HOUSTON, Nov. 9, 2020 /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, 2020.
"This quarter, our Company reached a significant milestone by
initiating our first Marker-sponsored study—a Phase 2 trial of
zelenoleucel or MT-401, our lead MultiTAA-specific T cell product
candidate for the treatment of post-transplant acute myeloid
leukemia," said Peter L. Hoang,
President & CEO of Marker Therapeutics. "We have enrolled the
first patient in the safety lead-in portion of the trial, and are
in the process of scheduling the donor in order to manufacture the
product."
Continued Mr. Hoang: "During this unprecedented time, we have
made significant progress by enrolling additional clinical sites
for our AML trial, advancing our manufacturing process, reducing
production time by 50% and improving the potency of our MT-401
product, and entering the final phase of the construction of our
new in-house cGMP manufacturing facility. I am extremely proud of
the dedication and resolve that our team has shown during these
challenging months. I want to acknowledge their hard work across
the organization that went into achieving these milestones."
PROGRAM UPDATES
MT-401: Multi-Antigen Targeted (MultiTAA)-Specific T Cell
Product Candidate for AML
Phase 2 AML Trial
The Company initiated the safety
lead-in portion of its Phase 2 study of zelenoleucel (MT-401) in
patients with acute myeloid leukemia (AML) following an allogeneic
stem cell transplant in both the adjuvant and active disease
settings. The Company anticipates treating the first patient by Q1
2021. The safety lead-in 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.
Marker has activated four clinical sites and is in the start-up
phase with additional clinical 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.
The study remains on partial clinical hold pending the review of
final data and subsequent acceptance of certificates of analysis
for the new reagent by the U.S. FDA. The Company received the
remaining reagent from the alternate supplier in Q3 2020 and is
currently conducting the comparability analyses between the
previous and new reagents, as required by FDA. Marker intends to
submit all required data to FDA by Q1 2021 to enable removal of the
partial clinical hold.
Over the past year, the Company has continued to streamline and
simplify the MT-401 manufacturing process. The technical
improvements include a 50% reduction in manufacturing time, a 95%
reduction in the number of required operator interventions, and
significant improvement in the consistency and reproducibility of
the manufacturing process, while yielding a significant increase in
the number of T cells available for patient administration. The
Company expects the new process to yield a measurably improved
product, with superior T cell phenotype and 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 clinical trial.
BUSINESS UPDATES
- Construction of the cGMP manufacturing facility has entered its
final phase. The facility, located in Houston near the George Bush Intercontinental
Airport, will be used to support the manufacture of study drug for
Marker's Phase 2 AML trial and for future hematological and solid
tumor trials, in addition to the potential commercialization of any
approved products. The construction is expected to be completed by
year-end with clinical activities to be initiated in the first half
of 2021.
THIRD QUARTER 2020 FINANCIAL RESULTS
Cash Position and Guidance: At September 30, 2020, Marker had cash and cash
equivalents of $27.0 million. The
Company raised $2.2 million through
the previously executed $30 million
common stock purchase agreement with Aspire Capital Fund, LLC. The
remaining $27.8 million available to
Marker from Aspire Capital along with current cash available, funds
operations into Q1 2022.
R&D Expenses: Research and development expenses
were $4.8 million for the quarter ended September 30,
2020, compared to $3.1 million for the quarter ended
September 30, 2019.
G&A Expenses: General and administrative
expenses were $2.6 million for the quarter
ended September 30, 2020, compared to $2.5 million for the quarter ended September 30, 2019.
Net Loss: Marker reported a net loss of $7.4
million for the quarter ended September 30, 2020,
compared to a net loss of $5.5 million for the quarter ended
September 30, 2019.
Conference Call and Webcast
The Company will host a webcast and conference call to discuss
its third quarter 2020 financial results and provide a corporate
update today at 5:00 PM EST.
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 Third
Quarter 2020 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.
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; the effectiveness of these programs or
the possible range of application and potential curative effects
and safety in the treatment of diseases; the impact of the COVID-19
pandemic; the timing, conduct and success of our clinical trials,
as well as clinical trials conducted by our collaborators; our
manufacturing processes and our ability to use our in-house
manufacturing facility 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
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
2020
|
|
2019
|
(Unaudited)
|
|
(Audited)
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
26,956,737
|
|
$
43,903,949
|
Prepaid expenses and
deposits
|
2,367,145
|
|
1,526,442
|
Interest
receivable
|
135
|
|
56,189
|
Other
receivable
|
1,000,000
|
|
-
|
Total current
assets
|
30,324,017
|
|
45,486,580
|
Non-current
assets:
|
|
|
|
Property, plant and
equipment, net
|
2,629,628
|
|
417,528
|
Construction in
progress
|
4,557,581
|
|
-
|
Right-of-use assets,
net
|
11,059,962
|
|
455,174
|
Total non-current
assets
|
18,247,171
|
|
872,702
|
|
|
|
|
Total
assets
|
$
48,571,188
|
|
$
46,359,282
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
5,746,149
|
|
$
1,757,680
|
Lease
liability
|
278,333
|
|
204,132
|
Warrant
liability
|
-
|
|
31,000
|
Total current
liabilities
|
6,024,482
|
|
1,992,812
|
Non-current
liabilities:
|
|
|
|
Lease liability, net
of current portion
|
11,948,781
|
|
280,247
|
Total non-current
liabilities
|
11,948,781
|
|
280,247
|
|
|
|
|
Total
liabilities
|
17,973,263
|
|
2,273,059
|
|
|
|
|
Commitments and
contingencies
|
-
|
|
-
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred stock -
$0.001 par value, 5 million shares authorized and 0 shares issued
and outstanding at September 30, 2020 and December 31, 2019,
respectively
|
-
|
|
-
|
Common stock, $0.001
par value, 150 million shares authorized, 48.0 million and 45.7
million shares issued and outstanding as of September 30, 2020 and
December 31, 2019, respectively
|
48,025
|
|
45,728
|
Additional paid-in
capital
|
378,282,157
|
|
371,573,909
|
Accumulated
deficit
|
(347,732,257)
|
|
(327,533,414)
|
Total stockholders'
equity
|
30,597,925
|
|
44,086,223
|
|
|
|
|
Total liabilities
and stockholders' equity
|
$
48,571,188
|
|
$
46,359,282
|
Marker
Therapeutics, Inc.
Condensed
Consolidated Statements of Operations
(Unaudited)
|
|
|
|
|
|
|
|
|
|
For the Three
Months Ended
|
|
For the Nine
Months Ended
|
|
September
30,
|
|
September
30,
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Revenues:
|
|
|
|
|
|
|
|
Grant
income
|
$
-
|
|
$
-
|
|
$
466,785
|
|
$
-
|
Total
revenues
|
-
|
|
-
|
|
466,785
|
|
-
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
4,803,605
|
|
3,118,530
|
|
12,897,275
|
|
9,103,670
|
General and
administrative
|
2,572,562
|
|
2,536,204
|
|
7,946,846
|
|
8,063,099
|
Total operating
expenses
|
7,376,167
|
|
5,654,734
|
|
20,844,121
|
|
17,166,769
|
Loss from
operations
|
(7,376,167)
|
|
(5,654,734)
|
|
(20,377,336)
|
|
(17,166,769)
|
Other income
(expense):
|
|
|
|
|
|
|
|
Change in fair value
of warrant liabilities
|
-
|
|
(64,000)
|
|
31,000
|
|
(80,000)
|
Interest
income
|
4,667
|
|
259,248
|
|
147,493
|
|
897,967
|
Net
loss
|
$
(7,371,500)
|
|
$
(5,459,486)
|
|
$
(20,198,843)
|
|
$
(16,348,802)
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.16)
|
|
$
(0.12)
|
|
$
(0.43)
|
|
$
(0.36)
|
Weighted average
number of common shares outstanding
|
46,867,119
|
|
45,655,387
|
|
46,509,391
|
|
45,541,434
|
Marker
Therapeutics, Inc.
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
|
|
|
|
|
|
For the Nine
Months Ended
|
|
September
30,
|
|
2020
|
|
2019
|
Cash Flows from
Operating Activities:
|
|
|
|
Net
loss
|
$
(20,198,843)
|
|
$
(16,348,802)
|
Reconciliation of
net loss to net cash used in operating activities:
|
|
|
|
Depreciation and
amortization
|
272,725
|
|
70,908
|
Changes in fair value
of warrant liabilities
|
(31,000)
|
|
80,000
|
Stock-based
compensation
|
3,974,536
|
|
4,073,505
|
Amortization on
right-of-use assets
|
337,530
|
|
134,919
|
Changes in
operating assets and liabilities:
|
|
|
|
Prepaid expenses and
deposits
|
(840,703)
|
|
(1,764,345)
|
Interest
receivable
|
56,054
|
|
30,032
|
Accounts payable and
accrued expenses
|
3,955,609
|
|
137,161
|
Lease
liability
|
(166,723)
|
|
(136,812)
|
Net cash used in
operating activities
|
(12,640,815)
|
|
(13,723,434)
|
Cash Flows from
Investing Activities:
|
|
|
|
Purchase of property
and equipment
|
(2,484,825)
|
|
(362,121)
|
Purchase of
construction in progress
|
(4,557,581)
|
|
-
|
Net cash used in
investing activities
|
(7,042,406)
|
|
(362,121)
|
Cash Flows from
Financing Activities:
|
|
|
|
Proceeds from
issuance of common stock
|
2,186,009
|
|
-
|
Proceeds from
exercise of stock options
|
-
|
|
57,744
|
Proceeds from
exercise of warrants
|
550,000
|
|
758,733
|
Net cash provided by
financing activities
|
2,736,009
|
|
816,477
|
Net decrease in
cash
|
(16,947,212)
|
|
(13,269,078)
|
|
|
|
|
Cash and cash
equivalents at beginning of the period
|
43,903,949
|
|
61,746,748
|
Cash and cash
equivalents at end of the period
|
$
26,956,737
|
|
$
48,477,670
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/marker-therapeutics-reports-third-quarter-2020-operating-and-financial-results-301168916.html
SOURCE Marker Therapeutics, Inc.