CYDY

CytoDyn Inc.

OTC · HEALTH CARE · PHARMACEUTICAL PREPARATIONS

0.26

+0.02 +8.33%

USD · close Oct 23

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MKT CAP $359.3MP/E —DIV YIELD —FCF YIELD —REV TTM —NET INCOME −$42.7M −1240.2%NET DEBT $26.5M52W 0.19 – 0.37SEC XBRL · TTM TO Invalid Date

How CYDY rewrote its risk factors

10-K ITEM 1A · FY2025 → FY2026

Text kept

79%

of sentences unchanged

Added

new sentences

Dropped

sentences removed

Length

+59

words, now 10,111

New in FY2026

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.
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. • 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. • Although we have reached an agreement in principle to resolve the ongoing class-action litigation filed against us, failure to finalize the contemplated settlement may result in material harm to our business. • We are subject to oversight by the SEC, FDA and other regulatory agencies.
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 and changes in priorities at the FDA and other government agencies caused by funding shortages, Executive Orders or other factors 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.
As of July 31, 2026, we had an unrestricted cash balance of approximately $12.2 million and no reserved cash balance.
In addition, as of July 31, 2026, we had approximately 206.3 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 $31.0 million on July 31, 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 study of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer; conducting additional studies exploring leronlimab and its therapeutic potential in other solid-tumor oncology indications, including but not limited to metastatic triple-negative breast cancer; pursuing research and development of longer-acting molecules; and evaluating other opportunities for preclinical studies and publishing data from previously conducted studies.
The continued low trading price of our common stock (with a closing price of $0.19 per share on July 31, 2026) presents a significant challenge to our ability to raise additional funds.
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, 2026.
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.
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.
Refer to Part II, Item 8, Note 10, Commitments and Contingencies – Legal Proceedings in this Form 10-K for additional information.
Although we have reached an agreement in principle to resolve the ongoing class-action litigation filed against us, failure to finalize the contemplated settlement may result in material harm to our business.
On November 23, 2025, we reached an agreement in principle to settle the securities class action pending in federal district court in the state of Washington.
The agreement in principle provides for payment by the Company to the class of $500,000 in cash and issuance of 49 million shares of our common stock in exchange for the dismissal and release of all claims against all defendants in the class action, subject to final documentation, court approval and other conditions.
There is no assurance that the settlement will ultimately be finalized on the terms currently contemplated, or at all.
The inability of the parties to finalize the settlement may have a material adverse effect on our financial condition, results of operations, cash flows and stock price.
Refer to Part II, Item 8, Note 10, Commitments and Contingencies – Securities Class Action Lawsuits in this Form 10-K for further information.
Pourhassan was sentenced to 30 months imprisonment to be followed by three years of supervised release, was ordered to self-surrender by April 27, 2026, and was ordered to pay $5,392,280 in restitution.
The Company cooperated fully with the DOJ and SEC investigations.
In September 2025, the SEC and DOJ informed the Company that their respective investigations are effectively closed, and that nothing further is required of the Company.
Refer to Part II, Item 8, Note 10, Commitments and Contingencies – Legal Proceedings in this Form 10-K for further information.
We face risks and uncertainties related to litigation and other claims.
Refer to Part II, Item 8, Note 10, Commitments and Contingencies – PRO 140 Acquisition and Licensing Arrangements in this Form 10-K for further information.
Disruptions and changes in priorities at the FDA and other government agencies caused by funding shortages, Executive Orders or other factors 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.
President 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.
Additionally, the Trump Administration has announced a number of changes to its grantmaking procedures in favor of a holistic review process that weighs alignment with agency priorities, public health needs, and other factors in making funding decisions.
If funding is reduced for studies related to the medical indications on which we are focused 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.
We are dependent on the success of leronlimab.
If a third party claims our actions, 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, • substantial damages for infringement if a court determines that our products or technologies infringe a third party’s patent or other proprietary rights, • 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.
From July 31, 2025, through July 31, 2026, the market price of our common stock has fluctuated from a high of $0.40 per share to a low of $0.19 per share.
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.

Gone since FY2025

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. 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. ● 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 class-action litigation filed against us could harm our business, and insurance coverage may not be sufficient to cover all related costs and damages. ● We are subject to oversight by the SEC, FDA, and other regulatory agencies.
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.
As of June 30, 2025, we had an unrestricted cash balance of approximately $12.1 million and no reserved cash balance.
In addition, as of June 30, 2025, we had approximately 172.8 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 $16.1 million on June 30, 2025.
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 study of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer; conducting a study of leronlimab in patients with metastatic triple-negative breast cancer; pursuing research and development of longer-acting molecules; and evaluating other opportunities for pre-clinical studies and publishing data from previously conducted studies.
The continued low trading price of our common stock (with a closing price of $0.27 per share on June 30, 2025) presents a significant challenge to our ability to raise additional funds.
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, 2025.
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.
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.
Refer to Part II, Item 8, Note 9, Commitments and Contingencies – Legal Proceedings in this Form 10-K for additional information.
The class-action litigation filed against us could harm our business, and insurance coverage may not be sufficient to cover all related costs and damages.
The securities class action lawsuits filed against the Company in March 2021 have exhausted certain coverage allowances under the Company’s D&O insurance applicable to the relevant time period.
This litigation, whether or not successful, may require us to incur substantial costs, which could harm our business and financial condition.
During the course of litigation, negative public announcements regarding the results of hearings, motions, or other interim proceedings or developments may occur, which could have a further negative effect on the market price of our common stock.
Refer to Part II, Item 8, Note 9, Commitments and Contingencies – Securities Class Action Lawsuits in this Form 10-K for further information.
We have received 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.
Kazempour are currently scheduled to be sentenced in September 2025.
The Company is cooperating fully with the DOJ and SEC investigations.
Refer to Part II, Item 8, Note 9, Commitments and Contingencies – Legal Proceedings in this Form 10-K for further information. We face risks and uncertainties related to litigation and other claims.
Refer to Part II, Item 8, Note 9, Commitments and Contingencies – Legal Proceedings in this Form 10-K for further information.
Refer to Part II, Item 8, Note 9, Commitments and Contingencies – PRO 140 Acquisition and Licensing Arrangements in this Form 10-K for further information.
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.
President Trump has issued Executive Orders that may significantly reduce the federal workforce and could adversely affect the FDA’s ability to attract and retain qualified scientific reviewers, which could result in longer review times for our applications.
Additionally, 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 focused 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. We are dependent on the success of leronlimab.
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, ● substantial damages for infringement if a court determines that our products or technologies infringe a third party’s patent or other proprietary rights, ● 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.
From June 1, 2024, through June 30, 2025, the market price of our common stock has fluctuated from a high of $0.49 per share to a low of $0.10 per share.
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.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2025 ↗, FY2026 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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