Progress and Outlook for 2025
CytoDyn achieved significant milestones in 2024 and anticipates further progress in 2025. The company confirmed it has sufficient cash and drug supplies to complete its clinical priorities for the upcoming year. In addition, CytoDyn is advancing the development of a long-acting formulation of leronlimab, which will enhance patient convenience and strengthen patent protection. To support its growth, the company welcomed several key consultants, including Dr. Melissa Palmer in hepatology, Dr. Max Lataillade in clinical development, and Dr. Richard Pestell in oncology. This strengthened expertise positions CytoDyn to capitalize on its momentum and make 2025 a pivotal year.
Oncology Priorities for 2025
Oncology will be the company’s focus in 2025 due to its potential for high-value returns, including possible partnerships and drug approvals. CytoDyn recently received FDA clearance for a Phase II study of leronlimab in patients with relapsed/refractory colorectal cancer (CRC), with enrollment set to begin in January under the leadership of Dr. Ben Weinberg. Initial dosing will undergo careful safety reviews, which will determine the next steps in the study’s progression. Additionally, CytoDyn is launching two preclinical studies in triple-negative breast cancer (TNBC) to further clarify leronlimab’s mechanism of action and identify treatment synergies for future clinical studies.
In glioblastoma (GBM), results from a preliminary preclinical study did not demonstrate a significant outcome, prompting a follow-up study combining temozolomide with leronlimab. Discussions are ongoing about initiating a pilot study in GBM patients based on this upcoming data.
Inflammation Development Pathways
CytoDyn is pursuing multiple indications to develop leronlimab as a treatment for chronic inflammation-related conditions. Preclinical studies in MASH and liver fibrosis showed promising results, with leronlimab outperforming Resmetirom in reversing liver fibrosis and fat deposition. Two follow-up studies are underway to validate these findings, with results expected in January 2025. Interest from an academic institution suggests potential funding for a pilot study in pulmonary fibrosis if results are confirmed.
For Long Covid, CytoDyn applied to the NIH RECOVER-TLC group for inclusion in upcoming treatment studies. While awaiting the outcome, the company paused its planned ME/CFS pilot study, as the two conditions overlap. If the NIH declines inclusion, CytoDyn will resume the ME/CFS study.
In Alzheimer’s disease, a fully funded pilot study will take place at Cornell Medical Center to evaluate leronlimab’s role in treating the condition using objective neuroradiology measures.
HIV Cure Initiative and Clinical Publications
CytoDyn continues its HIV research initiatives in collaboration with the American Foundation for AIDS Research (amfAR). The LATCH study will explore leronlimab’s potential to protect donor immune cells in stem cell transplants for curing HIV. Interest in this program has expanded internationally, with researchers in Germany expressing a desire to participate.
The company remains focused on publishing its clinical data. Recent successes include the publication of the CD10 trial results in Clinical Therapeutics and the acceptance of the CD02 HIV study by JAIDS. Additional manuscripts on severe COVID-19, TNBC, and MASH are progressing, alongside an integrated safety analysis for leronlimab-treated patients.
CEO’s Vision for the Future
CEO Jacob Lalezari expressed his confidence in leronlimab’s life-changing potential and CytoDyn’s ability to deliver value for shareholders. With strong relationships with the FDA, sufficient funding, and the expertise required to execute its strategy, the company is positioned for success in 2025. CytoDyn remains committed to advancing its clinical priorities, demonstrating the impact of leronlimab, and rewarding shareholder patience and trust as it continues its mission.
CytoDyn achieved significant milestones in 2024 and anticipates further progress in 2025. The company confirmed it has sufficient cash and drug supplies to complete its clinical priorities for the upcoming year. In addition, CytoDyn is advancing the development of a long-acting formulation of leronlimab, which will enhance patient convenience and strengthen patent protection. To support its growth, the company welcomed several key consultants, including Dr. Melissa Palmer in hepatology, Dr. Max Lataillade in clinical development, and Dr. Richard Pestell in oncology. This strengthened expertise positions CytoDyn to capitalize on its momentum and make 2025 a pivotal year.
Oncology Priorities for 2025
Oncology will be the company’s focus in 2025 due to its potential for high-value returns, including possible partnerships and drug approvals. CytoDyn recently received FDA clearance for a Phase II study of leronlimab in patients with relapsed/refractory colorectal cancer (CRC), with enrollment set to begin in January under the leadership of Dr. Ben Weinberg. Initial dosing will undergo careful safety reviews, which will determine the next steps in the study’s progression. Additionally, CytoDyn is launching two preclinical studies in triple-negative breast cancer (TNBC) to further clarify leronlimab’s mechanism of action and identify treatment synergies for future clinical studies.
In glioblastoma (GBM), results from a preliminary preclinical study did not demonstrate a significant outcome, prompting a follow-up study combining temozolomide with leronlimab. Discussions are ongoing about initiating a pilot study in GBM patients based on this upcoming data.
Inflammation Development Pathways
CytoDyn is pursuing multiple indications to develop leronlimab as a treatment for chronic inflammation-related conditions. Preclinical studies in MASH and liver fibrosis showed promising results, with leronlimab outperforming Resmetirom in reversing liver fibrosis and fat deposition. Two follow-up studies are underway to validate these findings, with results expected in January 2025. Interest from an academic institution suggests potential funding for a pilot study in pulmonary fibrosis if results are confirmed.
For Long Covid, CytoDyn applied to the NIH RECOVER-TLC group for inclusion in upcoming treatment studies. While awaiting the outcome, the company paused its planned ME/CFS pilot study, as the two conditions overlap. If the NIH declines inclusion, CytoDyn will resume the ME/CFS study.
In Alzheimer’s disease, a fully funded pilot study will take place at Cornell Medical Center to evaluate leronlimab’s role in treating the condition using objective neuroradiology measures.
HIV Cure Initiative and Clinical Publications
CytoDyn continues its HIV research initiatives in collaboration with the American Foundation for AIDS Research (amfAR). The LATCH study will explore leronlimab’s potential to protect donor immune cells in stem cell transplants for curing HIV. Interest in this program has expanded internationally, with researchers in Germany expressing a desire to participate.
The company remains focused on publishing its clinical data. Recent successes include the publication of the CD10 trial results in Clinical Therapeutics and the acceptance of the CD02 HIV study by JAIDS. Additional manuscripts on severe COVID-19, TNBC, and MASH are progressing, alongside an integrated safety analysis for leronlimab-treated patients.
CEO’s Vision for the Future
CEO Jacob Lalezari expressed his confidence in leronlimab’s life-changing potential and CytoDyn’s ability to deliver value for shareholders. With strong relationships with the FDA, sufficient funding, and the expertise required to execute its strategy, the company is positioned for success in 2025. CytoDyn remains committed to advancing its clinical priorities, demonstrating the impact of leronlimab, and rewarding shareholder patience and trust as it continues its mission.
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