United States v. Nader Pourhassan & Kazem Kazempour
PENDING CRIMINAL DIVISION CASES
United States v. Nader Pourhassan & Kazem Kazempour
Court Docket No.:22-CR-440
Court Assigned: This case is assigned to the U.S. District Court for the District of Maryland, U.S. Federal Building and Courthouse, 101 West Lombard Street Baltimore, MD 21201 before U.S. District Judge Paula Xinis.
On December 8, 2023, the court denied defendant Pourhassan’s and defendant Kazempour’s motions to dismiss. A status conference has been set for December 21, 2023 at 11:00 AM in Courtroom 2C before Judge Paula Xinis. A pretrial conference is set for March 1, 2024 at 10:00 AM.
A federal grand jury in the District of Maryland returned an indictment on December 15, 2022 charging two men for their roles in schemes to defraud investors in CytoDyn, Inc., a publicly traded biotechnology company (OTCQB: CYDY) based in Vancouver, Washington.
According to Indictment, Nader Pourhassan, 59, of Lake Oswego, Oregon, and Kazem Kazempour, 69, of Potomac, Maryland, allegedly engaged in a conspiracy and schemes 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 is separately charged with similar alleged schemes relating to leronlimab as a potential treatment for COVID-19 and with insider trading. The defendants 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 to benefit the defendants, 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 HIV to the FDA. In April 2020, after CytoDyn and Amarex repeatedly missed publicized timelines, Pourhassan 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 knew that the FDA would refuse to review an incomplete BLA. After Kazempour and Amarex 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 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 separately 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 and 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, each defendant faces a maximum penalty of 20 years in prison on each securities fraud and wire fraud count with which he is charged, and five years in prison on the conspiracy count. Kazempour also faces a maximum penalty of five years in prison on the false statement count. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.
For more information about the charges in this case, please see below:
Victim Impact Statement: If you would like to submit a Victim Impact Statement, you may do so by mailing the Victim Impact Statement below (or a letter to the court) to: Victim Witness Unit, U.S. Department of Justice, Criminal Division, Fraud Section, 10th & Constitution Avenue, NW, Bond Building, Room 4416, Washington, DC 20530. You also may submit the Victim Impact Statement via email at Victimassistance.email@example.com or by fax at: (202) 514-3708.
The information on this website will be updated as new developments arise in the case. If you have any questions, please call the Victim Assistance Line toll-free at (888) 549-3945 or email us at VictimAssistance.firstname.lastname@example.org.
Presumption of Innocence: It is important to keep in mind that a criminal indictment is merely an allegation, and defendants are presumed innocent until proven guilty and that presumption requires both the court and our office to take certain steps to ensure that justice is served.
Crime Victims’ Rights Act and Right to Retain Counsel: Because charges have been filed in this case in federal court, you also may be entitled to the following rights, according to the Crime Victims’ Rights Act, Title 18, United States Code, Section 3771: (1) The right to be reasonably protected from the accused; (2) The right to reasonable, accurate, and timely notice of any public court proceeding, or any parole proceeding, involving the crime or of any release or escape of the accused; (3) The right not to be excluded from any such public court proceeding, unless the court, after receiving clear and convincing evidence, determines that testimony by the victim would be materially altered if the victim heard other testimony at that proceeding; (4) The right to be reasonably heard at any public proceeding in the district court involving release, plea, sentencing, or any parole proceeding; (5) The reasonable right to confer with the attorney for the Government in the case; (6) The right to full and timely restitution as provided in law; (7) The right to proceedings free from unreasonable delay; (8) The right to be treated with fairness and with respect for the victim’s dignity and privacy; (9) The right to be informed in a timely manner of any plea bargain or deferred prosecution agreement; and (10) The right to be informed of the rights under this section and the services described in section 503(c) of the Victims’ Rights and Restitution Act of 1990 (42 U.S.C. § 10607(c)) and provided contact information for the Office of the Victims’ Rights Ombudsman of the Department of Justice. The Crime Victims’ Rights Act (18 U.S.C. § 3771) applies only to victims of the counts charged in federal court, and thus individuals may not be able to exercise all of these rights if the crime of which the individual is a victim was not charged.
Section 3771(c)(2) of this Act requires that we advise you that you have the right to retain counsel. Although the statute specifically sets forth your right to seek advice of an attorney with regard to your rights under the statute, there is no requirement that you retain counsel. The Government may not recommend any specific counsel, nor can the Government (or the Court) pay for counsel to represent you. Government attorneys represent the United States.
If you elect to obtain counsel to represent your interests, please have your attorney notify this office in writing at: U.S. Department of Justice, Criminal Division, Fraud Section, 10th & Constitution Avenue, NW, Bond Building, 4th Floor, Washington, DC 20530, Attention: Victim Witness Unit; fax: (202) 514-3708; or email: email@example.com. If you elect not to retain counsel to represent your interests, you do not need to do anything.
Plea Agreements: Please be aware that many criminal cases are resolved by plea agreement between the Department of Justice and the defendant. You should also know that it is not unusual for a defendant to seek to negotiate a plea agreement shortly before trial is scheduled to begin. Plea agreements can be made at any time and as late as the morning of trial, leaving little or no opportunity to provide notice to you of the date and time of the plea hearing. If the court schedules a plea hearing in this case, we will use our best efforts to notify you of available information as soon as practicable. If you want to inform the prosecutor of your views regarding potential plea agreements, or any other aspect of the case, please contact the prosecutor assigned to this case or call the Victim Assistance Line toll-free at (888) 549-3945 or email us at firstname.lastname@example.org.