FREQUENTLY ASKED QUESTIONS

Last updated March 2025

What are the 2025 clinical objectives of the Company?

i. Continue the pending Phase II trial of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer;

ii. 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

iii. Continue our work researching and developing a new or modified long-acting version of leronlimab.

The Company will also strategically work with select partners to explore leronlimab’s potential benefits in certain inflammatory diseases.

What is the current status of the longer-acting therapeutic project?

In order to develop a long-acting therapeutic, we have partnered with an experienced drug development company that uses generative artificial intelligence (AI), among other technologies, in its development activities. If successful, such a modified therapeutic would require less frequent injections for patients on drug, furthering the convenience and overall marketability of the product. Working with a company with established AI-capabilities allows for a robust development path for this modified, longer-acting therapeutic for the Company. This joint development initiative remains in progress at this time and the Company will provide further updates when appropriate.

Is leronlimab, an unapproved drug, currently available to the public outside of a clinical trial?

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.” For additional information about potentially obtaining leronlimab, through your medical provider, under an Expanded Access allowance, please feel free to email: 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, 2024, 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.