Humacyte (HUMA) investor relations material

Leadership and innovation

• Led by experienced executives and board members with backgrounds in medicine, biotech, and government.

• Pioneering universally implantable, off-the-shelf regenerative human tissues and organs.

• Platform enables scalable manufacturing of bioengineered tissues, including vascular and complex organ constructs.

Product pipeline and clinical results

• Symvess, an acellular tissue engineered vessel, is FDA approved for extremity vascular trauma and shows high patency, low infection, and amputation rates.

• V007 Phase 3 trial for dialysis access met co-primary endpoints, with ATEV outperforming AV fistula in function and patency, especially in women and high-risk subgroups.

• V012 Phase 3 interim results in women showed ATEV provided 91 more catheter-free days and fewer infections than AVF, with a favorable safety profile.

• Pipeline includes products for peripheral arterial disease, coronary bypass, and a BioVascular Pancreas for type 1 diabetes.

Market opportunity and economics

• U.S. target market for Symvess in vascular trauma is estimated at 26,000 patients annually.

• Symvess offers significant hospital cost savings by reducing infection and amputation rates compared to synthetic grafts.

• Budget impact models show Symvess is the second-most economical arterial graft after saphenous vein.

• Commercial launch focuses on 200 Level 1 trauma centers and 3,000 vascular surgeons.