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Humacyte (HUMA) takes ex-U.S. Symvess control as Fresenius retains 8.4% stake

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
SCHEDULE 13D/A

Rhea-AI Filing Summary

Humacyte, Inc. and Fresenius Medical Care have amended their 2018 distribution agreement for Symvess, an acellular tissue engineered vessel. Humacyte now has exclusive rights to distribute Symvess outside the U.S., while Fresenius Medical Care Holdings, Inc. will receive low-single-digit royalties on ex-U.S. net sales.

Existing terms for U.S. distribution remain unchanged. Fresenius Medical Care Holdings, Inc. and its parent, Fresenius Medical Care, report beneficial ownership of 18,312,735 shares of Humacyte common stock, representing 8.4% of the class, all with shared voting and dispositive power.

Positive

  • None.

Negative

  • None.

Insights

Humacyte regains ex-U.S. Symvess rights, Fresenius shifts to royalty role.

The amendment gives Humacyte full ex-U.S. distribution control for Symvess, with Fresenius Medical Care Holdings, Inc. retaining economic exposure through low-single-digit royalties on net sales. U.S. commercialization terms remain as before.

This shift aligns with Fresenius Medical Care AG’s “Legacy Portfolio Optimization program,” suggesting a move away from direct ex-U.S. distribution toward a lighter, royalty-based structure. The filing also confirms Fresenius entities still beneficially own 18,312,735 Humacyte shares, or 8.4% of the common stock, maintaining a meaningful equity interest.

Beneficial ownership 18,312,735 shares Humacyte common stock beneficially owned by each Fresenius reporting person
Ownership percentage 8.4% Percent of Humacyte common stock class represented by 18,312,735 shares
Shared voting power 18,312,735 shares Shares with shared voting power for each reporting person
Shared dispositive power 18,312,735 shares Shares with shared dispositive power for each reporting person
Event date 04/24/2026 Date of event requiring the Schedule 13D amendment
Amendment to Distribution Agreement April 21, 2026 Date of Third Amendment to 2018 Distribution Agreement
Symvess(R) (acellular tissue engineered vessel) medical
"Humacyte will have the exclusive rights to distribute Symvess(R) (acellular tissue engineered vessel) outside the U.S."
Distribution Agreement financial
"Third Amendment to the 2018 Distribution Agreement between FMCH and Humacyte."
A distribution agreement is a contract that lets one party sell, market or deliver another party’s products or services in specified places or channels, and spells out who handles pricing, inventory, delivery, payments and how long the arrangement lasts. For investors it matters because these deals determine how widely a product can reach customers, how quickly revenue can grow, what profit margin the company keeps, and what legal or operational risks the business assumes—think of it like a store deciding which wholesaler will stock and promote a product.
low-single-digit royalties financial
"FMCH will be entitled to low-single-digit royalties on net sales of Symvess(R) outside the U.S."
Legacy Portfolio Optimization program financial
"FMCH agreed to reversion of ex-U.S. distribution rights to Humacyte as part of FME AG's "Legacy Portfolio Optimization program,""
beneficially owned financial
"Aggregate amount beneficially owned by each reporting person 18,312,735.00"
Beneficially owned describes securities or assets where a person has the economic rights and control—such as the right to receive dividends and to direct voting—even if legal title is held in another name. Think of it like having the keys and using a car that’s registered to someone else: you get the benefits and make decisions. Investors care because beneficial ownership reveals who truly controls value and voting power, affecting corporate decisions and takeover dynamics.
shared voting power financial
"Shared Voting Power 18,312,735.00"
Shared voting power occurs when two or more parties jointly have the right to vote or decide how a block of company shares is cast, like co-owners who must agree before moving a piece of furniture. Investors care because who controls voting rights affects board elections, major corporate decisions and takeover outcomes, and shared control can alter regulatory disclosures and the practical influence any holder has over a company’s direction and value.





020751103

(CUSIP Number)
Robert A. Grauman
145 West 86 Street,
New York, NY, 10024
646 202-2932


Thomas D. Brouillard
Fresenius Medical Care Holdings, Inc., 920 Winter Street
Waltham, MA, 02451-1547
781 699 9000


Christof Koester
Fresenius Medical Care AG, Else-Kroener Strasse 1
Bad Homburg, 2M, 61352
011 49 6172 609 0

(Name, Address and Telephone Number of Person Authorized to Receive Notices and Communications)
04/24/2026

(Date of Event Which Requires Filing of This Statement)


If the filing person has previously filed a statement on Schedule 13G to report the acquisition that is the subject of this Schedule 13D, and is filing this schedule because of §§ 240.13d-1(e), 240.13d-1(f) or 240.13d-1(g), check the following box.

The information required on the remainder of this cover page shall not be deemed to be "filed" for the purpose of Section 18 of the Securities Exchange Act of 1934 ("Act") or otherwise subject to the liabilities of that section of the Act but shall be subject to all other provisions of the Act (however, see the Notes).




schemaVersion:


SCHEDULE 13D






SCHEDULE 13D






SCHEDULE 13D


Fresenius Medical Care Holdings, Inc.
Signature:/s/ Bryan Mello
Name/Title:Bryan Mello, Asst. Treasurer
Date:04/24/2026
Fresenius Medical Care AG
Signature:/s/ ppa Dr. Angela Koelbl
Name/Title:Dr. Angela Koelbl, Registered Manager (Prokurist)
Date:04/24/2026
Signature:/s/ ppa Christof Koester
Name/Title:Christof Koester, Registered Manager (Prokurist)
Date:04/24/2026

FAQ

What change did Humacyte (HUMA) and Fresenius make to their Symvess distribution deal?

Humacyte and Fresenius amended their 2018 distribution agreement so Humacyte now holds exclusive rights to distribute Symvess outside the U.S., while Fresenius earns low-single-digit royalties on ex-U.S. net sales, with all existing U.S. terms unchanged.

Who distributes Symvess outside the U.S. after this Humacyte (HUMA) filing?

After the amendment, Humacyte holds exclusive rights to distribute Symvess outside the U.S. Fresenius Medical Care Holdings, Inc. no longer has ex-U.S. distribution rights but will receive low-single-digit royalties on Humacyte’s Symvess net sales in those markets.

How many Humacyte (HUMA) shares do Fresenius entities beneficially own?

Fresenius Medical Care Holdings, Inc. and Fresenius Medical Care report beneficial ownership of 18,312,735 Humacyte common shares. This stake represents 8.4% of the outstanding common stock, with shared voting and shared dispositive power over all reported shares.

Does the Humacyte (HUMA) and Fresenius amendment affect U.S. Symvess distribution?

The amendment does not change U.S. Symvess terms. The filing states that existing provisions related to the U.S. remain unchanged, while only ex-U.S. rights revert to Humacyte, with Fresenius receiving low-single-digit royalties on ex-U.S. net sales.

Why did Fresenius agree to return ex-U.S. Symvess rights to Humacyte (HUMA)?

Fresenius Medical Care Holdings, Inc. agreed to return ex-U.S. distribution rights to Humacyte as part of Fresenius Medical Care AG’s “Legacy Portfolio Optimization program,” as described in its public filings, while retaining a royalty interest on Symvess sales outside the U.S.

What exhibit is associated with the Humacyte (HUMA) and Fresenius distribution amendment?

The related exhibit is the Third Amendment dated April 21, 2026 to the June 25, 2018 Distribution Agreement between Fresenius Medical Care Holdings, Inc. and Humacyte. It is incorporated by reference from Humacyte’s Form 8-K filed on April 24, 2026.