Highlights

  • CytoDyn secures third-party funding to initiate expanded access for TNBC patients.
  • Leronlimab expanded access program targets patients outside active clinical trials.
  • The funding is earmarked specifically for the establishment

CytoDyn Inc. (OTC:CYDY) announced that it has received dedicated funding from an anonymous benefactor to initiate an Expanded Access Program (EAP) for its investigational monoclonal antibody, Leronlimab, in patients with triple-negative breast cancer (TNBC). The funding is earmarked specifically for the establishment and administration of the program under the U.S. Food and Drug Administration’s expanded-access guidelines.

According to the company, the benefactor has a long history of supporting patient-access initiatives and has chosen to remain anonymous. The contribution enables CytoDyn to move forward with the EAP without referencing changes to its existing capital structure.

Focus on Patients With Limited Treatment Options
Triple-negative breast cancer is described as an aggressive subtype with limited approved treatment options, particularly for patients who have progressed after standard therapies or who are not eligible for ongoing clinical trials. The EAP is designed to provide access to Leronlimab for a select group of patients who meet FDA eligibility requirements.

CytoDyn stated that the program will operate outside of formal clinical trials and is intended for compassionate use. Participation will be limited and subject to regulatory review, with physician referrals required for enrollment.

Regulatory Process and CRO Engagement
The company has engaged With Every Patient (WEP Clinical) as the contract research organization (CRO) to manage the operational aspects of the expanded access initiative. CytoDyn expects the program to open for physician referrals in March 2026, pending FDA allowance of a revised protocol.

Stock Performance
CYDY shares traded at approximately USD 0.25 on January 27, 2026.