CNS Pharmaceuticals, Inc. 10-K

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. 1 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. 2 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. 3 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. 4 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. 5 · 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. 6 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. 7 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. G overnmental 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. 8 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. 9 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. 10 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. 11 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. 12 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. 13 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. 14 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.