Humacyte (HUMA) investor relations material

Commercial performance and strategy

• Symvess, an off-the-shelf acellular tissue engineered vessel, was FDA approved for extremity arterial injury in December 2024 and launched with a new commercial team in 2025.

• Q2 Symvess sales reached $0.4 million, below expectations, attributed to a commercial rebuild with new leadership and experienced hires from major medtech firms.

• The revamped commercial approach emphasizes deeper relationships with vascular surgeons and hospitals, value messaging, and a product replacement program for early infections.

• National contracting efforts are expanding access to 1,000 more hospitals, with 20 major health systems in adoption processes; contracting impacts expected in Q4 2025 and Q1 2026.

Regulatory and clinical pipeline

• Symvess is positioned as a beachhead for broader dialysis and cardiovascular indications, leveraging overlap in surgical teams and hospital settings.

• A supplemental BLA for dialysis access is planned for November 2026, supported by three phase III trials showing consistent benefits, especially for women.

• Approval for dialysis access is anticipated by mid-2027, with the same product and manufacturing as the trauma indication.

• The CABG program has FDA IND acceptance, with a phase II-A study starting in 2026; primary endpoint is two-month patency, with initial results expected in early 2027.

Clinical data and market opportunity

• In the V012 trial, women on dialysis had 91 more catheter-free days than with AV fistula; two-year data from V007 show a 5–6 month benefit in catheter-free days.

• Reducing catheter use lowers costs by up to $15,000 per patient annually and helps dialysis centers meet CMS targets.

• The BLA will target high-risk patients, including women and men with diabetes or obesity, supported by over 1,000 patient-years of data.

• Symvess may be used first-line in high-risk patients or after fistula failure, depending on surgeon assessment.