Marker Therapeutics(MRKR) - 2019 Q3 - Quarterly Report

PART I – FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, stockholders' equity, and cash flows, along with detailed notes explaining the company's operations, accounting policies, liquidity, and specific financial line items Condensed Consolidated Balance Sheets This table provides a snapshot of the company's financial position, detailing assets, liabilities, and equity at specific points in time Condensed Consolidated Balance Sheets (Unaudited): | Metric | Sep 30, 2019 ($) | Dec 31, 2018 ($) | | :-------------------------- | :----------- | :----------- | | Cash and cash equivalents | $48,477,670 | $61,746,748 | | Total current assets | $50,461,877 | $61,996,642 | | Total assets | $51,402,472 | $62,144,310 | | Total current liabilities | $3,187,074 | $2,803,572 | | Total liabilities | $3,520,554 | $2,803,572 | | Total stockholders' equity | $47,881,918 | $59,340,738 | Condensed Consolidated Statements of Operations This table presents the company's financial performance over specific periods, detailing revenues, expenses, and net loss Condensed Consolidated Statements of Operations (Unaudited) - Three Months Ended September 30: | Metric | 2019 ($) | 2018 ($) | Change ($) | % Change | | :---------------------------------- | :----------- | :----------- | :----------- | :------- | | Total revenues | $0 | $0 | $0 | 0% | | Research and development | $3,118,530 | $1,877,260 | $1,241,270 | 66% | | General and administrative | $2,536,204 | $2,551,146 | $(14,942) | (1)% | | Total operating expenses | $5,654,734 | $4,428,406 | $1,226,328 | 28% | | Loss from operations | $(5,654,734) | $(4,428,406) | $(1,226,328) | 28% | | Interest income | $259,248 | $0 | $259,248 | - | | Net loss | $(5,459,486) | $(4,388,406) | $(1,071,080) | 24% | | Net loss per share, basic and diluted | $(0.12) | $(0.32) | $0.20 | (63)% | Condensed Consolidated Statements of Operations (Unaudited) - Nine Months Ended September 30: | Metric | 2019 ($) | 2018 ($) | Change ($) | % Change | | :---------------------------------- | :----------- | :----------- | :----------- | :------- | | Total revenues | $0 | $205,994 | $(205,994) | (100)% | | Research and development | $9,103,670 | $5,303,647 | $3,800,023 | 72% | | General and administrative | $8,063,099 | $7,202,036 | $861,063 | 12% | | Total operating expenses | $17,166,769 | $12,505,683 | $4,661,086 | 37% | | Loss from operations | $(17,166,769) | $(12,299,689) | $(4,867,080) | 40% | | Interest income | $897,967 | $0 | $897,967 | - | | Net loss | $(16,348,802) | $(12,397,689) | $(3,951,113) | 32% | | Net loss per share, basic and diluted | $(0.36) | $(1.03) | $0.67 | (65)% | Condensed Consolidated Statement of Stockholders' Equity This table details changes in the company's equity over a period, reflecting transactions affecting capital and retained earnings Condensed Consolidated Statement of Stockholders' Equity (Unaudited) - Nine Months Ended September 30, 2019: | Metric | Amount ($) | | :-------------------------- | :----------- | | Balance at January 1, 2019 | $59,340,738 | | Stock options exercised for cash | $57,744 | | Warrants exercised for cash | $758,733 | | Stock warrants cashless exercised | $0 | | Stock-based compensation | $4,073,505 | | Net loss | $(16,348,802) | | Balance at September 30, 2019 | $47,881,918 | Condensed Consolidated Statements of Cash Flows This table summarizes the cash inflows and outflows from operating, investing, and financing activities over specific periods Condensed Consolidated Statements of Cash Flows (Unaudited) - Nine Months Ended September 30: | Cash Flow Activity | 2019 ($) | 2018 ($) | Change ($) | | :---------------------------------- | :----------- | :----------- | :----------- | | Net cash used in operating activities | $(13,723,434) | $(8,317,314) | $(5,406,120) | | Net cash used in investing activities | $(362,121) | $0 | $(362,121) | | Net cash provided by financing activities | $816,477 | $7,482,296 | $(6,665,819) | | Net decrease in cash | $(13,269,078) | $(835,018) | $(12,434,060) | | Cash and cash equivalents at end of period | $48,477,670 | $4,294,271 | $44,183,399 | Notes to Condensed Consolidated Financial Statements This section provides detailed explanations and additional information supporting the condensed consolidated financial statements NOTE 1: NATURE OF OPERATIONS This note describes the company's core business as a clinical-stage immuno-oncology firm developing T cell-based immunotherapies and peptide-based vaccines - Marker Therapeutics is a clinical-stage immuno-oncology company developing novel T cell-based immunotherapies and peptide-based vaccines for hematological malignancies and solid tumors[15] - Its MultiTAA T cell technology selectively expands non-engineered, tumor-specific T cells to recognize multiple tumor targets for broad anti-tumor activity[15] NOTE 2: BASIS OF PRESENTATION This note clarifies that the interim financial statements are unaudited, prepared under U.S. GAAP and SEC rules, and should be read in conjunction with the prior annual report - Interim financial statements are unaudited, prepared under U.S. GAAP and SEC rules, and include normal recurring adjustments[16][17] - They should be read in conjunction with the 2018 Form 10-K[17] NOTE 3: LIQUIDITY AND FINANCIAL CONDITION This note discusses the company's cash position, expected losses, and projected funding runway for operations - $48.5 million in cash and cash equivalents as of September 30, 2019[18] - The company anticipates substantial losses during its development phase[19] - Current cash resources are projected to fund operations through at least Q4 2020[21] NOTE 4: SIGNIFICANT ACCOUNTING POLICIES This note outlines key accounting policies, including the adoption of new lease accounting standards and their impact on financial reporting - Adopted ASC Topic 842, Leases, effective January 1, 2019, recognizing right-of-use assets and lease liabilities for operating leases[22][26] - Recorded approximately $637,000 in right-of-use assets and $670,000 in lease liabilities upon adoption[28] NOTE 5: NET LOSS PER SHARE This note provides details on the calculation of basic and diluted net loss per share, including the impact of anti-dilutive securities Net Loss Per Share (Basic and Diluted): | Period | 2019 ($) | 2018 ($) | | :-------------------------- | :----------- | :----------- | | Three Months Ended Sep 30 | $(0.12) | $(0.32) | | Nine Months Ended Sep 30 | $(0.36) | $(1.03) | Anti-dilutive Securities (Nine Months Ended Sep 30): | Security Type | 2019 (Number of Securities) | 2018 (Number of Securities) | | :-------------------------- | :----------- | :----------- | | Common stock options | 4,655,000 | 439,000 | | Common stock purchase warrants | 22,618,000 | 4,625,000 | | Common stock warrants - liability treatment | 56,000 | 27,000 | | Potentially dilutive securities | 27,329,000 | 5,091,000 | NOTE 6: PROPERTY AND EQUIPMENT This note details the company's property and equipment, net of accumulated depreciation, and related depreciation expenses Property and Equipment, Net: | Metric | Sep 30, 2019 ($) | Dec 31, 2018 ($) | | :-------------------------- | :----------- | :----------- | | Lab equipment | $100,000 | $0 | | Computers, equipment and software | $209,000 | $66,000 | | Office furniture | $178,000 | $82,000 | | Leasehold improvements | $23,000 | $0 | | Total | $510,000 | $148,000 | | Less: accumulated depreciation | $(71,000) | $0 | | Property and equipment, net | $439,000 | $148,000 | Depreciation Expense: | Period | Amount ($) | | :-------------------------- | :----------- | | Three Months Ended Sep 30, 2019 | $31,000 | | Nine Months Ended Sep 30, 2019 | $71,000 | NOTE 7: LEASES This note provides information on the company's operating lease liabilities, right-of-use assets, and lease expenses Operating Lease Information (Sep 30, 2019): | Metric | Amount ($) | | :-------------------------- | :----------- | | Operating lease liabilities | $533,000 | | Right-of-use assets | $502,000 | Lease Expense (Nine Months Ended Sep 30, 2019): | Expense Type | Amount ($) | | :-------------------------- | :----------- | | Operating lease expense | $165,000 | | Short-term lease expense | $73,000 | | Variable lease expense | $65,000 | | Total Lease Expense | $303,000 | NOTE 8: ACCOUNTS PAYABLE AND ACCRUED LIABILITIES This note details the composition and changes in the company's accounts payable and accrued liabilities Accounts Payable and Accrued Liabilities: | Category | Sep 30, 2019 ($) | Dec 31, 2018 ($) | Change ($) | | :-------------------------- | :----------- | :----------- | :----------- | | Accounts payable | $1,369,000 | $1,619,000 | $(250,000) | | Compensation and benefits | $1,060,000 | $416,000 | $644,000 | | Professional fees | $276,000 | $236,000 | $40,000 | | Technology license fees | $0 | $80,000 | $(80,000) | | Investor relations fees | $0 | $297,000 | $(297,000) | | Other | $154,000 | $106,000 | $48,000 | | Total | $2,859,000 | $2,754,000 | $105,000 | NOTE 9: WARRANT LIABILITY AND FAIR VALUE MEASUREMENTS This note explains the company's warrant liability, its fair value measurement, and changes during the period Warrant Liability (Level 3 Fair Value): | Metric | Sep 30, 2019 ($) | Dec 31, 2018 ($) | | :-------------------------- | :----------- | :----------- | | Warrant liability | $129,000 | $49,000 | Changes in Level 3 Liabilities (Nine Months Ended Sep 30, 2019): | Metric | Amount ($) | | :-------------------------- | :----------- | | Balance - January 1, 2019 | $49,000 | | Change in fair value of warrant liability | $80,000 | | Balance – September 30, 2019 | $129,000 | NOTE 10: COMMITMENTS AND CONTINGENCIES This note discloses the company's commitments and potential contingent liabilities, including an ongoing arbitration claim - The Company is defending an arbitration claim for approximately $1 million from a broker related to compensation for 2018 transactions, based on a 2017 placement agent agreement[44] NOTE 11: STOCKHOLDERS' EQUITY This note details changes in stockholders' equity, including common share issuances from warrant and option exercises, and stock-based compensation - 190,258 common shares were issued from warrant exercises, generating $759,000[45] - 11,980 common shares were issued from stock option exercises, generating $58,000[49] - 47,400 common shares were issued for consulting agreements, recognizing $265,000 in stock-based compensation, and 29,040 shares to non-employee directors, recognizing $174,000[50][51] Share Purchase Warrants (Sep 30, 2019): | Metric | Number of Warrants | Weighted Average Exercise Price ($) | Weighted Average Remaining Contractual Life (years) | Total Intrinsic Value ($) | | :-------------------------- | :----------------- | :------------------------------ | :------------------------------------------------ | :-------------------- | | Balance - January 1, 2019 | 23,016,000 | $4.78 | 4.29 | $26,066,000 | | Warrants granted | 45,000 | $4.26 | - | - | | Exercised for cash | (190,000) | $3.99 | - | - | | Cashless exercise | (7,000) | $3.97 | - | - | | Expired or cancelled | (190,000) | $13.88 | - | - | | Balance - September 30, 2019 | 22,674,000 | $4.71 | 3.59 | $16,676,000 | NOTE 12: STOCK-BASED COMPENSATION This note provides a breakdown of stock-based compensation expenses and the unrecognized compensation cost Stock Compensation Expenses: | Period | Sep 30, 2019 (3 Months) ($) | Sep 30, 2018 (3 Months) ($) | Sep 30, 2019 (9 Months) ($) | Sep 30, 2018 (9 Months) ($) | | :-------------------------- | :------------------------ | :------------------------ | :------------------------ | :------------------------ | | Research and development | $553,000 | $189,000 | $1,844,000 | $656,000 | | General and administrative | $631,000 | $662,000 | $2,230,000 | $1,292,000 | | Total | $1,184,000 | $851,000 | $4,074,000 | $1,948,000 | - Unrecognized stock-based compensation cost was $14.4 million as of September 30, 2019, with a weighted-average recognition period of 3.13 years[53] NOTE 13: RELATED PARTY TRANSACTIONS This note discloses transactions with related parties, including research agreements and consulting fees - Incurred $37,000 to BCM under a Sponsored Research Agreement for the nine months ended September 30, 2019[56] - Incurred $233,000 under a consulting agreement with Dr. Juan Vera, a board member who transitioned to an employee in September 2019[58][59] - No expenses were incurred under a Clinical Supply Agreement with BCM during the nine months ended September 30, 2019[58] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations. This section provides management's perspective on the company's financial performance and condition, detailing its business overview, recent operational developments, a comparative analysis of financial results for the three and nine months ended September 30, 2019, and a discussion of liquidity, capital resources, and critical accounting policies Company Overview This section describes the company's business as a clinical-stage immuno-oncology firm, its core technology, and lead clinical programs - Clinical-stage immuno-oncology company specializing in T cell-based immunotherapies and peptide-based vaccines for hematological malignancies and solid tumors[64] - MultiTAA T cell technology uses non-engineered, tumor-specific T cells, designed for broad anti-tumor activity with potentially easier manufacturing and reduced toxicities compared to CAR-T therapies[64] - Lead indication is post-transplant AML, with promising Phase 1/2 clinical trial results (11 of 13 adjuvant patients survived, 9 in complete remission; active disease patients showed 4-21 months survival vs. 4.5 months historical)[65] - Developing peptide-based immunotherapeutic vaccines (TPIV100 for HER2/neu breast cancer, TPIV200 for FRa breast/ovarian cancers), with TPIV200 receiving Orphan Drug and Fast Track Designations for ovarian cancer[68] Recent Developments This section highlights key recent operational events, including FDA clinical holds and the suspension of a Phase 2 trial - FDA placed a clinical hold on the planned Phase 2 trial for MultiTAA therapy in post-transplant AML, requesting additional information on third-party reagent specifications[71] - Company submitted a complete response to the FDA on October 28, 2019, and expects to initiate the Phase 2 trial in 2020[73] - Phase 2 clinical trial of TPIV200 for platinum-sensitive advanced ovarian cancer was suspended in October 2019 due to not meeting the pre-specified probability of success criteria, despite no safety concerns[74] Results of Operations This section provides a comparative analysis of the company's financial results for the three and nine months ended September 30, 2019 and 2018 Comparison of the Three Months Ended September 30, 2019 and September 30, 2018 This section compares the company's financial performance for the three-month periods, detailing changes in key expense categories and net loss Results of Operations - Three Months Ended September 30: | Metric | 2019 ($) | 2018 ($) | Change ($) | % Change | | :-------------------------- | :----------- | :----------- | :----------- | :------- | | Research and development | $3,119,000 | $1,877,000 | $1,242,000 | 66% | | General and administrative | $2,536,000 | $2,551,000 | $(15,000) | (1)% | | Total operating expenses | $5,655,000 | $4,428,000 | $1,227,000 | 28% | | Net loss | $(5,460,000) | $(4,388,000) | $(1,072,000) | 24% | | Interest income | $259,000 | $0 | $259,000 | - | - Increase in R&D costs driven by personnel-related expenses, including stock-based compensation and consulting, to build internal infrastructure for MultiTAA T cell product development[77] - Decrease in G&A expenses primarily due to a $0.6 million reduction in merger-related expenses from 2018, partially offset by increases in headcount-related expenses and legal/professional fees[81] - Interest income in 2019 was from net proceeds of October 2018 equity financing held in U.S. Treasury notes and government agency-backed securities[79] Comparison of the Nine months Ended September 30, 2019 and September 30, 2018 This section compares the company's financial performance for the nine-month periods, detailing changes in grant income, operating expenses, and net loss Results of Operations - Nine Months Ended September 30: | Metric | 2019 ($) | 2018 ($) | Change ($) | % Change | | :-------------------------- | :----------- | :----------- | :----------- | :------- | | Grant income | $0 | $206,000 | $(206,000) | (100)% | | Research and development | $9,104,000 | $5,304,000 | $3,800,000 | 72% | | General and administrative | $8,063,000 | $7,202,000 | $861,000 | 12% | | Total operating expenses | $17,167,000 | $12,506,000 | $4,661,000 | 37% | | Net loss | $(16,349,000) | $(12,398,000) | $(3,951,000) | 32% | | Interest income | $898,000 | $0 | $898,000 | - | - Grant income of $206,000 in 2018 was from a Department of Defense grant to Mayo Foundation for TPIV200 clinical trial supplies[83] - Increase in R&D costs due to higher personnel-related expenses, including stock-based compensation and consulting, for internal infrastructure build-up and MultiTAA T cell product development[84] - Increase in G&A expenses due to higher headcount-related expenses, legal and professional fees, and office-related expenses, partially offset by a $2.0 million decrease in merger-related expenses from 2018[84] - Interest income in 2019 was from net proceeds of October 2018 equity financing held in U.S. Treasury notes and government agency-backed securities[86] Liquidity and Capital Resources This section discusses the company's cash position, working capital, cash flow activities, and future funding requirements Cash and Working Capital: | Metric | Sep 30, 2019 ($) | Dec 31, 2018 ($) | | :-------------------------- | :----------- | :----------- | | Cash and cash equivalents | $48,478,000 | $61,747,000 | | Working capital | $47,275,000 | $59,193,000 | - Net cash used in operating activities was $13.7 million for the nine months ended September 30, 2019, primarily due to a net loss of $16.3 million and increased prepaid expenses[90] - Net cash provided by financing activities was $0.8 million in 2019, significantly lower than $7.5 million in 2018, which included proceeds from a private placement[93] - The Company expects to incur substantial losses and will require significant additional funding for R&D, clinical trials, and commercialization, projecting current cash to fund operations through at least Q4 2020[94][95] Critical Accounting Policies This section affirms the consistency of critical accounting estimates, judgments, and assumptions with the prior annual report - Critical accounting estimates, judgments, and assumptions are consistent with those described in the Annual Report on Form 10-K for the year ended December 31, 2018[98] Off-Balance Sheet Arrangements This section confirms the absence of material off-balance sheet arrangements that could impact the company's financial condition - No material off-balance sheet arrangements exist that could affect financial condition, results of operations, or liquidity[99] Item 3. Quantitative and Qualitative Disclosures About Market Risk. As a smaller reporting company, Marker Therapeutics, Inc. is not required to provide quantitative and qualitative disclosures about market risk - The Company is a smaller reporting company and is not required to provide market risk disclosures[100] Item 4. Controls and Procedures. This section addresses the effectiveness of the company's disclosure controls and procedures, highlighting a material weakness in internal control over financial reporting related to stock-based compensation, and outlines the remediation efforts undertaken Evaluation of Disclosure Controls and Procedures This section details the assessment of disclosure controls and procedures, noting a material weakness in internal control over financial reporting - Disclosure controls and procedures were not effective as of September 30, 2019, due to a material weakness in internal control over financial reporting[102] - Material weakness stemmed from ineffective controls related to the timing of recording non-cash stock-based compensation expenses for select stock option grants with non-standard vesting schedules[103] - Despite the material weakness, consolidated financial statements are deemed fairly stated in all material respects[102] Changes in Internal Control Over Financial Reporting This section describes the changes implemented to address the material weakness in internal control over financial reporting, including software adoption and consultant engagement - Transitioned manual calculation of stock-based compensation expenses to a third-party automated software system[111] - Implemented further internal control procedures, including hiring an equity administration consultant to review calculations[111] - No other material changes in internal controls over financial reporting during the three months ended September 30, 2019[105] PART II – OTHER INFORMATION Item 1. Legal Proceedings. As of September 30, 2019, the Company was not a party to any legal proceedings that management believes are likely to have a material adverse effect on its business - No legal proceedings are likely to have a material adverse effect on the Company's business as of September 30, 2019[106] Item 1A. Risk Factors. This section outlines significant risks that could materially affect the company's business, financial condition, and results of operations, categorized into risks related to business and intellectual property, government regulation, and the company's securities Risks Related to our Business and Intellectual Property This section details risks associated with the company's development-stage nature, personnel, clinical trials, competition, manufacturing, and intellectual property - The Company is a development-stage company with a history of operating losses and an accumulated deficit of $322.5 million as of September 30, 2019, expecting continued losses and requiring substantial additional financing[109] - Success depends on attracting and retaining key personnel and maintaining its strategic relationship with Baylor College of Medicine (BCM), which involves potential conflicts of interest due to multiple roles of officers/directors[112][114][117][118] - Product development is lengthy, expensive, and uncertain; early clinical results are not predictive of later-stage success, and clinical trials are subject to risks like recruitment delays, lack of efficacy, unacceptable side effects, and regulatory holds (e.g., FDA clinical hold on MultiTAA therapy for post-transplant AML)[120][124][125][126][129] - The biotechnology and immunotherapy industries are highly competitive, with rapid technological developments and numerous competitors, many with greater financial and R&D resources[121][219] - Manufacturing scale-up for complex cell therapies is challenging, costly, and subject to risks like process development issues, contamination, equipment failure, and reliance on sole-source vendors (e.g., Wilson Wolf for G-Rex® cell culture device)[146][147][151][154][157][158][162] - Commercial success depends on obtaining, maintaining, and enforcing patents and proprietary rights, but this is uncertain due to risks of patent invalidation, infringement claims, and reliance on licensed technologies from BCM and Mayo Foundation[169][170][174][180][187][193][198] Risks Related to Government Regulation This section addresses risks stemming from extensive FDA and international regulations, compliance requirements, healthcare reform, and orphan drug designation - Products are subject to extensive and costly FDA and international regulations, with no precedent for commercialization of its novel T cell therapies, leading to an uncertain and lengthy approval process[234][235] - Non-compliance with regulatory requirements (pre- or post-marketing) can lead to fines, product removal, delays, and other adverse consequences, and approval in one country does not guarantee approval in others[236][239][240][242] - Business activities are subject to federal and state healthcare fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act, HIPAA, Sunshine Act), with potential for significant civil/criminal penalties and exclusion from federal programs for non-compliance[246][247][248][255] - Healthcare reform measures (e.g., ACA, drug pricing scrutiny) could adversely affect product pricing, reimbursement, and commercialization, potentially limiting market access and profitability[250][251][253][254] - Benefits of orphan drug designation (e.g., 7-year market exclusivity for TPIV200 in ovarian cancer) are not guaranteed and can be lost, and new regulatory pathways for biosimilars could reduce market exclusivity[257][259][260][261] Risks Related to our Securities This section covers risks concerning internal control weaknesses, stock price volatility, potential dilution from future equity sales, warrant accounting, and dividend policy - Identified a material weakness in internal control over financial reporting related to stock-based compensation, which could materially affect financial condition and stock price if not remediated[265][266] - The common stock trading price is highly volatile due to various factors, including operating results, clinical trial outcomes, new equity issuances, and market conditions, making it susceptible to class action litigation[267][269] - Future sales of additional equity securities, including shares from 22.7 million outstanding warrants and 4.7 million options, could cause substantial dilution and adversely affect the market price[274] - Complex accounting for warrants with embedded derivative rights requires revaluation each period, leading to unpredictable charges to the statement of operations[275] - The Company does not anticipate paying cash dividends for the foreseeable future[276] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds. During the period, the Company issued 17,400 shares of common stock to Corporate Profile LLC pursuant to a vendor agreement, under exemptions from the Securities Act of 1933, including Section 4(2) - Issued 17,400 shares of common stock to Corporate Profile LLC under a vendor agreement, pursuant to Securities Act of 1933 exemptions (e.g., Section 4(2))[277] Item 3. Defaults Upon Senior Securities. The Company reported no defaults upon senior securities - No defaults upon senior securities[278] Item 4. Mine Safety Disclosure. This item is not applicable to the Company - Not applicable[278] Item 5. Other Information. This item is not applicable to the Company - Not applicable[278] Item 6. Exhibits. The report includes various exhibits, such as the Certificate of Incorporation, Bylaws, CEO and CFO certifications, and XBRL taxonomy documents - Exhibits include Certificate of Incorporation, Bylaws, CEO and CFO certifications (31.1, 31.2, 32.1, 32.2), and XBRL taxonomy documents[279] Signatures Signatures The report was signed on November 12, 2019, by Peter L. Hoang, President, Chief Executive Officer and Principal Executive Officer, and Anthony Kim, Chief Financial Officer and Principal Financial and Accounting Officer, on behalf of Marker Therapeutics, Inc. - The report was signed by Peter L. Hoang (President, CEO, Principal Executive Officer) and Anthony Kim (CFO, Principal Financial and Accounting Officer) on November 12, 2019[282]