Financial

Tenax Therapeutics Provides Business and Clinical Development Updates with Full Year 2023 Financial Results

CHAPEL HILL, N.C., March 28, 2024 (GLOBE NEWSWIRE) — Tenax Therapeutics, Inc. (Nasdaq: TENX), a Phase 3, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, announced full year 2023 financial results, and provided clinical development and business updates.

Shockwave Medical to Participate in the 23rd Annual Needham Virtual Healthcare Conference

SANTA CLARA, Calif., March 26, 2024 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (Nasdaq: SWAV), a pioneer in the development and commercialization of transformational technologies for the treatment of cardiovascular disease, announced today that the company will be participating in the 23rd Annual Needham Virtual Healthcare Conference, which is being held virtually from Monday, April 8 to Thursday, April 11, 2024. Shockwave’s management is scheduled for a live fireside chat on Tuesday, April 9, 2024, at 8:45 a.m. Eastern Time. Interested parties may access a live and archived webcast of the event on the “Investors” section of the company’s website at: https://ir.shockwavemedical.com. About Shockwave Medical, Inc. Shockwave Medical is a leader in the development and commercialization of innovative products that are transforming the treatment of cardiovascular disease. Its first-of-its-kind Intravascular Lithotripsy (IVL) technology has transformed the treatment of atherosclerotic cardiovascular disease by safely using sonic pressure waves to disrupt challenging calcified plaque, resulting in significantly improved patient outcomes. Shockwave has also recently acquired the Reducer, which is under clinical investigation in the United States and is CE Marked in Europe. By redistributing blood flow within the heart, the Reducer is designed to provide relief to the millions of patients worldwide suffering from refractory angina. Learn more at www.shockwavemedical.com. Media Contact:Scott Shadiowsshadiow@shockwavemedical.com Investor Contact:Debbie Kasterdkaster@shockwavemedical.com

Orchestra BioMed Announces Appointment of Medical Device Industry Expert David Pacitti to Board of Directors

David Pacitti is currently the President of Siemens Medical Solutions USA, Inc. and Head of the Americas, Siemens Healthineers; formerly Division Vice President of U.S. Commercial Operations, Sales, and Marketing at Abbott VascularMr. Pacitti brings nearly 30 years of experience in cardiovascular device and procedural imaging experience to the Orchestra BioMed Board of Directors after previously serving as a strategic advisor during the formation of the company NEW HOPE, Pa., March 26, 2024 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the appointment of David Pacitti to its Board of Directors, effective as of March 26, 2024. Mr. Pacitti is currently the President of Siemens Medical Solutions USA, Inc. and Head of the Americas, Siemens Healthineers. Prior to joining Siemens Healthineers, he was Division Vice President of U.S. Commercial Operations, Sales, and Marketing at Abbott Vascular, overseeing the company’s business in North America. As a member of the Senior Executive Staff, he worked with the CEO, CFO, and Research & Development team on business development initiatives and played pivotal roles in key launches, including Abbott Vascular’s first drug-eluting stent and structural heart franchise. “It’s an honor to welcome Dave to the Orchestra BioMed Board where we expect to benefit from his wealth of experience in driving the adoption of transformational device therapies and procedural imaging modalities,” said David Hochman, chairman, chief executive officer and founder of Orchestra BioMed. “Dave is a big thinker who believes in the power of partnerships and novel, out-of-the-box strategic collaboration to bring new technologies to patients, improve healthcare delivery and drive better outcomes. His extensive experience and broad network in interventional cardiology and cardiac rhythm management will add further strength to our knowledge and connections in those large, established markets that are core to our current pipeline. Having previously served as a strategic advisor, Dave is familiar with our strategy, differentiated business model and pipeline. We believe he can help guide the work we are doing with our existing programs and partnerships while also helping us identify and execute on new opportunities to leverage our partnership-enabled business model.” Mr. Pacitti commented, “I am thrilled to join the Orchestra BioMed Board and continue working with what I know to be an exceptional leadership team. AVIM therapy and Virtue SAB represent the kind of high-impact, transformational device-based therapies that I have helped commercialize my entire career. Moreover, I believe the Company’s novel, partnership driven business model, exemplified by the strategic collaborations in place with Medtronic and Terumo, is timely and necessary in an increasingly difficult environment for medical device innovation. I look forward to contributing my perspective to help Orchestra BioMed realize the full potential of its cardiovascular pipeline, strategic partnerships and differentiated business model.” About Orchestra BioMedOrchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is atrioventricular interval modulation (AVIM) therapy (also known as BackBeat Cardiac Neuromodulation Therapy (CNT™)) for the treatment of hypertension, a significant risk factor for death worldwide. Orchestra BioMed is also developing Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. Orchestra BioMed has additional product candidates and plans to potentially expand its product pipeline through acquisitions, strategic collaborations, licensing and organic development. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. References to Websites and Social Media Platforms References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the potential efficacy and safety of the Company’s commercial product candidates, the ability of the Company’s partnerships to accelerate clinical development, and the Company’s late-stage development programs, strategic partnerships and plans to expand its product pipeline. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve, expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission on May 12, 2023, as updated by any risk factors disclosed under the heading “Item 1A. Risk Factors” in the Company’s subsequently filed quarterly reports on Form 10-Q, as well as the risk factors that will be included in the Company’s annual report on Form 10-K for the year ended December 31, 2023, which is expected to be filed with the SEC on March 27, 2024. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor Contact:Bob YedidLifeSci Advisors(516) 428-8577Bob@lifesciadvisors.com Media Contact:Kelsey Kirk-EllisOrchestra BioMed(484) 682-4892Kkirkellis@orchestrabiomed.com

Protembis Announces Completion of € 30 Million Series B Financing Round and the Addition of Keith D Dawkins MD to the Board of Directors

AACHEN, Germany–(BUSINESS WIRE)– #CerebralProtection–Protembis GmbH (Protembis), a privately-held emerging cardiovascular medical device company, announced today the completion of a € 30 million Series B financing round to support the enrollment of the PROTEMBO Investigational Device Exemption (IDE) Pivotal Trial (NCT05873816). The funding round was structured in two separate capital increases which have both been completed. It was co-led by a European consortium of VC investors including Sweden-based Segulah Med

Novo Nordisk to acquire Cardior Pharmaceuticals and strengthen pipeline in cardiovascular disease

Bagsværd, Denmark, and Hannover, Germany, 25 March, 2024 – Novo Nordisk and Cardior Pharmaceuticals today announced that Novo Nordisk has agreed to acquire Cardior for up to 1.025 billion Euros, including an upfront payment and additional payments if certain development and commercial milestones are achieved. Cardior is a leader in the discovery and development of therapies that target RNA as a means to prevent, repair and reverse diseases of the heart. The company’s therapeutic approach targets distinctive non-coding RNAs as a platform for addressing root causes of cardiac dysfunctions with an aim to achieve lasting patient impact. The agreement includes Cardior’s lead compound CDR132L, currently in phase 2 clinical development for the treatment of heart failure. The acquisition is an important step forward in Novo Nordisk’s strategy to establish a presence in cardiovascular disease. Novo Nordisk aims to build a focused, impactful portfolio of therapies through internal and external innovation to address the significant unmet needs that still exist within cardiovascular disease, the most common cause of death globally. “By welcoming Cardior as a part of Novo Nordisk, we will strengthen our pipeline of projects in cardiovascular disease where we already have ongoing programmes across all phases of clinical development,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “We have been impressed by the scientific work carried out by the Cardior team, especially on CDR132L, which has a distinctive mode of action and potential to become a first-in-class therapy designed to halt or partially reverse the course of disease for people living with heart failure.” CDR132L is designed to halt and partially reverse cellular pathology by selectively blocking abnormal levels of the microRNA molecule miR-132, potentially leading to long-lasting improvement in heart function. In a phase 1b trial published in the European Heart Journal1, CDR132L was reported to be safe and well tolerated and the results suggested cardiac functional improvements in people with heart failure compared to placebo. CDR132L is currently being investigated in the phase 2 trial HF-REVERT in 280 people with heart failure with reduced ejection fraction (HFrEF) who have previously suffered a heart attack (myocardial infarction). The first patient was dosed in the HF-REVERT trial in July 2022. Novo Nordisk plans to initiate a second phase 2 trial that will investigate CDR132L in a chronic heart failure population with cardiac hypertrophy – a condition that causes the walls of the heart muscle to become thick and stiff, affecting the heart’s ability to pump blood. “This acquisition is a reflection of CDR132L’s transformative potential as a disease-modifying therapy for heart failure,” said Claudia Ulbrich, MD, CEO and co-founder of Cardior. “Novo Nordisk is the ideal partner based on its deep clinical and commercial expertise combined with its resources to accelerate our late-stage development programme, including through larger registrational studies. We look forward to advancing CDR132L towards market approval.” The closing of the acquisition is subject to receipt of applicable regulatory approvals and other customary conditions and is expected to happen in the second quarter of 2024. The transaction will not impact Novo Nordisk’s previously communicated operating profit outlook for 2024 or the ongoing share buy-back programme. Novo Nordisk will fund the acquisition from financial reserves. About heart failure Heart failure is a chronic, progressive condition in which the heart muscle is unable to pump enough blood to meet the body’s needs for blood and oxygen. The condition leads to frequent hospitalisations, and more than half of people diagnosed with heart failure die within five years2. Heart failure affects more than 65 million people globally and is most commonly caused by heart conditions such as ischaemic heart disease, cardiomyopathy or high blood pressure3. The condition cannot be cured. Current therapies can slow but not halt disease progression4, and morbidity and mortality remain high5. About Cardior’s approachCardior works to identify and counteract the molecular mechanisms of the broad area of ischaemic-induced heart failure as well as specific cardiac diseases such as hypertrophic and dilated cardiomyopathies. Cardior primarily seeks to advance a novel class of antisense oligonucleotides (ASOs) targeting so-called non-coding RNAs (ncRNAs) that are able to act on several key disease pathways simultaneously, triggering a concerted therapeutic effect against key hallmarks of heart disease, including cardiac hypertrophy, fibrosis, impaired contractility and reduced vascularization. Although ncRNAs are not translated into proteins, they are important for the regulation of critical cellular processes and their dysregulation is a hallmark of many diseases. With its deep knowledge in RNA biology, Cardior is developing a clinically-oriented approach to restore normal levels and functions of these key players in the pathological processes of cardiac diseases. About Novo NordiskNovo 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 63,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube. About CardiorCardior Pharmaceuticals is a leading clinical-stage biopharmaceutical company pioneering the discovery and development of RNA-based therapeutics designed to prevent, repair and reverse diseases of the heart. Cardior’s therapeutic approach uses distinctive non-coding RNAs as an innovative platform for addressing the root causes of cardiac dysfunctions. The company aspires to bring transformative therapeutics and diagnostics to patients and thereby make a lasting impact on the treatment of cardiac diseases worldwide. Contacts for further information Media: Ambre James-Brown+45 3079 9289abmo@novonordisk.com Liz Skrbkova (US) +1 609 917 0632 lzsk@novonordisk.comInvestors: Daniel Muusmann Bohsen+45 3075 2175 dabo@novonordisk.comJacob Martin Wiborg Rode+45 3075 5956jrde@novonordisk.comDavid Heiberg Landsted +45 3077 6915 dhel@novonordisk.comMark Joseph Root (US) +1 848 213 3219mjhr@novonordisk.comSina Meyer +45 3079 6656azey@novonordisk.comFrederik Taylor Pitter +45 3075 8259fptr@novonordisk.comCardior media Trophic CommunicationsStephanie May+49 171 1855682may@trophic.eu  1 Täubel J et al. European Heart Journal 2021 Jan 7;42(2):178-188 Novel antisense therapy targeting microRNA-132 in patients with heart failure: results of a first-in-human Phase 1b randomized, double-blind, placebo-controlled study – PubMed (nih.gov) 2 Jones NR et al. European Journal of Heart Failure 2019 Nov; 21(11): 1306–1325 Survival of patients with chronic heart failure in the community: a systematic review and meta‐analysis – PMC (nih.gov) 3 Bragazzi NL et al. Preventive Cardiology 2021;28(15):1682-1690 Burden of heart failure and underlying causes in 195 countries and territories from 1990 to 2017 – PubMed (nih.gov) 4 McDonagh TA et al. European Heart Journal 2021 Sep 21;42(36):3599-3726 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure – PubMed (nih.gov) 5 Savarese G, Lund LH. Cardiac Failure Review. 2017;03(01):7-11 Global Public Health Burden of Heart Failure – PubMed (nih.gov)
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Humacyte Fourth Quarter and Year End 2023 Financial Results and Business Update

-Biologics License Application (BLA) for HAV™ Accepted by FDA on February 8, 2024- -BLA Granted Priority Review for Vascular Trauma Indication; PDUFA date set for August 10, 2024- -Raised approximately $43.1 million in net proceeds from public offering of common stock- -Conference call and live webcast at 8:00 a.m. ET today- DURHAM, N.C., March 22, 2024 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced financial results for the fourth quarter and year ended December 31, 2023 and highlighted recent corporate accomplishments in advancing the investigational Human Acellular Vessel (HAV) closer to planned U.S. market launch. “During 2023, we accomplished major goals across all of our clinical programs. In December 2023, we submitted our Biologics License Application (BLA) to the Food and Drug Administration (FDA) seeking approval of the HAV in the vascular trauma indication,” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. “The FDA’s acceptance of our filing in February 2024 brings us another major step closer to our goal of providing an innovative regenerative medicine product for patients suffering traumatic vascular injury. We believe the FDA’s decision to grant Priority Review reflects their recognition that many patients with severe injuries are underserved by the current standard of care. We look forward to working with the agency toward their Prescription Drug User Fee Act (PDUFA) date of August 10, 2024.” “During the year we were also pleased with the progress made in our broader HAV pipeline, including completion of enrollment of our V007 Phase 3 trial of the HAV for use in AV access for hemodialysis, presentation and publication of clinical trial results in severe peripheral artery disease (PAD), and publication of preclinical results for our small caliber HAV in a juvenile heart disease preclinical model. The coming year will be exciting, and we thank the medical professionals, patients, researchers and our employees for their contributions to the continued advancement of the HAV,” concluded Dr. Niklason. Fourth Quarter 2023 and Recent Corporate Highlights Clinical and Regulatory Updates Biologics License Application for HAV Granted Priority Review by U.S. FDA for the Vascular Trauma Indication – In February 2024, the Company announced that the FDA had accepted and granted Priority Review to its BLA seeking approval of the HAV in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible. The BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial, as well as real-world evidence from the treatment of wartime injuries in Ukraine under a humanitarian aid program. The HAV was observed to have higher rates of patency (blood flow), and lower rates of amputation and infection, as compared to historic synthetic graft benchmarks in both the V005 Phase 2/3 clinical trial and the Ukraine humanitarian program.The PDUFA date, the FDA action date for their regulatory decision regarding the BLA, is August 10, 2024. The Priority Review designation is a mechanism reserved by FDA for products that, if approved, would significantly improve the treatment, diagnosis, or prevention of serious conditions. Priority Review applications have a six-month review time instead of ten months for a standard review. The Priority Review aligns with the Regenerative Medicine Advanced Therapy (RMAT) designation granted by the FDA in May 2023 for urgent arterial repair following extremity vascular trauma. The Priority Review is also consistent with the priority designation given by the Secretary of Defense under Public Law 115-92, which was enacted to expedite the FDA’s review of products that are intended to diagnose, treat or prevent serious or life-threatening conditions facing American military personnel. Presentations and Publications Presentations at a Major Vascular Surgery Symposium – Two presentations were made at the VEITH Symposium, a major vascular surgery meeting, held in New York City on November 15-18, 2023. These include an expanded presentation of positive results of the V005 vascular trauma trial, with the HAV observed to have higher rates of patency and lower rates of amputation and infection as compared to historic synthetic graft benchmarks.Results of the V005 trial were presented by Charles J. Fox, MD, FACS, Director of Vascular Surgery at the University of Maryland Capital Region, a clinical investigator in the V005 trial, in a podium presentation titled “Phase 2/3 Study for the Evaluation of Safety and Efficacy of HAV for Vascular Reconstruction in Patients with Limb or Life-Threatening Vascular Trauma.” Results from V005 and the Ukraine humanitarian program, with statistical comparison to historic benchmarks, were presented at a symposium titled “Vascular Trauma Repair Clinical Study Results with Humacyte Human Acellular Vessel (V005 & V017 Data)” by Dr. Moore, Dr. Fox, and Laura Niklason, MD, PhD, Chief Executive Officer of Humacyte. Publication of Preclinical Results in Juvenile Heart Disease Study – In October 2023, a publication in the Journal of Thoracic and Cardiovascular Surgery described a preclinical study showing the potential for the investigational small-diameter HAV to treat tetralogy of Fallot, a heart condition that affects one in every 2,000 babies born each year in the United States. In the preclinical study, researchers from Nationwide Children’s Hospital (Columbus, OH) and Humacyte implanted 3.5mm diameter HAVs into a juvenile animal model of pediatric heart disease. The 3.5mm HAVs remained patent for up to six months, and evidence of HAV repopulation by host cells was observed, similar to what has been observed in human patients. In connection with the study, Humacyte produced 3.5mm vessels using the same manufacturing platform used to produce Humacyte’s 6mm HAVs that are in current clinical use. The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agencies. Fourth Quarter and Full Year 2023 Financial Highlights The Company reported cash and cash equivalents of $80.4 million as of December 31, 2023. In addition, Humacyte completed two transactions in early 2024 which added to its cash balance. On March 5, 2024, the Company closed an underwritten public offering of its common stock and raised net proceeds of approximately $43.1 million. Furthermore, on March 11, 2024, the Company received $20 million in proceeds from an additional draw under its previously disclosed funding arrangement with Oberland Capital Management. Total net cash used was $69.0 million for the year ended December 31, 2023, compared to $67.7 million for the year ended December 31, 2022. Humacyte believes that its cash and cash equivalents, including net proceeds from the March offering and additional draw under the Oberland funding arrangement, will be adequate to finance operations for at least 12 months from the date of this financial report, well past the currently anticipated timelines for FDA approval of commercialization of the HAV in the vascular trauma indication. There was no revenue for either the fourth quarter of 2023 or the fourth quarter of 2022, and there was no revenue for the year ended December 31, 2023. Revenue was $1.6 million for the year ended December 31, 2022, and was related to a grant supporting the development of the HAV that was completed during 2022. Research and development expenses were $20.2 million for the fourth quarter of 2023, compared to $15.0 million for the fourth quarter of 2022, and were $76.6 million for the year ended December 31, 2023, compared to $63.3 million for the year ended December 31, 2022. The 2023 increases resulted primarily from increased personnel, external services expenses and materials expenses to support expanded research and development initiatives and our clinical trials, including the completion of our V005 Phase 2/3 and V017 Ukraine Humanitarian trials for the use of the HAV in extremity vascular trauma, our BLA filing in December 2023, and expansion of clinical development of the HAV for use in AV access for hemodialysis. General and administrative expenses were $6.0 million for the fourth quarter of 2023, compared to $5.8 million for the fourth quarter of 2022, and were $23.5 million for the year ended December 31, 2023, compared to $22.9 million for the year ended December 31, 2022. The slight net increases in 2023 resulted primarily from increased personnel costs, primarily driven by preparation for the planned commercial launch of the HAV in the vascular trauma indication. Other net income (expense) was net income of $1.1 million for the fourth quarter of 2023, compared to net income of $17.1 million for the fourth quarter of 2022, and was net expense of $10.7 million for the year ended December 31, 2023, compared to net income of $72.6 million for the year ended December 31, 2022. The reduction in other net income for the fourth quarter of 2023, and the increase in other net expense for the year December 31, 2023, resulted primarily from the non-cash remeasurement of the contingent earnout liability associated with the August 2021 merger with Alpha Healthcare Acquisition Corp. Net loss was $25.1 million for the fourth quarter of 2023, compared to $3.7 million for the fourth quarter of 2022, and net loss was $110.8 million for the year ended December 31, 2023, compared to $12.0 million for the year ended December 31, 2022. The 2023 increases in net loss resulted from the non-cash remeasurement of the contingent earnout liability, and operating expense increases, described above. Conference Call and Webcast Details Title:Humacyte Fourth Quarter and Year End 2023 Financial Results and Corporate UpdateDate:Friday, March 22, 2024Time:8:00 a.m. ETConference Call Details:Toll-Free: 1- 877-704-4453International: 1-201-389-0920Conference ID #: 13744046Call meTM Feature (avoid waiting for operator):Click HereWebcast:Webcast Link – 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. 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 initial opportunity, a portfolio of HAVs, is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, AV access for hemodialysis, and peripheral arterial disease. 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 HAV 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 HAV for urgent arterial repair following extremity vascular trauma also has received an RMAT designation. The HAV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. 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, statements regarding our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our plans and ability to obtain marketing approval from the FDA and other regulatory authorities for the HAV and other product candidates; the outcome of the FDA’s review of our BLA seeking approval of the HAV in the vascular trauma indication; 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, including for our V007 Phase 3 clinical trial; the characteristics and performance of the HAV; our ability to manufacture HAVs and other product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; our plans and ability to commercialize the HAV and other product candidates, if approved by regulatory authorities; and our anticipated cash runway. 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, 2022 and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, 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,  2023   2022   2023   2022 Grant revenue$—  $—  $—  $1,565         Operating expenses:       Research and development 20,180   14,957   76,550   63,260 General and administrative 6,002   5,833   23,497   22,883 Total operating expenses 26,182   20,790   100,047   86,143 Loss from operations  (26,182)  (20,790)  (100,047)  (84,578)        Other income (expense), net       Change in fair value of contingent earnout liability 1,685   17,118   (10,023)  75,767 Other expense (net) (609)  (48)  (706)  (3,154)Total other income (expense), net 1,076   17,070   (10,729)  72,613 Net loss and comprehensive loss$(25,106) $(3,720) $(110,776) $(11,965)        Net loss per share, basic and diluted$(0.24) $(0.04) $(1.07) $(0.12)Weighted-average shares outstanding, basic and diluted 103,607,631   103,162,219   103,420,238   103,051,366  Humacyte, Inc. Condensed Consolidated Balance Sheets (unaudited) (in thousands)  As of December 31,  2023   2022 Assets   Current assets:   Cash and cash equivalents$80,448  $149,772 Prepaid expenses and other current assets 2,830   2,329 Short-term investments —   2,107 Total current assets 83,278   154,208 Property, plant and equipment, net 26,791   30,039 Finance lease right-of-use assets, net 17,313   19,373 Other long-term assets 841   682 Total assets $128,223  $204,302     Liabilities and Stockholders’ Equity   Current liabilities:   Accounts payable$6,490  $1,595 Accrued expenses 9,340   7,108 Other current liabilities 2,613   2,306 SVB loan payable, current portion —   8,571 Total current liabilities 18,443   19,580     Revenue interest liability 38,600   — Contingent earnout liability 37,916   27,893 Finance lease obligation, net of current portion 16,293   18,853 Other long-term liabilities 3,425   712 SVB loan payable, net of current portion —   20,336 Total liabilities  114,677   87,374     Stockholders’ equity   Common stock and additional paid-in capital 550,860   543,466 Accumulated deficit (537,314)  (426,538)Total stockholders’ equity 13,546   116,928 Total liabilities and stockholders’ equity$128,223  $204,302 

Milestone Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Regulatory and Corporate Update

– On track to resubmit NDA for etripamil in PSVT early 2Q 2024 – Recent financing extends cash runway into 2026 – FDA reiterated prior guidance on regulatory pathway for AFib-RVR, End of Phase 2 Meeting expected mid-2024 MONTREAL and CHARLOTTE, N.C., March 21, 2024 (GLOBE NEWSWIRE) —  Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a regulatory and corporate update. “We look forward to resubmitting our NDA imminently. With the completion of our recent financing and potential future synthetic royalty payment, we believe we are well positioned to advance etripamil through potential approval and launch in PSVT,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “We’re excited to continue this positive momentum as we execute on our programs and advance etripamil.” Corporate Updates In March 2024, completed a public offering of common shares and pre-funded warrants, raising net proceeds of approximately $32.4 million. Milestone intends to use the proceeds from the Offering to continue the development of etripamil in its lead indication of paroxysmal supraventricular tachycardia (PSVT) and its subsequent indication of atrial fibrillation with a rapid ventricular rate (AFib-RVR), as well as for working capital and other general corporate purposes. Recent Program Updates Etripamil for Patients with PSVT Announced Plans to Resubmit New Drug Application (NDA) for Etripamil for PSVT in early 2Q 2024. Milestone held a Type A meeting with the FDA in February 2024 regarding steps required to resolve the items raised in the Refusal to File (RTF) letter received in December 2023. The Company is working to restructure the data sets that capture timing of reported adverse events (AEs) in the clinical etripamil studies and is reformatting certain data files to facilitate FDA’s analyses. The Company expects a standard NDA review period following resubmission of the NDA. Etripamil for Patients with AFib-RVR Phase 3 guidance received from FDA in 1Q2024 meeting. FDA reiterated prior guidance regarding the availability of a single-study supplemental New Drug Application (sNDA) pathway contingent on obtaining approval for the NDA in PSVT. FDA further concurred with respect to key study elements including powering, inclusion criteria, patient population, and statistical analyses, and offered clarification with respect to the endpoints to guide the design of the Phase 3 study. We anticipate progressing to an End of Phase 2 meeting to finalize the registrational study protocol in mid-2024.Positive Results from ReVeRA Phase 2 Study of Etripamil in AFib-RVR Presented as Featured Science at the American Heart Association (AHA) Scientific Sessions 2023 and Simultaneously Published in Circulation: Arrhythmia and Electrophysiology. In November 2023, Milestone announced positive data from the ReVeRA Phase 2 study that show that patients with AFib-RVR receiving etripamil demonstrated rapid and statistically superior ventricular rate reduction and improved symptom-relief when compared to placebo. Safety and tolerability reported in the 56-patient safety population who received etripamil was generally consistent with that observed in the Company’s extensive safety database from the PSVT program. The results were presented as a Featured Science presentation at the American Heart Association (AHA) Scientific Sessions 2023 and simultaneously published in Circulation: Arrhythmia and Electrophysiology, which can be found here. Fourth Quarter and Full Year 2023 Financial Results   As of December 31, 2023, Milestone had cash, cash equivalents, and short-term investments of $66.0 million, compared to $64.6 million as of December 31, 2022.There was no revenue recorded for the fourth quarter of 2023, compared with $3.5 million the fourth quarter of 2022. Revenue for the full year ended December 31, 2023 was $1.0 million compared to $5.0 million in the year ended December 31, 2022. Revenue in 2023 was related to a milestone payment received from Ji Xing Pharmaceuticals, under the Company’s License and Collaboration Agreement. Revenue in 2022 was related to two milestone payments received under the agreement with Ji Xing Pharmaceuticals.Research and development expense for the fourth quarter of 2023 was $5.5 million, compared with $10.6 million for the prior year period. For the full year ended December 31, 2023, research and development expense was $31.1 million, compared with $39.8 million for the prior year. The decrease year over year was primarily due to lower clinical expenses as a result of the completion of Phase 3 studies, partially offset by an increase in drug manufacturing consulting costs, drug manufacturing personnel costs and regulatory consulting costs.General and administrative expense for the fourth quarter of 2023 was $3.4 million, compared with $4.1 million for the prior year period. For the full year ended December 31, 2023, general and administrative expense was $15.9 million, compared with $15.7 million for the prior year.Commercial expense for the fourth quarter of 2023 was $5.0 million, compared with $2.6 million for the prior year period. For the full year ended December 31, 2023, commercial expense was $15.1 million, compared with $9.1 million for the prior year. The increase in commercial expense year over year was a result of additional personnel and professional costs required to expand capabilities and operations in anticipation of potential commercialization.For the fourth quarter of 2023, net loss was $13.6 million, compared to $13.2 million for the prior year period. For the full year ended December 31, 2023, Milestone’s net loss was $59.7 million, compared to $58.4 million for the prior year. For further details on the Company’s financials, refer to Form 10-K for the year ended December 31, 2023, filed with the SEC. About Paroxysmal Supraventricular Tachycardia An estimated two million people in the United States are currently diagnosed with PSVT which is a type of arrhythmia or abnormal heart rhythm. PSVT is characterized by episodes of sudden onset rapid heartbeats often exceeding 150 to 200 beats per minute. The heart rate spike is unpredictable and may last several hours. The rapid heart rate often causes disabling severe palpitations, shortness of breath, chest discomfort, dizziness or lightheadedness, and distress, forcing patients to limit their daily activities. The uncertainty of when an episode of PSVT will strike or how long it will persist can provoke anxiety in patients and negatively impact their day-to-day life between episodes. The impact and morbidity from an attack can be especially detrimental in patients with underlying cardiovascular or medical conditions, such as heart failure, obstructive coronary disease, or dehydration. Many health care providers are dissatisfied with the lack of effective treatment options with patients often requiring prolonged, burdensome, and costly trips to the emergency department or even invasive cardiac ablation procedures. About Atrial Fibrillation with Rapid Ventricular Rate An estimated five million Americans suffer from AFib, a common arrhythmia marked by an irregular, disruptive and often rapid heartbeat. The incidence of AFib is expected to grow to approximately 10 million by 2025 and up to about 12 million by 2030. A subset of patients with AFib experience episodes of abnormally high heart rate most often accompanied by palpitations, shortness of breath, dizziness, and weakness. While these episodes, known as AFib-RVR, may be treated by oral calcium channel blockers and/or beta blockers, patients frequently seek acute care in the emergency department to address symptoms. In 2016, nearly 800,000 patients were admitted to the emergency department due to AFib symptoms where treatment includes medically supervised intravenous administration of calcium channel blockers or beta blockers, or electrical cardioversion. With little available data for AFib-RVR, Milestone’s initial market research indicates that 30 to 40% of patients with AFib experience one or more symptomatic episodes of RVR per year that require treatment, suggesting a target addressable market of approximately three to four million patients in 2030 for etripamil in patients with AFib-RVR. About Etripamil Etripamil is Milestone’s lead investigational product. It is a novel calcium channel blocker nasal spray under clinical development for frequent and often highly symptomatic episodes of PSVT and AFib-RVR. It is designed as a self-administered rapid response therapy for patients thereby bypassing the need for immediate medical oversight. If approved, etripamil is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable, self-administered treatment may provide patients with active management and a greater sense of control over their condition. CARDAMYST™, the conditionally approved brand name for etripamil nasal spray, is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT and Phase 2 trial for the treatment of patients with AFib-RVR. About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. The Company’s focus on understanding unmet patient needs and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing their care. Milestone’s lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat highly symptomatic episodic attacks associated with PSVT and AFib-RVR. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “continue,” “could,” “demonstrate,” “designed,” “develop,” “estimate,” “expect,” “may,” “pending,” “plan,” “potential,” “progress,” “will”, “intend” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding: the timing and outcomes of future interactions with U.S. and foreign regulatory bodies, including the FDA, including the timing of the FDA’s potential review of the NDA, once resubmitted, and the timing of the End of Phase 2 meeting; our cash runway; our ability to receive the synthetic royalty payment; our ability to advance etripamil through approval and launch in PSVT; our ability to launch etripamil for PSVT; our intended use of proceeds from the March 2024 public offering of common shares and pre-funded warrants; our future target addressable market; and the ability of etripamil to provide health care providers with a new treatment option to enable on-demand care and patient self-management and to provide patients with active management and a greater sense of control over their condition. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, whether a Type A meeting will be granted and whether our future interactions with the FDA will have satisfactory outcomes; whether and when, if at all, our NDA for etripamil will be approved by the FDA; whether the FDA will require additional trials or data which may significantly delay and put at risk our efforts to obtain approval and may not be successful, the risks inherent in biopharmaceutical product development and clinical trials, including the lengthy and uncertain regulatory approval process; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of our clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, Russian hostilities in Ukraine and ongoing disputes in Israel and Gaza and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related the sufficiency of Milestone’s capital resources and its ability to raise additional capital in the current economic climate. These and other risks are set forth in Milestone’s filings with the U.S. Securities and Exchange Commission, including in its annual report on Form 10-K for the year ended December 31, 2023, under the caption “Risk Factors,” as such discussion may be updated from time to time by subsequent filings Milestone may make with the U.S. Securities & Exchange Commission. Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.                                                                                                                                                                          Milestone Pharmaceuticals Inc.Consolidated Statements of Loss(in thousands of US dollars, except share and per share data)           Years Ended    December 31,        2023     2022         Revenue  $1,000  $5,000         Operating expenses       Research and development, net of tax credits  $31,052  $39,829 General and administrative   15,932   15,718 Commercial   15,114   9,095         Loss from operations   (61,098)  (59,642)        Interest income   3,967   1,254 Interest expense   (2,554)  —         Net loss and comprehensive loss  $(59,685) $(58,388)        Weighted average number of shares and pre-funded warrants outstanding, basic and diluted    42,955,779   42,450,316         Net loss per share, basic and diluted  $(1.39) $(1.38) The accompanying notes are an integral part of these consolidated financial statements.        Milestone Pharmaceuticals Inc.Consolidated Balance Sheets(in thousands of US dollars, except share data)            December 31, 2023    December 31, 2022Assets               Current assets       Cash and cash equivalents $13,760  $7,636 Short-term investments  52,243   56,949 Research and development tax credits receivable  643   331 Prepaid expenses  3,178   6,005 Other receivables  3,208   882 Total current assets  73,032   71,803 Operating lease right-of-use assets  1,917   2,423 Property and equipment  277   257 Total assets $75,226  $74,483        Liabilities, and Shareholders’ Equity               Current liabilities        Accounts payable and accrued liabilities $6,680  $5,644 Operating lease liabilities  546   495 Total current liabilities  7,226   6,139 Operating lease liabilities, net of current portion  1,457   1,996 Senior secured convertible notes  49,772   — Total liabilities  58,455   8,135               Shareholders’ Equity       Common shares, no par value, unlimited shares authorized 33,483,111 shares issued and outstanding as of December 31, 2023, 34,286,002 shares issued and outstanding as of December 31, 2022  260,504   273,900 Pre-funded warrants – 9,577,257 issued and outstanding as of December 31, 2023 and 8,518,257 as of December 31, 2022  48,459   34,352 Additional paid-in capital  33,834   24,437 Accumulated deficit  (326,026)  (266,341)       Total shareholders’ equity   16,771   66,348        Total liabilities and shareholders’ equity  $75,226  $74,483  Contact: Kim Fox, Vice President, Communications kfox@milestonepharma.com 704-803-9295 Investor Relations Chris Calabrese ccalabrese@lifesciadvisors.com Kevin Gardner kgardner@lifesciadvisors.com

Vista.ai Appoints MedTech Veteran Daniel Hawkins as Chief Executive Officer

PALO ALTO, Calif.–(BUSINESS WIRE)–VISTA.AI today announced the appointment of Daniel Hawkins as President and CEO. The company is pioneering AI-driven MRI image acquisition enabling any MRI technician to consistently produce high quality scans for complex indications quickly, efficiently and affordably. Daniel joins Vista.ai at a pivotal time following FDA clearance and confirmatory early commercialization of the company’s initial product focused on Cardiac MRI (CMR). Over time, the company p