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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 partic

Key Takeaway: 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

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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 European
Medicines Agency (EMA) for multiTAA-specific T cell product candidate MT-401 (Zedenoleucel) for the treatment of patients with AML
Implemented leadership transition resulting in
appointments of Juan Vera, M.D. as President and Chief Executive Officer and Monic Stuart, M.D., MPH as Chief Medical Officer
Executed comprehensive non-dilutive agreement with
Cell ReadyTM effecting a significant reduction in overhead expenses and extending Marker's runway into the fourth quarter
Strategic prioritization of clinical pipeline with
focus on MT-601 (Neldaleucel) in patients with lymphoma
- March 25, 2024 - Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology
company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid
tumors, today reported recent corporate developments and financial results for the year ended December 31, 2023.
"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 Juan Vera, M.D. President and Chief Executive Officer of Marker Therapeutics. "A pinnacle
of last year's success was the Phase 1 lymphoma study milestone, where we observed a sustained complete response in our first study participant
treated with MT-601 following CAR T relapse. This patient relapsed within 90 days of CAR T therapy but has remained in a complete remission
for at least six months after MT-601 treatment, indicating that MT-601 has superior durability in this study participant. The promising
clinical and non-clinical observations from our lymphoma study reinforced our strategic decision, made public this January, to prioritize
the development of MT-601 in patients with lymphoma who have failed or are ineligible for CAR T therapy. Focusing on this unique niche
of patients and by targeting multiple antigens, our approach differs significantly from competitors, and we believe that MT-601 could
address an unmet medical need in this patient population with a better safety profile and at lower costs when compared to gene-modified
cell therapy approaches."
Further bolstering Marker's position is
the award of $2 million in non-dilutive funding from the NIH last year, which is instrumental in supporting the advancement of the Company's
MT-401 "Off-the-Shelf" (MT-401-OTS) program in patients with Acute Myeloid Leukemia (AML).
Dr. Vera added, "This award is expected
to enable us to proceed with the OTS program without affecting our ongoing study for patients with lymphoma. Decreasing time to treatment
is critical for rapidly progressing cancers, such as patients with minimal residual disease (MRD) in AML."
Utilizing an OTS product manufactured from healthy
donors will help to bypass the treatment delay that is associated with patient-specific manufacture and should shorten the time until
the product is made available to patients, while reducing manufacturing costs. Additionally, receiving Orphan Drug Designation (ODD) by
the European Medicines Agency (EMA) substantiates the potential impact of MT-401 in patients with AML and presents an opportunity to develop
the therapy on an expedited basis.
Marker also executed a comprehensive non-dilutive
agreement with Cell Ready which included a sale of select cell manufacturing assets from Marker for approximately $19 million in cash.
This major transaction, which we expect will enable a reduction of overhead expenses of about $11 million annually, not only improves
our financial health but, we believe, also positions us uniquely in the cell therapy industry - a sector where such significant
non-dilutive funding and operational savings are remarkably rare. This strategic foresight, together with the drawdowns available from
our grant funds, should extend the cash runway into the fourth quarter of 2025.
"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 Dr. Vera.
2023 PROGRAM UPDATES & OPERATIONAL
Non-Clinical Data on MT-601
MT-401-OTS (Acute Myeloid Leukemia or Myelodysplastic
2023 CORPORATE HIGHLIGHTS
FISCAL YEAR 2023 FINANCIAL HIGHLIGHTS
and Guidance: At December 31, 2023, Marker had cash and cash equivalents of $15.1 million. The Company believes that its
existing cash and cash equivalents will fund its operating expenses into the fourth quarter of 2025, inclusive of available drawdowns
Research and development expenses were $10.4 million for the year ended December 31, 2023, compared to $12.0 million for the year
ended December 31, 2022.
General and administrative expenses were $7.5 million for the year ended December 31, 2023, compared to $11.3 million for the year
ended December 31, 2022.
Marker reported a net loss of $8.2 million for the year ended December 31, 2023, compared to a net loss of $29.9 million for the
year ended December 31, 2022.
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.
About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a Houston, TX-based
clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment
of hematological malignancies and solid tumors. Clinical trials that enrolled more than 200 patients across various hematological and
solid tumor indications showed that the Company's autologous and allogeneic multiTAA-specific T cell products were well tolerated
and demonstrated durable clinical responses. Marker's goal is to introduce novel T cell therapies to the market and improve patient
outcomes. To achieve these objectives, the Company prioritizes the preservation of financial resources and focuses on operational excellence.
Marker's unique T cell platform is strengthened by non-dilutive funding from U.S. state and federal agencies supporting cancer research.
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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-OTS. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual
results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited
to the risks set forth in the Company's most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR
at WWW.SEC.GOV. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future
events or otherwise, after the date of this press release.
Marker Therapeutics, Inc.
Consolidated Balance Sheets
December 31, December 31,
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, $0.001 par value, 5 million shares authorized, 0 shares issued and outstanding at December 31, 2023 and 2022, respectively - -
Common stock, $0.001 par value, 30 million shares authorized, 8.9 million and 8.4 million shares issued and outstanding as of December 31, 2023 and 2022, respectively (see Note 10) 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
Marker Therapeutics, Inc.
Consolidated Statements of Operations
For the Years Ended
December 31,
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 $63,000 in tax 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
Last updated: Mar 25, 2024