Humacyte Inc. (NASDAQ:HUMA) stock plunged Thursday despite reporting positive interim Phase 3 data for its acellular tissue-engineered vessel (ATEV), as investors focused on a heavily dilutive stock offering announced alongside the clinical update.
On Wednesday, Humacyte released interim Phase 3 results for its acellular tissue-engineered vessel (ATEV) in female dialysis patients.
ATEV is a bioengineered human tissue derived from cultured human cells that is designed to be a universally implantable vascular conduit for use in vascular replacement and repair.
Phase 3 Trial Meets Primary Endpoint
The biotechnology company said a prespecified interim analysis of the first 80 patients enrolled in its Phase 3 V012 study met the trial’s primary endpoint.
Patients treated with the ATEV recorded an average of 220 catheter-free days, compared with 129 days for those receiving an autologous arteriovenous (AV) fistula, the current standard of care.
The 91-day improvement was statistically significant, with a p-value of 0.00070.
Safety Profile Remains Favorable
According to the company, patients receiving the ATEV experienced infections at a rate of six per 100 patient-years, compared with 23 per 100 patient-years among patients receiving AV fistulas.
No access-related infections were reported among ATEV recipients, while three occurred in the AV fistula group. Researchers also reported no spontaneous ruptures in either treatment arm and said no new or unexpected safety concerns emerged during the analysis.
Under the study protocol, enrollment will now end early after the primary endpoint is achieved, while enrolled patients will continue to be monitored.
Humacyte plans to submit a supplemental Biologics License Application to the FDA in the second half of 2026.
The proposed indication targets adults with end-stage kidney disease who face an elevated risk of AV fistula maturation failure.
Offering To Fund Commercialization And Development
Separately, Humacyte priced its underwritten public offering of 47.6 million shares of common stock at $1.05 per share, generating expected gross proceeds of approximately $50 million.
The company also granted underwriters an option to purchase up to an additional 7.1 million shares.
Humacyte will use the proceeds to support the commercialization of Symvess, prepare for the planned hemodialysis-related BLA supplement filing, advance pipeline programs, and fund general corporate activities.
HUMA Stock Price Activity: Humacyte shares were down 22.76% at $1.03 at the time of publication on Thursday, according to Benzinga Pro data.
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