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Humacyte to Announce Top Line Data from Phase 2/3 V005 Trial in Vascular Trauma Evaluating its Human Acellular Vessel™ (HAV™) Tuesday, September 12, 2023 at 8:00 AM ET

Key Takeaway: Humacyte, Inc. is set to announce top line data from its Phase 2/3 V005 trial that evaluates its Human Acellular Vessel (HAV) for vascular trauma repair. This virtual webinar will feature discussions by Dr. Michael Curi regarding the desperate need in the field of vascular trauma. The HAV has received important designations from the FDA and the Department of Defense, highlighting its potential as an innovative treatment option. The announcement is scheduled for September 12, 2023, at 8:00 AM ET.
Price reaction · baseline $3.79 (2023-09-08 close) · 1 other HUMA headline(s) in the window, move may be shared
day 0 close · peak
-2.4%

Market Sentiment Analysis

POSITIVE FACTORS

  • Humacyte is announcing top line data from a significant clinical trial.
  • The Human Acellular Vessel (HAV) has received priority designation for vascular trauma treatment.
  • Dr. Michael Curi will discuss the unmet clinical need, indicating strong clinical interest.
  • The HAV is positioned to address critical needs in both civilian and military applications.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+21%
120-day peak, hindsight
Typical move
7.2%
average across 3 past catalysts
Cash runway
~11 mo
Medium dilution risk
Lead asset
Acellular Tissue Engineered Vessel
Phase 3 · Vascular Trauma

Full Press Release Details

DURHAM, N.C., Sept. 11, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, will host a virtual webinar to announce top line data results from its Phase 2/3 V005 vascular trauma clinical trial. The V005 trial evaluated the HAV, an off-the-shelf, universally implantable bioengineered human tissue, in vascular trauma repair. The event will also feature Dr. Michael Curi (Rutgers University), who will discuss the unmet clinical need in vascular trauma, and the use of the HAV as a potential repair solution for patients and soldiers with limb- and life-threatening injuries. Dr. Curi has utilized the HAV and has participated in the V005 clinical trial.
The HAV has received priority designation for the treatment of vascular trauma by the U.S. Department of Defense and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.
A live question and answer session will follow the formal presentations. Details of the data announcement webinar are as follows:
Title: Phase 2/3 V005 Trial Top Line Data Announcement
Date: Tuesday, September 12, 2023
Time: 8:00 AM ET
Webcast: Webcast Link – Click Here
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 initial opportunity is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, AV access for hemodialysis, and peripheral arterial disease. 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 HAV for AV access for 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 HAV for urgent arterial repair following extremity vascular trauma also has received RMAT designation. The HAV 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:
LifeSci Advisors LLC
Humacyte Media Contact:
Precision Strategies

Frequently Asked Questions

What is the purpose of the V005 clinical trial?

The V005 trial assesses the HAV, a bioengineered tissue, for vascular trauma repair.

When is the webinar for the V005 trial results?

The webinar is scheduled for Tuesday, September 12, 2023, at 8:00 AM ET.

Who is Dr. Michael Curi?

Dr. Michael Curi is from Rutgers University and discusses vascular trauma's clinical needs.

What designations has the HAV received?

The HAV has received RMAT designation and priority designation for vascular trauma treatment.

What conditions does Humacyte target with its technology?

Humacyte targets vascular trauma, hemodialysis access, peripheral arterial disease, and more.

Last updated: Sep 11, 2023