Table of Contents As filed with the Securities and Exchange Commission on January 10, 2024. Registration No. 333-275973 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CNS Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) Nevada 2834 82-2318545 (I.R.S. Empl ...

Table of Contents As filed with the Securities and Exchange Commission on December 8, 2023. Registration No. 333-___ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CNS Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation or Organization) Nevada 2834 82-2318545 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Nu ...

Table of Contents SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ______________ Commission file number: 001-39126 CNS Pharmaceuticals, Inc. (Name of registrant as specified in its charter) Nevada 82-2318545 (Stat ...

Financial Instruments and Capital - The company entered into a short-term note payable for an aggregate of $449,874, bearing interest at 5.88% per year, with a balance of $166,396 as of June 30, 2023[41]. - The company sold 659,677 shares of common stock for net proceeds of $1,969,107 during the quarter ended June 30, 2023[43]. - The company sold 58,591 shares of common stock for net proceeds of $124,279 under the Capital on Demand™ Sales Agreement, with a total sales price of up to $20.0 million[69]. - The company has authorized 75,000,000 shares of common stock and 5,000,000 shares of preferred stock[42]. Stock-Based Compensation - The company recognized $544,248 of stock-based compensation related to outstanding stock options for the six months ended June 30, 2023[56]. - The company has a weighted average remaining term of 7.20 years for outstanding stock options as of June 30, 2023[48]. - The Board of Directors approved the issuance of 6,500 options to Dr. Cockroft at an exercise price of $2.27, contingent upon shareholder approval[70]. Research and Development - The company has committed to fund approximately $1,134,000 over a two-year period for research related to novel anticancer agents targeting CNS malignancies[66]. - The company is exploring additional patent protections related to Berubicin to extend intellectual property protections[62]. - The company received Fast Track Designation from the FDA for Berubicin, facilitating its development and review[63]. - The Company agreed to pay WPD an upfront payment of $225,000 and a subsequent payment of $775,000 upon the verified achievement of the Phase II Milestone[68]. Internal Controls and Compliance - As of June 30, 2023, the Company's disclosure controls and procedures were deemed ineffective due to material weaknesses in internal control over financial reporting[131]. - Management is addressing the lack of formal documentation in the control environment and is working with a third-party CRO to improve data reporting timeliness and completeness[131]. Legal and Risk Factors - The Company is involved in legal proceedings, but cannot estimate potential losses from these matters[133]. - The Company has insurance policies covering potential losses where such coverage is cost-effective[133]. - The Company faces additional risks and uncertainties that may adversely affect its business and financial condition, as discussed in the "Risk Factors" section of the 2022 Annual Report[134]. Executive Compensation - The company approved cash bonuses totaling $550,750 to the officers on March 29, 2023[52].

In addition to the other information set forth in this report, you should carefully consider the factors discussed in the section entitled "Risk Factors" in our 2022 Annual Report on Form 10-K, filed with the SEC, which are incorporated herein by reference, as well as the additional risk factors set forth below. The risks described in such reports are not the only risks facing our Company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materi ...

| --- | --- | --- | --- | |--------------|-------|-------|------------------------------------------------------------------------------------| | | | | | | | | | | | NASDAQ: CNSP | | | | | | | | | | April 2023 | | | www.cnspharma.com 2100 West Loop South, Suite 900 Houston, TX 77027 (800) 946-9185 | Forward-Looking Statements This presentation incorporates information from materials filed with the SEC and contains forward-looking statements. All statements contained herein other than statements of historica ...

Regulatory Approvals and Product Development - The company has not yet obtained any regulatory approvals for its drug candidates, including Berubicin, and has no products approved for sale[37] - The company is dependent on the success of Berubicin, as it has no other clinical-stage drug candidates in its portfolio[57] - The company may face increased expenses if required by the FDA to perform additional studies or trials beyond current expectations[60] - The company may experience delays in clinical trial enrollment and completion, which could increase product development costs and limit regulatory approval[91] - The company does not have agreements for supplies of Berubicin or other product candidates, which may affect commercialization if approvals are granted[97] - The company may seek collaborations with more experienced firms to manage the high costs associated with developing pharmaceutical products, conducting clinical trials, and obtaining regulatory approvals[99] Financial Performance and Condition - The company reported recurring losses from operations, raising substantial doubt about its ability to continue as a going concern[32] - The net loss for the year ended December 31, 2022, was $15,274,134, compared to a net loss of $14,495,200 for 2021, primarily due to decreased research and development costs[170] - The company has a history of negative cash flows from operations and expects to continue reporting such losses, raising substantial doubt about its ability to continue as a going concern[207] - Total operating expenses for the year ended December 31, 2022, were $15,267,107, an increase of 5.4% from $14,485,915 in 2021[215] - Net loss for the year ended December 31, 2022, was $15,274,134, compared to a net loss of $14,495,200 in 2021, representing an increase of 5.4%[218] Research and Development - Research and development expenses were $9,300,055 for the year ended December 31, 2022, a decrease from $9,805,075 in 2021, attributed to reduced manufacturing activity and a credit from WPD Pharmaceuticals[168] - Research and development expenses for the year ended December 31, 2021, were adjusted to $1,888,803 from $1,521,364, indicating an increase of about 24.2%[204] - The company plans to focus on completing a clinical trial for Berubicin, with expectations of increased research and development costs as the trial progresses[162] Capital and Funding - The company will require substantial additional capital to continue clinical development and commercialization activities, but the exact amount is uncertain[54] - The company intends to raise additional funds through equity or convertible debt securities, which could dilute existing stockholders' ownership[136] - The company plans to seek additional funding through equity offerings, debt financings, and other collaborations to support its operations[207] - The company estimates it will require additional financing of approximately $8 to $12 million to complete the Phase 2 trial for Berubicin, considering its cash on hand[162] Competition and Market Risks - The company faces intense competition from larger pharmaceutical companies with greater resources, which may hinder its ability to develop and commercialize its product candidates[72] - The expiration of U.S. patents in March 2020 may increase competition for the company's products, particularly for Berubicin, which has received Orphan Drug Designation[73] - The company faces competition from rivals that may offer more effective, safer, or cheaper products, which could hinder its commercial success[101] Legal and Compliance Risks - The company may be subject to litigation or product liability claims, which could divert significant resources[51] - The company may incur substantial costs due to litigation related to patent and intellectual property rights[102] - The company is not currently involved in any pending legal actions and has insurance policies covering potential losses[145] Internal Controls and Governance - The company has identified a material weakness in its internal controls over financial reporting, which has led to the correction of previously issued financial statements for multiple periods[113] - The company does not carry insurance for all categories of risk, which may expose it to significant liabilities[108] - The company is subject to the continued listing requirements of The Nasdaq Capital Market, including minimum stockholder's equity and market value of publicly-held shares[137] Stockholder Information - As of March 31, 2023, the company had approximately 10,000 stockholders of record, excluding beneficial owners[128] - The company has never declared or paid cash dividends on its capital stock and does not expect to do so in the foreseeable future[129] - The weighted average shares outstanding increased to 1,361,737 in 2022 from 878,443 in 2021, indicating potential dilution from equity financing[215] Cash Flow and Assets - Cash used in operating activities was $10,557,815 for the year ended December 31, 2022, compared to $13,538,309 for 2021, reflecting payments for drug development and other operational costs[163] - Cash and cash equivalents increased to $10,055,407 as of December 31, 2022, compared to $5,004,517 in 2021, representing a growth of about 100.5%[213] - The company reported a net change in cash and cash equivalents of $5,050,890 for the year ended December 31, 2022, compared to a decrease of $(9,034,976) in 2021, indicating a positive cash flow trend[218]

Table of Contents SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ______________ Commission file number: 001-39126 CNS Pharmaceuticals, Inc. (Name of registrant as specified in its charter) Nevada 82-2318545 (Stat ...

| --- | --- | --- | |--------------|-------|------------------------------------------------------------------------------------| | | | | | | | | | NASDAQ: CNSP | | | | | | | | August 2022 | | www.cnspharma.com 2100 West Loop South, Suite 900 Houston, TX 77027 (800) 946-9185 | 2 Forward-Looking Statements This presentation incorporates information from materials filed with the SEC and contains forward-looking statements. All statements contained herein other than statements of historical fact, including sta ...

Table of Contents SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ______________ Commission file number: 001-39126 CNS Pharmaceuticals, Inc. (Name of registrant as specified in its charter) Nevada 82-2318545 (State or ...