Humacyte prices $50M common stock offering to fund Symvess

Humacyte, Inc. (NASDAQ: HUMA) has priced an underwritten public offering of 47,619,048 shares of its common stock at a public offering price of $1.05 per share to raise aggregate gross proceeds of $50 million. The offering, expected to close on or about June 12, 2026, aims to secure capital for the commercialization of its FDA-approved product, Symvess, and other corporate activities. The company has granted underwriters a 30-day option to purchase up to an additional 7,142,857 shares at the public offering price, less underwriting discounts and commissions.

The net proceeds from the offering are designated for several strategic areas. Primary allocations include funding the commercialization of Symvess and the planned filing of a Biologics License Application supplement for a hemodialysis indication. Funds will also support the development of product candidates in the pipeline, as well as working capital and general corporate purposes.

Regulatory and Filing Details

A shelf registration statement on Form S-3 (No. 333-290231) was filed with the Securities and Exchange Commission (SEC) on September 12, 2025, and declared effective on September 22, 2025. A preliminary prospectus supplement and accompanying prospectus were filed with the SEC on June 10, 2026. The final prospectus supplement will be available on the SEC's website upon filing.

Underwriting and Contact Information

Barclays, BTIG, and Titan Partners, a division of American Capital Partners, are acting as joint book-running managers for the offering. Copies of the final prospectus supplement and accompanying prospectus can be obtained from the underwriters upon availability.

Underwriter	Contact Details
Barclays Capital Inc.	c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717. Tel: (888) 603-5847. Email: barclaysprospectus@broadridge.com
BTIG, LLC	65 East 55th Street, New York, New York 10022. Tel: (212) 593-7555. Email: ProspectusDelivery@btig.com
Titan Partners Group LLC	4 World Trade Center, 49th Floor, New York, NY 10007. Tel: (929) 833-1246. Email: prospectus@titanpartnersgrp.com

Humacyte, Inc. announced positive top-line interim results from the Phase 3 V012 study, demonstrating that its Acellular Tissue Engineered Vessel (ATEV) met the primary endpoint of superiority compared to the autologous arteriovenous (AV) fistula for dialysis access in female patients. The ATEV achieved an average of 220 catheter-free days versus 129 days for the AV fistula, a difference of 91 days that was statistically significant (p=0.00070). These results address a high-unmet-need population, as female patients often face suboptimal access options and higher failure rates with standard fistulas.

The V012 study is a prospective, multi-center, open-label, randomized, two-arm comparative study conducted in the United States. A prespecified interim analysis was conducted after the first 80 patients enrolled had completed 12 months of follow-up. As a result of meeting the primary endpoint, study enrollment will terminate, and existing patients will continue to be followed as per protocol.

Safety and Efficacy Data

The primary measure of efficacy was total days free from in-dwelling catheter until 365 days after access placement or until access abandonment. Beyond the efficacy benefit, the ATEV demonstrated a favorable safety profile. Patients receiving the ATEV incurred infections at a rate of 6 per 100 patient years, compared to 23 per 100 patient years for those receiving an AV fistula. There were no study access-associated infections reported in the ATEV group, compared to three in the AV fistula group, and no spontaneous ruptures were reported in either group.

Metric	ATEV	AV Fistula
Average Catheter-Free Days	220	129
Infection Rate (per 100 patient years)	6	23
Study Access-Associated Infections	0	3

Regulatory Pathway and Presentation

Based on these findings, Humacyte plans to file a supplemental Biologics License Application (BLA) with the Food and Drug Administration (FDA) during the second half of 2026. The target indication is adult patients with end-stage kidney disease who are at increased risk of AV fistula maturation failure. The company is scheduled to present the results on June 11, 2026, at the Society for Vascular Surgery's Vascular Annual Meeting in Boston.