Full Press Release Details
Marker Therapeutics Reports Second Quarter 2024
Financial Results and Provides Business Updates
Preliminary safety and efficacy with sustained
objective responses observed in patients with lymphoma treated with MT-601 in Phase 1 APOLLO study
MT-601 was well tolerated with no observation
of cytokine release syndrome (CRS) or immune effector cell associated neurotoxicity syndrome (ICANS)
Marker Therapeutics to receive $2 million funding
from NIH Small Business Innovation Research (SBIR) program to support clinical investigation of MT-601 in patients with lymphoma
Houston, TX - August 14, 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 corporate updates and financial results
for the second quarter ended June 30, 2024.
"The second quarter of 2024 was characterized
by ongoing momentum in our clinical programs," said Juan Vera, M.D., President and Chief Executive Officer of Marker Therapeutics.
"Following the positive outcomes reported in the first quarter, we continued to advance our Phase 1 APOLLO study investigating MT-601
in patients with lymphoma who have relapsed after anti-CD19 CAR-T cell therapy or where CAR-T therapy is not an option. In April, Geoffrey
Shouse, D.O., Ph.D., the Principal Investigator at City of Hope National Medical Center, presented encouraging data from the APOLLO study,
at the 11th Global Summit on Hematologic Malignancies. The data showed that three out of three participants had objective responses,
and that treatment was well tolerated among all patients with no significant treatment-related adverse events, further signifying the
potential benefit of MT-601 in patients with lymphoma. We are gratified by these preliminary results and expect to provide a more comprehensive
clinical update on the APOLLO study in the upcoming quarter."
"Additionally, after the close of the quarter,
we announced that Marker has been awarded a $2 million Small Business Innovation Research (SBIR) grant from the National Institutes of
Health (NIH) to support our Phase 1 APOLLO study evaluating the safety and efficacy of MT-601 in patients with non-Hodgkin's lymphoma
(NHL) who have relapsed following anti-CD19 CAR-T cell therapy. We were pleased to receive this highly competitive grant, which reinforces
the potential scientific merit and the capacity of the APOLLO study to address an unmet medical need," added Dr. Vera.
PROGRAM UPDATES & EXPECTED MILESTONES
MT-401-OTS (Acute Myeloid Leukemia or Myelodysplastic
SECOND QUARTER 2024 FINANCIAL HIGHLIGHTS
Cash Position and Guidance: At June 30,
2024, Marker had cash and cash equivalents of $7.8 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 from grant funds.
R&D Expenses: Research and development
expenses were $2.3 million for the quarter ended June 30, 2024, compared to $2.4 million for the quarter ended June 30, 2023.
G&A Expenses: General and administrative
expenses were $1.1 million for the quarter ended June 30, 2024, compared to $2.5 million for the quarter ended June 30, 2023.
Net Loss: Marker reported a net loss from
continuing operations of $2.2 million for the quarter ended June 30, 2024, compared to $4.1 million for the quarter ended June 30, 2023.
"The financial performance in the past quarter
demonstrates the benefits that we are seeing from our restructuring efforts that we initiated in the second quarter of 2023, including
our agreement with Cell Ready, and the favorable impact that they are having on our business, especially our Operating Expenses. Unlike
most small, pre-revenue companies in the Cell Therapy space, our extremely efficient structure, combined with our successful grant funding
initiatives, are allowing us to maximize our cash runway and to focus the majority of our available funds on our clinical programs,"
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. Unlike other T cell therapies, multiTAA-specific T cells allow the recognition
of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. Since multiTAA-specific
T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture,
with an improved safety profile, compared to current engineered T cell approaches, and may provide patients with meaningful clinical benefits.
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
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 for
the treatment of patients with lymphoma.
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 its forward-looking statements whether as a result of new information, future events or otherwise, after the
date of this press release except as may be required by law.
Marker Therapeutics, Inc.
Condensed Consolidated Balance Sheets
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 7,800,464 | $ | 15,111,450 | ||||
| Prepaid expenses and deposits | 1,384,394 | 988,126 | ||||||
| Other receivables | 2,490,147 | 1,027,815 | ||||||
| Total current assets | 11,675,005 | 17,127,391 | ||||||
| Total assets | $ | 11,675,005 | $ | 17,127,391 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 1,679,672 | $ | 1,745,193 | ||||
| Related party payable | 292,569 | 1,329,655 | ||||||
| Total current liabilities | 1,972,241 | 3,074,848 | ||||||
| Total liabilities | 1,972,241 | 3,074,848 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.001 par value, 5 million shares authorized, 0 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | - | - | ||||||
| Common stock, $0.001 par value, 30 million shares authorized, 8.9 million shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively (see Note 8) | 8,922 | 8,891 | ||||||
| Additional paid-in capital | 450,565,204 | 450,329,515 | ||||||
| Accumulated deficit | (440,871,362 | ) | (436,285,863 | ) | ||||
| Total stockholders' equity | 9,702,764 | 14,052,543 | ||||||
| Total liabilities and stockholders' equity | $ | 11,675,005 | $ | 17,127,391 |
Marker Therapeutics, Inc.
Condensed Consolidated Statements of Operations
| For the Three Months Ended | For the Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenues: | ||||||||||||||||
| Grant income | $ | 1,169,236 | $ | 762,658 | $ | 2,413,297 | $ | 1,996,995 | ||||||||
| Total revenues | 1,169,236 | 762,658 | 2,413,297 | 1,996,995 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,335,430 | 2,377,993 | 4,910,446 | 5,754,492 | ||||||||||||
| General and administrative | 1,141,871 | 2,518,725 | 2,359,934 | 4,686,044 | ||||||||||||
| Total operating expenses | 3,477,301 | 4,896,718 | 7,270,380 | 10,440,536 | ||||||||||||
| Loss from operations | (2,308,065 | ) | (4,134,060 | ) | (4,857,083 | ) | (8,443,541 | ) | ||||||||
| Other income (expenses): | ||||||||||||||||
| Interest income | 115,388 | 35,080 | 271,584 | 119,734 | ||||||||||||
| Loss from continuing operations | (2,192,677 | ) | (4,098,980 | ) | (4,585,499 | ) | (8,323,807 | ) | ||||||||
| Discontinued operations: | ||||||||||||||||
| Loss from discontinued operations, net of tax | - | (2,179,657 | ) | - | (2,922,406 | ) | ||||||||||
| Gain on disposal of discontinued operations | - | 8,794,426 | - | 8,794,426 | ||||||||||||
| Income from discontinued operations | - | 6,614,769 | - | 5,872,020 | ||||||||||||
| Net income/(loss) | $ | (2,192,677 | ) | $ | 2,515,789 | $ | (4,585,499 | ) | $ | (2,451,787 | ) | |||||
| Net loss per share: | ||||||||||||||||
| Loss from continuing operations, basic and diluted | $ | (0.25 | ) | $ | (0.47 | ) | $ | (0.51 | ) | $ | (0.95 | ) | ||||
| Income from discontinued operations, basic and diluted | $ | - | $ | 0.75 | $ | - | $ | 0.67 | ||||||||
| Net income/(loss) per share, basic and diluted | $ | (0.25 | ) | $ | 0.29 | $ | (0.51 | ) | $ | (0.28 | ) | |||||
| Weighted average number of common shares outstanding: | ||||||||||||||||
| Basic | 8,918,233 | 8,798,956 | 8,910,097 | 8,760,209 | ||||||||||||
| Diluted | 8,918,233 | 8,798,956 | 8,910,097 | 8,760,209 |
Marker Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
| For the Six Months Ended | ||||||||
| June 30, | ||||||||
| 2024 | 2023 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (4,585,499 | ) | $ | (2,451,787 | ) | ||
| Less: income from discontinued operations, net of tax | - | 5,872,020 | ||||||
| Net loss from continuing operations | (4,585,499 | ) | (8,323,807 | ) | ||||
| Reconciliation of net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 142,018 | 539,858 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and deposits | (396,268 | ) | (238,223 | ) | ||||
| Other receivables | (1,462,332 | ) | 655,904 | |||||
| Related party payable | (1,037,086 | ) | - | |||||
| Accounts payable and accrued expenses | (65,521 | ) | 197,030 | |||||
| Net cash used in operating activities - continuing operations | (7,404,688 | ) | (7,169,238 | ) | ||||
| Net cash used in operating activities - discontinued operations | - | (5,775,680 | ) | |||||
| Net cash used in operating activities | (7,404,688 | ) | (12,944,918 | ) | ||||
| Cash Flows from Investing Activities: | ||||||||
| Net cash provided by (used in) investing activities - discontinued operations | - | 18,664,122 | ||||||
| Net cash provided by (used in) investing activities | - | 18,664,122 | ||||||
| Cash Flows from Financing Activities: | ||||||||
| Proceeds from issuance of common stock, net | 36,902 | 619,974 | ||||||
| Proceeds from stock options exercise | 56,800 | 736 | ||||||
| Net cash provided by financing activities | 93,702 | 620,710 | ||||||
| Net (decrease)/increase in cash and cash equivalents | (7,310,986 | ) | 6,339,914 | |||||
| Cash and cash equivalents at beginning of the period | 15,111,450 | 11,782,172 | ||||||
| Cash and cash equivalents at end of the period | $ | 7,800,464 | $ | 18,122,086 |
TIBEREND STRATEGIC ADVISORS, INC.