Leronlimab

Investors claim that CytoDyn and former key executives mislad shareholders.\n Embattled CytoDyn and key ex-executives must face an investor lawsuit claiming the company knowingly misled shareholders about the status of its FDA application for leronlimab as a potential treatment for HIV and COVID-19.In the lawsuit, former CEO Nader Pourhassan, former chief financial officer Michael Mulholland and Scott Kelly, who previously served as board chairman and chief medical officer, are accused of making false and misleading statements about the company’s lead candidate over the span of two years to boost share prices. Investors, led by shareholder Brian Courter, sued the company and named executives in federal court in Washington State back in 2021 for alleged violations of the Securities Exchange Act.While CytoDyn argued for dismissal, contending that the complaint “ignores the context” in which many statements at issue were made, U.S. District Judge Benjamin H. Settle ultimately disagreed with the company\'s arguments. This week, the judge ruled (PDF) that the claims at issue are plausible, denying CytoDyn\'s motion for dismissal.Courter’s complaint alleges that in April 2020, the executives communicated to CytoDyn investors that the company\'s FDA Biologics License Application for leronlimab in HIV was complete when it was in fact not. The false disclosure spiked the company\'s stock price until the truth was revealed a week later, according to the lawsuit.Later that year, the company claimed that a secondary endpoint in a clinical trial for leronlimab as a COVID-19 treatment showed that the therapy was effective and supported an emergency use authorization (EUA) request to the FDA, according to the lawsuit. CytoDyn later admitted that it had not requested an EUA, despite previously assuring investors that it had, the suit contends.The situation continued through 2022, when executives continued to “falsely represent” that the drug was on a path to FDA approval and wouldn’t need another trial in HIV, the investor lawsuit claims. The FDA placed leronlimab’s development in HIV on a partial pause in 2022, along with a full hold in COVID. CytoDyn’s HIV program escaped the clinical hold in 2024. Under new leadership and a recently established oncology advisory board, the company is still moving forward with leronlimab in various solid tumor uses. New CEO Jacob Lalezari, M.D., made clear in a March letter to shareholders that he believes investors deserve “clear and direct updates” on business matters and that the company’s “collaborative relationship” with the FDA puts it on a “positive trajectory.”Meanwhile, Pourhassan, who led CytoDyn as CEO and president for ten years until being ousted by the board in 2022, was criminally convicted separately in December on four counts of securities fraud, two counts of fraud and three counts of insider trading. The former CEO was convicted alongside the ex-CEO of Amarex Clinical Research, the CRO that managed CytoDyn’s trials and FDA interactions. According to the Department of Justice, Pourhassan netted $4.4 million from CytoDyn’s stock sales during the time of the securities fraud scheme, while former Amarex head Kazem Kazempour made more than $340,000. The sentencing in the cases of Pourhassan and Kazempour has been pushed back to late September 2025.

Enrollment is now underway across multiple clinical sites, in partnership with Syneos HealthVANCOUVER, Washington, June 24, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that the first patient has been dosed in the Company’s clinical trial evaluating the efficacy of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer (“CRC”). In partnership with Syneos Health, the Company has engaged eight clinical sites and counting, and patient enrollment and processing efforts are underway. The lead principal investigator for the trial is Dr. Ben Weinberg, MD, from Georgetown University and the MedStar Health Alliance. According to the World Health Organization’s International Agency for Research on Cancer (“IARC”), colorectal cancer is the third most common cancer type worldwide, and the second most common cause of cancer-related deaths globally. IARC’s most recently published figures estimate that there are about 1.9 million new cases of colorectal cancer and more than 900,000 deaths due to colorectal cancer worldwide each year. The IARC also noted that the incidence rates of colorectal cancer in people younger than 50 years old have been increasing for at least 20 years, with some sources dating the increase trend back 30 years or more. “Dosing the first patient in our Phase II CRC trial is a significant step forward in our mission to bring innovative treatment options to patients facing this challenging disease. This milestone reflects the dedication of our team and clinical partners, and we look forward to advancing this study to better understand the potential impact of our therapy across solid tumor oncology,” said Dr. Jacob Lalezari, CEO of CytoDyn. The study builds on the Company’s prior research demonstrating the potential clinical benefit of leronlimab in patients with relapsed CRC, and will also further the evaluation of the potential for the Company’s recently announced mechanism of action for leronlimab in solid tumor oncology. Given the promising survival rates observed in the Company’s prior studies in patients with metastatic triple-negative breast cancer and the Company’s ongoing clinical investigation efforts in CRC, CytoDyn views its current line of scientific evaluation as the most expeditious path to determining how broadly applicable this mechanism may prove to be across various solid tumors. About CytoDyn CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn has studied leronlimab in multiple therapeutic areas, including oncology, infectious disease, and autoimmune conditions. About Syneos Health Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. Syneos Health translates unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Syneos Health brings a talented team of professionals with a deep understanding of patient and physician behaviors and market dynamics. Together, Syneos Health shares insights, uses the latest technologies and applies advanced business practices to speed its customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment. To learn more about how Syneos Health is shortening the distance from lab to life®, visit syneoshealth.com. Media Contacts CytoDynRiyaz LalaniGagnier CommunicationsCytoDyn@gagnierfc.com