SEC Form 10-K filed by CNS Pharmaceuticals Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C., 20549
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| ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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DOCUMENTS INCORPORATED BY REFERENCE
Portions of this registrant’s definitive proxy statement for its 2026 Annual Meeting of Stockholders to be filed with the SEC no later than 120 days after the end of the registrant’s fiscal year are incorporated herein by reference in Part III of this Annual Report on Form 10-K.
TABLE OF CONTENTS
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References in this Form 10-K to “we”, “us”, “its”, “our” or the “Company” are to CNS Pharmaceuticals, Inc., as appropriate to the context.
Cautionary Statement About Forward-Looking Statements
We make forward-looking statements under the “Risk Factors,” “Business,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in other sections of this report. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “should,” “would,” “could,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential” or “continue,” and the negative of these terms and other comparable terminology. These forward-looking statements, which are subject to known and unknown risks, uncertainties and assumptions about us, may include projections of our future financial performance based on our growth strategies and anticipated trends in our business. These statements are only predictions based on our current expectations and projections about future events. There are important factors that could cause our actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. In particular, you should consider the numerous risks and uncertainties described under “Risk Factors”.
While we believe we have identified material risks, these risks and uncertainties are not exhaustive. Other sections of this report may describe additional factors that could adversely impact our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible to predict all risks and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
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 report to conform our prior statements to actual results or revised expectations, and we do not intend to do so.
Forward-looking statements include, but are not limited to, statements about:
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our ability to secure rights to new pipeline assets via in-licensing, acquisition or collaboration;
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| · | our ability to obtain additional funding to develop our product candidates; | |
| · | our ability to maintain compliance with the NASDAQ Capital Market’s continued listing requirements, including any new continued listing requirements that are approved in the future; | |
| · | our ability to continue as a going concern given our current financial condition; | |
| · | the need to obtain regulatory approval of our product candidates; | |
| · | the success of our clinical trials through all phases of clinical development; | |
| · | compliance with obligations under intellectual property licenses with third parties; | |
| · | any delays in regulatory review and approval of product candidates in clinical development; | |
| · | our ability to commercialize our product candidates; | |
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| · | market acceptance of our product candidates; | |
| · | competition from existing products or new products that may emerge; | |
| · | potential product liability claims; | |
| · | our dependency on third-party manufacturers to supply or manufacture our products; | |
| · | our ability to establish or maintain collaborations, licensing or other arrangements; | |
| · | our ability and third parties’ abilities to protect intellectual property rights; | |
| · | our ability to adequately support future growth; and | |
| · | our ability to attract and retain key personnel to manage our business effectively. |
We caution you not to place undue reliance on the forward-looking statements, which speak only as of the date of this report in the case of forward-looking statements contained in this report.
You should not rely upon forward-looking statements as predictions of future events. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. We qualify all of our forward-looking statements by these cautionary statements. Although we believe that the expectations reflected in the forward looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Therefore, you should not rely on any of the forward-looking statements. In addition, with respect to all of our forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
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PART I
| Item 1. | Business. |
Overview
CNS Pharmaceuticals, Inc. (“CNS,” the “Company,” “we,” “us,” or “our”) is a biotechnology company focused on developing innovative therapies for serious diseases in neurology and oncology. Together, these therapeutic areas represent hundreds of billions of dollars in annual global pharmaceutical spending, encompass some of the most prevalent and difficult to treat diseases affecting humanity, and are characterized by significant unmet medical need. Significant progress has been made in the biological and molecular understanding of these diseases, enabling a shift to high-value disease-modifying therapies and precision medicine approaches. Together with advancements in diagnostic capabilities to aid in patient selection, there is the potential to improve the probability of success and reduce development timelines. We believe this combination of scale, urgency, and scientific development creates compelling opportunities for differentiated therapeutic approaches and novel mechanisms of action. Our executive team was purposefully built to focus on high-value therapeutic opportunities in these therapeutic areas and the Company is working to build a differentiated portfolio of assets with best-in-class potential to address significant unmet medical needs. CNS Pharmaceuticals is committed to advancing novel treatments that have the potential to improve patient outcomes.
Recent Developments
On January 1, 2026, the Company appointed Rami Levin, MBA, as President & Chief Executive Officer. Following Mr. Levin’s appointment, we engaged an independent life science focused advisory firm to conduct a comprehensive data-driven analysis of the Company including our pipeline, development priorities and long-term positioning (the “Strategic Analysis”). While this Strategic Analysis was being completed, we rebuilt the Company’s executive leadership team by appointing a new Chief Business Officer, Chief Financial Officer, Chief Medical Officer and Chief Technology Officer effective March 2, 2026. This executive team was assembled to execute on the findings and recommendations of the Strategic Analysis and develop and execute a new corporate strategy.
On March 11, 2026, we announced a new corporate growth strategy focused on building a high-value pipeline in neurology and oncology. This strategy follows the comprehensive, data-driven strategic review that incorporated clinical probability-of-success modeling, competitive landscape assessments, regulatory pathway analyses, and risk-adjusted return evaluations. Based on this work, we are pursuing a disciplined approach to identify, acquire or in-license differentiated preclinical and clinical-stage assets with strong biological rationale, validated or emerging clinical data, and clear development and regulatory pathways. We are prioritizing opportunities with near- to mid-term value inflection points, meaningful commercial potential, and relevance to our team’s expertise, while maintaining capital discipline. We have initiated a global asset search and are actively evaluating opportunities aligned with these criteria, with a focus on areas where investor interest, partnering activity, and long-term value creation potential are strongest.
Also on March 11, 2026, as part of our new corporate strategy, we announced that we are pivoting from the Company’s historical singular focus on glioblastoma multiforme (“GBM”). The Company’s prior development programs centered on two investigational compounds, TPI 287 and Berubicin, both of which were designed to penetrate the blood-brain barrier and target cancers of the central nervous system such as GBM. We believe patients with GBM need better treatment options and that TPI 287 and Berubicin have the potential to address those needs, but they are not in line with our new strategic direction. As a result, we intend to explore out-licensing opportunities for TPI 287 and Berubicin.
Market Opportunity: Neurology & Oncology
Neurological disorders represent a staggering public health crisis of global proportions. The World Health Organization (“WHO”) and the Global Burden of Disease study identify neurological conditions as among the leading causes of disability and death worldwide. According to WHO, neurological disorders affect more than one billion people globally and are the leading cause of disability-adjusted life years (“DALYs”) when all conditions are aggregated across the spectrum of central nervous system (“CNS”) disease. Neurological conditions share several characteristics that make them particularly challenging to treat and commercially significant: they are largely chronic and progressive, they carry high caregiver burdens, they predominantly affect aging populations, and many remain without adequate disease-modifying treatments.
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Cancer is among the foremost causes of morbidity and mortality worldwide, imposing an enormous burden on individuals, healthcare systems, and economies globally. According to the WHO, cancer accounts for approximately 10 million deaths per year, which accounted for nearly one in six deaths globally. In 2022, the International Agency for Research on Cancer (“IARC”) recorded nearly 20 million new cancer cases and approximately 9.7 million cancer-related deaths worldwide. In the United States alone, the National Cancer Institute (“NCI”) estimated that approximately 2,041,910 new cancer cases will be diagnosed in 2025, with approximately 618,120 deaths attributable to the disease.
Our new strategic focus on neurology and oncology positions us in two of the largest, fastest-growing, and most scientifically dynamic sectors in biopharmaceuticals. Together, these therapeutic areas represent hundreds of billions of dollars of investment. The global neurological therapeutics market exceeds $138 billion while the global oncology therapeutics market is projected to reach $400 billion in the next decade. However, several large neurology and oncology indications still lack disease-modifying therapies or have poor outcomes. These large commercial opportunities have the potential to be addressed by leveraging the recent advancements in the understanding of these diseases and breakthroughs in drug development.
As a result, there are significant research and development efforts being undertaken across academia, non-profit institutions, governmental agencies, emerging biotechnology companies and multinational pharmaceutical companies to address these disease indications. In 2025, neurology and oncology focused companies received nearly 50 percent of the venture capital investments in therapeutics. They were also the most active therapeutic areas based on the number of business development transactions completed from 2022 to 2025. Oncology was the most active therapeutic area with 457 announced transactions completed during this period and neurology was the second most active with 205 announced completed transactions. During this period, total mergers & acquisitions and licensing transactions exceeded $100 billion in total value for both neurology and oncology. This activity spanned stage of development from preclinical through approved products as well as therapeutic modality, which we believe demonstrates the potential value that can be created in these therapeutic areas with novel and differentiated assets.
Based on this, we believe that 1) there are a significant number of assets in neurology and oncology that are available for in-licensing, and 2) there is an established group of potential strategic commercial partners. Several global biopharmaceutical companies including but not limited to AstraZeneca, Astellas Pharma, Bristol Myers Squibb, Biogen, GlaxoSmithKline, Merck, Novartis, Pfizer and Takeda have established franchises in neurology and/or oncology and have demonstrated track records of acquiring or partnering with companies developing product candidates in our target areas.
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Neurology Market Drivers
The need for differentiated and novel neurology therapeutics is being driven by multiple factors including aging global demographics. The global population aged 65 and over is projected to more than double from approximately 700 million in 2020 to 1.5 billion by 2050, according to UN demographic projections. Because the incidence of most major neurodegenerative diseases, such as Alzheimer's disease and Parkinson's disease, increases sharply with age, this demographic shift is expected to dramatically expand patient populations and healthcare costs worldwide. As an example, the U.S. Alzheimer's Association has estimated that if no disease-modifying treatment is found, the number of Americans with Alzheimer's could grow to 13 million by 2050. However, significant unmet medical need remains across nearly all areas of neurodegeneration. Until 2023 and 2024, there were no approved therapies that demonstrated an ability to slow underlying neurodegeneration in Alzheimer’s disease. Current treatments for Parkinson's disease manage symptoms but do not arrest neurodegeneration. No approved neuroprotective or disease-modifying therapies exist for amyotrophic lateral sclerosis (“ALS”) or Huntington's disease, among many others. According to the National Institute of Neurological Disorders and Stroke, there are a total of 131 neurologic disorders. However, a 2024 analysis by Thomas et al. published in Neurology (A Comprehensive Review of Novel FDA-approved Neurological Medications from 2018-2023, P7-4.009, Vol. 102) found that only 32 novel neurological therapies were approved by the FDA from 2018 – 2023 for patients with migraines (9), multiple sclerosis (4), Alzheimer’s disease (3), Parkinson’s disease (3), Epilepsy/seizures (3), ALS (2), Neuromyelitis Optica (2), and several others for rare neurological conditions. This unmet need underpins both the scientific urgency, medical need and the commercial opportunity.
Advancement in the biological understanding of these diseases, aided by biomarker discovery and enhanced diagnostic capabilities, are also leading to advancement in the field and uncovering new opportunities for drug development. The development of blood-based biomarkers for neuroinflammation, including amyloid tau protein for Alzheimer’s, has dramatically reduced the cost and complexity of patient stratification in clinical trials, increasing feasibility and accelerating development timelines. Fluid and imaging biomarkers are increasingly accepted by the FDA as surrogate endpoints, potentially lowering the bar for early-stage proof of concept. Small and mid-sized biotechnology companies now originate the majority of novel neurology compounds entering clinical development. According to the industry research and contract research organization, IQVIA, neurology is among the fastest-growing areas of Phase II/III clinical trial activity.
In addition, neurological disorders have the potential for accelerated regulatory pathways including breakthrough therapy, fast track, and priority review designations, which have the potential to shorten development and approval timelines and enable increased interaction with the FDA. Finally, several commercial neurology therapies are facing loss of exclusivity (“LOE”) by 2030. Based on these demographic, biological, medical, pharmacoeconomic and commercial considerations, we believe neurology is a therapeutic area on which to focus and deploy our resources.
Oncology Market Drivers
Cancer rates increase dramatically with age, and all major developed-market nations are experiencing rapid population aging. As noted above, IARC projects 33 million new cases per year by 2050. This represents a 65% increase over 2022 levels and is being driven in large part by demographic shifts rather than changes in per-capita risk. In the United States alone, the National Cancer Institute (NCI) estimated that approximately 2,041,910 new cancer cases will be diagnosed in 2025, with approximately 618,120 deaths attributable to the disease. Estimated national expenditures for cancer care in the United States reached approximately $208.9 billion in 2020 and are expected to grow materially as the population ages. As a result, the global oncology pharmaceutical market is the largest and fastest-growing category within biopharmaceuticals.
The past decade has witnessed transformative advances in cancer biology and drug development. Immune checkpoint inhibition, which is led by anti-programmed cell death 1 (anti-PD-1/PD-L1) and anti-cytotoxic T-lymphocyte associated protein 4 (“CTLA-4”) antibodies have become foundational to the treatment of dozens of cancers. These therapies generate over $40 billion in annual worldwide sales and have catalyzed billions of dollars in follow-on investment. Chimeric antigen receptor T-cell (“CAR-T”) therapy has achieved durable remissions in subsets of hematologic malignancies. Antibody-drug conjugate (“ADC”) technologies have experienced a major resurgence, with multiple approvals in breast cancer, bladder cancer, lung cancer, and other solid tumors. However, there continues to be a need for targeted therapies that can improve overall survival, quality of life and overall outcomes of patients with cancer. Several new modalities are emerging as promising cancer treatments including but not limited to protein degraders, bispecific antibodies, and next-generation immunotherapies. We believe the robust investment in cancer drug discovery has created an opportunity to identify and select assets, including those with an underlying validated platform technology, to establish a differentiated oncology pipeline.
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Recent treatment approaches in oncology also demonstrate the shift towards precision medicine and the development of therapies with improved efficacy and safety profiles compared to non-targeted chemotherapies and radiation. Genomic profiling using next-generation sequencing (“NGS”), liquid biopsy, and companion diagnostics has transformed the standard of care for many cancers, enabling the matching of patients to targeted therapies based on specific molecular alterations. This trend drives demand for biomarker-guided therapy development and creates opportunities for companies developing therapies against specific genomic targets (e.g., KRAS, EGFR, ALK, BRAF, HER2, FGFR, RET, and many others). As of 2025, over 50 cancer-specific molecular targets have FDA-approved companion diagnostics. Precision medicine has uncovered a broad array of validated biological targets that continues to expand. This shift has created clearly defined addressable patient populations for which there are established clinical benchmarks and potential accelerated regulatory pathways.
We expect neurology and oncology will continue to evolve rapidly, which will reshape the competitive landscape in these areas, thereby creating opportunities for us to build our pipeline and focus our future development efforts. Leveraging our team’s collective experience in these therapeutic areas and relevant functions, we believe we are well positioned to capitalize on evolving market dynamics and a broad set of assets to build a pipeline that is novel, differentiated and has the potential to be best-in-class.
Our Team
To execute our neurology and oncology focused strategy, the Company appointed a new executive team in the first quarter of 2026 that brings decades of hands-on experience in neurology and oncology, including rare diseases and across several therapeutic modalities. Our executive team has diverse experience in clinical development, regulatory affairs, chemistry, manufacturing and controls (“CMC”), business development, finance, capital markets, commercialization and company transformation.
The Company’s newly formed executive team includes:
| · | Rami Levin, Chief Executive Officer, appointed January 1, 2026 | |
| · | Lynne Kelley, M.D., FACS, Chief Medical Officer, appointed March 2, 2026 | |
| · | Dylan Wenke, Chief Business Officer, appointed March 2, 2026 | |
| · | Steve O’Loughlin, Chief Financial Officer, appointed March 2, 2026 | |
| · | Eric Faulkner, Chief Technology Officer, appointed March 2, 2026 |
Rami Levin, MBA, brings nearly 30 years of global leadership experience across oncology, CNS, rare diseases, endocrinology, and cell and gene therapy, with a proven track record of scaling organizations, advancing late-stage clinical programs, and driving transformative value creation. Previously, Mr. Levin held senior leadership roles as President & Chief Executive Officer of Saniona and CEO of ImStem Biotechnology. He led strategic turnarounds, sharpened pipeline focus, secured significant financing, and advanced multiple programs toward clinical and regulatory milestones. He has also held senior commercial and operational leadership roles at Sobi, Merck Serono, and Schering AG, where he successfully launched and scaled global brands including Rebif®, Betaseron®, Kuvan®, Orfadin®, and Gamifant®. Earlier in his career, he played a central role in global brand strategy and lifecycle management for Rebif®, one of the world’s leading multiple sclerosis therapies. Mr. Levin holds an MBA from the Recanati Business School at Tel Aviv University and a BSc in Biology from Tel Aviv University.
Lynne Kelley, M.D., served as Chief Medical Officer at multiple public and private biotechnology and medical device companies, including TISSIUM, Servier Pharmaceuticals, X4 Pharmaceuticals and Senseonics. She has led clinical development programs resulting in INDs, NDAs, PMAs, and breakthrough and orphan drug designations, and has presented safety and efficacy data to FDA advisory committees resulting in unanimous approval votes. Dr. Kelley has also played key roles in corporate strategy, fundraising and M&A, including contributing to multi-billion-dollar oncology transactions. Earlier in her career, Dr. Kelley held senior leadership roles at Becton Dickinson, where she oversaw global medical affairs and regulatory strategy across devices, drugs and combination products. She began her career in academic medicine as an Assistant Professor of Surgery and Interventional Radiology at Yale University. Dr. Kelley holds an MD from Dartmouth Medical School and a BA in Biology from Boston University. She is board certified in General Surgery and Vascular Surgery and is a Fellow of the American College of Surgeons.
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Dylan Wenke, MBA, is an experienced corporate development and strategic transactions leader with a strong track record in biotechnology business development, licensing and financing. He has originated and executed high-value transactions across multiple therapeutic areas and modalities. Previously, he held senior business development roles at Corbus Pharmaceuticals, Bluejay Therapeutics and EuMentis Therapeutics, where he led portfolio-shaping transactions, financings and global partnering initiatives. Dylan holds an MBA from the Kelley School of Business at Indiana University and a B.Sc. in Chemistry from the University of North Florida.
Steve O’Loughlin brings nearly 20 years of corporate finance, capital markets, and business development experience in the biopharmaceutical industry. Most recently, he served as Chief Financial Officer of Actinium Pharmaceuticals, Inc. (NYSE American: ATNM), a clinical-stage radiopharmaceutical company, where he played a central role in the company’s growth and strategic development over a decade-long tenure. At Actinium, Mr. O’Loughlin oversaw SEC and NYSE compliance, investor relations, FP&A, corporate governance, and treasury management. He coordinated the execution of multiple capital markets and business development transactions including the exclusive European license agreement for a Phase 3 radiopharmaceutical asset with Immedica Pharma AB, generating $35 million in upfront proceeds and up to $417 million in potential milestone payments, as well as a preclinical research collaboration with Astellas Pharma, Inc. Prior to Actinium, Mr. O’Loughlin served as Vice President of Finance and Corporate Development at Protea Biosciences Group, Inc., where he executed capital raises, supported the growth of the Company’s bioanalytical services business built around its proprietary LAESI® mass spectrometry imaging technology and drove strategic collaborations with leading research institutions including Memorial Sloan Kettering Cancer Center and Yale University. Mr. O’Loughlin began his corporate career at Caliber I.D. (formerly Lucid Technologies) supporting the commercial launch of the FDA approved VivaScope® diagnostic imaging device and the Company’s IPO. Mr. O’Loughlin started his career in investment banking at Jesup & Lamont and Forge Financial Group focused on the life sciences industry. Mr. O’Loughlin holds a B.S. in Business with a concentration in Finance from Ramapo College of New Jersey.
Eric Faulkner, MS, MBA, brings over 30 years of global leadership, technical operations, quality management, product launch, and commercial experience within the biotechnology / pharma industry. Mr. Faulkner has extensive experience in product development, validation, manufacturing operations, supply chain, commercialization, and quality management systems across the following therapeutic areas: CNS, endocrinology, immunology, neurology, oncology, rare diseases, and gene therapy. Previously, Mr. Faulkner was CTO at IO Biotech where he built and led the Technical Operations organization on the BLA enabling submission of Cylembio®, a therapeutic cancer vaccine. Mr. Faulkner also held senior roles at Homology Medicines as Head of CMC Management & External Manufacturing for the IND submissions of multiple AAV vector programs. In addition, Mr. Faulkner was also the Product Operations Lead for the Rare Disease Business Unit at Shire (Takeda) overseeing product launch, commercialization and life cycle management activities for Elaprase® (intrathecal delivery), Gattex®, Natpara®, and Plenadren®. Mr. Faulkner also spent over 15 years at Biogen involved in the product development, technology transfers, validation, registration, and commercialization of Avonex®, Avonex Pen®, Tysabri®, and Tecfidera®. Mr. Faulkner obtained an MBA from Boston University, a MS in Biotechnology and Biomedical Science from the University of Massachusetts, Boston, and a BS in Biology from the State University of New York, Fredonia. Mr. Faulkner is a Lean Six Sigma Green Belt and is an ISO 13485 certified auditor.
Our Strategy
Our goal is to build a pipeline of neurology and oncology focused assets that have the potential to be best-in-class and to improve outcomes for patients. We are executing a decisive strategic pivot to reposition the company for long-term success. Our strategy to achieve this is to:
| · | Identify, evaluate and select assets with best-in-class potential. In doing so, we intend to simultaneously develop clinical development plans and regulatory strategies to transition to development efforts as efficiently as possible. Our focus is on novel, differentiated assets that are supported by a strong biological rationale. Our parameters for asset selection will also include clinical development and regulatory pathways, near-term milestones as well as commercial market viability. We have initiated a global asset search and will continue to identify and evaluate opportunities with the goal of securing the rights to an asset or assets that meet our criteria. |
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| · | Be data-driven in our decision making. We recognize that drug development is inherently risky. We will prioritize assets with clear pathways to demonstrate differentiation and meaningfully de-risk development. Our asset selection process is grounded in objective analysis of biological hypotheses that are supported by human genetics, translational data, and early clinical evidence but remain unvalidated. We will seek to prioritize programs with clearly defined development and clinical inflection points that have the potential to meaningfully validate the underlying biology, target, and modality. In evaluating potential assets, we will consider development feasibility, regulatory pathways, commercial dynamics, and the ability to generate interpretable data through near term clinical milestones. |
| · | Deploy capital efficiently and with discipline. Leveraging our team’s experience across relevant therapeutic and functional areas, we believe we are well positioned to advance assets across their lifecycles. This experience enables a holistic assessment of each program, including development timelines, capital requirements, and probability weighted outcomes. Drug development is a capital intensive, multi-year process, and we intend to pursue development strategies and regulatory pathways designed to generate high quality data that support clinical advancement, informed decision making, and, where successful, regulatory submissions for product approval. |
| · | Patient focused development addressing serious unmet medical needs. Our development efforts are centered on patients with serious diseases for which there are limited or inadequate treatment options. Each program we advance is grounded in a strong scientific rationale, with the potential to deliver clinically meaningful benefit and improve patient outcomes. In neurology, we focus on therapies that have the potential to modify disease progression rather than solely address symptoms. In oncology, we prioritize programs with the potential to improve overall survival, durability of response, and quality of life for patients. |
| · | Transform every aspect of CNS Pharmaceuticals. Our executive team was purpose-built to drive the Company’s strategic transformation. In addition to building a new, high-value pipeline in neurology and oncology, we are focused on transforming the way we operate and execute. As our pipeline builds and advances, we will work to also build our team, systems and capabilities in a stage-appropriate manner and with the intent of supporting our future growth. |
Legacy GBM Assets
TPI 287
TPI 287 is an investigational chemotherapy agent belonging to the abeotaxane class of compounds and is structurally related to the taxane family of microtubule-stabilizing agents. Taxanes such as paclitaxel and docetaxel are widely used in oncology but historically have demonstrated limited penetration across the blood-brain barrier, which has restricted their use in treating cancers involving the central nervous system.
TPI 287 was designed as a synthetic, lipophilic taxane derivative capable of penetrating the blood-brain barrier and achieving therapeutic concentrations within the central nervous system. Like other taxanes, TPI 287 stabilizes microtubules, disrupting cell division and inducing apoptosis in rapidly proliferating tumor cells.
TPI 287 has been evaluated in multiple early-phase clinical studies involving more than 300 patients across several oncology indications, including glioblastoma, metastatic breast cancer with brain metastases, non-small cell lung cancer, castration-resistant prostate cancer and neuroblastoma.
A Phase 1/2 clinical study evaluated TPI 287 in combination with bevacizumab in patients with recurrent glioblastoma. In that study, the combination demonstrated an objective response rate of approximately 54%, including two complete responses, and a disease control rate of approximately 92%. The regimen was generally well tolerated in the study population.
In July 2024, the Company entered into an Exclusive License Agreement with Cortice Biosciences, Inc. pursuant to which the Company obtained exclusive rights to certain intellectual property related to TPI 287 in the United States, Canada, Mexico and Japan.
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The Company is currently exploring out-licensing opportunities for TPI 287 to advance its development.
Berubicin
Berubicin is an investigational anthracycline chemotherapy agent originally discovered at The University of Texas M.D. Anderson Cancer Center.
Anthracyclines represent one of the most widely used classes of chemotherapy agents in oncology. Historically, however, anthracyclines have demonstrated limited penetration of the blood-brain barrier, which has restricted their use in treating cancers of the central nervous system.
Preclinical and early clinical studies have suggested that Berubicin may be capable of penetrating the blood-brain barrier and achieving therapeutic concentrations in brain tumors.
Berubicin was previously evaluated in Phase 1 clinical trials conducted by Reata Pharmaceuticals in patients with recurrent malignant gliomas. In that study, 25 patients were evaluable for response and the trial observed one complete response, one partial response and several cases of stable disease, representing a disease control rate of approximately 44%. One patient who achieved a complete response remained disease-free more than 17 years following treatment before passing away from causes unrelated to his GBM diagnosis.
The Company subsequently conducted a randomized Phase 2 superiority clinical trial, known as CNS-201, evaluating Berubicin compared to lomustine in patients with recurrent glioblastoma who had failed first-line therapy. In March 2025, the Company announced topline results from the primary analysis of the trial. While Berubicin demonstrated clinical activity and outcomes that appeared comparable to lomustine across several endpoints, the trial did not meet its primary end point in showing superiority compared to lomustine in overall survival.
The Company’s current plan for the Berubicin program is to complete the trial, close the trial sites and prepare the Clinical Study Report for the CNS-201 trial. As with TPI 287, we are currently exploring out-licensing opportunities that would enable further development of Berubicin.
Competition
The biotechnology and pharmaceutical industries are characterized by intense and rapidly evolving competition. We face significant competition from a variety of companies, including major pharmaceutical and biotechnology companies, early stage biotechnology companies, academic research institutions and other public and private research organizations. Many of our competitors have substantially greater financial, technical, manufacturing, marketing, and human resources than we do. Our competitors may succeed in developing products that are safer, more effective, or less costly than any product candidates we may develop, which could render our product candidates non-competitive or obsolete.
Our strategic expansion into neurology brings us into competition with one of the broadest and most active therapeutic areas in the pharmaceutical industry. Neurological disorders including, but not limited to, neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, and ALS, as well as epilepsy, multiple sclerosis, and neuropathic pain conditions represent large markets with substantial commercial interest. Competitors in neurology include major pharmaceutical companies with dedicated CNS franchises, such as Biogen, UCB, Novartis, AbbVie, and Eisai, as well as a large and growing number of clinical-stage biotechnology companies. The neurology space has experienced a significant resurgence of investment and pipeline activity, driven in part by recent regulatory approvals for novel disease-modifying therapies in Alzheimer's disease and other conditions, which has further increased competition for development resources, clinical investigators, and patient populations in clinical trials.
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The broader oncology market is among the most competitive segments in the pharmaceutical industry. Large, well-capitalized companies such as AstraZeneca, Bristol-Myers Squibb, Roche, Merck & Co., Pfizer, Eli Lilly, and Johnson & Johnson, among many others, maintain extensive oncology pipelines with significant clinical, regulatory, and commercial infrastructure. In addition, numerous mid-size and emerging biotechnology companies are actively developing oncology programs across modalities including targeted therapies, immunooncology agents, cell and gene therapies, radiopharmaceuticals, and RNA-based medicines. We expect competition in oncology to intensify as scientific understanding of tumor biology continues to advance and as additional modalities enter clinical development. Our ability to compete will depend on our ability to identify differentiated targets and mechanisms of action, advance product candidates through clinical development efficiently, establish intellectual property positions that provide meaningful market exclusivity, and enter into strategic partnerships or licensing arrangements that augment our resources and expertise.
Our strategy depends on our ability to identify and secure assets that are differentiated. In addition to pharmaceutical and biotechnology companies with established pipelines, we also face competition from companies that also seek to acquire or in-license assets including companies such as Roivant, Ligand Pharmaceuticals, Fortress Biosciences and several other private and public companies. These companies have more established track records of acquiring or in-licensing assets, advancing assets through development and regulatory requirements and commercial capabilities than we do.
Many of our current or future competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, obtaining reimbursement for and marketing of approved products than we do. Mergers and acquisitions in the biotechnology, pharmaceutical and diagnostic industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.
Intellectual Property
Our intellectual property is comprised of patents and know-how related to our legacy assets TPI 287 and Berubicin. Existing TPI 287 patents will expire in 2028. When we licensed TPI 287 from Cortice on July 29, 2024, it had previously been granted Orphan Drug Designation (“ODD”) by the FDA. On June 10, 2020, the FDA granted Orphan Drug Designation for Berubicin for the treatment of malignant gliomas. ODD from the FDA is available for drugs targeting diseases with less than 200,000 cases per year. ODD may enable market exclusivity of 7 years from the date of approval of a New Drug Application (“NDA”) in the United States. During that period the FDA generally could not approve another product containing the same drug for the same designated indication. Orphan drug exclusivity will not bar approval of another product under certain circumstances, including if a subsequent product with the same active ingredient for the same indication is shown to be clinically superior to the approved product on the basis of greater efficacy or safety, or providing a major contribution to patient care, or if the company with orphan drug exclusivity is not able to meet market demand. We do not hold or license any patents related to Berubicin and the ODD now constitutes our primary intellectual property protections although the Company is exploring if there are other patents that could be filed related to Berubicin to extend additional protections.
On July 24, 2021, the Company received Fast Track Designation from the FDA for Berubicin. Fast Track Designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
We are exploring the possibility to file additional patent applications that potentially will allow for further increase of the exclusive market protection for use of TPI 287 and Berubicin. However, we can provide no assurance that we will be able to file or receive additional patent protection. The failure to receive such additional patent protection will reduce the barrier to entry for competition for TPI 287 and Berubicin, which may adversely affect our ability to out-license either of these programs.
Governmental Regulation
Government authorities in the United States, at the federal, state and local level, and in other countries extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of products such as those we are developing. The pharmaceutical drug product candidates that we develop must be approved by the FDA before they may be marketed and distributed.
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In the United States, the FDA regulates pharmaceutical products under the Federal Food, Drug, and Cosmetic Act, and implementing regulations. Pharmaceutical products are also subject to other federal, state and local statutes and regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval, may subject an applicant to administrative or judicial sanctions. FDA and related enforcement activity could include refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls, product seizures, total or partial suspension of production or distribution injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us. The process required by the FDA before a pharmaceutical product may be marketed in the United States generally involves the following:
| · | Completion of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory Practices or other applicable regulations; | |
| · | Submission to the FDA of an Investigational New Drug application, or IND, which must become effective before human clinical studies may begin; | |
| · | Performance of adequate and well-controlled human clinical studies according to the FDA’s current good clinical practices (“GCP”), to establish the safety and efficacy of the proposed pharmaceutical product for its intended use; | |
| · | Submission to the FDA of an NDA for a new pharmaceutical product; | |
| · | Satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the pharmaceutical product is produced, to assess compliance with current good manufacturing practices (“cGMP”), to assure that the facilities, methods and controls are adequate to preserve the pharmaceutical product’s identity, strength, quality and purity; | |
| · | Potential FDA audit of the preclinical and clinical study sites that generated the data in support of the NDA; and | |
| · | FDA review and approval of the NDA. |
The lengthy process of seeking required approvals and the continuing need for compliance with applicable statutes and regulations require the expenditure of substantial resources and approvals, and continued compliance is inherently uncertain.
Before testing any compounds with potential therapeutic value in humans, the pharmaceutical product candidate enters the preclinical testing stage. Preclinical tests include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies to assess the potential safety and activity of the pharmaceutical product candidate. These early proof-of-principle studies are done using sound scientific procedures and thorough documentation. The conduct of the single and repeat dose toxicology and toxicokinetic studies in animals must comply with federal regulations and requirements including good laboratory practices. The sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA has concerns and notifies the sponsor. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical study can begin. If resolution cannot be reached within the 30-day review period, either the FDA places the IND on clinical hold or the sponsor withdraws the application. The FDA may also impose clinical holds on a pharmaceutical product candidate at any time before or during clinical studies for various reasons. Accordingly, we cannot be sure that submission of an IND will result in the FDA allowing clinical studies to begin, or that, once begun, issues will not arise that suspend or terminate such clinical study.
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Clinical studies involve the administration of the pharmaceutical product candidate to healthy volunteers or patients under the supervision of qualified investigators, generally physicians not employed by or under the clinical study sponsor’s control. Clinical studies are conducted under protocols detailing, among other things, the objectives of the clinical study, dosing procedures, subject selection and exclusion criteria, how the results will be analyzed and presented and the parameters to be used to monitor subject safety. Each protocol must be submitted to the FDA as part of the IND. Clinical studies must be conducted in accordance with GCP. Further, each clinical study must be reviewed and approved by an independent institutional review board (“IRB”) at, or servicing, each institution at which the clinical study will be conducted. An IRB is charged with protecting the welfare and rights of study participants and considers such items as whether the risks to individuals participating in the clinical studies are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the informed consent form that must be provided to each clinical study subject or his or her legal representative and must monitor the clinical study until completed.
Human clinical studies are typically conducted in three sequential phases that may overlap or be combined. While such designations are not officially defined by the regulatory agencies (including the FDA), the generally accepted meanings are:
| · | Phase 1: The pharmaceutical product is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. In the case of some products for severe or life-threatening diseases such as cancer, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients, with a goal of characterizing the safety profile of the drug and establishing a maximum tolerable dose. | |
| · | Phase 2: With the maximum tolerable dose established in a Phase 1 trial, the pharmaceutical product is evaluated in a limited patient population at the MTD to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases, to determine dosage tolerance, optimal dosage and dosing schedule and to identify patient populations with specific characteristics where the pharmaceutical product may be more effective. | |
| · | Phase 3: Clinical studies are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical study sites. These clinical studies are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for product labeling. The studies must be well controlled and usually include a control arm for comparison. One or two Phase 3 studies are usually required by the FDA for an NDA approval, depending on the disease severity and other available treatment options. In some instances, an NDA approval may be obtained based on Phase 2 clinical data with the understanding that the approved drug can be sold subject to a confirmatory trial to be conducted post-approval. |
Post-approval studies, or Phase 4 clinical studies, may be conducted after initial marketing approval. These studies are often used to gain additional experience from the treatment of patients in the intended therapeutic indication. The FDA also may require Phase 4 studies, Risk Evaluation and Mitigation Strategies (“REMS”) and post-marketing surveillance, among other things, to monitor the effects of an approved product or place conditions on an approval that could restrict the distribution or use of the product.
Progress reports detailing the results of the clinical studies must be submitted at least annually to the FDA and written IND safety reports must be submitted to the FDA and the investigators for serious and unexpected adverse events or any finding from tests in laboratory animals that suggests a significant risk for human subjects. Phase 1, Phase 2 and Phase 3 clinical studies may not be completed successfully within any specified period, if at all. The FDA or the sponsor or its data safety monitoring board may suspend a clinical study at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical study at its institution if the clinical study is not being conducted in accordance with the IRB’s requirements or if the pharmaceutical product has been associated with unexpected serious harm to patients.
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Concurrent with clinical studies, companies may complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the pharmaceutical product as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the pharmaceutical product candidate and, among other things, must develop methods for testing the identity, strength, quality and purity of the final pharmaceutical product. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the pharmaceutical product candidate does not undergo unacceptable deterioration over its shelf life.
The results of product development, preclinical studies and clinical studies, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of the pharmaceutical product, proposed labeling and other relevant information are submitted to the FDA as part of an NDA requesting approval to market the product. The submission of an NDA is subject to the payment of substantial user fees. A waiver of such fees may be obtained under certain limited circumstances.
The FDA reviews all NDAs submitted before it accepts them for filing and may request additional information rather than accepting an NDA for filing. Once the submission is accepted for filing, the FDA begins an in-depth review of the NDA. Under the goals and policies agreed to by the FDA under the Prescription Drug User Fee Act (“PDUFA”), the FDA has 10 months after the 60-day filing date in which to complete its initial review of a standard review NDA and respond to the applicant, and six months after the 60-day filing date for a priority review NDA. The FDA does not always meet its PDUFA goal dates for standard and priority NDAs.
After the NDA submission is accepted for filing, the FDA reviews the NDA application to determine, among other things, whether the proposed product is safe and effective for its intended use, and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, strength, quality and purity. The FDA may refer applications for novel pharmaceutical products or pharmaceutical products which present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions. During the pharmaceutical product approval process, the FDA also will determine whether a REMS is necessary to assure the safe use of the pharmaceutical product. If the FDA concludes that a REMS is needed, the sponsor of the NDA must submit a proposed REMS; the FDA will not approve the NDA without a REMS, if required.
Before approving an NDA, the FDA will inspect the facilities at which the product is manufactured. The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA, the FDA will typically inspect one or more clinical sites as well as the site where the pharmaceutical product is manufactured to assure compliance with GCP and cGMP. If the FDA determines the application, manufacturing process or manufacturing facilities are not acceptable, it will outline the deficiencies in the submission and often will request additional testing or information. In addition, the FDA will require the review and approval of product labeling.
The NDA review and approval process is lengthy and difficult, and the FDA may refuse to approve an NDA if the applicable regulatory criteria are not satisfied or may require additional clinical data or other data and information. Even if such data and information is submitted, the FDA may ultimately decide that the NDA does not satisfy the criteria for approval. Data obtained from clinical studies are not always conclusive and the FDA may interpret data differently than we interpret the same data. The FDA will issue a complete response letter if the agency decides not to approve the NDA. The complete response letter usually describes all of the specific deficiencies in the NDA identified by the FDA. The deficiencies identified may be minor, for example, requiring labeling changes, or major, for example, requiring additional clinical studies. Additionally, the complete response letter may include recommended actions that the applicant might take to place the application in a condition for approval. If a complete response letter is issued, the applicant may either resubmit the NDA, addressing all of the deficiencies identified in the letter, or withdraw the application.
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If a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict the commercial value of the product. Further, the FDA may require that certain contraindications, warnings, or precautions be included in the product labeling. In addition, the FDA may require Phase 4 testing which involves clinical studies designed to further assess pharmaceutical product safety and effectiveness and may require testing and surveillance programs to monitor the safety of approved products that have been commercialized.
Expedited Development and Review Programs
The FDA’s Fast Track program is intended to expedite or facilitate the process for reviewing new pharmaceutical products that meet certain criteria. Specifically, new pharmaceutical products are eligible for Fast Track designation if they are intended to treat a serious condition and demonstrate the potential to address unmet medical needs for the condition. Fast Track designation applies to the combination of the product and the specific indication for which it is being studied. Unique to a Fast Track product, the FDA may consider for review sections of the NDA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the NDA, if the FDA determines that the schedule is acceptable and if the sponsor pays any required user fees upon submission of the first section of the NDA. On July 24, 2021, the Company received Fast Track Designation from the FDA for Berubicin. The Company believes that TPI 287 has the potential to qualify for Fast Track Designation as well. However, at this time, we do not intend to develop Berubicin or TPI 287 further and are instead focused on evaluating opportunities to out-license these programs.
Any product submitted to the FDA for market, including a Fast Track program, may also be eligible for other FDA programs intended to expedite development and review, such as priority review and accelerated approval. Any product is eligible for priority review if it is intended to treat a serious condition and it offers a significant improvement in the treatment, diagnosis or prevention of a disease compared to marketed products. The FDA will attempt to direct additional resources to the evaluation of an application for a new pharmaceutical product designated for priority review in an effort to facilitate the review. Additionally, accelerated approval may be available for a product intended to treat a serious condition that provides meaningful therapeutic benefit over existing treatments, which means the product may be approved on the basis of adequate and well-controlled clinical studies establishing that the product has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit, or on the basis of an effect on an intermediate clinical endpoint. As a condition of accelerated approval, the FDA may require the sponsor to perform adequate and well-controlled post-marketing clinical studies. In addition, the FDA currently requires pre-approval of promotional materials for products receiving accelerated approval, which could impact the timing of the commercial launch of the product. Fast Track designation, priority review and accelerated approval do not change the standards for approval but may expedite the development or approval process.
Post-Approval Requirements
Any pharmaceutical products for which the Company receives FDA approvals are subject to continuing regulation by the FDA, including, among other things, cGMP compliance, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, complying with certain electronic records and signature requirements and complying with FDA promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising, prohibitions on promoting pharmaceutical products for uses or in patient populations that are not described in the pharmaceutical product’s approved labeling (known as “off-label use”), industry-sponsored scientific and educational activities and promotional activities involving the internet. Failure to comply with FDA requirements can have negative consequences, including adverse publicity, enforcement letters from the FDA, actions by the U.S. Department of Justice and/or U.S. Department of Health and Human Services’ Office of Inspector General, mandated corrective advertising or communications with doctors, and civil or criminal penalties. Although physicians may prescribe legally available pharmaceutical products for off-label uses, manufacturers may not directly or indirectly market or promote such off-label uses.
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We expect to rely on third parties for the production of clinical and commercial quantities of our products. Manufacturers of our products are required to comply with applicable FDA manufacturing requirements contained in the FDA’s cGMP regulations. cGMP regulations require, among other things, quality control and quality assurance, as well as the corresponding maintenance of records and documentation. Pharmaceutical product manufacturers and other entities involved in the manufacture and distribution of approved pharmaceutical products are required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance. Discovery of problems with a product after approval may result in restrictions on a product, manufacturer or holder of an approved NDA, including withdrawal of the product from the market. In addition, changes to the manufacturing process generally require prior FDA approval before being implemented and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval.
Pharmaceutical Coverage, Pricing and Reimbursement
Significant uncertainty exists as to the coverage and reimbursement status of any pharmaceutical product candidates for which we may obtain regulatory approval. In the United States and in markets in other countries, sales of any products for which we receive regulatory approval for commercial sale will depend in part upon the availability of reimbursement from third-party payers. Third-party payers include government payers such as Medicare and Medicaid, managed care providers, private health insurers and other organizations. The process for determining whether a payer will provide coverage for a pharmaceutical product may be separate from the process for setting the price or reimbursement rate that the payer will pay for the pharmaceutical product. Third-party payers may limit coverage to specific pharmaceutical products on an approved list, or formulary, which might not, and frequently does not, include all of the FDA-approved pharmaceutical products for a particular indication. Third-party payers are increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy. A payer’s decision to provide coverage for a pharmaceutical product does not imply that an adequate reimbursement rate will be approved. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development. In addition, in the United States there is a growing emphasis on comparative effectiveness research, both by private payers and by government agencies. We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of our products, in addition to the costs required to obtain the FDA approvals. Our pharmaceutical product candidates may not be considered medically necessary or cost-effective. To the extent other drugs or therapies are found to be more effective than our products, payers may elect to cover such therapies in lieu of our products and/or reimburse our products at a lower rate.
Orphan Drug exclusivity prevents for seven years the approval of another product with the same active moiety for the same rare disease. On June 10, 2020, the FDA granted Orphan Drug Designation for Berubicin for the treatment of malignant gliomas. If a product is a new chemical entity (i.e., generally that the moiety has not previously been approved), it may receive five years of exclusivity, during which period FDA may not accept for review certain NDAs for another product with the same moiety. If approval of a product required new clinical data, it may convey three years of exclusivity against approval of certain NDAs for similar products.
The marketability of any pharmaceutical product candidates for which we may receive regulatory approval for commercial sale may suffer if the government and third-party payers fail to provide adequate coverage and reimbursement. In addition, emphasis on managed care in the United States has increased and we expect this will continue to increase the pressure on pharmaceutical pricing. Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which we may receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
International Regulation
In addition to regulations in the United States, we will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of our future drugs. Whether or not we obtain FDA approval for a drug, we must obtain approval of a drug by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the drug in those countries. The approval process varies from country to country, and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country.
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Under European Union regulatory systems, marketing authorizations may be submitted either under a centralized or mutual recognition procedure. The centralized procedure provides for the grant of a single marketing authorization that is valid for all European Union member states. The mutual recognition procedure provides for mutual recognition of national approval decisions. Under this procedure, the holder of a national marketing authorization may submit an application to the remaining member states. Within 90 days of receiving the applications and assessment report, each member state must decide whether to recognize approval.
In addition to regulations in Europe and the United States, we will be subject to a variety of foreign regulations governing clinical trials and commercial distribution of our future drugs.
License Agreements
On November 21, 2017, we entered into the Reata Agreement. Pursuant to the Reata Agreement we purchased all of Reata’s intellectual property and development data regarding Berubicin, including all trade secrets, knowhow, confidential information and other intellectual property rights.
On December 28, 2017, the Company entered into a Technology Rights and Development Agreement with HPI. Pursuant to this agreement, the Company obtained a worldwide exclusive license to the chemical compound commonly known as WP744. In exchange for these rights, the Company agreed to pay consideration to HPI as follows: (i) a royalty of 2% of net sales of any product utilizing WP744 for a period of ten years after the first commercial sale of such; and (ii) $100,000 upon beginning Phase II clinical trials (paid in 2021); and (iii) $200,000 upon the approval by the FDA of a New Drug Application for any product utilizing WP744; and (iv) a series of quarterly development payments totaling $750,000 beginning immediately after the Company’s raise of $7,000,000 of investment capital. In addition, the Company issued 1 share of the Company’s common stock valued at $40,500 per share to HPI upon execution of the agreement. On November 13, 2019, the Company closed its IPO, thereby fulfilling all conditions precedent and completing the acquisition of the intellectual property discussed in the HPI agreement. During the years ended December 31, 2025 and 2024, the Company recognized $0 and $50,000 related to this agreement, respectively. Unrelated to this agreement, from time to time, the Company purchases pharmaceutical products from HPI which are necessary for the manufacturing of Berubicin API and drug product. On March 23, 2025, the Company terminated the HPI License.
On July 29, 2024, the Company entered into the Cortice Agreements, pursuant to which Cortice granted the Company 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.
Employees and Human Capital
As of March 31, 2026, we had eight full time employees. Five of our employees are members of our executive team. Our human capital objectives include identifying, recruiting, retaining, incentivizing and integrating our existing and new employees, advisors and consultants to support our operations as we obtain pipeline assets or the rights to pipeline assets. None of our employees are represented by labor unions or covered by collective bargaining agreements. We consider our relationship with our employees to be good.
Working Capital
As a development-stage biotechnology company, we have not generated any revenue from product sales and do not expect to generate product revenue unless and until we successfully complete development of, obtain regulatory approval for, and commercialize one or more of our drug candidates. We have incurred significant operating losses since inception and expect to continue to incur losses for the foreseeable future as we invest in business development activities to expand our pipeline, advance in-licensed drug candidates through clinical development and seek regulatory approvals. As of December 31, 2025, we had cash of approximately $7,201,000 and we had a working capital of approximately $4,002,000. Currently, we expect our cash on hand to fund operations into the third quarter of 2026. We will need to raise significant additional capital in the future in order to meet our future obligations and execute our business plan. 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 plan until sufficient additional capital is raised to support further 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.
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We have historically funded our operations primarily through the sale of equity securities in public and private offerings. We expect to continue to fund our operations through equity financings, debt financings, collaborations, strategic alliances, licensing arrangements or other sources of capital as may be available to us. Our ability to fund ongoing operations depends on our ability to raise additional capital through one or more of these methods. There can be no assurance that we will be able to obtain additional financing on acceptable terms, or at all.
Our primary working capital needs relate to business development activities to identify, evaluate and secure funding for research and development activities, including payments to contract research organizations, contract manufacturing organizations and other third-party service providers, as well as general and administrative expenses necessary to operate as a public company.
Legal Proceedings
From time to time in the ordinary course of our business, we may be involved in legal proceedings, the outcomes of which may not be determinable. The results of litigation are inherently unpredictable. Any claims against us, whether meritorious or not, could be time consuming, result in costly litigation, require significant amounts of management time and result in diversion of significant resources. We have insurance policies covering any potential losses where such coverage is cost effective.
We are not at this time involved in any additional legal proceedings that we believe could have a material effect on our business, financial condition, results of operations or cash flows.
Properties
Our corporate headquarters is located in a leased facility in Houston, Texas. We believe our facilities are sufficient to meet our current needs and that suitable space will be available as and when needed. We do not own any real property.
Available Information
Our Internet address is www.cnspharma.com. On this Web site, we post the following filings as soon as reasonably practicable after they are electronically filed with or furnished to the U.S. Securities and Exchange Commission (“SEC”): our Annual Reports on Form 10-K; our Quarterly Reports on Form 10-Q; our Current Reports on Form 8-K; our proxy statements related to our annual stockholders’ meetings; and any amendments to those reports or statements. The SEC maintains an internet site that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov. All such filings are also available on our Web site free of charge. The charters of our audit, nominating and governance and compensation committees and our Code of Business Conduct and Ethics Policy are also available on our Web site and in print to any stockholder who requests them. The content on our Web site is not incorporated by reference into this Form 10-K unless expressly noted.
| Item 1A. | Risk Factors. |
An investment in our securities involves a high degree of risk. You should consider carefully all of the material risks described below, together with the other information contained in this Form 10-K. If any of the following events occur, our business, financial condition, results of operations and cash flows may be materially adversely affected.
Risks Related to the Company’s Business and Industry
Our future success depends on our ability to identify, acquire or license new drug candidates, and we may not be successful in doing so.
A key element of our business strategy is to expand our pipeline by acquiring or licensing rights to additional drug candidates from third parties. The success of this strategy depends on our ability to identify, evaluate and acquire or license suitable drug candidates on commercially reasonable terms. Competition for attractive drug candidates is intense, and many of our competitors have substantially greater financial, technical and human resources than we do, which may limit our ability to identify and acquire promising therapeutic assets.
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We may not be able to identify drug candidates that meet our strategic criteria or that we believe have sufficient probability of clinical and commercial success. Even if we identify promising candidates, we may not be able to negotiate acquisition or licensing terms that are acceptable to us, or we may be outbid by competitors with greater resources. Additionally, due diligence evaluations of potential acquisition or licensing targets may not reveal all relevant risks, liabilities or issues, and we may acquire or license drug candidates that ultimately prove to be less valuable or more problematic than anticipated.
If we are unable to successfully identify and acquire or license new drug candidates, our pipeline may remain limited, which could materially and adversely affect our business, financial condition, results of operations and prospects.
Any drug candidates we acquire or license may require significant additional development, and there can be no assurance that such candidates will prove to be safe, effective or commercially viable.
Even if we are successful in acquiring or licensing new drug candidates, such candidates will likely require substantial additional investment and development before they could potentially receive regulatory approval and be commercialized. Drug development is inherently risky and uncertain. Many drug candidates fail to demonstrate adequate safety or efficacy in clinical trials, and there can be no assurance that any drug candidate we acquire or license will be successfully developed, receive regulatory approval or achieve commercial success.
In addition, drug candidates we acquire or license may have unknown liabilities, intellectual property defects or other issues that were not identified during our due diligence evaluation. We may also face challenges integrating newly acquired or licensed assets into our organization and development programs. Any of these factors could result in significant delays, increased costs or failure of our development programs, which could materially and adversely affect our business, financial condition and results of operations.
We may not have access to sufficient capital to pursue acquisition or licensing opportunities, which could limit our ability to expand our pipeline.
Acquiring or licensing drug candidates often requires significant upfront payments, milestone payments, royalty obligations and ongoing development costs. As a clinical-stage company with limited financial resources, we may not have access to sufficient capital to pursue attractive acquisition or licensing opportunities when they arise. Our ability to raise additional capital may be limited by market conditions, investor sentiment, our financial performance and other factors beyond our control.
If we are unable to raise sufficient capital on acceptable terms, we may be forced to forgo attractive acquisition or licensing opportunities, reduce the scope of our business development activities or delay or discontinue development of drug candidates we have already acquired. Any of these outcomes could limit our ability to expand our pipeline and materially harm our business and prospects.
We will require substantial funding to execute our new corporate strategy, which may not be available to us on acceptable terms, or at all, and, if not so available, may require us to delay, limit, reduce or cease our operations.
We have primarily used the proceeds from our previous financings to, among other uses, advance Berubicin through clinical development. In addition, we used proceeds from our previous financings to obtain the rights to TPI 287. Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is expensive.
Under our new corporate strategy, we will seek to obtain rights to new investigational product candidates, which could include upfront cash payments, milestone payments, royalties, issuing shares of our stock, assuming liabilities or a combination of any of these considerations. It is possible that any of these considerations may be greater than our currently available resources and require that we undertake additional financings or issue additional equity or debt securities. We are also evaluating TPI 287 and Berubicin as we explore the potential out-licensing of these programs but there can be no assurances that we will be able to successfully complete an out-licensing transaction. Potential licensors may require additional preclinical or clinical data, CMC data, intellectual property or other considerations before undertaking a transaction. We may determine that the generation of additional preclinical or clinical data, CMC data or new intellectual property is not feasible or cost prohibitive relative to potential financial considerations we could potentially receive and we may instead elect to sunset TPI 287, Berubicin or both programs.
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We will continue to require substantial additional capital to execute in-licensing to expand our pipeline, clinical development and commercialization activities. Because successful development of our product candidates is uncertain, we are unable to estimate the actual amount of funding we will require to complete research and development and commercialize our products under development.
We estimate that we have sufficient capital to fund operations into the third quarter of 2026. 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.
The amount and timing of our future funding requirements will depend on many factors, including but not limited to:
| · | the cost to obtain the rights to new assets; | |
| · | whether any clinical trials will be completed on a timely basis; | |
| · | the progress, costs, results of and timing of preclinical studies or clinical trials for new assets; | |
| · | the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals; | |
| · | the costs associated with securing and establishing commercialization and manufacturing capabilities; | |
| · | market acceptance of our product candidates; | |
| · | our ability to out-license TPI 287 or Berubicin; | |
| · | the costs of acquiring, licensing or investing in additional businesses, products, product candidates and technologies; | |
| · | our ability to maintain, expand and enforce the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights; | |
| · | our need and ability to hire additional management and scientific and medical personnel; | |
| · | the effect of competing drug candidates and new product approvals; | |
| · | our need to implement additional internal systems and infrastructure, including quality, financial and reporting systems; and | |
| · | the economic and other terms, timing of and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future. |
Some of these factors are outside of our control. We may seek additional funding through a combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. Additional funding may not be available to us on acceptable terms or at all. In addition, the terms of any financing may adversely affect the holdings or the rights of our stockholders.
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If we are unable to obtain funding on a timely basis, we may not be able to execute on our in-licensing focused strategy. We also could be required to seek funds through arrangements with collaborative partners or otherwise that may require us to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us.
The report of our independent registered public accounting firm expresses substantial doubt about our ability to continue as a going concern. Such “going concern” opinion could impair our ability to obtain financing.
Our auditors have indicated in their report on our financial statements for the fiscal year ended December 31, 2025 that conditions exist that raise substantial doubt about our ability to continue as a going concern due to our recurring losses from operations. A “going concern” opinion could impair our ability to finance our operations through the sale of equity, incurring debt, or other financing alternatives. Our ability to continue as a going concern will depend upon the availability and terms of future funding. If we are unable to achieve this goal, our business would be jeopardized and we may not be able to continue. If we ceased operations, it is likely that all of our investors would lose their investment.
We have never been profitable, we have no products approved for commercial sale, and we have not generated any revenue from product sales. As a result, our ability to reduce our losses and reach profitability is unproven, and we may never achieve or sustain profitability. Therefore, we may not be able to continue as a going concern.
We have never been profitable and do not expect to be profitable in the foreseeable future. We have not yet submitted any drug candidates for approval by regulatory authorities in the United States or elsewhere. Our ability to continue as a going concern is dependent upon our generating cash flow from sales that are sufficient to fund operations or finding adequate financing to support our operations. To date, we have had no revenues and have relied on equity-based financing from the sale of securities in public and private placements. The continuation of the Company as a going concern is dependent upon our ability to obtain necessary equity or debt financing to continue operations and the attainment of profitable operations. As of December 31, 2025 the Company has incurred an accumulated deficit of $100,275,268 since inception and had not yet generated any revenue from operations. Additionally, management anticipates that its cash on hand as of December 31, 2025, combined with capital raised subsequent to December 31, 2025, is sufficient to fund its planned operations within one year after the date that the financial statements are issued.
To date, we have devoted most of our financial resources to corporate overhead, preparing for and conducting the clinical trial and marketing of our securities. We have not generated any revenues from product sales. We expect to continue to incur losses for the foreseeable future, and we expect these losses to increase as we in-license and initiate development of and seek regulatory approvals for new assets or programs, prepare for and begin the commercialization of any approved products, and add infrastructure and personnel to support our continuing product development efforts. We anticipate that any such losses could be significant for the next several years. If any of our future drug candidates fail in clinical trials or do not gain regulatory approval, or if our drug candidates do not achieve market acceptance, we may never become profitable. As a result of the foregoing, we expect to continue to experience net losses and negative cash flows for the foreseeable future. These net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital.
Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. In addition, our expenses could increase if we are required by the FDA to perform studies or trials in addition to those currently expected, or if there are any delays in completing our clinical trials or the development of any of our drug candidates. The amount of future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues.
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We have a limited operating history and we expect a number of factors to cause our operating results to fluctuate on an annual basis, which may make it difficult to predict our future performance.
We are a clinical pharmaceutical company with limited operating history. Our operations to date have been limited to acquiring our technology portfolio, preparing for and conducting our clinical trials. We have not yet obtained any regulatory approvals for any of our drug candidates. Consequently, any predictions made about our future success or viability may not be as accurate as they could be if we had a longer operating history or approved products on the market. Our operating results are expected to significantly fluctuate from quarter to quarter or year to year due to a variety of factors, many of which are beyond our control. Factors relating to our business that may contribute to these fluctuations include:
| · | any delays or inability to identify, evaluate, negotiate or obtain rights to new assets; | |
| · | any delays or inability to conduct preclinical studies; | |
| · | delays in the commencement, enrollment and timing of clinical trials; | |
| · | difficulties in identifying patients suffering from our target indications; | |
| · | the success of our clinical trials through all phases of clinical development; | |
| · | potential side effects of our product candidates that could delay or prevent approval or cause an approved drug to be taken off the market; | |
| · | our ability to obtain additional funding to develop drug candidates; | |
| · | competition from existing products or new products that continue to emerge; | |
| · | our ability to adhere to clinical trial requirements directly or with third parties such as contract research organizations (CROs); | |
| · | our ability to establish or maintain collaborations, licensing, or other arrangements; | |
| · | our ability to defend against any challenges to our intellectual property including, claims of patent infringement; | |
| · | our ability to enforce our intellectual property rights against potential competitors; |
| · | our ability to secure additional intellectual property protection for our developing drug candidates and associated technologies; | |
| · | our ability to attract and retain key personnel to manage our business effectively; and | |
| · | potential product liability claims. |
These factors are our best estimates of possible factors but cannot be considered a complete recitation of possible factors that could affect the Company. Accordingly, the results of any historical quarterly or annual periods should not be relied upon as indications of future operating performance.
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We cannot be certain that any of our future product candidates will receive regulatory approval, and without regulatory approval we will not be able to market or commercialize them.
Our business strategy depends on identifying and in licensing the rights to new assets focused on neurology and oncology. There can be no assurances that we will be successful in executing on our strategy, which could have a material adverse impact on our business. Even if we are successful in securing rights to new assets, the development pathway to approval may be long, have uncertainty, and require more resources than we are able to obtain. Our ability to generate revenue related to product sales, if ever, will depend on the successful development and regulatory approval of any future product candidates.
We currently have no products approved for sale and we cannot guarantee that we will ever have marketable products. The development of a product candidate and issues relating to its approval and marketing are subject to extensive regulation by the FDA in the United States and regulatory authorities in other countries, with regulations differing from country to country. We are not permitted to market our product candidates in the United States until we receive approval of an NDA from the FDA. We have not submitted any marketing applications for any of our product candidates.
NDAs must include extensive preclinical and clinical data and supporting information to establish the product candidate’s safety and effectiveness for each desired indication. NDAs must also include significant information regarding the chemistry, manufacturing and controls for the product. Obtaining approval of an NDA is a lengthy, expensive, and uncertain process, and we may not be successful in obtaining approval. The FDA review processes can take years to complete, and approval is never guaranteed. If we submit an NDA to the FDA, the FDA must decide whether to accept or reject the submission for filing. We cannot be certain that any submissions will be accepted for filing and review by the FDA. Regulators in other jurisdictions have their own procedures for approval of product candidates. Even if a product is approved, the FDA may limit the indications for which the product may be marketed, require extensive warnings on the product labeling or require expensive and time-consuming clinical trials or reporting as conditions of approval. Regulatory authorities in countries outside of the United States and Europe also have requirements for approval of drug candidates with which we must comply with prior to marketing in those countries. Obtaining regulatory approval for marketing of a product candidate in one country does not ensure that we will be able to obtain regulatory approval in any other country. In addition, delays in approvals or rejections of marketing applications in the United States, Europe or other countries may be based upon many factors, including regulatory requests for additional analyses, reports, data, preclinical studies and clinical trials, regulatory questions regarding different interpretations of data and results, changes in regulatory policy during the period of product development and the emergence of new information regarding our product candidates or other products. Also, regulatory approval for any of our product candidates may be withdrawn.
If we are unable to obtain approval from the FDA, or other regulatory agencies, for our product candidates, or if, subsequent to approval, we are unable to successfully commercialize our product candidates or secure commercialization partners, we will not be able to generate sufficient revenue to become profitable or to continue our operations, likely resulting in the total loss of principal for our investors.
Any statements in this filing indicating that our legacy assets TPI 287 and Berubicin have demonstrated preliminary evidence of efficacy are our own and are not based on the FDA’s or any other comparable governmental agency’s assessment of TPI 287 and Berubicin and do not indicate that TPI 287 and Berubicin will achieve favorable efficacy results in any later stage trials or that the FDA or any comparable agency will ultimately determine that TPI 287 and Berubicin is effective for purposes of granting marketing approval. Based on our intention to explore out-licensing TPI 287 and Berubicin, we may have limited or no ability to determine the future development or regulatory activity for these programs.
Delays in the commencement, enrollment and completion of clinical trials could result in increased costs to us and delay or limit our ability to obtain regulatory approval for our product candidates.
Delays in the commencement, enrollment and completion of clinical trials could increase our product development costs or limit the regulatory approval of our product candidates. We do not know whether any future trials or studies of our other product candidates will begin on time or will be completed on schedule, if at all. The start or end of a clinical study is often delayed or halted due to changing regulatory requirements, manufacturing challenges, including delays or shortages in available drug product, required clinical trial administrative actions, slower than anticipated patient enrollment, changing standards of care, availability or prevalence of use of a comparative drug or required prior therapy, clinical outcomes or financial constraints. For instance, delays or difficulties in patient enrollment or difficulties in retaining trial participants can result in increased costs, longer development times or termination of a clinical trial. Clinical trials of a new product candidate require the enrollment of a sufficient number of patients, including patients who are suffering from the disease the product candidate is intended to treat and who meet other eligibility criteria. The rates of patient enrollment are affected by many factors, including the size of the patient population, the eligibility criteria for the clinical trial, that include the age and condition of the patients and the stage and severity of disease, the nature of the protocol, the proximity of patients to clinical sites and the availability of effective treatments and/or availability of investigational treatment options for the relevant disease.
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A product candidate can unexpectedly fail at any stage of preclinical and clinical development. The historical failure rate for product candidates is high due to scientific feasibility, safety, efficacy, changing standards of medical care and other variables. The results from preclinical testing or early clinical trials of a product candidate may not predict the results that will be obtained in later phase clinical trials of the product candidate. We, the FDA or other applicable regulatory authorities may suspend clinical trials of a product candidate at any time for various reasons, including, but not limited to, a belief that subjects participating in such trials are being exposed to unacceptable health risks or adverse side effects, or other adverse initial experiences or findings. We may not have the financial resources to continue development of, or to enter into collaborations for, a product candidate if we experience any problems or other unforeseen events that delay or prevent regulatory approval of, or our ability to commercialize, product candidates, including, but not limited to:
| · | inability to obtain sufficient funds required for a clinical trial; | |
| · | inability to reach agreements on acceptable terms with prospective CROs and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; | |
| · | negative or inconclusive results from our clinical trials or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct additional preclinical testing or clinical trials or abandon a program; | |
| · | serious and unexpected drug-related side effects experienced by subjects in our clinical trials or by individuals using drugs similar to our product candidates; | |
| · | conditions imposed by the FDA or comparable foreign authorities regarding the scope or design of our clinical trials; | |
| · | difficulty in enrolling research subjects in clinical trials including the inability to enroll any subjects at all; | |
| · | high dropout rates and high fail rates of research subjects; | |
| · | inadequate supply or quality of product candidate components or materials or other supplies necessary for the conduct of our clinical trials; | |
| · | greater than anticipated clinical trial costs; | |
| · | poor effectiveness of our product candidates during clinical trials; or | |
| · | unfavorable FDA or other regulatory agency inspection and review of a clinical trial site or vendor. |
We have never completed a clinical trial or submitted an NDA before, and any product candidate we advance through clinical trials may not have favorable results in later clinical trials or receive regulatory approval.
Clinical failure can occur at any stage of our clinical development. Clinical trials may produce negative or inconclusive results, and our collaborators or we may decide, or regulators may require us, to conduct additional clinical trials or nonclinical studies. In addition, data obtained from trials and studies are susceptible to varying interpretations, and regulators may not interpret our data as favorably as we do, which may delay, limit, or prevent regulatory approval. Success in preclinical studies and early clinical trials does not ensure that subsequent clinical trials will generate the same or similar results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate. Many companies in the pharmaceutical industry, including those with greater resources and experience than us, have suffered significant setbacks in clinical trials, even after seeing promising results in earlier clinical trials.
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In addition, the design of a clinical trial can determine whether its results will support approval of a product and flaws in the design of a clinical trial may not become apparent until the clinical trial is well advanced. We may be unable to design and execute a clinical trial to support regulatory approval. Further, clinical trials of potential products often reveal that it is not practical or feasible to continue development efforts.
If a future product candidate is found to be unsafe or ineffective, we will not be able to obtain regulatory approval for it and our business would be materially and possibly irreparably harmed.
In some instances, there can be significant variability in safety and/or efficacy results between different trials of the same product candidate due to numerous factors, including changes in trial protocols, differences in composition of the patient populations, adherence to the dosing regimen and other trial protocols and the rate of dropout among clinical trial participants. We do not know whether any clinical trials we or any of our potential future collaborators may conduct will demonstrate the consistent or adequate efficacy and safety that would be required to obtain regulatory approval and market any products. If we are unable to bring any of our future product candidates to market, or to acquire other products that are on the market or can be developed, our ability to create long-term stockholder value will be limited.
Interim or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
We may publicly disclose preliminary data from our clinical trials, which is based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a full analysis of all data related to the particular trial. We also make assumptions, estimations, calculations, and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the preliminary results that we report may differ from future results of the same trials, or different conclusions or considerations may qualify such results once additional data have been received and fully evaluated. Preliminary data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, preliminary data should be viewed with caution until the final data are available. We may also disclose interim data from our clinical trials. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Adverse differences between preliminary or interim data and final data could significantly harm our business prospects. Further, disclosure of preliminary or interim data by us could result in volatility in the price of shares of our common stock.
In addition, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the approvability of the particular drug candidate and our business in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular drug candidate or our business. If the interim data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for and commercialize our current or any our future drug candidate, our business, operating results, prospects or financial condition may be materially harmed.
Our product candidates may have undesirable side effects that may delay or prevent marketing approval, or, if approval is received, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales.
Unforeseen side effects from any of our product candidates could arise either during clinical development or after an approved product has been marketed. The range and potential severity of possible side effects from therapies for neurologic or cancer indications can be significant. If any of our product candidates causes undesirable or unacceptable side effects in the future, this could interrupt, delay or halt clinical trials and result in the failure to obtain or suspension or termination of marketing approval from the FDA and other regulatory authorities, or result in marketing approval from the FDA and other regulatory authorities only with restrictive label warnings.
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If any of our product candidates receives marketing approval and we or others later identify undesirable or unacceptable side effects caused by such products:
| · | regulatory authorities may require the addition of labeling statements, specific warnings, a contraindication or field alerts to physicians and pharmacies; | |
| · | we may be required to change instructions regarding the way the product is administered, conduct additional clinical trials or change the labeling of the product; | |
| · | we may be subject to limitations on how we may promote the product; |
| · | sales of the product may decrease significantly; | |
| · | regulatory authorities may require us to take our approved product off the market; | |
| · | we may be subject to litigation or product liability claims; and | |
| · | our reputation may suffer. |
Any of these events could prevent us or our potential future collaborators from achieving or maintaining market acceptance of the affected product or could substantially increase commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenues from the sale of our products.
If the FDA does not find the manufacturing facilities of our future contract manufacturers acceptable for commercial production, we may not be able to commercialize any of our product candidates, or such commercialization efforts may be delayed until we can contract with manufacturers with facilities acceptable to the FDA or other regulatory authorities.
We do not have any manufacturing capabilities and we do not intend to manufacture the pharmaceutical products that we plan to sell. We utilize contract manufacturers for the production of the active pharmaceutical ingredients and the formulation of drug product for our pre-clinical development and clinical trials that we will need to conduct prior to seeking regulatory approval. However, we currently do not have agreements for supplies for any product candidates and we may not be able to reach agreements with these or other contract manufacturers for sufficient supplies to commercialize any product, even if they are approved. Additionally, the facilities used by any contract manufacturer to manufacture any of our product candidates must be the subject of a satisfactory inspection before the FDA approves the product candidate manufactured at that facility. We will be completely dependent on these third-party manufacturers for compliance with the requirements of U.S. and non-U.S. regulators for the manufacture of our finished products. If our manufacturers cannot successfully manufacture material that conform to our specifications and the FDA’s current good manufacturing practice standards, or GMP, and other requirements of any governmental agency whose jurisdiction to which we are subject, our product candidates will not be approved or, if already approved, may be subject to recalls. Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured our product candidates, including:
| · | the possibility that we are unable to enter into a manufacturing agreement with a third party to manufacture our product candidates; | |
| · | the possible breach of the manufacturing agreements by the third parties because of factors beyond our control; and | |
| · | the possibility of termination or nonrenewal of the agreements by the third parties before we are able to arrange for a qualified replacement third-party manufacturer. |
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Any of these factors could cause the delay of approval or commercialization of our product candidates, cause us to incur higher costs or prevent us from commercializing our product candidates successfully. Furthermore, if any of our product candidates are approved and contract manufacturers fail to deliver the required commercial quantities of finished product on a timely basis at commercially reasonable prices and we are unable to find one or more replacement manufacturers capable of production at a substantially equivalent cost, in substantially equivalent volumes and quality and on a timely basis, we would likely be unable to meet demand for our products and could lose potential revenue. It may take several years to establish an alternative source of supply for our product candidates and to have any such new source approved by the government agencies that regulate our products.
We have no sales, marketing or distribution experience and we will have to invest significant resources to develop those capabilities or enter into third-party sales and marketing arrangements, the problems with which could materially harm our business at any time.
We have no sales, marketing, or distribution experience. To develop sales, distribution, and marketing capabilities, we will have to invest significant amounts of financial and management resources, some of which will need to be committed prior to any confirmation that our product candidates will be approved by the FDA. For product candidates where we decide to perform sales, marketing, and distribution functions ourselves or through third parties, we could face a number of additional risks, including that we or our third-party sales collaborators may not be able to build and maintain an effective marketing or sales force. If we use third parties to market and sell our products, we may have limited or no control over their sales, marketing and distribution activities on which our future revenues may depend.
We may not be successful in establishing and maintaining development and commercialization collaborations, which could adversely affect our ability to develop certain of our product candidates and our financial condition and operating results.
Because developing pharmaceutical products, conducting clinical trials, obtaining regulatory approval, establishing manufacturing capabilities and marketing approved products are expensive, we may seek to enter into collaborations with companies that have more experience. Additionally, if any of our product candidates receives marketing approval, we may enter into sales and marketing arrangements with third parties with respect to our unlicensed territories. If we are unable to enter into arrangements on acceptable terms, if at all, we may be unable to effectively market and sell our products in our target markets. We expect to face competition in seeking appropriate collaborators. Moreover, collaboration arrangements are complex and time consuming to negotiate, document and implement and they may require substantial resources to maintain. We may not be successful in our efforts to establish and implement collaborations or other alternative arrangements for the development of our product candidates.
One or more of our collaboration partners may not devote sufficient resources to the commercialization of our product candidates or may otherwise fail in their commercialization. The terms of any collaboration or other arrangement that we establish may contain provisions that are not favorable to us, or the favorability of which is dependent on conditions that are out of our control or unknowable at the time of execution. In addition, any collaboration that we enter into may be unsuccessful in the development and commercialization of our product candidates. In some cases, we may be responsible for continuing preclinical and initial clinical development of a product candidate or research program under a collaboration arrangement, and the payment we receive from our collaboration partner may be insufficient to cover the cost of this development. If we are unable to reach agreements with suitable collaborators for our product candidates, we would face increased costs, we may be forced to limit the number of our product candidates we can commercially develop or the territories in which we commercialize them. As a result, we might fail to commercialize products or programs for which a suitable collaborator cannot be found. If we fail to achieve successful collaborations, our operating results and financial condition could be materially and adversely affected.
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We face competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively.
The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological change. We have competitors in the United States, Europe, and other jurisdictions, including major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical and generic drug companies and universities and other research institutions. Many of our competitors have greater financial and other resources, such as larger research and development staff and more experienced marketing and manufacturing organizations than we do. Large pharmaceutical companies, in particular, have extensive experience in clinical testing, obtaining regulatory approvals, recruiting patients and manufacturing pharmaceutical products. These companies also have significantly greater research, sales and marketing capabilities and collaborative arrangements in our target markets with leading companies and research institutions. Established pharmaceutical companies may also invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make the product candidates that we develop obsolete. As a result of all of these factors, our competitors may succeed in obtaining patent protection and/or FDA approval or discovering, developing and commercializing drugs for the diseases that we are targeting before we do or may develop drugs that are deemed to be more effective or gain greater market acceptance than ours. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. In addition, many universities and private and public research institutes may become active in our target disease areas. Our competitors may succeed in developing, acquiring, or licensing on an exclusive basis, technologies and drug products that are more effective or less costly than any of our product candidates that we are currently developing or that we may develop, which could render our products obsolete or noncompetitive.
If our competitors market products that are more effective, safer or less expensive or that reach the market sooner than our future products, if any, we may not achieve commercial success. In addition, because of our limited resources, it may be difficult for us to stay abreast of the rapid changes in each technology. If we fail to stay at the forefront of technological change, we may be unable to compete effectively. Technological advances or products developed by our competitors may render our technologies or product candidates obsolete, less competitive or not economical.
Our licensed U.S. patents for Berubicin have expired and our licensed U.S. patents for TPI 287 will expire before commercialization is reasonably possible, and the expiration of our patents may subject us to increased competition, and the Orphan Drug Designations for TPI 287 and Berubicin will not bar approval of other similar products under certain circumstances.
The current U.S. and foreign patents for TPI 287 will all expire in 2028 well before commercialization is reasonably possible. TPI 287 held Orphan Drug Designation when we licensed it from Cortice and on June 10, 2020, the FDA granted Orphan Drug Designation for Berubicin for the treatment of malignant gliomas. ODD from the FDA is available for drugs targeting diseases with less than 200,000 cases per year. ODD may enable market exclusivity of 7 years from the date of approval of an NDA in the United States. During that period the FDA generally could not approve another product containing the same drug for the same designated indication. Orphan drug exclusivity will not bar approval of another product under certain circumstances, including if a subsequent product with the same active ingredient for the same indication is shown to be clinically superior to the approved product on the basis of greater efficacy or safety, or providing a major contribution to patient care, or if the company with orphan drug exclusivity is not able to meet market demand. The ODD now constitutes our primary intellectual property protections although we are exploring if there are other patents that could be filed related to Berubicin to extend additional protections. The ODD similarly strengthens our TPI 287 patent protections and would become our primary protection upon expiration of those patents, however, we are also exploring new patent opportunities related to TPI 287 and Berubicin. Nevertheless, we can provide no assurance that we will be able to file or receive additional patent protection. The failure to obtain additional patent protection will reduce the barrier to entry for competition for TPI 287 or Berubicin, which may adversely affect our operations.
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We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights.
We may from time to time seek to enforce our intellectual property rights against infringers when we determine that a successful outcome is probable and may lead to an increase in the value of the intellectual property. If we choose to enforce our patent rights against a party, then that individual or company has the right to ask the court to rule that such patents are invalid or should not be enforced. Additionally, the validity of our patents and the patents we have licensed may be challenged if a petition for post grant proceedings such as interpartes review and post grant review is filed within the statutorily applicable time with the U.S. Patent and Trademark Office (USPTO). These lawsuits and proceedings are expensive and would consume time and resources and divert the attention of managerial and scientific personnel even if we were successful in stopping the infringement of such patents. In addition, there is a risk that the court will decide that such patents are not valid and that we do not have the right to stop the other party from using the inventions. There is also the risk that, even if the validity of such patents is upheld, the court will refuse to stop the other party on the ground that such other party’s activities do not infringe our intellectual property rights. In addition, in recent years the U.S. Supreme Court modified some tests used by the USPTO in granting patents over the past 20 years, which may decrease the likelihood that we will be able to obtain patents and increase the likelihood of a challenge of any patents we obtain or license.
We may be subject to claims that our employees and contractors have wrongfully used or disclosed alleged trade secrets of their former employers.
As is common in the biotechnology and pharmaceutical industries, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies, including our competitors or potential competitors. We may be subject to claims that these employees, or we, have used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.
If we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology and products could be significantly diminished.
We rely on trade secrets to protect our proprietary technologies, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our employees, consultants, outside scientific collaborators, and other advisors to protect our trade secrets and other proprietary information. These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, others may independently discover our trade secrets and proprietary information. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position.
We will need to expand our operations and increase the size of our Company, and we may experience difficulties in managing growth.
As of March 31, 2026, we have eight full-time employees. As we secure rights to and advance product candidates through preclinical studies and clinical trials, we will need to increase our product development, scientific and administrative headcount to manage these programs. In addition, to meet our obligations as a public company, we may need to increase our general and administrative capabilities. Our management, personnel, and systems currently in place may not be adequate to support this future growth. If we are unable to successfully manage this growth and increased complexity of operations, our business may be adversely affected.
We may not be able to manage our business effectively if we are unable to attract and retain key personnel and consultants.
We may not be able to attract or retain qualified management, finance, scientific and clinical personnel, and consultants due to the intense competition for qualified personnel and consultants among biotechnology, pharmaceutical and other businesses. If we are not able to attract and retain necessary personnel and consultants to accomplish our business objectives, we may experience constraints that will significantly impede the achievement of our development objectives, our ability to raise additional capital.
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We are highly dependent on the development, regulatory, commercialization and business development expertise of our management team, key employees, and consultants. If we lose one or more of our executive officers or key employees or consultants, our ability to implement our business strategy successfully could be seriously harmed. Any of our executive officers or key employees or consultants may terminate their employment at any time. Replacing executive officers, key employees and consultants may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to develop, gain regulatory approval of and commercialize products successfully. Competition to hire and retain employees and consultants from this limited pool is intense, and we may be unable to hire, train, retain or motivate these additional key personnel and consultants. Our failure to retain key personnel or consultants could materially harm our business.
In addition, we have scientific and clinical advisors and consultants who assist us in formulating our research, development, and clinical strategies. These advisors are not our employees and may have commitments to, or consulting or advisory contracts with, other entities that may limit their availability to us and typically they will not enter into noncompete agreements with us. If a conflict of interest arises between their work for us and their work for another entity, we may lose their services. In addition, our advisors may have arrangements with other companies to assist those companies in developing products or technologies that may compete with ours.
We do not expect that our insurance policies will cover all of our business exposures thus leaving us exposed to significant uninsured liabilities.
We do not carry insurance for all categories of risk that our business may encounter. There can be no assurance that we will secure adequate insurance coverage or that any such insurance coverage will be sufficient to protect our operations to significant potential liability in the future. Any significant uninsured liability may require us to pay substantial amounts, which would adversely affect our financial position and results of operations.
Although dependent on certain key personnel, we do not have any key man life insurance policies on any such people.
We are dependent on our executive leadership team: Rami Levin, Eric Faulkner, Lynne Kelley, Steve O’Loughlin and Dylan Wenke in order to conduct our operations and execute our business plan, however, we have not purchased any insurance policies with respect to those individuals in the event of their death or disability. Therefore, if any of our current executives die or become disabled, we will not receive any compensation to assist with such person’s absence. The loss of such person could negatively affect us and our operations.
There may be limited suppliers for active pharmaceutical ingredients (“API”) used in our drug candidates. Problems with the third parties that manufacture the API used in our drug candidates, or in the supply chain between the manufacturer and CNS, may delay our clinical trials or subject us to liability.
We do not currently own or operate manufacturing facilities for clinical or commercial production of the API used in any of our drug candidates. We have no experience in API manufacturing, and we lack the resources and the capability to manufacture any of the APIs used in our drug candidates, on either a clinical or commercial scale. As a result, we rely on third parties to supply the API used in each of our drug candidates and commercial couriers to deliver the manufactured API to us. We expect to continue to depend on third parties to supply the API for our current and future product candidates and to supply the API in commercial quantities. We are ultimately responsible for confirming that the APIs used in our product candidates are manufactured in accordance with applicable regulations.
Our third-party suppliers and couriers may not carry out their contractual obligations or meet our deadlines. In addition, the API they supply to us may not meet our specifications and quality policies and procedures or they may not be able to supply the API in commercial quantities. If we need to find alternative suppliers for the API used in any of our product candidates, we may not be able to contract for such supplies on acceptable terms, if at all. Any such failure to supply or delay caused by such contract manufacturers or couriers would have an adverse effect on our ability to continue clinical development of our product candidates or commercialization of our product candidates.
If our third-party drug suppliers fail to achieve and maintain high manufacturing standards in compliance with cGMP regulations, we could be subject to certain product liability claims in the event such failure to comply resulted in defective product that caused injury or harm.
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We may not be able to recover from any catastrophic event affecting our suppliers.
Our suppliers may not have adequate measures in place to minimize and recover from catastrophic events that may substantially destroy their capability to meet customer needs and any measures they may have in place may not be adequate to recover production processes quickly enough to support critical timelines or market demands. These catastrophic events may include weather and geologic events such as tornadoes, earthquakes, floods, tidal waves, volcanic eruptions, and fires as well as infectious disease epidemics, acts of war, acts of terrorism and nationalization of private industry. In addition, these catastrophic events may render some or all of the products at the affect facilities unusable.
We may be materially adversely affected in the event of cyber-based attacks, network security breaches, service interruptions, or data corruption.
We rely on information technology to process and transmit sensitive electronic information and to manage or support variety of business processes and activities. We use technology systems to record, process, and summarize financial information and results of operations for internal reporting purposes and to comply with regulatory financial reporting, legal, and tax requirements. Our information technology systems, some of which are managed by third parties, may be susceptible to damage, disruptions or shut down student computer viruses, attacks by computer hackers, failures during the process of upgrading or replacing software, databases or components thereof, power outages, hardware failures, technology for communication failures, user errors or catastrophic events. Although we have developed systems and processes that are designed to protect proprietary or confidential information and prevent data loss and other security breaches, such measures cannot provide absolute security. If our systems are breached or suffer severe damage, disruption or shutdown and we are unable to effectively resolve the issues in a timely manner, our business and operating results may significantly suffer and we may be subject to litigation, government enforcement actions or potential liability. Security breaches could also cause us to incur significant remediation costs, result in product development delays, disrupt key business operations, including development of our product candidates, and divert attention of management and key information technology resources.
Our cash and cash equivalents could be adversely affected if the financial institutions in which we hold our cash and cash equivalents fail.
We regularly maintain cash balances at third-party financial institutions. Our cash investment strategy is intended to preserve capital and minimize cash balances that exceed the Federal Deposit Insurance Corporation, or FDIC, insurance limit. However, our cash balances may exceed the FDIC insurance limit from time to time. Events involving limitations to liquidity, defaults, non-performance or other adverse developments that affect financial institutions, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems. For example, on March 10, 2023, the FDIC, took control and was appointed receiver of Silicon Valley Bank (to which the Company had no exposure). If other banks and financial institutions enter receivership or become insolvent in the future in response to financial conditions affecting the banking system and financial markets, our ability to access our existing cash, cash equivalents and investments may be threatened and could have a material adverse effect on our business and financial condition.
Risks Related to Our Common Stock
Failure to maintain effective internal control over our financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act has caused and may cause in the future our financial reports to be inaccurate.
We are required pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, or Section 404, to maintain internal control over financial reporting and to assess and report on the effectiveness of those controls. This assessment includes disclosure of any material weaknesses identified by our management in our internal control over financial reporting. Our management concluded that our internal controls over financial reporting were, and continue to be, ineffective as of December 31, 2025, identified a material weakness in our internal controls due to the lack of sufficient personnel to allow for segregation of duties (resulting from the limited number of personnel available), limited access to timely and complete information regarding the status of costs incurred in the activation of investigational sites and costs from treating patients in our study which is a result of the use of a third-party Contract Research Organization (“CRO”) to manage the study, and the lack of formal documentation of our control environment. While management is working to remediate the material weaknesses, there is no assurance that such changes, when economically feasible and sustainable, will remediate the identified material weaknesses or that the controls will prevent or detect future material weaknesses. If we are not able to maintain effective internal control over financial reporting, our financial statements, including related disclosures, may be inaccurate, which could have a material adverse effect on our business.
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Failure to continue improving our accounting systems and controls could impair our ability to comply with the financial reporting and internal controls requirements for publicly traded companies.
As a public company, we operate in an increasingly demanding regulatory environment, which requires us to comply with the Sarbanes-Oxley Act of 2002, and the related rules and regulations of the SEC. Company responsibilities required by the Sarbanes-Oxley Act include establishing corporate oversight and adequate internal control over financial reporting and disclosure controls and procedures. Effective internal controls are necessary for us to produce reliable financial reports and are important to help prevent financial fraud.
Management performed an annual assessment as of December 31, 2025 of the effectiveness of our internal control over financial reporting for its annual report. Our management concluded that our internal control over financial reporting was, and continues to be, ineffective as of December 31, 2025, due to material weaknesses in our internal controls due to the lack of segregation of duties (resulting from the limited number of personnel available), limited access to timely and complete information regarding the status of costs incurred in the activation of investigational sites and costs from treating patients in our study which is a result of the use of a third-party Contract Research Organization (“CRO”) to manage the study, and the lack of formal documentation of our control environment. For as long as we remain a smaller reporting company as defined by Rule 12b-2 of the Exchange Act, we have and intend to consider to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not a smaller reporting company including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act. We may continue to take advantage of these reporting exemptions until we are no longer a smaller reporting company. To mitigate the lack of segregation of duties material weaknesses, we engaged an outside firm to assist management with such accounting and will continue to use outside firms as a resource to deal with other non-recurring or unusual transactions. To mitigate the lack of formal documentation of the control environment, we have key team members review the critical reports and reconciliations as well as reporting documents. To mitigate the limited access to timely and complete information regarding the status of costs incurred in the activation of investigational sites and costs from treating patients in the study which is a result of the use of a third-party Contract Research Organization (“CRO”) to manage the study, we have senior leaders of our finance and research teams review period end estimates. However, notwithstanding our mitigation efforts, there is no assurance we will not encounter accounting errors in the future. If we cannot provide reliable financial reports or prevent fraud, our business and results of operations could be harmed, and investors could lose confidence in our reported financial information.
Our current stockholders’ ownership may be diluted if additional capital stock is issued to raise capital, to finance acquisitions or in connection with strategic transactions.
We intend to seek to raise additional funds, finance acquisitions or develop strategic relationships by issuing equity or convertible debt securities, which would reduce the percentage ownership of our existing stockholders. Our board of directors has the authority, without action or vote of the stockholders, to issue all or any part of our authorized but unissued shares of common or preferred stock. Our articles of incorporation authorize us to issue up to 300,000,000 shares of common stock and 5,000,000 shares of preferred stock. Future issuances of common or preferred stock would reduce your influence over matters on which stockholders vote and would be dilutive to earnings per share. In addition, any newly issued preferred stock could have rights, preferences, and privileges senior to those of the common stock. Those rights, preferences, and privileges could include, among other things, the establishment of dividends that must be paid prior to declaring or paying dividends or other distributions to holders of our common stock or providing for preferential liquidation rights. These rights, preferences and privileges could negatively affect the rights of holders of our common stock, and the right to convert such preferred stock into shares of our common stock at a rate or price that would have a dilutive effect on the outstanding shares of our common stock.
We have in the past been unable to maintain compliance with the listing requirements of The Nasdaq Capital Market, and any future failure to maintain compliance could subject our common stock to be delisted from The Nasdaq Capital Market, which could have a material adverse effect on our financial condition and could make it more difficult for you to sell your shares.
Our common stock is listed on The Nasdaq Capital Market, and we are therefore subject to its continued listing requirements, including requirements with respect to the market value of publicly-held shares, market value of listed shares, minimum bid price per share, and minimum stockholder's equity, among others, and requirements relating to board and committee independence. If we fail to satisfy one or more of the requirements, we may be delisted from The Nasdaq Capital Market.
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During 2024, we experienced compliance deficiencies with respect to the requirement to maintain a closing bid price of $1.00 per share (the “Minimum Bid Price Requirement”) pursuant to Nasdaq Listing Rule 5550(a)(2), and the minimum $2,500,000 stockholders’ equity requirement for continued listing set forth in Listing Rule 5550(b) (the “Equity Requirement”). We have since remedied these deficiencies and, as of the date of this filing, we are in compliance with all applicable Nasdaq listing requirements.
Although we are currently in compliance with all applicable Nasdaq listing requirements, there can be no assurance that we will continue to meet such requirements in the future, and we could be subject to delisting at a future time. Delisting from The Nasdaq Capital Market would adversely affect our ability to raise additional financing through the public or private sale of equity securities, may significantly affect the ability of investors to trade our securities and may negatively affect the value and liquidity of our common stock. Delisting also could have other negative results, including the potential loss of employee confidence, the loss of institutional investors or interest in business development opportunities.
We may be required to repurchase certain of our warrants upon a fundamental transaction, which may prevent or deter a third party from acquiring us.
Certain of our warrants to purchase common stock provide that in the event of a “Fundamental Transaction” (as defined in the related warrant agreement, which generally includes any merger with another entity, the sale, transfer or other disposition of all or substantially all of our assets to another entity, or the acquisition by a person of more than 50% of our common stock), each warrant holder will have the right at any time prior to the consummation of the Fundamental Transaction to require us to repurchase the warrant for a purchase price in cash equal to the Black-Scholes value (as calculated under the warrant agreement) of the then remaining unexercised portion of such common warrant on the date of such Fundamental Transaction, which may materially adversely affect our financial condition and/or results of operations and may prevent or deter a third party from acquiring us.
General Risk Factors
As a biotechnology company, we may be at an increased risk of securities class action litigation.
Historically, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because biotechnology and pharmaceutical companies have experienced significant stock price volatility in recent years. If we were to be sued, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.
If securities or industry analysts do not publish research or reports about us, or if they adversely change their recommendations regarding our common stock, then our stock price and trading volume could decline.
The trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish about us, our industry and our market. If no analyst elects to cover us and publish research or reports about us, the market for our common stock could be severely limited and our stock price could be adversely affected. As a small-cap company, we are more likely than our larger competitors to lack coverage from securities analysts. In addition, even if we receive analyst coverage, if one or more analysts ceases coverage of us or fails to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline. If one or more analysts who elect to cover us issue negative reports or adversely change their recommendations regarding our common stock, our stock price could decline.
| Item 1B. | Unresolved Staff Comments. |
None.
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| Item 1C. | Cybersecurity. |
There have been an increasing number of cyberattacks on companies around the world, which have caused operational failures, compromised sensitive corporate or customer data, and/or resulted in significant financial damages. These attacks have occurred over the internet, through malware, viruses or attachments to e-mails, or through inside actors with access to systems within the organization.
Our cybersecurity management strategy consists of utilizing a combination of employee education, preventative controls, detective controls, and periodic third-party cybersecurity testing. During fiscal year 2023 we began to deploy and utilize enterprise scale technology to support an appropriate cybersecurity posture including: endpoint detection and response, firewalls, security information and event management, email security, multifactor authentication, and vulnerability management. As part of the service offering from our outsourced IT security services provider, cybersecurity related alerts will be issued to us as relevant situations develop. These alerts will be evaluated in concert with our IT provider and in the event an alert requires action within our environment, such actions will be taken promptly. Our process and cybersecurity posture will continue to be refined based on the results of periodic cybersecurity assessments conducted jointly with our IT provider. We have recently begun reporting on cybersecurity in reports to the Board of Directors and will continue to do so.
To operate our business, we rely upon certain third-party service providers to perform a variety of functions, such as outsourced business critical functions, clinical research, professional services, SaaS platforms, managed services, cloud-based infrastructure, content delivery, encryption and authentication technology, corporate productivity services, and other functions. We are developing certain vendor management processes designed to help to manage cybersecurity risks associated with our use of certain of these providers. Depending on the nature of the services provided, the sensitivity and quantity of information processed, and the identity of the service provider, our vendor management process may include reviewing the cybersecurity practices of such provider, contractually imposing obligations on the provider related to the services they provide and/or the information they process, conducting security assessments, conducting on-site inspections, requiring their completion of written questionnaires regarding their services and data handling practices, and conducting periodic re-assessments during their engagement. For our largest third-party provider, our Contract Research Organization (“CRO”) which is helping us manage our global trial of Berubicin, we are currently conducting a security assessment and review including their cybersecurity practices, protocols and protections, handling of information protected by HIPAA, and physical security.
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| Item 2. | Properties. |
Our corporate and executive offices are located in a leased facility in Houston, Texas. We believe our facilities are sufficient to meet our current needs and that suitable space will be available as and when needed. We do not own any real property.
| Item 3. | Legal Proceedings. |
From time to time in the ordinary course of our business, we may be involved in legal proceedings, the outcomes of which may not be determinable. The results of litigation are inherently unpredictable. Any claims against us, whether meritorious or not, could be time consuming, result in costly litigation, require significant amounts of management time and result in diversion of significant resources. However, we are currently not a party to any pending legal actions. We have insurance policies covering any potential losses where such coverage is cost effective.
We are not at this time involved in any additional legal proceedings that we believe could have a material effect on our business, financial condition, results of operations or cash flows.
| Item 4. | Mine Safety Disclosures. |
Not applicable.
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PART II
| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. |
Our common stock has been listed on the NASDAQ Capital Market under the symbol “CNSP” since November 8, 2019.
Holders of Common Equity
As of March 28, 2026, we had approximately 5 stockholders of record of our common stock holding shares directly with the transfer agent. This does not include beneficial owners of our common stock.
Dividends
We have never declared or paid any cash dividends on our capital stock. We currently intend to retain earnings, if any, to finance the growth and development of our business. We do not expect to pay any cash dividends on our common stock in the foreseeable future. Payment of future dividends, if any, will be at the discretion of our board of directors and will depend on our financial condition, results of operations, capital requirements, restrictions contained in any financing instruments, provisions of applicable law and other factors the board deems relevant.
Recent Sales of Unregistered Securities
Except as previously disclosed on Form 8-K, there were no sales of unregistered securities during the fourth quarter ended December 31, 2025.
Purchases of Equity Securities by the Issuer and Affiliated Purchasers
We did not repurchase any of our equity securities during the year ended December 31, 2025.
Equity Compensation Plan Information
See Part III, Item 12 to this Form 10-K for information relating to securities authorized for issuance under our equity compensation plans.
| Item 6. | [Reserved]. |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations. |
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-K. This discussion contains forward-looking statements reflecting our current expectations that involve risks and uncertainties, including those set forth under “Cautionary Statement About Forward-Looking Statements.” Actual results and experience could differ materially from the anticipated results and other expectations expressed in our forward-looking statements as a result of a number of factors, including but not limited to those discussed in this Item and in Item 1A - “Risk Factors.” 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-K.
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Overview
We are a biotechnology company organized as a Nevada corporation in July 2017. We are focused on building a high-value pipeline for neurology and oncology indications that have the potential to be best-in-class. We are leveraging our executive team’s experiences in these therapeutic areas to execute our new corporate strategy, which also includes pivoting from a singular focus on glioblastoma multiforme and exploring out-licensing opportunities for our legacy assets TPI 287 and Berubicin for which we have intellectual property rights under license agreement with Cortice and own pursuant to a collaboration and asset purchase agreement with Reata.
Results of Operations for the Year Ended December 31, 2025 Compared to the Year Ended December 31, 2024 (rounded to the nearest thousand)
General and Administrative Expense
General and administrative expense was approximately $6,215,000 for the year ended December 31, 2025 compared to approximately $5,612,000 for 2024. The increase in general and administrative expense was mainly attributable to an increase of approximately $34,000 in professional expenses, $913,000 in employee compensation, $142,000 in travel expenses, $48,000 in insurance expenses and other general and administrative expenses of $44,000. These changes were offset by decrease of approximately $575,000 in stock-based compensation and $3,000 in board of director compensation.
Research and Development Expense
Research and development expense was approximately $9,772,000 for the year ended December 31, 2025 compared to approximately $9,290,000 for 2024. The change in research and development expense during the period is primarily attributable to increase in expenditures preparing for a TPI 287 trial including drug manufacturing as well as other expenses offset by decline in trial costs for the Berubicin trial.
Other Income (Expense)
Interest income was approximately $154,000 and $60,000 for the years ended December 31, 2025 and 2024, respectively. Interest and other expenses were approximately $18,000 and $16,000 for the years ended December 31, 2025 and 2024, respectively.
Net Loss
The net loss for the year ended December 31, 2025 was approximately $15,851,000 compared to approximately $14,858,000 for 2024. The change in net loss is primarily attributable to increased research and development costs.
Liquidity and Capital Resources
On December 31, 2025, we had cash of approximately $7,201,000 and we had a working capital of approximately $4,002,000. We have historically funded our operations from proceeds from debt and equity sales.
On July 26, 2024 we entered into a Sales Agreement (the “AGP ATM Sales Agreement”) with A.G.P./Alliance Global Partners (“AGP”). Pursuant to the terms of the AGP ATM Sales Agreement, we are permitted to sell from time to time through AGP, as sales agent or principal, shares of our common stock. During the year ended December 31, 2025, we sold 185,521 shares of common stock pursuant to the AGP ATM Sales Agreement for net proceeds of approximately $9.5 million. As of December 31, 2025, the Company has sold 268,169 shares of common stock pursuant to the AGP ATM Sales Agreement for net proceeds of approximately $23.2 million.
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On May 13, 2025 we entered into a placement agency agreement with AGP for the public offering of (i) 27,084 shares of our 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 Common Warrants and Pre-Funded Warrants are collectively referred to herein as the (“Warrants”). The combined purchase price of one share of common stock and one accompanying Common Warrant was $15.18 and the combined purchase price of one Pre-Funded Warrant and one accompanying Common Warrant was $15.17.
Subject to certain ownership limitations, the Warrants are exercisable immediately upon issuance. Each Pre-Funded Warrant is exercisable into one share of Common Stock at a price per share of $0.001 and expire once such Pre-Funded Warrants are fully exercised. The Common Warrants are exercisable into one share of Common Stock at a price per share of $13.68 and expire five years from Initial Exercise Date. The gross proceeds to the Company from the offering were approximately $5 million, before deducting the Placement Agent’s fees and other offering expenses. The closing of this offering occurred on May 14, 2025.
We estimate that we have sufficient capital to take us into the third quarter of 2026. Our strategy is focused on identifying and securing the rights to development stage assets focused on neurology and oncology indications and advancing any assets we obtain the rights to. The timing, cost and ultimate success of which are all difficult to predict and as such the foregoing estimate may prove to be inaccurate. The cost of advancing any drug candidate will require significant additional capital. We have no commitments for such additional needed financing and will likely be required to raise additional capital through the sale of additional equity or debt securities.
We will need to raise significant additional capital in the future in order to meet our future obligations and execute our business plan. 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 plan until sufficient additional capital is raised to support further 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.
Summary of Cash Flows
Cash used in operating activities
Net cash used in operating activities was approximately $13,811,000 and $17,113,000 for the years ended December 31, 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.
Cash used in investing activities
Net cash used in investing activities was approximately $18,000 and $4,000 for the years ended December 31, 2025 and 2024 and included payments for furniture and equipment.
Cash provided by financing activities
Net cash provided by financing activities was approximately $14,569,000 and $23,030,000 for the years ended December 31, 2025 and 2024, respectively. We received net proceeds of approximately $14,046,000 from the issuance of common stock during the year ended December 31, 2025.
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Off-balance Sheet Arrangements
As of December 31, 2025, we did not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.
Purchase Commitments
We do not have any material commitments for capital expenditures, although we are required to pay certain milestone fees and royalties to Reata and Cortice as described in the section “Overview” above.
Critical Accounting Policies and Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates, assumptions and judgments that affect the amounts reported in the financial statements, including the notes thereto. We consider critical accounting policies to be those that require more significant judgments and estimates in the preparation of our financial statements. Management relies on historical experience and other assumptions believed to be reasonable in making its judgment and estimates. Actual results could differ materially from those estimates.
Management believes its application of accounting policies, and the estimates inherently required therein, are reasonable. These accounting policies and estimates are periodically reevaluated, and adjustments are made when facts and circumstances dictate a change. As of December 31, 2025, there were no critical audit estimates.
| Item 7A. | Quantitative and Qualitative Disclosure About Market Risk. |
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
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| Item 8. | Financial Statements and Supplementary Data. |
CNS Pharmaceuticals, Inc.
Index to Financial Statements
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and Board of Directors of
CNS Pharmaceuticals, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheets of CNS Pharmaceuticals, Inc.( the “Company”) as of December 31, 2025 and 2024, and the related statements of operations, stockholders’ equity (deficit), and cash flows for the years then ended, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.
Going Concern Matter
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company has suffered recurring losses from operations that raises substantial doubt about its ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.
/s/
www.malonebailey.com
We have served as the Company's auditor since 2019.
March 31, 2026
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CNS Pharmaceuticals, Inc.
Balance Sheets
| December 31, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Deferred offering costs | ||||||||
| Subscription receivable | ||||||||
| Prepaid expenses and other current assets | ||||||||
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| Noncurrent Assets: | ||||||||
| Prepaid expenses, net of current portion | ||||||||
| Property and equipment, net | ||||||||
| Total noncurrent assets | ||||||||
| Total Assets | $ | $ | ||||||
| Liabilities and Stockholders' Equity (Deficit) | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | $ | ||||||
| Notes payable | ||||||||
| Total current liabilities | ||||||||
| Total Liabilities | ||||||||
| Commitments and contingencies | ||||||||
| Stockholders' Equity (Deficit): | ||||||||
| Preferred stock, $ par value, shares authorized and shares issued and outstanding | ||||||||
| Common stock, $ par value, shares authorized and and shares issued and outstanding, respectively | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total Stockholders' Equity (Deficit) | ||||||||
| Total Liabilities and Stockholders' Equity (Deficit) | $ | $ | ||||||
See accompanying notes to the financial statements.
| 39 |
CNS Pharmaceuticals, Inc.
Statements of Operations
| Year ended | Year ended | |||||||
| December 31, 2025 | December 31, 2024 | |||||||
| Operating expenses: | ||||||||
| General and administrative | $ | $ | ||||||
| Research and development | ||||||||
| Total operating expenses | ||||||||
| Loss from operations | ( | ) | ( | ) | ||||
| Other income (expenses): | ||||||||
| Other expense | ( | ) | ||||||
| Interest income | ||||||||
| Interest expense | ( | ) | ( | ) | ||||
| Total other income (expense) | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Loss per share - basic | $ | ( | ) | $ | ( | ) | ||
| Loss per share - diluted | $ | ( | ) | $ | ( | ) | ||
| Weighted average shares outstanding - basic | ||||||||
| Weighted average shares outstanding - diluted | ||||||||
See accompanying notes to the financial statements.
| 40 |
CNS Pharmaceuticals, Inc.
Statements of Stockholders' Equity (Deficit)
For the years ended December 31, 2025 and 2024
| Additional | Total | |||||||||||||||||||
| Common Stock | Paid-in | Accumulated | Stockholders' | |||||||||||||||||
| Shares | Amount | Capital | Deficit | Equity (Deficit) | ||||||||||||||||
| Balance December 31, 2023 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| Common stock issued for cash and warrants, net | ||||||||||||||||||||
| Exercise of warrants, net | ||||||||||||||||||||
| Stock-based compensation | – | |||||||||||||||||||
| Shares issued for license agreement | ||||||||||||||||||||
| Stock issued for stock split rounding | ||||||||||||||||||||
| Net loss | – | ( | ) | ( | ) | |||||||||||||||
| Balance December 31, 2024 | ( | ) | ||||||||||||||||||
| Common stock issued for cash and warrants, net | ||||||||||||||||||||
| Exercise of warrants, net | ||||||||||||||||||||
| Stock repurchase during stock split rounding | ( | ) | ( | ) | ( | ) | ||||||||||||||
| Stock-based compensation | – | |||||||||||||||||||
| Net loss | – | ( | ) | ( | ) | |||||||||||||||
| Balance December 31, 2025 | $ | $ | $ | ( | ) | $ | ||||||||||||||
See accompanying notes to the financial statements.
| 41 |
CNS Pharmaceuticals, Inc.
Statements of Cash Flows
| Years Ended | Years Ended | |||||||
| December 31, 2025 | December 31, 2024 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | ||||||||
| Depreciation | ||||||||
| Common stock issued for license agreement | ||||||||
| Loss (gain) on disposal of fixed assets | ( | ) | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and other current assets | ( | ) | ||||||
| Accounts payable and accrued expenses | ( | ) | ||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash Flows from Investing Activities: | ||||||||
| Purchase of property and equipment | ( | ) | ( | ) | ||||
| Net cash used in investing activities | ( | ) | ( | ) | ||||
| Cash Flows from Financing Activities: | ||||||||
| Payments of deferred offering costs | ( | ) | ( | ) | ||||
| Payments on notes payable | ( | ) | ( | ) | ||||
| Stock repurchased during stock split rounding | ( | ) | ||||||
| Proceeds from subscription receivable | ||||||||
| Proceeds from exercise of warrants | ||||||||
| Proceeds from sale of common stock | ||||||||
| Net cash provided by financing activities | ||||||||
| Net change in cash and cash equivalents | ||||||||
| Cash and cash equivalents, at beginning of period | ||||||||
| Cash and cash equivalents, at end of period | $ | $ | ||||||
| Supplemental disclosures of cash flow information: | ||||||||
| Cash paid for interest | $ | $ | ||||||
| Cash paid for income taxes | $ | $ | ||||||
| Supplemental disclosure of non-cash investing and financing activities: | ||||||||
| Prepaid expense financed with note payable | $ | $ | ||||||
| Reclassification of deferred offering costs to equity | $ | $ | ||||||
| Common stock issued for subscription receivable | $ | $ | ||||||
| Stock issued for stock split rounding | $ | $ | ||||||
See accompanying notes to the financial statements.
| 42 |
CNS Pharmaceuticals, Inc.
Notes to the Financial Statements
Note 1 – Nature of Business
CNS Pharmaceuticals, Inc. (“we”, “our”, the “Company”) is a biotechnology company organized as a Nevada corporation in July 2017. We are focused on building a high-value pipeline for neurology and oncology indications that have the potential to be best-in-class. We are leveraging our executive team’s experiences in these therapeutic areas to execute our new corporate strategy, which also includes pivoting from a singular focus on glioblastoma multiforme and exploring out-licensing opportunities for our legacy assets TPI 287 and Berubicin for which we have intellectual property rights under license agreement with Cortice and own pursuant to a collaboration and asset purchase agreement with Reata.
On April 30, 2024, the stockholders of the Company approved an amendment
to the Company’s amended and restated articles of incorporation (the “Amendment”) to effect the reverse stock split
at a ratio in the range of 1-for-2 to 1-for-50. The reverse stock split became effective on June 4, 2024 on a
On November 26, 2024, the stockholders of the Company approved an amendment
to the Company’s amended and restated articles of incorporation (the “Amendment”) to effect the reverse stock split
at a ratio in the range of 1-for-2 to 1-for-50. The reverse stock split became effective on February 21, 2025 on a
On July 22, 2025, the Company effected a reverse stock split on a
On November 20, 2025, following approval by shareholders, the Company filed a Certificate of Amendment to its Amended and Restated Articles of Incorporation with the Secretary of State of the State of Nevada to increase the number of the Company’s authorized shares of common stock from shares to shares and to increase the total number of authorized shares of preferred stock from shares to shares.
Note 2 – Summary of Significant Accounting Policies
The accompanying financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and in accordance with the rules and regulations of the United States Securities and Exchange Commission (the “SEC”). The Company’s fiscal year end is December 31.
Use of Estimates in Financial Statement Presentation - The preparation of these financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
| 43 |
Liquidity and Going Concern - These financial statements have been prepared on a going concern basis, which assumes the Company will continue to realize its assets and discharge its liabilities in the normal course of business. The continuation of the Company as a going concern is dependent upon the ability of the Company to obtain equity financings to continue operations. The Company has a history of and expects to continue to report negative cash flows from operations and a net loss. For the year ended December 31, 2025, we recorded a net loss of approximately $ and used cash in operations for approximately $. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. These financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company may seek additional funding through a combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements, other collaborations, strategic alliances and licensing arrangements and delay planned cash outlays or a combination thereof. Management cannot be certain that such events or a combination thereof can be achieved.
Cash and Cash Equivalents - The Company considers all highly
liquid accounts with original maturities of three months or less at the date of acquisition to be cash equivalents. Periodically, the
Company may carry cash balances at financial institutions in excess of the federally insured limit of $250,000. The amount in excess of
the FDIC insurance at December 31, 2025 was $
Property and Equipment - Property and equipment is recorded at cost and depreciated over their estimated useful lives using the straight-line depreciation method as follows:
| Leasehold improvement | Shorter of estimated useful lives or the term of the lease |
| Computer equipment | |
| Machinery and equipment | |
| Furniture and office equipment |
Repairs and maintenance costs are expensed as incurred.
Impairment of Long-lived Assets - The Company evaluates its long-lived tangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. The recoverability of a long-lived asset is measured by comparison of the carrying amount to the expected future undiscounted cash flows that the asset is expected to generate. Any impairment to be recognized is measured by the amount by which the carrying amount of the asset exceeds its fair value.
Fair Value of Financial Instruments - The carrying value of short-term instruments, including cash and cash equivalents, accounts payable and accrued expenses, and short-term notes approximate fair value due to the relatively short period to maturity for these instruments.
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs. The Company utilizes a three-level valuation hierarchy for disclosures of fair value measurements, defined as follows:
Level 1 - inputs to the valuation methodology are quoted prices (unadjusted) for identical assets or liabilities in active markets.
Level 2 - inputs to the valuation methodology include quoted prices for similar assets and liabilities in active markets, and inputs that are observable for the assets or liability, either directly or indirectly, for substantially the full term of the financial instruments.
| 44 |
Level 3 - inputs to the valuation methodology are unobservable and significant to the fair value.
The Company does not have any assets or liabilities that are required to be measured and recorded at fair value on a recurring basis.
Related Parties - The Company follows ASC 850, Related Party Disclosures, for the identification of related parties and disclosure of related party transactions.
Income Taxes - The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of reported assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company must then assess the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized.
The Company accounts for uncertain tax positions in accordance with the provisions of Accounting Standards Codification (ASC) 740-10 which prescribes a recognition threshold and measurement attribute for financial statement disclosure of tax positions taken, or expected to be taken, on its tax return. The Company evaluates and records any uncertain tax positions based on the amount that management deems is more likely than not to be sustained upon examination and ultimate settlement with the tax authorities in the tax jurisdictions in which it operates.
Restricted Stock Units (“RSUs”) - Our RSUs vest over two or four years from the date of grant. The fair value of RSUs is the market price of our common stock at the date of grant.
Performance Units (“PUs”) - The PUs vest based on our performance against predefined share price targets and the achievement of Positive Interim, Clinical Data as defined by the Board.
Warrants - The Company evaluates all freestanding and embedded warrants to determine whether they meet the criteria for equity classification under ASC 815-40, Derivatives and Hedging—Contracts in Entity’s Own Equity, or if they must be classified as liabilities under ASC 480 or ASC 815-10. The Company evaluated the warrants and concluded they are indexed to the Company's common stock and meet the equity classification criteria under ASC 815-40, as they are settleable in shares, and the Company has sufficient shares authorized. The warrants were recorded at fair value upon issuance within stockholders' equity
Research and Development Costs - Research and development costs are expensed as incurred. The Company recognized the benefit of refundable research and development tax credits as a reduction of research and development expenses when there is reasonable assurance that the amount claimed will be recovered.
Segments Reporting
The Company manages its operations as a single segment for the purpose of assessing performance and making operating decisions. The Company’s Chief Operating Decision Maker (“CODM”) is its Chief Executive Officer. The CODM allocates resources and evaluates the performance of the Company using information about combined net income from operations. All significant operating decisions are based upon an analysis of the Company as operating segment, which is the same as its reporting segment. See statement of operations for information about combined net income from operations.
| 45 |
Recent Accounting Pronouncements
Income Taxes
In December 2023, the FASB issued Accounting Standards Update (“ASU”) No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). ASU 2023-09 requires enhanced disclosures surrounding income taxes, particularly related to rate reconciliation and income taxes paid information. In particular, on an annual basis, companies will be required to disclose specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold. Companies will also be required to disclose, on an annual basis, the amount of income taxes paid, disaggregated by federal, state, and foreign taxes, and also disaggregated by individual jurisdictions above a quantitative threshold. The standard is effective for the Company for annual periods beginning January 1, 2025 on a prospective basis, with retrospective application permitted for all prior periods presented. We adopted ASU No. 2023-09 during the year ended December 31, 2025, with no material impact to the Company’s financial statements or results of operations.
Disaggregation of Income Statement Expenses
In November 2024, the FASB issued Accounting Standards Update No. 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40) (“ASU 2024-03”). ASU 2024-03 requires specified information about certain costs and expenses be disclosed in the notes to the financial statements, including the expense caption on the face of the income statement in which they are disclosed, in addition to a qualitative description of remaining amounts not separately disaggregated. Entities will also be required to disclose their definition of “selling expenses” and the total amount in each annual period. The standard is effective for the Company for annual periods beginning January 1, 2027 and for interim periods beginning January 1, 2028, with updates applied either prospectively or retrospectively. Early adoption is permitted. The Company is currently evaluating the impact of this guidance on its disclosures.
Credit Losses
In July 2025, the FASB issued ASU 2025-05, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets, which provides updates related to CECL guidance for certain short-term receivables. The ASU is effective for fiscal years beginning after December 15, 2025. The Company is currently evaluating the impact of this guidance on its disclosures.
Note 3 – Note Payable
On November 8, 2025, the Company entered into a short-term note payable
for an aggregate of $
On November 28, 2024, the Company entered into a short-term note payable
for an aggregate of $
| 46 |
Note 4 – Equity
The Company has authorized shares of common stock having a par value of $ per share. In addition, the Company authorized shares of preferred stock to be issued having a par value of $. The specific rights of the preferred stock shall be determined by the board of directors.
Common Stock
2025
On May 13, 2025, the Company entered into a placement agency agreement (the “Placement Agency Agreement”) with A.G.P./Alliance Global Partners (the “Placement Agent”) for the public offering by the Company of (i) 27,084 shares of the Company’s 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 Common Warrants and Pre-Funded Warrants are collectively referred to herein as the (“Warrants”). The combined purchase price of one share of Common Stock and one accompanying Common Warrant was $15.18 and the combined purchase price of one Pre-Funded Warrant and one accompanying Common Warrant was $15.17.
Subject to certain ownership limitations, the Warrants are exercisable
immediately upon issuance. Each Pre-Funded Warrant is exercisable into one share of Common Stock at a price per share of $0.001 and expire
once such Pre-Funded Warrants are fully exercised. The Common Warrants are exercisable into one share of Common Stock at a price per share
of $13.68 and expire five years from Initial Exercise Date. The gross proceeds to the Company from the offering were approximately $
2024
On January 29, 2024, the Company entered into a placement agency agreement
with A.G.P./Alliance Global Partners (“AGP”) and Maxim Group LLC (“Maxim” and collectively with AGP, the “Placement
Agents”) (the “Placement Agreement”) for the public offering by the Company of (i) shares (the “Shares”)
of the Company’s common stock, par value $0.001 per share (the “Common Stock”) (ii) pre-funded warrants to purchase
shares of Common Stock (the “Pre-Funded Warrants”); (iii) Series A Warrants to purchase up to an aggregate of
shares of Common Stock (the “Series A Warrants”); and (iv) Series B Warrants to purchase up to an aggregate of shares
of Common Stock (the “Series B Warrants”, and together with the Series A Warrants, the “Common Warrants)). The Common
Warrants and Pre-Funded Warrants are collectively referred to herein as the (“Warrants”). The combined purchase price of one
share of Common Stock and accompanying Common Warrants was $9,000.00 and the combined purchase price of one Pre-Funded Warrant and accompanying
Common Warrants was $8,970.00. In connection with the offering, the Company entered into a Securities Purchase Agreement (the “Purchase
Agreement”) with certain institutional investors that participated in the offering. As of December 31, 2024,
| 47 |
On June 14, 2024, the Company entered into securities purchase agreements with institutional investors for the sale by the Company of shares of the Company’s common stock and pre-funded warrants to purchase shares of common stock in lieu thereof (the “June 14 Pre-Funded Warrants”) in a registered direct offering. In a concurrent private placement, the Company also sold to the investors unregistered warrants to purchase up to an aggregate of shares of common stock (the “June 14 Common Warrants”). The combined purchase price of one share of common stock (or pre-funded warrant in lieu thereof) and accompanying June 14 Common Warrant was $2,250.00. The closing of this offering and private placement occurred on June 17, 2024.
Subject to certain ownership limitations, each of the June 14 Common
Warrants is immediately exercisable, has an exercise price of $2,172.00 per share, and expire five years from the date of issuance. Each
June 14 Pre-Funded Warrant is exercisable into one share of common stock at a price per share of $0.60 (as adjusted from time to time
in accordance with the terms thereof). The gross proceeds to the Company from the offering was approximately $
On June 26, 2024, the Company entered into securities purchase agreements with institutional investors for the sale by the Company of shares of the Company’s common stock in a registered direct offering. In a concurrent private placement, the Company also sold to the investors unregistered warrants to purchase up to an aggregate of shares of common stock (the “June 26 Common Warrants”). The combined purchase price of one share of common stock and accompanying June 26 Common Warrant was $1,470.00. The closing of the offering and private placement occurred on June 27, 2024 (the “Closing Date”).
Subject to certain ownership limitations, each of the June 26 Common
Warrants is immediately exercisable, has an exercise price of $1,392.00 per share, and expire five years from the date of issuance. The
June 26 Common Warrants may only be exercised on a cashless basis if there is no registration statement registering, or a prospectus contained
therein in not available for, the resale of the shares of common stock underlying the June 26 Common Warrants. The gross proceeds to the
Company from the offering were approximately $
On July 3, 2024, the Company entered into securities purchase agreements with institutional investors for the sale by the Company of shares of the Company’s common stock in a registered direct offering. In a concurrent private placement, the Company also sold to the investors unregistered warrants to purchase up to an aggregate of shares of common stock (the “July 3 Common Warrants”). The combined purchase price of one share of common stock and accompanying July 3 Common Warrant is $834. The closing of this offering and private placement occurred on July 5, 2024.
Subject to certain ownership limitations, each of the July 3 Common
Warrants is immediately exercisable, has an exercise price of $756.00 per share, and expire five years from the date of issuance. The
gross proceeds to the Company from the offering were approximately $
Pursuant to the terms of the AGP ATM Sales Agreement entered into on
July 26, 2024, during the year ended December 31, 2024, the Company has sold Shares pursuant to the AGP ATM Sales Agreement for
net proceeds of approximately $
On October 23, 2024, the Company entered into securities purchase agreements with institutional investors for the sale by the Company of shares of the Company’s common stock in a registered direct offering. In a concurrent private placement, the Company also sold to the investors unregistered warrants to purchase up to an aggregate of shares of common stock (the “July 3 Common Warrants”). The per share purchase price of each share of common stock was $102.00 per share and the purchase price for each Pre-Funded Warrant was $101.40 per Pre-Funded Warrant. The closing of this offering and private placement occurred on October 23, 2024.
| 48 |
Subject to certain ownership limitations, each of the October 23 Common
Warrants is immediately exercisable, has an exercise price of $0.60 per share, and expire five years from the date of issuance. The gross
proceeds to the Company from the offering were approximately $
Common share issued for license agreement
On July 29, 2024, the Company entered into an Exclusive License Agreement and Stock Purchase Agreement (collectively, the “Cortice Agreements”) with Cortice Biosciences, Inc. (“Cortice”) pursuant to which Cortice granted the Company 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.
Pursuant to the Cortice Agreements, the Company agreed to issue Cortice
shares of the Company’s common stock upon the closing of the transaction, which occurred on July 29, 2024, and shares of
Company common stock upon the receipt of shareholder approval of such issuance as required by the rules of the Nasdaq Stock Market. The
Company also agreed to make milestone payments to Cortice in either cash or shares of Company common stock (at Cortice’s option)
upon: (i) meeting the primary endpoint a pivotal trial for a licensed product – either $15.0 million or 686 shares of Company common
stock; (ii) FDA acceptance of an New Drug Application for a licensed product – either $30.0 million or 1,371 shares of Company common
stock; (iii) the first commercial sale in the United States of a licensed product – either $45.0 million or 2,056 shares of Company
common stock; and (iv) the first commercial sale in Japan of a licensed product – either $10.0 million or 343 shares of Company
common stock. The Company’s obligation to pay the above milestones in Company common stock is subject to the receipt of shareholder
approval as required by the rules of the Nasdaq Stock Market. The Company also agreed to pay Cortice royalties on sales of licensed products
of between 3.0%-7.5%. Finally, to the extent Cortice is required to pay any milestone payments to the original holder of the intellectual
property rights licensed, the Company has agreed to make such payments to Cortice. As of December 31, 2024 and 2025, there were no accruals
related to the milestone payments and the Company issued Shares with a fair value of $
Stock Options
In 2017, the Board of Directors of the Company approved the CNS Pharmaceuticals, Inc. 2017 Stock Plan (the “2017 Plan”). The 2017 Plan allows for the Board of Directors to grant various forms of incentive awards for up to three shares of common stock.
In 2020, the Board of Directors of the Company approved the CNS Pharmaceuticals, Inc. 2020 Stock Plan (the “2020 Plan”). The 2020 Plan allows for the Board of Directors to grant various forms of incentive awards for up to four shares of common stock. The 2020 Plan was amended effective as of August 9, 2023, which was approved by the Company’s stockholders at the Company’s annual meeting on September 14, 2023. The amendment increased the 2020 Plan by shares of common stock.
On November 17, 2025, the Company held its scheduled 2025 Annual Meeting of Stockholders at which the Company’s stockholders approved amendments to the Company's 2020 Equity Plan including an increase in the number of shares of common stock, par value $ per share, authorized for issuance under the 2020 Plan by shares. As amended, the number of shares of the common stock that may be issued under the 2020 Plan is shares (this includes the 114,916 share increase).
| 49 |
2025
On March 11, 2025, the Board of Directors approved grants of
options to officers and employees. The options have a ten-year term at an exercise price of $. The options were approved by the Company’s
stockholders at the Company’s annual meeting held on November 17, 2025. The options vest as follows: (i) 50% on the six month anniversary
of the issuance date; (ii) 25% on the 12-month anniversary of the issuance date; and (iii) 25% on the 18-month anniversary of the issuance
date. The total fair value of these option grants at issuance was $
On November 17, 2025, the Company held its scheduled 2025 Annual Meeting
of Stockholders at which the Company’s stockholders approved grants of options to board members. The options have a ten-year
term at an exercise price of $. The options vest in four quarterly installments over a one-year period commencing on the stockholder
approval date. The total fair value of these option grants at issuance was $
2024
On January 19, 2024, the Board of Directors of the Company approved
the issuance of option to Ms. Mahery as compensation for her appointment to our Board of Directors. The options have a ten-year term
at an exercise price of $ and vest in 36 equal monthly installments succeeding the issuance date. The total fair value of these
option grants at issuance was $
On April 7, 2024, the Board of Directors approved grants of options
to officers, employees, and board of directors. The options have a ten-year term at an exercise price of $. Of the options
issued, five options vest on the first anniversary or at the time of the 2025 shareholder meeting, whichever occurs first and options
vest in 36 equal monthly installments over 3 years. The total fair value of these option grants at issuance was $
The following table summarizes the stock option activity for the years ended December 31, 2025 and 2024:
| Options | Weighted-Average Exercise Price Per Share | |||||||
| Outstanding, December 31, 2023 | $ | |||||||
| Granted | ||||||||
| Exercised | ||||||||
| Forfeited | ||||||||
| Expired | ||||||||
| Outstanding, December 31, 2024 | ||||||||
| Granted | ||||||||
| Exercised | ||||||||
| Forfeited | ( | ) | ||||||
| Expired | ||||||||
| Outstanding, December 31, 2025 | $ | |||||||
| Exercisable, December 31, 2025 | $ | |||||||
| 50 |
The aggregate fair value of the options measured during the years ended December 31, 2025 and 2024 were calculated using the Black-Scholes option pricing model based on the following assumptions:
| Year Ended | Year Ended | |||
| December 31, 2025 | December 31, 2024 | |||
| Fair value of common stock on measurement date | ||||
| Risk free interest rate (1) | % | % to % | ||
| Volatility (2) | % to % | % to % | ||
| Dividend yield (3) | % | % | ||
| Expected term (in years) | – | – |
| (1) | |
| (2) | |
| (3) |
As of December 31, 2025, the outstanding stock options have a weighted average remaining term of years and the aggregate intrinsic value of options vested and outstanding was $. As of December 31, 2025, there were awards remaining to be issued under the 2017 Plan and awards remaining to be issued under the 2020 Plan.
During the years ended December 31, 2025 and 2024, the Company recognized $ and $ of stock-based compensation, related to outstanding options, respectively. At December 31, 2025, the Company had $ of unrecognized expenses related to outstanding options.
Stock Warrants
The following table summarizes the stock warrant activity for the years ended December 31, 2025 and 2024:
| Warrants | Weighted-Average Exercise Price Per Share | |||||||
| Outstanding, December 31, 2023 | $ | |||||||
| Granted | ||||||||
| Exercised | ( | ) | ||||||
| Forfeited | ||||||||
| Expired | ( | ) | ||||||
| Outstanding, December 31, 2024 | ||||||||
| Granted | ||||||||
| Exercised | ( | ) | ||||||
| Forfeited | ||||||||
| Expired | ( | ) | ||||||
| Outstanding, December 31, 2025 | $ | |||||||
During the year ended December 31, 2025, the Company received $
| 51 |
As of December 31, 2025, the remaining weighted average term for the outstanding stock warrant is years.
During the year ended December 31, 2024, the Company received $
Restricted Stock Units
On April 7, 2024, the Board of Directors approved grants of RSUs
to officers, employees, and board of directors. Of the RSUs issued, three RSUs vest on the first anniversary or at the time of the 2025
shareholder meeting, whichever occurs first and six RSUs vest in 8 equal quarterly installments over 2 years. The Company valued the RSUs
based on the stock price at grant which total $
During the years ended December 31, 2025 and 2024, the Company recognized $ and $ of stock-based compensation, related to outstanding RSUs, respectively. At December 31, 2025, the Company had $ of unrecognized expenses related to outstanding RSUs.
The following table summarizes the RSUs activity for the years ended December 31, 2025 and 2024:
| RSUs | Weighted-Average Grant Date Fair Value | |||||||
| Non-vested, December 31, 2023 | $ | |||||||
| Granted | ||||||||
| Vested | ||||||||
| Forfeited | ||||||||
| Non-vested, December 31, 2024 | ||||||||
| Granted | ||||||||
| Vested | ||||||||
| Forfeited | ( | ) | ||||||
| Non-vested, December 31, 2025 | $ | |||||||
Performance Units
During the years ended December 31, 2025 and 2024, the Company recognized $ and $ related to outstanding stock PUs, respectively. At December 31, 2025, the Company had $ of unrecognized expenses related to PUs.
The following table summarizes the PUs activity for the years ended December 31, 2025 and 2024:
| PUs | Weighted-Average Grant Date Fair Value | |||||||
| Non-vested, December 31, 2023 | $ | |||||||
| Granted | ||||||||
| Vested | ( | ) | ||||||
| Forfeited | ( | ) | ||||||
| Non-vested, December 31, 2024 | ||||||||
| Granted | ||||||||
| Vested | ||||||||
| Forfeited | ( | ) | ||||||
| Non-vested, December 31, 2025 | $ | |||||||
| 52 |
Note 5 – Commitments and Contingencies
Executive Employment Agreements
On September 1, 2017, the Company entered into an employment agreement with Mr. John Climaco pursuant to which Mr. Climaco agreed to serve as Chief Executive Officer and Director of the Company commencing on such date for an initial term of three years. On September 1, 2020, the Company entered into an amendment to the employment agreement with Mr. Climaco. The amendment extended the term of employment under the employment agreement, which was originally for a three-year period, for additional twelve-month periods, unless and until either the Company or Mr. Climaco provides written notice to the other party not less than sixty days before such anniversary date that such party is electing not to extend the term.
On December 16, 2025, John Climaco resigned from his positions as chief
executive officer of the Company and as a member of the Company’s Board of Directors. The Company and Mr. Climaco entered into a
Separation and Severance Agreement dated as of December 16, 2025 (the “Separation Agreement”), which memorializes the terms
of his resignation and separation from service with the Company. Pursuant to the Separation Agreement, subject to Mr. Climaco’s
timely execution, non-revocation, and compliance with the agreement’s terms, the Company will provide severance benefits, including
(i) severance equal to twelve months of Mr. Climaco’s current annualized base salary, paid in twelve equal monthly installments,
and payment of his base salary through December 31, 2025; (ii) payment of Mr. Climaco’s 2025 cash bonus in the total amount of $
On December 16, 2025, the Company entered into an employment agreement
with Mr. Rami Levin pursuant to which Mr. Levin agreed to serve as Chief Executive Officer and President of the Company commencing on
such date. Pursuant to the employment agreement, the compensation committee of the board of directors reviews the base salary payable
to Mr. Levin annually during the term of the agreement. Commencing on January 1, 2026, the compensation committee of the board of directors
set Mr. Levin’s 2026 annual base salary to $
In March 2025, the Board of Directors approved, based upon the recommendation
of the Compensation Committee, cash bonuses totaling $
Scientific Advisory Board
On July 15, 2021, our Board approved the following compensation
policy for the Scientific Advisory Board members, which consisted at the time of Dr. Waldemar Priebe, our founder, and Dr. Sigmond
Hsu. Under this compensation policy, each scientific advisory board member was to receive annual cash compensation of $68,600. As of
August 25, 2022, Dr. Waldemar Priebe was no longer a member of the Scientific Advisory Board. On March 14, 2024, the Board of
Directors terminated the cash compensation program for the Scientific Advisory Board. As of March 14, 2024, Dr. Hsu was no longer a
member of the Scientific Advisory Board. As of December 31, 2025, the Company has accrued $
| 53 |
Cortice Biosciences, Inc. Exclusive License Agreement
On July 29, 2024, the Company entered into an Exclusive License Agreement
with Cortice Biosciences, Inc. (“Cortice”) pursuant to which Cortice granted the Company 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. Pursuant to the Cortice Agreements,
the Company agreed to issue Cortice
shares of the Company’s common stock upon the closing of the transaction, which occurred on July 29, 2024, and
shares of Company common stock upon the receipt of shareholder approval of such issuance as required by the rules of the Nasdaq Stock
Market. The Company also agreed to make milestone payments to Cortice in either cash or shares of Company common stock (at Cortice’s
option) upon: (i) meeting the primary endpoint of a pivotal trial for a licensed product – either $15.0 million or 686 shares of
Company common stock; (ii) FDA acceptance of a New Drug Application for a licensed product – either $30.0 million or 1,371 shares
of Company common stock; (iii) the first commercial sale in the United States of a licensed product – either $45.0 million or 2,056
shares of Company common stock; and (iv) the first commercial sale in Japan of a licensed product – either $10.0 million or 343
shares of Company common stock. The Company’s obligation to pay the above milestones in Company common stock is subject to the
receipt of shareholder approval as required by the rules of the Nasdaq Stock Market. The Company also agreed to pay Cortice royalties
on sales of licensed products of between 3.0%-7.5%. Finally, to the extent Cortice is required to pay any milestone payments to the original
holder of the intellectual property rights licensed, the Company has agreed to make such payments to Cortice. During the year ended December
31, 2024, the Company issued
shares of common stock with a fair value of $
Note 6 – Income Taxes
The Company is subject to United States federal income taxes at an approximate rate of 21%. The reconciliation of the provision for income taxes at the United States federal statutory rate compared to the Company’s income tax expense as reported is as follows:
| Year Ended | Year Ended | |||||||
| December 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Income tax benefit computed at the | $ | $ | ||||||
| Tax effect of: | ||||||||
| True-ups and non-deductible expenses | ( | ) | ||||||
| Change in valuation allowance | ( | ) | ( | ) | ||||
| Provision for income taxes | $ | $ | ||||||
The Company adopted ASC 2023-09 during the year ended December 31, 2025 prospectively. A reconciliation setting forth the differences between the effective tax rates and the U.S. federal statutory tax rate is as follows:
| Year Ended December 31, 2025 | ||||||||
| Amount | Rate | |||||||
| US federal statutory tax rate | $ | 3,329,000 | ||||||
| Changes in valuation allowances | (3,522,000 | ) | - | |||||
| Nontaxable or nondeductible items | 193,000 | |||||||
| Effective income tax rate | $ | – | ||||||
| 54 |
Significant components of the Company’s deferred tax assets and liabilities after applying enacted corporate income tax rates are as follows:
| As of | As of | |||||||
| December 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Deferred income tax assets | ||||||||
| Net operating losses | $ | $ | ||||||
| Stock-based compensation | ||||||||
| Capitalized 174 expenses | ||||||||
| Deferred income tax liability | ||||||||
| Prepaid expenses | ( | ) | ( | ) | ||||
| Valuation allowance | ( | ) | ( | ) | ||||
| Net deferred income tax assets | $ | $ | ||||||
As of December 31, 2025, the Company currently has net operating loss
carryforwards of approximately $
The Tax Reform Act of 1986 limits the use of net operating loss carryforwards in certain situations where changes occur in the stock ownership of a company. In the event that the Company has a change in ownership, utilization of carryforwards could be limited.
Note 7 – Subsequent Events
On February 10, 2026, the Company entered into an employment agreement with Steve O’Loughlin to serve as the Company’s Chief Financial Officer effective March 2, 2026. The employment agreement provides for an initial annual base salary of $450,000. The employment agreement also provides for an initial grant of 9,500 restricted stock units, vesting as follows: 25% on the six-month anniversary of the effective date, 25% on the twelve-month anniversary of the effective date, and the remaining 50% in twelve quarterly installments thereafter, subject to continued employment. Under the employment agreement, if Mr. O’Loughlin’s employment is terminated by the Company without cause or by Mr. O’Loughlin for good reason, he will be entitled to (i) severance equal to six months of base salary, payable over six months, (ii) his target annual bonus for the period of time between the end of the last fiscal year and the termination date; and (iii) accelerated vesting of all unvested equity previously granted, in each case subject to his timely execution and non-revocation of a release of claims and continued compliance with applicable covenants.
On February 13, 2026, the Company entered into an employment agreement with Christopher Downs, the Company’s current Chief Financial Officer, pursuant to which Mr. Downs agreed to resign as Chief Financial Officer effective March 2, 2026 and to serve as the Company’s Senior Vice President – Finance effective March 2, 2026. The employment agreement provides for an initial annual base salary of $350,000. Under the employment agreement, if Mr. Downs’s employment is terminated by the Company without cause or by Mr. Downs for good reason, he will be entitled to severance equal to six months of base salary, payable over six months.
On February 26, 2026, the Company entered into an employment agreement with Lynne Kelley to serve as the Company’s Chief Medical Officer effective March 2, 2026. The employment agreement provides for an initial annual base salary of $450,000. The employment agreement also provides for an initial grant of 9,500 restricted stock units, vesting as follows: 25% on the six-month anniversary of the effective date, 25% on the twelve-month anniversary of the effective date, and the remaining 50% in twelve quarterly installments thereafter, subject to continued employment. Under the employment agreement, if Dr. Kelley’s employment is terminated by the Company without cause or by Dr. Kelley for good reason, she will be entitled to (i) severance equal to six months of base salary, payable over six months, (ii) her target annual bonus for the period of time between the end of the last fiscal year and the termination date; and (iii) accelerated vesting of all unvested equity previously granted.
| 55 |
On February 27, 2026, the Company and Dr. Sandra Silberman, the Company’s former Chief Medical Officer, entered into a Separation and Severance Agreement (the “Separation Agreement”), which memorializes the terms of Dr. Silberman’s separation from service with the Company. Pursuant to the Separation Agreement, the Company will provide severance benefits, equal to three months of Dr. Silberman’s current annualized base salary, paid in three equal monthly installments.
On March 2, 2026, the Company entered into an employment agreement with Dylan Wenke to serve as the Company’s Chief Business Officer effective March 2, 2026. The employment agreement provides for an initial annual base salary of $415,000. The employment agreement also provides for an initial grant of 9,500 restricted stock units, vesting as follows: 25% on the six-month anniversary of the effective date, 25% on the twelve-month anniversary of the effective date, and the remaining 50% in twelve quarterly installments thereafter, subject to continued employment. Under the employment agreement, if Dr. Wenke’s employment is terminated by the Company without cause or by Dr. Wenke for good reason, she will be entitled to (i) payment of a prorated earned bonus, (ii) accelerated vesting of all unvested equity awards previously granted to the Executive, (iii) a severance payment equal to six months of base salary plus target bonus, and (iv) Company paid COBRA continuation at active-employee rates for up to six months.
On March 2, 2026, the Company entered into an employment agreement with Eric Faulkner to serve as the Company’s Chief Technology Officer effective March 2, 2026. The employment agreement provides for an initial annual base salary of $450,000. The employment agreement also provides for an initial grant of 9,500 restricted stock units, vesting as follows: 25% on the six-month anniversary of the effective date, 25% on the twelve-month anniversary of the effective date, and the remaining 50% in twelve quarterly installments thereafter, subject to continued employment. Under the employment agreement, if Dr. Faulkner’s employment is terminated by the Company without cause or by Dr. Faulkner for good reason, she will be entitled to (i) payment of a prorated earned bonus, (ii) accelerated vesting of all unvested equity awards previously granted to the Executive, (iii) a severance payment equal to six months of base salary plus target bonus, and (iv) Company paid COBRA continuation at active-employee rates for up to six months.
In March 2026, the Board of Directors approved, based upon the recommendation of the Compensation Committee, cash bonuses totaling $418,800 to the officers of the Company.
Pursuant to the terms of the May 13, 2025 AGP ATM Sales Agreement, the Company is permitted to sell from time to time through AGP, as sales agent or principal, shares of the Company’s common stock. Subsequent to December 31, 2025, the Company has sold 178,933 Shares pursuant to the AGP ATM Sales Agreement for gross proceeds of approximately $516,758.
| 56 |
| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosures. |
None.
| Item 9A. | Controls and Procedures. |
Evaluation of Disclosure Controls and Procedures
Our management, including our chief executive officer, who serves as our principal executive officer, and our chief financial officer, who serves as our principal financial officer, evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act), as of the end of the period covered by this Form 10-K. Based on this evaluation, our chief executive officer and our chief financial officer, concluded that as a result of the material weaknesses in our internal control over financial reporting discussed below, our disclosure controls and procedures were not effective at ensuring that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission's rules and forms and that such information is accumulated and communicated to our management, including our chief executive officer and our chief financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding disclosure.
Attestation Report of the Registered Public Accounting Firm
Our independent registered public accounting firm will not be required to formally attest to the effectiveness of our internal controls over financial reporting for as long as we are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act.
Critical Audit Matters
Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.
Management’s Report on Internal Control Over Financial Reporting
Our chief executive officer and our chief financial officer are responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f). Management conducted an assessment of the effectiveness of our internal control over financial reporting as of December 31, 2025. In making this assessment, management used the criteria described in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). Our management concluded that our internal control over financial reporting were, and continue to be ineffective, as of December 31, 2025 due to a lack of segregation of duties (resulting from the limited number of personnel available), limited access to timely and complete information regarding the status of costs incurred in the activation of investigational sites and costs from treating patients in our study which is a result of the use of a third-party Contract Research Organization (“CRO”) to manage the study, and the lack of formal documentation of our control environment. Management is commencing actions to address the lack of formal documentation of our control environment, although this will not address the lack of segregation of duties. Management is also working with the CRO to improve the timeliness and completeness of the data reported to the Company to address this material weakness, as well as conducting increased analytical analysis of such data to be performed by the Company.
A material weakness is a control deficiency (within the meaning of the Public Company Accounting Oversight Board (“PCAOB”) Auditing Standard 1305) or combination of control deficiencies that result in more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented or detected.
| 57 |
It should be noted that any system of controls, however well designed and operated, can provide only reasonable and not absolute assurance that the objectives of the system are met. In addition, the design of any control system is based in part upon certain assumptions about the likelihood of certain events. Because of these and other inherent limitations of control systems, there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions, regardless of how remote.
In light of the material weakness described above, we performed additional analysis and other post-closing procedures to ensure our financial statements were prepared in accordance with generally accepted accounting principles. Accordingly, we believe that the financial statements included in this report fairly present, in all material respects, our financial condition, results of operations and cash flows for the periods presented.
Changes in Internal Control over Financial Reporting
There has been no change in our internal control over financial reporting during our most recent calendar year that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
| Item 9B. | Other Information. |
During the year ended December 31, 2025, no director
or officer of the Company
| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. |
Not applicable.
| 58 |
PART III
| Item 10. | Directors, Executive Officers and Corporate Governance |
The information required by this item is incorporated by reference to our Proxy Statement for the 2026 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission within 120 days of the fiscal year ended December 31, 2025.
Our Board of Directors has adopted a written Code of Business Conduct and Ethics applicable to all officers, directors and employees, which is available on our website (www.cnspharma.com) under “Governance Documents” within the “Corporate Governance” section. We intend to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding amendment to, or waiver from, a provision of this Code and by posting such information on the website address and location specified above.
| Item 11. | Executive Compensation |
The information required by this item is incorporated by reference to our Proxy Statement for the 2026 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission within 120 days of the fiscal year ended December 31, 2025.
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters |
The information required by this item is incorporated by reference to our Proxy Statement for the 2026 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission within 120 days of the fiscal year ended December 31, 2025.
Securities Authorized for Issuance under Equity Compensation Plans
The following table sets forth information regarding our equity compensation plans at December 31, 2025:
| Plan category | Number of securities to be issued upon exercise of outstanding options, warrants and rights (a) | Weighted-average exercise price of outstanding options, warrants and rights (b) | Number of securities (by class) remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) (c) | |||||||||
| Equity compensation plans approved by security holders (1) | 19,873 | $ | 2,815.21 | 85,429 | ||||||||
| (1) | Represents shares of common stock issuable upon exercise of outstanding stock options and rights under our 2017 and 2020 Stock Plans. |
| 59 |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence |
The information required by this item is incorporated by reference to our Proxy Statement for the 2026 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission within 120 days of the fiscal year ended December 31, 2025.
| Item 14. | Principal Accounting Fees and Services |
The information required by this item is incorporated by reference to our Proxy Statement for the 2026 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission within 120 days of the fiscal year ended December 31, 2025.
| 60 |
PART IV
| Item 15. | Exhibits, Financial Statement Schedules |
| (a) | The following documents are filed or furnished as part of this Form 10-K: | ||
| 1. | Financial Statements. Reference is made to the Index to Financial Statements under Item 8, Part II hereof. | ||
| 2. | Financial Statement Schedules. The Financial Statement Schedules have been omitted either because they are not required or because the information has been included in the financial statements or the notes thereto included in this Annual Report on Form 10-K. | ||
| 3. | Exhibits | ||
EXHIBIT INDEX
| 61 |
| Exhibit Number |
Description of Document | |
| 4.2 | Form of Warrant issued in January 2022 offering (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the Commission on January 6, 2022) | |
| 4.3 | Form of Common Warrant issued in November 2023 offering (filed as exhibit 4.8 to the Company’s Form S-1 file no. 333-267975) | |
| 4.4 | Form of Placement Agent Warrant issued in November 2023 offering (filed as exhibit 4.9 to the Company’s Form S-1 file no. 333-267975) | |
| 4.5 | Form of Inducement Warrant issued in October 2023 (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the Commission on October 17, 2023) | |
| 4.6 | Form of Series A Common Warrant issued January 2024 (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the Commission on February 2, 2024) | |
| 4.7 | Form of Series B Common Warrant issued January 2024 (incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K filed with the Commission on February 2, 2024) | |
| 4.8 | Form of Warrant issued June 14 2024 (incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K filed with the Commission on June 14, 2024) | |
| 4.9 | Form of Warrant issued June 26 2024 (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the Commission on June 26, 2024) | |
| 4.10 | Form of Warrant issued July 3 2024 (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the Commission on July 3, 2024) | |
| 4.11 | Form of Warrant issued May 14, 2025 (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the Commission on May 15, 2025) | |
| 10.1 | Amended And Restated Patent License Agreement effective as of December 28, 2017 between CNS Pharmaceuticals, Inc. and Houston Pharmaceuticals, Inc. (filed as exhibit 6.1 to the Company’s Form 1-A file no. 024-10855) | |
| 10.2 | Collaboration and Asset Purchase Agreement between CNS Pharmaceuticals, Inc. and Reata Pharmaceuticals, Inc. dated November 21, 2017 (filed as exhibit 6.2 to the Company’s Form 1-A file no. 024-10855) | |
| 10.3 ** | 2017 Stock Plan of CNS Pharmaceuticals, Inc. (filed as exhibit 6.3 to the Company’s Form 1-A file no. 024-10855) | |
| 10.4 | Sublicense Agreement between CNS Pharmaceuticals, Inc. and Animal Life Sciences, LLC. dated August 31, 2018 (filed as exhibit 6.7 to the Company’s Form 1-A Amendment file no. 024-10855) |
| 62 |
| Exhibit Number |
Description of Document | |
| 10.5 ** | 2020 Stock Plan of CNS Pharmaceuticals, Inc. (as amended) (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the Commission on May 3, 2024) | |
| 10.6 | Non-Employee Director Compensation Policy effective July 15, 2021 (incorporated by reference to Exhibit 10.1 to the Company’s Form 10-Q filed with the Commission on August 12, 2022) | |
| 10.7 | Form of Amendment to Common Stock Warrants (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed with the Commission on February 2, 2024) | |
| 10.8 | Sales Agreement, dated July 26, 2024, by and between CNS Pharmaceuticals, Inc. and A.G.P./Alliance Global Partners (incorporated by reference to Exhibit 1.1 to the Current Report on Form 8-K filed with the Commission on July 26, 2024) | |
| 10.9 | Form of Waiver and Consent (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the Commission on July 26, 2024) | |
| 10.10 | Exclusive License Agreement between CNS Pharmaceuticals, Inc. and Cortice Biosciences, Inc. (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the Commission on July 30, 2024) | |
| 10.11 | Stock Purchase Agreement between CNS Pharmaceuticals, Inc. and Cortice Biosciences, Inc. (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed with the Commission on July 30, 2024) | |
| 10.12 ** | CNS Pharmaceuticals, Inc. 2020 Equity Plan (as amended and restated) (filed as Exhibit 10.1 to the Company’s Form 8-K filed November 21, 2025) | |
| 10.13 ** | Employment Agreement between Rami Levin and CNS Pharmaceuticals, Inc. dated December 16, 2025 (filed as Exhibit 10.1 to the Company’s Form 8-K filed December 17, 2025) | |
| 10.14 ** | Separation and Severance Agreement between John Climaco and CNS Pharmaceuticals, Inc. dated December 16, 2025 (filed as Exhibit 10.2 to the Company’s Form 8-K filed December 17, 2025) | |
| 10.15 ** | Employment Agreement between Steve O’Loughlin and CNS Pharmaceuticals, Inc. dated February 10, 2026 (filed as Exhibit 10.1 to the Company’s Form 8-K filed February 17, 2026) | |
| 10.16 ** | Employment Agreement between Christopher Downs and CNS Pharmaceuticals, Inc. dated February 13, 2026 (filed as Exhibit 10.2 to the Company’s Form 8-K filed February 17, 2026) | |
| 10.17 ** | Employment Agreement between Lynne Kelley and CNS Pharmaceuticals, Inc. dated February 26, 2026 (filed as Exhibit 10.1 to the Company’s Form 8-K filed March 2, 2026) | |
| 10.18 ** | Separation and Severance Agreement between Sandra Silberman and CNS Pharmaceuticals, Inc. dated February 27, 2026 (filed as Exhibit 10.2 to the Company’s Form 8-K filed March 2, 2026) |
| 63 |
| Exhibit Number |
Description of Document | |
| 10.19 * | Employment Agreement between Eric Faulkner and CNS Pharmaceuticals, Inc. dated February 10, 2026 | |
| 19.1 | ||
| 23.1 * | Consent of MaloneBailey LLP | |
| 31.1 * | Certification of Principal Executive Officer pursuant to Rule 13a-14 of the Securities Exchange Act of 1934, as amended | |
| 31.2 * | Certification of Principal Financial Officer pursuant to Rule 13a-14 of the Securities Exchange Act of 1934, as amended | |
| 32.1 * | Certification of Principal Executive Officer Pursuant to Section 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | |
| 32.2 * | Certification of Principal Financial Officer Pursuant to Section 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | |
| 97 | CNS Pharmaceuticals, Inc. Restatement Recoupment Policy (incorporated by reference to Exhibit 97 to the Annual Report on Form 10-K filed with the Commission on April 1, 2024) | |
| 101.INS | Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)** | |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document** | |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document** | |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document** | |
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document** | |
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document** | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
| * | Filed herewith. |
| ** | Management contract or compensatory plan, contract or arrangement. |
| + | Pursuant to Item 601(b)(10)(iv) of Regulation S-K promulgated by the SEC, certain portions of this exhibit have been redacted. The Company hereby agrees to furnish supplementally to the SEC, upon its request, an unredacted copy of this exhibit. |
| Item 16. | 10-K Summary |
None.
| 64 |
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized
| CNS PHARMACEUTICALS, INC. | ||
| Date: March 31, 2026 | By: | /s/ Rami Levin |
| Rami Levin | ||
|
Chief Executive Officer and Director (Principal Executive Officer) | ||
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacity and on the dates indicated.
| Date: March 31, 2026 | By: | /s/ Rami Levin |
| Rami Levin | ||
|
Chief Executive Officer, President (Principal Executive Officer) |
| Date: March 31, 2026 | /s/ Steve O’Loughlin |
| Steve O’Loughlin | |
|
Chief Financial Officer (Principal Financial and Accounting Officer) |
| Date: March 31, 2026 | /s/ Faith Charles |
| Faith Charles | |
| Director |
| Date: March 31, 2026 | /s/ Jerzy (George) Gumulka |
| Jerzy (George) Gumulka | |
| Director | |
| Date: March 31, 2026 | /s/ Jeffry Keyes |
| Jeffry Keyes | |
| Director | |
| Date: March 31, 2026 | /s/ Bettina Cockroft |
| Bettina Cockroft | |
| Director |
| Date: March 31, 2026 | /s/ Amy Mahery |
| Amy Mahery | |
| Director |
| 65 |