ptis Therapeutics (COEP) - 2022 Q4 - Annual Report

Part I Business Coeptis Therapeutics is a biopharmaceutical company focused on developing cell therapy platforms for cancer through strategic partnerships - On October 28, 2022, Coeptis Therapeutics Holdings, Inc. acquired Coeptis Therapeutics, Inc. in a reverse merger, with Coeptis Therapeutics, Inc. being the accounting acquirer[11][23] - The company's business model focuses on furthering its product portfolio through strategic partnerships, including in-licensing, out-licensing, and co-development in therapeutic areas like autoimmune disease and oncology[25] Collaborations for Product Development R&D is driven by key collaborations for CD38-targeting therapies and the SNAP-CAR T-cell platform - Coeptis has a 50% ownership interest in VyGen-Bio's CD38-Diagnostic and a 25% to 50% interest in the CD38-GEAR-NK product candidate, both targeting CD38-related cancers like multiple myeloma[26][32][33] - The company entered into an exclusive license agreement with the University of Pittsburgh for the SNAP-CAR T cell technology platform, paying an initial fee of $75,000. This platform is being developed as a universal therapeutic for solid tumors[35][37][39] - A sponsored research agreement with the University of Pittsburgh commits $716,714 over two years to perform pre-clinical research on the SNAP-CAR program, targeting HER2-positive solid tumors and other antigens[38] - The company is de-prioritizing its CPT60621 Parkinson's disease drug project with Vici Health Sciences and is negotiating a buy-out of its ownership rights[41] Growth Strategy The company's growth strategy focuses on pipeline optimization, strategic partnerships, business development, and commercialization analysis - The company's four-pronged growth strategy includes: Portfolio Optimization, Strategic Partnerships, Business Development, and Commercial Development[43][44][45] Risk Factors The company faces significant risks including going concern doubt, limited operating history, and material internal control weaknesses - There is substantial doubt about the company's ability to continue as a going concern, as cited by its independent registered public accounting firm, due to its need for additional capital[54] Risk Factors (in millions) | Metric | 2022 | 2021 | | :--- | :--- | :--- | | Net Loss | $37.57 | $13.45 | | Accumulated Deficit | $65.74 | $27.55 | - The company received a Nasdaq Staff Deficiency Letter on December 22, 2022, for failing to maintain the minimum $50 million market value of listed securities, giving it until June 20, 2023, to regain compliance[101] - The company has identified material weaknesses in its internal control over financial reporting, including a lack of segregation of duties, no formally documented accounting policies, and an ineffective financial statement close process[103][212][216] - The company needs to obtain additional financing to continue operations and implement its business plan, with current cash on hand sufficient only into the 4th quarter of 2023 without new strategic transactions[66] Unresolved Staff Comments The company reports no unresolved staff comments - There are no unresolved staff comments[110] Properties The company's principal place of business is a leased office in Wexford, Pennsylvania, with the lease expiring May 31, 2024 - The company's principal place of business is leased office space in Wexford, Pennsylvania. The lease expires on May 31, 2024[111] Legal Proceedings The company is not involved in any pending lawsuits expected to materially affect its business or financial condition - The company reports no pending litigation that would have a material adverse effect on its business[113] Mine Safety Disclosures This item is not applicable to the company - Not applicable[114] Part II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The company's common stock is listed on Nasdaq, and it does not anticipate paying dividends, focusing on business development - The company's common stock is listed on the Nasdaq Global Market under the symbol "COEP". As of March 27, 2023, there were 20,441,036 shares outstanding held by 119 record holders[117][118] - The 2022 Equity Incentive Plan authorizes a maximum of 2,340,000 shares of common stock for awards such as stock options, RSUs, and SARs[123] - The company has outstanding warrants to purchase 1,563,912 shares at an average price of $7.93 (assumed from the Merger) and 7,500,000 shares at an exercise price of $11.50 per share (issued pre-Merger)[164] - The company does not anticipate paying cash dividends and intends to retain future earnings to finance business development[119] Selected Financial Data As a smaller reporting company, Coeptis is not required to provide information for this item - The Company is a smaller reporting company and is not required to provide information under this item[166] Management's Discussion and Analysis of Financial Condition and Results of Operations The company reported no revenue in 2022, with increased operating expenses and a net loss, requiring additional capital Management's Discussion and Analysis of Financial Condition and Results of Operations | Financial Metric | 2022 | 2021 | | :--- | :--- | :--- | | Revenues | $0 | $75,000 | | Operating Expenses | $34,195,965 | $14,120,932 | | Net Loss | ($37,574,217) | ($13,449,280) | | Loss Per Share | ($2.63) | ($1.23) | - The increase in operating expenses in 2022 was mainly due to warrant expense related to strategic financing costs[201] - Cash and cash equivalents increased from $2.2 million at the end of 2021 to $3.8 million at the end of 2022[204][205] - The company has abandoned activities and ownership related to its two previously launched anti-hypertension products (505b2 applications) due to commercial challenges exacerbated by the COVID-19 pandemic[179][180] Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Coeptis is not required to provide information for this item - The Company is a smaller reporting company and is not required to provide information under this item[207] Financial Statements and Supplementary Data The required financial statements are appended to the report, with an index provided in Item 15 - The required financial statements are appended to the report, starting on page F-1[208] Changes in and Disagreements with Accountants on Accounting and Financial Disclosure Turner, Stone & Company, L.L.P. became the independent auditor for the consolidated company following the reverse merger - In connection with the Merger, Turner, Stone & Company, L.L.P, became the company's auditors[209] Controls and Procedures Management concluded that disclosure controls were ineffective due to material weaknesses in internal control over financial reporting - Management concluded that as of December 31, 2022, the company's disclosure controls and procedures were not effective[211] - Material weaknesses identified include: (1) lack of an implemented system of internal controls, resulting in no segregation of duties or formal accounting policies, and (2) an ineffective financial statement close process and lack of integrated IT systems[212][216] - The company is taking steps to remediate these weaknesses by hiring additional finance personnel, engaging outside consultants, and exploring new financial systems[213][214] Other Information The company reports no other information for this item - None[216] Part III Directors, Executive Officers and Corporate Governance This section details the company's leadership, board composition, independent directors, and established governance committees Directors and Executive Officers | Name | Position | | :--- | :--- | | David Mehalick | Chairman and Chief Executive Officer | | Daniel Yerace | Director and Vice President of Operations | | Christine Sheehy | Chief Financial Officer and Secretary | | Christopher Calise | Director | | Tara Maria DeSilva | Director | | Philippe Deschamps | Director | | Christopher Cochran | Director | | Gene Salkind | Director | - The Board has determined that Tara Maria DeSilva, Philippe Deschamps, Christopher Cochran, and Gene Salkind are independent directors[231] - The Board has three standing committees: Audit, Compensation, and Nominating and Corporate Governance, each composed of independent directors[232][233][235] Executive Compensation Executive compensation for 2021-2022 is detailed, including employment agreements and equity awards granted in January 2023 Executive Compensation | Name and Principal Position | Year | Salary ($) | | :--- | :--- | :--- | | David Mehalick, Chairman, CEO | 2022 | $360,000 | | | 2021 | $216,500 | | Daniel Yerace, VP of Operations | 2022 | $360,000 | | | 2021 | $205,000 | | Christine Sheehy, CFO | 2022 | $150,000 | | | 2021 | $133,500 | - Employment agreements for David Mehalick and Daniel Yerace provide for an annual salary of $360,000 and a guaranteed bonus of 20% of base salary[257][258] - No equity awards were outstanding at December 31, 2022. Subsequently, in January 2023, options to purchase 1,357,500 shares were granted under the 2022 Equity Incentive Plan[259][261] - No compensation was paid to non-employee directors for their service in 2021 or 2022[263] Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters This section details beneficial ownership of common stock, including holdings by directors, officers, and greater than 5% holders Beneficial Ownership of Common Stock | Name of Beneficial Owner | Percentage Ownership | | :--- | :--- | | Executive Officers and Directors | | | David Mehalick | 16.15% | | Christopher Calise | 6.79% | | Officers and Directors as a Group (8 persons) | 28.45% | | Greater than 5% Holders | | | Lisa Pharma LLC | 7.0% | | Lena Pharma LLC | 7.0% | Certain Relationships and Related Transactions, and Director Independence This section outlines related party transactions before and after the merger, and reiterates director independence assessments - Prior to the merger, the Predecessor's sponsor purchased founder shares and was reimbursed for certain out-of-pocket expenses[272][274] - In February 2021, David Mehalick purchased 8,000 shares of Series B Preferred Stock from Coral Investment Partners, LP for $1,000, which were later exchanged for common stock in the Merger[278] - The company has undertaken a review and determined that directors Tara Maria DeSilva, Philippe Deschamps, Christopher Cochran, and Gene Salkind are independent[282] Principal Accountant Fees and Services This section discloses audit fees paid to Turner, Stone & Company, LLP for fiscal years 2021 and 2022 Principal Accountant Fees and Services | Fee Type | 2022 | 2021 | | :--- | :--- | :--- | | Audit Fees | $92,550 | $148,564 | | Total | $92,550 | $148,564 | Part IV Exhibits and Financial Statement Schedules This section lists all documents filed as part of the Form 10-K, including financial statements and various exhibits - This section provides an index of all exhibits filed as part of the annual report, including the Agreement and Plan of Merger, Amended and Restated Certificate of Incorporation, and various employment and co-development agreements[308][310] Form 10-K Summary The company reports no summary for this item - None[307] Financial Statements Report of Independent Registered Public Accounting Firm The auditor's report includes a "Going Concern" warning and identifies co-development agreements as a critical audit matter - The auditor's report includes an explanatory paragraph expressing substantial doubt about the Company's ability to continue as a going concern due to recurring losses and insufficient working capital[319] - A critical audit matter was identified related to the accounting for co-development agreements, which required a high degree of auditor judgment to evaluate management's assumptions regarding recognition, amortization, and impairment[324] Consolidated Balance Sheets The consolidated balance sheet shows total assets of $7.9 million, liabilities of $3.1 million, and equity of $4.8 million for 2022 Consolidated Balance Sheets (in millions) | Balance Sheet Highlights (in millions) | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | Total Assets | $7.92 | $6.77 | | Cash | $3.79 | $2.18 | | Co-development options | $3.55 | $4.55 | | Total Liabilities | $3.11 | $4.41 | | Notes payable (current & long-term) | $1.65 | $4.07 | | Derivative liability warrants | $1.13 | $0 | | Total Stockholders' Equity | $4.80 | $2.35 | | Accumulated Deficit | ($65.74) | ($27.55) | Consolidated Statements of Operations The company reported zero revenue and a net loss of $37.6 million in 2022, driven by increased operating expenses Consolidated Statements of Operations (in millions) | Statement of Operations (in millions) | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | | :--- | :--- | :--- | | Total Sales | $0.00 | $0.075 | | Gross Profit | $0.00 | $0.075 | | General and administrative expenses | $34.17 | $14.12 | | Loss from Operations | ($34.20) | ($14.05) | | Net Loss | ($37.57) | ($13.45) | | Loss per share, basic and diluted | ($2.63) | ($1.23) | Consolidated Statements of Cash Flows Net cash used in operations was $3.9 million, offset by $5.5 million from financing, ending 2022 with $3.8 million cash Consolidated Statements of Cash Flows (in millions) | Statement of Cash Flows (in millions) | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | ($3.88) | ($4.49) | | Net Cash Used in Investing Activities | $0.00 | ($1.75) | | Net Cash Provided by Financing Activities | $5.49 | $8.22 | | Net Increase in Cash | $1.61 | $1.98 | | Cash at End of Year | $3.79 | $2.18 | Notes to Consolidated Financial Statements Notes provide context on the reverse merger, going concern uncertainty, co-development agreements, capital structure, and NOLs - The financial statements have been prepared on a going concern basis, but recurring losses and an accumulated deficit of $65.7 million raise substantial doubt about the company's ability to continue[358] - The company capitalized $5.0 million for its co-development rights to the CD38 Assets from VyGen-Bio, which is being amortized over five years[362] - The company entered an exclusive license with the University of Pittsburgh for SNAP-CAR T cell technology, paying a $75,000 fee, with future maintenance, milestone, and royalty payments required[429] - Public and Private Placement Warrants are classified as liabilities and re-measured to fair value each reporting period, with changes recognized in the statement of operations[343][379][380] - As of December 31, 2022, the company has approximately $59 million of unused net operating loss carryforwards, which are fully offset by a valuation allowance[435]