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GAITHERSBURG, Md., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that new data showing reductions of multiple classes of atherogenic and cardio-inflammatory lipids in subjects treated with pemvidutide will be presented in a poster session at The Liver Meeting® 2024 of the American Association for the Study of Liver Diseases (AASLD) in San Diego, CA taking place November 15-19, 2024. The data were derived from Altimmune’s 12-week Phase 1b randomized, placebo-controlled study in subjects with metabolic dysfunction-associated steatotic liver disease (MASLD), a precursor to the more serious metabolic dysfunction-associated steatohepatitis (MASH). The Company has completed enrollment in a Phase 2b efficacy trial of pemvidutide in patients with biopsy-confirmed F2/F3 MASH, with topline data expected in the second quarter of 2025. Details of the presentation are as follows: Title:Effect of Pemvidutide, a GLP-1/Glucagon Dual Receptor Agonist, on Plasma Lipidomic Profiles in Subjects with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)Presenter:Dr. Sarah K. Browne, Vice President, Clinical Development, AltimmuneDate/Time:Friday, November 15, 2024, at 1:00 pm PST The poster will be available on the Events section of the Altimmune website at the time of the presentation. About Pemvidutide Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and MASH. Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. Glucagon is also recognized as having direct effects on hepatic fat metabolism, which is believed to lead to rapid reductions in levels of liver fat and serum lipids. In clinical trials to date, once-weekly pemvidutide has demonstrated compelling weight loss, robust reductions in triglycerides, LDL cholesterol, liver fat content and blood pressure, while preserving lean mass. The U.S. FDA has granted Fast Track designation to pemvidutide for the treatment of MASH. Pemvidutide recently completed the MOMENTUM Phase 2 obesity trial and is being studied in the ongoing IMPACT Phase 2b MASH trial. About Altimmune Altimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics. The Company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity and MASH. For more information, please visit www.altimmune.com. Follow @Altimmune, Inc. on LinkedIn Follow @AltimmuneInc on Twitter Company Contact:Vipin GargPresident and Chief Executive OfficerPhone: 240-654-1450ir@altimmune.com Media Contact:Danielle CanteyInizio Evoke, BiotechPhone: 619-826-4657Danielle.cantey@inizioevoke.com Investor Contacts:Lee RothBurns McClellanPhone: 646-382-3403lroth@burnsmc.com Julia WeilmanBurns McClellanPhone: 646-732-4443jweilman@burnsmc.com This press release was published by a CLEAR® Verified individual.

Company announcement – No. 47 / 2024 Zealand Pharma announces that Boehringer receives U.S. FDA Breakthrough Therapy designation and initiates two Phase III trials in MASH for survodutide The U.S. FDA Breakthrough Therapy designation is for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate or advanced fibrosis, based on survodutide’s groundbreaking results from Phase II study Boehringer launches two Phase III studies of survodutide, LIVERAGE in adults with MASH and moderate or advanced fibrosis (stages 2 or 3), and LIVERAGE-Cirrhosis in those with MASH and cirrhosis (stage 4) Copenhagen, Denmark, October 8, 2024 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, reports that Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for survodutide (BI 456906), a dual glucagon/GLP-1 receptor agonist for the treatment of adults living with non-cirrhotic MASH and moderate or advanced fibrosis (stages 2 or 3). The Breakthrough Therapy designation expedites the development and review of medicines for serious or life-threatening diseases that have shown preliminary clinical evidence indicating substantial improvement over available treatments. In addition, Boehringer announced the initiation of two Phase III clinical trials for survodutide for the treatment of adults living with metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis (scarring). LIVERAGE will examine whether survodutide can improve MASH and/or fibrosis after 52 weeks of treatment and reduce the risk of end-stage liver disease outcomes after approximately seven years of treatment in approximately 1,800 adults living with MASH and moderate or advanced liver fibrosis (stages 2 or 3). LIVERAGE-Cirrhosis will examine whether survodutide can reduce the risk of end-stage liver disease outcomes after approximately four and a half years of treatment in approximately 1,590 adults living with MASH and compensated cirrhosis (fibrosis stage 4), a condition where the liver presents severe scarring. “Representing one of the most serious and fastest-growing obesity-related co-morbidities with limited treatment options available today, we are both pleased and excited to see Boehringer Ingelheim advance survodutide into two Phase III trials in MASH in both F2/F3 patients (moderate to advanced fibrosis) as well as F4 patients (cirrhosis),” said David Kendall, M.D., Chief Medical Officer of Zealand Pharma. “The U.S. FDA Breakthrough Therapy Designation follows the impressive and groundbreaking Phase II data with survodutide in MASH and fibrosis presented earlier this year which provided evidence of clear differentiation that position survodutide as a potentially leading incretin-based therapy for obesity and MASH in the future.” For additional information, please refer to Boehringer Ingelheim’s press release from today available at Survodutide US FDA Breakthrough Therapy phase 3 trials MASH | Boehringer Ingelheim (boehringer-ingelheim.com). About LIVERAGE and LIVERAGE-CirrhosisLIVERAGE and LIVERAGE-Cirrhosis are global Phase III clinical trials investigating the efficacy and safety of survodutide in adults with MASH and fibrosis stages 2 or 3 and in those with compensated MASH cirrhosis (stage 4), respectively. LIVERAGE will enroll approximately 1,800 adults, and LIVERAGE-Cirrhosis will enroll approximately 1,590 adults. In each trial, participants will be randomized to receive weekly injections of either survodutide, reaching a maximum dose of 6 mg, or placebo. LIVERAGE consists of two parts. The two primary endpoints of part one are proportion of patients achieving MASH resolution without worsening of fibrosis, and at least a 1-point improvement in fibrosis without worsening of MASH, after 52 weeks of treatment. The primary endpoint of part two, which will continue for approximately seven years, is time to first occurrence of liver-related events or all-cause mortality. The primary endpoint of LIVERAGE-Cirrhosis, which will continue for approximately four and a half years, is the time to first occurrence of all-cause mortality or liver-related events. About survodutide (BI 456906)Survodutide is a glucagon/GLP-1 receptor dual agonist that activates both the glucagon and GLP-1 receptors, which play a role in controlling metabolic functions. Survodutide is being evaluated in a robust Phase III clinical development program, including the LIVERAGE studies for people living with MASH and fibrosis and the SYNCHRONIZE studies for people living with overweight or obesity. Survodutide’s potential to treat adults with non-cirrhotic MASH and moderate or advanced fibrosis (stages 2 or 3) has been recognized by the U.S. FDA, which granted it: Fast Track designation in May 2021 and;Breakthrough Therapy designation in September 2024. Survodutide’s potential to treat adults with MASH and fibrosis has also been recognized by: the European Medicines Agency (EMA), through acceptance to its PRIME scheme in November 2023 and;the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA), which granted it Breakthrough Therapy designation in June 2024. Survodutide is licensed to Boehringer Ingelheim from Zealand Pharma, with Boehringer solely responsible for development and commercialization globally (subject to Zealand's co-promotion right in the Nordic countries). About metabolic dysfunction-associated steatohepatitis (MASH) MASH is a chronic and progressive liver disease caused by a build-up of fat in the liver and is a more severe form of metabolic dysfunction-associated steatotic liver disease (MASLD). In the US, cases of MASH are predicted to increase by 63% between 2015 and 2030, from 16.5 million to 27.0 million cases. MASH is a disease closely associated with connected cardiovascular, renal, and metabolic diseases, and it is estimated that 34% of people living with obesity also have MASH. MASH severity is assessed using a scale that ranges from F0 to F4, which measures the level of fibrosis (scarring): F0-F1: indicates no or mild fibrosisF2-F3: indicates moderate or advanced fibrosisF4: indicates cirrhosis About Zealand PharmaZealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products. Zealand was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. For more information about Zealand’s business and activities, please visit www.zealandpharma.com. Forward looking statementsThis company announcement contains “forward-looking statements”, as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products, the timing of the company’s pre-clinical and clinical trials and the reporting of data therefrom. These forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events, patient recruitment or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems at third party manufacturers; dependency on third parties, for instance contract research or development organizations; unexpected growth in costs and expenses; our ability to effect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty, including the ongoing military conflict in Ukraine and the uncertainty surrounding upcoming elections in the US. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this company announcement and are based on information available to Zealand Pharma as of the date of this announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice. ContactsAdam Lange (Investors)Investor Relations OfficerZealand PharmaEmail: alange@zealandpharma.com Anna Krassowska, PhD (Investor and Media)Vice President, Investor Relations & Corporate CommunicationsZealand PharmaEmail: akrassowska@zealandpharma.com

International diabetes pioneers and thought leaders from 11 countries will work with Biomea leadership to unlock the potential of menin science and beta cell biology to advance BMF-219 and Biomea’s evolving pipelineREDWOOD CITY, Calif., Oct. 01, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with metabolic diseases, obesity and genetically defined cancers, today announced the formation of Biomea Fusion’s Global Scientific Advisory Board (SAB) with internationally renowned experts in beta cell science and diabetes therapeutics. The SAB will work closely with Biomea’s leadership team as they unlock menin science and beta cell biology to design disease modifying agents that address a root cause of diabetes – beta cell dysfunction. The SAB will also provide strategic guidance for the further clinical development of Biomea’s lead candidate BMF-219 – an investigational novel covalent menin inhibitor developed to regenerate, restore, and improve the health and function of insulin-producing beta cells. “We are excited to welcome these extraordinary and prestigious scientific leaders to the Biomea Scientific Advisory Board,” said Thomas Butler, CEO and Chairman of Biomea. “Each of these visionaries has made groundbreaking contributions to diabetes therapeutics and beta cell research. Together, they form a powerhouse of expertise and innovation for Biomea, which will be invaluable as we leverage our deep understanding of menin science to regenerate insulin-producing beta cells." Juan Pablo Frias, Chief Medical Officer and Head of Diabetes at Biomea said, “We are honored to convene a world-class SAB, that represents remarkable experience and knowledge across diabetes drug development, data-driven global clinical trial design, and beta cell biology. With our advisors’ leadership, expertise and collaboration, we will optimize our clinical development and commercialization path for BMF-219." “I’ve had the privilege of collaborating with Biomea since mid-2022, witnessing firsthand the groundbreaking FUSION platform poised to revolutionize beta cell science and the diabetes space,” said Rohit N. Kulkarni, M.D. Ph.D, Chair of Biomea’s SAB. “I am excited to lead this effort for Biomea and welcome this group of world-renowned leaders to Biomea's SAB at this crucial juncture in the company’s evolution. Together, we will start with taking a deep dive into the clinical data generated to date with BMF-219 and review the overall path towards commerciality. We will explore the potential for BMF-219 as a monotherapy as well as in combination with standard of care agents and provide our advice to the clinical and scientific team at the company. We look forward to further unlock the immense potential of menin science and islet cell biology.” The inaugural members of the Global Biomea SAB are listed below. Full biographies of SAB members can be found at https://biomeafusion.com/leadership/. Alex Abitbol, MD, is an accomplished endocrinologist and Assistant Medical Director at LMC Healthcare in Toronto, Ontario. He completed his medical education and specialized in Endocrinology and Metabolism at McGill University. Dr. Abitbol focuses on diabetes care and management, particularly applying technology to improve patient outcomes, including developing the artificial pancreas and automated insulin therapy. He is a principal investigator at Centricity Research, involved in clinical trials for diabetes and cardiovascular disease. Board-certified in Internal Medicine and Endocrinology, Dr. Abitbol frequently speaks at conferences and is dedicated to advancing diabetes management technologies and patient care. Pablo Aschner Montoya, MD is an endocrinologist and diabetes researcher, serving as an Associate Professor of Endocrinology at Javeriana University School of Medicine in Bogotá, Colombia. He is also the Senior Research Advisor at San Ignacio University Hospital and the Scientific Director of the Colombian Diabetes Association. Dr. Aschner holds a medical degree from Javeriana University, specialized in internal medicine and endocrinology, and obtained a master’s in clinical Epidemiology. His research focuses on the prevention, diagnosis, control, and treatment of diabetes, emphasizing type 2 diabetes and its complications has significantly contributed to understanding diabetes care practices through influential studies like the International Diabetes Management Practices Study (IDMPS). He has held leadership roles in the Colombian Endocrine Society and the Latin American Diabetes Association (ALAD) and has been a member of the WHO Expert Advisory Panel and the IDF taskforce on Guidelines. Juliana Chan, MD is an endocrinologist, clinical pharmacologist and a diabetes researcher, currently serving as a Professor of Medicine and Therapeutics at The Chinese University of Hong Kong (CUHK). She is the Founding Director of the Hong Kong Institute of Diabetes and Obesity and the CEO of the Asia Diabetes Foundation. Dr. Chan also directs the CUHK-PWH International Diabetes Federation (IDF) Centre of Education and Centre of Excellence in Diabetes Care. Dr. Chan's research focuses on the epidemiology, genetics, clinical trials and data-driven clinical management of diabetes. She established the Hong Kong Diabetes Register and developed the Joint Asia Diabetes Evaluation (JADE) Technology, a web-based platform used in 11 Asian countries. This innovative approach has enrolled over 120,000 patients with diabetes and significantly contributed to a decline in the death rate among people with diabetes in Hong Kong. Alice YY Cheng, MD is an endocrinologist and Associate Professor at the University of Toronto, specializing in endocrinology and metabolism at Trillium Health Partners and Unity Health Toronto. She completed her medical education at the University of Toronto in 1998 and has since become a leading expert in diabetes care. Dr. Cheng has been involved with the development of the Diabetes Canada clinical practice guidelines since 2003, serving as Chair for the 2013 version. She is past-Chair of the Professional Section of Diabetes Canada. Her contributions have earned her prestigious awards, including the Charles H. Best Award and the Gerald S. Wong Service Award from Diabetes Canada. In addition to her clinical work, Dr. Cheng served as the Chair of the Scientific Planning Committee for the American Diabetes Association (ADA) annual scientific sessions (2023-2024) and is an Associate Editor for the journal, Diabetes Care, and co-hosts the "Diabetes Care On-Air" podcast. Melanie Davies, MD, CBE, MB ChB, MD, FRCP, FRCGP, FMedSci is a highly esteemed endocrinologist and Professor of Diabetes Medicine at the University of Leicester. She directs the NIHR Leicester Biomedical Research Centre and the Patient Recruitment Centre Leicester. With over 25 years in diabetes research and clinical care, she has led numerous global clinical trials on diabetes, obesity, physical activity, and cardiovascular disease. Dr. Davies has published over 900 articles, significantly impacting international clinical guidelines for insulin and GLP-1 therapy. Her co-leadership at the Leicester Diabetes Centre has established it as a global leader in diabetes research and education. Honored as a Commander of the Order of the British Empire (CBE) and elected Fellow of the Academy of Medical Sciences (FMedSci), Dr. Davies is recognized among the top 100 female scientists in the UK. Asma Deeb, MD, MBBS is a highly respected Consultant and Chief of Pediatric Endocrinology at Sheikh Shakhbout Medical City (SSMC) in Abu Dhabi, UAE. She is also a clinical professor at Khalifa University and Gulf University. Dr. Deeb trained in the UK, obtaining her MD from the University of Newcastle and specializing in Pediatric Endocrinology at the University of Cambridge. Her research focuses on disorders of sexual differentiation, pediatric diabetes management technology, and diabetes genetics. She has published extensively and conducted significant studies on diabetes treatments and the effects of fasting during Ramadan on young diabetes patients. Dr. Deeb is the President of the Arab Society of Pediatric Endocrinology and Diabetes (ASPED) and has held leadership roles in several international pediatric endocrinology organizations. Her contributions have earned her numerous awards, including the Research Innovation Award from the Dubai Health Authority and the Technology Innovation Pioneer award from SEHA. Ralph A. DeFronzo, MD is a renowned endocrinologist and diabetes researcher, currently serving as Professor of Medicine and Chief of the Diabetes Division at the University of Texas Health Science Center at San Antonio (UTHSCSA) and Deputy Director of the Texas Diabetes Institute. He graduated from Yale University and earned his medical degree from Harvard Medical School, with further training in Internal Medicine at Johns Hopkins Hospital and fellowships in Endocrinology and Nephrology. Dr. DeFronzo focuses on the pathogenesis and treatment of type 2 diabetes, particularly insulin resistance. He pioneered the euglycemic insulin clamp technique and played a key role in developing and obtaining FDA approval for metformin and SGLT2 inhibitors. He has received numerous prestigious awards, including the Banting Award and Claude Bernard Award, and published over 800 articles. His contributions have profoundly impacted diabetes understanding and management, influencing guidelines such as the ADA's 2022 Standards of Care. Thomas Danne, MD is a leading pediatric endocrinologist and diabetes expert who currently serves as the Chief Medical Officer International for JDRF (formerly JDRF) and as a Professor of Pediatrics at Hannover Medical School in Germany. He received his MD from the Medical School of the Freie University of Berlin and further enhanced his expertise through a Postdoctoral Fellowship at the German Research Council and a research fellowship at Harvard's Joslin Research Laboratory. He has held leadership roles in prominent organizations such as the International Society for Pediatric and Adolescent Diabetes (ISPAD), the German Diabetes Association, and INNODIA. With over 700 publications and more than 19,000 citations, Dr. Danne has made a substantial impact on the field, leading the EDITION JUNIOR clinical trials and co-authoring the International Consensus on Time in Range. His innovative approaches, including color-coded charts for children, have improved diabetes care and management. Dr. Danne's significant contributions to diabetes research and care have earned him numerous accolades, including ISPAD Prizes for Innovation and Achievement, the Helmut-Otto Medal, and a Lifetime Achievement Award from the International Diabetes Federation. Linda DiMeglio, MD, MPH is a celebrated pediatric endocrinologist and expert in type 1 diabetes research. She is the Edwin Letzter Professor of Pediatrics at Indiana University School of Medicine, Division Chief of Pediatric Endocrinology and Diabetology at Riley Children's Health in Indianapolis, and the co-director of Workforce Development for the Indiana Clinical and Translational Sciences Institute. Dr. DiMeglio graduated with honors from Harvard University and obtained her medical degree from the University of Pennsylvania. She completed her residency at Children's Memorial Hospital (now Lurie Children’s) and a fellowship in pediatric endocrinology at Indiana University-Purdue University, Indianapolis, where she also earned a Master of Public Health degree. Her research focuses on type 1 diabetes prevention, beta-cell preservation, and new diabetes management technologies and therapeutics. Dr. DiMeglio has led numerous clinical trials contributing significantly to the understanding of beta-cell stress biomarkers. Steven V. Edelman, MD is a renowned endocrinologist and diabetes specialist, currently serving as a Professor of Medicine in the Division of Endocrinology, Diabetes, and Metabolism at the University of California, San Diego (UCSD). He is also the founder and director of Taking Control of Your Diabetes (TCOYD), a not-for-profit organization dedicated to educating and empowering individuals with diabetes to manage their condition effectively. Dr. Edelman completed his medical education at the University of California, Davis, followed by a residency in internal medicine at the University of California, Los Angeles (UCLA). He further specialized in endocrinology and metabolism during his fellowship at the Joslin Diabetes Center in Boston. His research interests include diabetes management, patient education, and the development of new therapies for diabetes. Dr. Edelman has been involved in numerous clinical trials and has published extensively in the field of diabetes care. Franco Folli, MD, PhD is an internist and diabetes researcher, currently a Professor of Endocrinology and Metabolism at the Department of Health Sciences, Universita’ degli Studi di Milano and affiliated with ASST Santi Paolo e Carlo in Milan, Italy. He earned his medical degree and Ph.D. from the Università di Milano. Dr. Folli's research focuses on inflammation, insulin signaling, and the pathophysiology of diabetes, significantly advancing the understanding of insulin resistance and inflammation in diabetes. Previously, he was a Professor of Internal Medicine (with tenure) at the University of Texas Health Science Center at San Antonio, where he conducted groundbreaking clinical and basic research on diabetes. Supported by grants, from the Italian Ministry of Health, Telethon, National Institute of Health (USA), Dr. Folli has pioneered work on the molecular mechanisms of insulin action and resistance. Francesco Giorgino, MD, PhD is an endocrinologist and diabetes researcher, currently Professor of Endocrinology and Chairman of the Department of Precision and Regenerative Medicine at the University of Bari Aldo Moro, and Chief of the Division of Endocrinology at University Hospital Policlinico Consorziale in Bari, Italy. He has held leadership positions, including President of the Italian Society of Endocrinology (SIE) and Senior Vice President of the European Association for the Study of Diabetes (EASD). Dr. Giorgino has been also the Director of the Specialty School of Endocrinology and Metabolism at the University of Bari for several years, mentoring future endocrinologists. Dr. Giorgino research focuses on insulin resistance, beta-cell dysfunction, and the effects of diabetes drugs on pancreatic islets and the cardiovascular system. His notable studies include research on SGLT2 inhibitors and GLP-1 receptor agonists, impacting glycemic control and cardiovascular outcomes. Freddy Goldberg Eliaschewitz, MD is a prominent endocrinologist and diabetes researcher, currently the Director at CPClin Clinical Research Center in São Paulo, Brazil. He completed his medical degree and master's in Endocrinology at Universidade de São Paulo. Dr. Eliaschewitz has contributed significantly to clinical research and patient care at Hospital Israelita Albert Einstein in São Paulo. His research focuses on diabetes, particularly glycemic control, insulin therapy, and preventing diabetic complications. He has led numerous clinical trials, including the GOAL study and IDMPS, exploring the efficacy of ultra-long basal insulins like degludec. Dr. Eliaschewitz has served as a consultant and advisory board member for major pharmaceutical companies and published extensively in peer-reviewed journals. His work on insulin therapy and diabetes management has advanced treatment practices, especially in low- and middle-income countries. Mohamed Hassanein, MD is a Senior Consultant in Endocrinology and Diabetes at Dubai Hospital, UAE, since 2014, and a Senior Lecturer and Associate Director for Postgraduate Diabetes Education at Cardiff University, UK, since 2007. He graduated from the Faculty of Medicine, Alexandria, Egypt, and is renowned for his research on diabetes management during Ramadan. Dr. Hassanein has co-authored influential guidelines, including those for the American Diabetes Association and the IDF-DAR practical guidelines. He has published over 70 papers and presented at more than 50 conferences, focusing on the safety and efficacy of diabetes treatments, like SGLT2 inhibitors, during fasting. His research includes flash glucose monitoring and insulin pump therapy. Dr. Hassanein has been recognized with several awards, including the SAHF Lifetime Achievement Award in 2022. Steven E. Kahn, MB, ChB is the Leonard L. Wright & Marjorie C. Wright Term Chair of Medicine and Professor of Medicine at the University of Washington (UW). He also serves as a Staff Physician at the VA Puget Sound Health Care System and Director of the UW Diabetes Research Center. Dr. Kahn earned his medical degree from the University of Cape Town and completed his endocrine fellowship at UW. His research focuses on the pathophysiology of type 2 diabetes, specifically islet beta-cell dysfunction and insulin resistance. He has significantly contributed to understanding how islet amyloid formation leads to beta-cell loss and hyperglycemia. Involved in major clinical trials like the Diabetes Prevention Program (DPP) and the Restoring Insulin Secretion (RISE) Study, Dr. Kahn has published over 730 peer-reviewed articles. He has received numerous awards, including the American Diabetes Association Outstanding Achievement in Clinical Diabetes Research Award and European Association for the Study of Diabetes Claude Bernard Award. He currently serves as editor-in-chief of Diabetes Care. Rohit N. Kulkarni, MD, PhD is a physician scientist and diabetes researcher, serving as a Professor of Medicine at Harvard Medical School and holds the Diabetes Research and Wellness Foundation Chair. He is Co-Head of the Section on Islet and Regenerative Biology at the Joslin Diabetes Center, Principle Faculty of the Harvard Stem Cell Institute and Associate Member of the Broad Institute. Dr. Kulkarni's research focuses on pathways in islet cell biology that are critical to understand the pathophysiology of both type 1 and type 2 diabetes. His lab investigates growth factor receptors (e.g. insulin, IGF-1), mRNA modifications, and cross talk with incretin signaling. His lab has expertise in generating patient-derived induced pluripotent stem (iPS) cells for differentiation into insulin- or glucagon-secreting cells for potential therapeutic applications. Dr. Kulkarni has received numerous accolades, including the Ernst Oppenheimer Award (Endocrine Society), the Albert Renold Prize (European Association for Study of Diabetes) and Paul E. Lacy Medal (Midwest Islet Consortium), and is an elected Fellow of the American Society for Clinical Investigation, the Association of American Physicians and the American Association for the Advancement of Science. Chantal Mathieu, MD is a renowned endocrinologist and diabetes researcher, currently a Professor of Medicine at KU Leuven in Belgium and Chair of Endocrinology at University Hospital Gasthuisberg Leuven. She earned her M.D. and Ph.D. from the University of Leuven and trained in internal medicine and endocrinology there. Dr. Mathieu's research focuses on the prevention of type 1 diabetes, the effects of vitamin D on the immune system, and the functioning of insulin-producing beta cells. Notably, she coordinates the EDENT1FI project, a European initiative aimed at exploring screening strategies and early diagnosis of type 1 diabetes. She is Chair of the Board of the INNODIA initiative, a network of clinical trial sites for interventions in type 1 diabetes in Europe. Her contributions have earned her prestigious awards, including the InBev-Baillet Latour Prize for Clinical Research and the David Rumbough Award from the JDRF for her research on the pathophysiology of type 1 diabetes. Dr. Mathieu is also the President of the European Association for the Study of Diabetes (EASD). Jeremy Pettus, MD is an Associate Professor of Medicine in the Department of Endocrinology at the University of California, San Diego (UCSD), where he specializes in diabetes care and research. After earning his medical degree from Boston University School of Medicine, he completed his residency and fellowship in Endocrinology at UCSD. Dr. Pettus is actively involved in clinical trials, focusing on new therapies for type 1 diabetes, including glucagon receptor antagonists and the development of the artificial pancreas. His work is widely recognized, and he is a frequent speaker at national and international conferences. In addition to his research, Dr. Pettus is committed to patient education through his involvement with the non-profit Taking Control of Your Diabetes (TCOYD), where he leads the Type 1 Diabetes track at national conferences. His clinical practice emphasizes personalized care, understanding the unique challenges faced by people with diabetes. With a focus on patient empowerment and innovative treatments, Dr. Pettus continues to make impactful contributions to the field of diabetes management. Julio Rosenstock, MD is a renowned endocrinologist and expert in type 2 diabetes, serving as the Director of the Dallas Diabetes Research Center at Medical City Dallas and Clinical Professor of Medicine at the University of Texas Southwestern Medical Center. He earned his medical degree from Universidad Nacional Autónoma de México and completed his residency and fellowship at UT Southwestern. Dr. Rosenstock's research focuses on novel therapeutic strategies for optimal glycemic control in type 2 diabetes. He has led numerous clinical trials, contributing to the development of new oral antidiabetic agents, incretin-based therapies, and insulin preparations. His recent work includes research on insulin icodec, a potential once-weekly basal insulin. Dr. Rosenstock holds leadership positions, including Senior Scientific Advisor for Velocity Clinical Research, and serves on advisory boards for pharmaceutical companies. Desmond Schatz, MD is a highly esteemed pediatric endocrinologist and expert in type 1 diabetes research. He serves as a Professor of Pediatrics and the Medical Director of the Diabetes Institute at the University of Florida (UF), as well as the Director of the Clinical Research Center within UF's Clinical and Translational Science Institute (CTSI). Dr. Schatz earned his medical degree in South Africa. His research focuses on the prediction, natural history, genetics, immunopathogenesis, and prevention of type 1 diabetes, alongside developing new treatment strategies. He has been a key investigator in the Diabetes Prevention Trial and TrialNet and other multicenter studies. Dr. Schatz has received numerous accolades, including the Banting Award and JDRF's highest research award. He was honored with the UF College of Medicine Lifetime Achievement Award in 2020 and is a member of the Academy of Science and Medicine for Florida, and was a past president of the American Diabetes Association (ADA). Jay S. Skyler, MD is a distinguished endocrinologist and diabetes researcher, currently a Professor of Medicine, Pediatrics, and Psychology at the University of Miami Miller School of Medicine, where he also serves as Deputy Director for Clinical Research and Academic Programs at the Diabetes Research Institute. Dr. Skyler earned his medical degree from Jefferson Medical College and completed his training in Internal Medicine and Endocrinology at Duke University Medical Center. His research focuses on type 1 diabetes, particularly immune intervention strategies. He has led numerous clinical trials, including the NIH-sponsored Diabetes Prevention Trial for Type 1 Diabetes (DPT-1) and the Type 1 Diabetes TrialNet Clinical Trials Study Group. Dr. Skyler has received numerous awards, such as the Banting Medal, the Distinction in Endocrinology Award from the American College of Endocrinology, and the JDRF's Mary Tyler Moore/S. Robert Levine Award. Dr. Skyler has held leadership roles as President of the ADA, Vice-President of the International Diabetes Federation, and President of the International Diabetes Immunotherapy Group. He was the founding Editor-in-Chief of Diabetes Care and serves on multiple editorial boards. Kohjiro Ueki, MD, PhD is a distinguished endocrinologist and diabetes researcher, currently serving as the Director of the Diabetes Research Center at the National Center for Global Health, Japan. He also served as Professor of the Department of Molecular Diabetology, Graduate School of Medicine, the University of Tokyo where he earned his medical degree and PhD. Dr. Ueki's research focuses on insulin resistance, insulin secretion, and the pathogenesis of type 2 diabetes. He serves as the Chair of the Board of Directors of the Japan Diabetes Society and has been instrumental in developing clinical practice guidelines, including the "Kumamoto Declaration 2013". He has conducted significant studies on the efficacy and safety of diabetes treatments and the role of pancreatic alpha-cell function in insulin sensitivity. Supported by grants from prestigious organizations, Dr. Ueki has received numerous awards for his contributions. About COVALENT-111 COVALENT-111 is a multi-site, randomized, double-blind, placebo-controlled Phase I/II study. In the completed Phase I portion of the trial, healthy patients were enrolled in single ascending dose cohorts to evaluate safety at the prospective dosing levels for type 2 diabetic patients. Phase II consists of multiple ascending dose cohorts and includes adult patients with type 2 diabetes uncontrolled by standard of care medicines. Once the Escalation Phase of COVALENT-111 was completed, the study advanced into an Expansion Phase (Ph IIb) consisting of multiple cohorts dosing type 2 diabetes patients for longer dose durations. Additional information about this Phase I/II clinical trial of BMF-219 in type 2 diabetes can be found at ClinicalTrials.gov using the identifier NCT05731544. About COVALENT-112 COVALENT-112 is a multi-site, randomized, double-blind, placebo-controlled Phase II study in adults with stage 3 type 1 diabetes. This stage describes the period following clinical diagnosis of type 1 diabetes when symptoms are present due to significant beta cell loss. COVALENT-112 will be a multi-arm trial comparing two different doses of BMF-219 to placebo (1:1:1) to evaluate the efficacy, safety, and durability of BMF-219 in adults with type 1 diabetes. Approximately 150 patients will be enrolled in the trial and will receive either BMF-219 or placebo over 12 weeks, followed by a 40-week off treatment period. This trial also includes an open-label portion for adults with type 1 diabetes up to 15 years since diagnosis. The open-label portion (n=40) is examining the efficacy, safety, and durability of BMF-219 at two oral dose levels, 100 mg and 200 mg over 12-week treatment followed by a 40-week off treatment period. Additional information about the Phase II clinical trial of BMF-219 in type 1 diabetes can be found at ClinicalTrials.gov using the identifier NCT06152042. About Biomea Fusion Biomea Fusion is a clinical stage biopharmaceutical company focused on the discovery and development of oral covalent small molecules to treat patients with metabolic diseases and genetically defined cancers. A covalent small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response. We are utilizing our proprietary FUSION™ System to discover, design and develop a pipeline of next-generation covalent-binding small molecule medicines designed to maximize clinical benefit for patients. We aim to have an outsized impact on the treatment of disease for the patients we serve. We aim to cure. Visit us at biomeafusion.com and follow us on LinkedIn, Twitter and Facebook. Forward-Looking Statements Statements we make in this press release may include statements which are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact, including statements regarding expected contributions of our scientific advisory board, the clinical and therapeutic potential of our product candidates and development programs, including BMF-219, the potential of BMF-219 as a treatment for type 1 and type 2 diabetes, our research, development and regulatory plans, the progress of our ongoing and upcoming clinical trials, including our Phase I/II COVALENT-111 study of BMF-219 in type 2 diabetes, and our Phase II COVALENT-112 study of BMF-219 in type 1 diabetes, may be deemed to be forward-looking statements. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including the risk that we may encounter delays in preclinical or clinical development, patient enrollment and in the initiation, conduct and completion of our ongoing and planned clinical trials and other research and development activities. These risks concerning Biomea Fusion’s business and operations are described in additional detail in its periodic filings with the U.S. Securities and Exchange Commission (the “SEC”), including its most recent periodic report filed with the SEC and subsequent filings thereafter. Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.