HUMA

Business Context and Reporting Period

Company: Humacyte, Inc.
Filing Type: Form 8-K (Current Report)
Date of Report: April 21, 2026
Event: Entry into a Material Definitive Agreement (Third Amendment to Distribution Agreement) with Fresenius Medical Care Holdings, Inc.

Key Financial Metrics

This filing is a current report regarding a contractual amendment and does not contain audited financial statements, revenue, profit, cash flow, or balance sheet data. Specific financial metrics such as margins, debt, or liquidity are not provided in this document.

Material Changes Versus Prior Period

The filing details a significant strategic shift in the commercialization rights for Humacyte's 6 millimeter acellular tissue-engineered vessel (the "Distribution Product"):

• Reversion of Rights: Humacyte has regained the sole right to develop, commercialize, and handle regulatory matters for the Distribution Product on a worldwide basis, including outside the U.S.
• Previous Arrangement: Previously, Fresenius held rights to develop and commercialize the product outside the U.S.
• U.S. Operations: Humacyte continues to hold rights in the U.S., where it pays Fresenius royalties ranging from mid-single digits to low double digits on net sales.

Guidance, Outlook, and Contractual Terms

Royalty Obligations:

• Non-U.S. Sales: Humacyte will pay Fresenius low-single-digit royalties on net sales of the Distribution Product outside the U.S.
• Royalty-Free Period: A two-year royalty-free period applies following the launch of the Distribution Product in each applicable country outside the U.S.
• U.S. Sales: Existing royalty rates (mid-single to low double digits) remain in effect for U.S. net sales.

Commitments: Fresenius remains obligated to adopt the Distribution Product as a standard of care in hemodialysis patients where supported by clinical results and health economic analyses. Management Commentary: The filing includes a press release (Exhibit 99.1) issued on April 24, 2026, announcing the amendment. The document explicitly states that representations and warranties in the agreement are for the benefit of the parties and should not be relied upon as characterizations of actual facts by investors.

Investor Verification Checklist

• Verify the specific "low-single-digit" royalty percentage defined in the full text of the Third Amendment (Exhibit 10.1).
• Confirm the definition of "net sales" and the calculation methodology for royalties in both U.S. and non-U.S. territories.
• Review the press release (Exhibit 99.1) for any additional strategic commentary or timeline updates regarding the product launch.
• Assess the impact of regaining worldwide rights on Humacyte's future capital expenditure and operational costs.
• Monitor the status of the "standard of care" adoption obligation by Fresenius in the U.S. market.