Humacyte to Present at the H.C. Wainwright 28th Annual Global Investment Conference

Humacyte leadership will present at a major investor conference, highlighting its ATEV program and broader bioengineered tissue platform.

Rhea-AI Summary

Humacyte (HUMA)/b) will participate in a fireside chat at the H.C. Wainwright 28th Annual Global Investment Conference in New York on September 16, 2026, at 11:00 a.m. Eastern Time.Management will also be available for one-on-one investor meetings during the event at the Lotte New York Palace Hotel. A live webcast of the presentation and a replay for a limited time will be accessible through the Events & Presentations section of Humacyte’s website.

Humacyte is a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues. Its acellular tissue engineered vessel (ATEV) for vascular trauma received FDA Biologics License Application approval in December 2024 and holds priority designation from the U.S. Secretary of Defense. Additional ATEV programs are in late-stage clinical trials for arteriovenous access in hemodialysis and peripheral artery disease, and in preclinical development for several cardiovascular and metabolic indications.

Key Figures

Presentation date and time: September 16, 2026 at 11:00am ET

Presentation date and time

September 16, 2026 at 11:00am ET

H.C. Wainwright Global Investment Conference fireside chat

Key Terms

biologics license application, acellular tissue engineered vessel, regenerative medicine advanced therapy designation, fast track designation

4 terms

biologics license application regulatory

"Humacyte’s Biologics License Application for the acellular tissue engineered vessel"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

acellular tissue engineered vessel technical

"for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication"

Acellular tissue engineered vessels are lab-made replacement blood vessels created from biological materials but manufactured without living cells, so they act like a ready-made tube that the body can grow into and line with its own cells. For investors, they matter because they target a steady medical need (for example, replacing or bypassing damaged vessels) and carry commercial upside if proven safe and long-lasting, while also involving manufacturing, clinical trial and regulatory risks.

regenerative medicine advanced therapy designation regulatory

"receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation"

A U.S. regulatory designation that expedites development and review of certain cell, gene and tissue-based therapies designed to repair, replace or restore damaged tissue or organ function. It matters to investors because receiving the designation can shorten the path to approval, increase interaction with regulators, and make a program more attractive to partners or buyers — like giving a promising product a VIP pass through regulatory traffic, reducing time and risk to potential revenue.

fast track designation regulatory

"has also received FDA Fast Track designation"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

DURHAM, N.C., Sept. 10, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Founder, President, and Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 28^th Annual Global Investment Conference in New York, NY on September 16, 2026, at 11:00am Eastern Time. Management will also be available for one-on-one meetings.

Event: H.C. Wainwright 28^th Annual Global Investment Conference
Location: Lotte New York Palace Hotel, New York, NY
Presentation: Wednesday, September 16, 2026 at 11:00am ET
Webcast: click here

A replay will be available for a limited time following the presentation on the Events & Presentations portion of the Humacyte website.

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.

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

FAQ

Where and when is Humacyte’s presentation at the H.C. Wainwright conference?

The fireside chat is scheduled for Wednesday, September 16, 2026, at 11:00 a.m. Eastern Time at the Lotte New York Palace Hotel in New York, NY.

How can investors access the Humacyte presentation remotely?

A live webcast will be available via a link provided by the company, and a replay will be accessible for a limited time on the Events & Presentations section of Humacyte’s website.

Will Humacyte management be available for investor meetings at the conference?

Management will be available for one-on-one meetings during the H.C. Wainwright 28th Annual Global Investment Conference.

What is the regulatory status of Humacyte’s ATEV for vascular trauma?

Humacyte’s Biologics License Application for its acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024, and the ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense.

Which other indications are being pursued for Humacyte’s ATEVs?

ATEVs are in late-stage clinical trials for arteriovenous access for hemodialysis and peripheral artery disease. Preclinical development is underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and other cell and tissue applications.

What special FDA designations have Humacyte’s 6mm ATEVs received?

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 Fast Track designation. The 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced peripheral artery disease has also received RMAT designations.