HOUSTON, Aug. 10, 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
second quarter ended June 30, 2020.
"We continue to make progress toward advancing our planned Phase
2 trial with our novel MultiTAA-specific T cell therapy in patients
with acute myeloid leukemia, or AML," said Peter L. Hoang, President & CEO of Marker
Therapeutics. "While the COVID-19 pandemic has impacted hospital
systems globally, we have augmented our process development for our
MT-401 product, continued the buildout of our manufacturing
facility and added further clinical sites for our Phase 2 AML
trial. With a novel cell therapy product candidate that has
demonstrated the ability to induce broad and durable immune
responses in earlier clinical studies, Marker remains
well-positioned to provide a potential treatment option for
patients suffering from this devastating disease."
PROGRAM UPDATES
Multi-Antigen Targeted (MultiTAA) T Cell Therapies
Phase 2 AML Trial Update
The Company continues to identify and add clinical trial sites in
preparation for the Phase 2 AML trial initiation. The study is
currently subject to a partial clinical hold on the use of a new
reagent in the manufacturing process until the FDA reviews and
accepts the final data and certificates of analysis for the new
reagent. The alternate supplier has been delayed in providing the
reagent but expects to ship the reagent to Marker in Q3. Once
Marker receives the reagent and completes the required analyses for
FDA, the Company will provide additional clarification around the
timing of the AML trial enrollment.
USAN Council Approval of "Zelenoleucel" for
MT-401
Marker recently announced that the United States
Adopted Names (USAN) Council approved "zelenoleucel" as the
nonproprietary (generic) name for MT-401, a MultiTAA-specific T
cell product candidate for the treatment of patients with AML
following allogeneic stem cell transplant in both adjuvant and
active disease settings.
Pancreatic Cancer Data Presented During ASCO
Updated
clinical results from an ongoing investigator-sponsored Phase 1
trial led by the Baylor College of
Medicine, evaluating the Company's MultiTAA-specific T cell
therapy in patients with advanced or metastatic pancreatic
adenocarcinoma, were presented during the 2020 American Society of
Clinical Oncology (ASCO) Virtual Annual Meeting. Data from a cohort
of patients receiving MultiTAA-specific T cell therapy in
combination with standard-of-care chemotherapy in the first-line
setting (Arm A) were presented.
- Out of the 13 evaluable patients (best overall response): four
patients experienced objective responses, including one complete
response; six patients experienced stable disease; one patient
experienced a mixed response (some lesions increased in size and
others decreased for a net zero change in size of tumor
lesions).
- Patients had durable cancer control with 9 of the 13 patients
exceeding historical control of overall survival.
- Evidence of epitope-spreading was observed in all responders,
suggesting that the MultiTAA T cell therapy triggered the
recruitment of a broader endogenous immune system response for
improved anti-tumor activity.
- No infusion-related reactions, cytokine release syndrome or
neurotoxicity was observed.
BUSINESS UPDATES
On June 30, 2020, Marker announced
that the Company executed a lease agreement to establish an
in-house cGMP manufacturing facility in Houston, TX. The facility is expected to be
completed by year-end and operational in 2021. Marker will continue
to manufacture its MultiTAA-specific T cell therapy at the
Baylor College of Medicine to support
the Company-sponsored AML trial until the in-house cGMP
manufacturing facility is operational.
SECOND QUARTER 2020 FINANCIAL RESULTS
Cash Position and Guidance: At June 30, 2020, Marker had cash and cash
equivalents of $32.1 million. The
Company believes that its existing cash and cash equivalents will
fund its operating expenses and capital expenditure requirements
into Q2 2021.
R&D Expenses: Research and development expenses
were $4.3 million for the quarter ended June 30, 2020,
compared to $3.2 million for the quarter ended June 30, 2019.
G&A Expenses: General and administrative
expenses were $2.5 million for the quarter ended June 30,
2020, compared to $2.7 million for
the quarter ended June 30, 2019.
Net Loss: Marker reported a net loss of $6.3
million for the quarter ended June 30, 2020, compared to
a net loss of $5.6 million for the quarter ended June 30, 2019.
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; 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; 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
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
2020
|
|
2019
|
(Unaudited)
|
|
(Audited)
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
32,124,187
|
|
$
43,903,949
|
Prepaid expenses and
deposits
|
2,632,514
|
|
1,526,442
|
Interest
receivable
|
3,440
|
|
56,189
|
Total current
assets
|
34,760,141
|
|
45,486,580
|
Non-current
assets:
|
|
|
|
Property, plant and
equipment, net
|
1,592,094
|
|
417,528
|
Construction in
progress
|
2,629,141
|
|
-
|
Right-of-use assets,
net
|
9,542,228
|
|
455,174
|
Total non-current
assets
|
13,763,463
|
|
872,702
|
|
|
|
|
Total
assets
|
$
48,523,604
|
|
$
46,359,282
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
4,528,021
|
|
$
1,757,680
|
Lease
liability
|
456,065
|
|
204,132
|
Warrant
liability
|
-
|
|
31,000
|
Total current
liabilities
|
4,984,086
|
|
1,992,812
|
Non-current
liabilities:
|
|
|
|
Lease liability, net
of current portion
|
9,025,273
|
|
280,247
|
Total non-current
liabilities
|
9,025,273
|
|
280,247
|
|
|
|
|
Total
liabilities
|
14,009,359
|
|
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 June 30, 2020 and December 31, 2019,
respectively
|
-
|
|
-
|
Common stock, $0.001
par value, 150 million shares authorized, 46.6 million and 45.7
million shares issued and outstanding as of June 30, 2020 and
December 31, 2019, respectively
|
46,617
|
|
45,728
|
Additional paid-in
capital
|
374,828,385
|
|
371,573,909
|
Accumulated
deficit
|
(340,360,757)
|
|
(327,533,414)
|
Total stockholders'
equity
|
34,514,245
|
|
44,086,223
|
|
|
|
|
Total liabilities
and stockholders' equity
|
$
48,523,604
|
|
$
46,359,282
|
Marker
Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
|
|
|
For the Three
Months Ended
|
|
For the Six Months
Ended
|
|
June
30,
|
|
June
30,
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Revenues:
|
|
|
|
|
|
|
|
Grant
income
|
$
466,785
|
|
$
-
|
|
$
466,785
|
|
$
-
|
Total
revenues
|
466,785
|
|
-
|
|
466,785
|
|
-
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
4,277,052
|
|
3,152,445
|
|
8,093,670
|
|
5,985,140
|
General and
administrative
|
2,547,289
|
|
2,721,120
|
|
5,374,284
|
|
5,526,895
|
Total operating
expenses
|
6,824,341
|
|
5,873,565
|
|
13,467,954
|
|
11,512,035
|
Loss from
operations
|
(6,357,556)
|
|
(5,873,565)
|
|
(13,001,169)
|
|
(11,512,035)
|
Other income
(expense):
|
|
|
|
|
|
|
|
Change in fair value
of warrant liabilities
|
-
|
|
(7,000)
|
|
31,000
|
|
(16,000)
|
Interest
income
|
15,857
|
|
310,174
|
|
142,826
|
|
638,719
|
Net
loss
|
$
(6,341,699)
|
|
$
(5,570,391)
|
|
$
(12,827,343)
|
|
$
(10,889,316)
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.14)
|
|
$
(0.12)
|
|
$
(0.28)
|
|
$
(0.24)
|
Weighted average
number of common shares outstanding
|
46,572,739
|
|
45,501,078
|
|
46,328,561
|
|
45,483,513
|
|
|
|
|
|
|
|
|
Marker
Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
|
|
|
For the Six Months
Ended
|
|
June
30,
|
|
2020
|
|
2019
|
Cash Flows from
Operating Activities:
|
|
|
|
Net
loss
|
$
(12,827,343)
|
|
$
(10,889,316)
|
Reconciliation of
net loss to net cash used in operating activities:
|
|
|
|
Depreciation and
amortization
|
124,627
|
|
39,811
|
Changes in fair value
of warrant liabilities
|
(31,000)
|
|
16,000
|
Stock-based
compensation
|
2,705,365
|
|
2,889,243
|
Amortization on
right-of-use assets
|
96,973
|
|
89,178
|
Changes in
operating assets and liabilities:
|
|
|
|
Prepaid expenses and
deposits
|
(1,106,072)
|
|
(349,750)
|
Interest
receivable
|
52,749
|
|
10,023
|
Accounts payable and
accrued expenses
|
2,770,341
|
|
225,135
|
Lease
liability
|
(187,068)
|
|
(89,907)
|
Net cash used in
operating activities
|
(8,401,428)
|
|
(8,059,583)
|
Cash Flows from
Investing Activities:
|
|
|
|
Purchase of property
and equipment
|
(1,299,193)
|
|
(305,382)
|
Purchase of
construction in progress
|
(2,629,141)
|
|
-
|
Net cash used in
investing activities
|
(3,928,334)
|
|
(305,382)
|
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
|
(11,779,762)
|
|
(8,301,842)
|
|
|
|
|
Cash and cash
equivalents at beginning of the period
|
43,903,949
|
|
61,746,748
|
Cash and cash
equivalents at end of the period
|
$
32,124,187
|
|
$
53,444,906
|
|
|
|
|
|
|
|
|
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SOURCE Marker Therapeutics, Inc.