Last updated July 2024

What clinical trials is the Company currently working on?

In order of priority, the clinical trials currently under development are:

(i) a Phase II study of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer; and

(ii) a Phase II study exploring leronlimab and its effects on inflammation.

The oncology trial, if successful, will put the Company on track towards a commercial approval in that indication. The inflammation study is aimed at clarifying a number of past clinical observations as it relates to leronlimab.

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:

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 and review its overview regarding “Right to Try” allowances.

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.

What is the current status of the Amarex litigation effort?

On July 9, 2024, the Company announced that it settled its lawsuit against Amarex Clinical Research LLC, the Company’s former Contract Research Organization. The material terms of the settlement are as follows: (i) Amarex will pay $12,000,000 to CytoDyn, $10,000,000 was paid upon execution of the agreement and the remainder to be paid within the next 12 months; (ii) the surety bond, valued at $6,500,000, will be released to CytoDyn in full; (iii) all sums Amarex had claimed as due and payable, aggregating to approximately $14,000,000, will be eliminated, with no payment required from CytoDyn; and (iv) a mutual release of claims, resolving all legal claims between the parties.

CytoDyn Announces Settlement with Amarex Clinical Research LLC (press release dated July 9, 2024)

How does the Company make decisions as it relates to director and executive compensation?

Each year, the Company’s Board of Directors selects at least three independent members of the Board to serve on its compensation committee (the “Compensation Committee”). Among other duties, the Compensation Committee oversees compensation plans for directors, as well as incentive, equity-based and other compensatory plans for executive officers of the Company.

On an annual basis, the Compensation Committee evaluates the Company’s overall compensation philosophy and determines annual cash retainer fees and option grants for directors, as well as base salaries and other forms of compensation to be paid to executive officers, including cash incentive compensation and grants of stock options and other stock-based awards. Compensation paid to directors and executive officers is disclosed in the Company’s annual proxy statements as required by SEC rules. The Compensation Committee’s decisions are based on consultation, at least annually, with an independent executive compensation advisory firm retained by the Compensation Committee. At the direction of the Compensation Committee, the independent compensation consultant analyzes peer companies and other benchmarking and comparison data, and then provides advice as to the competitiveness of the Company’s executive compensation program and mix of compensation elements. The above process helps to ensure that the Company’s practices are in-line with industry standards, and competitive with companies of similar size and financial condition. This process also helps the Company attract and retain talented key employees.

At the 2019 Annual Meeting of the Company, our stockholders approved the Board’s recommendation that an advisory vote on executive compensation be conducted annually. Accordingly, each fiscal year, the shareholders are asked to place an advisory vote as to the compensation of our executive officers.

Additional information as it relates to responsibilities and processes of the Compensation Committee is set forth in its charter and director and executive officer compensation policy, which are posted on our website under Governance Documents. Additional, more-detailed information in relation to the compensation paid to executive officers can be found in the Company’s required SEC filings, including the Company’s Definitive Proxy Statement filed on September 25, 2023.

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, 2023, including the section captioned “Forward-Looking Statements” and in Item 1A, as supplemented by Part I, Item 2 and Part II, Item 1A in our Quarterly Report on Form 10-Q for the quarter ended February 29, 2024. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments.