Humacyte Late-Breaking Abstract Accepted for Oral Presentation on V007 Phase 3 AV Access Clinical Trial at the American Society of Nephrology’s Kidney Week 2024

Rhea-AI Summary

Humacyte, Inc. (Nasdaq: HUMA) announced that its late-breaking abstract on the V007 Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV™) in arteriovenous access for patients with end-stage renal disease has been accepted for an oral presentation at the American Society of Nephrology's (ASN) Kidney Week 2024. The presentation, titled "Prospective Randomized Trial of Humacyte's Acellular Tissue Engineered Vessel Versus Autologous Arteriovenous Fistula for Hemodialysis Access," will be delivered by Dr. Mohamad A. Hussain on October 26, 2024, in San Diego. Humacyte plans to provide additional details from the presentation in a future press release. The ATEV is still an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Positive

• Late-breaking abstract accepted for oral presentation at a major industry conference
• Phase 3 clinical trial results to be presented, indicating progress in product development
• Presentation by a prominent medical professional from Harvard Medical School

Negative

• ATEV is still an investigational product without regulatory approval

Insights

Medical Research Analyst

The acceptance of Humacyte's late-breaking abstract for oral presentation at ASN Kidney Week 2024 is a significant milestone for the company's V007 Phase 3 clinical trial. This presentation will showcase results from their acellular tissue engineered vessel (ATEV™) for arteriovenous access in end-stage renal disease patients.

The study compares ATEV™ to the current standard of autologous arteriovenous fistula, which could potentially revolutionize hemodialysis access if successful. The high-profile nature of the presentation at a major nephrology conference suggests the data may be compelling.

For investors, this event could be a catalyst for Humacyte's stock. Positive trial results could significantly advance the company's path to commercialization and potentially expand its $656 million market cap. However, it's important to note that ATEV™ is still investigational and not yet FDA-approved, which carries inherent risks.

While the presentation itself doesn't guarantee success, it provides a platform for Humacyte to showcase its technology to key opinion leaders in nephrology, potentially influencing future adoption if approved.

DURHAM, N.C., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced that its late-breaking abstract on the V007 Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV™) in arteriovenous access for patients with end-stage renal disease was accepted for an oral presentation at the American Society of Nephrology’s (ASN) Kidney Week 2024. The late-breaking abstract titled “Prospective Randomized Trial of Humacyte's Acellular Tissue Engineered Vessel Versus Autologous Arteriovenous Fistula for Hemodialysis Access” will be presented at the ASN meeting in San Diego on October 26, 2024.

Details of the presentation are as follows:

Late-Breaking Presentation Title: Prospective Randomized Trial of Humacyte's Acellular Tissue Engineered Vessel Versus Autologous Arteriovenous Fistula for Hemodialysis Access

Presenter: Dr. Mohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACS, Vascular and Endovascular Surgeon-Scientist at Brigham and Women’s Hospital, Core Faculty at the Center for Surgery and Public Health, and Assistant Professor of Surgery at Harvard Medical School

Session Title: High-Impact Clinical Trials - 2

Session Date/Time: Saturday, October 26, 2024 from 10:30 AM PT to 12:30 PM PT

For more information on the American Society of Nephrology (ASN) Kidney Week 2024, please click here.

Humacyte expects to provide additional details from the oral presentation in a future press release that will be posted to the News & Events section on the Investors page of the Humacyte website.

The ATEV 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. Humacyte develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial product candidates, a portfolio of ATEVs, are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. A Biologics License Application for the ATEV in the vascular trauma indication is currently under review by the FDA and was granted Priority Review. 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 an 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, the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our ATEV; our ability to successfully complete preclinical and clinical trials for our ATEVs; the anticipated benefits of the our ATEVs relative to existing alternatives; the anticipated commercialization of our ATEVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for 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, and/or competitive 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, 2023, filed by Humacyte with the SEC, and in subsequent 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

FAQ

What is the subject of Humacyte's (HUMA) late-breaking abstract at ASN Kidney Week 2024?

Humacyte's late-breaking abstract is on the V007 Phase 3 clinical trial of their acellular tissue engineered vessel (ATEV™) in arteriovenous access for patients with end-stage renal disease.

When and where will Humacyte (HUMA) present its Phase 3 clinical trial results?

Humacyte will present its Phase 3 clinical trial results on October 26, 2024, at the American Society of Nephrology's Kidney Week 2024 in San Diego.

Who will be presenting Humacyte's (HUMA) clinical trial results at ASN Kidney Week 2024?

Dr. Mohamad A. Hussain, a Vascular and Endovascular Surgeon-Scientist at Brigham and Women's Hospital and Assistant Professor of Surgery at Harvard Medical School, will present Humacyte's clinical trial results.

What is the regulatory status of Humacyte's (HUMA) ATEV product?

Humacyte's ATEV is still an investigational product and has not been approved for sale by the FDA or any other regulatory agency.