CNS Pharmaceuticals, Inc.

Previous wording

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the financial statements and the related notes appearing elsewhere in this Form 10-Q. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. See Item 1A. “Risk Factors” of our Form 10-K for the year ended December 31, 2024, available on the Security and Exchange Commission's (“SEC”) EDGAR website at www.sec.gov, for a discussion of the uncertainties, risks and assumptions associated with these statements. Actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors, including those set forth under “Risk Factors” and elsewhere in this Form 10-Q.

Current wording

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the financial statements and the related notes appearing elsewhere in this Form 10-Q. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties. See Item 1A. “Risk Factors” of our Form 10-K for the year ended December 31, 2024, available on the Securities and Exchange Commission's (“SEC”) EDGAR website at www.sec.gov, for a discussion of the uncertainties, risks and assumptions associated with these statements. Actual results and the timing of events could differ materially from those discussed in our forward-looking statements as a result of many factors, including those set forth under “Risk Factors” and elsewhere in this Form 10-Q.

Previous wording

Although we believe the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy or completeness of any of these forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. We are under no duty to update any of these forward-looking statements after the date of this Form 10-Q to conform our prior statements to actual results or revised expectations, and we do not intend to do so.

Current wording

Although we believe the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy or completeness of any of these forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Except as required by law, we are under no duty to update any of these forward-looking statements after the date of this Form 10-Q to conform our prior statements to actual results or revised expectations, and we do not intend to do so.

Previous wording

We are a clinical pharmaceutical company organized as a Nevada corporation in July 2017 to focus on the development of anti-cancer drug candidates for the treatment of brain and central nervous system tumors, based on intellectual property that we license under license agreements with Cortice Biosciences, Inc. (“Cortice”) and own pursuant to a collaboration and asset purchase agreement with Reata Pharmaceuticals, Inc. (“Reata”).

Current wording

We are a clinical-stage pharmaceutical company organized as a Nevada corporation in July 2017 to focus on the development of anti-cancer drug candidates for the treatment of brain and central nervous system tumors, based on intellectual property that we license under license agreements with Cortice Biosciences, Inc. (“Cortice”) and own pursuant to a collaboration and asset purchase agreement with Reata Pharmaceuticals, Inc. (“Reata”).

Previous wording

On March 25, 2025, CNS released topline data from a primary analysis of a clinical trial being conducted to evaluate the efficacy of Berubicin in patients with Glioblastoma Multiforme who have failed primary treatment for their disease. The trial compared the efficacy of Berubicin to that of Lomustine, a current standard of care in this setting, with a 2 to 1 randomization of the 252 patients to Berubicin or Lomustine. Patients receiving Berubicin were administered a 2-hour IV infusion of 7.5 mg/m2 berubicin hydrochloride daily for three consecutive days followed by 18 days off (a 21-day cycle). Lomustine is administered orally once every six weeks. The trial design included a pre-planned, non-binding interim futility analysis. We reached the criteria required by the study protocol to conduct this interim futility analysis, which an independent Data Safety Monitoring Board (“DSMB”) was responsible for conducting. The DSMB’s charter mandated that they review the primary endpoint, Overall Survival, as well as secondary endpoints and safety data to determine whether the efficacy data for the risk-benefit profile warrants modification or discontinuation of the study. On December 18, 2023, we released the DSMB’s recommendation which was to continue the study without modification. On March 25, 2025, we released topline data showed that although Berubicin produced clinically relevant outcomes that appear to be comparable (although the trial was not powered to determine non-inferiority) to Lomustine across multiple endpoints, it did not demonstrate a statistically significant difference in overall survival, the primary endpoint. Nevertheless, given the dearth of alternative approved therapies for GBM, we believe Berubicin has demonstrated potential value as a possible treatment for Glioblastoma. As such we are currently evaluating whether any potential paths forward exist for the program. Any such path will be planned and executed in consultation with the FDA. Even if Berubicin is approved, there is no assurance that patients will choose an infusion treatment, as compared to the current standard of care, which requires oral administration.

Current wording

On March 25, 2025, we released topline data from a primary analysis for the clinical trial being conducted to evaluate the efficacy of Berubicin in patients with Glioblastoma Multiforme who have failed primary treatment for their disease. The trial compared the efficacy of Berubicin to that of Lomustine, a current standard of care in this setting, with a 2 to 1 randomization of the 252 patients to Berubicin or Lomustine. Patients receiving Berubicin were administered a 2-hour IV infusion of 7.5 mg/m2 berubicin hydrochloride daily for three consecutive days followed by 18 days off (a 21-day cycle). Lomustine is administered orally once every six weeks. The trial design included a pre-planned, non-binding interim futility analysis. We reached the criteria required by the study protocol to conduct this interim futility analysis, which an independent Data Safety Monitoring Board (“DSMB”) was responsible for conducting. The DSMB’s charter mandated that they review the primary endpoint, Overall Survival, as well as secondary endpoints and safety data to determine whether the efficacy data for the risk-benefit profile warrants modification or discontinuation of the study. On December 18, 2023, we released the DSMB’s recommendation which was to continue the study without modification. On March 25, 2025, we released topline data that showed that although Berubicin produced clinically relevant outcomes that appear to be comparable (although the trial was not powered to determine non-inferiority) to Lomustine across multiple endpoints, it did not demonstrate a statistically significant difference in overall survival, the primary endpoint. Nevertheless, given the dearth of alternative approved therapies for GBM, we believe Berubicin has demonstrated potential value as a possible treatment for Glioblastoma. As such we are currently evaluating whether any potential paths forward exist for the program. Any such path will be planned and executed in consultation with the FDA. Even if Berubicin is approved, there is no assurance that patients will choose an infusion treatment, as compared to the current standard of care, which requires oral administration.

Previous wording

On July 29, 2024, we entered into an Exclusive License Agreement and Stock Purchase Agreement (collectively, the “Cortice Agreements”) with Cortice pursuant to which Cortice granted us an exclusive license to the intellectual property rights related to certain patents around the compound TPI 287 in the United States, Canada, Mexico and Japan. The term of the license will expire, other than due to a breach of the Cortice Agreements, at the end of the royalty term with respect to any licensed product in any of the included territories, which begins upon the first commercial sale in such territory and ends on the latest of (i) ten years after such sale, (ii) the expiration of regulatory or marketing exclusivity for such licensed product in such country, or (c) the expiration of the last to expire valid patent claim in such country covering such licensed product.

Current wording

On July 29, 2024, we entered into an Exclusive License Agreement and Stock Purchase Agreement (collectively, the “Cortice Agreements”) with Cortice pursuant to which Cortice granted us an exclusive license to the intellectual property rights related to certain patents around the compound TPI 287 in the United States, Canada, Mexico and Japan. The term of the license will expire, other than due to a breach of the Cortice Agreements, at the end of the royalty term with respect to any licensed product in any of the included territories, which begins upon the first commercial sale in such territory and ends on the latest of (i) ten years after such sale, (ii) the expiration of regulatory or marketing exclusivity for such licensed product in such country, or (iii) the expiration of the last to expire valid patent claim in such country covering such licensed product.

Previous wording

General and administrative expense was approximately $1,242,000 for the three months ended June 30, 2025 compared to approximately $1,412,000 for the comparable period in 2024. The decrease in general and administrative expense is attributable to decreases of approximately $36,000 in legal and professional expenses, $19,000 in travel expenses, $195,000 in stock-based compensation, which were offset by increases of approximately $51,000 in compensation expense and $29,000 in insurance expense.

Current wording

General and administrative expense was approximately $1,057,000 for the three months ended September 30, 2025 compared to approximately $1,384,000 for the comparable period in 2024. The decrease in general and administrative expense is attributable to decreases of approximately $207,000 in legal and professional expenses, $211,000 in stock-based compensation, and $22,000 in other expense, which were offset by increases of approximately $45,000 in travel expenses, $41,000 in compensation expense and $27,000 in marketing expense.

Previous wording

Research and development expense was approximately $1,167,000 for the three months ended June 30, 2025 compared to approximately $1,117,000 for the comparable period in 2024. The increase in research and development expense during the period is primarily attributable to declining trial costs on the Berubicin trial offset by expenditures preparing for a TPI 287 trial including drug manufacturing.

Current wording

Research and development expense was approximately $2,197,000 for the three months ended September 30, 2025 compared to approximately $4,245,000 for the comparable period in 2024. The decrease in research and development expense during the period is primarily attributable to an approximately $1,628,000 decline in trial costs for the Berubicin trial and a reduction of approximately $979,000 in TPI 287 expense due to expenses incurred as part of the in-licensing of TPI 287 in the prior year period which is partially offset by expenditures preparing for a TPI 287 trial including drug manufacturing.

Previous wording

The net loss for the three months ended June 30, 2025 was approximately $2,375,000 compared to approximately $2,531,000 for the comparable period in 2024. The change in net loss is primarily attributable to declining trial costs on the Berubicin trial.

Current wording

The net loss for the three months ended September 30, 2025 was approximately $3,218,000 compared to approximately $5,606,000 for the comparable period in 2024. The change in net loss is primarily attributable to declining trial costs on the Berubicin trial and by lower general and administrative expenses.

Previous wording

Results of Operations for the Six Months Ended June 30, 2025 Compared to the Six Months Ended June 30, 2024

Current wording

Results of Operations for the Nine Months Ended September 30, 2025 Compared to the Nine Months Ended September 30, 2024

Previous wording

General and administrative expense was approximately $2,337,000 for the six months ended June 30, 2025 compared to approximately $2,526,000 for the comparable period in 2024. The decrease in general and administrative expense is attributable to decreases of approximately $316,000 in stock-based compensation, $106,000 in marketing and advertising expenses, which were offset by increases of approximately $40,000 in legal and professional expenses, $62,000 in travel expenses, $105,000 in compensation expense and $26,000 in other expenses.

Current wording

General and administrative expense was approximately $3,394,000 for the nine months ended September 30, 2025 compared to approximately $3,910,000 for the comparable period in 2024. The decrease in general and administrative expense is attributable to decreases of approximately $527,000 in stock-based compensation, $108,000 in marketing and advertising expenses, and $186,000 in legal and professional expenses, which were offset by increases of approximately $106,000 in travel expenses, $123,000 in compensation expense, $42,000 in insurance expense and $34,000 in other expenses.

Previous wording

The net loss for the six months ended June 30, 2025 was approximately $6,676,000 compared to approximately $6,076,000 for the comparable period in 2024. The change in net loss is primarily attributable to timing of trial costs on the Berubicin trial partially offset by lower G&A expenses.

Current wording

The net loss for the nine months ended September 30, 2025 was approximately $9,895,000 compared to approximately $11,681,000 for the comparable period in 2024. The change in net loss is primarily attributable to timing of trial costs on the Berubicin trial and by lower general and administrative expenses.

Previous wording

On June 30, 2025, we had cash of approximately $12,130,000 and we had a working capital of approximately $12,755,000. We fund our operations from proceeds from equity sales.

Current wording

On September 30, 2025, we had cash of approximately $9,864,000 and we had a working capital of approximately $9,447,000. We have historically funded our operations with proceeds from equity sales and expect this to continue for the foreseeable future.

Previous wording

On July 26, 2024, we entered into a Sales Agreement (the “AGP ATM Sales Agreement”) with A.G.P./Alliance Global Partners (“AGP”). During the six months ended June 30, 2025, we sold 127,582 shares of common stock pursuant to the AGP ATM Sales Agreement for net proceeds of approximately $9 million. As of June 30, 2025, we had sold 210,230 shares of common stock pursuant to the AGP ATM Sales Agreement for net proceeds of approximately $22.8 million.

Current wording

On July 26, 2024, we entered into a Sales Agreement (the “AGP ATM Sales Agreement”) with A.G.P./Alliance Global Partners (“AGP”). During the nine months ended September 30, 2025, we sold 127,582 shares of common stock pursuant to the AGP ATM Sales Agreement for net proceeds of approximately $9 million. As of November 14, 2025, we had sold 255,940 shares of common stock pursuant to the AGP ATM Sales Agreement for net proceeds of approximately $23.2 million.

Previous wording

On May 13, 2025, the Company entered into a placement agency agreement with AGP for the public offering of (i) 27,084 shares) of common stock; (ii) pre-funded warrants to purchase 302,298 shares of common stock (the “Pre-Funded Warrants”); and (iii) Series F Warrants to purchase up to an aggregate of 329,381 shares of common stock (the “Common Warrants”). The net proceeds from the offering were approximately $4.5 million.

Current wording

On May 13, 2025, the Company entered into a placement agency agreement with AGP for the public offering of (i) 27,084 shares of common stock; (ii) pre-funded warrants to purchase 302,295 shares of common stock (the “Pre-Funded Warrants”); and (iii) Series F Warrants to purchase up to an aggregate of 329,381 shares of common stock (the “Common Warrants”). The net proceeds from the offering were approximately $4.5 million.

Previous wording

We estimate that we have sufficient working capital to take us into the second half of 2026. At that point, we expect to have already initiated a trial of TPI 287, as well as completed the Berubicin trial including its final analysis. In addition, we have working capital to fund our operations during the intervening period (with such operations estimated at $4.5 to $5.0 million per annum). We do not currently have a firm trial design for TPI 287 so estimates of development cost are not available, however, regardless of trial design, the cost of bringing TPI 287 to regulatory approval for marketing will require significant additional financing. The timing and costs of clinical trials are difficult to predict and as such the foregoing estimates may prove to be inaccurate. We have no commitments for such additional needed financing and will likely be required to raise such financing through the sale of additional equity or debt securities.

Current wording

We estimated that we have sufficient working capital to take us into the second half of 2026. This estimate is based on the assumption that our core operations expense run rate is approximately $5.5 million per year; that the TPI 287 trial is initiated in the second quarter of 2026; and our Berubicin trial and final analysis is completed by the end of the second quarter of 2026. Based on a preliminary assessment of the trial design, we estimate our TPI 287 trial will cost between $12 to 15 million, however this range could materially change as a result of the final trial design. Regardless of the final trial design, the cost of bringing TPI 287 to regulatory approval for marketing will require significant additional financing, which we may be unable to obtain on acceptable terms or at all. Further, the timing and costs of clinical trials are difficult to estimate even with a locked design, and as such, the foregoing estimates may materially change. We have no commitments for such additional needed financing and will likely be required to raise such financing through the sale of additional equity or debt securities to execute our business plans. If we are unable to raise sufficient funds, we will be required to develop and implement an alternative plan to further extend payables, reduce overhead or scale back our business until sufficient additional capital is raised to support continued operations. There can be no assurance that such a plan will be successful and if it is not successful, we may need to cease operations entirely.

Previous wording

Net cash used in operating activities was approximately $8,585,000 and $4,842,000 for the six months ended June 30, 2025 and 2024, respectively, and mainly included payments made for clinical trial costs, drug manufacturing and development, officer compensation, insurance, marketing and professional fees to our consultants, attorneys and accountants.

Current wording

Net cash used in operating activities was approximately $10,759,000 and $11,642,000 for the nine months ended September 30, 2025 and 2024, respectively, and mainly included payments made for clinical trial costs, drug manufacturing and development, officer compensation, insurance, marketing, professional fees to our consultants, attorneys and accountants and stock-based compensation.

Previous wording

Net cash provided by financing activities was approximately $14,254,000 for the six months ended June 30, 2025, related to the sale of common stock, which were offset by the repayment of notes payable. Net cash provided by financing activities was approximately $5,785,000 for the six months ended June 30, 2024, related to the sale of common stock and exercise of warrants, which were offset by the repayment of notes payable.

Current wording

Net cash provided by financing activities was approximately $14,162,000 for the nine months ended September 30, 2025, related to the sale of common stock, which were partially offset by the repayment of notes payable. Net cash provided by financing activities was approximately $18,067,000 for the nine months ended September 30, 2024, related to the sale of common stock and exercise of warrants, which were partially offset by the repayment of notes payable.