Full Press Release Details
Marker Therapeutics Reports Third Quarter 2021
Operating and Financial Results
Enrollment of first 20 patients of the Company's
Phase 2 AML trial anticipated in Q4 2021
Topline readout of Group 2 active disease anticipated
Company to host year-end conference call and
Houston, TX-November 10, 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 third quarter ended September 30, 2021.
"This quarter, we continued our momentum in advancing Marker's
Phase 2 trial of MT-401, Marker's lead MultiTAA-specific T cell therapy, for the treatment of post-transplant acute myeloid leukemia,
or AML," said Peter L. Hoang, President & CEO of Marker Therapeutics. "We are pleased to announce that the first
patients in Marker's Phase 2 AML trial have been dosed with study drug. Further, we are on track to enroll the first 20 patients
of the trial in the fourth quarter, with the first data readout expected in the first quarter of 2022. We look forward to providing year-end
updates in a conference call and webcast early next year."
ANTICIPATED PROGRAM MILESTONES
AML Trial Milestones
THIRD QUARTER 2021 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, including the Phase 2 trial of MT-401; our
ability to use our manufacturing facilities to support clinical and commercial demand; the timing and use of the CPRIT award; 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, | |||||||
| 2021 | 2020 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 48,705,297 | $ | 21,352,382 | ||||
| Prepaid expenses and deposits | 2,701,327 | 2,057,924 | ||||||
| Other receivables | 243 | 1,000,559 | ||||||
| Total current assets | 51,406,867 | 24,410,865 | ||||||
| Non-current assets: | ||||||||
| Property, plant and equipment, net | 9,846,745 | 3,570,736 | ||||||
| Construction in progress | 600,005 | 6,789,098 | ||||||
| Right-of-use assets, net | 10,086,158 | 10,844,116 | ||||||
| Total non-current assets | 20,532,908 | 21,203,950 | ||||||
| Total assets | $ | 71,939,775 | $ | 45,614,815 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 7,645,287 | $ | 6,013,010 | ||||
| Lease liability | 581,588 | 388,792 | ||||||
| Total current liabilities | 8,226,875 | 6,401,802 | ||||||
| Non-current liabilities: | ||||||||
| Lease liability, net of current portion | 11,430,892 | 11,868,440 | ||||||
| Total non-current liabilities | 11,430,892 | 11,868,440 | ||||||
| Total liabilities | 19,657,767 | 18,270,242 | ||||||
| Commitments and contingencies | - | - | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively | - | - | ||||||
| Common stock, $0.001 par value, 150 million shares authorized, 83.1 million and 50.7 million shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively | 83,079 | 50,731 | ||||||
| Additional paid-in capital | 440,553,968 | 383,533,326 | ||||||
| Accumulated deficit | (388,355,039 | ) | (356,239,484 | ) | ||||
| Total stockholders' equity | 52,282,008 | 27,344,573 | ||||||
| Total liabilities and stockholders' equity | $ | 71,939,775 | $ | 45,614,815 |
Marker Therapeutics, Inc.
Condensed Consolidated Statements of Operations
| For the Three Months Ended | For the Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenues: | ||||||||||||||||
| Grant income | $ | - | $ | - | $ | - | $ | 466,785 | ||||||||
| Total revenues | - | - | - | 466,785 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 6,784,390 | 4,803,605 | 19,777,454 | 12,897,275 | ||||||||||||
| General and administrative | 3,239,148 | 2,572,562 | 9,936,256 | 7,946,846 | ||||||||||||
| Total operating expenses | 10,023,538 | 7,376,167 | 29,713,710 | 20,844,121 | ||||||||||||
| Loss from operations | (10,023,538 | ) | (7,376,167 | ) | (29,713,710 | ) | (20,377,336 | ) | ||||||||
| Other income: | ||||||||||||||||
| Change in fair value of warrant liabilities | - | - | - | 31,000 | ||||||||||||
| Arbitration settlement | (2,406,576 | ) | - | (2,406,576 | ) | - | ||||||||||
| Interest income | 791 | 4,667 | 4,731 | 147,493 | ||||||||||||
| Net loss | $ | (12,429,323 | ) | $ | (7,371,500 | ) | $ | (32,115,555 | ) | $ | (20,198,843 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.15 | ) | $ | (0.16 | ) | $ | (0.43 | ) | $ | (0.43 | ) | ||||
| Weighted average number of common shares outstanding, basic and diluted | 83,078,675 | 46,867,119 | 74,290,598 | 46,509,391 |
Marker Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
| For the Nine Months Ended | ||||||||
| September 30, | ||||||||
| 2021 | 2020 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (32,115,555 | ) | $ | (20,198,843 | ) | ||
| Reconciliation of net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 1,584,495 | 272,725 | ||||||
| Changes in fair value of warrant liabilities | - | (31,000 | ) | |||||
| Stock-based compensation | 4,497,145 | 3,974,536 | ||||||
| Amortization on right-of-use assets | 757,958 | 337,530 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and deposits | (643,403 | ) | (840,703 | ) | ||||
| Other receivables | 1,000,316 | 56,054 | ||||||
| Accounts payable and accrued expenses | 2,742,154 | 2,065,929 | ||||||
| Lease liability | (244,752 | ) | (166,723 | ) | ||||
| Net cash used in operating activities | (22,421,642 | ) | (14,530,495 | ) | ||||
| Cash Flows from Investing Activities: | ||||||||
| Purchase of property and equipment | (1,262,092 | ) | (2,005,160 | ) | ||||
| Purchase of construction in progress | (1,519,196 | ) | (3,147,566 | ) | ||||
| Net cash used in investing activities | (2,781,288 | ) | (5,152,726 | ) | ||||
| Cash Flows from Financing Activities: | ||||||||
| Proceeds from issuance of common stock, net | 52,552,758 | 2,186,009 | ||||||
| Proceeds from exercise of warrants | - | 550,000 | ||||||
| Proceeds from exercise of stock options | 3,087 | - | ||||||
| Net cash provided by financing activities | 52,555,845 | 2,736,009 | ||||||
| Net increase (decrease) in cash | 27,352,915 | (16,947,212 | ) | |||||
| Cash and cash equivalents at beginning of the period | 21,352,382 | 43,903,949 | ||||||
| Cash and cash equivalents at end of the period | $ | 48,705,297 | $ | 26,956,737 |