Humacyte Inc Stock Price, News & Analysis

Humacyte (NASDAQ: HUMA) has received FDA full approval for SYMVESS, a first-in-class bioengineered human tissue designed as a universally implantable vascular conduit for arterial injury treatment. The approval is specifically for use in adults when urgent revascularization is needed to avoid limb loss and autologous vein graft isn't feasible.

Clinical testing demonstrated high patency rates and low amputation and infection rates. SYMVESS offers an off-the-shelf solution, eliminating the need for vein harvesting from trauma patients. The approval was based on positive results from the V005 pivotal Phase 2/3 clinical study and real-world evidence from Ukraine's wartime injuries treatment.

The company has already recruited and trained a sales team for the commercial launch. SYMVESS received RMAT designation in May 2023, and its BLA submission in December 2023 was granted Priority Review in February 2024.

Humacyte (Nasdaq: HUMA) announced its participation in the Piper Sandler 36th Annual Healthcare Conference in New York. Dr. Laura Niklason, the company's Founder, President, and CEO, will engage in a fireside chat presentation on December 5, 2024, at 8:00 a.m. EST at The Lotte New York Palace. The presentation will be accessible via webcast, with a replay available on the company's website. Management will also be available for one-on-one meetings during the conference.

Humacyte (Nasdaq: HUMA) announced it will present Phase 3 results comparing the efficacy and safety of its acellular tissue engineered vessel (ATEV™) with autologous AV fistulas in end-stage renal disease patients. The presentation will be delivered by Dr. Charles Keith Ozaki at the 51st Annual VEITH Symposium in New York on November 23, 2024. Dr. Ozaki is the Vascular Surgery Research Director at Brigham and Women's Hospital and John A. Mannick Professor of Surgery at Harvard Medical School. The ATEV remains an investigational product pending FDA approval.

Humacyte announced the publication of clinical results in JAMA Surgery evaluating their acellular tissue engineered vessel (ATEV) for repairing extremity civilian and military arterial injuries. Two studies demonstrated ATEV's superior performance compared to synthetic grafts, showing 91.5% 30-day secondary patency versus 78.9%, 4.5% amputation rate versus 24.3%, and 0.9% infection rate versus 8.4%. The average follow-up duration was 334.4 days, with no ATEV infections or patient deaths reported after month three. The ATEV is currently under FDA review for vascular trauma indication.

Humacyte presented positive preclinical results for their small-diameter (3.5mm) acellular tissue engineered vessel (sdATEV) in a non-human primate model of coronary artery bypass grafting. The six-month study showed that sdATEV maintained blood flow, recellularized with host cells, and adapted to match the native artery size. The study involved five baboons where sdATEV was implanted between the aorta and right coronary artery. All implants remained patent throughout the study period. The results are significant as over 400,000 CABG procedures are performed annually in the US, with current options having limitations including potential complications and low patency rates.

Humacyte (Nasdaq: HUMA) has announced a $15.0 million registered direct offering of common stock and warrants. The company will sell 2,808,988 shares of common stock and warrants to purchase an equal number of shares at $5.34 per share. Half of the warrants will expire in 180 days, while the other half will expire in four and a half years from issuance. The offering is expected to close around November 15, 2024. The proceeds will be approximately $15.0 million before expenses.

Humacyte reported Q3 2024 financial results and business updates. The FDA review of their acellular tissue engineered vessel (ATEV) BLA for vascular trauma treatment continues without a specified timeline. The company presented positive results from their V007 Phase 3 clinical trial for hemodialysis access at Kidney Week 2024, showing superior performance over standard treatment. Financial highlights include: no revenue for Q3 2024, R&D expenses of $22.9M, G&A expenses of $7.3M, and a net loss of $39.2M. The company reported $71M in cash and equivalents, with an additional $29.6M raised post-quarter through stock and warrant sales.

Humacyte (Nasdaq: HUMA), a clinical-stage biotechnology platform company focused on bioengineered human tissue development, has scheduled its third quarter 2024 financial results release for November 8, 2024. The company will host a conference call and webcast at 8:30 a.m. ET to discuss financial performance and provide updates on its acellular tissue engineered vessel (ATEV) programs. The presentation will be accessible via phone and webcast, with replay available on the company's investor website for 30 days.

Humacyte (HUMA) presented positive Phase 3 clinical trial results for their ATEV (acellular tissue engineered vessel) in arteriovenous access for hemodialysis patients. The trial demonstrated superior performance compared to standard autogenous fistula, with 81.3% functional patency at 6 months versus 66.4%, and 68.3% secondary patency at 12 months versus 62.2%. Notable improvements were seen in high-risk groups: female patients achieved 8.3 vs 5.0 months of dialysis duration, obese patients 7.7 vs 4.5 months, and diabetic patients 7.4 vs 5.5 months. While infection rates were similar between groups, ATEV showed higher thrombosis rates (52.1% vs 9.1%), though 94% of cases were successfully treated.