Skip to main content

CytoDyn Inc.

For the period ended Aug 31, 2025. Filed Oct 10, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Aug 31, 2025 · Filed Oct 10, 2025

CYDYStored price and day change unavailable

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-02-28; filed 2025-04-14.

0001558370-25-004774

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Current report: 10-Q

Period ended 2025-08-31; filed 2025-10-10.

0001104659-25-098552

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 61 previous paragraphs and 62 current paragraphs.

41 unchanged; 16 reworded; 4 added; 3 removed; 1 previous and 1 current paragraphs rearranged.

Tables are not compared: 9 previous and 9 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (4)

Current report

At the Company’s annual meeting scheduled for November 21, 2025, our stockholders will be asked to vote on an amendment to the Company’s Certificate of Incorporation to provide for an increase in the total number of shares of common stock authorized for issuance from 1,750,000 shares to 2,250,000 shares. As of September 30, 2025, the Company had approximately 164.5 million authorized by unissued shares of common stock available for issuance in future financing transactions.

Current report

authorized for issuance from 1,750,000 shares to 2,250,000 shares, the Company will be limited in its ability to engage in equity financing activities to pursue the Company’s business strategy over the next 12 months.
Removed paragraphs (3)

Previous report

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 Company’s 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 continue to be maintained so that they can be used in the future if needed.
Reworded paragraphs (16)

Previous wording

Forward-looking statements include, among others, statements about leronlimab, its ability to have 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 FDA and, potentially, drug regulatory agencies in 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 enter into or maintain partnership or licensing arrangements with third parties; (v) the Company’s ability to recruit and retain key employees; (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 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) stockholder actions or proposals with regard to the Company, its management, or its Board of 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.

Current wording

Forward-looking statements may include, among others, statements about leronlimab, its ability to have 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 FDA and, potentially, drug regulatory agencies in 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 enter into or maintain partnership or licensing arrangements with third parties; (v) the Company’s ability to recruit and retain key employees; (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 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) stockholder actions or proposals with regard to the Company, its management, or its Board of 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.

Previous wording

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

Current wording

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

Previous wording

The decrease in G&A expenses for the three- and nine-month periods ended February 28, 2025, compared to the same periods in the prior 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.

Current wording

The increase in G&A expenses for the three-month period ended August 31, 2025, compared to the same period in the prior year, was primarily due to other, and salaries, benefits, and other compensation. Other increased due to additional consulting costs. Salaries, benefits, and other compensation increased primarily due to additional headcount at the Company.

Previous wording

The increase in R&D expenses in the three-month period ended February 28, 2025, compared to the same period in the prior year, was primarily due to an increase in clinical expenses due to initial costs related to the Phase II trial of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer and the classification of clinical employees’ compensation as a research and development cost in the current fiscal year. The increase in R&D expenses was partially offset by a decrease in license and patent fees due to reduced manufacturing license fees agreed to in the three-month period ended February 28, 2025.

Current wording

The increase in R&D expenses in the three-month period ended August 31, 2025, compared to the same period in the prior year, was primarily due to a return of clinical expenses related to the settlement of the Company’s litigation with Amarex in the prior period. Additionally, clinical expenses increased due to costs related to the Phase II trial of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer in the current period.

Previous wording

The future trend of our R&D expenses is dependent on the costs of any future clinical trials, 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, the timing and outcomes of such efforts, and the timing of the final close-out of closed studies.

Current wording

The 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.

Previous wording

The decrease in interest and other expenses for the three- and nine-month periods ended February 28, 2025, compared with the same periods in the prior 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.

Current wording

The decrease in interest and other expenses for the three-month period ended August 31, 2025, compared with the same period in the prior year, was primarily due to the decreases in loss on induced conversion, loss on derivatives, and interest on convertible notes payable. The decrease in loss on induced conversion is due to the note payments in the current 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 current period. The decrease in interest on convertible notes payable is due to a lower interest rate in the current period compared to the prior period.

Previous wording

As of February 28, 2025, we had a total of approximately $16.4 million in cash and cash equivalents and approximately $70.6 million in short-term liabilities. We expect to continue to incur operating losses and require a significant amount of capital in the future as we continue to seek approval to commercialize leronlimab. There can be no 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 arrangements are deemed acceptable to both parties under then current circumstances and as necessary to fund our current and projected cash needs. As of March 31, 2025, we have approximately 193.7 million shares of common stock available for issuance in new financing transactions.

Current wording

As of August 31, 2025, we had a total of approximately $9.3 million in cash and cash equivalents and approximately $69.4 million in short-term liabilities. We expect to continue to incur operating losses and require a significant amount of capital in the future as we continue to seek approval to commercialize leronlimab. There can be no 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 arrangements are deemed acceptable to both parties under then current circumstances and as necessary to fund our current and projected cash needs. As of September 30, 2025, we had approximately 164.5 million shares of common stock available for issuance in new financing transactions. Consequently, if the Company’s stockholders do not vote, at the Company’s annual meeting in November 2025, to approve an amendment to the Company’s Certificate of Incorporation to provide for an increase in the total number of shares of common stock

Previous wording

The Company’s cash and cash equivalents position of approximately $16.4 million and no restricted cash as of February 28, 2025, increased by approximately $13.3 million and decreased by approximately $6.7 million, respectively, when compared to the balance of $3.1 million and $6.7 million, respectively, as of May 31, 2024. This increase was primarily the result of approximately $10.0 million cash received for a legal settlement, the release of the $6.7 million in cash collateral, and approximately $9.7 million in cash provided by financing activities during the nine months ended February 28, 2025. Refer to Item 1, Note 2,Summary of Significant Accounting Policies – Going Concern, and theGoing 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:

Current wording

The Company’s cash and cash equivalents position of approximately $9.3 million as of August 31, 2025, decreased by approximately $2.6 million when compared to the balance of $11.9 million as of May 31, 2025. This decrease was primarily the result of approximately $2.5 million cash used in operating activities. Refer to Item 1, Note 2,Summary of Significant Accounting Policies – Going Concern, and theGoing 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:

Previous wording

Net cash used in operating activities totaled approximately $3.1 million during the nine months ended February 28, 2025, representing an improvement of approximately $6.2 million compared to the nine months ended February 29, 2024. The increase in the net amount of cash provided by operating activities was due primarily to a legal settlement of approximately $10.0 million. Refer to Note 9,Commitments and Contingencies – Legal Proceedings – Settlement of Amarex Disputefor further discussion.

Current wording

Net cash used in operating activities totaled approximately $2.5 million during the three months ended August 31, 2025, representing an increase of approximately $7.9 million compared to the three months ended August 31, 2024. The increase in the net amount of cash used in operating activities was due primarily to a one-time legal settlement of approximately $10.0 million in the prior period.

Previous wording

Net cash provided by financing activities totaled approximately $9.7 million during the nine months ended February 28, 2025, an increase of approximately $1.4 million compared to the nine months ended February 29, 2024. The increase in net cash provided was primarily the result of raising funds through a warrant exchange tender offer during the current period compared to a lower amount raised through private placements of common stock and warrants in the prior period.

Current wording

Net cash provided by financing activities totaled approximately $0.1 million during the three months ended August 31, 2025, a decrease of approximately $9.8 million compared to the three months ended August 31, 2024. The decrease in net cash provided was primarily the result of no significant fundraising during the current period.

Previous wording

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 note accrues interest daily at a rate of 10% per annum, has a stated conversion price of $10.00 per share, and matures in April 2025. Subsequent to February 28, 2025, the Company and the noteholders entered into an amendment to the note, extending the maturity date by one year, changing the required monthly payment, and lowering the interest rate to 6%. For more information, see Note 10,Subsequent Eventsin Part I, Item 1 of this Form 10-Q. As of February 28, 2025, the outstanding balance of the April 2, 2021 Note, including accrued interest, was approximately $8.1 million.

Current wording

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 note accrues interest daily at a rate of 6% per annum, has a stated conversion price of $10.00 per share, and matures in April 2026. As of August 31, 2025, the outstanding balance of the April 2, 2021 Note, including accrued interest, was approximately $8.3 million.

Previous wording

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 note accrues interest daily at a rate of 10% per annum, has a stated conversion price of $10.00 per share, and matures in April 2025. Subsequent to February 28, 2025, the Company and the noteholders entered into an amendment to the note, extending the maturity date by one year, changing the required monthly payment, and lowering the interest rate to 6%. For more information, see Note 10,Subsequent Events* *in Part I, Item 1 of this Form 10-Q. As of February 28, 2025, the outstanding balance of the April 23, 2021 Note, including accrued interest, was approximately $37.8 million.

Current wording

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 note accrues interest daily at a rate of 6% per annum, has a stated conversion price of $10.00 per share, and matures in April 2026. As of August 31, 2025, the outstanding balance of the April 23, 2021 Note, including accrued interest, was approximately $35.4 million.

Previous wording

As of February 28, 2025, we had approximately 193.7 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.

Current wording

As of August 31, 2025, we had approximately 167.0 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.

Previous wording

Refer to Note 3,Accrued Liabilities and Compensation, Note 4,Convertible Instruments and Accrued Interest, and Note 9*, Commitments and Contingencies* included in Part I, Item 1 of this Form 10-Q, and Notes 5 and 10 in Part II, Item 8 in the 2024 Form 10-K.

Current wording

Refer to Note 3,Accrued Liabilities and Compensation, Note 4,Convertible Instruments and Accrued Interest, and Note 9*, Commitments and Contingencies* included in Part I, Item 1 of this Form 10-Q, and Notes 4 and 9 in Part II, Item 8 in the 2025 Form 10-K.

Previous wording

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, except for the nine months ended February 28, 2025. Net income of $9.7 million in the nine months ended February 28, 2025, 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 has an accumulated deficit of approximately $881.8 million as of February 28, 2025. 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.

Current wording

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, except for the three months ended August 31, 2024. Net income of $19.2 million in the three months ended August 31, 2024, 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 has an accumulated deficit of approximately $893.3 million as of August 31, 2025. 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.

Previous wording

This discussion and analysis of the Company’s financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of our financial statements and related disclosures requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenue and expenses during the reporting period. The Company’s critical accounting estimates are described under the headingManagement’s Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting Estimates in our 2024 Form 10-K.

Current wording

This discussion and analysis of the Company’s financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of our financial statements and related disclosures requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of expenses during the reporting period. The Company’s critical
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

accounting estimates are described under the headingManagement’s Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting Estimates in our 2025 Form 10-K.
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

The decrease in R&D expenses in the nine-month period ended February 28, 2025, compared to the same period in the prior year, was primarily due to a return of clinical expenses related to the settlement of the Company’s litigation with Amarex in July 2024.