Full Press Release Details
Marker Therapeutics Reports Full Year 2019 Operating and Financial Results
TX-March 12, 2020-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 full year ended December
a clear path forward for our Phase 2 trial in AML patients with our novel T cell therapy, and the cash resources needed to advance
our studies, 2020 is shaping up to be a busy and productive year for our Company," said Peter L. Hoang, President & CEO
of Marker Therapeutics. "Based on promising results observed with our MultiTAA T cell therapy across various forms of cancer
in investigator-sponsored trials, we are also evaluating opportunities for additional Marker-sponsored trials."
Targeted (MultiTAA) T Cell Therapies
Prepares to Initiate Phase 2 AML Trial
In February 2020, the Company announced
an updated study protocol for its Phase 2 clinical trial of MultiTAA T cell therapy in post-allogeneic
hematopoietic stem cell transplant patients with acute myeloid leukemia (AML) in both the adjuvant and active disease setting.
Under an amended trial design, the U.S. Food and Drug Administration (FDA) has permitted the trial to move forward with the safety
lead-in. During the second half of 2020, Marker expects to complete enrollment of the first three patients and to submit the information
required by the FDA to lift a partial clinical hold during the second half of 2020. The Company does not currently expect the partial
clinical hold to significantly impact site or patient enrollment.
Investigator-Sponsored
Trials with MultiTAA T Cell Therapy Continue to Generate Positive Results
Marker previously reported interim data from an ongoing Phase
1/2 clinical trial of MultiTAA T cell therapy for the treatment of patients with pancreatic adenocarcinoma being conducted by its
partners at the Baylor College of Medicine (BCM). In this trial, the modified T cells exhibited activity against both targeted
tumor-associated antigens (TAA) and non-targeted TAAs, indicating induction of antigen spreading. To date, there has not been any
cytokine release syndrome or neurotoxicity observed in this trial.
2 Triple Negative Breast Cancer Trial Progressing
Marker's T cell-based
vaccine program in triple negative breast cancer has delivered the following results as of September 30, 2019:
2 Platinum-Sensitive Advanced Ovarian Cancer Trial
FULL YEAR 2019 FINANCIAL RESULTS
Position and Guidance: At December 31, 2019, Marker had cash and cash equivalents of $43.9 million. The Company
believes that the financial flexibility provided by the Aspire transaction will enable the cash runway to extend beyond the second
Expenses: Research and development expenses were $12.8 million for the year ended December 31, 2019 compared
to $8.0 million for the year ended December 31, 2018. The increase was primarily attributable to increases in personnel-related
expenses relating to the build-up of Marker's internal infrastructure, an increase in clinical consulting and professional
expenses relating to preparation of the AML trial, an increase in process development expenses, offset by a decrease in clinical
trial expenses due to the stages of ongoing clinical trials and the decreased number of active patients in such trials.
G&A Expenses: General and administrative expenses
were $10.0 million for the year ended December 31, 2019, compared to $24.4 million for the year ended December 31,
2018. The decrease was primarily attributable to a decrease of $12.8 million in stock-based compensation expenses due to executive
stock option grants issued in fiscal year 2018, as well as a decrease in merger-related expenses during fiscal year 2019, offset
by increased expenses in headcount-related and legal and other professional expenses.
Net Loss: Marker reported a net loss of $21.4
million for the year ended December 31, 2019, compared to a net loss of $148.0 million for the year ended December
About Marker Therapeutics,
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
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Statement Disclaimer
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 use of proceeds from any sales
under the Common Stock Purchase Agreement with Aspire Capital; our research, development and regulatory activities and expectations
relating to our non-engineered multi-tumor antigen specific T cell therapies and our TPIV200 and TPIV100/110 programs; the effectiveness
of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases;
and, the timing and success of our clinical trials, as well as clinical trials conducted by our collaborators. 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. 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
| December 31, | December 31, | |||||||
| 2019 | 2018 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 43,903,949 | $ | 61,746,748 | ||||
| Prepaid expenses and deposits | 1,526,442 | 141,717 | ||||||
| Interest receivable | 56,189 | 108,177 | ||||||
| Total current assets | 45,486,580 | 61,996,642 | ||||||
| Non-current assets: | ||||||||
| Property, plant and equipment, net | 417,528 | 147,668 | ||||||
| Right-of-use assets, net | 455,174 | - | ||||||
| Total non-current assets | 872,702 | 147,668 | ||||||
| Total assets | $ | 46,359,282 | $ | 62,144,310 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 1,757,680 | $ | 2,754,572 | ||||
| Lease liability | 204,132 | - | ||||||
| Warrant liability | 31,000 | 49,000 | ||||||
| Total current liabilities | 1,992,812 | 2,803,572 | ||||||
| Non-current liabilities: | ||||||||
| Lease liability, net of current portion | 280,247 | - | ||||||
| Total non-current liabilities | 280,247 | - | ||||||
| Total liabilities | 2,273,059 | 2,803,572 | ||||||
| Commitments and contingencies | - | - | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at December 31, 2019 and 2018, respectively | - | - | ||||||
| Common stock, $0.001 par value, 150 million shares authorized, 45.7 million and 45.4 million shares issued and outstanding as of December 31, 2019 and 2018, respectively | 45,728 | 45,440 | ||||||
| Additional paid-in capital | 371,573,909 | 365,400,748 | ||||||
| Accumulated deficit | (327,533,414 | ) | (306,105,450 | ) | ||||
| Total stockholders' equity | 44,086,223 | 59,340,738 | ||||||
| Total liabilities and stockholders' equity | $ | 46,359,282 | $ | 62,144,310 |
Marker Therapeutics, Inc.
Consolidated Statements of Operations
| For the Years Ended | ||||||||
| December 31, | ||||||||
| 2019 | 2018 | |||||||
| Revenues: | ||||||||
| Grant income | $ | 213,194 | $ | 205,994 | ||||
| Total revenues | 213,194 | 205,994 | ||||||
| Operating expenses: | ||||||||
| Research and development - intellectual property acquired | - | 116,044,886 | ||||||
| Research and development | 12,764,804 | 7,952,870 | ||||||
| General and administrative | 9,977,196 | 24,379,871 | ||||||
| Total operating expenses | 22,742,000 | 148,377,627 | ||||||
| Loss from operations | (22,528,806 | ) | (148,171,633 | ) | ||||
| Other income (expense): | ||||||||
| Change in fair value of warrant liabilities | 18,000 | (40,000 | ) | |||||
| Interest income | 1,082,842 | 253,723 | ||||||
| Net loss | $ | (21,427,964 | ) | $ | (147,957,910 | ) | ||
| Net loss per share, basic and diluted | $ | (0.47 | ) | $ | (7.75 | ) | ||
| Weighted average number of common shares outstanding | 45,587,734 | 19,091,926 |
Marker Therapeutics, Inc.
Consolidated Statements of Cash Flows
| For the Years Ended | ||||||||
| December 31, | ||||||||
| 2019 | 2018 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (21,427,964 | ) | $ | (147,957,910 | ) | ||
| Reconciliation of net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 105,123 | - | ||||||
| Changes in fair value of warrant liabilities | (18,000 | ) | 40,000 | |||||
| Stock-based compensation | 5,356,972 | 16,350,592 | ||||||
| Amortization on right-of-use assets | 181,459 | - | ||||||
| Research and development - intellectual property acquired | - | 116,044,886 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and deposits | (1,384,725 | ) | (90,567 | ) | ||||
| Interest receivable | 51,988 | (108,177 | ) | |||||
| Accounts payable and accrued expenses | (963,967 | ) | 1,241,260 | |||||
| Lease liability | (185,179 | ) | - | |||||
| Net cash used in operating activities | (18,284,293 | ) | (14,479,916 | ) | ||||
| Cash Flows from Investing Activities: | ||||||||
| Purchase of property and equipment | (374,983 | ) | (147,668 | ) | ||||
| Net cash used in investing activities | (374,983 | ) | (147,668 | ) | ||||
| Cash Flows from Financing Activities: | ||||||||
| Proceeds from issuance of common stock and warrants in private placement, net of offering costs | - | 66,945,000 | ||||||
| Proceeds from exercise of stock options | 57,744 | 18,125 | ||||||
| Proceeds from exercise of warrants, net of offering costs | 758,733 | 4,353,628 | ||||||
| Repurchase of common stock to pay for employee withholding taxes | - | (71,710 | ) | |||||
| Net cash provided by financing activities | 816,477 | 71,245,043 | ||||||
| Net (decrease) increase in cash | (17,842,799 | ) | 56,617,459 | |||||
| Cash and cash equivalents at beginning of year | 61,746,748 | 5,129,289 | ||||||
| Cash and cash equivalents at end of year | $ | 43,903,949 | $ | 61,746,748 |