Humacyte: Additional Time to Complete FDA Review of BLA

 2nd quarter conference call to be held Tuesday, August 13th, at 8:30 a.m. ET –

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of its Biologic License Application (BLA) for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication. The ATEV trauma program BLA was submitted to FDA in December 2023, and the FDA granted a Priority Review in February 2024 and assigned a PDUFA date of August 10, 2024. In a phone call from FDA CBER leadership today, the Company was informed that the FDA required additional time to complete its review.

“We received a call from FDA CBER leadership this afternoon apologizing to us and stating that additional time was required for review.” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. “FDA leadership noted that Humacyte’s ATEV is a first-in-class product, and that Priority Review had been granted, which allows only a six-month review cycle, as compared to the standard ten-month review cycle for most products. During the course of the BLA review, the FDA has conducted inspections of our manufacturing facilities and clinical sites and has actively engaged with us in multiple discussions regarding our BLA filing, including post-marketing and labeling discussions. Based on these interactions, we are confident in the approvability of the ATEV in treating vascular trauma. The FDA leadership expressed an apology for their inability to complete the review by the PDUFA date, and currently we do not yet have a revised action date.”

Conference Call Information

Management will be available during its 2nd quarter 2024 financial report and business update conference call, details ss follows:

Date:	August 13, 2024
Time:	8:30 AM Eastern Time
Conference Call Details:	1-877-704-4453 (U.S. Investors Dial) 1-201-389-0920 (International Investors Dial) 13747913 (Conference ID)
Call meTM Feature:	Click Here
Webcast:	Webcast Link - Click Here

https://www.globenewswire.com/news-release/2024/08/09/2927921/0/en/Humacyte-Announces-FDA-Communication-of-Additional-Time-Required-to-Complete-Review-of-acellular-tissue-engineered-vessel-ATEV-BLA-for-the-Treatment-of-Vascular-Trauma.html