HOUSTON, May 11, 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
first quarter ended March 31,
2020.
"While we are eager to initiate our planned Phase 2 trial with
our novel MultiTAA-specific T cell therapy in patients with acute
myeloid leukemia (AML), we anticipate that the initiation of our
trial will be delayed by the impacts the COVID-19 pandemic has had
on our clinical trial partners and throughout our supply chain. As
a result of the uncertainty, we believe it is prudent to withdraw
our prior guidance on the timing of this trial until the outlook
clarifies," said Peter L. Hoang,
President & CEO of Marker Therapeutics. "Despite these
pandemic-related effects, we remain optimistic that when the study
opens, there will be significant patient interest. We are moving
expediently in the interim to secure clinical trial sites and are
monitoring the situation closely to prioritize the health and
wellness of our employees and the patients we serve."
Continued Mr. Hoang: "We continue to be encouraged by the
potential of our MultiTAA-specific T cell therapy to change the
treatment paradigm for patients with both liquid and solid tumors.
Recently, we received Orphan Drug designation from the U.S. FDA for
MT-401, our MultiTAA-specific T cell product candidate to treat
patients with AML post-stem cell transplant, our lead indication.
Additionally, we are looking forward to soon reporting an update
from an ongoing academic-sponsored trial in pancreatic
adenocarcinoma, which will be presented during the upcoming ASCO
annual meeting."
PROGRAM UPDATES
Multi-Antigen Targeted (MultiTAA) T Cell Therapies
Phase 2 AML Trial Update
Due to the COVID-19 pandemic, Marker expects to be delayed in
initiating its planned Phase 2 trial in post-transplant AML
patients per previously communicated timelines. Under an amended
trial protocol announced in February
2020, the U.S. FDA cleared the Company to initiate the
trial, beginning with a safety lead-in. Marker has paused opening
the study for enrollment of the first three patients, as the
manufacturing facility it utilizes to supply study drug remains
closed during the pandemic. The Company continues to identify
potential trial sites in the interim, in addition to establishing
its own manufacturing facility. The latter portion of the safety
lead-in, which involves use of a new reagent, remains on hold until
the FDA reviews and accepts the final data and certificate of
analysis. The alternate supplier providing these has informed the
Company that it will be delayed in providing the reagent.
Orphan Drug Designation Granted for MultiTAA T Cell Therapy
in AML
In April, the FDA's Office of Orphan Products
Development granted Orphan Drug designation to MT-401, Marker's
MultiTAA-specific T cell product candidate for the treatment of
patients with post-transplant AML. Orphan designation is granted to
advance the evaluation and development of safe and effective
therapies for the treatment of rare diseases or conditions
affecting fewer than 200,000 people in the U.S.
Pancreatic Cancer Data Update During ASCO
Updated
data from an ongoing Phase 1/2 clinical trial being conducted with
Marker's MultiTAA-specific T cell product at the Baylor College of Medicine (BCM) in patients with
pancreatic adenocarcinoma will be presented during the Annual
Meeting of the American Society of Clinical Oncology (ASCO)—which
due to the COVID-19 pandemic, will be held virtually. As previously
reported, in the front-line treatment arm in combination with
standard-of-care chemotherapy, clinical benefit was observed in
correlation with the post-infusion detection of tumor-reactive T
cells in patients' peripheral blood. These T cells exhibited
activity against both targeted antigens and non-targeted TAAs,
indicating induction of antigen spreading. To date, there has not
been any cytokine release syndrome or neurotoxicity observed in
this trial.
T Cell-Based Vaccines
Phase 2 Triple Negative Breast Cancer Trial Results
Marker's T cell-based vaccine program in triple negative breast
cancer has delivered the following results as of September 30, 2019:
- 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, 16 have shown
disease progression following treatment with TPIV200.
FINANCING UPDATE
- On March 2, 2020, Marker
announced that the Company entered into a Common Stock Purchase
Agreement of up to $30 million with
Aspire Capital Fund, LLC, a Chicago-based institutional investor and
long-term Marker shareholder.
FIRST QUARTER 2020 FINANCIAL RESULTS
Cash Position and
Guidance: At March 31, 2020,
Marker had cash and cash equivalents of $40.3 million. The Company believes that its
existing cash and cash equivalents will fund its operating expenses
and capital expenditure requirements into the second quarter of
2021.
R&D
Expenses: Research and development expenses were $3.8
million for the quarter ended March 31, 2020 compared
to $2.8 million for the quarter ended March 31, 2019. The increase was primarily
attributable to headcount-related personnel expenses.
G&A
Expenses: General and administrative expenses
were $2.8 million for the quarter ended March 31, 2020
and March 31, 2019.
Net Loss: Marker
reported a net loss of $6.5 million for the quarter
ended March 31, 2020, compared to a net loss of $5.3
million for the quarter ended March 31,
2019.
Conference Call and Webcast
The Company will host a
webcast and conference call to discuss its first quarter 2020
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 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.
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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 and our TPIV200
program; the effectiveness of these programs or the possible range
of application and potential curative effects and safety in the
treatment of diseases; the potential benefits of orphan drug
designation; the impact of the COVID-19 pandemic; 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. 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,
|
2020
|
|
2019
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
40,255,062
|
|
$
43,903,949
|
Prepaid expenses and
deposits
|
1,716,092
|
|
1,526,442
|
Interest
receivable
|
24,605
|
|
56,189
|
Total current
assets
|
41,995,759
|
|
45,486,580
|
Non-current
assets:
|
|
|
|
Property, plant and
equipment, net
|
482,084
|
|
417,528
|
Right-of-use assets,
net
|
407,813
|
|
455,174
|
Total non-current
assets
|
889,897
|
|
872,702
|
|
|
|
|
Total
assets
|
$
42,885,656
|
|
$
46,359,282
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
2,955,293
|
|
$
1,757,680
|
Lease
liability
|
209,081
|
|
204,132
|
Warrant
liability
|
-
|
|
31,000
|
Total current
liabilities
|
3,164,374
|
|
1,992,812
|
Non-current
liabilities:
|
|
|
|
Lease liability, net
of current portion
|
226,111
|
|
280,247
|
Total non-current
liabilities
|
226,111
|
|
280,247
|
|
|
|
|
Total
liabilities
|
3,390,485
|
|
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 March 31, 2020 and December 31, 2019,
respectively
|
-
|
|
-
|
Common stock, $0.001
par value, 150 million shares authorized, 46.5 million and 45.7
million shares issued and outstanding as of March 31, 2020 and
December 31, 2019, respectively
|
46,532
|
|
45,728
|
Additional paid-in
capital
|
373,467,697
|
|
371,573,909
|
Accumulated
deficit
|
(334,019,058)
|
|
(327,533,414)
|
Total stockholders'
equity
|
39,495,171
|
|
44,086,223
|
|
|
|
|
Total liabilities
and stockholders' equity
|
$
42,885,656
|
|
$
46,359,282
|
Marker
Therapeutics, Inc.
|
Condensed
Consolidated Statements of Operations
|
(Unaudited)
|
|
|
For the Three
Months Ended
|
|
March
31,
|
|
2020
|
|
2019
|
Operating
expenses:
|
|
|
|
Research and
development
|
$
3,816,618
|
|
$
2,832,695
|
General and
administrative
|
2,826,995
|
|
2,805,775
|
Total operating
expenses
|
6,643,613
|
|
5,638,470
|
Loss from
operations
|
(6,643,613)
|
|
(5,638,470)
|
Other income
(expense):
|
|
|
|
Change in fair value
of warrant liabilities
|
31,000
|
|
(9,000)
|
Interest
income
|
126,969
|
|
328,545
|
Net
loss
|
$
(6,485,644)
|
|
$
(5,318,925)
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.14)
|
|
$
(0.12)
|
Weighted average
number of common shares outstanding
|
46,084,383
|
|
45,465,754
|
Marker
Therapeutics, Inc.
|
Condensed
Consolidated Statements of Cash Flows
|
(Unaudited)
|
|
|
For the Three
Months Ended
|
|
March
31,
|
|
2020
|
|
2019
|
Cash Flows from
Operating Activities:
|
|
|
|
Net
loss
|
$
(6,485,644)
|
|
$
(5,318,925)
|
Reconciliation of
net loss to net cash used in operating activities:
|
|
|
|
Depreciation
and amortization
|
35,265
|
|
10,514
|
Changes in fair
value of warrant liabilities
|
(31,000)
|
|
9,000
|
Stock-based
compensation
|
1,344,592
|
|
1,525,976
|
Amortization on
right-of-use assets
|
47,361
|
|
44,211
|
Changes in
operating assets and liabilities:
|
|
|
|
Prepaid
expenses and deposits
|
(189,650)
|
|
(74,716)
|
Interest
receivable
|
31,584
|
|
(4,023)
|
Accounts
payable and accrued expenses
|
1,197,613
|
|
(27,628)
|
Lease
liability
|
(49,187)
|
|
(44,575)
|
Net cash used
in operating activities
|
(4,099,066)
|
|
(3,880,166)
|
Cash Flows from
Investing Activities:
|
|
|
|
Purchase of property
and equipment
|
(99,821)
|
|
(223,126)
|
Net cash used in
investing activities
|
(99,821)
|
|
(223,126)
|
Cash Flows from
Financing Activities:
|
|
|
|
Proceeds from
exercise of stock options
|
-
|
|
57,744
|
Proceeds from
exercise of warrants
|
550,000
|
|
5,379
|
Net cash provided by
financing activities
|
550,000
|
|
63,123
|
Net decrease in
cash
|
(3,648,887)
|
|
(4,040,169)
|
|
|
|
|
Cash and cash
equivalents at beginning of the period
|
43,903,949
|
|
61,746,748
|
Cash and cash
equivalents at end of the period
|
$
40,255,062
|
|
$
57,706,579
|
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SOURCE Marker Therapeutics, Inc.