Humacyte (HUMA) Piper Sandler 36th Annual Healthcare Conference summary

Platform overview and clinical progress

• Regenerative medicine platform enables growth of universally implantable human tissues, with nearly 600 patients treated and no rejection episodes.

• Lead indication targets traumatic injury using engineered arteries, with additional clinical and preclinical programs in the pipeline.

Regulatory review and approval timeline

• Biologics License Application (BLA) submitted in December 2022; FDA review ongoing, with regular informal updates indicating progress but no final decision yet.

• Post-approval commitments and paperwork have been submitted as required; company remains patient, opting not to force regulatory action.

• FDA has repeatedly indicated no advisory committee (Adcom) is needed; approval could come within weeks to a couple of months, with hopes for year-end resolution.

• Upon approval, product shipment could begin approximately six weeks later, pending final labeling and packaging sign-off.

Clinical data highlights and publications

• Recent trauma data published in JAMA Surgery showed significantly lower amputation and infection rates compared to synthetic grafts, with durable vessel performance over 12+ months.

• Dialysis access phase III trial demonstrated superior usability and patency versus arteriovenous fistula, especially in underserved subgroups like women, obese patients, and diabetics.

• Ongoing follow-up and additional trials in women aim to strengthen data and support future regulatory filings.