10-K: Coeptis Therapeutics Reports 2025 Results, Strategic Shift

Coeptis Therapeutics Holdings, Inc. reports a net loss of $12.28 million for 2025, driven by increased operating expenses, while strategically expanding its technology segment and pursuing a merger and spin-out of its biotech operations.

Summary

• Net loss for the year ended December 31, 2025, was $12,277,192, an increase from $10,877,412 in 2024.
• The accumulated deficit reached $109,953,728 as of December 31, 2025.
• Generated sales of $1,363,045 in 2025 from lead generation and webinar services through its NexGenAI platform, compared to no sales in 2024.
• Operating expenses increased to $14,225,918 in 2025 from $10,054,488 in 2024, primarily due to higher professional services and stock-based compensation.
• Cash balance significantly increased to $5,674,302 in 2025 from $532,885 in 2024, mainly from a private placement and draws under a Standby Equity Purchase Agreement (SEPA).
• Entered into an Agreement and Plan of Merger with Z Squared, Inc. on April 25, 2025, which includes a spin-out of its biotechnology operations, expected to close in Q2 2026.
• Licensed exclusive worldwide development and commercialization rights to the GEAR (Gene Edited Antibody Resistant) Cell Therapy Platform from Vy-Gen-Bio, Inc. in March 2025.
• Acquired the assets of NexGenAI Affiliates Network Platform on December 19, 2024, marking a strategic expansion into the technology division.
• The FDA designated the CD38-Diagnostic as a Class II type device in September 2023, providing clarity for future development activities.
• Colleen Delaney, Chief Scientific and Medical Officer, resigned effective March 24, 2025, and continued on a consulting basis for six months.
• The independent registered public accounting firm's report includes an explanatory paragraph indicating substantial doubt about the company's ability to continue as a going concern.

Sentiment

Score: 3

Explanation: StockSavvy.ai views this as a challenging report, with increasing losses and a going concern warning, despite some positive strategic moves and initial revenue generation from a new segment. The long development timelines for biotech assets and reliance on future financing temper optimism.

Positives

• Cash balance significantly increased to $5,674,302 in 2025 from $532,885 in 2024, primarily due to successful financing activities.
• Generated $1,363,045 in sales in 2025 from the newly acquired NexGenAI platform, establishing a new revenue stream for the technology segment.
• Acquired NexGenAI Affiliates Network Platform assets in December 2024, diversifying the business into AI-powered marketing software and robotic process automation.
• Secured exclusive worldwide development and commercialization rights to the GEAR Cell Therapy Platform in March 2025, enhancing the biotechnology pipeline with a first-in-class approach.
• The FDA designated the CD38-Diagnostic as a Class II type device in September 2023, which is beneficial for planning and executing future development activities.
• Recognized a gain on the change in fair value of derivative liabilities of $1,098,055 in 2025, compared to a loss of $341,660 in 2024.
• Reported an unrealized gain on marketable securities of $76,596 for the year ended December 31, 2025.
• Regained compliance with Nasdaq's annual meeting requirement in February 2026.

Negatives

• Incurred a net loss of $12,277,192 in 2025, an increase from $10,877,412 in 2024.
• The accumulated deficit grew to $109,953,728 as of December 31, 2025, indicating significant historical losses.
• Operating expenses increased substantially to $14,225,918 in 2025 from $10,054,488 in 2024, outpacing revenue generation.
• The independent auditor's report includes an explanatory paragraph indicating substantial doubt about the company's ability to continue as a going concern.
• The biotechnology segment is currently non-revenue generating and is not expected to generate significant revenue for at least the next year.
• Discontinued allocating resources to the CPT60621 Parkinson's Disease drug co-development, with Vici Health Sciences, LLC intending to buy out remaining ownership rights.
• Colleen Delaney, Chief Scientific and Medical Officer, resigned in March 2025, potentially impacting scientific leadership.
• A convertible promissory note with an outstanding balance of $100,000 was in default as of December 31, 2025.
• Recognized an unrealized loss on investments of $163,500 for the year ended December 31, 2025.

Risks

• Inability to successfully implement the growth strategy on a timely basis or at all.
• Difficulties managing anticipated growth or failure to grow at all.
• History of losses and expectation to incur future losses, with no assurance of achieving or maintaining profitability.
• Inability to initiate and complete preclinical studies and clinical trials for product candidates, which could adversely affect the business.
• Inability to obtain and maintain necessary third-party relationships for product development, commercialization, and manufacturing.
• Need to obtain financing to continue operations and pursue strategic transactions; additional financing may not be available on acceptable terms or at all.
• The drug development and approval process is uncertain, time-consuming, and expensive.
• Competition in the biotechnology, pharmaceutical, and technology industries may result in competing products, superior marketing, and lower revenues or profits.
• Federal laws or regulations on drug importation could make lower-cost versions of future products available, adversely affecting revenues.
• The regulatory approval process is costly and lengthy, and there is no guarantee of successfully obtaining all required regulatory approvals.
• Healthcare reform measures could adversely affect the business.
• Protecting and defending against intellectual property claims may have a material adverse effect on the business.
• Inability to retain the current senior management team and scientific advisors or attract and retain qualified scientific, technical, and business personnel.
• Risk of not being able to maintain listing on the Nasdaq Capital Market.
• Substantial doubt about the ability to continue as a going concern.
• Clinical trials are expensive, difficult to design and implement, and involve uncertain outcomes; results of previous studies may not be predictive of future results.
• Planned clinical trials may produce negative or inconclusive results, or be prolonged, delayed, or stopped.
• The design or execution of clinical trials may not support regulatory approval.
• Difficulty enrolling patients in clinical trials given the limited number of patients for the diseases being studied.
• The business plan is not based on independent market studies, relying on management's experience, judgment, and assumptions.
• The Board of Directors may change policies without shareholder approval.
• The holding company structure makes the company dependent on its subsidiaries for cash flow and could subordinate shareholder rights to subsidiary creditors.
• Delaware law and corporate documents contain certain anti-takeover provisions that could delay or discourage takeover attempts.
• Exclusive forum provisions in the Amended and Restated Certificate of Incorporation could limit stockholders' ability to choose the judicial forum for disputes.
• The reduced disclosure requirements applicable to emerging growth companies may make the company's securities less attractive to investors.
• Cybersecurity incidents could disrupt operations, compromise sensitive data, or result in financial or reputational harm.
• The company's business and operations could be negatively affected if it becomes subject to any securities litigation or shareholder activism.

Future Outlook

The company expects to incur significant losses over the next five years due to planned product development and strategic expansion pursuits. It does not anticipate receiving revenue from its early-stage product candidates for several years, if at all, and expects continued operating losses and negative cash flow from operations at least through the end of 2025. Management believes that the ability to raise capital through equity transactions will increase liquidity and enable the execution of its operating strategy in 2026. Human clinical trials for GEAR-NK are planned for 2027 or later, and the merger with Z Squared, Inc. is expected to close in the second quarter of 2026.

Management Comments

• "We believe that there is significant market opportunity related to each of the assets we are currently pursuing."
• "We believe CD38-GEAR-NK could potentially revolutionize how CD38-related cancers are treated, by protecting CD38+ NK cells from destruction by anti-CD38 mAbs, thereby promoting the opportunity to improve the treatment of CD38-related cancers."
• "Our management believes that CD38-Diagnostic also has the potential to develop as a platform technology beyond CD38, including to identify patients likely to benefit for broad range of mAb therapies across myriad indications."
• "We believe CD38-Diagnostic provides opportunity to make more cost-effective medical decisions for the treatment of B cell malignancies with high CD38 expression, including multiple myeloma, which may help to avoid unnecessary administration of anti-CD38 therapies."
• "We believe the SNAP-CAR platform could help accelerate the utilization and effectiveness of CAR T-cell therapies for the treatment of solid tumors."
• "Management does not expect the Company to generate any significant revenue in the Biotechnology segment for at least the next year, during which time drug development will continue toward the goal of commercializing, through a partnership or otherwise, one or more of the Company's target products or technologies."
• "Moving into 2026, the Company believes that the ability to raise capital through equity transactions will increase liquidity and enable the execution of management's operating strategy."

Industry Context

StockSavvy.ai notes Coeptis's strategic pivot into AI-powered marketing software and robotic process automation, alongside its core biopharmaceutical focus, reflects a broader industry trend of diversification and leveraging technology for operational efficiency. The biopharmaceutical division's focus on cell therapy platforms for cancer, autoimmune, and infectious diseases aligns with high-growth areas in biotech, particularly in the CAR T-cell therapy market, which is projected to grow significantly. The acquisition of NexGenAI and the licensing of the GEAR Cell Therapy Platform demonstrate an aggressive growth strategy through both internal development and strategic partnerships, a common approach for smaller biotech firms seeking to expand their pipeline and market reach.

Comparison to Industry Standards

• The global multiple myeloma market was $28.42 billion in 2024 and is expected to reach $47.04 billion by 2031, indicating a substantial and growing market for CD38-GEAR-NK, aligning with high-growth areas in oncology.
• The CAR T-cell therapy market size is expected to reach $20.56 billion by 2029 from $1.96 billion in 2021, representing a compound annual growth rate (CAGR) of 31.6%, highlighting the high growth potential of the SNAP-CAR platform within a rapidly expanding therapeutic area.
• The company's focus on solid tumors with SNAP-CAR is a key differentiator, as currently, no FDA-approved CAR-T therapies are specifically marketed for solid tumors, positioning Coeptis in a high-need, high-potential area compared to existing CAR-T therapies primarily for hematologic malignancies.
• The designation of CD38-Diagnostic as a Class II device by the FDA is a positive regulatory step, providing a clearer path to market compared to more stringent Class III devices, which could accelerate development relative to competitors facing higher regulatory hurdles.

Management Changes

Corporate Governance

Legal Proceedings

• No pending lawsuits or claims that, individually or in the aggregate, are believed to have a material adverse effect on the business, financial condition, or yearly results of operations.

Related Party Transactions

• Christopher Calise, a current member of the Board of Directors, participated in the Series A preferred stock offering personally and through an entity controlled by him.
• An unsecured note agreement for $500,000 with an investment fund, where the manager is a member of the Company's board of directors, was converted to equity in June 2024.
• In September 2023, the Company entered into a transaction with AG Bio Life Capital I LP (AG), where an employee of the Company is the general partner, involving the issuance of common stock for cash and a promissory note. The AG Note was paid in full in August 2024 by transferring shares of common stock in a privately held company.
• As of December 31, 2025, the Company accrued $32,500 of professional services expenses related to Board of Directors and Scientific Advisory Board compensation, which were paid in Q1 2026.
• The Company's Chief Executive Officer and Chief Financial Officer each hold ownership interests in certain privately held companies in which the Company also holds investments.
• Christopher Calise and Tara Maria DeSilva, both directors, are first cousins.

Stakeholder Impact

• Shareholders face potential dilution from ongoing capital raises (equity transactions, SEPA, convertible notes) and risk of share price volatility due to financial performance and the going concern warning. However, there is potential for long-term value creation if the biotechnology pipeline and technology segment succeed.
• Employees are impacted by management changes, such as the Chief Scientific and Medical Officer's resignation. Stock-based compensation plans are in place, and an option repricing/exchange program was implemented to re-incentivize personnel.
• Creditors face risk due to a convertible promissory note being in default as of December 31, 2025, and the independent auditor's going concern warning, which may impact confidence and future lending terms.
• Customers of the NexGenAI platform continue to receive lead generation and webinar services, indicating ongoing business operations in the technology segment.
• Partners such as Vy-Gen, the University of Pittsburgh, Monarch Therapeutics, and Karolinska Institutet are involved in ongoing collaborations for product development and research, which are crucial for the company's strategic initiatives.

Next Steps

• Continue to evaluate, prioritize, and optimize the pipeline portfolio, making changes as market dynamics and product opportunities evolve.
• Focus on expanding the existing pipeline through establishing strategic partnerships with companies having novel, preclinical, and clinical assets, particularly in oncology.
• Actively seek partnerships and strategic collaborations for platform technologies beyond current focus areas.
• Further develop the licensed SNAP-CAR technology and identify optimal cancer indication(s) for study.
• Conduct human clinical trials for GEAR-NK, planned for 2027 or later.
• Close the merger with Z Squared, Inc., expected in the second quarter of 2026.
• Continue to strengthen internal control processes and procedures following remediation efforts.
• Pay performance-based fees, milestone, and royalty payments related to the GEAR license agreement in 2026 and beyond.
• Collect the remaining $500,000 subscription receivable from the Q3 2025 private placement.
• Collect $3,120,000 in promissory notes from two private investors by December 18, 2026.
• Amortize the subscription receivable from the Series A preferred stock investor through June 2026 as professional services expense.

Key Dates

Recommendation

The company faces substantial doubt about its ability to continue as a going concern, reported significant net losses, and has a large accumulated deficit. While there are strategic initiatives and new revenue streams, the financial instability and reliance on future capital raises present high risks for investors. The resignation of a key scientific officer adds to the uncertainty in the biotech division. Given these factors, a seasoned investor would likely recommend selling due to the high risk and uncertain path to profitability.

Keywords

Biotechnology, Cell Therapy, Cancer Treatment, AI Marketing Software, Robotic Process Automation, SEC Filing, 10-K, Financial Report, Drug Development, Clinical Trials, Corporate Governance, Nasdaq, Merger, Spin-out, CD38-GEAR-NK, CD38-Diagnostic, SNAP-CAR, NexGenAI, Multiple Myeloma, AML, MDS