Launch of Innovative Therapy for People Living with Extensive-Stage Small Cell Lung Cancer is Supported by the G1 to One™ Patient Support Program, the Single Source for COSELA Access Solutions

RESEARCH TRIANGLE PARK, N.C. and RIDGEFIELD, Conn., March 02, 2021 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX) and Boehringer Ingelheim today announced that COSELA™ (trilaciclib) for injection is now available in the U.S. On February 12, 2021, the U.S. Food and Drug Administration (FDA) approved COSELA to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). It is the first and only therapy designed to help protect bone marrow (myeloprotection) when administered prior to treatment with chemotherapy.

“This is an exciting time for the combined G1 and Boehringer Ingelheim team as we are now able to provide COSELA, the first proactive multilineage myeloprotection therapy, to patients with extensive-stage small cell lung cancer,” said Soma Gupta, Chief Commercial Officer at G1 Therapeutics. “Our commitment includes ensuring excellence in support and access to COSELA; to that end, we are excited to launch the G1 to One Patient Support Program which is designed to provide access and affordability solutions to eligible patients.”

“We are proud to help bring COSELA to the physicians and their patients who are in need of options when it comes to managing ES-SCLC treatment,” said Dan Asch, Head of Commercial Oncology at Boehringer Ingelheim Pharmaceuticals, Inc. “G1’s experienced and passionate commercial and medical teams along with Boehringer Ingelheim’s seasoned oncology team are eager to engage with the community to communicate the clinical benefits of this innovative therapy.”

“Because ES-SCLC cannot be cured, the goals of treatment are increased life expectancy and improved quality of life; most patients prioritize quality of life, but clinicians have very few tools to do this,” said Jared Weiss, MD, Associate Professor of Medicine, Division of Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina Chapel Hill, NC. “Chemotherapy can result in potentially debilitating side effects, many of which are hematologically driven, such as severe low white blood cell counts (neutropenia) and anemia, which can cause fatigue. Doctors accept these side effects because we lack tools to help prevent them. COSELA (trilaciclib) provides the first proactive approach to help protect against myelosuppression through a unique mechanism of action that helps proactively protect the bone marrow from damage when given prior to chemotherapy.”

Chemotherapy is an effective and important weapon against cancer. However, chemotherapy does not differentiate between healthy cells and cancer cells. It kills both, including important hematopoietic stem and progenitor cells (HSPCs) in the bone marrow that produce white blood cells (immune cells that help fight infection), red blood cells (cells that carry oxygen from the lungs to the tissues), and platelets (cells that prevent bleeding from cancer, surgeries, chronic diseases, and injuries). Chemotherapy-induced bone marrow damage, known as myelosuppression, can lead to increased risk of infection, anemia, thrombocytopenia, and other complications. Myeloprotection is a novel approach to protect HSPCs in the bone marrow from chemotherapy-induced damage. This approach can help reduce some chemotherapy-related toxicities, which helps make chemotherapy safer and more tolerable, while also reducing the need for reactive rescue interventions.

COSELA is available through the following specialty distributors: Amerisource Specialty Distribution, Oncology Supply, McKesson Plasma and Biologics, McKesson Specialty and Cardinal Specialty. COSELA is expected to be widely covered by insurance plans.

The G1 to One™ Patient Support Program offers a suite of solutions to address common access and reimbursement challenges, such as benefits verification for patient coverage and out-of-pocket costs. The program provides payor-specific guidance for prior authorizations and appeals to address patient needs; offering solutions for insurance-related delays and connecting patients, regardless of insurance type, to appropriate resources that can address high deductibles, co-pays/co-insurance, or lack of coverage when certain eligibility requirements are met. For more information, patients and providers can call G1 to One at 833-G1toONE (833-418-6663) from 8:00 AM to 8:00 PM Eastern time.

About COSELA™ (trilaciclib)

COSELA™ (trilaciclib) is the first and only myeloprotection therapy to help decrease the incidence of chemotherapy-induced myelosuppression. Administered intravenously as a 30-minute infusion within four hours prior to the start of chemotherapy, COSELA helps proactively deliver multilineage myeloprotection to patients with extensive-stage small cell lung cancer (ES-SCLC) being treated with chemotherapy. COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC.

For more information about COSELA visit www.cosela.com.

COSELA (trilaciclib) Co-Promotion Agreement with Boehringer Ingelheim

In June 2020, G1 announced a three-year co-promotion agreement with Boehringer Ingelheim for COSELA in small cell lung cancer in the U.S. and Puerto Rico. G1 will lead marketing, market access and medical engagement initiatives for COSELA. 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 COSELA 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.

About Small Cell Lung Cancer

In the U.S., approximately 30,000 small cell lung cancer patients are treated annually. SCLC, one of the two main types of lung cancer, accounts for about 10% to 15% of all lung cancers. SCLC is an aggressive disease and tends to grow and spread faster than NSCLC. It is usually asymptomatic; once symptoms do appear, it often indicates that the cancer has spread to other parts of the body. About 70% of people with SCLC will have cancer that has metastasized at the time they are diagnosed. The severity of symptoms usually increases with increased cancer growth and spread. From the time of diagnosis, the general five-year survival rate for people with SCLC is 6%. The five-year survival rates for limited-stage (the cancer is confined to one side of the chest) SCLC is 12% to 15%; and for extensive stage (ES; cancer has spread to the other lung and beyond), survival rates are less than 2%. Chemotherapy is the most common treatment for ES-SCLC.

COSELA™ (trilaciclib) for Injection  

INDICATION

COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

• COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

WARNINGS AND PRECAUTIONS

Injection-Site Reactions, Including Phlebitis and Thrombophlebitis

• COSELA administration can cause injection-site reactions, including phlebitis and thrombophlebitis, which occurred in 56 (21%) of 272 patients receiving COSELA in clinical trials, including Grade 2 (10%) and Grade 3 (0.4%) adverse reactions. Monitor patients for signs and symptoms of injection-site reactions, including infusion-site pain and erythema during infusion. For mild (Grade 1) to moderate (Grade 2) injection-site reactions, flush line/cannula with at least 20 mL of sterile 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP after end of infusion. For severe (Grade 3) or life-threatening (Grade 4) injection-site reactions, stop infusion and permanently discontinue COSELA. Injection-site reactions led to discontinuation of treatment in 3 (1%) of the 272 patients.

Acute Drug Hypersensitivity Reactions

• COSELA administration can cause acute drug hypersensitivity reactions, which occurred in 16 (6%) of 272 patients receiving COSELA in clinical trials, including Grade 2 reactions (2%). Monitor patients for signs and symptoms of acute drug hypersensitivity reactions. For moderate (Grade 2) acute drug hypersensitivity reactions, stop infusion and hold COSELA until the adverse reaction recovers to Grade ≤1. For severe (Grade 3) or life-threatening (Grade 4) acute drug hypersensitivity reactions, stop infusion and permanently discontinue COSELA.

Interstitial Lung Disease/Pneumonitis

• Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with cyclin-dependent kinases (CDK)4/6 inhibitors, including COSELA, with which it occurred in 1 (0.4%) of 272 patients receiving COSELA in clinical trials. Monitor patients for pulmonary symptoms of ILD/pneumonitis. For recurrent moderate (Grade 2) ILD/pneumonitis, and severe (Grade 3) or life-threatening (Grade 4) ILD/pneumonitis, permanently discontinue COSELA.

Embryo-Fetal Toxicity

• Based on its mechanism of action, COSELA can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use an effective method of contraception during treatment with COSELA and for at least 3 weeks after the final dose.

ADVERSE REACTIONS

• Serious adverse reactions occurred in 30% of patients receiving COSELA. Serious adverse reactions reported in >3% of patients who received COSELA included respiratory failure, hemorrhage, and thrombosis.
• Fatal adverse reactions were observed in 5% of patients receiving COSELA. Fatal adverse reactions for patients receiving COSELA included pneumonia (2%), respiratory failure (2%), acute respiratory failure (<1%), hemoptysis (<1%), and cerebrovascular accident (<1%).
• Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received COSELA. Adverse reactions leading to permanent discontinuation of any study treatment for patients receiving COSELA included pneumonia (2%), asthenia (2%), injection-site reaction, thrombocytopenia, cerebrovascular accident, ischemic stroke, infusion-related reaction, respiratory failure, and myositis (<1% each).
• Infusion interruptions due to an adverse reaction occurred in 4.1% of patients who received COSELA.
• The most common adverse reactions (≥10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

DRUG INTERACTIONS

• COSELA is an inhibitor of OCT2, MATE1, and MATE-2K. Co-administration of COSELA may increase the concentration or net accumulation of OCT2, MATE1, and MATE-2K substrates in the kidney (e.g., dofetilide, dalfampridine, and cisplatin).

To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information here.

For more information about COSELA, please call 1-800-790-G1TX (1-800-790-4189) or visit www.cosela.com.

About G1 Therapeutics

G1 Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the discovery, development and delivery of next generation therapies that improve the lives of those affected by cancer, including the Company’s first commercial product, COSELA™ (trilaciclib). G1 has a deep clinical pipeline evaluating targeted cancer therapies in a variety of solid tumors, including colorectal, breast, lung, and bladder cancers. G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

G1 Therapeutics™ and the G1 Therapeutics logo, COSELA™ and the COSELA logo, G1 to One™ and the G1 to One logo are trademarks of G1 Therapeutics, Inc.

About Boehringer Ingelheim in Oncology

Cancer takes. Takes away time. Takes away loved ones. At Boehringer Ingelheim Oncology, we are giving patients new hope, by taking cancer on. We are dedicated to collaborating with the oncology community on a shared journey to deliver leading science. Our primary focus is in lung and gastrointestinal cancers, with the goal of delivering breakthrough, first-in-class treatments that can help win the fight against cancer. Our commitment to innovation has resulted in pioneering treatments for lung cancer and we are advancing a unique pipeline of cancer cell directed agents, immuno-oncology therapies and intelligent combination approaches to help combat many cancers.

About Boehringer Ingelheim

Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of around $21.3 billion (19 billion euros). Our significant investment of over $3.9 billion (3.5 billion euros) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies. In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA.

Boehringer Ingelheim is committed to improving lives and strengthening our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives.

For more information, please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.

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, COSELA’s (trilaciclib) possibility to improve patient outcomes, COSELA may fail to achieve the degree of market acceptance for commercial success, 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 dependence on the commercial success of COSELA; the development and commercialization of new drug products is highly competitive; 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: Will Roberts
G1 Therapeutics, Inc.
Vice President, Investor Relations and Corporate Communications
(919) 907-1944
wroberts@g1therapeutics.com

LISLE, IL – MARCH 2, 2021 – Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the appointment of seasoned medical device industry executive Dan Dearen to its Board of Directors. Mr. Dearen currently serves as the President and Chief Financial Officer of Axonics Modulation Technologies, Inc. (Nasdaq: AXNX), a medical technology company he helped take public in 2018 with sales in 2020 of over $111 million and a current market capitalization of $2 billion. Mr. Dearen joins the Endotronix Board as an Independent Director and will serve as Chair of the Audit Committee.

“We welcome Dan’s healthcare experience and leadership as Endotronix prepares for commercial growth and rapid expansion,” said Paul LaViolette, Managing Partner at SV Health Investors and Chairman of the Board. “Dan’s extensive track record of building best-in-class organizations, establishing rigorous financial frameworks, and scaling businesses will be invaluable during this next phase of Endotronix’s growth.”

Mr. Dearen brings more than three decades of executive leadership experience in the medical device and life sciences industries. He co-founded Axonics and has served in his current role for over seven years, during which time the company developed, obtained FDA approval for, and launched its sacral neuromodulation system to treat overactive bladder, acquired Bulkamid to treat stress urinary incontinence, and raised $138 million in its 2018 IPO plus $267 million through two subsequent equity offerings. Previously, Mr. Dearen was the Chief Operating and Financial Officer of Vessix Vascular through the acquisition and integration into Boston Scientific for $425 million in 2012. He also served as Chief Financial Officer of Miraval Holding, Q3DM (acquired by Beckman Coulter), Medication Delivery Devices (acquired by Baxter Healthcare) and was a Principal at Ventana Growth Funds, an international venture capital firm. Mr. Dearen started his career as a CPA in the healthcare group at Ernst & Young. He holds a BBA in Accounting & Business from Southern Methodist University and an MBA from Boston College.

“I have had the pleasure of following the team’s progress and am impressed by the growing data demonstrating the value of the Cordella System,” commented Mr. Dearen. “I am excited to join Endotronix as the company prepares for commercial launch and rapid growth in this duopoly interventional heart failure segment, pulmonary artery (PA) pressure-guided HF management. And I look forward to leveraging my diverse experiences to accelerate the company along its mission to transform the standard of care for chronic heart failure patients.”

The Cordella™ Heart Failure System from Endotronix is a comprehensive heart failure management solution that enables proactive management and early detection of worsening heart failure. The platform consists of a comprehensive remote patient management system with non-invasive daily health metrics that seamlessly integrates a next generation implantable pulmonary artery pressure sensor to streamline heart failure care management, reduce heart-failure-related hospitalizations, and support reimbursement for care delivery.

Endotronix is actively enrolling heart failure patients in PROACTIVE-HF, their U.S. investigational device exemption (IDE) clinical trial, and SIRONA II, their CE Mark clinical trial. The studies seek to demonstrate the benefits of PA pressure-guided therapy for the remote management of chronic heart failure patients and provide market access for the Cordella™ PA Sensor. Full trial enrollment remains a core focus as the company plans for commercial launch of the Cordella PA sensor.

About Endotronix

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

The Cordella System, without the sensor, is available for commercial use in the U.S. and E.U. and is currently in cardiology centers across the U.S. The Cordella PA Sensor is currently under clinical investigation in Europe (SIRONA II CE Mark Trial) and the U.S. (PROACTIVE-HF IDE Trial) and is not currently available for commercial use in any geography.

Cautionary Statement Regarding Forward-Looking Statements

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

MEDIA CONTACT:
Carla Benigni
Sprig Consulting, LLC
+1 (847) – 951 – 7430
carla@sprigconsulting.com

Management to host conference call at 8:00 AM Eastern Time on Tuesday, March 2, 2021

TORONTO, CHICAGO and MONTREAL, March 01, 2021 (GLOBE NEWSWIRE) — Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP) (OTCQX: MEDXF) (Frankfurt: P731) today announced its financial and operating results for the three and nine months ended December 31, 2020. All dollar amounts below are in Canadian dollars unless specified otherwise.

Third Quarter Fiscal 2021 Financial Highlights:

• The Company achieved record revenue of $31.5 million for the three-month period ended December 31, 2020, versus $16.2 million for the same period last year. As previously reported, the revenue for the period included approximately $3 million in IXINITY® revenues, which were originally expected to be realized in September 2020, but were instead realized in October 2020 due to a delay in receipt of finished product from the Company’s contract manufacturing partner.
• Adjusted EBITDA* increased to $5.1 million compared to $0.7 million for the same period last year. Adjusted EBITDA* was also positively impacted by the delayed October shipment of IXINITY®.
• With the significant share price appreciation in the quarter, the non-cash fair value of the derivative associated with the conversion rights of the existing debentures increased materially to $16.5 million. This increase in fair value of derivatives was the primary driver for the reported net loss of $17.1 million compared to $2.6 million for the same period last year. On a year over year basis, the Adjusted Net Loss* improved by$4.7 million to $0.5 million as compared to $5.2 million.
• Operating income improved by $5.3 million to $2.0 million, compared to an operating loss of $3.3 million for the same period last year.

Ken d’Entremont, Chief Executive Officer of Medexus, noted, “The fiscal third quarter of 2021 was a record quarter with $31.5 million in revenue. We continued to generate solid growth while managing our expenses and the $5.3 million improvement in operating income was a strong reflection of that. Our $82.7 million in revenue for the first nine months of Fiscal 2021 reflects a 70% increase over the previous year and achieved strong Adjusted EBITDA* performance of a more than six-fold increase over the previous year. With a strong base of

revenues from Rasuvo®, IXINITY® Metoject® and Rupall, we believe that the recent additions to our portfolio will become major drivers of our growth going forward. Subsequent to the end of the quarter, we completed a transformative licensing deal for treosulfan in the United States and materially enhanced our ability to fund our growth initiatives, with the completion of an oversubscribed financing of $32.5 million. In the coming quarters we will continue to invest in our business, putting in place the people and infrastructure required to support the launch of treosulfan. This investment will be the key to supporting and enabling the significant revenue growth that we expect from treosulfan. Despite this material addition to our product portfolio, the quality of our in-licensing opportunities continues to broaden and deepen and we are working diligently to prioritize and pursue those that will best enable us to further leverage our North American commercial infrastructure. Finally, we are working to achieve a Nasdaq listing which should provide us much greater exposure to the broader North American investment community as we execute on key initiatives.

Operational Highlights**:

Bought Deal Public Offering: On February 23, 2021, the Company completed a bought deal public offering by way of a short form prospectus in Canada, including the full exercise of an over-allotment option, at a price of $7.10 per unit, representing aggregate gross proceeds to the Company of approximately $32.5 million; the offering was conducted by a syndicate of underwriters led by Raymond James Ltd. and Stifel Nicolaus Canada Inc.
Treosulfan: On February 2, 2021, the Company entered into an exclusive license to commercialize treosulfan in the United States. The Prescription Drug User Fee Act date is scheduled for August 2021 with potential to commercialize shortly thereafter. In accordance with the Orphan Drug Act, seven years of exclusivity for this indication is expected upon FDA approval. The current market leading alkylating agent for Allo-HSCT reached peak sales of US$126M in the U.S. As announced by the Company on September 10, 2020, Health Canada granted priority review for treosulfan, which could be approved as early as June 2021. Medexus is currently negotiating the license in anticipation of a full commercial launch following Health Canada approval.
IXINIT®: The Company has now enrolled more than 73% of patients for its ongoing Phase 4 clinical trial for IXINITY® to evaluate the safety and efficacy of IXINITY® in previously treated patients for a pediatric indication.
Gleolan®: On February 25, 2021, Medexus initiated commercial launch of Gleolan® in Canada, replacing use under the Health Canada Special Access Program.
Triamcinolone Hexacetonide (TH): On December 18, 2020, Medexus entered into an exclusive agreement to register and commercialize TH in the United States. The Company is in discussions with FDA regarding the drug shortage and anticipates receipt of a special import authorization for TH prior to seeking approved marketing authorization.
Nasdaq Application: On January 21, 2021, the Company announced that it had submitted its application to list its common shares on the Nasdaq. The listing of its common shares on the Nasdaq remains subject to the approval of the Nasdaq and the satisfaction of all applicable listing and regulatory requirements.

Operating and Financial Results Summary for the Three-Months Ended December 31, 2020
The Company achieved record revenue of $31.5 million for the three-month period ended December 31, 2020, versus $16.2 million for the three-month period ended December 31, The increase was mainly due to the acquisition of IXINITY® as well as unit demand growth of the Company’s key products in the market over the period.
Adjusted EBITDA* increased to $5.1 million compared to $0.7 million for the same period last year.
Net loss was $17.1 million compared to $2.6 million for the same period last year. Adjusted Net Loss* was $0.5 million compared to $5.2 million for the same period last year.
Achieved operating income of $2.0 million, compared to an operating loss of $3.3 million for the same period last year.
Operating and Financial Results Summary for the Nine-Months Ended December 31, 2020
Total revenue reached $82.7 million for the nine-month period ended December 31, 2020, compared to revenue of $48.7 million for the nine-month period ended December 31, 2019,
as a result of the acquisition of IXINITY® as well as unit demand growth of the Company’s key products in the market over the period.
Adjusted EBITDA* for the nine-month period ended December 31, 2020 increased to $13.1 million compared to $1.8 million for the nine-month period ended December 31, 2019.
Net loss for the nine-month period ended December 31, 2020 was $23.9 million, compared to net loss of $4.1 million for same period last year. Adjusted Net Loss* was $3.3 million compared to $11.7 million for the same period last year.
Selling and administrative expenses as a percentage of revenue decreased to 41.8%, from 62.4% for the same period last year, as the Company continues to leverage its platform and significantly increase its revenue with only modest increases to operating expenses.
Achieved operating income of $4.2 million, compared to an operating loss of $5.8 million for the same period last year.
Available liquidity of $15.2 million at December 31, 2020, compared to $7.4 million at March 31, 2020.
The Company’s financial statements and management discussion and analysis (“MD&A”) for the period ended December 31, 2020 are available on our corporate website at www.medexus.com and in our corporate filings on SEDAR at www.sedar.com.

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

Conference Call Details:
Medexus will host a conference call at 8:00 AM Eastern Time on Tuesday, March 2, 2021 to discuss the Company’s financial results for the fiscal 2021 third quarter ended December 31, 2020, as well as the Company’s corporate progress and other developments.

The conference call will be available via telephone by dialing toll free 888-506-0062 for Canadian and U.S. callers or +1 973-528-0011 for international callers and using entry code 414918. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2010/40181 or on the Company’s Investor Events section of the website: https://www.medexus.com/en_US/investors/news-events.

A webcast replay will be available on the Company’s Investor Events section of the website (https://www.medexus.com/en_US/investors/news-events) through Wednesday, June 2, 2021. A telephone replay of the call will be available approximately one hour following the call, through Tuesday, March 9, 2021 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: 40181.

About Medexus Pharmaceuticals Inc.
Medexus is a leader in innovative rare disease treatment solutions with a strong North American commercial platform. From a foundation of proven best in class products we are building a highly differentiated company with a portfolio of innovative and high value orphan and rare disease products that will underpin our growth for the next decade. The Company’s vision is to provide the best healthcare products to healthcare professionals and patients, through our core values of Quality, Innovation, Customer Service and Teamwork. Medexus Pharmaceuticals is focused on the therapeutic areas of auto-immune disease, hematology, and allergy. The Company’s 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; IXINITY, 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; and Rupall®, an innovative prescription allergy medication with a unique mode of action.
For more information, please contact:

Ken d’Entremont, Chief Executive Officer
Medexus Pharmaceuticals Inc.
Tel.: 905-676-0003
E-mail: ken.dentremont@medexus.com
Roland Boivin, Chief Financial Officer
Medexus Pharmaceuticals Inc.
Tel.: 514-344-8675 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):
Tina Byers
Investor Relations
Tel: 905-330-3275
E-mail: tina@adcap.ca

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Cautionary Note Regarding Comparative Financial Information
On February 28, 2020, the Company announced that it had, indirectly through its wholly-owned subsidiary, Medexus Pharma Inc. completed a major acquisition (the “2020 Acquisition”) in acquiring all of the outstanding limited liability company interests of Aptevo BioTherapeutics LLC, a Delaware limited liability company, from Aptevo Therapeutics, Inc. pursuant to a purchase agreement dated February 28, 2020.

Accordingly, 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-2020 Acquisition period to a post-2020 Acquisition 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 2020 Acquisition. Readers are advised that the comparative information included in this press release for the three- and nine-month periods ended December 31, 2019, includes only pre-2020 Acquisition results for the Company (i.e., the comparative information for such periods consists of (i) results prior to February 28, 2020, which reflect only the pre-2020 Acquisition results for the Company, and (ii) results subsequent to February 28, 2020, which reflect the consolidated results of the Company post-2020 Acquisition).

Forward-Looking Statements
Certain statements made in this press release contain forward-looking information within the meaning of applicable securities laws (“forward-looking statements”). The words “anticipates”, “believes”, “expects”, “will”, “plans” and similar expressions are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Specific forward-looking statements contained in this news release include, but are not limited to, statements with respect to the Company’s future expectations regarding growth and increased investment in the Company’s portfolio; expectations regarding the Company’s ability to fund planned initiatives; expectations regarding the approval, commercialization and launch of treosulfan in the United States and the benefits from the Treosulfan licensing deal; expectations regarding a commercial launch of the Treosulfan in Canada; expected results and likelihood of approval of the Company’s Nasdaq listing application; and the anticipated receipt of a special import authorization for TH prior to seeking approved marketing authorization. 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 materials filed with the Canadian securities regulatory authorities from time to time, including the Company’s most recent annual information form and management’s discussion and analysis; future capital requirements and dilution; intellectual property protection and infringement risks; competition (including potential for generic competition); reliance on key management personnel; the Company’s ability to implement its business plan; the Company’s ability to leverage its United States and Canadian infrastructure to promote additional growth, including with respect to the infrastructure of Medexus Inc. and Medac Pharma, Inc. and the potential benefits the Company expects to derive therefrom; regulatory approval by the Canadian health authorities; product reimbursement by third party payers; patent litigation or patent expiry; litigation risk; stock price volatility; government regulation; and potential third party claims. Given these risks, undue reliance should not be placed on these forward-looking statements, which apply only as of the date hereof. Other than as specifically required by law, the Company undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.

Non-IFRS Financial Measures
This press release uses the terms “Adjusted Net Income (Loss)” and “Adjusted EBITDA” which are non-IFRS financial measures, which do not have any standardized meaning prescribed by IFRS and are therefore unlikely to be comparable to similar measures presented by other companies. Rather, these measures are provided as additional information to complement those IFRS measures by providing 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 Net Income (Loss) and Adjusted EBITDA as measures of the Company’s performance. The Company defines Adjusted Net Income (Loss) as net income (loss) before unrealized loss (gain) on fair value of derivatives. The Company defines Adjusted EBITDA as earnings before financing and special transaction costs (including, for greater certainty, fees related to the 2020 Acquisition and related financing), interest expenses, income taxes, interest income, depreciation of property and equipment, amortization of intangible assets, non-cash share-based compensation, income from sale of assets, gain or loss on the convertible debenture embedded derivative, foreign exchange gains or losses, termination benefits, and impairment of intangible assets. The Company considers Adjusted Net Income (Loss) and Adjusted EBITDA as key metrics 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 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 these non-IFRS measures, including the reconciliation of each of Adjusted Net Income (Loss) and Adjusted EBITDA to Net Income (Loss), can be found in our MD&A, which is available through the SEDAR website (www.sedar.com).

Source: Medexus Pharmaceuticals Inc

SOUTH SAN FRANCISCO, Calif., March 01, 2021 (GLOBE NEWSWIRE) — Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA) a clinical-stage biopharmaceutical company, today announced that it has agreed to sell 14,084,507 shares of its common stock to certain institutional investors in a private investment in public equity (PIPE) financing. The Company anticipates gross proceeds from the PIPE will be approximately $80 million, before deducting fees to the placement agents and other estimated offering expense payable by the Company, based on the offering price of $5.68 per share, the last reported sale price of our common stock on The Nasdaq Global Market on February 26, 2021.  The financing was led by Commodore Capital and New Enterprise Associates, L.P. with participation from new and existing investors including RA Capital Management, Vivo Capital, Samlyn Capital, Surveyor Capital (a Citadel company), Aspire Capital Fund, funds managed by Ghost Tree Capital Group, LP, Point72 Asset Management and Logos Capital as well as Satsuma co-founder, Shin Nippon Biomedical Laboratories, Ltd.

The financing is subject to standard closing conditions and the Company anticipates the closing to occur on March 3, 2021. In addition the financing was executed in compliance with applicable Nasdaq rules and priced at the “Minimum Price” (as defined in the Nasdaq rules).

SVB Leerink served as Satsuma’s exclusive financial advisor in connection with the PIPE financing.

“We are pleased to have the continued support of leading healthcare investors as we continue Phase 3 clinical development of STS101 as outlined in our separate press release also announced today,” said John Kollins, President & Chief Executive Officer of Satsuma. “We believe there is a compelling rationale for continuing development of STS101, and the proceeds from this financing better position us to deliver this potential migraine treatment to market.”

The securities sold in this private placement have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the U.S. except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Satsuma has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in these private placements.

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

About Satsuma Pharmaceuticals and STS101

Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic product candidate for the acute treatment of migraine. Its product candidate, STS101, is a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate, or DHE, which is designed to be quickly and easily self-administered with a proprietary pre-filled, single-use, nasal delivery device. DHE products have long been recommended as a first-line therapeutic option for the acute treatment of migraine and have significant advantages over other therapeutics for many patients. However, broad use has been limited by invasive and burdensome administration and/or sub-optimal clinical performance of available injectable and liquid nasal spray products. STS101 is in Phase 3 development and specifically designed to deliver the clinical advantages of DHE while overcoming these shortcomings.

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 includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements. Accordingly, you should not rely on any of these forward-looking statements, including statements regarding the size, timing or completion of the financing. Additional applicable risks and uncertainties include those identified in the Company’s current and future reports filed with the SEC, including its Quarterly Report on Form 10-Q filed with the SEC on November 10, 2020. The forward-looking statements contained in this press release are based on information currently available to Satsuma and speak only as of the date on which they are made. Satsuma does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise, except as required by law.

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

INVESTOR AND CORPORATE CONTACTS:         

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

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

TORONTO, The Globe and Mail (Ontario Edition) – One of Canada’s most celebrated scientists is bringing her new discovery to market, a pain-reducing alternative to opioids.

AmacaThera Inc., spun out of a U of T lab, has raised millions from investors for discovery of gel that targets postoperative pain relief. One of Canada’s most celebrated scientists, Molly Shoichet, is stepping up plans to take a key discovery out of her lab and into the marketplace. On Monday, AmacaThera Inc., the third startup spun out of Dr. Shoichets University of Toronto lab, is announcing it has raised $10.3-million from investors in Canada, the United States and Europe to take its product an injectable gel that can improve post-surgery pain treatment into human safety trials this year.

Dr. Shoichet is chief science officer, while her former postdoctoral research student and co-founder, Michael Cooke, is chief executive officer. Dr. Shoichet holds the Canada Research Chair in Tissue Engineering and was Ontario’s first chief scientist. She has won two of Canada’s top science prizes the $1-million Gerhard Herzberg Canada Gold Medal for Science and Engineering in 2020 and the Killam Prize for engineering in 2017. “She’s the reason we did the deal,” said Peter van der Velden, managing general partner with Toronto’s Lumira Ventures. Which led the financing, backed by Viva BioInnovator, BDC Capital Women in Technology Venture Fund, Inveready, MBX Capital, CR Capital Management, StandUp Ventures and MaRS Investment Accelerator Fund.

The work out of that lab is truly transformative and she’s a leader in the space. We thought there was an opportunity to build an interesting platform company based on her core technology. Dr. Shoichet’s lab uses materials called hydrogels to surround and protect drugs or stem cells when injected in the body, enabling them time to do their job. Work from her lab has led to applications to treat cancer, strokes and blindness. AmacaThera’s core material is an invention licensed from the lab that combines hyaluronic acid, commonly used in anti-wrinkle cosmetics, and methyl cellulose, which turns into a gel when heated. On its own, methyl cellulose gels at 90 C; combined with the acid, it does so at body temperature, making it usable in humans.

When existing drugs are mixed into the concoction, we can control how quickly they are released in the body, Dr. Shoichet said. I like to think of us as the FedEx of cells and drug delivery. FedEx provides the packaging and figures out how to get what’s inside where and when it needs to be there. AmacaThera’s initial target is postoperative pain relief. Doctors typically use local anesthetics such as bupivacaine for surgeries. But the drugs wear off in 12 to 18 hours, at which point opioids are prescribed for pain relief. Studies have shown that leads to millions of cases of opioid dependency annually. Dr. Shoichet and Mr. Cooke say they believe that if their hydrogel can hold and gradually release a larger dose of the anesthetic over three days, it can get post-surgical patients to the point where they don’t need opioids. That could improve pain management, cut hospital stays and reduce opioid addictions. The economic effect [would be] huge, and on top of that there’s the benefit to the patients and society, Mr. Cooke said.

Hance Clarke, an anesthetist who directs pain services at Toronto General Hospital, said a product for sale in the United States called Exparel can extend the anesthetic effect to 24 hours. There’s no doubt this would be a significant breakthrough if [AmacaThera] could come up with a therapeutic option lasting 72 hours after surgery. If they can get this across the finish line there’s certainly a home for this to land in clinical medicine. A growing number of research academics have warmed to the idea of commercializing their work in recent decades, although Canada has been slower to embrace the trend.

That was never the case for Toronto-born Dr. Shoichet, the daughter of two entrepreneurs, who worked early in her career at a U.S. biotech startup. She was keen to spin out inventions from her lab after starting at the University of Toronto in 1995, making her an anomaly at the time, she said. She was concerned her graduate students were leaving for the U.S. because there were very few opportunities here. So I became motivated to make a difference and help create more opportunities in Canada. The first startup spun out of her lab in 1998 was called BoneTec Corp. She sold her shares to co-founder John Davies three years later. In 2002, she founded MatRegen Corp. and served as president, raising more than $2-million before the company wound up in 2008. By the time she and Mr. Cooke co-founded AmacaThera in 2016, Dr. Shoichet had learned a few lessons as an entrepreneur: Keep early stage commercial technology in an academic setting as long as necessary and make your mistakes in as safe a place as possible.

The company also needed a full-time CEO she could trust, she said. She couldn’t fill that job herself and also run a lab, but Mr. Cooke, who had joined her lab in 2008 while pursuing his PhD, was game. AmacaThera, which raised US$1.8-million in seed funding in 2018, hopes to pass the safety trials and move to efficacy trials involving 100 post-surgical patients next year, Mr. Cooke said. The hope is that the technology can eventually be used to deliver a range of drugs, providing greater benefits with its time release properties. We really like that approach, said Michelle Scarborough, managing partner with the BDC fund. It solves a really big problem with a line of sight to commercial potential.

Source

Series B financing to support ongoing Phase 1/2a clinical trial of Tegavivint in desmoid tumors and initiation of clinical trials in acute myeloid leukemia, non-small cell lung cancer and pediatric cancers

HOUSTON, Feb. 16, 2021 /PRNewswire/ — Iterion Therapeutics, Inc. (“Iterion”), a venture-backed, clinical stage biotechnology company developing novel cancer therapeutics, announced today that it has raised $17 million USD in a Series B financing led by Lumira Ventures, with the participation of existing investors, including Santé Ventures, as well as new investors Venture Investors, GPG Ventures, and Viva BioInnovator.

Iterion plans to utilize the proceeds from this financing to advance the development of its lead clinical candidate, Tegavivint, a novel, potent and selective nuclear beta-catenin inhibitor. Tegavivint is currently being investigated in a Phase 1/2a clinical trial in patients with desmoid tumors, which are rare, non-metastasizing sarcomas that overexpress nuclear beta-catenin. Iterion has received Orphan Drug Designation for Tegavivint to treat desmoid tumors, a disease for which there are no FDA approved therapies.

In addition to desmoid tumors, Iterion is preparing to initiate clinical programs in 2021 to investigate Tegavivint in acute myeloid leukemia (AML), non-small cell lung cancer (NSCLC), and pediatric cancers, including sarcomas, lymphoma and other solid tumors.  These cancers are often characterized by nuclear beta-catenin overexpression, providing potential high-value target expansions for Tegavivint.

“We envision incredible potential therapeutic benefits associated with Tegavivint, and are excited to support the Iterion team in its exploration of multiple clinical development opportunities for this potentially groundbreaking therapeutic,” said Benjamin Rovinski, Ph.D., Managing Director at Lumira Ventures. “2021 is expected to be a pivotal year for Iterion as the company anticipates initiating clinical trials in AML, NSCLC and pediatric cancers, all indications in which nuclear beta-catenin signaling plays a role. By pursuing a novel mechanism of action, we believe Tegavivint has the potential to overcome challenges faced by prior drugs targeting this pathway.”

Nuclear beta-catenin is a highly-studied oncology target associated with numerous cancer types. Tegavivint is unique among nuclear beta-catenin inhibitors in that it binds to TBL1 (Transducin Beta-like Protein One), a novel downstream target in the Wnt-signaling pathway. As such, Tegavivint enables silencing of Wnt-pathway gene expression without affecting other necessary Wnt/beta-catenin functions in the cell membrane, thus avoiding toxicity issues common to other drugs in this pathway.

“We are grateful to have the confidence of investors, including Lumira Ventures, Santé Ventures and others, that appreciate Tegavivint’s potential to treat a host of cancers,” said Rahul Aras, Ph.D., CEO of Iterion. “Nuclear beta-catenin has historically been considered an ‘undruggable’ oncology target with prior inhibitors having been plagued by toxicity issues, greatly limiting their therapeutic use.  Research suggests that these toxicity concerns can be negated by targeting TBL1, a novel downstream target in the Wnt-signaling pathway necessary for beta-catenin’s oncogenic activity.  This is precisely Tegavivint’s mechanism of action and why we believe the technology holds such substantial promise.”

Dr. Aras continued, “With the Series B funding, Iterion has the potential to significantly expand our clinical footprint through completion of our ongoing desmoid tumor study and initiate clinical trials in 2021 to investigate Tegavivint in AML, NSCLC, and certain pediatric cancers.”

About Iterion Therapeutics
Iterion Therapeutics is a venture-backed, clinical stage biotechnology company developing novel cancer therapeutics. The company’s lead product, Tegavivint, is a potent and selective inhibitor of nuclear beta-catenin, a historically “undruggable” oncology target implicated in cell proliferation, differentiation, immune evasion and stem cell renewal. Research demonstrating potent anti-tumor activity in a broad range of pre-clinical models indicate that Tegavivint has the potential for clinical utility in multiple cancer types. Tegavivint is currently the subject of a Phase 1/2a clinical trial in patients with progressive desmoid tumors. Iterion is also pursuing clinical programs in additional cancers where nuclear beta-catenin signaling has been shown to play a role, including acute myeloid leukemia (AML), non-small cell lung cancer (NSCLC), and pediatric cancers, including sarcomas, lymphoma and other solid tumors. Iterion is the recipient of an up to $15.9 million Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT). For more information on Iterion, please visit https://iteriontherapeutics.com or follow the Company on Twitter and Linkedin.

Tiberend Strategic Advisors, Inc. 
Ingrid Mezo (Media)
646-604-5150
imezo@tiberend.com

SOURCE Iterion Therapeutics

COSELA is the only FDA-approved therapy that helps proactively deliver multilineage myeloprotection to patients with extensive-stage small cell lung cancer being treated with chemotherapy

– Myeloprotective efficacy of COSELA resulted in reductions in the incidence and duration of severe neutropenia, and impacted anemia and the need for rescue interventions such as growth factors and red blood cell transfusions –

– G1 will host conference call Tuesday, February 16, 2021 at 8:00 a.m. ET –

RESEARCH TRIANGLE PARK, N.C., Feb. 12, 2021 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved COSELA™ (trilaciclib) for injection to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). It is the first and only therapy designed to help protect bone marrow (myeloprotection) when administered prior to treatment with chemotherapy. COSELA is expected to be commercially available through G1’s specialty distributor partner network in early March.

“The approval of trilaciclib (COSELA) is an important advance in the treatment of patients with extensive-stage small cell lung cancer receiving chemotherapy,” said Dr. Jeffrey Crawford, Geller Professor for Research in Cancer in the Department of Medicine and Duke Cancer Institute. “The most serious and life-threatening side effect of chemotherapy is myelosuppression, or damage to the bone marrow, resulting in reduced white blood cells, red blood cells and platelets. Chemotherapy-induced myelosuppression may lead to increased risks of infection, severe anemia, and/or bleeding. These complications impact patients’ quality of life and may also result in chemotherapy dose reductions and delays. To date, approaches have included the use of growth factor agents to accelerate blood cell recovery after the bone marrow injury has occurred, along with antibiotics and transfusions as needed. By contrast, trilaciclib provides the first proactive approach to myelosuppression through a unique mechanism of action that helps protect the bone marrow from damage by chemotherapy. In clinical trials, the addition of trilaciclib to extensive-stage small cell lung cancer chemotherapy treatment regimens reduced myelosuppression and improved clinical outcomes. The good news is that these benefits of trilaciclib will now be available for our patients in clinical practice.”

Chemotherapy is an effective and important weapon against cancer. However, chemotherapy does not differentiate between healthy cells and cancer cells. It kills both, including important hematopoietic stem and progenitor cells (HSPCs) in the bone marrow that produce white blood cells (immune cells that help fight infection), red blood cells (cells that carry oxygen from the lungs to the tissues), and platelets (cells that prevent bleeding from cancer, surgeries, chronic diseases, and injuries). This chemotherapy-induced bone marrow damage, known as myelosuppression, can lead to increased risk of infection, anemia, thrombocytopenia, and other complications. Myeloprotection is a novel approach of protecting HSPCs in the bone marrow from chemotherapy-induced damage. This approach can help reduce some chemotherapy-related toxicity, making chemotherapy safer and more tolerable, while also reducing the need for reactive rescue interventions.

“Chemotherapy is the most effective and widely used approach to treating people diagnosed with extensive-stage small cell lung cancer; however, standard of care chemotherapy regimens are highly myelosuppressive and can lead to costly hospitalizations and rescue interventions,” said Jack Bailey, Chief Executive Officer at G1 Therapeutics. “COSELA will help change the chemotherapy experience for people who are battling ES-SCLC. G1 is proud to deliver COSELA to patients and their families as the first and only therapy to help protect against chemotherapy-induced myelosuppression.”

COSELA is administered intravenously as a 30-minute infusion within four hours prior to the start of chemotherapy and is the first FDA-approved therapy that helps provide proactive, multilineage protection from chemotherapy-induced myelosuppression. The approval of COSELA is based on data from three randomized, placebo-controlled trials that showed patients receiving COSELA prior to the start of chemotherapy had clinically meaningful and statistically significant reduction in the duration and severity of neutropenia. Data also showed a positive impact on red blood cell transfusions and other myeloprotective measures. The trials evaluated COSELA in combination with carboplatin/etoposide (+/- the immunotherapy atezolizumab) and topotecan chemotherapy regimens. Approximately 90% of all patients with ES-SCLC will receive at least one of these regimens during the course of their treatment.

The majority of adverse reactions reported with COSELA were mild to moderate in severity. The most common adverse reactions (≥10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia. Serious adverse reactions occurred in 30% of patients receiving COSELA. Serious adverse reactions reported in >3% of patients who received COSELA included respiratory failure, hemorrhage, and thrombosis. Grade 3/4 hematological adverse reactions occurring in patients treated with COSELA and placebo included neutropenia (32% and 69%), febrile neutropenia (3% and 9%), anemia (16% and 34%), thrombocytopenia (18% and 33%), and leukopenia (4% and 17%), respectively.

“Quite often, people diagnosed with extensive-stage small cell lung cancer rely on chemotherapy to not only extend their lives, but also to acutely alleviate their symptoms,” said Bonnie J. Addario, lung cancer survivor, co-founder and board chair of the Go2 Foundation for Lung Cancer. “Unfortunately, the vast majority will experience chemotherapy-induced side effects, resulting in dose delays and reductions, and increased utilization of healthcare services. G1 shares our organization’s goal to improve the quality of life of those diagnosed with lung cancer and to transform survivorship among people living with this insidious disease. We are thrilled to see new advancements that can help improve the lives of those living with small cell lung cancer.”

Approximately 30,000 small cell lung cancer patients are treated in the United States annually. G1 is committed to helping patients with extensive-stage small cell lung cancer in the U.S. gain access to treatment with COSELA. For more information on access and affordability programs, patients and providers should call the G1toOne support center at 833-G1toONE (833-418-6663) from 8:00 a.m. to 8:00 p.m. Eastern time.

G1 received Breakthrough Therapy Designation from the FDA in 2019 based on positive data in small cell lung cancer patients from three randomized Phase 2 clinical trials. As is common with breakthrough-designated products that receive priority review, G1 will conduct certain post-marketing activities, including in vitro drug-drug interaction and metabolism studies, and a clinical trial to assess impact of trilaciclib on disease progression or survival in patients with ES-SCLC with chemotherapy-induced myelosuppression treated with a platinum/etoposide-containing or topotecan-containing regimen with at least a two year follow up. G1 intends to initiate the post-approval clinical trial in 2022.

Webcast and Conference Call
The management team will host a webcast and conference call at 8:00 a.m. ET on Tuesday, February 16, 2021 to discuss the FDA approval of COSELA (trilaciclib). The live call may be accessed by dialing 866-763-6020 (domestic) or (210) 874-7713 (international) and entering the conference code: 6195528. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

COSELA (trilaciclib) Co-Promotion Agreement with Boehringer Ingelheim

In June 2020, G1 announced a three-year co-promotion agreement with Boehringer Ingelheim for COSELA in small cell lung cancer in the U.S. and Puerto Rico. G1 will lead marketing, market access and medical engagement initiatives for COSELA. 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 COSELA 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.

About Small Cell Lung Cancer

In the United States, approximately 30,000 small cell lung cancer patients are treated annually. SCLC, one of the two main types of lung cancer, accounts for about 10% to 15% of all lung cancers. SCLC is an aggressive disease and tends to grow and spread faster than NSCLC. It is usually asymptomatic; once symptoms do appear, it often indicates that the cancer has spread to other parts of the body. About 70% of people with SCLC will have cancer that has metastasized at the time they are diagnosed. The severity of symptoms usually increases with increased cancer growth and spread. From the time of diagnosis, the general 5-year survival rate for people with SCLC is 6%. The five-year survival rates for limited-stage (the cancer is confined to one side of the chest) SCLC is 12% to 15%, and for extensive stage (cancer has spread to the other lung and beyond), survival rates are less than 2%. Chemotherapy is the most common treatment for ES-SCLC.

COSELA™ (trilaciclib) for Injection  
INDICATION
COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

• COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

WARNINGS AND PRECAUTIONS

Injection-Site Reactions, Including Phlebitis and Thrombophlebitis

• COSELA administration can cause injection-site reactions, including phlebitis and thrombophlebitis, which occurred in 56 (21%) of 272 patients receiving COSELA in clinical trials, including Grade 2 (10%) and Grade 3 (0.4%) adverse reactions. Monitor patients for signs and symptoms of injection-site reactions, including infusion-site pain and erythema during infusion. For mild (Grade 1) to moderate (Grade 2) injection-site reactions, flush line/cannula with at least 20 mL of sterile 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP after end of infusion. For severe (Grade 3) or life-threatening (Grade 4) injection-site reactions, stop infusion and permanently discontinue COSELA. Injection-site reactions led to discontinuation of treatment in 3 (1%) of the 272 patients.

Acute Drug Hypersensitivity Reactions

• COSELA administration can cause acute drug hypersensitivity reactions, which occurred in 16 (6%) of 272 patients receiving COSELA in clinical trials, including Grade 2 reactions (2%). Monitor patients for signs and symptoms of acute drug hypersensitivity reactions. For moderate (Grade 2) acute drug hypersensitivity reactions, stop infusion and hold COSELA until the adverse reaction recovers to Grade ≤1. For severe (Grade 3) or life-threatening (Grade 4) acute drug hypersensitivity reactions, stop infusion and permanently discontinue COSELA.

Interstitial Lung Disease/Pneumonitis

• Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with cyclin-dependent kinases (CDK)4/6 inhibitors, including COSELA, with which it occurred in 1 (0.4%) of 272 patients receiving COSELA in clinical trials. Monitor patients for pulmonary symptoms of ILD/pneumonitis. For recurrent moderate (Grade 2) ILD/pneumonitis, and severe (Grade 3) or life-threatening (Grade 4) ILD/pneumonitis, permanently discontinue COSELA.

Embryo-Fetal Toxicity

• Based on its mechanism of action, COSELA can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use an effective method of contraception during treatment with COSELA and for at least 3 weeks after the final dose.

ADVERSE REACTIONS

• Serious adverse reactions occurred in 30% of patients receiving COSELA. Serious adverse reactions reported in >3% of patients who received COSELA included respiratory failure, hemorrhage, and thrombosis.
• Fatal adverse reactions were observed in 5% of patients receiving COSELA. Fatal adverse reactions for patients receiving COSELA included pneumonia (2%), respiratory failure (2%), acute respiratory failure (<1%), hemoptysis (<1%), and cerebrovascular accident (<1%).
• Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received COSELA. Adverse reactions leading to permanent discontinuation of any study treatment for patients receiving COSELA included pneumonia (2%), asthenia (2%), injection-site reaction, thrombocytopenia, cerebrovascular accident, ischemic stroke, infusion-related reaction, respiratory failure, and myositis (<1% each).
• Infusion interruptions due to an adverse reaction occurred in 4.1% of patients who received COSELA.
• The most common adverse reactions (≥10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

DRUG INTERACTIONS

• COSELA is an inhibitor of OCT2, MATE1, and MATE-2K. Co-administration of COSELA may increase the concentration or net accumulation of OCT2, MATE1, and MATE-2K substrates in the kidney (e.g., dofetilide, dalfampridine, and cisplatin).

To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information here

For more information about COSELA, please call 1-800-790-G1TX (1-800-790-4189)

About G1 Therapeutics
G1 Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the discovery, development and delivery of next generation therapies that improve the lives of those affected by cancer, including the Company’s first commercially available product COSELA™ (trilaciclib), a first-in-class therapy approved by the U.S. Food and Drug Administration to help protect against chemotherapy-induced myelosuppression in patients with extensive-stage small cell lung cancer being treated with chemotherapy. Trilaciclib is also being evaluated in other solid tumors, including colorectal, breast and bladder cancers. G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

Tecentriq® (atezolizumab) is a registered trademark of Genentech.

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 COSELA (trilaciclib), and COSELA’s (trilaciclib) possibility to improve patient outcomes, 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:
Will Roberts
G1 Therapeutics, Inc.
Vice President, Investor Relations and Corporate Communications
(919) 907-1944
wroberts@g1therapeutics.com

Christine Rogers
G1 Therapeutics, Inc.
Associate Director, Corporate Communications
(984) 365-2819
crogers@g1therapeutics.com

A PDF accompanying this announcement is available here

A photo accompanying this announcement is available here

ATLANTA, Feb. 11, 2021 (GLOBE NEWSWIRE) — Antios Therapeutics, Inc. (“Antios”) today announced the appointment of Patrick T. Higgins to the company’s board of directors. Mr. Higgins is a highly accomplished biopharmaceutical executive with more than two decades of experience leading companies in the development of therapies to treat infectious diseases of the liver including HBV and HCV.

“We have made significant progress on our lead asset, ATI-2173, a potential backbone treatment in a functional curative regimen for chronic HBV infection,” said Abel De La Rosa, Ph.D., co-founder of Antios and Chairman of its Board of Directors. “In conjunction with the completion of our Phase 1b clinical study in chronic HBV patients and with data expected to be presented at an upcoming medical conference, the addition of Pat’s significant expertise to our Board is very timely. We look forward to his guidance as we advance ATI-2173 in clinical development.”

Mr. Higgins has more than 35 years of biopharmaceutical executive experience of which the last 25 were with companies focused on infectious diseases including HBV and HCV for liver disease. His most recent position was as chief operating officer for Arbutus Biopharma, which is focused on developing a cure for HBV. In a prior role, he was a co-founder and chief executive officer of OnCore Biopharma, which he took public by merging with Tekmira Pharmaceuticals to form Arbutus. Before co-founding OnCore, he served as executive vice president, Commercial, for Pharmasset, which developed sofosbuvir, an FDA-approved therapy for HCV. Mr. Higgins was responsible for developing and executing the commercial strategy for sofosbuvir before the Company was acquired by Gilead Sciences in 2012 for $11 billion. Prior to Pharmasset, he led the infectious disease portfolio, including Pegasys^® for hepatitis infections, for Hoffman-LaRoche and spent 13 years at Schering Plough in various roles. Mr. Higgins is currently a director on the Board of Saronic Biotechnology. He earned is B.A. at Villanova University and his M.B.A. at Seton Hall University.

“I have spent much of my career in the pharmaceutical industry working for companies seeking treatments and cures for chronic hepatitis infections,” said Mr. Higgins. “Antios is focused on developing a functional cure for HBV, a public health objective that has yet to be achieved. I am looking forward to working with the Antios team to make this dream a reality.”

About ATI-2173
ATI-2173 is a novel, orally-administered, liver-targeted Active Site Polymerase Inhibitor Nucleotide (ASPIN) molecule designed to deliver the 5’-monophosphate of clevudine to the liver. This L-nucleoside’s active 5’-triphosphate has unique antiviral properties as a non-competitive, non-chain terminating HBV polymerase inhibitor that distorts the active site of HBV polymerase resulting in potent HBV antiviral activity and extended off-treatment suppression of HBV DNA. ATI-2173 targets the liver, delivering high levels of the unique 5’- triphosphate while limiting systemic exposure to the parent L-nucleoside. ATI-2173 has the potential to 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.

VANCOUVER, BC, Feb. 10, 2021 /PRNewswire/ — Notch Therapeutics, Inc., a biotechnology company developing renewable, induced pluripotent stem cell (iPSC)-derived cell therapies for cancer, announced today the closing of an oversubscribed U.S. $85 million Series A financing. The financing was led by an exclusively healthcare-focused investment fund, with participation by existing investors Allogene Therapeutics, Inc. (NASDAQ: ALLO), Lumira Ventures, and CCRM Enterprises Holdings Ltd., an affiliate of Centre for Commercialization of Regenerative Medicine (CCRM); along with new investors EcoR1 Capital, a undisclosed leading global investment firm, Casdin Capital, Samsara BioCapital, and Amplitude Ventures. Proceeds from the financing will support the continuing development of Notch’s portfolio of iPSC-derived T cell therapeutic product candidates and clinical readiness of the company’s proprietary Engineered Thymic Niche (ETN) platform. The financing will also enable Notch to expand its team to support the company’s future growth, including establishing operations in Seattle, in addition to the company’s existing operations in Vancouver and Toronto.

“We are gratified to have the confidence of this exceptional group of investors and have them share in our vision that our platform can be game-changing for cell therapies by easing cell manufacturing and broadening their clinical and commercial potential,” said David Main, President and Chief Executive Officer of Notch. “The level of interest in this financing round enabled us to far exceed our original capital-raising goals. With this support, Notch is well positioned to support our partners and advance development of our initial cell therapy products for patients with cancer.”

Notch is applying its scalable Engineered Thymic Niche (ETN) technology platform to develop homogeneous and universally compatible, stem cell-derived cell therapies. To date, Notch has assembled a world-class scientific team and built a fully integrated, tightly controlled platform for generating and editing immune cells from clonal stem cells to enable development of a broad range of T cell therapeutics. Notch has an existing partnership with Allogene Therapeutics to apply Notch’s proprietary ETN platform to develop CAR-targeted, iPSC-derived, off-the-shelf T cell or natural killer (NK) cell therapies for hematologic cancer indications.

“We have great confidence in Notch’s high-caliber management team and the rigorous science underlying its research programs,” said David Chang, M.D., Ph.D., President, Chief Executive Officer, and Co-Founder of Allogene and a member of the Notch Board of Directors. “We are impressed by the company’s innovation and accomplishments and pleased to continue our support of Notch as the company advances the development of a new generation of cell therapies for cancer and other immune disorders.”

About Notch Therapeutics (www.notchtx.com)
Notch is developing a pipeline of cellular immunotherapies originating from pluripotent stem cells that are specifically engineered to address the underlying biology of complex disease systems. The company has unlocked the ability for large-quantity production of T cells and other cells from any source of stem cells to bring best-in-class cell therapies for cancer and other immune disorders to thousands of patients. The core of the Notch platform is the Engineered Thymic Niche (ETN), which enables precision control of cell fate during the differentiation and expansion of stem cells in suspension bioreactors without the need for feeder cells or serum. The ETN has the potential to generate immunotherapies with decreased variability, increased potency, and engineered improvements. The technology was invented in the laboratories of Juan-Carlos Zúñiga-Pflücker, Ph.D. at Sunnybrook Research Institute and Peter Zandstra, Ph.D., FRSC at the University of Toronto. Notch was founded by these two institutions, in conjunction with MaRS Innovation (now Toronto Innovation Acceleration Partners) and the Centre for Commercialization of Regenerative Medicine (CCRM), which initially incubated the company.

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

SOURCE Notch Therapeutics

TORONTO, ON / ACCESSWIRE / February 2, 2021 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has secured a commitment of up to C$14 million (US$ 11 million) from the Government of Canada to complete the Phase 2 portion of a Phase 2/Phase 3 clinical study of its investigational drug, EB05, for the treatment of hospitalized COVID-19 patients. The funding will also help fund certain pre-clinical research intended to broaden the utility of the company’s experimental therapy, including treatments for other respiratory pathogens. The funds were awarded under the federal government’s Strategic Innovation Fund following a multi-disciplinary review of Edesa’s drug technology and plans.

“The award of this competitive funding is an important validation of the therapeutic potential of EB05 and the scientific rationale behind our efforts. The funds will be targeted toward rapidly getting EB05 into the hands of physicians on the front line of this health crisis,” said Dr. Par Nijhawan, Chief Executive Officer of Edesa. “By targeting the body’s underlying response, our experimental drug offers a potential solution that could be effective despite variations in the virus.”

The Honorable François-Philippe Champagne, Minister of Innovation, Science and Industry, said that Strategic Innovation Fund (SIF) funding announced today is part of the government’s plan to support the development of novel medical countermeasures for COVID-19 patients. “As countries around the world begin to distribute and administer COVID-19 vaccines to their populations, we cannot lose sight of the importance of developing treatments to limit the long-term impacts of the virus on Canadians. Today’s contribution will support Edesa as they take their promising treatment through clinical trials and subsequent approvals. Once approved, this therapy has the potential to be an important tool in treating and preventing lung injuries caused by COVID-19. As the government continues to protect and support Canadians through this pandemic, it must also lay the foundation for a better-prepared, healthier and more prosperous future,” he said.

EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive immune response associated with Acute Respiratory Distress Syndrome (ARDS) – the leading cause of death in COVID-19 patients. Specifically, the drug inhibits toll-like receptor 4 (TLR4) signaling – an important mediator of inflammation responsible for acute lung injury that has been shown to be activated by SARS-CoV2, SARS-CoV1 and Influenza viruses. The goal of the experimental treatment is to suppress inflammation, fluid accumulation and lung injury, thereby reducing the number of ICU patients and intubation/ventilation procedures, and ultimately saving lives.

The company intends to use the SIF funding for Phase 2 study expenses. Edesa’s ongoing Phase 2/3 study is an adaptive, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EB05 in adult hospitalized COVID-19 patients. Up to 316 patients will be enrolled in the first phase of the trial. Patients will be infused intravenously with a single dose of EB05 or placebo. Should the antibody treatment demonstrate promising results at the Phase 2 readout, the company plans to continue with a pivotal Phase 3 study.

“We greatly appreciate the support of the Government of Canada and the effort of the staff of the Innovation, Science and Economic Development (ISED) department in leading the technical review of our application,” said Michael Brooks, PhD, President of Edesa Biotech. “We look forward to working with the government on the next steps in the program and continuing to build on Canada’s emergency preparedness capabilities.”

In addition to the ongoing clinical study, the SIF funding will also be used to support a research project at a Canadian university. Among other objectives, the in vitro pre-clinical study will examine the potential therapeutic utility of EB05 against a panel of pathogens, including coronavirus variants and influenza strains.

Hospitals and physicians interested in participating in the Phase 2/3 study of EB05 should contact info@edesabiotech.com or visit www.clinicaltrials.gov (Identifier: NCT04401475)

About ARDS

Acute Respiratory Distress Syndrome is the leading cause of death in COVID-19 patients. The U.S. Centers for Disease Control (CDC) reports that 20% to 42% of hospitalized COVID-19 patients develop ARDS, which increases to 67% to 85% for patients admitted to the ICU. Mortality among patients admitted to the ICU ranges from 39% to 72% depending on the study and characteristics of patient population, according to the CDC. ARDS involves an exaggerated immune response leading to inflammation and injury to the lungs that results in edema that deprives the body of oxygen. For moderate to severe cases, there are currently few meaningful treatments, other than supplemental oxygen and mechanical ventilation, and patients suffer high mortality rates. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury and other causes. Prior to COVID-19, ARDS accounted for approximately 10% of intensive care unit admissions, representing more than 3 million patients globally each year.

About Edesa Biotech, Inc.

Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory and immune-related diseases with clear 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. The company is developing late-stage monoclonal antibodies that block certain immune signaling proteins, known as TLR4 and CXCL10. These molecules are associated with a broad range of diseases, including the inflammation associated infectious diseases. Due to the global health emergency, Edesa has prioritized the development of EB05 as a potential treatment for hospitalized COVID-19 patients. The company is based in Markham, Ontario, Canada, with a U.S. subsidiary located in Southern California. Sign up for news alerts.

Edesa Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “should,” “might,” “potential,” or “continue” and variations or similar expressions, including statements related to: the company’s belief that EB05 could regulate the overactive immune response associated with ARDS, the company’s belief that EB05 could modulate the TLR4 signaling pathway for the benefit of patients, the company’s belief that EB05 could provide effective treatment for current and future variations of the SARS-CoV2 virus, and the company’s plans regarding its Phase 2/3 study and the use of SIF funding. 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, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises, such as COVID-19. 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.

Contact:

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

 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (“Aurinia” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved LUPKYNIS^TM (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). LUPKYNIS is the first FDA-approved oral therapy for LN. LN causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. It is one of the most serious and common complications of the autoimmune disease systemic lupus erythematosus (SLE). LUPKYNIS is now available to patients in the United States (U.S.).

In pivotal trials, patients treated with LUPKYNIS in combination with standard-of-care (SoC) were more than twice as likely to achieve renal response and experienced a decline in urine protein creatinine ratio (UPCR) twice as fast as patients on typical SoC alone. UPCR is a standard measurement used to monitor protein levels in the kidney. Early intervention and kidney response are linked to better long-term outcomes and prevent irreversible kidney damage. Patients treated with LUPKYNIS showed improved response rates in all parameters across immunologically-active classes of LN studied.

“The LUPKYNIS approval marks a turning point for the lupus nephritis community – patients, caregivers, families, and healthcare professionals – all of whom we thank for their partnership in the development of this innovative novel treatment. We are thrilled to bring LUPKYNIS to the people impacted by this devastating condition,” said Peter Greenleaf, President and Chief Executive Officer of Aurinia Pharmaceuticals. “The approved label supports the efficacy and safety of LUPKYNIS as well as Aurinia’s proprietary and patented eGFR pharmacodynamic dosing protocol. We have worked tirelessly to put the correct team and infrastructure in place to ensure we are ready for swift commercial adoption of LUPKYNIS.”

“For years treating patients with lupus nephritis has been challenging. We have had a very limited number of therapeutic options, and these have been only modestly effective but highly toxic,” said Brad H. Rovin, M.D., Professor of Medicine and the Director of the Division of Nephrology, Ohio State University Wexler Medical Center, and AURORA clinical trial investigator. “The FDA approval of LUPKYNIS allows us to treat patients safely and more effectively with a rapid acting therapy which requires far less steroids, something our patients will appreciate.”

To assist LUPKYNIS patients and the healthcare provider (HCPs) who prescribe the treatment, Aurinia has developed and launched Aurinia Alliance™, a patient support program featuring dedicated nurse case managers who provide personalized educational resources and assistance in navigating insurance and Aurinia medication costs throughout each patient’s LUPKYNIS treatment journey. To learn more about Aurinia Alliance or LUPKYNIS, visit www.LUPKYNIS.com.

“People with lupus nephritis have desperately needed approved treatments to help them avoid irreversible kidney damage and the eventual need for kidney transplant,” said Stevan W. Gibson, President and CEO, Lupus Foundation of America. “The approval of a tailored therapy represents a significant step forward in treating lupus nephritis and is excellent news for the lupus community.”

“Despite strong efforts in research to find solutions for SLE and LN, options to-date have been limited. Once patients progress to LN, they face inevitable life-altering effects,” said Kenneth M. Farber, President and CEO, Lupus Research Alliance. “We have long supported Aurinia Pharmaceuticals and are encouraged by the U.S. FDA approval of voclosporin, a much-needed oral treatment option to address the challenges faced by people living with LN.”

“New treatments indicated specifically for lupus nephritis will contribute to our quest for health equity in kidney diseases,” commented National Kidney Foundation’s Chief Medical Officer Joseph Vassalotti, M.D. “Interventions that are effective to manage and potentially prevent irreversible kidney damage are exciting for people living with lupus nephritis and their clinicians in nephrology and rheumatology.”

“As a patient-led organization who understands all too well the urgent need for more efficacious treatments for people struggling to live with diseases of unmet need like lupus nephritis, we are thrilled with the approval of LUPKYNIS,” said Kathleen A. Arntsen President and CEO of Lupus and Allied Diseases Association. “There is now a new treatment for this debilitating and life-diminishing condition that is four times higher for people of African descent and Asians and two times higher for Hispanics/Latinos and Native Americans. At a time when our nation faces extreme challenges such as addressing and overcoming social inequities and health disparities, this is welcome and promising news, especially since both lupus nephritis and COVID-19 disproportionately impact communities of color.”

LUPKYNIS was approved by the FDA under Priority Review and was previously granted Fast Track designation from the Agency in 2016. To learn more visit www.auriniapharma.com.

Multimedia Components and Conference Call Information

Multimedia components are available with this press release (link here). Aurinia will host a conference call and webcast to discuss the approval of LUPKYNIS on Monday, January 25, 2021 at 8:30 a.m. ET. The webcast can be accessed on the investor section of the Aurinia website at www.auriniapharma.com. To participate in the teleconference, please dial +1-877-407-9170 (Toll-free U.S. & Canada).

Clinical Trial Overview of LUPKYNIS (voclosporin)

The approval of LUPKYNIS is based on data from Aurinia’s pioneering late-stage global clinical studies in LN – the pivotal AURORA Phase 3 study and the AURA-LV Phase 2 study. These studies together demonstrated the ability of LUPKYNIS treatment to significantly improve outcomes as reported up to 52 weeks, for patients on several parameters when added to the typical SoC, mycophenolate mofetil (MMF), and low dose steroids.

In both studies, a total of 533 patients with LN were randomized to receive either LUPKYNIS 23.7 mg or placebo twice daily used with SoC. All patients were dosed with concurrent MMF at a target dose 2 g/day. In both studies, initial treatment with intravenous (IV) methylprednisolone up to a cumulative dose of 1 g was administered on Days 1 and 2, and all patients received a subsequent taper of oral corticosteroids. The starting dose of oral prednisone was 20 mg/day for patients with a body weight of <45 kg and 25 mg/day for patients ≥45 kg. The dose of oral corticosteroid was tapered down to achieve a target dose of 2.5 mg/day by Week 16. The studies enrolled patients with LN of Class III or IV (alone or in combination with Class V) or pure Class V. Enrolled patients were required to have baseline eGFR >45 mL/min/1.73 m².

In the Phase 3 study, at one year, LUPKYNIS plus SoC was more than two times as effective at achieving a complete renal response than the SoC alone. Patients in the study taking LUPKYNIS also achieved a 50 percent reduction in UPCR twice as fast as SoC, and a higher portion of LUPKYNIS-treated patients achieved a complete renal response at 24 weeks compared to patients receiving SoC. The study results were achieved using a protocol-defined steroid taper. Patients treated with LUPKYNIS showed improved response rates in all parameters across immunologically-active classes of LN studied.

The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.

About Lupus Nephritis

Lupus nephritis (LN) is a serious progression of SLE, a chronic, complex and autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals have already developed LN at the time of SLE diagnosis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals with Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

About Aurinia

Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company has introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN). The Company’s head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATIONS

LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN). Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS

Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.

CONTRAINDICATIONS: LUPKYNIS is contraindicated inpatients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients.

WARNINGS AND PRECAUTIONS

Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent.

Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections (including opportunistic infections), which may lead to serious, including fatal, outcomes.

Nephrotoxicity: LUPKYNIS, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity.

Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy.

Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions.

Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia.

QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.

Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.

Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.

Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Reduce dosage of certain P-gp substrates with narrow therapeutic windows when co-administered.

ADVERSE REACTIONS

The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.

SPECIFIC POPULATIONS

Pregnancy/Lactation: May cause fetal harm. Advise not to breastfeed.

Renal Impairment: Not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m² unless benefit exceeds risk. Severe renal impairment: Reduce LUPKYNIS dose.

Mild and Moderate Hepatic Impairment: Reduce LUPKYNIS dose. Severe hepatic impairment: Avoid LUPKYNIS use.

Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS.

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: Aurinia’s estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who will develop LN; the proportion of Black and Asian individuals, and individuals with Hispanic ancestry, compared to Caucasian individuals, to develop LN; Aurinia enhancing access with a variety of patient services and healthcare engagement initiatives. 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 accuracy of the results from our clinical trials; the accuracy of reported data from third party studies and reports; that Aurinia’s intellectual property rights are valid and do not infringe the intellectual property rights of third 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 we may experience in completing the commercialization of voclosporin; the market for the LN business may not be as estimated; Aurinia may have to pay unanticipated expenses; Aurinia may not be able to obtain sufficient supply to meet commercial demand for voclosporin in a timely fashion; unknown impact and difficulties imposed by the COVID-19 pandemic on our business operations including nonclinical, clinical, regulatory and commercial activities; the results from our clinical studies and from third party studies and reports may not be accurate; and our assets or business activities may be subject to disputes that may result in litigation or other legal claims. 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.

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

View source version on businesswire.com: https://www.businesswire.com/news/home/20210122005501/en/

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

Corporate:
Dana Lynch
Corporate Communications, Aurinia
dlynch@auriniapharma.com

Media:
Stefan Riley
Ten Bridge Communications
stefan@tenbridgecommunications.com

Source: Aurinia Pharmaceuticals Inc.

Released January 22, 2021

Hillrom (NYSE: HRC) today announced it has reached a definitive agreement to acquire Bardy Diagnostics, Inc. (BardyDx), an innovator in digital health and a leading provider of ambulatory cardiac monitoring technologies. Under the terms of the agreement, Hillrom will purchase BardyDx for a cash consideration of $375 million and future potential payments based on the achievement of certain commercial milestones. Hillrom is also acquiring net operating losses valued at more than $20 million that are expected to result in future tax benefits.

“This acquisition provides Hillrom with a highly strategic and differentiated diagnostic cardiology platform aligned with our vision of Advancing Connected Care™, as well as an attractive recurring, high-growth revenue stream and gross margin profile,” said Hillrom President and CEO John Groetelaars. “BardyDx brings a talented team with significant commercial, clinical and scientific expertise, and dedicated independent diagnostic testing facilities. We look forward to welcoming the 230 employees who will join us in our mission of enhancing outcomes for patients and their caregivers.”

The acquisition of BardyDx complements Hillrom’s current cardiology portfolio of cardiac stress exercise, Holter and resting electrocardiography (ECG) devices. BardyDx, with annualized revenue of approximately $30 million, provides a differentiated, wearable bio-sensing technology, the Carnation Ambulatory Monitor (or CAM™ patch), that is engineered for patient-comfort, superior P-wave clarity, exceptional diagnostic yield and superior clinical accuracy.

“We set out to elevate ECG monitoring through an entirely new approach to signal processing, ECG reader training and report analysis tools and format, which allow for precise diagnoses of both common and abstruse arrhythmias,” said Gust H. Bardy, M.D., electrophysiologist, founder and chief medical officer of Bardy Diagnostics. “Our team coupled advanced diagnostics with comfort and ease-of-use for the patient, and simple implementation for clinicians. By joining Hillrom, we will broaden our footprint globally with the goal of providing greater patient value and more confident physician diagnoses.” 

The CAM patch is designed to promote patient compliance, streamline clinical workflow, and yield clinically actionable data in a unique and proprietary CAM™ report that enables physicians to identify specific arrhythmias to aid clinical decision-making. The device employs a novel circuit design and uses advanced compression algorithms to process the signal, ensuring P-wave recording and accuracy, a significant attribute for cardiologists and electrophysiologists.

Hillrom’s existing global brand, channel and presence in acute and primary care settings, and capabilities around market access, payor contracting, data security and EMR integration, are expected to drive accelerated adoption of the CAM patch and BardyDx’s related suite of ECG analysis services and tools.

Hillrom intends to finance the acquisition through a combination of cash on hand and borrowings under existing credit facilities, and expects to close the transaction in the fiscal second quarter of 2021, subject to customary closing conditions. Hillrom expects the transaction to be dilutive to fiscal 2021 adjusted earnings by approximately $0.10 per diluted share and does not expect the transaction to have an impact on its previously issued fiscal 2021 financial guidance. The transaction is expected to be dilutive in the first twelve months, increasingly accretive thereafter, and generate 10% return on invested capital by year five. The company will provide additional information on its fiscal first quarter 2021 earnings conference call.

About Bardy Diagnostics, Inc.
Bardy Diagnostics was founded in 2013 by electrophysiologist Gust H. Bardy, M.D. The company’s mission is to improve clinical management and outcomes for patients and their physicians by deploying innovative P-wave-centric ECG detection into patient-friendly technologies that result in greater patient compliance and more confident physician diagnoses. After years of meticulous R&D, BardyDx developed the first continuous-wear, wire-free ambulatory patch monitor that provides unparalleled signal clarity with a focus on the P-wave: the Carnation Ambulatory Monitor, or CAM™ patch. Learn more at BardyDx.com.

About Hillrom
Hillrom is a global medical technology leader whose 10,000 employees have a single purpose: enhancing outcomes for patients and their caregivers by advancing connected care. Around the world, our innovations touch over 7 million patients each day. They help enable earlier diagnosis and treatment, optimize surgical efficiency and accelerate patient recovery while simplifying clinical communication and shifting care closer to home. We make these outcomes possible through digital and connected care solutions and collaboration tools, including smart bed systems, patient monitoring and diagnostic technologies, respiratory health devices, advanced equipment for the surgical space and more, delivering actionable, real-time insights at the point of care. Learn more at hillrom.com.

Cyrano Therapeutics, a clinical stage regenerative medicine company developing a novel intranasal therapy for smell and flavor restoration, has raised $12.8 million in a Series A financing led by Remiges Ventures and Lumira Ventures, with the participation of additional investors. The funds will be used to complete a Phase 2 clinical trial of the company’s lead product, CYR-064, in the U.S. and Europe.  As part of the financing, Taka Koda of Remiges Ventures and Gerry Brunk of Lumira Ventures have joined the company’s board of directors.

The chronic loss of smell and flavor is a condition affecting at least 5% of the population in the U.S. with a similar incidence in Europe and Asia. Influenza, allergic rhinitis and traumatic brain injury are commonly known causes of chronic smell and flavor loss. In the neurodegenerative disease sector, it is also known that 95 percent of Parkinson’s patients experience smell and flavor loss, often as the first symptom of the disease. 

Over the past year, clinicians now recognize that over 90% of COVID-19 patients experience at least some smell loss or smell distortion (known as anosmia, hyposmia or parosmia), with over half of them experiencing severe to complete loss of smell and flavor. Although many patients recover, an indeterminate number may have a chronic dysfunction in need of long-term treatment. The company expects to include COVID-19 patients in its clinical trial, along with patients whose loss of smell resulted from other viral infections.

Cyrano Therapeutics was founded after Chief Executive Officer Rick Geoffrion experienced a long-term loss of smell and flavor due to the flu several years ago. Partnering with Robert Henkin, PhD, Director of The Taste and Smell Clinic in Washington D.C., they co-founded Cyrano Therapeutics to bring a safe and effective treatment to patients.

“When losing all sense of smell and flavor, you realize the magnitude of the issue and how much these senses are intertwined with general social interaction, appetite, libido and memory.  These are the building blocks of everyday life and integral to one’s physical and mental quality of life. Importantly, our sense of smell also alerts us to threats including gas leaks, smoke and spoiled food. Together with Dr. Henkin, we are on a mission to take this therapy through rigorous trials and provide full access for the millions who need it,” says Geoffrion.

About Cyrano Therapeutics

Cyrano Therapeutics is a private, venture-backed clinical stage regenerative medicine company developing a novel therapy to restore smell and flavor function. The chronic loss of smell and flavor is a condition affecting at least 5% of the U.S. population with a similar incidence in Europe and Asia. Influenza, allergic rhinitis and traumatic brain injury are commonly known causes of chronic smell and flavor loss. The condition is now recognized as a widely prevalent long-term condition suffered by many patients who have recovered from COVID-19.   www.cyranotherapeutics.com

SOURCE:Cyrano Therapeutics

enGene Inc., A biotechnology company developing non-viral gene therapies for local administration into mucosal tissues enabled by its proprietary DDX platform, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to enGene for EG-70, the company’s lead investigational non-viral gene therapy for the treatment of patients with Bacille Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC).  

The Fast Track program is intended to facilitate the development and expedite the review of therapies that treat serious conditions and fill an unmet medical need. Therapeutic programs that receive Fast Track Designation can benefit from more frequent communication with the FDA, eligibility for Priority Review and Accelerated Approval, and potentially for Rolling Review of the marketing application.

“Fast Track Designation underscores the urgent need for new and effective treatments for BCG-unresponsive NMIBC patients,” said Jason Hanson, Chief Executive Officer at enGene. “We are pleased with the FDA’s recognition of our EG-70 program with this designation and we look forward to working closely with the FDA throughout the clinical development process to bring this innovative treatment to patients as quickly as possible.”

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 EG-70 for BCG-unresponsive NMIBC, enGene is developing unique genetic medicines for respiratory indications and the company is evolving its technology to enable applications in multiple mucosal tissues with areas of high unmet medical need. http://www.engene.com 

Former CEO and Antios co-founder, Abel De La Rosa, Ph.D., appointed Chairman of the Board of Directors

Mayes to lead continued development of ATI-2173 as a potential backbone of a curative regimen for Hepatitis B (“HBV”)

ATLANTA, Dec. 01, 2020 (GLOBE NEWSWIRE) — Antios Therapeutics, Inc. (“Antios”) today announced the appointment of Gregory T. Mayes as Chief Executive Officer and Director. Mr. Mayes succeeds Abel De La Rosa, Ph.D., who co-founded Antios in 2018 and has served as CEO and Director since its inception. Dr. De La Rosa, who is retiring from his full-time role, will remain with Antios as an advisor and will assume the role of Chairman of its Board of Directors.

“On behalf of our Board of Directors, we are thrilled to have Greg join Antios as our new CEO and lead the company to its next stage of development,” said Dr. De La Rosa. “Greg is an accomplished biopharma executive with a sterling track record of success at both building startups and managing established organizations. He has led companies through early- and late-stage clinical development programs as well as commercial launches. Our lead clinical candidate, ATI-2173, is approaching an important inflection point in its development with the upcoming readout from our Phase 1 study in both healthy volunteers and HBV-infected subjects and the commencement of our Phase 2 program in early 2021.”

“Having led Antios from preclinical development to the well capitalized, clinical stage biopharmaceutical company it is today, I feel this is the opportune time for a leadership change. I truly believe that we are well positioned for continued success and I am confident that Antios will flourish under Greg’s leadership. As a co-inventor of ATI-2173, I am deeply committed to its success, and look forward to remaining actively involved, both as Chairman of the Board and in my new role as Senior Scientific and Strategic Advisor.”

Mr. Mayes joins Antios following the acquisition of Engage Therapeutics (“Engage”) by UCB in June 2020. He co-founded Engage and served as CEO from 2017 until its acquisition, which came following positive data from a large, randomized Phase 2 clinical trial of its lead product candidate in development for a new product category called REST (Rapid Epileptic Seizure Termination). Prior to founding Engage, he was Chief Operating Officer and a Board member at Advaxis Immunotherapies, where he developed the Phase 3 registration strategy and clinical development plan for its lead product candidate and established multiple major pharma partnerships. Previously, he was President, General Counsel and Board member at Unigene Laboratories, where he led out-licensing efforts for a novel oral peptide delivery platform. He was also Vice President, General Counsel, and Chief Compliance Officer at ImClone Systems (“ImClone”), where he was actively involved in the clinical development and commercial launch plans for ERBITUX® (cetuximab) and was instrumental in ImClone’s sale to Eli Lilly in 2008. He began his career as Senior Counsel at AstraZeneca Pharmaceuticals LP, where he provided legal services related to the development and commercialization of multiple oncology products. He earned his J.D. degree from Temple University School of Law, where he was Articles Editor on the Temple Law Review and holds a bachelor’s degree from Syracuse University. Mayes currently sits on the Boards of AVEO Oncology and Receptor Life Sciences.

“I am extremely grateful to the Board for this opportunity and excited to build upon the solid foundation that Abel and his team have established over the last several years,” said Mr. Mayes. “In ATI-2173, we have a promising clinical candidate and compelling scientific rationale to position it as the potential backbone of a functional cure regimen for HBV, a significant unmet need. I look forward to leading its continued clinical development and to the many opportunities that lie ahead for 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.

CONTACTS

Investors:
Idean Marvasty
ir@antiostherapeutics.com

Media:
Antios Public Relations
pr@antiostherapeutics.com

TEWKSBURY, Mass., Nov. 17, 2020 /PRNewswire/ — Corvia Medical, Inc., a company dedicated to transforming the treatment of heart failure (HF), today announced completion of randomization in its REDUCE LAP-HF II global, pivotal trial. The trial is evaluating the Corvia^® Atrial Shunt (IASD^®) – a novel, transcatheter implant – to reduce elevated left atrial pressures (LAP), the primary cause of HF symptoms, in heart failure patients with preserved ejection fraction (HFpEF) or mid-range ejection fraction (HFmrEF). The company also announced authorization by the Food and Drug Administration (FDA) to continue evaluation of the Corvia Atrial Shunt under a Continued Access Protocol (CAP) while its pre-market approval (PMA) application is under review. PMA submission is planned for late 2021.

REDUCE LAP-HF II is the world’s first large, prospective, multicenter, randomized, sham-controlled trial to evaluate interatrial shunting. The study randomized 626 patients at 109 sites across 15 countries, with the aim to improve quality of life, reduce HF symptoms and decrease HF-related hospitalizations. Primary outcome measures will be evaluated after the last randomized patient completes 12-month follow-up. Sanjiv Shah, MD from Northwestern University Feinberg School of Medicine in Chicago, Illinois, and Martin Leon, MD from the Columbia University Irving Medical Center in New York, NY serve as lead principal investigators.

“The outcome of the landmark REDUCE LAP-HF II trial has the potential to revolutionize how we treat these heart failure patients, which is the greatest unmet need in cardiology today,” stated Sanjiv Shah, MD. “Treating this population is challenging, and often frustrating, because standard treatments for heart failure don’t work well. Data from this study evaluating the efficacy of the Corvia Atrial Shunt will provide valuable information regarding this novel therapy in this underserved patient population.” Martin Leon, MD added, “In light of the increasing incidence of heart failure, innovative treatment options are of critical importance. We are pleased with the study execution and enrollment pace of this trial, and are eagerly awaiting the results, which have the potential to change the treatment paradigm for heart failure.”

“Randomizing the last pivotal trial patients is a significant milestone for Corvia and brings us one step closer to providing this innovative technology to patients in the US,” said George Fazio, President and CEO of Corvia Medical. “REDUCE LAP-HF II is one of the largest randomized heart failure device trials ever undertaken and demonstrates our commitment to building a strong body of clinical evidence showing how atrial shunting advances care for patients suffering with the debilitating symptoms of heart failure.”

Corvia also announced FDA authorization to continue patient enrollment under a CAP. The open label REDUCE LAP-HF IV study will enroll patients at existing pivotal trial centers. “We are pleased to have the opportunity to continue to offer this breakthrough therapy to heart failure patients,” said Jan Komtebedde, Senior Vice President and Chief Medical Officer at Corvia Medical. “In collaboration with our advisors and investigators, we are committed to generating unbiased evidence to support this new therapeutic class of atrial shunting for heart failure. This study provides an opportunity to generate additional safety and efficacy evidence to support future therapy adoption.”

About Heart Failure
Heart failure (HF) is a chronic condition that affects approximately 26 million people worldwide.By 2030, that number will increase by almost 50%, to nearly 38 million people. More than half of all HF patients have HFpEF/HFmrEF, and that number is increasing, driven by population aging and other risk factors. In patients with HFpEF/HFmrEF, the proportion of blood pumped out of the heart is normal or relatively normal, but because the muscles of the left atrium and ventricle are stiff, the heart cannot relax and fill properly, causing an increase in pressures in the left heart chambers and the lungs. HFpEF/HFmrEF remains one of the most significant unmet needs in cardiovascular medicine. While there have been significant advances in treatment for heart failure with reduced ejection fraction (HFrEF), there currently are no effective treatments for HFpEF/HFmrEF. 

About the Corvia Atrial Shunt (IASD^®)
The Corvia Atrial Shunt is a novel, transcatheter implant for patients suffering from symptomatic heart failure (HF) and the first therapeutic device designed to directly address elevated left atrial pressure (LAP), the primary contributor of HF symptoms. The device (about the size of a dime) is implanted by an interventional cardiologist or electrophysiologist during a minimally invasive, outpatient procedure. After a small opening is created in the atrial septum, the Corvia Atrial Shunt 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 LAP and pressure in the lungs. By facilitating continuous and dynamic decompression of the left atrium, the Corvia Atrial Shunt aims to improve HF symptoms and quality of life, decrease HF hospitalizations, and reduce the overall cost of managing HF patients. The Corvia Atrial Shunt is the most clinically studied interatrial shunt for the reduction of LAP in symptomatic HF patients. It has been implanted in more than 400 patients worldwide and reviewed in over 20 publications. For more information, visit http://treatmyheartfailure.com. The Corvia Atrial Shunt is an investigational device and is not available for commercial distribution in the United States. The device is available for sale in the European Union.

About Corvia Medical, Inc.
Corvia Medical, Inc. is revolutionizing the treatment of heart failure through novel transcatheter cardiovascular devices. Founded in 2009 and headquartered in Tewksbury, MA, Corvia Medical is dedicated to transforming the standard of care for heart failure treatment, enabling patients to reclaim their lives. Privately held, the company is backed by Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, Edwards Lifesciences and an undisclosed strategic investor.

For more information, visit http://corviamedical.com/.

MEDIA CONTACT:
Lisa Ensz
Vice President, Marketing
Corvia Medical, Inc.
+1 978-654-6120
lensz@corviamedical.com

SOURCE Corvia Medical, Inc.Back

OTTAWA, ON, Nov. 10, 2020 /CNW/ – The world is shining the spotlight on science now more than ever as we face the challenges of the COVID-19 pandemic. As Canadian science and engineering researchers continue to lead on the world stage, the Government of Canada celebrates the country’s research excellence by honoring some of its best and brightest.

Today, Her Excellency the Right Honourable Julie Payette, Governor General of Canada, the Honourable Navdeep Bains, Minister of Innovation, Science and Industry, and Professor Alejandro Adem, President of the Natural Sciences and Engineering Research Council of Canada (NSERC) are pleased to announce this year’s recipients of NSERC Prizes. Twenty-six of Canada’s world-leading scientists and engineers, and 13 of their industry partners received NSERC prizes recognizing their contributions in a range of research fields. Topics explored include advancements to our understanding of the effects of climate change on biodiversity in urban, natural and ocean environments, the impact of aerosols on the Arctic, the development of sustainable pesticides, and innovations in quantum computing technology.

Dr. Molly Shoichet is this year’s recipient of Canada’s most prestigious science prize, the Gerhard Herzberg Canada Gold Medal for Science and Engineering, worth up to $1 million. Dr. Shoichet’s breakthrough invention of hydrogels enabled researchers to grow human cells in three-dimensional environments, and has since led to game-changing applications in the areas of tissue engineering, regenerative medicine and pharmaceutical testing. Dr. Shoichet’s contributions have fundamentally advanced biomedical engineering research and placed the next generation of medical treatments within our grasp.

Dr. Karen Maxwell is receiving this year’s John C. Polanyi Award in recognition of her ground-breaking discovery and ongoing contributions to the field of biochemistry. Dr. Maxwell and her team discovered that the soil-dwelling bacteria Streptomyces produces molecules that stop viruses in their tracks and prevent fast replication, a breakthrough that opens up a new method to screen for drugs that could be useful for the treatment of human cancers and viral infections.

NSERC celebrates research excellence with a wide range of prizes. Individual awards focus on accomplishments that range from innovative discoveries by young researchers to lifetime achievement and influence. 

Quotes

“Our government is steadfastly committed to science and research, and is proud to honor today’s recipients for their outstanding achievements in their fields. These researchers exemplify Canada’s culture of curiosity and innovation, and are making the breakthroughs that have the power to improve the lives of all Canadians from better understanding the effects of climate change to making medical advancements.”
–  The Honourable Navdeep Bains, Minister of Innovation, Science and Industry

“This year is about highlighting and celebrating how much science is playing an important role in our everyday lives. The prize winners showcase their excellence in science research with their breakthrough successes in diverse fields. Congratulations to all prize winners for their significant achievements.”
–  Professor Alejandro Adem, President of NSERC

“When I found out that I had won the Herzberg award, I was overwhelmed because it seems so unreachable. When you look at all the people who have won this award before me, they are people that I hold in such high esteem. To be among them, and to have my peers consider me to be among them, is so exciting and so thrilling.”
–  Dr. Molly Shoichet, Professor of Chemical Engineering & Applied Chemistry and Biomaterials & Biomedical Engineering, University of Toronto

Quick facts

• Honouring the memory of Canadian Nobel laureate Gerhard Herzberg, the NSERC Herzberg Gold Medal is the agency’s highest honour. It provides recipients with up to $1 million in discovery research funding over five years.
• Today’s ceremony celebrates the outstanding achievements of recipients who received five NSERC prizes totaling up to $3.95 million.
• NSERC-funded researchers are honoured every year for achievements that showcase the high caliber of talent and the innovative research taking place in Canadian universities and colleges.

Associated Links

Full list of NSERC prizes, this year’s winners and their profiles

NSERC invests over $1.2 billion each year in natural sciences and engineering research in Canada. Our investments deliver discoveries—valuable world firsts in knowledge claimed by a brain trust of over 11,000 professors. Our investments enable partnerships and collaborations that connect the makers and users of discoveries. Research partnerships established by NSERC help inform research and development and solve scale-up challenges.

NSERC also provides scholarships and hands-on training experience for more than 30,000 post-secondary students and post-doctoral fellows. These young researchers will be the next generation of science and engineering leaders in Canada.

SOURCE NSERC

For further information: John Power, Press Secretary, Office of the Minister of Innovation, Science and Industry, 343-550-1456, john.power@canada.ca; Media Relations, Innovation, Science and Economic Development Canada, 343-291-1777, ic.mediarelations-mediasrelations.ic@canada.ca; Christine Seguin, Media and Public Affairs Officer, Natural Sciences and Engineering Research Council of Canada, media@nserc-crsng.gc.ca

Related Links

https://www.canada.ca

Prizes recognize exemplary achievements by some of the best and brightest researchers in the world

OTTAWA, ON, Nov. 10, 2020 /CNW/ – The world is shining the spotlight on science now more than ever as we face the challenges of the COVID-19 pandemic. As Canadian science and engineering researchers continue to lead on the world stage, the Government of Canada celebrates the country’s research excellence by honoring some of its best and brightest.

Today, Her Excellency the Right Honourable Julie Payette, Governor General of Canada, the Honourable Navdeep Bains, Minister of Innovation, Science and Industry, and Professor Alejandro Adem, President of the Natural Sciences and Engineering Research Council of Canada (NSERC) are pleased to announce this year’s recipients of NSERC Prizes. Twenty-six of Canada’s world-leading scientists and engineers, and 13 of their industry partners received NSERC prizes recognizing their contributions in a range of research fields. Topics explored include advancements to our understanding of the effects of climate change on biodiversity in urban, natural and ocean environments, the impact of aerosols on the Arctic, the development of sustainable pesticides, and innovations in quantum computing technology.

Dr. Molly Shoichet is this year’s recipient of Canada’s most prestigious science prize, the Gerhard Herzberg Canada Gold Medal for Science and Engineering, worth up to $1 million. Dr. Shoichet’s breakthrough invention of hydrogels enabled researchers to grow human cells in three-dimensional environments, and has since led to game-changing applications in the areas of tissue engineering, regenerative medicine and pharmaceutical testing. Dr. Shoichet’s contributions have fundamentally advanced biomedical engineering research and placed the next generation of medical treatments within our grasp.

Dr. Karen Maxwell is receiving this year’s John C. Polanyi Award in recognition of her ground-breaking discovery and ongoing contributions to the field of biochemistry. Dr. Maxwell and her team discovered that the soil-dwelling bacteria Streptomyces produces molecules that stop viruses in their tracks and prevent fast replication, a breakthrough that opens up a new method to screen for drugs that could be useful for the treatment of human cancers and viral infections.

NSERC celebrates research excellence with a wide range of prizes. Individual awards focus on accomplishments that range from innovative discoveries by young researchers to lifetime achievement and influence. 

Quotes

“Our government is steadfastly committed to science and research, and is proud to honor today’s recipients for their outstanding achievements in their fields. These researchers exemplify Canada’s culture of curiosity and innovation, and are making the breakthroughs that have the power to improve the lives of all Canadians from better understanding the effects of climate change to making medical advancements.”
–  The Honourable Navdeep Bains, Minister of Innovation, Science and Industry

“This year is about highlighting and celebrating how much science is playing an important role in our everyday lives. The prize winners showcase their excellence in science research with their breakthrough successes in diverse fields. Congratulations to all prize winners for their significant achievements.”
–  Professor Alejandro Adem, President of NSERC

“When I found out that I had won the Herzberg award, I was overwhelmed because it seems so unreachable. When you look at all the people who have won this award before me, they are people that I hold in such high esteem. To be among them, and to have my peers consider me to be among them, is so exciting and so thrilling.”
–  Dr. Molly Shoichet, Professor of Chemical Engineering & Applied Chemistry and Biomaterials & Biomedical Engineering, University of Toronto

Quick facts

• Honouring the memory of Canadian Nobel laureate Gerhard Herzberg, the NSERC Herzberg Gold Medal is the agency’s highest honour. It provides recipients with up to $1 million in discovery research funding over five years.
• Today’s ceremony celebrates the outstanding achievements of recipients who received five NSERC prizes totaling up to $3.95 million.
• NSERC-funded researchers are honoured every year for achievements that showcase the high caliber of talent and the innovative research taking place in Canadian universities and colleges.

Associated Links

Full list of NSERC prizes, this year’s winners and their profiles

NSERC invests over $1.2 billion each year in natural sciences and engineering research in Canada. Our investments deliver discoveries—valuable world firsts in knowledge claimed by a brain trust of over 11,000 professors. Our investments enable partnerships and collaborations that connect the makers and users of discoveries. Research partnerships established by NSERC help inform research and development and solve scale-up challenges.

NSERC also provides scholarships and hands-on training experience for more than 30,000 post-secondary students and post-doctoral fellows. These young researchers will be the next generation of science and engineering leaders in Canada.

SOURCE NSERC

For further information: John Power, Press Secretary, Office of the Minister of Innovation, Science and Industry, 343-550-1456, john.power@canada.ca; Media Relations, Innovation, Science and Economic Development Canada, 343-291-1777, ic.mediarelations-mediasrelations.ic@canada.ca; Christine Seguin, Media and Public Affairs Officer, Natural Sciences and Engineering Research Council of Canada, media@nserc-crsng.gc.ca

Related Links

https://www.canada.ca

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