Core Insights - CytoDyn has made significant progress in 2025, particularly in demonstrating the potential of leronlimab in solid tumor oncology, especially for metastatic Triple-Negative Breast Cancer (mTNBC) [1][2][3] - The company is optimistic about 2026, anticipating important clinical and regulatory milestones that could enhance its position in the biotech industry [8][9] Operational Strengthening - In 2025, CytoDyn focused on regulatory preparations, clinical strategy refinement, and internal process improvements, including data integrity and trial oversight [4] - The company engaged more constructively with regulators and investigators to enhance operational efficiency [4] Clinical Program Advancement - CytoDyn's scientific team made foundational progress in therapeutic areas, improving study designs and aligning with clinical experts to create a realistic roadmap for future success [5] - The Phase II study for metastatic colorectal cancer (mCRC) was launched in July 2025, with early results showing promise [12][13] Financial Discipline - The company maintained prudent financial management in 2025, focusing on extending its financial runway and directing resources toward high-potential programs [6] Future Outlook - CytoDyn is preparing for several clinical and regulatory inflection points in 2026, including advancements in ongoing studies and data readouts to confirm the proposed mechanism of action for leronlimab [8][9] - The company plans to open an Expanded Access Program (EAP) for leronlimab in early 2026, pending FDA approval, to provide treatment options for patients who have exhausted other therapies [16] Collaborative Initiatives - CytoDyn is collaborating with various academic centers on multiple studies, including a pilot study for recurrent Glioblastoma and a project for Alzheimer's Disease, indicating a broadening of its research focus [17][18][19]

Leronlimab treatment is associated with upregulation of PD-L1 in circulating tumor cells and cancer-associated macrophage-like cells Remarkably longer survival was observed in patients treated with leronlimab in combination with or followed by an immune checkpoint inhibitor VANCOUVER, Washington, Dec. 08, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 r ...

VANCOUVER, Washington, Dec. 01, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including metastatic triple-negative breast cancer (mTNBC) and colorectal cancer (mCRC), today announced that it has reached an agreement in principle to resolve the previously disclosed securities class action ...

Company to deliver a poster presentation on clinical data demonstrating sustained remissionfollowing immune checkpoint inhibitor therapy with or after leronlimab treatmentin patients with metastatic or locally advanced triple-negative breast cancer VANCOUVER, Washington, Nov. 24, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic p ...

Core Insights - CytoDyn Inc. is set to present clinical data at the San Antonio Breast Cancer Symposium, showcasing sustained remission in patients with metastatic triple-negative breast cancer (mTNBC) following treatment with leronlimab and immune checkpoint inhibitors [1][3] Company Overview - CytoDyn is a clinical-stage oncology company focused on advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor, with potential applications in various cancers, including mTNBC and colorectal cancer [1][6] Clinical Data Presentation - Dr. Milana V. Dolezal from Stanford University will present a poster detailing the prolonged survival of mTNBC patients treated with leronlimab in combination with PD-L1/PD-1 immune checkpoint inhibitors, highlighting the upregulation of PD-L1 levels [2][9] - The poster presentation is scheduled for December 12, 2025, from 12:30 PM to 2:00 PM CST at the Exhibit Hall [9] Treatment Efficacy - The use of leronlimab has been associated with increased PD-L1 levels, which may enhance the efficacy of immune checkpoint inhibitors in mTNBC patients, particularly those with low PD-L1 expression [2][3]

Core Insights - CytoDyn Inc. has secured a $30 million funding commitment from Yorkville Advisors Global to support the development of its lead product, leronlimab, which targets the CCR5 receptor and has potential applications in various cancers [1][2][3] Funding Agreement - The agreement allows CytoDyn to sell up to $30 million worth of common stock to Yorkville over the next 36 months, with CytoDyn controlling the timing of sales [2] - There are no minimum commitments or penalties for not utilizing the full amount, and the arrangement does not restrict the company's operational activities [2] Strategic Development - The funding will be used to further develop leronlimab, particularly its ability to upregulate PD-L1, providing the company with flexibility to seek additional capital through other financing or strategic partnerships [3] Company Overview - CytoDyn is a clinical-stage oncology company focused on advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor, which plays a significant role in immune function related to cancer and other diseases [4]

Core Points - CytoDyn Inc. is a clinical-stage oncology company focused on advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor, with potential applications in multiple indications including triple-negative breast cancer and metastatic colorectal cancer [1][4] - CFO Robert E. Hoffman will present a corporate overview at the LD Micro Main Event XIX Investor Conference from October 19 to 21, 2025, in San Diego, California [1][2] - The presentation is scheduled for October 21, 2025, at 9 a.m. PDT, and Mr. Hoffman will be available for one-on-one meetings with attendees to discuss the company's development strategy and upcoming milestones [2] Company Information - CytoDyn is dedicated to improving patients' quality of life through therapeutic innovation and is committed to integrity, responsibility, and service [4] - The company is advancing leronlimab, which is implicated in cancer, infectious diseases, and autoimmune disorders, targeting a key regulator of immune function [4] - For more information, CytoDyn can be contacted via their website or through their corporate email [5][7]

Core Insights - CytoDyn Inc. is making significant progress with leronlimab as a treatment for oncology, particularly in addressing unmet needs in solid tumor oncology, supported by both preclinical and clinical evidence [1][3][4] - The company has appointed Robert E. Hoffman as the new Chief Financial Officer to enhance its financial and strategic capabilities [2] - Leronlimab's novel mechanism of action shows promise in increasing PD-L1 expression, potentially allowing for better synergy with immune checkpoint inhibitors [3][24] Clinical Development - Leronlimab has shown prolonged survival in patients with Metastatic Triple-Negative Breast Cancer (mTNBC), with a 5-year survival rate around 15% [4] - A Phase II proof of concept protocol for PD-L1-negative mTNBC patients will be submitted, combining leronlimab with standard chemotherapy and an immune checkpoint inhibitor [4][5] - The company is also advancing leronlimab in metastatic Colorectal Cancer (mCRC), with ongoing enrollment in a Phase II study [6] Scientific Progress - Data presented at the European Society for Medical Oncology (ESMO) meeting indicates that leronlimab induces PD-L1 expression, which could transform treatment approaches for solid tumors [3][24] - In a study, 76% of patients showed increased PD-L1 expression after starting leronlimab, suggesting a shift from a "cold" to a "hot" tumor microenvironment [24] - The company is preparing to submit a comprehensive manuscript detailing the clinical and PD-L1 data from the ESMO presentation [31][32] Regulatory Matters - CytoDyn has successfully resolved investigations by the SEC and DOJ, indicating a positive compliance standing [9] - The company maintains a collaborative relationship with the FDA, focusing on responsible pathways for oncology development [10] Commitment to Shareholders - The company expresses gratitude for shareholder support and emphasizes the importance of maintaining respectful communication with industry partners [11] - CytoDyn is actively pursuing collaborations to maximize the potential of leronlimab [11] Future Directions - The company is exploring the use of leronlimab in glioblastoma, with funding secured for an investigator-initiated study [28] - Ongoing projects include studies on Alzheimer's disease and HIV, with recent approvals and funding arrangements in place [29][30]

Core Insights - CytoDyn Inc. is advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor, with potential applications in multiple cancer types, including triple-negative breast cancer (TNBC) and colorectal cancer (CRC) [1][3] - The company will present findings on leronlimab's effects on PD-L1 expression and patient survival in metastatic TNBC at the AACR Special Conference in Cancer Research [1][3] - A retrospective analysis indicated that leronlimab treatment led to PD-L1 expression in 88% of patients treated with doses greater than 525 mg/week, suggesting improved survival outcomes when combined with immune checkpoint inhibitors (ICIs) [1][4] Presentation Details - The oral and poster presentations will take place on September 26 and 27, 2025, respectively, focusing on the association between CCR5 inhibition, enhanced PD-L1 expression, and long-term survival in metastatic TNBC [3][4] Clinical Implications - The findings suggest that leronlimab may enhance the effectiveness of ICIs in patients with metastatic TNBC, a group historically resistant to such treatments [2][4] - The study showed that 18% of heavily pretreated metastatic TNBC patients were alive after a median of approximately 60 months, indicating a potential survival benefit from CCR5 inhibition [4] Company Overview - CytoDyn is dedicated to developing leronlimab as a versatile therapeutic platform aimed at addressing serious unmet medical needs across various high-value markets [5] - The company emphasizes its commitment to improving patients' quality of life through innovative therapies [5]

Core Insights - CytoDyn Inc. has been selected for a poster and oral presentation at the AACR Special Conference in Cancer Research, focusing on the effects of leronlimab on metastatic triple-negative breast cancer [1][2] Presentation Details - The oral presentation will be delivered by Dr. Richard Pestell, highlighting the impact of leronlimab on metastatic triple-negative breast cancer [2] - The poster presentation is scheduled for September 26, 2025, from 6:30 p.m. to 8:30 p.m. EDT, while the podium presentation will take place on September 27, 2025, from 10:25 a.m. to 10:40 a.m. EDT [4] Research Findings - Preliminary findings suggest that leronlimab may convert 'cold' tumors into 'hot' tumors, enhancing their responsiveness to checkpoint inhibitors, particularly in aggressive metastatic triple-negative breast cancer [3] - The research aims to elucidate the mechanism of action for leronlimab, which may have broad applicability for solid tumors with limited treatment options [3] Company Overview - CytoDyn is a clinical-stage biotechnology company focused on advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor, which plays a crucial role in immune function related to cancer and other diseases [5]