~~Table~~As offiled ~~Contents~~with the Securities and Exchange Commission on April 22, 2026

As filed with the Securities and Exchange Commission on September 6, 2024

Registration No. 333-

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

CYTODYN INC.

(Exact name of registrant as specified in its charter)

Delaware	83-1887078
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification Number)

1111 Main Street, Suite 660

Vancouver, Washington 98660

(360) 980-8524

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

~~Mitchell~~Tyler ~~Cohen~~Blok

~~Interim~~ Chief ~~Financial~~Legal Officer

CytoDyn Inc.

1111 Main Street, Suite 660

Vancouver, Washington 98660

Telephone: (360) 980-8524

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies of all communications, including communications sent to the agent for service, to:

Mary Ann ~~Frantz~~FrantzMiller Nash LLP1140 SW Washington St, Suite 700Portland, Oregon 97205Tel: (503) 224-5858

~~Miller Nash LLP~~

1140 SW Washington St, Suite 700

Portland, Oregon 97205

Telephone: (503) 224-5858

Approximate date of commencement of proposed sale to the public: From time to time after this Registration Statement becomes effective.

If the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please check the following box: ☐

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check the following box: ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box. ☐

If this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer:	☐	Accelerated filer:	☐

Non-accelerated filer:	☒	Smaller reporting company:	☒

		Emerging growth company:	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of Securities Act ☐

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until this registration statement shall become effective on such date as the Commission acting pursuant to said Section 8(a), may determine.

~~Table~~The ofinformation ~~Contents~~in this prospectus is not complete and may be changed. A registration statement relating to these securities has been filed with the Securities and Exchange Commission. These securities may not be sold until the registration statement is effective. This prospectus is not an offer to sell these securities and does not solicit an offer to buy these securities in any state or other jurisdiction where the offer or sale is not permitted.

~~Subject to completion, preliminary prospectus dated September , 2024.~~

UpSubject to ~~486~~completion,~~646,723~~ ~~Shares~~preliminary ofprospectus ~~Common~~dated ~~Stock~~April 22, 2026.

~~This~~Up ~~prospectus relates~~ to ~~the resale of up to 279~~278,~~236~~076,~~439~~375 ~~shares of our common stock, par value $0.001 per share (the “common stock”), and 207,410,284 shares of our common stock underlying certain warrants (collectively, the “~~Shares~~”),~~ ~~by the selling stockholders identified in this prospectus under “Selling Stockholders.” The selling stockholders may sell all or a portion~~ of ~~the~~Common Shares from time to time, in amounts, at prices and on terms determined at the time of sale. The Shares may be sold by any means described in the section of this prospectus entitled “Plan of Distribution” beginning on page 75.Stock

WeThis ~~are~~prospectus ~~not~~relates ~~selling~~to ~~any~~the resale of up to 184,135,636 shares of our ~~Common~~common ~~Stock~~stock, ~~under~~par ~~this~~value ~~prospectus~~$0.001 per share (the “common stock”) and ~~will~~93,940,739 ~~not~~shares ~~receive~~of ~~any~~our ~~proceeds~~common ~~from~~stock ~~the~~underlying ~~sale~~certain ofwarrants ~~these~~(collectively, the “Shares”) by the selling stockholders. Weidentified ~~will,~~in ~~however,~~this ~~receive~~prospectus ~~proceeds~~under ~~from~~“Selling ~~any~~Stockholders.” ~~warrants~~The ~~that~~selling ~~are~~stockholders ~~exercised~~may ~~through~~sell ~~the~~all ~~payment~~or a portion of the ~~exercise~~Shares ~~price~~from intime ~~cash.~~to Wetime, ~~will~~in ~~bear all other costs~~amounts, ~~fees~~at prices and ~~expenses~~on ~~incurred~~terms indetermined ~~effecting~~at the ~~registration~~time of ~~the~~sale. The Shares ~~covered~~may bybe ~~this~~sold ~~prospectus.~~by ~~All~~any ~~selling~~means ~~and~~described ~~other~~in ~~expenses~~the ~~incurred~~section byof ~~the~~this ~~selling~~prospectus ~~stockholders~~entitled ~~will~~“Plan beof ~~borne~~Distribution” bybeginning ~~the~~on ~~selling~~page ~~stockholders~~81.

We are not selling any shares of our common stock under this prospectus and will not receive any proceeds from the sale of these Shares by the selling stockholders. We will, however, receive proceeds from any warrants that are exercised through the payment of the exercise price in cash. We will bear all other costs, fees and expenses incurred in effecting the registration of the Shares covered by this prospectus. All selling and other expenses incurred by the selling stockholders will be borne by the selling stockholders.

We are registering the offer and sale of the Shares pursuant to certain registration rights granted to the selling stockholders. The registration of these Shares does not necessarily mean that any of the Shares will be offered or sold by the selling stockholders. The timing and amount of any sale is within the sole discretion of the selling stockholders.

Our common stock is quoted on the OTCQB of OTC Markets Group, Inc. under the symbol “CYDY.” On ~~September~~April 415, ~~2024~~2026, the closing price of our common stock was $0.1634 per share.

Investing in our securities involves risk. You should carefully consider the risks that we have described under the section captioned “Risk Factors” in this prospectus on page 109 before buying our securities.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

The date of this prospectus is ~~September~~ , ~~2024~~2026

Table of Contents

TABLE OF CONTENTS

ABOUT THIS PROSPECTUS		1
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS		2
PROSPECTUS SUMMARY		3
THIS OFFERING		76
RISK FACTORS		109
USE OF PROCEEDS		2221
MARKET FOR OUR COMMON STOCK AND DIVIDEND POLICY		2322
OUR BUSINESS		2423
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS		4339
MANAGEMENT		5048
EXECUTIVE AND DIRECTOR COMPENSATION		5351
CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS		5958
SECURITY OWNERSHIP BY CERTAIN BENEFICIAL OWNERS AND MANAGEMENT		6159
SELLING STOCKHOLDERS		6260
PLAN OF DISTRIBUTION		7581
DESCRIPTION OF SECURITIES		7783
SECURITIES ACT RESTRICTIONS ON RESALE OF SECURITIES		8187
LEGAL MATTERS		8288
EXPERTS		8288
WHERE YOU CAN FIND MORE INFORMATION		8288
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS		F-1

In making your investment decision, you should rely only on the information contained in this prospectus.

We have not authorized anyone to provide you with different or additional information. We are not making an offer to sell or seeking an offer to buy any shares of common stock in any jurisdiction where the offer or sale is not permitted.

You should not assume that the information contained in this prospectus is complete and accurate as of any date other than the date of this prospectus, regardless of the time of delivery of this prospectus or any sale of securities offered hereby.

Table of Contents

ABOUT THIS PROSPECTUS

This prospectus is part of a registration statement on Form S-1 (the “Registration Statement”) that we filed with the SEC. You should read this prospectus and the exhibits filed with or incorporated by reference in the Registration Statement carefully. Such documents contain important information you should consider when making your investment decision. See “Where You Can Find More Information” in this prospectus.

This prospectus may be supplemented from time to time to add, update, or change information in this prospectus. Any statement contained in this prospectus will be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained in such prospectus supplement modifies or supersedes such statement. Any statement so modified will be deemed to constitute a part of this prospectus only as so modified, and any statement so superseded will be deemed not to constitute a part of this prospectus. You may only rely on the information contained in this prospectus or that we have referred you to. We have not authorized anyone to provide you with different information. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities other than the securities offered by this prospectus. This prospectus and any future prospectus supplement do not constitute an offer to sell or a solicitation of an offer to buy any securities in any circumstances in which such offer or solicitation is unlawful. Neither the delivery of this prospectus or any prospectus supplement nor any sale made hereunder shall, under any circumstances, create any implication that there has been no change in our affairs since the date of this prospectus or such prospectus supplement or that the information contained by reference to this prospectus or any prospectus supplement is correct as of any time after its date.

This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed or incorporated by reference as exhibits to the Registration Statement, and you may obtain copies of those documents as described below under “Where You Can Find More Information.”

CytoDyn Inc. and its consolidated subsidiaries are referred to herein as “CytoDyn,” “the Company,” “we,” “us” and “our,” unless the context indicates otherwise.

Table of Contents

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes,” “hopes,” “intends,” “estimates,” “expects,” “projects,” “plans,” “anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Our forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements. In evaluating all such statements, we urge you to specifically consider various risk factors identified in this prospectus, including the matters set forth under the heading “Risk Factors”, any of which could cause actual results to differ materially from those indicated by our forward-looking statements.

Our forward-looking statements reflect our current views with respect to future events and are based on currently available financial, economic, scientific, and competitive data and information on current business plans.

Forward-looking statements include, among others, statements about leronlimab, its ability to provide positive health outcomes, the Company’s ability to implement a successful operating strategy for the development of leronlimab and thereby create shareholder value, the ability to obtain regulatory approval of the Company’s drug products for commercial sales, and the strength of the Company’s leadership team. The Company’s forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties, including: (i) the regulatory determinations of leronlimab’s safety and effectiveness to treat the disease and conditions for which we are studying the product by the U.S. Food and Drug Administration (the “FDA”) and, potentially, drug regulatory agencies in various other countries; (ii) the Company’s ability to raise additional capital to fund its operations; (iii) the Company’s ability to meet its debt and other payment obligations; (iv) the Company’s ability to recruit or retain key employees; (v) the Company’s ability to enter into partnership or licensing arrangements with third parties; (vi) the timely and sufficient development, through internal resources or third-party consultants, of analyses of the data generated from the Company’s clinical trials required by the FDA or other regulatory agencies in connection with applications for approval of the Company’s drug product; (vii) the Company’s ability to achieve approval of a marketable product; (viii) the design, implementation, and conduct of the Company’s clinical trials; (ix) the results of any such clinical trials, including the possibility of unfavorable clinical trial results; (x) the market for, and marketability of, any product that is approved; (xi) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company’s products; (xii) regulatory initiatives, compliance with governmental regulations and the regulatory approval process; (xiii) legal proceedings, investigations, or inquiries affecting the Company or its products;, ~~(xiv)~~including ~~general~~the ~~economic~~finalization ~~and~~of ~~business~~an ~~conditions;~~agreement ~~(xv)~~in ~~changes~~principle into ~~foreign,~~settle ~~political,~~the ~~and~~class-action ~~social~~litigation ~~conditions~~filed against the Company in the state of Washington; (~~xvi~~xiv) stockholder actions or proposals with regard to the Company, its management, or its ~~board~~Board of ~~directors~~Directors; (xv) general economic and business conditions; (xvi) changes in domestic and foreign political and social conditions; and (xvii) various other matters, many of which are beyond the Company’s control.

We intend that all forward-looking statements made in this prospectus will be subject to the safe harbor protection of the federal securities laws and regulations pursuant to ~~Section 27A of~~ the Securities Act of 1933, as amended (the “Securities Act”), and ~~Section 21E of~~ the Securities Exchange Act of 1934, as amended (the “Exchange Act”), to the extent applicable. Except as required by law, we do not undertake any responsibility to update these forward-looking statements to consider events or circumstances that occur after the date of this prospectus. Additionally, we do not undertake any responsibility to update you on the occurrence of any unanticipated events that may cause actual results to differ from those expressed or implied by these forward-looking statements.

Table of Contents

PROSPECTUS SUMMARY

This summary highlights certain information about us, this offering and information appearing elsewhere in this prospectus and in the documents we incorporate by reference as exhibits. This summary is not complete and does not contain all the information that you should consider before investing in our securities. To fully understand this offering and its consequences to you, you should read this entire prospectus carefully, including the information referred to under the heading “Risk Factors” in this prospectus on page 109, and the financial statements and other information in this prospectus, when making an investment decision. This is only a summary and may not contain all the information that is important to you. You should carefully read both this prospectus and any accompanying prospectus supplement, and any other offering materials, together with the additional information described under the heading “Where You Can Find More Information.”

About Us

The Company is a clinical stage biotechnology company focused on the clinical development and potential commercialization of its product candidate, leronlimab, which is being studied for ~~oncology~~its ~~and inflammation, as well as other~~ potential ~~indications,~~in ~~including but not limited to human immunodeficiency virus (“HIV”) and metabolic dysfunction~~solid-~~associated~~tumor ~~steatohepatitis (“MASH”), formerly known as nonalcoholic steatohepatitis (“NASH”)~~oncology.

Our current business strategy is the clinical development of leronlimab, which may include the following:

1. ~~Conducting~~Continue athe Phase II2 study of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer;

2. ~~Conducting~~Conduct aadditional ~~Phase~~studies ~~II study~~ exploring leronlimab and its ~~effect~~therapeutic onpotential ~~inflammation~~in other solid-tumor oncology indications, including but not limited to metastatic triple-negative breast cancer; and

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

Other programs that may be pursued include steatosis and liver fibrosis associated with MASH, either alone or as a combination therapy; and for metastatic triple-negative breast cancer with current standard of care, and/or exploring other trials with current standard of care and other cancer and immunologic indications.

Corporate Information

CytoDyn Inc. is a Delaware corporation with its principal executive offices at 1111 Main Street, Suite 660, Vancouver, Washington 98660, telephone (360) 980-8524. Our website can be found at www.cytodyn.com. We do not intend to incorporate any contents from our website into this prospectus. Effective August 27, 2015, we completed a reincorporation from Colorado to Delaware. Effective November 16, 2018, we implemented a holding company reorganization, as a result of which we became the successor issuer and reporting company to the former CytoDyn Inc. (now our wholly owned subsidiary, CytoDyn Operations Inc.).

Smaller Reporting Company

We are a “smaller reporting company” as defined in the Securities Exchange Act of 1934, as amended (the “Exchange Act”). As a result, we may take advantage of certain reduced disclosure obligations available to smaller reporting companies, including the exemption from compliance with the auditor attestation requirements pursuant to the Sarbanes-Oxley Act of 2022, reduced disclosure about our executive compensation arrangements and the requirements to provide only two years of audited financial statements in our annual reports and registration statements. We will continue to be a “smaller reporting company” as long as (1) we have a public float (i.e., the market value of our common stock held by non-affiliates) less than $250 million calculated as of the last business day of our most recently completed second fiscal quarter, or (2) our annual revenues are less than $100 million for our previous fiscal year and we have either no public float or a public float of less than $700 million as of the end of that fiscal year’s second fiscal quarter. Reduced disclosures in our SEC filings due to our status as a “smaller reporting company” may make it harder for investors to analyze our results of operations and financial prospects.

Description of Transactions in which Shares of Common Stock and Warrants Held by Selling Stockholders Were Issued

The selling stockholders identified in this prospectus may sell shares of our common stock as shown under “Selling Stockholders” below. The transactions in which the shares of our common stock available for resale under this prospectus were or may be acquired by the selling stockholders, including shares underlying warrants to purchase our common stock, are described below.

~~Warrants~~Sales Issued to 4-Good Ventures LLC. On February 14, 2022, we entered into a Surety Bond Backstop Agreement (the “Backstop Agreement”) with David F. Welch, Ph.D., both individually and in his capacity as trustee of aCommon ~~revocable~~Stock ~~trust, LRFA, LLC, a Delaware limited liability company,~~ and ~~certain~~Warrants ~~other related parties (collectively, the “Indemnitors”). Pursuant to the Backstop Agreement, the Indemnitors agreed to assist the Company~~ in ~~obtaining~~Private aOfferings ~~surety~~through ~~bond~~Paulson ~~(the~~Investment ~~“Surety Bond”) for posting in connection with the~~ Company~~’s ongoing litigation with Amarex Clinical Research~~, LLC,. ~~by,~~During ~~among other things, agreeing to indemnify~~ the ~~issuer~~period offrom ~~the~~December 2011 ~~Surety~~through ~~Bond~~September ~~with respect to the Company’s obligations under the Surety Bond. Under the Backstop Agreement~~2023, the Company ~~issued~~engaged toin ~~4-Good~~a ~~Ventures~~series ~~LLC, an affiliate~~ of ~~the~~private ~~Indemnitors~~offerings ~~(“4-Good Ventures”), two warrants, each for the purchase~~ of ~~15,000,000 shares of our~~ common stock, ~~as a backstop fee, each with a five-year term~~ and, ~~as amended in July 2022 and December 2022, an exercise price of $0.10 per share and an additional two~~ warrants, ~~each~~to ~~for the~~ purchase ~~of 7,500,000 shares of our~~ common stock, ~~each~~to ~~with~~accredited ainvestors ~~five-year~~through ~~term~~Paulson ~~and~~Investment anCompany, ~~exercise~~LLC, ~~price~~as ofplacement $0agent.10 ~~per~~A ~~share~~total ~~(the “Backstop Warrants”). The remaining 41,000,000~~

~~Table~~of 59,107,245 shares of ~~Contents~~our common stock sold in the offerings or issued upon the exercise of warrants sold in the offerings are among those being offered for resale as shown under “Selling Stockholders”.

~~shares~~Issuances of ~~common~~Shares ~~stock~~of ~~underlying~~Common ~~the~~Stock ~~Backstop~~in Settlement of Convertible Promissory Notes and Exercise of Warrants, asSold ~~well~~in asPrivate 3Offerings by Us. In August 2015 and early 2018,~~000,000~~ we issued shares of common stock ~~received~~in settlement of the principal amount of, plus accrued but unpaid interest on, convertible promissory notes previously sold by us in private offerings of the ~~revocable~~notes ~~trust~~and ~~upon~~warrants ~~exercise~~to purchase common stock to accredited investors. A total of a1,569,734 ~~portion~~shares of ~~one~~our common stock issued in settlement of the ~~Backstop~~convertible ~~Warrants,~~promissory notes and upon the exercise of related warrants are among those being offered for resale as shown under “Selling Stockholders”.

~~Sales~~Shares ofIssued ~~Common~~upon ~~Stock~~Exercise ~~and~~of Warrants inIssued ~~Private~~to ~~Sales~~Paulson ~~through~~Investment aCompany, ~~Placement Agent. During the period from January through April 2023~~LLC, weas ~~issued~~Compensation in aConnection ~~private~~with ~~placement~~Offerings toof ~~accredited~~Common ~~investors~~Stock ~~through~~and ~~Paulson~~Warrants ~~Investment~~and ~~Company,~~Convertible ~~LLC, an~~Promissory ~~aggregate~~Notes. A total of 712,~~577~~453,~~702~~ 058 shares of ~~our~~ common stock, ~~together~~issued ~~with~~upon ~~warrants~~the toexercise ~~purchase an aggregate~~ of upwarrants to ~~71,577,702 shares~~ ofpurchase our common stock ~~with~~issued anto ~~exercise~~Paulson ~~price~~Investment ofCompany, ~~$0.50 per share~~LLC, ~~for~~or ~~total~~to ~~proceeds~~its ofdesignees, ~~approximately~~as ~~$16.5 million~~compensation ~~(the~~for ~~“March~~its ~~2023~~services ~~Placement”). The~~in ~~warrants~~connection ~~issued~~with toprivate ~~investors~~offerings ~~have a five-year term~~ and ~~were~~registered ~~immediately~~direct ~~exercisable~~offerings ~~upon~~of ~~issuance. Shares~~shares of our common stock, asand ~~well~~warrants asthat ~~shares~~occurred ofduring ~~common stock underlying~~ the ~~warrants,~~period ~~issued~~from inDecember ~~connection~~2011 ~~with~~through ~~the~~July ~~offering~~2023 are among those being offered for resale as shown under “Selling Stockholders”.

~~Sales~~Public ofTender ~~Common~~Offers. ~~Stock~~The ~~and~~Company ~~Warrants~~conducted ina ~~Private~~total ~~Sales~~of ~~Conducted~~four bypublic ~~Us. In~~tender ~~February~~offers ~~2023,~~during ~~Dr. Arman~~2018, ~~the Company’s then President~~2019, ~~entered~~and ~~into~~2024 apursuant ~~transaction~~to which ~~with~~ the Company inoffered ~~which~~to heexchange ~~purchased~~warrants ~~434,782~~held ~~shares~~by ofthe ~~our~~investors ~~common~~for ~~stock,~~warrants ~~together~~ with a ~~warrant~~reduced ~~to purchase up to 434,782 shares of our common stock with an~~ exercise price ~~of $0.50 per share~~, ~~for~~conditioned ~~total~~upon ~~proceeds~~the ofimmediate ~~approximately~~exercise ~~$0.1 million. The terms and conditions~~ of the ~~sale~~warrants. ~~and~~A ~~issuance~~total of ~~the~~4,545,900 ~~warrant~~shares ~~were the same as those offered to other investors in the March 2023 Placement. Shares~~ of common stock, asissued ~~well~~pursuant asto the ~~shares~~exercise of ~~common stock underlying~~ the warrants, issued in ~~connection with~~ the ~~transaction~~tender ~~with~~offers ~~Dr. Arman~~ are among those being offered for resale as shown under “Selling Stockholders”.

~~Issuance~~Private ofWarrant ~~Warrants~~Exchanges. In toMay ~~Placement~~2019, ~~Agent~~January in2020, ~~Connection~~June ~~with~~2020, ~~Private~~March ~~Placement~~2021, ~~Offerings.~~and InDecember ~~connection~~2022, ~~with~~ the ~~March~~Company ~~2023~~entered ~~Private~~into ~~Placement, we~~warrant ~~issued~~exchange toagreements ~~Paulson~~with ~~Investment~~investors ~~Company,~~in ~~LLC,~~which asthe ~~placement~~Company ~~agent,~~offered or to ~~its~~issue ~~designees,~~ warrants to purchase ~~a total of 10,736,575~~ shares of ~~our~~ common stock. ~~The~~with ~~warrants~~a ~~have~~reduced aexercise ~~10-year~~price ~~term~~in ~~and~~exchange ~~were~~for ~~immediately~~warrants ~~exercisable~~held ~~upon~~by ~~issuance.~~the ~~The~~investors, ~~warrants~~conditioned ~~have~~on anthe immediate exercise ~~price~~ of $0the warrants issued in exchange.23 ~~per~~In ~~share~~some cases, ~~and include~~additional ashares ~~cashless~~of ~~exercise~~common ~~provision~~stock were issued as an added inducement for the exercises. ~~Shares~~A total of 19,394,496 shares of common stock ~~underlying~~issued in connection with the ~~warrants~~private warrant exchanges are among those being offered for resale as shown under “Selling Stockholders”.

~~Warrants~~Legal ~~Issued~~Settlement ~~to Richard G~~Issuances. ~~Pestell, M.D., Ph.D.~~ In ~~May~~August ~~2022~~2021, we ~~issued~~settled toa ~~Richard~~dispute ~~G. Pestell, M.D., Ph.D., warrants~~ with a ~~three-year term~~ toplacement ~~purchase 7,000,000 shares~~agent ofin ~~common~~part ~~stock~~through ~~with~~the anissuance ~~exercise price~~ of ~~$0.37 per~~warrants ~~share~~to inpurchase ~~connection~~common ~~with~~stock. ~~the~~A ~~settlement~~total of a23,597 ~~lawsuit~~shares ~~related~~of tocommon ~~Dr.~~stock ~~Pestell’s~~issued ~~former~~upon ~~employment~~exercise ~~as our CMO. The shares~~ of ~~common~~the ~~stock~~warrants are among those being offered for resale as shown under “Selling Stockholders”.

Sales of Common Stock and Warrants in Private Sales ~~through~~Conducted aby ~~Placement Agent~~Us. During November 2021, the period from ~~July~~February 2022 through ~~September~~April ~~2023~~2022, weand ~~issued~~January in2026, athe ~~private~~Company ~~placement~~entered tointo ~~accredited~~private ~~investors~~sale ~~through~~transactions ~~Paulson Investment Company, LLC, an aggregate~~ of ~~21,453,125 shares of our~~ common stock, ~~together~~directly with ~~warrants~~accredited toinvestors, ~~purchase~~as anwell ~~aggregate~~as ofwarrants up to ~~21,453,125~~ ~~shares~~purchase ~~of our~~ common stock ~~with~~in ancertain ~~exercise price of $0~~transactions.50 ~~per~~A ~~share, for~~ total ~~proceeds~~ of ~~approximately~~15,293,430 ~~$3.4 million. The~~shares ~~warrants~~of ~~issued~~common tostock ~~investors~~sold ~~have~~in athe ~~five-year~~private ~~term~~sale ~~and~~transactions ~~were~~or ~~immediately~~issued ~~exercisable~~ upon ~~issuance. Shares~~the ofexercise ~~common stock, as well as shares~~ of ~~common stock underlying the~~ warrants, ~~issued~~sold in ~~connection~~the ~~with~~private ~~the~~sale ~~offering~~transactions, are among those being offered for resale as shown under “Selling Stockholders”.

~~Issuance~~Sales of ~~Warrants~~Common toStock ~~Placement~~and ~~Agent~~Warrants in ~~Connection~~Private ~~with~~Sales ~~Private~~through a Placement ~~Offerings~~Agent. InDuring ~~connection with~~ the ~~private~~period ~~placement~~from January through aFebruary ~~placement~~2026, ~~agent~~in ~~described~~a ~~above, we~~private ~~issued~~placement to accredited investors through Paulson Investment Company, LLC, we orissued ~~its~~a ~~designees~~total of 81,283,708 shares of our common stock, together with warrants to purchase a total of up to 381,~~217~~283,~~963~~708 shares of our common stock with an exercise price of $0.26 per share, for total proceeds of approximately $17.5 million (the “February 2026 Placement”). The warrants issued in these transactions have a 10five-year term and were immediately exercisable upon issuance. Shares ~~The warrants have an exercise price~~ of ~~$0.16~~common ~~per~~stock, ~~share~~as ~~and~~well ~~include~~as ashares ~~cashless exercise provision. Shares~~ of common stock underlying the warrants, issued in connection with the offering are among those being offered for resale as shown under “Selling Stockholders”.

~~Sale~~Issuance of ~~Placement Agent Notes and~~ Warrants. ~~During~~to ~~the~~Placement ~~period~~Agent ~~from~~in ~~April through~~Connection ~~June 2023,~~with wePrivate ~~issued~~Placement ~~secured~~Offerings. ~~promissory~~In ~~notes~~connection with anthe ~~18-month~~February ~~term~~2026 toPlacement, we ~~accredited~~issued ~~investors~~to ~~through~~ Paulson Investment Company, LLC, in anor ~~aggregate~~its ~~principal~~designees, ~~amount~~warrants ofto ~~approximately~~purchase ~~$2.3~~a ~~million~~total ~~(“Placement Agent Notes”). The Placement Agent Notes~~of ~~provide~~12,192,563 ~~for~~shares ~~an accrual~~ of ~~interest~~our atcommon anstock. ~~annual~~The ~~rate~~warrants ofhave ~~6%.~~a As10-year ~~part~~term ofand ~~the~~were ~~sale~~immediately weexercisable ~~issued~~upon ~~fully~~issuance. ~~exercisable~~The warrants tohave ~~purchase~~ an ~~aggregate of 2,271,000 shares of our common stock with an~~ exercise price of $0.502153 per share~~. The~~ ~~warrants~~and ~~issued~~include ~~in these transactions have~~ a ~~three-year~~cashless ~~term~~exercise ~~and were immediately exercisable upon issuance~~provision. Shares of common stock underlying the warrants, ~~issued in connection with the Placement Agent Notes~~ are among those being offered for resale as shown under “Selling Stockholders”.

Sales of Common Stock and Warrants in a Private Sale Conducted by Us. In February 2026, in a private sale transaction with an accredited investor conducted directly by the Company, the accredited investor purchased 464,468 shares of our common stock, together with a warrant to purchase up to 464,468 shares of our common stock with an exercise price of $0.26 per share, for total

~~Table~~proceeds of ~~Contents~~approximately $0.1 million. The terms and conditions of the sale and issuance of the warrant were the same as those offered to investors in the February 2026 Placement. Shares of common stock, as well as the shares of common stock underlying the warrants, issued in the transaction are among those being offered for resale as shown under “Selling Stockholders”.

Issuance of Warrants to Placement Agent in Connection with Sale of Placement Agent Notes. In connection with the sale of Placement Agent Notes through a placement agent described above, we issued to Paulson Investment Company, LLC, or its designees, warrants to purchase a total of 738,075 shares of our common stock. The warrants have a 10-year term and were immediately exercisable upon issuance. The warrants have an exercise price of $0.26 per share and include a cashless exercise provision. Shares of common stock underlying the warrants are among those being offered for resale as shown under “Selling Stockholders”.

Conversion of Placement Agent Notes into Shares and Warrants. In July 2023, the Placement Agent Notes were converted into an aggregate of 14,339,222 shares of common stock, together with warrants to purchase an aggregate of up to 14,339,222 shares of common stock with an exercise price of $0.306 per share. The warrants issued in these transactions have a five-year term and were immediately exercisable upon issuance. Shares of common stock, as well as shares of common stock underlying the warrants, issued in connection with the Placement Agent Notes conversion are among those being offered for resale as shown under “Selling Stockholders”.

Sales of Common Stock and Warrants in Private Sales Conducted by Us. During the period from February 2022 through April 2022, in private sale transactions with accredited investors conducted directly by the Company, certain of the selling stockholders identified in this prospectus purchased an aggregate of 12,745,096 shares of our common stock, together with warrants to purchase an aggregate of 9,558,822 shares of our common stock with an exercise price of $0.306 per share, for total proceeds of approximately $3.3 million. The warrants issued in these transactions have a five-year term and were immediately exercisable upon issuance. Shares of common stock underlying the warrants are among those being offered for resale as shown under “Selling Stockholders”.

Previous Sales of Common Stock and Warrants in Private Sales through a Placement Agent. In November 2021, we issued in a private placement to accredited investors through Paulson Investment Company, LLC, an aggregate of 11,361,000 shares of our common stock, together with warrants to purchase an aggregate of up to 3,408,300 shares of our common stock with an exercise price of $1.00 per share, for total proceeds of approximately $11.4 million. The warrants issued in these transactions have a five-year term and were immediately exercisable upon issuance. Shares of common stock underlying the warrants issued in connection with the offering are among those being offered for resale as shown under “Selling Stockholders”.

During the period from April 2022 through June 2022, we issued in a private placement to accredited investors through Paulson Investment Company, LLC, an aggregate of 85,378,497 shares of our common stock, together with warrants to purchase an aggregate of up to 64,033,829 shares of our common stock, with an exercise price of $0.306 per share, for total proceeds of approximately $21.8 million. The warrants issued in these transactions have a five-year term and were immediately exercisable upon issuance. Shares of common stock underlying the warrants issued in connection with the offering are among those being offered for resale as shown under “Selling Stockholders”.

Previous Issuance of Warrants to Placement Agent in Connection with Private Placement Offerings. During November 2021 and the period from April through June 2022, in connection with private placements of common stock and warrants to accredited investors, we issued to Paulson Investment Company, LLC, as placement agent, or to its designees, warrants to purchase a total of 20,786,835 shares of our common stock. The warrants have a 10-year term and were immediately exercisable upon issuance. Warrants to purchase up to 1,363,320 shares have an exercise price of $1.00 per share and warrants to purchase up to 19,423,515 shares have an exercise price of $0.255 per share. The warrants include a cashless exercise provision. Shares of common stock underlying the warrants are among those being offered for resale as shown under “Selling Stockholders”.

Sales of Common Stock and Warrants in Private Sales through a Placement Agent. During the period from December through May 2024, we issued in a private placement to accredited investors through Paulson Investment Company, LLC, an aggregate of 54,169,201 shares of our common stock, together with warrants to purchase an aggregate of up to 54,169,201 shares of our common stock with an exercise price of $0.21 per share, for total proceeds of approximately $7.0 million. The warrants issued in these transactions have a five-year term and were immediately exercisable upon issuance. Shares of common stock, as well as shares of common stock underlying the warrants, issued in connection with the offering are among those being offered for resale as shown under “Selling Stockholders”.

Issuance of Warrants to Placement Agent in Connection with Private Placement Offerings. In connection with the private placement through a placement agent described above, we issued to Paulson Investment Company, LLC, or its designees, warrants to purchase a total of 7,894,615 shares of our common stock. The warrants have a 10-year term and were immediately exercisable upon

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issuance. The warrants have an exercise price of $0.13 per share and include a cashless exercise provision. Shares of common stock underlying the warrants are among those being offered for resale as shown under “Selling Stockholders”.

Sale of Short-term Notes and Warrants. During the period from November through December 2023, we issued secured promissory notes with a 6-month term to accredited investors through Paulson Investment Company, LLC, in an aggregate principal amount of approximately $1.0 million (“Short-term Notes”). The Short-term Notes provide for an accrual of interest at an annual rate of 10%. As part of the sale we issued fully exercisable warrants to purchase an aggregate of 1,000,000 shares of our common stock with an exercise price of $0.35 per share. The warrants issued in these transactions have a five-year term and were immediately exercisable upon issuance. Shares of common stock underlying the warrants issued in connection with the Short-term Notes are among those being offered for resale as shown under “Selling Stockholders”.

Issuance of Warrants to Placement Agent in Connection with Sale of Short-term Notes. In connection with the sale of Short-term Notes through a placement agent described above, we issued to Paulson Investment Company, LLC, or its designees, warrants to purchase a total of 428,571 shares of our common stock. The warrants have a 10-year term and were immediately exercisable upon issuance. The warrants have an exercise price of $0.35 per share and include a cashless exercise provision. Shares of common stock underlying the warrants are among those being offered for resale as shown under “Selling Stockholders”.

Conversion of Short-term Notes into Shares and Warrants. In December 2023, the Short-term Notes were converted into an aggregate of 10,070,544 shares of common stock, together with warrants to purchase an aggregate of up to 10,070,544 shares of common stock with an exercise price of $0.21 per share. The warrants issued in these transactions have a five-year term and were immediately exercisable upon issuance. Shares of common stock, as well as shares of common stock underlying the warrants, issued in connection with the Short-term Notes conversion are among those being offered for resale as shown under “Selling Stockholders”.

Tender Offer. In July 2024, pursuant to a public tender offer, the Company entered into warrant exchange agreements with investors holding warrants to purchase Company common stock with specified original exercise prices ranging from $0.21 to $1.00 per share. The tender offer was conducted with the assistance of a soliciting agent. Investors that accepted the tender offer were required to exercise their tendered warrants at a reduced exercise price of $0.09387 per share. The Company issued a total of 152,504,608 shares of Common Stock upon exercise of the warrants, including 25,417,426 shares issued as an inducement for the exercises. Gross proceeds from the tender offer totaled approximately $11.9 million. Shares of common stock issued in connection with the tender offer are among those being offered for resale as shown under “Selling Stockholders”.

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THIS OFFERING

We are registering for resale by the Selling Stockholders named herein an aggregate of 486,646,723 shares of our common stock as described below.

Issuer:		CytoDyn Inc.

Securities being offered:		279,236,439 shares of common stock and 207,410,284 shares underlying outstanding warrants to purchase our common stock, as listed in the table under “Selling Stockholders” below.

Common stock outstanding prior to this offering:		1,219,841,932 shares of common stock as of August 31, 2024.

Use of proceeds:		We will not receive any of the proceeds from the sale or other disposition of the Shares by the selling stockholders. The selling stockholders will bear all selling and other expenses incurred in connection with the sale or other disposition by them of the Shares covered hereby. However, if all the warrants covered by this prospectus are exercised for cash, we may receive proceeds of up to approximately $48.5 million, as further described in “Use of Proceeds.”

Market for common stock:		Our common stock is quoted on the OTCQB of the OTC Market under the symbol “CYDY.” On September 4, 2024, the closing price of our common stock was $0.16 per share.

Risk factors:		The purchase of our securities involves a high degree of risk. See “Risk Factors” beginning on page 10 and other information included in this prospectus for a discussion of factors you should carefully consider before deciding to invest in our securities.

We have registered for resale by the Selling Stockholders named herein a remaining aggregate of 278,076,375 shares of our common stock as described below.


Issuer:		CytoDyn Inc.

Securities being offered:		184,135,636 shares of common stock and 93,940,739 shares underlying outstanding warrants to purchase our common stock, as listed in the table under “Selling Stockholders” below.

Common stock outstanding prior to this offering:		1,366,029,885 shares of common stock as of April 15, 2026.

Use of proceeds		We will not receive any of the proceeds from the sale or other disposition of the Shares by the selling stockholders. The selling stockholders will bear all selling and other expenses incurred in connection with the sale or other disposition by them of the Shares covered hereby. However, if all the warrants covered by this prospectus are exercised for cash, we may receive proceeds of up to approximately $23.9 million, as further described in “Use of Proceeds.”

Market for common stock		Our common stock is quoted on the OTCQB of the OTC Market under the symbol “CYDY.” On April 15, 2026, the closing price of our common stock was $0.34 per share.

Risk factors		The purchase of our securities involves a high degree of risk. See “Risk Factors” beginning on page 9 and other information included in this prospectus for a discussion of factors you should carefully consider before deciding to invest in our securities.

Summary Risk Factors

Risks Related to Our Financial Position and Need for Additional Capital

●

Our cash reserves are low and we do not expect to receive substantial, if any, revenues for the foreseeable future such that we will need to raise substantial additional financing to fund our ongoing operations and manage our payment obligations, which financing continues to be extremely difficult to secure in light of the low trading price of our common stock.

●

We are a clinical stage biotechnology company with a history of significant operating losses; we expect to continue to incur operating losses, and we may never achieve profitability.

●

The amount of financing we require will depend on various factors, many of which are beyond our control. The results of our operations, financial condition, and stock price are likely to be adversely affected if we are unable to obtain additional funding on improved terms compared to previous financings.

●

Our future cash requirements may differ significantly from our current estimates.

●

Our auditors have issued a going concern opinion, and we will not be able to achieve our objectives and will have to cease operations if we cannot find adequate financing.

●

We have written off the value of our pre-launch inventories of leronlimab and related raw materials, the costs of which were previously capitalized, and may be unable to use all or a portion of those inventories in the development of our product candidate.

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Risks Related to Our Ability to Maintain Effective Operational and Internal Controls Environment

●

The recruitment and retention of skilled directors, executives, employees and consultants may be difficult and expensive, may result in dilution to our stockholders, and any failure to attract and retain such individuals may adversely affect our drug development and commercialization activities.

●

The loss, temporary loss, or transition of members of our senior management team or any other key employees may adversely affect our business.

●

If we are unable to maintain an effective system of internal control over financial reporting, we may not be able to accurately or timely report our financial results and our stock price could be adversely affected.

●

Our information technology systems could fail to perform adequately or experience data corruption, cyber-based attacks, or network security breaches.

Risks Related to Legal Proceedings

●

Our business, operating results, and financial condition could be negatively affected as a result of litigation and other demands made by stockholders.

● ~~The~~Although we have reached an agreement in principle to resolve the ongoing class-action litigation filed against us, ~~could~~failure ~~harm~~to ~~our~~finalize ~~business,~~the ~~and~~contemplated ~~insurance~~settlement ~~coverage~~ may ~~not~~result bein ~~sufficient~~material harm to ~~cover~~our ~~all related costs and damages~~business.

●

We are subject to oversight by the SEC, FDA, and other regulatory agencies. Investigations and proceedings by those agencies may divert management’s focus and have a material adverse effect on our reputation and financial condition.

●

We face risks and uncertainties related to litigation and other claims.

Risks Related to Development and Commercialization of Our Drug Candidate

●

Certain agreements and related license agreements require us to make significant milestone, royalty, and other payments, which will require additional financing and, in the event we do commercialize leronlimab, will decrease the revenues we may ultimately receive on sales. To the extent that such milestone, royalty and other payments are not timely made, the counterparties to such agreements in certain cases have repurchase and termination rights thereunder with respect to leronlimab.

●

If we are unable to obtain all required regulatory approvals for leronlimab, we will not be able to commercialize our primary product candidate, which would materially and adversely affect our business, financial condition, and stock price.

●

Disruptions at the FDA and other government agencies caused by funding shortages, Executive Orders, or global health concerns could hinder their ability to hire, retain, or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved, or commercialized in a timely manner or at all, which could negatively impact our business.

●

We are dependent on the success of leronlimab. If we, either alone or with collaborators, are unable to complete the clinical development of, obtain and maintain marketing approval for, or successfully commercialize leronlimab, including with respect to adequate coverage and reimbursement, or if we continue to experience significant delays in doing so, our business will be harmed.

●

Our competitors may develop drugs that are more effective, safer, and less expensive than ours.

●

We may not be able to identify, negotiate, and maintain the strategic alliances necessary to develop and commercialize our products and technologies, and we will be dependent on our corporate partners if we do.

●

Known third-party patent rights could delay or otherwise adversely affect our planned development and sale of leronlimab. We have identified but not exhaustively analyzed other patents that could relate to our proposed products.

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Risks Related to Our Dependence on Third Parties

●

We have a limited number of internal research and development personnel, making us dependent on consulting relationships and strategic alliances with industry partners.

●

We may continue to rely on third parties, such as clinical research organizations (“CRO(s)”) and third-party manufacturers, to conduct clinical trials for our product candidate, leronlimab, and to produce our pre-clinical and clinical product candidate supplies. Such third parties are subject to significant regulation. A failure by such third parties to perform their obligations properly and successfully to us, or failure of manufacturers on which we rely to meet regulatory requirements, may result in our inability to obtain regulatory approvals for or commercialize our product candidate.

Risks Related to Our Intellectual Property Rights

●

Our success depends upon our ability to obtain and maintain intellectual property protection relating to our product candidate and future product candidates.

●

If we are sued for infringing on third-party intellectual property rights, it will be costly and time-consuming, and an unfavorable outcome would have a significant adverse effect on our business. We may also undertake infringement or other legal proceedings against third parties, causing us to spend resources on litigation and exposing our own intellectual property portfolio to challenge.

●

We may become involved in disputes with our present or future contract partners over intellectual property ownership or other matters, which could have a significant adverse effect on our business.

Risks Related to Ownership of Our Common Stock

●

Our common stock is classified as “penny stock” and trading of our shares may be restricted by the SEC’s penny stock regulations.

●

The trading price of our common stock has been and could remain volatile, and the market price of our common stock may decrease.

●

Since our inception, we have been insolvent and have required debt and equity financing to maintain operations. We expect our debt service obligations and our need for additional funding to finance operations will cause additional dilution to our existing stockholders and could adversely affect the trading price of our common stock.

●

Our certificate of incorporation permits our Board of Directors (the “Board”) to create new series of preferred stock without further approval by our stockholders, which could adversely affect the rights of the holders of our common stock.

●

Anti-takeover provisions of our certificate of incorporation, our bylaws, and Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult, and may prevent attempts by our stockholders to replace or remove the current members of our Board and management.

●

We do not expect to pay cash dividends on our common shares in the foreseeable future.

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RISK FACTORS

Our business is subject to numerous risks and uncertainties, including those highlighted in this section, that represent challenges we face in our efforts to successfully implement our strategy. You should carefully consider the risks described below, as well as other information set forth in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the consolidated financial statements and related notes included in this prospectus. These risks, some of which have occurred and any of which may occur, alone or in combination with other events in the future, may have a material adverse effect on our business, financial condition, cash flows, results of operations, or the trading price of our common stock. The risks described below are not the only risks we face. Additional risks and uncertainties not currently known to us, or that we currently deem to be immaterial, may occur or become material in the future. Therefore, historical financial and business performance, events, and trends are often not a reliable indicator of future operating results, financial and business performance, events, or trends.

Risks Related to Our Financial Position and Need for Additional Capital

Our cash reserves are ~~extremely~~ low and we do not expect to receive substantial, ~~requiring~~if any, revenues for the foreseeable future such that we will need to raise substantial additional financing to ~~satisfy~~fund our ~~current~~ongoing ~~payment~~operations ~~obligations~~ and tomanage ~~fund~~ our ~~operations~~payment obligations, which financing continues to be extremely difficult to secure in light of the low trading price of our common stock.

As of ~~August~~April 3115, ~~2024~~2026, we had an unrestricted cash balance of approximately $2413.94 million and no reserved cash balance. We must continue to raise additional funds in the near term to meet our payment obligations and fund our operations. Additional funding may not be available on acceptable terms or at all. In addition, as of ~~August~~April 3115, ~~2024~~2026, we had approximately ~~199~~298.20 million shares of common stock unreserved for other purposes and available for issuance in new financing transactions. Our outstanding accounts payable and accrued liabilities totaled approximately $1629.73 million on ~~July~~February 3128, ~~2024~~2026. If we are not able to raise additional funds on a timely basis, we may be forced to delay, reduce the scope of, or eliminate one or more of our planned operating activities, including: conducting a ~~Phase II~~ study of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer; conducting aadditional ~~Phase~~studies IIexploring ~~study~~leronlimab ~~evaluating~~and ~~the~~its ~~effects~~therapeutic ofpotential ~~leronlimab~~in onother ~~chronic~~solid-tumor ~~immune~~oncology ~~activation~~indications, ~~and~~including ~~inflammation~~but not limited to metastatic triple-negative breast cancer; pursuing research and development of longer-acting molecules; ~~evaluating whether to conduct a combination pre-clinical study or monotherapy Phase 2b/3 clinical trial in MASH;~~ and evaluating other opportunities for pre-clinical studies and publishing data from previously conducted studies. Any delay or inability to pursue our planned activities likely will adversely affect our business, financial condition, and stock price. The continued low trading price of our common stock (with a closing price of $0.1634 per share on ~~September~~April 415, ~~2024~~2026) presents a significant challenge to our ability to raise additional funds. If we deplete our cash reserves, we may have to discontinue our operations and liquidate our assets.

We are a clinical stage biotechnology company with a history of significant operating losses; we expect to continue to incur operating losses, and we may never achieve profitability.

We have not generated revenue from product sales, licensing, or other income opportunities to date. Since our inception, we have incurred operating losses each year due to costs incurred for research and development activities and general and administrative expenses related to our operations. We expect to incur losses for the foreseeable future, with no or only minimal revenues as we continue to pursue development of, and seek regulatory approvals for, leronlimab. If leronlimab fails to gain regulatory approval, or if it or other drug or biologic candidates we may acquire or license in the future do not achieve approval or market acceptance, we will not be able to generate revenue or explore other opportunities to enhance stockholder value, such as through a sale. If we fail to generate revenue or if we are unable to fund our continuing operations, our stockholders could lose a portion or all of their investments.

Our future funding requirements will depend on many factors, including, but not limited to:

●

the costs of preparing required regulatory submissions, as well as any clinical trial programs and pre-clinical studies we may pursue and other development activities conducted by us directly,

●

the costs involved with our chemistry, manufacturing and controls (“CMC”) activities,

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●

the satisfaction of payment obligations we have already incurred,

●

the costs and timing of obtaining regulatory approvals and making related milestone payments due to third parties with whom we have licensing or similar agreements,

●

the costs of filing, prosecuting, maintaining, and enforcing patents and other intellectual property rights and defending against potential claims of infringement,

●

the costs associated with hiring and retaining needed scientific and administrative employees, advisors, and consultants,

●

the cost of legal and other professional advisors needed to support our development efforts, responsibilities as a public reporting company, regulatory compliance and investigations, and legal proceedings,

●

the costs of compliance with laws, regulations, or judicial decisions applicable to us, and

●

the costs of general and administrative infrastructure required to manage our business and protect corporate assets and stockholder interests.

If any of these factors cause our funding needs to be greater than expected, our ability to continue operations, financial condition, and stock price may be adversely affected.

Our future cash requirements may differ significantly from our current estimates.

Our cash requirements may differ significantly from our estimates from time to time, depending on a number of factors, including:

●

our ability to attract strategic partners to pay for or share costs related to our product development efforts,

●

whether our outstanding convertible notes are converted into equity,

●

whether we receive additional cash upon the exercise of our outstanding warrants and stock options for common stock, and

●

our ability to obtain funding under future licensing agreements or other collaborative relationships.

If we deplete our cash reserves and are unable to obtain additional funding, we may be forced to discontinue our operations and liquidate our assets.

Our auditors have issued a going concern opinion, and we will not be able to achieve our objectives and will have to cease operations if we cannot find adequate financing.

Our auditors issued an opinion, which includes a going concern explanatory paragraph, in connection with the audit of our annual consolidated financial statements for the fiscal year ended May 31, ~~2024~~2025. A going concern paragraph in an audit opinion means that there is substantial doubt that we can continue as an ongoing business for the 12 months from the date the consolidated financial statements are issued. If we are unable to continue as an ongoing business, we might have to liquidate our assets and the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our financial statements. In addition, the inclusion of an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern and our lack of cash resources may materially and adversely affect our share price and our ability to raise new capital or to enter into critical contractual relations with third parties. There is no assurance that we will be able to adequately fund our operations in the future.

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Pre-launch inventories consist of costs of raw materials and work-in-progress related to our product candidate leronlimab. As of ~~August~~ May 31, ~~2024~~2023, our inventories had been written off in full for accounting purposes. Although a portion of the inventories that were written off continue to be physically maintained and currently may be eligible for use in certain clinical contexts, we may be unable to ~~use all or a portion of these inventories in the development of our product candidate.~~

use all or a portion of these inventories in the development of our product candidate, which may require us to engage a third party to produce additional clinical supplies of leronlimab to pursue our planned studies and clinical trials.

Risks Related to Our Ability to Maintain an Effective Operational and Internal Controls Environment

The recruitment and retention of skilled directors, executives, employees, and consultants may be difficult and expensive, may result in dilution to our stockholders, and any failure to attract and retain such individuals may adversely affect our drug development and commercialization activities.

Our business depends on the skills, performance, and dedication of our officers and key scientific and technical advisors, as well as our directors. All of our current scientific advisors are independent contractors and are either self-employed or employed by other organizations. As a result, they may have conflicts of interest or other commitments, such as consulting or advisory contracts with other organizations, that may affect their ability to provide services to us in a timely manner. We likely will need to recruit additional directors, executive management, employees, and advisors, particularly scientific and technical personnel. In addition, there is currently intense competition for skilled directors, executives, and employees with relevant scientific and technical expertise, and this competition is likely to continue. We compete for these qualified personnel against companies with greater financial resources than ours. These recruitment and retention efforts likely will require additional financial resources. To successfully recruit and retain qualified employees, we will need to offer a combination of salary, cash incentives, and equity compensation. Future issuances of our equity securities for compensatory purposes will dilute existing stockholders’ ownership interests and reduce the shares available for future funding transactions. If we are unable to attract and retain individuals with relevant scientific, technical, and managerial experience, we may be forced to limit or delay our product development activities or may experience difficulties in successfully conducting our business, which would adversely affect our operations and financial condition.

The loss, temporary loss, or transition of members of our senior management team or any other key employees may adversely affect our business.

~~During~~We ~~the past 24 months, we have experienced significant turnover among our senior executives, and~~ currently have only three executive officers. Jacob Lalezari, M.D., our current Chief Executive Officer, entered into an employment agreement with us in January 2024 that can be terminated by either party at any time. ~~Mitchell~~Our ~~Cohen, our~~ current ~~Interim~~ Chief Financial Officer, ~~was~~Robert ~~appointed~~E. ~~effective February 1~~Hoffman, ~~2024,~~joined ~~pursuant~~the toCompany anon ~~agreement~~May ~~with Rapid Deployment LLC d/b/a InterimExecs (“InterimExecs”)~~15, ~~under which he serves as an independent contractor~~2025. The agreement may be terminated at any time by either party upon 30 days’ advance notice in writing. The Board plans to initiate a search for a long-term Chief Financial Officer as soon as practicable in collaboration with Mr. Cohen. If we are successful in recruiting one or more additional individuals to executive positions, the complexity inherent in integrating aadditional ~~new~~ key ~~member~~members of the senior management team with existing senior management may limit the effectiveness of any such successor or otherwise adversely affect our business. Leadership transitions and any disruptions that result are inherently difficult to manage and may cause uncertainty or a disruption to our business or increase the likelihood of turnover of other key officers and employees. Further, we may incur significant expenses related to any executive transitions. Finding suitable replacements for senior management and other key employees can be difficult, and there is no assurance we will be successful in attracting or retaining qualified personnel.

Our success depends significantly on the individual and collective contributions of our senior management team and key employees. ~~The individual and collective efforts of these employees are important~~ as we continue our efforts to develop leronlimab. The loss of the services of a member of our current senior management team or the inability to hire and retain experienced management personnel ~~likely~~may ~~would~~ have a material adverse effect on our business and operations.

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Section 404 of the Sarbanes-Oxley Act of 2002 and related regulations require us to evaluate the effectiveness of our internal control over financial reporting as of the end of each fiscal year, and to include a management report assessing the effectiveness of our internal control over financial reporting in our Form 10-K for that fiscal year. Failure to maintain our controls or operation of these controls may harm our operations, decrease the reliability of our financial reporting, and cause us to fail to meet our financial reporting obligations, which could adversely affect our business and reduce our stock price.

Our information technology systems could fail to perform adequately or experience data corruption, cyber-based attacks, or network security breaches.

We rely on information technology networks and systems, including the internet, to process, transmit, and store electronic information. In particular, we depend on our information technology infrastructure to effectively manage our business data, finance, and other business processes and electronic communications between our personnel and corporate partners. If we do not allocate and effectively manage the resources necessary to build and sustain an appropriate technology infrastructure, security breaches or system failures of this infrastructure may result in system disruptions, shutdowns, or unauthorized disclosure of confidential information, including patient information in violation of HIPAA requirements. In addition, our employees, contractors, and other corporate partners increasingly are working from remote locations. As a result, we rely on information technology systems that are outside our direct control. These systems are potentially vulnerable to cyber-based attacks and security breaches. In addition, cyber criminals are increasing their attacks on individual employees, including scams designed to trick victims into transferring sensitive data or funds or stealing credentials that compromise information systems. If one of our employees falls victim to these attacks, or our information technology systems or those of our partners are compromised, our operations could be disrupted, or we may suffer financial loss, loss or misappropriation of intellectual property or other critical assets, reputational harm, and regulatory fines and intervention, and our business and financial condition may be adversely affected.

failures of this infrastructure may result in system disruptions, shutdowns, or unauthorized disclosure of confidential information, including patient information in violation of HIPAA requirements. In addition, our employees, contractors, and other corporate partners increasingly are working from remote locations. As a result, we rely on information technology systems that are outside our direct control. These systems are potentially vulnerable to cyber-based attacks and security breaches. In addition, cyber criminals are increasing their attacks on individual employees, including scams designed to trick victims into transferring sensitive data or funds or stealing credentials that compromise information systems. If one of our employees falls victim to these attacks, or our information technology systems or those of our partners are compromised, our operations could be disrupted, or we may suffer financial loss, loss or misappropriation of intellectual property or other critical assets, reputational harm, and regulatory fines and intervention, and our business and financial condition may be adversely affected.

Risks Related to Legal Proceedings

Our business, operating results, and financial condition could be negatively affected as a result of litigation and other demands made by stockholders.

We are and have been involved in legal proceedings and other claims brought by stockholders, including class actions alleging securities law violations, derivative actions alleging waste of corporate assets, unjust enrichment, other breaches of fiduciary duties by former directors and current and former executive officers, and demands by activist investors. Similar actions may occur in the future. While the Company welcomes opinions of all stockholders, responding to demands, litigation, proxy contests, or other initiatives by stockholders or activist investors may divert the attention of our Board, management team, and employees from their regular duties in the pursuit of business opportunities to enhance stockholder value. Such actions may also cause our existing or potential employees, strategic partners, and stockholders to have questions or doubts about the future direction of the Company and may provide our competitors with an opportunity to exploit these concerns. Such circumstances could cause significant fluctuations in our stock price based on temporary or speculative market perceptions or other factors that do not necessarily reflect the underlying fundamentals and prospects of our business. Refer to information under the heading “Legal Proceedings” and Note 10, Commitments and Contingencies – Legal Proceedings in the consolidated financial statements for the ~~year~~quarter ended ~~May~~February 3128, ~~2024~~2026, included in this prospectus for additional information.

~~The~~Although we have reached an agreement in principle to resolve the ongoing class-action litigation filed against us, ~~could~~failure ~~harm~~to ~~our~~finalize ~~business,~~the ~~and~~contemplated ~~insurance~~settlement ~~coverage~~ may ~~not~~result bein ~~sufficient~~material harm to ~~cover~~our ~~all related costs and damages~~business.

~~The~~On ~~securities~~November ~~class~~23, ~~action~~2025, ~~lawsuits~~we ~~filed~~reached ~~against~~an ~~the~~agreement ~~Company~~ in ~~March 2021~~principle ~~have~~to ~~exhausted~~settle ~~certain~~the ~~coverage~~securities ~~allowances~~class ~~under~~action ~~the~~pending ~~Company’s~~in ~~D&O~~federal ~~insurance~~district ~~applicable~~court toin the ~~relevant~~state ~~time~~of ~~period~~Washington. ~~This~~The ~~litigation,~~agreement ~~whether~~in orprinciple ~~not~~provides ~~successful,~~for ~~may~~payment ~~require~~by usthe Company to ~~incur~~the ~~substantial~~class ~~costs~~of $500,000 ~~which~~in ~~could~~cash ~~harm~~and issuance of 49 million shares of our ~~business~~common ~~and~~stock ~~financial~~in ~~condition.~~exchange ~~During~~for the ~~course~~dismissal and release of ~~litigation,~~all ~~negative~~claims ~~public~~against ~~announcements~~all ~~regarding~~defendants in the ~~results~~class ofaction, ~~hearings~~subject to final documentation, ~~motions~~court approval, orand other ~~interim~~conditions. ~~proceedings~~There oris ~~developments~~no ~~may~~assurance ~~occur,~~that ~~which~~the ~~could~~settlement ~~have~~will aultimately ~~further~~be ~~negative~~finalized ~~effect~~ on the ~~market~~terms ~~price~~currently ofcontemplated, ~~our~~or ~~common~~at ~~stock~~all. ~~Refer~~The inability of the parties to ~~Note 10~~finalize ~~Commitments~~the ~~and~~settlement ~~Contingencies –~~may ~~Securities~~have ~~Class Action~~a ~~Lawsuits~~material ~~for~~adverse ~~the~~effect ~~year~~on ~~ended~~our ~~May~~financial 31condition, ~~2024~~results ~~included~~of inoperations, ~~this~~cash ~~prospectus~~flows ~~for~~and ~~further~~stock ~~information~~price.

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We are subject to the regulation and oversight by the ~~Securities and Exchange Commission (“~~SEC”) and state regulatory agencies, in addition to the FDA and other federal regulatory agencies. As a result, we may face legal or administrative proceedings by these agencies. WeOn ~~have~~December 20, ~~received~~2022, ~~subpoenas from~~ the ~~SEC and the~~ U.S. Department of Justice (the “DOJ”) requesting documents and information concerning, among other matters, leronlimab, our public statements regarding the use of leronlimab as a potential treatment for COVID-19, HIV, and triple-negative breast cancer, related communications with the FDA, investors, and others, litigation involving former employees, our retention of investor relations consultants, and trading in our securities. On December 20, 2022, the DOJ announced the unsealing of a criminal indictment charging both our former CEO, Nader Z. Pourhassan, and Kazem Kazempour, CEO of Amarex ~~Clinical Research~~, ~~LLC (“Amarex”),~~ our former CRO. That same day, the SEC announced charges against both Mr. Pourhassan and Mr. Kazempour for alleged violations of federal securities laws. ~~The~~In ~~Company~~December is2024, ~~cooperating~~a ~~fully~~federal ~~with~~jury ~~the~~convicted ~~DOJ~~Mr. Pourhassan and ~~SEC~~Mr. ~~investigations~~Kazempour on a number of counts. WeOn ~~are~~January ~~unable~~23, 2026, Mr. Pourhassan was sentenced to ~~predict~~30 ~~the~~months ~~effect~~imprisonment ofto ~~any~~be ~~governmental~~followed ~~investigations~~by onthree ~~our~~years ~~business,~~of ~~financial~~supervised ~~condition~~release, orwas ~~reputation.~~ordered Into ~~addition,~~self-surrender ~~publicity~~by ~~surrounding~~April ~~any~~27, ~~investigation~~2026, ~~even~~and ifwas ~~ultimately~~ordered ~~resolved~~to ~~favorably~~pay $5,392,280 ~~could~~in ~~have~~restitution. aOn ~~material~~January ~~adverse~~26, ~~effect~~2026, onMr. ~~our~~Kazempour ~~business~~was granted a new trial. ~~Refer~~The toCompany ~~Note 10,~~cooperated ~~Commitments~~fully with the DOJ and ~~Contingencies –~~SEC ~~Legal~~investigations. ~~Proceedings~~In inSeptember 2025, the ~~consolidated~~SEC ~~financial~~and ~~statements~~DOJ ~~for~~informed the ~~year~~Company ~~ended~~that ~~May~~their ~~31,~~respective ~~2024~~investigations ~~included~~are ineffectively ~~this~~closed, ~~prospectus~~and ~~for~~that nothing further ~~information~~is required of the Company.

We are unable to predict the effect of any future governmental investigations on our business, financial condition, or reputation. In addition, publicity surrounding any investigation, even if ultimately resolved favorably, could have a material adverse effect on our business. Refer to information under the heading “Legal Proceedings” and Note 10, Commitments and Contingencies – Legal Proceedings in the consolidated financial statements for the quarter ended February 28, 2026, included in this prospectus for information about other proceedings involving the Company.

We face risks and uncertainties related to litigation and other claims.

We are parties to a variety of litigation and other claims, in addition to the regulatory investigations and related proceedings described above. For example, two putative class action lawsuits have been filed against us and certain former officers and directors, asserting violations of federal securities laws under Section 10(b) and Section 20(a) of the Exchange Act, and alleging that the Company and certain former officers and directors made purportedly false or misleading statements and that some of the individual defendants violated Section 20A of the Exchange Act by selling shares of the Company’s common stock, purportedly while in possession of material nonpublic information. Separately, three purported stockholder derivative actions have been filed against certain former officers and directors; the Company was named as a nominal defendant. Refer to information under the heading “Legal Proceedings” and Note 10, Commitments and Contingencies – Legal Proceedings in the consolidated financial statements for the ~~year~~quarter ended ~~May~~February 3128, ~~2024~~2026, included in this prospectus for further information.

In addition, from time to time, we may also be involved in legal proceedings and investigations arising in the ordinary course of business, including those relating to employment matters, relationships with partners, intellectual property disputes, and other business matters. Any such claims or investigations may be time-consuming, costly, divert management resources, or otherwise have a material adverse effect on our business, financial condition, or results of operations. Any claims or litigation, even if fully indemnified or insured, could damage our reputation and make it more difficult to compete effectively or obtain adequate insurance in the future.

Risks Related to Development and Commercialization of Our Drug Candidate

Certain agreements and related license agreements require us to make significant milestone, royalty, and other payments, which will require additional financing and, in the event we do commercialize leronlimab, decrease the revenues we may ultimately receive on sales. To the extent that such milestone, royalty, and other payments are not timely made, the counterparties to such agreements in certain cases have repurchase and termination rights thereunder with respect to leronlimab.

Under agreements we have with Progenics Pharmaceuticals, Inc. (“Progenics”) and Lonza Sales AG (“Lonza”), as well as a Development and License Agreement (the “PDL License”) between Protein Design Labs (now AbbVie Inc. (“AbbVie”)) and Progenics, we are required to pay significant milestone payments, license fees for “system know-how” technology, and royalties related to leronlimab upon the occurrence of specified events. To make these milestone and license payments, we will need to raise additional funds. In addition, our royalty obligations will reduce the economic benefits to us of future sales, if any. To the extent that such milestone payments and royalties are not timely made, under their respective agreements, Progenics has certain repurchase rights relating to the assets sold to us, and AbbVie has certain termination rights relating to our license of leronlimab under the PDL License. Refer to Note 9, Commitments and Contingencies – PRO 140 Acquisition and Licensing Arrangements in the ~~audited~~consolidated financial statements for the year ended May 31, 2025, included in this prospectus for further information.

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Clinical testing is expensive, difficult to design and implement, may take many years to complete, and its outcome is uncertain. The research, testing, manufacturing, labeling, packaging, storage, approval, sale, marketing, advertising and promotion, pricing, export, import, and distribution of drug products are subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries, with regulations differing from country to country. We are not permitted to market a drug candidate as prescription pharmaceutical products in the United States until we receive approval from the FDA, or in foreign markets until we receive the requisite approval from comparable regulatory authorities in foreign countries. In the United States, the FDA generally requires the completion of clinical trials of each drug to establish its safety and efficacy, and extensive pharmaceutical development to ensure its quality before approval. Regulatory authorities in other jurisdictions impose similar requirements. Of the substantial number of drugs in development, only a small percentage are approved for commercialization. Receipt of necessary regulatory approval for the use of leronlimab for one or more indications is subject to a number of risks which include, among others:

●

the FDA or comparable foreign regulatory authorities or institutional review boards (“IRBs”) may disagree with the future design or implementation of our clinical trials,

●

we may not be able to provide acceptable evidence of the safety and efficacy of our drug candidate,

●

the results of our clinical trials may not be satisfactory or may not meet the level of statistical or clinical significance required by the FDA or foreign regulatory authorities for marketing approval,

●

patients in our clinical trials may suffer adverse effects for reasons that may or may not be related to our drug candidate,

●

the data collected from clinical trials may not be sufficient to support the submission of an application for marketing approval in the United States or elsewhere,

●

the FDA or foreign regulatory authorities may not approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies, and

●

the approval policies or regulations of the FDA or foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

We cannot guarantee that regulators will agree with our assessment of the results of our past or future clinical trials or that such trials will be considered by regulators to have shown safety or efficacy of our product candidate. The FDA has substantial discretion in the approval process and may refuse to accept any application or may require additional clinical trials or pre-clinical or other studies. Additionally, we have limited experience in filing the applications necessary to gain regulatory approvals and expect to continue to rely on consultants and our CROs to assist us in this process. Securing FDA approval requires the submission of pre-clinical, clinical, and/or pharmacokinetic data, information about product manufacturing processes and inspection of facilities, and supporting information for each therapeutic indication to establish a product candidate’s safety and efficacy for each indication. Our drug candidate may prove to have undesirable or unintended side effects, toxicities, or other characteristics that may preclude us from obtaining regulatory approval or prevent or limit commercial use with respect to one or all intended indications. Failure to obtain regulatory approval for leronlimab will prevent us from commercializing it as a prescription product, and our ability to generate revenue will be seriously impaired.

WeDisruptions ~~are~~at ~~substantially~~the ~~dependent~~FDA onand ~~the~~other ~~success~~government ofagencies ~~leronlimab.~~caused Ifby wefunding shortages, ~~either~~Executive ~~alone~~Orders, or ~~with~~global ~~collaborators,~~health ~~are~~concerns ~~unable~~could tohinder ~~complete~~their ~~the~~ability ~~clinical~~to ~~development~~hire, ofretain, ~~obtain~~or ~~and~~deploy ~~maintain~~key ~~marketing~~leadership ~~approval~~and ~~for~~other personnel, or ~~successfully~~otherwise ~~commercialize~~prevent ~~leronlimab,~~new ~~including~~or ~~with~~modified ~~respect~~products tofrom ~~adequate~~being ~~coverage~~developed, ~~and reimbursement~~approved, or ifcommercialized wein ~~continue~~a totimely ~~experience~~manner ~~significant~~or ~~delays~~at ~~in doing so~~all, ~~our~~which ~~business~~could ~~will~~negatively beimpact ~~harmed~~our business.

WeThe ~~currently~~ability ~~have~~of nothe FDA to review and approve new products ~~approved~~can ~~for~~be ~~sale~~affected by a variety of factors, including government budget and ~~are~~funding ~~investing~~levels, astatutory, ~~significant~~regulatory, ~~portion~~and policy changes, the FDA’s ability to hire and retain key personnel and accept the payment of ~~our~~user ~~resources~~fees, inand other events that may otherwise affect the ~~development~~FDA’s ability to perform routine functions. In addition, government funding of ~~leronlimab~~other ~~for~~government ~~marketing~~agencies ~~approval~~that infund research and development activities is subject to the ~~United~~political ~~States~~process, which is inherently fluid and ~~potentially~~unpredictable. ~~other~~President ~~countries~~Trump has issued Executive Orders that could adversely affect the FDA’s ability to attract and retain qualified scientific reviewers, which could result in longer review times for our applications. ~~Our~~Additionally, ~~prospects~~the Trump Administration is seeking to reduce research funding by the NIH for medical research. If the funding is reduced for studies related to the medical indications on which we are ~~substantially~~focused ~~dependent~~or on which researchers were or may have been considering applying for federal grants, our research and development initiatives could be delayed or otherwise affected.

15We are dependent on the success of leronlimab. If we, either alone or with collaborators, are unable to complete the clinical development of, obtain and maintain marketing approval for, or successfully commercialize leronlimab, including with respect to adequate coverage and reimbursement, or if we continue to experience significant delays in doing so, our business will be harmed.

~~Table~~We currently have no products approved for sale and are investing a significant portion of ~~Contents~~our resources in the development of leronlimab for marketing approval in the United States and potentially other countries. Our prospects are substantially dependent on our ability to develop, obtain marketing approval for, and successfully commercialize leronlimab in the United States in one or more disease indications. The success of our Company will depend on a number of factors, including the following:

our ability to develop, obtain marketing approval for, and successfully commercialize leronlimab in the United States in one or more disease indications. The success of our Company will depend on a number of factors, including the following:

●

a safety, tolerability, and efficacy profile for leronlimab that is satisfactory to the FDA and potential foreign regulatory authorities,

●

timely receipt of marketing approvals for leronlimab from applicable regulatory authorities, including the FDA,

●

the performance of third-party contractors that we engage to manage our clinical studies and the resulting data,

●

obtaining and maintaining patent, trade secret protection, and regulatory exclusivity, both in the United States and internationally, including our ability to maintain our license agreement with AbbVie, as successor to Progenics,

●

protection of our rights in our intellectual property portfolio, including our ability to maintain our license agreement with AbbVie,

●

a continued acceptable safety profile for leronlimab following marketing approval, if any,

●

commercial acceptance of leronlimab by patients, the medical community, and third-party payors, and

●

our ability to position leronlimab to compete with other therapies.

Many of these factors are beyond our control. If we are unable to develop, receive marketing approval for, and successfully provide for commercialization of leronlimab on our own or through third parties, or if we continue to experience delays as a result of any of these factors or otherwise, our business will be substantially harmed.

Our competitors may develop drugs that are more effective, safer and less expensive than ours.

The biopharmaceutical industry is competitive, and our future success depends on our ability to demonstrate and maintain a competitive advantage with respect to the design, development, and commercialization of product candidates. For example, new or improved therapies in the oncology and immunology arenas are the subject of frequent announcements. If approved for marketing by the FDA, depending on the approved clinical indication, leronlimab may be competing with existing and future treatments. Our competitors may:

●

develop drug candidates and market drugs that increase the levels of safety or efficacy that our product candidate will need to show to obtain regulatory approval,

●

develop drug candidates and market drugs that are less expensive or more effective than ours,

●

commercialize competing drugs before we or our partners can launch any products we are working to develop,

●

hold or obtain proprietary rights that could prevent us from commercializing our products, and

●

introduce therapies or market drugs that render our product candidate obsolete.

We expect to compete against large pharmaceutical and biotechnology companies and smaller companies that are collaborating with larger pharmaceutical companies, new companies, academic institutions, government agencies, and other public and private research organizations. These competitors, in nearly all cases, operate research and development programs that have greater financial resources than we do. Our competitors also have significantly greater experience in:

●

developing drug and other product candidates,

●

undertaking pre-clinical testing and clinical trials,

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●

building relationships with key customers and opinion-leading physicians,

●

obtaining and maintaining FDA and other regulatory approvals,

●

formulating and manufacturing drugs,

●

launching, marketing, and selling drugs, and

●

providing management oversight for all of the above-listed operational functions.

If we fail to achieve superiority over other existing or newly developed treatments, we may be unable to obtain regulatory approval. If our competitors market drugs that are less expensive, safer, or more effective than our product candidate, or which gain or maintain greater market acceptance, we may not be able to compete effectively.

We may seek to enter into a strategic alliance with a pharmaceutical company for further development and approval of our product candidate in one or more indications. Strategic alliances could potentially provide us with additional funds, expertise, access, and other resources in exchange for exclusive or non-exclusive licenses or other rights to the technologies and products that we are currently developing or may explore in the future. We cannot give any assurance we will be able to enter into strategic relationships with a pharmaceutical company or other strategic partner in the near future or at all or maintain our current relationships. In addition, we cannot ~~assure~~ensure that any agreements we may reach will achieve our goals or be on terms that prove to be economically beneficial to us. We anticipate that if we were to enter into strategic or contractual relationships, we may become dependent on the successful performance of our partners or counterparties. If they fail to perform as expected, such failure could adversely affect our financial condition, lead to increases in our capital needs, or hinder or delay our development efforts.

We are aware of patent rights held by a third party that may cover certain compositions within our leronlimab candidate. The patent holder has the right to prevent others from making, using, or selling a drug that incorporates the patented compositions, while the patent remains in force. While we believe that the third party’s patent rights will not affect our planned development, regulatory clearance, and eventual commercial production, marketing, and sale of leronlimab, there can be no assurance that this will be the case. We believe the relevant patent expires before we expect to commercially introduce leronlimab. In addition, the Hatch-Waxman exemption to U.S. patent law permits all uses of compounds in clinical trials and for other purposes reasonably related to obtaining the FDA clearance of drugs that will be sold only after patent expiration; we believe our use of leronlimab in those FDA-related activities would not infringe the patent holder’s rights. However, were the patent holder to assert its rights against us before expiration of the patent for activities unrelated to the FDA clearance, the development and ultimate sale of a leronlimab product could be significantly delayed, and we could incur expenses for defending a patent infringement suit and for damages that may relate to periods prior to the patent’s expiration. In connection with our acquisition of rights to leronlimab, our patent counsel conducted a freedom-to-operate search that identified other patents that could relate to our proposed leronlimab candidate. Based upon research and analysis to date, we believe leronlimab likely does not infringe those patent rights. If any of the holders of the identified patents were to assert patent rights against us, the development and sale of leronlimab could be delayed, we could be required to spend time and money defending patent litigation, and we could incur liability for infringement or be enjoined from producing our products if the patent holders prevailed in an infringement suit.

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Risks Related to Our Dependence on Third Parties

We have a limited number of internal research and development personnel, making us dependent on consulting relationships and strategic alliances with industry partners.

We have few employees dedicated to quality control and CMC activities. We rely and intend to continue to rely on third parties to supplement many of these critical functions. If we commence additional clinical trials, we will contract with third-party, full-service CROs to manage our trials. As a result, we are likely to be dependent on consultants and strategic partners in our development activities, and it may be administratively challenging for us to monitor and coordinate these relationships. If we do not appropriately manage our relationships with third parties, we may not be able to successfully manage development, testing, and preparation of regulatory filings for our product or commercialize any approved product, which would have a material and adverse effect on our business, financial condition and stock price.

We may continue to rely on third parties, such as CROs and third-party manufacturers, to conduct clinical trials for our product candidate, leronlimab, and to produce our pre-clinical and clinical product candidate supplies. Such third parties are subject to significant regulation. A failure by such third parties to perform their obligations properly and successfully to us, or failure of manufacturers on which we rely to meet regulatory requirements, may result in our inability to obtain regulatory approvals for or commercialize our product candidate.

We are dependent on third parties for important aspects of our product development strategy. We do not have the required financial and human resources to independently conduct the pre-clinical and clinical development of our current product candidate. We also do not have the capability or resources to manufacture, store, market or sell our current product candidate. As a result, we contract with and rely on third parties to perform such essential functions. We compete with larger companies for the resources of these third parties. Although we plan to continue to rely on these third parties to conduct any future clinical trials and manufacturing, we are responsible for ensuring that each of our clinical trials is conducted in accordance with its general investigational plan and protocol and adheres to the FDA’s regulations regarding Good Laboratory Practice and that the manufacturing of our product complies with the FDA’s current good manufacturing practices (“cGMP”) enforced through its facilities inspection program. Moreover, we are required to comply with regulations and standards, including good clinical practices, for designing, conducting, monitoring, recording, analyzing, and reporting the results of clinical trials to assure that the data and results are credible and accurate and that the rights, integrity, and confidentiality of trial participants are protected. Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements. The third parties on whom we rely generally may terminate their engagements with us at any time. If these third parties do not successfully carry out their duties under their agreements with us, if the quality or accuracy of the data they obtain, process, and analyze is compromised for any reason, or if they otherwise fail to comply with clinical trial protocols or meet expected deadlines, future clinical trials that we may undertake may experience delays or may fail to meet regulatory requirements. If our clinical trials do not meet regulatory requirements or if these third parties need to be replaced, our pre-clinical development activities or clinical trials may be extended, delayed, suspended, or terminated. If any of these events occur, or if problems develop in our relationships with third parties, or if such parties fail to perform as expected, we may experience delays or lack of progress, significant cost increases, changes in our strategies, and even failure of our product initiatives, potentially resulting in our inability to obtain regulatory approval of our product candidate and harming our reputation. Refer to Note 10, Commitments and Contingencies – Commitments with Samsung BioLogics Co., Ltd. and – Amarex Dispute in the consolidated financial statements for the year ended May 31, 2024 included in this prospectus for further information.

these third parties. Although we plan to continue to rely on these third parties to conduct any future clinical trials and manufacturing, we are responsible for ensuring that each of our clinical trials is conducted in accordance with its general investigational plan and protocol and adheres to the FDA’s regulations regarding Good Laboratory Practice and that the manufacturing of our product complies with the FDA’s current good manufacturing practices (“cGMP”) enforced through its facilities inspection program. Moreover, we are required to comply with regulations and standards, including good clinical practices, for designing, conducting, monitoring, recording, analyzing, and reporting the results of clinical trials to assure that the data and results are credible and accurate and that the rights, integrity, and confidentiality of trial participants are protected. Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements. The third parties on whom we rely generally may terminate their engagements with us at any time. If these third parties do not successfully carry out their duties under their agreements with us, if the quality or accuracy of the data they obtain, process, and analyze is compromised for any reason, or if they otherwise fail to comply with clinical trial protocols or meet expected deadlines, future clinical trials that we may undertake may experience delays or may fail to meet regulatory requirements. If our clinical trials do not meet regulatory requirements or if these third parties need to be replaced, our pre-clinical development activities or clinical trials may be extended, delayed, suspended, or terminated. If any of these events occur, or if problems develop in our relationships with third parties, or if such parties fail to perform as expected, we may experience delays or lack of progress, significant cost increases, changes in our strategies, and even failure of our product initiatives, potentially resulting in our inability to obtain regulatory approval of our product candidate and harming our reputation.

Risks Related to Our Intellectual Property Rights

Our success depends upon our ability to obtain and maintain intellectual property protection relating to our product candidate and future product candidates.

Due to evolving legal standards relating to the patentability, validity, and enforceability of patents covering pharmaceutical inventions and the claim scope of patents, our ability to enforce our existing patents and to obtain and enforce patents that may issue from any pending or future patent applications is uncertain and involves complex legal, scientific, and factual questions. To date, no consistent policy has emerged regarding the breadth of claims allowed in biotechnology and pharmaceutical patents. We have pending patents for certain indications for our core product candidate and continue to seek patent coverage for various potential therapeutic applications for leronlimab. However, we cannot be sure that any patents will issue from any pending or future patent applications owned by or licensed to us. Even if patents do issue, we cannot be sure that the claims of these patents will be held valid or enforceable by a court of law, will provide us with any significant protection against competing products, or will afford us a commercial advantage over competitive products. If one or more products resulting from our product candidate is approved for sale by the FDA and we do not have adequate intellectual property protection for those products, competitors could duplicate them for approval and sale in the United States without repeating the extensive testing required of us or our partners to obtain FDA approval, once our data exclusivity period has expired.

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enforceable by a court of law, will provide us with any significant protection against competing products, or will afford us a commercial advantage over competitive products. If one or more products resulting from our product candidate is approved for sale by the FDA and we do not have adequate intellectual property protection for those products, competitors could duplicate them for approval and sale in the United States without repeating the extensive testing required of us or our partners to obtain FDA approval, once our data exclusivity period has expired.

Our ability to commercialize our product candidate depends on our ability to use, manufacture, and sell that product without infringing on the patents or other proprietary rights of third parties. Numerous U.S. and foreign issued patents and pending patent applications owned by third parties exist in the monoclonal antibody therapeutic area in which we are developing our product candidate and seeking new potential product candidates. There may be existing patents, unknown to us, on which our activities with our product candidate could infringe.

If a third party claims our actions, or products or technologies infringe on its patents or other proprietary rights, we could face a number of issues that could harm our competitive position, including, but not limited to:

●

infringement and other intellectual property claims that, even if meritless, can be costly and time-consuming, delay the regulatory approval process, and divert management’s attention from our core business operations,

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substantial damages for infringement if a court determines that our products or technologies infringe a third party’s patent or other proprietary rights,

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a court prohibiting us from selling or licensing our products or technologies unless the holder licenses the patent or other proprietary rights to us, which it is not required to do, and

●

even if a license is available from a holder, we may have to pay substantial royalties or grant cross-licenses to our patents or other proprietary rights.

If any of these events occur, it could significantly harm our operations and financial condition and negatively affect our stock price. Additionally, although no third party asserted a claim of infringement against us, others may hold proprietary rights that could prevent our product candidate from being marketed. Any patent-related legal action against us claiming damages and seeking to enjoin commercial activities relating to our product candidate or our processes could subject us to potential liability for damages and require us to obtain a license to continue to manufacture or market leronlimab or any other product candidates. We cannot predict whether we would prevail in any such actions or that any license required under any of these patents would be made available on commercially acceptable terms, if at all. Further, we cannot be sure that we could redesign leronlimab or any other product candidates or processes to avoid infringement, if necessary. Accordingly, an adverse determination in a judicial or administrative proceeding, or the failure to obtain necessary licenses, could prevent us from developing and commercializing leronlimab or another product candidate, which could harm our business, financial condition, and operating results.

We may come to believe that third parties are infringing on our patents or other proprietary rights. To prevent infringement or unauthorized use, we may need to file infringement and/or misappropriation suits, which are extremely expensive and time-consuming and would distract management’s attention. Also, in an infringement or misappropriation proceeding, a court may decide that one or more of our patents is invalid, unenforceable, or both, in which case third parties may be able to use our technology without paying license fees or royalties. Even if the validity of our patents is upheld, a court may refuse to stop the other party from using the technology at issue on the ground that the other party’s activities are not covered by our patents.

We may become involved in disputes with our present or future contract partners over intellectual property ownership or other matters, which could have a significant adverse effect on our business.

Inventions discovered in the course of performance of contracts with third parties may become jointly owned by our strategic partners and us, in some cases, and the exclusive property of one of us, in other cases. Under some circumstances, it may be difficult to determine who owns a particular invention or whether it is jointly owned, and disputes could arise regarding ownership or use of those inventions. Other disputes may also arise relating to the performance or alleged breach of our agreements with third parties. Any disputes could be costly and time-consuming, and an unfavorable outcome could have a significant adverse effect on our business.

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to determine who owns a particular invention or whether it is jointly owned, and disputes could arise regarding ownership or use of those inventions. Other disputes may also arise relating to the performance or alleged breach of our agreements with third parties. Any disputes could be costly and time-consuming, and an unfavorable outcome could have a significant adverse effect on our business.

Risks Related to Ownership of Our Common Stock

Our common stock is classified as “penny stock” and trading of our shares may be restricted by the SEC’s penny stock regulations.

Rules 15g-1 through 15g-9 promulgated under the Exchange Act impose sales practice and disclosure requirements on certain brokers-dealers who engage in transactions involving a “penny stock.” The SEC has adopted regulations which generally define “penny stock” to be any equity security that has a market price of less than $5.00 per share or an exercise price of less than $5.00 per share, subject to certain exceptions. Our common stock is covered by the penny stock rules, which impose additional sales practice requirements on broker-dealers who sell to persons other than established customers and “accredited investors.” The penny stock rules require a broker-dealer, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document in a form prepared by the SEC that provides information about penny stocks and the nature and level of risks in the penny stock market. The broker-dealer also must provide the prospective investor with current bid and offer quotations for the penny stock, the compensation of the broker-dealer and its salesperson in the transaction, and monthly account statements showing the market value of each penny stock held in the investor’s account. In addition, the penny stock rules require that, prior to a transaction in a penny stock that is not otherwise exempt, the broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written agreement to the transaction. These disclosure requirements may have the effect of reducing the level of trading activity in the secondary market for stock that is subject to these penny stock rules. Consequently, these penny stock rules may affect the ability of broker-dealers to trade our securities. We believe that the penny stock rules may discourage investor interest in and limit the marketability of our common stock.

The trading price of our common stock has been and could remain volatile, and the market price of our common stock may decrease.

The market price of our common stock has historically experienced and may continue to experience significant volatility. From ~~June~~April 1, ~~2023~~2025, through ~~August~~March 31, ~~2024~~2026, the market price of our common stock has fluctuated from a high of $0.4245 per share to a low of $0.1119 per share. The volatile nature of our common share price may cause investment losses for our stockholders. In addition, the market price of stock in small capitalization biotech companies is often driven by investor sentiment, expectation, and perception, all of which may be independent of fundamental, objective, and intrinsic valuation metrics or traditional financial performance metrics, thereby exacerbating volatility. In addition, our common stock is quoted on the OTCQB of the OTC Markets marketplace, which may increase price quotation volatility and could limit liquidity, all of which may adversely affect the market price of our shares.

market price of stock in small capitalization biotech companies is often driven by investor sentiment, expectation, and perception, all of which may be independent of fundamental, objective, and intrinsic valuation metrics or traditional financial performance metrics, thereby exacerbating volatility. In addition, our common stock is quoted on the OTCQB of the OTC Markets marketplace, which may increase price quotation volatility and could limit liquidity, all of which may adversely affect the market price of our shares.

Since our inception, we have not achieved cash flows from revenues sufficient to cover basic operating costs. As a result, we have relied heavily on debt and equity financing. Equity financing, including securities convertible into equity, in particular has had a dilutive effect on our common stock, which has hampered our ability to attract reasonable financing terms.

The terms of our convertible note financings require us to make periodic debt repayments to reduce the outstanding balance of our debt. As a result, we likely will be required to use a significant portion of our available cash to satisfy our payment obligations, which will reduce the amount of capital available to finance our operations and other business activities. We expect to continue to seek to exchange all or part of our outstanding debt for shares of common stock. If the Company enters into any future exchange offers, they will likely be negotiated at a discount to the market price of our common stock and will cause additional dilution to our existing stockholders. If the convertible noteholders sell the common stock they receive in exchange for outstanding debt, this could result in downward pressure on our stock price. In addition, the exercise of our outstanding warrants and stock options for shares of our common stock, which we have encouraged from time to time through public or private warrant exchange offers, including in July 2024, will result in further dilution of our existing common stockholders.

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Issuances of additional equity or convertible debt securities will continue to reduce the percentage ownership of our then-existing stockholders. We may also be required to grant potential investors new securities rights, preferences, or privileges senior to those possessed by our then-existing stockholders to induce them to invest in our company. The issuance of these senior securities may adversely affect the holders of our common stock as a result of preferential dividend and liquidation rights over the common stock and dilution of the voting power of the common stock.

As the result of these and other factors, the issuance of additional equity or convertible debt securities may have an adverse impact on the market price of our common stock. For the foreseeable future, we will be required to continue to rely on debt and equity financing to maintain our operations.

Our certificate of incorporation permits our Board to create new series of preferred stock without further approval by our stockholders, which could adversely affect the rights of the holders of our common stock.

Our Board has the authority to fix and determine the relative rights and preferences of preferred stock. Currently, our Board has the authority to designate and issue approximately 4.9 million additional shares of our preferred stock without further stockholder approval. As a result, our Board could authorize the issuance of another series of preferred stock that would grant to holders the preferred right to our assets upon liquidation, the right to receive dividend payments before dividends are distributed to the holders of common stock, and the right to redemption of the shares, together with a premium, prior to the redemption of our common stock. In addition, our Board could authorize the issuance of a series of preferred stock that has greater voting power than our common stock or that is convertible into our common stock, which could decrease the relative voting power of our common stock or result in dilution to our existing stockholders.

Certain provisions of our amended and restated certificate of incorporation and bylaws could discourage, delay, or prevent a merger, acquisition, or other change of control that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for shares of common stock. Furthermore, these provisions could frustrate attempts by our stockholders to replace or remove members of our Board. These provisions also could limit the price that investors might be willing to pay in the future for our common stock, thereby depressing the market price of our common stock. Stockholders who wish to participate in these transactions may not have the opportunity to do so. Among other things, these provisions:

pay in the future for our common stock, thereby depressing the market price of our common stock. Stockholders who wish to participate in these transactions may not have the opportunity to do so. Among other things, these provisions:

●

allow us to designate and issue shares of preferred stock, without stockholder approval, which could adversely affect the rights, preferences, and privileges of the holders of our common stock and could make it more difficult or less economically beneficial to acquire or seek to acquire us,

●

provide that special meetings of stockholders may be called only by the Board acting pursuant to a resolution approved by the affirmative majority of the entire Board, and

●

do not include a provision for cumulative voting in the election of directors. Under cumulative voting, a minority stockholder holding a sufficient number of shares may be able to ensure the election of one or more directors. The absence of cumulative voting may have the effect of limiting the ability of minority stockholders to effect changes in the composition of our Board.

In addition, we are governed by the provisions of Section 203 of the Delaware General Corporation Law (the “DGCL”), which may, unless certain criteria are met, prohibit large stockholders, particularly those owning 15% or more of our voting stock, from merging or combining with us for a prescribed period.

We do not expect to pay cash dividends on our common shares in the foreseeable future.

We have never declared or paid a cash dividend on our common shares, and we do not anticipate declaring or paying dividends on our common shares for the foreseeable future. We expect to use future financing proceeds and earnings, if any, to fund operating expenses. Consequently, common stockholders’ only opportunity to achieve a return on their investment is if the price of our stock appreciates and they sell their shares at a profit. We cannot assure common stockholders of a positive return on their investment when they sell their shares or that stockholders will not lose the entire amount of their investment.

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USE OF PROCEEDS

We will not receive any proceeds from the sale of shares of our common stock by the selling stockholders. A portion of the shares of common stock covered by this prospectus are issuable upon exercise of warrants issued to the selling stockholders. The exercise price of such warrants ranges from $0.~~09387~~2153 to $10.0026 per share. The exercise price and number of shares of common stock issuable upon exercise of the warrants may be adjusted in certain circumstances, including stock splits or dividends, mergers, reclassifications, or similar events. Upon any exercise of warrants for cash, the selling stockholders will pay us the exercise price. The warrants issued to our placement agent include a cashless exercise feature, while all other warrants do not. To the extent we receive proceeds from the cash exercise of outstanding warrants, we intend to use the proceeds for working capital and other general corporate purposes. We will bear all other costs, fees and expenses incurred in effecting the registration of the shares covered by this prospectus. All selling and other expenses incurred by the selling stockholders will be borne by the selling stockholders. See “Selling Stockholders” and “Plan of Distribution” below.

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MARKET FOR OUR COMMON STOCK AND DIVIDEND POLICY

Market Information

Our common stock is quoted on the OTCQB of the OTC Markets marketplace under the trading symbol CYDY. Over-the-counter market quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission, and may not necessarily represent actual transactions. Historically, trading in our stock has been volatile and the trades that occurred cannot be characterized as those in a more established public trading market. As a result, the trading prices of our common stock may not reflect the price that would result if our stock ~~was~~were traded on a more mature market.

Holders

The number of record holders of our common stock on ~~August~~April 3115, ~~2024~~2026 was approximately 1,000.

Dividends

Holders of our common stock are entitled to receive dividends if declared by our Board. While we have no contractual restrictions or restrictions in our governing documents on our ability to pay dividends, other than the preferential rights provided to the holders of our outstanding preferred stock, we have never paid cash dividends to holders of common stock and do not anticipate paying any in the foreseeable future as we retain earnings, if any, for use in our operations.

Also, under Section 170 of the DGCL, we are permitted to pay dividends only out of capital surplus or, if none, out of net profits for the fiscal year in which the dividend is declared or net profits from the preceding fiscal year. As of ~~May~~February 3128, ~~2024~~2026, the Company had an accumulated deficit of approximately $~~891~~920.56 million and had net loss in each fiscal year since inception, and therefore is prohibited from paying any dividends, whether in cash, other property, or shares of capital stock.

Refer to Note 54, Convertible Instruments and Accrued Interest in the audited financial statements for the year ended May 31, 2025, included in this prospectus for additional information.

Unregistered Sales of Equity Securities

Issuances of Shares in Convertible Note Exchange Transactions

In July 2024, the Company and the holder of its April 23, 2021 Note, in partial satisfaction of the holder’s redemption rights, entered into an exchange agreement pursuant to which a portion of the original note was partitioned into a new note with an aggregate principal amount of $0.5 million. The new note was exchanged concurrently with issuance of a total of approximately 3.9 million shares of common stock. The Company relied on the exemption provided by Section 3(a)(9) of the Securities Act in connection with the exchange transaction.

Warrant Tender Offer

On July 19, 2024, the Company closed a tender offer in which warrants to purchase approximately 127.1 million shares of common stock were exercised at a $0.09387 exercise price, resulting in gross proceeds of approximately $11.9 million and net proceeds of approximately $10.5 million. The Company also issued approximately 25.4 million shares of common stock as bonus shares in the tender offer. The Company relied on the exemption provided by Section 4(a)(2) of the Securities Act and Rule 506 thereunder in connection with the exercise of the warrants for shares of common stock and issuance of bonus shares in the tender offer.22

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OUR BUSINESS

Corporate History/Business Overview

CytoDyn Inc. (together with its wholly owned subsidiary, the “Company”) was originally incorporated under the laws of Colorado on May 2, 2002, under the name RexRay Corporation and, effective August 27, 2015, reincorporated under the laws of Delaware. The Company is a clinical-stage biotechnology company focused on the clinical development of innovative treatments for multiple therapeutic indications based on its product candidate, leronlimab (also referred to as PRO 140), a novel humanized monoclonal antibody targeting the C-C chemokine receptor type 5 (“CCR5”). The pre-clinical and early clinical development of PRO 140 was led by Progenics through 2011. The Company acquired the asset from Progenics in October 2012. In November 2018, the United States Adopted Names Council adopted “leronlimab” as the official nonproprietary name for PRO 140. The Company has conducted clinical trials of leronlimab as a viral entry inhibitor for human immunodeficiency virus (“HIV”), believed to competitively bind to the N-terminus and second extracellular loop of the CCR5 receptor. For immunology, the CCR5 receptor is believed to be implicated in immune-mediated illnesses such as Metabolic dysfunction-associated steatohepatitis (“MASH”), formerly known as nonalcoholic steatohepatitis (“NASH”). The CCR5 receptor may also be present on cells that undergo malignant transformation and in the tumor microenvironment. Studies of leronlimab have also been conducted in MASH and solid tumors in oncology, in addition to HIV, where CCR5 is believed to play an integral role.

The consolidated financial statements included in this prospectus include the accounts of CytoDyn Inc. and its wholly owned subsidiary CytoDyn Operations Inc.

Business Overview

Our current business strategy is to continue to pursue the clinical development of leronlimab, which may include the following:

1. ~~Conducting~~Continue athe Phase II2 ~~study~~trial of leronlimab in patients with relapsed/refractory ~~microsatellite~~micro-satellite stable colorectal cancer;

2. ~~Conducting~~Conduct aadditional ~~Phase~~studies ~~II study~~ exploring leronlimab and its ~~effects~~therapeutic onpotential ~~inflammation~~in other solid-tumor oncology indications, including but not limited to metastatic triple-negative breast cancer; and

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

~~Other~~We ~~programs~~may ~~that~~need ~~may~~significant beadditional ~~pursued~~funding ~~include~~to ~~steatosis~~execute ~~and~~the ~~liver~~above ~~fibrosis~~business ~~associated~~strategy ~~with~~in ~~MASH~~full, ~~either~~which ~~alone~~may orinclude asconducting a ~~combination~~variety ~~therapy;~~of additional pre-clinical studies and ~~for~~clinical ~~metastatic~~trials, ~~triple-negative~~in ~~breast~~furtherance ~~cancer~~of ~~with~~our ~~current~~efforts ~~standard~~to ofobtain ~~care~~FDA approval to commercialize leronlimab. In addition to traditional fundraising, ~~and/or~~the ~~exploring~~Company ~~other~~will ~~trials~~pursue ~~with~~non-dilutive ~~current~~financing ~~standard~~opportunities, ofsuch ~~care~~as license agreements and ~~other~~co-development ~~cancer~~or ~~and~~strategic ~~immunologic~~partnerships, ~~indications~~to help implement its strategy.

We will need significant additional funding to execute the business strategy described above, including conducting additional pre-clinical studies and clinical trials, in furtherance of our efforts to obtain FDA approval to commercialize leronlimab. In addition to traditional fundraising, the Company will pursue non-dilutive financing opportunities, such as license agreements and co-development or strategic partnerships, to help implement its strategy.

As further discussed in Note 2, Summary of Significant Accounting Policies – Inventories, and Note 3, Inventories, net, in the audited financial statements included in this prospectus, the Company previously capitalized procured or produced pre-launch inventories in preparation for product launches. As of May 31, 2024, the Company had reserved for or written-off the full $99.2 million of previously capitalized pre-launch inventories. Although these inventories have been written-off from an accounting perspective, they can be used in certain clinical contexts, and could possibly be sold commercially upon regulatory approval if the shelf-lives can be extended as a result of the performance of on-going and future stability tests.

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Recent Corporate Developments

On ~~November 9~~May 2, ~~2023~~2025, atthe Company entered into an employment agreement with Robert E. Hoffman under which he began serving as the Company’s ~~annual~~Chief ~~meeting,~~Financial ~~our~~Officer ~~stockholders~~effective ~~voted~~as inof ~~favor~~May of15, an2025, ~~amendment~~as towell as the Company’s ~~Certificate~~principal offinancial ~~Incorporation~~officer toand ~~increase~~principal accounting officer. Mr. Hoffman assumed the ~~total~~role ~~number~~from ofMitchell ~~shares~~Cohen, ofwho ~~common~~served ~~stock~~as ~~authorized~~the ~~for~~Company’s ~~issuance~~Interim Chief Financial Officer from February 1,~~350~~ 2024,~~000,000~~ ~~shares~~until toMay 115,~~750,000,000~~ ~~shares~~2025.

OnBased ~~January 10~~on information provided by Marcum LLP (“Marcum”), ~~2024~~the Company’s then current independent registered public accounting firm, to the Company, ~~entered~~the ~~into~~attest anbusiness ~~agreement~~of ~~with~~Marcum anwas ~~executive~~acquired ~~services~~by ~~firm~~CBIZ toCPAs ~~engage~~P.C. ~~Mitchell~~(“CBIZ”) ~~Cohen~~on toNovember ~~provide~~1, ~~financial~~2024, and ~~accounting~~substantially all the partners and staff of Marcum that provided attestation services joined CBIZ as of that date. Marcum continued to serve as the Company’s asindependent anregistered ~~independent~~public ~~contractor.~~accounting Onfirm ~~January 19~~until May 14, ~~2024~~2025, when Marcum notified the Company by letter that Marcum was resigning as the Company’s ~~Board~~independent registered public accounting firm as of ~~Directors~~that ~~approved~~date. Also on May 14, 2025, with the ~~appointment~~approval of ~~Mr. Cohen~~the asAudit Committee of the Company’s ~~Interim~~Board ~~Chief~~of ~~Financial Officer effective February 1~~Directors, ~~2024.~~CBIZ ~~Mr. Cohen~~was ~~also~~engaged ~~serves~~ as the Company’s ~~principal~~independent ~~financial~~registered ~~officer~~public ~~and~~accounting ~~principal~~firm ~~accounting~~for ~~officer~~its fiscal year ended May 31, 2025.

OnIn ~~January 26,~~September ~~2024~~2025, the ~~Company~~Securities ~~entered~~and ~~into~~Exchange anCommission ~~employment~~(“SEC”) ~~agreement~~and ~~with~~Department ~~Jacob P.~~of ~~Lalezari,~~Justice ~~M.D.,~~(“DOJ”) ~~under~~informed ~~which he is serving as~~ the Company’s ~~Chief~~that ~~Executive~~their ~~Officer,~~respective ~~effective~~investigations aswere ofeffectively ~~January 26~~closed, ~~2024.~~and ~~Dr. Lalezari~~that ~~previously~~nothing ~~served~~further aswas ~~the~~required ~~Company’s~~of ~~Interim CEO beginning November 17, 2023. Dr. Lalezari is responsible for leading~~ the Company~~’s corporate and product development, with a focus on short-term clinical development and related fundraising~~.

On April 3, 2024, the Company and Samsung BioLogics Co., Ltd. (“Samsung”) executed an agreement (the “Letter Agreement”), wherein the parties agreed on an orderly process for winding down services and restructuring the amount payable by the Company to Samsung (the “Total Balance”). The Letter Agreement resolved the Company’s obligations under the Master Services Agreement and related ancillary agreements first entered into between Samsung and the Company in or around April 2019 (collectively, the “Agreement”). The Total Balance due as restructured under the Letter Agreement, is $43,821,231.32. Except for a single $250,000 payment due on or before December 31, 2024, the entirety of the Total Balance is conditional, and will only be due and payable, upon the Company achieving a qualifying “Revenue” event, as that term is defined in the Letter Agreement. Under the Letter Agreement, the Company agreed to pay 20% of its qualifying Revenue generated in each calendar year, if any, with such payments to be applied to reduce the Total Balance until it is repaid in full. Interest will not accrue on the Total Balance throughout the prospective repayment period. For additional information on the Samsung matter, refer to Note 8, Commitments and Contingencies – Commitments with Samsung in the audited financial statements included in this Prospectus.23

On ~~June~~November 2721, ~~2024~~2025, at the ~~Audit~~Company’s ~~Committee~~annual ofmeeting, ~~the~~our ~~Board~~stockholders ofvoted ~~Directors~~in favor of an amendment to the Company’s ~~engaged~~Certificate ~~Marcum~~of ~~LLP~~Incorporation ~~(“Marcum”)~~to ~~and~~provide ~~appointed~~for ~~the~~an ~~firm~~increase asin the ~~Company’s~~total ~~independent~~number ~~registered~~of ~~public~~shares ~~accounting~~of ~~firm,~~common ~~effective~~stock ~~immediately~~authorized for issuance from 1,750,000,000 shares to ~~perform~~2,250,000,000 ~~audit~~shares. ~~services~~Additionally, ~~for~~stockholders ~~the~~voted ~~Company’s~~in ~~fiscal~~favor ~~year~~of ~~ended~~the ~~May~~reelection ~~31,~~of ~~2024~~existing directors, ~~and~~on ~~review~~an ~~services~~advisory ~~for~~basis in favor of CBIZ CPAs P.C. as the ~~quarters~~Company’s ~~ending~~independent ~~August~~registered ~~31,~~public ~~2024,~~accounting ~~November~~firm ~~30,~~for ~~2024,~~the ~~and~~fiscal ~~February~~year 28ending May 31, ~~2025.~~2026, ~~The~~on ~~appointment~~an ofadvisory ~~Marcum~~basis ~~followed~~in ~~the~~favor ~~Audit~~of ~~Committee’s~~named ~~dismissal~~executive ofofficer BFcompensation, ~~Borgers~~and ~~CPA~~on PCan ~~(“BF~~advisory ~~Borgers”),~~basis ~~the~~in ~~Company’s~~favor ~~prior~~of ~~independent~~holding ~~accounting~~an ~~firm,~~advisory vote on ~~May~~executive 3,compensation ~~2024~~every year.

On ~~July~~November 223, ~~2024~~2025, the Company ~~and~~reached ~~Amarex~~an ~~entered~~agreement ~~into~~in anprinciple ~~agreement~~to ~~settling~~settle athe ~~lawsuit~~securities ~~filed~~class byaction pending in the ~~Company~~United inStates ~~October~~District ~~2021~~Court for the Western District of Washington (the “~~Settlement Agreement~~Court”), Courter et al. ~~The~~v. ~~terms~~CytoDyn ofInc. ~~the~~et ~~Settlement~~al, ~~Agreement~~Case ~~include:~~No. C21-5190 BHS (ithe “Securities Class Action”). ~~the~~The agreement in principle provides for a payment by ~~Amarex~~the Company to the class of $12500,000~~,000~~ toin cash and the issuance of 49 million shares of common stock of the Company, in exchange for the dismissal and release of ~~which~~all ~~$10~~claims against all defendants in the Securities Class Action. The agreement is subject to final documentation,~~000~~ court approval,~~000~~ ~~was~~and ~~paid~~other onconditions. ~~execution~~There can be no assurances as to the ultimate outcome of the ~~Settlement~~class ~~Agreement~~action, ~~and~~including that the ~~balance~~final settlement agreement will be ~~paid~~executed, onthat orthe ~~before~~settlement ~~July~~agreement, 2if executed, ~~2025;~~will ~~(ii)~~include the ~~release~~terms ofand conditions currently anticipated by the Company’s, ~~surety~~that ~~bond~~such ~~posted~~agreement inwill be approved by the ~~lawsuit~~Court, or that any revised settlement terms, if applicable, will be finalized by the parties and approved by the ~~return~~Court. A final, non-appealable closure of the ~~Company’s~~litigation ~~cash~~could ~~collateral~~take several months. The agreement in principle does not constitute an admission by the ~~amount~~Company of ~~$6,500,000~~any ~~provided~~fault asor ~~security~~liability toand the ~~surety;~~Company ~~(iii)~~does not admit fault or liability. If the ~~crediting~~settlement ofcannot ~~all~~be ~~amounts~~finalized ~~claimed~~by the parties or is not approved by ~~Amarex~~the asCourt, ~~due~~the Company will defend the class action vigorously and ~~payable~~believes ~~for~~there ~~its~~are ~~CRO~~meritorious ~~services~~defenses and legal standards that must be met for, ~~totaling~~among ~~approximately~~other ~~$14~~things,~~000,000,~~ ~~reducing~~success by the ~~Company’s~~plaintiffs ~~outstanding~~on ~~balance~~the tomerits. ~~zero,~~If ~~with~~the noparties ~~funds~~are ~~required~~unable to befinalize ~~paid~~the bysettlement, the ~~Company;~~class ~~and~~action ~~(iv)~~could have a ~~mutual~~material ~~release~~adverse ofeffect ~~claims,~~on ~~resolving~~the ~~all~~Company’s ~~legal~~financial ~~claims~~condition, ~~between~~results ~~the~~of ~~parties~~operations, and cash flows.

Background: Leronlimab asand ~~a CCR5 Antagonist~~Cancer

~~CytoDyn is focused on developing leronlimab, a CCR5 receptor antagonist, to be used as a platform drug for various indications.~~ The CCR5 receptor is a protein located on the surface of various cells, including white blood cells and cancer cells. On white blood cells, it serves as a receptor for chemical attractants known as chemokines. Chemokines are key orchestrators of cell trafficking by directing immune cells to ~~the~~ sites of inflammation. AtChemokines are released at the site of an inflammatory reaction~~, chemokines are released~~. These chemokines bind to the CCR5 receptor and ~~cause~~facilitate the migration of T-cells to these sites, promoting further inflammation. ~~The~~Leronlimab is a humanized monoclonal antibody that binds to human CCR5 ~~receptor~~receptors iswith ~~also~~a unique mechanism of action. Preclinical research has shown that leronlimab blocks calcium channel signaling of the ~~co-~~CCR5 receptor ~~needed~~when ~~for~~present on the ~~most~~surface ~~common~~of ~~strains~~cancer ofcells. ~~HIV~~It is believed that calcium channel signaling through the CCR5 receptor is a crucial component leading to ~~infect~~the ~~healthy~~metastatic ~~T-cells~~spread of cancer.

~~The~~Among ~~mechanism~~other ofpotential ~~action~~benefits, ~~(“MOA”)~~leronlimab’s mechanism of ~~leronlimab~~action has the potential to modulate the movement of T-cells to inflammatory sites, which could be beneficial by diminishing overactive inflammatory responses. Leronlimab is a unique ~~humanized~~ monoclonal antibody. ~~Leronlimab~~that binds to the second extracellular loop and N-terminus of the CCR5 receptor, and, due to its selectivity and target-specificity, does not appear to activate the immune function of the CCR5 receptor through agonist activity. This apparent target specificity differentiates leronlimab from other CCR5 antagonists. Leronlimab is a competitive rather than allosteric inhibitor of the CCR5 receptor.

Research indicates that the CCR5 receptor works as a potential “GPS” system for cancer cells that promotes the spread of metastatic disease. Pre-clinical studies have shown that leronlimab blocks the calcium channel signaling of the CCR5 receptor and has the potential to disable this GPS system. CCR5 inhibition may disrupt signaling and ultimately diminish the spread of CCR5+ Circulating Tumor Cells (“CTCs”). Most current therapies are directed to the primary tumor rather than the tumor microenvironment, and/or the spread of cancer in the bloodstream. However, it is metastatic disease and not the primary tumor itself that is the cause of death in most cancer patients.

Research has shown that CCR5 expression is increased in a variety of solid tumors including breast, colon, prostate, and pancreatic cancer, among others. Increased CCR5 expression has also been identified as an indicator of increased risk of progression in several cancers. Research has hypothesized that CCR5 may play a variety of roles in the progression of cancer. As already indicated, the CCR5 receptor on cancer cells appears to play a role in the migration and invasion of cancer cells into the bloodstream, which may lead to metastasis. Second, blocking the CCR5 receptor on immunosuppressive immune cells known as Regulatory T cells (Tregs) and Myeloid-derived suppressor cells (MDSCs) could unleash anti-tumor fighting immune cells into the tumor microenvironment. A third observation is that blocking the interaction of CCR5 with a chemokine known as RANTES (also known as CCL5) has a potentially synergistic effect with chemotherapy in causing DNA damage and promoting the death of cancer cells. Fourth, animal studies revealed a significant decrease in angiogenesis or new blood vessel formation following CCR5 inhibition with

the administration of leronlimab. Such new blood vessel formation is critically important for the growth of tumors. And lastly, it is hypothesized that leronlimab exerts an effect on tissue macrophages in the tumor microenvironment to repolarize these cells into anti-tumor fighting cells.

Leronlimab and Colorectal Cancer (“CRC”)

In August 2024, the Company completed a meeting with the U.S. Food and Drug Administration (FDA) to gain alignment on the rationale and proposed dosing for a Phase 2 study investigating the preliminary safety and activity of leronlimab in combination with trifluridine plus tipiracil (TAS-102) and bevacizumab in participants with CCR5+, microsatellite stable (“MSS”), relapsed or refractory metastatic colorectal cancer (mCRC).

In October 2024, the Company engaged Syneos Health as the contract research organization (“CRO”) for its Phase 2 trial of leronlimab in patients with relapsed/refractory MSS mCRC. Syneos Health is a leading fully integrated biopharmaceutical solutions organization that supports customers in accelerating the delivery of life-saving therapies to market. Syneos Health leverages advanced data analytics and AI/ML capabilities to improve outcomes at every stage of the asset lifecycle, from clinical development to commercialization.

In November 2024, the Company received clearance from the U.S. Food and Drug Administration (“FDA”) to commence its Phase 2 CRC trial. This milestone reflected the continued improvement in the Company’s relationship with the FDA.

In December 2024, the Company announced that Dr. Ben Weinberg from Georgetown University and the MedStar Health Alliance had agreed to be the lead Principal Investigator for the CRC study. As requested by FDA, the first five patients enrolled in this study will receive 350 mg of leronlimab SQ once/week in combination with TAS-102 and Bevacizumab. After a preliminary safety review, subsequent patients will then be randomized to 350 or 700 mg of weekly leronlimab with the same background regimen. The Data and Safety Monitoring Board (DSMB) will perform a second safety review after the first 20 patients have completed at least 1 cycle of therapy. The DSMB could then recommend restricting further enrollment to a single dose level, should they identify a signal of superior activity in either one of the treatment arms.

In June 2025, the first patient was dosed in the Company’s Phase 2 trial evaluating the efficacy of leronlimab in patients with relapsed/refractory MSS mCRC, and that patient enrollment and initiating additional clinical sites was underway through Syneos Health.

In July 2025, the Company announced encouraging historical clinical findings among patients with advanced mCRC, previously treated with leronlimab. The results indicated that three of five patients treated with leronlimab had at least a partial response, as measured by radiologic criteria, including one patient with a complete response who remains alive five years later. These final results, from patients treated under a prior compassionate use protocol, reiterate a favorable safety profile of leronlimab as well as its potential for clinical benefit in patients with mCRC. The results also support the rationale for the design and therapeutic potential of the Phase 2 CRC trial.

In April 2026, the Company announced that it had completed enrollment in its Phase 2 CRC trial, concluding with just over 60 patients participating across several clinical sites located across the United States.

Leronlimab and Metastatic Triple-Negative Breast Cancer (“mTNBC”)

In November 2018, the Company received FDA approval of its Investigational New Drug (“IND”) submission and subsequently initiated a Phase 1b/2 clinical trial for mTNBC. In May 2019, the FDA granted Fast Track designation for leronlimab for use in combination with carboplatin to treat patients with CCR5+ positive mTNBC. The first patient in the trial was treated in September 2019. This Phase 1b/2 trial evaluated the feasibility of leronlimab in combination with carboplatin in patients with CCR5+ mTNBC. This trial eventually advanced from Phase 1b/2 to Phase 2. The Phase 2 trial was a single arm study to test the hypothesis that the combination of intravenous carboplatin and maximum tolerated dose of subcutaneous leronlimab will increase progression free survival. This study also evaluated the change in Circulating Tumor Cells as a potential prognostic marker for clinical efficacy. Leronlimab, in combination with carboplatin was well-tolerated at all three dose levels of 350mg, 525mg, and 700mg.

A compassionate use study was also commenced in 2019. This was a single-arm study of leronlimab combined with a treatment of Physician’s Choice (“TPC”) in patients with metastatic/locally advanced CCR5+ mTNBC. Leronlimab was administered subcutaneously as a weekly dose of 350 mg until disease progression or intolerable toxicity. Based on the Company’s prior success in

~~Table~~the ofPhase ~~Contents~~1b/2 mTNBC trial with 350 mg dose, the Company was eventually able to transition the compassionate use patients to 525 mg dose. In this study, patients were evaluated for tumor response approximately every three months or according to the institution’s standard practice by CT, PET/CT or MRI with contrast (per treating investigator’s discretion) using the same method as at baseline.

~~specific~~During ~~MOA~~this same time period, itthe ~~does~~Company ~~not~~also ~~appear~~conducted toa ~~activate~~compassionate ~~the~~use ~~immune~~study ~~function~~in ofpatients ~~the~~with a variety of CCR5+ ~~receptor~~solid ~~through~~tumors ~~agonist~~in ~~activity~~a Phase 2 Basket Study. This ~~apparent~~was ~~target~~a ~~specificity~~single ~~differentiates~~arm study of leronlimab ~~from~~in ~~other~~patients with CCR5+ ~~antagonists~~locally advanced or metastatic solid tumors. Leronlimab iswas administered subcutaneously as a ~~competitive~~weekly ~~rather~~dose ~~than~~of ~~allosteric~~350 ~~inhibitor~~mg and 525 mg until disease progression or intolerable toxicity. Subjects participating in this study were also allowed to receive/continue standard-of-care chemotherapy or radiotherapy. In this study, patients were evaluated for tumor response approximately every three months or according to the ~~CCR5~~institution’s ~~receptor~~standard practice by CT, PET/CT or MRI with contrast using the same method as at baseline. Data analysis on the above studies was delayed due to the Company’s subsequent dispute with its former CRO. Following the resolution of the Company’s dispute with its former CRO in 2024, the Company was able to obtain and analyze the underlying data and follow-up records as to patients treated with leronlimab in the above studies.

~~Leronlimab~~In ~~prevents~~February ~~CCR5~~and ~~tropic~~March ~~strains of HIV~~2025, ~~which are~~ the ~~great~~Company ~~majority~~announced ofencouraging ~~circulating~~survival ~~viruses,~~outcomes ~~from~~among ~~using the CCR5 receptor as~~ a ~~gateway~~group toof ~~enter~~patients ~~healthy~~with ~~cells.~~mTNBC ~~Pre-clinical~~treated ~~research~~with ~~has~~leronlimab ~~shown~~in ~~that~~the ~~leronlimab~~aforementioned ~~blocks~~2019 ~~calcium~~trial(s). ~~channel~~Although ~~signaling~~mTNBC ofpatients ~~the~~typically ~~CCR5~~have ~~receptor~~a ~~when~~poor ~~present~~prognosis, onobserved ~~the~~survival ~~cancer~~rates ~~cell~~at ~~surface. This~~12, ~~research~~24, ~~also~~36, ~~suggests~~and ~~that~~48 ~~calcium~~months ~~channel~~after ~~signaling~~treatment ofwith ~~the~~leronlimab ~~CCR5~~compare ~~receptor~~favorably iswith areported ~~crucial~~life ~~component~~expectancy toafter ~~the~~treatment ~~spread~~with ofcurrently ~~metastatic~~approved ~~cancer~~therapies. ~~The~~In ~~CCR5~~addition, ~~receptor~~the ~~has~~Company ~~been~~confirmed ~~identified~~that as a ~~potential~~small ~~therapeutic~~group ~~target~~of inpatients awho ~~variety~~failed oftreatment ~~settings,~~after ~~including~~developing ~~HIV,~~metastatic ~~graft-versus-host~~ disease ~~(“GvHD”),~~survived ~~MASH,~~more ~~Alzheimer’s~~than ~~disease,~~48 ~~cancer~~months ~~metastasis,~~after ~~multiple~~receiving ~~sclerosis~~leronlimab, ~~traumatic~~are ~~brain~~alive ~~injury~~today, ~~stroke recovery,~~ and acurrently ~~variety~~identify ofas ~~inflammatory~~having ~~conditions,~~no ~~including~~evidence ~~COVID-19. This could present the potential for multiple opportunities for leronlimab to provide benefit in a variety~~ of ~~clinical~~ongoing ~~settings~~disease.

~~Leronlimab~~In May 2025, the Company announced new data suggesting a novel mechanism of action of leronlimab for the treatment of solid tumors. The Company analyzed data from its prior clinical trials of patients with mTNBC and ~~Cancer~~found that leronlimab treatment correlated with increased expression of an immune cell protein or “checkpoint inhibitor” known as programmed death-ligand 1 (“PD-L1”) on patient’s circulating tumor cells (“CTCs”). The results indicated that 15 of 17 (88%) of patients who received a weekly dose of 525 mg or higher experienced a significant increase in PD-L1 expression on their CTCs over a 30-to-90-day period after starting leronlimab. Increasing expression of PD-L1 can be likened to turning “cold” tumors “hot”, elevating PD-L1 levels to the level necessary for patients to potentially derive benefit from further treatment with a class of drugs known as immune checkpoint inhibitors (“ICIs”). The Company also confirmed that all five patients (100%) who demonstrated a significant increase in PD-L1 expression after receiving leronlimab and received treatment with any ICI remain alive today.

Research indicates that the CCR5 receptor works as a potential “GPS” system for cancer cells that promotes the spread of metastatic disease. Pre-clinical studies have shown that leronlimab blocks the calcium channel signaling of the CCR5 receptor and has the potential to disable this GPS system. CCR5 inhibition may disrupt signaling and ultimately the spread of CCR5+ Circulating Tumor Cells (“CTCs”). Most current therapies are directed to the primary tumor rather than the movement or spread of cancer in the bloodstream. However, it is metastatic disease and not the primary tumor that is the cause of death in most cancer patients.

~~Research~~The ~~has~~Company ~~shown that CCR5 expression~~ is ~~increased~~currently in athe ~~number~~process of ~~solid~~resuming ~~tumors~~its ~~including~~clinical ~~breast,~~development ~~colon,~~in ~~prostate~~mTNBC, ~~and~~with ~~pancreatic~~the ~~cancer~~intention ~~among~~to ~~others. Increased~~prospectively ~~CCR5~~confirm ~~expression~~the ~~has~~retrospective ~~also~~observations ~~been~~in ~~identified~~mTNBC asoutlined anabove. ~~indicator~~In ofearly ~~increased~~2025, ~~risk~~the ofCompany ~~progression~~announced in several ~~cancers.~~preclinical ~~Research~~studies ~~has~~in ~~hypothesized~~TNBC ~~that~~intended ~~CCR5~~to ~~may~~identify ~~play~~treatment astrategies ~~variety~~to ofoptimize ~~roles in~~ the ~~progression~~design of ~~cancer. The first is that the CCR5 receptor on cancer cells potentially plays~~ a ~~role~~future inPhase ~~the~~2 ~~migration~~study, and ~~invasion~~to offurther ~~cells~~examine ~~into~~ the ~~bloodstream,~~apparent ~~which~~mechanism ~~may~~behind ~~lead to metastasis. The second is that blocking~~ the ~~CCR5~~observed ~~receptor~~increase onin asurvival ~~group of immunosuppressive immune cells known~~ as ~~Regulatory~~compared Tto ~~cells~~existing ~~(Tregs)~~treatment ~~could turn on anti-tumor fighting properties thereby restoring immune function~~paths. AIn ~~third observation is that blocking~~ the ~~interaction~~interim, ofongoing ~~CCR5~~discussions with aKOLs ~~chemokine~~are ~~known~~being asconducted ~~RANTES~~towards ~~(also~~initiating ~~known as CCL5) has~~ a ~~potentially~~study ~~synergistic~~in ~~effect~~patients with ~~chemotherapy~~mTNBC inon controlling cancer progression. Fourth, animal studies revealed a significant decrease in angiogenesis or new blood vessel formation following administration of leronlimab. Such new blood vessel formation is critically important for the growth of tumors. And lastly, it is hypothesized that leronlimab exerts an ~~effect~~abbreviated ~~on tissue macrophages in the tumor microenvironment to repolarize these cells into anti-tumor fighting cells~~timeline.

Leronlimab and Glioblastoma Multiforme (“GBM”) ~~Pre-Clinical Development~~

In December 2023, the Company entered into a partnership with Albert Einstein College of Medicine and Montefiore Medical Center, located in New York. The Company ~~will~~provided ~~be providing~~ leronlimab to support atwo pre-clinical ~~study~~studies evaluating the efficacy of leronlimab independently and in combination with temozolomide in treating glioblastoma multiforme, also known as grade IV astrocytoma (“GBM”) in infected humanized mice. The study ~~will~~evaluated ~~involve~~ three groups of humanized mice: one control group, one group that will receive only leronlimab, and another group that will receive a combination of leronlimab and temozolomide. The primary objective of this study iswas to evaluate the effect of leronlimab on the primary tumor growth and occurrence of metastases on CCR5+ and CCR5- cells in humanized mice. ~~Upon completion of the study~~Unfortunately, the ~~academic~~unexpectedly ~~institutions~~aggressive ~~will~~behavior ~~provide~~of the ~~Company~~Glioblastoma ~~with~~cell alines ~~research~~used ~~report~~for ~~outlining~~these ~~the~~studies ~~study~~rendered ~~results,~~interpretation ~~and~~of ~~they~~these ~~will~~preclinical ~~have~~results ~~the~~difficult. ~~right~~Currently, ~~to publish and present~~ the ~~study~~Company ~~results. GBM~~ is ~~the~~pursuing ~~most~~follow-up ~~common~~murine ~~type~~studies, ofas ~~primary~~well ~~malignant~~as ~~brain~~an ~~tumor and is aggressive and fast~~investigator-~~growing.~~initiated ~~This~~pilot study isin ~~expected~~a togroup ~~take~~of ~~place~~patients inwith ~~the~~recurrent ~~2024 calendar year~~GBM.

Metastatic Triple-Negative Breast Cancer Pre-Clinical Development

In late November 2018, CytoDyn received FDA approval of our Investigational New Drug (“IND”) submission and subsequently initiated a Phase 1b/2 clinical trial for metastatic Triple-Negative Breast Cancer (“mTNBC”) patients. We previously reported that a pre-clinical research study with leronlimab reduced the incidence of human breast cancer metastasis in a mouse xenograft model for cancer through six weeks with leronlimab by more than 98%. The temporal equivalency of this six-week study in mice may be up to six years in humans. In May 2019, the FDA granted Fast Track designation for leronlimab for use in combination with carboplatin to treat patients with CCR5+ positive mTNBC.

Metastatic Trial for Triple-Negative Breast Cancer Phase 1b/2 Trial

This trial evaluated the feasibility of leronlimab in combination with carboplatin in patients with CCR5+ mTNBC. This trial advanced from Phase 1b/2 to Phase 2. The Phase 2 trial was a single arm study to test the hypothesis that the combination of

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intravenous carboplatin and maximum tolerated dose of subcutaneous leronlimab will increase progression free survival. This study also evaluated the change in Circulating Tumor Cells as a potential prognostic marker for clinical efficacy. The first patient was treated in September 2019. Leronlimab, in combination with carboplatin was well-tolerated at all three dose levels of 350mg, 525mg, and 700mg. Leronlimab showed early signs of anti-tumor activity in patients with CCR5+ mTNBC and publication of the study results is pending.

Metastatic Triple-Negative Breast Cancer Compassionate Use Study

This was a single-arm, compassionate use study of leronlimab combined with a treatment of Physician’s Choice (“TPC”) in patients with CCR5+ mTNBC. Leronlimab was administered subcutaneously as a weekly dose of 350 mg until disease progression or intolerable toxicity. Based on our success in the Phase 1b/2 mTNBC trial with 350 mg dose, we were able to transition the compassionate use patients to 525 mg dose. TPC is defined as one of the following single-agent chemotherapy drugs administrated according to local practice: eribulin, gemcitabine, capecitabine, paclitaxel, nab-paclitaxel, vinorelbine, ixabepilone, or carboplatin. In this study, patients were evaluated for tumor response approximately every three (3) months or according to the institution’s standard practice by CT, PET/CT or MRI with contrast (per treating investigator’s discretion) using the same method as at baseline. This trial is no longer active, and publication of the results is pending.

Locally Advanced or Metastatic Solid Tumors for CCR5+ Phase 2 Basket Trial

This was a single arm Phase 2 study of leronlimab in patients with CCR5+ locally advanced or metastatic solid tumors. Leronlimab was administered subcutaneously as a weekly dose of 350 mg and 525 mg until disease progression or intolerable toxicity. Subjects participating in this study were also allowed to receive/continue standard-of-care chemotherapy or radiotherapy. In this study, patients were evaluated for tumor response approximately every three months or according to the institution’s standard practice by CT, PET/CT or MRI with contrast using the same method as at baseline. This trial is no longer active.

Leronlimab and HIV

We believe that leronlimab shows promise as an antiviral agent with the potential advantage of lower toxicity and less frequent dosing requirements as compared to certain daily drug therapies currently in use for the treatment of HIV. Leronlimab belongs to a class of HIV therapies known as viral entry inhibitors that block HIV from entering and infecting specific cells. Leronlimab blocks HIV from entering a cell by binding to a receptor called CCR5, a normal cell surface receptor protein to which CCR5 tropic strains of HIV, referred to as “R5” strains, attach as part of HIV’s entry into a cell. Leronlimab binds to a precise site on CCR5 that R5 strains of HIV use to enter the cell and, in doing so, inhibits the ability of these strains of HIV to infect the cell. As a result, we believe leronlimab represents a distinct class of CCR5 inhibitors with advantageous virological and immunological properties and may provide a unique tool to treat HIV-infected patients. We plan to explore the potential for leronlimab to be used in PrEP if a longer acting version of subcutaneous leronlimab is successfully developed. This longer acting version could also potentially be used in combination with standard of care therapies to treat HIV patients.

We continue to believe leronlimab is positioned to add value to the HIV market, as an alternative, or in addition to current therapies, which are failing primarily due to patient non-compliance, which causes drug resistance. Several factors give rise to patient non-compliance issues, such as toxicity and side effects, coupled with the need for a strict daily dosing regimen. In 26 clinical studies previously conducted, leronlimab was generally well tolerated. In addition, there were no dose-limiting toxicities or patterns of drug-related toxicities observed during these trials. We believe the results of these trials establish that leronlimab’s antiviral activity is potent, rapid, prolonged, and dose-dependent. Because leronlimab’s MOA as a monoclonal antibody in HIV is a relatively new therapeutic approach, it provides a potentially advantageous method of suppressing the virus in treatment-experienced patients who have failed a prior HIV regimen and need new treatment options.

To date, leronlimab has been tested and administered to patients primarily as a subcutaneous injection once per week. We believe that if leronlimab is approved by the FDA for use in HIV, it could be an attractive and marketable therapeutic option for patients, particularly in the following scenarios:

● Patients experiencing difficulties with existing treatment regimens due to side effects or medical co-morbidities;

● Patients with difficulty adhering to daily drug regimens;

● Patients who poorly tolerate existing therapies; and

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● Patients with compromised organ function, such as hepatoxicity or renal insufficiency.

In 2016, we initiated a pivotal Phase 2b/3 trial for leronlimab as a combination therapy with existing HAART drug regimens for highly treatment-experienced HIV patients. The trial was completed in February 2018 and achieved its primary endpoint with a p-value of 0.0032. Most of the patients who completed this trial transitioned to an FDA-cleared rollover study, as requested by the treating physicians, to enable them to have continued access to leronlimab. This pivotal trial was the basis for the Company’s Biologic License Application (“BLA”) submission to the FDA, which was subsequently withdrawn by the Company in October 2022. We also conducted a rollover study for HIV, as combination therapy, designed for patients who had successfully completed the Phase 2b/3 combination therapy trial and for whom the treating physicians requested a continuation of leronlimab therapy to maintain suppressed viral load. Some of the patients received four years of treatment in this extension arm prior to its termination.

Leronlimab and MASH

As previously noted, CytoDyn believes that the CCR5 receptor is a crucial component in inflammatory responses. Some disease processes that could potentially benefit from CCR5 blockade include transplantation rejection, neuroinflammation, chronic inflammation, cancer, and MASH. Due to leronlimab’s MOA, we believe leronlimab may have the potential for reduced side effects over other CCR5 antagonists and may be able to prevent the progression of Metabolic Dysfunction-Associated Steatotic Liver Disease (“MAFLD”) into MASH. MAFLD is an inflammatory disease caused by the build-up of fat in hepatocytes (steatosis). In severe cases, MAFLD progresses into MASH. MASH is a chronic liver disease characterized by the presence of hepatic inflammation and fibrosis. Patients with advanced fibrosis due to MASH are at significantly higher risk of liver-related mortality. It is estimated that 30% to 40% of adults in the United States have MAFLD, while 3% to 12% of adults in the United States have MASH. If left untreated, MASH may progress to hepatocellular carcinoma and is expected to become the leading cause of liver transplantation. Further, liver disease is one of the leading causes of non-AIDS-related death in HIV patients. The Company is identifying the next steps in clinical development to continue the investigation of leronlimab in the MASH indication.

In MASH, liver homeostasis is impaired due to an accumulation of toxic lipids which can activate both Kupffer cells (KCs) and tissue-resident macrophages resulting in the production of fibrogenic cytokines and chemoattractant chemokines such as transforming growth factor-beta (TGF-β) and monocyte chemoattractant protein1 (MCP1). Not only do these cytokines/chemokines promote differentiation of hepatic stellate cells (HSCs) into myofibroblasts (the primary source for fibrillary collagens), but they also amplify the immune response by recruiting additional cells into the damaged area. Recruitment of extra-hepatic inflammatory cells to the site of hepatic injury is typically mediated by interactions between cytokines/chemokines and their receptors. It has also been shown that patients with MASH also have high levels of CCR5 and the associated ligand, CCL5, thus demonstrating a potential role of CCR5 and its ligands in liver fibrosis.

MASH Pre-Clinical Development

The potential for leronlimab in the treatment of MASH was demonstrated in a pre-clinical model of fatty liver disease. Immunodeficient, NOD-SCID Gamma (NSG) mice were fed a high fat, MASH-inducing diet, transplanted with human stem cells to repopulate the deficient immune system, and treated with leronlimab. Sixteen (16) male NOD.Cg-Prkdcscid Il2rgtm1Wjl/SzJ, commonly known as the NOD scid IL2 receptor gamma knockout mice (NSG), were first humanized by intravenous inoculation with normal human umbilical cord blood cells (105). After 5 weeks on normal mouse chow, mice were successfully humanized, demonstrating >25% human CD45 cells in peripheral blood. Mice were switched to high fat (52%) high cholesterol (1.25%) diet (FPC diet: fructose, palmitate, cholesterol, trans-fat; Envigo-Teklad TD.160785). Leronlimab and control antibody (normal human IgG, Sigma) were administered i.p. at a dose of 2mg i.p. twice weekly, n=8 mice/group. The results showed that leronlimab inhibited fatty liver development, a key characteristic of early-stage MASH, such that treatment of humanized NSG mice with leronlimab caused a three-fold reduction in hepatic steatosis compared to control in an animal model of high fructose, high palmitate, high cholesterol diet.

MASH Phase 2a Exploratory Study

The Company has reported clinical data from patients with MASH from the CDI-MASH01 trial which was designed as a multi-center Phase 2a study and was subsequently converted into an exploratory study to evaluate the dose, efficacy, and safety of leronlimab at 350 mg and 700 mg, versus placebo. The study also included an expansive biomarker program designed to inform future clinical trials and to more fully understand leronlimab’s mechanism of action within the MASH setting. CDI-MASH01 was conducted in two parts. Part 1 of the study was designed to assess the efficacy of leronlimab 700 mg (n=22) in measurements of liver steatosis

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and liver fibro-inflammation in adult patients diagnosed with MASH compared to placebo (n=28). Part 2 was subsequently added to assess leronlimab 350 mg in improving these same measurements in adult patients diagnosed with MASH (n=22). In Part 1 of the study, eligible subjects were randomized 1:1 to one of the two study arms to receive either leronlimab 700mg (Group A), or placebo (Group B), given once per week (±1day) at the study site for up to 13 weeks during the treatment period. In Part 2 of the study, eligible subjects were enrolled using the same inclusion and exclusion criteria to Part 1 and received open-label leronlimab 350 mg once per week (±1day) at the study site for up to 13 weeks during the treatment period. The primary efficacy objective was percent change from baseline in hepatic fat fraction, as assessed by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) at week 14. The secondary efficacy objective was absolute change from baseline in fibro-inflammatory activity in the liver as assessed by MRI-corrected T1 imaging (MRI-cT1) at week 14. MRI-cT1 is obtained by multiparametric magnetic resonance imaging of the liver and is a quantitative metric for assessing a composite of liver inflammation and fibrosis, expressed in milliseconds (msec). MRI-PDFF is being studied as an imaging surrogate endpoint for the fat density in the liver. MRI-cT1 is being studied as an imaging surrogate endpoint for hepatic fibro-inflammation. This is a critical unmet need in the MASH space, as many agents have been unable to show reductions in fibro-inflammation despite reductions in hepatic steatosis.

All analyses performed are being treated as exploratory. Treatment with leronlimab was well tolerated in both Part 1 and Part 2 compared to placebo. In Part 1 of the study, leronlimab 700 mg did not reduce mean change in PDFF and cT1 from baseline to week 14 vs. placebo. In Part 2, leronlimab 350 mg reduced mean change in PDFF and cT1 from baseline to week 14 vs. the placebo group from Part 1, despite increased degree of baseline fibro-inflammation. In the combined group of patients with moderate (≥ 875 msec) and severe (≥ 950 msec) cT1 values at baseline, leronlimab 350 mg reduced cT1 from baseline to week 14 vs. placebo. The study has been completed and publication of the results is pending.

Leronlimab and Other Immunological Applications

SARS-CoV 2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The virus is highly contagious and has developed several variants. COVID-19 disease typically transmits person to person through respiratory droplets, commonly resulting from close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed SARS-CoV2 infections, symptoms have included fever, cough, and shortness of breath, amongst many others. The symptoms of COVID19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-symptomatic to severe and fatal.

Based upon analyses of potential effects of leronlimab on the immune system and the results from over 60 Emergency Investigation New Drug (“EIND”) authorizations provided by the FDA, the Company conducted and completed two clinical trials in the United States for COVID-19 starting in fiscal 2020 and ending in fiscal 2022. Subsequently, the Company paused two additional clinical COVID trials in Brazil which commenced during fiscal 2022. Further, the Company withdrew its COVID-19 IND with the FDA, and the FDA put the COVID-19 program on a full clinical hold in March 2022. If CytoDyn were to continue to pursue the COVID-19 indication, we believe that subgroup analyses from our previous trials may inform the design of future clinical trials investigating leronlimab for the treatment of COVID-19.

Pre-Clinical Development of Long-Acting CCR5 Antagonist

InThe ~~March 2023,~~Company ~~the~~has ~~Company~~an ~~entered~~active ~~into~~and aongoing joint development agreement with a third-party company with generative AI drug discovery and development ~~company~~tools in an effort to develop one or more longer-acting molecules. The Company believes ~~working~~this ~~with~~collaboration ~~a partner with AI capabilities~~ will result in the expedited development of a modified, longer-acting therapeutic, and could lead to greater acceptance by patients due to the requirement for less frequent injections. The services provided by the third party may yield extended intellectual property protection, thereby increasing the value of the Company’s patent portfolio. InIf ~~December 2023~~successful, ~~the~~such ~~Company~~a ~~received~~modified ~~various iterations of potential long-acting therapeutics, on which the Company will be performing assays to determine the suitability and feasibility of the long-acting~~ therapeutic ~~candidates~~would ~~for further development.~~

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.26

Werequire ~~are~~less ~~focused~~frequent oninjections ~~developing~~for ~~leronlimab,~~patients aon ~~CCR5 receptor antagonist~~drug, tofurthering bethe ~~used~~convenience asand aoverall ~~platform~~marketability ~~drug~~of ~~for~~the ~~various indications~~product. ~~The~~ ~~CCR5~~Working ~~receptor~~with is a ~~protein~~company ~~located~~with onestablished ~~the~~AI-capabilities ~~surface~~allows offor ~~various~~a ~~cells~~robust ~~including~~development ~~white~~path ~~blood~~for ~~cells~~this ~~and~~modified, ~~cancer~~longer-acting ~~cells.~~therapeutic Onfor ~~white~~the ~~blood~~Company. ~~cells,~~This itjoint ~~serves~~development asinitiative aremains ~~receptor~~in ~~for~~progress ~~chemical~~at ~~attractants~~this ~~known~~time asand ~~chemokines. Chemokines are~~ the ~~key~~Company ~~orchestrators~~will ofprovide ~~leukocyte~~further ~~trafficking~~updates bywhen appropriate.

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attracting immune cells to the sites of inflammation. At the site of an inflammatory reaction, chemokines are released. These chemokines are specific for CCR5 and cause the migration of T-cells to these sites promoting further inflammation. The CCR5 receptor is also the co-receptor needed for certain strains of HIV to infect healthy T-cells.

Patents, Proprietary Technology and Data Exclusivity

Protection of the Company’s intellectual property rights is important to our business. We may file patent applications in the U.S., Canada, China, Japan, European countries that are party to the European Patent Convention, and other countries on a selective basis, to protect inventions we consider to be important to the development of our business.

Generally, patents issued in the U.S. are effective for 20 years from the earliest asserted filing date. A U.S. patent, to be selected by us upon receipt of FDA regulatory approval, may be subject to up to a five-year patent term extension in certain instances. While the duration of foreign patents varies in accordance with the provisions of applicable local law, most countries provide for a patent term of 20 years measured from the application filing date and some may also allow for patent term extension to compensate for regulatory approval delay.

We pursue opportunities for seeking new meaningful patent protection on an ongoing basis. Absent patent protection, others may attempt to make and use the leronlimab antibody for uses not covered by later patent filings, such as attempts to produce and sell the leronlimab antibody as a research reagent and/or as a component for use in diagnostics. However, the formulation composition patent protection remains viable, and third parties face additional regulatory hurdles together with ~~CytoDyn~~the Company’s various method patents with respect to any contemplated attempts to commercialize leronlimab for therapeutic indications. We currently anticipate, absent patent term extension, that patent protection relating to the leronlimab antibody itself started to expire in 2023, the leronlimab concentrated protein formulation will start to expire in 2031, certain methods of using leronlimab for treatment of HIV will start to expire on or before 2035, certain methods of using leronlimab for ~~cancer~~treatment ~~indications~~of ifCOVID-19 ~~granted~~ will start to expire in 2040, certain methods of using leronlimab for treatment of ~~COVID-19~~MASH if granted will start to expire in ~~2040~~2043, and certain newly developed methods of using leronlimab for ~~treatment~~cancer ofindications ~~MASH~~ if granted will start to expire in ~~2043~~2046.

Patents do not enable us to preclude competitors from commercializing drugs in direct competition with our products that are not covered by granted and enforceable patent claims. Consequently, patents may not provide us with any meaningful competitive advantage. Refer to “Risk Factors” beginning on page 10 9 of this prospectus for the related risks. We may also rely on data exclusivity, trade secrets, and proprietary know-how to develop and attempt to achieve a competitive position with our product candidates. We require our employees, consultants, and partners who have access to our proprietary information to sign confidentiality agreements to protect our intellectual property.

Separate from and in addition to the patent rights noted above, we expect that leronlimab will be subject to market and data exclusivity period, during which period no other applications referencing leronlimab will be approved by FDA. Accordingly, this period of regulatory exclusivity is expected to provide a term of protection against competing products shown to be biosimilar or interchangeable with leronlimab. Similar data exclusivity or data protection periods may be provided in other countries. We note that data exclusivity is not an extension of patent rights, and it does not prevent the introduction of generic versions of the innovative drug during the data exclusivity period, as long as the marketing approval of the generic version does not use or rely upon the innovator’s test data.

Patents and data exclusivity are different concepts, protect different subject matter, arise from different efforts, and have different legal effects over different time periods. Information with respect to our current patent portfolio as of ~~August~~April 3115, ~~2024~~2026 is as follows:


				Number of Patent
	Number of Patents			Applications
	U.S.	International	Expiration Dates(1)	U.S.	International
Leronlimab (PRO 140) product candidate(2)	32	1613	~~2024-~~2032	3—	31
Methods of treatment by indication (e.g., HIV-1; COVID-19; GvHD)(2)	3—	—	~~2036-2040~~	32	51
Methods of treatment – Cancer, MASH (formerly, NASH)	—	—1	2040	39	3021

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(1)	Patent term extensions and pending patent applications may extend periods of patent protection.

(2)	Leronlimab (PRO 140) patents and applications relate to the antibody and formulations.

Research, development and commercialization of a biopharmaceutical product often requires choosing between alternative development and optimization routes at various stages in the development process. Preferred routes depend upon availability of financial resources and may also be affected by subsequent discoveries, test results and other factors, and therefore cannot be identified with certainty. There are numerous third-party patents in fields in which we work, and we may need to obtain licenses under patents of others to pursue a preferred development route of one or more of our product candidates. The need to obtain a license would decrease the ultimate value and profitability of an affected product. If we cannot negotiate such a license, we might have to pursue a less desirable development route or terminate the program altogether.

Government Regulation

The research, development, testing, manufacture, quality control, packaging, labeling, storage, record-keeping, distribution, import, export, promotion, advertising, marketing, sale, and reimbursement of pharmaceutical products is extensively regulated by governmental authorities in the United States and other countries. The processes for obtaining regulatory approvals in the United States and in foreign countries and jurisdictions, along with compliance with applicable statutes and regulations and other requirements, both pre-approval and post-approval, require the expenditure of substantial time and financial resources. The regulatory requirements applicable to product development, approval, and marketing are subject to change, and regulations and administrative guidance often are revised or reinterpreted by the agencies in ways that may have a significant impact on our business.

Licensure and Regulation of Biological Products in the United States

In the United States, the FDA regulates human drugs under the Federal Food, Drug, and Cosmetic Act, or the FDCA, and in the case of biological products, also under the Public Health Service Act, or the PHSA, and their implementing regulations. The failure to comply with the applicable U.S. requirements may result in FDA refusal to approve any pending applications or delays in development and may subject an applicant to administrative or judicial sanctions, such as issuance of warning letters, or the imposition of fines, civil penalties, product recalls, product seizures, total or partial suspension of production or distribution, and injunctions and/or civil or criminal prosecution brought by the FDA and the U.S. Department of Justice or other governmental entities.

The FDA must approve product candidates for therapeutic indications before they may be marketed in the United States. For biological products, such as our product candidate, leronlimab, the FDA must approve a BLA. An applicant seeking approval to market and distribute a new biologic in the United States generally must satisfactorily complete each of the following steps:

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completion of pre-clinical laboratory tests, animal studies, and formulation studies according to good laboratory practices, or GLP, regulations, or other applicable regulations;

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submission to the FDA of an IND, which must become effective before human clinical trials may begin and must be updated when certain changes are made;

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approval by an independent institutional review board (“IRB”), or ethics committee representing each clinical trial site before each clinical trial may be initiated;

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performance of adequate and well-controlled human clinical trials in accordance with applicable IND regulations, good clinical practices, or GCPs, and other clinical-trial related regulations to evaluate the safety and efficacy of the investigational product for each proposed indication;

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preparation and submission to the FDA of a BLA requesting marketing approval for one or more proposed indications, including payment of application user fees;

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review of the BLA by an FDA advisory committee, where applicable;

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satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the biologic is produced to assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity;

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satisfactory completion of any FDA audits of clinical trial sites to assure compliance with GCPs and the integrity of the clinical data submitted in support of the BLA; and

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FDA review and approval of the BLA, which may be subject to additional post-approval requirements, including the potential requirement to implement a REMS, and any post-approval studies required by the FDA.

Pre-clinical Studies

Before an applicant begins testing a product candidate with potential therapeutic value in humans, the product candidate enters the pre-clinical testing stage. Pre-clinical tests include laboratory evaluations of product chemistry, formulation, and stability, as well as other studies to evaluate, among other things, the toxicity of the product candidate. The conduct of the pre-clinical tests and formulation of the compounds for testing must comply with federal regulations and requirements, including GLP regulations and standards. The results of the pre-clinical tests, together with manufacturing information and analytical data, are submitted to the FDA as part of an IND. Some long-term pre-clinical testing, such as animal tests of reproductive adverse events and carcinogenicity, and long-term toxicity studies, may continue after the IND is submitted.

The IND and IRB Processes

An IND is an exemption from the premarket approval requirements of the FDCA allowing an unapproved product candidate to be shipped in interstate commerce for use in an investigational clinical trial. An IND must be in effect prior to interstate shipment and administration of any product candidate that is not the subject of an approved NDA or BLA. When submitting an IND to the FDA, applicants must submit a protocol for each planned clinical trial, and any subsequent protocol amendments must be submitted to the FDA as part of the IND. The FDA requires a 30-day waiting period after the filing of each IND before clinical trials may begin. This waiting period is designed to allow the FDA to review the IND to determine whether human research subjects will be exposed to unreasonable health risks. At any time during this 30-day period, the FDA may raise concerns or questions about the conduct of the trials as outlined in the IND and impose a clinical hold or partial clinical hold. In this case, the IND sponsor and the FDA must resolve any outstanding concerns before clinical trials can begin.

At any time after the IND goes into effect, the FDA may also place a clinical hold or partial clinical hold on the IND or on any clinical trial that has commenced under the IND. A clinical hold is an order issued by the FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. A partial clinical hold is a delay or suspension of only part of the clinical work requested under the IND. For example, a partial clinical hold might state that a specific protocol or part of a protocol may not proceed, while other parts of a protocol or other protocols may do so. No more than 30 days after the imposition of a clinical hold or partial clinical hold, the FDA will provide the sponsor with a written explanation of the basis for the hold. Following the issuance of a clinical hold or partial clinical hold, a clinical investigation may only resume once the FDA has notified the sponsor that the investigation may proceed. The FDA will base that determination on information provided by the sponsor correcting the deficiencies previously cited or otherwise satisfying the FDA that the investigation can proceed or recommence.

For each foreign clinical study, a sponsor may choose, but is not required, to conduct it under an IND. When a foreign clinical study is conducted under an IND, all IND requirements must be met unless waived by the FDA. When a foreign clinical study is not conducted under an IND, the sponsor must ensure that the study complies with certain regulatory requirements of the FDA ~~in order~~ to use the study as support for an IND or application for marketing approval. Specifically, the studies must be conducted in accordance with GCP, including undergoing review and receiving approval by an independent ethics committee, or IEC, and seeking and receiving informed consent from subjects. The GCP requirements in the final rule encompass both ethical and data integrity standards for clinical studies. The FDA’s regulations are intended to help ensure the protection of human subjects enrolled in non-IND foreign clinical studies, as well as the quality and integrity of the resulting data.

In addition to the foregoing IND requirements, an IRB must review and approve the plan for any clinical trial before it commences at each institution participating in the clinical trial, and the IRB must conduct continuing review and reapprove the study at least annually. The IRB, which must operate in compliance with FDA regulations, must review and approve, among other things, the study protocol and informed consent information to be provided to study subjects. An IRB can suspend or terminate approval of a clinical trial at its institution, or an institution it represents, if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the product candidate has been associated with unexpected serious harm to patients.

32Additionally, some trials are overseen by an independent group of qualified experts organized by the trial sponsor, known as a data safety monitoring board, or DSMB. This group provides authorization as to whether a trial may move forward at designated

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~~the~~checkpoints ~~study~~based ~~protocol~~on ~~and~~review ~~informed~~of ~~consent~~available ~~information~~data tofrom bethe ~~provided~~study, to ~~study~~which ~~subjects.~~only Anthe ~~IRB~~DSMB ~~can~~maintains ~~suspend~~access. Suspension or ~~terminate~~termination ~~approval~~of development during any phase of a clinical trial atcan ~~its~~occur ~~institution,~~if orthe anDSMB ~~institution~~determines itthat ~~represents, if~~ the ~~clinical~~participants ~~trial~~or ispatients ~~not~~are being ~~conducted~~exposed into ~~accordance~~an ~~with~~unacceptable ~~the~~health ~~IRB’s~~risk. ~~requirements~~A sponsor may suspend or ifterminate ~~the~~development ~~product~~for ~~candidate~~other ~~has~~reasons, ~~been~~including ~~associated~~evolving ~~with~~business ~~unexpected~~objectives ~~serious~~and/or ~~harm~~a tocompetitive ~~patients~~climate.

Additionally, some trials are overseen by an independent group of qualified experts organized by the trial sponsor, known as a data safety monitoring board, or DSMB. This group provides authorization as to whether or not a trial may move forward at designated checkpoints based on review of available data from the study, to which only the DSMB maintains access. Suspension or termination of development during any phase of a clinical trial can occur if the DSMB determines that the participants or patients are being exposed to an unacceptable health risk. A sponsor may suspend or terminate development for other reasons, including evolving business objectives and/or a competitive climate.

Expanded Access

Expanded access, sometimes called “compassionate use,” is the use of investigational new drug products outside of clinical trials to treat patients with serious or immediately life-threatening diseases or conditions when there are no comparable or satisfactory alternative treatment options. The rules and regulations related to expanded access are intended to improve access to investigational drugs for patients who may benefit from investigational therapies. FDA regulations allow access to investigational drugs under an IND by the company or the treating physician for treatment purposes on a case-by-case basis for: individual patients (single-patient IND applications for treatment in emergency settings and non-emergency settings); intermediate-size patient populations; and larger populations for use of the drug under a treatment protocol or Treatment IND Application. FDA’s regulations also provide for emergency procedures if there is a situation that requires the patient to be treated before a written submission can be made.

When considering an IND application for expanded access to an investigational product with the purpose of treating a patient or a group of patients, the sponsor and treating physicians or investigators will determine suitability when all of the following criteria apply: patient(s) have a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition; the potential patient benefit justifies the potential risks of the treatment and the potential risks are not unreasonable in the context or condition to be treated; and the expanded use of the investigational drug for the requested treatment will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the product or otherwise compromise the potential development of the product.

There is no obligation for a sponsor to make its drug products available for expanded access; however, as required by the 21st Century Cures Act, or Cures Act, passed in 2016, a sponsor must make its policy regarding how it evaluates and responds to expanded access requests public and readily available. Sponsors are required to make such policies publicly available upon the earlier of initiation of a Phase 2 or Phase 3 study; or 15 days after the investigational drug or biologic receives designation as a breakthrough therapy, fast track product, or regenerative medicine advanced therapy.

In addition, on May 30, 2018, the Right to Try Act was signed into law. The law, among other things, provides a federal framework for certain patients to access certain investigational new products that have completed a Phase 1 clinical trial and that are undergoing investigation for FDA approval. Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under the FDA expanded access program. There is no obligation for a manufacturer to make its products available to eligible patients as a result of the Right to Try Act, but the manufacturer must develop an internal policy and respond to patient requests according to that policy.

Human Clinical Trials in Support of an NDA or BLA

Clinical trials involve the administration of the investigational product candidate to human subjects under the supervision of a qualified investigator in accordance with GCP requirements which include, among other things, the requirement that all research subjects provide their informed consent in writing before they participate in any clinical trial. Clinical trials are conducted under written clinical trial protocols detailing, among other things, the objectives of the study, inclusion and exclusion criteria, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated.

Human clinical trials are typically conducted in three sequential phases, but the phases may overlap or be combined. Additional studies may also be required after approval. As described in FDA’s regulations at 21 CFR 312.21, the three phases are as follows:

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Phase 1 includes the initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. The total number of subjects and patients included in Phase 1 studies varies with the drug but is generally in the range of 20 to 80. Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes.

Phase 2 includes the controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects.

Phase 3 studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. Phase 3 studies usually include from several hundred to several thousand subjects.

In some cases, the FDA may approve an NDA or BLA for a product candidate but require the sponsor to conduct additional clinical trials to further assess the product candidate’s safety and effectiveness after approval. Such post-approval trials are typically referred to as Phase 4 clinical trials. These trials are used to gain additional experience from the treatment of a larger number of patients in the intended treatment group and to further verify and describe clinical benefit in the case of products approved under FDA’s accelerated approval regulations. Failure to exhibit due diligence regarding conducting Phase 4 clinical trials could result in withdrawal of FDA approval for products.

Progress reports detailing the results of clinical trials must be submitted annually to the FDA. In addition, IND safety reports must be submitted to the FDA for any of the following: serious and unexpected suspected adverse reactions; findings from other studies or animal or in vitro testing that suggest a significant risk in humans exposed to the product; and any clinically important increase in the occurrence of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. Expedited reporting is required for unexpected fatal or life-threatening suspected adverse reactions. Phase 1, Phase 2, and Phase 3 clinical trials may not be completed successfully within any specified period, or at all. The FDA will typically inspect one or more clinical sites to assure compliance with GCP and the integrity of the clinical data submitted.

Expedited Programs for Serious Conditions

The FDA is authorized to expedite the development and review of new therapeutic products to address unmet need in the treatment of a serious or life-threatening condition. A product development program may qualify for one or more of FDA’s expedited programs for serious conditions: fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation.

Any product candidate submitted to the FDA for marketing, including under a Fast Track program, may be eligible for other types of FDA programs intended to expedite development and review, such as breakthrough therapy designation, priority review, and accelerated approval.

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Fast Track Designation. The sponsor of a product candidate may request the FDA to designate the product for a specific indication as a Fast Track product concurrent with or after the filing of the IND. Candidate products are eligible for Fast Track designation if they are intended to treat a serious or life-threatening condition and nonclinical or clinical data demonstrate the potential to address unmet medical needs for the condition. Fast Track designation applies to the combination of the product candidate and the specific indication for which it is being studied. In addition to other benefits, such as the ability to have greater interactions with the FDA, the FDA may initiate review of sections of a Fast Track application before the application is complete, a process known as rolling review.

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Breakthrough therapy designation. To qualify for the breakthrough therapy designation, product candidates must be intended to treat a serious or life-threatening disease or condition and preliminary clinical evidence must indicate that such product candidates may demonstrate substantial improvement on one or more clinically significant endpoints over existing therapies. Features of breakthrough therapy designation include intensive guidance on an efficient development program, intensive involvement of senior managers and experienced staff on a proactive, collaborative and cross-disciplinary review, and rolling review.

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Priority review. A product candidate is eligible for priority review if it treats a serious condition and, if approved, it would be a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention compared to marketed products. In addition, specific statutory provisions provide for priority review for various types of applications. FDA aims to complete its review of priority review applications within six months as opposed to 10 months for standard review.

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Accelerated approval. FDA may grant accelerated approval to a product that treats a serious condition, generally provides a meaningful advantage over available therapies, and has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit, or on an intermediate clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity and prevalence of the condition and the availability or lack of alternative treatments. As a condition of approval, the FDA may require that a sponsor of a drug or biological product candidate receiving accelerated approval perform adequate and well controlled post-marketing clinical trials. In addition, the FDA currently requires, as a condition for accelerated approval, pre-submission of promotional materials.

None of these expedited programs change the standards for approval but they may help expedite the development or approval process of product candidates.

Emergency Use Authorizations

The FDA has the authority to permit the use of unapproved medical products following a determination of a public health emergency (“PHE”) by the Secretary of Health and Human Services (the “Secretary”) and a declaration by the Secretary that circumstances exist justifying the authorization of emergency use of types of medical products to respond to the PHE. Once the Secretary has made the requisite determination and declaration, the FDA may issue Emergency Use Authorizations, or EUAs, for specific unapproved medical products if the following statutory criteria have been met: (1) the pathogen that is the subject of the PHE can cause a serious or life-threatening condition; (2) based on the totality of the scientific evidence available, it is reasonable to believe that (i) the product may be effective in preventing or treating such condition, and (ii) the known and potential benefits of the product outweigh the known and potential risks; and (3) there is no adequate, approved, and available alternative to the product.

If an EUA is granted, it generally will remain in effect until the Secretary’s declaration that circumstances exist justifying the authorization of emergency use of the type of products at issue or the product is approved under one of FDA’s traditional approval pathways. The EUA also may be revoked or revised for other reasons, including a finding that the criteria for its issuance are no longer met or other circumstances make a revision or revocation appropriate to protect public health or safety.

Review and Approval of BLAs

Assuming successful completion of the required clinical testing, the results of the pre-clinical studies and clinical trials, along with information relating to the product’s chemistry, manufacturing, and controls and proposed labeling, are submitted to the FDA as part of a BLA requesting approval to market the product for one or more indications. Data may come from company-sponsored clinical trials intended to test the safety and efficacy of a product’s use or from a number of alternative sources, including studies initiated by investigators. To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety, potency, and purity of the investigational product to the satisfaction of the FDA. The fee required for the submission of an NDA or BLA under the Prescription Drug User Fee Act, or PDUFA, is substantial (for example, for FY2024 the application fee is approximately $4.0 million), and the sponsor of an approved BLA is also subject to an annual program fee, approximately $0.4 million per program. These fees are typically adjusted annually, but exemptions and waivers may be available under certain circumstances.

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The FDA conducts a preliminary review of all BLAs within 60 days of receipt and informs the sponsor by the 74th day after the FDA’s receipt of the submission whether an application is sufficiently complete to permit substantive review. If the FDA determines that a BLA does not satisfy this standard, it will issue a Refuse to File, or RTF, determination to the applicant. Typically, an RTF for a BLA will be based on administrative incompleteness, such as clear omission of information or sections of required information; scientific incompleteness, such as omission of critical data, information, or analyses needed to evaluate safety, purity, and potency or provide adequate directions for use; or inadequate content, presentation, or organization of information such that substantive and meaningful review is precluded. The FDA may request additional information rather than accept a BLA for filing. In this event, the application must be resubmitted with the additional information. The resubmitted application is also subject to review before the FDA accepts it for filing.

After the submission is accepted for filing, the FDA begins an in-depth substantive review of the application. Under the goals and policies agreed to by the FDA under PDUFA, the FDA aims to review and act on 90 percent of standard submissions within ten months of the filing date and 90 percent of priority review submissions within six months of the filing date. The review process may be extended by the FDA for three additional months to consider new information or, in the case of a clarification provided by the applicant, to address an outstanding deficiency identified by the FDA following the original submission. Despite these review goals, it is not uncommon for FDA review of a BLA to extend beyond the PDUFA goal date.

applicant, to address an outstanding deficiency identified by the FDA following the original submission. Despite these review goals, it is not uncommon for FDA review of a BLA to extend beyond the PDUFA goal date.

Before approving a BLA, the FDA will typically conduct a pre-approval inspection of the manufacturing facilities for the new product to determine whether the manufacturing processes and facilities comply with GMPs. The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. The FDA also may inspect the sponsor and one or more clinical trial sites to assure compliance with GCP requirements and the integrity of the clinical data submitted to the FDA.

Additionally, the FDA may refer a BLA, including applications for novel product candidates which present difficult questions of safety or efficacy, to an advisory committee for review, evaluation, and recommendation as to whether the application should be approved and under what conditions. Typically, an advisory committee is a panel of independent experts, including clinicians and other scientific experts. The FDA is not bound by the recommendation of an advisory committee, but it considers such recommendations when making final decisions on approval. The FDA also may require submission of a risk evaluation and mitigation strategy, or REMS, if it determines that a REMS is necessary to ensure that the benefits of the product outweigh its risks and to assure the safe use of the biological product. If the FDA concludes a REMS is needed, the sponsor of the BLA must submit a proposed REMS and the FDA will not approve the BLA without a REMS.

The FDA reviews a BLA to determine, among other things, whether the product is safe, pure, and potent and whether the facility in which it is manufactured, processed, packed, or held meets standards designed to assure the product’s continued safety, purity, and potency. The approval process is lengthy and often difficult, and the FDA may refuse to approve a BLA if the applicable regulatory criteria are not satisfied or may require additional clinical or other data and information. After evaluating the application and all related information, including the advisory committee recommendations, if any, and inspection reports of manufacturing facilities and clinical trial sites, the FDA may issue either an approval letter or a Complete Response Letter, or CRL.

An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications. A CRL indicates that the review cycle of the application is complete, and the application will not be approved in its present form. A CRL generally outlines the deficiencies in the submission and may require substantial additional testing or information for the FDA to reconsider the application. The CRL may require additional clinical or other data, additional pivotal Phase 3 clinical trial(s) and/or other significant and time-consuming requirements related to clinical trials, pre-clinical studies, or manufacturing. If a CRL is issued, the applicant may either resubmit the BLA addressing all the deficiencies identified in the letter or withdraw the application. If and when those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the BLA, the FDA will issue an approval letter. The FDA has committed to reviewing and acting on 90 percent of such resubmissions in response to an issued CRL in either two or six months depending on the type of information included. Even with the submission of this additional information, however, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.

If a product receives marketing approval from the FDA, the approval is limited to the conditions of use (e.g., patient population, indication) described in the FDA-approved labeling. Further, depending on the specific risk(s) to be addressed, the FDA may require that contraindications, warnings, or precautions be included in the product labeling, require that post-approval trials, including Phase 4 clinical trials, be conducted to further assess a product’s safety after approval, require testing and surveillance programs to monitor the product after commercialization or impose other conditions, including distribution and use restrictions or other risk management mechanisms under a REMS which can materially affect the potential market and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-marketing trials or surveillance programs. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes, and additional labeling claims, are subject to further testing requirements and FDA review and approval.

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product after commercialization or impose other conditions, including distribution and use restrictions or other risk management mechanisms under a REMS which can materially affect the potential market and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-marketing trials or surveillance programs. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes, and additional labeling claims, are subject to further testing requirements and FDA review and approval.

Reference Product Exclusivity for Biological Products

With approval of a BLA, a biological product is licensed for marketing by FDA, and the product may be entitled to certain types of market and data exclusivity barring FDA from approving competing products for certain periods of time. For example, in March 2010, the Patient Protection and Affordable Care Act was enacted in the United States and included the Biologics Price Competition and Innovation Act of 2009, or the BPCIA. The BPCIA amended the PHSA to create an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed biological reference product. To date, the FDA has approved several biosimilars, and in 2021, the FDA approved the first interchangeable biologic. The FDA has also issued several guidance documents outlining its approach to reviewing and approving biosimilars and interchangeable biologics.

Under the BPCIA, a manufacturer may apply for a product that is “biosimilar to” or “interchangeable with” a previously approved biological product or “reference product.” For the FDA to approve a biosimilar product, it must find that there are no clinically meaningful differences between the reference product and the proposed biosimilar product in terms of safety, purity, and potency. For the FDA to approve an interchangeable biological product, the agency must find that the biological product is biosimilar to the reference product, can be expected to produce the same clinical results as the reference product, and “for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.” Upon licensure by the FDA, an interchangeable biosimilar may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product, although the substitutability of drug and biological products are determined at the state level.

The biosimilar applicant generally must demonstrate that the product is biosimilar based on data from analytical studies showing that the biosimilar product is highly like the reference product, data from animal studies (including toxicity) and data from one or more clinical studies to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is approved. The FDA, however, may waive any of these data requirements upon a finding that the data are “unnecessary.” In addition, the applicant must show that the biosimilar and reference products have the same mechanism of action for the approved conditions of use, route of administration, dosage and strength, and the production facility must meet standards designed to assure product safety, purity, and potency.

In the USUnited States, a reference biological product is granted 12 years of exclusivity from the time of first licensure of the product, and the first approved interchangeable biological product will be granted an exclusivity period of up to one year after it is first commercially marketed. The FDA will not accept an application for a biosimilar or interchangeable product until four years after the date of first licensure of the reference product.

The BPCIA is complex, and there have been various legislative proposals to change certain aspects of the BPCIA. As a result, the ultimate impact, implementation, and meaning of aspects of the BPCIA are subject to significant uncertainty.

Orphan Drug Designation and Exclusivity

Orphan drug designation in the United States is designed to encourage sponsors to develop products intended for treatment of rare diseases or conditions. In the United States, a rare disease or condition is statutorily defined as a condition that affects fewer than 200,000 individuals in the United States or that affects more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making available the drug for the disease or condition will be recovered from sales of the product in the United States.

Orphan drug designation may qualify a company for certain tax credits and market exclusivity for seven years following the date of the product’s marketing approval if granted by the FDA. An application for designation as an orphan product can be made any time prior to the filing of an application for approval to market the product. A product that has received orphan drug designation must go through the review and approval process like any other product.

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prior to the filing of an application for approval to market the product. A product that has received orphan drug designation must go through the review and approval process like any other product.

A sponsor may request orphan drug designation of a previously unapproved product or new orphan indication for an already marketed product. In addition, a sponsor of a product that is otherwise the same drug as an already approved orphan drug may seek and obtain orphan drug designation for the subsequent product for the same rare disease or condition if it can present a plausible hypothesis that its product may be clinically superior to the first drug. More than one sponsor may receive orphan drug designation for the same drug for the same rare disease or condition, but each sponsor seeking orphan drug designation must file a complete request for designation.

If a product with orphan drug designation receives the first FDA approval for the rare disease or condition for which it has such designation, the product generally will receive orphan drug exclusivity. Orphan drug exclusivity means that the FDA may not approve another sponsor’s marketing application for the same drug for the same disease or condition for seven years, except in certain limited circumstances.

The period of exclusivity begins on the date that the marketing application is approved by the FDA. Orphan drug exclusivity will not bar approval of another product under certain circumstances, including if the company with orphan drug exclusivity is not able to meet market demand or the subsequent product that is otherwise considered the same drug for the same disease or condition is shown to be clinically superior to the approved product based on greater efficacy or safety, or providing a major contribution to patient care. Additionally, the statute requires that a sponsor must demonstrate clinical superiority in order to receive orphan drug exclusivity for a product that is considered the same drug as a previously approved product for the same rare disease or condition.

Additionally, the statute requires that a sponsor must demonstrate clinical superiority in order to receive orphan drug exclusivity for a product that is considered the same drug as a previously approved product for the same rare disease or condition.

Patent Term Restoration and Extension

In the United States, a patent claiming a new biological product, its method of use or its method of manufacture may be eligible for a limited patent term extension under the Hatch Waxman Act, which permits a patent extension of up to five years for patent term lost during product development and FDA regulatory review. Assuming grant of the patent for which the extension is sought, the restoration period for a patent covering a product is typically one half the time between the effective date of the IND involving human beings and the submission date of the BLA, plus the time between the submission date of the BLA and the ultimate approval date. Patent term restoration cannot be used to extend the remaining term of a patent past a total of 14 years from the product’s approval date in the United States. Only one patent applicable to an approved product is eligible for the extension, and the application for the extension must be submitted prior to the expiration of the patent for which extension is sought. A patent that covers multiple products for which approval is sought can only be extended in connection with one of the approvals. The USPTO reviews and approves the application for any patent term extension in consultation with the FDA.

Post-approval Requirements

Following approval of a new product, the manufacturer and the approved product are subject to pervasive and continuing regulation by the FDA, governing, among other things, monitoring and recordkeeping activities, reporting of adverse experiences with the product and product problems to the FDA, product sampling and distribution, manufacturing, and promotion and advertising. Although physicians may prescribe legally available products for unapproved uses or patient populations (i.e., “off-label uses”), manufacturers may not market or promote such uses. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.

Specifically, if a company is found to have promoted off-label uses, it may become subject to adverse public relations and administrative and judicial enforcement by the FDA, the Department of Justice, or the Office of the Inspector General of the Department of Health and Human Services, as well as state authorities. This could subject a company to a range of penalties that could have a significant commercial impact, including civil and criminal fines and agreements that materially restrict the way a company promotes or distributes drug products. The federal government has levied large civil and criminal fines against companies for alleged improper promotion and has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed.

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Further, if there are any modifications to the product, including changes in indications, labeling, or manufacturing processes or facilities, the applicant may be required to submit and obtain FDA approval of a new BLA or a BLA supplement, which may require the applicant to develop additional data or conduct additional pre-clinical studies and clinical trials. The FDA may also place other conditions on approvals including the requirement for a REMS to assure the safe use of the product, which may require substantial commitment of resources post-approval to ensure compliance. A REMS could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries, and other risk minimization tools. Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription, or dispensing of products. Product approvals may be withdrawn for non-compliance with regulatory standards or if problems occur following initial marketing.

In addition, FDA regulations require that biological products be manufactured in specific approved facilities and in accordance with cGMPs. The cGMP regulations include requirements relating to organization of personnel, buildings and facilities, equipment, control of components and drug product containers and closures, production and process controls, packaging and labeling controls, holding and distribution, laboratory controls, records and reports, and returned or salvaged products. The manufacturing facilities for our product candidates must meet cGMP requirements and satisfy the FDA or comparable foreign regulatory authorities’ satisfaction before any product is approved and our commercial products can be manufactured.

We rely, and expect to continue to rely, on third parties to produce clinical (and, in the future, commercial) supplies of our product candidate in accordance with cGMP regulations. These manufacturers must comply with cGMP regulations, including requirements for quality control and quality assurance, the maintenance of records and documentation, and the obligation to investigate and correct any deviations from cGMP. Manufacturers and other entities involved in the manufacture and distribution of approved drugs or biologics are required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws. Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance. Inspections by the FDA and other regulatory agencies may identify compliance issues at facilities that may disrupt production or distribution or require substantial resources to correct. In addition, the discovery of conditions that violate these rules, including failure to conform to cGMPs, could result in enforcement actions, and the discovery of problems with a product after approval may result in restrictions on a product, manufacturer, or holder of an approved BLA, including voluntary recall and regulatory sanctions as described below.

periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws. Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance. Inspections by the FDA and other regulatory agencies may identify compliance issues at facilities that may disrupt production or distribution or require substantial resources to correct. In addition, the discovery of conditions that violate these rules, including failure to conform to cGMPs, could result in enforcement actions, and the discovery of problems with a product after approval may result in restrictions on a product, manufacturer, or holder of an approved BLA, including voluntary recall and regulatory sanctions as described below.

The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in mandatory revisions to the approved labeling to add new safety information, imposition of post-market clinical trials requirement to assess new safety risks or imposition of distribution or other restrictions under a REMS program. Other potential consequences include, among other things:

●

restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;

●

safety alerts, Dear Healthcare Provider letters, press releases, or other communications containing warnings or other safety information about a product;

●

mandated modification of promotional materials and labeling and issuance of corrective information;

●

fines, warning letters, untitled letters or other enforcement-related letters, or clinical holds on post-approval clinical trials;

●

refusal of the FDA to approve pending NDAs/BLAs or supplements to approved NDAs/BLAs, or suspension or revocation of product approvals;

●

product seizure or detention or refusal to permit the import or export of products;

●

injunctions or the imposition of civil or criminal penalties; and

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●

consent decrees, corporate integrity agreements, debarment, or exclusion from federal health care programs; or mandated modification of promotional materials and labeling and the issuance of corrective information.

In addition, the distribution of prescription pharmaceutical products is subject to the Prescription Drug Marketing Act, or PDMA, which regulates the distribution of samples at the federal level and sets minimum standards for the registration and regulation of drug distributors by the states. Additionally, the Drug Supply Chain Security Act, or DSCSA, imposes requirements related to identifying and tracing certain prescription products distributed in the United States, including most biological products.

Other U.S. Healthcare Laws and Regulations

In the United States, biopharmaceutical manufacturers and their products are subject to extensive regulation at the federal and state level, such as laws intended to prevent fraud and abuse in the healthcare industry. These laws, some of which apply only to approved products, include:

●

federal false claims, false statements, and civil monetary penalties laws prohibiting, among other things, any person from knowingly presenting, or causing to be presented, a false claim for payment of government funds or knowingly making, or causing to be made, a false statement to get a false claim paid;

●

federal healthcare program anti-kickback law, which prohibits, among other things, persons from offering, soliciting, receiving, or providing remuneration, directly or indirectly, to induce either the referral of an individual for, or the purchasing or ordering of, a good or service for which payment may be made under federal healthcare programs such as Medicare and Medicaid;

●

the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which, in addition to privacy protections applicable to healthcare providers and other entities, prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

●

FDCA, which among other things, strictly regulates marketing, prohibits manufacturers from marketing such products prior to approval or for off-label use, and regulates the distribution of samples;

●

federal laws that require pharmaceutical manufacturers to report certain calculated product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under government healthcare programs;

●

federal transparency law, which requires pharmaceutical companies to report certain payments to healthcare providers;

●

state laws and regulations analogous to the above; and

● laws and regulations prohibiting bribery and corruption such as the Foreign Corrupt Practices Act ~~(“FCPA”)~~, which, among other things, prohibits U.S. companies and their employees and agents from authorizing, promising, offering, or providing, directly or indirectly, corrupt or improper payments or anything else of value to foreign government officials, employees of public international organizations or foreign government-owned or affiliated entities, candidates for foreign public office, and foreign political parties or officials thereof.

Violations of these laws are punishable by criminal and/or civil sanctions, including, in some instances, exclusion from participation in federal and state health care programs, such as Medicare and Medicaid. Ensuring compliance is time consuming and costly.

Similar healthcare laws and regulations exist in the European Union (the “EU”) and other jurisdictions, including reporting requirements detailing interactions with and payments to healthcare providers and laws governing the privacy and security of personal information.

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U.S. Privacy Law

In the U.S., there are numerous state and federal laws and regulations governing the security and privacy of personal information. Additionally, state and federal regulators have begun to pay more attention to companies’ data processing activities.

At the state level, laws require companies to safeguard personal information and take action in the event of a data breach (e.g., notifying governmental authorities and data subjects). State attorneys general have been active in using their consumer protection authority to investigate companies’ data security practices. A number of states have passed laws governing data privacy and many others have similar legislation under consideration. Although many of these laws contain exceptions for certain health data, these exceptions are not comprehensive. All of these laws give rights to residents in their states and require businesses to take certain actions with respect to those rights (similar to the General Data Protection Regulation in effect in the EU, but with notable differences).

At the federal level, the Federal Trade Commission has been active in using its Section 5 authority to bring enforcement actions against companies for deceptive or unreasonable data processing activities.

Registrational Clinical Trials Process

Described below is the traditional registrational drug development track.

Phase 1 includes the initial introduction of an investigational new drug or biologic into humans. These studies are closely monitored and may be conducted in patients but are usually conducted in a small number of healthy volunteer patients. These studies are designed to determine the metabolic and pharmacologic actions of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the investigational product’s pharmacokinetics and pharmacological effects are obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. Phase 1 studies of PRO 140 were conducted and completed by or on behalf of Progenics by certain principal investigators prior to our acquisition of PRO 140.

Phase 2 includes the early controlled clinical studies conducted to obtain some preliminary data on the effectiveness of the drug for a particular indication or indications in patients with the disease or condition. This phase of testing also helps determine the common short-term side effects and risks associated with the drug. Phase 2 studies are typically well-controlled, closely monitored, and conducted in a relatively small number of patients, typically no more than several hundred people. In some cases, depending upon the need for a new drug, a particular drug candidate may be licensed for sale in interstate commerce after a “pivotal” Phase 2 trial. Phase 2 is often broken into Phase 2a, which can be used to refer to “pilot trials,” or more limited trials evaluating exposure response in patients, and Phase 2b trials that are designed to evaluate dosing efficacy and ranges.

Phase 3 studies are expanded controlled clinical studies. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained in Phase 2 and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit/risk relationship of the drug. Phase 3 studies also provide an adequate basis for extrapolating the results to the general population and transmitting that information in the physician labeling. Phase 3 studies usually involve significantly larger groups of patients, and considerable additional expense. We were required to pay significant fees to third parties upon the first patient dosing in a Phase 3 trial of leronlimab, and we may be required to make additional fee payments to third parties upon the completion of additional milestones. Refer to Note 9, Commitments and Contingencies - PRO 140 Acquisition and Licensing Arrangements in the audited financial statements for the year ended May 31, 2025, included in this prospectus for further information.

Manufacturing

We do not own or operate manufacturing facilities to produce leronlimab or perform CMC related activities. As such, we must depend on third-party manufacturing organizations and suppliers for all of our CMC activities. We continue to explore alternative CMC partners and sources to obtain access to adequate resources to support our CMC efforts for leronlimab in a cost-efficient manner.

We previously engaged two global contract manufacturing organizations (“CMOs”), to initiate the scale-up to commercial batch quantities of product and develop the necessary controls and specifications to manufacture product on a consistent and reproducible manner. We also contracted with suitable CMOs to fill, finish, label, and package product into the final commercial package for commercial use. To commercialize product, this scaled-up material will need to be validated under best practices and demonstrated to meet approved specifications on an ongoing basis. GMP material will be produced as needed to support clinical trials for all therapeutic indications and until commercial product is approved by the FDA. We will continue to rely on active CMO relationships for all of our developmental and commercial needs.

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commercial use. To commercialize product, this scaled-up material will need to be validated under best practices and demonstrated to meet approved specifications on an ongoing basis. GMP material will be produced as needed to support clinical trials for all therapeutic indications and until commercial product is approved by the FDA. We will continue to rely on active CMO relationships for all of our developmental and commercial needs. As noted above under “Recent Corporate Developments,” we terminated our relationship with Samsung in April 2024 and currently maintain one active CMO relationship. We will continue to evaluate the need for any additional CMO services and/or relationships, as well as the potential use of our remaining pre-launch inventories described under the heading “Business Overview” above.

Research and Development Costs

The Company’s research and development expenses totaled approximately $7(16.29) million and $27.62 million for the fiscal years ended May 31, 2025, and 2024, respectively, and ~~2023~~approximately $11.1 million and $(20.2) million for the nine months ended February 28, 2026 and 2025, respectively.

Properties

We lease the space at which our principal executive offices are located at a monthly cost of approximately $15,~~600~~400. We do not own or lease any other properties.

Employees and Human Capital Resources

As of ~~August~~April 3115, ~~2024~~2026, we had ~~seven~~thirteen ~~full-time~~ employees, as well as a number of independent consultants, ~~including our interim Chief Financial Officer~~ and other individuals assisting us with the Company’s regulatory, quality, and medical matters. Our research and development team is geographically dispersed throughout the United States. ~~CytoDyn~~We isare committed to pay equity regardless of gender or race/ethnicity. We invest in our workforce by offering competitive salaries and benefits. We may award stock options or other stock-based awards to selected employees and consultants under our equity incentive plan. We also offer various benefits to all eligible employees, including health care coverage and a 401(k) plan. None of our employees are subject to a collective bargaining agreement. We consider our relationship with our employees to be good. There can be no assurance, however, that we will be able to identify or hire and retain additional employees or consultants on acceptable terms in the future.

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations together with the other sections of this prospectus, including our financial statements and the related notes beginning on page F-1 of this prospectus. Some of the information contained in this discussion and analysis or set forth elsewhere in this prospectus, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks, uncertainties and assumptions. See “Special Note Regarding Forward-Looking Statements.” You should review the “Risk Factors” section of this prospectus for a discussion of important factors that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Overview

Our current business strategy is the clinical development of leronlimab, which may include the following:

1. ~~Conducting~~Continue athe pending Phase II2 ~~study~~trial of leronlimab in patients with relapsed/refractory ~~microsatellite~~micro-satellite stable colorectal cancer;

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

~~Other~~We ~~programs~~will ~~that~~need ~~may~~significant beadditional ~~pursued~~funding ~~include~~to ~~steatosis~~execute ~~and~~the ~~liver~~above ~~fibrosis~~business ~~associated~~strategy ~~with~~in ~~MASH~~full, ~~either~~which ~~alone~~may orinclude asconducting a ~~combination~~variety ~~therapy;~~of additional pre-clinical studies and ~~for~~clinical ~~metastatic~~trials, ~~triple-negative~~in ~~breast~~furtherance ~~cancer~~of ~~with~~our ~~current~~efforts ~~standard~~to ofobtain ~~care~~FDA approval to commercialize leronlimab. In addition to traditional fundraising, ~~and/or~~the ~~exploring~~Company ~~other~~will ~~trials~~pursue ~~with~~non-dilutive ~~current~~financing ~~standard~~opportunities, ofsuch ~~care~~as license agreements and ~~other~~co-development ~~cancer~~or ~~and~~strategic ~~immunologic~~partnerships, ~~indications~~to help implement its strategy.

WeFluctuations ~~will need significant additional funding to execute the business strategy described above, including conducting additional pre-clinical studies and clinical trials,~~ in ~~furtherance~~operating ofresults our efforts to obtain FDA approval to commercialize leronlimab. In addition to traditional fundraising, the Company will pursue non-dilutive financing opportunities, such as license agreements and co-development or strategic partnerships, to help implement its strategy.

~~Results~~The Company’s operating results may fluctuate significantly depending on the outcomes, number and timing of ~~operations~~pre-clinical and clinical studies, patient enrollment and/or completion rates in the studies, and their related effect on research and development expenses, regulatory and compliance activities, activities related to seeking FDA approval of our drug product, general and administrative expenses, professional fees, and legal and regulatory proceedings and related consequences. We require a significant amount of capital to continue to operate; therefore, we regularly conduct financing offerings to raise capital, which may result in various forms of non-cash interest expense or other expenses. Additionally, we periodically seek to negotiate settlement of debt payment obligations in exchange for equity securities of the ~~fiscal years~~ ~~ended~~Company ~~May 31~~and enter into warrant exchanges or modifications that may result in non-cash charges. Our ability to continue to fund operations will depend on our ability to raise additional funds. See the Risk Factors, ~~2024~~Liquidity and ~~2023~~Capital Resources and Going Concern sections in this prospectus.

~~Fluctuations in Operating Results~~39

~~The~~Results ~~Company’s operating results may fluctuate significantly depending on the outcomes, number and timing~~ of ~~pre-clinical~~operations and clinical studies, patient enrollment and/or completion rates in the studies, and their related effect on research and development expenses, regulatory and compliance activities, activities related to seeking FDA approval of our drug product, general and administrative expenses, professional fees, and legal and regulatory proceedings and related consequences. We require a significant amount of capital to continue to operate; therefore, we regularly conduct financing offerings to raise capital, which may result in various forms of non-cash interest expense or other expenses. Additionally, we periodically seek to negotiate settlement of debt payment obligations in exchange for ~~equity securities of~~ the ~~Company and enter into warrant exchanges or modifications that may result in non~~nine-~~cash~~month ~~charges.~~fiscal ~~Our~~periods ~~ability~~ended toFebruary ~~continue to fund operations will depend on our ability to raise additional funds. Refer to Risk Factors~~28, ~~Liquidity~~2026 and ~~Capital Resources, and Going Concern sections included in this prospectus.~~2025

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The results of operations were as follows for the periods presented:


	Nine months ended February 28,				Change
(in thousands, except for per share data)	2026		2025		$		%
Operating expenses:
General and administrative	$	5,166	$	5,423	$	(257)	(5)	%
Research and development		11,183		(20,150)		31,333	155
Legal settlement loss		16,587		—		16,587	100
Total operating expenses		32,936		(14,727)		47,663	324
Operating (loss) gain		(32,936)		14,727		(47,663)	(324)
Interest and other income (expense):
Interest income		166		441		(275)	(62)
Interest on convertible notes		(1,934)		(3,469)		1,535	44
Amortization of discount on convertible notes		—		(348)		348	100
Standby equity purchase agreement commitment fee		(325)		—		(325)	(100)
Issuance costs for private placement of shares and warrants through placement agent		(1,628)		—		(1,628)	(100)
Legal settlement revaluation		3,842		—		3,842	100
Loss on induced conversion		—		(1,180)		1,180	100
Finance charges		(22)		(25)		3	12
Gain on restructuring of payables		—		407		(407)	(100)
Loss on derivatives		—		(852)		852	100
Total interest and other expenses		99		(5,026)		5,125	102
(Loss) gain before income taxes		(32,837)		9,701		(42,538)	(438)
Income tax benefit		—		—		—	—
Net (loss) income	$	(32,837)	$	9,701	$	(42,538)	(438)	%
(Loss) income per share:
Basic	$	(0.03)	$	0.01	$	(0.04)	(400)	%
Diluted	$	(0.03)	$	0.01	$	(0.04)	(400)	%

Weighted average common shares used in calculation of (loss) income per share:
Basic		1,262,834		1,194,561		68,273	6	%
Diluted		1,262,834		1,225,538		37,296	3	%


	Years ended May 31,				Change
(in thousands, except for per share data)	2024		2023		$		%
Operating expenses:
General and administrative	$	10,789	$	17,136	$	(6,347)	(37)	%
Research and development		7,240		2,632		4,608	175
Depreciation		29		43		(14)	(33)
Amortization		—		132		(132)	(100)
Inventory charge		—		20,633		(20,633)	(100)
Total operating expenses		18,058		40,576		(22,518)	(55)
Operating loss		(18,058)		(40,576)		22,518	55
Interest and other expenses:
Interest on convertible notes		(4,659)		(4,624)		(35)	(1)
Amortization of discount on convertible notes		(1,076)		(2,126)		1,050	49
Amortization of debt issuance costs		(572)		(69)		(503)	(729)
Issuance costs for private placement of shares and warrants through placement agent		(2,819)		(9,678)		6,859	71
Loss on induced conversion		(6,680)		(5,312)		(1,368)	(26)
Finance charges		(2,367)		(8,689)		6,322	73
Loss on note extinguishment		(13,374)		—		(13,374)	(100)
Loss on derivatives		(236)		(8,750)		8,514	97
Total interest and other expenses		(31,783)		(39,248)		7,465	19
Loss before income taxes		(49,841)		(79,824)		29,983	38
Income tax benefit		—		—		—	—
Net loss	$	(49,841)	$	(79,824)	$	29,983	38	%
Basic and diluted:
Weighted average common shares outstanding		969,509		836,528		132,981	16
Loss per share	$	(0.05)	$	(0.10)	$	0.05	50	%

General and administrative (“G&A”) expenses

G&A expenses consisted of the following:


	Nine months ended February 28,				Change
(in thousands)	2026		2025		$		%
Salaries, benefits, and other compensation	$	1,571		1,139	$	432	38	%
Stock-based compensation		276		638		(362)	(57)
Legal fees		993		1,374		(381)	(28)
Insurance		824		944		(120)	(13)
Other		1,502		1,328		174	13
Total general and administrative	$	5,166	$	5,423	$	(257)	(5)	%

	Years ended May 31,				Change
(in thousands)	2024		2023		$		%
Salaries, benefits, and other compensation	$	2,507	$	4,114	$	(1,607)	(39)	%
Stock-based compensation		2,415		4,222		(1,807)	(43)
Legal fees		2,089		2,805		(716)	(26)
Insurance		1,850		2,399		(549)	(23)
Other		1,928		3,596		(1,668)	(46)
Total general and administrative	$	10,789	$	17,136	$	(6,347)	(37)	%

The decrease in G&A expenses for the nine-month period ended February 28, 2026, compared to the same period in the prior year, was primarily due to legal fees and stock-based compensation, offset by an increase in salaries, benefits, and other compensation. The decrease in legal fees is primarily attributable to decreased legal activity compared to the prior year. The decrease in stock-based compensation is primarily due to difference in timing of annual option grants. The increase in salaries, benefits, and other compensation is primarily attributable to headcount increases.

Research and development (“R&D”) expenses

R&D expenses consisted of the following:


	Nine months ended February 28,				Change
(in thousands)	2026		2025		$		%
Clinical	$	9,338	$	3,388	$	5,950	176	%
Non-clinical		741		700		41	6
CMC		1,227		957		270	28
License and patent fees		(123)		(210)		87	(41)
Return of clinical expenses		—		(24,985)		24,985	(100)
Total research and development	$	11,183	$	(20,150)	$	31,333	(155)	%

The ~~decreases~~primary factor contributing to the increase in GR&AD expenses ~~for~~in the ~~fiscal~~nine-month ~~year~~period ended ~~May~~February 3128, ~~2024,~~2026 compared to the ~~prior~~same ~~fiscal~~period ~~year, were primarily due to reductions~~ in ~~other,~~the ~~stock-based~~prior ~~compensation~~year, ~~salaries,~~was ~~benefits,~~a ~~and~~return ~~other~~of ~~compensation,~~clinical ~~and legal fees. The decrease in other~~ expenses ~~was~~related ~~primarily~~to the ~~result~~settlement of athe ~~reduction~~Company’s inlitigation ~~audit-related~~with ~~fees.~~Amarex ~~The decreases~~ in ~~stock~~the nine-~~based~~month ~~compensation~~period ~~and~~ended ~~salaries,~~February ~~benefits~~28, ~~and~~2025. ~~other~~Additionally, ~~compensation~~the ~~were~~increase ~~primarily~~in ~~related~~R&D toexpense ~~headcount reductions~~ in ~~an effort by~~ the ~~Company~~nine-month toperiod ~~preserve~~ended ~~cash~~February 28, ~~and~~2026, ~~align~~compared ~~resources~~to ~~with~~the ~~corporate~~same ~~priorities.~~period ~~The decrease~~ in ~~legal~~the ~~fees~~prior year, was ~~primarily~~ due to ~~decreased~~higher ~~fees~~clinical expenses related to the ~~SEC~~Phase ~~and~~2 ~~DOJ~~trial ~~investigations,~~of ~~offset~~leronlimab byin ~~less~~patients ~~fees~~with ~~covered~~relapsed/refractory bymicro-satellite ~~the~~stable ~~Company’s~~colorectal ~~insurance~~cancer ~~carrier(s)~~in ~~and increased fees related to~~ the ~~Amarex~~fiscal ~~litigation~~2026 period.

44The future trend of our R&D expenses is dependent on the costs of any future clinical trials and our decisions regarding which indications on which to focus our future efforts toward the development and study of leronlimab, which may include pre-clinical and clinical studies for oncology and inflammation, as well as efforts to develop a long-acting new or modified therapeutic, and the timing and outcomes of such efforts.

~~Table~~Interest ofand ~~Contents~~other income (expense)

Interest and other income (expense) consisted of the following:


	Nine months ended February 28,				Change
(in thousands)	2026		2025		$		%
Interest income	$	166		441	$	(275)	(62)	%
Interest on convertible notes		(1,934)	$	(3,469)		1,535	(44)
Amortization of discount on convertible notes		—		(348)		348	(100)
Standby equity purchase agreement commitment fee		(325)		—		(325)	100
Issuance costs for private placement of shares and warrants through placement agent (Note 5)		(1,628)		—		(1,628)	(100)
Legal settlement revaluation		3,842		—		3,842	100
Loss on induced conversion		—		(1,180)		1,180	(100)
Finance charges		(22)		(25)		3	(12)
Gain on restructuring of payables		—		407		(407)	(100)
Loss on derivatives		—		(852)		852	(100)
Total interest and other expenses	$	99	$	(5,026)	$	5,125	(102)	%

The decrease in interest and other expenses for the nine-month period ended February 28, 2026, compared with the same period in the prior year, was primarily due to the legal settlement revaluation, interest on convertible notes payable, loss on induced conversion, and loss on derivatives. The legal settlement revaluation is related to the change in value of the Securities Class Action settlement. The decrease in interest on convertible notes payable is due to a lower interest rate compared to the prior period. The decrease in loss on induced conversion is due to the note payments in the current fiscal year being exchanged with an equal value of shares of common stock. The decrease in loss on derivatives is due to no derivative activity in the fiscal 2026 period. The decrease in interest and other expenses for the nine-month period ended February 28, 2026 was partially offset by issuance costs related to the private placement of common stock and warrants through a placement agent.

Results of operations for the fiscal years ended May 31, 2025 and 2024

The results of operations were as follows for the periods presented:

	Years ended May 31,				Change
(in thousands, except for per share data)	2025		2024		$		%
Operating expenses:
General and administrative	$	7,260	$	10,818	$	(3,558)	(33)	%
Research and development		(16,921)		7,240		(24,161)	(334)
Total operating expenses		(9,661)		18,058		(27,719)	(153)
Operating gain (loss)		9,661		(18,058)		27,719	153
Interest and other income (expense):
Interest income		565		217		348	160
Interest on convertible notes		(4,424)		(4,659)		235	5
Amortization of discount on convertible notes		(407)		(1,076)		669	62
Amortization of debt issuance costs		—		(572)		572	100
Issuance costs for private placement of shares and warrants through placement agent		—		(2,819)		2,819	100
Loss on induced conversion		(1,180)		(6,680)		5,500	82
Finance charges		(25)		(2,584)		2,559	99
Loss on note extinguishment		—		(13,374)		13,374	100
Gain on restructuring of payables		407		—		407	100
Loss on derivatives		(852)		(236)		(616)	(261)
Total interest and other income (expense)		(5,916)		(31,783)		25,867	81
Gain (loss) before income taxes		3,745		(49,841)		53,586	108
Income tax benefit		—		—		—	—
Net income (loss)	$	3,745	$	(49,841)	$	53,586	108	%
Income (loss) per share:
Basic	$	0.00	$	(0.05)	$	0.05	104	%
Diluted	$	0.00	$	(0.05)	$	0.05	104	%

Weighted average common shares used in calculation of income (loss) per share:
Basic		1,205,755		969,509		236,246	24	%
Diluted		1,242,922		969,509		273,413	28	%

General and administrative (“G&A”) expenses

G&A expenses consisted of the following:

		Years ended May 31,				Change
(in thousands)		2025		2024		$		%
Salaries, benefits, and other compensation		$	1,554	$	2,507	$	(953)	(38)
Stock-based compensation			826		2,415		(1,589)	(66)
Legal fees			1,663		2,089		(426)	(20)
Insurance			1,239		1,850		(611)	(33)
Other			1,978		1,957		21	1
Total general and administrative		$	7,260	$	10,818	$	(3,558)	(33)

The decrease in G&A expenses for the fiscal year ended May 31, 2025, compared to the prior fiscal year, was primarily due to a reduction in stock-based compensation and salaries, benefits and other compensation due to classifying clinical employees’ compensation as a research and development expense in the current fiscal year.

Research and development expenses

R&D expenses consisted of the following:

	Years ended May 31,						Change
		Years ended May 31,						Change
(in thousands)	2025			2024			$			%
(in thousands)		2024			2023			$			%
Clinical	$	5,790		$	1,898		$	3,892		205	%
Clinical		$	1,898		$	(92)		$	1,990		(2,163)	%
Non-clinical		1,066			493			573		116
Non-clinical			493			136			357		263
CMC		1,091			3,867			(2,776)		(72)
CMC			3,867			1,687			2,180		129
License and patent fees		117			982			(865)		(88)
License and patent fees			982			901			81		9
Return of clinical expenses		(24,985)			—			(24,985)		—
Total research and development	$	$(16,921)	~~7,240~~	$	$7,240	~~2,632~~	$	$(24,161)	~~4,608~~	(334)	~~175~~%	%

The ~~increase~~decrease in R&D ~~expense~~expenses in the fiscal year ended May 31, ~~2024~~2025, compared to the prior fiscal year, was primarily ~~related~~due to ana ~~increase~~return inof ~~CMC and~~ clinical expenses. ~~The increase in CMC expenses primarily relate to storage costs~~ related to ~~inventory.~~the ~~The~~settlement ~~increase~~of inthe ~~clinical~~Company’s ~~expenses~~litigation ~~was~~with ~~primarily~~Amarex ~~related to a credit balance~~ in ~~the~~July ~~prior~~2024. ~~year~~Refer ~~due~~ to aNote ~~reduction in CRO costs for the Brazilian COVID-19 trials~~9, ~~resulting~~Commitments inand ~~vendor~~Contingencies ~~credits,~~– ~~and~~Legal ~~Brazilian~~Proceedings ~~COVID-19~~– ~~CRO~~Settlement ~~close-out~~of ~~costs~~Amarex ~~incurred~~Dispute in the ~~current~~consolidated ~~period,~~financial ~~offset~~statements byfor ~~decreases in costs related to~~ the ~~HIV~~year ~~program~~ended ~~partial~~May ~~clinical hold~~31, ~~and studies completed~~2025, ~~paused,~~included orin ~~closed~~this inprospectus ~~the~~for ~~prior~~further ~~year~~information.

The future trend of our R&D expenses is dependent on the costs of any future clinical trials, ~~our decision-making~~ and ~~timing~~our ofdecisions regarding which indications on which to focus our future efforts toward the development and study of leronlimab, which may include pre-clinical and clinical studies for oncology, ~~MASH~~ and ~~HIV related indications~~inflammation, as well as efforts to develop a long-acting new or modified therapeutic, the timing and outcomes of such efforts, and the timing of the final close-out of closed studies.

Inventory charge

The decrease in the inventory charge for the fiscal year ended May 31, 2024, compared to the prior fiscal year was attributable to the full inventory being written-off in the prior year because the pre-launch inventories no longer qualified for inventory capitalization following the withdrawal of the Company’s BLA submissions to the FDA. See Note 3, Inventories, net in the audited financial statements included in this prospectus for additional information.

Interest and other expense

Interest and other expenses consisted of the following:

	Years ended May 31,				Change
(in thousands)	~~2024~~2025		~~2023~~2024		$		%
Interest on convertible notes payable	$	(4,659)	$	(4,624)	$	(35)	1	%
Interest income		565		217		348	160
Amortization of discount on convertible notes		(1,076)		(2,126)		1,050	(49)
Interest on convertible notes	$	(4,424)	$	(4,659)	$	235	5	%
Amortization of debt issuance costs		(572)		(69)		(503)	729
Amortization of discount on convertible notes		(407)		(1,076)		669	62
Issuance costs for private placement of shares and warrants through placement agent		(2,819)		(9,678)		6,859	71
Amortization of debt issuance costs		—		(572)		572	100
Loss on induced conversion		(6,680)		(5,312)		(1,368)	26
Issuance costs for private placement of shares and warrants through placement agent		—		(2,819)		2,819	100
Finance charges		(2,367)		(8,689)		6,322	(73)
Loss on induced conversion		(1,180)		(6,680)		5,500	82
Loss on note extinguishment		(13,374)		—		(13,374)	(100)
Finance charges		(25)		(2,584)		2,559	99
Loss on derivatives		(236)		(8,750)		8,514	(97)
Loss on note extinguishment		—		(13,374)		13,374	100
Total interest and other expenses	$	(31,783)	$	(39,248)	$	7,465	(19)	%
Gain on restructuring of payables		407		—		407	100
Loss on derivatives		(852)		(236)		(616)	(261)
Total interest and other income (expense)	$	(5,916)	$	(31,783)	$	25,867	(81)	%

The decreases in interest and other expenses for the fiscal year ended May 31, 2024, compared to the same period in the prior fiscal year were primarily due to a decrease in non-cash loss on derivatives and finance charges and issuance costs for private placement of shares and warrants through a placement agent, partially offset by increases in loss on note extinguishment and loss on induced conversion. The decrease in loss on derivatives is due to the issuance of fewer liability-classified warrants in the current period. The decrease in issuance costs for private placement of shares and warrants through a placement agent is due to smaller PIPE transactions in the current fiscal year compared to the prior fiscal year. The increase in loss on note extinguishment resulted from the Company retiring outstanding convertible debt by converting notes outstanding to common stock and warrants, and due to the final closing price of the related private placements being lower than the initial closing price. The increase in loss on induced conversion

45The decrease in interest and other expenses for the fiscal year ended May 31, 2025, compared with the prior fiscal year, was primarily due to the decreases in loss on induced conversion, loss on note extinguishment and finance charges. The decrease in loss on induced conversion is due to recent note payments classified as gains on restructuring of payables. The decrease in loss on note extinguishment is due to note extinguishments occurring in the prior period. The decrease in finance charges is due to restructuring the balance due to Samsung, which removed any future interest.

~~Table~~Refer ofto ~~Contents~~Note 4, Convertible Instruments and Accrued Interest and Note 13, Subsequent Events in the consolidated financial statements for the year ended May 31, 2025, included in this prospectus for additional information.

resulted from the Company settling a larger balance of the outstanding convertible debt with common stock in the current fiscal year compared to the prior fiscal year.

Liquidity and Capital Resources

As of ~~May 31~~February 28, ~~2024~~2026, we had a total of approximately $315.17 million in cash and ~~$6.7 million in restricted~~ cash equivalents and approximately $8450.24 million in short-term liabilities ~~consisting primarily of approximately $45~~.0 million representing the principal of and accrued interest on convertible notes payable, net of unamortized debt discount, and approximately $32.4 million in accounts payable and accrued liabilities and compensation. We ~~will~~expect to continue to incur operating losses and ~~the Company will~~ require a significant amount of ~~additional~~ capital in the future as we continue to seek approval to commercialize leronlimab. ~~Despite~~There ~~the~~can ~~Company’s negative working capital position, vendor relations remain relatively accommodative given liquidity constraints. We cannot~~ be ~~certain,~~no ~~however,~~assurance that future funding will be available to us when needed on terms that are acceptable to us, or at all. We sell securities and incur debt when the terms of such ~~agreements~~arrangements are deemed ~~favorable~~acceptable to both parties under then current circumstances and as necessary to fund our current and projected cash needs. As

of February 28, 2026, we had approximately 312.8 million shares of common stock available for issuance in new financing transactions.

Since inception, the Company has financed its activities principally from the public and private sale of equity securities as well as with proceeds from issuances of convertible notes. The Company intends to finance its future operating activities and its working capital needs largely from the sale of equity and debt securities. The sale of equity and convertible debt securities to raise additional capital is likely to result in dilution to stockholders and those securities may have rights senior to those of common shares. If the Company raises funds through the issuance of additional preferred stock, convertible debt securities or other debt or equity financing, the related transaction documents may contain covenants restricting its operations.

During the 2021 fiscal year, the Company entered into long-term convertible notes that are secured by all of our assets (excluding our intellectual property), and include certain restrictive provisions, including limitations on incurring additional indebtedness and future dilutive issuances of securities, any of which could impair our ability to raise additional capital on acceptable terms.

On November 3, 2025, the Company entered into a Standby Equity Purchase Agreement (the “Purchase Agreement”) with YA II PN, Ltd., a Cayman Islands exempt limited partnership (“Yorkville”). From time to time during the term of the Purchase Agreement, the Company has the right to sell to Yorkville up to $30.0 million of the Company’s shares of common stock, subject to certain limitations and conditions set forth in the Purchase Agreement.

Future third-party funding arrangements may also require the Company to relinquish valuable rights. Additional capital, if available, may not be available on reasonable or non-dilutive terms.

Cash

The Company’s cash and ~~restricted~~ cash equivalents position of approximately $315.~~1 million and $6.~~7 million, ~~respectively,~~ as of ~~May 31~~February 28, ~~2024~~2026, increased by approximately $03.68 million ~~and~~when ~~increased~~compared byto ~~approximately~~the balance of $011.29 million, ~~respectively~~as of May 31, ~~when~~2025. ~~compared~~This toincrease was primarily the ~~balance~~result of approximately $216.51 million ~~and~~cash $6provided by financing activities offset by operational expenses.5 ~~million,~~Refer ~~respectively~~to Note 2, asSummary of ~~May~~Significant 31Accounting Policies – Going Concern in the consolidated financial statements for the quarter ended February 28, ~~2023~~2026, and the Going Concern discussion below for information regarding concerns about the Company’s ability to continue to fund its operations and satisfy its payment obligations and commitments. A summary of cash flows and changes between the periods presented is as follows:


	Nine months ended February 28,						Change
(in thousands)	2026			2025			$
Net cash (used in) provided by:
Net cash (used in) provided by operating activities	$	(12,319)		$	(3,102)		$	(9,217)
Net cash (used in) provided by financing activities	$	16,071		$	9,688		$	6,383

A summary of cash flows and changes between the periods presented is as follows:

	Years ended May 31,				Change
(in thousands)	2024		2023		$
Net cash (used in) provided by:
Net cash used in operating activities	$	(10,982)	$	(25,110)	$	14,128
Net cash provided by/ used in investing activities	$	—	$	—	$	—
Net cash provided by financing activities	$	11,748	$	29,927	$	(18,179)

Cash used in operating activities

Net cash used in operating activities totaled approximately $1112.03 million during the ~~fiscal~~nine ~~year~~months ended ~~May 31~~February 28, ~~2024~~2026, representing an ~~improvement~~increase of approximately $149.12 million compared to the ~~prior~~nine ~~year~~months ended February 28, 2025. The ~~decrease~~increase in the net amount of cash used ~~was~~in ~~primarily~~operating ~~attributable~~activities towas ~~decreased~~due ~~G&A,~~primarily ~~and working capital fluctuations, all of which are highly variable, and which led~~ to a ~~significant~~one-time ~~decrease~~legal insettlement ~~our~~of ~~net~~approximately ~~loss~~$10.0 ~~Refer~~million toin ~~General~~the ~~and~~prior ~~administrative above for further discussion~~period.

Cash ~~provided~~used byin financing activities

Net cash ~~provided~~used byin financing activities totaled approximately $1116.71 million during the nine months ended February 28, a2026, ~~decrease~~an increase of approximately $186.24 million compared to the ~~prior~~nine ~~year~~months ended February 28, 2025. The ~~decrease~~increase in net cash provided was primarily the result of ~~raising~~the ~~less funds from~~ private ~~placements~~sale of common stock and warrants~~, and a decrease in cash received from warrant transactions and exercises~~.

~~Pre-launch inventories~~

The Company previously capitalized pre-launch inventories which were subsequently charged-off in October 2022 for GAAP accounting purposes due to no longer qualifying for pre-launch inventory capitalization resulting from the withdrawal of the BLA submission. Work-in-progress and finished drug product inventories continue to be physically maintained, can be used for clinical trials, and can be sold commercially upon regulatory approval if the shelf-lives can be extended as a result of the performance of on-going stability tests. Raw materials continued to be maintained so that they can be used in the future if needed.44

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Convertible debt

April 2, 2021 Convertible Note

On April 2, 2021, we issued a convertible note with a principal amount of $28.5 million, resulting in net cash proceeds of $25.0 million, after $3.4 million of debt discount and $0.1 million of offering costs. ~~The~~At ~~note~~February ~~accrues~~28. 2026, the Note terms provided for accruing interest daily at a rate of 106% per annum, ~~contains~~ a stated conversion price of $10.00 per share, and ~~matures~~maturity in April ~~2025~~ 2026. ~~The~~Subsequent ~~April 2,~~to ~~2021~~February ~~Note required monthly~~28, ~~debt~~2026, ~~reduction~~the ~~payments~~Company ofand ~~$7.5~~the ~~million~~Noteholders ~~for~~entered ~~the~~into ~~six months~~an ~~beginning~~amendment into ~~May 2021~~the Note, ~~which~~extending ~~could~~the ~~also~~maturity bedate ~~satisfied~~ by ~~payments~~36 onmonths, ~~other~~changing ~~notes~~the ~~held~~required bymonthly payment, and lowering the ~~noteholder~~interest orrate ~~its~~to ~~affiliates~~5%. ~~Beginning~~For ~~six months~~more ~~after~~information, ~~the~~see ~~issuance~~Note ~~date~~12, Subsequent Events in the ~~noteholder~~consolidated ~~may~~financial ~~request monthly~~statements ~~redemptions~~for ofthe upquarter toended ~~$3.5~~February ~~million~~28, 2026. As of ~~May 31~~February 28, ~~2024~~2026, the outstanding balance of the April 2, 2021 Note, including accrued interest, was approximately $78.56 million.

April 23, 2021 Convertible Note

On April 23, 2021, we issued a convertible note with a principal amount of $28.5 million, resulting in net cash proceeds of $25.0 million, after $3.4 million of debt discount and $0.1 million of offering costs. ~~The~~At ~~note~~February ~~accrues~~28. 2026, the Note terms provided for accruing interest daily at a rate of 106% per annum, ~~contains~~ a stated conversion price of $10.00 per share, and ~~matures~~maturity in April ~~2025~~ 2026. ~~Beginning~~Subsequent ~~six~~to February 28, 2026, the Company and the Noteholders entered into ~~months~~an amendment ~~after~~to the ~~issuance~~Note, extending the maturity date by 36 months, changing the ~~noteholder~~required ~~may~~monthly ~~request~~payment, ~~monthly~~and ~~redemptions~~lowering the ofinterest uprate to $75%.0 ~~million~~For more information, see Note 12, Subsequent Events in the consolidated financial statements for the quarter ended February 28, 2026, included in this prospectus. As of ~~May 31~~February 28, ~~2024~~2026, the outstanding balance of the April 23, 2021 Note, including accrued interest, was approximately $3831.9 million. In March 2026, in satisfaction of the required monthly payment, the Company and the Noteholder of the April 23, 2021 Note entered into an exchange agreement, pursuant to which a portion of the April 23, 2021 Note was partitioned into a new note with an aggregate principal amount of approximately $0.8 million. The new note was exchanged concurrently for approximately 2.7 million shares. Refer to Note 12. Subsequent Events in the consolidated financial statements for the quarter ended February 28, 2026, included in this prospectus for additional information.

Common stock

We have 12,~~750~~250.0 million authorized shares of common stock. The table below summarizes intended uses of common stock.

	As of	~~As of~~
(in millions)	February 28, 2026	~~May 31, 2024~~
Issuable upon:
Warrant exercises	300.2	~~361.4~~
Convertible preferred stock and undeclared dividends conversion	42.2	~~37.0~~
Outstanding stock option exercises		25.8
Outstanding stock option exercises or vesting of outstanding PSUs	41.7
Reserved for issuance pursuant to future stock-based awards under equity incentive plan	18.6	~~12.5~~
Reserved and issuable upon conversion of outstanding convertible notes		12.0
Reserved for issuance under Standby Equity Purchase Agreement	115.5
Total shares reserved for future uses		448.7
Reserved for issuance pursuant to legal settlement, subject to court approval	49.0
Common stock outstanding		1,058.6
Reserved and issuable upon conversion of outstanding convertible notes	12.0
Total shares reserved for future uses	579.2
Common stock outstanding	1,358.0

As ~~a result, as~~ of ~~May~~February 3128, ~~2024~~2026, we had approximately ~~242~~312.7 8 million unreserved authorized shares of common stock available for issuance. Our ability to continue to fund our operations depends on our ability to raise capital. The funding necessary for our operations may not be available on acceptable terms, or at all. If we deplete our cash reserves, we may have to discontinue our operations and liquidate our assets. In extreme cases, we could be forced to file for bankruptcy protection~~, discontinue operations or liquidate assets~~.

Off-Balance Sheet Arrangements

As of ~~May 31~~February 28, ~~2024~~2026, we did not have any off-balance sheet arrangements that have, or are reasonably likely to have, a material effect on our current or future financial condition, results of operations, liquidity, capital expenditures, or capital resources.

Contractual Obligations

Refer to Note 5 3, Accrued Liabilities and Compensation, Note 4, Convertible Instruments and Accrued Interest, and Note 10, Commitments and Contingencies included in the consolidated financial statements for the quarter ended February 28, 2026 included in this prospectus, and Notes 4 and 9 of the audited financial statements for the year ended May 31, 2025 included in this prospectus.

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Legal Proceedings

The Company is a party to various legal proceedings described in Note 10, Commitments and Contingencies – Legal Proceedings, of the ~~audited~~consolidated financial statements for the quarter ended February 28, 2026 included in this prospectus. The Company recognizes accruals for such proceedings to the extent a loss is determined to be both probable and reasonably ~~estimated~~estimable. The best estimate of a loss within a possible range is accrued; however, if no estimate in the range is more probable than another, then the minimum amount in the range is accrued. If it is determined that a material loss is not probable but reasonably possible and the loss or range of loss can be estimated, the possible loss is disclosed.

It generally is not possible to ~~determine~~predict the outcome of these proceedings, including the defense and other litigation-related costs and expenses that may be incurred by the Company, as the outcomes of legal proceedings are inherently uncertain, and the outcomes could differ significantly from recognized accruals. Therefore, it is possible that the ultimate outcome of any proceeding, if in excess of a recognized accrual, or if ~~no accrual has been made~~any, could be material to the Company’s consolidated financial statements. As of February 28, 2026, the Company had not recorded any accruals related to the outcomes of the legal matters discussed in this prospectus, other than approximately $12.7 million in connection with an agreement in principle to settle the Securities Class Action, as discussed above under “Corporate Developments.”

Going Concern

The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As presented in the accompanying consolidated financial statements, the Company had losses for all periods presented., ~~The~~except ~~Company~~for ~~incurred~~the anine ~~net~~months ~~loss~~ended February 28, 2025. Net income of $499.87 million ~~for~~in the ~~fiscal~~nine ~~year~~months ended ~~May 31~~February 28, ~~2024~~2025, ~~and~~resulted from the recovery of approximately $25.0 million in clinical expenses due to the settlement of the Company’s litigation with Amarex, which is a non-recurring event. The Company had an accumulated deficit of approximately $~~891~~920.56 million as of ~~May~~February 3128, ~~2024~~2026. These factors, among several others, raise substantial doubt about our ability to continue as a going concern. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of assets and liabilities that might be necessary should the Company be unable to continue as a going concern.

The Company ~~had no activities that produced revenue in the periods presented and has operated at a loss since inception. The Company~~’s ~~continuation~~continuance as a going concern is dependent upon its ability to obtain ~~a significant amount of~~ additional operating capital ~~to continue to fund operations and pay its liabilities and commitments~~, ~~its~~complete ~~research~~the ~~into multiple indications for and~~ development of its product candidate, toleronlimab, obtain ~~FDA~~ approval ofto ~~its~~commercialize ~~product~~leronlimab ~~candidate~~from ~~for~~regulatory ~~use in treating one or more indications~~agencies, continue to outsource manufacturing of ~~its product~~leronlimab, and ultimately toachieve revenues and attain profitability. WeThe ~~intend~~Company plans to ~~seek~~continue ~~additional~~to ~~funding~~engage ~~through~~in ~~equity~~research ~~or debt offerings, licensing agreements, supply~~ and ~~distribution~~development ~~agreements,~~activities ~~and~~related ~~strategic alliances~~ to ~~implement~~leronlimab ~~our~~and ~~business~~a ~~plan.~~new ~~There~~or ~~are~~modified nolonger-acting ~~assurances,~~therapeutic ~~however,~~and ~~that~~expects ~~we will be successful in these endeavors. If we are not able~~ to ~~raise~~incur ~~capital~~significant onresearch aand ~~timely~~development ~~basis~~expenses onin ~~favorable~~the ~~terms~~future, ifprimarily atrelated ~~all, we may need~~ to ~~significantly~~its ~~change~~regulatory ~~or scale back operations~~compliance, including ~~pursuing~~performing ~~other~~additional ~~development~~clinical ~~and~~trials ~~commercialization initiatives,~~ and ~~obtaining~~seeking ~~adequate~~regulatory ~~funding~~approval toof ~~cover~~its ~~the~~product ~~costs~~candidate offor ~~the~~commercialization. ~~legal~~These ~~proceedings~~research inand ~~which~~development weactivities are ~~involved,~~subject ~~all~~to ofsignificant ~~which~~risks ~~individually~~and oruncertainties. inThe ~~combination~~Company ~~could~~intends ~~materially impede our ability~~ to ~~achieve~~finance ~~profitability.~~its ~~The~~future ~~Company’s~~development ~~failure~~activities toand ~~raise~~its ~~additional~~working capital ~~could~~needs ~~also~~primarily ~~affect~~from ~~our~~the ~~relationships~~sale ~~with~~of ~~key~~equity ~~vendors~~ and ~~disrupt~~debt ~~our~~securities, ~~ability~~combined towith ~~timely~~additional ~~execute~~funding ~~our~~from ~~business~~other ~~plan~~sources. InHowever, ~~extreme~~there ~~cases,~~can be no assurance that the Company ~~could~~will be ~~forced~~successful toin ~~file~~these ~~for~~endeavors. ~~bankruptcy~~See ~~protection,~~also ~~discontinue~~Liquidity ~~operations,~~and orCapital ~~liquidate~~Resources ~~assets~~above.

~~Since~~Refer inception, the Company has financed its activities principally from the public and private sale of equity securities, as well as with proceeds from issuance of convertible notes and related party notes payable. The Company intends to ~~finance~~Risk ~~its~~Factors ~~future~~on ~~development~~page ~~activities~~9 ~~and its working capital needs primarily from the sale~~ of ~~equity~~this ~~and~~prospectus ~~debt securities. As of July 31, 2024, the Company had only approximately 202.2 million shares of common stock, authorized~~ for ~~issuance under its certificate of incorporation, as amended, and available for future uses. The sale of equity and convertible debt securities to raise~~ additional ~~capital is likely to result in dilution to stockholders and those securities may have rights senior to the common stock~~information. If the Company raises funds through the issuance of additional preferred stock, convertible debt securities, or other debt or equity financing, the related transaction documents could contain covenants restricting its operations.

In April 2021, the Company entered into long-term convertible notes that are secured by all of our assets (excluding our intellectual property), and include certain restrictive provisions, including limitations on incurring additional indebtedness and future dilutive issuances of securities, any of which could impair our ability to raise additional capital on acceptable terms. Future third-party funding arrangements may also require the Company to relinquish valuable rights. Additional capital, if available, may not be available on reasonable or non-dilutive terms.

Refer to Risk Factors in this prospectus for additional information.

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New Accounting Pronouncements

See Note 2, Summary of Significant Accounting Policies – Recent Accounting Pronouncements of the ~~audited~~consolidated financial statements for the quarter ended February 28, 2026, included in this prospectus.

Critical Accounting Estimates

We prepare our consolidated financial statements in accordance with U.S. generally accepted accounting principles, which require our management to make estimates that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the balance sheet dates, as well as the reported amounts of revenues and expenses during the reporting periods. To the extent that there are material differences between these estimates and actual results, our financial condition or results of operations would be affected. We base our estimates on our own historical experience and other assumptions that we believe are reasonable after taking account of our circumstances and expectations for the future based on available information. We evaluate these estimates on an ongoing basis.

We consider an accounting estimate to be critical if: (i) the accounting estimate requires us to make assumptions about matters that were highly uncertain at the time the accounting estimate was made, and (ii) changes in the estimate that are reasonably likely to occur from period to period or use of different estimates that we reasonably could have used in the current period, would have a material impact on our financial condition or results of operations. There are items within our financial statements that require estimation but are not deemed critical, as defined above.Click or tap here to enter text.

Table of Contents

MANAGEMENT

Members of Our Board of Directors

The following table sets forth information about our current directors, including their current principal occupation or employment and age as of ~~August~~April 3115, ~~2024~~2026:

Board committees

Director name

 

Age

 

Principal occupation

 

Independent

 

Audit

 

Compensation

 

Nom/Gov

Tanya D. Urbach, Board Chair

Partner, Eagle Bay Advisors

Yes

Lishomwa C. Ndhlovu, M.D., Ph.D.

Professor, Immunology in Medicine and Neuroscience, Weill Cornell Medicine

Yes

Karen J. Brunke, Ph.D.

Executive Vice President, Corporate and Business Development, Jaguar Health, Inc. (NASDAQ: JAGX)

Yes

Ryan M. Dunlap

Chief Financial Officer, Gurobi Optimization

Yes

Stephen M. Simes

Independent advisor to companies and organizations in the pharmaceutical industry

Yes

Board committees

Director name

Age

Principal occupation

Independent

Audit

Compensation

Nom/Gov

Tanya D. Urbach, Board Chair

Partner, Eagle Bay Advisors

Yes

Lishomwa C. Ndhlovu, M.D., Ph.D.

Professor, Immunology in Medicine and Neuroscience, Weill Cornell Medicine

Yes

Karen J. Brunke, Ph.D.

Executive Vice President, Corporate and Business Development, Jaguar Health, Inc. (NASDAQ: JAGX)

Yes

Ryan M. Dunlap

Chief Financial Officer, Gurobi Optimization

Yes

Stephen M. Simes

Independent advisor to companies and organizations in the pharmaceutical industry

Yes

C	indicates chair of respective board committee.

M	indicates member of respective board committee.

Tanya D. Urbach. Ms. Urbach has been a director since November  24,  2021, and has served as our Board Chair since January  24, 2022. She is currently Partner/Co-Head of Family Office Services for Eagle Bay Family Office, which provides family office and investment advisory services. ~~to ultra-high net worth clients~~Ms. ~~Tanya~~ Urbach also provides corporate governance, ~~and~~ corporate finance and legal advice to Dynepic,  Inc., which provides an integrated platform to power immersive training programs for companies and U.S. military forces. From November  2020 through March  31, 2021, Ms.  Urbach was a sole practitioner advising broker-dealers, investment advisers and their professionals. From January  2019 through October  2020, she was a shareholder at the law firm Markun, Zusman, Freniere  & Compton in Portland, Oregon. She served as General Counsel for Paulson Investment Company, LLC, a registered broker-dealer that provides investment banking services to the Company from time to time, from July  2015 until January  2019, providing advice regarding corporate governance, securities regulatory compliance, corporate finance, and other legal and securities-related issues. Ms.  Urbach earned her bachelor’s degree at ~~the Clark Honors College at the~~ University of Oregon and her law degree at Lewis  & Clark Law School. She served on the Executive Committee of the Oregon State Bar Securities Regulation Section  from 2007 through 2015 and 2019 to 2021. She brings extensive training and expertise in the conduct of securities offerings, securities litigation, corporate finance and business growth, corporate governance, and other corporate business and legal issues to the Board.

Lishomwa C. Ndhlovu, M.D., Ph.D. Dr. Ndhlovu has been a director since November 24, 2021, and previously served on the Company’s Scientific Advisory Board. ~~Appointed~~He was appointed to Weill Cornell Medicine in 2019, heas ~~is the Herbert J. and Ann L. Siegel Distinguished~~ Professor of ~~Medicine~~Immunology in ~~the~~Medicine ~~Division~~and ofNeuroscience ~~Infectious Diseases~~ and ~~holds~~is athe ~~secondary~~Herbert ~~appointment~~J. asand aAnn ~~tenured~~L. ~~Professor~~Siegel ofEndowed ~~Immunology~~Distinguished ~~in Neuroscience at the Feil Family Brain and Mind Institute~~Professor. Before joining Weill Cornell Medicine, Dr. Ndhlovu was on the faculty at the University of Hawaii and University of California San Francisco from 2010 to 2019. As co-leader of the $26.5 million NIH-supported Martin Delaney Collaboratory, “HOPE”, testing novel ~~retroviral silencing and gene editing~~ approaches towards an HIV cure, ~~and~~ the $11 million ~~NIH- funded~~ “SCORCH” consortium, investigating how substances that can lead to addition modify effects of HIV in the brain, and awarded an NIH MERIT award with $8 million to investigate mechanisms by which stem cell transplantation leads to HIV cure and how to translate these insights into broadly applicable immunotherapies, he is a recognized expert in basic and complex translational immunology and engineered immunotherapy research. He has focused much of his work on confronting the challenges of HIV and aging, addressing molecular mechanism of HIV pathogenesis, complications, and persistence. Dr. Ndhlovu received his M.D. from the University of Zambia and his Ph.D. from Tohoku University in Japan and is an elected Fellow of the American Academy of Microbiology, ~~Chair~~member of the American ~~foundation~~Association ~~for~~of ~~AIDS~~Physicians, ~~(amfAR)~~Chair ~~Research~~of ~~Scientific~~The ~~Advisory~~Foundation ~~Committee~~for ~~and~~AIDS ~~California~~Research ~~HIV~~(amfAR) Research ~~Program~~Council, and ~~member~~Chair onof the ~~NIH/NIAID~~Advisory ~~Office~~Board of ~~AIDS~~Ledidi ~~Research Advisory Committee~~AS. He brings a deep understanding of the ~~complications~~central ~~associated~~nervous ~~with~~system aspects of HIV and research expertise in major arenas in which the Company is studying its drug product to the Board.

50Karen J. Brunke, Ph.D. Dr. Brunke was appointed as a director as of April 1, 2022. Dr. Brunke has over 30 years of scientific, operational, clinical, senior executive, and corporate/business development managerial experience with large and small biotechnology companies. She is currently the Executive Vice President of Corporate and Business Development at Jaguar Health, Inc. (JAGX), a position she has held since September 2021, following seven months as an independent consultant to Jaguar. Jaguar is a commercial

~~Table of Contents~~48

Karen J. Brunke, Ph.D. Dr. Brunke was appointed as a director effective April 1, 2022. Dr. Brunke has over 30 years of scientific, operational, clinical, senior executive, and corporate/business development managerial experience with large and small biotechnology companies. She is currently the Executive Vice President of Corporate and Business Development at Jaguar Health, Inc. (JAGX), a position she has held since September 2021, following seven months as an independent consultant to Jaguar. Jaguar is a commercial stage pharmaceuticals company focused on developing novel, sustainably derived gastrointestinal products on a global basis. AsSince of January 2023, Dr. Brunke has also ~~serves~~served as acting CEO of Magdalena Biosciences, Inc., a joint venture of Jaguar and Filament Health Corp ~~(FH.NE and FLHLF)~~ funded by OneSmallPlanet. During her career, Dr. Brunke has been a business development and strategy consultant to multiple companies and was instrumental in the initiation of several startup companies, including during the period from 2017 through 2020. Dr. Brunke was part of the executive team that merged Mercator Genetics Inc. with Progenitor, a subsidiary of Interneuron Pharmaceuticals, in 1999 and helped take the resulting company public. Dr. Brunke was Chief Operating Officer of Anexus Pharmaceuticals, a subsidiary of the Japanese public company MediBic, responsible for in- and out-licensing assistance for Japanese companies, from 2004 through June 2006, and was founding Chief Executive Officer of Cardeus Pharmaceuticals, a neuroscience company, from 2011 through March 2014. Dr. Brunke received her BAB.A. in Biochemistry as well as a Ph.D. in Microbiology from the University of Pennsylvania. Her many years of service in executive management, business development, operations, and corporate development roles at biotechnology companies isare of valuable assistance to the Board.

Ryan M. Dunlap. Mr. Dunlap was appointed as a director effective August 24, 2022. Mr. Dunlap has over 27 28 years’ experience in finance and operations leadership, developing significant expertise in strategy setting, improving operational efficiency and effectiveness, fundraising and investor relations, financial reporting and compliance, and risk management. Mr. Dunlap joined Gurobi Optimization, a company that offers customers a mathematical optimization solver to address business problems, in October 2019. Prior to that, he was CFO beginning in January 2016, as well as COO beginning in December 2017, at MolecularMD (now ICON Specialty Labs), a growth equity-backed molecular diagnostics company. Mr. Dunlap also previously served as the CFO of Galena Biopharma, Inc., a publicly traded biotechnology and pharmaceutical sales company. Earlier in his career, Mr. Dunlap held various financial and operational leadership roles in large, multinational organizations, and spent 11 years with public accounting firms such as PricewaterhouseCoopers LLP (“PwC”), KPMG, and Moss Adams, where he provided business assurance and advisory services to both public and private companies predominately in the software, technology, and life sciences industries. Mr. Dunlap earned a B.S. degree in Accounting from the University of Oregon and is an active licensed CPA in the state of Oregon. His expertise as an “audit committee financial expert,” particularly in matters faced by the audit committee of a biotechnology company, as well as his significant experience in executive management, finance, operations, and strategic planning, is of valuable assistance to the Board.

Stephen M. Simes. Mr. Simes was appointed as a director effective October 13, 2022. Mr. Simes brings extensive experience to our Board through his service as CEO or a director of a number of pharmaceutical companies, both public and private. His career in the pharmaceutical industry started over 40 years ago with G.D. Searle & Co. (now a part of Pfizer Inc.). He has been an independent advisor to companies and organizations in the pharmaceutical industry since 2016 and is currently Entrepreneur in Residence at Helix 51 and the Innovation and Research Park of Rosalind Franklin University of Medicine and Science in North Chicago, Illinois. Mr. Simes also serves as a director of BioLife4D Corporation, a private company developing a patient-specific, fully functioning human heart using 3D bioprinting and the patient’s own cells ~~and currently preparing for an IPO~~. HeMr. Simes is also chairman of the board of Bio-XL Limited, an Israeli company developing products in oncology. Mr. Simes was the CEO of RestorGenex Corporation from 2014 to 2016, when it was acquired by Diffusion Pharmaceuticals. From 1998 to 2013, Mr. Simes was the President and CEO of BioSante Pharmaceuticals, which was acquired by ANI Pharmaceuticals Inc. in June 2013. He previously served on the boards of directors of Therapix Biosciences (2016 - 2020), RestorGenex Corporation (2014 - 2016), Ceregene, Inc. (2009 - 2013), BioSante Pharmaceuticals (1998 - 2013), Unimed Pharmaceuticals, Inc. (1994 - 1997), Bio-Technology General (1993 - 1995), and Gynex Pharmaceuticals, Inc. (1989 - 1993). HeStephen has a ~~BSc~~B.S. in Chemistry from Brooklyn College of the City University of New York and an MBA from New York University. ~~Mr.~~ Simes brings substantial biotech experience to the board, including in the realms of corporate governance, executive management, operations, business development, drug development and capital markets. He also has substantial experience serving on boards of both privately owned and publicly traded entities.

Director Independence

We are not a “listed issuer” as that term is used in Regulation S-K Item 407 adopted by the SEC. However, in determining director independence, we use the definition of independence in Rule 5605(a)(2) and Rule 5605(c)(2) of the listing rules of The Nasdaq Stock Market (the “Nasdaq Rules”).

51The Board has determined that all of our current directors, Ms. Urbach, Drs. Brunke and Ndhlovu, and Messrs. Dunlap and Simes, are independent as defined in the Nasdaq Rules and none of them otherwise has a relationship that, in the opinion of the Board, would interfere with their exercise of independent judgment in carrying out the responsibilities of a director. See also “Related Person Transactions” below.

~~Table~~Dr. Ndhlovu served on the Company’s Scientific Advisory Board for a period of ~~Contents~~time. As compensation for that service, Dr. Ndhlovu was granted an option to purchase 50,000 shares of common stock with an exercise price of $3.36 per share that will

The Board has determined that all of our current directors are independent as defined in the Nasdaq Rules, including for purposes of membership on the Board’s Audit, Compensation, and Nominating and Corporate Governance Committees, and that none of them otherwise has a relationship that, in the opinion of the Board, would interfere with their exercise of independent judgment in carrying out the responsibilities of a director. See also “Principal Relationships and Related Person Transactions” below.49

expire on August 31, 2030, and an option to purchase an additional 50,000 shares of common stock with an exercise price of $0.50 per share that will expire on September 6, 2032. The awards were not subject to disclosure under Regulation S-K Item 404(a), but the Board took them into consideration in determining that Dr. Ndhlovu is independent under the Nasdaq Rules.

Executive Officers

Information about our current executive officers is set forth below:


Name	Age	Position
Name	Age	Position
Dr. Jacob P. Lalezari	66	Chief Executive Officer
Jacob P. Lalezari, M.D.	65	Chief Executive Officer
Robert E. Hoffman	60	Chief Financial Officer
Mitchell Cohen	68	Interim Chief Financial Officer
Tyler Blok	38	Chief Legal Officer and Corporate Secretary
Tyler Blok	37	Corporate Secretary, and Executive Vice President of Legal Affairs

Dr. Jacob P. Lalezari. Dr. Lalezari has served as the Company’s Chief Executive Officer and principal executive officer since January 26, 2024, after previously serving as the Company’s Interim CEO beginning November 17, 2023. Dr. Lalezari is currently the CEO and Medical Director of Lalezari Medical Corp., dba Quest Clinical Research (“Quest”), a company he founded in 1989. Dr. Lalezari has also served as a board member and Medical Director of Siempre Unidos, a nonprofit that operates HIV and primary care treatment clinics in Honduras, since 2006, the Chief Medical Officer of Virion Therapeutics, LLC, in 2018, and a board member and the Vice President of NP2, a non-profit pharmaceutical company, since 2018. He previously served as CytoDyn’s interim Chief Medical Officer and/or Chief Science Advisor from March 2020 to November 2020. Dr. Lalezari received his M.D. from the University of Pennsylvania, his M.A. from the University of Virginia, and his B.A. from the University of Rochester. He also holds a board certification from the American Board of Internal Medicine.

~~Mitchell~~Robert ~~Cohen~~E. Hoffman. Mr. ~~Cohen~~Hoffman has ~~been~~more ~~engaged~~than as30 anyears ~~independent~~of ~~contractor~~financial, byoperations ~~InterimExecs~~and ~~since~~general ~~January~~business ~~2024.~~experience, Heserving ~~has~~in ~~served~~a asnumber ~~the~~of ~~Company’s~~biotech ~~interim~~executive ~~Chief~~and ~~Financial~~board ~~Officer~~roles. ~~since~~From ~~February~~November 1,2021 to October 2024, ~~pursuant~~Mr. toHoffman anserved ~~agreement~~as ~~between~~President, ~~the~~CEO, ~~Company~~interim ~~and~~Chief ~~InterimExecs.~~Financial HeOfficer ~~has~~and ~~more~~Chairperson ~~than~~of 30the ~~years~~board of ~~financial,~~directors ~~operations~~of ~~and~~Kintara ~~general~~Therapeutics, ~~business~~Inc., ~~experience~~a asclinical astage ~~senior~~biopharmaceutical ~~executive~~company ofpreviously ~~both~~listed ~~public~~on Nasdaq and ~~private~~focused ~~companies.~~on ~~During~~ the ~~six~~development ~~years~~and ~~preceding~~commercialization ~~2024,~~of ~~Mr.~~new ~~Cohen~~cancer ~~provided~~therapies. ~~financial~~Mr. ~~consulting~~Hoffman ~~and~~previously ~~chief~~served ~~financial~~as ~~officer~~Senior ~~services~~Vice toPresident ~~a variety of public~~ and ~~private~~Chief ~~companies~~Financial ~~through~~Officer ~~MMC~~of ~~Ventures,~~Heron ~~LLC~~Therapeutics, ~~Business~~Inc. ~~Talent~~(Nasdaq: ~~Group and~~HRTX), ~~beginning~~a incommercial-stage ~~April~~biotechnology ~~2022~~company, ~~Randstad~~from ~~Professionals~~April ~~US,~~2017 ~~LLC. Through~~to ~~those~~October ~~consulting~~2020; ~~firms,~~and ~~he served~~ as ~~interim~~Chief ~~chief~~Financial ~~financial~~Officer ~~officer~~ of ~~Blue Apron Holdings~~AnaptysBio, Inc. (Nasdaq: ANAB), a ~~distributor~~specialty ofpharmaceutical ~~prepared meals~~company, from ~~October~~July ~~2022~~2015 to ~~November~~September ~~2023;~~2016. ~~Redbox Entertainment Inc~~Mr., anHoffman ~~entertainment~~is ~~and~~currently ~~software~~a ~~company,~~member ~~from~~of ~~May~~the ~~through~~boards ~~August~~of ~~2022;~~directors ~~and~~of ~~Cerence~~Esperion Therapeutics, Inc. (Nasdaq: ESPR), a ~~software~~commercial stage biopharmaceutical company; TuHURA Biosciences (Nasdaq: HURA), ~~from~~a ~~February~~clinical ~~through~~stage ~~April~~immuno-oncology ~~2022;~~company ~~and~~that ~~served~~acquired asKintara ~~chief~~Therapeutics ~~financial~~in ~~officer~~October of2024; ~~Bolt~~and ~~Mobility~~Fibrobiologics, aInc. ~~startup~~(Nasdaq: ~~micro~~FBLG), ~~mobility~~a ~~company,~~clinical ~~from~~stage ~~March~~company ~~2021~~focused toon ~~January~~treating ~~2022~~chronic diseases. Mr. ~~Cohen~~Hoffman ~~earned~~holds ~~his~~a ~~bachelor’s~~B.B.A. ~~degree in economics~~ from ~~Queens~~St. ~~College~~Bonaventure University.

Tyler Blok. Mr. Blok has served as the Company’s in-house legal counsel since July 25, 2022, ~~and~~ was appointed by the Board as Executive Vice President of Legal Affairs effective August 15, 2023, and later Chief Legal Officer effective September 27, 2024. Prior to joining the Company, Mr. Blok was an attorney at Buckley Law P.C., from 2021 to 2022, working in the firm’s business and transactional practice group, representing corporate clients in the mergers and acquisitions process, and advising business clients in relation to corporate governance matters. From 2013 to 2021, Mr. Blok worked at Markun Zusman Freniere & Compton LLP as both a law clerk and an attorney, later associating with TT&E Law Group LLP (2020 - 2021), where he represented various corporate clients in arbitration matters, complex commercial disputes, securities litigation, and regulatory examination and enforcement matters. Mr. Blok earned his bachelor’s degree at Western Oregon University and his law degree at Lewis & Clark Law School.

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EXECUTIVE AND DIRECTOR COMPENSATION

The following ~~tables~~table ~~provide~~sets forth information regarding the compensation awarded or paid to, or earned by, oreach ~~paid~~individual ~~to the three individuals~~ who served as ~~the~~an ~~Company’s principal~~ executive officer ~~during~~of the Company during our fiscal year ended May 31, ~~2024, and two additional individuals who were executive officers of the Company as of May 31, 2024~~2025. WeThe ~~refer~~amounts toshown ~~these~~are ~~five~~for ~~individuals~~full asfiscal ~~our~~year(s) ~~“named~~during ~~executive~~which ~~officers.”~~the Noofficer ~~other~~was ~~individuals~~employed ~~served~~by ~~as executive officers of~~ the Company ~~during fiscal year 2024~~.

Summary Compensation Table

The table below sets forth information regarding the compensation of our named executive officers for our fiscal years ended May 31, 2024 and 2023.

										Stock		Non-equity
								Stock		option		incentive plan		All other
				Salary		Bonus		awards		awards		compensation		compensation
Name and Principal Position		Year		($)		($)⁽⁵⁾		($)⁽⁶⁾		($)⁽⁷⁾		($)⁽⁵⁾		($)⁽⁸⁾		Total ($)
Dr. Jacob P. Lalezari⁽¹⁾		2025		400,000		30,000		—		342,000		—		11,850		783,850
Chief Executive Officer		2024		152,242		70,000		—		459,624		—		3,500		685,366
Mitchell Cohen⁽²⁾		2025		576,000		—		—		—		—		—		576,000
Interim Chief Financial Officer		2024		218,400		—		—		—		—		—		218,400
Robert E. Hoffman⁽³⁾		2025		20,000		—		—		368,526		—		—		388,526
Chief Financial Officer
Tyler Blok⁽⁴⁾		2025		365,000		15,000		—		142,500		—		9,994		532,494
Chief Legal Officer		2024		291,042		—		—		176,055		100,000		8,731		575,828


				Stock
			Stock	option	All other
		Salary	awards	awards	compensation
Name and Principal Position	Year	($)(6)	($)(7)	($)(8)	($)(9)	Total ($)
Jacob Lalezari, M.D.(1)	2024	152,242	—	459,624	3,500	615,366
Chief Executive Officer
Mitchell Cohen(2)	2024	218,400	—	—	—	218,400
Interim Chief Financial Officer
Tyler Blok(3)	2024	291,042	—	176,055	8,731	475,828
Executive Vice President, Legal Affairs
Cyrus Arman, Ph.D.(4)	2024	270,000	—	109,487	8,100	387,587
Senior Vice President, Business Operations	2023	394,700	375,000	750,000	8,711	1,528,411
Antonio Migliarese(5)	2024	384,724	—	90,556	7,961	483,241
Chief Financial Officer	2023	428,418	—	1,318,800	10,065	1,757,283

(1)	Dr. Lalezari was appointed as the Company’s interim Chief Executive Officer effective November 17, 2023, and was appointed as Chief Executive Officer on January 26, 2024.

(2) Mr. Cohen iswas an independent contractor and was appointed as the Company’s Interim Chief Financial Officer effective February 1, 2024. He resigned as Interim Chief Financial Officer effective May 12, 2025. The terms of Mr. Cohen’s compensation ~~are~~were set forth in an agreement between the Company and InterimExecs.

(3) Mr. ~~Blok~~Hoffman was appointed asby ~~Executive~~the ~~Vice~~Board ~~President~~as ofChief ~~Legal~~Financial ~~Affairs~~Officer effective ~~August~~May 15, ~~2023~~2025. ~~His compensation is shown for the full 2024 fiscal year.~~

(4) DrMr. ~~Arman~~Blok was appointed ~~President~~by onthe ~~July~~Board 9,as ~~2022.~~Executive HeVice ~~was~~President ~~placed~~of onLegal ~~medical~~Affairs, ~~leave~~effective ~~beginning~~August ~~May 18~~15, 2023, ~~through~~to ~~July~~September 626, ~~2023~~2024, ~~when~~and ~~he resigned from that position. He~~ was appointed as ~~the~~Chief ~~Company’s~~Legal ~~Senior~~Officer ~~Vice President, Business Operations, a part time, nonexecutive position,~~ effective ~~July~~September 727, ~~2023. His compensation for fiscal year~~ 2024 ~~is shown for the full fiscal year~~.

(5) ~~Mr.~~See ~~Migliarese~~“Annual ~~also~~Cash ~~served~~Incentive asPlan ~~Interim~~and ~~President~~Cash ~~from~~Bonuses” ~~January 24, 2022 through July 9, 2022 as well as beginning May 18, 2023 through November 17, 2023~~below. ~~He resigned as Chief Financial Officer effective January 31, 2024.~~

(6) ~~Beginning~~PSUs ~~March~~awarded ~~31,~~to ~~2022~~Mr. ~~through~~Hoffman ~~November~~in ~~30,~~fiscal ~~2022,~~year ~~25%~~2025 ofwere ~~Mr.~~deemed ~~Migliarese’s~~to ~~salary~~have ~~was~~zero ~~paid~~grant indate ~~the~~fair ~~form~~value ofbased ~~shares~~on ofthe ~~common~~probable ~~stock~~outcome ~~instead~~ of ~~cash.~~the ~~The~~performance ~~amount~~conditions ~~reflecting~~on the grant date. The value of ~~shares~~the ofPSUs ~~common~~at ~~stock~~the ~~included~~grant indate, assuming the ~~Salary~~performance ~~column~~conditions inwere ~~fiscal~~met ~~2023~~at ~~for~~the ~~Mr.~~maximum ~~Migliarese~~level (100%), was $511,~~875~~435,000.

(7) Stock ~~The~~option ~~amount shown for stock~~ awards ~~represents~~represent the aggregate grant date fair value of anthe ~~award~~awards ofpursuant ~~restricted stock units (“RSUs”)~~ to ~~Dr.~~ASC ~~Arman in 2023. The RSUs were scheduled to vest in four equal annual installments~~718, ~~subject~~as todescribed ~~continued employment through the applicable vesting date. Awards subject to performance conditions (“PSUs”) that were made to Dr. Arman~~ in ~~fiscal~~Note ~~year~~6 ~~2023 were deemed~~ to ~~have zero fair value based on~~ the ~~probable~~audited ~~outcome~~financial ofstatements ~~the~~for ~~performance conditions on~~ the ~~grant~~year ~~date.~~ended ~~The~~May ~~value of the PSUs at the grant date~~31, ~~assuming~~2025 ~~the~~included ~~performance~~in ~~conditions~~this ~~were met at the maximum level (100%), was $375,000~~prospectus. InSee ~~connection~~“Long-Term ~~with~~Equity ~~Dr.~~Incentives” ~~Arman’s~~below ~~appointment~~for asdiscussion ~~Senior~~of ~~Vice~~the ~~President,~~cancellation ~~Business~~and ~~Operations~~replacement as of ~~July~~certain 7,outstanding ~~2023,~~stock ~~the~~options ~~RSUs~~in ~~and~~January ~~PSUs were forfeited~~2024.

53(8) Represents our qualified non-elective contributions to the Company’s 401(k) employee savings plan. The total value of all personal benefits received by any named executive officer was less than $10,000 during each fiscal year.

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~~(8)~~Outstanding ~~Stock~~Equity ~~option~~Awards ~~awards~~at ~~represent~~2025 ~~the aggregate grant date fair value of the awards pursuant to ASC 718, as described in Note 7 to the consolidated financial statements included in this prospectus.~~Fiscal Year-End

~~(9) Represents our qualified non-elective contributions to the Company’s 401(k) employee savings plan.~~ The ~~total~~table ~~value~~below ofshows ~~all~~equity ~~personal~~awards ~~benefits~~held ~~received~~ by ~~any~~our named executive ~~officer~~officers inas ~~fiscal~~of ~~years 2023 and 2024 was less than $10~~May 31,~~000~~ 2025.

Outstanding Equity Awards at 2024 Fiscal Year-End

The table below sets forth information regarding the equity awards held by our named executive officers on May 31, 2024.

										Equity
									Equity	incentive
	~~Number of~~		~~Number of~~						incentive	plan awards:
	~~securities~~		~~securities~~						plan awards:	Market or
	~~underlying~~		~~underlying~~						Number of	payout
	~~unexercised~~Number of		~~unexercised~~Number of		~~Option~~			~~Option~~	unearned	value of
	~~options (#)~~securities		~~options (#)~~securities		~~exercise~~			~~expiration~~	shares, units	unearned shares,
Name	exercisable		unexercisable		price ($)			date
	underlying		underlying						or other	units or other
Jacob Lalezari, M.D.	125,000		2,875,000	(2)	$	0.21		3/7/2034
	unexercised		unexercised		Option			Option	rights that	rights that
Tyler Blok	45,830		54,170	(3)	$	0.21	(7)	7/25/2032
	options (#)		options (#)		exercise			expiration	have not	have not
	70,580		79,420	(4)	$	0.35		11/1/2032
Name	exercisable		unexercisable		price ($)			date	vested (#)	vested ($)(8)
	249,996		750,004	(5)	$	0.21		1/3/2024
Dr. Jacob P. Lalezari	875,000		2,125,000	(1)	$	0.21		3/7/2034
Cyrus Arman, Ph.D.	1,575,557	(1)	—		$	0.21	(7)	9/20/2032
	750,000		2,250,000	(2)	$	0.13		10/28/2034
	112,500		337,500	(5)	$	0.21		1/3/2032
Robert E. Hoffman	—		1,000,000	(3)	$	0.41		5/15/2035
Antonio Migliarese	50,000		—	(6)	$	0.21	(7)	8/15/2025
									3,500,000	1,190,000
	50,000		—	(6)	$	0.21	(7)	8/15/2025
Tyler Blok	312,492		937,508	(2)	$	0.13		10/28/2034
	~~100~~110,00292		—39,708	(64)	$	0.2135	~~(7)~~	811/151/~~2025~~2032
	33499,~~300~~992		—500,008	(65)	$	0.21	~~(7)~~	81/153/~~2025~~2034
	~~666~~70,~~000~~826		—29,174	(6)	$	0.21	(7)	87/1525/~~2025~~2032
	315,104		—	(6)	$	0.21	(7)	8/15/2025
	1,910,640		—	(6)	$	0.35		8/15/2025

Note: All awards in the table are subject to forfeiture in the event Continuous Service, as the term is defined in the 2012 Plan, terminates prior to the applicable vesting date.

~~Note:~~(1) ~~All~~Vests ~~awards~~ in ~~the~~34 ~~table~~equal ~~are~~monthly ~~subject~~installments tobeginning ~~forfeiture~~on inJune ~~the event Continuous Service~~7, ~~as the term is defined in our Amended and Restated 2012 Equity Incentive Plan (the “2012 Plan”), terminates prior to the applicable vesting date~~2025.

(12) InVests connection with Dr. Arman’s appointment to the non-executive position of Senior Vice President, Business Operations, vesting of the options was accelerated as follows: 630,222 shares vested on July 7, 2023, and the balance vested in ~~six~~36 equal monthly installments beginning on ~~August~~June 930, ~~2023~~2025.

(23) ~~Vests~~250,000 options will vest on May 15, 2026. The balance will vest in 4636 equal ~~monthly~~ installments beginning on ~~June~~May 731, ~~2024~~2026.

(34) Vests in 2612 equal monthly installments beginning on June 30, ~~2024~~2025.

(45) Vests in 24 equal monthly installments beginning on June 30, ~~2024~~2025.

(56) Vests in 3614 equal monthly installments beginning on June 30, ~~2024~~2025.

(6) Effective February 15, 2024, the Compensation Committee approved the amendment of Mr. Migliarese’s stock options to be fully vested and exercisable and extended the post-termination exercise period from 90 days following termination to August 15, 2025.

(7)	See “Long-Term Equity Incentives” below for discussion of the cancellation and replacement of outstanding stock options for stock options with exercise prices of $0.21 per share.

54(8) Based on closing price of common stock on May 31, 2025, of $0.34 per share.

~~Table~~Equity ofCompensation ~~Contents~~Plan Information

The following table sets forth information regarding outstanding stock options, RSUs and PSUs, as well as shares reserved for future issuance under our 2012 Plan, as of May 31, 2025.


Plan category		Number of securities to be issued upon exercise or vesting of outstanding options (a)		Weighted average exercise price of outstanding options (b)			Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) (c)
Equity compensation plans approved by stockholders		37,524,473	(1)	$	0.42		6,173,286	(2)
Equity compensation plans not approved by stockholders (3)		800,000		$	2.11		—
Total		38,324,473			0.46		6,173,286

(1)	Represents outstanding stock options, and PSUs granted to current or former employees and directors of the Company pursuant to the 2012 Plan. With regard to the 3,500,000 PSUs included in the total, no exercise price is paid upon vesting.

(2)

Represents shares available for future awards under the 2012 Plan that may be in the form of stock options, stock appreciation rights, restricted stock, RSUs, or other stock-based awards. The number of shares available for issuance automatically increases on June 1 of each calendar year in an amount equal to one percent of the Company’s total outstanding shares, unless the Company’s Board of Directors determines, before the immediately preceding fiscal yearend, that there should be a smaller or no increase. Pursuant to this provision, the number of shares covered by the 2012 Plan was increased by 12,491,746 shares effective June 1, 2025, which are not reflected in the table.

(3)	Represents outstanding stock options granted as compensation for certain consulting or advisory services provided to the Company by independent contractors and by members of our Scientific Advisory Board outside of the 2012 Plan.

Additional Information Regarding our Executive Compensation Program

Executive Compensation Policies and Procedures

Our Company believes that our executive compensation program should be designed to attract, motivate and retain highly qualified executives by paying them competitively and rewarding and encouraging individual and superior company performance, on both a short- and long-term basis, thereby aligning our executives’ behavior with long-term stockholder interests. The Board’s Compensation Committee is tasked with reviewing compensation policies and practices applicable to all executive officers. Effective July 2, 2021, the Compensation Committee adopted a written policy regarding executive compensation to govern the committee in making its determinations and fulfilling its responsibilities. Under the policy, the Compensation Committee will:

●

be composed of at least three members who are independent directors as provided under the Nasdaq Rules or rules of another applicable national securities exchange on which the Company’s stock is listed;

●

select and engage one or more independent compensation advisors and receive written recommendations from such advisors to assist the Compensation Committee in determining types and levels of compensation for executive officers and non-employee directors on an annual basis;

●

assess the compensation levels and composition of the Company’s peer group annually, based on factors the Compensation Committee deems relevant after discussion with its independent compensation advisor(s), and consider for selection as peers, as deemed appropriate by the Compensation Committee, companies that are operating in the same industries as the Company and have similar market capitalization;

● consider and approve the compensation ofelements for the Company’s executive officers annually, including the criteria upon which executive compensation is based, the specific relationship of corporate performance to executive compensation, and the composition of executive compensation in terms of base salary, deferred compensation, performance-based compensation, equity-based compensation, and other benefits to be provided to executive officers; this decision-making process will ~~occur~~be followed once per year, including evaluation of the achievement of goals for the most recent performance period(s) and establishment of goals for the ensuing performance period(s);

●

consider and approve the annual compensation for non-employee directors for each fiscal year, including cash retainers for service as directors and as members of Board committees, equity-based compensation, and other benefits to be provided to non-employee directors; and

●

refrain from recommending or approving bonuses to non-employee directors based on Company performance.

The policy expressly permits the Compensation Committee to make decisions regarding executive or director compensation in connection with the addition of new directors, the hiring of new executive officers or promotion of existing executive officers, and other circumstances that are, in the judgment of the Compensation Committee, exceptional. All decisions of the Compensation Committee are reported to our Board.

Role of Independent Compensation Consultant

The Compensation Committee has the sole authority and responsibility to select, retain, and terminate its independent compensation advisors and to approve their fees and terms of engagement. InThe ~~June 2022, the~~ Compensation Committee ~~retained~~initially ~~Aon/Radford~~selected (“Aon”) as its independent compensation consultant. ~~The Compensation Committee selected Aon~~ in ~~part~~April ~~due~~2021, tobased on its experience in developing ~~comparative compensation analyses by industry. Aon was also asked to review and evaluate the Company’s peer group for compensation comparison purposes~~independent, ~~to provide~~ comparative ~~information regarding executive~~ compensation at peer companies, and to assist in designing the Company’s executive compensation program for fiscal year 2024. The peer group approved by the Compensation Committee in June 2022 was composed of 22 pre-revenue, publicly traded companies with one to five drugs under development and located in biotech hubs throughout the United States.

5553

~~Table~~analyses by industry. Beginning in 2022, the Compensation Committee has renewed its engagement of ~~Contents~~Aon each subsequent fiscal year. In August 2024, at the Compensation Committee’s request, Aon provided updated salary, target cash incentive, and equity award information for fiscal year 2025, compared to the companies in a peer group recommended by Aon and approved by the Compensation Committee in April 2023. The peer group comprised 17 pre-commercial, publicly traded biotechnology companies conducting Phase 1/2 trials for up to five drugs under development. The Committee’s determinations regarding the Company’s executive compensation program for fiscal 2025 discussed below were based upon information and recommendations provided by Aon.

Base Salaries

Based on comparative compensation information and recommendations provided by Aon ~~in April~~, ~~June~~an ~~and~~independent ~~September~~compensation ~~2024~~consultant, the Compensation Committee fixed ~~their~~executive officer base salaries in fiscal year 2025 as follows: MrDr. ~~Migliarese,~~Lalezari’s ~~$421,600,~~annual ~~identical~~base ~~to his~~ salary ~~for~~as ~~fiscal~~CEO ~~year~~remained ~~2023~~at $400,000; and Mr. Blok’s annual base salary, ~~effective~~in aspart in recognition of ~~August~~a ~~15,~~change ~~2023,~~in ~~the~~his ~~date~~title asto ofChief ~~which~~Legal heOfficer ~~was~~and ~~appointed~~his ~~Executive~~service ~~Vice~~in ~~President~~multiple roles on behalf of ~~Legal~~the ~~Affairs~~Company, was ~~fixed~~increased ateffective June 1, 2024, from $315,000; ~~and~~to Dr$365,000. ~~Lalezari~~Mr. Cohen’s ~~annual~~consulting ~~base~~fees ~~salary~~of $576,000 ~~upon~~were ~~his~~specified ~~appointment~~in asthe ~~Interim~~Company’s ~~CEO~~consulting ~~effective~~agreement ~~November~~with ~~17,~~InterimExecs. ~~2023,~~When Mr. Hoffman was ~~fixed~~hired atas the ~~statutory~~Company’s ~~minimum~~Chief ~~under~~Financial ~~California~~Officer ~~law~~effective ofMay ~~approximately~~15, ~~$66~~2025,~~650,~~ ~~and~~the ~~was~~Compensation ~~increased~~Committee tofixed ~~$400,000 upon~~ his ~~promotion~~annual tobase ~~CEO~~salary ~~effective~~at ~~January 26~~$450, ~~2024~~000.

InAnnual ~~accordance~~Cash ~~with~~Incentive ~~the~~Plan ~~January 10, 2024, consulting agreement between the Company~~ and ~~InterimExecs~~Cash ~~relating to Mr. Cohen’s services as the Company’s Interim CFO, the Company pays InterimExecs a fixed rate of $48,000 per month.~~Bonuses

Annual ~~Cash~~cash ~~Incentive~~incentives ~~Plan~~are paid based on the Compensation Committee’s determinations regarding the satisfaction of corporate or individual performance goals, if any, established by the committee and the committee’s evaluation of the individual performance of each executive officer in its sole discretion. Target amounts for Dr. Lalezari and Mr. Blok for services during fiscal year 2025 were set at 40% of base salary, and Mr. Hoffman’s target amount for fiscal year 2026 was also set at 40% of base salary in May 2025. Mr. Cohen was not eligible for a bonus for services in fiscal year 2025 under the terms of the Company’s consulting agreement with InterimExecs.

~~Annual~~In ~~cash~~July ~~incentives~~2025, ~~are paid based on~~ the Compensation Committee’s ~~determinations~~met ~~regarding~~to discuss the ~~satisfaction~~attainment of ~~corporate~~fiscal or2025 ~~individual~~ performance goals, ifthat ~~any,~~had ~~established~~been approved by the committee ~~and~~in ~~the~~September ~~committee’s~~2024. ~~evaluation~~The ~~of the individual~~ performance ofgoals ~~each~~established ~~executive~~for ~~officer in its sole discretion~~Dr. ~~Effective~~Lalezari ~~January~~and ~~26, 2024, Dr~~Mr. ~~Lalezari’s~~Blok ~~target~~generally ~~bonus~~mirrored ~~was~~the ~~set~~strategic atcorporate ~~40%~~goals ofapproved ~~base~~by ~~salary~~the ~~earned~~Board ~~during~~for ~~fiscal~~the ~~year 2024~~Company. ~~Mr.~~The ~~Blok’s~~Compensation ~~target~~Committee ~~bonus~~unanimously ~~was~~concluded ~~set~~that atnone ~~40%~~ of ~~his~~the ~~base~~performance ~~salary~~goals ~~earned~~had ~~for~~been ~~fiscal~~met, ~~year~~but ~~2024.~~also ~~Mr.~~determined ~~Migliarese~~that ~~did~~both ~~not~~executive ~~receive~~officers ahad ~~bonus~~made ~~for~~exemplary efforts during fiscal year ~~2024~~2025 ~~due~~that toimproved ~~his departure from~~ the Company’s onprospects ~~February~~in ~~15,~~future ~~2024~~years. ~~Mr.~~Accordingly, ~~Cohen~~the isCompensation ~~not~~Committee ~~eligible~~approved ~~for~~the apayment ~~bonus~~of ~~under~~a ~~the~~discretionary ~~terms~~bonus ofto ~~the~~Dr. ~~consulting~~Lalezari ~~agreement~~and ~~with InterimExecs~~Mr. AsBlok ofin the ~~date~~amount of ~~this prospectus~~$30,000 ~~the Compensation Committee had not made any determination(s) as to bonuses~~ and~~/or~~ ~~cash~~$15,000, ~~incentive payments for fiscal year 2024~~respectively.

Long-Term Equity Incentives

We provide long-term incentives to our named executive officers under the Company’s Amended and Restated 2012 ~~Plan.~~Stock ~~For~~Incentive ~~fiscal years~~Plan ~~2024~~(the ~~and~~“2012 ~~2023,~~Plan”). ~~equity~~Equity awards during fiscal year 2025 were granted based on advice from Aon regarding the predominant practices of pre-revenue biotech companies and primarily took the form of grants of nonqualified stock options. Stock options provide our executives with opportunities for financial gain derived from the potential appreciation in stock price from the date the option is granted until the date the option is exercised. Stock options are granted to executives with an exercise price equal to or above the closing sale price of our common stock on the OTCQB on the grant date. Our long-term performance ultimately determines the value of stock options because gains from stock option exercises are entirely dependent on long-term appreciation in the price of our common stock. As a result, we believe stock options encourage our executives and other employees to focus on creating shareholder value. Nonqualified stock options do not provide holders with the tax advantages afforded to holders of incentive stock options under Section 422 of the Internal Revenue Code of 1986, as amended; rather, they benefit the Company by permitting it to deduct compensation expense for tax purposes when options are exercised in an amount equal to the compensation income recognized by the option holder. The Compensation Committee’s policy is to avoid granting stock options while the Company is in possession of material nonpublic information.

OnDuring ~~March~~fiscal 7,year 2024, the Compensation Committee ~~granted~~determined ~~Dr.~~to ~~Lalezari~~cancel aall ~~nonqualified~~ stock ~~option~~options toheld ~~purchase~~by ~~3,000,000~~then ~~shares~~employees of ~~common~~the ~~stock~~Company, inincluding ~~connection~~certain ~~with~~options ~~his~~held ~~promotion~~by toexecutive ~~CEO~~officers, inwith ~~January~~exercise ~~2024~~prices above $0.35 per share. The ~~options~~Compensation ~~vest~~Committee ~~over~~took athis ~~four-year~~action ~~period. On~~(i) ~~January~~in 3,an ~~2024~~effort to further incentivize employee retention and performance, ~~the~~and ~~Compensation~~(ii) ~~Committee~~because ~~granted~~the ~~Mr.~~cancellation ~~Blok~~and areplacement ~~nonqualified~~of the existing stock ~~option~~options would result in less dilution to ~~purchase~~stockholders ~~1,000,000~~than ~~shares~~granting additional stock options with a lower exercise price. The Compensation Committee approved the concurrent grant of ~~common~~new nonqualified stock ~~that~~options ~~will~~to ~~vest~~the ~~ratably~~Company’s inexecutive 48officers ~~equal~~with ~~monthly~~an ~~installments~~exercise ~~ending~~price onof ~~May~~$0.21 ~~31,~~per ~~2027~~share ~~(such~~for ~~that~~a ~~seven~~number ~~installments~~of ~~were~~shares ~~vested~~equal onto the ~~grant~~total ~~date).~~number of options

On January 3, 2024, the Compensation Committee also determined to cancel all stock options held by then employees of the Company, including executive officers, with exercise prices above $0.35 per share. The Compensation Committee took this action primarily because (i) the outstanding stock options no longer provided an incentive for exceptional performance due to being significantly out-of-the-money and (ii) cancellation and replacement of the existing stock options would result in less dilution to stockholders than granting additional stock options with a lower exercise price. As a result of the Compensation Committee’s action, stock options held by then and former executive officers with exercise prices ranging from $0.54 to $5.57 were cancelled as follows: Mr. Migliarese, stock options for 1,880,222 shares; Mr. Blok, stock options for 100,000 shares; and Dr. Arman, stock options for 1,575,557 shares. The Compensation Committee approved the concurrent grant of new nonqualified stock options to the Company’s executive officers with an exercise price of $0.21 per share for a number of shares equal to the total number of options cancelled and with an identical vesting schedule as the cancelled options.

~~Stock~~cancelled ~~options~~and ~~provide our executives~~ with opportunities for financial gain derived from the potential appreciation in stock price from the date the option is granted until the date the option is exercised. Stock options are granted to executives with an ~~exercise~~identical ~~price~~vesting ~~equal~~schedule toas ~~or above~~ the ~~closing~~cancelled ~~sale price of our common stock on the OTCQB on the grant date~~options. ~~Our~~The ~~long-term~~outstanding ~~performance ultimately determines the value of~~ stock options, ~~because gains from stock option exercises~~ are ~~entirely~~shown ~~dependent on long-term appreciation~~ in the ~~price~~table of our common stock. As a result, we believe stock options encourage our executives and other employees to focus on creating shareholder value. Nonqualified stock options do not provide holders with the tax advantages afforded to holders of incentive stock options under ~~Section 422 of~~ the ~~Internal~~heading ~~Revenue~~“Outstanding ~~Code~~Equity ofAwards ~~1986,~~at as2025 ~~amended;~~Fiscal ~~rather,~~Year-End” ~~they benefit the Company by permitting it to deduct compensation expense for tax purposes when options are exercised in an amount equal to the compensation income recognized by the option holder~~above.

56During fiscal year 2025, the Compensation Committee granted nonqualified stock options with a 10-year term to the Company’s executive officers as follows: Dr. Lalezari, 3,000,000 shares; Mr. Blok, 1,250,000 shares; and Mr. Hoffman, 1,000,000 shares. Dr. Lalezari’s grant was for the same number as the annual grant in fiscal year 2024, while Mr. Blok’s grant was 25% higher than the prior year’s annual grant, placing him slightly below the 50th percentile for comparable positions in the Company’s peer group. The options awarded to Dr. Lalezari and Mr. Blok vest in 48 equal monthly installments through May 31, 2028, while 25% of the options granted to Mr. Hoffman will vest on May 15, 2026, and the balance in equal monthly installments through April 30, 2029. Mr. Hoffman also received an award of performance stock units (“PSUs”) under the 2012 Plan relating to 3,500,000 shares of the Company’s common stock, with vesting based on the earlier to occur of (i) 30 calendar days after the effective date of the Company’s successful uplisting from the OTCQB to a major US securities exchange, or (ii) a Change of Control (as defined in the 2012 Plan).

Table of Contents

Employee Pension, Profit Sharing or Other Retirement Plans

Effective January 1, 2010, we adopted an employee savings plan pursuant to Section 401(k) of the Internal Revenue Code (the “401(k) Plan”) ~~that~~and ~~covered~~covering substantially all employees. We make “safe harbor” qualified non-elective contributions, which vest immediately, equal to 3% of each participant’s salary, up to the maximum limit permitted under Section 401(k). In addition, participants in the 401(k) Plan may contribute a percentage of their compensation, up to the maximum limit under the Internal Revenue Code. We do not have any other defined benefit pension plan, or profit sharing, or retirement plan.

Employment Agreements

The Company has entered into employment agreements with Dr. Lalezari, Mr. Hoffman and Mr. Blok that provide for an indefinite term of employment until terminated under the terms of the agreement, payment of a base salary (as adjusted by the Compensation Committee from time to time), a target bonus under the Company’s ~~short-term~~annual cash incentive plan described ~~below~~above, equity awards under the 2012 Plan (or any successor plan) as determined by the Compensation Committee, and benefits generally made available to the Company’s senior leadership. ~~Mr. Cohen’s employment is pursuant to a consulting agreement with InterimExecs as described under “Base Salaries” above. Either party may terminate the agreement upon 30 days’ written notice.~~

Our current executive officers, ~~other than Mr. Cohen,~~ are eligible to participate in our short- and long-term incentive plans, with a target annual bonus equal to a percentage ~~or range~~ of ~~percentages of~~ annual base salary, as set by the Compensation Committee. The actual amount of the target awards paid is based on the Compensation Committee’s evaluation of the level of achievement of related performance goals or individual performance and are payable, as determined by the Compensation Committee, either in cash in full, or 50% in cash and 50% in unrestricted shares of common stock. The executive must remain actively employed by the Company through the date of a cash incentive payment to be entitled to payment.

Payments upon Termination of Employment, Death or Disability, or Change in Control

~~The~~Mr. ~~only~~Hoffman ~~current~~and ~~executive~~Mr. ~~officer~~Blok ofare ~~the~~each ~~Company~~ entitled to severance or similar benefits upon termination of employment ~~is Mr~~. ~~Blok.~~ Under Mr. ~~Blok~~Hoffman’s employment agreement, in the event we terminate his employment without cause in the absence of a change in control, and subject to his execution and non-revocation of a release of claims and continued compliance with certain restrictive covenants, he will be entitled to (x) during the first six months of employment, six payments based on his then base salary rate beginning on the first payroll date that is 60 days following termination of employment and (y) thereafter, one additional monthly payment for each additional month of employment up to a maximum of six additional monthly payments, in each case payable in regular installments in accordance with the Company’s regular payroll schedule. Mr. Blok’s employment agreement provides for similar terms, except that he will be entitled to (x) a lump sum payment equal to the sum of three months of base salary plus (y) payments equal to nine months of base salary payable in regular installments ~~corresponding~~in accordance with the Company’s regular payroll schedule. ~~The~~In each case, the payments may, at the discretion of the Compensation Committee, be made in whole or in part through the issuance of shares of common stock. The total payments may not exceed the maximum amount qualified for the exemption from Section 409A of the Internal Revenue Code governing deferred compensation (the “Severance Limit”). ~~Also,~~Unless ~~all~~otherwise provided in an award agreement, outstanding and unvested stock awards ~~granted~~held toby MrMessrs. ~~Blok~~Hoffman ~~will vest~~ and ~~(if~~Blok ~~applicable)~~will ~~become~~be ~~immediately~~forfeited ~~exercisable~~to ~~upon~~the ~~such~~extent ~~termination,~~not ~~except~~vested asprior ~~otherwise~~to ~~specifically provided in an award agreement~~termination.

In the event we terminate the employment of Mr. Hoffman (after 180 days of full-time, continuous employment) or Mr. Blok, without cause, or hethe executive resigns for good reason, within 12 months following a change in control, and subject to his execution and non-revocation of a release of claims, ~~his~~(x) Mr. Hoffman’s employment agreement provides for a lump sum payment ~~equal~~60 todays ~~the~~thereafter ~~sum~~equal ofto 18 eight months of base salary~~; provided that the total of such payments may not exceed the Severance Limit. Also~~, ~~all~~followed ~~then~~by ~~outstanding~~a ~~and~~lump ~~unvested~~sum ~~stock~~payment ~~awards~~equal ~~generally~~to ~~will~~10 ~~vest~~months as of ~~the~~base ~~change~~salary inpayable ~~control~~270 ~~date~~days and (if applicable) become immediately exercisable, unless otherwise specifically provided in an award agreement. The definitions of certain terms used in Mr. Blok’s employment agreement are summarized below:

“Cause” means, among other things, fraudulent or similar acts intended to enrich the executive personally to the detriment or at the expense of the Company; willful failure to perform the duties or obligations reasonably assigned to the executive; a material breach of the confidentiality or non-competition provisions of the employment agreement; conviction of or guilty plea to a crime involving a felony or a misdemeanor involving dishonesty or moral turpitude; and other willful engagement in misconduct, including conduct reasonably likely to result in negative publicity for the Company or harm to its reputation.55

~~“Good~~following ~~reason”~~termination ~~generally~~of ~~means~~employment, aand ~~material~~(y) ~~reduction~~Mr. ~~in the executive~~Blok’s ~~authority,~~employment ~~duties,~~agreement orprovides ~~responsibilities;~~for a ~~material~~lump ~~decrease~~sum inpayment ~~the~~60 ~~executive’s~~days following termination of employment equal to 18 months of base salary; aprovided ~~material~~that ~~breach~~the total of ~~the~~such ~~employment~~payments, ~~agreement~~in byeach case, may not exceed the ~~Company;~~Severance orLimit. aAlso, ~~relocation~~all ofthen ~~his~~outstanding ~~principal~~and ~~place~~unvested stock awards will be deemed to vest immediately prior to termination of employment byas adescribed ~~distance~~in the preceding sentence and (if applicable) become immediately exercisable, unless otherwise provided in an award agreement. The definitions of ~~more~~certain ~~than~~terms 50used ~~miles~~in Mr. Hoffman’s and Mr. Blok’s employment agreements are summarized below:

57“Cause” generally means fraudulent or similar acts intended to enrich the executive personally to the detriment or at the expense of the Company; willful failure to perform the duties or obligations reasonably assigned to the executive; a material breach of the confidentiality or non-competition provisions of the employment agreement; conviction of or guilty plea to a crime involving a felony or a misdemeanor involving dishonesty or moral turpitude; and other willful engagement in misconduct, including conduct reasonably likely to result in negative publicity for the Company or harm to its reputation.

~~Table~~“Good reason” generally means a material reduction in the executive’s authority, duties, or responsibilities; a material decrease in the executive’s base salary (with certain exceptions); a material breach of ~~Contents~~the employment agreement by the Company; or a relocation of his principal place of employment by a distance of more than 50 miles.

“Change in control” generally means the acquisition by a person or group of more than 50% of the total fair market value or total voting power of our outstanding stock; the replacement of a majority of the members of the Board during any 12-month period (unless endorsed by a majority of the existing directors); or the acquisition by a person or group of assets representing at least 40% of the total gross fair market value of our assets.

Upon either Mr. Hoffman’s or Mr. Blok’s death or disability, the Company will satisfy its accrued obligations to pay ~~his~~their salary and benefits through the date of the event.

Director Compensation

During the 2025 fiscal ~~year~~ ~~2024~~year, our non-employee director compensation program was not adjusted from the 2024 fiscal year, and provided for: (i)  $40,000 in annual cash retainer;, (ii)  an additional annual cash retainer of $30,000 for service as Lead Independent Director or independent Board Chair, (iii)  additional annual cash retainers for committee chairs equal to $20,000 for the Audit Committee, $15,000 for the Compensation Committee, and $10,000 for the Nominating and Governance Committee, (iv)  annual cash retainers for committee members of $10,000 for the Audit Committee, $7,500 for the Compensation Committee, and $5,000 for the Nominating and Governance Committee, and (v)  an annual grant of a non-qualified stock option ~~with~~to apurchase ~~grant~~800,000 ~~date~~shares ~~fair~~of ~~value~~common stock (the same number of ~~$136~~shares as in fiscal year 2024),~~800~~ ~~and~~with an exercise price equal to the closing sale price of the common stock on the date of grant, a 10-year term, and vesting in 12 equal monthly installments ~~through~~during ~~the end of the applicable~~ fiscal ~~year~~ 2025.

~~The~~Director ~~table~~compensation ~~below~~is ~~sets~~evaluated ~~forth~~an ~~certain~~annual ~~information~~basis, ~~regarding~~and ~~the~~decisions ~~compensation~~are ~~earned~~made bybased oron ~~awarded~~comparative tocompensation ~~each~~information ~~non-employee~~and ~~director~~recommendations ~~for~~provided ~~services~~by ~~during~~Aon/Radford ~~fiscal year~~(“Aon”), ~~2024:~~the Company’s independent compensation consultant.

The following table sets forth certain information regarding the compensation earned by or awarded to each non-employee director for services during fiscal year 2025:

				Stock option
Name of non-employee director		Cash fees		awards ⁽¹⁾⁽²⁾		Total
Tanya D. Urbach ⁽³⁾		$	97,500	$	91,200	$	188,700
Lishomwa C. Ndhlovu, M.D., Ph.D.		$	45,000	$	91,200	$	136,200
Karen J. Brunke, Ph.D.		$	47,500	$	91,200	$	138,700
Ryan M. Dunlap		$	65,000	$	91,200	$	156,200
Stephen M. Simes		$	65,000	$	91,200	$	156,200

(1)

Stock option awards represent the grant date fair value of the awards pursuant to Financial Accounting Standards Board Accounting Standards Codification Topic 718, Compensation – Stock Compensation (“ASC 718”), as described in Note 6 to the consolidated financial statements included in the Annual Report on Form 10-K for the fiscal year ended May 31, 2025 (the “2025 Form 10-K”), to which reference is hereby made.

(2)	The shares of common stock underlying stock options held by the non-employee directors as of May 31, 2025, are shown in the table below:

	Number of shares underlying		~~Stock option~~
Name of non-employee director	~~Cash~~outstanding ~~fees~~stock option awards		~~awards (1)(2)~~		~~Total~~
Tanya D. Urbach (3)	$	97,500	$	136,800	$	234,300
Tanya D. Urbach	1,959,611
Lishomwa C. Ndhlovu, M.D., Ph.D.	$2,059,611	~~45,000~~	$	~~136,800~~	$	~~181,800~~
Karen J. Brunke, Ph.D.	$1,884,611	~~47,500~~	$	~~136,800~~	$	~~184,300~~
Ryan M. Dunlap	$1,785,334	~~65,000~~	$	~~136,800~~	$	~~201,800~~
Stephen M. Simes	$1,778,012	~~65,000~~	$	~~136,800~~	$	~~201,800~~

(1) Stock option awards represent the grant date fair value of the awards pursuant to Financial Accounting Standards Board Accounting Standards Codification Topic 718, Compensation – Stock Compensation (“ASC 718”), as described in Note 5 to the consolidated financial statements included in this prospectus, to which reference is hereby made.

(2) The total shares of common stock underlying stock options held by the non-employee directors as of May 31, 2024, are shown in the table below:

		Number of shares underlying
Name of non-employee director		outstanding stock option awards
Tanya D. Urbach		1,159,611
Lishomwa C. Ndhlovu, M.D., Ph.D.		1,259,611
Karen J. Brunke, Ph.D.		1,084,611
Ryan M. Dunlap		985,334
Stephen M. Simes		978,012

(3)	Cash fees include annual fees for service as independent Board Chair.

5857

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CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS

We describe below each transaction or series of similar transactions, since June 1, ~~2021~~2023, to which we were a party or will be a party, in which:

● the amounts involved exceeded or may exceed $~~112~~120,~~140~~000; and

● any of our directors, executive officers or holders of more than 5% of our capital stock, or any member of the immediate family of the foregoing persons, at any time since June 1, ~~2021~~2023, had or will have a direct or indirect material interest.

The Audit Committee of the Board reviews and approves all related party transactions in accordance with the Company’s Related Party Transactions Policy, which is available on our website, www.cytodyn.com/investors. Generally, it is the Company’s policy to enter into or ratify related party transactions only when the Board, acting through the Audit Committee, determines that the transaction in question is in, or is not inconsistent with, the best interests of the Company and its stockholders. Specifically, when reviewing a related party transaction, the Audit Committee considers all relevant factors, including but not limited to (if and to the extent possible): the benefits to the Company; the impact on a director’s independence in the event the related party is a director, an immediate family member of a director or an entity in which a director is a partner, stockholder or executive officer; the availability of other sources for comparable products or services; the terms of the transaction; and the terms available to unrelated third parties or to employees generally. We believe the terms of the related party transactions described below were comparable to terms we could have obtained in arm’s length dealings with unrelated third parties.

~~The~~Dr. ~~Center~~Lalezari, ~~for~~the ~~Advanced~~Company’s ~~Research &~~current ~~Education~~CEO, ~~LLC~~owns ~~(“CARE”),~~Lalezari ~~owned~~Medical ~~by Julie Recknor, Ph~~Corp.D., ~~the~~dba ~~spouse~~Quest ofClinical DrResearch (“Quest”). ~~Christopher~~ ~~Recknor,~~In ~~was~~the ~~one~~years ofprior ~~several~~to ~~clinical~~Dr. ~~locations for the Company~~Lalezari’s ~~MASH~~appointment ~~and~~as ~~COVID-19 long-hauler clinical trials~~CEO, ~~and~~Quest was aone of several clinical ~~location~~locations for the Company’s ~~completed~~past ~~Phase~~COVID19 ~~2b/3 mild-to-moderate and severe-to-critical COVID-19~~ clinical trials. ~~Dr. Julie Recknor serves as the Site Director of CARE and manages its day-to-day operations.~~ The Company entered into a Clinical Trial Agreement (“CTA”) with ~~CARE~~Quest ~~for~~in ~~each~~relation ofto ~~these~~said clinical trials. Each CTA was negotiated in the ordinary course of business by ~~Amarex,~~ the Company’s former CRO, ~~prior~~years tobefore Dr. ~~Christopher Recknor~~ Lalezari’s appointment as anCEO ~~executive officer~~ of the Company, and the operational and financial terms of the CTA with ~~CARE~~Quest were comparable to the terms available to unrelated clinical locations. Dr. ~~Christopher Recknor~~ Lalezari was not ~~involved~~employed inby the Company’s ~~decision~~at tothe ~~choose~~time ~~CARE~~period asof athe ~~clinical~~trials. ~~location~~Since ~~for~~June ~~its~~1, ~~ongoing~~2023, ~~trials~~the orlargest intotal ~~patient~~balance ~~recruitment~~owed atby the ~~CARE~~Company ~~site~~to Quest was approximately $0.4 ~~The~~million. Since June 1, 2023, the Company ~~made~~has ~~payments~~paid ~~totaling~~Quest approximately $0.2 million tofor ~~CARE~~its ~~during~~services ~~the~~in ~~fiscal year~~conducting ~~ended~~clinical ~~May 31~~trials of leronlimab. In addition, since Dr. Lalezari became CEO in November 2023, the Company has incurred approximately $45,990 for services performed at Quest, as conducted by an independent contractor serving as the designated principal investigator. As of February 28, 2026, the total outstanding balance owed by the Company to Quest was approximately $0.2 million.

On February 14, 2022, the Company entered into a Surety Bond Backstop Agreement (the “Backstop Agreement”) with David F. Welch, Ph.D., in his individual capacity and as trustee of a revocable trust, as well as certain other related parties (collectively, the “Indemnitors”). Pursuant to the Backstop Agreement, the Indemnitors agreed to assist the Company in obtaining a surety bond (the “Surety Bond”) for posting in connection with the Company’s ongoing litigation with its former contract research organization, Amarex, by, among other things, agreeing to indemnify the issuer of the Surety Bond (the “Surety”) with respect to the Company’s obligations under the Surety Bond. As a result of two amendments to the Backstop Agreement executed in July and December of 2022, the Indemnitors’ agreement to indemnify the Surety was extended until April 2023. As consideration for the Indemnitors’ obligations under the Backstop Agreement, including the amendments, the Company issued the Backstop Warrants to entities controlled by Dr. Welch to purchase a total of 45,000,000 shares of common stock at an exercise price of $0.10 per share. The warrants are fully exercisable and will expire at various dates in 2027 and 2028. Upon the issuance of the final two warrants to purchase a total of 15,000,000 shares in February 2023, Dr. Welch was deemed to beneficially own in excess of 5% of the Company’s outstanding shares of common stock.

The payment obligations of the Company to the Indemnitors bore interest at 10% per annum and were secured by substantially all of the patents held by the Company. In March 2023, as required by and in connection with the extension of the Backstop Agreement, the Company relieved the Indemnitors of the remaining $1.4 million of cash collateral pledged by the Indemnitors in support of the Surety Bond. Subsequently, the Indemnitors were fully released from their indemnification obligations, they released their security interest in the Company’s patents securing the Company’s obligations under the Backstop Agreement, and the Company fully assumed the Surety Bond. The shares underlying the warrants are included in the shares registered for resale pursuant to this prospectus. See “Selling Stockholders” for more information.

Table of Contents

On February 13, 2023, Dr. Arman, the Company’s then President, purchased approximately 0.4 million units consisting of one share of common stock and one warrant to purchase one share of common stock from the Company at an exercise price of $0.50. The terms and conditions of Dr. Arman’s investment totaling $0.1 million were identical to those offered to other investors in a private placement through a placement agent that ended in April 2023.

Dr. Lalezari, the Company’s current CEO, owns Lalezari Medical Corp., dba Quest Clinical Research (“Quest”). In the years prior to Dr. Lalezari’s appointment to CEO, Quest was one of several clinical locations for the Company’s past COVID19 clinical trials. The Company entered into a Clinical Trial Agreement (“CTA”) with Quest in relation to said clinical trials. Each CTA was negotiated in the ordinary course of business by Amarex, the Company’s former CRO, years before Dr. Lalezari’s appointment as CEO of the Company, and the operational and financial terms of the CTA with Quest were comparable to the terms available to unrelated clinical locations. Dr. Lalezari was not employed by the Company at the time period of the trials. Since June 1, 2021, the Company has paid Quest approximately $1.2 million for its services in conducting clinical trials of leronlimab. As of August 31, 2024, the outstanding balance owed by the Company to Quest was approximately $0.4 million.

~~Table of Contents~~58

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

The following table sets forth the beneficial ownership of common stock as of ~~August~~April 3115, ~~2024~~2026, by (i) each of our directors; (ii) each of our named executive officers; and (iii) our current executive officers and directors as a group. AsTo our knowledge, as of ~~August~~April 3115, ~~2024~~2026, there were no beneficial owners of more than 5% of our outstanding ~~shares of~~ common stock.


	Amount and Nature of	Percent of
Name and Address of Beneficial Owner (1)	Beneficial Ownership (2)	Total (3)
Name of Beneficial Owner	Beneficial Ownership (1)	Total (2)
Directors and Named Executive Officers:
Jacob Lalezari, M.D. (4)	437,500	*
Jacob Lalezari, M.D. (3)	3,187,500	*
Robert Hoffman(3)	250,000	*
Mitchell Cohen	—	*
Tyler Blok(5)	468,746	*
Tyler Blok(4)	1,621,066	*
A. Cyrus Arman, Ph.D.(6)	2,595,121	*
Tanya Durkee Urbach (5)	2,217,454	*
Antonio Migliarese(7)	3,324,951	*
Lishomwa C. Ndhlovu, M.D., Ph.D. (3)	2,155,341	*
Karen J. Brunke, Ph.D.(4)	1,084,611	*
Karen J. Brunke, Ph.D.(3)	1,980,341	*
Ryan C. Dunlap(4)	985,334	*
Ryan Dunlap(3)	1,881,064	*
Lishomwa C. Ndhlovu, M.D., Ph.D.(4)	1,259,611	*
Stephen M. Simes(3)	1,873,742	*
Stephen M. Simes(4)	978,012	*
Current directors and executive officers as a group (8 persons)(6)	15,166,508	1	%
Tanya Durkee Urbach(8)	1,321,724	*
Current directors and executive officers as a group (8 persons)(9)	6,373,425	*

*	Less than 1% of the outstanding shares of common stock.

(1) ~~Unless~~Beneficial ~~otherwise~~ownership ~~indicated~~includes shares of common stock as to which a person or group has sole or shared voting power or investment power. Beneficial ownership also includes shares subject to stock options, ~~the~~warrants, ~~business~~or ~~address~~other rights to acquire shares that are exercisable currently or within 60 days following April 15, 2026; such shares are deemed outstanding for purposes of ~~each~~computing ~~current~~the ~~director~~number of shares beneficially owned and ~~executive~~percentage ~~officer~~ownership isof ~~c/o~~the ~~CytoDyn~~person ~~Inc.~~or ~~1111~~group ~~Main~~holding ~~Street~~such stock options, ~~Suite~~warrants ~~660~~or other rights, ~~Vancouver~~but are not deemed outstanding for purposes of computing the percentage of any other person. Unless otherwise stated, ~~Washington~~numbers ~~98660~~represent shares of common stock.

(2) ~~Beneficial~~Percentages ~~ownership~~are ~~includes~~based ~~shares~~on ~~of common stock as to which a person or group has sole or shared voting power or investment power. Beneficial ownership also includes shares subject to stock options~~1, ~~warrants~~366, ~~or other rights to acquire shares that are exercisable currently or within 60 days following August 31~~029,885 ~~2024; such~~ shares ~~are deemed outstanding for purposes~~ of ~~computing~~common ~~the number of shares beneficially owned and percentage ownership of the person or group holding such~~ stock ~~options, warrants or other rights, but are not deemed~~ outstanding ~~for~~as ~~purposes~~ of ~~computing~~April ~~the percentage of any other person. Unless otherwise stated~~15, ~~numbers represent shares of common stock~~2026.

(3) ~~Percentages~~Represents ~~are based on 1,219,841,932~~ shares ofsubject ~~common~~to stock ~~outstanding as of August 31, 2024~~options.

(4) ~~Represents~~Includes 1,620,816 shares subject to stock options.

(5) Includes ~~468~~2,~~746~~055,341 shares subject to stock options.

(6) Includes: ~~(i) a warrant covering 434~~15,~~782 shares; and (ii) 1~~004,~~725,557~~145 shares subject to stock options.

(7) Includes 3,141,744 shares subject to stock options.

(8) Includes 1,159,611 shares subject to stock options.

(9) Includes 6,373,425 shares subject to stock options.

6159

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SELLING STOCKHOLDERS

When we refer to the “selling stockholders” in this prospectus, we mean the persons or entities specifically identified in the table below, as well as the permitted transferees, pledgees, donees, assignees, successors and other successors-in-interest who may subsequently hold any of the selling stockholders’ interests other than through a public sale.

The table below sets forth information concerning the resale of our shares by the selling stockholders. The total number of common shares sold under this prospectus may be adjusted to reflect adjustments due to stock dividends, stock distributions, splits, combinations or recapitalizations with regard to the common stock. Unless otherwise stated below in the footnotes, to our knowledge, neither the selling stockholders, nor any affiliate of such stockholders, has held any position or office with us during the three years prior to the date of this prospectus.

We have registered ~~279~~184,~~236~~135,~~439~~636 shares of our common stock and ~~207~~93,~~410~~940,~~284~~739 shares underlying outstanding warrants to purchase our common stock for resale by the selling stockholders named below. We will not receive any of the proceeds of sales by the selling stockholders of any of the shares of common stock covered by this prospectus. However, if all of the warrants covered by this prospectus are exercised for cash, we may receive proceeds of up to approximately $4823.59 million, as further described in “Use of Proceeds.”

Set forth below are the names of the selling stockholders and the amount and percentage of common stock beneficially owned by each of the selling stockholders (including shares which the stockholders have the right to acquire within 60 days of ~~August~~April 3115, ~~2024~~2026) prior to the offering, the shares to be sold in the offering, and the amount and percentage of common stock to be owned by each (including shares which the stockholders have the right to acquire within 60 days of ~~August~~April 3115, ~~2024~~2026) after the offering assuming all shares are sold. The footnotes provide information about persons who have voting and dispositive power with respect to shares held by the selling stockholders.

The amounts and information set forth below are based upon information the Company received from the selling stockholders, and/or Company records. The selling stockholders may sell all or some of the shares of common stock they are offering, and may sell, unless indicated otherwise in the footnotes below, shares of our common stock otherwise than pursuant to this prospectus. The table below assumes that the selling stockholders sell all of the shares offered by them in offerings pursuant to this prospectus and do not acquire any additional shares. We are unable to determine the exact number of shares that will actually be sold or when or if these sales will occur.

	Shares
	Shares
	Beneficially		Common Stock		Number of
	Owned	%Owned	Offered in this	Warrant	Shares	% of shares
Name of Selling Stockholder	Pre-Offering(1)	Pre-offering(2)	Offering	Shares	Post-Offering	Post offering(2)
2012 Daniel R Edelson Revocable Trust	392,306	*	196,153	196,153	-	*
2000 Welch Charitable Remainder Unitrust Agreement II(3)	47,548,145	3%	929,486	-	46,618,659	3%
3NT Management LLC	4,093,490	*	1,764,706	-	2,328,784	*
2020 Welch Charitable Remainder Unitrust (3)	47,548,145	3%	1,607,091	-	45,941,054	3%
A & M Trust	461,538	*	230,769	230,769	-	*
Abdo Balikcioglu	464,468	*	232,234	232,234	-	*
Aaron Eastman	352,940	*	352,940	-	-	*
Adam Moshofsky	1,857,872	*	928,936	928,936	-	*
Aaron Lehmann	191,303	*	191,303	-	-	*
Adam Schofield	232,234	*	116,117	116,117	-	*
Adam Vierra	186,274	*	8898,~~235~~039	-	9888,~~039~~235	*
Adeel Shahid	~~550~~3,~~000~~336,808	*	~~550~~1,~~000~~393,404	-1,393,404	-550,000	*
Adolfo & Donna Carmona	953,109	*	953,109	-	-	*
Aggarwal Family Revocable Trust	718,313	*	232,234	232,234	253,845	*
Aggarwal Family Revocable Trust	253,845	*	253,845	-	-	*
Alexander & Donna Tosi	1,734,401	*	1,734,401	-	-	*
Alicja Socha	3,800,000	*	3,200,000	600,000	-	*
Alok & Aruna Agrawal	13,600	*	3,600	-	10,000	*
Anders P. Lindholm	130,000	*	-	30,000	100,000	*


	Shares
	Beneficially		Common Stock		Number of
	Owned	%Owned	Offered in this	Warrant	Shares	% of shares
Name of Selling Stockholder	Pre-Offering⁽¹⁾	Pre-offering⁽²⁾	Offering	Shares	Post-Offering	Post offering⁽²⁾
Albert Konetzni Jr.	199,998	*	133,332	-	66,666	*
Albrecht Catalan	50,000	*	50,000	-	-	*
Alexander B. Hardt	464,468	*	232,234	232,234	-	*
Alexander Tosi & Donna Tosi	3,771,957	*	1,161,169	1,161,169	1,449,619	*
Alicja Socha	2,610,914	*	255,457	255,457	2,100,000	*
Allen & Cassie Gabriel	119,018	*	119,018	-	-	*
Allen Gabriel	631,339	*	399,105	232,234	-	*
Alliance Trust Company Cust FBO Brian Mark Miller Roth Ira	792,000	*	792,000	-	-	*
ALLO Enterprises, LLC	464,468	*	232,234	232,234	-	*
Alok & Aruna Agrawal	13,600	*	10,000	-	3,600	*
Alon Cohen	53,333	*	53,333	-	-	*
AltoIRA Cust FBO Howard C Fritz Roth IRA	464,468	*	232,234	232,234	-	*
Alva Terry Staples	69,999	*	69,999	-	-	*
Anders P. Lindholm	130,000	*	100,000	-	30,000	*
Andrea Metkus Living Trust dtd 12-05-2020	392,156	*	392,156	-	-	*
Andreas & Brianne Johnson Trust dtd 04-16-2018	155,000	*	155,000	-	-	*
Andrew Lechter	174,066	*	100,537	-	73,529	*
Andrew Lowry	696,702	*	348,351	348,351	-	*
Andrew Van den Houten	232,234	*	116,117	116,117	-	*
Andy Davis	50,000	*	50,000	-	-	*
Angus J. Bruce	786,105	*	232,234	232,234	321,637	*
Ann Darda	942,728	*	232,234	232,234	478,260	*
Anthony & Angela Reed Family Trust dtd 05-30-2002	530,680	*	302,147	-	228,533	*
Anthony Eleftheriades	305,763	*	116,117	116,117	73,529	*
Anthony Nieto 401k Profit Sharing Plan	464,468	*	232,234	232,234	-	*
Ardara Capital LP	928,936	*	464,468	464,468	-	*
Arthur Steinberg	40,800	*	30,000	-	10,800	*
Ashbaugh Living Trust dtd 2-28-2000	77,433	*	77,433	-	-	*
Ashit & Minaxi Vijapura	68,000	*	50,000	-	18,000	*


	Shares
	Beneficially		Common Stock		Number of
	Owned	%Owned	Offered in this	Warrant	Shares	% of shares
Name of Selling Stockholder	Pre-Offering⁽¹⁾	Pre-offering⁽²⁾	Offering	Shares	Post-Offering	Post offering⁽²⁾
Ashok Patel	33,333	*	33,333	-	-	*
Ashok Patel & Harshida Patel	1,359,807	*	593,591	199,721	566,495	*
Aurora Taylor-Rojas	1,857,872	*	928,936	928,936	-	*
Austin 1997 Trust	33,333	*	33,333	-	-	*
Bailey Family Trust	20,364	*	-	10,182	10,182	*
Barbara Clark	7,844	*	7,844	-	-	*
Baron Lonner	2,045,356	*	892,156	-	1,153,200	*
Barrett Marshall Miller	220,000	*	220,000	-	-	*
Barry Saxe	395,714	*	395,714	-	-	*
Barry Schifrin	25,000	*	25,000	-	-	*
Beacon Investments, LLC	7,980,042	*	-	8,815	7,971,227	*
Benito Tosi & Nicolena Tosi Rev Trust dtd 05-15-2014	1,119,198	*	232,234	232,234	654,730	*
Binit J. Shah	99,999	*	66,666	-	33,333	*
Blaine 2000 Revocable Trust	464,468	*	232,234	232,234	-	*
BMM Capital LLC	440,000	*	440,000	-	-	*
Boston Light Advisors, LLC	434,401	*	400,000	-	34,401	*
Bradley & Lori Abeson Family Trust dtd 08-26-1997	34,000	*	25,000	-	9,000	*
Bravo Papa, LLC	2,493,550	*	-	53,626	2,439,924	*
Brendan M. Thorson	746,736	*	196,078	-	550,658	*
Brenna Tanzosh	38,462	*	38,462	-	-	*
Brian & Veronica Kline	350,000	*	350,000	-	-	*
Brian Skillern	75,000	*	75,000	-	-	*
Brian Sterling	11,622	*	11,622	-	-	*
Brinda Thimmappa	175,000	*	100,000	-	75,000	*
Bruce & Laura Goethe	405,000	*	245,000	-	160,000	*
Bruce A. Clarke & Paula J. Ignatowicz Family Trust dtd 04-18-2000	23,076	*	15,384	-	7,692	*
Bruce H. Seyburn	136,220	*	136,220	-	-	*
Bruce Inglis & Nancy Inglis	75,000	*	75,000	-	-	*
Bruce Lansky Revocable Trust dtd 03-16-2011	50,000	*	50,000	-	-	*

Table of Contents


	Shares
	Beneficially		Common Stock		Number of
	Owned	%Owned	Offered in this	Warrant	Shares	% of shares
Name of Selling Stockholder	Pre-Offering⁽¹⁾	Pre-offering⁽²⁾	Offering	Shares	Post-Offering	Post offering⁽²⁾
Bruce Mcfadden	50,250	*	50,250	-	-	*
Bruce Seyburn	848,525	*	577,267	162,563	108,695	*
Bruce Wagner	620,000	*	400,000	-	220,000	*
Bryan Thompson	325,000	*	262,500	-	62,500	*
Byron Crowe	32,104	*	32,104	-	-	*
C. James & Karen A. Prieur	699,516	*	278,680	278,680	142,156	*
Calcott Family Trust	22,334	*	22,334	-	-	*
Calcott Family Trust	254,568	*	125,833	116,117	12,618	*
Callaham Family Education Trust 11-04-2015	50,000	*	50,000	-	-	*
Callaham Irrevocable Investment Trust I dtd 11-04-2015	725,000	*

Filing Compare · CytoDyn Inc.