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
Received Orphan Drug Designation (ODD) from
Implemented leadership transition resulting in appointments of
Executed comprehensive non-dilutive agreement with Cell Ready™ effecting a significant reduction in overhead expenses and extending Marker’s runway into the fourth quarter of 2025
Strategic prioritization of clinical pipeline with focus on MT-601 (Neldaleucel) in patients with lymphoma
“The progress achieved in 2023 we believe establishes a robust foundation for Marker and sets the stage for continued advancement in our clinical programs and business operations in the upcoming year,” commented
Further bolstering Marker’s position is the award of
Utilizing an
Marker also executed a comprehensive non-dilutive agreement with Cell Ready which included a sale of select cell manufacturing assets from Marker for approximately
“These accomplishments underline our commitment to driving scientific innovation, our vision in making major impact with our novel multiTAA technology for patients in need, and our emphasis on cash preservation and operational excellence. As we have pivoted into 2024, we remain poised to advance our clinical endeavors with the goal of introducing transformative therapies to the market and improving patient outcomes,” concluded
2023 PROGRAM UPDATES & OPERATIONAL HIGHLIGHTS
MT-601 (Lymphoma)
Non-Clinical Data on MT-601
- Marker developed a long-term in vitro killing assay 1) to investigate resistance mechanisms after CAR T cell treatment, and 2) to analyze if MT-601 (targeting 6 TAAs) can eliminate CAR-resistant lymphoma cells.
- Anti-CD19 CAR T cell treatment killed 98% of lymphoma cells in vitro. However, after three weeks, CD19-negative tumor cells started to grow. Further anti-CD19 CAR T cell treatments were ineffective as these tumor cells lack target antigen (CD19) expression (Pre-Clinical Data in Lymphoma,
May 31, 2023 ). - Treatment with MT-601 demonstrated long-term growth inhibition (over three weeks) of CAR-resistant lymphoma cells, highlighting that MT-601 has the potential to effectively treat CD19 CAR-resistant tumors (Press Release,
May 31, 2023 ).
Clinical Highlights
- 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.
- The first study participant, a 57-year-old female with diffuse large B cell lymphoma (DLBCL), was enrolled in the Phase 1 dose escalation stage of the trial after failing 4 prior lines of therapy, including relapsing within 90 days of anti-CD19 CAR T cell therapy. Without prior lymphodepletion, the participant was treated with MT-601. In
December 2023 , the Company announced that the study participant tolerated initial dose level well and had maintained a complete response to therapy six months after initial treatment with MT-601 (Press Release,December 11, 2023 ). - The Company is enrolling additional patients in the Phase 1 APOLLO trial and expects to report further data in the first half of 2024.
- MT-601 designated non-proprietary name “Neldaleucel” by United States Adopted Name (USAN) Counsel and International Nonproprietary Names (INN) Expert Committee.
MT-601 (Pancreatic)
- Investigational New Drug (IND) application cleared by U.S. Food and Drug Administration (FDA) for multicenter Phase 1 trial of MT-601 in patients with metastatic pancreatic cancer in combination with front-line chemotherapy.
- Clinical advancement will be pending additional financial support from non-dilutive grant activities.
MT-401-
U.S. FDA has granted an Investigational New Drug (IND) to investigate MT-401 as an “Off-the-Shelf” (MT-401-OTS ) product in patients with AML or Myelodysplastic Syndrome (MDS). MT-401-OTS is manufactured from healthy donors and a cellular inventory has been established with ongoing efforts to expand.- Marker announced non-clinical proof-of-concept data supporting the clinical benefits of MT-401-
OTS in AML. - The Company has secured
$2M in non-dilutive funding from theNIH Small Business Innovation Research (SBIR) program. These funds will support the clinical investigation of MT-401-OTS in patients with AML without affecting the ongoing Phase 1 APOLLO study in patients with lymphoma. - Granted ODD from the Committee for Orphan Medicinal Products of the EMA for the treatment of patients with AML in 2023. ODD was received from the
U.S. FDA in 2020. - Clinical program initiation of MT-401-
OTS anticipated for the second half of 2024.
2023 CORPORATE HIGHLIGHTS
- Announced clinical pipeline prioritization in
January 2024 to strategically focus on MT-601 in patients with lymphoma. This announcement also included program updates that highlighted the potential of the Company’s MT-401-OTS program for AML. - Appointed
Juan Vera , M.D., as President and Chief Executive Officer andMonic Stuart , M.D., MPH, as Chief Medical Officer.Dr. Vera was also appointed the Company’s Principal Financial and Accounting Officer. - On
June 26, 2023 , Marker completed a non-dilutive transaction with Cell Ready, under which Cell Ready purchased certain cell manufacturing assets from Marker for approximately$19 million in cash. OnFebruary 22, 2024 , Marker entered into a Master Services Agreement for Product Supply with Cell Ready. Under this agreement, Cell Ready will perform a wide variety of services for Marker, including research and development, and manufacturing in support of Marker’s clinical trials. - Terminated common stock purchase agreement with
Lincoln Park Capital . - Extended financial runway into the fourth quarter of 2025.
FISCAL YEAR 2023 FINANCIAL HIGHLIGHTS
Cash Position and Guidance: At
R&D Expenses: Research and development expenses were
G&A Expenses: General and administrative expenses were
Net Loss: Marker reported a net loss of
About multiTAA-specific T cells
The multi-tumor associated antigen (multiTAA)-specific T cell platform is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient's/donor’s blood capable of recognizing a broad range of tumor antigens. Since multiTAA-specific T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefits. As a result, Marker believes that its portfolio of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies.
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Forward-Looking Statements
This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and the timing, conduct and success of our clinical trials of our product candidates, including MT-601 and MT-401-
Consolidated Balance Sheets (Audited) |
||||||||
| 2023 | 2022 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 15,111,450 | $ | 11,782,172 | ||||
| Prepaid expenses and deposits | 988,126 | 1,849,239 | ||||||
| Other receivables | 1,027,815 | 2,402,004 | ||||||
| Current assets of discontinued operations | – | 585,840 | ||||||
| Total current assets | 17,127,391 | 16,619,255 | ||||||
| Non-current assets of discontinued operations | – | 17,802,929 | ||||||
| Total assets | $ | 17,127,391 | $ | 34,422,184 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 1,745,193 | $ | 2,521,193 | ||||
| Related party payable | 1,329,655 | – | ||||||
| Current liabilities of discontinued operations | – | 5,260,616 | ||||||
| Total current liabilities | 3,074,848 | 7,781,809 | ||||||
| Non-current liabilities of discontinued operations | – | 7,039,338 | ||||||
| Total liabilities | 3,074,848 | 14,821,147 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, |
– | – | ||||||
| Common stock, |
8,891 | 8,406 | ||||||
| Additional paid-in capital | 450,329,515 | 447,641,680 | ||||||
| Accumulated deficit | (436,285,863 | ) | (428,049,049 | ) | ||||
| Total stockholders' equity | 14,052,543 | 19,601,037 | ||||||
| Total liabilities and stockholders' equity | $ | 17,127,391 | $ | 34,422,184 | ||||
Consolidated Statements of Operations (Audited) |
||||||||
| For the Years Ended | ||||||||
| 2023 | 2022 | |||||||
| Revenues: | ||||||||
| Grant income | $ | 3,311,133 | $ | 3,513,544 | ||||
| Total revenues | 3,311,133 | 3,513,544 | ||||||
| Operating expenses: | ||||||||
| Research and development | 10,416,789 | 11,968,428 | ||||||
| General and administrative | 7,475,722 | 11,336,120 | ||||||
| Total operating expenses | 17,892,511 | 23,304,548 | ||||||
| Loss from operations | (14,581,378 | ) | (19,791,004 | ) | ||||
| Other income (expenses): | ||||||||
| Arbitration settlement | – | (232,974 | ) | |||||
| Interest income | 539,158 | 248,063 | ||||||
| Loss from continuing operations before income taxes | (14,042,220 | ) | (19,775,915 | ) | ||||
| Income tax expense | 3,675 | – | ||||||
| Net loss from continuing operations | (14,045,895 | ) | (19,775,915 | ) | ||||
| Discontinued operations: | ||||||||
| Loss from discontinued operations | (2,922,406 | ) | (10,154,779 | ) | ||||
| Gain on disposal of discontinued operations, net of |
8,731,487 | – | ||||||
| Income (loss) from discontinued operations | 5,809,081 | (10,154,779 | ) | |||||
| Net loss | $ | (8,236,814 | ) | $ | (29,930,694 | ) | ||
| Net earnings (loss) per share: | ||||||||
| Loss from continuing operations, basic and diluted | $ | (1.59 | ) | $ | (2.37 | ) | ||
| Income (loss) from discontinued operations, basic and diluted | $ | 0.66 | $ | (1.22 | ) | |||
| Net loss per share, basic and diluted | $ | (0.94 | ) | $ | (3.58 | ) | ||
| Weighted average number of common shares outstanding: | ||||||||
| Basic | 8,809,382 | 8,351,003 | ||||||
| Diluted | 8,809,382 | 8,351,003 | ||||||
Consolidated Statements of Cash Flows (Audited) |
||||||||
| For the Years Ended | ||||||||
| 2023 | 2022 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (8,236,814 | ) | $ | (29,930,694 | ) | ||
| Less: gain (loss) from discontinued operations, net of |
5,809,081 | (10,154,779 | ) | |||||
| Net loss from continuing operations | (14,045,895 | ) | (19,775,915 | ) | ||||
| Reconciliation of net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 858,269 | 3,304,634 | ||||||
| Gain on lease termination | – | (278,681 | ) | |||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and deposits | 861,113 | 104,147 | ||||||
| Other receivables | 1,374,189 | (2,401,767 | ) | |||||
| Accounts payable and accrued expenses | 611,262 | (1,319,710 | ) | |||||
| Deferred revenue | – | (1,146,186 | ) | |||||
| Net cash used in operating activities – continuing operations | (10,341,062 | ) | (21,513,478 | ) | ||||
| Net cash used in operating activities – discontinued operations | (6,098,899 | ) | (5,458,675 | ) | ||||
| Net cash used in operating activities | (16,439,961 | ) | (26,972,153 | ) | ||||
| Cash Flows from Investing Activities: | ||||||||
| Net cash provided by (used in) investing activities – discontinued operations | 18,664,122 | (4,945,136 | ) | |||||
| Net cash provided by (used in) investing activities | 18,664,122 | (4,945,136 | ) | |||||
| Cash Flows from Financing Activities: | ||||||||
| Proceeds from issuance of common stock, net | 1,014,640 | 202,130 | ||||||
| Proceeds from stock options exercise | 90,477 | – | ||||||
| Net cash provided by financing activities | 1,105,117 | 202,130 | ||||||
| Net increase (decrease) in cash and cash equivalents | 3,329,278 | (31,715,159 | ) | |||||
| Cash and cash equivalents at beginning of the year | 11,782,172 | 43,497,331 | ||||||
| Cash and cash equivalents at end of the year | $ | 15,111,450 | $ | 11,782,172 | ||||
Contacts
TIBEREND STRATEGIC ADVISORS, INC.
Investors
(862) 213-1398
dboateng@tiberend.com
Source: Marker Therapeutics