Full Press Release Details
Marker Therapeutics Reports Q1 2022 Operating
and Financial Results
Topline readout of Phase 2 AML trial Group
2 active disease anticipated in Q2 2022
Company plans to file INDs in lymphoma and
pancreatic cancer by year end, with clinical trials to be initiated in 2023
Houston, TX-May 13, 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 first quarter ended March 31, 2022.
"2022 has already been
an exciting year for Marker as we reported encouraging initial results from the six-patient safety lead-in portion of our Phase 2 AML
trial-including elimination of MRD in one MRD positive patient-and announced plans for Company-sponsored trials of our second
cell therapy product candidate, MT-601, in pancreatic cancer and lymphoma," said Peter L. Hoang, Marker's President
and Chief Executive Officer. "We also implemented a new MultiTAA-specific T cell therapy manufacturing process, details of which
were presented at the 2022 International Society for Cell & Gene Therapy (ISCT) annual meeting. After completing enrollment
of the first 20 patients in the Phase 2 AML trial last year, we anticipate reporting topline data from the active disease group in the
main phase of the trial next quarter."
PROGRAM UPDATES AND EXPECTED
Acute Myeloid Leukemia
Additional Clinical Programs
FIRST QUARTER 2022 FINANCIAL RESULTS
Cash Position and Guidance:
At March 31, 2022, Marker had cash, cash equivalents and restricted cash of $28.8 million.
R&D Expenses: Research
and development expenses were $7.0 million for the quarter ended March 31, 2022, compared to $5.6 million for the quarter ended
G&A Expenses: General
and administrative expenses were $3.7 million for the quarter ended March 31, 2022, compared to $3.1 million for the quarter ended
Net Loss: Marker reported
a net loss of $9.9 million for the quarter ended March 31, 2022, compared to a net loss of $8.8 million for the quarter ended March 31,
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
Marker Therapeutics, Inc.
Condensed Consolidated Balance Sheets
| March 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 28,637,217 | $ | 42,351,145 | ||||
| Restricted cash | 181,864 | 1,146,186 | ||||||
| Prepaid expenses and deposits | 2,196,225 | 2,484,634 | ||||||
| Other receivables | 2,185 | 237 | ||||||
| Total current assets | 31,017,491 | 45,982,202 | ||||||
| Non-current assets: | ||||||||
| Property, plant and equipment, net | 10,276,936 | 10,096,861 | ||||||
| Construction in progress | 4,089,135 | 2,225,610 | ||||||
| Right-of-use assets, net | 9,572,572 | 9,830,461 | ||||||
| Total non-current assets | 23,938,643 | 22,152,932 | ||||||
| Total assets | $ | 54,956,134 | $ | 68,135,134 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 7,348,680 | $ | 11,134,913 | ||||
| Lease liability | 683,969 | 620,490 | ||||||
| Deferred revenue | 181,864 | 1,146,186 | ||||||
| Total current liabilities | 8,214,513 | 12,901,589 | ||||||
| Non-current liabilities: | ||||||||
| Lease liability, net of current portion | 11,035,857 | 11,247,950 | ||||||
| Total non-current liabilities | 11,035,857 | 11,247,950 | ||||||
| Total liabilities | 19,250,370 | 24,149,539 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively | - | - | ||||||
| Common stock, $0.001 par value, 150 million shares authorized, 83.5 million and 83.1 million shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively | 83,451 | 83,079 | ||||||
| Additional paid-in capital | 443,651,176 | 442,020,871 | ||||||
| Accumulated deficit | (408,028,863 | ) | (398,118,355 | ) | ||||
| Total stockholders' equity | 35,705,764 | 43,985,595 | ||||||
| Total liabilities and stockholders' equity | $ | 54,956,134 | $ | 68,135,134 |
Marker Therapeutics, Inc.
Condensed Consolidated Statements of Operations
| For the Three Months Ended | ||||||||
| March 31, | ||||||||
| 2022 | 2021 | |||||||
| Revenues: | ||||||||
| Grant income | $ | 964,322 | $ | - | ||||
| Total revenues | 964,322 | - | ||||||
| Operating expenses: | ||||||||
| Research and development | $ | 7,026,066 | $ | 5,643,029 | ||||
| General and administrative | 3,733,001 | 3,137,958 | ||||||
| Total operating expenses | 10,759,067 | 8,780,987 | ||||||
| Loss from operations | (9,794,745 | ) | (8,780,987 | ) | ||||
| Other income (expenses): | ||||||||
| Arbitration settlement | (118,880 | ) | - | |||||
| Interest income | 3,117 | 1,537 | ||||||
| Net loss | $ | (9,910,508 | ) | $ | (8,779,450 | ) | ||
| Net loss per share, basic and diluted | $ | (0.12 | ) | $ | (0.16 | ) | ||
| Weighted average number of common shares outstanding, basic and diluted | 83,107,649 | 56,470,247 |
Marker Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
| For the Three Months Ended | ||||||||
| March 31, | ||||||||
| 2022 | 2021 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (9,910,508 | ) | $ | (8,779,450 | ) | ||
| Reconciliation of net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 576,331 | 502,743 | ||||||
| Stock-based compensation | 1,630,677 | 1,377,038 | ||||||
| Amortization of right-of-use assets | 257,889 | 251,626 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and deposits | 288,409 | 95,000 | ||||||
| Other receivables | (1,948 | ) | (308 | ) | ||||
| Accounts payable and accrued expenses | (3,953,976 | ) | (1,482,473 | ) | ||||
| Deferred revenue | (964,322 | ) | - | |||||
| Lease liability | (148,614 | ) | (64,329 | ) | ||||
| Net cash used in operating activities | (12,226,062 | ) | (8,100,153 | ) | ||||
| Cash Flows from Investing Activities: | ||||||||
| Purchase of property and equipment | (826,583 | ) | (442,277 | ) | ||||
| Cash used for construction in progress | (1,625,605 | ) | (958,965 | ) | ||||
| Net cash used in investing activities | (2,452,188 | ) | (1,401,242 | ) | ||||
| Cash Flows from Financing Activities: | ||||||||
| Proceeds from issuance of common stock, net | - | 52,656,588 | ||||||
| Net cash provided by financing activities | - | 52,656,588 | ||||||
| Net (decrease) increase in cash, cash equivlants and restricted cash | (14,678,250 | ) | 43,155,193 | |||||
| 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 | $ | 28,819,081 | $ | 64,507,575 |
Investors and Media Contacts
Marker Therapeutics:
Vice President/Head of Investor Relations, PR &