VANCOUVER, Washington, Nov. 03, 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 triple-negative breast cancer (TNBC) and metastatic colorectal cancer (mCRC), today announced that it has secured a $30 million funding commitment from Yorkville Advisors Global. Under the terms of the ...

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]

Core Points - CytoDyn Inc. is a clinical-stage biotechnology company focused on advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications [1][2] - The company announced a change in the timing of its management's live presentation at the H.C. Wainwright 27th Annual Global Investment Conference to September 10, 2025, at 9 a.m. EDT [1][2] - CytoDyn's mission is to improve patients' quality of life through therapeutic innovation, emphasizing integrity, responsibility, and service [3] Event Details - The H.C. Wainwright 27th Annual Global Investment Conference will take place from September 8-10, 2025, in New York City [2] - CFO Robert E. Hoffman will deliver a live presentation and be available for one-on-one meetings during the event [2] Company Information - CytoDyn is dedicated to bringing transformative treatments to patients worldwide, particularly focusing on immune function related to cancer, infectious diseases, and autoimmune disorders [2][3] - For more information, the company can be contacted through its investor relations email or its media contacts [4]

Core Points - CytoDyn Inc. is a clinical-stage biotechnology company focused on advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications [1][3] - The company will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8 to 10, 2025, in New York City [1] - Robert E. Hoffman, the Chief Financial Officer, will present on September 10 at 1:30 p.m. EDT, and will be available for one-on-one meetings with registered attendees [2] Company Overview - CytoDyn is dedicated to improving patients' quality of life through therapeutic innovation, focusing on conditions related to cancer, infectious diseases, and autoimmune disorders [3] - The company emphasizes integrity, responsibility, and service in its mission to bring transformative treatments to patients worldwide [3]

Core Insights - CytoDyn Inc. announced positive clinical findings for leronlimab in patients with advanced metastatic colorectal cancer (mCRC), with 3 out of 5 patients showing at least a partial response, including one complete response [1][3] - Dr. Benjamin Weinberg will present the final results at the ESMO Gastrointestinal Cancers Congress 2025 in Barcelona, Spain [2] - The results support the ongoing Phase II trial for relapsed/refractory microsatellite stable CRC, with the first patient recently dosed and additional patients being enrolled [3][5] Clinical Significance - The findings from the compassionate use protocol highlight a favorable safety profile for leronlimab and its potential clinical benefits in mCRC [3] - If confirmed, leronlimab could be effective for a variety of solid tumor types, and it has shown promise as a "priming" agent for patients with low PD-L1 levels who are unresponsive to checkpoint inhibitors [4] Company Overview - CytoDyn is a clinical-stage biotechnology company focused on developing leronlimab, a humanized IgG4 monoclonal antibody targeting CCR5, with applications in oncology, infectious diseases, and autoimmune conditions [6]

Core Insights - CytoDyn Inc. has initiated patient enrollment for a clinical trial assessing the efficacy of leronlimab in relapsed/refractory microsatellite stable colorectal cancer [1][2] - The trial is being conducted in partnership with Syneos Health, involving multiple clinical sites [2] - Colorectal cancer is a significant global health issue, with approximately 1.9 million new cases and over 900,000 deaths annually [3] Company Overview - CytoDyn is a clinical-stage biotechnology company focused on developing leronlimab, a monoclonal antibody targeting CCR5, with applications in oncology and other therapeutic areas [6] - The company aims to provide innovative treatment options for challenging diseases, as highlighted by the dosing of the first patient in the Phase II CRC trial [4] Clinical Trial Details - The trial is led by Dr. Ben Weinberg from Georgetown University and aims to evaluate the potential clinical benefits of leronlimab in colorectal cancer [2][5] - Previous studies have shown promising survival rates for leronlimab in metastatic triple-negative breast cancer, indicating its potential applicability across various solid tumors [5] Industry Context - The World Health Organization's IARC identifies colorectal cancer as the third most common cancer type and the second leading cause of cancer-related deaths globally [3] - The increasing incidence of colorectal cancer in individuals under 50 years old has been noted for over 20 years, indicating a growing public health concern [3]

Core Insights - CytoDyn Inc. is a biotechnology company focused on developing leronlimab, a CCR5 antagonist with potential applications in multiple therapeutic areas, including oncology, infectious diseases, and autoimmune conditions [2] Group 1: Company Developments - CytoDyn presented a poster at the European Society for Medical Oncology's Breast Cancer meeting, highlighting the novel mechanism of action of leronlimab for treating solid tumors [1] - The poster presentation took place from May 14-17, 2025, in Munich, Germany [1] - Additional information regarding the data presented at ESMO was released in a press release on May 13, 2025 [1] Group 2: Product Information - Leronlimab is an investigational humanized IgG4 monoclonal antibody designed to bind to CCR5, a protein on immune system cells involved in various disease processes [2] - The company has explored the use of leronlimab across multiple therapeutic areas, indicating its versatility and potential in treating different conditions [2]