Cytodyn Inc Stock Price, News & Analysis

CytoDyn (OTCQB: CYDY) has revealed promising new data about leronlimab's mechanism of action in treating solid tumors. The company's analysis of metastatic Triple-Negative Breast Cancer (mTNBC) trials showed that 88% (15/17) of patients receiving weekly doses of 525mg or higher experienced significant increases in PD-L1 expression on circulating tumor cells within 30-90 days.

Notably, 100% (5/5) of patients who showed increased PD-L1 expression and received immune checkpoint inhibitors (ICIs) treatment are still alive, with 80% (4/5) showing no evidence of disease. This suggests leronlimab can potentially convert "cold" tumors to "hot" tumors, making them responsive to checkpoint inhibitor therapy. The company believes this mechanism could benefit various solid tumor types, particularly in patients with low PD-L1 levels who were previously unresponsive to checkpoint inhibitors.

CytoDyn (OTCQB: CYDY) has appointed Robert E. Hoffman as its new Chief Financial Officer, effective May 15, 2025. Hoffman, a seasoned biotech veteran, will replace interim CFO Mitch Cohen. With extensive experience in financial leadership, Hoffman previously served as President, CEO, interim CFO, and Chairperson at Kintara Therapeutics, and held CFO positions at companies including Heron Therapeutics, Innovus Pharmaceuticals, and AnaptysBio.

Hoffman currently serves on the boards of several companies, including Esperion Therapeutics, TuHURA Biosciences, and Fibrobiologics. His appointment aims to support CytoDyn's clinical development pipeline, particularly in oncology indications. The company is developing leronlimab, a CCR5 antagonist with potential for multiple therapeutic applications.

CytoDyn announces its participation in the upcoming ESMO Breast Cancer meeting in Munich, Germany, scheduled for May 14-17, 2025. The company will present promising survival data for its drug leronlimab in treating metastatic triple-negative breast cancer (mTNBC).

Key highlights:

• CEO Dr. Jacob Lalezari and Lead Consultant Dr. Richard Pestell will lead the presentation
• Poster presentation scheduled for May 15, 2025
• Notable survival rates observed at 12, 24, and 36 months
• Four patients show no evidence of disease after 48 months
• One additional patient maintains stable disease

The company reports these outcomes compare favorably to current approved therapies and suggests a potential paradigm shift in solid tumor oncology treatment. CytoDyn has initiated a follow-up protocol to monitor surviving patients.

CytoDyn Inc. has reported significant progress in their oncology programs as of March 2025. The company announced increased survival rates in patients with metastatic Triple-Negative Breast Cancer (mTNBC) treated with leronlimab, with some patients now cancer-free. Their Phase II colorectal cancer study is advancing with eight approved clinical sites.

Key developments include:

• Submission of findings to the European Society for Medical Oncology meeting in Munich (May 2025)
• Initiation of follow-up protocols for surviving mTNBC patients
• Advancement in preclinical studies for TNBC treatment optimization
• Progress in glioblastoma multiforme (GBM) research

In inflammation studies, CytoDyn is awaiting NIH/RECOVER-TLC decision for Long Covid treatment studies and has finalized a pilot study protocol for Alzheimer's Disease at Cornell Medical Center. Recent laboratory results showed statistically significant reversal of liver fibrosis (p< 0.01) in all three SMC Laboratories studies. The company reports having sufficient cash and drug supply to advance clinical priorities in 2025.

CytoDyn (OTCQB: CYDY) announced encouraging survival outcomes for metastatic triple-negative breast cancer (mTNBC) patients treated with leronlimab, their CCR5 antagonist drug candidate. The company reported favorable survival rates at 12, 24, and 36 months compared to current therapies, with some patients who previously failed treatment now showing no evidence of disease.

Following resolution of a dispute with their former CRO, CytoDyn obtained follow-up records and submitted findings to the upcoming ESMO Breast Cancer meeting in Munich. The company has initiated two pre-clinical studies to evaluate potential synergies between leronlimab and other treatments (sacituzumab govitecan and pembrolizumab).

The drug was reported to be well-tolerated with minimal treatment-related adverse events. The company plans to accelerate its oncology efforts, with future announcements expected in both mTNBC and colorectal cancer treatments.

CytoDyn (OTCQB: CYDY) has announced significant results from three preclinical studies conducted with SMC Laboratories, demonstrating that leronlimab, their CCR5 antagonist drug, achieved statistically significant reversal of liver fibrosis in monotherapy (p-values < 0.01 vs control). Two studies completed in late 2024 evaluated leronlimab in the STAM™ model of metabolic dysfunction associated steatohepatitis (MASH) with fibrosis, while a third study concluded in January 2025 assessed liver fibrosis reversal using carbon tetrachloride.

Dr. Melissa Palmer, the Company's Lead Consultant in Hepatology, emphasized the significant unmet need in hepatology for managing advanced liver fibrosis. The company is exploring partnership opportunities to advance leronlimab's clinical development for treating fibrosis in the liver and potentially other organs, while maintaining focus on its 2025 oncology objectives.

CytoDyn (CYDY) provided a comprehensive year-end update highlighting several key developments. The company has secured sufficient cash and drug supplies for its 2025 clinical priorities and is making progress on developing a long-acting formulation of leronlimab. Recent additions to the development team include Dr. Melissa Palmer (Lead Consultant in Hepatology), Dr. Max Lataillade (SVP and Head of Clinical Development), and Dr. Richard Pestell (Lead Consultant in Oncology).

The company is prioritizing oncology in 2025, having received FDA clearance to initiate a Phase II study in colorectal cancer. Additional focus areas include triple-negative breast cancer (TNBC) and glioblastoma (GBM). In inflammation, promising results were reported from preclinical MASH studies, with ongoing research in Long Covid and Alzheimer's disease. The company is also partnering with amfAR for an HIV cure study called LATCH.

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.