Humacyte, Inc. (HUMA) Securities Class Action

The investigation focuses on Humacyte’s statements about the FDA’s inspections and the company’s disclosures about its communications with the FDA’s inspections, particularly about the FDA’s inspections of the company’s facilities for the manufacture of its tissue engineered vessel (ATEV) in the vascular trauma indication.

On May 12, 2024, during the company’s Q1 2024 earnings call, an analyst specifically questioned Humacyte management about the company’s facility inspection with the FDA. Humacyte’s Chief Operating Officer (Heather Prichard) said in part that “our manufacturing facility and had a very successful outcome[] [a]nd based on the outcome of inspection and all of the other FDA interactions on the whole, we remain very confident in approval of HAV in vascular trauma.”

When Prichard made the above statements, the FDA had on April 5, 2024 sent her a letter on Form 483 which was not published until October 17, 2024 that communicated serious matters listing inspectional observations. The FDA observed in its April 5, 2024 Form 483 that the company’s facility had no microbial quality assurance, inadequate quality assurance, and reciting that under FDA regulations its observer in his or her judgment indicated that the observations consisted in whole or part of filthy, putrid, or decomposed substance or has been prepared, packed or held under insanitary conditions whereby it may have been become contaminated with filth, or whereby it may have been rendered injurious to health.

But on August 12, 2024, Humacyte’s shares plunged 16% on news that the FDA communicated its delay in considering the company’s biologics license application for ATEV. Then, on October 17, 2024 the FDA published its April 5, 2024 Form 483 addressed to Prichard, driving the price of Humacyte shares down another 16%.

FREQUENTLY ASKED QUESTIONS ABOUT THE CASE

What is the HUMA investigation about?

We are focused on Prichard’s ‘very successful outcome’ assurance versus the FDA’s publication on October 17, 2024.

WHAT SHOULD I DO?

I worked at HUMA. What should I do?

If you were an employee of HUMA, you may have valuable information that could be relevant to the investigation. Hagens Berman is one of the nation’s top whistleblower law firms, and has successfully represented many individuals who come forward with information regarding corporate malfeasance. Under the new SEC Whistleblower program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, contact Reed Kathrein at 844-916-0895 or [email protected].

There are multiple law firms participating, do I need to contact all of them?

No, you do not need to contact all participating law firms. Generally, class-action investigations and lawsuits are consolidated into a single case to streamline the legal process, and attorneys from only a few law firms are selected to serve in a leadership role on the consolidated case. Hagens Berman has a proven track record of being appointed to leadership roles in complex, multidistrict litigation regarding investor fraud and other consumer rights issues, and your claim will be handled by attorneys who have helped secure approximately $325 billion in class-action settlements on behalf of individuals who have suffered due to corporate malfeasance and the wrongdoing of other powerful institutions.

AM I ELIGIBLE?

What is the threshold amount to be eligible? What are “substantial” losses?

The threshold amount and the definition of "substantial" losses may vary depending on a number of factors specific to the case, including the size of the company, market cap, shares outstanding and who holds them and the damages alleged by the fraud. In general, to be eligible to participate in a class-action lawsuit, you must be able to demonstrate that you suffered financial losses as a result of the alleged wrongdoing and that your losses meet the criteria set by the court or law firm. Fill out the form and submit your losses.

CAN I PARTICIPATE?

Am I affected? What do I need to do to participate?

If you were an investor in HUMA, you may be affected and eligible to participate in the case. To determine your eligibility and potential involvement, fill out the form and submit your losses.

Can any HUMA investor participate?

In most class-action investigations and cases, any investor who meets the eligibility criteria, including purchasing the shares during the relevant period, can participate, regardless of the size of their investment. Fill out the form to find out your rights.

I bought on a non-U.S. Exchange. Can I participate?

No. This investigation only covers shares bought on a U.S. exchange, i.e. NASDAQ or NYSE. Fill out the form to find out your rights.

Am I included if I still hold my shares, or do I need to sell to participate?

Participation is based on purchasing shares during the relevant period, rather than your current holdings. Accordingly, you do not need to sell to participate. Fill out the form to find out your rights.