Humacyte Faces Class Action Lawsuit Over Alleged Misstatements and Regulatory Compliance Issues

### Humacyte Faces Class Action Lawsuit Over Alleged Misstatements

Humacyte, Inc., a biotechnology company specializing in regenerative medicine, finds itself in the midst of a class action lawsuit initiated by Glancy Prongay & Murray LLP. The lawsuit, filed in the United States District Court for the Middle District of North Carolina, targets the company for allegedly violating securities laws during a critical period in which it sought approval for its acellular tissue engineered vessel (ATEV). The legal action, identified under case number 1:24-cv-00954, claims that Humacyte misled investors regarding its operations and compliance with federal regulations, particularly in relation to its Biologic License Application (BLA) for the ATEV.

The lawsuit comes on the heels of significant setbacks for Humacyte, notably after the U.S. Food and Drug Administration (FDA) indicated that it required additional time to review the BLA due to compliance issues at the company’s Durham facility. On August 9, 2024, this announcement resulted in a sharp decline in Humacyte's stock price, dropping 16.4% to close at $6.62 per share. The situation worsened when, on October 17, 2024, the FDA issued a Form 483, outlining multiple violations related to quality oversight and microbial testing. This led to another fall in stock value, plunging 16.35% to $4.86 per share. The class action alleges that Humacyte's management failed to disclose these critical compliance issues, exposing investors to significant risks regarding the ATEV's approval process.

As part of the lawsuit, individuals and entities that acquired Humacyte securities between May 10, 2024, and October 17, 2024, are encouraged to seek lead plaintiff status, with a 60-day window from the notice date to act. The plaintiffs allege that the company’s misleading statements concerning its operational stability and regulatory compliance have resulted in substantial financial losses for investors. In light of these developments, GPM is actively reaching out to affected individuals to help them navigate their potential claims under federal securities laws.

In addition to the legal ramifications, the ongoing scrutiny from the FDA raises critical questions about Humacyte’s operational integrity and its ability to deliver on its promise of innovative medical solutions. The fallout from these compliance issues not only affects investor confidence but also poses challenges to the company’s future endeavors in the rapidly evolving regenerative medicine sector. As Humacyte navigates this tumultuous period, the outcome of the lawsuit could have lasting implications for its operational and financial health.