OSTON and MONTRÉAL, Oct. 29, 2020 /PRNewswire/ -enGene Inc., a biotechnology company developing non-viral gene therapies for local administration into mucosal tissues enabled by its proprietary DDX platform, announced today an award from the Cystic Fibrosis Foundation for the discovery of genetic medicines to treat patients with cystic fibrosis (CF).

The award was made as a part of the CF Foundation’s $500 million Path to a Cure initiative to accelerate the discovery and development of treatments that address the underlying cause of the disease.

Affecting over 75,000 patients worldwide, CF is a genetic disease caused by mutations in a gene known as the cystic fibrosis transmembrane conductance regulator (CFTR) that render a non-functional CFTR protein. Consequently, multiple organs are affected by disease, chief among them the lungs, where chronic infections and a worsening ability to breathe leads to progressive lung damage and premature death. Patients with nonsense and other rare mutations in both copies of the CFTR gene currently have no therapies that treat the underlying cause of the disease.

“Gene therapy holds promise for the treatment of CF by delivering a functional copy of the CFTR gene to the lungs to restore function and alleviate disease. enGene is developing a DDX-based inhalable formulation to carry DNA to the airways with the goal of functional complementation of CFTR mutations. We are thrilled to have the support of the Cystic Fibrosis Foundation to discover novel gene therapy candidates for patients with CF,” commented Jose Lora, CSO of enGene.

In developing an inhalable gene therapy for CF, enGene is coupling a non-viral DNA payload to its biocompatible DDX carrier in an effort to create genetic medicines that allow repeatable and titratable dosing to achieve meaningful efficacy.

“Gene therapies have made a remarkable impact in many fields of medicine, but unlocking their full potential in mucosal tissues such as the lung has been elusive, leaving many patients with CF without available treatment options. We are honored to be working with the CF Foundation to accelerate our research and development efforts towards improving and extending the lives of all CF patients,” said Jason Hanson, enGene’s President and CEO.

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 with broad tissue and disease applications. In addition to developing gene therapies for the lungs, enGene has developed a unique dual-immune activator for patients with non-muscle invasive bladder cancer which has completed IND-enabling studies. The company is evolving its technology to enable applications in multiple mucosal tissues with areas of high unmet medical need. www.engene.com/

Note regarding forward-looking statements
This press release contains certain “forward-looking statements” that reflect the Company’s beliefs and assumptions based on currently available data and information. These forward-looking statements fall within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on enGene’s current beliefs, expectations, and assumptions that by definition involve risks, uncertainties, that are difficult to predict and are subject to factors outside of management’s control and that could cause actual results to differ substantially from statements made including but not limited to: risks associated with the success of preclinical studies, clinical trials, research and development programs, as well as regulatory approval processes. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. enGene has no approved drugs available for sale marketing at this time and may never have an approved drug. You are cautioned not to rely on enGene’s forward looking statements, which are only made as of the date hereof. The Company is under no obligation to update these statements.

SOURCE enGene

TORONTO, Oct. 20, 2020 /PRNewswire – AmacaThera Inc. is pleased to announce approval from Health Canada to proceed to a Phase 1 clinical trial with its lead asset, a long-acting anesthetic formulation for the treatment of post-surgical pain.

“This huge milestone was achievable due to all of the hard work and the relentless nature of the AmacaThera team,” co-founder and CEO Dr. Mike Cooke remarked.

“In a matter of 18 months, AmacaThera has gone from a proof-of-concept technology housed at the University of Toronto to a clinical-stage company. This important milestone validates the strong scientific basis of the technology and supports our confidence in the team,” stated Peter van der Velden, Managing Partner, Lumira Ventures.

Mike Serrano-Wu, Partner, Sprout BioVentures (Boston) said: “We congratulate AmacaThera on reaching this key milestone and are excited that its quest to bring better solutions to patients will not be slowed by COVID-19.”

Co-founder and CSO Dr. Molly Shoichet added: “We are thrilled to bring our lead indication to the clinic as this substantiates what we have seen in the lab. Amaca gel has shown broad utility with an array of small-molecule drugs, biologics and cells for many different indications. We are excited to explore these opportunities and diversify our product pipeline with corporate partnerships.”

AmacaThera is funded by Lumira Ventures, Sprout BioVentures/Viva BioInnovator and Grey Sky Venture Partners.

Article Link

As COVID-19 continues its destructive path as the most formidable global pandemic in a century, pharmaceutical companies around the globe are racing to develop drug treatments to mitigate the damage. Edesa Biotech, Inc., headquartered in Markham, Ont., is on the frontlines of that fight. Edesa has a monoclonal antibody designed to treat acute respiratory distress system (ARDS), the leading cause of death for patients with COVID-19. “Given how COVID-19 changed the world overnight, and how severe the disease has been, we decided to prioritize our ARDS project to see if we can help patients in the near future,” says Dr. Par Nijhawan, chief executive officer of Edesa, which he founded in 2015 ARDS is a common condition that affects three million patients a year around the world.

It can impact all age groups and results from multiple potential triggers, including viral, bacterial or chemical. Even prior to COVID-19, ARDS accounted for about ten per cent of all ICU beds in the world.During the current pandemic, ARDS has occurred in up to 42 per cent of hospitalized COVID-19 patients, and up to 85 per cent of patients in the ICU, according to the U.S. Centers for Disease Control. The syndrome is primarily caused by an exaggerated immune response to the infection. After the virus enters the body, the body naturally tries to defend itself by triggering an immune response, but in severe patients the exaggerated, prolonged response results in dangerous inflammation, damage and fluid build-up in the lungs. “As COVID-19 patients clinically progress towards ARDS, key inflammatory mediators are often increased. As a result, you get increased cell damage, because even though the immune response is trying to prevent the body from getting damaged, the reality is that the inflammation itself is causing most of the damage,” Dr. Nijhawan explains.

Edesa’s experimental therapy, which targets and inhibits toll-like receptor 4 (TLR4), is intended to suppress this inflammation by blocking the initiation of a key pathway implicated in acute lung injury. Edesa has filed a Clinical Trial Application with Health Canada, which has approved the Phase 2/Phase 3 study. Edesa has also completed the manufacturing/formulation of the drug product to be used in the study.“Our product candidate has already been used in humans and has demonstrated a favourable safety profile. We are looking to getting into clinical trials very shortly and hopefully have an approvable product in the near term,” says Dr. Nijhawan.Ultimately, he believes that focusing on the prevention or treatment of ARDS can lessen the worry about COVID mutations and could also help allow economies to be safely opened up with the assurance that a therapy is available for somebody with even the most severe reaction.“We can potentially take away the biggest fear factor. Especially with COVID being so rampant in the U.S, we feel it will make a difference.” Dr. Nijhawan adds.

Source: BIOTECanada, Insights Fall 2020.
https://issuu.com/biotecanada_insights/docs/insights_fall_2020/84

MINNEAPOLIS, Sept. 9, 2020 /PRNewswire/ — HistoSonics, developer of the non-invasive Edison platform and novel sonic beam therapy, announced today the appointment of Joe Amaral, MD, to the newly created position of Vice President of Medical Affairs, where he will oversee global clinical development initiatives for the company.  Dr. Amaral brings with him more than 35 years of significant clinical and executive leadership in the healthcare space.  Most recently, Dr. Amaral was Global Vice President of Surgical Innovation at Ethicon, Inc. where he developed industry leading hepatobiliary and minimally invasive surgical strategies, led multiple technology investments and acquisitions, and drove new product developments that resulted in advancing minimally invasive therapies across the globe, impacting the lives of a countless number of physicians and patients.

Prior to his career with Johnson & Johnson, Dr. Amaral was President and CEO of Rhode Island Hospital and its pediatric division, Hasbro Children’s Hospital.  Dr. Amaral has also previously served as the Chairman of the Department of Surgery at Brown University School of Medicine, Chief of Surgery at Rhode Island Hospital, and President of University Surgical Associates.  Dr. Amaral was also a Professor of Surgery at Brown University School of Medicine, is a member of 25 professional societies, author of over 100 clinical papers and book chapters, and has delivered over 400 national and international presentations. 

As an innovator of companies and technology, Dr. Amaral’s hallmark success was at Ultracision®, co-developing the Harmonic Scalpel, the first ultrasonically activated cutting and coagulating surgical device.  The technology, which is used globally, enabled minimally invasive surgery and is considered one of the major advancements in surgical technology of the past twenty years. 

“We are extremely excited to add Joe to our company and senior team,” said HistoSonics’ President and CEO, Mike Blue.  “He brings an incredibly unique set of skills and experiences as a surgeon, innovator, and hospital and corporate executive, and he will be a significant asset to the team as we continue to build our long-term strategy and enter a new stage of growth.”

Dr. Amaral commented, “Rarely in one’s medical career do you see something that makes you stop and say, the world just changed.  That was my immediate reaction when I was first introduced to HistoSonics.  Histotripsy has the potential to change all aspects of patient care by enabling precise, tissue sparing, non-invasive treatments.  I could not be more fortunate and humbled than to have the opportunity to work with an amazingly talented team to bring the future of non-invasive, or minimally invasive care to benefit patients.”

Earlier this year, HistoSonics raised $40M in a Series C-1 financing to be used for continued development of its Edison™ Platform, global clinical studies, and new strategic projects.

About HistoSonics

HistoSonics is a venture-backed medical device company developing a non-invasive platform and novel sonic beam therapy utilizing the science of histotripsy. The company’s new platform delivers personalized, tissue specific treatments with unparalleled precision and control, and without the undesirable side effects of many of today’s interventional and surgical modalities.  Histotripsy was developed at the University of Michigan and exclusively licensed to HistoSonics.  The company is led by a team of experienced domain experts and industry leaders with offices in Ann Arbor, Michigan and Minneapolis, MN.

For more information please visit: www.histosonics.com

SOURCE HistoSonics, Inc.

ATLANTA, Sept. 1, 2020 /PRNewswire/ — Antios Therapeutics, Inc. (“Antios”), a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure viral diseases, announced today the publication of preclinical results of ATI-2173, Antios’ lead oral drug candidate for treating patients infected with Hepatitis B virus (HBV).

The manuscript, published in the peer-reviewed journal Antimicrobial Agents and Chemotherapy and titled ATI-2173, a Novel Liver-Targeted Non-Chain-Terminating Nucleotide for Hepatitis B Virus Cure Regimens, described ATI-2173 as a selective inhibitor of HBV with an anti-HBV 50% effective concentration (EC50) of 1.31nM in primary human hepatocytes and minimal to no toxicity in hepatocytes, skeletal muscle, liver, kidney, bone marrow, and cardiomyocytes. ATI-2173 showed good oral bioavailability with liver targeting in rat and cynomolgus monkey studies, leading to reduced systemic plasma and skeletal muscle exposure while still maintaining effective concentrations of the active 5′-triphosphate in the liver.

“Unlike chain terminating nucleos(t)ide analogues, the active 5′-triphosphate of ATI-2173 is a non-chain-terminating inhibitor of the HBV polymerase that could potentially be combined with currently approved chain terminating nucleos(t)ide analogues, as well as other classes of HBV inhibitors in development,” said Abel De La Rosa, Ph.D., CEO of Antios.

Douglas Mayers, M.D., Chief Medical Officer of Antios said, “This research highlights the favorable preclinical profile of ATI-2173. We are excited to have started our phase I clinical studies.”

A phase I clinical trial is ongoing to investigate the safety, tolerability, pharmacokinetics, and anti-HBV activity of ATI-2173 in healthy subjects and subjects with chronic HBV infection.

About ATI-2173

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

About Antios Therapeutics Inc.

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

Media Contact:

pr@antiostherapeutics.com

SOURCE Antios Therapeutics, Inc.

Forbius’s Lead TGF-beta Asset, AVID200, is an Isoform-Selective TGF-beta Inhibitor, Currently in Phase 1 for Oncology and Fibrosis

NEW YORK & MONTREAL– Bristol Myers Squibb (NYSE: BMY) and Forbius, a privately held, clinical-stage protein engineering company that designs and develops biotherapeutics for the treatment of cancer and fibrotic diseases, today announced that they have entered into a definitive agreement under which Bristol Myers Squibb will acquire Forbius. Forbius has developed a portfolio of highly selective and potent inhibitors of TGF-beta 1 & 3, which are key mediators of immunosuppression and fibrosis. The transaction includes an upfront payment and future success-based milestone payments. Prior to closing, Forbius’ non-TGF-beta assets will be transferred to a newly formed private company, which will be retained by Forbius’ existing shareholders.

The companies anticipate completing the transaction in the fourth quarter of 2020, subject to the satisfaction of customary closing conditions.

Under this transaction, Bristol Myers Squibb would acquire Forbius’s TGF-beta program, including the program’s lead investigational asset, AVID200. TGF-beta is a key cytokine that regulates various cell processes, including regulation of the immune system. Selective inhibition of TGF-beta 1 & 3 may enhance anti-tumor efficacy by acting synergistically with immunotherapy. Bristol Myers Squibb intends to initially focus research and development efforts of AVID200 in oncology and may consider advancing the asset in other disease areas, such as fibrosis.

“With this acquisition, we extend our leading position in oncology by including new pathways that complement our expansive oncology pipeline with the potential to serve more patients with cancer, including those who may not respond to immunotherapy,” said Rupert Vessey, M.A., B.M., B.Ch., F.R.C.P., D.Phil., Executive Vice President & President, Research & Early Development, Bristol Myers Squibb. “As a science driven company, this transaction shows our continued commitment to source innovation internally and externally to develop new treatments for patients with significant unmet medical needs.”

“Our portfolio of highly selective TGF-beta inhibitors has shown potential across a broad range of therapeutic areas,” said Ilia A. Tikhomirov, President and CEO of Forbius. “We are proud that Bristol Myers Squibb recognizes this potential given their global leadership in oncology and unique position to translate innovative science into meaningful treatments for patients with cancer across the globe.”

– PDUFA action date of February 15, 2021 assigned by U.S. Food and Drug Administration
– Priority Review for trilaciclib is based on positive data from three randomized clinical trials showing robust myelopreservation benefits
– G1 launching expanded access program (EAP) for patients with small cell lung cancer in the U.S.

RESEARCH TRIANGLE PARK, N.C., Aug. 17, 2020 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for trilaciclib for small cell lung cancer (SCLC) patients being treated with chemotherapy and granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of February 15, 2021. Trilaciclib is a first-in-class investigational therapy designed to preserve bone marrow and immune system function during chemotherapy and improve patient outcomes.

“There are currently no available therapies to protect patients from chemotherapy-induced toxicities before they occur,” said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. “If approved, trilaciclib would be the first proactively administered myelopreservation therapy that is intended to make chemotherapy safer and reduce the need for rescue interventions, such as growth factor administrations and blood transfusions.”

The FDA grants Priority Review to applications for potential therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. The trilaciclib NDA was supported by compelling myelopreservation data from three randomized, double-blind, placebo-controlled clinical trials in which trilaciclib was administered prior to chemotherapy treatment in patients with SCLC. Trilaciclib has been granted Breakthrough Therapy Designation by the FDA. In the NDA acceptance letter, the FDA also stated that it is currently not planning to hold an advisory committee meeting to discuss this application.

“While undergoing chemotherapy, many patients experience significant myelosuppression, become fatigued and susceptible to infection, and often require transfusions and growth factor administrations,” said Jared Weiss, M.D., Lineberger Comprehensive Cancer Center, University of North Carolina Chapel Hill, NC. “Preventing bone marrow damage proactively is an opportunity to improve the quality of life of patients receiving chemotherapy for small cell lung cancer and reduce costly rescue interventions.”

Myelosuppression is the result of damage to bone marrow stem cells and is one of the most common side effects of chemotherapy. Myelosuppression can lead to serious conditions such as anemia, neutropenia or thrombocytopenia, which have broad ranging clinical, patient experience and economic impacts on ongoing cancer treatment and overall outcomes. In clinical trials, trilaciclib significantly reduced chemotherapy-induced myelosuppression, and patients receiving trilaciclib experienced fewer dose delays/reductions, infections, hospitalizations, and need for rescue therapies compared to patients receiving chemotherapy alone.

Expanded Access Program
G1 is making trilaciclib available to SCLC patients in the U.S., who are unable to enter clinical trials and for whom there are no appropriate alternative treatments while the trilaciclib NDA is under regulatory review, pursuant to FDA’s expanded access program (EAP). To facilitate needed access through the EAP, G1 is collaborating with Bionical Emas, a global specialist clinical research organization (CRO). For more information about the EAP access to trilaciclib, email patient.access.us@Bionical-emas.com.

“Complications from myelosuppression have been a long-standing challenge when treating patients with SCLC,” said Dr. Malik. “Establishing an expanded access program provides qualified patients in serious need with access to trilaciclib while the NDA is under review.”

Trilaciclib in Small Cell Lung Cancer
Trilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy. In 2019, trilaciclib received FDA Breakthrough Therapy Designation, and, in June 2020, G1 submitted the NDA based on myelopreservation data from three randomized, double-blind, placebo-controlled clinical trials in which trilaciclib was administered prior to chemotherapy in patients with small cell lung cancer (SCLC). In August 2020, G1 received FDA Priority Review with the Prescription Drug User Fee Act (PDUFA) date of February 15, 2021.

In June 2020, G1 announced a co-promotion agreement with Boehringer Ingelheim for trilaciclib in small cell lung cancer in the U.S. and Puerto Rico. If approved, G1 will lead marketing, market access and medical engagement initiatives for trilaciclib. The Boehringer Ingelheim oncology commercial team, well-established in lung cancer, will lead sales force engagement initiatives. G1 will book revenue and retain development and commercialization rights to trilaciclib and pay Boehringer Ingelheim a promotional fee based on net sales. The three-year agreement does not extend to additional indications that G1 is evaluating for trilaciclib. Press release details of the G1/ Boehringer Ingelheim agreement can be found here.

Evaluating Trilaciclib in Other Cancers
In a randomized trial of women with metastatic triple-negative breast cancer, preliminary data showed that trilaciclib improved overall survival when administered in combination with chemotherapy compared with chemotherapy alone. The company plans to present final overall survival data from this trial in the fourth quarter of 2020. Trilaciclib is being evaluated in neoadjuvant breast cancer as part of the I-SPY 2 TRIAL™, and the company expects to initiate a Phase 3 trial in patients treated with chemotherapy for colorectal cancer in the fourth quarter of 2020.

About G1 Therapeutics
G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of next generation therapies that improve the lives of those affected by cancer. The company is developing and advancing two novel therapies: trilaciclib is a first-in-class therapy designed to improve outcomes for patients being treated with chemotherapy; rintodestrant is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. In 2020, the company out-licensed global development and commercialization rights to its differentiated oral CDK4/6 inhibitor, lerociclib.

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

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 press release include, but are not limited to, those relating to the therapeutic potential of trilaciclib, rintodestrant and lerociclib, the timing of marketing applications in the U.S. and Europe for trilaciclib in SCLC, trilaciclib’s possibility to improve patient outcomes across multiple indications, rintodestrant’s potential to be best-in-class oral SERD, lerociclib’s differentiated safety and tolerability profile over other marketed CDK4/6 inhibitors, our reliance on partners to develop and commercial licensed products, and the impact of pandemics such as COVID-19 (coronavirus), 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.

Contacts:
Investors:
Jeff Macdonald
G1 Therapeutics, Inc.
Senior Director, Investor Relations & Corporate Communications
919-907-1944
jmacdonald@g1therapeutics.com
Media:
Christine Rogers
G1 Therapeutics, Inc.
Associate Director, Corporate Communications
984-365-2819
crogers@g1therapeutics.com

ASCEND results expected to support STS101 NDA filing in Q4 2021

SOUTH SAN FRANCISCO, Calif., Aug. 06, 2020 (GLOBE NEWSWIRE) — Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company, today announced the initiation of patient enrollment in the ASCEND trial,  a multi-center, open-label, 12-month study to evaluate the safety and tolerability of STS101 (dihydroergotamine (DHE) nasal powder) as an acute treatment for migraine.

“We are pleased to have enrolled the first patient in our Phase 3 open-label, safety trial of STS101,” commented John Kollins, Satsuma’s President and Chief Executive Officer. “We anticipate that the results of the ASCEND trial will support the long term safety and tolerability of STS101 as an acute treatment for migraine when patients administer the product candidate on an as-needed basis.  The ASCEND trial is complementary to our STS101 EMERGE Phase 3 pivotal trial, which has completed the patient treatment phase and for which we expect to report topline results in late September or early October 2020.”

The STS101 ASCEND open-label, safety trial will enroll subjects between 18 and 65 years of age who have a history of migraine and will be conducted at geographically diverse sites located throughout the United States.  The primary objective of the trial is to evaluate the long-term safety of STS101 as an as-needed acute treatment for migraine.  Secondary outcome measures include efficacy evaluations, for example proportion of subjects free from pain and most bothersome symptom (from among photophobia, phonophobia and nausea) at multiple time points up to 48 hours following administration of STS101.  The trial is expected to enroll up to 300 subjects, with at least 150 subjects treating a minimum of two migraine attacks per month with STS101 over a six-month period and at least 50 participants over a 12-month period.  The Company anticipates that data from the ASCEND trial, in conjunction with results from the STS101 EMERGE Phase 3 pivotal trial, if successful, will support a New Drug Application filing in the fourth quarter of 2021.
                    
For further information regarding the STS101 Phase 3 ASCEND safety trial, see www.ClinicalTrials.gov, identifier NCT04406649:  A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine (ASCEND).

For further information regarding the STS101 Phase 3 EMERGE efficacy trial, see www.ClinicalTrials.gov, identifier NCT03901482:  A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine (EMERGE).

About Satsuma Pharmaceuticals and STS101

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

Satsuma is headquartered in South San Francisco, California with operations in both California and Research Triangle Park, North Carolina. 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 expectations with regard to the initiation and availability of data to be derived from its ongoing and planned Phase 3 clinical trials; and the timing and likelihood of regulatory filings and approvals for STS101. 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 March 31, 2020, filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of STS101; the results of preclinical and clinical studies may not be predictive of future results; the risk that the COVID-19 worldwide pandemic may negatively impact the Company’s business, operations, clinical trials or ability to raise capital; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; 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
212-915-2577
cdavis@lifesciadvisors.com

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

Breakthrough medical platform offers vision of non-invasive procedures to eliminate diseased tissues and tumors

MINNEAPOLIS, June 8, 2020 /PRNewswire/ — HistoSonics, developer of a non-invasive robotic platform and sonic beam therapy, announced today that it has closed $40 million in an oversubscribed Series C-1 financing.  The round was led by Yonjin Venture, LLC, who specializes in innovative early and mid-stage life science companies, and included additional new strategic investors.  Also participating were existing investors Varian Medical Systems, Inc., Johnson & Johnson Innovation – JJDC, Inc. (JJDC), Venture Investors, Lumira Ventures, State of Wisconsin Investment Board, and others.  The financing will be used to accelerate activities focused on the Company’s Edison™ Platform, as well as launch new strategic projects. 

HistoSonics’ Edison Platform uses advanced imaging and proprietary sensing technology to deliver non-invasive, personalized treatments with unparalleled precision and control, and uses the science of histotripsy and focused sound energy to generate pressures strong enough to liquify and completely destroy targeted tissues at sub-cellular levels. The company believes that the novel mechanism of action of their proprietary technology provides significant advantages to patients, including the ability of the treatment site to recover and heal quickly, as well as provides physicians the unique ability to monitor the destruction of tissue under continuous real-time visualization and control, unlike any modality that exists today.

“We believe that having the ability to precisely destroy targeted tissue without entering the body and without the use of radiation or thermal energy, will provide meaningful change to patients and the physicians who care for them.” said Mr. Wen Chen, Venture Partner at Yonjin Venture.  “We believe that histotripsy and the Edison Platform have the ability to provide meaningful clinical, quality of life, and economic benefits across a very broad range of applications, starting in the liver, and with far reaching implications, and we are excited to join HistoSonics on this journey.”

As part of the financing, HistoSonics will add Mr. Chen to their Board of Directors.  Prior to joining Yonjin, Mr. Chen held the positions of Senior Vice President, Head of Business Development and Operations at Tigermed, a publicly traded company located in China, Chief Operating Officer of HD Biosciences, and Executive Vice President of HUYA Bioscience International.  Mr. Chen received his bachelor’s degree in Biochemistry from Purdue University, a master’s degree in Immunology and Oncology from Washington University in St. Louis, and a Master of Business Administration from Durham University.

“We are thrilled to welcome Wen and the team from Yonjin Venture”, commented HistoSonics’ President and CEO, Mike Blue.  “Their deep experience and domain expertise in strategic markets, as well as passion for our mission and vision, were very important to us in a partner, and we look forward to working closely with their team moving forward to execute on our global plan.”

In addition to the Series C-1 financing, HistoSonics also recognized progress across many of the company’s key imperatives including their first-in-human liver tumor study, encouraging on-going preclinical research in the University of Michigan Immunology Lab, new manufacturing facility and executive offices in Minneapolis, and continued expansion of key personnel. 

About HistoSonics

HistoSonics is a venture-backed medical device company developing a non-invasive platform and novel sonic beam therapy utilizing the science of histotripsy. The company’s new platform delivers personalized, tissue specific treatments with unparalleled precision and control, and without the undesirable side effects of many of today’s interventional and surgical modalities.  Histotripsy was developed at the University of Michigan and exclusively licensed to HistoSonics.  The company is led by a team of experienced domain experts and industry leaders with offices in Ann Arbor, MI. and Minneapolis, MN.

For more information please visit: www.histosonics.com/

• Initial results demonstrate anti-fibrotic effects of AVID200 as indicated by rapid and sustained declines in skin fibrosis.
• AVID200 was well-tolerated, and no dose-limiting toxicities, SAEs or adverse events greater than Grade 2 were observed. The MTD was not reached.
• AVID200 demonstrated pharmacodynamic responses as shown by modulation of downstream targets of TGF-beta and biomarkers associated with scleroderma disease activity.

Austin, TX, and Montreal, QC (Jun. 5, 2020) – Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat fibrosis and cancer, today presented the first AVID200 Phase 1b results from its scleroderma development program in a poster tour at the Annual European Congress of Rheumatology (EULAR) 2020.

“The results seen to date in this Phase 1 trial with AVID200 are compelling. MRSS, a measure of skin fibrosis, declined in all patients and was supported by patient reported outcomes and biomarker modulation. These results, along with the favorable safety profile, demonstrate that AVID200 has the potential to be a disease modifying treatment of fibrotic diseases such as systemic sclerosis,” commented Robert Lafyatis, M.D., Medsger Professor and Director of the University of Pittsburgh Scleroderma Center at the University of Pittsburgh Medical Center, and coordinating PI in the trial.

Highlights of the presentation, “Safety, Target Engagement, and Initial Efficacy of AVID200, a First-in-Class Potent and Isoform-Selective Inhibitor of TGF-beta 1 and 3, in Patients with Diffuse Cutaneous Systemic Sclerosis (dcSSc): A Phase 1 Dose Escalation Study (Abstract # THU0329)”, included:

• A total of nine patients received escalating doses of AVID200 at 1, 3 and 9 mg/kg once every two weeks and have completed the initial treatment period (3 cycles). AVID200 was well-tolerated, and no dose-limiting toxicities, SAEs or adverse events greater than Grade 2 were observed. The MTD was not reached.
• All patients reported a reduction in skin fibrosis following the initial treatment period as measured by a decline in Modified Rodnan Skin Score (MRSS). 5 out of 9 patients reported declines between -8 and -10 points, representing a reduction between -25 and -45% from baseline.
• AVID200 also demonstrated an improvement in patient reported outcomes in a majority of patients as well as pharmacodynamic responses as shown by modulation of downstream targets of TGF-beta and biomarkers associated with scleroderma disease activity.

AVID200 is a first-in-class, selective inhibitor of TGF-beta 1 & 3, the central mediators of fibrosis. AVID200 spares TGF-beta 2 for optimal safety.

The Phase 1b clinical study in patients with diffuse cutaneous systemic sclerosis (AVID200-01, NCT03831438) is designed to assess the safety and initial anti-fibrotic activity of escalating doses of AVID200.

– END –

About TGF-beta 1 & 3

TGF-beta 1 & 3 are central mediators of fibrosis, a leading cause of morbidity and mortality worldwide. TGF-beta 1 & 3 drive fibrosis by promoting the accumulation of extracellular matrix proteins in tissues; consequently, their inhibition is proposed to have broad potential as an anti-fibrotic therapy across several indications with high unmet need.

About AVID200 and the AVID200-01 Trial (NCT03831438)

Systemic Sclerosis (SSc) is a rare, severe and progressively debilitating fibrotic disease that predominately affects women in mid-life. The 10-year survival rate of SSc patients is approximately 55%. No therapeutic is currently approved for the treatment of SSc, which affects an estimated 90,000 people in the U.S. alone.

AVID200-01 (NCT03831438) is a Phase 1 open-label, dose-escalation study to evaluate safety, pharmacokinetics, pharmacodynamics and anti-fibrotic activity of AVID200 in patients with documented diffuse cutaneous SSc.

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.

Contact

Ilia Tikhomirov, CEO
ir@forbius.com

DARTMOUTH, Nova Scotia–(BUSINESS WIRE)– IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company, today announced its intention to complete a private placement (the “Private Placement”) of 7,797,203 units of the Company (each, a “Unit”) at the market price of Cdn$2.86 per Unit based on the volume-weighted average price calculated over the 5 days ending Friday, April 24, 2020.

With aggregate gross proceeds of approximately Cdn$22.3 million this non-brokered private placement is being co-led by Fonds de Solidarité FTQ, an existing investor, and Lumira Ventures, a new investor in the Company, along with participation by Altium Capital, also a new investor in IMV and including other institutional investors. The Company intends to use the net proceeds from the Private Placement for the clinical development of its lead candidate, DPX-Survivac, currently being assessed in advanced ovarian cancer, as well as in multiple clinical studies in combination with Merck’s Keytruda®. The balance of the net proceeds will be used for general corporate purposes, including funding research and development, preclinical and clinical expenses, and corporate costs.

Each Unit will consist of one common share of the Company (“Common Share”) and 0.35 of one common share purchase warrant (each whole common share purchase warrant, a “Warrant”). Each Warrant will have an exercise price of Cdn$3.72 and will be exercisable until 24 months after its issuance.

The Company anticipates that the Private Placement will close on or about May 7, 2020. The Private Placement is conditional upon the Company receiving the conditional approval of the Toronto Stock Exchange (the “TSX”) to list the Common Shares underlying the Units and the Warrants on the TSX. Listing will be subject to satisfying all of the requirements of the TSX. The Private Placement is also subject to the requirements of the NASDAQ Stock Market (“NASDAQ”).

All securities issued pursuant to the Private Placement will be subject to a four month and one day hold period in Canada in accordance with applicable securities laws.

About IMV

IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company’s proprietary drug delivery platform (DPX). This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac in advanced ovarian cancer, as well as in a combination therapy in multiple clinical studies with Merck’s Keytruda^®. IMV is also developing a DPX-based vaccine to fight against COVID-19. Connect at www.imv-inc.com.

Cautionary Language Regarding Forward-Looking Statements

This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In the press release, such forward-looking statements include, but are not limited to, statements regarding the Company’s ability to obtain requisite approvals, including approval of the TSX and NASDAQ for the Private Placement, the Company’s ability to complete the Private Placement on the terms described herein or at all, the anticipated closing date for the Private Placement and the proposed use of proceeds. Such statements should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks and uncertainties affecting the Company and its products.

The Company assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties and those risks and uncertainties include, but are not limited to, the satisfaction of customary closing conditions related to the Private Placement, including obtaining the requisite approvals and other risks detailed from time to time in the Company’s ongoing filings and in its annual information form filed with the Canadian regulatory authorities on SEDAR as www.sedar.com and with the United States Securities and Exchange Commission on EDGAR at www.sec/edgar. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read the Company’s continuous disclosure documents which are available on SEDAR and on EDGAR.

The Units, Common Shares and Warrants have not been registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200430005268/en/

Investor Relations

Marc Jasmin, Senior Director, Investor Relations, IMV
O: (902) 492-1819, ext: 1042
M: (514) 617-9481 E: mjasmin@imv-inc.com

Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: josh.rappaport@sternir.com

Media

Delphine Davan, Director of Communications, IMV
M: (514) 968-1046
E: ddavan@imv-inc.com

Source: IMV Inc.

Released April 30, 2020

TORONTO, ON / ACCESSWIRE / April 20, 2020 / Edesa Biotech, Inc. (EDSA), a clinical-stage biopharmaceutical company, today announced a strategic agreement with Light Chain Bioscience (a brand of NovImmune SA), a leading Swiss pharmaceutical development company, for an exclusive worldwide license to develop and commercialize two Phase 2-ready biologic drug candidates for all therapeutic, prophylactic and diagnostic applications.

The monoclonal antibodies licensed from Light Chain Bioscience block certain signaling proteins, known as TLR4 and CXCL10. These molecules are associated with a broad range of diseases, including infectious diseases. Edesa plans to pursue the development of these signaling molecules as potential treatments for acute respiratory distress syndrome and lung injury resulting from viral respiratory infections, such as the coronavirus that causes COVID-19, and other disorders.

Par Nijhawan, MD, Chief Executive Officer of Edesa, said that the company’s work has been made more urgent by the COVID-19 crisis. “While we originally sought these assets primarily for use in indications in line with our strategic focus areas, there is compelling data that these drug candidates could help regulate the exaggerated immune response that causes acute injury to the respiratory tract in patients with coronavirus pneumonia and other respiratory infections.”

Dr. Nijhawan noted that the administration of TLR4 and CXCL10 antagonists have been demonstrated to rescue mice from lethal influenza infection and ameliorate virus-induced acute lung injury. “With human safety data available and the lead drug already manufactured, we are preparing regulatory applications for clinical studies and plan to seek expedited government approval and support, including potential non-dilutive funding,” he said.

In consideration for the late-stage clinical assets, Edesa will issue to Light Chain Bioscience Series A-1 Convertible Preferred Shares at an agreed value of $2.5 million with a fixed conversion price and, subject to meeting certain business and clinical milestones, provide near-term consideration of up to $6.0 million for drug product inventory and other milestone fees. Edesa will be responsible for development, product registration and commercialization. Light Chain Bioscience will be eligible to receive up to $363.5 million in aggregate development, approval and commercial sales milestone payments and other consideration. Light Chain Bioscience is also eligible to receive royalties based on sales. During the term of the agreement, Edesa has the option to purchase the assets.

“Light Chain Bioscience has been at the forefront of antibody development technology for the last two decades and is a world leader in antibody engineering, and we are pleased to have been able to identify and in-license two potential best-in-class biologics for use in a broad range of therapeutic areas. As we learned more about these assets we were excited to recognize their potential application for acute respiratory distress syndrome and lung injury,” said Dr. Nijhawan. “Our strategic agreement with Light Chain Bioscience is structured to allow us to rapidly advance these experimental therapies into the clinic while minimizing immediate cash outlays.”

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, announced today that the Company has initiated a Rolling Submission of its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for voclosporin, a next-generation calcineurin inhibitor for the treatment of lupus nephritis (“LN”). The rolling NDA allows completed portions of an NDA to be submitted and reviewed by the Agency on an ongoing basis. Aurinia has submitted the Nonclinical Module and expects to complete the submission of all Modules by the end of the second quarter of 2020.

Related Article: Aurinia Partners with National Kidney Foundation on Awareness Initiative

“Following a positive pre-NDA meeting with the FDA in February, we are pleased to initiate our rolling NDA submission to the Agency, a critical step toward making voclosporin available to patients as soon as possible. We look forward to working with the FDA throughout the process.”

– Larry Mandt, Senior Vice President, Quality and Regulatory Affairs, Aurinia

Voclosporin was granted Fast Track designation by the FDA in 2016, with a Priority Review to be requested as part of the complete NDA submission anticipated by the end of Q2 2020.

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 diseases with a high unmet medical need. The Company is currently developing an investigational drug for the treatment of LN, focal segmental glomerulosclerosis (“FSGS”) and dry eye syndrome (“DES”). The Company’s head office is in Victoria, British Columbia and focuses its development efforts globally.

Forward-Looking Statements

Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to completing the submission of all modules to the FDA by the end of the second quarter of 2020; receiving a positive review of the NDA; and receiving approval during early 2021. It is possible that such results or conclusions may change based on further analyses of these data. Words such as “anticipate”, “will”, “believe”, “estimate”, “expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may” and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about Aurinia being able to obtain all necessary regulatory approvals for the commercialization of voclosporin for use in LN on terms that are acceptable to it and that are commercially viable; and global conditions may cause delays in regulatory approvals, including those caused by or related to the novel coronavirus. 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: Aurinia may not be able to obtain necessary regulatory approvals for the commercialization of voclosporin in a timely fashion, or at all (including any delays caused or related to the novel coronavirus). 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

RESEARCH TRIANGLE PARK, N.C. (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced the appointments of Jack Bailey to its Board of Directors and Soma Gupta as its Chief Commercial Officer (CCO).

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

“We are pleased to welcome Jack and Soma, and their breadth of commercial experience, as we work toward the approval of trilaciclib in small cell lung cancer. We are on track to submit an NDA for trilaciclib next quarter, and are excited about its potential to improve outcomes for cancer patients treated with chemotherapy.”

– Mark Velleca, M.D., Ph.D., CEO, G1 Therapeutics

Mr. Bailey most recently served as President – U.S. at GlaxoSmithKline (GSK). In this role, he was responsible for leading commercialization across GSK’s oncology, immunology/rare disease, respiratory, and vaccine portfolios. Earlier in his career, he held various senior leadership positions at Eli Lilly and Company. His background includes extensive account management, government affairs, sales, and marketing experience. Mr. Bailey currently serves on the board of Emergo Therapeutics, Inc., and is a past member of the board of directors of Pharmaceutical Research and Manufacturers of America (PhRMA), the pharmaceutical industry trade association.

“I’m excited to work with the G1 board and executive team to build value for shareholders during the company’s evolution to a commercial-stage enterprise. With trilaciclib, G1 has a tremendous opportunity to bring an innovative breakthrough therapy to patients with small cell lung cancer.”

– Jack Bailey, Member, G1’s Board of Directors

Ms. Gupta, the company’s newly appointed CCO, has extensive experience in leading global product launches and driving brand growth. Most recently, she led the global commercial launch of Vyndaqel^® (tafamidis meglumine) while serving as Vice President, Global Marketing for Amyloidosis and Cardiac Rare Disease at Pfizer Inc. Previously, Ms. Gupta led the global commercial team responsible for Pfizer’s oncology portfolio, including Ibrance^® (palbociclib).

“Trilaciclib represents the first innovation for chemotherapy-induced myelosuppression in several decades. I look forward to collaborating with my colleagues across the company to educate patients, healthcare professionals and payors about the potential benefits and value that this therapy can provide.”

– Soma Gupta, CCO, G1 Therapeutics

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

In connection with Ms. Gupta’s appointment, the company is reporting an inducement option grant under Nasdaq Listing Rule 5635(c)(4). The compensation committee of the G1 Board of Directors has approved a non-qualified stock option award to purchase an aggregate of 300,000 shares of G1’s common stock to Ms. Gupta. The option was granted outside of G1’s Amended and Restated 2017 Employee, Director and Consultant Equity Plan as an inducement material to Ms. Gupta’s acceptance of employment with G1. The stock option will have an exercise price equal to the closing price of G1’s common stock on March 31, 2020. The option has up to a ten-year term and vests over four years, with 25% of the award vesting on the first anniversary of her employment, and as to an additional 1/48th of the shares monthly thereafter, subject to Ms. Gupta’s continued service through the applicable vesting dates (subject to the terms and conditions of the stock option agreement covering the grant). John Demaree left his post as CCO to pursue other professional opportunities.

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

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, those relating to the therapeutic potential of trilaciclib, rintodestrant and lerociclib, 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
919-213-9835
jmacdonald@g1therapeutics.com

TORONTO, ON / ACCESSWIRE / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today announced a collaborative research project with the National Research Council of Canada (NRC) to develop novel immunotherapies for vitiligo as well as other indications.

Related Article: Edesa Biotech Reports Financial Results for 2019 Fiscal Year

Vitiligo is a life-altering autoimmune disease that results in the depigmenting of the skin. People who have vitiligo develop white patches of skin due to the destruction of special cells called melanocytes which produce the skin pigment melanin. The cause of vitiligo is not known but evidence strongly suggests that vitiligo is an autoimmune disorder in which the body’s immune system mistakenly targets and injures these cells. Vitiligo can affect any area of skin, but it commonly occurs on the face, neck, and hands. According to the World Health Organization, vitiligo affects approximately 1% of the world’s population. It is a lifelong condition.

“Despite high prevalence, vitiligo remains one of the most untouched areas in modern medical treatments and there has been little research compared to other immune disorders. Currently, there are few treatment options available for patients with limited efficacy. To address this unmet medical need, we are focusing our development on novel immune targets implicated in vitiligo pathogenesis and with the support of the NRC plan to advance these treatments toward clinical validation in a rapid, cost-effective manner.”

– Dr. Par Nijhawan, CEO of Edesa

“Working with innovative Canadian companies like Edesa is core to our aim here at the NRC of advancing and accelerating the development of therapeutic technologies,” said Anne Marcil, NRC Team Lead for the project. “Immunotherapies are changing the standard of care for many diseases and we’re excited to support Edesa’s efforts in developing new therapies for patients with vitiligo and other autoimmune diseases.”

Under the agreement, NRC scientists will produce multiple monoclonal antibodies for Edesa to identify a lead candidate to take into IND-enabling studies. The NRC will grant Edesa an exclusive worldwide license for the antibodies arising from the project. Edesa expects to complete the initial phase of the project by the end of the year.

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.

National Research Council Canada

Founded in 1916, the National Research Council of Canada (NRC) is Canada’s largest federal research and development organization. The NRC partners with the Canadian industry to take research impacts from the lab to the marketplace. This market-driven focus is designed to shorten the time between early-stage research and development and commercialization, enhance people’s lives and address some of the world’s most pressing problems. The Ministry of Innovation, Science and Economic Development oversees the NRC.

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 timing of project milestones. 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

Media Relations
National Research Council of Canada
613-991-1431
1-855-282-1637
media@nrc-cnrc.gc.ca

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 new initiatives to support the lupus nephritis (LN) community and raise disease awareness on World Kidney Day, during National Kidney Month and beyond. These initiatives and resources include:

• #ALLINorange: Through the ALL IN program, Aurinia is once again partnering with the National Kidney Foundation (NKF) on its #ALLINorange campaign throughout the month of March to raise awareness and understanding of LN. The ALL IN program is a source of information, resources, and support for those affected by LN and their care partners. ALL IN community members and those who newly register in March will receive #ALLINorange disease awareness bracelets to show support for National Kidney Month and the LN community.
• ALL IN Lupus Nephritis Awareness Resource Kit: Aurinia also launched today a new resource kit for people living with LN and their care partners. The kit was created with input from members of the LN community to help expand awareness and knowledge of lupus nephritis. The resource kit is available at www.allinforln.com/awarenesskit.

There is currently no FDA-approved therapy for LN, which is inflammation of the kidneys caused by systemic lupus erythematosus (SLE) and represents a serious progression of SLE. LN affects up to 50% of the SLE patient population.

“Observances such as National Kidney Month and World Kidney Day are a reminder that people living with lupus nephritis are affected by the severe symptoms and complications associated with this disease each and every day. We are honored to work together with the community to advance understanding of this serious disease. The ALL IN program is a source of information, resources, and support for those affected by LN, and we are committed to continuing to build on materials and initiatives that benefit the community.”

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

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

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 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 National Kidney Foundation

The National Kidney Foundation (NKF) is the largest, most comprehensive, and longstanding patient-centric organization dedicated to the awareness, prevention, and treatment of kidney disease in the U.S.

Forward-Looking Statement

Certain of the statements made in this presentation may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable U.S. securities law. These forward-looking statements or information include but are not limited to statements or information with respect to lupus nephritis (LN), FSGS and Dry Eye Syndrome.

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

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

SUMMIT, N.J. (GLOBE NEWSWIRE) — Engage Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing an orally inhaled therapy designed to terminate an active epileptic seizure, today announced that its Phase 2b StATES study of Staccato^® alprazolam met its primary endpoint which was the proportion of responders achieving cessation of seizure activity within two minutes of treatment administration and no recurrence within two hours.

Related Article: Epilepsia Publishes Phase 2a Data for Staccato Alprazolam

“With statistically significant and clinically meaningful Phase 2 results in this randomized, placebo-controlled trial, Staccato alprazolam has demonstrated the ability to rapidly terminate seizures in patients with epilepsy in two minutes or less and prevent recurrence of seizure within two hours,” said Jaqueline French, MD, the study’s principal investigator and professor of neurology and co-director of epilepsy research and epilepsy clinical trials at NYU Langone Health’s Comprehensive Epilepsy Center, and founder/director of the Epilepsy Study Consortium. “We are now one step closer to bringing to patients an EpiPen^®-like rescue treatment that works fast enough to terminate an active seizure episode. We look forward to initiating a Phase 3 study in the outpatient setting later this year.”

The multi-center StATES Study (Staccato Alprazolam Terminates Epileptic Seizures – NCT03478982) was designed to evaluate the safety, efficacy, and usability of Staccato alprazolam in adults living with focal or generalized epilepsy who have a predictable seizure pattern in an in-patient environment. Data from the trial will be presented during the American Academy of Neurology (AAN) Annual Meeting in Toronto on Sunday, April 26, at noon.

There were 116 patients enrolled in the double-blind portion of the trial and randomized to one of two treatment arms (1mg of Staccato alprazolam, N=38 or 2mg N=38) or placebo (N=40). In the two treatment arms of the trial, 50 of 76 total patients achieved the primary endpoint of seizure cessation with no recurrence:

	Placebo	1 mg Staccato alprazolam	2 mg Staccato alprazolam	Combined treatment arms
Patients	40	38	38	76
Responders	17 (42.5%)	25 (65.8%)	25 (65.8%)	50 (65.8%)
P value		0.0392	0.0392	0.0158

In assessing the primary endpoint of seizure activity cessation within two minutes, Staccato alprazolam showed rapid onset of action by ceasing seizure activity in approximately 30 seconds, on average.

Staccato alprazolam was generally well-tolerated in both treatment arms, as the majority of adverse events were mild in nature and there were no treatment-related serious adverse events. The most common adverse event was somnolence which was reported by 11 (14.5 percent) of the 76 patients in the treatment arms. Other adverse events included cough (14.5 percent), dysgeusia or a distortion of taste (13.2 percent), dizziness (5.3 percent), sedation (2.6 percent) and throat irritation (2.6 percent).

“As a parent, I have personally experienced the need for a product that can work fast enough to terminate an active seizure when it occurs,” said Gregory T. Mayes, Founder, and CEO of Engage Therapeutics. “We believe these data from the StATES study show what we hoped could be done – can be done. As we move the clinical development forward, we want to see Staccato alprazolam become a tool that patients with epilepsy can use to rapidly stop a seizure.”

About Staccato Alprazolam
Staccato alprazolam is an investigational drug designed to be used as a single-use, epileptic seizure rescue therapy that combines the Staccato delivery technology, which is currently used in a U.S. Food and Drug Administration (FDA) approved product, with alprazolam, an FDA-approved benzodiazepine. It is a small, hand-held inhaler device designed for easy delivery of alprazolam with a single normal breath potentially providing a way for people with epilepsy and their caregivers to stop an active seizure. The Staccato system rapidly vaporizes alprazolam to form an aerosol, with particle size designed for deep lung delivery to produce a rapid, systemic effect.

About Engage Therapeutics, Inc.
Engage Therapeutics is developing Staccato alprazolam for the immediate termination of an active epileptic seizure, or Rapid Epileptic Seizure Termination (REST). The Company anticipates advancing Staccato alprazolam to a Phase 3 registration trial in 2020. Engage Therapeutics is based in Summit, N.J.

Contact:
Mark Theeuwes
mtheeuwes@engagetherapeutics.com

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

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

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

– John Kollins, Satsuma’s President & CEO

Financial Results for Q4 2019 & FY2019

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

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

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

Business Update & FY 2019 Highlights

STS101 EMERGE Phase 3 Efficacy Trial Update

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

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

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

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

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

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

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

Financing activities and corporate update

2019 financing activities raised approximately $153 million:

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

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

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

Upcoming 2020 Milestones

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

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

Cautionary Note on Forward-Looking Statements

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

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

INVESTOR AND CORPORATE CONTACTS:            

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

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

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

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

– Rick Wypych, Chief Operating Officer, Cardiac Dimensions

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

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

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

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

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

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

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

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

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

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

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

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

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

– John Kollins, Satsuma’s President and CEO

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

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

– Rob Janosky

Related Article: Satsuma Pharmaceuticals Publishes Phase 1 Trial Results

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

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

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

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

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

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

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

– Peter Greenleaf, President and Chief Executive Officer of Aurinia

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

Recent Operational Highlights

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

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

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

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

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

– Neil Solomons, Chief Medical Officer of Aurinia

AURORA Phase 3 LN Trial

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

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

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

AURORA 2 Extension Trial

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

Voclosporin Drug-Drug Interaction (“DDI”) Study

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

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

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

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

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

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

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

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

Financial Liquidity at December 31, 2019

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

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

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

Financial Results for the Year Ended December 31, 2019

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

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

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

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

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

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

Financial Results for the Fourth Quarter Ended December 31, 2019

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

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

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

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

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

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

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

About Voclosporin

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

ABOUT AURINIA

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

Forward-Looking Statements

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

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

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

We seek safe harbour.

Aurinia Pharmaceuticals Inc.

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

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

Key Highlights

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

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

– Ken d’Entremont, Chief Executive Officer, Medexus

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

New Credit Facility

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

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

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

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

About Medexus Pharmaceuticals Inc.

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

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

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

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

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

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

Forward-Looking Statements

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

_______________________

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Fourth Quarter Regulatory, Clinical and Corporate Highlights

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

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

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

Key Anticipated 2020 Milestones

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

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

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

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

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

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

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

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

– Peter Greenleaf, President & Chief Executive Officer, Aurinia

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

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

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

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

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

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

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

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

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

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

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

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

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

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

We seek safe harbour.

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

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

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

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

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

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

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

Operational highlights*:

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

Operating and Financial Results Summary*

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

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

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

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

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

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

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

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

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

Conference Call Details

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

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

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

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

About Medexus Pharmaceuticals Inc.

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

For more information, please contact:

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

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

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

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

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

Cautionary Note Regarding Comparative Financial Information

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

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

Forward-Looking Statements

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

Non-IFRS Financial Measures

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

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

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

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

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

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

– Harry Rowland, CEO, Endotronix

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

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

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

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

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

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

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

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

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

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

– Douglas Mayers M.D., CMO of Antios

About ATI-2173

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

About Antios Therapeutics Inc.

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

For Media Inquiries, please contact pr@antiostherapeutics.com

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

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

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

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

Read the study and article in full.

About Prostate Cancer

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

Diagnosing Prostate Cancer

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

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

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

About Exact Imaging

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

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

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

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

Related Article: Satsuma Completes $90.8M Initial Public Offering

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

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

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

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

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

Cautionary Note on Forward-Looking Statements

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

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

INVESTOR AND CORPORATE CONTACTS:            

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

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

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

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

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

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

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

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

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

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

About Zymeworks Inc.

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

Cautionary Note Regarding Forward-Looking Statements

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

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

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

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

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

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

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

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

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

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

– Ken Nelson, Chief Commercial Officer, BardyDx

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

About Bardy Diagnostics:

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

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

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

Read the Full Report here.

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

The Results

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

Background

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

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

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

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

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

Conclusions

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

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

References

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Authors

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

Author Affiliations

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

Contributors

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

Funding

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

Competing interests

None declared

Patient consent for publication

None required

Ethics approval

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

Provenance and peer review

Not commissioned; externally peer-reviewed.

Data availability statement

Data are available upon reasonable request

Open access

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

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

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

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

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

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

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

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

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

About Zymeworks Inc.

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

Cautionary Note Regarding Forward-Looking Statements

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

– Mike Blue, CEO & President, HistoSonics

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

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

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

About HistoSonics

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

– Louis Laflamme, President and CEO, Opsens

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

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

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

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

About Opsens Inc.

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

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

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

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

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

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

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

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

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

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

– Ed Vertatschitsch, COO, BardyDx

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

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

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

– Mark Handfelt, Chief Administrative Officer, BardyDx

About Bardy Diagnostics:

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

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

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

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

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

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

Related Article: Zymeworks Earns Milestone Payment in Merck Collaboration

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

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

About Breast Cancer

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

About ZW25

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

About Zymeworks Inc.

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

Cautionary Note Regarding Zymeworks’ Forward-Looking Statements

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

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

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

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