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What changed in Coeptis Therapeutics Holdings, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Coeptis Therapeutics Holdings, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+155 added−147 removedSource: 10-K (2026-03-19) vs 10-K (2025-03-28)

Top changes in Coeptis Therapeutics Holdings, Inc.'s 2025 10-K

155 paragraphs added · 147 removed · 117 edited across 4 sections

Item 1. Business

Business — how the company describes what it does

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Biggest changeThe Convertible Note matures on November 1, 2025. Risks Associated with our Business There are a number of risks related to us and our operations. You should carefully review the risks described in “ Risk Factors and Special Considerations ” beginning on page 9.
Biggest changeRisks Associated with our Business There are a number of risks related to us and our operations. You should carefully review the risks described in “ Risk Factors and Special Considerations ” beginning on page 9. If any of these risks actually occur, our business, financial condition, results of operations and prospects would likely be materially, adversely affected.
In support of the exclusive license, the Company also entered into with Deverra (i) an asset purchase agreement (the “APA”) pursuant to which we purchased certain assets from Deverra, including but not limited to two Investigational New Drug (IND) applications and two Phase 1 clinical trial stage programs (NCT04901416, NCT04900454) investigating infusion of DVX201, an unmodified natural killer (NK) cell therapy generated from pooled donor CD34+ cells, in hematologic malignancies and viral infections and (ii) a non-exclusive sublicense agreement (the “Sublicense Agreement”), in support of the assets obtained by the exclusive license, pursuant to which the Company sublicensed from Deverra certain assets which Deverra has rights to pursuant a license agreement (“FHCRC Agreement”) by and between Deverra and The Fred Hutchinson Cancer Research Center (“FHCRC”).
In support of the exclusive license, the Company also entered into with Deverra (i) an asset purchase agreement (the “APA”) pursuant to which we purchased certain assets from Deverra, including but not limited to two Investigational New Drug (IND) applications and two Phase 1 clinical trial stage programs (NCT04901416, NCT04900454) investigating infusion of DVX201, an unmodified natural killer (NK) cell therapy generated from pooled donor CD34+ cells, in hematologic malignancies and viral infections and (ii) a non-exclusive sublicense agreement (the “Sublicense Agreement”), in support of the assets obtained by the exclusive license, pursuant to which the Company sublicensed from Deverra certain assets which Deverra has rights pursuant to a license agreement (“FHCRC Agreement”) by and between Deverra and The Fred Hutchinson Cancer Research Center (“FHCRC”).
Our SEC filings will also be available free of charge through the home page of our website https://coeptistx.com as soon as reasonably practicable after they are filed with or furnished to the SEC. Our website and the information contained on or connected to that site are not incorporated into this Annual Report on Form 10-K. 8
Our SEC filings will also be available free of charge through the home page of our website https://coeptistx.com as soon as reasonably practicable after they are filed with or furnished to the SEC. Our website and the information contained on or connected to that site are not incorporated into this Annual Report on Form 10-K.
CD38 Therapeutic and Diagnostic; Vy-Gen Bio, Inc. In May 2021, we entered into two exclusive option agreements (the “CD38 Agreements”) relating to separate technologies (described below) designed to improve the treatment of CD38-related cancers (e.g., multiple myeloma, chronic lymphocytic leukemia, and acute myeloid leukemia) with Vy-Gen-Bio, Inc.
In May 2021, we entered into two exclusive option agreements (the “CD38 Agreements”) relating to separate technologies (described below) designed to improve the treatment of CD38-related cancers (e.g., multiple myeloma, chronic lymphocytic leukemia, and acute myeloid leukemia) with Vy-Gen-Bio, Inc.
As consideration for the Deverra transaction described above, we paid Deverra approximately $570,000 in cash, issued to Deverra 4,000,000 shares of the Company’s common stock and assumed certain liabilities related to the ongoing clinical trials.
As consideration for the Deverra transaction described above, we paid Deverra approximately $570,000 in cash, issued to Deverra 200,000 shares of the Company’s common stock and assumed certain liabilities related to the ongoing clinical trials.
GEAR-NK is an autologous, gene-edited, natural killer cell-based therapeutic development platform that allows for modified NK cells to be co-administered with targeted mAbs, which, in the absence of the GEAR-NK, would otherwise be neutralized by mAb therapy. GEAR-NK is a pre-clinical in vitro proof-of-concept product with in vivo evaluations planned for 2025.
GEAR-NK is an autologous, gene-edited, natural killer cell-based therapeutic development platform that allows for modified NK cells to be co-administered with targeted mAbs, which, in the absence of the GEAR-NK, would otherwise be neutralized by mAb therapy. GEAR-NK is a pre-clinical in vitro proof-of-concept product..
About the Company’s Subsidiaries . We are now a holding company that currently operates through our direct and indirect subsidiaries SNAP Biosciences, Inc. and GEAR Therapeutics, Inc., which are majority owned, and Coeptis Therapeutics, Inc., Coeptis Pharmaceuticals, Inc. and Coeptis Pharmaceuticals, LLC, which are wholly owned.
About the Company’s Subsidiaries . We are now a holding company that currently operates through our direct and indirect subsidiaries SNAP Biosciences, Inc. and GEAR Therapeutics, Inc., which are majority owned, and Coeptis Therapeutics, Inc., Coeptis Pharmaceuticals, Inc. and Coeptis Pharmaceuticals, LLC, which are wholly owned. Coeptis is a biopharmaceutical and technology company.
Employees Currently, we have seven employees, of which five are full-time employees and two are part-time employees. Our employees are not represented by any labor union or any collective bargaining arrangement with respect to their employment with the Company. We have never experienced any work stoppages or strikes as a result of labor disputes.
Employees Currently, we have six employees, of which four are full-time employees and two are part-time employees. Our employees are not represented by any labor union or any collective bargaining arrangement with respect to their employment with the Company. We have never experienced any work stoppages or strikes as a result of labor disputes.
The term of the SRA expires by its terms at the end of January 2025.
The term of the SRA expired by its terms at the end of January 2025.
Until December 2024 we operated under a Shared Services Agreement (“SSA”) with Deverra, which provided Coeptis and Deverra to share resources and collaborate on the development of Coeptis’ GEAR and SNAP-CAR platforms. The Company is continuing its development focus on both GEAR and SNAP-CAR, and will be considering prospective strategic partners for such development.
Until December 2024 we operated under a Shared Services Agreement (“SSA”) with Deverra, which provided Coeptis and Deverra to share resources and collaborate on the development of Coeptis’ GEAR and SNAP-CAR platforms. The Company is continuing its development focus on both GEAR and SNAP-CAR and is considering prospective strategic partners for such development. CD38 Therapeutic and Diagnostic; Vy-Gen Bio, Inc.
Details of the co-development and steering committee agreement are summarized in the agreement attached as Exhibit 4.1 to our Current Report on Form 8-K dated December 27, 2021.
Details of the co-development and steering committee agreement are summarized in the agreement attached as Exhibit 4.1 to our Current Report on Form 8-K dated December 27, 2021. In March 2025, the Company reached an agreement with Vy-Gen-Bio, Inc.
As we continue to direct its operational focus towards the Vy-Gen opportunities previously described, we have recently stopped allocating priority resources to the development of CPT60621. We are currently in negotiations in which Vici intends to buy-out most or all of our remaining ownership rights. 5 Current Opportunity Vy-Gen-Bio, Inc.
As we continue to direct its operational and financial focus towards the other assets and opportunities previously described, we have stopped allocating resources to the development of CPT60621. We are currently in negotiations in which Vici intends to buy-out most or all of the remaining ownership rights.
Collaborations for Product Development — Research and Development We believe that there is significant market opportunity related to each of the assets we are currently pursuing. Set forth below is a brief summary of our current target assets.
This division features AI-powered marketing software and robotic process automation tools designed to optimize business processes and improve overall efficiency. Biopharmaceutical Division Collaborations for Product Development — Research and Development We believe that there is significant market opportunity related to each of the assets we are currently pursuing. Set forth below is a brief summary of our current target assets.
If any of these risks actually occurs, our business, financial condition, results of operations and prospects would likely be materially, adversely affected. In that event, the trading price of our Common Stock could be adversely impacted, and you could lose part or all of your investment.
In that event, the trading price of our Common Stock could be adversely impacted, and you could lose part or all of your investment.
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Our current business model is designed around furthering the development of our current product portfolio. Our biopharmaceutical division is continually exploring partnership opportunities with companies that have novel therapies in various stages of development or companies with technologies that improve the way that drugs are delivered to patients.
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The biopharmaceutical division focuses on developing innovative cell therapy platforms for cancer, autoimmune, and infectious diseases. Coeptis aims to advance treatment paradigms and improve patient outcomes through its cutting-edge research and development efforts. The technology division focuses on enhancing operational capabilities through advanced technologies.
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We seek the best strategic relationships, which relationships could include in-license agreements, out-license agreements, co-development arrangements and other strategic partnerships in new and exciting therapeutic areas such as oncology, respiratory viral infections, and autoimmune diseases.
Added
Multiple myeloma is the first cancer indication targeted with CD38-GEAR-NK. The global multiple myeloma market was $28.42B in 2024 and is expected to reach $47.04B by 2031 [Source: Data Bridge Market Research]. GEAR-NK Product Plan Overview.
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Multiple myeloma is the first cancer indication targeted with CD38-GEAR-NK. Our intent is to seek regulatory approval in the 8 major markets comprised of the United States, the UK, Germany, Spain, France, Italy, China, and Japan.
Added
(“Vy-Gen”) to successfully license the exclusive worldwide development and commercialization rights to the GEAR™ (Gene Edited Antibody Resistant) Cell Therapy Platform, representing a first-in-class approach to modifying potent cancer-targeting immune cells to optimize the likelihood of deep remission in patients with hematologic malignancies and other cancers. Coeptis had previously held limited co-development rights to GEAR.
Removed
The total multiple myeloma market size in these 8 countries was $16.27 billion in 2019 and is expected to increase modestly through 2030, according to DelveInsight. GEAR-NK Product Plan Overview.
Added
Technology Division NexGenAI Affiliates Network On December 19, 2024, the Company acquired the assets of NexGenAI Affiliates Network Platform (“NexGenAI”), from the seller NexGenAI Solutions Group, Inc., which contains AI-powered marketing software and robotic process automation capabilities.
Removed
We are currently exploring on a non-exclusive basis a previously announced strategic opportunity that we believe would add to our current GEAR development platform and provide additional growth opportunities to our assets in the area of cellular immunotherapy.
Added
The acquired assets include intellectual property, a domain name and associated website, and the technology stack as defined in the agreement. 5 The acquired assets include technology-enabled AI driven marketing automation platform, along with associated tools and infrastructure that enable the Company to offer managed digital marketing services under its own brand.
Removed
The acquisition of these assets, if completed, would allow us to expand our collaboration with Vy-Gen-Bio, beyond its current focus on the use of CD38-GEAR-NK, a natural killer (NK) cell therapy for the treatment of CD38+ cancers for the treatment of multiple myeloma, and the development of CD38-Diagnostic, an in vitro diagnostic tool aimed toward identifying cancer patients who may be appropriate candidates for anti-CD38 mAb therapy.
Added
Originally launched in the third quarter of 2023, the platform was developed to support client efforts in enhancing brand visibility, generating qualified leads, and advancing strategic growth initiatives. The Company’s managed service offerings now include lead generation, content marketing, social media marketing, email marketing, account-based marketing, marketing analytics, event marketing, and branding support.
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We believe that our employee relations are good.
Added
The Company is utilizing a proprietary suite of automation and virtual assistant technologies to streamline client outreach, engagement workflows, and digital marketing operations across our operations.
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Certain of our employees have been reporting to work remotely and may continue to do so moving forward. 6 Recent Developments November 2024 Standy Equity Purchase Agreement As previously disclosed in a Current Report on Form 8-K filed on November 6, 2024, the Company entered into a Standby Equity Purchase Agreement (“SEPA”) pursuant to which the Company has the right to sell Yorkville up to $20,000,000 of its shares of Company Common Stock, subject to certain limitations and conditions set forth in the SEPA, from time to time during the term of the SEPA (such transaction, the “Yorkville Transaction”).
Added
We believe that our employee relations are good. Certain of our employees have been reporting to work remotely and may continue to do so moving forward.
Removed
In connection with the SEPA, Yorkville has agreed to advance to the Company in the form of a convertible promissory note (the “Convertible Note”) an aggregate principal amount of up to $1,304,758 (the “Pre-Paid Advance”), which has been previously paid and replaces the $1,235,178 YA Note-1 outstanding balance.
Added
Recent Developments Pending Merger Transaction On April 25, 2025, the Company (“Coeptis” or the “Purchaser”), entered into an Agreement and Plan of Merger (the “Merger Agreement”) with CP Merger Sub Inc., a Wyoming corporation and wholly-owned subsidiary of Coeptis (“Merger Sub”), and Z Squared, Inc., a Wyoming corporation (“Z Squared”). 6 Pursuant to the Merger Agreement, subject to the terms and conditions set forth therein, upon the consummation of the transactions contemplated by the Merger Agreement (the “Closing”), (i) Merger Sub will merge with and into Z Squared (the “Merger”) and (ii) Coeptis will immediately prior to the Merger effect a spin out of its biotechnology operations (the “Spin Out” and, together with Merger and the other transactions contemplated by the Merger Agreement, the “Transactions”), with Z squared continuing as the surviving corporation in the Merger and becoming a wholly-owned subsidiary of Coeptis.
Removed
The Convertible Note bears an interest rate of 8% per annum and is convertible in whole or in part at any time by Yorkville into shares of common stock of the Company at a conversion price determined based on the lower of (i) $1.00 per common share (the “Fixed Price”), or (ii) 95% of the lowest daily volume weighted average price during the five consecutive trading days immediately preceding the conversion date (the “Variable Price”), but which Variable Price shall not be lower than the floor price of $0.80 (the “Floor Price”).
Added
In the Merger, all shares of Z Squared common stock issued and outstanding immediately prior to the effective time of the Merger (other than those properly exercising any applicable dissenters rights under Wyoming law), will be converted into the right to receive a portion of the Merger Consideration (as defined below) and (ii) any other outstanding securities with the right to convert into or acquire equity securities of Z Squared will be terminated.
Added
At the Closing, Coeptis will change its name as mutually agreed upon by the Purchaser and Z Squared. The Merger is expected to close in the second quarter 2026.
Added
In connection with the Spin Out, all of Coeptis’ assets comprising its biotechnology business will be assigned and contributed prior to Closing to one or more Spin Out Subsidiaries, which will then spin out to Coeptis’ stockholders of record on the record date established for the Coeptis Special Meeting (as defined below).
Added
The aggregate Merger Consideration received by Z Squared security holders from Coeptis at the Closing will be a number of shares of Purchaser Common Stock that represents at Closing the Applicable Percentage of Purchaser’s issued and outstanding shares of Purchaser Common Stock as calculated on a Fully-Diluted Basis.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

46 edited+5 added−13 removed141 unchanged
Biggest changeHowever, if this were to occur, the Company could face significant material adverse consequences, including: · a limited availability of market quotations for its securities; · reduced liquidity for its securities; · a determination that the Common Stock is a “penny stock” which will require brokers trading in the common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for the Company’s securities; · a limited amount of news and analyst coverage; and · a decreased ability to issue additional securities or obtain additional financing in the future. 22 We have previously identified weaknesses in our internal control over financial reporting and we may identify additional weaknesses in the future or otherwise fail to maintain effective internal control over financial reporting, which may result in material misstatements of our Consolidated Financial Statements or cause us to fail to meet our periodic reporting obligations or cause our access to the global markets to be impaired.
Biggest changeHowever, if this were to occur, the Company could face significant material adverse consequences, including: · a limited availability of market quotations for its securities; · reduced liquidity for its securities; · a determination that the Common Stock is a “penny stock” which will require brokers trading in the common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for the Company’s securities; · a limited amount of news and analyst coverage; and · a decreased ability to issue additional securities or obtain additional financing in the future.
The commencement or completion of these planned clinical trials could be substantially delayed or prevented by many factors, including, but not limited to: · discussions with the FDA or other regulatory agencies regarding the scope or design of our clinical trials; · the limited number of, and competition for, suitable sites to conduct our clinical trials, many of which may already be engaged in other clinical trial programs, including some that may be for the same indication as our product candidates; · any delay or failure to obtain approval or agreement to commence a clinical trial in any of the countries where enrollment is planned; · inability to obtain sufficient funds required for a clinical trial; · clinical holds on, or other regulatory objections to, a new or ongoing clinical trial; · delay or failure to manufacture sufficient supplies of product candidates for our clinical trials; · delay or failure to reach agreement on acceptable clinical trial agreement terms or clinical trial protocols with prospective sites or clinical research organizations (“CROs”), the terms of which can be subject to extensive negotiation and may vary significantly among different sites or CROs; · delay or failure to obtain institutional review board (“IRB”) approval to conduct a clinical trial at a prospective site; · slower than expected rates of patient recruitment and enrollment; · failure of patients to complete the clinical trial; · the inability to enroll a sufficient number of patients in studies to ensure adequate statistical power to detect statistically significant treatment effects; · unforeseen safety issues, including severe or unexpected drug-related adverse effects experienced by patients, including possible deaths; · lack of efficacy during clinical trials; · termination of our clinical trials by one or more clinical trial sites; · inability or unwillingness of patients or clinical investigators to follow our clinical trial protocols; · inability to monitor patients adequately during or after treatment; · clinical study sites failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, deviating from the protocol or dropping out of a study; · inability to address any non-compliance with regulatory requirements or safety concerns that arise during the course of a clinical trial; · the need to repeat or terminate clinical trials as a result of inconclusive or negative results or unforeseen complications in testing; and · our clinical trials may be suspended or terminated upon a breach or pursuant to the terms of any agreement with, or for any other reason by, current or future strategic partners that have responsibility for the clinical development of any of our product candidates.
The commencement or completion of these planned clinical trials could be substantially delayed or prevented by many factors, including, but not limited to: · discussions with the FDA or other regulatory agencies regarding the scope or design of our clinical trials; · the limited number of, and competition for, suitable sites to conduct our clinical trials, many of which may already be engaged in other clinical trial programs, including some that may be for the same indication as our product candidates; · any delay or failure to obtain approval or agreement to commence a clinical trial in any of the countries where enrollment is planned; · inability to obtain sufficient funds required for a clinical trial; · clinical holds on, or other regulatory objections to, a new or ongoing clinical trial; · delay or failure to manufacture sufficient supplies of product candidates for our clinical trials; · delay or failure to reach agreement on acceptable clinical trial agreement terms or clinical trial protocols with prospective sites or clinical research organizations (“CROs”), the terms of which can be subject to extensive negotiation and may vary significantly among different sites or CROs; · delay or failure to obtain institutional review board (“IRB”) approval to conduct a clinical trial at a prospective site; · slower than expected rates of patient recruitment and enrollment; · failure of patients to complete the clinical trial; · the inability to enroll a sufficient number of patients in studies to ensure adequate statistical power to detect statistically significant treatment effects; · unforeseen safety issues, including severe or unexpected drug-related adverse effects experienced by patients, including possible deaths; 9 · lack of efficacy during clinical trials; · termination of our clinical trials by one or more clinical trial sites; · inability or unwillingness of patients or clinical investigators to follow our clinical trial protocols; · inability to monitor patients adequately during or after treatment; · clinical study sites failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, deviating from the protocol or dropping out of a study; · inability to address any non-compliance with regulatory requirements or safety concerns that arise during the course of a clinical trial; · the need to repeat or terminate clinical trials as a result of inconclusive or negative results or unforeseen complications in testing; and · our clinical trials may be suspended or terminated upon a breach or pursuant to the terms of any agreement with, or for any other reason by, current or future strategic partners that have responsibility for the clinical development of any of our product candidates.
Among other things, the Amended and Restated Certificate of Incorporation and Bylaws include provisions regarding: · the ability of the Company Board to issue shares of preferred stock, including “blank check” preferred stock and to determine the price and other terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquirer; · the limitation of the liability of, and the indemnification of, the Company’s directors and officers; · the right of the Company Board to elect a director to fill a vacancy created by the expansion of the Company Board or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on the Company Board; · a prohibition on stockholder action by written consent (except as required for holders of future series of preferred stock), which forces stockholder action to be taken at an annual or special meeting of stockholders and could delay the ability of stockholders to force consideration of a stockholder proposal or to take action, including the removal of directors; 20 · the requirement that a special meeting of stockholders may be called only by the Company Board, the chairman of the Company Board, which could delay the ability of stockholders to force consideration of a proposal or to take action, including the removal of directors; · controlling the procedures for the conduct and scheduling of the Company Board and stockholder meetings; · the requirement for the affirmative vote of holders of at least a majority of the voting power of all of the voting power of the then outstanding shares of the voting stock, voting as a single class, to amend, alter, change or repeal any provision of the Company’s Bylaws and certain provisions in the Amended and Restated Certificate of Incorporation, respectively, which could preclude stockholders from bringing matters before annual or special meetings of stockholders and delay changes in the Company Board and also may inhibit the ability of an acquirer to effect such amendments to facilitate an unsolicited takeover attempt; · the ability of the Company Board to amend the Bylaws by an affirmative vote of a majority of the Board, which may allow the Company Board to take additional actions to prevent an unsolicited takeover and inhibit the ability of an acquirer to amend the Bylaws to facilitate an unsolicited takeover attempt; and · advance notice procedures with which stockholders must comply to nominate candidates to the Company Board or to propose matters to be acted upon at a stockholders’ meeting, which could preclude stockholders from bringing matters before annual or special meetings of stockholders and delay changes in the Company Board and also may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of Company.
Among other things, the Amended and Restated Certificate of Incorporation and Bylaws include provisions regarding: · the ability of the Company Board to issue shares of preferred stock, including “blank check” preferred stock and to determine the price and other terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquirer; · the limitation of the liability of, and the indemnification of, the Company’s directors and officers; · the right of the Company Board to elect a director to fill a vacancy created by the expansion of the Company Board or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on the Company Board; · a prohibition on stockholder action by written consent (except as required for holders of future series of preferred stock), which forces stockholder action to be taken at an annual or special meeting of stockholders and could delay the ability of stockholders to force consideration of a stockholder proposal or to take action, including the removal of directors; · the requirement that a special meeting of stockholders may be called only by the Company Board, the chairman of the Company Board, which could delay the ability of stockholders to force consideration of a proposal or to take action, including the removal of directors; · controlling the procedures for the conduct and scheduling of the Company Board and stockholder meetings; · the requirement for the affirmative vote of holders of at least a majority of the voting power of all of the voting power of the then outstanding shares of the voting stock, voting as a single class, to amend, alter, change or repeal any provision of the Company’s Bylaws and certain provisions in the Amended and Restated Certificate of Incorporation, respectively, which could preclude stockholders from bringing matters before annual or special meetings of stockholders and delay changes in the Company Board and also may inhibit the ability of an acquirer to effect such amendments to facilitate an unsolicited takeover attempt; · the ability of the Company Board to amend the Bylaws by an affirmative vote of a majority of the Board, which may allow the Company Board to take additional actions to prevent an unsolicited takeover and inhibit the ability of an acquirer to amend the Bylaws to facilitate an unsolicited takeover attempt; and · advance notice procedures with which stockholders must comply to nominate candidates to the Company Board or to propose matters to be acted upon at a stockholders’ meeting, which could preclude stockholders from bringing matters before annual or special meetings of stockholders and delay changes in the Company Board and also may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors or otherwise attempting to obtain control of Company.
If we fail to comply with these obligations, the licensor may have the right to terminate the license, in which event we might not be able to market any product that is covered by the licensed patents. 15 We may need to resort to litigation to enforce or defend our intellectual property rights, including any patents issued to us.
If we fail to comply with these obligations, the licensor may have the right to terminate the license, in which event we might not be able to market any product that is covered by the licensed patents. We may need to resort to litigation to enforce or defend our intellectual property rights, including any patents issued to us.
Further, its stock price could be subject to significant fluctuation or otherwise be adversely affected by the events, risks and uncertainties of any securities litigation and shareholder activism. 17 Risk Related to Regulation The regulatory approval process is costly and lengthy, and we may not be able to successfully obtain all required regulatory approvals.
Further, its stock price could be subject to significant fluctuation or otherwise be adversely affected by the events, risks and uncertainties of any securities litigation and shareholder activism. Risk Related to Regulation The regulatory approval process is costly and lengthy, and we may not be able to successfully obtain all required regulatory approvals.
We have experienced a lack of adequate capital resources causing us to be unable to fully implement our full business plan. We believe that we need to raise or otherwise obtain additional financing beyond our current cash position in order to satisfy our existing obligations and fully implement our business plan.
We have experienced a lack of adequate capital resources causing us to be unable to fully implement our full business plan. We believe that we need to raise or otherwise obtain additional financing beyond our current cash position in order to satisfy our existing obligations or fully implement our business plan.
Any failure or significant delay in commencing or completing clinical trials for our product candidates may adversely affect our ability to obtain regulatory approval and our commercial prospects and our ability to generate product revenue will be diminished. 10 The design or our execution of clinical trials may not support regulatory approval.
Any failure or significant delay in commencing or completing clinical trials for our product candidates may adversely affect our ability to obtain regulatory approval and our commercial prospects and our ability to generate product revenue will be diminished. The design or our execution of clinical trials may not support regulatory approval.
There is, of course, no assurance that we will enjoy rapid development in our business. 12 The Company’s ability to be successful will depend upon the efforts of the Company’s Board and our key personnel and the loss of such persons could negatively impact the operations and profitability of the Company’s business.
There is, of course, no assurance that we will enjoy rapid development in our business. The Company’s ability to be successful will depend upon the efforts of the Company’s Board and our key personnel and the loss of such persons could negatively impact the operations and profitability of the Company’s business.
Accordingly, our shareholders will not be entitled to approve changes in our policies, which policy changes may have a material adverse effect on our financial condition and results of operations. We need to obtain financing in order to continue our operations and pursue strategic transactions.
Accordingly, our shareholders will not be entitled to approve changes in our policies, which policy changes may have a material adverse effect on our financial condition and results of operations. 12 We need to obtain financing in order to continue our operations and pursue strategic transactions.
In the absence of adequate patent protection in other countries, competitors may similarly be able to obtain regulatory approval in those countries of products that duplicate our products. We will be required to comply with our obligations in our intellectual property licenses and other agreements with third parties.
In the absence of adequate patent protection in other countries, competitors may similarly be able to obtain regulatory approval in those countries of products that duplicate our products. 14 We will be required to comply with our obligations in our intellectual property licenses and other agreements with third parties.
We will remain an emerging growth company until the earliest of (i) December 31, 2025, (ii) the first fiscal year after our annual gross revenue exceed $1.07 billion, (iii) the date on which we have, during the immediately preceding three-year period, issued more than $1.00 billion in non-convertible debt securities, or (iv) the end of any fiscal year in which the market value of our common stock held by non-affiliates exceeds $700.0 million as of the end of the second quarter of that fiscal year.
We will remain an emerging growth company until the earliest of (i) December 31, 2027, (ii) the first fiscal year after our annual gross revenue exceed $1.07 billion, (iii) the date on which we have, during the immediately preceding three-year period, issued more than $1.00 billion in non-convertible debt securities, or (iv) the end of any fiscal year in which the market value of our common stock held by non-affiliates exceeds $700.0 million as of the end of the second quarter of that fiscal year.
Data obtained from preclinical and clinical activities is susceptible to varying interpretations, which could delay, limit, or prevent regulatory approvals. We have limited experience in conducting the clinical trials required to obtain regulatory approval.
Data obtained from preclinical and clinical activities is susceptible to varying interpretations, which could delay, limit, or prevent regulatory approvals. 16 We have limited experience in conducting the clinical trials required to obtain regulatory approval.
Any of these results could decrease or prevent any sales of our approved product or substantially increase the costs and expenses of commercializing and marketing our product. 18 Healthcare reform measures could adversely affect our business.
Any of these results could decrease or prevent any sales of our approved product or substantially increase the costs and expenses of commercializing and marketing our product. Healthcare reform measures could adversely affect our business.
Negative or inconclusive results from a preclinical study or clinical trial, adverse medical events during a clinical trial or safety issues resulting from products of the same class of drug could cause a preclinical study or clinical trial to be repeated or a program to be terminated, even if other studies or trials relating to the program are successful. 14 We will be required to sustain and further build our intellectual property rights.
Negative or inconclusive results from a preclinical study or clinical trial, adverse medical events during a clinical trial or safety issues resulting from products of the same class of drug could cause a preclinical study or clinical trial to be repeated or a program to be terminated, even if other studies or trials relating to the program are successful. 13 We will be required to sustain and further build our intellectual property rights.
Our business plan is not based on independent market studies. We have not commissioned any independent market studies concerning our business plans. Rather, our plans for implementing our business strategy and achieving profitability are based on the experience, judgment and assumptions of our management. If these assumptions prove to be incorrect, we may not be successful in our business operations.
We have not commissioned any independent market studies concerning our business plans. Rather, our plans for implementing our business strategy and achieving profitability are based on the experience, judgment and assumptions of our management. If these assumptions prove to be incorrect, we may not be successful in our business operations.
We cannot predict whether investors will find our common stock less attractive if we rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our securities, and the market price of our securities may be more volatile. 23
We cannot predict whether investors will find our common stock less attractive if we rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our securities, and the market price of our securities may be more volatile. 22
We anticipate that we will continue to generate operating losses and experience negative cash flow from operations at least through the end of 2024. We cannot be certain that we will ever achieve profitability or that, if profitability is achieved, that it will be maintained.
We anticipate that we will continue to generate operating losses and experience negative cash flow from operations at least through the end of 2025. We cannot be certain that we will ever achieve profitability or that, if profitability is achieved, that it will be maintained.
In addition to the other challenges they will face, such individuals may be unfamiliar with the requirements of operating a public company, which could cause the Company’s management to expend time and resources becoming familiar with such requirements. We have employment agreements in place with Mr. Mehalick, Colleen Delaney and Daniel Yerace, but no other persons.
In addition to the other challenges they will face, such individuals may be unfamiliar with the requirements of operating a public company, which could cause the Company’s management to expend time and resources becoming familiar with such requirements. We have employment agreements in place with Mr. Mehalick and Daniel Yerace, but no other persons. The loss of service of Mr.
We believe that cash on hand will be sufficient to meet our short-term financial requirements through the 2 nd quarter of 2025 assuming that we elect not to pursue and consummate strategic transactions prior to that time.
We believe that cash on hand will be sufficient to meet our short-term financial requirements through at least the 2 nd quarter of 2026 assuming that we elect not to pursue and consummate strategic transactions prior to that time.
If we receive approval to commercialize any product candidates, the manufacturing, marketing and sale of these drugs will be subject to continuing regulation, including compliance with quality systems regulations, good manufacturing practices, adverse event requirements, and prohibitions on promoting a product for unapproved uses.
The FDA continues to review products even after they receive initial approval. If we receive approval to commercialize any product candidates, the manufacturing, marketing and sale of these drugs will be subject to continuing regulation, including compliance with quality systems regulations, good manufacturing practices, adverse event requirements, and prohibitions on promoting a product for unapproved uses.
This would adversely affect our ability to generate revenues. 16 Competition in the biotechnology and pharmaceutical industries may result in competing products, superior marketing of other products and lower revenues or profits for us. There are many companies that are seeking to develop products and therapies for the treatment of the same diseases that we are currently targeting.
Competition in the biotechnology and pharmaceutical industries may result in competing products, superior marketing of other products and lower revenues or profits for us. There are many companies that are seeking to develop products and therapies for the treatment of the same diseases that we are currently targeting.
Regardless of the validity or the success of the assertion of claims, we could incur significant costs and diversion of resources in protecting or defending against claims, which could have a material adverse effect on our business, financial condition or results of operations. We may not have the funds or resources available to protect our intellectual property.
Regardless of the validity or the success of the assertion of claims, we could incur significant costs and diversion of resources in protecting or defending against claims, which could have a material adverse effect on our business, financial condition or results of operations.
Similarly, pre-clinical interim results of a clinical trial are not necessarily predictive of final results. 9 If clinical trials for our product candidates are prolonged, delayed or stopped, we may be unable to obtain regulatory approval and commercialize our product candidates on a timely basis, or at all, which would require us to incur additional costs and delay our receipt of any product revenue.
If clinical trials for our product candidates are prolonged, delayed or stopped, we may be unable to obtain regulatory approval and commercialize our product candidates on a timely basis, or at all, which would require us to incur additional costs and delay our receipt of any product revenue.
If we are unable to recruit and retain key personnel, our business may be harmed. If we are unable to attract and retain key personnel, our business may be harmed. Our failure to enable the effective transfer of knowledge and facilitate smooth transitions with regard to our key employees could adversely affect our long-term strategic planning and execution.
If we are unable to attract and retain key personnel, our business may be harmed. Our failure to enable the effective transfer of knowledge and facilitate smooth transitions with regard to our key employees could adversely affect our long-term strategic planning and execution. Our business plan is not based on independent market studies.
Many factors may affect our ability to identify, enroll and maintain qualified patients, including the following: · eligibility criteria of our ongoing and planned clinical trials with specific characteristics appropriate for inclusion in our clinical trials; · design of the clinical trial; · size and nature of the patient population; · patients’ perceptions as to risks and benefits of the product candidate under study and the participation in a clinical trial generally in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating; · the availability and efficacy of competing therapies and clinical trials; · pendency of other trials underway in the same patient population; · willingness of physicians to participate in our planned clinical trials; · severity of the disease under investigation; · proximity of patients to clinical sites; · patients who do not complete the trials for personal reasons; and · issues with CROs and/or with other vendors that handle our clinical trials. 11 General Risks There is a substantial doubt about our ability to continue as a going concern.
If we experience delays in our clinical trials, the timeline for obtaining regulatory approval of our product candidates will most likely be delayed. 10 Many factors may affect our ability to identify, enroll and maintain qualified patients, including the following: · eligibility criteria of our ongoing and planned clinical trials with specific characteristics appropriate for inclusion in our clinical trials; · design of the clinical trial; · size and nature of the patient population; · patients’ perceptions as to risks and benefits of the product candidate under study and the participation in a clinical trial generally in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating; · the availability and efficacy of competing therapies and clinical trials; · pendency of other trials underway in the same patient population; · willingness of physicians to participate in our planned clinical trials; · severity of the disease under investigation; · proximity of patients to clinical sites; · patients who do not complete the trials for personal reasons; and · issues with CROs and/or with other vendors that handle our clinical trials.
If the laws or regulations are changed to permit or more easily permit the importation of drugs into the United States in circumstances that are currently not permitted, such a change could have an adverse effect on our business by making available lower priced alternatives to our future products. 19 Failure to obtain regulatory and pricing approvals in foreign jurisdictions could delay or prevent commercialization of our products abroad.
If the laws or regulations are changed to permit or more easily permit the importation of drugs into the United States in circumstances that are currently not permitted, such a change could have an adverse effect on our business by making available lower priced alternatives to our future products.
The loss of service of Mr. Mehalick, in particular, for any reason, could seriously impair our ability to effectuate our business plan, which could have a materially adverse effect on our business and future results of operations. We also have not purchased any key-man life insurance.
Mehalick, in particular, for any reason, could seriously impair our ability to effectuate our business plan, which could have a materially adverse effect on our business and future results of operations. We also have not purchased any key-man life insurance. If we are unable to recruit and retain key personnel, our business may be harmed.
The risks associated with the approval process include: · failure of our product candidates to meet a regulatory agency’s requirements for safety, efficacy and quality; · limitation on the indicated uses for which a product may be marketed; · unforeseen safety issues or side effects; and · governmental or regulatory delays and changes in regulatory requirements and guidelines.
The risks associated with the approval process include: · failure of our product candidates to meet a regulatory agency’s requirements for safety, efficacy and quality; · limitation on the indicated uses for which a product may be marketed; · unforeseen safety issues or side effects; and · governmental or regulatory delays and changes in regulatory requirements and guidelines. 17 Even if we receive regulatory approvals for marketing our product candidates, if we fail to comply with continuing regulatory requirements, we could lose our regulatory approvals, and our business would be adversely affected.
Various proposals have been advanced to permit the importation of drugs from other countries to provide lower cost alternatives to the products available in the United States.
The prices of some drugs are lower in other countries than in the United States because of government regulation and market conditions. Various proposals have been advanced to permit the importation of drugs from other countries to provide lower cost alternatives to the products available in the United States.
On January 29, 2024, we received notice from the Listing Qualifications Staff of Nasdaq indicating that, based upon the closing bid price of our common stock for the prior 30 consecutive business days, we were not in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq as set forth In Nasdaq Listing Rule 5550(a)(2).
Such a delisting would likely have a negative effect on the price of the Company’s securities and may impair your ability to sell or purchase the Company’s securities when you wish to do so. 21 On January 29, 2024, we received notice from the Listing Qualifications Staff of Nasdaq indicating that, based upon the closing bid price of our common stock for the prior 30 consecutive business days, we were not in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq as set forth In Nasdaq Listing Rule 5550(a)(2).
If our revenue grows at a slower rate than we anticipate or if our product development, marketing and operating expenses exceed our expectations or cannot be adjusted accordingly, our business, results of operation and financial condition will be materially adversely affected, and we may be unable to continue operations.
If our revenue grows at a slower rate than we anticipate or if our product development, marketing and operating expenses exceed our expectations or cannot be adjusted accordingly, our business, results of operation and financial condition will be materially adversely affected, and we may be unable to continue operations. 11 We will not be able to generate meaningful product revenue unless and until one of our product candidates or co-development products successfully completes clinical trials and receives regulatory approval.
The time required to obtain approval abroad may differ from that required to obtain FDA approval. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval and additional risks associated with requirements particular to those foreign jurisdictions where we will seek regulatory approval of our products.
The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval and additional risks associated with requirements particular to those foreign jurisdictions where we will seek regulatory approval of our products. We may not obtain foreign regulatory approvals on a timely basis, if at all.
While the MMA applies only to drug benefits for Medicare beneficiaries, private payers often follow Medicare coverage policy and payment limitations in setting their own reimbursement systems, and any limits on or reductions in reimbursement that occur in the Medicare program may result in similar limits on or reductions in payments from private payers.
While the MMA applies only to drug benefits for Medicare beneficiaries, private payers often follow Medicare coverage policy and payment limitations in setting their own reimbursement systems, and any limits on or reductions in reimbursement that occur in the Medicare program may result in similar limits on or reductions in payments from private payers. 18 Federal laws or regulations on drug importation could make lower cost versions of our future products available, which could adversely affect our revenues, if any.
Any provision of the Amended and Restated Certificate of Incorporation, Bylaws or Delaware law that has the effect of delaying or preventing a change in control could limit the opportunity for stockholders to receive a premium for their shares of the Company’s capital stock and could also affect the price that some investors are willing to pay for the common stock.
Any provision of the Amended and Restated Certificate of Incorporation, Bylaws or Delaware law that has the effect of delaying or preventing a change in control could limit the opportunity for stockholders to receive a premium for their shares of the Company’s capital stock and could also affect the price that some investors are willing to pay for the common stock. 20 The Amended and Restated Certificate of Incorporation designates a state or federal court located within the State of Delaware as the exclusive forum for substantially all disputes between the Company and its stockholders, which could limit the Company’s stockholders’ ability to choose the judicial forum for disputes with the Company or its directors, officers, or employees.
Section 22 of the Securities Act creates concurrent jurisdiction for state and federal courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. 21 Any person or entity purchasing or otherwise acquiring any interest in any of the securities of the Company will be deemed to have notice of and consented to these provisions.
Section 22 of the Securities Act creates concurrent jurisdiction for state and federal courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder.
If we succeed in developing any products, we intend to market them in the European Union and other foreign jurisdictions. In order to do so, we must obtain separate regulatory approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing.
Failure to obtain regulatory and pricing approvals in foreign jurisdictions could delay or prevent commercialization of our products abroad. If we succeed in developing any products, we intend to market them in the European Union and other foreign jurisdictions. In order to do so, we must obtain separate regulatory approvals and comply with numerous and varying regulatory requirements.
In addition, many competitors have greater name recognition and more extensive collaborative relationships. Our competitors could commence and complete clinical testing of their product candidates, obtain regulatory approvals, and begin commercial-scale manufacturing of their products faster than we or our co-development partners are able to for our products.
Our competitors could commence and complete clinical testing of their product candidates, obtain regulatory approvals, and begin commercial-scale manufacturing of their products faster than we or our co-development partners are able to for our products. They could develop products that would render our product candidates and co-development candidates, and those of our collaborators, obsolete and noncompetitive.
We may not obtain foreign regulatory approvals on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or by the FDA.
Approval by the FDA does not ensure approval by regulatory authorities in other countries, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or by the FDA.
Our inability to take advantage of opportunities in the industry because of capital constraints may have a material adverse effect on our business and our prospects.
Our inability to take advantage of opportunities in the industry because of capital constraints may have a material adverse effect on our business and our prospects. If we fail to obtain the capital necessary to fund our operations, we will be unable to advance our development programs and complete our clinical trials.
Our competitors and potential competitors may develop products and technologies that make ours less attractive or obsolete. Many companies, universities, and research organizations developing competing product candidates have greater resources and significantly greater experience in financial, research and development, manufacturing, marketing, sales, distribution, and technical regulatory matters than we have.
Many companies, universities, and research organizations developing competing product candidates have greater resources and significantly greater experience in financial, research and development, manufacturing, marketing, sales, distribution, and technical regulatory matters than we have. In addition, many competitors have greater name recognition and more extensive collaborative relationships.
They could develop products that would render our product candidates and co-development candidates, and those of our collaborators, obsolete and noncompetitive. If we are unable to compete effectively against these companies, then we may not be able to commercialize our product candidates or achieve a competitive position in the market.
If we are unable to compete effectively against these companies, then we may not be able to commercialize our product candidates or achieve a competitive position in the market. This would adversely affect our ability to generate revenues.
For the year ended December 31, 2024, we incurred a net loss of $10,877,412 and, as of that date, we had an accumulated deficit of $98,233,673. For the year ended December 31, 2023, we incurred a net loss of $21,266,537 and, as of that date, had an accumulated deficit of $87,356,260.
For the year ended December 31, 2025, we incurred a net loss of $12,277,192 and, as of that date, we had an accumulated deficit of $109,953,728. For the year ended December 31, 2024, we incurred a net loss of $10,877,412 and, as of that date, had an accumulated deficit of $98,036,713.
The risk factors discussed below cover not only our current products, product candidates and relationships, but also the risks we expect to encounter when and if we add new product candidates and approved products to our proprietary portfolio, which new products, if added, we expect to be at various stages of pre-clinical and perhaps clinical development.
The risk factors discussed below cover not only our current products, product candidates and relationships, but also the risks we expect to encounter when and if we add new product candidates and approved products to our proprietary portfolio, which new products, if added, we expect to be at various stages of pre-clinical and perhaps clinical development. 8 Throughout this section, references to “Company,” “Coeptis,” “we,” “us,” “our” and similar terms refer collectively to Coeptis Therapeutics Holdings, Inc., a Delaware corporation, and its operating subsidiaries, as the context so requires.
Delaware law and the Amended and Restated Certificate of Incorporation and Bylaws contain certain provisions, including anti-takeover provisions that limit the ability of stockholders to take certain actions and could delay or discourage takeover attempts that stockholders may consider favorable.
Creditors of those subsidiaries will be entitled to payment in full from the sale or other disposal of the assets of those subsidiaries before our company, as a shareholder, would be entitled to receive any distribution from that sale or disposal. 19 Delaware law and the Amended and Restated Certificate of Incorporation and Bylaws contain certain provisions, including anti-takeover provisions that limit the ability of stockholders to take certain actions and could delay or discourage takeover attempts that stockholders may consider favorable.
Throughout this section, references to “Company,” “Coeptis,” “we,” “us,” “our” and similar terms refer collectively to Coeptis Therapeutics Holdings, Inc., a Delaware corporation, and its operating subsidiaries, as the context so requires. Risks Related to the Development and Regulatory Approval of Our Product Candidates Clinical trials are expensive, time consuming, difficult to design and implement, and involve uncertain outcomes.
Risks Related to the Development and Regulatory Approval of Our Product Candidates Clinical trials are expensive, time consuming, difficult to design and implement, and involve uncertain outcomes.
If we fail to obtain the capital necessary to fund our operations, we will be unable to advance our development programs and complete our clinical trials. 13 In addition, our research and development expenses could exceed our current expectations.
In addition, our research and development expenses could exceed our current expectations.
Removed
If we experience delays in our clinical trials, the timeline for obtaining regulatory approval of our product candidates will most likely be delayed.
Added
Similarly, pre-clinical interim results of a clinical trial are not necessarily predictive of final results.
Removed
We will not be able to generate meaningful product revenue unless and until one of our product candidates or co-development products successfully completes clinical trials and receives regulatory approval.
Added
General Risks There is a substantial doubt about our ability to continue as a going concern.
Removed
Even if we receive regulatory approvals for marketing our product candidates, if we fail to comply with continuing regulatory requirements, we could lose our regulatory approvals, and our business would be adversely affected. The FDA continues to review products even after they receive initial approval.
Added
We may not have the funds or resources available to protect our intellectual property. 15 Our competitors and potential competitors may develop products and technologies that make ours less attractive or obsolete.
Removed
Federal laws or regulations on drug importation could make lower cost versions of our future products available, which could adversely affect our revenues, if any. The prices of some drugs are lower in other countries than in the United States because of government regulation and market conditions.
Added
The approval procedure varies among countries and can involve additional testing. The time required to obtain approval abroad may differ from that required to obtain FDA approval.
Removed
Creditors of those subsidiaries will be entitled to payment in full from the sale or other disposal of the assets of those subsidiaries before our company, as a shareholder, would be entitled to receive any distribution from that sale or disposal.
Added
Any person or entity purchasing or otherwise acquiring any interest in any of the securities of the Company will be deemed to have notice of and consented to these provisions.
Removed
The Amended and Restated Certificate of Incorporation designates a state or federal court located within the State of Delaware as the exclusive forum for substantially all disputes between the Company and its stockholders, which could limit the Company’s stockholders’ ability to choose the judicial forum for disputes with the Company or its directors, officers, or employees.
Removed
Such a delisting would likely have a negative effect on the price of the Company’s securities and may impair your ability to sell or purchase the Company’s securities when you wish to do so.
Removed
In connection with the preparation of our 2022 financial statements, Management self-identified material weaknesses in our internal control over financial reporting. In the past we have not designed and maintained an effective control environment or sufficient accounting and reporting protocols or effectively selected and developed control activities that mitigate risks.
Removed
The material weaknesses were self-diagnosed, and were not issued by our independent auditors, Turner, Stone & Company, LLP. These self-diagnosed material weaknesses resulted in deficiencies surrounding the controls related to the preparation, review, and analysis of accounting information and financial statements.
Removed
Those controls were not adequately designed or appropriately implemented to identify material misstatements in financial reporting on a timely basis. We implemented a plan to remediate these self-diagnosed material weaknesses.
Removed
With the oversight of senior management and our audit committee, we hired additional accounting personnel with technical accounting and financial reporting experience and have implemented improved process level and management review controls with respect to the completeness, accuracy, and validity of complex accounting measurements on a timely basis.
Removed
We also have supplemented internal accounting resources with external advisors to assist with performing technical accounting activities. Management took deliberate actions and implemented a plan to remediate these self-diagnosed weaknesses. Our efforts may not remediate these self-diagnosed material weaknesses in our internal control over financial reporting and may not prevent additional material weaknesses from being identified in the future.
Removed
Our failure to implement and maintain effective internal control over financial reporting could result in errors in our Consolidated Financial Statements that could result in a restatement of our Consolidated Financial Statements, and could cause us to fail to meet our reporting obligations, any of which could diminish investor confidence in us and cause a decline in our equity value.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

36 edited+6 added−1 removed79 unchanged
Biggest changeOn October 26, 2023, in connection with the private placement described elsewhere in the Annual Report on Form 10-K, the Company issued to an institutional investor (i) 777,000 Shares of the Company’s common stock, (ii) Pre-Funded Warrants to purchase up to 1,223,000 shares of Common Stock, (iii) Series A Warrants to purchase up to 2,000,000 shares of Common Stock with an exercise price of $1.36 per share, and (iv) Series B Warrants (the “Series B Warrants” and together with the Pre-Funded Warrants and the Series A Warrants , the “Warrants”) to purchase up to 2,000,000 shares of Common Stock with an exercise price of $1.36 per share, for gross proceeds to the Company of $2,000,000.
Biggest changeOn September 29, 2023, the Company issued 30,000 shares of common stock of the Company to a private investor in exchange for $600,000, $100,000 of which was paid in cash and the balance of which was paid with a promissory note. 29 On October 26, 2023, in connection with the private placement described elsewhere in the Annual Report on Form 10-K, the Company issued to an institutional investor (i) 38,850 Shares of the Company’s common stock, (ii) Pre-Funded Warrants to purchase up to 61,150 shares of Common Stock, (iii) Series A Warrants to purchase up to 100,000 shares of Common Stock with an exercise price of $27.20 per share, and (iv) Series B Warrants (the “Series B Warrants” and together with the Pre-Funded Warrants and the Series A Warrants , the “Warrants”) to purchase up to 100,000 shares of Common Stock with an exercise price of $27.20 per share, for gross proceeds to the Company of $2,000,000.
Restricted Stock Unit Awards . Restricted stock unit awards are granted under restricted stock unit award agreements in a form approved by the Committee. Restricted stock unit awards may be granted in consideration for any form of legal consideration that may be acceptable to our board of directors and permissible under applicable law.
Restricted stock unit awards are granted under restricted stock unit award agreements in a form approved by the Committee. Restricted stock unit awards may be granted in consideration for any form of legal consideration that may be acceptable to our board of directors and permissible under applicable law.
In addition, the following summary is based upon an analysis of the Code as currently in effect, existing laws, judicial decisions, administrative rulings, regulations and proposed regulations, all of which are subject to change and does not address state, local or other tax laws. Nonstatutory Stock Options. Generally, there is no taxation upon the grant of a NSO.
In addition, the following summary is based upon an analysis of the Code as currently in effect, existing laws, judicial decisions, administrative rulings, regulations and proposed regulations, all of which are subject to change and does not address state, local or other tax laws. 27 Nonstatutory Stock Options. Generally, there is no taxation upon the grant of a NSO.
The Committee may grant other awards based in whole or in part by reference to our Common Stock. The Compensation Committee will set the number of shares under the stock award (or cash equivalent) and all other terms and conditions of such awards. Non-Employee Director Compensation Limit .
The Committee may grant other awards based in whole or in part by reference to our Common Stock. The Compensation Committee will set the number of shares under the stock award (or cash equivalent) and all other terms and conditions of such awards. 26 Non-Employee Director Compensation Limit .
Subject to the requirement of reasonableness, the deduction limits under Section 162(m) of the Code and the satisfaction of a tax reporting obligation, the Company will generally be entitled to a tax deduction equal to the taxable ordinary income realized by the recipient of the restricted stock award. Restricted Stock Unit Awards.
Subject to the requirement of reasonableness, the deduction limits under Section 162(m) of the Code and the satisfaction of a tax reporting obligation, the Company will generally be entitled to a tax deduction equal to the taxable ordinary income realized by the recipient of the restricted stock award. 28 Restricted Stock Unit Awards.
In addition, any escrow, holdback, earn out or similar provisions in the definitive agreement for the corporate transaction may apply to such payment to the same extent and in the same manner as such provisions apply to the holders of Common Stock. 28 Plan Amendment or Termination .
In addition, any escrow, holdback, earn out or similar provisions in the definitive agreement for the corporate transaction may apply to such payment to the same extent and in the same manner as such provisions apply to the holders of Common Stock. Plan Amendment or Termination .
Any shares previously issued which are reacquired in satisfaction of tax withholding obligations or as consideration for the exercise or purchase price of a stock award will again become available for issuance under the Plan. Plan Administration .
Any shares previously issued which are reacquired in satisfaction of tax withholding obligations or as consideration for the exercise or purchase price of a stock award will again become available for issuance under the Plan. 24 Plan Administration .
The holders of common stock will have no conversion rights. Preemptive and Similar Rights. The holders of common stock will have no preemptive or similar rights. Redemption/Put Rights. There will be no redemption or sinking fund provisions applicable to the Common Stock. All of the outstanding shares of common stock are fully-paid and nonassessable. Options/Stock Awards.
The holders of common stock will have no conversion rights. Preemptive and Similar Rights. The holders of common stock will have no preemptive or similar rights. Redemption/Put Rights. There will be no redemption or sinking fund provisions applicable to the Common Stock. All of the outstanding shares of common stock are fully-paid and nonassessable. 31 Options/Stock Awards.
In the event of a termination for cause, stock appreciation rights generally terminate immediately upon the occurrence of the event giving rise to the termination of the individual for cause. In no event may a stock appreciation right be exercised beyond the expiration of its term. 27 Performance Awards .
In the event of a termination for cause, stock appreciation rights generally terminate immediately upon the occurrence of the event giving rise to the termination of the individual for cause. In no event may a stock appreciation right be exercised beyond the expiration of its term. Performance Awards .
Generally, the recipient of a restricted stock award will recognize ordinary income at the time the stock is received equal to the excess, if any, of the fair market value of the stock received over any amount paid by the recipient in exchange for the stock.
Restricted Stock Awards. Generally, the recipient of a restricted stock award will recognize ordinary income at the time the stock is received equal to the excess, if any, of the fair market value of the stock received over any amount paid by the recipient in exchange for the stock.
On September 29, 2023, the Company issued 2,400,000 shares of common stock of the Company to a private investor in exchange for $2,400,000, $400,000 of which was paid in cash and the balance of which was paid with a promissory note.
On September 29, 2023, the Company issued 120,000 shares of common stock of the Company to a private investor in exchange for $2,400,000, $400,000 of which was paid in cash and the balance of which was paid with a promissory note.
In February 2024 the Company sold a pre-funded warrant to Alamo Board Marketing, LLC that are currently exercisable to acquire up to 6,000,000 of the shares being registered hereunder for the benefit of such shareholder, for gross proceeds to the Company of $2,400,000 comprised of $500,000 in cash and a $1,900,000 promissory note.
In February 2024 the Company sold a pre-funded warrant to Alamo Board Marketing, LLC that are currently exercisable to acquire up to 300,000 of the shares being registered hereunder for the benefit of such shareholder, for gross proceeds to the Company of $2,400,000 comprised of $500,000 in cash and a $1,900,000 promissory note.
In December 2023, the Company sold a pre-funded warrant to AMLS Holdings, LLC that are currently exercisable to acquire up to 2,000,000 of the shares of Common Stock being registered hereunder for the benefit of such shareholder, for gross proceeds to the Company of $1,200,000 comprised of $100,000 in cash and a $1,100,000 promissory note.
In December 2023, the Company sold a pre-funded warrant to AMLS Holdings, LLC that are currently exercisable to acquire up to 150,000 of the shares of Common Stock being registered hereunder for the benefit of such shareholder, for gross proceeds to the Company of $1,200,000 comprised of $100,000 in cash and a $1,100,000 promissory note.
In November 2024, we issued 400,000 shares of Common Stock (“Commitment Shares”), to Yorkville as consideration for Yorkville’s commitment to purchase shares of Common Stock at the Company’s direction upon the terms and subject to the conditions set forth in the SEPA, upon execution of the SEPA.
In November 2024, we issued 20,000 shares of Common Stock (“Commitment Shares”), to Yorkville as consideration for Yorkville’s commitment to purchase shares of Common Stock at the Company’s direction upon the terms and subject to the conditions set forth in the SEPA, upon execution of the SEPA.
The promissory note accrues interest at the rate of six (6%) percent per annum (increasing to eighteen percent (18%) per annum from and after the occurrence of a default) and matures on November 29, 2024, and has provision for mandatory prepayment.
The promissory note accrues interest at the rate of six (6%) percent per annum (increasing to eighteen percent (18%) per annum from and after the occurrence of a default) and matured on November 29, 2024, and has provision for mandatory prepayment.
The promissory note accrues interest at the rate of six (6%) percent per annum (increasing to eighteen percent (18%) per annum from and after the occurrence of a default) and matures on December 31, 2024, and has provision for mandatory prepayment.
The promissory note accrues interest at the rate of six (6%) percent per annum (increasing to eighteen percent (18%) per annum from and after the occurrence of a default) and matured on December 31, 2024, and has provision for mandatory prepayment.
No ISO may be granted to any person who, at the time of the grant, owns or is deemed to own stock possessing more than 10% of our total combined voting power or that of any of our parent or subsidiary corporations unless (i) the option exercise price is at least 110% of the fair market value of the stock subject to the option on the date of grant and (ii) the term of the ISO does not exceed five years from the date of grant.
No ISO may be granted to any person who, at the time of the grant, owns or is deemed to own stock possessing more than 10% of our total combined voting power or that of any of our parent or subsidiary corporations unless (i) the option exercise price is at least 110% of the fair market value of the stock subject to the option on the date of grant and (ii) the term of the ISO does not exceed five years from the date of grant. 25 Restricted Stock Unit Awards .
If there is a disqualifying disposition of a share, however, the Company will generally be entitled to a tax deduction equal to the taxable ordinary income realized by the participant, subject to the requirement of reasonableness, the deduction limits under Section 162(m) of the Code and provided that either the employee includes that amount in income or the Company timely satisfies its reporting requirements with respect to that amount. 29 Restricted Stock Awards.
If there is a disqualifying disposition of a share, however, the Company will generally be entitled to a tax deduction equal to the taxable ordinary income realized by the participant, subject to the requirement of reasonableness, the deduction limits under Section 162(m) of the Code and provided that either the employee includes that amount in income or the Company timely satisfies its reporting requirements with respect to that amount.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock is listed on the Nasdaq Global Market under the symbol “COEP.” The closing price of our common stock on Nasdaq on December 31, 2024 was $5.50 per share.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common stock is listed on the Nasdaq Global Market under the symbol “COEP.” The closing price of our common stock on Nasdaq on December 31, 2025 was $14.25 per share.
In connection with the October 2023 private placement, the Company also issued placement agent warrants (the “Placement Agent Warrants”) to purchase 120,000 shares of our common stock at an exercise price of $1.40 per share.
In connection with the October 2023 private placement, the Company also issued placement agent warrants (the “Placement Agent Warrants”) to purchase 6,000 shares of our common stock at an exercise price of $28.00 per share.
In October 2023 the Company granted options to purchase an aggregate of 300,000 shares of its common stock under the 2022 Equity Incentive Plan, to two officers/employees and consultants, at an exercise price of $1.07 per share The Company has also granted a stand-alone option to a former employee to purchase up to 100,000 shares of our common stock at an exercise price of $10 per share.
In October 2023 the Company granted options to purchase an aggregate of 15,000 shares of its common stock under the 2022 Equity Incentive Plan, to two officers/employees and consultants, at an exercise price of $21.40 per share The Company has also granted a stand-alone option to a former employee to purchase up to 5,000 shares of our common stock at an exercise price of $200 per share.
In January 2023 the Company granted options to purchase an aggregate of 1,357,500 shares of its common stock under the 2022 Equity Incentive Plan, to various officers, directors, employees and consultants, at an average exercise price of $1.63 per share.
In January 2023 the Company granted options to purchase an aggregate of 67,875 shares of its common stock under the 2022 Equity Incentive Plan, to various officers, directors, employees and consultants, at an average exercise price of $32.60 per share.
Warrants The Company has warrants outstanding to purchase (i) 1,024,316 shares of our common stock at an average exercise price of approximately $19.87 per share which were assumed from Coeptis Therapeutics, Inc. as part of the Merger, and (ii) 375,000 shares of our common stock at an exercise price of $230.00 per share, which were issued prior to the Merger. 32
Warrants The Company has warrants outstanding to purchase (i) 570,105 shares of our common stock at an average exercise price of approximately $31.71 per share which were assumed from Coeptis Therapeutics, Inc. as part of the Merger, and (ii) 375,000 shares of our common stock at an exercise price of $230.00 per share, which were issued prior to the Merger.
On August 16, 2023, Coeptis Therapeutics Holdings, Inc. (the “Company”) entered into an exclusive licensing arrangement (with Deverra Therapeutics Inc., and, issued to Deverra 4,000,000 shares of the Company’s common stock and assumed certain liabilities related to the ongoing clinical trials.
(the “Company”) entered into an exclusive licensing arrangement (with Deverra Therapeutics Inc., and, issued to Deverra 200,000 shares of the Company’s common stock and assumed certain liabilities related to the ongoing clinical trials.
Acceptable consideration for the purchase of Common Stock issued upon the exercise of a stock option will be determined by the Committee and may include (i) cash, check, bank draft or money order, (ii) a broker-assisted cashless exercise, (iii) the tender of shares of our Common Stock previously owned by the option holder, (iv) a net exercise of the option if it is an NSO or (v) other legal consideration approved by the Board. 26 Unless the Committee provides otherwise, options or stock appreciation rights generally are not transferable except by will or the laws of descent and distribution.
Acceptable consideration for the purchase of Common Stock issued upon the exercise of a stock option will be determined by the Committee and may include (i) cash, check, bank draft or money order, (ii) a broker-assisted cashless exercise, (iii) the tender of shares of our Common Stock previously owned by the option holder, (iv) a net exercise of the option if it is an NSO or (v) other legal consideration approved by the Board.
There were 82,875 stock options outstanding at December 31, 2023. The Company subsequently granted in 2024 options to purchase an aggregate of 196,750 shares of our common stock under the 2022 Equity Incentive Plan, to various officers, directors, employees and consultants, at an average exercise price of $9.56 per share. There were 279,625 stock options outstanding at December 31, 2024.
There were 279,625 stock options outstanding at December 31, 2024. The Company subsequently granted in 2025 options to purchase an aggregate of 87,375 shares of our common stock under the 2022 Equity Incentive Plan, to various officers, directors, employees and consultants, at an average exercise price of $10.52 per share. There were 437,000 stock options outstanding at December 31, 2025.
Holders of Common Stock As of March 26, 2025, we had 3,364,939 shares of our common stock issued and outstanding, and there were 121 record holders of our common stock. Certain shares are held in “street” name and accordingly, the number of beneficial owners of such shares is not known or included in the foregoing number.
Holders of Common Stock As of March 18, 2026, we had 6,223,221 shares of our common stock issued and outstanding, and there were 128 record holders of our common stock. Certain shares are held in “street” name and accordingly, the number of beneficial owners of such shares is not known or included in the foregoing number.
As of December 31, 2024, a total of 279,625 stock options to purchase shares of common stock were granted under the Plan. 25 Shares subject to stock awards granted under the Plan that expire or terminate without being exercised in full or that are paid out in cash rather than in shares do not reduce the number of shares available for issuance under our Plan.
Shares subject to stock awards granted under the Plan that expire or terminate without being exercised in full or that are paid out in cash rather than in shares do not reduce the number of shares available for issuance under our Plan.
The aggregate fair market value, determined at the time of grant, of our Common Stock with respect to ISOs that are exercisable for the first time by an award holder during any calendar year under all of our stock plans may not exceed $100,000. Options or portions thereof that exceed such limit will generally be treated as NSOs.
Tax Limitations on ISOs . The aggregate fair market value, determined at the time of grant, of our Common Stock with respect to ISOs that are exercisable for the first time by an award holder during any calendar year under all of our stock plans may not exceed $100,000.
Preferred Stock There were 6,520 shares of series A preferred stock outstanding at December 31, 2024.
Preferred Stock There were no shares of series A preferred stock outstanding at December 31, 2025.
These foregoing securities were issued pursuant to exemptions from registration under the Securities Act in transactions not involving an underwriter. 31 Description of our Capital Stock The following description summarizes the most important terms of our capital stock.
In December 2025 the Company sold 260,000 shares of common stock to two private investors for $3,120,000 in promissory notes. These foregoing securities were issued pursuant to exemptions from registration under the Securities Act in transactions not involving an underwriter. Description of our Capital Stock The following description summarizes the most important terms of our capital stock.
In April 2023 the Company issued an aggregate of 1,000,000 shares of common stock in connection with the termination of several investment banking agreements and all future rights and obligations under such agreements. 30 In June 2023, in connection with the June 2023 Offering, the Company issued warrants to the underwriter of such offering to acquire up to 210,000 shares of the Company’s common stock at an exercise price of $1.25.
In April 2023 the Company issued an aggregate of 50,000 shares of common stock in connection with the termination of several investment banking agreements and all future rights and obligations under such agreements.
Subject to approval of the Committee or a duly authorized officer, an option may be transferred pursuant to a domestic relations order, official marital settlement agreement or other divorce or separation instrument. Tax Limitations on ISOs .
Unless the Committee provides otherwise, options or stock appreciation rights generally are not transferable except by will or the laws of descent and distribution. Subject to approval of the Committee or a duly authorized officer, an option may be transferred pursuant to a domestic relations order, official marital settlement agreement or other divorce or separation instrument.
Recent Sales of Unregistered Securities Set forth below is information regarding shares of capital stock issued by us within the past three years.
Recent Sales of Unregistered Securities Set forth below is information regarding shares of capital stock issued by us within the past three years. All shares are presented on a post reverse stock split basis. In January 2023 the Company issued an aggregate of 43,709 shares of its common stock to service providers as compensation for services.
On October 28, 2022, in connection with the Merger, the Company assumed warrants from Coeptis Therapeutics, Inc. and delivered to the holders thereof replacement warrants to purchase 1,563,912 shares of the Company’s common stock at an average exercise price of approximately $7.93.
In June 2023, in connection with the June 2023 Offering, the Company issued warrants to the underwriter of such offering to acquire up to 10,500 shares of the Company’s common stock at an exercise price of $25.00. On August 16, 2023, Coeptis Therapeutics Holdings, Inc.
On September 29, 2023, the Company issued 600,000 shares of common stock of the Company to a private investor in exchange for $600,000, $100,000 of which was paid in cash and the balance of which was paid with a promissory note.
From July 2025 to September 2025 the Company sold 436,467 shares of common stock through a private placement for $2,500,000 in cash and $2,500,000 in promissory notes. The Company collected $2,000,000 of the $2,500,000 in promissory notes as of December 31, 2025.
Removed
In January 2023 the Company issued an aggregate of 874,197 shares of its common stock to service providers as compensation for services.
Added
As of December 31, 2025, a total of 339,500 stock options to purchase shares of common stock were granted under the Plan.
Added
Options or portions thereof that exceed such limit will generally be treated as NSOs.
Added
In January 2024 the Company granted options to purchase an aggregate of 76,750 shares of its common stock under the 2022 Equity Incentive Plan, to various officers, directors, employees and consultants, at an average exercise price of $12.92 per share.
Added
In June 2024 the Company granted options to purchase an aggregate of 120,000 shares of its common stock under the 2022 Equity Incentive Plan, to our CEO, at an exercise price of $6.20 per share.
Added
In January 2025 we issued warrants to a service provider to acquire up to 100,000 shares of the Company’s common stock at an exercise price of $12.00 per share. 30 In January 2025 we issued a stand-alone option to a service provider to acquire up to 100,000 shares of the Company’s common stock at an exercise price of $5.72 per share.
Added
In March 2025 the Company granted options to purchase an aggregate of 87,375 shares of its common stock under the 2022 Equity Incentive Plan, to various officers, directors, employees and consultants, at an average exercise price of $10.52 per share.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

21 edited+14 added−6 removed41 unchanged
Biggest changeGeneral and administrative expenses consist primarily of warrant expense related to strategic financing costs, salaries and related costs for personnel and professional fees for consulting services related to regulatory, pharmacovigilance, quality, legal, and business development. We expect that our general and administrative expenses will increase in the future as we increase our headcount to support the business growth.
Biggest changeHowever, we have not yet achieved profitability, and there remains uncertainty regarding our ability to generate sufficient revenue to cover operating expenses and fund our business plan without additional capital. Operating Expenses. Operating expenses consist primarily of salaries and related costs for personnel and professional fees for consulting services related to regulatory, pharmacovigilance, quality, legal, and business development.
During both these time periods, the Company continues to operate a minimal infrastructure in order to maintain its ability to fund operations, keep full focus on all product development targets and to stay current with all of the Company’s scientist consultants, legal counsel, and accountants.
During both of these time periods, the Company continues to operate a minimal infrastructure in order to maintain its ability to fund operations, keep full focus on all product development targets and to stay current with all of the Company’s scientist consultants, legal counsel, and accountants.
We assume no obligation to update any of the forward-looking statements included herein except as expressly required by law. Implications of Being an Emerging Growth Company As a company with less than $1.07 billion in revenue during our last fiscal year, we qualify as an emerging growth company, as defined in the JOBS Act.
We assume no obligation to update any of the forward-looking statements included herein except as expressly required by law. 32 Implications of Being an Emerging Growth Company As a company with less than $1.07 billion in revenue during our last fiscal year, we qualify as an emerging growth company, as defined in the JOBS Act.
Following the reverse merger transaction, we continue to focus on identifying and investing resources into innovative products and technologies which we believe will significantly transform our current products and therapies. 34 During 2020 and continuing through 2021, we faced several operational challenges related to the COVID-19 global pandemic, which we continue to work to overcome.
Following the reverse merger transaction, we continue to focus on identifying and investing resources into innovative products and technologies which we believe will significantly transform our current products and therapies. During 2020 and continuing through 2021, we faced several operational challenges related to the COVID-19 global pandemic, which we continue to work to overcome.
The historical financial statements of Vinings before the Merger were replaced with the historical financial statements of Coeptis before the Merger in all future filings with the Securities and Exchange Commission (the “SEC”). Overview and Outlook We are a biopharmaceutical and technology company which owns, acquires, and develops cell therapy technologies for cancer and other diseases.
The historical financial statements of Vinings before the Merger were replaced with the historical financial statements of Coeptis before the Merger in all future filings with the Securities and Exchange Commission (the “SEC”). 33 Overview and Outlook We are a biopharmaceutical and technology company which owns, acquires, and develops cell therapy technologies for cancer and other diseases.
CD38-Diagnostic also has the potential to develop as a platform technology beyond CD38, to identify patients likely to benefit for broad range of mAb therapies across myriad indications. Market Opportunity .
CD38-Diagnostic also has the potential to develop as a platform technology beyond CD38, to identify patients likely to benefit for broad range of mAb therapies across myriad indications. 34 Market Opportunity .
The confirmation of this classification is beneficial as we’re now better able to plan for and execute future development activities. 35 GEAR-NK Product Overview .
The confirmation of this classification is beneficial as we’re now better able to plan for and execute future development activities. GEAR-NK Product Overview .
Management does not expect the Company to generate any significant revenue 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. Operating Expenses . Overview .
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. 36 Operating Expenses . Overview .
Under the terms of the SSA, Coeptis and Deverra will share resources and collaborate to further the development of Coeptis’ GEAR and SNAP-CAR platforms, as well as the purchased and licensed assets under the License Agreement and APA. The SSA expired on December 31, 2024. Vici Health Sciences, LLC .
Under the terms of the SSA, Coeptis and Deverra will share resources and collaborate to further the development of Coeptis’ GEAR and SNAP-CAR platforms, as well as the purchased and licensed assets under the License Agreement and APA. The SSA expired on December 31, 2024.
As we continue to direct its operational focus towards the Vy-Gen opportunities previously described, we have recently stopped allocating priority resources to the development of CPT60621. We are currently in negotiations in which Vici intends to buy-out most or all of our remaining ownership rights. Our Results of Operations In General Revenue .
As we continue to direct its operational and financial focus towards the other assets and opportunities previously described, we have stopped allocating resources to the development of CPT60621. We are currently in negotiations in which Vici intends to buy-out most or all of the remaining ownership rights. Our Results of Operations In General Revenue .
During 2025, the Company believes that the ability to raise capital through equity transactions will increase liquidity and enable the execution of management’s operating strategy.
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.
In 2019, we entered into a co-development agreement with Vici Health Sciences, LLC (“Vici”). Through this partnership, we would co-develop, seek FDA approval and share ownership rights with Vici to CPT60621, a novel, ready to use, easy to swallow, oral liquid version of an already approved drug used for the treatment of Parkinson’s Disease (PD).
Through this partnership, we would co-develop, seek FDA approval and share ownership rights with Vici to CPT60621, a novel, ready to use, easy to swallow, oral liquid version of an already approved drug used for the treatment of Parkinson’s Disease (PD).
In support of the exclusive license, the Company also entered into with Deverra (i) an asset purchase agreement (the “APA”) pursuant to which the Company purchased certain assets from Deverra, including but not limited to two Investigational New Drug (IND) applications and two Phase 1 clinical trial stage programs (NCT04901416, NCT04900454) investigating infusion of DVX201, an unmodified natural killer (NK) cell therapy generated from pooled donor CD34+ cells, in hematologic malignancies and viral infections and (ii) a non-exclusive sublicense agreement (the “Sublicense Agreement”), in support of the assets obtained by the exclusive license, pursuant to which the Company sublicensed from Deverra certain assets which Deverra has rights to pursuant a license agreement (“FHCRC Agreement”) by and between Deverra and The Fred Hutchinson Cancer Research Center (“FHCRC”).
In support of the exclusive license, the Company also entered into with Deverra (i) an asset purchase agreement (the “APA”) pursuant to which the Company purchased certain assets from Deverra, including but not limited to two Investigational New Drug (IND) applications and two Phase 1 clinical trial stage programs (NCT04901416, NCT04900454) investigating infusion of DVX201, an unmodified natural killer (NK) cell therapy generated from pooled donor CD34+ cells, in hematologic malignancies and viral infections and (ii) a non-exclusive sublicense agreement (the “Sublicense Agreement”), in support of the assets obtained by the exclusive license, pursuant to which the Company sublicensed from Deverra certain assets which Deverra has rights to pursuant a license agreement (“FHCRC Agreement”) by and between Deverra and The Fred Hutchinson Cancer Research Center (“FHCRC”). 35 As consideration for the transactions described above, the Company paid Deverra approximately $570,000 in cash, issued to Deverra 4,000,000 shares of the Company’s common stock and assumed certain liabilities related to the ongoing clinical trials.
These provisions include: · Only two years of audited consolidated financial statements in addition to any required unaudited interim financial statements with correspondingly reduced Management’s Discussion and Analysis of Financial Condition and Results of Operations disclosure. · Reduced disclosure about our executive compensation arrangements. · Not having to obtain non-binding advisory votes on executive compensation or golden parachute arrangements. · Exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting. 33 We may take advantage of these exemptions for up to five years or such earlier time that we are no longer an emerging growth company.
These provisions include: · Only two years of audited consolidated financial statements in addition to any required unaudited interim financial statements with correspondingly reduced Management’s Discussion and Analysis of Financial Condition and Results of Operations disclosure. · Reduced disclosure about our executive compensation arrangements. · Not having to obtain non-binding advisory votes on executive compensation or golden parachute arrangements. · Exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting.
In addition, in accordance with the terms of the Sublicense Agreement, the Company agreed to pay FHCRC certain specified contingent running royalty payments and milestone payments under the FHCRC Agreement, in each case to the extent such payments are triggered by the Company’s development activities. 36 On October 26, 2023, the Company entered into a Shared Services Agreement (“SSA”) with Deverra, in accordance with requirements set forth in the APA.
In addition, in accordance with the terms of the Sublicense Agreement, the Company agreed to pay FHCRC certain specified contingent running royalty payments and milestone payments under the FHCRC Agreement, in each case to the extent such payments are triggered by the Company’s development activities.
Details of the co-development and steering committee agreement are summarized in our Current Report on Form 8-K dated December 27, 2021, including Exhibits 4.1 and 4.2 thereto. Deverra Therapeutics, Inc . On August 16, 2023, the Company entered into an exclusive licensing arrangement (the “License Agreement”) with Deverra Therapeutics Inc.
Details of the co-development and steering committee agreement are summarized in our Current Report on Form 8-K dated December 27, 2021, including Exhibits 4.1 and 4.2 thereto. In March 2025, the Company reached an agreement with Vy-Gen-Bio, Inc.
We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance, insurance, and investor relation expenses associated with operating as a public company. Research and Development Costs . Research and developments costs will continue to be dependent on the strategic business collaborations and agreements will are anticipating in the future.
We expect that our general and administrative expenses will increase in the future as we increase our headcount to support the business growth. We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance, insurance, and investor relation expenses associated with operating as a public company. Research and Development Costs .
We expect development costs to increase to support our new strategic initiatives. Comparison of the years ended December 31, 2024 and December 31, 2023 . Revenues . Revenues recorded in the years ended December 31, 2024 and 2023 respectively, continue to be minimal. The Company’s activities primarily include product development, raising capital, and building infrastructure.
Research and developments costs will continue to be dependent on the strategic business collaborations and agreements we are anticipating in the future. We expect development costs to increase to support our new strategic initiatives. Comparison of the years ended December 31, 2025 and December 31, 2024 . Revenues .
Interest expense was $107,685 for the year ended December 31, 2023 and was $329,927 for the year ended December 31, 2024. Interest was related to notes payable, which are discussed in detail in the Footnotes to the consolidated financial statements, incorporated by reference herein.
Interest expense related to notes payable, which are discussed in detail in the notes to the consolidated financial statements, incorporated by reference herein. Change in Fair Value of Derivative Liabilities.
Operating expenses decreased from $21,491,125 in the year ended December 31, 2023 to $10,054,488 in the year ended December 31, 2024. The significant decrease in 2024 is primarily a result of less research and development expenses, given the 2023 Deverra Therapeutics transactions, legal fees, and consulting services, partially offset by higher stock based compensation expense. General and Administrative Expenses .
Operating expenses increased from $10,054,488 during the year ended December 31, 2024 to $14,225,918 during the year ended December 31, 2025. The significant increase in 2025 is primarily a result of increased professional services expenses, including consulting and legal fees in connection with the Merger Agreement, and higher stock based compensation expense resulting from 2025 stock option grants.
The Company had limited financial resources during the year ended December 31, 2023 with cash of $1,469,134. For the year ended December 31, 2024, cash decreased to $532,885.
The Company had limited financial resources during the year ended December 31, 2024 with cash of $532,885. For the year ended December 31, 2025, cash increased to $5,674,302. The increase in cash resulted primarily from the 2025 private placement common stock offering and draws under the SEPA.
Removed
As consideration for the transactions described above, the Company paid Deverra approximately $570,000 in cash, issued to Deverra 4,000,000 shares of the Company’s common stock and assumed certain liabilities related to the ongoing clinical trials.
Added
We may take advantage of these exemptions for up to five years or such earlier time that we are no longer an emerging growth company.
Removed
To date, we have generated minimal revenue mostly from consulting arrangements and product sales. Due to the COVID-19 global pandemic and the resulting market dynamics, it is uncertain if the current marketed products can generate sufficient sales to cover expenses. Operating Expenses.
Added
(“Vy-Gen”) to successfully license the exclusive worldwide development and commercialization rights to the GEAR™ (Gene Edited Antibody Resistant) Cell Therapy Platform, representing a first-in-class approach to modifying potent cancer-targeting immune cells to optimize the likelihood of deep remission in patients with hematologic malignancies and other cancers. Coeptis had previously held limited co-development rights to GEAR. Deverra Therapeutics, Inc .
Removed
For the years ended December 31, 2023 and 2024, general and administrative expenses are included in operating expenses. All costs incurred can be attributed to the planned principal operations of product development, raising capital, and building infrastructure. 37 Interest Expense .
Added
On August 16, 2023, the Company entered into an exclusive licensing arrangement (the “License Agreement”) with Deverra Therapeutics Inc.
Removed
Management expects that in 2025 and thereafter, interest expense will be at least consistent as it may take on debt from insiders or independent third parties to fund operations either while awaiting receipt of the proceeds of equity capital financings or as a stand-alone strategy in addition to raising capital through equity capital financings. Other Income (Expense) .
Added
On October 26, 2023, the Company entered into a Shared Services Agreement (“SSA”) with Deverra, in accordance with requirements set forth in the APA.
Removed
Total other income was $224,588 for the year ended December 31, 2023 and other expense was $822,924 for the year ended December 31, 2024. The significant decrease in 2024 was primarily related to the loss on change in fair value of derivative liability, and the loss on extinguishment of debt related to the Yorkville SEPA. Financial Resources and Liquidity.
Added
The Company is continuing its development focus on both GEAR and SNAP-CAR, and is considering prospective strategic partners for such development. Vici Health Sciences, LLC . In 2019, we entered into a co-development agreement with Vici Health Sciences, LLC (“Vici”).
Removed
David Mehalick, our President and Chief Executive Officer, Colleen Delaney, M.D., M.Sc., our Chief Scientific and Medical Officer, and Daniel Yerace, our Vice President of Operations, and all agreed to waive their rights to a 2023 guaranteed bonus payment under their respective employment agreements to further maintain our ability to fund operations.
Added
In fiscal year 2025, we generated sales of $1,363,045 from lead generation and webinar services offered through our NexGenAI platform. This represents a meaningful transition from prior periods when we generated minimal revenue.
Added
Sales of $1,363,045 resulted from lead generation and webinar services offered through our technology segment’s NexGenAI platform in the year ended December 31, 2025. The Company had no sales recorded during year ended December 31, 2024. The Company’s activities in its Biotechnology segment primarily include product development, raising capital, and building infrastructure.
Added
The year-over-year decrease in research and development expense is primarily a result of the SSA termination with Deverra Therapeutics in December, 2024, as well as lower total salary expense in fiscal year 2025 as compared to 2024. General and Administrative Expenses .
Added
General and administrative expenses increased from $945,641 during the year ended December 31, 2024 to $1,148,004 during the year ended December 31, 2025. The increase was primarily due to fees incurred in connection with the resolution of an arbitration matter that has been concluded. Interest Expense .
Added
Interest expense was $246,116 for the year ended December 31, 2024 and was $96,744 for the year ended December 31, 2025. The decrease was primarily a result of the satisfaction of the Purple Biotech convertible note and the Yorkville convertible notes.
Added
The change in fair value for the year ended December 31, 2024 was recorded as a loss of $341,660 and was recorded as a gain of $1,098,055 for the year ended December 31, 2025.
Added
The year over year change is a result of a gain on the change in fair value of the SEPA derivative liability in the amount of $906,430, and a gain on the change in fair value of the derivative liability warrants in the amount of $191,625. Unrealized gain on marketable securities.
Added
The Company recognized an unrealized gain on its portfolio of marketable securities of $76,596 for the year ended December 31, 2025. The unrealized gain was attributable to an increase in the market value of the securities during the period.
Added
The unrealized gain is non-cash in nature and reflects a temporary change in fair value as of the consolidated balance sheet date. Management does not expect the unrealized gain to have a material impact on the Company’s liquidity or ongoing operations. Financial Resources and Liquidity.

Other COEP 10-K year-over-year comparisons