Annuncio • Jun 13
CytoDyn Doses First Patient in Phase 2A Study Evaluating Leronlimab in Alzheimer’s Disease CytoDyn had the first patient dosed in a Phase 2a clinical study evaluating leronlimab in patients with Alzheimer’s disease, in collaboration with Weill Cornell Medicine. The study, known as SALIENT-AD (Safety Assessment of Leronlimab and Its Effect on Neuroinflammation Targets in Alzheimer’s Disease), is a Phase 2a, open-label, proof-of-concept study designed to evaluate the safety and biological activity of leronlimab in approximately 10 to 20 patients over the age of 50 with early-stage, biomarker-confirmed Alzheimer’s disease. Patients will receive weekly subcutaneous injections of leronlimab over a 12-week treatment period. The primary endpoint will assess changes in brain inflammation and microglial activation using advanced PET imaging techniques. Secondary endpoints include safety and tolerability, cognitive assessments, blood-based biomarkers of inflammation and neurodegeneration, and measures of blood-brain barrier integrity using MRI. The study will be led by Tracy Butler, MD, Associate Professor of Neurology in Radiology and Psychiatry and Medical Director of the Brain Health Imaging Institute at Weill Cornell Medicine. Alzheimer’s disease is a complex and multifactorial neurodegenerative condition characterized not only by amyloid-beta plaques and tau tangles, but also by chronic neuroinflammation, microglial activation, and disruption of the blood-brain barrier. Emerging research suggests that CCR5, a chemokine receptor expressed on immune cells, may play a central role in regulating these processes. Preclinical and translational research suggests that CCR5 plays a role in synaptic plasticity, memory formation, and microglial signaling, and may influence processes such as autophagy, vascular health, and blood-brain barrier stability. By blocking CCR5, leronlimab may help reduce maladaptive immune signaling and support neuronal resilience. Annuncio • Apr 29
CytoDyn Inc Announces First Patient Dosed in Expanded Access Program for Leronlimab in Triple-Negative Breast Cancer CytoDyn Inc. announced the successful enrollment and initial dosing of the first participant in its Expanded Access Program (EAP) for patients with triple-negative breast cancer (TNBC). The EAP is designed to provide eligible patients access to leronlimab outside of a clinical study setting. The program is intended for patients who have exhausted available treatment options and are not eligible for ongoing or planned clinical studies, in accordance with U.S. Food and Drug Administration (FDA) guidelines. In addition to providing compassionate access, the EAP is expected to generate real-world insights into the biological activity of leronlimab in heavily pretreated patients. Recent data, presented at the American Association for Cancer Research (AACR) Annual Meeting 2026, highlight the potential role of CCR5 inhibition in modulating the tumor microenvironment in metastatic triple-negative breast cancer, with observed associations in PD-L1 expression and broader immune signaling pathways. Together, these findings provide a scientific foundation for the EAP and support continued exploration of leronlimab as a strategy to enhance responses to immune checkpoint inhibitor (ICI) therapies. To support execution of the program, the Company has engaged With Every Patient (WEP Clinical) as the clinical research organization to support program execution, including patient identification, site coordination, and regulatory compliance. The EAP is now open for physician referrals, and CytoDyn expects to expand participation as additional sites are activated. The program will operate under applicable U.S. Food and Drug Administration (FDA) guidelines, and additional information for physicians and eligible patients, including referral details, is available on the Company’s website. Annuncio • Apr 24
CytoDyn Inc. Completes Enrollment in Phase 2 Metastatic Colorectal Cancer Study CytoDyn Inc. completed enrollment in its Phase 2 clinical study evaluating leronlimab in combination with trifluridine and tipiracil (TAS-102) plus bevacizumab in patients with CCR5-positive, microsatellite stable (MSS), relapsed/refractory metastatic colorectal cancer (mCRC), also known as CLOVER – CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen. The open-label, randomized, two-arm, multi-center study is evaluating leronlimab in combination with trifluridine and tipiracil (TAS-102) plus bevacizumab in patients who have progressed following prior standard therapies. With enrollment now complete, CytoDyn will advance the study through treatment and follow-up, with resulting data expected to inform the program’s development strategy and potential next steps. CLOVER is designed to prospectively assess the activity of leronlimab in combination with an established regimen in a difficult to treat and highly refractory patient population with microsatellite stable (MSS) metastatic colorectal cancer. The CLOVER study builds on emerging clinical and translational findings from CytoDyn’s ongoing Phase 2 mCRC program, including data being presented at the AACR Annual Meeting 2026. Preliminary results demonstrated early signals of clinical and biomarker activity with leronlimab in combination with TAS-102 and bevacizumab, including rapid reductions in circulating tumor DNA and modulation of immune-related markers. These findings support further evaluation of CCR5 inhibition as a strategy to enhance anti-tumor activity in metastatic colorectal cancer. Leronlimab is a monoclonal antibody targeting CCR5, a receptor involved in immune cell trafficking and tumor biology. By blocking CCR5, leronlimab may help modulate the tumor microenvironment and enhance the activity of existing therapies in difficult-to-treat cancers. CytoDyn plans to share topline data from the study as they become available. This Phase 2 clinical study is an open-label, randomized, two-arm, multi-center study evaluating leronlimab in combination with trifluridine and tipiracil (TAS-102) plus bevacizumab in patients with CCR5-positive, microsatellite stable (MSS), relapsed/refractory metastatic colorectal cancer (mCRC), also known as CLOVER – CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen. Approximately 60 patients were enrolled and randomized 1:1 to receive either 350 mg or 700 mg of leronlimab in combination with standard-of-care therapy. Eligible participants are adults with histologically confirmed mCRC who have progressed following prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and, where appropriate, anti-EGFR therapy. The primary endpoint of the study is objective response rate (ORR), as defined by RECIST v1.1 criteria. Secondary endpoints include safety and tolerability, duration of response, and overall survival. Patients will be followed for up to 12 months. Annuncio • Apr 22
CytoDyn Inc Presents New Leronlimab Data in Metastatic Colorectal Cancer CytoDyn Inc. had announced that new clinical data from its ongoing Phase 2 study in metastatic colorectal cancer (mCRC) were presented at the AACR Annual Meeting 2026, taking place April 17–22, 2026, at the San Diego Convention Center. The presentation highlighted findings supporting CCR5 inhibition with leronlimab as a strategy to modulate the tumor microenvironment, enhance immune engagement, and improve outcomes in metastatic colorectal cancer (mCRC), particularly in combination with standard-of-care therapies. Metastatic colorectal cancer remains a significant clinical challenge, particularly in patients with refractory disease who have progressed on multiple prior lines of therapy. While standard regimens such as TAS-102 in combination with bevacizumab provide modest benefit, treatment resistance and immune evasion continue to limit durable responses. Results presented at AACR demonstrate that CCR5 inhibition with leronlimab may enhance anti-tumor activity by modulating the tumor microenvironment and improving immune engagement. Key findings from the ongoing Phase 2 mCRC study include: Among pre-screened patients with evaluable samples (N=33), CCR5 expression was detected in 100% of cases, supporting its potential as a therapeutic target in mCRC. Early clinical and biomarker responses were observed, including rapid and substantial reductions in circulating tumor DNA (ctDNA), with median declines of approximately 70% by week 2 across evaluable patients (N=19). The combination regimen has been well tolerated, with no leronlimab-related dose-limiting toxicities (DLTs) observed, and escalation to 700 mg dosing underway. The study continues to enroll toward full enrollment, reflecting significant unmet need in previously treated mCRC. The poster presentation titled “Preliminary results of a phase 2 study of leronlimab in combination with TAS-102 and bevacizumab in previously treated metastatic colorectal cancer” was presented by Dr. Kasi on April 21, 2026, from 2:00 p.m. – 5:00 p.m. PT (Poster #6466). A copy of the poster will be made available on CytoDyn’s website under the Publications & Posters section. Annuncio • Apr 21
CytoDyn Presents New Leronlimab Data in Metastatic Triple-Negative Breast Cancer at AACR Annual Meeting 2026 CytoDyn Inc. announced that new clinical and translational data in metastatic triple-negative breast cancer (mTNBC) were presented at the AACR Annual Meeting 2026, taking place April 17–22, 2026, at the San Diego Convention Center. The presentation highlighted emerging evidence supporting CCR5 inhibition with leronlimab as a strategy to modulate the tumor microenvironment, enhance immune responsiveness, and improve outcomes in metastatic triple-negative breast cancer (mTNBC). Metastatic triple-negative breast cancer remains an aggressive disease with limited treatment options and poor long-term survival. While immune checkpoint inhibitors (ICIs) have demonstrated benefit in select patients, many tumors exhibit low PD-L1 expression and resistance to immunotherapy. Preclinical and clinical findings presented at AACR show that CCR5 inhibition with leronlimab modulates immune checkpoint signaling, potentially sensitizing tumors to immune checkpoint inhibitor therapy. Key findings from baseline tumor biology and leronlimab treatment analysis in TNBC include: Across breast cancer cohorts (N=1,096), CCR5 expression correlated with gene signatures of T-cell immune exhaustion and immune infiltration. CCR5 expression was enriched in TNBC subtypes associated with immune modulation, including mesenchymal-like immune-altered (MLIA) and immunomodulatory (IM) subtypes. In TNBC cell models, CCR5 inhibition with leronlimab increased PD-L1 expression, suggesting a potential mechanism to enhance responsiveness to PD-L1-targeted therapies. Proteomic analyses demonstrated that CCR5 activity promotes expression of immune checkpoint mediators, including sB7-H3 (CD276) and Tyro3 signaling, both associated with resistance to ICIs; these effects were attenuated with leronlimab. In a retrospective analysis of 28 patients with mTNBC, leronlimab treatment was associated with induction of PD-L1 in circulating tumor cells (CTCs) and cancer-associated macrophage-like cells (CAMLs). Higher leronlimab dose, PD-L1 induction, and use in combination or sequence with ICIs were associated with improved patient survival outcomes. Notably, 17.9% (5/28) of heavily pretreated patients remain alive after more than 60 months of follow-up. Dr Pestell is the first author of the poster presentation titled “Leronlimab induces PD-L1 expression and is associated with long term survival with an ICI in PD-L1 low metastatic TNBC” on April 19, 2026, from 2:00 p.m. – 5:00 p.m. PT (Poster #1033). A copy of the poster will be made available on CytoDyn’s website under the Publications & Posters section. New Risk • Apr 08
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$18m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$18m free cash flow). Share price has been highly volatile over the past 3 months (23% average weekly change). Negative equity (-US$104m). Revenue is less than US$1m. 