HUMA

EX-99.1

2 huma-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Humacyte Reports Third Quarter 2026 Results, Highlighted by More Than Doubling Symvess Revenue and Expanding Commercial Adoption – Commercial adoption of Symvess® accelerated during the third quarter with sales totaling $1.0 million, a 151% increase over the 2nd quarter. – Symvess commercial momentum continued into the fourth quarter, with October 2026 sales totaling $0.8 million. – Supplemental Biologics License Application (sBLA) for the ATEV in dialysis access on track for filing with the Food and Drug Administration (FDA) in November 2026. – Company initiates first-in-human clinical Phase 2a study of CTEV for CABG. – Conference call today at 8:00 am ET. DURHAM, N.C., November 10, 2026 – Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced financial results for the third quarter ended September 30, 2026, and provided a business update. “During our third quarter, we continued the transformation of our Symvess commercial program in vascular injury repair, doubling revenue over our second quarter and significantly increasing the number of hospitals ordering Symvess,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “In our future targeted market in dialysis access, our plan is to file a supplemental BLA for the ATEV in November 2026, supported by results from three Phase 3 studies. Publication of our V007 Phase 3 results in The Lancet Digital Health and presentation of our V012 Phase 3 results in a late-breaking session at ASN Kidney Week gave the vascular surgery and nephrology communities an overview of the data that will form the basis of our sBLA filing. These results also support our belief that the ATEV has the potential to address significant unmet needs for dialysis patients seeking improved hemodialysis access options. Elsewhere in our pipeline, we have initiated our Phase 2a study in coronary artery bypass grafting (CABG) and look forward to enrollment of the first patients.” “Execution of our revamped commercial program for Symvess generated significant momentum during the third quarter,” said Jim Mercadante, Chief Commercial Officer of Humacyte. “Symvess sales revenue for the third quarter was $1.0 million, more than double our results for the second quarter, and achieved the goal we set for the period. Momentum has continued into the fourth quarter and based on expanded hospital adoptions and physician engagement, we anticipate at least doubling our third quarter sales revenue in Q4 2026. We believe the strategy we’ve established is working and that we have positioned Symvess for sustainable growth throughout the remainder of 2026 and beyond.” Third Quarter 2026 and Recent Corporate Highlights Symvess Commercialization • Third Quarter Commercial Highlights: Hospital adoption expanded significantly during the third quarter, with the number of hospitals that ordered Symvess increasing by 44%, from 34 hospitals at the end of the second quarter to 49 hospitals as of September 30, 2026.

• Commercial sales reached $1.0 million in Q3, more than doubling the prior quarter, with new hospital orders increasing sequentially each month throughout the third quarter.

• Symvess commercial growth accelerated entering the fourth quarter, with October 2026 sales reaching $0.8 million and Q4 2026 sales expected to at least double compared with Q3 sales.

• Humacyte anticipates adding at least 20 new hospitals during the second half of 2026.

Breakthrough Phase 3 Results of ATEV in Dialysis Support Planned BLA Filing • Phase 3 V012 Trial Results for ATEV in Women Requiring Hemodialysis Access Presented in Late-Breaking Session at ASN Kidney Week 2026: Interim results from the V012 Phase 3 clinical trial were presented in a prestigious late-breaking oral presentation at the American Society of Nephrology (ASN) Kidney Week 2026 conference in October 2026. The Phase 3 results were presented by Prabir Roy-Chaudhury, M.D., Ph.D., FASN, of the University of North Carolina at Chapel Hill School of Medicine. In the V012 Phase 3 trial, women implanted with the ATEV were observed to achieve functional access more than three months sooner and spent significantly more time free of dialysis catheters over the first year than women who received an AV fistula, which is the current standard of care for hemodialysis access.

• Planned BLA Filing: The above V012 results, combined with results from the V007 Phase 3 trial reported previously, suggest that the ATEV could represent the first major advance in dialysis access in decades, offering surgeons an alternative option for patients where AV fistula maturation is difficult. Based on these results, Humacyte plans to submit a supplemental Biologics License Application to the FDA in November 2026 to add dialysis access as a second approved indication.

• Lancet Dig