Full Press Release Details
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.
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:
LifeSci Advisors LLC
Humacyte Media Contact:
Precision Strategies