CYTODYN INC - CYDY STOCK NEWS

CytoDyn has appointed Richard Pestell, M.D., Ph.D. as Lead Consultant in Preclinical and Clinical Oncology. Dr. Pestell, who previously served as Vice Chairman and CMO, will lead the company's R&D strategy in oncology for leronlimab development. He brings over 30 years of research experience and currently serves as President of the Pennsylvania Cancer and Regenerative Medicine Research Center. During his previous tenure at CytoDyn, he was instrumental in obtaining FDA Fast Track Designation for leronlimab in combination with carboplatin for CCR5-positive metastatic triple-negative breast cancer treatment. Dr. Pestell's work includes over 600 publications with more than 95,000 citations.

CytoDyn (OTCQB: CYDY) has received FDA clearance to begin its Phase II oncology trial evaluating leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer (CRC). The clearance follows productive feedback sessions with the FDA and submission of the final study protocol in September 2024. The trial will be conducted in partnership with Syneos Health, with a kickoff meeting scheduled for late November 2024 and patient enrollment beginning in early 2025. The company's CCR5 antagonist, leronlimab, shows potential for multiple therapeutic indications.

CytoDyn (OTCQB: CYDY) has appointed Dr. Melissa Palmer as Lead Consultant in Hepatology to drive the company's research and development strategy for liver conditions. Following promising initial results, CytoDyn has commissioned two follow-up studies with SMC Laboratories to confirm fibrosis reversal observations, with results expected in early 2025. The studies will compare leronlimab alone and in combination with other therapies, including resmetirom and a GLP-1 agonist. Dr. Palmer, an internationally renowned hepatologist with over three decades of experience and previous interim CMO role at CytoDyn, will oversee these studies focusing on MASH and liver fibrosis treatments.

CytoDyn Inc. (OTCQB: CYDY) has appointed Dr. Max Lataillade as Senior Vice President and Head of Clinical Development. Dr. Lataillade, with over 20 years of research experience, will lead the company's global R&D strategy and oversee end-to-end R&D activities. He previously served as Vice President at ViiV Healthcare and Bristol-Myers Squibb, specializing in HIV research. Dr. Lataillade is also an assistant clinical professor at Yale University School of Medicine.

CytoDyn's CEO, Dr. Jacob Lalezari, expressed enthusiasm about the appointment, citing Dr. Lataillade's industry accomplishments and skillset as valuable assets for progressing the company's development pipeline. Dr. Lataillade aims to leverage his experience to pursue strategic development opportunities and advance CytoDyn's clinical pipeline, particularly focusing on the development of leronlimab, a CCR5 antagonist with potential for multiple therapeutic indications.

CytoDyn Inc. (OTCQB: CYDY) announced the acceptance of an abstract for presentation at the 5th annual HIV Research for Prevention Conference. The abstract highlights research on combining early antiretroviral therapy (ART) with broadly neutralizing antibodies (bNAbs) and leronlimab, a CCR5 antagonist, in infant rhesus macaques infected with Simian Human Immunodeficiency Virus (SHIV).

Key findings include:

• The study aimed to assess if this combination could provide sustained viral control without continuous ART
• 18 infant rhesus macaques were treated with various combinations of ART, bNAbs, and leronlimab
• No virus rebound was observed in treated animals over a 27-week period
• Results suggest potential for durable viral control and reduced need for ongoing ART

The study, funded by an NIH grant to OHSU, will be presented by Dr. Jonah B. Sacha at the conference in Lima, Peru on October 10, 2024.

CytoDyn Inc. (OTCQB: CYDY) has engaged Syneos Health as the contract research organization (CRO) for its upcoming Phase II oncology trial. The trial will evaluate the efficacy of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer (CRC). Syneos Health is a leading biopharmaceutical solutions organization with advanced data analytics and AI/ML capabilities.

Dr. Jacob Lalezari, CEO of CytoDyn, stated that investigating leronlimab in oncology remains their top priority. The company expects to generate clinical data affirming the utility of leronlimab in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab. CytoDyn submitted the final study protocol to the FDA for approval in September 2024 and anticipates starting patient screening in early 2025.

CytoDyn Inc. (OTCQB: CYDY) has announced preliminary findings from a preclinical study conducted by SMC Laboratories on leronlimab, its CCR5 antagonist. The study assessed optimal dosing for MASH (Metabolic dysfunction-Associated Steatohepatitis) and potential synergies with Resmetirom. Key findings include:

1. Leronlimab monotherapy (700 mg) showed statistically significant fibrosis reversal compared to control (p<0.01).
2. Dose-dependent antifibrotic activity was observed, with 700 mg performing better than 350 mg.
3. Leronlimab (700 mg) appeared to have better anti-fibrotic activity than Resmetirom (p=0.057).

Dr. Jacob Lalezari, CEO of CytoDyn, expressed excitement about the results, stating they confirm leronlimab's potential to benefit patients with various medical concerns. The company is in discussions with SMC Laboratories regarding next steps, including supplemental studies to expand on these findings and advance their clinical pipeline.

CytoDyn Inc. (CYDY) has made significant progress in 2024, as outlined in the September shareholder letter. Key developments include:

• FDA lifting the clinical hold on leronlimab in March 2024
• Submission of two clinical trial protocols to the FDA
• Settlement with Amarex, resulting in a $10 million cash influx
• Initiation of pre-clinical and clinical leronlimab trials
• Progress on developing a longer-acting therapeutic with an AI partner

The company is focusing on oncology, with a Phase II study in colorectal cancer and exploration of triple-negative breast cancer and glioblastoma. In inflammation, CytoDyn is evaluating leronlimab for HIV-related chronic inflammation, Alzheimer's Disease, and chronic fatigue syndrome. Other areas include MASH and HIV cure research. The company believes it has sufficient cash to commence clinical trials and advance development initiatives into 2025.

CytoDyn Inc. (OTCQB: CYDY) has announced the engagement of Syneos Health as the contract research organization (CRO) for its upcoming Phase II study on leronlimab's effects on chronic inflammation. Syneos Health is a leading biopharmaceutical solutions provider with a strong track record, having contributed to the development or commercialization of 92% of novel new drugs approved by the FDA in the last five years (2019-2023) and 91% of products granted marketing authorization by the European Medicines Agency.

Dr. Jacob Lalezari, CEO of CytoDyn, expressed optimism about the collaboration, stating that their goal is to generate clinical data that will affirm leronlimab's utility in addressing various medical concerns impacting patients globally.