Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q DELAWARE 45-4497941 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 9350 Kirby Drive, Suite 300 Houston, Texas 77054 (Address of principal executive offices) (Zip Code) (713) 400-6400 (Issuer's telephone number) 4551 Kennedy Commerce Drive, Houston, Texas, 77032 ☒ Quarterly Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quart ...

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, 2023 ☐ 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 ...

[PART I – FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) This section presents the unaudited condensed consolidated financial statements, management's discussion and analysis, market risk disclosures, and internal controls for the company [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for Marker Therapeutics, Inc. for the quarter ended March 31, 2023, including balance sheets, statements of operations, stockholders' equity, and cash flows, along with detailed notes explaining the company's operations, liquidity, accounting policies, and recent financial activities [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a decrease in cash and total assets, alongside a reduction in total liabilities and stockholders' equity from December 31, 2022, to March 31, 2023 | Metric | March 31, 2023 ($) | December 31, 2022 ($) | | :-------------------------- | :------------- | :---------------- | | Cash and cash equivalents | $6,401,243 | $11,782,172 | | Total current assets | $10,912,872 | $16,619,255 | | Total assets | $27,941,047 | $34,422,184 | | Total current liabilities | $5,204,048 | $7,781,809 | | Total liabilities | $12,027,699 | $14,821,147 | | Total stockholders' equity | $15,913,348 | $19,601,037 | - The Company effected a **one-for-ten (1-for-10) reverse stock split** of its common stock on January 26, 2023, and a corresponding reduction in authorized shares from **300 million to 30 million**. All historical share and per share amounts have been adjusted[6](index=6&type=chunk) [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The statement of operations reveals a significant increase in total revenues, primarily from related party services, leading to a substantial reduction in net loss for the three months ended March 31, 2023 | Metric | Three Months Ended March 31, 2023 ($) | Three Months Ended March 31, 2022 ($) | | :-------------------------------------- | :-------------------------------- | :-------------------------------- | | Grant income | $1,234,336 | $964,322 | | Related party service revenue | $3,500,000 | — | | Total revenues | $4,734,336 | $964,322 | | Research and development | $7,270,742 | $7,026,066 | | General and administrative | $2,515,824 | $3,733,001 | | Total operating expenses | $9,786,566 | $10,759,067 | | Loss from operations | $(5,052,230) | $(9,794,745) | | Net loss | $(4,967,576) | $(9,910,508) | | Net loss per share, basic and diluted | $(0.57) | $(1.19) | - Total revenues significantly increased by **391% to $4.7 million** for the three months ended March 31, 2023, primarily due to **$3.5 million** in related party service revenue[8](index=8&type=chunk) - Net loss decreased by **50% to $(4.97) million** for the three months ended March 31, 2023, compared to **$(9.91) million** in the prior year period[8](index=8&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) The statement of stockholders' equity shows a decrease in total equity from January 1, 2023, to March 31, 2023, primarily driven by the net loss, partially offset by stock issuances | Metric | January 1, 2023 ($) | March 31, 2023 ($) | | :-------------------------------- | :-------------- | :------------- | | Common Stock Shares | 8,405,771 | 8,798,829 | | Common Stock Par value | $8,406 | $8,799 | | Additional Paid-in Capital | $447,641,680 | $448,921,174 | | Accumulated Deficit | $(428,049,049) | $(433,016,625) | | Total Stockholders' Equity | $19,601,037 | $15,913,348 | - Total stockholders' equity decreased from **$19.6 million** at January 1, 2023, to **$15.9 million** at March 31, 2023, primarily due to the net loss of **$4.97 million**, partially offset by common stock issuances and stock-based compensation[11](index=11&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) The cash flow statement indicates a significant reduction in net cash used in operating activities, but an overall net decrease in cash and cash equivalents for the three months ended March 31, 2023 | Cash Flow Activity | Three Months Ended March 31, 2023 ($) | Three Months Ended March 31, 2022 ($) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(5,888,295) | $(12,226,062) | | Net cash used in investing activities | $(112,608) | $(2,452,188) | | Net cash provided by financing activities | $619,974 | — | | Net decrease in cash and cash equivalents | $(5,380,929) | $(14,678,250) | | Cash and cash equivalents at end of period | $6,401,243 | $28,819,081 | - Net cash used in operating activities decreased significantly from **$(12.23) million** in Q1 2022 to **$(5.89) million** in Q1 2023[14](index=14&type=chunk) - Cash and cash equivalents at the end of the period decreased to **$6.4 million** as of March 31, 2023, from **$11.8 million** at the beginning of the period[14](index=14&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed explanations of the company's business, significant accounting policies, liquidity, recent transactions, and other financial information for the reporting period - Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company developing novel T cell-based immunotherapies for hematological malignancies and solid tumors, utilizing multiTAA T cell technology[16](index=16&type=chunk) - The Company completed a **one-for-ten reverse stock split** on January 26, 2023, reducing authorized shares from **300 million to 30 million**[17](index=17&type=chunk) - As of March 31, 2023, the Company had approximately **$6.4 million** in cash and cash equivalents and expects this to fund operations into the **third quarter of 2023**, excluding the anticipated **$19.0 million** from the Cell Ready Agreement[20](index=20&type=chunk)[31](index=31&type=chunk) - The Company recognized **$1.1 million** from a CPRIT grant and **$0.1 million** from an FDA Orphan Products Grant for its MT-401 Phase 2 clinical trial during the three months ended March 31, 2023[23](index=23&type=chunk)[25](index=25&type=chunk) - The Company recognized **$3.5 million** in related party service revenue from Wilson Wolf Manufacturing Corporation, including a **$1.0 million** milestone payment for completing services within one year[24](index=24&type=chunk)[53](index=53&type=chunk)[54](index=54&type=chunk) - In May 2023, the Company entered into the Cell Ready Agreement to assign manufacturing facility leases, sell equipment, and assign related contracts to Cell Ready, LLC for approximately **$19.0 million**, with the transaction expected to close on **June 26, 2023**[28](index=28&type=chunk)[29](index=29&type=chunk)[73](index=73&type=chunk)[74](index=74&type=chunk)[75](index=75&type=chunk) - The Company's future funding requirements depend on clinical trial progress, R&D, regulatory approvals, commercialization efforts, and strategic transactions, raising substantial doubt about its ability to continue as a going concern[32](index=32&type=chunk)[33](index=33&type=chunk)[34](index=34&type=chunk)[35](index=35&type=chunk) - Stock-based compensation expense for the three months ended March 31, 2023, was **$0.66 million**, down from **$1.63 million** in the prior year, with **$3.5 million** in unrecognized compensation cost remaining[62](index=62&type=chunk) - Juan Vera was appointed President and CEO on **April 27, 2023**, replacing Peter Hoang, with an option grant of **100,000 shares** approved on **May 10, 2023**[76](index=76&type=chunk)[145](index=145&type=chunk)[146](index=146&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) This section provides management's perspective on the company's financial condition and results of operations for the three months ended March 31, 2023, compared to the same period in 2022. It covers revenue, operating expenses, net loss, liquidity, capital resources, and recent developments, highlighting the company's reliance on external funding and the going concern uncertainty [Company Overview](index=20&type=section&id=Company%20Overview) This section outlines Marker Therapeutics' focus as a clinical-stage immuno-oncology company developing T cell-based immunotherapies for various cancers, leveraging its multiTAA-specific T cell technology - Marker Therapeutics is a clinical-stage immuno-oncology company focused on developing T cell-based immunotherapies for hematological malignancies and solid tumors, leveraging its multiTAA-specific T cell technology licensed from The Baylor College of Medicine[83](index=83&type=chunk)[84](index=84&type=chunk) - The company is advancing three product candidates: autologous treatment for lymphoma and solid tumors, allogeneic T cells for AML, and off-the-shelf products, with current clinical programs including MT-401 for post-transplant AML and MT-601 for pancreatic cancer and lymphoma[85](index=85&type=chunk) [Recent Developments](index=21&type=section&id=Recent%20Developments) This section highlights key recent events, including the Cell Ready Agreement for manufacturing facility sale and the one-for-ten reverse stock split - In **May 2023**, the Company entered into the Cell Ready Agreement to sell its manufacturing facilities, equipment, and related contracts to Cell Ready, LLC for approximately **$19.0 million**, with the transaction expected to close on **June 26, 2023**[87](index=87&type=chunk)[88](index=88&type=chunk)[89](index=89&type=chunk) - On **January 26, 2023**, the Company completed a **one-for-ten reverse stock split**, reducing authorized common stock shares from **300 million to 30 million**[90](index=90&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance for the three months ended March 31, 2023, focusing on revenue growth, expense management, and the resulting net loss reduction Summary of Operations (Three Months Ended March 31) | Metric | 2023 (Thousands of $) | 2022 (Thousands of $) | Change (Thousands of $) | Change (%) | | :-------------------------- | :----------- | :----------- | :------------- | :--------- | | Grant income | 1,234 | 964 | 270 | 28% | | Related party service revenue | 3,500 | — | 3,500 | 100% | | Total revenues | 4,734 | 964 | 3,770 | 391% | | Research and development | 7,271 | 7,026 | 245 | 3% | | General and administrative | 2,516 | 3,733 | (1,217) | (33)% | | Total operating expenses | 9,787 | 10,759 | (972) | (9)% | | Loss from operations | (5,052) | (9,795) | 4,743 | (48)% | | Net loss | (4,968) | (9,911) | 4,943 | (50)% | | Net loss per share | (0.57) | (1.19) | 0.62 | (52)% | - Total revenues increased by **391% to $4.7 million** in Q1 2023, driven by **$3.5 million** in related party service revenue from Wilson Wolf and increased grant income[92](index=92&type=chunk)[93](index=93&type=chunk)[94](index=94&type=chunk)[95](index=95&type=chunk)[96](index=96&type=chunk) - Operating expenses decreased by **9% to $9.8 million** in Q1 2023, primarily due to a **33% decrease** in general and administrative expenses, partially offset by a **3% increase** in research and development expenses[92](index=92&type=chunk)[97](index=97&type=chunk)[98](index=98&type=chunk)[99](index=99&type=chunk) - The decrease in net loss by **50% to $(4.97) million** was attributed to the timing of process development expenses, lower BCM clinical supplies costs, and higher grant income, despite continued R&D expansion[92](index=92&type=chunk)[102](index=102&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, working capital, cash flow activities, and future funding requirements, highlighting the going concern uncertainty Cash and Working Capital | Metric | March 31, 2023 ($) | December 31, 2022 ($) | | :-------------------- | :------------- | :---------------- | | Cash and cash equivalents | $6,401,000 | $11,782,000 | | Working capital | $5,709,000 | $8,837,000 | Summary of Cash Flows (Three Months Ended March 31) | Cash Flow Activity | 2023 (Thousands of $) | 2022 (Thousands of $) | | :-------------------------------- | :----------- | :----------- | | Net cash used in operating activities | (5,888) | (12,226) | | Net cash used in investing activities | (113) | (2,452) | | Net cash provided by financing activities | 620 | — | | Net decrease in cash and cash equivalents | (5,381) | (14,678) | - The Company expects its cash and cash equivalents of **$6.4 million** as of March 31, 2023, to fund operating expenses and capital expenditure requirements into the **third quarter of 2023**, excluding the anticipated **$19.0 million** from the Cell Ready Agreement[118](index=118&type=chunk) - The Company has no product sales revenue and relies on equity/debt financings and collaboration arrangements to fund operations, facing substantial doubt about its ability to continue as a going concern[110](index=110&type=chunk)[119](index=119&type=chunk)[125](index=125&type=chunk)[126](index=126&type=chunk) - During Q1 2023, the Company sold **200,261 shares** for **$0.6 million** under its ATM Agreement and **12,500 shares** for **$33,000** under a purchase agreement with Lincoln Park Capital Fund, LLC[123](index=123&type=chunk)[124](index=124&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk.](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) 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 quantitative and qualitative disclosures about market risk[128](index=128&type=chunk) [Item 4. Controls and Procedures.](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management, including the principal executive and financial officers, evaluated the effectiveness of the company's disclosure controls and procedures, concluding they were effective as of March 31, 2023. No material changes to internal control over financial reporting were reported during the quarter - Management concluded that the Company's disclosure controls and procedures were effective as of March 31, 2023[129](index=129&type=chunk)[130](index=130&type=chunk) - No material changes in internal control over financial reporting occurred during the three months ended March 31, 2023[133](index=133&type=chunk) [PART II – OTHER INFORMATION](index=31&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) This section provides disclosures on legal proceedings, risk factors, equity sales, senior securities, mine safety, other corporate information, and exhibits [Item 1. Legal Proceedings.](index=31&type=section&id=Item%201.%20Legal%20Proceedings.) The Company is not currently a party to any material legal proceedings and is unaware of any pending or threatened legal actions that could adversely affect its business, operating results, or financial condition - The Company is not currently a party to any material legal proceedings and is not aware of any pending or threatened legal actions that could adversely affect its business[134](index=134&type=chunk) [Item 1A. Risk Factors.](index=31&type=section&id=Item%201A.%20Risk%20Factors.) This section refers to the risk factors detailed in the Company's Annual Report on Form 10-K, with no material changes noted other than those specifically related to the announcement and potential non-completion of the Cell Ready transaction, which could disrupt business operations and impact financial performance - No material changes to risk factors were identified, other than those related to the announcement and pendency of the Cell Ready transaction[135](index=135&type=chunk) - The Cell Ready transaction could cause business disruptions, impair ability to attract/retain key personnel, create difficulties with partners, limit alternative business opportunities, and lead to litigation[136](index=136&type=chunk)[137](index=137&type=chunk)[143](index=143&type=chunk) - Failure to complete the Cell Ready transaction could adversely affect the Company's stock price, result in significant unrecoverable costs, and generate negative publicity[139](index=139&type=chunk)[144](index=144&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) The Company did not record any issuances of unregistered equity securities during the three months ended March 31, 2023 - No unregistered sales of equity securities were recorded during the three months ended March 31, 2023[140](index=140&type=chunk) [Item 3. Defaults Upon Senior Securities.](index=32&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) The Company reported no defaults upon senior securities during the period - There were no defaults upon senior securities[141](index=141&type=chunk) [Item 4. Mine Safety Disclosure.](index=32&type=section&id=Item%204.%20Mine%20Safety%20Disclosure.) This item is not applicable to the Company - This item is not applicable[142](index=142&type=chunk) [Item 5. Other Information.](index=33&type=section&id=Item%205.%20Other%20Information.) This section discloses the grant of a one-time stock option for 100,000 shares to Juan Vera, the newly appointed President and Chief Executive Officer, with a four-year annual vesting schedule - On **May 10, 2023**, the board approved a one-time stock option grant of **100,000 shares** to Juan Vera, the new President and CEO, vesting in equal annual installments over **four years**[145](index=145&type=chunk)[146](index=146&type=chunk) [Item 6. Exhibits.](index=34&type=section&id=Item%206.%20Exhibits.) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including corporate documents, agreements, certifications, and XBRL interactive data files - The report includes various exhibits such as the Certificate of Incorporation, Bylaws, Separation Agreement with Peter Hoang, Purchase Agreement with Cell Ready, and certifications from the CEO and CFO[148](index=148&type=chunk) [Signatures](index=36&type=section&id=Signatures) The report is signed by Juan Vera, President, Chief Executive Officer and Principal Executive Officer, and Michael J. Loiacono, Chief Accounting Officer and Principal Financial and Accounting Officer, certifying its submission in accordance with the Exchange Act - The report was signed on **May 15, 2023**, by Juan Vera, President, Chief Executive Officer and Principal Executive Officer, and Michael J. Loiacono, Chief Accounting Officer and Principal Financial and Accounting Officer[152](index=152&type=chunk)[153](index=153&type=chunk)

Part I [Business](index=6&type=section&id=Item%201.%20Business) Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company developing non-engineered, multi-tumor associated antigen (multiTAA)-specific T cell therapies for hematological malignancies and solid tumors - The company's core technology is a **multiTAA-specific T cell platform** that manufactures non-engineered, tumor-specific T cells designed to recognize and kill cancer cells by targeting multiple tumor-associated antigens (TAAs)[19](index=19&type=chunk) - Key advantages of the multiTAA platform include targeting multiple antigens to minimize tumor escape, inducing a broader immune response, a **strong clinical safety profile** with no reported CRS, and a **less complex, lower-cost manufacturing process** compared to CAR-T therapies[22](index=22&type=chunk) Clinical Pipeline Overview | Product Candidate | Indication | Phase | Sponsor | |---|---|---|---| | MT-401 (zedenoleucel) | Post-Transplant AML (Adjuvant & Active Disease) | Phase 2 (ARTEMIS) | Company | | MT-401-OTS | AML/MDS | Phase 2 (IND Cleared) | Company | | MT-601 | Pancreatic Cancer (in combination with chemo) | Phase 1 (PANACEA) | Company | | MT-601 | Relapsed/Refractory Non-Hodgkin Lymphoma | Phase 1 (APOLLO) | Company | | multiTAA-T | Pancreatic Cancer | Phase 1/2 | BCM | | multiTAA-T | Lymphoma | Phase 1 | BCM | | multiTAA-T | Multiple Myeloma | Phase 1b/2a | BCM | | multiTAA-T | Acute Lymphoblastic Leukemia (ALL) | Phase 1 | BCM | | multiTAA-T | Breast Cancer | Phase 2 | BCM | - The company has developed an improved T cell manufacturing process that reduces production time from **over 30 days to 9 days**, yielding a product with **five times** the measurable specificity and **four times** the potency[32](index=32&type=chunk)[47](index=47&type=chunk) - The company operates its **own fully validated, FDA-registered cGMP manufacturing facility** in Houston, Texas, reducing reliance on contract manufacturing organizations (CMOs)[26](index=26&type=chunk)[103](index=103&type=chunk)[104](index=104&type=chunk) - The company holds a worldwide, exclusive license from Baylor College of Medicine (BCM) for the multiTAA-specific T cell technology, including up to **$64.85 million** in milestone payments and tiered royalties from **0.65% to 5.0%** on net sales[111](index=111&type=chunk)[112](index=112&type=chunk) [Risk Factors](index=51&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks related to its financial position, clinical development, and reliance on third parties - The company has a history of operating losses and expects them to continue, which raises **substantial doubt** about its ability to continue as a going concern, with cash reserves expected to fund operations only into the **third quarter of 2023**[183](index=183&type=chunk)[185](index=185&type=chunk)[186](index=186&type=chunk) - All product candidates are in clinical development, facing a **high risk of failure**, with no guarantee of successful trial completion, regulatory approval, or commercialization[190](index=190&type=chunk)[191](index=191&type=chunk) - The company's strategic relationship with Baylor College of Medicine (BCM) is **critical**, as the multiTAA-specific T cell therapy was developed through this collaboration, and most intellectual property is exclusively licensed from BCM[236](index=236&type=chunk)[237](index=237&type=chunk)[238](index=238&type=chunk) - Manufacturing of cell therapies is **complex and costly**, with risks related to scaling up production, equipment failures, and reliance on a **limited number of vendors** for specialized equipment and materials like the G-Rex® device[220](index=220&type=chunk)[225](index=225&type=chunk)[228](index=228&type=chunk) - The biotechnology industry is **highly competitive**, with Marker Therapeutics competing against larger, well-funded pharmaceutical and biotech companies that have **greater resources and experience** in development and commercialization[258](index=258&type=chunk)[259](index=259&type=chunk) - The business is subject to **extensive and costly government regulation** by the FDA and other authorities, with a lengthy and unpredictable regulatory approval process and no precedent for successful commercialization of multiTAA-specific T cell therapies[312](index=312&type=chunk)[313](index=313&type=chunk)[314](index=314&type=chunk) [Unresolved Staff Comments](index=113&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - None[375](index=375&type=chunk) [Properties](index=113&type=section&id=Item%202.%20Properties) Marker Therapeutics leases a manufacturing facility and principal business office in Houston, Texas, under a ten-year agreement expiring in November 2030, and a separate research facility under a 71-month lease - The company leases its principal business office and manufacturing facility in Houston, TX, with the lease set to expire in **November 2030**[376](index=376&type=chunk) - A separate research facility in Houston, TX is leased for a term of **71 months**, which commenced in **April 2020**[377](index=377&type=chunk) [Legal Proceedings](index=114&type=section&id=Item%203.%20Legal%20Proceedings) The company was involved in a FINRA arbitration proceeding regarding compensation for 2018 financing transactions, resulting in a total payment of $2.6 million - A FINRA arbitration panel awarded a broker **$2.4 million** for compensation, interest, and attorney fees related to 2018 financing transactions, with the company's motion to vacate the award denied[380](index=380&type=chunk) - The company paid the **$2.5 million** judgment (including interest) in March 2022 and an additional **$0.1 million** in post-judgment interest in January 2023, resolving the matter[380](index=380&type=chunk) [Mine Safety Disclosure](index=114&type=section&id=Item%204.%20Mine%20Safety%20Disclosure) This item is not applicable to the company - Not Applicable[381](index=381&type=chunk) Part II [Market For Registrant's Common Equity, Related Stockholder Matters And Issuer Purchases Of Equity Securities](index=115&type=section&id=Item%205.%20Market%20For%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20And%20Issuer%20Purchases%20Of%20Equity%20Securities) The company's common stock is traded on the Nasdaq Capital Market under "MRKR", and it has never paid cash dividends due to recurring losses - The company's common stock is listed on the **Nasdaq Capital Market** under the symbol "**MRKR**"[383](index=383&type=chunk) - **No dividends** have been declared or paid, and the company does not anticipate paying cash dividends in the foreseeable future[384](index=384&type=chunk) [Management's Discussion And Analysis Of Financial Condition And Results Of Operations](index=116&type=section&id=Item%207.%20Management%27s%20Discussion%20And%20Analysis%20Of%20Financial%20Condition%20And%20Results%20Of%20Operations) For FY2022, Marker Therapeutics reported $9.0 million in revenue, a net loss of $29.9 million, and a cash position of $11.8 million, raising substantial doubt about its going concern ability Results of Operations (2022 vs. 2021) | | For the Year Ended December 31, | Change | % Change | |---|---|---|---|---| | | 2022 | 2021 | ($) | (%) | | **Total revenues** | **$9,014,000** | **$1,242,000** | **$7,772,000** | **626%** | | Grant income | $3,514,000 | $1,242,000 | $2,272,000 | 183% | | Related party service revenue | $5,500,000 | $— | $5,500,000 | 100% | | **Total operating expenses** | **$38,959,000** | **$40,720,000** | **($1,761,000)** | **(4)%** | | Research and development | $26,139,000 | $27,795,000 | ($1,656,000) | (6)% | | General and administrative | $12,820,000 | $12,925,000 | ($105,000) | (1)% | | **Loss from operations** | **($29,946,000)** | **($39,478,000)** | **$9,532,000** | **(24)%** | | **Net loss** | **($29,931,000)** | **($41,879,000)** | **$11,948,000** | **(29)%** | | **Net loss per share** | **($3.58)** | **($5.47)** | **$1.89** | **(35)%** | - The company's cash, cash equivalents, and restricted cash decreased from **$43.5 million** at year-end 2021 to **$11.8 million** at year-end 2022[419](index=419&type=chunk) - Management states that existing cash will only fund operations into the **third quarter of 2023**, which raises **substantial doubt** about the company's ability to continue as a going concern[434](index=434&type=chunk)[442](index=442&type=chunk) - In December 2022, the company entered into a purchase agreement with Lincoln Park Capital Fund for the right to sell up to **$25.0 million** of its common stock over a **24-month period**[440](index=440&type=chunk) - A **one-for-ten reverse stock split** was effected on **January 26, 2023**, and all share and per-share data in the report have been retroactively adjusted[392](index=392&type=chunk)[393](index=393&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=136&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Marker Therapeutics is not required to provide the information for this item - The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide this information[464](index=464&type=chunk) [Financial Statements and Supplementary Data](index=136&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section contains the company's audited consolidated financial statements for FY2022 and FY2021, including the independent auditor's report and accompanying notes [Report of Independent Registered Public Accounting Firm](index=152&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The independent auditor issued an unqualified opinion on the financial statements, highlighting **substantial doubt** about the company's ability to continue as a **going concern** - The auditor's report contains an explanatory paragraph expressing **substantial doubt** about the Company's ability to continue as a **going concern**[515](index=515&type=chunk) - A critical audit matter identified was the determination of **impairment indicators** for **long-lived assets** and **right-of-use assets**, which involved significant management judgment[519](index=519&type=chunk)[521](index=521&type=chunk) [Consolidated Financial Statements](index=154&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements detail the company's financial position and performance, showing a decrease in total assets and a net loss for 2022 Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2022 | Dec 31, 2021 | |---|---|---| | Cash and cash equivalents | $11,782 | $42,351 | | Total Current Assets | $16,619 | $45,982 | | Total Assets | $34,422 | $68,135 | | Total Current Liabilities | $7,782 | $12,902 | | Total Liabilities | $14,821 | $24,150 | | Total Stockholders' Equity | $19,601 | $43,986 | Consolidated Cash Flow Data (in thousands) | | Year Ended Dec 31, 2022 | Year Ended Dec 31, 2021 | |---|---|---| | Net cash used in operating activities | $(26,972) | $(27,280) | | Net cash used in investing activities | $(4,945) | $(3,131) | | Net cash provided by financing activities | $202 | $52,556 | | **Net (decrease) increase in cash** | **$(31,715)** | **$22,145** | [Notes to Consolidated Financial Statements](index=158&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes provide detailed information on the reverse stock split, going concern uncertainty, related party transactions, grant income, and net operating loss carryforwards - A **one-for-ten reverse stock split** was effected on **January 26, 2023**, with all share and per-share data retrospectively adjusted[535](index=535&type=chunk) - The company entered into a services agreement with Wilson Wolf, a related party, receiving an **$8.0 million** cash payment for training and research services, with **$5.5 million** recognized as revenue for 2022[542](index=542&type=chunk)[594](index=594&type=chunk)[599](index=599&type=chunk) - The company is recognizing revenue from a **$13.1 million** CPRIT grant and a **$2.0 million** FDA Orphan Products Grant to support its Phase 2 trial of MT-401[539](index=539&type=chunk)[543](index=543&type=chunk) - As of December 31, 2022, the company had approximately **$135.2 million** of federal and **$38.5 million** of state net operating loss (NOL) carryforwards, though their use may be limited under **Section 382**[634](index=634&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=136&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its principal independent accountants - The company had no changes in, or disagreements with, its principal independent accountants[466](index=466&type=chunk) [Controls and Procedures](index=137&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective as of December 31, 2022 - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2022[468](index=468&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2022[469](index=469&type=chunk) [Other Information](index=138&type=section&id=Item%209B.%20Other%20Information) The company reports no other information for this item - None[475](index=475&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=139&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information for this item is incorporated by reference from the company's 2023 Annual Meeting of Stockholders proxy statement - Information is incorporated by reference from the registrant's definitive proxy statement for the 2023 Annual Meeting of Stockholders[479](index=479&type=chunk) [Executive Compensation](index=139&type=section&id=Item%2011.%20Executive%20Compensation) Information for this item is incorporated by reference from the company's definitive proxy statement - Information is incorporated by reference from the registrant's definitive proxy statement[481](index=481&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=139&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information for this item is incorporated by reference from the company's definitive proxy statement - Information is incorporated by reference from the registrant's definitive proxy statement[482](index=482&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=139&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information for this item is incorporated by reference from the company's definitive proxy statement - Information is incorporated by reference from the registrant's definitive proxy statement[484](index=484&type=chunk) [Principal Accounting Fees and Services](index=139&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information for this item is incorporated by reference from the company's definitive proxy statement - Information is incorporated by reference from the registrant's definitive proxy statement[485](index=485&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=140&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists the exhibits filed as part of the Form 10-K, including corporate governance documents, material contracts, and required certifications - This section contains the index of all exhibits filed with the Form 10-K[489](index=489&type=chunk) [Form 10-K Summary](index=148&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company did not provide a summary for this item - None[500](index=500&type=chunk)

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 ...