Full Press Release Details
Marker Therapeutics Reports First 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
Study participant with Non-Hodgkin's Lymphoma
who relapsed within 90 days of anti-CD19 CAR T cell therapy remains in complete response nine months after MT-601 treatment
Company received approval from United States
Adopted Name (USAN) council and International Nonproprietary Names (INN) expert committee for "neldaleucel" as nonproprietary
Houston, TX - May 15, 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 first quarter ended March 31, 2024.
"We are pleased to report a strong start
to the first quarter of 2024, marked by continued advances in our clinical programs," said Juan Vera, M.D., President and Chief
Executive Officer of Marker Therapeutics. "Building on our positive results, we continue to observe objective responses in our Phase
1 APOLLO study investigating MT-601 in patients with lymphoma who have relapsed or are ineligible for CAR T therapy. We recently announced
that our first patient treated in this study achieved a complete response, which was maintained nine months after initial treatment with
MT-601. This patient relapsed within 90 days of CAR T therapy, indicating that MT-601 has superior durability in this study participant.
In April, our Principal Investigator at City of Hope National Medical Center was invited to share his findings from the APOLLO trial at
a medical conference, where he presented data from two additional study participants and that three out of three subjects treated at City
of Hope demonstrated objective responses. While we plan to provide a more comprehensive clinical update on the APOLLO study in the second
half of this year, we are encouraged by these preliminary results, which underscore the potential benefit of MT-601 in patients with lymphoma."
"Another significant milestone this quarter
was to receive approval from the United States Adopted Name (USAN) council and International Nonproprietary Names (INN) expert committee
for "neldaleucel" as nonproprietary drug name for MT-601. Having made these steady advances, we are confident that
we are well positioned to achieve our near- and long-term goals related to MT-601 in patients with lymphoma," concluded Dr. Vera.
PROGRAM UPDATES & EXPECTED MILESTONES
selected as lead program based on promising
preliminary clinical results and non-clinical proof-of-concept data (Press
Release, January 8, 2024).
MT-401-OTS (Acute Myeloid Leukemia or Myelodysplastic
FIRST QUARTER 2024 FINANCIAL HIGHLIGHTS
Cash Position and Guidance: At March 31,
2024, Marker had cash and cash equivalents of $11.3 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 $2.6 million for the quarter ended March 31, 2024, compared to $3.4 million for the quarter ended March 31, 2023.
G&A Expenses: General and administrative
expenses were $1.2 million for the quarter ended March 31, 2024, compared to $2.2 million for the quarter ended March 31, 2023.
Net Loss: Marker reported a net loss of
$2.4 million for the quarter ended March 31, 2024, compared to a net loss of $4.9 million for the quarter ended March 31, 2023.
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.
Condensed Consolidated Balance Sheets
| March 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 11,323,428 | $ | 15,111,450 | ||||
| Prepaid expenses and deposits | 917,009 | 988,126 | ||||||
| Other receivables | 1,851,462 | 1,027,815 | ||||||
| Total current assets | 14,091,899 | 17,127,391 | ||||||
| Total assets | $ | 14,091,899 | $ | 17,127,391 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 1,949,700 | $ | 1,745,193 | ||||
| Related party payable | 353,965 | 1,329,655 | ||||||
| Total current liabilities | 2,303,665 | 3,074,848 | ||||||
| Total liabilities | 2,303,665 | 3,074,848 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.001 par value, 5 million shares authorized, 0 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | - | - | ||||||
| Common stock, $0.001 par value, 30 million shares authorized, 8.9 million issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | 8,910 | 8,891 | ||||||
| Additional paid-in capital | 450,458,009 | 450,329,515 | ||||||
| Accumulated deficit | (438,678,685 | ) | (436,285,863 | ) | ||||
| Total stockholders' equity | 11,788,234 | 14,052,543 | ||||||
| Total liabilities and stockholders' equity | $ | 14,091,899 | $ | 17,127,391 |
Marker Therapeutics, Inc.
Condensed Consolidated Statements of Operations
| For the Three Months Ended | ||||||||
| March 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenues: | ||||||||
| Grant income | $ | 1,244,061 | $ | 1,234,336 | ||||
| Total revenues | 1,244,061 | 1,234,336 | ||||||
| Operating expenses: | ||||||||
| Research and development | 2,575,015 | 3,376,497 | ||||||
| General and administrative | 1,218,063 | 2,167,318 | ||||||
| Total operating expenses | 3,793,078 | 5,543,815 | ||||||
| Loss from operations | (2,549,017 | ) | (4,309,479 | ) | ||||
| Other income (expenses): | ||||||||
| Interest income | 156,195 | 84,654 | ||||||
| Loss from continuing operations | (2,392,822 | ) | (4,224,825 | ) | ||||
| Discontinued operations: | ||||||||
| Loss from discontinued operations, net of tax | - | (742,751 | ) | |||||
| Income (loss) from discontinued operations | - | (742,751 | ) | |||||
| Net loss | $ | (2,392,822 | ) | $ | (4,967,576 | ) | ||
| Net earnings (loss) per share: | ||||||||
| Loss from continuing operations, basic and diluted | $ | (0.27 | ) | $ | (0.48 | ) | ||
| Income (loss) from discontinued operations, basic and diluted | $ | - | $ | (0.09 | ) | |||
| Net loss per share, basic and diluted | $ | (0.27 | ) | $ | (0.57 | ) | ||
| Weighted average number of common shares outstanding: | ||||||||
| Basic | 8,901,962 | 8,721,031 | ||||||
| Diluted | 8,901,962 | 8,721,031 |
Marker Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
| For the Three Months Ended | ||||||||
| March 31, | ||||||||
| 2024 | 2023 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (2,392,822 | ) | $ | (4,967,576 | ) | ||
| Less: loss from discontinued operations, net of tax | - | (742,751 | ) | |||||
| Net loss from continuing operations | (2,392,822 | ) | (4,224,825 | ) | ||||
| Reconciliation of net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | 79,417 | 659,913 | ||||||
| Changes in operating assets and liabilities: | - | - | ||||||
| Prepaid expenses and deposits | 71,117 | 36,452 | ||||||
| Other receivables | (823,647 | ) | 1,319,118 | |||||
| Related party receivable | - | (1,000,000 | ) | |||||
| Related party payable | (975,690 | ) | ||||||
| Accounts payable and accrued expenses | 204,507 | 111,171 | ||||||
| Net cash used in operating activities - continuing operations | (3,837,118 | ) | (3,098,171 | ) | ||||
| Net cash used in operating activities - discontinued operations | - | (2,790,124 | ) | |||||
| Net cash used in operating activities | (3,837,118 | ) | (5,888,295 | ) | ||||
| Cash Flows from Investing Activities: | ||||||||
| Net cash provided by (used in) investing activities - discontinued operations | - | (112,608 | ) | |||||
| Net cash provided by (used in) investing activities | - | (112,608 | ) | |||||
| Cash Flows from Financing Activities: | ||||||||
| Proceeds from issuance of common stock, net | - | 619,974 | ||||||
| Proceeds from stock options exercise | 49,096 | - | ||||||
| Net cash provided by financing activities | 49,096 | 619,974 | ||||||
| Net increase (decrease) in cash and cash equivalents | (3,788,022 | ) | (5,380,929 | ) | ||||
| Cash and cash equivalents at beginning of the period | 15,111,450 | 11,782,172 | ||||||
| Cash and cash equivalents at end of the period | $ | 11,323,428 | $ | 6,401,243 |
TIBEREND STRATEGIC ADVISORS, INC.
Daniel Kontoh-Boateng