Humacyte, Inc.

Humacyte, Inc. announced the appointment of Dr. Robert J. Kossmann and Dr. Prabir Roy-Chaudhury as advisors. These leading nephrologists will assist in preparing for the planned commercialization of the acellular tissue engineered vessel (ATEV) for hemodialysis access. Their roles will involve developing health economic, reimbursement, and market access strategies, as well as providing scientific and medical education support. This strategic move follows the recent release of positive Phase 3 study results and Humacyte's intention to file a supplemental Biologic License Application with the FDA.

Humacyte, Inc. announced the pricing of an underwritten public offering of 47,619,048 shares of its common stock at $1.05 per share. The company also granted underwriters an option to purchase up to an additional 7,142,857 shares. The offering is expected to generate approximately $46.80 million in net proceeds, or $53.85 million if the option is fully exercised, which will be used to fund the commercialization of Symvess, support a Biologics License Application supplement, develop its product pipeline, and for general corporate purposes. The closing is anticipated around June 12, 2026.

Humacyte, Inc. announced the pricing of an underwritten public offering of 47,619,048 shares of its common stock at $1.05 per share, aiming to raise $50 million in gross proceeds. The offering is expected to close around June 12, 2026, with underwriters also having an option for additional shares. The company intends to use the net proceeds to fund the commercialization of Symvess®, support a planned Biologics License Application supplement for a hemodialysis indication, advance its product pipeline, and for general corporate purposes.

Humacyte, Inc. announced positive top-line interim results from its Phase 3 V012 clinical trial for its acellular tissue engineered vessel (ATEV) in arteriovenous access for female patients with end-stage renal disease requiring hemodialysis. The study met its primary endpoint, showing ATEV provided 91 more catheter-free days compared to the standard of care AV fistula, with a statistically significant p-value of 0.00070. Additionally, ATEV patients experienced fewer infections. The company plans to file a supplemental Biologics License Application (BLA) with the FDA in the second half of 2026. Humacyte also made an investor presentation available on the same day.

Humacyte, Inc. announced the commencement of an underwritten public offering of its common stock. The company intends to grant the underwriters an option to purchase up to an additional 15% of the shares sold for a period of 30 days. Humacyte plans to use the net proceeds to fund the commercialization of Symvess, support the planned Biologics License Application supplement filing for a hemodialysis indication, advance its product pipeline, and for general corporate purposes.

Humacyte announced positive top-line interim results from its V012 Phase 3 study for the acellular tissue engineered vessel (ATEV) in female dialysis patients. The ATEV met its primary endpoint, demonstrating significantly more catheter-free days compared to the standard of care, autologous AV fistula. The company plans to file a supplemental Biologic License Application with the FDA in the second half of 2026. The ATEV also showed a favorable safety profile with a lower infection rate.

Humacyte, Inc. held its 2026 Annual Meeting of Stockholders, where shareholders approved an amendment to increase the number of authorized common stock from 350,000,000 to 550,000,000 shares. Additionally, stockholders elected three Class II directors, approved named executive officer compensation on an advisory basis, and ratified Pricewaterhouse Coopers LLP as the independent auditor for 2026. They also voted for an annual frequency for future advisory votes on executive compensation.

Humacyte, Inc. announced that it has regained compliance with The Nasdaq Global Select Market's minimum $1.00 per share bid price requirement. The company had previously received a notification on May 4, 2026, regarding non-compliance. Nasdaq confirmed on June 5, 2026, that Humacyte met the requirement, closing the matter.

Humacyte, Inc. announced its first quarter 2026 financial results, reporting Symvess sales of $0.5 million, a significant increase from $0.1 million in Q1 2025. The company also appointed James Mercadante as Chief Commercial Officer and Dr. Todd Rasmussen as Chief Surgical Officer to accelerate commercialization. Key business updates include a $1.475 million purchase commitment for Symvess in Saudi Arabia, Israeli regulatory acceptance, and upcoming top-line interim results from its Phase 3 hemodialysis access trial in June 2026. Humacyte implemented a restructuring, reducing headcount by 25% and expecting $14.3 million in net savings for the remainder of 2026, while reporting a net loss of $17.6 million for the quarter, primarily due to a non-cash item.

Humacyte, Inc. announced the appointment of Todd E. Rasmussen, M.D., as its new Chief Surgical Officer. Dr. Rasmussen, a distinguished vascular surgeon with decades of clinical experience from the U.S. Air Force and Mayo Clinic, will focus on providing scientific support, medical education, and technical insights to healthcare providers. This strategic appointment is expected to bring important surgical perspective to Humacyte's leadership as the clinical adoption of Symvess® ramps up and pipeline indications move toward approval.