Full Press Release Details
Marker Therapeutics Reports Second Quarter 2021
Operating and Financial Results
Marker continues to enroll patients and activate
clinical sites in Phase 2 AML trial following
completion of safety lead-in
Company's new in-house cGMP manufacturing
facility in Houston is fully operational
Houston, TX-August 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 second quarter ended June 30, 2021.
"Marker accomplished a number of strategic goals and clinical
milestones this quarter, including completing the safety lead-in portion of our company-sponsored Phase 2 trial investigating Marker's
MultiTAA-specific T cell therapy in post-transplant acute myeloid leukemia, or AML," said Peter L. Hoang, President & CEO
of Marker Therapeutics. "We are now enrolling patients as well as activating additional clinical sites in the main portion
of the trial. In parallel, we opened a new in-house cGMP manufacturing facility in Houston and recently announced that the facility is
fully operational. We look forward to manufacturing study drug at the new facility next quarter, which we expect will yield quality product,
reduce manufacturing costs and expand patient access to Marker's MultiTAA-specific cell therapies."
ANTICIPATED PROGRAM MILESTONES
AML Trial Milestones
Manufacturing Milestones
SECOND 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, as well as clinical trials conducted by our collaborators; our manufacturing processes and our ability to
use our current and planned 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
| June 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 57,221,434 | $ | 21,352,382 | ||||
| Prepaid expenses and deposits | 2,801,800 | 2,057,924 | ||||||
| Other receivables | 286 | 1,000,559 | ||||||
| Total current assets | 60,023,520 | 24,410,865 | ||||||
| Non-current assets: | ||||||||
| Property, plant and equipment, net | 10,107,579 | 3,570,736 | ||||||
| Construction in progress | - | 6,789,098 | ||||||
| Right-of-use assets, net | 10,339,884 | 10,844,116 | ||||||
| Total non-current assets | 20,447,463 | 21,203,950 | ||||||
| Total assets | $ | 80,470,983 | $ | 45,614,815 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 5,100,943 | $ | 6,013,010 | ||||
| Lease liability | 558,657 | 388,792 | ||||||
| Total current liabilities | 5,659,600 | 6,401,802 | ||||||
| Non-current liabilities: | ||||||||
| Lease liability, net of current portion | 11,568,072 | 11,868,440 | ||||||
| Total non-current liabilities | 11,568,072 | 11,868,440 | ||||||
| Total liabilities | 17,227,672 | 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 June 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 June 30, 2021 and December 31, 2020, respectively | 83,079 | 50,731 | ||||||
| Additional paid-in capital | 439,085,948 | 383,533,326 | ||||||
| Accumulated deficit | (375,925,716 | ) | (356,239,484 | ) | ||||
| Total stockholders' equity | 63,243,311 | 27,344,573 | ||||||
| Total liabilities and stockholders' equity | $ | 80,470,983 | $ | 45,614,815 |
Marker Therapeutics, Inc.
Condensed Consolidated Statements of Operations
| For the Three Months Ended | For the Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenues: | ||||||||||||||||
| Grant income | $ | - | $ | 466,785 | $ | - | $ | 466,785 | ||||||||
| Total revenues | - | 466,785 | - | 466,785 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 7,350,035 | 4,277,052 | 12,993,064 | 8,093,670 | ||||||||||||
| General and administrative | 3,559,150 | 2,547,289 | 6,697,108 | 5,374,284 | ||||||||||||
| Total operating expenses | 10,909,185 | 6,824,341 | 19,690,172 | 13,467,954 | ||||||||||||
| Loss from operations | (10,909,185 | ) | (6,357,556 | ) | (19,690,172 | ) | (13,001,169 | ) | ||||||||
| Other income: | ||||||||||||||||
| Change in fair value of warrant liabilities | - | - | - | 31,000 | ||||||||||||
| Interest income | 2,403 | 15,857 | 3,940 | 142,826 | ||||||||||||
| Net loss | $ | (10,906,782 | ) | $ | (6,341,699 | ) | $ | (19,686,232 | ) | $ | (12,827,343 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.13 | ) | $ | (0.14 | ) | $ | (0.28 | ) | $ | (0.28 | ) | ||||
| Weighted average number of common shares outstanding, basic and diluted | 83,030,470 | 46,572,739 | 69,823,729 | 46,328,561 |
Marker Therapeutics, Inc.
Condensed Consolidated Statements of Cash
| For the Six Months Ended | ||||||||
| June 30, | ||||||||
| 2021 | 2020 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (19,686,232 | ) | $ | (12,827,343 | ) | ||
| Reconciliation of net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 1,032,971 | 124,627 | ||||||
| Changes in fair value of warrant liabilities | - | (31,000 | ) | |||||
| Stock-based compensation | 3,029,125 | 2,705,365 | ||||||
| Amortization on right-of-use assets | 504,232 | 96,973 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and deposits | (743,876 | ) | (1,106,072 | ) | ||||
| Other receivables | 1,000,273 | 52,749 | ||||||
| Accounts payable and accrued expenses | (912,067 | ) | 2,770,341 | |||||
| Lease liability | (130,503 | ) | (187,068 | ) | ||||
| Net cash used in operating activities | (15,906,077 | ) | (8,401,428 | ) | ||||
| Cash Flows from Investing Activities: | ||||||||
| Purchase of property and equipment | (780,716 | ) | (1,299,193 | ) | ||||
| Purchase of construction in progress | - | (2,629,141 | ) | |||||
| Net cash used in investing activities | (780,716 | ) | (3,928,334 | ) | ||||
| Cash Flows from Financing Activities: | ||||||||
| Proceeds from issuance of common stock, net | 52,552,758 | - | ||||||
| Proceeds from exercise of warrants | - | 550,000 | ||||||
| Proceeds from exercise of stock options | 3,087 | |||||||
| Net cash provided by financing activities | 52,555,845 | 550,000 | ||||||
| Net increase (decrease) in cash | 35,869,052 | (11,779,762 | ) | |||||
| Cash and cash equivalents at beginning of the period | 21,352,382 | 43,903,949 | ||||||
| Cash and cash equivalents at end of the period | $ | 57,221,434 | $ | 32,124,187 |