Business
Humacyte Second Quarter 2023 Financial Results and Business Update
– Completed Enrollment in Phase 2/3 V005 Trial of HAV™ in Vascular Trauma Repair; Top-Line Results on Track for Q3 2023 – – Results from Vascular Trauma
About this update from Humacyte, Inc.
[{"type":"text","content":"– Completed Enrollment in Phase 2/3 V005 Trial of HAV™ in Vascular Trauma Repair; Top-Line Results on Track for Q3 2023 – – Results from Vascular Trauma Humanitarian Program in Ukraine Highlighted at 2023 Military Health System Research Symposium – - Conference call and live webcast at 8:00 a.m. ET today - DURHAM, N.C., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced financial results for the second quarter ended June 30, 2023, and highlighted recent corporate accomplishments. “Humacyte has made significant strides in the first half of 2023 in advancing our universally implantable Human Acellular Vessel™ (HAV) across our clinical development programs,” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. “Notably, we are excited that enrollment in the V005 trial in vascular trauma repair is now complete, and activities to report results are underway. We remain on track to report topline clinical trial outcomes in the third quarter of 2023, followed by a planned Biologics License Application (BLA) filing for the vascular trauma indication with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2023. We are also proud that our humanitarian efforts in Ukraine have resulted in successful outcomes to date, saving lives and limbs in a wartime setting. Finally, we are pleased that the potential of the HAV to resist infection was featured in a recent publication in Journal of Vascular Surgery – Vascular Science, adding to the growing body of literature supporting HAV use in multiple indications. We look forward to building our momentum throughout the second half of 2023 as we advance toward the expected regulatory submission in our first indication.” Second Quarter 2023 and Recent Corporate Highlights Clinical and Regulatory Updates Completed enrollment of Phase 2/3 clinical trial of HAV in vascular trauma repair – In July 2023, the Company announced enrollment completion in its Phase 2/3 trial of the HAV in vascular trauma repair (V005). The V005 trial is a single-arm, open-label, pivotal study of patients suffering from vascular trauma injuries, conducted at Level 1 Trauma Centers in the U.S. and Israel. The primary efficacy assessment is...