HOUSTON, Aug. 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
second quarter ended June 30, 2021.
"Marker accomplished a number of strategic goals and clinical
milestones this quarter, including completing the safety lead-in
portion of our Company-sponsored Phase 2 trial investigating
Marker's MultiTAA-specific T cell therapy in post-transplant acute
myeloid leukemia, or AML," said Peter L.
Hoang, President & CEO of Marker Therapeutics. "We
are now enrolling patients as well as activating additional
clinical sites in the main portion of the trial. In parallel, we
opened a new in-house cGMP manufacturing facility in Houston and recently announced that the
facility is fully operational. We look forward to manufacturing
study drug at the new facility next quarter, which we expect will
yield quality product, reduce manufacturing costs and expand
patient access to Marker's MultiTAA-specific T cell therapies."
PROGRAM UPDATES
- In June 2021, Marker completed
the six-patient safety lead-in portion of the Company's Phase 2
trial of MT-401, its lead MultiTAA-specific T cell product
candidate, for the treatment of post-transplant AML.
- The Company continues to enroll patients in the main portion of
the trial and activate clinical sites across the U.S. 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
- Marker recently announced that the Company's new cGMP
manufacturing facility in Houston,
TX, located near the George Bush Intercontinental Airport,
is fully operational. The facility will manufacture Marker's
MultiTAA-specific T cell products for the Company's Phase 2 AML
trial as well as future hematological and solid tumor trials, in
addition to producing the potential commercial supply of any
approved products.
ANTICIPATED PROGRAM MILESTONES
AML Trial Milestones
- Complete enrollment of 20 patients in main portion of Phase 2
trial in Q4 2021
- Topline readout of Group 2 (active disease) in Q1 2022
Manufacturing Milestones
- Manufacture MT-401 at Marker's new cGMP facility for Phase 2
AML trial in Q3 2021
SECOND QUARTER 2021 FINANCIAL RESULTS
- Cash Position and Guidance: At June 30, 2021, Marker had cash and cash
equivalents of $57.2 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
$7.4 million for the quarter ended
June 30, 2021 compared to
$4.3 million for the quarter ended
June 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 $3.6 million for the quarter
ended June 30, 2021 compared to
$2.5 million for the quarter ended
June 30, 2020.
- Net Loss: Marker reported a net loss of $10.9 million for the quarter ended June 30, 2021, compared to a net loss of
$6.3 million for the quarter ended
June 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.
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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, as well as clinical trials conducted by
our collaborators; our manufacturing processes and our ability to
use our current and planned manufacturing facilities to support
clinical and commercial demand; 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)
|
|
|
June
30,
|
|
December
31,
|
|
2021
|
|
2020
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
57,221,434
|
|
$
21,352,382
|
Prepaid expenses and
deposits
|
2,801,800
|
|
2,057,924
|
Other
receivables
|
286
|
|
1,000,559
|
Total current
assets
|
60,023,520
|
|
24,410,865
|
Non-current
assets:
|
|
|
|
Property, plant and
equipment, net
|
10,107,579
|
|
3,570,736
|
Construction in
progress
|
-
|
|
6,789,098
|
Right-of-use assets,
net
|
10,339,884
|
|
10,844,116
|
Total non-current
assets
|
20,447,463
|
|
21,203,950
|
|
|
|
|
Total
assets
|
$
80,470,983
|
|
$
45,614,815
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
5,100,943
|
|
$
6,013,010
|
Lease
liability
|
558,657
|
|
388,792
|
Total current
liabilities
|
5,659,600
|
|
6,401,802
|
Non-current
liabilities:
|
|
|
|
Lease liability, net
of current portion
|
11,568,072
|
|
11,868,440
|
Total non-current
liabilities
|
11,568,072
|
|
11,868,440
|
|
|
|
|
Total
liabilities
|
17,227,672
|
|
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 June 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 June 30, 2021 and
December 31, 2020, respectively
|
83,079
|
|
50,731
|
Additional paid-in
capital
|
439,085,948
|
|
383,533,326
|
Accumulated
deficit
|
(375,925,716)
|
|
(356,239,484)
|
Total stockholders'
equity
|
63,243,311
|
|
27,344,573
|
|
|
|
|
Total liabilities
and stockholders' equity
|
$
80,470,983
|
|
$
45,614,815
|
Marker
Therapeutics, Inc.
|
Condensed
Consolidated Statements of Operations
|
(Unaudited)
|
|
|
For the Three
Months Ended
|
|
For the Six Months
Ended
|
|
June
30,
|
|
June
30,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Revenues:
|
|
|
|
|
|
|
|
Grant
income
|
$
-
|
|
$
466,785
|
|
$
-
|
|
$
466,785
|
Total
revenues
|
-
|
|
466,785
|
|
-
|
|
466,785
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
7,350,035
|
|
4,277,052
|
|
12,993,064
|
|
8,093,670
|
General and
administrative
|
3,559,150
|
|
2,547,289
|
|
6,697,108
|
|
5,374,284
|
Total operating
expenses
|
10,909,185
|
|
6,824,341
|
|
19,690,172
|
|
13,467,954
|
Loss from
operations
|
(10,909,185)
|
|
(6,357,556)
|
|
(19,690,172)
|
|
(13,001,169)
|
Other
income:
|
|
|
|
|
|
|
|
Change in fair value
of warrant liabilities
|
-
|
|
-
|
|
-
|
|
31,000
|
Interest
income
|
2,403
|
|
15,857
|
|
3,940
|
|
142,826
|
Net
loss
|
$
(10,906,782)
|
|
$
(6,341,699)
|
|
$
(19,686,232)
|
|
$
(12,827,343)
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.13)
|
|
$
(0.14)
|
|
$
(0.28)
|
|
$
(0.28)
|
Weighted average
number of common shares outstanding, basic and diluted
|
83,030,470
|
|
46,572,739
|
|
69,823,729
|
|
46,328,561
|
Marker
Therapeutics, Inc.
|
Condensed
Consolidated Statements of Cash Flows
|
(Unaudited)
|
|
|
For the Six Months
Ended
|
|
June
30,
|
|
2021
|
|
2020
|
Cash Flows from
Operating Activities:
|
|
|
|
Net
loss
|
$
(19,686,232)
|
|
$
(12,827,343)
|
Reconciliation of
net loss to net cash used in operating activities:
|
|
|
|
Depreciation and
amortization
|
1,032,971
|
|
124,627
|
Changes in fair value
of warrant liabilities
|
-
|
|
(31,000)
|
Stock-based
compensation
|
3,029,125
|
|
2,705,365
|
Amortization on
right-of-use assets
|
504,232
|
|
96,973
|
Changes in
operating assets and liabilities:
|
|
|
|
Prepaid expenses and
deposits
|
(743,876)
|
|
(1,106,072)
|
Other
receivables
|
1,000,273
|
|
52,749
|
Accounts payable and
accrued expenses
|
(912,067)
|
|
2,770,341
|
Lease
liability
|
(130,503)
|
|
(187,068)
|
Net cash used in
operating activities
|
(15,906,077)
|
|
(8,401,428)
|
Cash Flows from
Investing Activities:
|
|
|
|
Purchase of property
and equipment
|
(780,716)
|
|
(1,299,193)
|
Purchase of
construction in progress
|
-
|
|
(2,629,141)
|
Net cash used in
investing activities
|
(780,716)
|
|
(3,928,334)
|
Cash Flows from
Financing Activities:
|
|
|
|
Proceeds from
issuance of common stock, net
|
52,552,758
|
|
-
|
Proceeds from
exercise of warrants
|
-
|
|
550,000
|
Proceeds from
exercise of stock options
|
3,087
|
|
-
|
Net cash provided by
financing activities
|
52,555,845
|
|
550,000
|
Net increase
(decrease) in cash
|
35,869,052
|
|
(11,779,762)
|
|
|
|
|
Cash and cash
equivalents at beginning of the period
|
21,352,382
|
|
43,903,949
|
Cash and cash
equivalents at end of the period
|
$
57,221,434
|
|
$
32,124,187
|
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SOURCE Marker Therapeutics, Inc.