HOUSTON, May 9, 2019 /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
first quarter ended March 31, 2019.
"We continued to make significant progress this quarter. Based
on our early interactions with the U.S. FDA, we are confident in
our submission package for our IND for post-transplant acute
myeloid leukemia (AML). In light of the feedback from the FDA, we
plan to submit an IND for a Phase 2 clinical trial in the third
quarter, which should enable us to enroll the first patient by
the end of the year," said Peter L. Hoang, President & CEO
of Marker Therapeutics. "Depending on the results and upon further
discussions with the FDA, we believe that if results are positive,
this has the potential to serve as a pivotal trial—particularly if
results are consistent with data generated to date from our
MultiTAA therapies in investigator-sponsored trials. We look
forward to initiating our first company-sponsored trial in such an
important disease area, for which there are limited treatment
options. Additionally, we anticipate reporting an update from our
solid tumor program in pancreatic cancer in the third quarter."
PROGRAM HIGHLIGHTS AND CURRENT UPDATES
Multi-Antigen Targeted (MultiTAA) T Cell Therapies
- Company Prepares IND for Potentially Pivotal Trial in
Post-Transplant AML
Based on interactions with the U.S.
Food and Drug Administration (FDA) on the clinical trial design of
the planned Marker-sponsored Phase 2 clinical trial in
post-transplant AML, the Company remains on track to submit an
Investigational New Drug (IND) application in the third quarter,
and anticipates first patient enrolled by the end of 2019. The
multicenter trial will evaluate clinical efficacy of Marker's
MultiTAA-specific T cells in patients with AML in both the adjuvant
and active disease setting, following an allogeneic hematopoietic
stem cell transplant (HSCT). The dose to be administered in the
trial is expected to be the maximum tolerated dose currently
determined in the Baylor College of
Medicine-sponsored Phase 1 trial. In the adjuvant setting,
patients will be randomized to either MultiTAA therapy at
approximately 90 days post-transplant or standard of care
observation, while the active disease patients will receive
MultiTAA T cells as part of a single-arm group at approximately 90
days post-transplant.
- MultiTAA T Cell Therapies Continue to Generate Positive
Clinical Data Across Various Indications
In several ongoing investigator-sponsored Phase 1 clinical trials
led by Baylor College of Medicine
(BCM), Marker's MultiTAA therapies have demonstrated the potential
to mediate a meaningful anti-tumor effect, as well as significant
in vivo expansion of T cells. Across all hematological
indications studied in these trials—including AML, lymphoma, acute
lymphoblastic leukemia (ALL), and multiple myeloma—MultiTAA therapy
has appeared to be well-tolerated, with no incidence of cytokine
release syndrome, neurotoxicity or any other serious adverse events
related to the therapy.
- Company to Report Update from Phase 1/2 Trial in Pancreatic
Cancer in Q3 2019
Marker plans to report additional interim
data from BCM's ongoing Phase 1/2 clinical trial in pancreatic
cancer in the third quarter of 2019. The Phase 1/2 trial is a
three-arm trial which includes chemo-responsive patients (Arm A),
chemo-refractory patients (Arm B) and an exploratory arm for
patients who have surgically-resectable disease (Arm C). Patients
in the chemo-responsive arm have completed at least three months of
standard-of-care chemotherapy, and are receiving up to six
administrations of MultiTAA T cells in alternation with
chemotherapy. Patients in the chemo-refractory arm are either
ineligible for chemotherapy or have progressed on chemotherapy, and
are receiving up to six doses of MultiTAA T cells as a monotherapy.
The surgically-resectable patients are receiving a dose of T cells
prior to surgical resection which allows Marker to assess the tumor
samples for T-cell infiltration, epitope spreading and other
important characteristics. These patients are eligible to receive
five additional doses of T cells after surgical resection.
T Cell Based Vaccines
- Ovarian Cancer Data
As of January 2019, the Company has completed
enrollment in its Phase 2 clinical trial in ovarian cancer using
TPIV200 as a maintenance therapy for patients in their first
remission after surgery and platinum-based chemotherapy, with a
total of 120 patients enrolled, randomized, and treated at 17
clinical sites. The trial completed enrollment six months faster
than anticipated and the Company expects to reach its planned
interim analysis trigger of 55 patients who have progressed before
the end of 2019 and to report the results of this interim analysis
in the fourth quarter of 2019.
- Triple Negative Breast Cancer Data
The Company
reported initial findings from its dose-finding, four-arm Phase 2
clinical trial in triple negative breast cancer, including low- and
high-dose TPIV200 with or without cyclophosphamide. Of 27
patients evaluated for immunogenicity, 26 showed significant immune
response to the vaccine treatment. Of 80 patients treated at 11
clinical sites, 14 have shown disease progression, as of
April 30, 2019, following treatment
with TPIV200.
FIRST QUARTER 2019 FINANCIAL RESULTS
Net loss for the quarter ended March 31, 2019 was
$5.3 million compared to a net loss
of $3.2 million for the quarter ended
March 31, 2018.
Research and development expenses were $2.8 million for the quarter ended March 31, 2019, an increase of $1.2 million, compared to $1.6 million for the quarter ended March 31, 2018. The increase was primarily
attributable to increased headcount-related expenses, stock-based
compensation expenses and consulting expenses resulting from the
expansion of our internal infrastructure as we advance the clinical
development of our MultiTAA T cell product candidates.
General and administrative expenses were $2.8 million for the quarter ended March 31, 2019, an increase of $1.2 million, compared to $1.6 million for the quarter ended March 31, 2018. The increase was primarily
attributable to an increase in general and administrative headcount
and stock-based compensation expenses.
CASH POSITION AND GUIDANCE
At March 31, 2019, Marker had cash
and cash equivalents of $57.7
million. The Company believes that its existing cash and
cash equivalents will fund the Company's current operations into
late 2020.
UPCOMING NEAR-TERM POTENTIAL MILESTONES
- First update in solid tumor program planned for third quarter
of 2019;
- IND submission for Company-sponsored Phase 2 AML clinical trial
in the third quarter of 2019, with first patient enrolled by end of
2019;
- Interim analysis readout in the TPIV200 ovarian trial expected
in fourth quarter of 2019; and
- Overall update on ongoing clinical trials in cell therapy to be
provided by the end of 2019.
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 cells
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
therapeutic product profile, as compared to current gene-modified
CAR-T and TCR-based therapies.
Marker is also advancing a number of innovative peptide- and
gene-based immuno-therapeutics for the treatment of metastatic
solid tumors, including the Folate Receptor Alpha program (TPIV200)
for breast and ovarian cancers and the HER2/neu program
(TPIV100/110) for breast cancer, currently in Phase 2 clinical
trials.
For additional information, please call toll free at (904)
862-6490 or visit: markertherapeutics.com
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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 research and development activities
relating to our non-engineered multi-tumor antigen specific T cell
therapies; 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
|
(Unaudited)
|
|
|
|
|
|
March
31,
|
|
December
31,
|
2019
|
|
2018
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
57,706,579
|
|
$
61,746,748
|
Prepaid expenses and
deposits
|
216,433
|
|
141,717
|
Interest
receivable
|
112,200
|
|
108,177
|
Total current
assets
|
58,035,212
|
|
61,996,642
|
Non-current
assets:
|
|
|
|
Property, plant and
equipment, net
|
360,280
|
|
147,668
|
Right-of-use assets,
net
|
592,422
|
|
-
|
Total non-current
assets
|
952,702
|
|
147,668
|
|
|
|
|
TOTAL
ASSETS
|
$
58,987,914
|
|
$
62,144,310
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
2,694,019
|
|
$
2,754,572
|
Lease
liability
|
189,791
|
|
-
|
Warrant
liability
|
58,000
|
|
49,000
|
Total current
liabilities
|
2,941,810
|
|
2,803,572
|
Non-current
liabilities:
|
|
|
|
Lease liability, net
of current portion
|
435,192
|
|
-
|
Total non-current
liabilities
|
435,192
|
|
-
|
|
|
|
|
Total
liabilities
|
3,377,002
|
|
2,803,572
|
|
|
|
|
COMMITMENTS AND
CONTINGENCIES
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock -
$0.001 par value, 5 million shares authorized at March 31, 2019 and
December 31, 2018, respectively
|
|
|
|
Series A, $0.001 par
value, 1.25 million shares designated, 0 shares issued and
outstanding as of March 31, 2019 and December 31, 2018,
respectively
|
-
|
|
-
|
Series B, $0.001 par
value, 1.5 million shares designated, 0 shares issued and
outstanding as of March 31, 2019 and December 31, 2018,
respectively
|
-
|
|
-
|
Common stock, $0.001
par value, 150 million shares authorized, 45.5 million and 45.4
million shares issued and outstanding as of March 31, 2019 and
December 31, 2018, respectively
|
45,484
|
|
45,440
|
Additional paid-in
capital
|
366,989,803
|
|
365,400,748
|
Accumulated
deficit
|
(311,424,375)
|
|
(306,105,450)
|
Total stockholders'
equity
|
55,610,912
|
|
59,340,738
|
|
|
|
|
TOTAL LIABILITIES
AND STOCKHOLDERS' EQUITY
|
$
58,987,914
|
|
$
62,144,310
|
Marker
Therapeutics, Inc.
|
Consolidated
Statements of Operations
|
(Unaudited)
|
|
|
|
|
|
For the Three
Months Ended
|
|
March
31,
|
|
2019
|
|
2018
|
Operating
expenses:
|
|
|
|
Research and
development
|
$
2,832,695
|
|
$
1,599,550
|
General and
administrative
|
2,805,775
|
|
1,597,936
|
Total operating
expenses
|
5,638,470
|
|
3,197,486
|
Loss from
operations
|
(5,638,470)
|
|
(3,197,486)
|
Other income
(expense):
|
|
|
|
Change in fair value
of warrant liabilities
|
(9,000)
|
|
1,000
|
Interest
income
|
328,545
|
|
-
|
Net
loss
|
$
(5,318,925)
|
|
$
(3,196,486)
|
|
|
|
|
Net loss per share,
Basic and Diluted
|
$
(0.12)
|
|
$
(0.30)
|
Weighted average
number of common shares outstanding
|
45,465,754
|
|
10,622,420
|
Marker
Therapeutics, Inc.
|
Consolidated
Statements of Cash Flows
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
For the Three
Months Ended
|
|
March
31,
|
|
2019
|
|
2018
|
Cash Flows from
Operating Activities:
|
|
|
|
Net
loss
|
$
(5,318,925)
|
|
$
(3,196,486)
|
Reconciliation of
net loss to net cash used in operating activities:
|
|
|
|
Depreciation and
amortization
|
10,514
|
|
-
|
Changes in fair value
of warrant liabilities
|
9,000
|
|
(1,000)
|
Stock-based
compensation
|
1,525,976
|
|
136,193
|
Amortization on
right-of-use assets
|
44,211
|
|
-
|
Changes in
operating assets and liabilities:
|
|
|
|
Prepaid expenses and
deposits
|
(74,716)
|
|
(77,878)
|
Interest
receivable
|
(4,023)
|
|
-
|
Accounts payable and
accrued expenses
|
(27,628)
|
|
792,849
|
Lease
liability
|
(44,575)
|
|
-
|
Net cash used in
operating activities
|
(3,880,166)
|
|
(2,346,322)
|
Cash Flows from
Investing Activities:
|
|
|
|
Purchase of property
and equipment
|
(223,126)
|
|
-
|
Net cash used in
investing activities
|
(223,126)
|
|
-
|
Cash Flows from
Financing Activities:
|
|
|
|
Proceeds from
exercise of stock options
|
57,744
|
|
18,125
|
Proceeds from
exercise of warrants
|
5,379
|
|
-
|
Net cash provided by
financing activities
|
63,123
|
|
18,125
|
Net decrease in
cash
|
(4,040,169)
|
|
(2,328,197)
|
|
|
|
|
Cash and cash
equivalents at beginning of period
|
61,746,748
|
|
5,129,289
|
Cash and cash
equivalents at end of period
|
$
57,706,579
|
|
$
2,801,092
|
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SOURCE Marker Therapeutics, Inc.