Humacyte Inc - HUMA STOCK NEWS

Humacyte, Inc. (Nasdaq: HUMA) has announced a significant collaboration with JDRF International to advance its Biovascular Pancreas (BVP) product candidate, aimed at improving treatments for type 1 diabetes (T1D). The BVP utilizes Humacyte’s innovative Human Acellular Vessel™ (HAV™) to deliver insulin-producing islets. JDRF will provide funding to facilitate the development and testing of BVP technology, which has the potential to enhance the efficiency of insulin delivery in diabetic patients. This partnership reflects a commitment towards addressing the challenges faced by T1D sufferers, with hopes of making substantial impacts on the quality of life for millions. The BVP and HAV remain investigational products and are not yet FDA-approved.

Humacyte, Inc. (Nasdaq: HUMA) announced the publication of a preclinical study in the Journal of Trauma and Acute Care Surgery showing that its Human Acellular Vessel (HAV) outperforms expanded polytetrafluorethylene (ePTFE) grafts in vascular repair after arterial trauma. The study involved 36 pigs and measured factors like limb function recovery and graft patency over 28 days. Results indicated that the HAV demonstrated superior host recellularization, reduced infection risk, and mechanical failure compared to ePTFE. The company is nearing completion of enrollment in its Phase 2/3 V005 clinical trial, with 65 patients treated so far. The HAV has shown promising potential in various clinical applications, with a significant amount of patient-years experience globally. However, the HAV is still investigational and not yet FDA-approved.

Humacyte, Inc. (HUMA) has completed enrollment for its Phase 3 clinical trial, V007, aimed at evaluating the safety and efficacy of the Human Acellular Vessel (HAV) for hemodialysis access in patients with end-stage renal disease (ESRD). The trial involves 240 participants across multiple centers in the U.S. and compares the HAV to autogenous arteriovenous (AV) fistulas. Primary efficacy endpoints include usability assessments at six and twelve months, while secondary endpoints focus on infection rates. The HAV technology aims to provide quicker access to dialysis and reduce reliance on infection-prone catheters. With approximately 786,000 Americans impacted by ESRD, the HAV offers a promising alternative to current vascular access methods, which have significant risks. The product remains investigational and is not yet approved by the FDA.

Humacyte, Inc. (Nasdaq: HUMA) announced financial results for Q4 and the year ended Dec 31, 2022, reporting no revenue in Q4 2022 versus $177,000 in Q4 2021, and $1.6 million for the year, up from $1.3 million in 2021. The company is nearing enrollment completion in its Phase 2/3 HAV trial for vascular trauma, with 63 patients treated and plans for a Biologics License Application (BLA) filing within four months post-trial completion. The Phase 3 trial for AV access in hemodialysis has enrolled 238 patients. Humacyte's cash reserves stand at $151.9 million, expected to fund operations through 2024. Net loss for Q4 2022 was $3.7 million, compared to a net income of $42.6 million in Q4 2021.

Humacyte (Nasdaq: HUMA) will announce its financial results for Q4 and the year ended December 31, 2022, on March 24, 2023, at 8:00 AM ET. A webcast and conference call will follow to provide a corporate and financial update.

Humacyte focuses on developing bioengineered human tissues for various medical applications, notably in vascular treatments. Their human acellular vessels are in late-stage clinical trials and have received important FDA designations, including Regenerative Medicine Advanced Therapy (RMAT) and Fast Track.

DURHAM, N.C., Feb. 27, 2023 – Humacyte, a clinical-stage biotechnology platform company (Nasdaq: HUMA), has announced that CEO Laura Niklason and CFO Dale Sander will represent the company at two upcoming investor conferences in March. The Cowen’s 43rd Annual Health Care Conference will take place from March 6-8, with Humacyte presenting on March 6 at 1:30 p.m. ET. The Oppenheimer’s 33rd Annual Healthcare Conference is scheduled for March 13-15, with a presentation on March 14 at 2:40 p.m. ET. Webcast replays will be available for at least 30 days after each event. Humacyte focuses on developing bioengineered human tissues and advanced organ systems.

Humacyte, Inc. (Nasdaq: HUMA) announced significant findings from a six-year analysis of its Phase 2 clinical trial on human acellular vessels (HAVs). Results published in the Journal of Vascular Surgery – Vascular Science indicate a 60% overall secondary patency rate, with no reported graft rejection, infection, or amputations among patients with critical limb ischemia. The HAV demonstrated mechanical durability and potential for long-term use in restoring blood supply in patients with peripheral artery disease (PAD). Humacyte emphasizes the growing demand for effective PAD treatments, with over 200 million affected globally.

Humacyte, Inc. (Nasdaq: HUMA) is hosting a webinar on December 15, 2022, featuring key Ukrainian surgeons discussing the application of its Human Acellular Vessels (HAV) in treating wartime vascular trauma. The HAV has received priority designation from the U.S. Secretary of Defense for vascular trauma treatment and is designed to be infection-resistant and readily available. Humacyte's HAV is undergoing a Phase 2/3 clinical trial for civilian vascular trauma and has been used in over 460 implantations. However, the HAV remains investigational and has not received FDA approval.