc., a privately-held company with a first-in-class structural heart device to treat heart failure, today announced the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its InterAtrial Shunt Device (IASD^®) for heart failure. The IASD^® is the world’s first transcatheter device for heart failure with preserved (HFpEF) and mid-range (HFmrEF) ejection fraction.

Related Article: Edwards Lifesciences announces the exclusive right to acquire Corvia Medical, Inc.

“Receiving Breakthrough Device designation from the FDA underscores the significant unmet need for more effective treatment options for heart failure patients. We look forward to continuing our work with the FDA through our ongoing pivotal trial in more than 100 hospitals, and providing the clinical evidence which will accelerate the timeline to bring the IASD^® to the US market.”

– George Fazio, President and CEO, Corvia Medical

What is Breakthrough Device Designation?

FDA Breakthrough Device designation is granted to medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program intends to help patients have more timely access to medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, clearance of a premarket notification (510(k)), and marketing authorization via the De Novo classification process.

The IASD^® is designed to provide continuous and dynamic decompression of the left atrium, which may reduce symptoms and slow the progression of heart failure. The device is being studied in REDUCE LAP-HF II, a large multi-national prospective, double-blind, sham-controlled trial randomizing 608 HFpEF and HFmrEF patients in the United States, European Union, Australia, Japan and Canada. Recruitment is ongoing.

“The FDA program should accelerate market access and adoption of novel treatments for heart failure patients in the US. Demonstrating reduced recurrent heart failure hospitalizations and improved quality of life for these patients, through rigorous clinical trials that generate real evidence, is the company’s primary objective.”

– Kate Stohlman, VP of Quality and Regulatory Affairs, Corvia Medical

About Heart Failure

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

About the InterAtrial Shunt Device (IASD^®)

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

About Corvia Medical, Inc.

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

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

TORONTO, Oct. 3, 2019 / PRNewswire/ — AmacaThera Inc. is pleased to announce the closing of its US$3.6 million seed financing round. A first close of the round was led by Sprout BioVentures/Viva Biotech with participation from Grey Sky Venture Partners, and the round was recently completed with an investment by Toronto-based Lumira Ventures.

“We are thrilled to have the Lumira team as part of our investor group and look forward to working closely with them and our other investors in executing the company’s business plan.”

– Dr. Molly Shoichet, Ph.D., Co-Founder and Chief Scientific Officer of AmacaThera

“We have followed the evolution of the AmacaThera story for some time and, as a result, we had the opportunity to work closely with Molly, Mike and the rest of the team before our investment. That relationship, and the insights we gained gave us confidence in their technology, development strategy and the opportunity to develop a novel non-opioid-based product for the treatment of post-surgical pain.”

– Peter van der Velden, Managing General Partner at Lumira Ventures, who joins AmacaThera’s Board of Directors

AmacaThera’s goal is to use its proprietary technology to develop injectable and biocompatible hydrogels that can enhance the delivery, targeting, and release of a diverse range of therapeutic agents. AmacaThera’s first product, AMT-143, is being developed to improve post-operative pain control thereby reducing or eliminating opioid use following surgery.

“We are thankful for the support of our investors. This capital will allow us to advance our drug delivery platform technology into clinical trials in 2020.”

– Mike Cooke, AmacaThera’s Co-Founder and CEO

About AmacaThera

AmacaThera is focused on the commercialization of a hydrogel platform for sustained drug release. AmacaThera’s propriety hydrogel technology can be combined with therapeutic agents to form a product, which can be injected into a tissue to localize the therapeutics to the injection site. AmacaThera’s first product is aimed at sustained post-operative pain relief to reduce the need for opioids and to provide superior pain relief. AmacaThera was nurtured in Dr. Shoichet’s laboratory with assistance from numerous accelerators, including the Creative Destruction Lab at the Rotman School of Management, University of Toronto Early Stage Technology, the Ontario Biosciences Innovation Organization (OBIO), TIAP (formerly MaRS Innovation), and the U of T Innovations & Partnership Office. AmacaThera is currently a resident company at the Johnson & Johnson Innovation – JLABS incubator (JLABS @ Toronto).

About Sprout BioVentures and Viva Biotech

Sprout BioVentures and Viva Biotech are focused on propelling high-potential companies from idea to value creation. With a particular emphasis on seed-stage investments, Sprout BioVentures and Viva Biotech leverage proprietary technology and nimble incubator resources to efficiently de-risk drug discovery efforts. 

About Grey Sky Venture Partners

Grey Sky Venture Partners is an early-stage investment fund providing capital and intellectual property to passionate entrepreneurs building innovative, next-generation life sciences companies that will create an impact in the complex and rapidly changing healthcare system.

About Lumira Ventures

Lumira Ventures is Canada’s largest and most active healthcare venture capital firm. Lumira invests in best-in-class North American companies developing innovative therapeutics and medical technologies whose products offer transformative improvements to patient health outcomes and/or meaningful reductions to the overall cost of healthcare delivery. Lumira executes a proven and differentiated investment strategy and as a lead investor is an active partner to its portfolio companies as they develop, commercialize and deliver their products to patients. Since inception, Lumira’s portfolio companies have brought 40+ new therapies to market, impacting the lives of 1 billion patients globally, generating $65+ billion in cumulative revenue.

BARCELONA, Spain–(BUSINESS WIRE) — Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announced updated data from the ongoing multi-center Phase 1 clinical trial evaluating ZW25 in patients with HER2‑expressing solid tumors, including biliary tract cancer (BTC), colorectal cancer (CRC), gynecological cancers, and gastroesophageal adenocarcinoma (GEA), in a poster discussion presentation at the ESMO 2019 Congress, taking place September 27 – October 1 in Barcelona, Spain.

“The data presented today at ESMO confirm previous findings that ZW25 monotherapy can provide durable disease control in patients with a variety of HER2-expressing solid tumors that have progressed following standard of care therapies, including HER2-targeted agents. Notably, the single-agent objective response rate in biliary tract cancer is highly encouraging given the poor prognosis and limited treatment options for these patients. We are working closely with regulatory agencies to initiate a registration-enabling Phase 2 trial in second-line HER2‑expressing biliary tract cancer with the goal of bringing ZW25 to patients as quickly as possible.”

– Diana Hausman, M.D., Chief Medical Officer at Zymeworks

Based on the data from the ongoing Phase 1 study, Zymeworks has initiated a broad clinical development program for ZW25 in multiple HER2-expressing cancers. In addition to the Phase 2 BTC trial announced today, Zymeworks is continuing to evaluate ZW25 as a potential treatment for patients with other HER2-expressing cancers, including CRC and gynecological cancers (Phase 1; NCT02892123). For patients with HER2-expressing GEA, ZW25 is being developed as a first-line treatment in combination with standard of care chemotherapy (Phase 2; NCT03929666). Zymeworks also plans to initiate a Phase 2 study of ZW25 in combination with a CDK4/6 inhibitor and hormone therapy in third-line HER2-expressing, HR-positive breast cancer.

ZW25 Clinical Results Presented Today
The Safety, Efficacy and Biomarker Results of the HER2-Targeted Bispecific Antibody ZW25 in HER2-Expressing Solid Tumors (Abstract# 3575, Poster Discussion on Saturday, September 28 at 4:30 pm CEST)

Findings from this ongoing Phase 1 study of ZW25 in patients with HER2-expressing solid tumors were last presented at the 2018 EORTC-NCI-AACR Symposium. The updated results were presented today by Dr. Funda Meric-Bernstram, M.D., Clinical Investigator and Chair of the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center.

Data were reported from 58 patients diagnosed with HER2-expressing solid tumors other than breast cancer who received ZW25 at the recommended dose of either 10 mg/kg weekly or 20 mg/kg every other week. Patients had a median age of 61 years and received a median of four prior therapies. Thirty-two (55%) patients received prior HER2‑targeted therapies including 87% of GEA patients. Of all patients, 23 were diagnosed with GEA, 13 with CRC, nine with BTC, and 13 with other HER2‑expressing cancers, including endometrial, ovarian, pancreatic, and salivary gland.

At the time of data cut-off, 46 of 58 patients were response evaluable. Overall, the majority of patients experienced a decrease in their target lesions with a disease control rate of 72%, comprising 16 (35%) patients with partial responses and 17 (37%) with stable disease. The objective response rate in the six evaluable biliary tract cancer patients was 67%, with the majority of patients experiencing disease control greater than six months. In the 11 CRC and 19 GEA patients, the objective response rates were 36% and 32%, respectively. The overall median progression-free survival was 5.2 months, with 27 (47%) of the 58 total patients still on study at the time of data cut-off.

Among all patients, ZW25 was well tolerated as an outpatient therapy. The most common adverse events were diarrhea, infusion-related reaction, and nausea. All treatment-related adverse events occurring in 10% or more of patients were Grade 1 or 2.

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

About the Phase 1 Clinical Trial

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

About ZW25

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

About Zymeworks Inc.

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

Cautionary Note Regarding Zymeworks’ Forward Looking Statements

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

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

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

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

LISLE, IL – Endotronix, Inc., a digital health, medtech company dedicated to advancing the treatment of heart failure (HF), today announced the expansion of its Series D financing round, bringing the total for the round to $70 million. The expansion syndicate for the LSP-led round includes new investment from an additional unnamed medical device strategic investor as well as participation from existing investors, including Aperture Venture Partners, BioVentures Investors, Lumira Ventures, OSF Ventures, Seroba Life Sciences, Skydeck LLC, SV Health Investors, Wanxiang Healthcare Investments, and an unnamed corporate strategic investor. The funds will be used to support the landmark PROACTIVE-HF IDE clinical trial of the Cordella Pulmonary Artery Sensor System (Cordella™ Sensor) and commercialization of the Cordella Heart Failure System (Cordella™ System).

“Endotronix has built a strong syndicate of both institutional and strategic investors who believe in the benefits of remote heart failure management with the Cordella™ Sensor and System. The team is set to deliver an elegant solution that we believe will show a definitive benefit in reducing heart failure-related hospitalizations and improving outcomes for patients and clinicians.”

– Fouad Azzam Ph.D., General Partner at LSP

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

“Heart failure care providers are seeking better solutions to manage patients and we believe the Cordella™ System with PA pressure-guided management delivers on that need. This financing expansion allows us to execute on the PROACTIVE-HF trial to provide the highest level of clinical evidence which will redefine the standard of care for heart failure patients and accelerate our time to market.”

– Harry Rowland, CEO at Endotronix

Endotronix has two active clinical studies for the Cordella™ Sensor:

PROACTIVE-HF is a prospective, multi-center, randomized, controlled, single-blind trial that will evaluate the safety and efficacy of the Cordella™ Sensor in over 950 New York Heart Association (NYHA) Class III heart failure patients at up to 60 sites across the U.S. The trial has received FDA approval and enrollment is expected to begin in the fourth quarter of 2019. The pivotal trial is designed to show a definitive benefit for PA pressure-guided management in the reduction of HF hospitalizations and mortality as well as provide the data required for access to the U.S. market and reimbursement of the implantable Cordella™ Sensor across the U.S.

The open-label SIRONA II CE Mark trial is currently enrolling 60 patients at up to 8 European medical centers. The trial will evaluate the safety and efficacy of the Cordella™ Sensor for the management of NYHA Class III heart failure patients and provide data for market access to the European market.

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. 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.

About Endotronix, Inc.

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

Related Article: Endotronix Raises $45 Million in Series D Financing for the Treatment of 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.

This global, randomized, double-blind, placebo-controlled, multicenter, Phase 2 study (NCT03041311) assessed the potential of trilaciclib to reduce the incidence and consequences of chemotherapy-induced myelosuppression in patients with newly diagnosed extensive-stage small-cell lung cancer (ES-SCLC) treated with etoposide, carboplatin and atezolizumab (a programmed death-ligand 1 inhibitor).

Patient Eligibility

• Aged ≥ 18 years
• Chemotherapy and checkpoint inhibitor naïve
• Histologically or cytologically confirmed ES-SCLC with measurable disease
• Eastern Cooperative Oncology Group Performance Status 0–2
• Adequate organ function
  • Hemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count ≥ 1.5 × 10⁹ L
  • Platelet count ≥ 100 × 10⁹ L
• No symptomatic brain metastases
• No active, known, or suspected autoimmune disease that required systemic treatment in the past 2 years

Study Design

• The study schematic is shown in Figure 2. The study objectives and endpoints are shown in Table 1
• Primary prophylactic hematopoietic growth factors were prohibited in cycle 1; otherwise, standard supportive care was allowed throughout the study
• Data presented are from the following data cuts: Aug 17, 2018 for final myelosuppression endpoints (ie, after all patients had the opportunity to receive 4 cycles of induction therapy) and Aug 05, 2019 for all other endpoints

Assessments

• Complete blood counts were obtained on days 1, 3, 8, and 15 of each cycle of trilaciclib/placebo plus etoposide, carboplatin, and atezolizumab (induction) or atezolizumab (maintenance)
• Adverse events (AEs) were graded according to the National Cancer Institute’s Common Terminology Criteria for AEs version 4.03
• Patient-reported outcomes were assessed using Functional Assessment of Cancer Therapy-Lung (FACT-L) and Functional Assessment of Cancer Therapy-Anemia (FACT-An) instruments, administered to patients on day 1 of each cycle and at posttreatment visits
• Tumor response was assessed per Response Evaluation Criteria in Solid Tumors version 1.1

Results

Myelopreservation

• Trilaciclib reduced both the duration of severe neutropenia in cycle 1 (P < 0.0001), a surrogate for febrile neutropenia and infections, and the occurrence of severe neutropenia (P < 0.0001), compared with placebo (Figure 3)
• Although not statistically significant, trilaciclib also reduced the need for red blood cell (RBC) and platelet transfusions and the use of granulocyte colony-stimulating factor and erythropoiesis-stimulating agents, compared with placebo (Figure 3)

Safety

• The most common all-grade and Grade ≥ 3 treatment-emergent AEs (TEAEs) occurring during the induction and maintenance phases are shown in Table 4
• There were fewer Grade ≥ 3 TEAEs with trilaciclib compared with placebo, mostly due to a lower number of Grade ≥ 3 hematologic AEs
  • Overall Grade ≥ 3 TEAEs: 63.5% with trilaciclib versus 86.8% with placebo
  • Drug-related Grade ≥ 3 TEAEs: 51.9% with trilaciclib versus 75.5% with placebo
• 16 patients had TEAEs considered related to trilaciclib
  • The most common TEAEs considered related to trilaciclib were fatigue (9.6%), nausea (7.7%), and anemia and infusion-related reaction (5.8% each); most of these were low grade, with the exception of Grade 3 fatigue (1.9%)
• 12 (23.1%) patients in the trilaciclib arm and 11 (20.8%) in the placebo arm had atezolizumab AEs of special interest, which were mostly immune-related
• Serious TEAEs were reported in 32.7% of patients treated with trilaciclib and 47.2% of patients treated with placebo; 1 (1.9%) serious TEAE (deep vein thrombosis) was considered possibly related to trilaciclib
• In the trilaciclib treatment group, there were 2 deaths due to TEAEs: hemoptysis (n = 1) and pneumonia (n = 1), both considered unrelated to trilaciclib

Health-Related Quality of Life

• Enrolled patients had a moderate level of functioning and were moderately symptomatic at baseline as measured by the validated FACT-L and FACT-An instruments
• Trilaciclib improved the patient experience by delaying deterioration of patient functioning and symptom measures over time, compared with placebo. Overall, the benefit of trilaciclib was seen with functional well-being, quality of life measures specific for patients with lung cancer, and symptoms and impact of fatigue, as well as with symptoms and effects on physical and functional well-being due to anemia (Figure 4)
• Statistically significant differences between the trilaciclib and placebo treatment groups were observed for Functional Well-being, Lung-Trial Outcome Index, and FACT-An total score (Figure 4)

Antitumor Efficacy

• Investigator-assessed objective response rate (ORR) was comparable between trilaciclib (56.0%) and placebo (63.5%) treatment groups
• The clinical benefit rate, including patients with confirmed complete response, confirmed partial response, or stable disease for at least 5 weeks from cycle 1, day 1, was 96.0% with trilaciclib compared with 90.4% with placebo
• Median progression-free survival (PFS) was 5.9 (95% CI, 4.2–7.1) months for trilaciclib compared with 5.4 (95% CI, 4.3–5.7) months for placebo (hazard ratio [HR], 0.83; P = 0.3079; Figure 5)
• With a median follow-up of 10.9 months (range, 0.0–24.3 months), median overall survival (OS) was 12.0 (95% CI, 9.6–16.2) months for trilaciclib compared with 12.8 (95% CI, 7.9–15.5) months for placebo (HR, 0.95; P = 0.9461; Figure 5)

Flow Cytometry

• The addition of trilaciclib to etoposide, carboplatin, and atezolizumab treatment increased the number of circulating activated CD8+ T and Th1 cells during chemotherapy, and increased the ratio of total and activated CD8+ T cells to regulatory T cells in both the induction and maintenance phases of treatment in peripheral blood (Figure 6A–D)
• Patients treated with trilaciclib had significantly higher numbers of expanded T-cell clones than patients treated with placebo (P = 0.01; Figure 6E)
• Regardless of treatment, patients with high levels of T-cell clones had longer PFS (Figure 6F)

Conclusions

• Compared with placebo, trilaciclib makes etoposide, carboplatin, and atezolizumab treatment safer and more tolerable by protecting patients from chemotherapy-induced myelosuppression as evidenced by:
  • Effects on neutrophils (statistically significant improvement in primary endpoints of the duration of severe neutropenia, and occurrence of severe neutropenia), RBCs (lower rates of Grade 3/4 anemia and transfusions), and platelets (lower rates of Grade 3/4 thrombocytopenia and transfusions)
  • Fewer supportive care requirements
  • Fewer chemotherapy dose reductions
  • Numerically increased relative dose intensities of etoposide, carboplatin, and atezolizumab
  • Improved overall safety profile, primarily due to a reduction in high-grade hematologic AEs attributable to cytotoxic chemotherapy
• Validated patient-reported outcome instruments suggest that the addition of trilaciclib improves the patient experience on chemotherapy
• ORR, PFS, and OS data demonstrate that trilaciclib does not impair chemotherapy/atezolizumab antitumor efficacy
• Flow cytometry data suggest that during treatment with etoposide, carboplatin, and atezolizumab, coadministration of trilaciclib can enhance the T-cell immune response
• These data confirm the myelopreservation benefits of trilaciclib observed in another first-line trial of trilaciclib in combination with etoposide and carboplatin in ES-SCLC (NCT02499770)⁵ as well as in combination with topotecan in patients previously treated for ES-SCLC (NCT02514447)⁷

Related Article: New Patient-Reported Outcomes Data shows Trilaciclib Improves Chemotherapy Experience for Patients

RESEARCH TRIANGLE PARK, N.C. and BARCELONA, Spain, Sept. 28, 2019 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today reported preliminary overall survival (OS) data from the company’s randomized Phase 2 trial of trilaciclib in combination with chemotherapy for the treatment of metastatic triple-negative breast cancer (mTNBC). In the trial, median overall survival for patients treated with trilaciclib in combination with a chemotherapy regimen of gemcitabine/carboplatin (GC) was 20.1 months, compared with 12.6 months for patients receiving chemotherapy alone. This data was reported as part of a late-breaking oral presentation (LBA22) at the European Society for Medical Oncology (ESMO) 2019 Congress and featured in a concurrent publication in The Lancet Oncology.

Updated data from a separate randomized Phase 2 trial of trilaciclib in small cell lung cancer (SCLC) will be presented during a poster session (1742PD) on Sunday, September 29 at ESMO 2019 in Barcelona, Spain.

“Triple-negative breast cancer is the most aggressive form of breast cancer and tends to have a poorer prognosis than other breast cancers. We need new therapeutic approaches that improve outcomes for women diagnosed with triple-negative breast cancer. As an oncologist specializing in triple-negative breast cancer, I am encouraged that trilaciclib has the potential to improve the survival of patients diagnosed with this disease.”

– Joyce A. O’Shaughnessy, M.D., Baylor University Medical Center, Texas Oncology, U.S. Oncology, and lead investigator of the trial

“Trilaciclib is a first-in-class therapy that has improved outcomes for people with cancer being treated with chemotherapy in four randomized Phase 2 trials. The findings from these trials in small cell lung cancer and triple-negative breast cancer indicate that the clinical benefits of trilaciclib are meaningful and context-dependent,” said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. “In metastatic triple-negative breast cancer, the benefit manifests as improved overall survival. In small cell lung cancer, patients experience myelopreservation benefits, including reduced rates of neutropenia, anemia and other chemotherapy-related side effects, and a corresponding decrease in the use of rescue therapies required to address those toxicities. Importantly, patient-reported outcome measures across all of our trials showed that trilaciclib improved the patient experience on chemotherapy.”

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

“Based on feedback from our pre-NDA meeting with the FDA, we will begin a rolling NDA submission for small cell lung cancer in the fourth quarter of this year, which we expect to complete in the second quarter of 2020. We have also had initial discussions with the FDA regarding the development of trilaciclib in triple-negative breast cancer, including the preliminary design of a Phase 3 trial. In 2020, we plan to initiate a Phase 3 trial in triple-negative breast cancer and a Phase 3 trial in colorectal cancer, with the goal of demonstrating the benefits of trilaciclib to patients receiving chemotherapy for multiple tumor types.”

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

Overall survival benefit in mTNBC
The randomized, open-label Phase 2 study (NCT02978716) of trilaciclib in combination with GC, a current standard of care for TNBC, enrolled 102 patients who had received up to two prior chemotherapy regimens for locally recurrent or metastatic TNBC. In this three-arm trial, all three groups received a chemotherapy regimen of GC. Patients were randomized to receive GC only (Group 1) or GC plus one of two dosing schedules of trilaciclib: trilaciclib administered on the day of chemotherapy (Group 2) or trilaciclib administered the day prior to and the day of chemotherapy (Group 3). Primary endpoints for the trial included myelopreservation measures; secondary endpoints included additional myelopreservation measures and anti-tumor efficacy measures of overall response rate (ORR), progression-free survival (PFS) and OS. Myelopreservation and preliminary anti-tumor efficacy results from the trial were reported at the 2018 San Antonio Breast Cancer Symposium (press release here). Topline OS findings were announced in June 2019 (press release here); detailed OS results were reported for the first time at ESMO 2019.

Updated results from the trial showed:

The addition of trilaciclib to chemotherapy resulted in a significant increase in OS in both treatment groups compared to chemotherapy alone.

• Compared to GC alone (Group 1), OS was improved for both trilaciclib arms (Groups 2 and 3) with median OS of 12.6 months, 20.1 months and 17.8 months, respectively (Group 2: HR=0.33, p=0.0283; Group 3: HR=0.34, p=0.0023). The median OS for Groups 2 and 3 combined was 20.1 months (HR=0.36, p=0.0015). The median OS for GC alone (Group 1, 12.6 months) was consistent with historical data.

PFS and ORR were consistent with previously reported data.

The safety and tolerability of trilaciclib were consistent with previously reported data.

• There have been no serious adverse events attributed to treatment with trilaciclib in this trial.

Patient-reported outcome (PRO) measures related to anemia were improved in patients receiving trilaciclib versus patients receiving chemotherapy alone.

As previously reported, primary endpoints (myelopreservation measures) were not met.

Trilaciclib in SCLC
On Sunday, September 29, G1 Therapeutics will present updated results from its randomized, double-blind, placebo-controlled Phase 2 trial (NCT03041311) evaluating trilaciclib in extensive-stage SCLC patients receiving first-line chemotherapy and the checkpoint inhibitor Tecentriq^® (atezolizumab). The findings were consistent with previously reported data (press release here):

• Trilaciclib demonstrated myelopreservation benefits, as shown by statistically significant and clinically meaningful improvement in reduction of myelosuppression endpoints, reduction of chemotherapy side effects and reduction of rescue interventions.
• Trilaciclib was well tolerated, with fewer ≥ Grade 3 adverse events (AEs) compared to placebo.
• PRO measures related to anemia were improved in patients receiving trilaciclib versus patients receiving placebo.
• Trilaciclib did not adversely impact chemotherapy anti-tumor efficacy as measured by ORR, PFS and OS.

Additionally, data from another randomized Phase 1b/2 trial of trilaciclib in patients with SCLC receiving first-line chemotherapy were recently published in Annals of Oncology, the official journal of ESMO. Data in this trial demonstrated the myelopreservation benefits of trilaciclib as indicated by a statistically significant reduction in clinically relevant consequences of myelosuppression compared to placebo, resulting in fewer supportive care interventions and dose reductions. Trilaciclib did not adversely impact the anti-tumor efficacy of chemotherapy.

Webcast and Conference Call Details
G1 Therapeutics will host a webcast and conference call of its investor and analyst event on Sunday, September 29, 2019, at 6:45 p.m. CEST (12:45 p.m. ET) to review the data being presented at ESMO 2019, as well as long-range development plans for all three of its clinical-stage therapies and commercial plans for trilaciclib. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 5878315. A live and archived webcast will be available on the Events & Presentations page of the company’s website.

About Trilaciclib
Trilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy. Based on results from three randomized trials in patients with small cell lung cancer, trilaciclib has received Breakthrough Therapy Designation, and G1 Therapeutics expects to submit marketing applications in the U.S. and Europe for myelopreservation in small cell lung cancer in 2020. In a randomized trial of women with metastatic triple-negative breast cancer, trilaciclib improved overall survival when administered in combination with chemotherapy compared with chemotherapy alone. The company plans to initiate a Phase 3 clinical trial in triple-negative breast cancer and a Phase 3 clinical trial in colorectal 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. Trilaciclib has received Breakthrough Therapy Designation from the FDA; a rolling NDA submission for small cell lung cancer will begin in 4Q19 and is expected to be completed in the second quarter of 2020. Lerociclib is a differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies. G1T48 is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. G1 Therapeutics also has an active discovery program focused on cyclin-dependent kinase targets. G1 Therapeutics is based in Research Triangle Park, N.C. 

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, the timing for the commencement and completion of marketing applications in the U.S. and Europe for trilaciclib in SCLC, and plans to initiate additional trials in colorectal cancer and TNBC, and are based on the company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the company’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, the company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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

VANCOUVER, British Columbia — Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, announced that Lota Zoth has been appointed as its Chair of the Board of Directors. Ms. Zoth succeeds Nick Bedford, who has retired from his functions as Chair and Board member. Mr. Bedford served as Board Chair since September 2004.

“Lota has provided valuable insights and a wealth of experience as a member of Zymeworks’ Board since 2016 and we are pleased to welcome her as our new Chair as we further advance our lead clinical assets towards commercialization,” said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. “On behalf of the Board and the executive team, I thank Nick for his contributions to Zymeworks. He has been instrumental to our success over the past fifteen years, particularly through the Company’s IPO in 2017.”

Ms. Zoth served as Chief Financial Officer of MedImmune prior to the acquisition by AstraZeneca in 2007, and currently serves on the boards of several biopharmaceutical companies, including Inovio Pharmaceuticals, Inc., NewLink Genetics Corporation, and Spark Therapeutics, Inc. Ms. Zoth also served as Chair of the Board of Directors of Aeras, a biopharmaceutical product development partner funded by the Bill & Melinda Gates Foundation.

Related Article: Zymeworks Appoints Accomplished Executives to Board of Directors

Zymeworks has also made a strategic decision to voluntarily delist its common shares from the Toronto Stock Exchange (TSX) in Canada, which is currently anticipated to occur on or around October 1, 2019. Zymeworks’ shares will continue to be traded on the New York Stock Exchange (NYSE) under the symbol “ZYME” and Canadian shareholders can continue to trade their shares on the NYSE.

With active daily trading on the NYSE having accounted for the vast majority of Zymeworks’ liquidity, the Company conducted a thorough evaluation of its dual listing, considering such factors as overall liquidity, the needs of its shareholders, costs, regulatory compliance and complexity, and future capital raising opportunities. In summary, the Company believes that the financial and administrative costs associated with maintaining a dual listing are no longer justified.

Answers to questions about the voluntary delisting.

About Zymeworks Inc.

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

Cautionary Note Regarding 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 expected delisting of the Company’s shares from the TSX, the continued listing of its shares on the NYSE, Canadian shareholders’ continued ability to trade their shares on the NYSE, and other information that is not historical information. When used herein, words such as “believe”, “will”, “continue”, “anticipate”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under “Risk Factors” in Zymeworks’ Quarterly Report on Form 10-Q for the three month period ended June 30, 2019 (a copy of which may be obtained at www.sec.gov and www.sedar.com). Consequently, forward-looking statements should be regarded solely as Zymeworks’ current plans, estimates, and beliefs. You should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events, except as may be required by law.

Investor Inquiries:

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

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

Media Inquiries:

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

SOUTH SAN FRANCISCO, Calif. — Satsuma Pharmaceuticals, Inc. (“Satsuma” or the “Company”) (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder) for the acute treatment of migraine, today announced the closing of the Company’s previously announced initial public offering of 5,500,000 shares of common stock at a public offering price of $15.00 per share, which does not include the exercise by the underwriters of their option to purchase up to an additional 825,000 shares of common stock. Aggregate gross proceeds to the Company were approximately $82.5 million, before underwriting discounts, commissions and estimated offering expenses. All of the shares in the offering were offered by Satsuma. Satsuma’s common stock is listed on The Nasdaq Global Market under the ticker symbol “STSA.”

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

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

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

Registration statements relating to the shares sold in this offering were declared effective by the Securities and Exchange Commission on September 12, 2019. The offering was made only by means of a prospectus. Copies of the prospectus 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.

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

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

MONTREAL, Sept. 12, 2019 (GLOBE NEWSWIRE) — Medexus Pharmaceuticals Inc.  (the “Company” or “Medexus”) (TSXV: MDP, OTCQB: PDDPF) announces that Health Quality Ontario, under the guidance of the Ontario Health Technology Advisory Committee, has recommended public funding of Gliolan® (5-aminolevulinic acid hydrochloride) for guiding maximal surgical resection of high-grade gliomas in adults, conditional on Health Canada approval. Gliolan® assists neurosurgeons to better visualize and more completely remove malignant brain tumors (gliomas) by causing them to become fluorescent and glow during surgery.

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

Health Canada previously granted Medexus authorization to distribute Gliolan® in Canada under the Special Access Program, which provides healthcare practitioners with access to non-marketed drugs to treat patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The Company has long-term exclusive rights to market and distribute Gliolan® in Canada. 

“The response to Gliolan® from the medical community has been extremely positive, as evidenced by strong market uptake, even prior to full registration. The recommendation for public reimbursement from Health Quality Ontario further validates our belief that Gliolan® not only improves outcomes, but is a cost effective solution for high level glioblastoma patients. Furthermore, we expect broader distribution of Gliolan® in Canada, as a fully registered product, which we believe has the potential to improve survival and represents a sizable market opportunity. We have now held a pre-registration meeting with Health Canada for the Gliolan® application. We plan to file for registration of Gliolan® with Health Canada in 2019 and anticipate receiving full registration within 6 to 18 months following application.”

– Ken d’Entremont, CEO, Medexus

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 is focused on the therapeutic areas of auto-immune disease and pediatrics. The leading products are Rasuvo™ and Metoject®, a unique formulation of methotrexate (auto-pen and pre-filled syringe) designed to treat rheumatoid arthritis and other auto-immune diseases; and Rupall™, an innovative allergy medication with a unique mode of action.  

For more information, please contact:

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

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

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

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

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

READER ADVISORIES

Forward-Looking Statements

Certain statements made in this press release contain forward-looking information within the meaning of applicable securities laws (“forward-looking statements”). The words “anticipates”, “believes”, “expects”, “will”, “plans” and similar expressions are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Specific forward-looking statements contained in this news release include, but are not limited to, statements with respect to future business operations, the timing of regulatory applications and approvals and the efficacy and success of certain drug therapies. These statements are based on factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, including assumptions based on historical trends, current conditions and expected future developments. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. The Company cautions that although it is believed that the assumptions are reasonable in the circumstances, these risks and uncertainties give rise to the possibility that actual results may differ materially from the expectations set out in the forward-looking statements. Material risk factors include those set out in the Company’s most recent MD&A; future capital requirements and dilution; intellectual property protection and infringement risks; competition (including potential for generic competition); reliance on key management personnel; the Company’s ability to implement its business plan; the Company’s ability to leverage its United States and Canadian infrastructure to promote additional growth, including with respect to the infrastructure of Medexus Inc. and Medac Pharma, Inc. and the potential benefits the Company expects to derive therefrom;, regulatory approval by the Canadian health authorities; product reimbursement by third party payers; patent litigation or patent expiry; litigation risk; stock price volatility; government regulation; and potential third party claims. Given these risks, undue reliance should not be placed on these forward-looking statements, which apply only as of the date hereof. Other than as specifically required by law, the Company undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.

Study Conclusions

Yesterday, Cardiac Dimensions met its primary endpoint. Results from the REDUCE FMR clinical study were published in the Journal of American College of Cardiology: Heart Failure.

In this first blinded and sham-controlled randomized controlled trial of a percutaneous heart valve therapy, REDUCE-FMR, has demonstrated that a low-risk transvenous approach to mitral annuloplasty can successfully and safely reduce FMR. This reduction is associated with reverse LV remodeling. The simplicity of this approach is supported by the study being largely done by centers previously unfamiliar with the technology. Other advantages include the right-sided approach, avoidance of trans-septal puncture and the fact that Carillon® device placement does not preclude any future mitral valve treatment if needed later. Studies are now underway to assess the effect of this approach on clinical outcomes.

Related Article: New Data Confirms Cardiac Dimensions’ Carillon System Provides Acute Hemodynamic Efficacy in Patients with Functional Mitral Regurgitation

Key Findings:

• Treatment with the Carillon® device resulted in a statistically significant reduction of mitral regurgitant volume vs. the control group (decrease of 7.1 mL/beat vs. an increase of 3.3 mL/beat; p=0.049)
• Treatment with the Carillon® device induced a significant reduction of left ventricular volumes vs. the control group, (LVEDV: decrease of 10.4 mL vs. an increase of 6.5 mL; p=0.03 and LVESV: decrease of 6.2 mL vs. an increase of 6.1 mL; p=0.04)
• Significant improvements in regurgitant volume and LVEDV were observed across all MR grades with the absolute improvement in both measures the greatest in patients with MR grades 3+ and 4+ after 12 months (reduction of mitral regurgitant volume: 12.8 ± 21.6 (n=15), change in LVEDV: -26.9 ± 16.3 (n=13) and change in LVESV: -17.5 ± 18.9 (n=13))
• Patients treated with the Carillon® device had a significant improvement in 6-minute walk distance at 12 months compared with baseline (p=0.002) whereas patients in the control group did not (p=0.29)
• Patients in the Carillon® treatment group had a significant improvement in NYHA class at 12 months compared with baseline (p=0.002) whereas patients allocated to the control group did not (p=0.75)
• The Carillon® device showed a positive safety profile with a similar incidence of major adverse events between groups through the follow-up period
• Treatment with the Carillon® device enabled patients to experience 48% fewer repeat (>1) heart failure hospitalizations during follow-up (11% v 21%, p=0.23).

About the Study

The Carillon® mitral contour system, a mitral annuloplasty device delivered percutaneously to the coronary sinus, is designed to reduce the mitral annular dimension by virtue of the close anatomic relationship between the coronary sinus and posterior mitral annulus. The REDUCE-FMR (Carillon® Mitral Contour System for Reducing Functional Mitral Regurgitation) study was the first sham-controlled randomized trial of any catheter-based therapy for patients with valvular heart disease. The aim was to evaluate the effects of the Carillon® device on FMR severity and LV remodeling.

Study Procedures

After undergoing screening for clinical eligibility, patients provided informed written consent. They then underwent quantitative transthoracic echocardiography by appropriately trained local echocardiographers for the assessment of mitral regurgitation and LV structure and function. After review by the local investigator, with the support of the local heart valve disciplinary team according to local practice, a decision was made about the patient’s suitability for the REDUCE-FMR study.

At a subsequent study visit, patients underwent a 6-minute walk test, submitted blood tests for renal function and natriuretic peptides, and completed a Kansas City Cardiomyopathy Quality of Life Questionnaire (KCCQ). Following this, the patients were taken to the cardiac catheterization laboratory, where they were put under either general anesthesia (n=47) or conscious sedation, using headphones and blindfolds (n=73) as required to maintain blinding. Patients underwent coronary angiography through radial or femoral access. A 10-F sheath was inserted into the right internal jugular vein, and a Carillon® delivery catheter was used to engage the coronary sinus.

Quantitative venous angiography was performed. If the venous dimensions were suitable in diameter and length for a Carillon® device, randomization was performed. In patients randomized to sham control, the procedure was terminated and the sheaths withdrawn. In patients randomized to device implantation, an appropriately sized device was inserted into the delivery catheter and deployed. The distal anchor was unsheathed and locked in a suitable segment of the great cardiac vein. Tension was applied, and the proximal anchor was deployed in the desired location if left coronary angiography had confirmed no impingement of or obstruction to flow in the circumflex coronary artery or its branches.

Subsequently, patients underwent echocardiographic and clinical follow-up at 1, 6, and 12 months after the procedure. All echocardiograms were interpreted according to established guidelines. Specifically to the assessment of mitral regurgitation, a multi-parametric and quantitative approach was used to divide FMR into 4 grades. Trial definitions and the published write-up can be reviewed here.

VICTORIA, British Columbia–(BUSINESS WIRE)– Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today announced that it has entered into an Open Market Sales Agreement with Jefferies LLC (“Jefferies”) pursuant to which the Company may from time to time sell, through at-the-market (“ATM”) offerings with Jefferies acting as sales agent, such common shares as would have an aggregate offer price of up to US$40,000,000. Aurinia has also filed a prospectus supplement with securities regulatory authorities in Canada in the provinces of British Columbia, Alberta, and Ontario, and with the United States Securities and Exchange Commission, which supplements Aurinia’s short form base shelf prospectus dated March 26, 2018, and Aurinia’s shelf registration statement on Form F-10 dated March 26, 2018, declared effective on March 29, 2018. The listing of any shares sold pursuant to the ATM offering is subject to the approval of the Toronto Stock Exchange and Nasdaq. Jefferies, at Aurinia’s discretion and instruction, will use its commercially reasonable efforts to sell the common shares at market prices from time to time. Sales in the ATM offering will only be conducted in the United States through Nasdaq or another exchange at market prices. No sales will be conducted in Canada or through the Toronto Stock Exchange.

Related Article: Aurinia Releases Q2 2019 Financial Results

Aurinia currently intends to use the proceeds from sales related to the ATM offering, if any to fund its operations, which includes, but is not limited to, its dry eye syndrome program, clinical development of voclosporin, commercial production of voclosporin (whether for lupus nephritis or other indications), regulatory, pre-marketing and commercialization preparation activities for voclosporin primarily for lupus nephritis, and for general corporate purposes and working capital.

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

Copies of the prospectus supplement and the accompanying prospectus relating to these securities may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 547-6340, or by e-mail at Prospectus_Department@Jefferies.com.

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.

Cautionary Note Regarding Forward-looking Statements

This press release contains forward-looking statements. Forward-looking statements in this news release include, without limitation, statements about the possible sales of common shares and statements that Aurinia intends to use the proceeds from the sale of shares to fund its dry eye syndrome program, clinical development of voclosporin, commercial production of voclosporin (whether for lupus nephritis or other indications), regulatory, pre-marketing and commercialization preparation activities for voclosporin primarily for lupus nephritis, and for working capital and general corporate purposes. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, the ability of the Company to protect its intellectual property rights, securing and maintaining corporate alliances and partnerships, the need to raise additional capital and the effect of capital market conditions and other factors on capital availability, the potential of its products, the success and timely completion of clinical studies and trials, and the combined company’s and its partners’ ability to successfully obtain regulatory approvals and commercialize voclosporin on a timely basis. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. For additional information on risks and uncertainties relating to these forward-looking statements, investors should review the prospectus supplement and accompanying prospectus and consult the Company’s ongoing quarterly filings, annual reports, and the Annual Information Form and other filings found on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.

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

Corvia Medical is actively enrolling and sponsoring a first-of-its-kind 100+ site, global, Phase 3 clinical trial leveraging continuous multivariate wearable sensor data and artificial intelligence (AI) based analytics to evaluate the clinical efficacy of it’s InterAtrial Shunt Device (IASD®) in patients with heart failure. In addition to measuring traditional heart failure endpoints, Corvia has partnered with PhysIQ to leverage its remote monitoring platform which will continuously collect physiological data and utilize AI to assess the therapeutic impact and disease progression.

“Heart Failure is a major global health problem and HF with preserved and mid-range ejection fraction remains a large unmet need. At Corvia Medical, we are evaluating a first-in-class approach to treating heart failure and, as such, see a powerful opportunity to include digital data to support IASD efficacy. It’s in this innovative spirit that we chose to partner with physIQ and bring novel real-world insights into how to assess therapeutic impact.”

– Dr. Jan Komtebedde, Chief Medical Officer, Corvia Medical

In the randomized controlled double-blinded study, enrolled patients are provided with a wearable biosensor and mobile data transfer hub. Each patient wears the biosensor prior to study randomization to establish a personalized pre-intervention baseline and then for up to 12 months after the device implant. Data will continuously stream from the biosensor to the cloud for retrospective analysis with PhysIQ’s proprietary analytics platform. With real-world data and personalized analytics, the objective is to assist in demonstrating a meaningful change in cardiopulmonary function and support novel clinical endpoints.

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

Of particular note in the REDUCE LAP HF-II study is the fact that the continuous biosensor data and Artificial Intelligence analytics will be generated in conjunction with the periodic evaluation of the six-minute walking distance test (6MWDT) and Kansas City Cardiomyopathy Questionnaire (KCCQ) assessments. By integrating these traditional markers of heart failure, novel continuous multivariate biosensor data, and hard clinical outcomes, there is an extraordinary opportunity to transform how heart failure clinical trials are designed, implemented, and evaluated.

“With our solution, we are developing biomarkers with life science companies that allow them to quantify clinical impact on a continuous basis – and this insight can be applied in a clinical context to support regulatory submissions or to demonstrate real world evidence to payers and providers.”

– Matt Pinpke, Chief Technology Officer, PhysIQ

The study is anticipated to complete enrollment in 2020 and, upon conclusion, will generate more than 2 million hours of continuous, annotated, clinical-level physiological data.

About Corvia Medical, Inc.

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

About PhysIQ

PhysIQ is a company dedicated to enabling proactive care delivery models through pinpointIQ™, its highly scalable cloud-based platform for personalized physiology analytics. Our FDA 510(k)-cleared data analytics platform is designed to process multiple vital signs from wearable sensors to create a personalized dynamic baseline for each individual. By mapping vital sign relationships this way, physIQ’s analytics detect subtle deviations that may be a precursor to disease exacerbation or change in health. With applications in both healthcare and clinical trial support, PhysIQ is transforming continuous physiological data into insight for providers, health systems, payers and pharmaceutical, and medical device companies.

Media Contact

Jodi Perkins
Jodi@outlookmarketingsrv.com
(847) 508-0877

TORONTO, Sept. 10, 2019 /PRNewswire/ – Exact Imaging, the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, has received CE Mark approval for its Sterile Transperineal Needle Guide for use with Exact Imaging EV29L transducer.

Operating on the ExactVu™ micro-ultrasound system, the Sterile Transperineal Needle Guide now allows urologists to perform targeted prostate biopsies leveraging the near-microscopic resolution of the micro-ultrasound for transperineal-based biopsies.  The ExactVu™ system provides the highest real-time resolution for the guidance of prostate biopsies and with the growth of demand for the system in European markets and facilities that favor transperineal approaches for prostate biopsies, it is now able to be used in those clinical settings.

“The ability to perform targeted transperineal biopsies guided by ExactVu 29 MHz micro-ultrasound represents a real breakthrough by virtue of being able to image the target volume in real-time in the office.”

– Mark Emberton, Professor of Interventional Oncology, Division of Surgery and Interventional Science, University College London (UCL) and Clinical Director, Clinical Effectiveness Unit, Royal College of Surgeons of England

Related Article: Exact Imaging’s Abdominal Imaging Release Receives CE Mark Approval

The ExactVu™ micro-ultrasound system, its FusionVu™ application and the newly released Sterile Transperineal Needle Guide will be showcased live at the forthcoming major European urology meetings, DGU 2019 in Hamburg, SIU 2019 Congress in Athens, ESUI19 / EMUC19 in Vienna, and AFU 2019 in Paris.

“In some markets, there is increasing movement towards transperineal-based biopsies, with the aim of reducing rates of infection. With the CE Mark for our new Sterile Transperineal Needle Guide, the ExactVu micro-ultrasound system can now be used in all clinical settings for targeted prostate biopsies, including FusionVu™ and cognitive fusion biopsies.”

– Randy AuCoin, President & CEO, Exact Imaging

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). 

SEATTLE, Sept. 6, 2019 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for the 14-Day version of the Carnation Ambulatory Monitor (“CAM™”), the industry’s only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device. Developed to provide clinicians greater flexibility in cardiac monitoring over a longer period, the award-winning CAM patch will now be offered in a 14-day extended wear version that utilizes the same innovative P-wave focused technology that powers the existing 2-Day and 7-Day CAM product lines.

“Comfortable dermal ECG recordings that focus on the P-wave for up to 14 days carry the potential to minimize the use of costly additional rhythm diagnostic tools. We are excited to receive clearance from the FDA to enable clinicians the option to monitor longer and anticipate incremental detection of accurate, medically actionable data to improve patient management.”

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

The CAM patch’s breakthrough technology reliably detects and records the P-wave, a small amplitude signal of the ECG originating in the atrium that is essential to accurate arrhythmia diagnosis and patient management. Unlike other commercially available patches that include licensed, acquired, or off-the-shelf technologies, the CAM was specially engineered by BardyDx engineers for optimal detection and recording of the P-wave in relation to the rest of the ECG signal to deliver industry-leading diagnostic accuracy. The critically acclaimed disruptive technology has been well-received by clinicians, particularly for its ease of use and workflow-friendly design, which allows patients to mail the device back for analysis or the physician office to upload data from a patient’s monitor within several minutes upon completion of a study.

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

The new 14-Day CAM patch enables up to double the duration of P-wave optimized detection and monitoring over the current 7-Day CAM patch, potentially discovering additional, less-frequent arrhythmias. The clinical value of P-wave focused detection was highlighted in the American Heart Journal that published the results of a head-to-head comparison with the iRhythm Zio® XT patch. The study, “Comparison of two ambulatory patch ECG monitors: The benefit of the P-wave and signal clarity,” (Am Heart J 2018; 203:109-117) concluded that the BardyDx CAM patch identified 40% more arrhythmias and resulted in better, more informed clinical decision-making in 41% of patients compared to the iRhythm Zio XT patch. 

In addition, a preceding study comparing the BardyDx CAM patch and a traditional Holter monitor, entitled “Comparison of diagnostic value using a small, single channel, P-wave centric sternal ECG monitoring patch with a standard 3-lead Holter system over 24 hours,” (Am Heart J 2017; 185:65-73) showed a four times increase in arrhythmia detection using the CAM patch, including arrhythmias missed or incorrectly identified using the Holter monitor. The study concluded that the CAM patch offered significantly improved rhythm diagnosis and avoided inaccurate diagnoses made using a Holter monitor.

“Combining the excellence of our proven P-wave technology with the capability of longer duration monitoring produces an unmatched cardiac monitoring solution. We are excited to offer a 14-Day CAM patch that truly provides value for clinicians and patients alike.”

–  Ken Nelson, Chief Commercial Officer, BardyDx

The innovative P-wave centric CAM patch continues to distinguish itself in an increasingly crowded market of cardiac monitoring patch entrants. Recently, BardyDx was named the winner of the 2019 MedTech Breakthrough Award for Best New Diagnostic Technology and the winner of the 2019 Frost & Sullivan Award for Technology Innovation in Remote Cardiac Monitoring. Also, BardyDx has been 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 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