The filed complaint alleges that Humacyte, Inc. made materially false and/or misleading statements and/or failed to disclose that: (1) the Company’s Durham, North Carolina facility failed to comply with good manufacturing practices, including quality assurance and microbial testing; (2) the FDA’s review of the biologics license application would be delayed while Humacyte remediated these deficiencies; and (3) as a result, there was a substantial risk to FDA approval of acellular tissue engineered vessel for vascular trauma; and (4) as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.