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CytoDyn Inc.

For the period ended May 31, 2026. Filed Aug 31, 2026.

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About this filing

A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2026 · Filed Aug 31, 2026

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Previous report: 10-K

Period ended 2025-05-31; filed 2025-07-25.

0001558370-25-009617

ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Current report: 10-K

Period ended 2026-05-31; filed 2026-08-31.

0001175680-26-000014

Item 7. 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 81 previous paragraphs and 89 current paragraphs.

42 unchanged; 29 reworded; 18 added; 6 removed; 4 previous and 0 current paragraphs rearranged.

Tables are not compared: 16 previous and 6 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 (18)

Current report

Complete our Phase 2 study of leronlimab in patients with relapsed/refractory microsatellite-stable colorectal cancer, also known as the CLOVER study;

Current report

Conduct additional studies exploring leronlimab and its therapeutic potential in other solid-tumor oncology indications, including but not limited to metastatic triple-negative breast cancer; and

Current report

Pursue strategic partnerships that will fund, advance and/or expedite clinical development and regulatory progress towards the prospective commercialization of leronlimab.

Current report

• Refining and executing on our clinical strategy to focus on solid-tumor oncology;

Current report

• Recruiting and retaining key employees and consultants towards executing on clinical trial objectives, and sourcing and/or exploring strategic partnership opportunities;

Current report

• Entering into strategic partnerships with reputable industry third parties, to further the development of leronlimab in key respects;

Current report

• Entering into strategic partnerships with academic institutions and private organizations to further the development of leronlimab on a cost-effective basis;

Current report

• Further building out our patent portfolio around clinical developments and related observations; and

Current report

• Closing on strategic financing transactions to provide funding for the Company’s continued operations and initiatives.

Current report

In April 2026, the Company announced the successful completion of enrollment in its Phase 2 clinical study evaluating leronlimab in combination with trifluridine and tipiracil (TAS-102) plus bevacizumab in patients with CCR5-positive, microsatellite stable (MSS), relapsed/refractory metastatic colorectal cancer (mCRC), also known as CLOVER – CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen (ClinicalTrials.gov Identifier: NCT06699836). Enrollment concluded with just over 60 patients participating through several clinical sites located across the United States.

Current report

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

Current report

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 the Phase 1b/2 mTNBC study 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.

Current report

During this same time period, the Company also conducted a compassionate use study in patients with a variety of CCR5+ solid tumors in a Phase 2 Basket Study. This was a single-arm 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. 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.

Current report

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 provided leronlimab to support two preclinical 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 evaluated three groups of humanized mice: one control group, one group that received only leronlimab, and another group that received a combination of leronlimab and temozolomide. The primary objective of this study was to evaluate the effect of leronlimab on the primary tumor growth and occurrence of metastases in CCR5+ and CCR5- cells in humanized mice. Unfortunately, the unexpected aggressive behavior of the glioblastoma cell lines used for these studies rendered interpretation of these preclinical results difficult. Currently, the Company is pursuing follow-up murine studies, as well as an investigator-initiated pilot study in a group of patients with recurrent GBM.

Current report

The Company is currently in the process of commencing several projects towards the clinical development of leronlimab in GBM. We currently expect to commence at least one, and potentially multiple GBM projects in the next fiscal year. A pre-clinical project is already in progress, and we are currently exploring an opportunity to initiate a GBM pilot study in early 2027 with an academic institution partner that will be announced at a later date.

Current report

The decrease in interest and other expenses for the fiscal year ended May 31, 2026, compared with the prior fiscal year, was primarily due to lower interest on convertible notes payable, absence of losses on induced conversion and on derivatives in the most recent fiscal year. 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 fiscal year ended May 31, 2026 was partially offset by issuance costs related to the private placement of common stock and warrants through a placement agent.
Removed paragraphs (6)

Previous report

In June 2025, the Company announced that the first patient has been dosed in its Phase II trial evaluating the efficacy of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer (“CRC”), and that patient enrollment and opening additional clinical sites was underway through Syneos Health.

Previous report

As of July 25, 2025, nine clinical sites had been approved to participate in the Phase II CRC trial, and two patients had received at least one dose in the trial. For additional information, the CRC trial protocol is posted on the NCI Clinical Trials website, and can be viewed here: https://clinicaltrials.gov/study/NCT06699836?cond=colorectal%20cancer&intr=leronlimab&rank=1

Previous report

study, and to further examine the apparent mechanism behind the observed increase in survival as compared to existing treatment paths. In the interim, ongoing discussions with KOLs are being conducted towards initiating a study in patients with mTNBC on an abbreviated timeline.

Previous report

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.

Previous report

The 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.
Reworded paragraphs (29)

Previous wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the other sections of this Form 10-K, including our consolidated financial statements and related notes set forth in Part II, Item 8. This discussion and analysis contains forward-looking statements, including information about possible or assumed results of our operations, our performance, financial condition, plans, and objectives, that

Current wording

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the other sections of this Form 10-K, including our consolidated financial statements and related notes set forth in Part II, Item 8. This discussion and analysis contains forward-looking statements, including information about possible or assumed results of our operations, our performance, financial condition, plans and objectives, which involve risks, uncertainties and assumptions. The actual results may differ materially from those anticipated and set forth in such forward-looking statements. See Forward-Looking Statements preceding Part I and Item 1A, Risk Factors in this Form 10-K.

Previous wording

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

We may need significant additional funding to execute the above business strategy in full, which may include conducting a variety of 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.

Current wording

We may need significant additional funding to execute the above business strategy in full, which may include conducting a variety of additional preclinical 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.

Previous wording

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 II 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).

Current wording

In August 2024, the Company completed a meeting with the FDA to gain alignment on the rationale and proposed dosing for a Phase 2 study investigating the 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").

Previous wording

In October 2024, the Company engaged Syneos Health as the contract research organization (“CRO”) for its Phase II trial, which will evaluate the efficacy of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer (“CRC”). 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.

Current wording

In October 2024, the Company engaged Syneos Health as the contract research organization (“CRO”) for its Phase 2 study 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 artificial intelligence ("AI")/machine learning capabilities to improve outcomes at every stage of the asset lifecycle, from clinical development to commercialization.

Previous wording

In November 2024, the Company received clearance from the US Food and Drug Administration (“FDA”) to commence its Phase II CRC trial, evaluating the efficacy of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer. This milestone reflected the continued positive development of the Company’s improved relationship with the FDA.

Current wording

In November 2024, the Company received clearance from the FDA to commence its Phase 2 CRC study. This milestone reflects the continued improvement in the Company’s relationship with the FDA.

Previous wording

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.

Current wording

In June 2025, the first patient was dosed in the CRC study and patient enrollment and initiation of additional clinical sites commenced through Syneos Health. As requested by the FDA, the first five patients enrolled in this study received 350 mg of leronlimab subcutaneously once/week in combination with TAS-102 and bevacizumab. After a preliminary safety review, subsequent patients were then randomized to 350 or 700 mg of weekly leronlimab with the same background regimen. The Data and Safety Monitoring Board (DSMB) performed a second safety review after the first 20 patients completed at least 1 cycle of therapy.

Previous wording

In July 2025, the Company announced encouraging historical clinical findings among patients with advanced mCRC, previously treated with leronlimab. The final 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. The 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 II CRC trial.

Current wording

In July 2025, the Company presented clinical data at the European Society for Medical Oncology (“ESMO”) Gastrointestinal Cancers Congress 2025, sharing 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 between April 2020 and January 2021 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 study.

Previous wording

In February and March 2025, the Company announced encouraging survival outcomes among a group of patients with mTNBC treated with leronlimab in the Company’s 2019 trial(s). Although mTNBC patients typically have a poor prognosis, observed survival rates at 12, 24, 36, and 48 months after treatment with leronlimab compare favorably with reported life expectancy after treatment with currently approved therapies. In addition, the Company confirmed that a small group of patients who failed treatment after developing metastatic disease survived more than 48 months after receiving leronlimab, are alive today, and currently identify as having no evidence of ongoing disease.

Current wording

In February and March 2025, the Company announced encouraging survival outcomes among a group of patients with mTNBC treated with leronlimab in the aforementioned 2019 study(ies). Although mTNBC patients typically have a poor prognosis, observed survival rates at 12, 24, 36, and 48 months after treatment with leronlimab compare favorably with reported life expectancy after treatment with currently approved therapies. In addition, the Company confirmed that a small group of patients who failed treatment after developing metastatic disease survived more than 48 months after receiving leronlimab, are alive today, and currently identify as having no evidence of ongoing disease.

Previous wording

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 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.

Current wording

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 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 patients’ circulating tumor cells. 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.

Previous wording

The Company is currently in the process of resuming its clinical development in mTNBC, with the intention to prospectively confirm the retrospective observations in mTNBC outlined above. In early 2025, the Company announced several preclinical studies in TNBC intended to identify treatment strategies to optimize the design of a future Phase II

Current wording

The Company is currently in the process of resuming its clinical development in mTNBC, with the intention to prospectively confirm the retrospective observations in mTNBC outlined above. The Company currently expects to commence at least one, and potentially multiple studies in patients with breast cancer, with the first such study set to start enrolling in the Fall of 2026.

Previous wording

The Company has an active and ongoing joint development agreement with a third-party company with generative AI drug discovery and development tools in an effort to develop one or more longer-acting molecules. The Company believes this collaboration 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.

Current wording

The Company has an active and ongoing joint development agreement with a third-party company with generative AI drug discovery and development tools in an effort to develop one or more longer-acting molecules. If successful, a longer-acting formulation has the potential to improve patient convenience, support chronic administration where appropriate, and enhance the commercial profile of leronlimab across selected indications. This joint development initiative remains in progress at this time, and the Company will provide further updates when appropriate.

Previous wording

The Company’s operating results may fluctuate significantly depending on the outcomes, number and timing of 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 Company 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. Refer toRisk Factors,Liquidity and Capital Resources, andGoing Concern sections included in this report.

Current wording

The Company’s operating results may fluctuate significantly depending on the outcomes, number and timing of preclinical 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-cash charges. Our ability to continue to fund operations will depend on our ability to raise additional funds. Refer to Risk Factors, Liquidity and Capital Resources and Going Concern sections included in this Form 10-K.

Previous wording

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.

Current wording

The increase in G&A expenses for the fiscal year ended May 31, 2026, compared to the prior fiscal year, was primarily attributable to salaries, benefits, and other compensation arising from headcount increases.

Previous wording

The decrease in R&D expenses in the fiscal year ended May 31, 2025, compared to the prior fiscal year, was primarily due to a return of clinical expenses related to the settlement of the Company’s litigation with Amarex in July 2024. Refer to Note 9,Commitments and Contingencies – Legal Proceedings – Settlement of Amarex Disputefor further information.

Current wording

The increase in R&D expenses in the fiscal year ended May 31, 2026, compared to the prior fiscal year, was due to higher clinical expenses related to the Phase 2 preclinical study of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer. Additionally, the primary factor contributing to the increase in R&D expenses was a return of clinical expenses related to the settlement of the Company’s litigation with Amarex in July 2024.

Previous 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, 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 preclinical and clinical studies for oncology and inflammation, as well as the timing and outcomes of efforts to develop a long-acting new or modified therapeutic.

Previous wording

will require a significant amount of additional capital in the future as we continue to seek approval to commercialize leronlimab. Despite the Company’s negative working capital position, vendor relations remain relatively accommodative given liquidity constraints. We cannot be certain, however, 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 are deemed favorable to both parties under then current circumstances and as necessary to fund our current and projected cash needs.

Current wording

As of May 31, 2026, we had a total of approximately $11.9 million in cash and cash equivalents, and approximately $53.7 million in short-term liabilities consisting primarily of approximately $12.0 million representing the short-term portion of the principal and accrued interest on convertible notes payable, and approximately $32.1 million in accounts payable and accrued liabilities and compensation. We will 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 the Company’s negative working capital position, vendor relations remain relatively accommodative given liquidity constraints. We cannot be certain, however, 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 are deemed favorable to both parties under then current circumstances and as necessary to fund our current and projected cash needs.

Previous wording

The Company’s cash and cash equivalents position of approximately $11.9 million and zero restricted cash, respectively, on May 31, 2025, increased by approximately $8.8 million and decreased by $6.7 million, respectively, compared to the cash balance of approximately $3.1 million and restricted cash balance of approximately $6.7 million on May 31, 2024.

Current wording

The Company’s cash and cash equivalents position of approximately $11.9 million on May 31, 2026, had little change compared to the cash balance of approximately $11.9 million on May 31, 2025.

Previous wording

Net cash used in operating activities totaled approximately $8.8 million during the fiscal year ended May 31, 2025, representing an improvement of approximately $2.2 million compared to the prior year. The increase in the net amount of cash provided by operating activities was due primarily to a legal settlement of approximately $10.0 million, offset by additional clinical research payments. Refer to Note 9,Commitments and Contingencies – Legal Proceedings – Settlement of Amarex Disputefor further information.

Current wording

Net cash used in operating activities totaled approximately $17.3 million during the fiscal year ended May 31, 2026, representing an increase of approximately $8.5 million compared to the prior year. 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 $10.9 million, a decrease of approximately $0.9 million compared to the prior year. The decrease in net cash provided was primarily the result of raising less funds from private placements of common stock and warrants, offset by an increase in funds raised from warrant exchange transactions.

Current wording

Net cash provided by financing activities totaled approximately $17.2 million, an increase of approximately $6.3 million compared to the prior year. The increase in net cash provided was primarily the result of the private sale of common stock and warrants.

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 as amended in April 2025 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 May 31, 2025, the outstanding balance of the April 2, 2021 Note, including accrued interest, was approximately $8.2 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 as amended in March 2026 accrues interest daily at a rate of 5% per annum, has a stated conversion price of $10.00 per share, and matures in April 2029. As of May 31, 2026, the outstanding balance of the April 2, 2021 Note, including accrued interest, was approximately $8.7 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 as amended in April 2025 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 May 31, 2025, the outstanding balance of the April 23, 2021 Note, including accrued interest, was approximately $37.1 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 as amended in March 2026 accrues interest daily at a rate of 5% per annum, has a stated conversion price of $10.00 per share, and matures in April 2029. As of May 31, 2026, the outstanding balance of the April 23, 2021 Note, including accrued interest, was approximately $29.6 million.

Previous wording

We have 1,750.0 million authorized shares of common stock. The table below summarizes intended uses of common stock.

Current wording

We have 2,250.0 million authorized shares of common stock. The table below summarizes intended uses of common stock.

Previous wording

As a result, as of May 31, 2025, we had approximately 187.7 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, discontinue operations or liquidate assets.

Current wording

As a result, as of May 31, 2026, we had approximately 291.3 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.

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. Net income of $3.7 million for the fiscal year ended May 31, 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 had an accumulated deficit of $887.8 million as of May 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

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. Net income of $3.7 million for the fiscal year ended May 31, 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 had an accumulated deficit of $930.5 million as of May 31, 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.

Previous wording

The Company had no activities that produced revenue in the periods presented and had operating losses since inception. The Company’s continuation 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, to pursue its research into multiple indications for and development of its product candidate, to obtain FDA approval of its product candidate for use in treating one or more indications, to outsource manufacturing of its product, and ultimately to attain profitability. We intend to seek additional funding through equity or debt offerings, licensing agreements, supply and distribution agreements, and strategic alliances to implement our business strategies. There are no assurances, however, that we will be successful in these endeavors. If we are not able to raise capital on a timely basis on favorable terms, if at all, we may need to significantly change or scale back operations, including pursuing other development and commercialization initiatives and obtaining adequate funding to cover the costs of the legal proceedings in which we are involved, all of which individually or in combination could materially impede our ability to achieve profitability. The Company’s failure to raise additional capital could also affect our relationships with key vendors and disrupt our ability to timely execute our business plan. In extreme cases, the Company could be forced to file for bankruptcy protection, discontinue operations, or liquidate assets.

Current wording

The Company had no activities that produced revenue in the periods presented and has had operating losses since inception. The Company’s continuation 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, to pursue its research into multiple indications for and development of its product candidate, to obtain FDA approval of its product candidate for use in treating one or more indications, to outsource manufacturing of its product and ultimately to attain profitability. We intend to seek additional funding through equity or debt offerings, licensing agreements, supply and distribution agreements, and strategic alliances to implement our business strategies. There are no assurances, however, that we will be successful in these endeavors. If we are not able to raise capital on a timely basis on favorable terms, if at all, we may need to significantly change or scale back operations, including pursuing other development and commercialization initiatives and obtaining adequate funding to cover the costs of the legal proceedings in which we are involved, all of which individually or in combination could materially impede our ability to achieve profitability. The Company’s failure to raise additional capital could also affect our relationships with key vendors and disrupt our ability to timely execute our business plan. In extreme cases, the Company could be forced to file for bankruptcy protection, discontinue operations or liquidate assets.

Previous wording

Since 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 its future development activities and its working capital needs primarily from the sale of equity and debt securities. As of June 30, 2025, the Company had approximately 172.8 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. 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.

Current wording

Since 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 its future development activities and its working capital needs primarily from the sale of equity and debt securities. As of July 31, 2026, the Company had approximately 206.3 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. 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.

Previous wording

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.

Current wording

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 into account our circumstances and expectations for the future based on available information. We evaluate these estimates on an ongoing basis.
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Previous report — wording carried elsewhere

Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

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involve risks, uncertainties, and assumptions. The actual results may differ materially from those anticipated and set forth in such forward-looking statements. SeeForward-Looking Statements preceding Part I and Item 1A,Risk Factors in this Form 10-K.

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As of May 31, 2025, we had a total of approximately $11.9 million in cash and cash equivalents, and approximately $70.5 million in short-term liabilities consisting primarily of approximately $45.4 million representing the principal of and accrued interest on convertible notes payable, net of unamortized debt discount, and approximately $16.9 million in accounts payable and accrued liabilities and compensation. We will continue to incur operating losses and the Company

Previous report — wording carried elsewhere

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.