HOUSTON, Nov. 12, 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
third quarter ended September 30,
2019.
"We continue to make progress in advancing our next-generation
T-cell based immunotherapies for the treatment of hematological
malignancies and solid tumors," said Peter
L. Hoang, President and CEO of Marker Therapeutics. "Our
partner-sponsored MultiTAA T-cell therapy trials at the
Baylor College of Medicine continue to
show promising results. In addition, we continue to expand our team
and build out our infrastructure to support future Marker-sponsored
clinical trials. We expect the next 12 to 18 months to be an
exciting and productive time for our Company."
Continued Mr. Hoang: "We recently filed an Investigational New
Drug (IND) application with the U.S. Food and Drug Administration
(FDA) for our MultiTAA T-cell therapy as part of a planned Marker
Phase 2 study in post-allogeneic hematopoietic stem cell transplant
patients with acute myeloid leukemia in both the adjuvant and
active disease setting. The FDA reviewed our submission and
requested additional information regarding certain quality and
technical specifications for two reagents supplied by third party
vendors that are used in our manufacturing process. Because the FDA
requires these data in order to clear the IND, the Marker AML trial
has been placed on clinical hold until our complete response to the
technical questions is satisfactory to the FDA. While these
reagents are not present in the final product, we worked with
respective manufacturers of these reagents to satisfy the FDA's
questions and subsequently submitted a complete response to the FDA
in late October. We currently project to initiate our Phase 2 trial
in 2020 and look forward to providing an update on our clinical
path forward upon receiving the FDA's feedback."
PROGRAM UPDATES
Multi-Antigen Targeted (MultiTAA) T-Cell Therapies
Marker Submits Response to FDA Clinical Hold on AML
Trial
The Company worked with regulatory and quality groups at the
respective manufacturers to address the FDA's request and submitted
a complete response to the issues raised by the FDA on October 28, 2019. The FDA will respond within 30
days after receiving Marker's complete response, indicating
whether the hold is lifted and, if not, specifying the reasons the
clinical trial remains on hold. Marker expects to initiate its
Phase 2 clinical trial of MultiTAA therapy for the treatment of
post-transplant AML in 2020.
T Cell-Based Vaccines
Phase 2 Triple Negative Breast Cancer Trial
Progressing
Marker continues to advance its T cell-based vaccine program in
triple negative breast cancer. To date, results have shown:
- 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, 14 have shown
disease progression, as of September 30,
2019, following treatment with TPIV200.
Phase 2 Platinum-Sensitive Advanced Ovarian Cancer Trial
Update
Marker will be discontinuing the development of TPIV200 in patients
with platinum-sensitive advanced ovarian cancer based on an
unblinded review of interim results from its Phase 2 study
conducted by an independent Data and Safety Monitoring Board
(DSMB). Although the DSMB did not express any safety concerns with
respect to TPIV200, Marker has elected to suspend the trial because
it did not meet the threshold for probability of success based upon
the Company's pre-specified criteria. Pending full review of the
data, Marker anticipates closing the trial in the first quarter of
2020.
CORPORATE UPDATES
- Nadia Agopyan, Ph.D., RAC,
former Director of Regulatory Affairs, Global Regulatory Lead at
Kite Pharma, appointed as Vice President of Regulatory Affairs
- Steve Elms, Managing Partner at
Aisling Capital, appointed to Board of Directors
THIRD QUARTER 2019 FINANCIAL RESULTS
Net loss for the quarter ended September
30, 2019 was $5.5 million,
compared to a net loss of $4.4
million for the quarter ended September 30, 2018.
Research and development expenses during the three months ended
September 30, 2019 were $3.1 million, compared to $1.9 million during the three months ended
September 30, 2018. The increase of
$1.2 million was primarily
attributable to increases in personnel-related expenses, relating
to the build-up of Marker's internal infrastructure.
General and administrative expenses were $2.5 million during the three months ended
September 30, 2019 as compared to
$2.6 million during the three months
ended September 30, 2018. The
decrease was primarily attributable to $0.6
million of merger-related expenses incurred during the three
months ended September 30, 2018,
offset by increased expenses in headcount-related and legal and
other professional expenses.
CASH POSITION AND GUIDANCE
At September 30, 2019, Marker had
cash and cash equivalents of $48.5
million. The Company believes that its existing cash and
cash equivalents will fund its current operations through at least
the fourth quarter of 2020.
Conference Call and Webcast
The Company will host a webcast and conference call to discuss
its third quarter 2019 financial results and provide an update on
recent corporate activities today at 5:00
p.m. EST.
The webcast will be accessible in the Investors section of the
Company's website at www.markertherapeutics.com. Individuals can
participate in the conference call by dialing 877-407-8913
(domestic) or 201-689-8201 (international) and referring to the
"Marker Therapeutics Third Quarter 2019 Earnings Call."
The archived webcast will be available for replay on the Marker
website following the event.
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 cancer and the HER2/neu program (TPIV100/110) for breast
cancer, currently in Phase 2 clinical trials.
To receive future press releases via email, please
visit: https://www.markertherapeutics.com/email-alerts/
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; 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)
|
|
|
September
30,
|
|
December
31,
|
2019
|
|
2018
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
48,477,670
|
|
$
61,746,748
|
Prepaid expenses and
deposits
|
1,906,062
|
|
141,717
|
Interest
receivable
|
78,145
|
|
108,177
|
Total current
assets
|
50,461,877
|
|
61,996,642
|
Non-current
assets:
|
|
|
|
Property, plant and
equipment, net
|
438,881
|
|
147,668
|
Right-of-use assets,
net
|
501,714
|
|
-
|
Total non-current
assets
|
940,595
|
|
147,668
|
|
|
|
|
Total
assets
|
$
51,402,472
|
|
$
62,144,310
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
2,858,808
|
|
$
2,754,572
|
Lease
liability
|
199,266
|
|
-
|
Warrant
liability
|
129,000
|
|
49,000
|
Total current
liabilities
|
3,187,074
|
|
2,803,572
|
Non-current
liabilities:
|
|
|
|
Lease liability, net
of current portion
|
333,480
|
|
-
|
Total non-current
liabilities
|
333,480
|
|
-
|
|
|
|
|
Total
liabilities
|
3,520,554
|
|
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 September 30, 2019 and December 31, 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 September 30, 2019 and
December 31, 2018, respectively
|
45,723
|
|
45,440
|
Additional paid-in
capital
|
370,290,447
|
|
365,400,748
|
Accumulated
deficit
|
(322,454,252)
|
|
(306,105,450)
|
Total stockholders'
equity
|
47,881,918
|
|
59,340,738
|
|
|
|
|
Total liabilities
and stockholders' equity
|
$
51,402,472
|
|
$
62,144,310
|
Marker
Therapeutics, Inc.
|
Condensed
Consolidated Statements of Operations
|
(Unaudited)
|
|
|
For the Three
Months Ended
|
|
For the Nine
Months Ended
|
|
September
30,
|
|
September
30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenues:
|
|
|
|
|
|
|
|
Grant
income
|
$
-
|
|
$
-
|
|
$
-
|
|
$
205,994
|
Total
revenues
|
-
|
|
-
|
|
-
|
|
205,994
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
3,118,530
|
|
1,877,260
|
|
9,103,670
|
|
5,303,647
|
General and
administrative
|
2,536,204
|
|
2,551,146
|
|
8,063,099
|
|
7,202,036
|
Total operating
expenses
|
5,654,734
|
|
4,428,406
|
|
17,166,769
|
|
12,505,683
|
Loss from
operations
|
(5,654,734)
|
|
(4,428,406)
|
|
(17,166,769)
|
|
(12,299,689)
|
Other income
(expense):
|
|
|
|
|
|
|
|
Change in fair value
of warrant liabilities
|
(64,000)
|
|
40,000
|
|
(80,000)
|
|
(98,000)
|
Interest
income
|
259,248
|
|
-
|
|
897,967
|
|
-
|
Net
loss
|
$
(5,459,486)
|
|
$
(4,388,406)
|
|
$
(16,348,802)
|
|
$
(12,397,689)
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.12)
|
|
$
(0.32)
|
|
$
(0.36)
|
|
$
(1.03)
|
Weighted average
number of common shares outstanding
|
45,655,387
|
|
13,733,406
|
|
45,541,434
|
|
12,082,176
|
Marker
Therapeutics, Inc.
|
Condensed
Consolidated Statements of Cash Flows
|
(Unaudited)
|
|
|
For the Nine
Months Ended
|
|
September
30,
|
|
2019
|
|
2018
|
Cash Flows from
Operating Activities:
|
|
|
|
Net
loss
|
$
(16,348,802)
|
|
$
(12,397,689)
|
Reconciliation of
net loss to net cash used in operating activities:
|
|
|
|
Depreciation and
amortization
|
70,908
|
|
-
|
Changes in fair value
of warrant liabilities
|
80,000
|
|
98,000
|
Stock-based
compensation
|
4,073,505
|
|
1,947,733
|
Amortization on
right-of-use assets
|
134,919
|
|
-
|
Changes in
operating assets and liabilities:
|
|
|
|
Prepaid expenses and
deposits
|
(1,764,345)
|
|
(45,817)
|
Interest
receivable
|
30,032
|
|
-
|
Accounts payable and
accrued expenses
|
137,161
|
|
2,080,459
|
Lease
liability
|
(136,812)
|
|
-
|
Net cash used in
operating activities
|
(13,723,434)
|
|
(8,317,314)
|
Cash Flows from
Investing Activities:
|
|
|
|
Purchase of property
and equipment
|
(362,121)
|
|
-
|
Net cash used in
investing activities
|
(362,121)
|
|
-
|
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, net of offering costs
|
758,733
|
|
4,344,171
|
Net cash provided by
financing activities
|
816,477
|
|
7,482,296
|
Net decrease in
cash
|
(13,269,078)
|
|
(835,018)
|
|
|
|
|
Cash and cash
equivalents at beginning of period
|
61,746,748
|
|
5,129,289
|
Cash and cash
equivalents at end of period
|
$
48,477,670
|
|
$
4,294,271
|
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SOURCE Marker Therapeutics, Inc.