Celldex Announces Appointment of Teri Lawver as Chief Commercial Officer




Celldex Announces Appointment of Teri Lawver as Chief Commercial Officer

HAMPTON, N.J., Nov. 10, 2025 (GLOBE NEWSWIRE) — Celldex (NASDAQ: CLDX) today announced the appointment of Teri Lawver as Senior Vice President, Chief Commercial Officer. Ms. Lawver is an accomplished global healthcare executive with 30 years of strategic, commercial launch and operating P&L leadership across the biopharmaceutical, medical device and consumer health technology sectors. Ms. Lawver succeeds Richard Wright, who will retire from Celldex following more than a decade of dedicated leadership and service.

“We are thrilled to welcome Teri to the Celldex leadership team,” said Anthony Marucci, Co-founder, President, and Chief Executive Officer of Celldex. “Teri brings an extraordinary record of success across global biopharmaceutical and medical technology companies. Her deep experience in immunology and inflammation and track record building and scaling commercial organizations will be invaluable as we prepare for the potential launch of barzolvolimab and advance our broader pipeline. I also want to sincerely thank Rick for his exceptional contributions over the past ten years. His leadership and commitment have been instrumental in positioning Celldex for our next phase of growth, and we wish him all the best in his retirement.”

Ms. Lawver brings extensive experience in immunology and inflammation, having overseen multiple first-in-class portfolio advances and blockbuster launches, including pivotal indications for REMICADE^® (infliximab), STELARA^® (ustekinumab), and TREMFYA^® (guselkumab). Prior to joining Celldex, Ms. Lawver was Principal and Owner of Thera Lifescience Advisors, where she was a strategic advisor to CEOs and investors at pioneering life science and health technology companies. Previously, Ms. Lawver was Chief Commercial Officer at Dexcom, Inc. where she was responsible for $4B in annual revenue and 1900 employees across 50 countries. Prior to that, Ms. Lawver was an executive at Johnson & Johnson where she led significant and diverse global business units over her 20-year tenure, culminating as Worldwide Vice President for Janssen Immunology. She joined J&J through Centocor, where she was responsible for launching the industry’s first biologic therapies in the gastroenterology space. Before J&J, Ms. Lawver was an Associate Principal at McKinsey & Company, and leader in the Firm’s Healthcare Practice. She began her career as a Derivatives Analyst at Bloomberg Financial Markets. She currently serves on the Board of Directors of Altimmune, Inc. Ms. Lawver holds a B.S. in Linguistics from Georgetown University and an M.B.A. from Duke University’s Fuqua School of Business.

Ms. Lawver added, “I am thrilled to join Celldex at such a pivotal time in the company’s evolution. The company’s leadership in advancing mast cell biology and the team’s commitment to transforming outcomes for patients with severe allergic and inflammatory diseases are truly exciting. I look forward to contributing to Celldex’s mission and working alongside this talented team to bring the potential of these important therapies to patients in need.”

About Celldex
Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. Visit www.celldex.com.

Forward Looking Statement
This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159) and CDX-622, in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company’s programs to continue to develop; our ability to protect the Company’s intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’s products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under “Risk Factors” in our annual report on Form 10-K and quarterly reports on Form 10-Q.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.

Company Contact
Sarah Cavanaugh
Senior Vice President, Corporate Affairs & Administration
(508) 864-8337
scavanaugh@celldex.com

Patrick Till
Meru Advisors
(484) 788-8560
ptill@meruadvisors.com

UK High Court Rules in Favor of Alvotech Paving Way for Manufacture and Market Entry of AVT06, biosimilar to Eylea® (aflibercept)




UK High Court Rules in Favor of Alvotech Paving Way for Manufacture and Market Entry of AVT06, biosimilar to Eylea® (aflibercept)

REYKJAVIK, Iceland, Nov. 10, 2025 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today the outcome of expedited infringement proceedings before the UK High Court by Regeneron Pharmaceuticals Inc. (“Regeneron”) and Bayer AG (“Bayer”) against Alvotech and its contract manufacturing organization (CMO) in the United Kingdom. The court rejected Regeneron’s and Bayer’s injunction request in relation to manufacturing activities at Alvotech’s CMO in the UK for Alvotech’s biosimilar to Eylea^® (AVT06). The decision will support commercial launches of Alvotech’s biosimilar in the European Economic Area, the UK and other countries after the expiry date for Supplementary Protection Certificates (SPCs) for Eylea^®, which is November 23, 2025.

“The outcome of this case was never in doubt in my mind, but we are of course very pleased to have obtained this decision by the UK High Court. This will allow Alvotech to proceed with its manufacturing activities and supports bringing our biosimilar to Eylea to patients and caregivers in Europe and the rest of the world,” said Robert Wessman chairman and CEO of Alvotech. “It took years to put an SPC waiver system in place, and it is very important for European biosimilars manufacturers that the waiver system is functional and not abused. An important objective is to bring biosimilars production and jobs back into Europe. This decision by the UK High Court is therefore not only a victory for Alvotech and its partners, but also for patients and caregivers in Europe and in the rest of the world who need better access to quality biologics.”

The case focused on the issue of an SPC waiver exempting certain acts of third-party manufacturers from infringement. The SPC regulation provides that SPCs should not block manufacturing of biosimilars for stockpiling during six months before the SPC expiry, in support of product launches in the European Economic Area and the UK, as well as export to countries outside this region during the lifetime of the SPC. The decision of the UK High Court means that Alvotech and its CMO can continue to manufacture and store AVT06 in the UK, for later distribution in the UK, EEA and rest of the world.

Alvotech announced on August 21, 2025, that the European Commission had approved AVT06 as a biosimilar to Eylea^®, for marketing in the European Economic Area. The UK Medicines and Healthcare products Regulatory Agency (MHRA) approved AVT06 for marketing in the UK on August 28, 2025.

About AVT06 (aflibercept)
AVT06 (aflibercept) is a recombinant fusion protein and has been approved in Japan, the United Kingdom and the European Economic Area as a biosimilar to Eylea^® (aflibercept), which binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [1]. Dossiers for AVT06, are currently under review in multiple countries globally, including the United States.

[1] AVT02 EEA product info

About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, to Humira^® (adalimumab) and Stelara^® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube.

Alvotech Forward Looking Statements
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS
Benedikt Stefansson, VP
alvotech.ir@alvotech.com

UK High Court Rules in Favor of Alvotech Paving Way for Manufacture and Market Entry of AVT06, biosimilar to Eylea® (aflibercept)         




UK High Court Rules in Favor of Alvotech Paving Way for Manufacture and Market Entry of AVT06, biosimilar to Eylea® (aflibercept)         

REYKJAVIK, ICELAND (November 10, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today the outcome of expedited infringement proceedings before the UK High Court by Regeneron Pharmaceuticals Inc. (“Regeneron”) and Bayer AG (“Bayer”) against Alvotech and its contract manufacturing organization (CMO) in the United Kingdom. The court rejected Regeneron’s and Bayer’s injunction request in relation to manufacturing activities at Alvotech’s CMO in the UK for Alvotech’s biosimilar to Eylea® (AVT06). The decision will support commercial launches of Alvotech’s biosimilar in the European Economic Area, the UK and other countries after the expiry date for Supplementary Protection Certificates (SPCs) for Eylea®, which is November 23, 2025.

“The outcome of this case was never in doubt in my mind, but we are of course very pleased to have obtained this decision by the UK High Court. This will allow Alvotech to proceed with its manufacturing activities and supports bringing our biosimilar to Eylea to patients and caregivers in Europe and the rest of the world,” said Robert Wessman chairman and CEO of Alvotech. “It took years to put an SPC waiver system in place, and it is very important for European biosimilars manufacturers that the waiver system is functional and not abused. An important objective is to bring biosimilars production and jobs back into Europe. This decision by the UK High Court is therefore not only a victory for Alvotech and its partners, but also for patients and caregivers in Europe and in the rest of the world who need better access to quality biologics.”

The case focused on the issue of an SPC waiver exempting certain acts of third-party manufacturers from infringement. The SPC regulation provides that SPCs should not block manufacturing of biosimilars for stockpiling during six months before the SPC expiry, in support of product launches in the European Economic Area and the UK, as well as export to countries outside this region during the lifetime of the SPC. The decision of the UK High Court means that Alvotech and its CMO can continue to manufacture and store AVT06 in the UK, for later distribution in the UK, EEA and rest of the world.

Alvotech announced on August 21, 2025, that the European Commission had approved AVT06 as a biosimilar to Eylea®, for marketing in the European Economic Area. The UK Medicines and Healthcare products Regulatory Agency (MHRA) approved AVT06 for marketing in the UK on August 28, 2025.

About AVT06 (aflibercept)
AVT06 (aflibercept) is a recombinant fusion protein and has been approved in Japan, the United Kingdom and the European Economic Area as a biosimilar to Eylea® (aflibercept), which binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [1]. Dossiers for AVT06, are currently under review in multiple countries globally, including the United States.

[1] AVT06 EEA product info

About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Two biosimilars, to Humira® (adalimumab) and Stelara® (ustekinumab) are already approved and marketed in multiple global markets. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube.

Alvotech Forward Looking Statements
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS
Benedikt Stefansson, VP
alvotech.ir@alvotech.com

GENFIT Enters Research Collaboration with EVerZom to Advance Exosome-based Regenerative Technology in ACLF




GENFIT Enters Research Collaboration with EVerZom to Advance Exosome-based Regenerative Technology in ACLF

• EVerZom’s investigational drug candidate EViv, developed to treat ACLF, using its proprietary exosome platform, represents a novel approach to regenerative therapies
• Pending successful in vivo proof-of-concept results, GENFIT has an exclusive option to take a license to drive EViv into clinical development
• Under this research collaboration, EVerZom will contribute exosome expertise with associated bioproduction platform, while GENFIT will spearhead preclinical evaluation of EViv

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), November 10, 2025 – GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announces a research collaboration with EVerZom to expand its Acute-On-Chronic Lier Failure (ACLF) research via exosome-based regenerative technology.

GENFIT and EVerZom plan to run exploratory studies to assess efficacy for EViv in ACLF, with a clear decision point within 18 months on whether to advance into clinical development.

Pascal Prigent, CEO of GENFIT, commented: “Through this collaboration, GENFIT has exclusive rights to explore a novel mechanism of action supporting organ repair, complementing our existing programs G1090N, SRT-015 and CLM-022. Our shared objective is to rapidly generate proof-of-concept data to determine whether EViv confirms its potential for clinical development.”

Drug candidate EViv leverages a proprietary exosome platform to bring an innovative regenerative therapy approach to ACLF. In the case of, and following, positive in vivo proof-of-concept results, GENFIT has an exclusive option to take an exclusive license in the field of liver disease to advance EViv into clinical development. The collaboration combines EVerZom’s exosome expertise with GENFIT’s leadership in ACLF, aiming to accelerate therapeutic progress.

Jeanne Volatron, CEO and Co-founder of EVerZom, added: “As a pioneer in the exosome field, our goal is to push the boundaries of gene and cell therapies and open new avenues for regenerative medicine. ACLF is a highly relevant indication for positioning our candidate EViv and this collaboration with GENFIT marks the first partnership for EViv in this indication. With GENFIT’s proven track record in advancing therapies in emerging areas and expertise in ACLF, we see it as the ideal partner to accelerate preclinical development and move toward the clinical stage.”

Exosomes are tiny biological vesicles (30 to 150 nanometers) naturally secreted by cells. They play a key role in intercellular communication, transporting proteins, messenger RNAs, and other functional biomolecules between cells. EVerZom leverages exosomes derived from mesenchymal stem cells, known for their regenerative and immunomodulatory properties. Compared to the cells themselves, exosomes offer numerous advantages: increased stability, reduced variability, enhanced patient safety, and simplified logistics (direct hospital storage and immediate availability).

ABOUT GENFIT

GENFIT is a biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades.  

Today, GENFIT focuses on Acute on-chronic Liver Failure (ACLF) and associated conditions such as acute decompensation (AD) and hepatic encephalopathy (HE). It develops therapeutic assets which have complementary mechanisms of action, selected to address key pathophysiological pathways. GENFIT also targets other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorders (UCD) and organic acidemia (OA). Its R&D portfolio, covering several stages of development, ensures a constant news flow.

GENFIT’s expertise in developing high-potential molecules – from early to advanced pre-commercialization stages – culminated in 2024 with the accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for the treatment of Primary Biliary Cholangitis (PBC). Iqirvo® is now marketed in several countries.¹   

Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® for the detection of Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis).

GENFIT is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Nasdaq Global Select Market² and on the Euronext regulated market in Paris, Compartment B (Nasdaq and Euronext: GNFT). In 2021, Ipsen became one of GENFIT’s largest shareholders, acquiring an 8% stake in the Company’s capital. www.genfit.com

ABOUT EVERZOM

EVerZom is a French biotechnology company pioneering next-generation regenerative therapies based on mesenchymal stem-cell-derived exosomes. Its proprietary bioproduction platform enables high-yield, GMP-compliant exosome manufacturing and innovative formulation approaches that combine exosomes with biomaterials to enhance therapeutic efficacy and durability.

For more information, visit: https://everzom.com/

FORWARD LOOKING STATEMENTS

This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to GENFIT, including, but not limited to statements the ability to rapidly generate proof-of-concept data to assess EViv’s potential within the next 18 months and the intention to take a license to move towards the clinical stage The use of certain words, such as “believe”, “potential”, “expect”, “target”, “may”, “will”, “should”, “could”, “if” and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including in relation to non-clinical and pre-clinical programs, reproducibility of preclinical results, the translation of animal model data to human biology, in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, patient recruitment, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, pricing, approval and commercial success of elafibranor in the relevant jurisdictions, exchange rate fluctuations, and our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 “Risk Factors and Internal Control” of the Company’s 2024 Universal Registration Document filed on April 29, 2025 (no. 25-0331) with the Autorité des marchés financiers (“AMF”), which is available on GENFIT’s website (www.genfit.fr) and the AMF’s website (www.amf.org), and those discussed in the public documents and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s 2024 Annual Report on Form 20-F filed with the SEC on April 29, 2025 and subsequent filings and reports filed with the AMF or SEC, including the Half-Year Business and Financial Report at June 30, 2025 or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this press release. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.

CONTACTS

GENFIT | Investors

Tel: +33 3 2016 4000 | investors@genfit.com

GENFIT | Media

Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com

EVERZOM | Media

Florence Portejoie – Press relations | Tel: + 33 6 07 76 82 83|fportejoie@fp2com.fr

GENFIT | 885 Avenue Eugène Avinée, 59120 Loos – FRANCE | +333 2016 4000 | www.genfit.com

1 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo®
2  On October 30 2025, GENFIT announced its intention to voluntarily delist its American Depositary Shares from The Nasdaq Global Select Market

Attachment

• GENFIT Enters Research Collaboration with EVerZom to Advance Exosome-based Regenerative Technology in ACLF

GENFIT Presents Promising New Preclinical Data on NTZ/G1090N for the Treatment of ACLF at The Liver Meeting® 2025




GENFIT Presents Promising New Preclinical Data on NTZ/G1090N for the Treatment of ACLF at The Liver Meeting® 2025

• Preclinical studies demonstrated significant efficacy on systemic inflammation and organ function in ACLF disease models
• Safety data from Phase 1 on healthy volunteers and initial efficacy signals from ex-vivo functional assays expected by year-end 2025

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), November 10, 2025 – GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today presents promising new preclinical data in ACLF at The Liver Meeting® 2025 with nitazoxanide (NTZ). GENFIT is advancing NTZ through a novel formulation, investigational drug G1090N, which serves as the cornerstone of our ACLF pipeline and reflects our commitment to addressing critical unmet needs in liver disease. G1090N was designed to optimize dose-response and permit sufficient dosing flexibility in patients with ACLF, who are known to have varying degrees of renal or hepatic impairment or failure.

Dr. Jonel Trebicka, MD, PHD, Head of Department and Professor of Medicine, University of Münster, Germany, commented: “These preclinical findings demonstrate beneficial effects on systemic inflammation and organ failure in ACLF disease models and add to a growing body of evidence for this therapy. We eagerly await the upcoming safety data from G1090N in healthy volunteers, along with potential efficacy signals on key biomarkers from ex-vivo approaches. Positive results at the end of this year could pave the way to further clinical development.”

ACLF presents as a syndrome defined by a combination of hepatic and extrahepatic organ dysfunctions and failures and a uniformly poor prognosis. In patients with liver cirrhosis and acute hepatic decompensation, ACLF can be triggered by a precipitating event (e.g. an infection) that leads to a progressive functional deterioration of multiple organs with high short-term mortality (23% to 74% mortality at 28 days¹).

Poster #4165 Efficacy of Nitazoxanide (NTZ) on systemic inflammation and organ function in disease models of acute-on-chronic liver failure (ACLF) when administered post-ACLF trigger highlights NTZ’s demonstrated efficacy on systemic inflammation and organ function in disease models of ACLF when administered post-ACLF trigger. NTZ was shown to reduce LPS-induced inflammatory cytokines levels both vitro and in vivo. Moreover, a rapid restoration of hepatic and renal functions was observed upon a single dose of NTZ administration in a disease model of ACLF.

These preclinical findings further support the development of investigational drug G1090N as a new therapeutic approach for ACLF.

A Phase 1 First-in-Human study in healthy volunteers is currently underway with safety data expected at the end of this year. Early signals of efficacy from ex-vivo functional assays are also expected at the same time.

END

ABOUT GENFIT

GENFIT is a biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades. GENFIT has built up a diversified and rapidly expanding R&D portfolio of programs at various stages of development. The Company focuses on a broad spectrum of conditions that patients with ACLF (Acute-on-Chronic Liver Failure) may experience, including Acute Decompensation (AD) or Hepatic Encephalopathy (HE), with several assets based on complementary mechanisms of action using different routes of administration. GENFIT also targets other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorder (UCD) and organic acidemia (OA). GENFIT’s expertise in the development of high-potential molecules from early to advanced stages, and in pre-commercialization, was demonstrated in the accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and Drug Administration, the European Medicines Agency and the Medicines and Healthcare Regulatory Agency in the UK for Primary Biliary Cholangitis (PBC). Iqirvo® is currently commercially launched in several countries.² Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® in Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis). GENFIT is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Nasdaq Global Select Market³ and on the Euronext regulated market in Paris, Compartment B (Nasdaq and Euronext: GNFT). In 2021, Ipsen became one of GENFIT’s largest shareholders, acquiring an 8% stake in the Company’s capital. www.genfit.com

FORWARD LOOKING STATEMENTS

This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to GENFIT, including, but not limited to statements related to GENFIT’s expectations regarding the availability of safety data from the ongoing Phase 1 study and initial efficacy signals from ex-vivo assays by year-end 2025; the potential initiation of a Phase 2 proof-of-concept study in the first half of 2026; the anticipated impact of positive results on the progression of clinical development; and the continued development of investigational drug G1090N as a new therapeutic approach for ACLF. The use of certain words, such as “believe”, “potential”, “expect”, “target”, “may”, “will”, “should”, “could”, “if” and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, patient recruitment, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, pricing, approval and commercial success of elafibranor in the relevant jurisdictions, exchange rate fluctuations, and our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 “Risk Factors and Internal Control” of the Company’s 2024 Universal Registration Document filed on April 29, 2025 (no. 25-0331) with the Autorité des marchés financiers (“AMF”), which is available on GENFIT’s website (www.genfit.fr) and the AMF’s website (www.amf.org), and those discussed in the public documents and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s 2024 Annual Report on Form 20-F filed with the SEC on April 29, 2025 and subsequent filings and reports filed with the AMF or SEC or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this press release. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.

CONTACTS

GENFIT | Investors

Tel: +33 3 2016 4000 | investors@genfit.com

GENFIT | Media

Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com

GENFIT | 885 Avenue Eugène Avinée, 59120 Loos – FRANCE | +333 2016 4000 | www.genfit.com       

1 Arroyo V et al., Nat. Rev. Dis. Primers 2 (2016)
2 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo®
3 On October 30, 2025 GENFIT announced its intention to voluntary delist its American Depository Shares from The Nasdaq Global Select Market

Attachment

• GENFIT Presents Promising New Preclinical Data on NTZ/G1090N for the Treatment of ACLF at The Liver Meeting® 2025

[Ad hoc announcement pursuant to Art. 53 LR] Roche’s fenebrutinib shows unprecedented positive Phase III results as the potential first and only BTK inhibitor in both relapsing and primary progressive multiple sclerosis




[Ad hoc announcement pursuant to Art. 53 LR] Roche’s fenebrutinib shows unprecedented positive Phase III results as the potential first and only BTK inhibitor in both relapsing and primary progressive multiple sclerosis

• The first (FENhance 2) of two pivotal RMS studies met its primary endpoint, showing investigational fenebrutinib significantly reduced relapses compared to teriflunomide
• In a pivotal PPMS study (FENtrepid), fenebrutinib slowed disability progression at least as effectively as OCREVUS, the only approved therapy in PPMS
• Full data from both studies will be shared at upcoming medical meetings; once the second RMS study (FENhance 1) has read out, which is expected in the first half of 2026, all data together will be considered for submission to regulatory authorities

Basel, 10 November 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the first Phase III (FENhance 2) of two pivotal, similarly-designed Phase III studies (FENhance 1 and 2) in patients with relapsing multiple sclerosis (RMS) met its primary endpoint. Fenebrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor, significantly reduced the annualised relapse rate (ARR) compared to teriflunomide over a period of at least 96 weeks of treatment.

Additionally, the Phase III FENtrepid pivotal study evaluating fenebrutinib, compared with OCREVUS® (ocrelizumab) in patients with primary progressive multiple sclerosis (PPMS), met its primary endpoint. The results showed that fenebrutinib was non-inferior compared to ocrelizumab, the only approved therapy in PPMS, as measured by a delay in the onset of composite confirmed disability progression over a period of at least 120 weeks of treatment. A numerical benefit for fenebrutinib compared to ocrelizumab was seen as early as week 24, and lasted throughout the observation period.

“Fenebrutinib substantially reduced the number of relapses in RMS and slowed disability progression in PPMS. These unprecedented results suggest that fenebrutinib could potentially become a best-in-disease medicine as the first high-efficacy, oral treatment for people with RMS or PPMS,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Therefore, these pivotal results for fenebrutinib may offer new hope for people living with MS, and they reaffirm our enduring commitment to the MS community.”

Liver safety was consistent with previous fenebrutinib studies. Additional safety data is being further evaluated. The results of the second RMS Phase III trial (FENhance 1) are expected by the first half of 2026.

Fenebrutinib targets cells in the immune system known as B cells and microglia. Targeting B cells helps control the acute inflammation that causes relapses, while targeting microglia inside the brain addresses the chronic damage that is thought to drive long-term disability progression. Fenebrutinib, a non-covalent BTKi, is designed to have high potency, selectivity and reversibility. This design allows it to act throughout the body, and also to cross the blood-brain barrier into the central nervous system (CNS) targeting chronic inflammation.

About the FENhance 1 and 2 studies
FENhance 1 and 2 are similarly designed Phase III multicentre, randomised, double-blind, double-dummy, parallel-group studies to evaluate the efficacy and safety of investigational fenebrutinib compared with teriflunomide in a total of 1,497 adult patients with RMS. Eligible participants were randomised 1:1 to receive treatment with either oral fenebrutinib twice a day (and placebo matched to oral teriflunomide once a day) or oral teriflunomide once a day (and placebo matched to oral fenebrutinib twice a day) for at least 96 weeks.

The primary endpoint is annualised relapse rate (ARR). Key secondary endpoints include the time to onset of composite 24-week confirmed disability progression (cCDP24), 12-week confirmed disability progression (CDP12) and 24-week confirmed disability progression (CDP24).

Following the double-blind treatment period, patients have the option to enter an open-label extension (OLE) phase, in which all patients receive treatment with fenebrutinib.

About the FENtrepid study
FENtrepid is a Phase III multicentre, randomised, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of fenebrutinib compared with OCREVUS in 985 adult patients with PPMS. Eligible participants were randomised 1:1 to receive treatment with either daily oral fenebrutinib (and placebo matched to intravenous [IV] OCREVUS) or IV OCREVUS (and placebo matched to oral fenebrutinib) for at least 120 weeks.

The primary endpoint is the time to onset of 12-week composite confirmed disability progression (cCDP12). The cCDP incorporates three measures of disability – total functional disability measured by the Expanded Disability Status Scale (EDSS), walking speed measured by the timed 25-foot walk (T25FW), and upper limb function measured by the nine-hole peg test (9HPT). This comprehensive composite endpoint offers greater sensitivity than the EDSS alone, capturing additional aspects of disability and often earlier. Key secondary endpoints include the time to onset of 24-week composite confirmed disability progression (cCDP24), 12-week confirmed disability progression (CDP12) and 24-week confirmed disability progression (CDP24).

Following the double-blind treatment period, patients have the option to enter an open-label extension (OLE) phase, in which all patients receive treatment with fenebrutinib.

About fenebrutinib
Fenebrutinib is an investigational oral, central nervous system (CNS)-penetrant, reversible and non-covalent Bruton’s tyrosine kinase (BTK) inhibitor with an optimised pharmacokinetics (PK) profile. Fenebrutinib has been shown to be 130 times more selective for BTK vs. other kinases. Fenebrutinib is an inhibitor of both B-cell and microglia activation. This dual inhibition may be able to reduce both multiple sclerosis disease activity and disability progression, thereby potentially addressing the key unmet medical need of disability progression in people living with multiple sclerosis and providing comprehensive multiple sclerosis care. The fenebrutinib Phase III programme includes two similarly-designed trials in relapsing multiple sclerosis (RMS) (FENhance 1 and 2) with active comparator teriflunomide and the only trial in primary progressive multiple sclerosis (PPMS) (FENtrepid) in which a BTK inhibitor is being evaluated against OCREVUS.

About OCREVUS® (ocrelizumab)
OCREVUS is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. OCREVUS IV and OCREVUS subcutaneous (SC; marketed as OCREVUS ZUNOVO® [ocrelizumab hyaluronidase-ocsq] in the U.S.) are the only therapies approved for both RMS (including relapsing-remitting multiple sclerosis [RRMS] and active, secondary progressive multiple sclerosis [SPMS], as well as clinically isolated syndrome [CIS] in the U.S.) and primary progressive multiple sclerosis (PPMS). Both OCREVUS IV and SC are administered every six months. The initial IV dose is given as two 300 mg infusions two weeks apart with subsequent doses given as single 600 mg infusions. OCREVUS SC is given as a single 920 mg subcutaneous injection every six months.

About multiple sclerosis
Multiple sclerosis is a chronic disease that affects more than 2.9 million people worldwide. People with all forms of multiple sclerosis experience disease progression from the beginning of their disease. Therefore, an important goal of treating multiple sclerosis is to slow, stop and ideally prevent progression as early as possible.

Approximately 85% of people with multiple sclerosis have a relapsing form of the disease (RMS) characterised by relapses and also worsening disability over time. Primary progressive multiple sclerosis (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with multiple sclerosis are diagnosed with the primary progressive form of the disease. Until the FDA approval of OCREVUS®, there had been no FDA-approved treatments for PPMS and OCREVUS is still the only approved treatment for PPMS.

About Roche in Neuroscience
Neuroscience is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.

Roche is investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.
 

Roche Global Media Relations

Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Roche Investor Relations

Investor Relations North America

Attachment

• Media Investor Release fenebrutinib Phase III study FENhance 2 English

AHA 2025: Late-Breaking Data Reinforce the Prognostic Power of AI-Driven Heartflow Plaque Analysis as the Most Clinically Validated Framework for Coronary Risk Stratification




AHA 2025: Late-Breaking Data Reinforce the Prognostic Power of AI-Driven Heartflow Plaque Analysis as the Most Clinically Validated Framework for Coronary Risk Stratification

Multicenter outcomes FISH&CHIPS study of nearly 8,000 patients confirms total plaque volume as a powerful independent predictor of long-term cardiovascular events

NEW ORLEANS, Nov. 09, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today announced late-breaking data from the FISH&CHIPS Study presented at the American Heart Association (AHA) Scientific Sessions 2025. The new data add to the robust and growing body of evidence supporting AI-powered Heartflow Plaque Analysis with Heartflow Plaque Staging* — the most clinically validated framework for actionable CAD care.

The retrospective analysis, which evaluated nearly 8,000 symptomatic patients from a cohort of the FISH&CHIPS Study, represents the largest validation to date of the Heartflow Plaque Staging framework based on total plaque volume (TPV) measurement.¹

Key findings include:

• Patients in the highest TPV stage experienced more than a 5x greater risk of major cardiovascular events compared with patients in the lowest stage (hazard ratio 5.10, p-value < 0.0001).
• Higher plaque volume stages were independently associated with significantly increased rates of cardiovascular death and myocardial infarction over a median 3.3 years of follow-up.
• Associations remained significant after adjustment for coronary stenosis, FFR_CT values and cardiovascular risk factors.

“This study provides strong validation of TPV-based staging measured with Heartflow Plaque Analysis as a predictor of future heart attacks or cardiovascular death,” said Timothy Fairbairn, Ph.D., principal investigator for the FISH&CHIPS study, Liverpool Heart and Chest Hospital, and Associate Professor at the University of Liverpool, UK. “The ability to accurately measure plaque will enable cardiologists to better predict which patients are most at risk above the traditional risk factors, and thus personalize treatment, in order to prevent heart attacks or death in the future.”

The findings build on results from the DECIDE Registry presented at the Society of Cardiovascular Computed Tomography (SCCT) 2025 Annual Scientific Meeting in July. DECIDE data showed that Heartflow Plaque Analysis with Plaque Staging led to changes in medical management for more than half of patients, resulting in an average reduction in LDL cholesterol of 18.7 mg/dL at 90 days. These results indicate management changes guided by Heartflow Plaque Staging result in an expected 15% decrease in risk of a cardiac event.^2,3,4

“We are demonstrating how AI-powered Heartflow Plaque Analysis with Heartflow Plaque Staging can fundamentally change the way we manage CAD,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. “These latest findings show that by embedding plaque insights directly into the diagnostic pathway, we can help physicians make more confident decisions to guide personalized and precise treatment for their patients.”

*Heartflow Plaque Analysis is an FDA-cleared device. Heartflow Plaque Staging is an investigational-only framework, and its safety and effectiveness have not been reviewed by the FDA.

About Heartflow’s Technology and Research
Heartflow’s technology is redefining precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,400 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by ACC/AHA guidelines and supported by more than 600 peer-reviewed publications, Heartflow has redefined how clinicians manage care for nearly 500,000 patients worldwide. Key benefits include:

• Proprietary data pipeline: Built from more than 110 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible insights across diverse patient populations.
• Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 100 studies assessing over 365,000 patients. Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 96%.
• Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay.
• Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST, SOC 2 Type 2, GDPR, HIPAA, CCPA, ISO 13485, and ISO 27001.

About Heartflow, Inc.
Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com.

Media Contact
Elliot Levy
elevy@heartflow.com

Investor Contact
Nick Laudico
nlaudico@heartflow.com

Photos accompanying this announcement are available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/4702aa38-c48c-4291-91aa-937325c8206f

https://www.globenewswire.com/NewsRoom/AttachmentNg/a2a0e458-a265-4790-90b4-33f7403b0b2e

¹ Fairbairn et al. AHA 2025.
² Rinehart SJ, et al. DECIDE Primary Outcomes. J Cardiovasc Comput Tomogr. 2025; 19(4):S78-79. doi.org/10.1016/j.jcct.2025.05.185
³ Collins et al. Lancet 2016. DOI: 10.1016/S0140-6736(16)31357-5
⁴ Fairbairn et al. HEART. 2025. doi:10.1136/heartjnl-2025-BSCI.5

George Medicines presents long-term efficacy and safety data for single pill triple combination therapy for hypertension at American Heart Association’s Scientific Sessions 2025




George Medicines presents long-term efficacy and safety data for single pill triple combination therapy for hypertension at American Heart Association’s Scientific Sessions 2025

London, UK, Boston, MA, 9 November 2025 – George Medicines, a late-stage biopharmaceutical company focused on addressing significant unmet needs in cardiometabolic disease, today presented long-term efficacy and safety data from a 52-week open-label extension of its pivotal Phase 3 study in treatment-naïve patients with hypertension. In this 52-week follow-up period of 50 subjects, treatment with GMRx2 (US tradename WIDAPLIK^TM), demonstrated sustained blood pressure (BP) control out to one year, with good tolerability and low treatment discontinuation.

The data were presented in a moderated poster session, “Change is in the Air! New Discoveries in Hypertension Treatment”, at the American Heart Association’s (AHA) Scientific Sessions 2025, taking place in New Orleans, USA.

WIDAPLIK is an innovative single pill combination of three medicines: telmisartan, amlodipine and indapamide, for the treatment of hypertension, developed in three doses, including two doses that are lower than those currently available in single pill combinations. By leveraging a multi-mechanism approach and lower doses, WIDAPLIK is formulated to deliver the blood pressure-lowering benefits of a triple combination therapy early in the treatment pathway, with the known safety profiles of existing antihypertensive medicines.

To evaluate the long-term efficacy and safety of WIDAPLIK-based treatment when used in usual clinical care, 50 participants from Sri Lanka and Nigeria sites of the placebo-controlled GMRx2_PCT study (NCT04518306), were enrolled into an open-label extension phase with GMRx2 treatment to one year. A total of 48 (96%) participants completed the study.

• Mean home and in-clinic blood pressures following 4-weeks of the core double blind study period entering into the open-label extension were 121/78 mmHg and 126/79 mmHg, respectively.
• Following 52-week open label dosing, mean home BP was maintained at 120/78 mmHg, as was in-clinic BP of 122/77 mmHg.
• Home BP control (<130/80 mmHg) was 56%, and clinic BP control (<140/90 mmHg) was 88% at the end of the open-label extension
• Tolerability was good, with no participants discontinuing treatment due to an adverse event.

Dr. Paul Whelton, Show Chwan Chair of Global Public Health at Tulane University, New Orleans, Louisiana, and Past President of the World Hypertension League, who presented the data at Scientific Sessions 2025, said: “These data reinforce the value of single pill triple combination therapy to effectively manage hypertension in the long term. With globally recognized treatment guidelines acknowledging the preferred use of single pill combinations, and the addition of triple combination antihypertensives to the WHO’s Model List of Essential Medicines, there is growing global recognition of their potential to improve blood pressure control and help patients to stay on therapy.”

Mark Mallon, Chief Executive Officer of George Medicines, said: “We are proud that the long-term data from our Phase 3 program of GMRx2 have been shared at AHA Scientific Sessions, one of the most prestigious global forums for cardiovascular science. These results reinforce the potential of GMRx2 to transform hypertension treatment by offering a single-pill combination, in lower doses than are currently available, enabling more patients to achieve sustained blood pressure control.”

Ends

INDICATIONS
WIDAPLIK^TM is a prescription medicine used to treat high blood pressure (hypertension) in adults. WIDAPLIK may be used as the first medicine to lower high blood pressure in patients likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure may reduce the risk of having a stroke or heart attack.

IMPORTANT SAFETY INFORMATION FOR PATIENTS

WARNING: WIDAPLIK™ can cause fetal harm when administered to a pregnant woman. When pregnancy is detected, discontinue WIDAPLIK as soon as possible. Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and death to the developing fetus. Talk with your doctor about other ways to lower blood pressure if you plan to become pregnant.

• Before taking WIDAPLIK, tell your doctor if you are breastfeeding or plan to breastfeed. Discuss with your doctor other ways to lower your blood pressure. Breastfeeding while taking WIDAPLIK is not recommended.
• Do not take WIDAPLIK if you make less urine because of kidney problems (anuria).
• Do not take aliskiren-containing products with WIDAPLIK if you have diabetes.
• Tell your doctor about all your medical conditions, including if you have heart problems, have gout, or have liver or kidney problems. Kidney problems may become worse in people that already have kidney disease. If you have kidney problems, you may need blood tests, and your doctor may need to lower your dose or may need to stop treatment with WIDAPLIK. During treatment with WIDAPLIK, certain people who have severe heart failure, narrowing of the artery to the kidney, or who lose too much body fluid such as with nausea, vomiting, bleeding, or trauma, may develop sudden kidney failure.
• Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other medicines to treat your high blood pressure or heart problem; water pills (diuretics); lithium; or digoxin.
• WIDAPLIK may cause serious side effects, including low blood pressure (hypotension) which may cause you to feel faint or dizzy. Vomiting and diarrhea, a low salt diet, sweating a lot, dialysis treatments, or not drinking enough fluid can also lead to low blood pressure.
• If you feel faint or dizzy, lie down and call your doctor right away. If you pass out (faint), have someone call your doctor or get medical help. Stop taking WIDAPLIK.
• If you have fluid and body salt (electrolyte) problems, tell your doctor if you experience any of the following symptoms: dry mouth, confusion, thirst, lack of energy (lethargic), weakness, drowsiness, passing very little urine or passing large amounts of urine, seizures, muscle pain/cramps, restlessness, muscle tiredness (fatigue), fast or abnormal heartbeat, nausea and vomiting, or constipation.
• People who have increased levels of uric acid in the blood may develop gout. If you already have gout, tell your doctor about worsening of your gout symptoms.
• In clinical studies, the most common side effects seen with WIDAPLIK were dizziness from low blood pressure, low blood sodium, or low blood potassium.

The Important Safety Information does not include all the information needed to use WIDAPLIK safely and effectively.

For further information, please see accompanying complete Prescribing Information for WIDAPLIK.

To report SUSPECTED ADVERSE REACTIONS contact either:

• Azurity Pharmaceuticals, Inc. at 1-800-461-7449; or
• FDA at: www.fda.gov/medwatch or call 1-800-FDA-1088

About GMRx2
GMRx2 is a combination tablet of telmisartan, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker and indapamide, a thiazide-like diuretic, available in three dosage forms – 10/1.25/0.625 mg; 20/2.5/1.25 mg and 40/5/2.5 mg.

GMRx2 was approved by the US Food and Drug Administration (FDA) in June 2025 as WIDAPLIK™ (telmisartan, amlodipine and indapamide) for the treatment of hypertension and is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Further regulatory filings for GMRx2 are anticipated across additional territories as part of George Medicines’ commitment to bring the value of this important medicine to patients globally.

In clinical trials, the most common adverse event reported in patients treated with WIDAPLIK is symptomatic hypotension. WIDAPLIK is contraindicated in patients with known hypersensitivity to telmisartan, amlodipine, indapamide, or to other sulfonamide-derived drugs. WIDAPLIK carries a Boxed Warning for fetal toxicity and should be discontinued as soon as pregnancy is detected. Please see full Prescribing Information and Important Safety Information, including Boxed Warning for WIDAPLIK here.

About George Medicines
George Medicines is a late-stage biopharmaceutical company addressing significant unmet need in the treatment of cardiometabolic diseases with innovative single-pill combinations of existing treatments, designed for a balance of efficacy and safety, with the potential to improve patient adherence. Multi-mechanism, single-pill combinations offer the potential to bring significant improvements in clinical outcomes with cardiometabolic disorders, including hypertension, which remain among the leading causes of premature death and disability worldwide.

George Medicines is an independent spin-out company from The George Institute for Global Health, one of the world’s leading medical research institutes with a focus on addressing global health inequity. The Company is backed by George Health, the commercial arm of The George Institute, and Brandon Capital, Australia’s leading life sciences venture capital firm.

For more information, please visit www.george-medicines.com.

Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to George Medicines’ financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential. In addition, this press release also contains forward-looking statements relating to George Medicines’ growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including George Medicines’ ability to successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of drug candidates.

Media contacts
ICR Healthcare
David Daley, Lindsey Neville, Tom Daniel
georgemedicines@icrhealthcare.com; Tel: +44 (0) 203 709 5700

Monopar Presents New Data and Analyses on Rapidly Improved Copper Balance in Wilson Disease Patients on Tiomolybdate Choline at AASLD – The Liver Meeting® 2025




Monopar Presents New Data and Analyses on Rapidly Improved Copper Balance in Wilson Disease Patients on Tiomolybdate Choline at AASLD – The Liver Meeting® 2025

WILMETTE, Ill., Nov. 09, 2025 (GLOBE NEWSWIRE) — Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, is presenting new data and analyses today from the Phase 2 ALXN1840-WD-204 copper balance study at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting^® 2025, taking place in Washington, D.C., from November 7-11, 2025.

In an oral presentation titled “Rapidly Improved Cu Balance in Wilson Disease Patients on Tiomolybdate Choline,” Professor Aftab Ala, MBBS, M.D., FRCP, Ph.D., Professor of Hepatology and Consultant Hepatologist at the Institute of Liver Studies at King’s College Hospital in London, will be sharing results showing that treatment with ALXN1840 (tiomolybdate choline) led to a rapid and sustained improvement in daily copper balance in patients with Wilson disease, primarily through increased fecal copper excretion.

The mean daily copper balance among patients treated with ALXN1840 in the study (n=8) was significantly lower – indicating improvement – compared with their pre-treatment baseline. Copper balance improved both during the initial 15 mg once-daily dosing period (days 1-28) and over the entire treatment duration (days 1-39), which included patients receiving either 15 mg every other day or 30 mg once daily. Additional new nonclinical and clinical data supporting these findings from the ALXN1840-WD-204 study will also be presented.

The presentation materials are available on Monopar’s website, and the abstract can be accessed on the AASLD conference website.

About Monopar Therapeutics Inc.

Monopar Therapeutics is a clinical-stage biopharmaceutical company with late-stage ALXN1840 for Wilson disease, and radiopharmaceutical programs including Phase 1-stage MNPR-101-Zr for imaging advanced cancers, and Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for the treatment of advanced cancers. For more information, visit: www.monopartx.com.

Forward-Looking Statements        

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements involve risks and uncertainties including, but not limited to: uncertainties related to the regulatory process that Monopar intends to initiate related to ALXN1840 and the outcome thereof; the rate of market acceptance and competitiveness in terms of pricing, efficacy and safety, of any products for which Monopar receives marketing approval, and Monopar’s ability to competitively market any such products as compared to larger pharmaceutical firms; Monopar’s ability to raise sufficient funds in order for the Company to support continued preclinical, clinical, regulatory, precommercial and commercial development of its programs and to make contractual milestone payments, as well as its ability to further raise additional funds in the future to support any existing or future product candidate programs through completion of clinical trials, the approval processes and, if applicable, commercialization; and the significant general risks and uncertainties surrounding the research, development, regulatory approval, and commercialization of imaging agents and therapeutics. Actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Monopar’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Monopar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Any forward-looking statements contained in this press release represent Monopar’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

CONTACT:

Monopar Therapeutics Inc.
Investor Relations
Quan Vu
Chief Financial Officer
vu@monopartx.com

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Medera Presents Late-Breaking Data from First-In-Human Gene Therapy Trial for Heart Failure with Preserved Ejection Fraction at American Heart Association Scientific Sessions 2025




Medera Presents Late-Breaking Data from First-In-Human Gene Therapy Trial for Heart Failure with Preserved Ejection Fraction at American Heart Association Scientific Sessions 2025

BOSTON, Nov. 09, 2025 (GLOBE NEWSWIRE) — Medera Inc. (“Medera”), a clinical-stage biopharmaceutical company focused on targeting cardiovascular diseases by developing next-generation therapeutics, today announced that positive interim data from its ongoing MUSIC-HFpEF Phase 1/2a clinical trial was presented at the American Heart Association (AHA) Scientific Sessions 2025 taking place November 7-10, 2025, in New Orleans, Louisiana.

The late-breaking presentation, titled “First-in-Human Gene Therapy Trial for Patients with Heart Failure with Preserved Ejection Fraction (HFpEF): MUSIC-HFpEF – Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Preserved Ejection Fraction,” was delivered by Marat Fudim, MD, MHS, Advanced Heart Failure Specialist and Associate Professor at Duke University Medical Center, during the Featured Science session on Biological and Pragmatic Interventions in Heart Failure: From Present to Future on Sunday, November 9, 2025, at 8:00 AM CST.

The MUSIC-HFpEF trial is investigating SRD-002, a one-time gene therapy treatment for heart failure with preserved ejection fraction (HFpEF) delivered through a proprietary minimally invasive intracoronary infusion methodology. SRD-002 utilizes an adeno-associated type 1 virus vector carrying the cardiac isoform of the sarcoplasmic reticulum calcium ATPase pump (SERCA2a) to directly target the molecular pathways underlying the core pathology of HFpEF by enhancing myocardial relaxation and reducing stiffness.

The presentation highlighted data from the ongoing trial, which, as of the interim data cutoff date of October 15, 2025, has treated five patients in Cohort A with a low dose of 3E13 viral genomes (vg) who completed the twelve-month follow-up and five patients in Cohort B with a high dose of 4.5E13 vg. SRD-002 demonstrated a favorable safety profile and early clinical benefits. With follow-up ranging from 6 to 12 months, no gene therapy-related serious adverse events have been reported. Patients in the low-dose cohort have shown improvements in New York Heart Association (NYHA) heart failure classification and Kansas City Cardiomyopathy Questionnaire at both 6 and 12 months, with clinically meaningful stabilizations and improvements in pulmonary capillary wedge pressure (PCWP) at rest and peak exercise. The data support progression to the Phase 2 portion of the ongoing trial to test durable disease-modification in HFpEF by SRD-002.

Patients in Cohort A and B received higher optimized doses of 3.0E13 vg and 4.5E13 vg, respectively—substantially higher than in prior studies, yet still significantly lower than systemic intravenous (IV) infusion. The dosing strategy was rationally designed and optimized using Medera’s proprietary human-based mini-Heart™ technology platform, including its HFpEF disease model co-developed with AstraZeneca, which has contributed to a US Food and Drug Administration (FDA) Investigational New Drug (IND) clearance and Fast Track Designation.

“The data presented today at the AHA Scientific Sessions demonstrate continued safety and clinical benefits with SRD-002,” said Marat Fudim, MD, MHS. “These results reinforce the potential of gene therapy to address the fundamental pathophysiological mechanisms in HFpEF and provide hope for patients with this challenging condition.”

“We are pleased to announce the completion of enrollment for this innovative clinical trial and are encouraged by the outcomes observed in the low dose cohort,” said Ronald Li, PhD, CEO and Founder of Medera. “We remain dedicated to advancing this investigational gene therapy, which targets a condition characterized by significant unmet medical needs.”

The AHA Scientific Sessions is the premier global event in cardiovascular health and science offering unmatched access to groundbreaking research, dynamic learning, and career-defining connections.

For additional information about the MUSIC-HFpEF trial, visit ClinicalTrials.gov using the study identifier NCT06061549.

About Heart Failure with Preserved Ejection Fraction (HFpEF)

Heart failure (HF) is a global pandemic with an estimated 64.3 million cases worldwide and a rising prevalence trend. Accounting for 50% or more of the overall HF population, HFpEF is an age-related condition that has become increasingly prevalent in recent years. This surge is partly due to better awareness and identification of the condition and partly due to lifestyle changes affecting cardiac myocytes. Individuals affected by HFpEF experience similar morbidity and mortality to patients with HF with reduced ejection fraction (HFrEF). Despite the growing epidemic of this emerging syndrome, HFpEF-focused interventional trials have had little success, except for the use of sacubitril-valsartan (Entresto™) and the sodium glucose transporter-2 (SGLT-2) inhibitor empagliflozin (Jardiance™) for reducing cardiovascular mortality and heart failure hospitalization. However, these agents are not disease-modifying, highlighting the critical need for therapeutic interventions targeting the physiological mechanisms involved in HFpEF.

About Medera Inc.

Medera is a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat and currently incurable diseases by developing a range of next-generation therapeutics. Medera operates via its two preclinical and clinical business units, Novoheart and Sardocor, respectively.

Novoheart capitalizes on the world’s first and award-winning “mini-Heart” Technology for revolutionary disease modelling and drug discovery, uniquely enabling the modelling of human-specific diseases and discovery of therapeutic candidates free from species-specific differences in accordance to the FDA Modernization Act 2.0. Novoheart’s versatile technology platform provides a range of state-of-the-art automation hardware and software as well as screening services, for human-specific disease modelling, therapeutic target discovery and validation, drug toxicity and efficacy screening, and dosage optimization carried out in the context of healthy and/or diseased human heart chambers and tissues. Global pharmaceutical and academic leaders are using Novoheart’s technology platform for their drug discovery and development purposes. The Novoheart platform has facilitated and accelerated the development of Sardocor’s lead therapeutic candidates that are currently in clinical trials.

Sardocor is dedicated to the clinical development of novel next-generation therapies for Medera. Leveraging Novoheart’s human-based drug discovery and validation platforms, Sardocor aims to expedite drug development and regulatory timelines for its gene and cell therapy pipeline. Sardocor has received Investigational New Drug (IND) clearances from the FDA for three ongoing AAV-based cardiac gene therapy clinical trials targeting Heart Failure with Reduced Ejection Fraction (HFrEF), Heart Failure with Preserved Ejection Fraction (HFpEF) with the Fast Track Designation, and Duchenne Muscular Dystrophy-associated Cardiomyopathy (DMD-CM) with the Orphan Drug Designation. Additionally, Sardocor’s pipeline includes four preclinical gene therapy and three preclinical small molecule candidates targeting various cardiac, pulmonary, and vascular diseases.

For more information, please visit www.medera.bio.

Contacts

Ally Stubin
Public Relations
ICR Healthcare
Ally.stubin@icrhealthcare.com
646.667.1861

Stephanie Carrington
Investor Relations
ICR Healthcare
Stephanie.carrington@icrhealthcare.com
646.277.1282