Full Press Release Details
Therapeutics Reports First Quarter 2021 Operating and Financial Results
continues to advance Phase 2 AML trial, recently dosing first patient
closed financing extending cash runway into Q1 2023
to host conference call and webcast today at 5:00 p.m. ET
TX-May 12, 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 first quarter ended March 31, 2021.
had a productive first quarter supported by our recently completed financing, strengthening our overall cash position and enabling continued
growth and expansion of our Multi-TAA pipeline," Peter L. Hoang, President & CEO of Marker Therapeutics. "In addition,
we continue to make strong progress on both the clinical and manufacturing fronts. In March, we dosed the first patient in the safety
lead-in portion of our Phase 2 trial in post-transplant acute myeloid leukemia, or AML, and continue to activate clinical sites. In parallel,
we 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-among other benefits-as we prepare to operationalize our new in-house cGMP facility
in the first half of the year."
ANTICIPATED PROGRAM MILESTONES
AML Trial Milestones
Manufacturing Milestones
FIRST QUARTER 2021 FINANCIAL RESULTS
Conference Call and Webcast
The Company will host a webcast and conference call to discuss its first quarter 2021 financial results and provide a corporate update
today at 5:00 p.m. EDT. The webcast will be accessible in the Investors section of the Company's website at markertherapeutics.com.
Individuals can participate in the conference call by dialing 877-407-8913 (domestic) or 201-689-8201 (international) and referring to
the "Marker Therapeutics First Quarter 2021 Earnings Call."
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; 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.
Marker Therapeutics, Inc.
Condensed Consolidated Balance Sheets
| March 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 64,507,575 | $ | 21,352,382 | ||||
| Prepaid expenses and deposits | 1,962,924 | 2,057,924 | ||||||
| Other receivables | 1,000,867 | 1,000,559 | ||||||
| Total current assets | 67,471,366 | 24,410,865 | ||||||
| Non-current assets: | ||||||||
| Property, plant and equipment, net | 10,298,225 | 3,570,736 | ||||||
| Construction in progress | - | 6,789,098 | ||||||
| Right-of-use assets, net | 10,592,490 | 10,844,116 | ||||||
| Total non-current assets | 20,890,715 | 21,203,950 | ||||||
| Total assets | $ | 88,362,081 | $ | 45,614,815 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 3,674,259 | $ | 6,013,010 | ||||
| Lease liability | 473,077 | 388,792 | ||||||
| Total current liabilities | 4,147,336 | 6,401,802 | ||||||
| Non-current liabilities: | ||||||||
| Lease liability, net of current portion | 11,719,826 | 11,868,440 | ||||||
| Total non-current liabilities | 11,719,826 | 11,868,440 | ||||||
| Total liabilities | 15,867,162 | 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 March 31, 2021 and December 31, 2020, respectively | - | - | ||||||
| Common stock, $0.001 par value, 150 million shares authorized, 83.0 million and 50.7 million shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively | 83,014 | 50,731 | ||||||
| Additional paid-in capital | 437,430,839 | 383,533,326 | ||||||
| Accumulated deficit | (365,018,934 | ) | (356,239,484 | ) | ||||
| Total stockholders' equity | 72,494,919 | 27,344,573 | ||||||
| Total liabilities and stockholders' equity | $ | 88,362,081 | $ | 45,614,815 |
Marker Therapeutics, Inc.
Condensed Consolidated Statements of Operations
| For the Three Months Ended | ||||||||
| March 31, | ||||||||
| 2021 | 2020 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 5,643,029 | $ | 3,816,618 | ||||
| General and administrative | 3,137,958 | 2,826,995 | ||||||
| Total operating expenses | 8,780,987 | 6,643,613 | ||||||
| Loss from operations | (8,780,987 | ) | (6,643,613 | ) | ||||
| Other income (expense): | ||||||||
| Change in fair value of warrant liabilities | - | 31,000 | ||||||
| Interest income | 1,537 | 126,969 | ||||||
| Net loss | $ | (8,779,450 | ) | $ | (6,485,644 | ) | ||
| Net loss per share, basic and diluted | $ | (0.16 | ) | $ | (0.14 | ) | ||
| Weighted average number of common shares outstanding, basic and diluted | 56,470,247 | 46,084,383 |
Marker Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
| For the Three Months Ended | ||||||||
| March 31, | ||||||||
| 2021 | 2020 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (8,779,450 | ) | $ | (6,485,644 | ) | ||
| Reconciliation of net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 502,743 | 35,265 | ||||||
| Changes in fair value of warrant liabilities | - | (31,000 | ) | |||||
| Stock-based compensation | 1,377,038 | 1,344,592 | ||||||
| Amortization on right-of-use assets | 251,626 | 47,361 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and deposits | 95,000 | (189,650 | ) | |||||
| Other receivables | (308 | ) | 31,584 | |||||
| Accounts payable and accrued expenses | (2,442,581 | ) | 1,197,613 | |||||
| Lease liability | (64,329 | ) | (49,187 | ) | ||||
| Net cash used in operating activities | (9,060,261 | ) | (4,099,066 | ) | ||||
| Cash Flows from Investing Activities: | ||||||||
| Purchase of property and equipment | (441,134 | ) | (99,821 | ) | ||||
| Net cash used in investing activities | (441,134 | ) | (99,821 | ) | ||||
| Cash Flows from Financing Activities: | ||||||||
| Proceeds from issuance of common stock, net | 52,656,588 | - | ||||||
| Proceeds from exercise of warrants | - | 550,000 | ||||||
| Net cash provided by financing activities | 52,656,588 | 550,000 | ||||||
| Net increase (decrease) in cash | 43,155,193 | (3,648,887 | ) | |||||
| Cash and cash equivalents at beginning of the period | 21,352,382 | 43,903,949 | ||||||
| Cash and cash equivalents at end of the period | $ | 64,507,575 | $ | 40,255,062 |
SOURCE: Marker Therapeutics, Inc.