Humacyte, Inc. - HUMA STOCK NEWS

Humacyte (Nasdaq: HUMA) presented positive long-term results from a humanitarian program in Ukraine using their investigational acellular tissue engineered vessel (ATEV) to treat vascular injuries. The study, known as the 'V017 trial', showed high rates of patency and avoidance of amputation and infection in severe wartime injuries.

Key findings include:

• 12-month primary and secondary patency rates of 87.1%
• Zero instances of ATEV infections, amputations, or deaths
• Mean follow-up duration of 357.9 days
• Only one event of ATEV thrombosis after month six
• No reports of ATEV aneurysm or pseudo-aneurysm

The ATEV is designed as an off-the-shelf, universally implantable vascular conduit for arterial replacement, repair, and hemodialysis access. It is still investigational and not yet approved for sale by the FDA or other regulatory agencies.

BioAesthetics has appointed Dr. Juliana Blum as its new Chief Executive Officer, effective August 12, 2024. Dr. Blum, co-founder and former EVP of Corporate Development at Humacyte (NASDAQ: HUMA), brings 20 years of experience in biotech development and commercialization. Her expertise includes global regulatory affairs, CMC development, and manufacturing scale-up.

BioAesthetics, a biotechnology company focused on biomaterials advancements, is developing the NACgraft™ biologic matrix, an acellular tissue graft for nipple regeneration in breast reconstruction patients. The company is also working on a drug-eluting graft technology for soft tissue reconstruction. Dr. Blum's appointment is seen as a strategic move to guide the company's products towards clinical trials and commercialization.

Humacyte (Nasdaq: HUMA) reported Q2 2024 financial results and business updates. Key highlights include:

1. FDA requires additional time to review ATEV™ BLA for vascular trauma treatment.

2. Positive topline results from Phase 3 trial of ATEV in hemodialysis access, showing superior functional patency over standard care.

3. ATEV received third RMAT designation from FDA for advanced peripheral artery disease.

4. Q2 2024 financial results: No revenue, R&D expenses $23.8M, G&A expenses $5.7M, net loss $56.7M.

5. Cash and cash equivalents of $93.6M as of June 30, 2024.

The company remains confident in ATEV's approvability for vascular trauma treatment despite the FDA review extension.

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology company developing universally implantable, bioengineered human tissue, will release its Q2 2024 financial results on August 13, 2024. The company will host a webcast and conference call at 8:30 a.m. ET to discuss recent corporate updates from its acellular tissue engineered vessel (ATEV) programs. Investors can join via phone (U.S.: 1-877-704-4453, International: 1-201-389-0920, Conference ID: 13747913) or webcast. A replay will be available on the company's investor website for at least 30 days after the event.

Humacyte (Nasdaq: HUMA) announced that the FDA requires additional time to review its Biologic License Application (BLA) for the acellular tissue engineered vessel (ATEV) in vascular trauma treatment. The FDA granted Priority Review in February 2024 with a PDUFA date of August 10, 2024. Despite active engagement and inspections, the FDA couldn't complete the review by the PDUFA date due to ATEV being a first-in-class product.

ATEV is designed as a universally implantable vascular conduit for arterial replacement and repair, available off-the-shelf. The BLA included positive results from the V005 pivotal Phase 2/3 clinical study and real-world evidence from Ukraine. ATEV showed high patency rates and low amputation and infection rates in both civilian and military clinical studies.

Humacyte (Nasdaq: HUMA) announced positive top-line results from its V007 Phase 3 Clinical Trial of the acellular tissue engineered vessel (ATEV) for arteriovenous access in hemodialysis patients. The ATEV demonstrated superior function and patency at six and 12 months compared to the current standard of care, autogenous fistula.

Key findings include:

• 81.3% of ATEV patients had functional patency at 6 months vs 66.4% for AV fistula
• 68.3% of ATEV patients had secondary patency at 12 months vs 62.2% for AV fistula
• ATEV patients achieved significantly longer duration of hemodialysis over 12 months

Humacyte plans to discuss potential market authorization with the FDA soon and present detailed results at upcoming medical conferences.

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology company, has strengthened its Board of Directors with the addition of two industry veterans. Dr. John P. Bamforth, former Chief Marketing Officer at Eli Lilly, and Dr. Keith Anthony Jones, Chief Physician Executive of the University of Alabama at Birmingham Health System, have joined the board.

This strategic move comes as Humacyte prepares for the planned commercial launch of its Acellular Tissue Engineered Vessel (ATEV™) for vascular trauma. Dr. Bamforth brings extensive commercialization and brand-development expertise, while Dr. Jones offers valuable medical and administrative experience. These additions are expected to support Humacyte's transition to commercial operations and the introduction of ATEV into major health systems.

Pluristyx and Humacyte have entered into a license agreement to develop the BioVascular Pancreas (BVP) using Pluristyx’s clinical-grade PluriBank™ induced Pluripotent Stem Cell (iPSC) line. This agreement allows Humacyte to utilize Pluristyx’s panCELLa™ platform, which generates 'hypoimmune' cells for clinical implantation. The partnership aims to create insulin-producing cells to integrate with Humacyte’s Acellular Tissue Engineered Vessel (ATEV™), potentially revolutionizing type 1 diabetes treatment. The BVP is designed to deliver and sustain insulin-producing islets inside the body. The Acellular Tissue Engineered Vessel and BVP are investigational and not yet approved by the FDA or other regulatory bodies.

PluriBank™ iPSCs are derived from regulatory-compliant donors and have undergone extensive characterization, expansion, and banking to ensure purity, identity, and genetic integrity. This collaboration aligns with Pluristyx's goal of providing safer and more effective cell therapies.

Humacyte's Acellular Tissue Engineered Vessel (ATEV) has received its third FDA RMAT designation, this time for advanced peripheral artery disease (PAD). The RMAT designation aims to expedite the development and review of regenerative medicine therapies for serious conditions. This follows the FDA's clearance of a new IND application for ATEV in PAD. ATEV is designed for vascular replacement and repair, being universally implantable and ready off-the-shelf. PAD affects the leg arteries, with many patients lacking suitable autologous veins for bypass. ATEV's availability could significantly improve patient outcomes.