HOUSTON, Aug. 8, 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 second quarter ended
June 30, 2019.
"We are encouraged by the data generated to date with our
MultiTAA T cell therapies—particularly in pancreatic cancer—a
disease that has not seen meaningful improvements in treatment
outcomes in more than 40 years," said Peter
L. Hoang, President & CEO of Marker Therapeutics. "These
data suggest that our therapy—which targets multiple
antigens—continues to demonstrate epitope spreading, potentially
contributing to the T cells' ability to expand and produce a
lasting anti-tumor effect, with no added toxicities. We will
continue to follow these patients and enroll new patients to
further evaluate durability."
Continued Mr. Hoang: "Encouraged by results from our
investigator-sponsored trials, we are now looking forward to
initiating our first Marker-sponsored trial with MultiTAA T cell
therapies in patients with post-transplant acute myeloid leukemia,
and look forward to continuing our discussions with the FDA
regarding our Phase 2 trial."
PROGRAM HIGHLIGHTS AND CURRENT UPDATES
Multi-Antigen Targeted (MultiTAA) T Cell Therapies
Encouraging Interim Pancreatic Cancer Data Reported at AACR
Meeting in July
Marker recently reported interim data from an ongoing
investigator-sponsored Phase 1/2 clinical trial led by Baylor College of Medicine (BCM), evaluating the
Company's MultiTAA T cell therapy in patients with pancreatic
adenocarcinoma. Investigators plan to enroll a total of 45 patients
with advanced or borderline resectable pancreatic cancer in the
three-arm trial and a total of 19 patients had received infusions
of MultiTAA T cell therapy as of July 5,
2019. The results from these patients—which were reviewed in
an oral presentation during a plenary session at AACR's Cell
Therapy meeting in July—suggested that MultiTAA T cell therapy may
contribute to more durable responses without added toxicity when
used in combination with standard-of-care chemotherapy, or as a
second-line therapy for patients who are chemo-refractory.
Additionally, in patients with borderline surgically resectable
disease—a challenging setting due to the associated dense fibrotic
tissue—interim data suggest that MultiTAA T cells are capable of
meaningfully infiltrating the tumor. Marker plans to follow these
patients and enroll new patients to further evaluate
durability.
Marker Preparing for Company-Sponsored Phase 2 Clinical Trial
in AML
The multicenter trial will evaluate clinical efficacy of Marker's
MultiTAA T cell therapy in patients with AML in both the adjuvant
and active disease setting following an allogeneic hematopoietic
stem cell transplant (HSCT). The dose in the Phase 2 trial is
expected to be the maximum tolerated dose currently determined in
the BCM-sponsored Phase 1 trial. In the adjuvant setting, patients
will be randomized to either MultiTAA T cell therapy at
approximately 90 days post-transplant or standard-of-care
observation, while the active disease patients will receive
MultiTAA T cells upon relapse as part of a single-arm group.
T Cell-Based Vaccines
The Company continues to advance its T cell-based vaccine
programs in ovarian cancer and triple negative breast cancer.
Phase 2 Ovarian Cancer Clinical Trial Highlights
- TPIV200 is being studied as a maintenance therapy for patients
in their first remission after surgery and platinum-based
chemotherapy.
- Trial is fully enrolled, with a total of 120 patients
randomized and treated at 17 clinical sites.
- Company expects to reach planned interim analysis trigger of 55
patients who have progressed before the end of 2019 and to report
results of this interim analysis in the fourth quarter of
2019.
Phase 2 Triple Negative Breast Cancer Trial
Highlights
- Based on preliminary analysis of 34 patients evaluated to date
in the dose-finding, four-arm trial—including low and high-dose
TPIV200 with or without cyclophosphamide—31 showed meaningful
immune response to the vaccine treatment (subject to final review
by independent biostatistical analysis).
- Of 80 patients treated at 11 clinical sites, 14 have shown
disease progression, as of June 30,
2019, following treatment with TPIV200.
CORPORATE UPDATE
- On August 6, Steve Elms was appointed to Marker's Board of
Directors. Mr. Elms currently serves as Managing Partner at Aisling
Capital.
SECOND QUARTER 2019 FINANCIAL RESULTS
Net loss for the quarter ended June 30,
2019 was $5.6 million,
compared to a net loss of $4.8
million for the quarter ended June
30, 2018.
Research and development expenses were $3.2 million for the quarter ended June 30, 2019, an increase of $1.4 million, compared to $1.8 million for the quarter ended June 30, 2018. The increase was primarily
attributable to increases in personnel-related expenses, including
stock-based compensation expenses and consulting expenses, relating
to the build-up of Marker's internal infrastructure as the Company
advances the clinical development of its MultiTAA T cell product
candidates.
General and administrative expenses were $2.7 million for the quarter ended June 30, 2019, a decrease of $0.4 million, compared to $3.1 million for the quarter ended June 30, 2018. The decrease was primarily
attributable to $1.2 million of
merger-related expenses incurred during the three months ended
June 30, 2018, offset by increased
expenses relating to $0.3 million of
headcount-related expenses, $0.4
million of non-merger-related legal and other professional
expenses and $0.1 million of
office-related and insurance expenses.
CASH POSITION AND GUIDANCE
At June 30, 2019, Marker had cash and
cash equivalents of $53.4 million.
The Company believes that its existing cash and cash equivalents
will fund the Company's current operations into late 2020.
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.
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.
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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, 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.
|
Condensed
Consolidated Balance Sheets
|
(Unaudited)
|
|
|
|
|
|
June
30,
|
|
December
31,
|
2019
|
|
2018
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
53,444,906
|
|
$
61,746,748
|
Prepaid expenses and
deposits
|
491,467
|
|
141,717
|
Interest
receivable
|
98,154
|
|
108,177
|
Total current
assets
|
54,034,527
|
|
61,996,642
|
Non-current
assets:
|
|
|
|
Property, plant and
equipment, net
|
413,239
|
|
147,668
|
Right-of-use assets,
net
|
547,455
|
|
-
|
Total non-current
assets
|
960,694
|
|
147,668
|
|
|
|
|
Total
assets
|
$
54,995,221
|
|
$
62,144,310
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
2,946,782
|
|
$
2,754,572
|
Lease
liability
|
194,482
|
|
-
|
Warrant
liability
|
65,000
|
|
49,000
|
Total current
liabilities
|
3,206,264
|
|
2,803,572
|
Non-current
liabilities:
|
|
|
|
Lease liability, net
of current portion
|
385,169
|
|
-
|
Total non-current
liabilities
|
385,169
|
|
-
|
|
|
|
|
Total
liabilities
|
3,591,433
|
|
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 June 30, 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 June 30, 2019 and
December 31, 2018, respectively
|
45,513
|
|
45,440
|
Additional paid-in
capital
|
368,353,041
|
|
365,400,748
|
Accumulated
deficit
|
(316,994,766)
|
|
(306,105,450)
|
Total stockholders'
equity
|
51,403,788
|
|
59,340,738
|
|
|
|
|
Total liabilities
and stockholders' equity
|
$
54,995,221
|
|
$
62,144,310
|
Marker
Therapeutics, Inc.
|
Condensed
Consolidated Statements of Operations
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
For the Three
Months Ended
|
|
For the Six Months
Ended
|
|
June
30,
|
|
June
30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenues:
|
|
|
|
|
|
|
|
Grant
income
|
$
-
|
|
$
205,994
|
|
$
-
|
|
$
205,994
|
Total
revenues
|
-
|
|
205,994
|
|
-
|
|
205,994
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
3,152,445
|
|
1,826,837
|
|
5,985,140
|
|
3,426,387
|
General and
administrative
|
2,721,120
|
|
3,052,954
|
|
5,526,895
|
|
4,650,890
|
Total operating
expenses
|
5,873,565
|
|
4,879,791
|
|
11,512,035
|
|
8,077,277
|
Loss from
operations
|
(5,873,565)
|
|
(4,673,797)
|
|
(11,512,035)
|
|
(7,871,283)
|
Other income
(expense):
|
|
|
|
|
|
|
|
Change in fair value
of warrant liabilities
|
(7,000)
|
|
(139,000)
|
|
(16,000)
|
|
(138,000)
|
Interest
income
|
310,174
|
|
-
|
|
638,719
|
|
-
|
Net
loss
|
$
(5,570,391)
|
|
$
(4,812,797)
|
|
$
(10,889,316)
|
|
$
(8,009,283)
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.12)
|
|
$
(0.41)
|
|
$
(0.24)
|
|
$
(0.71)
|
Weighted average
number of common shares outstanding
|
45,501,078
|
|
11,838,371
|
|
45,483,513
|
|
11,233,755
|
Marker
Therapeutics, Inc.
|
Condensed
Consolidated Statements of Cash Flows
|
(Unaudited)
|
|
|
For the Six Months
Ended
|
|
June
30,
|
|
2019
|
|
2018
|
Cash Flows from
Operating Activities:
|
|
|
|
Net
loss
|
$
(10,889,316)
|
|
$
(8,009,283)
|
Reconciliation of
net loss to net cash used in operating activities:
|
|
|
|
Depreciation and
amortization
|
39,811
|
|
-
|
Changes in fair value
of warrant liabilities
|
16,000
|
|
138,000
|
Stock-based
compensation
|
2,889,243
|
|
1,096,472
|
Amortization on
right-of-use assets
|
89,178
|
|
-
|
Changes in
operating assets and liabilities:
|
|
|
|
Prepaid expenses and
deposits
|
(349,750)
|
|
(57,566)
|
Interest
receivable
|
10,023
|
|
-
|
Accounts payable and
accrued expenses
|
225,135
|
|
2,086,840
|
Lease
liability
|
(89,907)
|
|
-
|
Net cash used in
operating activities
|
(8,059,583)
|
|
(4,745,537)
|
Cash Flows from
Investing Activities:
|
|
|
|
Purchase of property
and equipment
|
(305,382)
|
|
-
|
Net cash used in
investing activities
|
(305,382)
|
|
-
|
Cash Flows from
Financing Activities:
|
|
|
|
Proceeds from
issuance of common stock and warrants in private placement, net of
offering costs
|
-
|
|
3,120,000
|
Proceeds from
exercise of stock options
|
57,744
|
|
18,125
|
Proceeds from
exercise of warrants
|
5,379
|
|
4,261,085
|
Net cash provided by
financing activities
|
63,123
|
|
7,399,210
|
Net (decrease)
increase in cash
|
(8,301,842)
|
|
2,653,673
|
|
|
|
|
Cash and cash
equivalents at beginning of period
|
61,746,748
|
|
5,129,289
|
Cash and cash
equivalents at end of period
|
$
53,444,906
|
|
$
7,782,962
|
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SOURCE Marker Therapeutics, Inc.