Coeptis Therapeutics Holdings, Inc.
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, 2023
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 $1.55 reported on the Nasdaq Capital
Market was: $28,807,680.
The number of shares outstanding
of each of the registrant’s classes of common stock as of the latest practicable date was: 36,089,917 shares of $0.0001 par
value common stock outstanding as of March 22, 2024.
Coeptis Therapeutics Holdings, Inc.
Annual Report on Form 10-K for the Year Ended
December 31, 2023
TABLE OF CONTENTS
Item Page
Part I
1. Business 1
1A. Risk Factors 9
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 32
7A. Quantitative and Qualitative Disclosures About Market Risk 37
8. Financial Statements and Supplementary Data 37
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 55
Part IV
15. Exhibits and Financial Statement Schedules 56
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, 2023. This report also includes our audited financial statements as of and for the
year ended December 31, 2022.
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;
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 wholly owned subsidiaries
Coeptis Therapeutics, Inc., Coeptis Pharmaceuticals, Inc. and Coeptis Pharmaceuticals, LLC.
Our current business model
is designed around furthering the development of our current product portfolio. We are 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.
In October 2023 we entered
into a Shared Services Agreement (“SSA”) with Deverra, in accordance with requirements set forth in the APA. 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 term of the SSA is six months from the effective
date.
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 November 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 2023. 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 2025.
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 are 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 is two years, and we have committed financing in the amount of $716,714 over
the next two years towards achieving the target objectives.
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 further 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, four-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
October 2023 Private Placement
As previously disclosed in
a Current Report on Form 8-K filed on October 26, 2023, we issued to an institutional investor in a private placement (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, 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
for gross proceeds to the Company of $2,000,000. In connection with the private placement we also issued Private Placement Warrants to
purchase up to 120,000 shares of Common Stock. The resale of these shares of common stock, as well as the shares of common stock issuable
upon exercise of the Warrants and Private Placement Warrants, were registered and previously disclosed in a Current Report on Form S-1
filed on November 15, 2023 to satisfy certain registration rights granted to this investor.
In
addition, in consideration for the Investor’s participation in the October Private Placement, the Company also agreed to amend the
Investor’s existing Series A warrants to purchase up to 3,062,500 shares at an exercise price of $1.65 per share and Series B warrants
to purchase up 3,062,500 shares of Common Stock at an exercise price of $1.65 per share issued on June 16, 2023 (collectively the “Existing
Warrants”), by (i) reducing the exercise price of the Existing Warrants to $1.36 per share and the exercise and (ii) amending the
Initial Exercise Date (as defined therein) of the Existing Warrants to be the earlier of (a) the Shareholder Approval Date (as defined
in the Purchase Agreement) or (b) April 26, 2024 (the “Warrant Amendment”). The Warrant Amendment became effective upon closing
of the October Private Placement.
September 2023 Private Sales
As previously disclosed in a Current
Report on Form 8-K filed on October 12, 2023, we issued to two separate investors 2,400,000 shares and 600,000 shares of common stock
of the Company, respectively, in private placements, for gross proceeds to the Company of $3,000,000 comprised of $500,000 in cash and
$2,500,000 in promissory notes. The resale of these shares of common stock were registered and previously disclosed in a Current Report
on Form S-1 filed on November 15, 2023 to satisfy certain registration rights granted to these investors.
June 2023 Offering
As previously disclosed in
the Company’s S-1 Registration Statement, on June 13, 2023, the Company entered into an Underwriting Agreement (the “Underwriting
Agreement”) with Ladenburg Thalmann & Co. Inc. (the “Underwriter”), pursuant to which the Company issued and sold,
in a registered public offering by the Company, (i) 2,150,000 shares of common stock (the “Shares”), (ii) 1,350,000 pre-funded
warrants (the “Pre-funded Warrants”), and (iii) 3,062,500 Series A Warrants with an exercise price of $1.65 per share and
which are exercisable for a period of five years commencing six months after the issuance date (the “June Series A Warrants”),
and (iv) 3,062,500 Series B Warrants with an exercise price of $1.65 per share and which are exercisable for a period of five years commencing
six months after the issuance date (the “June Series B Warrants, and together with the June Series A Warrants, the “June Warrants”).
In addition to the June Warrants the Company also issued to the Underwriter an underwriter’s warrants exercisable to acquire up
to 210,000 shares of common stock. The resale of the shares of common stock issuable upon exercise of the Underwriter Warrants were
registered and previously disclosed in a Current Report on Form S-1 filed on November 15, 2023.
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 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 a 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 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, 2023, we incurred a net loss of $21,266,537 and, as of that date, we had an accumulated deficit of $87,356,260. For the year ended
December 31, 2022, we incurred a net loss of $37,574,217 and, as of that date, had an accumulated deficit of $66,089,723. 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 2023 or longer. We cannot be certain that we will ever achieve profitability or that, if profitability is
achieved, that is 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.
The COVID-19 pandemic could have a material
adverse impact on our business, results of operations and financial condition.
In December 2019, a novel
strain of coronavirus was reported to have surfaced in Wuhan, China. In January 2020, the World Health Organization declared the
COVID-19 outbreak a “Public Health Emergency of International Concern.” This worldwide outbreak has resulted in the implementation
of significant governmental measures, including lockdowns, closures, quarantines and travel bans intended to control the spread of the
virus. Companies are also taking precautions, such as requiring employees to work remotely, imposing travel restrictions and temporarily
closing businesses and facilities. These restrictions, and future prevention and mitigation measures, have had an adverse impact on global
economic conditions and are likely to have an adverse impact on consumer confidence and spending, which could materially adversely affect
the supply of, as well as the demand for, our products. Uncertainties regarding the economic impact of COVID-19 is likely to result in
sustained market turmoil, which could also negatively impact our business, financial condition and cash flows.
If our operations or productivity
continue to be impacted throughout the duration of the COVID-19 outbreak and government-mandated closures, which may negatively impact
our business, financial condition and cash flows. The extent to which the COVID-19 pandemic will further impact our business will depend
on future developments and, given the uncertainty around the extent and timing of the potential future spread or mitigation and around
the imposition or relaxation of protective measures, we cannot reasonably estimate the impact to our business at this time.
The extent of COVID-19’s
effect on our operational and financial performance will depend on future developments, including the duration, spread and intensity of
the outbreak, all of which are uncertain and difficult to predict considering the rapidly evolving landscape. As a result, it is not currently
possible to ascertain the overall impact of COVID-19 on our business. However, if the pandemic continues for a prolonged period it could
have a material adverse effect on our business, results of operations, financial condition and cash flows and adversely impact the trading
price of our Common Stock.
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