Business
Humacyte Third Quarter 2022 Financial Results and Business Update
-- Progress Continues in Clinical Development of Human Acellular Vessel™ (HAV™) for Vascular Trauma; BLA Filing Anticipated mid 2023 – -- Experience with HAV
About this update from Humacyte, Inc.
[{"type":"text","content":"-- Progress Continues in Clinical Development of Human Acellular Vessel™ (HAV™) for Vascular Trauma; BLA Filing Anticipated mid 2023 – -- Experience with HAV in Ukrainian War Vascular Trauma Mirrors Clinical Experiences in Civilians in the U.S., High Patency and Low Rates of Amputation and Infection Observed – -- Pre-Clinical Studies of Small Diameter HAV in Coronary Bypass Continue to be Promising – -- Strengthened Board of Directors with Appointment of Lt. General C. Bruce Green, M.D., USAF-ret and Senior Management Team with Appointment of Yang (Cindy) Cao, Ph.D. as Chief Regulatory Officer – -- Conference Call and Live Webcast at 8:00 a.m. ET Today – DURHAM, N.C., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues, advanced tissue constructs and organ systems at commercial scale, today announced financial results for the third quarter ended September 30, 2022, and highlighted recent corporate accomplishments. “The third quarter of 2023 proved to be highly productive for Humacyte, with continued progress across our clinical and preclinical programs and multiple data presentations at key medical meetings,” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. “We expect to file our Biologics License Application (BLA) for an indication in vascular trauma in mid 2023. We are pleased with the trial’s progress and the positive results obtained to date. In addition, we are proud to be partnering with the Diabetes Research Institute to support our Biovascular Pancreas product development program in severe type 1 diabetes. The opportunity to work with the outstanding scientists and physicians at DRI is an exciting addition to our BVP program that we anticipate will accelerate our product development. Finally, we welcome to the Humacyte leadership team Dr. Lt. General Bruce Green and Dr. Cindy Cao, whose extensive expertise will be invaluable as our HAVs continue to progress toward approval.” Third Quarter 2022 and Recent Corporate Highlights Clinical Updates The Company plans to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for an indication in vascular trauma in mid 2023. As of October 31, 2022, 56 patients had received the HAV in the V005 Phase 2/...