Full Press Release Details
Marker Therapeutics Reports Fiscal Year
2020 Operating and Financial Results
Houston, TX-March 9, 2021-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 fiscal year ended December 31, 2020.
"We are proud of our Company's continued progress,
which has positioned us for a busy and productive year ahead," said Peter L. Hoang, President & CEO of Marker Therapeutics.
"Recently, we dosed the first patient in the safety lead-in portion of our Phase 2 trial in post-transplant acute myeloid
leukemia (AML). In the fourth quarter, we completed construction of a new in-house cGMP manufacturing facility in Houston, which
we anticipate will be fully operational in the first half of this year. We also continue to optimize the MT-401 cell therapy manufacturing
process, which we believe could result in an increase in the number of T cells available for patient administration, superior T
cell phenotype and antigen specificity, and the potential for improved patient outcomes."
RECENT PROGRAM UPDATES
MT-401: Multi-Antigen Targeted (MultiTAA)-Specific T Cell
Product Candidate for AML
Manufacturing and Process Improvements
FISCAL YEAR 2020 FINANCIAL RESULTS
Cash Position and Guidance: At December 31, 2020,
Marker had cash and cash equivalents of $21.4 million. The Company raised $6.2 million through the previously executed $30 million
common stock purchase agreement with Aspire Capital Fund, LLC. The remaining $23.8 million available to Marker from Aspire Capital,
along with current cash available, funds operations into Q1 2022.
R&D Expenses: Research and development expenses
were $18.9 million for the year ended December 31, 2020, compared to $12.8 million for the year ended December 31,
G&A Expenses: General and administrative expenses
were $10.5 million for the year ended December 31, 2020, compared to $10.0 million for the year ended December 31, 2019.
Net Loss: Marker reported a net loss of $28.7
million for the year ended December 31, 2020, compared to a net loss of $21.4 million for the year ended December
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
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Forward-Looking Statement Disclaimer
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, including the Phase 2 trial of MT-401, as well as clinical trials conducted by our collaborators; the timing and success
of the technology transfer process related to our planned manufacturing facility and the receipt of regulatory approval for the
related cGMP; our manufacturing processes and our ability to use our current and planned manufacturing facilities to support clinical
and commercial demand. 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.
Consolidated Balance Sheets
| December 31, | December 31, | |||||||
| 2020 | 2019 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 21,352,382 | $ | 43,903,949 | ||||
| Prepaid expenses and deposits | 2,057,924 | 1,526,442 | ||||||
| Interest receivable | 559 | 56,189 | ||||||
| Other receivable | 1,000,000 | - | ||||||
| Total current assets | 24,410,865 | 45,486,580 | ||||||
| Non-current assets: | ||||||||
| Property, plant and equipment, net | 3,570,736 | 417,528 | ||||||
| Construction in progress | 6,789,098 | - | ||||||
| Right-of-use assets, net | 10,844,116 | 455,174 | ||||||
| Total non-current assets | 21,203,950 | 872,702 | ||||||
| Total assets | $ | 45,614,815 | $ | 46,359,282 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 6,013,010 | $ | 1,757,680 | ||||
| Lease liability | 388,792 | 204,132 | ||||||
| Warrant liability | - | 31,000 | ||||||
| Total current liabilities | 6,401,802 | 1,992,812 | ||||||
| Non-current liabilities: | ||||||||
| Lease liability, net of current portion | 11,868,440 | 280,247 | ||||||
| Total non-current liabilities | 11,868,440 | 280,247 | ||||||
| Total liabilities | 18,270,242 | 2,273,059 | ||||||
| Commitments and contingencies | - | - | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at December 31, 2020 and 2019, respectively | - | - | ||||||
| Common stock, $0.001 par value, 150 million shares authorized, 50.7 million and 45.7 million shares issued and outstanding as of December 31, 2020 and 2019, respectively | 50,731 | 45,728 | ||||||
| Additional paid-in capital | 383,533,326 | 371,573,909 | ||||||
| Accumulated deficit | (356,239,484 | ) | (327,533,414 | ) | ||||
| Total stockholders' equity | 27,344,573 | 44,086,223 | ||||||
| Total liabilities and stockholders' equity | $ | 45,614,815 | $ | 46,359,282 |
Marker Therapeutics, Inc.
Consolidated Statements of Operations
| For the Years Ended | ||||||||
| December 31, | ||||||||
| 2020 | 2019 | |||||||
| Revenues: | ||||||||
| Grant income | $ | 466,785 | $ | 213,194 | ||||
| Total revenues | 466,785 | 213,194 | ||||||
| Operating expenses: | ||||||||
| Research and development | 18,880,751 | 12,764,804 | ||||||
| General and administrative | 10,471,846 | 9,977,196 | ||||||
| Total operating expenses | 29,352,597 | 22,742,000 | ||||||
| Loss from operations | (28,885,812 | ) | (22,528,806 | ) | ||||
| Other income (expense): | ||||||||
| Change in fair value of warrant liabilities | 31,000 | 18,000 | ||||||
| Interest income | 148,742 | 1,082,842 | ||||||
| Net loss | $ | (28,706,070 | ) | $ | (21,427,964 | ) | ||
| Net loss per share, basic and diluted | $ | (0.61 | ) | $ | (0.47 | ) | ||
| Weighted average number of common shares outstanding | 47,039,862 | 45,587,734 |
Marker Therapeutics, Inc.
Consolidated Statements of Cash Flows
| For the Years Ended | ||||||||
| December 31, | ||||||||
| 2020 | 2019 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (28,706,070 | ) | $ | (21,427,964 | ) | ||
| Reconciliation of net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 485,641 | 105,123 | ||||||
| Changes in fair value of warrant liabilities | (31,000 | ) | (18,000 | ) | ||||
| Stock-based compensation | 5,228,409 | 5,356,972 | ||||||
| Amortization on right-of-use assets | 590,039 | 181,459 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and deposits | (531,482 | ) | (1,384,725 | ) | ||||
| Interest receivable | 55,630 | 51,988 | ||||||
| Accounts payable and accrued expenses | 4,222,470 | (963,967 | ) | |||||
| Lease liability | (173,268 | ) | (185,179 | ) | ||||
| Net cash used in operating activities | (18,859,631 | ) | (18,284,293 | ) | ||||
| Cash Flows from Investing Activities: | ||||||||
| Purchase of property and equipment | (3,638,849 | ) | (374,983 | ) | ||||
| Purchase of construction in progress | (6,789,098 | ) | - | |||||
| Net cash used in investing activities | (10,427,947 | ) | (374,983 | ) | ||||
| Cash Flows from Financing Activities: | ||||||||
| Proceeds from issuance of common stock | 6,186,011 | - | ||||||
| Proceeds from exercise of stock options | - | 57,744 | ||||||
| Proceeds from exercise of warrants | 550,000 | 758,733 | ||||||
| Net cash provided by financing activities | 6,736,011 | 816,477 | ||||||
| Net decrease in cash | (22,551,567 | ) | (17,842,799 | ) | ||||
| Cash and cash equivalents at beginning of the period | 43,903,949 | 61,746,748 | ||||||
| Cash and cash equivalents at end of the period | $ | 21,352,382 | $ | 43,903,949 |