Full Press Release Details
Marker Therapeutics Reports Q3 2022 Operating
and Financial Results
Company awarded $2 million U.S. FDA Orphan Products
Grant to support Phase 2 ARTEMIS trial of its lead T cell therapy candidate MT-401 in patients with post-transplant AML
Houston, TX- November 10,
2022-Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company specializing in the
development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications,
today provided a corporate update and reported financial results for the third quarter ended September 30, 2022.
quarter we reached a major milestone in treating the first six patients in our Phase 2 AML trial with T cells derived from our new manufacturing
process, which are designed for increased potency against tumor antigens," said Peter L. Hoang, Marker's President and
Chief Executive Officer. "We are also pleased to receive a grant from the FDA Orphan Products program to support the Phase
2 treatment arm evaluating MT-401 in patients with minimal residual disease. We believe the MRD-positive patient population represents
a significant opportunity for MT-401 as we continue to dose more patients in the trial and measure long-term response."
PROGRAM UPDATES AND EXPECTED MILESTONES
Acute Myeloid Leukemia (MT-401)
Pancreatic Cancer (MT-601)
THIRD QUARTER 2022 FINANCIAL RESULTS
About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a clinical-stage immuno-oncology
company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies
and solid tumor indications. Marker's cell therapy technology is based on the selective expansion of non-engineered, tumor-specific
T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. This population of
T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient's immune system
to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cell therapies, we believe that our
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 benefit. As a result, Marker believes 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; the timing, conduct and success of our clinical trials of our
product candidates; our ability to use our manufacturing facilities to support clinical and commercial demand; and our future operating
expenses and capital expenditure requirements. 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. Such risks and uncertainties may be amplified by the COVID-19 pandemic and its impact
on our business and the global economy. 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
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 18,076,379 | $ | 42,351,145 | ||||
| Restricted cash | - | 1,146,186 | ||||||
| Prepaid expenses and deposits | 2,665,668 | 2,484,634 | ||||||
| Other receivables | 1,681,019 | 237 | ||||||
| Total current assets | 22,423,066 | 45,982,202 | ||||||
| Non-current assets: | ||||||||
| Property, plant and equipment, net | 13,059,816 | 10,096,861 | ||||||
| Construction in progress | - | 2,225,610 | ||||||
| Right-of-use assets, net | 5,631,683 | 9,830,461 | ||||||
| Total non-current assets | 18,691,499 | 22,152,932 | ||||||
| Total assets | $ | 41,114,565 | $ | 68,135,134 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 5,746,404 | $ | 11,134,913 | ||||
| Related party deferred revenue | 5,050,000 | - | ||||||
| Lease liability | 490,449 | 620,490 | ||||||
| Deferred revenue | - | 1,146,186 | ||||||
| Total current liabilities | 11,286,853 | 12,901,589 | ||||||
| Non-current liabilities: | ||||||||
| Lease liability, net of current portion | 7,225,990 | 11,247,950 | ||||||
| Total non-current liabilities | 7,225,990 | 11,247,950 | ||||||
| Total liabilities | 18,512,843 | 24,149,539 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at September 30, 2022 and December 31,2021, respectively | - | - | ||||||
| Common stock, $0.001 par value, 300 million and 150 million shares authorized, 83.6 million and 83.1 million shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively | 83,599 | 83,079 | ||||||
| Additional paid-in capital | 446,710,757 | 442,020,871 | ||||||
| Accumulated deficit | (424,192,634 | ) | (398,118,355 | ) | ||||
| Total stockholders' equity | 22,601,722 | 43,985,595 | ||||||
| Total liabilities and stockholders' equity | $ | 41,114,565 | $ | 68,135,134 |
Marker Therapeutics, Inc.
Condensed Consolidated Statements of Operations
| For the Three Months Ended | For the Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenues: | ||||||||||||||||
| Grant income | $ | 999,571 | $ | - | $ | 2,754,401 | $ | - | ||||||||
| Related partry service revenue | 2,950,000 | - | 2,950,000 | - | ||||||||||||
| Total revenues | 3,949,571 | - | 5,704,401 | - | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 7,290,899 | 6,784,390 | 20,872,264 | 19,777,454 | ||||||||||||
| General and administrative | 3,678,005 | 3,239,148 | 10,926,189 | 9,936,256 | ||||||||||||
| Total operating expenses | 10,968,904 | 10,023,538 | 31,798,453 | 29,713,710 | ||||||||||||
| Loss from operations | (7,019,333 | ) | (10,023,538 | ) | (26,094,052 | ) | (29,713,710 | ) | ||||||||
| Other income (expenses): | ||||||||||||||||
| Arbitration settlement | - | (2,406,576 | ) | (118,880 | ) | (2,406,576 | ) | |||||||||
| Interest income | 99,750 | 791 | 138,653 | 4,731 | ||||||||||||
| Net loss | $ | (6,919,583 | ) | $ | (12,429,323 | ) | $ | (26,074,279 | ) | $ | (32,115,555 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.08 | ) | $ | (0.15 | ) | $ | (0.31 | ) | $ | (0.43 | ) | ||||
| Weighted average number of common shares outstanding, basic and diluted | 83,599,187 | 83,078,675 | 83,434,760 | 74,290,598 |
Marker Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
| For the Nine Months Ended | ||||||||
| September 30, | ||||||||
| 2022 | 2021 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (26,074,279 | ) | $ | (32,115,555 | ) | ||
| Reconciliation of net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 1,975,996 | 1,584,495 | ||||||
| Stock-based compensation | 4,626,833 | 4,497,145 | ||||||
| Amortization on right-of-use assets | 739,446 | 757,958 | ||||||
| Loss on disposal of assets | 25,995 | - | ||||||
| Gain on lease termination | (278,681 | ) | - | |||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and deposits | (181,034 | ) | (643,403 | ) | ||||
| Other receivables | (1,680,782 | ) | 1,000,316 | |||||
| Accounts payable and accrued expenses | (3,310,051 | ) | 2,742,154 | |||||
| Related party deferred revenue | 5,050,000 | - | ||||||
| Deferred revenue | (1,146,186 | ) | - | |||||
| Lease liability | (413,988 | ) | (244,752 | ) | ||||
| Net cash used in operating activities | (20,666,731 | ) | (22,421,642 | ) | ||||
| Cash Flows from Investing Activities: | ||||||||
| Purchase of property and equipment | (1,328,664 | ) | (1,262,092 | ) | ||||
| Purchase of construction in progress | (3,489,130 | ) | (1,519,196 | ) | ||||
| Net cash used in investing activities | (4,817,794 | ) | (2,781,288 | ) | ||||
| Cash Flows from Financing Activities: | ||||||||
| Proceeds from issuance of common stock, net | 63,573 | 52,552,758 | ||||||
| Proceeds from exercise of stock options | - | 3,087 | ||||||
| Net cash provided by financing activities | 63,573 | 52,555,845 | ||||||
| Net (decrease) increase in cash, cash equivalents and restricted cash | (25,420,952 | ) | 27,352,915 | |||||
| Cash, cash equivalents and restricted cash at beginning of the period | 43,497,331 | 21,352,382 | ||||||
| Cash, cash equivalents and restricted cash at end of the period | $ | 18,076,379 | $ | 48,705,297 |