Humacyte ATEV Beats Fistula in Dialysis Trial
The company plans a supplemental BLA in the second half of 2026 after women on the vessel gained 91 more catheter-free days than those on AV fistula.
Humacyte, Inc. (HUMA), a commercial-stage biotechnology platform company developing bioengineered human tissues, said its acellular tissue engineered vessel outperformed autologous arteriovenous fistula in a prespecified interim analysis of the first 80 patients in the V012 Phase 3 trial in female dialysis patients, meeting the study’s primary efficacy endpoint.
The company presented the results in June at the Society for Vascular Surgery’s Vascular Annual Meeting. Women who received the ATEV achieved an average of 91 more catheter-free days than those receiving an AV fistula, a statistically significant difference (p=0.00070). Infections were also less common: 6 per 100 patient-years on the ATEV versus 23 per 100 patient-years on an AV fistula. Founder and Chief Executive Officer Laura Niklason said the results exceeded the company’s expectations and that it looks forward to using the data to file a supplemental Biologics License Application with the FDA later this year.
Combined with previously reported V007 Phase 3 results, the ATEV could represent the first major advance in dialysis access in decades. The company plans to submit the supplemental BLA in the second half of 2026. It appointed nephrologists Robert J. Kossmann and Prabir Roy-Chaudhury as advisors to prepare for planned commercialization if the FDA approves the indication.
The FDA also accepted an Investigational New Drug application for a first-in-human study of the company’s coronary tissue engineered vessel in coronary artery bypass grafting. Humacyte plans to start a Phase 2a CABG study in the third quarter of 2026 and has completed the first large-scale manufacturing lot of CTEV at commercial-scale facilities. Niklason said no new off-the-shelf conduits have been introduced for CABG in the past 40 years.
Commercial sales of Symvess, the FDA-approved ATEV for extremity arterial injury, were $0.4 million in the second quarter of 2026, compared with $0.1 million a year earlier. For the six months ended June 30, 2026, Symvess sales were $0.9 million versus $0.2 million a year earlier. Total revenue was $406 thousand in the three months ended June 30, 2026, versus $301 thousand a year earlier, and $901 thousand for the six months versus $818 thousand. Contract revenue was negligible after a research collaboration ended in the prior year.
Chief Commercial Officer Jim Mercadante, recently appointed, said the company focused the quarter on rebuilding the Symvess commercial effort and an enterprise-wide transformation aimed at hospital product adoption and usage. He said the company remodeled its commercial team, refined introductory pricing incentives, professional-to-professional education, and value-analysis-committee processes, and that influential hospitals were already adopting Symvess as utilization strengthened. Dr. Todd E. Rasmussen joined as Chief Surgical Officer. Israel’s Ministry of Health accepted a marketing authorization application for Symvess in April 2026 with a 180-working-day review period. The FY 2026 U.S. Department of Defense Appropriations Act includes funding to evaluate biologic vascular repair technologies.
Cost of goods sold was $1.2 million in the second quarter, including a $0.7 million inventory reserve and unused-capacity overhead. Research and development expenses were $18.1 million, reflecting fewer non-commercial manufacturing runs and lower clinical trial costs. General and administrative expenses were $8.0 million. Loss from operations was $27.0 million. Net loss was $36.8 million, or $0.16 a share, compared with a $37.7 million loss, or $0.24 a share, a year earlier. Other net expense of $9.8 million reflected non-cash remeasurement of contingent earnout and derivative liabilities.
In May the company reduced headcount by about 45 employees through a reduction in force and deferred hires, estimating net savings of about $14.3 million during 2026 after severance. In June it raised $57.5 million of gross proceeds in a common-stock offering, which it intends to use for Symvess commercialization, the planned dialysis BLA supplement, pipeline development, and working capital. Cash, cash equivalents, and restricted cash were $80.3 million as of June 30, 2026. Total net cash provided was $29.4 million for the first six months of 2026, compared with $6.9 million used a year earlier.