Humacyte reports ATEV outperformed AV fistula in Phase 3 dialysis trial

Humacyte announced second-quarter 2026 results on August 12, 2026, highlighting interim Phase 3 data and pipeline progress. In a pre-specified interim analysis of the first 80 patients in the V012 Phase 3 study, the ATEV outperformed AV fistula, the current standard of care, reducing use of infection-prone catheters, with women receiving the ATEV achieving an average of 91 more catheter-free days than those receiving AV fistula, a statistically significant result (p=0.00070) that met the study's primary efficacy endpoint.¹ Infection rates were also lower with the ATEV, at 6 infections per 100 patient years versus 23 per 100 patient years for AV fistula.¹

Based on the V012 and prior V007 Phase 3 data, Humacyte said it plans to submit a supplemental Biologics License Application to the FDA in the second half of 2026.¹

On the coronary program, the FDA has accepted the IND application for a first-in-human clinical study of the CTEV in coronary artery bypass grafting.¹ Humacyte said it intends to begin a Phase 2a CABG study this quarter, having already completed the first large-scale manufacturing lot of CTEV at its commercial-scale facilities.¹

On commercialization, Israel's Ministry of Health accepted for review in April 2026 the company's Marketing Authorization Application for Symvess in arterial injury repair, setting a 180-working-day review period given the drug's existing FDA approval for extremity vascular injury.¹

Financially, Humacyte reported cash, cash equivalents and restricted cash of $80.3 million as of June 30, 2026.¹ In June 2026 the company raised $57.5 million in gross proceeds from a public stock offering,¹ and in May 2026 it cut headcount by about 45 employees, projecting roughly $14.3 million in net savings during 2026.¹