Influenza, Human

VANCOUVER, BC / ACCESSWIRE / March 19, 2024 / Gemina Laboratories Ltd. (CSE:GLAB)(FRA:8I7) (the "Company" or "Gemina") is pleased to announce that further to its news release dated February 22, 2024, it has raised gross proceeds of $910,000 under its non-brokered private placement (the "Private Placement") of unsecured convertible notes of the Company (the "Notes"). Please see the Company's news release dated February 22, 2024 for additional details regarding the terms of the Notes. The proceeds from the Private Placement are intended to be used for general working capital and corporate purposes. All securities issued pursuant to the Private Placement are and will be subject to a four month hold period from the date of issue, expiring July 19, 2024, in addition to such other restrictions as may apply under applicable securities laws of jurisdictions outside Canada. No finder's fees, commission, bonus, agent's options or other compensation was paid in connection with the Private Placement. None of the securities sold under the Private Placement have been and will not be registered under the United States Securities Act of 1933, as amended, and no such securities may be offered or sold in the United States absent registration or an applicable exemption from the registration requirements. This news release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in the United States or any jurisdiction in which such offer, solicitation or sale would be unlawful. On Behalf of the Board of Directors Brian Firth Chief Executive Officer Gemina Laboratories Ltd. About Gemina Laboratories Ltd. Gemina Labs is a biosensor and diagnostic company with a transformative, patented, proprietary chemistry that powers next-generation testing platforms for a wide range of pathogens that affect human health and wellness. Our technology drives testing platforms that are fast, affordable, and accurate, and easily self-administered. Our development pipeline includes platforms for the rapid testing of COVID-19, tuberculosis, influenza and other viruses. Additional information on the Company can be found at . Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this Release. Forward Looking Statements This news release includes forward-looking information and statements, which may include, but are not limited to, information and statements regarding or inferring the future business, operations, financial performance, prospects, and other plans, intentions, expectations, estimates, and beliefs of the Company. Such statements include statements regarding the anticipated terms of any proposed transaction or engagement. Information and statements which are not purely historical fact are forward-looking statements. Forward-looking information and statements involve and are subject to assumptions and known and unknown risks, uncertainties, and other factors which may cause actual events, results, performance, or achievements of the Company to be materially different from future events, results, performance, and achievements expressed or implied by forward-looking information and statements herein. Although the Company believes that any forward-looking information and statements herein are reasonable, in light of the use of assumptions and the significant risks and uncertainties inherent in such information and statements, there can be no assurance that any such forward-looking information and statements will prove to be accurate, and accordingly readers are advised to rely on their own evaluation of such risks and uncertainties and should not place undue reliance upon such forward-looking information and statements. Furthermore, the Company is presently unable to fully quantify the impact that the Covid-19 pandemic will have on its operations and recognizes that certain eventualities may affect planned or assumed performance moving forward. As such, any forward-looking information and statements herein are made as of the date hereof, and except as required by applicable laws, the Company assumes no obligation and disclaims any intention to update or revise any forward-looking information and statements herein or to update the reasons that actual events or results could or do differ from those projected in any forward looking information and statements herein, whether as a result of new information, future events or results, or otherwise, except as required by applicable laws. For more information regarding the Company, please contact: Gemina Laboratories Ltd Brian Firth, Chief Executive Officer Email: investor@geminalabs.com SOURCE: Gemina Laboratories Ltd. View the original press release on accesswire.com

Feedback provides greater clarity on regulatory requirements for planned Phase 2b trial BOTHELL, Wash., March 19, 2024 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces it has received Pre-Investigational New Drug (Pre-IND) feedback from the U.S. Food and Drug Administration (FDA) regarding CC-42344 as a potential oral treatment for pandemic and seasonal influenza A. A Pre-IND review provides the opportunity to obtain FDA guidance and clarification on critical steps such as the proposed clinical trial design, as well as clinical drug manufacturing and nonclinical studies deemed necessary before filing the trial design. The feedback was provided in a written response to a Pre-IND package and questions submitted by the Company in January 2024. “We value the FDA guidance as we prepare to IND for our Phase 2b trial and open enrollment of patients in the U.S.,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “This is an important milestone that provides greater clarity on the regulatory requirements and our planned oral CC-42344 clinical program.” A Phase 2a challenge study of oral CC-42344 is underway in the United Kingdom to evaluate safety, and viral and clinical measures in healthy volunteers who are infected with the influenza A virus. The Company expects to report topline results from this study in the second half of this year. In addition, preparations are underway to begin a Phase 1 study in Australia with the Company’s inhaled formulation of CC-42344 as a potential influenza A treatment and prophylaxis for those exposed to the virus. Recent preclinical data showed that inhaled CC-42344 exhibited highly effective delivery into the lung, superior lung exposure, efficacy in influenza-infected human lung epithelia, and a favorable safety profile. CC-42344 Influenza A PB2 Inhibitor CC-42344 is a novel, broad-spectrum, investigational antiviral candidate for the treatment of pandemic and seasonal influenza A. CC-42344 inhibits the first step in the viral replication process of influenza A by binding to a highly conserved PB2 site of the polymerase complex that is essential to replication. In vitro testing with CC-42344 showed excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant to Tamiflu® and Xofluza®, while also demonstrating favorable pharmacokinetic and safety pro In addition, oral CC-42344 demonstrated favorable safety and tolerability results in a Phase 1 study in Australia. This antiviral candidate was discovered using the Company’s proprietary structure-based drug discovery platform technology. About Seasonal Influenza Each year there are approximately 1 billion cases of seasonal influenza worldwide, with 3-5 million severe illnesses and up to 650,000 deaths, according to the World Health Organization. On average about 8% of the U.S. population contracts influenza each season. In addition to the health risk, influenza is responsible for approximately $10.4 billion in direct costs for hospitalizations and outpatient visits for adults in the U.S. annually. About Cocrystal Pharma, Inc. Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit . Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected results of the Phase 2a trial for CC-42344 for the oral treatment of influenza A in the second half of 2024, efforts in preparation for an anticipated Phase 2b trial for oral treatment of influenza A following the Phase 2a trial, efforts to begin a Phase 1 study in Australia for an inhaled formulation of CC-42344 as a potential influenza A treatment and prophylaxis, and the potential efficacy and clinical benefits of, and market for, such product candidates. The words "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "could," "target," "potential," "is likely," "will," "expect" and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, risks relating to our ability to proceed with the studies including recruiting volunteers and procuring materials for such studies by our clinical research organizations and vendors, the results of such studies and our ability to obtain FDA approval to initiate the Phase 2b study. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2022. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Investor Contact: LHA Investor Relations Jody Cain 310-691-7100 jcain@lhai.com Media Contact: JQA Partners Jules Abraham 917-885-7378 Jabraham@jqapartners.com # # #

Aegis Life receives a program-related investment of $4.45M from the Bill & Melinda Gates Foundation This investment supports the continuation of the ongoing research collaboration between Aegis Life and Entos Pharmaceuticals Aegis Life is developing novel DNA-based encoded antibody therapeutics against HIV and malaria using the Entos Fusogenix PLV nucleic acid delivery technology SAN DIEGO & EDMONTON, Alberta--(BUSINESS WIRE)-- Aegis Life, Inc. (Aegis) and its parent company Entos Pharmaceuticals (Entos) announced today that Aegis Life has received a program-related investment from the Bill & Melinda Gates Foundation (the “foundation”). This press release features multimedia. View the full release here: Aegis will receive up to $4.45 million in funding through a convertible promissory note from the foundation’s Strategic Investment Fund for the purpose of developing DNA-based encoded neutralizing antibody therapies for infectious diseases using the Entos Fusogenix PLV platform. This investment follows an initial grant from the foundation to Aegis made in June 2023 to support this collaborative development project with a focus on HIV and malaria. Aegis and Entos will also commit to making any resulting neutralizing antibody therapeutics for these conditions available and accessible to those most in need, including low- and middle-income countries. “We are thrilled that the Bill & Melinda Gates Foundation, based on promising data from our previous grant-funded work, continues to support this exciting project to develop DNA-encoded antibody therapeutics,” said John Lewis, Ph.D., CEO of Aegis. HIV and malaria persist globally and result in significant mortality worldwide. “Neutralizing antibodies are promising treatments in the fight against HIV and other serious infectious diseases and work by blocking transmission and reducing disease severity,” said Dr. Steve Chen, Chief Medical Officer at Aegis Life. “The high stability, durability, and potency pro the PLV technology makes PLV-based DNA-encoded antibodies perfectly suited for deployment in the countries bearing the brunt of these infections. We’re grateful for this latest support, which provides Aegis the opportunity to perform necessary research that could save the lives of those who are most vulnerable.” Treating viral diseases with neutralizing antibodies is an important defense because these antibodies can block infection when they bind to the virus. This approach has been highly effective when used therapeutically by infusing patients with purified neutralizing antibodies, but it is limited by low durability and high cost. To address this, Aegis and Entos are developing DNA-encoded antibodies using the Fusogenix PLV platform that can be administered through intramuscular injection. This approach enables the patient’s own cells to manufacture and secrete neutralizing antibodies, allowing for high durability at a substantially lower cost. The Fusogenix PLV is fridge-stable and can be manufactured at scale cost-effectively, making it accessible for those living in rural, remote, or infrastructure-poor regions. About Aegis Life, Inc. At Aegis Life, we develop next generation genetic vaccines and therapies for the world’s most dangerous infectious diseases. Leveraging the Fusogenix PLV platform for nucleic acid delivery, developed by parent company Entos Pharmaceuticals, this breakthrough non-viral gene delivery platform allows us to rapidly develop and advance safe and effective RNA or DNA vaccines and therapeutics. For more information, visit . About Entos Pharmaceuticals Inc. A new reality in genetic medicine lies ahead, one that will be ushered in with the advent of safe, effective, and re-dosable nucleic acid delivery technologies. Since its inception in 2016, Entos® has been dedicated to advancing next-generation genetic medicines using our proprietary Fusogenix™ PLV™ drug delivery system. The Fusogenix PLV platform is formulated with FAST™ proteins to enable the delivery of nucleic acid to target cells through direct fusion. Entos is pioneering the development of life-changing medicines for patients and has partnered with global companies, such as Eli Lilly, to accelerate and expand the impact of our platform. Entos Pharmaceuticals Inc. is headquartered in Edmonton, Canada, with its wholly owned U.S. and U.K. subsidiaries based in San Diego, California and London, United Kingdom, respectively. Entos® word mark and design logo, Fusogenix™, PLV™ and FAST™ are registered trademarks of Entos Pharmaceuticals Inc. All other trademarks and registered trademarks are the property of their respective owners. For more information, visit , or follow Entos on LinkedIn. Forward Looking Statements This press release contains forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements contained in this press release include statements regarding Aegis’ belief as to the mode of action and potential and benefits of the Fusogenix proteolipid vehicle platform and the mode of action and potential and benefits of the delivery of DNA-encoded monoclonal antibodies for the treatment of HIV, influenzas, and malaria; and other statements related to anticipated developments in Aegis’ business and technologies. In any forward-looking statement in which Aegis expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation, or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Aegis’ actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of Fusogenix as a nucleic acid delivery vehicle, the efficacy of DNA-encoded monoclonal antibody therapies, the success and timely completion of preclinical studies, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results, and financial condition. Investors should consult with the U.S. Securities Commission for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake any obligation to update these forward-looking statements except as required by applicable laws.