Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ Quarterly Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended September 30, 2022 MARKER THERAPEUTICS, INC. (Name of registrant in its charter) | DELAWARE | | 45-4497941 | | --- | --- | --- | | (State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) | | 4551 Kennedy Commerce Drive | | | | Houston, Texas | | 770 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ Quarterly Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended June 30, 2022 ☐ Transition Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from _____ to _____. Commission File Number: 001-37939 MARKER THERAPEUTICS, INC. (Name of registrant in its charter) | DELAWARE 45-4497941 | | | --- | --- | | (State or oth ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Commission File Number: 001-37939 Table of Contents MARKER THERAPEUTICS, INC. (Name of registrant in its charter) | DELAWARE | | 45-4497941 | | --- | --- | --- | | (State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) | | 3200 Southwest Freeway, Suite 2500 | | | | Houston, Texas | | 77027 | | (Address of principal executive offices) | | (Zip Code) | | (713) 400-6400 | | | | (Is ...

For the Fiscal Year Ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to ______________. Commission File Number: 001-37939 MARKER THERAPEUTICS, INC. Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of registrant as specified in its charter) (State ...

PART I – FINANCIAL INFORMATION [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Marker Therapeutics, Inc. as of September 30, 2021, including the balance sheet, statements of operations, stockholders' equity, and cash flows, with notes on accounting policies, liquidity, financing, and legal contingencies [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of September 30, 2021, reflects a substantial increase in total assets and stockholders' equity, primarily driven by a significant rise in cash and cash equivalents due to recent financing activities Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $48,705 | $21,352 | | Total current assets | $51,407 | $24,411 | | Total assets | $71,940 | $45,615 | | **Liabilities & Equity** | | | | Total current liabilities | $8,227 | $6,402 | | Total liabilities | $19,658 | $18,270 | | Total stockholders' equity | $52,282 | $27,345 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three and nine months ended September 30, 2021, the company reported no revenue and a higher net loss due to significantly increased operating expenses, including R&D activities and an arbitration settlement Condensed Consolidated Statements of Operations Highlights (in thousands) | Metric | Q3 2021 | Q3 2020 | Nine Months 2021 | Nine Months 2020 | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $0 | $0 | $0 | $467 | | Research and development | $6,784 | $4,804 | $19,777 | $12,897 | | General and administrative | $3,239 | $2,573 | $9,936 | $7,947 | | Loss from operations | $(10,024) | $(7,376) | $(29,714) | $(20,377) | | Net loss | $(12,429) | $(7,372) | $(32,116) | $(20,199) | | Net loss per share | $(0.15) | $(0.16) | $(0.43) | $(0.43) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2021, net cash used in operating activities increased, while a significant inflow from financing activities, primarily from common stock issuance, resulted in a net increase in cash Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(22,422) | $(14,530) | | Net cash used in investing activities | $(2,781) | $(5,153) | | Net cash provided by financing activities | $52,556 | $2,736 | | Net increase (decrease) in cash | $27,353 | $(16,947) | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's financial condition and accounting policies, including cash runway, recent financing activities, and a significant arbitration accrual - As of September 30, 2021, the Company had cash and cash equivalents of approximately **$48.7 million**, expected to fund operating expenses and capital expenditure requirements into the first quarter of 2023[18](index=18&type=chunk)[23](index=23&type=chunk) - In March 2021, the company raised net proceeds of **$52.6 million** from an underwritten public offering of **32,282,857 shares** of common stock[20](index=20&type=chunk)[49](index=49&type=chunk) - In August 2021, the company entered into an At-The-Market (ATM) agreement to offer and sell up to **$75.0 million** of its common stock, with no shares sold to date under this agreement[19](index=19&type=chunk) - The company accrued **$2.4 million** related to a FINRA arbitration award for broker compensation from 2018 financing transactions, and filed a motion to vacate the award in October 2021[46](index=46&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's business as a clinical-stage immuno-oncology firm, highlighting the significant increase in operating expenses and net loss for 2021, alongside a strengthened liquidity position expected to fund operations into Q1 2023 [Company Overview and Pipeline](index=17&type=section&id=Company%20Overview%20and%20Pipeline) Marker Therapeutics is a clinical-stage immuno-oncology company developing T cell-based immunotherapies, with its lead product MT-401 in a Phase 2 clinical trial for AML, supported by an operational cGMP manufacturing facility - The company is advancing its lead product candidate, **MT-401 (zedenoleucel)**, in a Phase 2 clinical trial for post-allogeneic HSCT patients with AML[69](index=69&type=chunk) - The company's cGMP manufacturing facility became fully operational in July 2021 and is expected to begin manufacturing MT-401 for the Phase 2 trial in Q4 2021[69](index=69&type=chunk) - The company's MultiTAA-specific T cell therapies have been generally well tolerated in clinical trials with no incidents of cytokine release syndrome or neurotoxicity[71](index=71&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) The company's net loss increased significantly for both the three and nine months ended September 30, 2021, primarily driven by higher Research and Development expenses for clinical trials and increased headcount, along with a one-time arbitration settlement loss Comparison of Operating Results (in thousands) | Metric | Q3 2021 | Q3 2020 | Change | Nine Months 2021 | Nine Months 2020 | Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | $6,785 | $4,804 | +41% | $19,778 | $12,897 | +53% | | G&A Expenses | $3,239 | $2,572 | +26% | $9,936 | $7,947 | +25% | | Net Loss | $(12,429) | $(7,371) | +69% | $(32,116) | $(20,199) | +59% | - The increase in R&D expenses was primarily driven by a **$1.0 million** increase in costs for the AML clinical trial and a **$0.6 million** increase in headcount-related expenses in Q3 2021[77](index=77&type=chunk) - A loss on settlement of **$2.4 million** was recorded in Q3 2021 related to a FINRA arbitration proceeding[74](index=74&type=chunk)[80](index=80&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) The company's financial position significantly strengthened in 2021, with cash and cash equivalents increasing to **$48.7 million** due to a public offering, providing sufficient funds for operations into the first quarter of 2023 Liquidity Position (in thousands) | Metric | Sep 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $48,705 | $21,352 | | Working capital | $43,180 | $18,009 | - Net cash provided by financing activities was **$52.6 million** for the nine months ended September 30, 2021, primarily from an underwritten public offering[100](index=100&type=chunk)[103](index=103&type=chunk) - The company received notice of a **~$13.1 million** award from the Cancer Prevention and Research Institute of Texas (CPRIT) to support its Phase 2 clinical trial of MT-401, though no funds have been received to date[107](index=107&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is classified as a smaller reporting company and is not required to provide information for this item - As a smaller reporting company, Marker Therapeutics is not required to provide quantitative and qualitative disclosures about market risk[111](index=111&type=chunk) [Item 4. Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of September 30, 2021, with no material changes in internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[112](index=112&type=chunk) - No changes in internal controls over financial reporting occurred during the nine months ended September 30, 2021, that have materially affected, or are reasonably likely to materially affect, internal controls[115](index=115&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings) As of September 30, 2021, the company reports that it is not a party to any legal proceedings likely to have a material adverse effect on its business - The company states it was not a party to any legal proceedings that management believes are likely to have a material adverse effect on the business as of September 30, 2021[116](index=116&type=chunk) [Item 1A. Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) The company indicates that there have been no material changes to the risk factors previously disclosed in its Annual Report on Form 10-K for the fiscal year ended December 31, 2020 - There have been no material changes to the risk factors described in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2020[117](index=117&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=26&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company did not issue or sell any unregistered securities during the nine months ended September 30, 2021 - The company did not record any issuances of unregistered securities during the nine months ended September 30, 2021[118](index=118&type=chunk) [Item 6. Exhibits](index=28&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the company's Certificate of Incorporation, Bylaws, CEO and CFO certifications, and interactive data files - The report includes a list of exhibits filed, notably the certifications by the Chief Executive Officer and Chief Financial Officer pursuant to SEC rules[123](index=123&type=chunk)

Table of Contents ◻ Transition Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from _____ to _____. Commission File Number: 001-37939 MARKER THERAPEUTICS, INC. (Name of registrant in its charter) DELAWARE 45-4497941 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 3200 Southwest Freeway, Suite 2500 Houston, Texas 77027 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ⌧ Quarte ...

[PART I – FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) Marker Therapeutics reported an increased net loss for Q1 2021, but significantly strengthened its financial position through a public offering [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Marker Therapeutics reported an increased net loss for Q1 2021, while a public offering substantially boosted cash and equity [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets and stockholders' equity significantly increased as of March 31, 2021, primarily due to a substantial rise in cash from a stock offering Condensed Consolidated Balance Sheet Highlights (Unaudited) | Balance Sheet Item | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $64,507,575 | $21,352,382 | | Total current assets | $67,471,366 | $24,410,865 | | Total assets | $88,362,081 | $45,614,815 | | Total liabilities | $15,867,162 | $18,270,242 | | Total stockholders' equity | $72,494,919 | $27,344,573 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported an increased net loss for Q1 2021, primarily driven by higher research and development expenses Statement of Operations Summary (Unaudited) | Metric | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | Research and development | $5,643,029 | $3,816,618 | | General and administrative | $3,137,958 | $2,826,995 | | Loss from operations | ($8,780,987) | ($6,643,613) | | Net loss | ($8,779,450) | ($6,485,644) | | Net loss per share, basic and diluted | ($0.16) | ($0.14) | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity significantly increased in Q1 2021, primarily due to substantial net proceeds from a common stock issuance - In Q1 2021, the company issued **32,282,857 shares** of common stock, resulting in net proceeds of **$52.55 million** after offering costs of **$3.9 million**[10](index=10&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased, while a significant stock offering provided substantial cash from financing activities Cash Flow Summary (Unaudited) | Cash Flow Activity | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($9,060,261) | ($4,099,066) | | Net cash used in investing activities | ($441,134) | ($99,821) | | Net cash provided by financing activities | $52,656,588 | $550,000 | | Net increase (decrease) in cash | $43,155,193 | ($3,648,887) | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Key notes detail the company's immuno-oncology focus, a significant public offering, cash runway, and an ongoing arbitration proceeding - The company is a clinical-stage immuno-oncology company developing T cell-based immunotherapies (MultiTAA T cell technology) for hematological malignancies and solid tumors[14](index=14&type=chunk) - On March 11, 2021, the company completed an underwritten public offering, issuing **32,282,857 shares** of common stock for net proceeds of **$52.6 million**[37](index=37&type=chunk) - The company expects its cash of **$64.5 million** as of March 31, 2021, to fund operations and capital expenditures into the first quarter of 2023[20](index=20&type=chunk) - An arbitration proceeding was brought against the company by a broker seeking approximately **$1.0 million** in compensation for financing transactions from 2018[36](index=36&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) The company, a clinical-stage immuno-oncology firm, saw an increased net loss in Q1 2021, but secured funding expected to last into Q1 2023 [Company Overview](index=15&type=section&id=Company%20Overview) Marker Therapeutics is a clinical-stage immuno-oncology company developing T cell-based therapies, with its lead candidate MT-401 for AML entering Phase 2 - The company's lead product candidate, MT-401 (zedenoleucel), is a MultiTAA-specific T cell therapy for post-allogeneic HSCT patients with AML[55](index=55&type=chunk) - The FDA granted orphan drug designation to MT-401 for the treatment of AML after an allogeneic stem cell transplant in April 2020[54](index=54&type=chunk) - The company plans to initiate the Phase 2 trial for MT-401 in Q3 2021 and expects to report results from the active disease arm in Q1 2022[55](index=55&type=chunk) [Results of Operations](index=17&type=section&id=Results%20of%20Operations) Total operating expenses and net loss increased in Q1 2021, primarily due to higher research and development costs Comparison of Operations for the Three Months Ended March 31 | Metric | 2021 | 2020 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $5,643,000 | $3,817,000 | $1,826,000 | 48% | | General and administrative | $3,138,000 | $2,827,000 | $311,000 | 11% | | Loss from operations | ($8,781,000) | ($6,644,000) | ($2,137,000) | 32% | | Net loss | ($8,779,000) | ($6,486,000) | ($2,293,000) | 35% | - The **$1.8 million** increase in R&D expenses was driven by higher headcount costs (**$0.6 million**), sponsored research (**$0.2 million**), rent/utilities (**$0.3 million**), and depreciation for the manufacturing facility (**$0.4 million**)[63](index=63&type=chunk) [Liquidity and Capital Resources](index=18&type=section&id=Liquidity%20and%20Capital%20Resources) The company significantly improved its liquidity in Q1 2021 through a public offering, extending its cash runway into the first quarter of 2023 Liquidity Position | | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $64,508,000 | $21,352,000 | | Working capital | $63,324,000 | $18,009,000 | - In March 2021, the company raised net proceeds of **$52.6 million** from an underwritten public offering[73](index=73&type=chunk) - The company expects its cash as of March 31, 2021, will fund operations and capital expenditure requirements into the first quarter of 2023[73](index=73&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=20&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, Marker Therapeutics is exempt from providing market risk disclosures - The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information required under this item[80](index=80&type=chunk) [Controls and Procedures](index=21&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2021, with no material changes in internal controls - Based on an evaluation as of the end of the period, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures are effective[82](index=82&type=chunk) - There were no changes in internal controls over financial reporting during the first quarter of 2021 that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[85](index=85&type=chunk) [PART II – OTHER INFORMATION](index=21&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, and other disclosures, noting no material changes or applicable items [Legal Proceedings](index=21&type=section&id=Item%201.%20Legal%20Proceedings.) As of March 31, 2021, management believes no legal proceedings are likely to have a material adverse effect on the business - As of March 31, 2021, the company was not a party to any legal proceedings that, in the opinion of management, are likely to have a material adverse effect on its business[86](index=86&type=chunk) [Risk Factors](index=21&type=section&id=Item%201A.%20Risk%20Factors.) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K - There have been no material changes to the risk factors described in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2020[87](index=87&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=21&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) The company reported no issuances of unregistered securities during the three months ended March 31, 2021 - The company did not record any issuances of unregistered securities during the three months ended March 31, 2021[88](index=88&type=chunk) [Defaults Upon Senior Securities](index=21&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) None [Mine Safety Disclosure](index=22&type=section&id=Item%204.%20Mine%20Safety%20Disclosure.) Not applicable [Other Information](index=22&type=section&id=Item%205.%20Other%20Information.) Not applicable [Exhibits](index=22&type=section&id=Item%206.%20Exhibits.) The report includes various required exhibits, such as corporate documents and CEO/CFO certifications

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to ______________. Commission File Number: 001-37939 MARKER THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State ...

Marker Therapeutics, Inc. (NASDAQ:MRKR) Q3 2020 Earnings Conference Call November 9, 2020 5:00 PM ET Company Participants Anthony Kim - CFO Peter Hoang - President, CEO & Director Mythili Koneru - Chief Medical Officer Juan Vera - Chief Development Officer & Director Conference Call Participants Matthew Biegler - Oppenheimer Operator Good afternoon, ladies and gentlemen, and welcome to the Marker Therapeutics' conference call. [Operator Instructions]. As a reminder, this conference call is being recorded. I ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Commission File Number: 001-37939 MARKER THERAPEUTICS, INC. (Name of registrant in its charter) | DELAWARE | 45-4497941 | | --- | --- | | (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | | 3200 Southwest Freeway, Suite 2500 | | | Houston, Texas | 77027 | | (Address of principal executive offices) | (Zip Code) | | (713) 400-6400 | | | (Issuer's telephone n ...