Humacyte (Nasdaq: HUMA) regains ex-U.S. Symvess rights from Fresenius
Rhea-AI Filing Summary
Humacyte, Inc. entered a Third Amendment to its distribution agreement with Fresenius Medical Care, giving Humacyte the sole right to develop, manage regulatory matters for, and commercialize its 6 millimeter acellular tissue engineered vessel, branded Symvess, on a worldwide basis.
In return, Humacyte will pay Fresenius low-single-digit royalties on net sales of Symvess outside the U.S., after a two-year royalty-free period following launch in each country, while existing U.S. royalty rates from mid-single digits to low double digits remain in place and Fresenius stays obligated to adopt Symvess as a standard of care where supported. Humacyte highlights that this realignment supports its planned international expansion and potential indication-specific partnerships, while Symvess currently holds FDA approval only for extremity vascular trauma and remains investigational for other uses.
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Insights
Humacyte consolidates global Symvess rights while preserving its Fresenius partnership.
Humacyte has amended its agreement with Fresenius Medical Care so that Humacyte now controls development, regulatory activities, and commercialization of Symvess worldwide. This shifts ex‑U.S. distribution authority back to Humacyte while keeping Fresenius economically aligned through royalties.
The amendment introduces low‑single‑digit royalties on net sales of Symvess outside the U.S., after a two‑year royalty‑free launch period in each country. U.S. royalty tiers from mid‑single digits to low double digits are unchanged, and Fresenius remains obligated to adopt Symvess as standard of care where supported by data.
Strategically, this structure lets Humacyte pursue region‑specific and indication‑specific commercial partnerships, including in Saudi Arabia and Israel, while retaining an incentive‑based relationship with its largest shareholder. Actual financial impact will depend on regulatory progress, clinical uptake, and future corporate partnering terms disclosed in subsequent filings.
8-K Event Classification
Key Figures
Key Terms
acellular tissue engineered vessel medical
Regenerative Medicine Advanced Therapy (RMAT) designation regulatory
Biologics License Application regulatory
hemodialysis medical
peripheral artery disease (PAD) medical
extremity vascular trauma medical
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 1.01. Entry into a Material Definitive Agreement.
On April 21, 2026, Humacyte, Inc. (the “Company”) entered into the Third Amendment to Distribution Agreement (the “Amendment”) with Fresenius Medical Care Holdings, Inc. (“Fresenius”), to amend the Distribution Agreement, dated as of June 25, 2018, as amended, between the Company and Fresenius (the “Agreement”). Under the Agreement, Humacyte granted to Fresenius rights to develop and commercialize the Company’s 6 millimeter acellular tissue engineered vessel-tyod (the “Distribution Product”) outside of the U.S. As a result of the Amendment, the Company has the sole right to develop and commercialize, and conduct all regulatory matters relating to, the Distribution Product on a worldwide basis. Additionally, the Company will pay to Fresenius low-single-digit royalties on net sales of the Distribution Product in connection with this reversion of ex-U.S. rights to the Company under the Amendment subject to a two-year royalty free period following launch of the Distribution Product in each applicable country, The Company will continue to pay royalties on net sales of the Distribution Product in the U.S. at rates ranging from mid-single digits to low double digits and Fresenius remains obligated to adopt the Distribution Product as a standard of care in hemodialysis patients for which such use is supported by clinical results and health economic analyses..
The description of the Amendment set forth above is only a summary of its material terms and does not purport to be complete, and is qualified in its entirety by reference to the full and complete terms contained in the Amendment, which is filed as Exhibit 10.1 to this Form 8-K and is incorporated into this Item 1.01 by reference. The Amendment is not intended to be a source of factual, business or operational information about the Company or its subsidiaries. The representations, warranties and covenants contained in the Amendment were made only for purposes of the Amendment and as of specific dates, were solely for the benefit of the parties to the Amendment, and may be subject to limitations agreed upon by the parties, including being qualified by disclosures for the purpose of allocating contractual risk between the parties instead of establishing matters as facts; and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors or security holders. Accordingly, investors should not rely on the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the parties.
Item 7.01. Regulation FD Disclosure
On April 24, 2026, the Company issued a press release announcing the entry into the Amendment. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Item 7.01 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Item 7.01 shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit Number |
Description | |
| 10.1* | Third Amendment to Distribution Agreement, dated as of April 21, 2026, between Humacyte, Inc. and Fresenius Medical Care Holdings, Inc. | |
| 99.1 | Press release, dated April 24, 2026. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
* Certain confidential information contained in this exhibit, market by brackets, has been omitted because the information (i) is not material and (ii) is the type of information the company both customarily and actually treats as private or confidential.
1
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| HUMACYTE, INC. | |||
| Date: April 24, 2026 | By: | /s/ Dale A. Sander | |
| Name: | Dale A. Sander | ||
| Title: | Chief Financial Officer, Chief Corporate Development Officer and Treasurer | ||
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Exhibit 99.1
Humacyte Expands Commercial and Business Development Opportunities Through Realignment of Ex-U.S. Rights to Symvess®
- Ex-U.S. rights realigned under amendment to distribution agreement with Fresenius Medical Care -
- Positions Humacyte to advance discussions with corporate partners regarding international and indication-specific rights to Symvess –
- Existing terms related to U.S. distribution of Symvess remain unchanged
DURHAM, N.C., April 24, 2026 – Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that it has realigned the ex-U.S. rights to Symvess (acellular tissue engineered vessel) through an amendment to its distribution agreement with Fresenius Medical Care (FME).
““We are pleased to have worked successfully with our long-time partner and largest shareholder Fresenius Medical Care, to realign the global rights to Symvess in a manner that benefits both companies and best enables Humacyte’s planned international expansion,” said Dr. Laura Niklason, CEO of Humacyte. “The restructuring of ex-U.S. commercial rights enables us to fully advance the commercial initiatives that we previously announced in the Kingdom of Saudi Arabia and Israel in vascular injury repair and other indications. In addition, we are now positioned to advance discussions with prospective corporate partners regarding international and indication-specific rights to Symvess. As amended, the distribution agreement now provides that Humacyte will have the exclusive rights to distribute Symvess outside the U.S., and FME will be entitled to low-single-digit royalties on our net sales of Symvess outside the U.S. Existing terms related to the U.S. remain unchanged.”
For uses other than the FDA approval in the extremity vascular trauma indication, Symvess is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
About Humacyte
Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following
extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.
Forward-Looking Statements
This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize Symvess (including commercial initiatives in the Kingdom of Saudi Arabia and Israel) and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; the degree of market acceptance of and the availability of third-party coverage and reimbursement for Symvess and, if approved by regulatory authorities, our product candidates; our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated benefits of our ATEVs relative to existing alternatives; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials; the anticipated characteristics and performance of our ATEVs; the implementation of our business model and strategic plans for our business; our ability to execute and achieve the expected benefits of our cost-saving measures and whether our efforts will result in further actions or additional asset impairment charges that adversely affect our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, competitive and/or reputational factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Humacyte Investor Contact:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com
Humacyte Media Contact:
Rich Luchette
Precision Strategies
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com