Aspirin

– Data Further Advance Understanding of VASCEPA®/VAZKEPA® Potential Mechanism of Action and Utility as A Complementary Therapy for Residual Risk Reduction in Combination with Statins in Important Patient Sub-Categories –DUBLIN and BRIDGEWATER, N.J., March 31, 2025 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today highlighted key data presentations at ACC.25 showcasing the mechanistic activity of eicosapentaenoic acid (EPA) on lipoprotein(a) [Lp(a)]-enriched plasma and the effects of a glucagon-like peptide-1 (GLP-1) receptor agonist in combination with EPA on the expression of proteins in endothelial cells. “The data presented at ACC.25 continue to underscore the therapeutic value of icosapent ethyl (IPE) and EPA in potentially addressing known pathways of cardiovascular (CV) risk beyond LDL lowering for patients,” said R. Preston Mason, Ph.D., Brigham and Women’s Hospital. “While emerging therapeutic approaches are being explored to address residual CV risk, especially in patients with additional risk factors like obesity and elevated glucose levels, cardiovascular disease remains the world's leading cause of death and we cannot afford to wait. High-risk patients must be treated now, using proven therapies that have consistently demonstrated their ability to reduce CV risk—on top of the standard of care, including statins. We already have effective treatments available, and it is imperative that we utilize them to reduce patients’ CV risk and save lives today. These learnings further advance understanding of how EPA and VASCEPA/VAZKEPA may be working to reduce CV events in at-risk patients.” The key findings are outlined below: More Rapid Oxidation of Lipoprotein(a) [Lp(a)]-enriched Plasma Compared to Small Dense- and Triglyceride-rich Lipoproteins is Limited by Eicosapentaenoic Acid (EPA) In this analysis, researchers analyzed rates of oxidation for Lp(a)-enriched plasma to other atherogenic particles, including enriched small dense LDL (sdLDL), LDL, or triglyceride (TG)-rich lipoproteins (VLDL) with and without the introduction of EPA at a pharmacologic concentration. An elevated Lp(a) level is known to increase CV risk. New data from this analysis show that EPA dose-dependently inhibited oxidation in all lipoproteins tested, especially Lp(a) enriched human plasma. This is an important finding as the potent inhibition of Lp(a) oxidation by EPA may contribute to the benefit observed in REDUCE-IT, including in those subjects with elevated Lp(a) levels as recently reported in this publication. Addition of Eicosapentaenoic Acid (EPA) to a GLP-1 Agonist Enhanced Expression of Detoxification Proteins in Endothelial Cells During Inflammation In Vitro In this mechanistic analysis, researchers evaluated the separate versus combined effects of EPA and GLP-1 receptor agonist liraglutide on expression of proteins in endothelial cells. We know there is clear evidence backing the benefits of EPA in reducing cardiovascular events in at-risk patients. However, with emerging therapeutic approaches to address residual cardiovascular risk there is added value in exploring the combination of proven therapies, in this case EPA and GLP-1 receptor agonist, with complementary or additive protective mechanisms that may potentially play a role in further reducing cardiovascular risk on top of the statin therapy. The combination of EPA and GLP-1 receptor agonist favorably modulated the expression of proteins associated with detoxifying reactive oxygen species under disease-like conditions. Recent Data Published in JAHA: REDUCE-IT Analysis Shows Clear VASCEPA/ VAZKEPA Outcomes Benefit in Patients with Well-Controlled LDL-C A recent post hoc analysis of REDUCE-IT was published in the Journal of the American Heart Association this past month evaluating the impact of icosapent ethyl on top of statin therapy in reducing cardiovascular events in at-risk patients with various baseline LDL-C levels, including those with well-controlled LDL-C (<55 mg/dL). These findings showed cardiovascular risk reduction benefit consistent with the primary endpoint of the REDUCE-IT trial, which further reinforces the story around VASCEPA/VAZKEPA being a “complementary” therapy to current LDL-C lowering therapies. Additionally, these data point out that even when a patient has a very low LDL-C level (<55 mg/dL and down to 40 mg/dL), patients were still at risk and saw benefit from taking VAZKEPA, highlighting the need to go beyond LDL-C lowering for greater cardiovascular risk reduction. About Amarin Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world.   About REDUCE-IT® REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort). REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.1 The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.2 The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.3  About Cardiovascular Risk Cardiovascular disease is the number one cause of death in the world. In the United States alone, cardiovascular disease results in 859,000 deaths per year.4 And the number of deaths in the United States attributed to cardiovascular disease continues to rise. In addition, in the United States there are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds). Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. In aggregate, in the United States alone, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, 1 every 13 seconds. Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.5 Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.6,7,8 About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules VASCEPA (icosapent ethyl) capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk despite being on statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than twenty-five million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Australia, Lebanon, the United Arab Emirates, Saudi Arabia, Qatar, Bahrain, and Kuwait. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. In April 2021 marketing authorization for VAZKEPA (icosapent ethyl) was granted in Great Britain (applying to England, Scotland and Wales). VAZKEPA (icosapent ethyl) is currently approved and sold in Europe in Sweden, Finland, England/Wales, Spain, Netherlands, Scotland, Greece, Portugal, Italy and Denmark. United States Indications and Limitation of Use VASCEPA is indicated:   As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and   established cardiovascular disease or   diabetes mellitus and two or more additional risk factors for cardiovascular disease.   As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.   Important Safety Information   VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.   VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.   It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.   VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.   Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).   Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).   Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.   Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.   FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM. Europe   For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please click here. Globally, prescribing information varies; refer to the individual country product label for complete information. Forward-Looking Statements This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about the potential for VASCEPA (marketed as VAZKEPA in Europe); beliefs about icosapent ethyl (IPE)’s role concerning appropriate patients suffering from cardiovascular disease (CVD) and potential population health impact, as well as general beliefs about the safety and effectiveness of VASCEPA. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the full year ended 2024. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate. Availability of Other Information About Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (www.amarincorp.com/investor-relations), including but not limited to investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933. Amarin Contact InformationInvestor & Media Inquiries:Mark MarmurAmarin Corporation plcPR@amarincorp.com Investor.relations@amarincorp.com 1 Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.2 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22.3 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol. 2019;73:2791-2802.4 American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139-e596.5 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.6 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.7 Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.8 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563

- Received U.S. Food and Drug Administration (FDA) approval of Symvess™ (acellular tissue engineered vessel-tyod) for the treatment of extremity vascular trauma - - Commenced market launch and first commercial sales of Symvess - - Budget Impact Model for Symvess published in Journal of Medical Economics - - IND filing planned in 2025 to support first-in-human clinical study of small-diameter ATEV™ for coronary artery bypass grafting - - Conference call today at 8:30am ET - DURHAM, N.C., March 28, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced financial results for the fourth quarter and year ended December 31, 2024, and provided a business update. “The past year has been a landmark time for Humacyte, highlighted by the FDA’s approval of Symvess for the treatment of extremity vascular trauma,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “Symvess is a biologic product that went through more than 20 years of research and development, and we believe that this first-in-class approval marks an important new era in vascular surgery. We are thrilled to deliver this transformative innovation to surgeons and patients in need of a new option to save limbs and lives. Results from our clinical studies suggest that there are patients walking on their own legs today who would not be doing so if Symvess were not available.” “Our commercial launch of Symvess is proceeding at full speed and we are excited by the response to date from hospitals and healthcare providers,” continued Dr. Niklason. “So far the market has responded well, and 34 hospitals have already initiated the Value Analysis Committee (VAC) approval process. We are also excited that just 16 days after having the commercial inventory availability, we made our first shipments of Symvess. The potential health economic benefits of Symvess are supported by our Budget Impact Model that was just published in the Journal of Medical Economics, which concludes that the avoidance of vascular infections and amputations drive cost reduction with the use of Symvess in traumatic injury. Our commercial team will continue to work closely with health care providers to make Symvess available to patients in need nationwide.” Fourth Quarter, Year End 2024 and Recent Corporate Highlights Symvess FDA Approval and Market Launch FDA Approval: The FDA granted full approval for Symvess on December 19, 2024 for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.VAC Approval Process: Commencement of sales to hospitals for new products typically requires review and approval by a VAC, which is a centralized decision-making body within the institution. Thirty-four hospitals have already initiated the VAC approval process, with additional hospitals expected to commence the process in the near term. These hospitals are a mix of leading trauma centers that were participants in Humacyte clinical studies, combined with institutions that have been newly introduced to Symvess. VACs have been engaged from individual institutions, and from larger hospital networks, meaning that individual VAC approvals could apply to multiple hospitals. Although the VAC process often takes three to six months to complete, three hospitals have already approved the purchase of Symvess.First Commercial Sales: Humacyte commenced its commercial launch of Symvess in late February 2025 after the first commercial batch was released by the FDA. The first commercial shipments containing multiple units of Symvess were made last week to two Level 1 trauma centers.Economic Value of Symvess: The Company’s Budget Impact Model was published several weeks ago in the Journal of Medical Economics. Based on the model, the per-patient cost of treating patients with Symvess is estimated to be less than the cost of treating trauma patients with synthetic grafts, cryopreserved allografts, or xenografts. Major drivers of cost savings were attributed to reductions in the rate of amputation and vascular conduit infection.NTAP Reimbursement: In October 2024, Humacyte submitted a New Technology Add-On Payment (NTAP) application for Symvess to the Centers for Medicare and Medicaid Services (CMS). Humacyte presented the Symvess data at a public town hall with CMS in December 2024. If successful, NTAP reimbursement will begin on October 1, 2025, offering hospitals additional payment to cover a portion of the costs associated with purchasing Symvess.Manufacturing Patent: In January 2025, Humacyte was issued a new U.S. Patent covering key aspects of our biomanufacturing platform. The newly issued patent provides protection into 2040, and complements a family of existing patents and patent applications encompassing the design and composition of Symvess and Humacyte’s product candidates, and their methods of manufacture. ATEV Earlier Stage Pipeline and Corporate Updates V007 Results in Dialysis: Positive results from the V007 Phase 3 clinical trial of the ATEV in arteriovenous (AV) access for patients with end-stage renal disease were presented in October 2024 at the American Society of Nephrology’s (ASN) Kidney Week 2024. The Phase 3 study met the co-primary endpoints, and the ATEV was observed to have superior function and patency (blood flow) at 6 and 12 months compared to AV fistula, which is the current standard of care for hemodialysis patients. The ATEV was also observed to have superior function in female, obese, and diabetic patients, each of which is a high-need subgroup having historically poor outcomes with AV fistula.Planned Supplemental BLA in Dialysis: A total of 76 patients have been enrolled to date in the V012 Phase 3 trial, which is designed to assess the usability of the ATEV for dialysis in comparison to AV fistulas in female patients. An interim analysis is planned when the first 80 patients reach one-year of follow up. Subject to these interim results, Humacyte’s plan is to submit a supplemental BLA in the second half of 2026, that includes data from V012 and V007, to add AV access for hemodialysis as an indication for the ATEV.Planned IND Filing in CABG: Humacyte plans to file an Investigational New Drug (IND) application with the FDA to enable first-in-human clinical testing of the small-diameter (3.5mm) acellular tissue engineered vessel (sdATEV) in coronary artery bypass grafting (CABG). Results of a six-month preclinical study of the sdATEV in primates were presented in November 2024 at The American Heart Association’s Scientific Sessions 2024 meeting. In the preclinical CABG model, the sdATEV was observed to sustain patency, recellularized with the animals’ host cells, and remodel so as to match the size of the animals’ native coronary arteries. Fourth Quarter and Full Year 2024 Financial Highlights There was no revenue for the fourth quarter of 2024 and 2023, and there was no revenue for the years ended December 31, 2024 and 2023.Research and development expenses were $20.7 million for the fourth quarter of 2024, less than the $22.9 million incurred for the third quarter of 2024. The decrease in expenses compared to the prior quarter was primarily attributed to a reduction in materials expenses due to the timing of manufacturing runs. Research and development expenses for the fourth quarter of 2024 were $20.7 million, a slight increase compared to the $20.2 million incurred in the fourth quarter of 2023. Research and development expenses were $88.6 million for the year ended December 31, 2024, compared to $76.6 million for the year ended December 31, 2023. The increase in expenses during the year ended December 31, 2024 resulted primarily from increased materials expense associated with manufacturing runs and personnel expenses. These increases supported expanded research and development initiatives and clinical trials, including the expansion of manufacturing activities and support of the FDA review of the BLA in extremity vascular trauma.General and administrative expenses were $7.4 million for the fourth quarter of 2024, consistent with the $7.3 million incurred for the third quarter of 2024. General and administrative expenses were $7.4 million for the fourth quarter of 2024 compared to $6.0 million for the fourth quarter of 2023, and were $25.8 million for the year ended December 31, 2024 compared to $23.5 million for the year ended December 31, 2023. The increases during 2024 resulted primarily from preparation for the planned commercial launch of Symvess, including increases in personnel expenses and professional fees. These increases were partially offset by a decrease in non-cash stock compensation expense during 2024.Other net income (expense) was net income of $7.1 million for the fourth quarter of 2024, compared to net expense of $9.0 million for the third quarter of 2024. The increase in other net income compared to the prior quarter was due to the non-cash remeasurement of the contingent earnout liability associated with the Company’s 2021 merger with Alpha Healthcare Acquisition Corp. Other net income for the fourth quarter of 2024 was $7.1 million compared to other net income of $1.1 million for the fourth quarter of 2023, and other net expense of $34.3 million for the year ended December 31, 2024 compared to net expense of $10.7 million for the year ended December 31, 2023. The increase in other net income during the fourth quarter of 2024 compared to 2023, and the increase in other net expense during the year ended December 31, 2024 compared to 2023, resulted primarily from non-cash remeasurements of the contingent earnout liability.Net loss was $20.9 million for the fourth quarter of 2024, compared to $39.2 million for the third quarter of 2024 and to $25.1 million for the fourth quarter of 2023. The decreases in net loss for the fourth quarter of 2024 compared to the prior quarter and to the fourth quarter of 2023 resulted from the non-cash remeasurement of the contingent earnout liability described above. Net loss was $148.7 million for the year ended December 31, 2024 compared to $110.8 million for the year ended December 31, 2023. The year-over-year increase in net loss in 2024 compared to 2023 resulted from the non-cash remeasurement of the contingent earnout liability and operating expense increases, both described above.The Company reported cash, cash equivalents and restricted cash of $95.3 million as of December 31, 2024. Subsequent to December 31, 2024, in March 2025 the Company completed an underwritten public offering of common stock which provided approximately $46.6 million in net proceeds, with the potential for another $7.1 million in net proceeds subject to an underwriter option that is exercisable before April 26, 2025. Total net cash provided was $14.5 million for the year ended December 31, 2024, compared to total net cash used of $69.0 million for the year ended December 31, 2023. The increase in net cash provided resulted primarily from the receipt of approximately $43.0 million in net proceeds from an underwritten public offering of common stock in March 2024, $43.1 million in net proceeds from two registered direct offerings of common stock and warrants completed in October and November 2024, and $20 million in proceeds from an additional draw under Humacyte’s funding arrangement with Oberland Capital Management. Conference Call and Webcast Details Title:Humacyte Fourth Quarter and Full Year 2024 Financial Results and Corporate UpdateDate:March 28, 2025Time:8:30 AM Eastern TimeConference Call Details:1-877-704-4453 (U.S. Investors Dial)1-201-389-0920 (International Investors Dial)13751524 (Conference ID)Call meTM Feature: Click HereWebcast:Click Here A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the investors section of the Company’s website for at least 30 days. INDICATION Symvess is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible. IMPORTANT SAFETY INFORMATION BOXED WARNING: GRAFT FAILURE Loss of Symvess integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage. CONTRAINDICATIONS DO NOT use Symvess in patients who have a medical condition that would preclude long-term antiplatelet therapy (such as aspirin or clopidogrel) after resolution of acute injuries. WARNINGS AND PRECAUTIONS Graft Rupture Vascular graft rupture has occurred in patients treated with Symvess. Advise patients that arterial bleeding can be life-threatening and to seek emergent medical evaluation for any signs or symptoms of graft rupture such as bleeding, pain and swelling in the extremity, or signs of extremity ischemia. Anastomotic Failure Anastomotic failure has occurred in patients treated with Symvess. In clinical studies of Symvess, anastomotic failure occurred within the first 36 days post-implantation. Monitor patients for signs of anastomotic failure such as pain and swelling at the surgical site, decreasing hemoglobin or other signs and symptoms of bleeding. Advise patients to seek urgent medical evaluation if they have any signs or symptoms that may be indicative of anastomotic failure such as bleeding, swelling or worsening pain at the surgical site or changes in color of overlying skin. Thrombosis Thrombosis has occurred in patients treated with Symvess. In clinical trials of Symvess, patients received antiplatelet therapy following implantation of Symvess to reduce the risk of thrombosis. The risk of thrombosis may increase in patients who discontinue antiplatelet therapy. Anti-platelet therapy is recommended following treatment with Symvess. Transmission of Infectious Diseases Symvess is manufactured using cells and reagents that may transmit infectious diseases or infectious agents. The cells used in the manufacture of Symvess are derived from a donor who met the donor eligibility requirements for transmissible infectious diseases which includes screening and testing of risks associated with human immunodeficiency virus 1 (HIV-1), human immunodeficiency virus 2 (HIV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis (Treponema pallidum). The cell banks are tested negative for human and animal viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma. While all animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use, these measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Fetal bovine serum is sourced to minimize the risk of transmitting a prion protein that causes bovine spongiform encephalopathy and the cause of a rare fatal condition in humans called variant Creutzfeldt-Jakob disease. No transmissible agent infections have been reported during clinical testing. ADVERSE REACTIONS The most common adverse reactions (occurring at ≥ 10%), were vascular graft thrombosis, pyrexia (fever) and pain. Please see full Prescribing Information at www.symvess.com, including Boxed Warning, for Symvess. 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 the vascular trauma indication 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 our ATEV in the United States under the brand name Symvess in vascular trauma repair; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our ATEVs; our ability to successfully complete preclinical and clinical trials for our ATEVs; the anticipated benefits of the ATEV relative to existing alternatives; the anticipated commercialization of our ATEVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for 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, and/or competitive 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, 2023, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, 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 Humacyte, Inc.Condensed Consolidated Statements of Operations and Comprehensive Loss(unaudited)(in thousands except for share and per share amounts) Three Months EndedDecember 31, Year EndedDecember 31, 2024 2023 2024 2023 Revenue$ — $ — $ — $ — Operating expenses: Research and development 20,656 20,180 88,599 76,550 General and administrative 7,432 6,002 25,799 23,497 Total operating expenses 28,088 26,182 114,398 100,047 Loss from operations (28,088) (26,182) (114,398) (100,047) Other income (expense), net Change in fair value of contingent earnout liability 5,608 1,685 (33,045) (10,023)Other income (expense) (net) 1,540 (609) (1,258) (706)Total other income (expense), net 7,148 1,076 (34,303) (10,729)Net loss and comprehensive loss$ (20,940) $ (25,106) $ (148,701) $ (110,776) Net loss per share, basic and diluted$ (0.16) $ (0.24) $ (1.26) $ (1.07)Weighted-average shares outstanding, basic and diluted 126,983,464 103,607,631 118,479,097 103,420,238 Humacyte, Inc.Condensed Consolidated Balance Sheets(unaudited)(in thousands) As of December 31, 2024 2023 Assets Current assets: Cash and cash equivalents$ 44,937 $ 80,448 Prepaid expenses and other current assets 2,922 2,830 Total current assets 47,859 83,278 Restricted cash 50,209 209 Property, plant and equipment, net 23,063 26,791 Finance lease right-of-use assets, net 15,490 17,313 Other long-term assets 1,251 632 Total assets $ 137,872 $ 128,223 Liabilities and Stockholders’ Equity (Deficit) Current liabilities: Accounts payable$ 4,490 $ 6,490 Accrued expenses 11,424 9,340 Other current liabilities 4,040 2,613 Total current liabilities 19,954 18,443 Contingent earnout liability 70,961 37,916 Revenue interest liability 63,354 38,600 Common stock warrant liabilities 19,254 78 Finance lease obligation, net of current portion 13,620 16,293 Other long-term liabilities 3,398 3,347 Total liabilities 190,541 114,677 Stockholders’ equity (deficit) Common stock and additional paid-in capital 633,346 550,860 Accumulated deficit (686,015) (537,314)Total stockholders’ equity (deficit) (52,669) 13,546 Total liabilities and stockholders’ equity (deficit)$ 137,872 $ 128,223