Coeptis Therapeutics Holdings, Inc. 10-K
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
(Mark One)
For the Fiscal Year Ended December
31, 2024
Or
For the transition period from _____________
to _____________
Commission File Number: 001-39669
Coeptis Therapeutics Holdings, Inc.
(Exact name of registrant as specified in its charter)
105 Bradford Rd, Suite 420
Wexford, Pennsylvania15090
(Address of Principal Executive Offices) (Zip Code)
(Registrant’s Telephone Number,
Including Area Code): (724) 934-6467
Securities registered pursuant to Section 12(b)
of the Act:
Title of Each Class Trading Symbol(s) Name of Each Exchange on which Registered
Common Stock, par value $0.0001 per share COEP Nasdaq Capital Market
Indicate by check mark if the registrant is a
well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No☒
Indicate by check
mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒
Indicate by check
mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject
to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check
mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of
Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required
to submit such files.) Yes ☒ No ☐
Indicate by check mark whether
the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging
growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting
company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
Emerging growth company ☒
If an emerging
growth company, indicate by a check mark if the registrant has elected not to use the extended transition period for complying with any
new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check
mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal
control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting
firm that prepared or issued its audit report. ☐
If securities
are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included
in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether
any of those error corrections are restatements that required a recovery analysis of incentive- based compensation received by any of
the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by a
check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The aggregate market value
of the voting and non-voting common equity held by non-affiliates of the registrant, as of the last business day of the registrant’s
most recently completed second fiscal quarter, based on the closing sale price of $5.78 reported on the Nasdaq Capital Market was: $8,455,735.40.
The number of shares outstanding
of each of the registrant’s classes of common stock as of the latest practicable date was: 3,364,939 shares of $0.0001 par value
common stock outstanding as of March 26, 2025.
Coeptis Therapeutics Holdings, Inc.
Annual Report on Form 10-K for the Year Ended
December 31, 2024
TABLE OF CONTENTS
Item Page
Part I
1. Business 1
1A. Risk Factors 10
1B. Unresolved Staff Comments 24
1C. Cybersecurity 24
2. Properties 24
3. Legal Proceedings 24
4. Mine Safety Disclosures 24
Part II
6. Selected Financial Data 33
7A. Quantitative and Qualitative Disclosures About Market Risk 38
8. Financial Statements and Supplementary Data 38
9A. Controls and Procedures 38
9B. Other Information 39
Part III
10. Directors, Executive Officers and Corporate Governance 40
11. Executive Compensation 47
13. Certain Relationships and Related Transactions, and Director Independence 51
14. Principal Accountant Fees and Services 54
Part IV
15. Exhibits and Financial Statement Schedules 55
i
PRESENTATION OF FINANCIAL AND
OTHER INFORMATION
On October
28, 2022, Coeptis Therapeutics Holdings, Inc. (“Coeptis”, ‘‘we’’, ‘‘us’’ or
the “Company”), formerly Bull Horn Holdings Corp., acquired Coeptis Therapeutics, Inc. (“Coeptis Sub”) in an all-stock
transaction. The acquisition of Coeptis Sub was accomplished through a reverse merger of our wholly owned subsidiary BH Merger Sub, Inc.
with and into Coeptis Sub, with Coeptis Sub determined to be the accounting acquirer of us (the “Merger”). As such, the historical
financial statements of the registrant for periods prior to October 28, 2022, are those of Coeptis Sub and, in connection with the acquisition,
Coeptis Sub’s equity was exchanged for shares of our common stock. The acquisition of Coeptis Sub was treated as a “reverse
merger.” Unless otherwise stated or the context otherwise requires, the historical business information described in this Annual
Report on Form 10-K prior to consummation of the acquisition of Coeptis Sub is that of Coeptis Sub and, following consummation of the
acquisition of Coeptis Sub, reflects business information of us and Coeptis Sub on a consolidated basis.
This report includes our audited consolidated financial statements
as of and for the year ended December 31, 2024. This report also includes our audited consolidated financial statements as of and for
the year ended December 31, 2023.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This Annual
Report on Form 10-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We
intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section
27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934,
as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this Annual Report
on Form 10-K are “forward-looking statements” for purposes of federal and state securities laws, including statements regarding
our expectations and projections regarding future developments, operations and financial conditions, and the anticipated impact of our
acquisitions, business strategy, and strategic priorities. These statements involve known and unknown risks, uncertainties and other important
factors that may cause our actual results, performance or achievements to be materially different from any future results, performance
or achievements expressed or implied by the forward-looking statements.
In some cases,
you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,”
“plan,” “anticipate,” “could,” “intend,” “target,” “project,”
“contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue”
or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking
statements in this Annual Report on Form 10-K are only predictions and are based largely on our current expectations and projections about
future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking
statements speak only as of the date of this Annual Report on Form 10-K and are subject to a number of known and unknown risks, uncertainties
and assumptions. Although we believe the expectations reflected in any of our forward-looking statements are reasonable, actual results
could differ materially from those projected or assumed in any of our forward-looking statements. Our future financial condition and results
of operations, as well as any forward-looking statements, are subject to change and inherent risks and uncertainties.
These forward-looking
statements present our estimates and assumptions only as of the date of this Annual Report on Form 10-K. Accordingly, you are cautioned
not to place undue reliance on forward-looking statements, which speak only as of the dates on which they are made. Except as required
by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of
any new information, future events, changed circumstances or otherwise. Important factors that could cause actual results to differ materially
from those in the forward-looking statements include, but are not limited to, those summarized below:
ii
· We need to obtain financing in order to continue our operations;
· Healthcare reform measures could adversely affect our business;
· We may not be able to maintain our listing on the Nasdaq Capital Market;
Given these
uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our
estimates and assumptions only as of the date of this Annual Report on Form 10-K and, except as required by law, we undertake no obligation
to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise after
the date of this Annual Report on Form 10-K. We qualify all of our forward-looking statements by these cautionary statements.
NOTE REGARDING TRADEMARKS
We own or
have rights to use the trademarks and trade names that we use in conjunction with the operation of our business. Each trademark or trade
name of any other company appearing in this Annual Report on Form 10-K is, to our knowledge, owned by such other company. Solely for convenience,
our trademarks and trade names referred to in this Annual Report on Form 10-K may appear without the ® or TM symbols, but those
references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or
the right of the applicable licensor to these trademarks and trade names.
iii
PART I
ITEM 1. BUSINESS
As discussed
elsewhere in this Annual Report on Form 10-K, pursuant to the Merger, we acquired our primary operating subsidiary Coeptis Therapeutics,
Inc. Since prior to the Merger the Company was a shell company, the business description below is a description of the Company’s
business based on our subsidiaries’ operations.
Company History
General. We
were originally incorporated in the British Virgin Islands on November 27, 2018, under the name Bull Horn Holdings Corp. On October
27, 2022, Bull Horn Holdings Corp. domesticated from the British Virgin Islands to the State of Delaware. On October 28, 2022, in
connection with the closing of the Merger, we changed our corporate name from Bull Horn Holdings Corp. to “Coeptis
Therapeutics Holdings, Inc.”
The
Merger Transaction. On October 28, 2022, a wholly owned subsidiary of Bull Horn Holdings Corp., merged with and into Coeptis
Therapeutics, Inc., with Coeptis Therapeutics, Inc. as the surviving corporation of the Merger. As a result of the Merger, we acquired
the business of Coeptis Therapeutics, Inc., which we now continue to operate as our wholly owned subsidiary.
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.
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. 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.
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.
Product Pipeline
Program Target Indication Pre-Clinical Phase I Phase II Phase III
Unmodified Natural Killer Cells Acute Myeloid Leukemia
Unmodified Natural Killer Cells Acute Respiratory Diseases
License
of Stem Cell Expansion Platform & Acquisition of Phase 1 Studies
On
August 16, 2023, we entered into an exclusive licensing arrangement (the “License Agreement”) with Deverra Therapeutics Inc.
(“Deverra”), pursuant to which we completed the exclusive license of key patent families and related intellectual property
related to a proprietary allogeneic stem cell expansion and directed differentiation platform for the generation of multiple distinct
immune effector cell types, including natural killer (NK) and monocyte/macrophages. The License Agreement provides us with exclusive rights
to use the license patents and related intellectual property in connection with development and commercialization efforts in the defined
field of use (the “Field”) of (a) use of unmodified NK cells as anti-viral therapeutic for viral infections, and/or as a therapeutic
approach for treatment of relapsed/refractory AML and high-risk MDS; (b) use of Deverra’s cell therapy platform to generate NK cells
for the purpose of engineering with Coeptis SNAP-CARs and/or Coeptis GEAR Technology; and (c) use of Deverra’s cell therapy platform
to generate myeloid cells for the purpose of engineering with the Company’s current SNAP-CAR and GEAR technologies. 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”).
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. 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.
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.
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. (“Vy-Gen”), a majority-owned subsidiary of Vycellix, Inc., a Tampa, Florida-based private, immune-centric discovery life
science company focused on the development of transformational platform technologies to enhance and optimize next-generation cell and
gene-based therapies, including T-cell and Natural Killer (NK) cell-based cancer therapies. In August 2021, we exercised those two options
and acquired a 50% ownership interest in such technologies. In December 2021, we completed our purchase of the 50% ownership interest
in the CD38-Diagnostic, and subsequently in December 2022 we completed our purchase of the 50% ownership interest for the CD38-GEAR-NK
product candidate.
The CD38 Agreements
relate to two separate Vy-Gen drug product candidates, as follows:
Market Opportunity. We
believe CD38-GEAR-NK could potentially revolutionize how CD38-related cancers are treated, by protecting CD38+ NK cells from destruction
by anti-CD38 mAbs, thereby promoting the opportunity to improve the treatment of CD38-related cancers, including multiple myeloma, chronic
lymphocytic leukemia, and acute myeloid leukemia.
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. 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.
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. Vy-Gen is actively engaged in the research
and development of GEAR-NK, and through the joint steering committee, we are assessing market opportunities, intellectual property protection
and potential regulatory strategy. No human clinical trials have been conducted for GEAR-NK but are planned for 2027 or later.
Market Opportunity.
We believe CD38-Diagnostic provides opportunity to make more cost-effective medical decisions for the treatment of B cell malignancies
with high CD38 expression, including multiple myeloma, which may help to avoid unnecessary administration of anti-CD38 therapies. CD38-Diagnostic
is anticipated to reduce the number of patients that are subjected to ineffective therapy and to potentially result in significant savings
to healthcare systems.
CD38-Diagnostic is
viewed as a potential in-vitro diagnostic for determining patient suitability and likelihood of positive treatment outcomes for CD38-GEAR-NK
and/or CD38 monoclonal antibody therapies.
On September
28, 2023, we received FDA’s response to our 513(g) request for information submission pertaining to the classification of the CD38-Diagnostic.
The CD38-Diagnostic has been designated a Class II type device. The confirmation of this classification is beneficial as we’re now
better able to plan for and execute future development activities.
In May 2021,
we made initial payments totaling $750,000 under the CD38 Agreements, to acquire the exclusive options to acquire co-development rights
with respect to CD38-GEAR-NK and CD38-Diagnostic. On August 15, 2021, we entered into amendments to each of the CD38 Agreements.
In connection with the two amendments, we delivered to Vy-Gen promissory notes aggregating $3,250,000 with maturity dates of December 31,
2021, and made a cash payment of $1,000,000, upon which cash payment we exercised the two definitive option purchase agreements. In December
2021, we completed our payment obligations to secure our rights to 50% of the net revenue stream related to the CD38-Diagnostic, and in
November 2022 we completed our purchase of the 50% ownership interest for the CD38-GEAR-NK product candidate. Details of the two August
amendments and the December amendment are summarized in the amendments attached at Exhibits 4.1 and 4.2 to our Current Report on Form 8-K
dated August 19, 2021, and Exhibit 4.2 to our Current Report on Form 8-K dated December 27, 2021.
In connection
with the Vy-Gen relationship and the Company’s rights in respect of the two product candidates described above, in December 2021
we entered into a co-development and steering committee agreement with Vy-Gen. The co-development and steering committee agreement provides
for the governance and economic agreements between the Company and Vy-Gen related of the development of the two Vy-Gen drug product candidates
and the revenue sharing related thereto, including each company having a 50% representation on the steering committee and each company
receiving 50% of the net revenues related to the Vy-Gen product candidates. Related to the joint development, under the direction of the
joint steering committee, we are currently assessing market opportunities, intellectual property protection and potential regulatory strategies
for the CD38 Assets, and Vy-Gen is overseeing the development activities being conducted through the scientists at Karolinska Institute.
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.
SNAP-CAR
Technologies; University of Pittsburgh
The
SNAP-CAR License: On August 31, 2022, we entered into an exclusive license agreement with the University of Pittsburgh for certain
intellectual property rights related to the universal self-labeling SynNotch and CARs for programable antigen-targeting technology platform.
We paid the University of Pittsburgh a non-refundable fee in the amount of $75,000 for the exclusive patent rights to the licensed technology.
In September
2023, we executed the first amendment to the SNAP-CAR License in which we expanded the field of use to include natural killer cells. We
believe this is a valuable addition as we continue to develop the SNAP-CAR platform as a universal therapeutic.
A key potential
benefit that we see in the licensed technology is its potential application in therapeutic treatments that involve solid tumors. While
there are currently a number of FDA-approved CAR-T therapies for hematologic malignancies, there are currently no CAR-T therapies marketed
that are indicated for the treatment of solid tumors.
Under the
terms of the agreement, we have been assigned the worldwide development and commercialization rights to the licensed technology in the
field of human treatment of cancer with antibody or antibody fragments using SNAP-CAR T-cell technology, along with (i) an intellectual
property portfolio consisting of issued and pending patents and (ii) options regarding future add-on technologies and developments. In
consideration of these rights, we paid an initial license fee of $75,000, and will have annual maintenance fees ranging between $15,000
and $25,000, as well as developmental milestone payments (as defined in the agreement and royalties equal to 3.5% of net sales. Additionally,
the agreement contemplates that we will enter into a Sponsored Research Agreement with the University of Pittsburgh within ninety days
of the execution of the agreement, with the goal of further researching and optimizing the SNAP-CAR platform.
The Sponsored Research
Agreement: In January 2023 we entered into a sponsored research agreement (“SRA”) with the University of Pittsburgh, the
focus of which is to perform pre-clinical research as it relates to our SNAP-CAR program. Our target objectives have been to: (i) test
and validate CRO antibody conjugation chemistry and improve the activity of adaptors by investigating alternative chemical composition,
(ii) investigate HER2 and other solid-tumor model in mice for both breast and ovarian cancers, (iii) identify and test other non-HER2
targets, (iv) further investigate multi-antigen targeting by dosing multiple adaptors simultaneously to address tumor heterogeneity/resistance
in hematological and/or solid tumors and (v) expand the potential impact of SNAP-CAR by performing in vitro screening of many additional
antigen-antibody combinations in hematological and/or solid tumors. The term of the SRA expires by its terms at the end of January 2025.
The data generated during the term of the SRA will be instrumental in determining target indications, development plans, and clinical
study designs.
The SNAP-CAR
Platform: Chimeric antigen receptor (CAR) therapy is a treatment for cancer in which a patient’s T-cells (a type of immune cell)
are genetically engineered to recognize cancer cells to target and destroy them. Cells are extracted from the patient and then genetically
engineered to make the CAR and are re-introduced back into the patient. This therapy is revolutionizing the treatment of many blood cancers
including B cell leukemias and lymphomas by targeting specific proteins found on these cancers, and there is hope in treating additional
cancers including solid tumors by having them recognize new targets. The “SNAP-CAR” CAR cell therapy platform is being developed
to be a universal therapeutic. The SNAP-CAR technology is in the preclinical stage of development at the University of Pittsburgh. Instead
of directly binding to a target on the tumor cell, the CAR T-cells are co-administered with one or more antibody adaptors that bind to
the tumor cells and are fitted with a chemical group that irreversibly connects them to the SNAP-CAR on the therapeutic cells via a covalent
bond. A covalent bond is the highest affinity bond possible, and we believe this binding could translate into highly potent therapeutic
activity.
Pre-clinical
studies in mice have demonstrated a potential benefit that by targeting solid tumors via antibody adaptor molecules, the SNAP-CAR therapy
may be able to provide a highly programmable therapeutic platform, one that we envision could deliver several potential advantages over
standard CAR-T treatments, including:
Market Opportunity:
Due to its unique targeting and binding properties, we believe the SNAP-CAR platform could help accelerate the utilization and effectiveness
of CAR T-cell therapies for the treatment of solid tumors. By way of market size, according to Polaris Market Research, the CAR T-cell
therapy market size is expected to reach $20.56 billion by 2029 (from $1.96 billion in 2021), representing a compound annual growth rate
(CAGR) of 31.6% during the forecast period from 2022 to 2029. However, based on the anticipated application of the licensed technology
(i.e. initially focusing on solid tumor treatment) we cannot at this time project the market size of our target market until we further
develop the licensed technology and settle on the initial target indications and follow-up indications. Additional research and analysis
are being conducted which will aid us in the proper identification and selection of the cancer indication(s) we intend to further study.
Once the optimal indication(s) are selected and the overall development strategy is fully identified, the market opportunity can be further
defined.
CPT60621;
Vici Health Sciences, LLC
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). 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.
Current Opportunity
Vy-Gen-Bio,
Inc. 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. 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.
Our Growth Strategy
To achieve our goals, we intend
to deploy an aggressive, three-pronged, growth strategy listed below that we believe will help us maximize our success and deleverage
some of the risk of finding, solely developing and funding our own products.
Portfolio
Optimization — We will continue to evaluate, prioritize, optimize, and make appropriate changes in our pipeline portfolio
as market development dynamics and/or product opportunities change. For example, it may be a strategic business decision for us to divest
certain products and/or agreements to other companies so we can best focus on its core assets.
Strategic
Partnerships — We will focus on expanding our existing pipeline through establishing strategic partnerships with companies
that have interesting products and technologies. We intend to focus on novel, preclinical and clinical assets in a variety of therapeutic
areas, including oncology.
Business
Development — We are actively seeking partnerships and/or strategic collaborations with companies that share in our
vision and therapeutic focus. Our platform technologies have expansive capabilities and thus we believe they are conducive to partnerships
beyond our current focus.
Sales and Marketing
We currently do not have in-house
commercial capabilities required to market and distribute FDA-approved products. Therefore, we will be required to partner with firms
who are capable of conducting all sales, marketing, distribution, contracting and pricing for our future products. There is no assurance
that we will be able to secure the services of such a firm or that any such firm will be able to achieve sales expectations.
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. 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.
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”). 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. 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”). The 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. 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. Below is a summary of some of the principal risks we face:
· We need to obtain financing in order to continue our operations;
· Healthcare reform measures could adversely affect our business;
· We may not be able to maintain our listing on the Nasdaq Capital Market; and
· There is a substantial doubt about our ability to continue as a going concern.
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. As an emerging growth company, we have elected to take advantage of specified reduced disclosure and other
requirements that are otherwise applicable generally to public companies. These provisions include:
· Reduced disclosure about our executive compensation arrangements.
We may take advantage of these
exemptions for up to five years or such an earlier time that we are no longer an emerging growth company. We would cease to be an
emerging growth company if we have more than $1.07 billion in annual revenue, we have more than $700 million in market value
of our stock held by non-affiliates, or we issue more than $1 billion of non-convertible debt over a three-year period. We may choose
to take advantage of some but not all of these reduced burdens. We have taken advantage of these reduced reporting burdens herein, and
the information that we provide may be different than what you might get from other public companies in which you hold stock.
Available Information
We file annual,
quarterly and current reports and other information with the United States Securities and Exchange Commission (“SEC”) that
are publicly available through the SEC’s website at www.sec.gov. 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.
ITEM 1A. RISK FACTORS
As a smaller reporting
company, we are not required to provide a statement of risk factors. Nonetheless, we are voluntarily providing risk factors herein. You
should consider carefully the following risk factors, together with all the other information in this Annual Report on Form 10-K, including
our consolidated financial statements and notes thereto, and in our other public filings with the SEC. 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 occurrence of any of the following risks could harm our business, financial
condition, results of operations and/or growth prospects or cause our actual results to differ materially from those contained in forward-looking
statements we have made in this report and those we may make from time to time. You should consider all of the risk factors described
when evaluating our business.
We operate
in a highly competitive and highly regulated business environment. Our business can be expected to be affected by government regulation,
economic, political and social conditions, business’ response to new and existing products and services, technological developments
and the ability to obtain and maintain patent and/or other intellectual property protection for our products and intellectual property.
Our actual results could differ materially from management’s expectations because of changes both within and outside of our control.
Reviewers of this Annual Report on Form 10-K are cautioned not to place undue reliance upon such forward-looking statements. Such forward-looking
statements may include projections with respect to market size and acceptance, revenues and earnings, marketing and sales strategies and
business operations, as well as efficacy of our products. 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.
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. Results of previous pre-clinical studies and clinical
trials may not be predictive of future results, and the results of our current and planned clinical trials may not satisfy the requirements
of the FDA or other regulatory authorities.
Positive or
timely results from pre-clinical or early-stage trials do not ensure positive or timely results in late-stage clinical trials or product
approval by the FDA or comparable foreign regulatory authorities. We will be required to demonstrate with substantial evidence through
well-controlled clinical trials that our product candidates are safe and effective for use in a diverse population before we can seek
regulatory approvals for their commercialization. Our planned clinical trials may produce negative or inconclusive results, and we or
any of our current and future strategic partners may decide, or regulators may require us, to conduct additional clinical or pre-clinical
testing.
Success in
pre-clinical studies or early-stage clinical trials does not mean that future clinical trials or registration clinical trials will be
successful because product candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction
of the FDA and foreign regulatory authorities, despite having progressed through pre-clinical studies and initial clinical trials. Product
candidates that have shown promising results in early clinical trials may still suffer significant setbacks in subsequent clinical trials
or registration clinical trials. For example, a number of companies in the biopharmaceutical industry, including those with greater resources
and experience than us, have suffered significant setbacks in advanced clinical trials, even after obtaining promising results in earlier
clinical trials. Similarly, pre-clinical interim results of a clinical trial are not necessarily predictive of final results.
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.
We may experience
delays in our ongoing or future pre-clinical studies or clinical trials, and we do not know whether future pre-clinical studies or clinical
trials will begin on time, need to be redesigned, enroll an adequate number of patients or be completed on schedule, if at all. The commencement
or completion of these planned clinical trials could be substantially delayed or prevented by many factors, including, but not limited
to:
· inability to obtain sufficient funds required for a clinical trial;
· slower than expected rates of patient recruitment and enrollment;
· failure of patients to complete the clinical trial;
· lack of efficacy during clinical trials;
· termination of our clinical trials by one or more clinical trial sites;
· inability to monitor patients adequately during or after treatment;
Changes in
regulatory requirements, policies and guidelines may also occur and we may need to significantly amend clinical trial protocols to reflect
these changes with appropriate regulatory authorities. These changes may require us to renegotiate terms with CROs or resubmit clinical
trial protocols to IRBs for re-examination, which may impact the costs, timing or successful completion of a clinical trial. Our clinical
trials may be suspended or terminated at any time by the FDA, other regulatory authorities, the IRB overseeing the clinical trial at issue,
any of our clinical trial sites with respect to that site, or us. 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.
The design
or execution of a clinical trial can determine whether its results will support regulatory approval and flaws in the design or execution
of a clinical trial may not become apparent until the clinical trial is well advanced. In some instances, there can be significant variability
in safety or efficacy results between different trials of the same product candidate due to numerous factors, including changes in trial
protocols, differences in size and type of the patient populations, adherence to the dosing regimen and other trial protocols and the
rate of dropout among clinical trial participants. We do not know whether any clinical trials we may conduct will demonstrate consistent
or adequate efficacy and safety to obtain regulatory approval to market our product candidates.
Further, the
FDA and comparable foreign regulatory authorities have substantial discretion in the approval process and in determining when or whether
regulatory approval will be obtained for any of our product candidates. Our product candidates may not be approved even if they achieve
their primary endpoints in future clinical trials. The FDA or foreign regulatory authorities may disagree with our trial design and our
interpretation of data from pre-clinical studies and clinical trials. In addition, any of these regulatory authorities may change requirements
for the approval of a product candidate even after reviewing and providing comments or advice on a protocol for clinical trial that has
the potential to result in FDA or other agencies’ approval. In addition, such regulatory authorities may also approve a product
candidate for fewer or more limited indications than we request or may grant approval contingent on the performance of costly post-marketing
clinical trials. The FDA or foreign regulatory authorities may not approve the labeling claims that we believe would be necessary or desirable
for the successful commercialization of our product candidates which may have a material adverse effect on our business.
We may find it difficult
to enroll patients in our clinical trials given the limited number of patients who have the diseases for which our product candidates
are being studied which could delay or prevent the start of clinical trials for our product candidates.
Identifying
and qualifying patients to participate in clinical trials of our product candidate is essential to our success. The timing of our clinical
trials depends in part on the rate at which we can recruit patients to participate in clinical trials of our product candidates, and we
may experience delays in our clinical trials if we encounter difficulties in enrollment. If we experience delays in our clinical trials,
the timeline for obtaining regulatory approval of our product candidates will most likely be delayed.
Many factors
may affect our ability to identify, enroll and maintain qualified patients, including the following:
· design of the clinical trial;
· size and nature of the patient population;
· 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.
General Risks
There is a substantial doubt
about our ability to continue as a going concern.
The report of our independent
registered public accounting firm that accompanies our consolidated financial statements includes an explanatory paragraph indicating
there is a substantial doubt about our ability to continue as a going concern, citing our need for additional capital for the future planned
expansion of our activities and to service our ordinary course activities (which may include servicing of indebtedness). The inclusion
of a going concern explanatory paragraph in the report of our independent registered public accounting firm will make it more difficult
for us to secure additional financing or enter into strategic relationships on terms acceptable to us, if at all, and likely will materially
and adversely affect the terms of any financing that we might obtain. Our consolidated financial statements do not include any adjustments
that may result from the outcome of this uncertainty.
We have incurred significant losses in prior
periods, and losses in the future could cause the quoted price of our Common Stock to decline or have a material adverse effect on our
financial condition, our ability to pay its debts as they become due, and on its cash flows.
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. Any losses in
the future could cause the quoted price of our Common Stock to decline or have a material adverse effect on our financial condition, its
ability to pay its debts as they become due, and on its cash flows.
To date, we have generated
only minimal product revenue. We expect that our planned product development and strategic expansion pursuits will increase losses significantly
over the next five years. In order to achieve profitability, we will be required to generate significant revenue. We cannot be certain
that we will generate sufficient revenue to achieve profitability. 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. 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.
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. As some of our current and projected future product candidates or co-development
products are, and we expect will be, at an early proof-of-concept stage, we do not expect to receive revenue from any of these products
for several years, if at all. We intend to seek to obtain revenue from collaboration or licensing agreements with third parties. We expect
that we will need to rely on key third-party agreements, in order to be in a position to realize material revenues in the future, and
we may never enter into any such agreements or realize material, ongoing future revenue. Even if we eventually generate revenues, we
may never be profitable, and, if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly
or annual basis.
If we are unable to manage
future expansion effectively, our business may be adversely impacted.
In the future,
we may experience rapid growth in our business, which could place a significant strain on our operations, in general, and our internal
controls and other managerial, operating and financial resources, in particular. If we are unable to manage future expansion effectively,
our business would be harmed. 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.
The Company’s
ability to be successful is dependent upon the efforts of the Company’s board members and key personnel, in particular our President
and Chief Executive Officer David Mehalick. We cannot assure you that the Company’s board members and key personnel will be effective
or successful or remain with the Company. 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. 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.
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.
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.
Our Board of Directors may
change our policies without shareholder approval.
Our policies,
including any policies with respect to investments, leverage, financing, growth, debt and capitalization, will be determined by our Board
of Directors or officers to whom our Board of Directors delegate such authority. Our Board of Directors will also establish the amount
of any dividends or other distributions that we may pay to our shareholders. Our Board of Directors or officers to which such decisions
are delegated will have the ability to amend or revise these and our other policies at any time without shareholder vote. 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.