Marker Therapeutics Reports Full Year 2019 Operating and Financial Results
HOUSTON, March 12, 2020 /PRNewswire/ -- 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 31, 2019.
"With 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."
PROGRAM UPDATES
Multi-Antigen Targeted (MultiTAA) T Cell Therapies
Marker 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.
T Cell-Based Vaccines
Phase 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:
-- Based on a preliminary analysis of 34 patients enrolled in the triple
negative breast cancer trial, 31 patients showed meaningful immune
response to vaccine treatment;
-- Of 80 patients treated at 11 clinical sites, 16 have shown disease
progression following treatment with TPIV200.
Phase 2 Platinum-Sensitive Advanced Ovarian Cancer Trial
-- As previously announced, Marker has discontinued the development of
TPIV200 in patients with platinum-sensitive advanced ovarian cancer
based on an unblinded review of interim results from the trial conducted
by the Data Safety Monitoring Board (DSMB). While the DSMB did not
express safety concerns, Marker elected to discontinue the trial as it
did not meet the threshold for probability of clinical benefit based
upon the Company's pre-specified criteria.
FINANCING UPDATE
-- On March 2, 2020, Marker announced that the Company entered into a
Common Stock Purchase Agreement of up to $30 million with Aspire Capital
Fund, LLC, a Chicago-based institutional investor and long-term Marker
shareholder.
FULL YEAR 2019 FINANCIAL RESULTS
Cash 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 quarter of 2021.
R&D 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 31, 2018.
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
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Forward-Looking Statement Disclaimer
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 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
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SOURCE Marker Therapeutics, Inc.
