A federal grand jury in the District of Maryland returned an indictment that was unsealed December 20 charging two men for their roles in schemes to defraud investors in CytoDyn, a publicly traded biotechnology company based in Vancouver, Washington.
Article continues below
According to court documents, Nader Pourhassan, 59, of Lake Oswego, Oregon, and Kazem Kazempour, 69, of Potomac, Maryland, allegedly engaged in a conspiracy to defraud investors through false and misleading representations and material omissions relating to CytoDyn’s development of leronlimab, a monoclonal antibody investigational drug also known as PRO 140, as a potential treatment for human immunodeficiency virus (HIV).
Pourhassan and Kazempour allegedly deceived investors about the timeline and status of CytoDyn’s regulatory submissions to the U.S. Food and Drug Administration (FDA) to artificially inflate and maintain the price of CytoDyn’s stock and attract new investors, and for their personal benefit, including by selling their personal shares of CytoDyn stock.
Pourhassan was CytoDyn’s president and CEO at the time of the alleged fraud. Kazempour is the co-founder, president, and CEO of Amarex Clinical Research LLC (Amarex), a private company with offices in Germantown, Maryland, that managed CytoDyn’s clinical trials, and was CytoDyn’s regulatory agent in interactions with the FDA.
Kazempour also served on CytoDyn’s Disclosure Committee, which was responsible for reviewing and approving CytoDyn’s periodic filings with the U.S. Securities and Exchange Commission.
The indictment alleges that Pourhassan and Kazempour made and caused CytoDyn to make materially false and misleading representations about the timelines by which CytoDyn and Amarex would complete and submit CytoDyn’s biologics license application (BLA) for leronlimab’s treatment of HIV to the FDA.
In April 2020, after CytoDyn and Amarex repeatedly missed publicized timelines, Pourhassan allegedly directed Kazempour and Amarex to submit the BLA – even if it was incomplete – so that Pourhassan and CytoDyn could announce to investors that the BLA had been submitted.
Pourhassan and Kazempour allegedly knew that the FDA would refuse to review an incomplete BLA.
After Kazempour and Amarex allegedly submitted the incomplete BLA at Pourhassan’s direction, Pourhassan and CytoDyn misrepresented in a press release that a “complete” BLA had been submitted to the FDA when, in truth and in fact, it had not.
Pourhassan then allegedly sold millions of dollars’ worth of CytoDyn stock based on material non-public information, including information about the fact that the BLA was, in truth and in fact, incomplete when submitted.
The indictment also alleges that Pourhassan made, and caused CytoDyn to make, materially false and misleading representations about CytoDyn’s investigation and development of leronlimab as a potential treatment for COVID-19, including the results and significance of clinical trials and the status of CytoDyn’s regulatory submissions to the FDA.
Pourhassan allegedly knew that, in truth and in fact, leronlimab’s clinical studies failed to achieve the results necessary to obtain any form of FDA approval for use as a treatment for COVID-19 and the results CytoDyn publicly touted were neither statistically significant nor scientifically sound.
Pourhassan and Kazempour are each charged with one count of conspiracy to commit securities fraud and wire fraud, three counts of securities fraud, and two counts of wire fraud related to the HIV BLA scheme.
Pourhassan is separately charged with an additional count of securities fraud, an additional count of wire fraud related to the COVID-19 scheme, and three counts of insider trading. Kazempour is separately charged with one count of making false statements to federal law enforcement agents.
If convicted, Pourhassan and Kazempour each face a maximum penalty of 20 years in prison on each securities fraud and wire fraud count, and five years in prison on the conspiracy count. Kazempour also faces a maximum penalty of five years in prison on the false statements count.
A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors. ■