Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C., 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ ANNUAL 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. (Exact Name of Registrant as Specified in its Charter) (St ...

Core Insights - CNS Pharmaceuticals has launched a new corporate strategy aimed at building a high-value pipeline in neurology and oncology, two rapidly growing sectors in biopharma [1] - The newly formed executive team is focused on acquiring differentiated therapeutic assets and leveraging their extensive experience in drug development [1] - A comprehensive strategic review was conducted to evaluate the existing pipeline and market opportunities, incorporating various analytical models [1] Company Strategy - The company is pivoting from a singular focus on glioblastoma to a broader strategy that includes acquiring or in-licensing preclinical and clinical-stage assets in neurology and oncology [1] - CNS Pharmaceuticals aims to prioritize programs with strong biological rationale, differentiated mechanisms of action, and compelling clinical and commercial potential [1] - The company plans to explore out-licensing of legacy assets TPI 287 and berubicin to concentrate resources on new acquisitions [1] Market Context - Neurology and oncology are identified as two of the most active and rapidly advancing sectors in biotechnology, supported by large global markets and significant scientific innovation [1] - The strategic transformation is seen as a common and successful approach in biotechnology, with the potential to create substantial value [1] - The company is committed to advancing novel treatments that address significant unmet medical needs while creating long-term value for patients and shareholders [1]

Core Viewpoint - CNS Pharmaceuticals, Inc. has appointed Dr. Lynne Kelley as Chief Medical Officer, bringing extensive experience in drug development and regulatory strategy, particularly in oncology and CNS [1] Group 1: Leadership Appointment - Dr. Kelley has over two decades of global leadership experience in clinical development, translational medicine, and regulatory strategy [1] - The newly formed executive team is focused on execution and the evolution of the company, emphasizing value for patients and stakeholders [1] Group 2: Company Focus - CNS Pharmaceuticals specializes in developing novel treatments for primary and metastatic cancers affecting the brain and central nervous system [1]

Core Viewpoint - CNS Pharmaceuticals, Inc. has appointed Rami Levin as the new President and Chief Executive Officer, succeeding John Climaco, indicating a leadership change aimed at enhancing the company's strategic direction in biopharmaceuticals focused on cancer treatments [1] Group 1: Leadership Change - John Climaco has stepped down as Chief Executive Officer of CNS Pharmaceuticals [1] - Rami Levin, MBA, has been appointed as the new President and Chief Executive Officer [1] Group 2: Executive Background - Rami Levin brings nearly 30 years of global leadership experience in various medical fields including oncology, neurology, rare diseases, endocrinology, and cell and gene therapy [1] - Levin has a proven track record of scaling organizations and advancing late-stage clinical programs [1] - His experience includes driving transformative value creation within the biopharmaceutical sector [1]

PresentationJohn ClimacoCEO, President & Director Welcome, everyone. The Annual Meeting of the Stockholders of CNS Pharmaceuticals, Inc. is hereby convened and called to order. I'm John Climaco, CEO and President of CNS Pharmaceuticals, Inc., and I welcome all of you to the company's Annual Meeting of Stockholders. Christopher Downs, the Chief Financial Officer of the company by active Secretary of the meeting and Inspector of the election. This meeting has been called pursuant to do notice. Proxies were s ...

Core Insights - CNS Pharmaceuticals, Inc. is focused on advancing next-generation anti-cancer therapies that are engineered to cross the blood-brain barrier, potentially improving efficacy for patients [1] - The lead program, TPI 287, is progressing towards a Phase 2 study for the treatment of glioblastoma multiforme (GBM), a highly aggressive brain cancer with a median survival of approximately 15 months from diagnosis [1] - The company expects its cash reserves to fund operations into the second half of 2026, indicating a stable financial position for ongoing research and development [1] Financial Performance - CNS Pharmaceuticals reported its financial results for the third quarter ended September 30, 2025, highlighting its commitment to developing treatments for brain and central nervous system cancers [1] - The company is entering the final quarter of the year with a focus on delivering meaningful developments for patients battling these cancers [1]

Financial Performance - General and administrative expenses decreased to approximately $1,057,000 for the three months ended September 30, 2025, down from approximately $1,384,000 in the same period in 2024, reflecting a reduction of about 23.5%[70] - Research and development expenses were approximately $2,197,000 for the three months ended September 30, 2025, compared to approximately $4,245,000 in the same period in 2024, indicating a decline of about 48.3%[71] - The net loss for the three months ended September 30, 2025, was approximately $3,218,000, a reduction from approximately $5,606,000 in the comparable period in 2024, representing a decrease of about 42.5%[72] - General and administrative expenses decreased to approximately $3,394,000 for the nine months ended September 30, 2025, down from approximately $3,910,000 in 2024, reflecting a reduction of about 13.2%[73] - Research and development expenses were approximately $6,607,000 for the nine months ended September 30, 2025, compared to approximately $7,792,000 in 2024, a decrease of about 15.2%[74] - The net loss for the nine months ended September 30, 2025, was approximately $9,895,000, an improvement from a net loss of approximately $11,681,000 in 2024, representing a reduction of about 15.3%[75] - Net cash used in operating activities was approximately $10,759,000 for the nine months ended September 30, 2025, compared to $11,642,000 in 2024, a decrease of about 7.6%[80] - Net cash provided by financing activities was approximately $14,162,000 for the nine months ended September 30, 2025, compared to $18,067,000 in 2024, a decrease of about 21.7%[81] Cash and Working Capital - As of September 30, 2025, the company had cash of approximately $9,864,000 and working capital of approximately $9,447,000[76] - The company estimates sufficient working capital to last into the second half of 2026, based on an annual core operations expense run rate of approximately $5.5 million[79] - The company has no commitments for additional financing and may need to raise funds through the sale of equity or debt securities to support operations[79] Research and Development - The decrease in research and development expenses was primarily due to a decline of approximately $1,628,000 in trial costs for the Berubicin trial[71] - The estimated cost for the TPI 287 trial is projected to be between $12 million and $15 million, subject to final trial design[79] Clinical Trials and Drug Development - TPI 287 has been granted Orphan Drug Designation by the FDA, potentially providing market exclusivity of 7 years upon approval of a New Drug Application[61] - Berubicin's clinical trial for Glioblastoma Multiforme involved 252 patients, with a 2 to 1 randomization to Berubicin or Lomustine, and the trial design included a pre-planned interim futility analysis[65] - The first patient in the Berubicin trial was treated during the third quarter of 2021, with overall survival as the primary endpoint recognized by the FDA for oncology drug approval[64] - The company is exploring additional intellectual property rights for compounds to develop drugs for brain and other cancers, contingent on securing further financing[68] Licensing and Manufacturing - The company entered into an Exclusive License Agreement with Cortice for TPI 287, covering the United States, Canada, Mexico, and Japan, with the license term expiring after ten years from the first commercial sale[69] - The company does not have manufacturing facilities and outsources all manufacturing activities to third parties[66]

Core Viewpoint - Premarket trading is showing notable activity with significant price movements indicating potential investment opportunities before the market opens [1] Premarket Gainers - FGI Industries Ltd. (FGI) is up 278% at $15.02 [3] - Senmiao Technology Limited (AIHS) is up 96% at $4.22 [3] - Conifer Holdings, Inc. (CNFR) is up 86% at $2.11 [3] - WEBTOON Entertainment Inc. (WBTN) is up 39% at $20.81 [3] - Nukkleus Inc. (NUKK) is up 18% at $6.08 [3] - Tantech Holdings Ltd (TANH) is up 12% at $2.13 [3] - Check-Cap Ltd. (CHEK) is up 9% at $2.33 [3] - Ivanhoe Electric Inc. (IE) is up 8% at $9.71 [3] - Wolfspeed, Inc. (WOLF) is up 8% at $3.21 [3] - Bolt Projects Holdings, Inc. (BSLK) is up 5% at $3.95 [3] Premarket Losers - Envirotech Vehicles, Inc. (EVTV) is down 17% at $2.27 [4] - Dave & Buster's Entertainment, Inc. (PLAY) is down 15% at $20.40 [4] - NanoVibronix, Inc. (NAOV) is down 12% at $9.37 [4] - ADTRAN Holdings, Inc. (ADTN) is down 10% at $9.37 [4] - Rain Enhancement Technologies Holdco, Inc. (RAIN) is down 10% at $6.00 [4] - CNS Pharmaceuticals, Inc. (CNSP) is down 7% at $8.50 [4] - AVITA Medical, Inc. (RCEL) is down 7% at $6.22 [4] - Vince Holding Corp. (VNCE) is down 7% at $2.60 [4] - Monte Rosa Therapeutics, Inc. (GLUE) is down 6% at $6.50 [4] - Meiwu Technology Company Limited (WNW) is down 6% at $2.06 [4]

Group 1 - Maxim upgraded CNS Pharmaceuticals (CNSP) to Buy from Hold with a price target of $20 [1] - The company is focusing on its oncology asset TPI-287, which is a blood-brain barrier crossing taxane in development for recurrent glioblastoma [1] - CNS Pharma's roadmap for TPI-287, along with a potential path forward with Berubicin and cash runway extending into the second half of 2026, positions the stock for recovery [1]

CNS Pharmaceuticals FY Conference Summary Company Overview - CNS Pharmaceuticals specializes in neuro-oncology treatments for primary and metastatic brain cancers, focusing on drugs that effectively cross the blood-brain barrier [2][4] - The company has a strong financial position with over $12 million in cash as of Q2 2025, sufficient to fund operations into the second half of 2026 [2][22] Core Products TPI-287 - TPI-287 is a late-stage, blood-brain barrier-penetrant abiotoxin from the taxane class, designed to treat glioblastoma multiforme (GBM) [3][12] - The drug has shown promising results in clinical trials, with a median overall survival of 13.4 months for second-line GBM patients, compared to 6-8 months for standard treatments [15][16] - TPI-287 has fast-track and orphan designations, and the company plans to initiate a Phase 2 study in the first half of 2026 [14][24] Berubicin - Berubicin is a novel blood-brain barrier-penetrant anthracycline, currently under evaluation after a pivotal study involving 252 patients [17][18] - Although it did not meet its primary endpoint, it is considered clinically relevant as it provides a potential third-line treatment option for GBM patients who have limited options [19][20] - The drug has shown no cardiotoxicity in patients, which could represent a significant breakthrough for the anthracycline class [21][22] Market Opportunity - The primary brain cancer market is valued in the multi-billion dollar range, despite being classified as orphan diseases with approximately 15,000 new GBM cases annually in the U.S. [5][6] - There is a significant unmet need for effective treatments, as current therapies are ineffective in 60% of GBM patients [10][11] - The company also sees potential in the metastatic brain cancer market, particularly for patients with triple-negative breast cancer, which has 45,000 cases of brain metastases annually [6][7] Clinical Development and Strategy - CNS Pharmaceuticals has established a global network of investigators and trial sites, enhancing the efficiency of its clinical trials [8][9] - The company emphasizes the importance of patient concierge services to facilitate participation in studies, recognizing the difficult decisions faced by patients and families [9][10] - The focus on well-understood drug classes (taxanes and anthracyclines) aids in clinician acceptance and regulatory engagement [10][13] Financial Position - CNS Pharmaceuticals has a market cap significantly discounted to its cash reserves, indicating potential undervaluation in the current biotech market [22][23] - The company is led by experienced executives with a history of successful drug development, enhancing confidence in its future prospects [23][24] Conclusion - CNS Pharmaceuticals is positioned to make a significant impact in the neuro-oncology space with its innovative drug candidates, strong financial backing, and strategic clinical development approach, addressing critical unmet needs in the treatment of GBM and metastatic brain cancers [2][24]