Humacyte (HUMA) investor relations material

Key learnings and commercial progress

• Launch of a first-in-class vascular product in 2025 revealed that hospital value analysis committee (VAC) approvals take longer post-COVID, but approval rates exceed 70%.

• Price adjustment to $17,000–$20,000 per unit improved administrative acceptance and hospital adoption.

• Expanded focus on surgeon and hospital education, growing the medical science liaison team, and recruiting senior surgical talent to support adoption.

• Product is primarily used in critically ill patients lacking other options, with high surgeon satisfaction and repeat use.

• Sales momentum is building, with ongoing discussions with group purchasing organizations (GPOs).

Clinical evidence and upcoming milestones

• Multiple 2025 publications, including a budget impact model, demonstrated cost savings for trauma centers by reducing amputations and infections.

• Clinical outcomes in trauma patients without available vein are comparable to traditional vein grafts.

• Positive phase III trial data in dialysis access, with a second trial in women nearing interim readout; a supplemental BLA filing is expected later in 2026 if results are positive.

• Addressing unmet needs in women, where fistula failure rates are high, is a key clinical and value proposition.

Market strategy and reimbursement

• Commercial efforts in trauma and dialysis target overlapping surgeon populations, with trauma focused on inpatient DRG reimbursement and dialysis on outpatient CMS reimbursement.

• Active engagement with CMS aims for pass-through reimbursement at ASP plus six, with approval targeted for mid-2027.

• Relationship with Fresenius provides global distribution support and strategic collaboration, especially in Europe.

• U.S. distribution rights are retained, while Fresenius holds European rights for trauma, dialysis, and PAD indications.