DURHAM, N.C. — August 11, 2025 — Leads & Copy — Humacyte, Inc. (Nasdaq: HUMA) announced its financial results for the second quarter ended June 30, 2025, along with a business update.
Total revenues reached $301,000 for the quarter and $818,000 for the first six months of 2025, derived from sales and a collaborative research agreement. 82 civilian hospitals now have VAC approval to purchase Symvess™, and ECAT approval makes Symvess available to 35 Military Treatment Facilities and 160 U.S. Department of Veterans Affairs hospitals.
Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte, stated that the company continued to execute on its U.S. commercial launch during Q2 2025, with 82 civilian hospitals now eligible to purchase Symvess, a substantial increase from five hospitals in May. This increase is due to individual hospital and healthcare system Value Analysis Committee (VAC) approvals. The recent ECAT inclusion also makes Symvess available to approximately 190 Military Treatment Facilities and U.S. Department of Veterans Affairs (VA) hospitals.
The company faced headwinds in Q2 2025 due to unsubstantiated attacks, but VAC approvals accelerated in late June and July. July product sales exceeded total sales recorded during the first half of the year. Humacyte also achieved its first commercial sale to a U.S. military treatment facility in July, which has since re-ordered the Symvess product.
The V007 trial data was selected for special mention by the Society of Vascular Surgery in June, highlighting the strength of the results in their announcement. In the V007 trial, the ATEV showed superior functional patency during the first year over the autologous fistula control group, particularly in women and men with diabetes and obesity. The results from the V007 Phase 3 clinical trial are expected to be published in a major peer-reviewed medical journal this year.
To date, a total of 13 VACs have approved the Symvess product, making 82 civilian hospitals eligible to purchase Symvess. An additional 40 VACs are currently conducting their review process. In July 2025, Symvess was granted ECAT listing approval from the U.S. Defense Logistics Agency, making it available to healthcare professionals treating military service members, veterans, and other patients at approximately 35 Military Treatment Facilities and approximately 160 VA hospitals.
Following the ECAT approval, the first sale of Symvess to a U.S. Military Treatment Facility was completed in July. The facility provides healthcare to approximately 200,000 active-duty service personnel, retirees, and their family members and has re-ordered Symvess. Active discussions are ongoing with additional DOD facilities expressing interest in purchasing Symvess.
Results from the V007 Pivotal Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV™) in arteriovenous (AV) access were presented at the Society for Vascular Surgery Vascular Annual Meeting (VAM25) in June 2025. A total of 100 patients have been enrolled to date in the V012 Phase 3 clinical trial, designed to assess the efficacy and safety of the ATEV for dialysis in comparison to AV fistulas in female patients. Subject to these interim results, Humacyte plans to submit a supplemental Biologics License Application (BLA) in the second half of 2026 to expand the Symvess label to add AV access for hemodialysis as an indication, subject to FDA approval.
For the three months ended June 30, 2025, there was $0.3 million in revenue, of which $0.1 million related to U.S. sales of Symvess. Revenue for the six months ended June 30, 2025, was $0.8 million, of which $0.2 million related to U.S. sales of Symvess.
During the three months ended June 30, 2025, Humacyte implemented a plan to reduce its workforce by 30 employees and reduce other operating expenses. The Company estimates that it has incurred and will incur aggregate charges representing one-time cash expenditure for severance and other employee termination benefits of approximately $0.7 million. Humacyte estimates a net savings due to workforce reductions, operating cost reductions and reduced capital expenditures, net of termination severance and benefits, totaling approximately $13.8 million in 2025.
Conference call and webcast details are available for August 11, 2025, at 8:00 AM Eastern Time.
Contact:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com
Rich Luchette
Precision Strategies
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com
Please see full Prescribing Information at www.symvess.com, including Boxed Warning, for Symvess.
For more information, visit www.Humacyte.com.
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.
Forward-looking statements involve risks, uncertainties, and other factors that may cause actual results to differ materially from the information expressed or implied. The company is not updating any of the forward-looking statements in this press release.
Source: Humacyte, Inc.
