The Latest Cardiac and Vascular News
Appointment highlights Cardiosense’s growth trajectory following FDA clearance, clinical milestones, and expanded leadership team CHICAGO–(BUSINESS WIRE)–Cardiosense, a digital health company pioneering AI-enabled solutions for cardiac disease management, today announced the appointment of Eric Meizlish as Chief Executive Officer (CEO). Meizlish, a seasoned healthcare technology executive with experience scaling innovative health platforms, will […]
SYMPHONY-PE Trial Demonstrated Strong Efficacy, Efficiency, and Safety Results with No Mortality and No Device-Related Serious Adverse Events CAMPBELL, Calif.–(BUSINESS WIRE)–Imperative Care, Inc. today announced positive efficacy and safety results from the pivotal SYMPHONY-PE Trial (NCT06062329) evaluating the company’s Symphony® Thrombectomy System in the treatment of acute pulmonary embolism (PE). Results […]
LAGUNA HILLS, Calif.–(BUSINESS WIRE)–Adagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced that acute results from the Company’s FULCRUM-VT U.S. pivotal study have been accepted for presentation in a late-breaking clinical science session at […]
$6 million upfront with up to an additional $6 million of potential aggregate gross proceeds upon the exercise in full of short-term warrantsSUNNYVALE, Calif., Sept. 18, 2025 (GLOBE NEWSWIRE) — BioCardia®, Inc. [NASDAQ:BCDA] (“BioCardia” or the “Company”), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the pricing of a public offering of an aggregate of 4,800,000 shares of its common stock and short-term warrants to purchase up to 4,800,000 shares of common stock, at a combined public offering price of $1.25 per share and accompanying short-term warrant. The short-term warrants will have an exercise price of $1.25 per share, will be exercisable upon issuance and will expire two years thereafter. The closing of the offering is expected to occur on or about September 19, 2025, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses payable by the Company, are expected to be $6 million. The potential additional gross proceeds to the Company from the short-term warrants, if fully-exercised on a cash basis, will be $6 million. No assurance can be given that any of such short-term warrants will be exercised. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes, which include, but are not limited to, advancing our investigational biotherapeutic candidates and our biotherapeutic delivery partnering business. The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-290283), which was declared effective by the Securities and Exchange Commission (the “SEC”) on September 18, 2025. The offering is being made only by means of a prospectus forming part of the effective registration statement relating to the offering. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at http://www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix biotherapeutic delivery and Morph® vascular navigation product platforms. Forward-Looking Statements This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the completion of the offering, the satisfaction of customary closing conditions related to the offering, the exercise of the short-term warrants prior to their expiration and the intended use of net proceeds from the offering. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors,” and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Media Contact: Miranda Peto, Investor Relations Email: mpeto@BioCardia.com Phone: 650-226-0120 Investor Contact: David McClung, Chief Financial Officer Email: investors@BioCardia.com Phone: 650-226-0120
SUNNYVALE, Calif., Sept. 18, 2025 (GLOBE NEWSWIRE) — BioCardia, Inc. (NASDAQ: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the primary endpoint results of the open label roll-in cohort of the CardiAMP® Cell Therapy in Chronic Myocardial Ischemia Trial. Results from the open label roll-in cohort patients having chronic myocardial ischemia with refractory angina show that the minimally-invasive CardiAMP Cell Therapy procedure was well tolerated with no treatment emergent major adverse cardiac events. All patients were on guideline-directed medical therapy (GDMT) and responded positively to the autologous cell therapy. Patients experienced increased exercise tolerance of an average of 80 seconds and an average of 82% reduction in angina episodes at the six-month primary endpoint when compared to measurements prior to cell therapy treatment. Sixty percent of the patients showed substantial improvements in both measures. These early, open-label results compare favorably to those demonstrated by current FDA approved therapies such as Ranolazine and Enhanced External Counter Pulsation (EECP) (1,2,3). Patients already on Ranolazine experienced dramatic reduction in angina episodes at the six-month follow-up. These results are in line with previous compelling investigational trial results utilizing cost prohibitive cell therapy (4). “With these final roll-in results, this novel investigational therapy shows promise in addressing debilitating refractory angina, a significant unmet need for patients with chronic myocardial ischemia,” said Carl Pepine, MD, MACC, Professor of Medicine, Division of Cardiovascular Medicine, University of Florida at Gainesville. “We are working with our investigators to submit these results for peer reviewed scientific publication,” said Peter Altman, President and CEO. “The results from this roll-in cohort supports our continued development of this novel therapeutic approach for chronic myocardial ischemia with refractory angina and enhances the value of our CardiAMP cell therapy platform.” About Chronic Myocardial Ischemia with Refractory Angina Chronic myocardial ischemia occurs in the setting of coronary artery disease when there is reduced blood flow to the heart. This causes angina, a type of chest pain which is characterized as refractory angina when this pain cannot be controlled by a combination of optimal medical therapy, angioplasty or bypass surgery, and is estimated to impact 600,000 to 1.8 million patients in the United States. Up to 15% of patients who have ischemia or angina and undergo cardiac catheterization are suboptimal candidates for conventional revascularization. Although prognosis of refractory angina has improved in recent years, patients with refractory angina experience a significantly impaired quality of life with disproportionately high utilization of healthcare services. These observations reflect the great need for new therapies for these patients. Promising results in treating this patient population with an autologous bone marrow derived cell therapy have been shown previously (4). About the CardiAMP Cell Therapy Program Designated by the FDA as a Breakthrough Therapy for Ischemic Heart Failure, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy: a pre-procedural cell analysis for patient selection, a high target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and exponentially more successful in cell retention. The CardiAMP cell therapy trials for the indications of both chronic myocardial ischemia and ischemic heart failure are covered by the Center for Medicare and Medicaid for both treatment and control procedures. CAUTION – Limited by United States law to investigational use. About BioCardia®BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms, and soon the Heart3D™ fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies. For more information visit www.biocardia.com. Reference: 1Stone PH, Gratsiansky NA, Blokhin A, Huang IZ, Meng L; ERICA Investigators. Antianginal efficacy of ranolazine when added to treatment with amlodipine: the ERICA (Efficacy of Ranolazine in Chronic Angina) trial. J Am Coll Cardiol. 2006 Aug 1;48(3):566-75. doi: 10.1016/j.jacc.2006.05.044. Epub 2006 Jun 15. PMID: 16875985. 2 Sendón JL, Lee S, Cheng ML, Ben-Yehuda O; CARISA study investigators. Effects of ranolazine on exercise tolerance and angina frequency in patients with severe chronic angina receiving maximally-tolerated background therapy: analysis from the Combination Assessment of Ranolazine In Stable Angina (CARISA) randomized trial. Eur J Prev Cardiol. 2012 Oct;19(5):952-9. doi: 10.1177/2047487312450133. Epub 2012 Jun 11. PMID: 22689417. 3 Arora RR, Chou TM, Jain D, Fleishman B, Crawford L, McKiernan T, Nesto RW. The multicenter study of enhanced external counterpulsation (MUST-EECP): effect of EECP on exercise-induced myocardial ischemia and anginal episodes. J Am Coll Cardiol. 1999 Jun;33(7):1833-40. doi: 10.1016/s0735-1097(99)00140-0. PMID: 10362181. 4Henry TD, Losordo DW, Traverse JH, Schatz RA, Jolicoeur EM, Schaer GL, Clare R, Chiswell K, White CJ, Fortuin FD, Kereiakes DJ, Zeiher AN, Sherman W, Hunt AS, and Povsic TJ. Autologous CD34 cell therapy improves exercise capacity, angina frequency and reduces mortality in no-option refractory angina: a patient-level pooled analysis of randomized double-blinded trials, European Heart Journal, 2018. Forward Looking Statements: This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements may include, among other things, statements relating to the continued development and cost of BioCardia’s autologous cell-based therapies, the probability of success of the CardiAMP clinical trials, ability to offset clinical costs utilizing Medicare reimbursement and the ultimate success of our clinical cell therapy programs. These forward-looking statements are made as of the date of this press release. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully advance its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors,” and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. MEDIA CONTACT:Miranda Peto, Investor Relations mpeto@biocardia.com (650) 226-0120 INVESTOR CONTACT:David McClung, Chief Financial Officerinvestors@biocardia.com (650) 226-0120
– Results were published in JACC: Basic to Translational Science – – Publication evaluated coronary tissue engineered vessel (CTEV) as a conduit for CABG in a nonhuman primate model – – All implanted CTEVs remained patent through six months, demonstrated adaptive remodeling, and recellularized with host coronary artery cells – – Humacyte plans to advance CTEV into first-in-human study in CABG – DURHAM, N.C., Sept. 18, 2025 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the publication of new preclinical data as part of a study evaluating the coronary tissue engineered vessel (CTEV) as a coronary artery bypass graft conduit in a non-human primate model. In the study, published in JACC: Basic to Translational Science, a specialist journal launched by the Journal of the American College of Cardiology (JACC), the CTEV was observed to sustain blood flow, recellularize with the animals’ host cells, and remodel to reduce the initial size mismatch between the CTEV and the animals’ native artery. “Innovation in CABG has been stagnant for far too long,” said Alan Kypson, MD, FACS, Cardiothoracic Surgeon, UNC REX Hospital. “Our results suggest that we may be on the verge of a new option — one that remodels to match the native artery and recellularizes with host cells, potentially providing superior patency relative to saphenous vein grafts. The CTEV has the potential to address a significant unmet clinical need in coronary bypass surgery and ultimately improve patient outcomes.” Cardiovascular disease is the leading cause of death worldwide, comprising one in every three deaths in the United States in 2023. The most common form is coronary artery disease (CAD), which affects 1 in 20 adults aged 20 and older. Coronary artery bypass grafting, a procedure that improves blood flow to the heart by using the internal mammary artery and saphenous vein to bypass narrowed or blocked coronary arteries, remains the current standard of care. However, saphenous vein grafts – used in 80%-90% of CABG cases – demonstrate poor long-term patency, with approximately 50% failing at 10 years. Many patients also lack usable autologous veins or arteries due to prior harvest, ablation, or poor quality, highlighting the unmet clinical need for alternative conduits. For the past half century, no novel CABG conduits have gained routine clinical use. The recent JACC study, titled “Acellular Tissue Engineered Vessels as Coronary Artery Bypass Grafts”, follows five adult baboons undergoing CABG to the right coronary artery with the CTEV. All CTEVs remained patent throughout the 6-month study. At the end of follow-up, the CTEV was observed to have recellularized with host cells to form a multi-layered tissue, including transanastomotic neomedial tissue that effectively reduced the initial size mismatch with the right coronary artery (RCA). The results suggest that the CTEV may be a durable alternative CABG conduit. The CTEV is 3.5mm blood vessel produced in the same bioengineering manufacturing system as Humacyte’s acellular tissue engineered vessel (ATEV™). The CTEV is also referred to as the small-diameter ATEV, or sdATEV. Humacyte also announced that it plans to advance the CTEV into its first-in-human study in CABG. To support human study, the Company anticipates filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) during the 4th Quarter of 2025. The Company’s current plans for filing an IND are based on the outcome of a meeting held early this year with the FDA, including agreements reached with the agency. “We’re pleased that this new publication of preclinical data demonstrates the promise of CTEVs as an alternative for native vessel grafts in CABG,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “As one of the leading causes of early death, coronary artery disease poses unique challenges for patient care. We are looking forward to proceeding into the first-in-human study of the CTEV in CABG and hopefully offering surgeons another option for treating this disease.” The CTEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in extremity vascular trauma was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize Symvess and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; the degree of market acceptance of and the availability of third-party coverage and reimbursement for Symvess and, if approved by regulatory authorities, our product candidates; our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated benefits of our ATEVs and our CTEVs relative to existing alternatives; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials; the anticipated characteristics and performance of our ATEVs and our CTEVs; the implementation of our business model and strategic plans for our business; our ability to execute and achieve the expected benefits of our cost-saving measures and whether our efforts will result in further actions or additional asset impairment charges that adversely affect our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, competitive and/or reputational factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and Form 10-Q for the quarter ended June 30, 2025, each filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com
Ozempic® (once-weekly injectable semaglutide) was associated with a 23% reduced risk of heart attack, stroke and death in people with type 2 diabetes and cardiovascular disease on Medicare versus dulaglutide1Data also highlighted Ozempic® was associated with a 26% lower risk of death versus dulaglutide1This study is the first to directly compare these glucagon-like peptide 1 receptor agonist (GLP-1 RA) medications in everyday real-life use. It fills a significant gap in understanding their effects on heart health in older people at high risk, which could help support informed treatment decisions and health policies.1 Bagsværd, Denmark, 18 September 2025 – Novo Nordisk today announced results from the REACH real-world study, which demonstrated that compared to dulaglutide, Ozempic® (once-weekly injectable semaglutide) was associated with a reduced risk of major adverse cardiovascular events such as a heart attack or stroke by 23%1. The data span nearly 60,000 US Medicare patients (aged ≥66 years) living with type 2 diabetes, atherosclerotic cardiovascular disease (ASCVD) – a condition where fatty deposits build up in blood vessels, reducing blood flow and increasing the risk of heart attacks, strokes and related problems – and multiple health conditions2. The results were presented at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting on 15–19 September in Vienna, Austria1. “As we age, the risk of experiencing a heart attack, stroke or dying from a cardiovascular event increases. At the same time, there are limited clinical data for people living with diabetes and cardiovascular disease aged 66 years or older. These data, showing a 23% risk reduction of a heart attack, stroke and death, fill an important gap and reinforce the well-established clinical evidence of semaglutide,” said Filip Krag Knop, senior vice president and incoming chief medical officer at Novo Nordisk. “This is great news for older patients as well as healthcare professionals, as these results build on the importance of our randomised clinical trial data assessing the effectiveness of treatments in a real-life setting. This also supports what we already know from our clinical development programmes that not all GLP-1 RAs are the same.”Beyond these essential benefits, once-weekly semaglutide was also associated with a 25% risk reduction of heart attack, stroke, hospitalisation for unstable angina or heart failure, and death from any cause (five-point MACE)1. Ozempic® is the only GLP-1 RA that has proven risk reduction of cardiovascular and kidney events in people with type 2 diabetes3-6. These results provide the first direct comparison of cardiovascular outcomes between Ozempic® and dulaglutide in US Medicare beneficiaries and add to the body of evidence for Ozempic®. About REACH REACH is a comprehensive series of studies assessing the cardiovascular disease-related outcomes of the once-weekly GLP-1 RA class, including semaglutide, compared to glucose-lowering therapies such as DPP4 inhibitors, SGLT2 inhibitors and others. It also includes within-class comparisons of GLP-1 RAs from multiple administrative claims and electronic health record databases. The study presented at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting is a real-world evidence analysis evaluating cardiovascular risk reduction with GLP-1 RAs – semaglutide and dulaglutide – in people with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD). This study draws from Medicare fee-for-service claims data, using a target-trial emulation framework, including 58,336 matched patients (29,168 patients in each treatment group) aged ≥66 years with type 2 diabetes and ASCVD who initiated once-weekly semaglutide or dulaglutide. Direct cardiovascular outcome comparisons between GLP-1 RAs are lacking. These results address a critical gap for insights, particularly in an older Medicare population with multiple comorbidities underrepresented in randomised clinical trials. About Ozempic®Ozempic® (semaglutide) injection 0.25 mg, 0.5 mg, 1.0 mg or 2.0 mg is a once-weekly GLP-1 RA indicated, along with diet and exercise, to improve blood sugar (glucose) in adults with type 2 diabetes and to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease. Ozempic® is the only GLP-1 RA indicated to reduce the risk of worsening kidney disease and risk of death from cardiovascular events in adults with type 2 diabetes and chronic kidney disease. Ozempic® is currently marketed in 72 countries, and 7 million people with type 2 diabetes are currently being treated with Ozempic® worldwide. Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289 globalmedia@novonordisk.com Liz Skrbkova (US) +1 609 917 0632 lzsk@novonordisk.com Investors: Jacob Martin Wiborg Rode +45 3075 5956 jrde@novonordisk.com Sina Meyer +45 3079 6656 azey@novonordisk.com Max Ung +45 3077 6414 mxun@novonordisk.com Christoffer Sho Togo Tullin +45 3079 1471 cftu@novonordisk.com Alex Bruce +45 34 44 26 13 axeu@novonordisk.com Frederik Taylor Pitter +1 609 613 0568 fptr@novonordisk.com _______________________References1. Tan M, et al. Late-breaking oral presentation presented at the European Association for the Study of Diabetes (EASD) 2025; Sep 15-19 2025; Vienna, Austria.2. Dai D, et al. Cancer Control. 2022;29:10732748221140691.3. Marso SP, et al. N Engl J Med. 2016;375:1834-1844.4. Perkovic V, et al. N Engl J Med. 2024;391:109-121.5. Ozempic® (once-weekly semaglutide): US Prescribing Information. 2025 [online]. Available at: https://www.novo-pi.com/ozempic.pdf Last accessed: September 2025.6. EMA. Ozempic® (once-weekly semaglutide) Summary of Product Characteristics. 2025 [online]. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/ozempic. Last accessed: September 2025.
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PR250918-EASD-REACH
– 89bio stockholders to receive up to $20.50 per share in cash, comprised of $14.50 per share in cash at closing and a non-tradeable contingent value right (CVR) to receive up to an aggregate of $6.00 per share in cash; transaction represents total equity value of up to approximately $3.5 billion – – Transaction reflects pegozafermin’s potential best-in-disease profile for the treatment of moderate to severe metabolic dysfunction-associated steatohepatitis (MASH) – – 89bio to join the Roche Group as part of Roche’s Pharmaceuticals Division – SAN FRANCISCO, Calif., Sept. 17, 2025 (GLOBE NEWSWIRE) — 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced that it has entered into a merger agreement to be acquired by Roche at a price of $14.50 per share in cash at closing, representing a premium of approximately 79% to 89bio’s closing stock price on September 17, 2025, the last trading day before the announcement of the transaction, and a premium of 52% to 89bio’s 60-day volume-weighted average price (VWAP). In addition, 89bio stockholders will receive a non-tradeable CVR to receive certain contingent payments of up to an aggregate of $6.00 per share in cash upon achievement of specified milestones, for a total transaction equity value of up to approximately $3.5 billion on a fully diluted basis. The merger agreement has been unanimously approved by 89bio’s Board of Directors, and 89bio’s Board of Directors unanimously recommends that 89bio stockholders tender their shares in the tender offer. “Our mission at 89bio has always been to develop innovative therapies to help patients with serious liver and cardiometabolic diseases, a commitment demonstrated by the strategic design and successful execution of the development program for pegozafermin over the years,” said Rohan Palekar, Chief Executive Officer of 89bio. “We are thrilled to be joining with Roche to combine the promise of pegozafermin with Roche’s established global development, manufacturing, and commercialization capabilities, to accelerate and maximize potential benefit for patients in need and unlock significant shareholder value. I am tremendously proud of the entire team at 89bio and would like to express my deepest thanks and gratitude to them, our Board, investigators, clinical trial participants, numerous vendors, and MASH and SHTG communities for helping us reach this pivotal moment.” “We are excited about this agreement and to further develop this promising therapy, which we hope will provide people with moderate to severe MASH a new treatment option,” said Boris L. Zaïtra, Head of Roche Corporate Business Development. “By adding pegozafermin to our cardiovascular, renal, and metabolism portfolio and with our Diagnostics expertise in cardiovascular and metabolic diseases, we are aiming to transform the standard of care and positively impact patients’ lives.” Transaction TermsUnder the terms of the merger agreement, an affiliate of Roche will commence a tender offer to acquire all of 89bio’s outstanding shares for a price of $14.50 per share in cash at closing, representing an aggregate payment of $2.4 billion. In addition, 89bio’s stockholders will receive a non-tradeable CVR to receive up to an aggregate of $6.00 per share in cash, for a total transaction equity value of up to approximately $3.5 billion on a fully diluted basis. Each non-tradeable CVR will entitle its holders to receive the following contingent cash payments, conditioned upon the achievement of certain milestones, within specified time periods: $2.00 per share in cash, upon the first commercial sale of pegozafermin in F4 MASH cirrhotic patients (by March 31, 2030)$1.50 per share in cash, upon pegozafermin reaching annual net sales globally of at least US $3.0 billion in any calendar year (by December 31, 2033)$2.50 per share in cash, upon pegozafermin reaching annual net sales globally of at least US $4.0 billion in any calendar year (by December 31, 2035) The closing of the transaction is subject to customary closing conditions, including the tender of shares representing at least a majority of 89bio’s outstanding shares (other than shares held by 89bio, Roche or any of their respective subsidiaries, and any dissenting shares), the completion of regulatory review and other customary closing conditions. Upon the successful completion of the tender offer, Roche will acquire all remaining 89bio shares that are not tendered into the tender offer through a second-step merger at the same price of $14.50 per share in cash at closing, plus a non-tradeable CVR to receive up to an aggregate of $6.00 per share in cash, payable upon achievement of the specified milestones. The closing of the transaction is currently expected to take place in the fourth quarter of 2025, subject to satisfaction of the closing conditions described above. Until that time, 89bio will continue to operate as a separate and independent company. Moelis & Company LLC and Centerview Partners LLC are serving as financial advisors to 89bio and Gibson, Dunn & Crutcher LLP is serving as legal counsel to 89bio. Citi is acting as financial advisor to Roche and Sidley Austin LLP is acting as legal counsel to Roche. About 89bio 89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The Company is in Phase 3 trials for its lead candidate, pegozafermin, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) with advanced fibrosis, including patients with compensated cirrhosis, and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The Company is headquartered in San Francisco. For more information, visit www.89bio.com or follow the Company on LinkedIn. Additional Information and Where to Find ItThe tender offer described in this communication has not yet commenced. This communication is for information purposes only and is neither an offer to buy nor a solicitation of an offer to sell any securities of 89bio, Inc. (“89bio”), nor is it a substitute for the tender offer materials that Roche Holdings, Inc. (“Roche”) and its wholly owned acquisition subsidiary, Bluefin Merger Subsidiary, Inc. (“Merger Sub”), will file with the Securities and Exchange Commission (the “SEC”). The solicitation and the offer to buy shares of 89bio’s common stock will only be made pursuant to a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and other related materials that Roche and Merger Sub intend to file with the SEC. In addition, 89bio will file with the SEC a Solicitation/ Recommendation Statement on Schedule 14D-9 with respect to the tender offer. Once filed, investors will be able to obtain the tender offer statement on Schedule TO, the offer to purchase, the Solicitation/Recommendation Statement of 89bio on Schedule 14D-9 and related materials with respect to the tender offer and merger, free of charge at the website of the SEC at www.sec.gov or from the information agent named in the tender offer materials. Investors may also obtain, at no charge, the documents filed with or furnished to the SEC by 89bio under the “Investors & Media” section of 89bio’s website at www.89bio.com. STOCKHOLDERS AND INVESTORS ARE STRONGLY ADVISED TO READ THESE DOCUMENTS WHEN THEY BECOME AVAILABLE, INCLUDING THE SOLICITATION/RECOMMENDATION STATEMENT OF 89BIO ON SCHEDULE 14D-9 AND ANY AMENDMENTS THERETO, AS WELL AS ANY OTHER DOCUMENTS RELATING TO THE TENDER OFFER AND THE MERGER THAT ARE FILED WITH THE SEC, CAREFULLY AND IN THEIR ENTIRETY PRIOR TO MAKING ANY DECISIONS WITH RESPECT TO WHETHER TO TENDER THEIR SHARES INTO THE TENDER OFFER BECAUSE THEY CONTAIN IMPORTANT INFORMATION, INCLUDING THE TERMS AND CONDITIONS OF THE TENDER OFFER. Forward-Looking StatementsCertain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding the ability to complete and the timing of completion of the transactions contemplated by the Agreement and Plan of Merger dated as of September 17, 2025 by and among 89bio, Roche and Merger Sub (the “Merger Agreement”), including the parties’ ability to satisfy the conditions to the consummation of the tender offer and the other conditions to the consummation of the subsequent merger set forth in the Merger Agreement, and the possibility of any termination of the Merger Agreement. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “anticipate,” “goal,” “opportunity,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While 89bio believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in 89bio’s filings with the Securities and Exchange Commission (SEC)), many of which are beyond 89bio’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: risks associated with the timing of the closing of the proposed transaction, including the risks that a condition to closing would not be satisfied within the expected timeframe or at all or that the closing of the proposed transaction will not occur; uncertainties as to how many of 89bio’s stockholders will tender their shares in the offer; the possibility that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the possibility that competing offers will be made; the occurrence of any event, change or other circumstance that could give rise to the termination of the transaction; the outcome of any legal proceedings that may be instituted against the parties and others related to the merger agreement; unanticipated difficulties or expenditures relating to the proposed transaction, the response of business partners and competitors to the announcement of the proposed transaction, and/or potential difficulties in employee retention as a result of the announcement and pendency of the proposed transaction; risks related to non-achievement of the CVR milestones and that holders of the CVRs will not receive payments in respect of the CVRs; and other risks and uncertainties identified in 89bio’s Annual Report on Form 10-K for the year ended December 31, 2024 and other subsequent disclosure documents filed with the SEC. 89bio claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. 89bio expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. Investor & Media Contacts: Ryan Martins89bio, Inc.ryan.martins@89bio.com Annie Chang89bio, Inc.investor@89bio.com Eva Bilange89bio, Inc.eva.bilange@89bio.com Sheryl SeapyReal Chemistrysseapy@realchemistry.com
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