DURHAM, N.C., June 09, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced today that the results from its V007 Pivotal Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV™) in arteriovenous access for patients at high risk of autologous arteriovenous fistula (AVF) maturation failure with end-stage renal disease were presented in a plenary ses ...

DURHAM, N.C., June 02, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced that its abstract on the V007 Pivotal Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV™) in arteriovenous access for high-risk patients with end-stage renal disease was accepted for an oral presentation at the Society for Vascular Surgery Vascular Annual Meeting (VAM ...

DURHAM, N.C., May 19, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Founder, President, and Chief Executive Officer, will present at the H.C. Wainwright 3rd Annual BioConnect Investor Conference at Nasdaq in New York, NY on Tuesday, May 20, 2025. Management will also be available for one-on-one meetings. Event: H.C. ...

Core Insights - Humacyte, Inc. has successfully launched its product Symvess™ for treating extremity vascular trauma, marking a significant milestone for the company [2][3] - The company reported total revenues of $517,000 for the first quarter of 2025, with $147,000 from the initial commercial sales of Symvess and $370,000 from a research collaboration [9][27] - Humacyte completed a public offering that raised $46.7 million in net proceeds, which will help extend its cash runway [6][9] Market Launch and Sales - The commercial launch of Symvess began in late February 2025, with initial shipments to three Level 1 trauma centers [3] - 45 hospitals have initiated the Value Analysis Committee (VAC) approval process for Symvess, with five hospitals already approving its purchase [2][3] - The company anticipates further approvals and sales growth in the upcoming quarters [3] Financial Performance - The first quarter of 2025 saw a revenue increase to $517,000 compared to no revenue in the same period of 2024 [9][27] - Research and development expenses decreased to $15.4 million from $21.3 million year-over-year, attributed to reduced material costs and clinical study expenses [9][27] - General and administrative expenses rose to $8.1 million from $5.3 million, primarily due to the costs associated with the commercial launch of Symvess [9][27] Cost Management and Future Plans - The company implemented cost reduction measures, including workforce reductions and deferring new hires, aiming for estimated savings of approximately $13.8 million in 2025 and up to $38 million in 2026 [6][9] - Humacyte plans to file an Investigational New Drug (IND) application with the FDA for the small-diameter ATEV™ in coronary artery bypass grafting (CABG) later this year [2][8] - The company is on track to submit a supplemental Biologics License Application (BLA) for ATEV in dialysis in 2026, following a major enrollment milestone in its Phase 3 trial [2][8] Corporate Developments - Humacyte was issued a new U.S. patent in January 2025, providing protection for its biomanufacturing platform until 2040 [4] - The company reported a net income of $39.1 million for the first quarter of 2025, a significant improvement from a net loss of $31.9 million in the same period of 2024 [17][27] - As of March 31, 2025, Humacyte had cash, cash equivalents, and restricted cash totaling $113.2 million [17][28]

Core Viewpoint - Humacyte, Inc. is set to release its financial results for Q1 2025 on May 13, 2025, and will provide a corporate and financial update during a webcast and conference call [1][2]. Company Overview - Humacyte, Inc. is a clinical-stage biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [1][3]. - The company manufactures acellular tissues aimed at treating various diseases, injuries, and chronic conditions [3]. - The FDA approved the Biologics License Application for Humacyte's acellular tissue engineered vessel (ATEV) for vascular trauma in December 2024 [3]. - ATEVs are currently in late-stage clinical trials for additional vascular applications, including arteriovenous access for hemodialysis and peripheral artery disease [3]. - Preclinical development is ongoing for coronary artery bypass grafts, pediatric heart surgery, type 1 diabetes treatment, and other novel cell and tissue applications [3]. - Humacyte's 6mm ATEV for AV access in hemodialysis is notable for being the first product to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and has also received Fast Track designation [3]. - The ATEV has received priority designation for vascular trauma treatment from the U.S. Secretary of Defense [3]. Financial Results Announcement - The financial results for the quarter ended March 31, 2025, will be announced on May 13, 2025, at 8:30 AM ET [2]. - A conference call will be available for U.S. and international investors, with specific dial-in numbers provided [2]. - The webcast will be accessible 15 minutes prior to the call and will be available for replay for at least 30 days [2].

DURHAM, N.C., March 26, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, will release its financial results for the fourth quarter and year ended December 31, 2024, on Friday, March 28, 2025. Management will host a webcast and conference call at 8:30 a.m. ET. Title:Humacyte Fourth Quarter and Full Year 2024 Financial Results and Corporate UpdateDate:March 28, 2025Time:8: ...