Humacyte, Inc.

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    There is no cost or obligation associated with submitting your information. If you are a shareholder who suffered a loss, please submit your contact information and purchase information to participate in the putative class action.

    We also encourage you to contact Lesley F. Portnoy of The Portnoy Law Firm, at 310.692.8883, to discuss your rights free of charge. You can also reach us through the firm’s website at www.portnoylaw.com, or by email at info@portnoylaw.com.

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    CONTACT:
    Portnoy Law Firm
    Lesley F. Portnoy, Esq.,
    www.portnoylaw.com
    Office: 310.692.8883
    1800 Century Park East, Suite 600
    Los Angeles, CA 90067
    info@portnoylaw.com

    Case Allegations:

    Humacyte is involved in developing and manufacturing bioengineered, off-the-shelf human tissues designed for implantation, aiming to treat various diseases and conditions across different parts of the body. The company is currently working on Acellular Tissue Engineered Vessel (ATEV) and, in December 2023, submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its use in urgent arterial repair following vascular trauma, especially when synthetic grafts or autologous veins are not viable options.

    The class action lawsuit against Humacyte claims that, during the relevant period, the company made false or misleading statements, and failed to disclose critical information, including:

    1. Humacyte’s Durham, North Carolina manufacturing facility did not meet good manufacturing practices (GMP), including failing in quality assurance and microbial testing.
    2. The FDA’s review of the BLA would be delayed due to these issues, which would pose a significant risk to receiving FDA approval for ATEV as a treatment for vascular trauma.

    Additionally, the lawsuit claims that on August 9, 2024, Humacyte revealed that the FDA would need more time to complete its review of the BLA for ATEV in vascular trauma. The company also disclosed that the FDA had inspected their manufacturing facilities and clinical sites, engaging in discussions about the BLA filing. Following this announcement, Humacyte’s stock price dropped by more than 16%, according to the complaint.

    On October 17, 2024, the lawsuit further claims that the FDA issued a Form 483, which highlighted several violations at Humacyte’s Durham facility, including a lack of microbial quality assurance, no microbial testing, and insufficient quality oversight. This news caused Humacyte’s stock price to fall by an additional 16.35%.