Last updated May 2026

The latest Company announcements can be found here: Newsroom

The Company’s latest publications and presentations at industry conferences can be found here: Publications

The Company’s latest filings with the SEC can be found here: SEC Filings

Our Investors Relations page also offers a number of links and resources to additional information.

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  1. Continue the Phase 2 (CLOVER) study of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer;
  2. Conduct additional studies exploring leronlimab and its therapeutic potential in other solid-tumor oncology indications, including but not limited to metastatic Triple-Negative Breast Cancer; and
  3. Continue our work researching and developing a new or modified long-acting version of leronlimab.

The CLOVER study, CytoDyn’s Phase 2 study in Colorectal Cancer, completed enrollment in April 2026. Below are several resources where future updates and/or additional information about the study will be published/shared:

Newsroom

Publications

Clinicaltrials.gov - CLOVER - NCT06699836

The Our Science page contains information about leronlimab, including certain videos and illustrations meant to help explain its proposed mechanism(s) of action.

Access to Leronlimab Policy 

As an unapproved drug, leronlimab is not available to the general public. However, certain patients who are facing serious illnesses, and who have exhausted all available treatment options, may be able to receive early access to investigational drugs that haven’t yet been approved by government regulatory agencies. The FDA allows for two options for treating patients with an unapproved drug, biologic or test article outside of a clinical trial. One option is “Expanded Access.” The other option is “Right to Try.”

It is important that you first consult with your healthcare provider before inquiring about potential access to leronlimab. Your healthcare provider can then use the contact information below to submit access request(s) to the Company.

For inquiries relating to CytoDyn’s currently active Expanded Access Program (EAP) for patients with triple-negative breast cancer (TNBC): CytoDynEAP@wepclinical.com

For all other (eIND) requests: dai@cytodyn.com

For the most up-to-date information regarding The Right to Try Act, and/or potential access for patients who have been diagnosed with life-threatening diseases or conditions, have tried all approved treatment options, and are unable to participate in a clinical trial to access certain investigational treatment options, please visit FDA.gov and review its overview regarding “Right to Try” allowances. https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try

WARNING: Leronlimab has not received regulatory approval from the FDA. The potential risks and benefits are not known. Doctors and patients should consider all possible benefits and risks before applying for expanded access (or right to try) to leronlimab.

Note Regarding Forward-Looking Statements

This Frequently Asked Questions supplement contains forward-looking statements relating to, among other things, future operating and financial performance, product development, market position and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2025, including the section captioned “Forward-Looking Statements” and in Item 1A. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments.