HOUSTON, Nov. 10, 2021 /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,
2021.
"This quarter, we continued our momentum in advancing Marker's
Phase 2 trial of MT-401, Marker's lead MultiTAA-specific T cell
therapy, for the treatment of post-transplant acute myeloid
leukemia, or AML," said Peter L.
Hoang, President & CEO of Marker Therapeutics. "We
are pleased to announce that the first patients in Marker's Phase 2
AML trial have been dosed with study drug. Further, we are on track
to enroll the first 20 patients of the trial in the fourth quarter,
with the first data readout expected in the first quarter of 2022.
We look forward to providing year-end updates in a conference call
and webcast early next year."
PROGRAM UPDATES
- The Company continues to enroll patients and activate clinical
sites across the U.S. in Marker's Phase 2 trial of MT-401, its lead
MultiTAA-specific T cell product candidate, for the treatment of
post-transplant AML. The trial is expected to enroll approximately
120 patients in the adjuvant setting and 40 patients with active
disease at approximately 20 clinical sites.
BUSINESS UPDATES
- The Company's new cGMP manufacturing facility in Houston, Texas is fully operational and is
supporting ongoing operations. The facility will also manufacture
Marker's MultiTAA-specific T cell products for future hematological
and solid tumor trials, in addition to producing the potential
commercial supply of any products, if approved.
- In August, the Company announced that it received notice of a
Product Development Research award totaling approximately
$13.1 million from the Cancer
Prevention and Research Institute of Texas (CPRIT) to support the Company's Phase 2
AML trial.
ANTICIPATED PROGRAM MILESTONES
AML Trial Milestones
- Enrollment of first 20 patients of the Phase 2 AML trial
expected in Q4 2021
- Topline readout of Group 2 active disease anticipated in Q1
2022
THIRD QUARTER 2021 FINANCIAL RESULTS
- Cash Position and Guidance: At September 30, 2021, Marker had cash and cash
equivalents of $48.7 million. The
Company believes that its existing cash and cash equivalents will
fund its operating expenses and capital expenditure requirements
into the first quarter of 2023.
- R&D Expenses: Research and development expenses were
$6.8 million for the quarter ended
September 30, 2021 compared to
$4.8 million for the quarter ended
September 30, 2020. The increase was
primarily attributable to increases in clinical trial and sponsored
research expenses and headcount-related expenses due to growth of
research and development operations.
- G&A Expenses: General and administrative expenses
were $3.2 million for the quarter
ended September 30, 2021 compared to
$2.6 million for the quarter ended
September 30, 2020.
- Net Loss: Marker reported a net loss of $12.4 million for the quarter ended September 30, 2021, compared to a net loss of
$7.4 million for the quarter ended
September 30, 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.
To receive future press releases via email, please visit:
https://www.markertherapeutics.com/email-alerts.
Forward-Looking Statements
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; the effectiveness of
these programs or the possible range of application and potential
curative effects and safety in the treatment of diseases; the
timing, conduct and success of our clinical trials, including the
Phase 2 trial of MT-401; our ability to use our manufacturing
facilities to support clinical and commercial demand; the timing
and use of the CPRIT award; and our future operating expenses and
capital expenditure requirements. 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. Such risks and
uncertainties may be amplified by the COVID-19 pandemic and its
impact on our business and the global economy. 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,
|
|
2021
|
|
2020
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
48,705,297
|
|
$
21,352,382
|
Prepaid expenses and
deposits
|
2,701,327
|
|
2,057,924
|
Other
receivables
|
243
|
|
1,000,559
|
Total current
assets
|
51,406,867
|
|
24,410,865
|
Non-current
assets:
|
|
|
|
Property, plant and
equipment, net
|
9,846,745
|
|
3,570,736
|
Construction in
progress
|
600,005
|
|
6,789,098
|
Right-of-use assets,
net
|
10,086,158
|
|
10,844,116
|
Total non-current
assets
|
20,532,908
|
|
21,203,950
|
|
|
|
|
Total
assets
|
$
71,939,775
|
|
$
45,614,815
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
7,645,287
|
|
$
6,013,010
|
Lease
liability
|
581,588
|
|
388,792
|
Total current
liabilities
|
8,226,875
|
|
6,401,802
|
Non-current
liabilities:
|
|
|
|
Lease liability, net
of current portion
|
11,430,892
|
|
11,868,440
|
Total non-current
liabilities
|
11,430,892
|
|
11,868,440
|
|
|
|
|
Total
liabilities
|
19,657,767
|
|
18,270,242
|
|
|
|
|
Commitments and
contingencies
|
-
|
|
-
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock -
$0.001 par value, 5 million shares authorized and 0 shares issued
and outstanding at September 30, 2021 and December 31, 2020,
respectively
|
-
|
|
-
|
Common stock, $0.001
par value, 150 million shares authorized, 83.1 million and 50.7
million shares issued and outstanding as of September 30, 2021 and
December 31, 2020, respectively
|
83,079
|
|
50,731
|
Additional paid-in
capital
|
440,553,968
|
|
383,533,326
|
Accumulated
deficit
|
(388,355,039)
|
|
(356,239,484)
|
Total stockholders'
equity
|
52,282,008
|
|
27,344,573
|
|
|
|
|
Total liabilities
and stockholders' equity
|
$
71,939,775
|
|
$
45,614,815
|
Marker
Therapeutics, Inc.
|
Condensed
Consolidated Statements of Operations
|
(Unaudited)
|
|
|
For the Three
Months Ended
|
|
For the Nine
Months Ended
|
|
September
30,
|
|
September
30,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Revenues:
|
|
|
|
|
|
|
|
Grant
income
|
$
-
|
|
$
-
|
|
$
-
|
|
$
466,785
|
Total
revenues
|
-
|
|
-
|
|
-
|
|
466,785
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
6,784,390
|
|
4,803,605
|
|
19,777,454
|
|
12,897,275
|
General and
administrative
|
3,239,148
|
|
2,572,562
|
|
9,936,256
|
|
7,946,846
|
Total operating
expenses
|
10,023,538
|
|
7,376,167
|
|
29,713,710
|
|
20,844,121
|
Loss from
operations
|
(10,023,538)
|
|
(7,376,167)
|
|
(29,713,710)
|
|
(20,377,336)
|
Other
income:
|
|
|
|
|
|
|
|
Change in fair value
of warrant liabilities
|
-
|
|
-
|
|
-
|
|
31,000
|
Arbitration
settlement
|
(2,406,576)
|
|
-
|
|
(2,406,576)
|
|
-
|
Interest
income
|
791
|
|
4,667
|
|
4,731
|
|
147,493
|
Net
loss
|
$
(12,429,323)
|
|
$
(7,371,500)
|
|
$
(32,115,555)
|
|
$
(20,198,843)
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.15)
|
|
$
(0.16)
|
|
$
(0.43)
|
|
$
(0.43)
|
Weighted average
number of common shares outstanding, basic and diluted
|
83,078,675
|
|
46,867,119
|
|
74,290,598
|
|
46,509,391
|
Marker
Therapeutics, Inc.
|
Condensed
Consolidated Statements of Cash Flows
|
(Unaudited)
|
|
|
For the Nine
Months Ended
|
|
September
30,
|
|
2021
|
|
2020
|
Cash Flows from
Operating Activities:
|
|
|
|
Net
loss
|
$
(32,115,555)
|
|
$
(20,198,843)
|
Reconciliation of
net loss to net cash used in operating activities:
|
|
|
|
Depreciation and
amortization
|
1,584,495
|
|
272,725
|
Changes in fair value
of warrant liabilities
|
-
|
|
(31,000)
|
Stock-based
compensation
|
4,497,145
|
|
3,974,536
|
Amortization on
right-of-use assets
|
757,958
|
|
337,530
|
Changes in
operating assets and liabilities:
|
|
|
|
Prepaid expenses and
deposits
|
(643,403)
|
|
(840,703)
|
Other
receivables
|
1,000,316
|
|
56,054
|
Accounts payable and
accrued expenses
|
2,742,154
|
|
2,065,929
|
Lease
liability
|
(244,752)
|
|
(166,723)
|
Net cash used in
operating activities
|
(22,421,642)
|
|
(14,530,495)
|
Cash Flows from
Investing Activities:
|
|
|
|
Purchase of property
and equipment
|
(1,262,092)
|
|
(2,005,160)
|
Purchase of
construction in progress
|
(1,519,196)
|
|
(3,147,566)
|
Net cash used in
investing activities
|
(2,781,288)
|
|
(5,152,726)
|
Cash Flows from
Financing Activities:
|
|
|
|
Proceeds from
issuance of common stock, net
|
52,552,758
|
|
2,186,009
|
Proceeds from
exercise of warrants
|
-
|
|
550,000
|
Proceeds from
exercise of stock options
|
3,087
|
|
-
|
Net cash provided by
financing activities
|
52,555,845
|
|
2,736,009
|
Net increase
(decrease) in cash
|
27,352,915
|
|
(16,947,212)
|
|
|
|
|
Cash and cash
equivalents at beginning of the period
|
21,352,382
|
|
43,903,949
|
Cash and cash
equivalents at end of the period
|
$
48,705,297
|
|
$
26,956,737
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/marker-therapeutics-reports-third-quarter-2021-operating-and-financial-results-301421532.html
SOURCE Marker Therapeutics, Inc.