Marker Therapeutics(MRKR)

Search documents
Marker Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Updates
Newsfilter· 2024-05-15 20:15
MT-601 (Lymphoma) Phase 1 multicenter APOLLO trial (clinicaltrials.gov identifier: NCT05798897), investigating MT-601 in patients with lymphoma who relapsed or are ineligible for anti-CD19 CAR T cell therapies, was selected as lead program based on promising preliminary clinical results and non-clinical proof-of-concept data (Press Release, January 8, 2024). Three patients were treated at City of Hope National Medical Center as part of the APOLLO study: First study participant treated with MT-601 had diffus ...
Marker Therapeutics(MRKR) - 2024 Q1 - Quarterly Report
2024-05-15 20:03
[PART I – FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Marker Therapeutics reported a net loss of **$2.4 million** for Q1 2024, a significant reduction from **$5.0 million** in Q1 2023, driven by lower operating expenses [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$14.1 million** as of March 31, 2024, from **$17.1 million** at year-end 2023, primarily due to reduced cash and cash equivalents Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $11,323 | $15,111 | | Total current assets | $14,092 | $17,127 | | **Total assets** | **$14,092** | **$17,127** | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $2,304 | $3,075 | | **Total liabilities** | **$2,304** | **$3,075** | | **Total stockholders' equity** | **$11,788** | **$14,053** | | **Total liabilities and stockholders' equity** | **$14,092** | **$17,127** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss significantly decreased to **$2.4 million** in Q1 2024 from **$5.0 million** in Q1 2023, driven by reduced R&D and G&A expenses Condensed Consolidated Statements of Operations (in thousands) | | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Grant income | $1,244 | $1,234 | | **Total revenues** | **$1,244** | **$1,234** | | Research and development | $2,575 | $3,376 | | General and administrative | $1,218 | $2,167 | | **Total operating expenses** | **$3,793** | **$5,544** | | Loss from operations | ($2,549) | ($4,309) | | Loss from continuing operations | ($2,393) | ($4,225) | | Loss from discontinued operations | $0 | ($743) | | **Net loss** | **($2,393)** | **($4,968)** | | **Net loss per share** | **($0.27)** | **($0.57)** | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$3.8 million** in Q1 2024, leading to a net decrease in cash and cash equivalents to **$11.3 million** Condensed Consolidated Statements of Cash Flows (in thousands) | | For the Three Months Ended March 31, 2024 | For the Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($3,837) | ($5,888) | | Net cash used in investing activities | $0 | ($113) | | Net cash provided by financing activities | $49 | $620 | | **Net decrease in cash and cash equivalents** | **($3,788)** | **($5,381)** | | Cash and cash equivalents at beginning of period | $15,111 | $11,782 | | **Cash and cash equivalents at end of period** | **$11,323** | **$6,401** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's immuno-oncology focus, the strategic shift from its 2023 asset sale, reliance on grant funding, and projected cash runway into Q4 2025 - The company is a clinical-stage immuno-oncology company focused on developing multiTAA-specific T cell immunotherapies[14](index=14&type=chunk) - In June 2023, the company sold its manufacturing facilities and related assets to Cell Ready, LLC for **$19.0 million**, treated as a discontinued operation and a significant strategic shift[15](index=15&type=chunk)[16](index=16&type=chunk) - The company effected a **1-for-10 reverse stock split** on January 26, 2023, reducing authorized common stock from **300 million** to **30 million** shares[21](index=21&type=chunk) - Based on current plans, the company expects its cash and cash equivalents of **$11.3 million** as of March 31, 2024, will fund operations into the **fourth quarter of 2025**[30](index=30&type=chunk) - In Q1 2024, the company incurred **$1.2 million** in expenses for services from Cell Ready, a related party, for GMP drug product manufacturing[72](index=72&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management attributes improved Q1 2024 financial results to significant cost reductions post-asset sale, focusing on advancing its clinical pipeline with outsourced manufacturing, while relying on external financing for future operations [Company Overview and Pipeline](index=24&type=section&id=Company%20Overview%20and%20Pipeline) Marker Therapeutics is a clinical-stage immuno-oncology company developing multiTAA-specific T cell therapies, with a pipeline including MT-601 and MT-401-OTS, offering advantages over CAR-T - The company specializes in multiTAA-specific T cell technology, which expands a patient's own tumor-specific T cells to recognize and kill cancer cells[78](index=78&type=chunk) - Key advantages cited over CAR-T therapies include targeting multiple tumor antigens, a strong clinical safety profile with no observed CRS, and a non-genetically engineered process reducing manufacturing complexity and cost[80](index=80&type=chunk)[81](index=81&type=chunk) - The clinical pipeline features **MT-601** (autologous) for lymphoma and pancreatic cancer, and **MT-401-OTS** (off-the-shelf) for various indications[80](index=80&type=chunk)[84](index=84&type=chunk) - Recent data from the APOLLO study of **MT-601** presented in April 2024 showed that participants tolerated the initial dose level well and demonstrated durable objective responses[83](index=83&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Loss from continuing operations decreased **43%** to **$2.4 million** in Q1 2024, driven by a **32%** reduction in total operating expenses, including R&D and G&A Comparison of Operations for the Three Months Ended March 31 (in thousands) | | 2024 | 2023 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Grant income | $1,244 | $1,234 | $10 | 1% | | Research and development | $2,575 | $3,376 | ($801) | (24)% | | General and administrative | $1,218 | $2,167 | ($949) | (44)% | | **Loss from continuing operations** | **($2,393)** | **($4,224)** | **$1,831** | **(43)%** | - The **$0.8 million** decrease in R&D expenses was mainly due to lower process development, clinical trial, and headcount costs, partially offset by a **$1.2 million** increase in outsourced clinical manufacturing costs with Cell Ready[107](index=107&type=chunk)[108](index=108&type=chunk) - The **$1.0 million** decrease in G&A expenses was primarily driven by reduced headcount-related costs (**$0.4 million**) and lower legal and professional fees (**$0.4 million**)[108](index=108&type=chunk)[109](index=109&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) The company's cash and cash equivalents decreased to **$11.3 million** by March 31, 2024, with current funds projected to last into Q4 2025, necessitating continued reliance on external financing Cash and Working Capital (in thousands) | | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $11,323 | $15,111 | | Working capital | $11,788 | $14,053 | - Net cash used in operating activities from continuing operations was **$3.8 million** for Q1 2024[113](index=113&type=chunk)[114](index=114&type=chunk) - The company expects its cash on hand as of March 31, 2024, will fund operating expenses and capital requirements into the **fourth quarter of 2025**[124](index=124&type=chunk) - The company has access to capital through an ATM agreement, though its use is limited, selling **8,178 shares** for net proceeds of **$0.04 million** in April 2024[128](index=128&type=chunk)[73](index=73&type=chunk) - The company terminated its **$25 million** stock purchase agreement with Lincoln Park Capital on February 29, 2024[129](index=129&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, Marker Therapeutics is exempt from providing quantitative and qualitative disclosures about market risk - 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 under this item[131](index=131&type=chunk) [Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded that disclosure controls and procedures were effective as of March 31, 2024, with no material changes to internal control over financial reporting during the quarter - Management evaluated disclosure controls and procedures and concluded they were effective as of the end of the period covered by the report[132](index=132&type=chunk) - There were no changes in internal control over financial reporting during the fiscal quarter ended March 31, 2024, that materially affected, or are reasonably likely to materially affect, internal controls[135](index=135&type=chunk) [PART II – OTHER INFORMATION](index=38&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings.) The company is not currently a party to any material legal proceedings, nor is it aware of any pending or threatened litigation - The company is not currently a party to any material legal proceedings[136](index=136&type=chunk) [Risk Factors](index=38&type=section&id=Item%201A.Risk%20Factors.) No material changes to the risk factors previously disclosed in the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 - There have been no material changes to the risk factors described in the Annual Report on Form 10-K for the fiscal year ended December 31, 2023[137](index=137&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=38&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) The company recorded no unregistered sales of equity securities during the three months ended March 31, 2024 - No issuances of unregistered securities were recorded during the three months ended March 31, 2024[138](index=138&type=chunk) [Exhibits](index=39&type=section&id=Item%206.%20Exhibits.) This section lists exhibits filed with the Form 10-Q, including CEO and CFO certifications and interactive data files - The report includes CEO and CFO certifications pursuant to Rule 13a-14(a) and Section 906 of the Sarbanes-Oxley Act of 2002[142](index=142&type=chunk) - The Master Services Agreement with Cell Ready LLC is incorporated by reference[142](index=142&type=chunk)
Marker Therapeutics(MRKR) - 2023 Q4 - Annual Results
2024-03-25 22:18
Exhibit 99.1 Marker Therapeutics Reports Year-End 2023 Corporate and Financial Results Lead program in patients with lymphoma demonstrated preliminary safety and efficacy results with sustained complete response in first study participant treated with MT-601 (Neldaleucel) following CAR T relapse Secured non-dilutive funding of $2 million from National Institute of Health (NIH) to support clinical program for treatment of patients with Acute Myeloid Leukemia (AML) Received Orphan Drug Designation (ODD) from ...
Marker Therapeutics(MRKR) - 2023 Q4 - Annual Report
2024-03-25 21:37
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, 2023 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) Delawa ...
Marker Therapeutics(MRKR) - 2023 Q3 - Quarterly Report
2023-11-09 21:31
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 ...
Marker Therapeutics(MRKR) - 2023 Q2 - Quarterly Report
2023-08-14 20:03
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 ...
Marker Therapeutics(MRKR) - 2023 Q1 - Quarterly Report
2023-05-15 20:08
[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)
Marker Therapeutics(MRKR) - 2022 Q4 - Annual Report
2023-03-22 12:00
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)
Marker Therapeutics(MRKR) - 2022 Q3 - Quarterly Report
2022-11-10 21:04
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 ...
Marker Therapeutics(MRKR) - 2022 Q2 - Quarterly Report
2022-08-11 20:38
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 ...