Humacyte, Inc. (HUMA), a commercial-stage biotechnology platform, announced positive top-line interim results from the Phase 3 study dubbed V012 by meeting the trial's primary endpoint of the acellular tissue-engineered vessel (ATEV) in female patients undergoing dialysis access. In parallel, the firm also priced a public offering of $50 million in gross proceeds.
Humacyte's ATEV is a bioengineered human tissue, derived from cultured human cells, designed as a universally implantable vascular conduit for vascular replacement and repair. Company Profile
Humacyte develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Symvess is Humacyte's lead FDA-approved acellular tissue-engineered vascular (ATEV) product for use as an arteriovenous (AV) graft for the treatment of adults with extremity vascular trauma when autologous vein grafting is not feasible. The ATEV's are currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD).
Trial Details
VO12 is a Phase 3, prospective, multi-centre, open-label, randomised, two-arm comparative study conducted in the United States, involving up to 150 patients, with 120 currently enrolled.
The study is designed to demonstrate the efficacy and safety of the ATEV as a dialysis access method compared with an autologous AV fistula in female dialysis patients. The primary measure of efficacy is total days free from indwelling catheter until 365 days after access placement, or until access abandonment, whichever occurs first. The primary safety measure is the number and severity of infections associated with all accesses, including catheters, from the date of access creation through 365 days thereafter.
Key Findings
-At the primary endpoint, patients implanted with the ATEV achieved an average of 220 catheter-free days compared to 129 catheter-free days for patients who received an AV fistula.
-In terms of the primary safety measure, patients receiving the ATEV experienced infections at a rate of 6 per 100 patient-years, compared with 23 per 100 patient-years for patients receiving an AV fistula procedure.
-Also, no study access-associated infections were reported among ATEV patients, whereas three were reported among AV fistula patients.
Prices $50 Mln Public Offering
In the parallel announcement, the company priced a public offering of 47.62 million shares at $1.05 per share, with gross proceeds expected to be $50 million.
Humacyte intends to use the net proceeds to fund the commercialisation of Symvess, the planned filing of a Biologics License Application supplement for a hemodialysis indication and related activities, the development of the product candidates in its pipeline, and working capital and general corporate purposes.
In addition, Humacyte has granted the underwriters a 30-day option to purchase up to an additional 7.143 million shares of Humacyte at the public offering price.
The closing of the offering is expected to occur on June 12, 2026.
For the first quarter ended March 31, 2026, the company incurred a net loss of $17.6 million, compared with net income of $39.1 million for the same period a year ago.
Commercial sales of Symvess increased to $0.5 million, or 29 units, in the first quarter of 2026 compared to $0.1 million, or five units, in the prior year.
ConclusionFor dialysis, doctors need a reliable access point to the bloodstream so blood can flow to the dialysis machine and back into the body.
According to Humacyte estimates, over 0.8 million Americans are currently living with end-stage kidney disease, and nearly 0.5 million Americans depend on hemodialysis for survival.
Humacyte believes ATEVs can help overcome the challenges of Autogenous AV fistulas, particularly for women, for whom Autogenous AV fistulas often fail to function after surgery, given small vessel anatomy, advanced age, obesity, or other comorbidities.
HUMA has traded between $0.54 and $2.84 over the last year. The stock closed Wednesday's trade at $1.34, down 3.60%.
In the overnight market, HUMA is down 16.42% at $1.12.
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Business News
June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.