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.