Enrollment of first 20 patients of the Company’s Phase 2 acute myeloid leukemia (AML) trial completed in Q4 2021
Topline readout of 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, March 17, 2022 (GLOBE NEWSWIRE) -- 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, 2021.
“In 2021, we completed enrollment of the first 20 patients in our Phase 2 AML trial investigating our lead product candidate, MT-401,” said Peter L. Hoang, Marker’s President and Chief Executive Officer. “We also developed a new nine-day manufacturing process which increased the potency and antigen specificity and diversity of our products and significantly reduced the time it takes to manufacture our patient-specific T cell therapies. In February 2022, we reported initial results from the six-patient safety lead-in phase of the Phase 2 AML trial, which demonstrated that MT-401 was well-tolerated and satisfied the safety requirements with FDA. We expect to report topline data from the active disease group in the main phase of the Phase 2 trial next quarter. In addition, we look forward to expanding our pipeline beyond AML and expect to file INDs for lymphoma and pancreatic cancer by the end of the year.”
PROGRAM UPDATES AND EXPECTED MILESTONES
Acute Myeloid Leukemia (AML)
MT-401
- In February 2022, Marker announced the initial results of the safety lead-in stage of its Company-sponsored Phase 2 AML trial evaluating MT-401, Marker’s lead MultiTAA-specific T cell product candidate. Results from the safety lead-in demonstrate that MT-401 was well-tolerated, eliminated measurable residual disease (MRD) in one MRD positive patient and induced epitope spreading across multiple AML-associated antigens in that patient.
- The safety lead-in satisfied safety requirements with the FDA and the main Phase 2 stage of the AML trial began enrolling in July 2021.
- Enrollment of the first 20 patients of the Phase 2 AML trial was completed in Q4 2021.
- Topline readout of Group 2 active disease is anticipated in Q2 2022.
Off-the-Shelf (MT-401-OTS)
- Marker announced in February 2022 that it intends to expand its AML program with the development of MT-401-OTS, a scalable, off-the-shelf product candidate with the potential to match patients to treatment in under three days. Marker’s open Investigational New Drug application (IND) for MT-401 for the treatment of AML includes approval of an off-the-shelf program. The Company is in the process of developing a patient cell bank inventory and expects to dose the first patient with MT-401-OTS in 2023.
Additional Clinical Programs (MT-601)
- Marker recently announced that the Company intends to file INDs for MT-601, Marker’s second MultiTAA-specific T cell product candidate, in lymphoma and pancreatic cancer in 2022. The Company expects to initiate these trials in 2023.
- In January 2022, Marker announced that the U.S. Food and Drug Administration granted Orphan Drug designation to MT-601 for the treatment of pancreatic cancer.
BUSINESS UPDATES
- On December 9, 2021, Marker announced the appointment of Katharine Knobil, M.D., to the Company's Board of Directors.
- Marker began manufacturing MT-401 for its Phase 2 AML trial at the Company’s cGMP manufacturing facility in the fourth quarter of 2021.
- The Company developed and is implementing a new nine-day MultiTAA-specific T cell manufacturing process for its current Company-sponsored Phase 2 AML trial as well as future clinical trials using a patient-specific manufacturing approach. The new T cell manufacturing process is designed to improve potency, increase antigen specificity and diversity and significantly reduce manufacturing time.
FISCAL YEAR 2021 FINANCIAL RESULTS
Cash Position and Guidance: At December 31, 2021, Marker had cash, cash equivalents and restricted cash of $43.5 million. The Company believes that its existing cash, cash equivalents and restricted cash will fund its operating expenses and capital expenditure requirements into the first quarter of 2023.
R&D Expenses: Research and development expenses were $27.8 million for the year ended December 31, 2021, compared to $18.9 million for the year ended December 31, 2020.
G&A Expenses: General and administrative expenses were $12.9 million for the year ended December 31, 2021, compared to $10.5 million for the year ended December 31, 2020.
Net Loss: Marker reported a net loss of $41.9 million for the year ended December 31, 2021, compared to a net loss of $28.7 million for the year ended December 31, 2020.
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 and our planned trials of MT-401-OTS and MT-601; our ability to use our manufacturing facilities to support clinical and commercial demand; the success of our new manufacturing process; 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.
Consolidated Balance Sheets
(Audited)
| December 31, | December 31, | ||||||
| 2021 | 2020 | ||||||
| ASSETS | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 42,351,145 | $ | 21,352,382 | |||
| Restricted cash | 1,146,186 | - | |||||
| Prepaid expenses and deposits | 2,484,634 | 2,057,924 | |||||
| Other receivables | 237 | 1,000,559 | |||||
| Total current assets | 45,982,202 | 24,410,865 | |||||
| Non-current assets: | |||||||
| Property, plant and equipment, net | 10,096,861 | 3,570,736 | |||||
| Construction in progress | 2,225,610 | 6,789,098 | |||||
| Right-of-use assets, net | 9,830,461 | 10,844,116 | |||||
| Total non-current assets | 22,152,932 | 21,203,950 | |||||
| Total assets | $ | 68,135,134 | $ | 45,614,815 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| Current liabilities: | |||||||
| Accounts payable and accrued liabilities | $ | 11,134,913 | $ | 6,013,010 | |||
| Lease liability | 620,490 | 388,792 | |||||
| Deferred revenue | 1,146,186 | - | |||||
| Total current liabilities | 12,901,589 | 6,401,802 | |||||
| Non-current liabilities: | |||||||
| Lease liability, net of current portion | 11,247,950 | 11,868,440 | |||||
| Total non-current liabilities | 11,247,950 | 11,868,440 | |||||
| Total liabilities | 24,149,539 | 18,270,242 | |||||
| Stockholders' equity: | |||||||
| Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at December 31, 2021 and 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 December 31, 2021 and 2020, respectively | 83,079 | 50,731 | |||||
| Additional paid-in capital | 442,020,871 | 383,533,326 | |||||
| Accumulated deficit | (398,118,355 | ) | (356,239,484 | ) | |||
| Total stockholders' equity | 43,985,595 | 27,344,573 | |||||
| Total liabilities and stockholders' equity | $ | 68,135,134 | $ | 45,614,815 | |||
Marker Therapeutics, Inc.
Consolidated Statements of Operations
(Audited)
| For the Years Ended | |||||||
| December 31, | |||||||
| 2021 | 2020 | ||||||
| Revenues: | |||||||
| Grant income | $ | 1,241,710 | $ | 466,785 | |||
| Total revenues | 1,241,710 | 466,785 | |||||
| Operating expenses: | |||||||
| Research and development | 27,794,879 | 18,880,751 | |||||
| General and administrative | 12,924,826 | 10,471,846 | |||||
| Total operating expenses | 40,719,705 | 29,352,597 | |||||
| Loss from operations | (39,477,995 | ) | (28,885,812 | ) | |||
| Other income: | |||||||
| Change in fair value of warrant liabilities | - | 31,000 | |||||
| Arbitration settlement | (2,406,576 | ) | - | ||||
| Interest income | 5,700 | 148,742 | |||||
| Net loss | $ | (41,878,871 | ) | $ | (28,706,070 | ) | |
| Net loss per share, basic and diluted | $ | (0.55 | ) | $ | (0.61 | ) | |
| Weighted average number of common shares outstanding, basic and diluted | 76,505,675 | 47,039,862 | |||||
Marker Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
(Audited)
| For the Years Ended | |||||||
| December 31, | |||||||
| 2021 | 2020 | ||||||
| Cash Flows from Operating Activities: | |||||||
| Net loss | $ | (41,878,871 | ) | $ | (28,706,070 | ) | |
| Reconciliation of net loss to net cash used in operating activities: | |||||||
| Depreciation and amortization | 2,148,983 | 485,641 | |||||
| Changes in fair value of warrant liabilities | - | (31,000 | ) | ||||
| Stock-based compensation | 5,964,048 | 5,228,409 | |||||
| Amortization on right-of-use assets | 1,013,655 | 590,039 | |||||
| Changes in operating assets and liabilities: | |||||||
| Prepaid expenses and deposits | (426,710 | ) | (531,482 | ) | |||
| Other receivables | 1,000,322 | 55,630 | |||||
| Accounts payable and accrued expenses | 4,141,414 | 3,047,410 | |||||
| Deferred revenue | 1,146,186 | - | |||||
| Lease liability | (388,792 | ) | (173,268 | ) | |||
| Net cash used in operating activities | (27,279,765 | ) | (20,034,691 | ) | |||
| Cash Flows from Investing Activities: | |||||||
| Purchase of property and equipment | (1,572,161 | ) | (3,422,754 | ) | |||
| Purchase of construction in progress | (1,558,970 | ) | (5,830,133 | ) | |||
| Net cash used in investing activities | (3,131,131 | ) | (9,252,887 | ) | |||
| Cash Flows from Financing Activities: | |||||||
| Proceeds from issuance of common stock, net | 52,552,758 | 6,186,011 | |||||
| Proceeds from exercise of warrants | - | 550,000 | |||||
| Proceeds from exercise of stock options | 3,087 | - | |||||
| Net cash provided by financing activities | 52,555,845 | 6,736,011 | |||||
| Net increase (decrease) in cash, cash equivlants and restricted cash | 22,144,949 | (22,551,567 | ) | ||||
| Cash, cash equivalents and restricted cash at beginning of the year | 21,352,382 | 43,903,949 | |||||
| Cash, cash equivalents and restricted cash at end of the year | $ | 43,497,331 | $ | 21,352,382 | |||
Investors and Media Contacts
Marker Therapeutics:
Neda Safarzadeh
Vice President/Head of Investor Relations, PR & Marketing
(713) 400-6451
Investor.Relations@markertherapeutics.com
Solebury Trout:
Media
Amy Bonanno
Abonanno@soleburytrout.com
