Humacyte Inc Stock Price, News & Analysis

Humacyte, Inc. (Nasdaq: HUMA) announced participation in the 34th Annual Piper Sandler Healthcare Conference on December 1, 2022. CEO Laura Niklason and CFO Dale Sander will engage in a fireside chat at 12 PM ET in New York City. The event will be accessible via a live webcast, with a replay available for 30 days afterward. Humacyte is focused on developing bioengineered human tissues for treating various medical conditions, with significant advancements in acellular tissue technology, including their human acellular vessels currently in late-stage clinical trials.

Humacyte, Inc. (HUMA) reported progress in clinical development for its Human Acellular Vessel™ (HAV™) aimed at vascular trauma, anticipating a Biologics License Application (BLA) filing by mid-2023. The V005 Phase 2/3 trial demonstrated high patency and low rates of amputation and infection among 56 patients. The company reported a net loss of $25.3 million for Q3 2022, a decrease from the previous year, while revenue reached $31 thousand. The appointment of Lt. General Bruce Green and Dr. Cindy Cao to the board and management is expected to enhance oversight and regulatory strategy.

Humacyte, Inc. (Nasdaq: HUMA) presented promising six-month results of their Human Acellular Vessels (HAV) in a baboon coronary artery bypass grafting (CABG) model at the AHA Scientific Sessions. The HAV grafts showed patency and repopulation with the subjects' own cells, potentially overcoming issues faced by traditional saphenous vein grafts, which have a high failure rate. Additionally, the HAV demonstrates low rates of amputation and infection in clinical trials. The company is preparing for a 2023 BLA submission for vascular trauma and arteriovenous access.

Humacyte, Inc. (Nasdaq: HUMA) will announce its financial results for Q3 2022 on November 10, 2022. Management will provide a corporate and financial update during a conference call starting at 8:00 a.m. ET. Humacyte specializes in developing universally implantable bioengineered human tissues and organs, with ongoing late-stage clinical trials for human acellular vessels (HAVs) aimed at treating various vascular applications. The HAVs have received FDA designations, including Regenerative Medicine Advanced Therapy (RMAT) and Fast Track, indicating promising potential in the market.

Humacyte, Inc. (Nasdaq: HUMA) presented a clinical update on its Human Acellular Vessel (HAV) for vascular trauma at the 36th European Society for Vascular Surgery Annual Meeting in Rome. Surgeons in Ukraine reported utilizing HAV for treating injuries caused by the ongoing war, noting its role in facilitating vascular reconstructions without the need for harvesting veins. Clinical cases demonstrated successful outcomes, with patients recovering post-implantation. HAV has received priority designation from the U.S. Secretary of Defense and is under evaluation in Phase 2/3 trials for vascular trauma.

Humacyte, Inc. (Nasdaq: HUMA) announced significant leadership changes, appointing Lt. General Bruce Green, M.D., USAF-ret., to its Board of Directors and Yang (Cindy) Cao, Ph.D., as Chief Regulatory Officer. Green's military medical background and Cao's extensive experience in drug development position the company well for advancing its Human Acellular Vessels™ (HAV™) technology towards regulatory approval. The HAV™ has shown promise in addressing vascular trauma and has received notable designations from the FDA, positioning Humacyte for critical advancements in regenerative medicine.

Humacyte has announced a clinical update on its Human Acellular Vessel (HAV) presented by Dr. Todd E. Rasmussen at the ICMM World Congress. The HAV aims to improve the treatment of vascular trauma, being infection-resistant and readily available for quick implantation. Over 500 patients have received HAV implants in ongoing clinical trials, which also include humanitarian efforts in Ukraine. The HAV has received FDA designations such as RMAT and Fast Track, indicating its potential in addressing vascular injury, especially in combat scenarios.

Humacyte, Inc. (Nasdaq: HUMA) announced an oral presentation of its Human Acellular Vessel (HAV) by Dr. Todd E. Rasmussen at the 44th ICMM World Congress, held in Brussels on September 7, 2022. The presentation focused on innovations for wartime vascular injuries. Additionally, Humacyte will participate in the HC Wainwright 24th Annual Global Investment Conference on September 14, 2022, in New York. The company continues to advance its acellular tissue technology aimed at treating various vascular conditions and has received multiple designations from the FDA for its HAV products.

Humacyte, a clinical-stage biotechnology company, reported second-quarter 2022 revenue of $1.3 million, up from $0.7 million in 2021. The company successfully implanted its Human Acellular Vessels™ in wounded Ukrainian citizens, reportedly saving limbs. Notable appointments were made to the Board, including Diane Seimetz as a new director and Shamik Parikh as Chief Medical Officer. Despite a net income of $36.9 million for the quarter, the company continues to spend heavily on R&D, totaling $14.7 million for the quarter, reflecting ongoing initiatives and preparations for a commercial launch.