HOUSTON, May 12, 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 first quarter ended March
31, 2021.
"We had a productive first quarter supported by our recently
completed financing, strengthening our overall cash position and
enabling continued growth and expansion of our Multi-TAA pipeline,"
said Peter L. Hoang, President &
CEO of Marker Therapeutics. "In addition, we continue to make
strong progress on both the clinical and manufacturing fronts. In
March, we dosed the first patient in the safety lead-in portion of
our Phase 2 trial in post-transplant acute myeloid leukemia, or
AML, and continue to activate clinical sites. In parallel, we
continue to optimize the MT-401 cell therapy manufacturing process,
which we believe could result in an increase in the number of T
cells available for patient administration—among other benefits—as
we prepare to operationalize our new in-house cGMP facility in the
first half of the year."
PROGRAM UPDATES
- In March 2021, Marker dosed the
first patient in the safety lead-in portion of its Phase 2 trial in
AML, which is expected to enroll a total of six patients: three of
which will be treated with MT-401 manufactured with a legacy
reagent, and the remaining three to be treated with study drug
manufactured with a new reagent from an alternate supplier.
- The clinical operations team has made considerable progress in
opening sites to enroll patients for the safety lead-in portion of
the AML trial. The Company has also received commitments from
additional clinical sites to participate in the Phase 2 AML trial
following the safety lead-in phase and anticipates activating a
total of approximately 20 sites.
- Marker continues to streamline and simplify the MT-401
manufacturing process, which could potentially result in a product
with a superior T cell phenotype and improved antigen specificity
as compared to the original process. The new process improvements
have been updated in the CMC section of the IND and will be used
for all patients in the Marker AML Phase 2 clinical trial.
- Marker presented early results of robotic automation of T cell
generation for the treatment of AML at the American Society of Gene
& Cell Therapy 24th Annual Meeting on May 11, 2021. The results will also be presented
at the upcoming International Society for Cell & Gene Therapy
2021 Annual Meeting, taking place virtually May 26-28, 2021.
BUSINESS UPDATES
- In March, Marker closed an underwritten public offering of
32,282,857 shares of its common stock at a public offering price of
$1.75 per share. The gross proceeds
to Marker from the offering, before deducting the underwriting
discounts and commissions and other offering expenses, were
approximately $56.5 million.
- The Company is preparing to open its new cGMP manufacturing
facility in Houston, TX, which
will be used to manufacture study drug for Marker's Phase 2 AML
trial (MT-401) and for future hematological and solid tumor trials,
in addition to the potential commercialization of any approved
products. Marker initiated the technology transfer from
Baylor College of Medicine to the cGMP
facility in Q1 2021 and expects the facility to be fully
operational in the first half of 2021.
ANTICIPATED PROGRAM MILESTONES
AML Trial Milestones
- Complete safety lead-in (6 patients) in Q2 2021
- Initiate main portion of Phase 2 trial in Q3 2021
- 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
- Receive regulatory approval for Marker cGMP in Q2 2021
- Manufacture MT-401 at Marker cGMP for Phase 2 AML trial in Q3
2021
FIRST QUARTER 2021 FINANCIAL RESULTS
- Cash Position and Guidance: At March 31, 2021, Marker had cash and cash
equivalents of $64.5 million. The
Company believes that its existing cash and cash equivalents will
fund its operating expenses and capital expenditure requirements
into Q1 2023.
- R&D Expenses: Research and development expenses were
$5.6 million for the quarter ended
March 31, 2021 compared to
$3.8 million for the quarter ended
March 31, 2020. The increase was
primarily attributable to increases in headcount-related expenses
and infrastructure expenses due to growth of research and
development operations.
- G&A Expenses: General and administrative expenses
were $3.1 million for the quarter
ended March 31, 2021 compared to
$2.8 million for the quarter ended
March 31, 2020.
- Net Loss: Marker reported a net loss of $8.8 million for the quarter ended March 31, 2021, compared to a net loss of
$6.5 million for the quarter ended
March 31, 2020.
Conference Call and Webcast
The Company will host a webcast and conference call to discuss its
first quarter 2021 financial results and provide a corporate update
today at 5:00 p.m. EDT. The webcast will be accessible in the
Investors section of the Company's website at
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 First
Quarter 2021 Earnings Call."
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;
the timing and success of the technology transfer process related
to our planned manufacturing facility and the receipt of regulatory
approval for the related cGMP; our manufacturing processes and our
ability to use our current and planned manufacturing facilities to
support clinical and commercial demand. 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)
|
|
|
March
31,
|
|
December
31,
|
|
2021
|
|
2020
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
64,507,575
|
|
$
21,352,382
|
Prepaid expenses and
deposits
|
1,962,924
|
|
2,057,924
|
Other
receivables
|
1,000,867
|
|
1,000,559
|
Total current
assets
|
67,471,366
|
|
24,410,865
|
Non-current
assets:
|
|
|
|
Property, plant and
equipment, net
|
10,298,225
|
|
3,570,736
|
Construction in
progress
|
-
|
|
6,789,098
|
Right-of-use assets,
net
|
10,592,490
|
|
10,844,116
|
Total non-current
assets
|
20,890,715
|
|
21,203,950
|
|
|
|
|
Total
assets
|
$
88,362,081
|
|
$
45,614,815
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
3,674,259
|
|
$
6,013,010
|
Lease
liability
|
473,077
|
|
388,792
|
Total current
liabilities
|
4,147,336
|
|
6,401,802
|
Non-current
liabilities:
|
|
|
|
Lease liability, net
of current portion
|
11,719,826
|
|
11,868,440
|
Total non-current
liabilities
|
11,719,826
|
|
11,868,440
|
|
|
|
|
Total
liabilities
|
15,867,162
|
|
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 March 31, 2021 and December 31, 2020,
respectively
|
-
|
|
-
|
Common stock, $0.001
par value, 150 million shares authorized, 83.0 million and 50.7
million
shares issued and outstanding as of March 31, 2021 and December 31,
2020, respectively
|
83,014
|
|
50,731
|
Additional paid-in
capital
|
437,430,839
|
|
383,533,326
|
Accumulated
deficit
|
(365,018,934)
|
|
(356,239,484)
|
Total stockholders'
equity
|
72,494,919
|
|
27,344,573
|
|
|
|
|
Total liabilities
and stockholders' equity
|
$
88,362,081
|
|
$
45,614,815
|
Marker
Therapeutics, Inc.
Condensed
Consolidated Statements of Operations
(Unaudited)
|
|
|
For the Three
Months Ended
|
|
March
31,
|
|
2021
|
|
2020
|
Operating
expenses:
|
|
|
|
Research and
development
|
$
5,643,029
|
|
$
3,816,618
|
General and
administrative
|
3,137,958
|
|
2,826,995
|
Total operating
expenses
|
8,780,987
|
|
6,643,613
|
Loss from
operations
|
(8,780,987)
|
|
(6,643,613)
|
Other income
(expense):
|
|
|
|
Change in fair value
of warrant liabilities
|
-
|
|
31,000
|
Interest
income
|
1,537
|
|
126,969
|
Net
loss
|
$(8,779,450)
|
|
$(6,485,644)
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.16)
|
|
$
(0.14)
|
Weighted average
number of common shares outstanding, basic and diluted
|
56,470,247
|
|
46,084,383
|
Marker
Therapeutics, Inc.
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
|
|
|
For the Three
Months Ended
|
|
March
31,
|
|
2021
|
|
2020
|
Cash Flows from
Operating Activities:
|
|
|
|
Net
loss
|
$
(8,779,450)
|
|
$
(6,485,644)
|
Reconciliation of
net loss to net cash used in operating activities:
|
|
|
|
Depreciation and
amortization
|
502,743
|
|
35,265
|
Changes in fair value
of warrant liabilities
|
-
|
|
(31,000)
|
Stock-based
compensation
|
1,377,038
|
|
1,344,592
|
Amortization on
right-of-use assets
|
251,626
|
|
47,361
|
Changes in
operating assets and liabilities:
|
|
|
|
Prepaid expenses and
deposits
|
95,000
|
|
(189,650)
|
Other
receivables
|
(308)
|
|
31,584
|
Accounts payable and
accrued expenses
|
(2,442,581)
|
|
1,197,613
|
Lease
liability
|
(64,329)
|
|
(49,187)
|
Net cash used in
operating activities
|
(9,060,261)
|
|
(4,099,066)
|
Cash Flows from
Investing Activities:
|
|
|
|
Purchase of property
and equipment
|
(441,134)
|
|
(99,821)
|
Net cash used in
investing activities
|
(441,134)
|
|
(99,821)
|
Cash Flows from
Financing Activities:
|
|
|
|
Proceeds from
issuance of common stock, net
|
52,656,588
|
|
-
|
Proceeds from
exercise of warrants
|
-
|
|
550,000
|
Net cash provided by
financing activities
|
52,656,588
|
|
550,000
|
Net increase
(decrease) in cash
|
43,155,193
|
|
(3,648,887)
|
|
|
|
|
Cash and cash
equivalents at beginning of the period
|
21,352,382
|
|
43,903,949
|
Cash and cash
equivalents at end of the period
|
$
64,507,575
|
|
$
40,255,062
|
|
|
|
|
Supplemental
disclosure of cash flow information
|
|
|
|
Cash paid for
interest
|
$
-
|
|
$
-
|
Cash paid for
taxes
|
$
-
|
|
$
-
|
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SOURCE Marker Therapeutics, Inc.