Marker Therapeutics Reports Fiscal Year 2021 Operating and Financial Results
March 17 2022 - 4:45PM
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
fiscal year ended December 31, 2021.
“In 2021, we completed enrollment of the first 20 patients in
our Phase 2 AML trial investigating our lead product candidate,
MT-401,” said Peter L. Hoang, Marker’s President and Chief
Executive Officer. “We also developed a new nine-day manufacturing
process which increased the potency and antigen specificity and
diversity of our products and significantly reduced the time it
takes to manufacture our patient-specific T cell therapies. In
February 2022, we reported initial results from the six-patient
safety lead-in phase of the Phase 2 AML trial, which demonstrated
that MT-401 was well-tolerated and satisfied the safety
requirements with FDA. We expect to report topline data from the
active disease group in the main phase of the Phase 2 trial next
quarter. In addition, we look forward to expanding our pipeline
beyond AML and expect to file INDs for lymphoma and pancreatic
cancer by the end of the year.”
PROGRAM UPDATES AND EXPECTED MILESTONES
Acute Myeloid Leukemia (AML)
MT-401
- In February 2022, Marker announced
the initial results of the safety lead-in stage of its
Company-sponsored Phase 2 AML trial evaluating MT-401, Marker’s
lead MultiTAA-specific T cell product candidate. Results from the
safety lead-in demonstrate that MT-401 was well-tolerated,
eliminated measurable residual disease (MRD) in one MRD positive
patient and induced epitope spreading across multiple
AML-associated antigens in that patient.
- The safety lead-in satisfied safety
requirements with the FDA and the main Phase 2 stage of the AML
trial began enrolling in July 2021.
- Enrollment of the first 20 patients
of the Phase 2 AML trial was completed in Q4 2021.
- Topline readout of Group 2 active
disease is anticipated in Q2 2022.
Off-the-Shelf (MT-401-OTS)
- Marker announced in February 2022
that it intends to expand its AML program with the development of
MT-401-OTS, a scalable, off-the-shelf product candidate with the
potential to match patients to treatment in under three days.
Marker’s open Investigational New Drug application (IND) for MT-401
for the treatment of AML includes approval of an off-the-shelf
program. The Company is in the process of developing a patient cell
bank inventory and expects to dose the first patient with
MT-401-OTS in 2023.
Additional Clinical Programs (MT-601)
- Marker recently announced that the Company intends to file INDs
for MT-601, Marker’s second MultiTAA-specific T cell product
candidate, in lymphoma and pancreatic cancer in 2022. The Company
expects to initiate these trials in 2023.
- In January 2022, Marker announced that the U.S. Food and Drug
Administration granted Orphan Drug designation to MT-601 for the
treatment of pancreatic cancer.
BUSINESS UPDATES
- On December 9, 2021, Marker announced the appointment of
Katharine Knobil, M.D., to the Company's Board of Directors.
- Marker began manufacturing MT-401 for its Phase 2 AML trial at
the Company’s cGMP manufacturing facility in the fourth quarter of
2021.
- The Company developed and is implementing a new nine-day
MultiTAA-specific T cell manufacturing process for its current
Company-sponsored Phase 2 AML trial as well as future clinical
trials using a patient-specific manufacturing approach. The new T
cell manufacturing process is designed to improve potency, increase
antigen specificity and diversity and significantly reduce
manufacturing time.
FISCAL YEAR 2021 FINANCIAL RESULTS
Cash Position and Guidance: At December 31,
2021, Marker had cash, cash equivalents and restricted cash of
$43.5 million. The Company believes that its existing cash, cash
equivalents and restricted cash will fund its operating expenses
and capital expenditure requirements into the first quarter of
2023.
R&D Expenses: Research and development
expenses were $27.8 million for the year ended December 31, 2021,
compared to $18.9 million for the year ended December 31, 2020.
G&A Expenses: General and administrative
expenses were $12.9 million for the year ended December 31, 2021,
compared to $10.5 million for the year ended December 31, 2020.
Net Loss: Marker reported a net loss of $41.9
million for the year ended December 31, 2021, compared to a net
loss of $28.7 million for the year ended December 31,
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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Forward-Looking StatementsThis
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 and our planned trials of MT-401-OTS and
MT-601; our ability to use our manufacturing facilities to support
clinical and commercial demand; the success of our new
manufacturing process; 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.Consolidated Balance
Sheets(Audited)
|
December
31, |
|
December
31, |
|
|
2021 |
|
|
|
2020 |
|
ASSETS |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
42,351,145 |
|
|
$ |
21,352,382 |
|
Restricted cash |
|
1,146,186 |
|
|
|
- |
|
Prepaid expenses and deposits |
|
2,484,634 |
|
|
|
2,057,924 |
|
Other receivables |
|
237 |
|
|
|
1,000,559 |
|
Total current assets |
|
45,982,202 |
|
|
|
24,410,865 |
|
Non-current
assets: |
|
|
|
Property, plant and equipment, net |
|
10,096,861 |
|
|
|
3,570,736 |
|
Construction in progress |
|
2,225,610 |
|
|
|
6,789,098 |
|
Right-of-use assets, net |
|
9,830,461 |
|
|
|
10,844,116 |
|
Total non-current assets |
|
22,152,932 |
|
|
|
21,203,950 |
|
|
|
|
|
Total assets |
$ |
68,135,134 |
|
|
$ |
45,614,815 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable and accrued liabilities |
$ |
11,134,913 |
|
|
$ |
6,013,010 |
|
Lease liability |
|
620,490 |
|
|
|
388,792 |
|
Deferred revenue |
|
1,146,186 |
|
|
|
- |
|
Total current liabilities |
|
12,901,589 |
|
|
|
6,401,802 |
|
Non-current
liabilities: |
|
|
|
Lease liability, net of current portion |
|
11,247,950 |
|
|
|
11,868,440 |
|
Total non-current liabilities |
|
11,247,950 |
|
|
|
11,868,440 |
|
|
|
|
|
Total
liabilities |
|
24,149,539 |
|
|
|
18,270,242 |
|
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
Preferred stock - $0.001 par value, 5 million shares authorized and
0 shares issued and outstanding at December 31, 2021 and 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
December 31, 2021 and 2020, respectively |
|
83,079 |
|
|
|
50,731 |
|
Additional paid-in capital |
|
442,020,871 |
|
|
|
383,533,326 |
|
Accumulated deficit |
|
(398,118,355 |
) |
|
|
(356,239,484 |
) |
Total
stockholders' equity |
|
43,985,595 |
|
|
|
27,344,573 |
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
68,135,134 |
|
|
$ |
45,614,815 |
|
|
|
|
|
Marker Therapeutics, Inc.Consolidated
Statements of Operations(Audited)
|
|
|
|
|
For the
Years Ended |
|
December 31, |
|
|
2021 |
|
|
|
2020 |
|
Revenues: |
|
|
|
Grant income |
$ |
1,241,710 |
|
|
$ |
466,785 |
|
Total
revenues |
|
1,241,710 |
|
|
|
466,785 |
|
Operating expenses: |
|
|
|
Research and development |
|
27,794,879 |
|
|
|
18,880,751 |
|
General and administrative |
|
12,924,826 |
|
|
|
10,471,846 |
|
Total
operating expenses |
|
40,719,705 |
|
|
|
29,352,597 |
|
Loss from
operations |
|
(39,477,995 |
) |
|
|
(28,885,812 |
) |
Other income: |
|
|
|
Change in fair value of warrant liabilities |
|
- |
|
|
|
31,000 |
|
Arbitration settlement |
|
(2,406,576 |
) |
|
|
- |
|
Interest income |
|
5,700 |
|
|
|
148,742 |
|
Net
loss |
$ |
(41,878,871 |
) |
|
$ |
(28,706,070 |
) |
|
|
|
|
Net loss per
share, basic and diluted |
$ |
(0.55 |
) |
|
$ |
(0.61 |
) |
Weighted
average number of common shares outstanding, basic and diluted |
|
76,505,675 |
|
|
|
47,039,862 |
|
|
|
|
|
Marker Therapeutics,
Inc.Condensed Consolidated Statements of Cash
Flows(Audited)
|
For the
Years Ended |
|
December 31, |
|
|
2021 |
|
|
|
2020 |
|
Cash
Flows from Operating Activities: |
|
|
|
Net loss |
$ |
(41,878,871 |
) |
|
$ |
(28,706,070 |
) |
Reconciliation of net loss to net cash used in operating
activities: |
|
|
|
Depreciation and amortization |
|
2,148,983 |
|
|
|
485,641 |
|
Changes in fair value of warrant liabilities |
|
- |
|
|
|
(31,000 |
) |
Stock-based compensation |
|
5,964,048 |
|
|
|
5,228,409 |
|
Amortization on right-of-use assets |
|
1,013,655 |
|
|
|
590,039 |
|
Changes in operating assets and liabilities: |
|
|
|
Prepaid expenses and deposits |
|
(426,710 |
) |
|
|
(531,482 |
) |
Other receivables |
|
1,000,322 |
|
|
|
55,630 |
|
Accounts payable and accrued expenses |
|
4,141,414 |
|
|
|
3,047,410 |
|
Deferred revenue |
|
1,146,186 |
|
|
|
- |
|
Lease liability |
|
(388,792 |
) |
|
|
(173,268 |
) |
Net cash used in operating activities |
|
(27,279,765 |
) |
|
|
(20,034,691 |
) |
Cash
Flows from Investing Activities: |
|
|
|
Purchase of property and equipment |
|
(1,572,161 |
) |
|
|
(3,422,754 |
) |
Purchase of construction in progress |
|
(1,558,970 |
) |
|
|
(5,830,133 |
) |
Net cash used in investing activities |
|
(3,131,131 |
) |
|
|
(9,252,887 |
) |
Cash
Flows from Financing Activities: |
|
|
|
Proceeds from issuance of common stock, net |
|
52,552,758 |
|
|
|
6,186,011 |
|
Proceeds from exercise of warrants |
|
- |
|
|
|
550,000 |
|
Proceeds from exercise of stock options |
|
3,087 |
|
|
|
- |
|
Net cash provided by financing activities |
|
52,555,845 |
|
|
|
6,736,011 |
|
Net increase
(decrease) in cash, cash equivlants and restricted cash |
|
22,144,949 |
|
|
|
(22,551,567 |
) |
|
|
|
|
Cash, cash
equivalents and restricted cash at beginning of the year |
|
21,352,382 |
|
|
|
43,903,949 |
|
Cash, cash equivalents and restricted cash at end of the
year |
$ |
43,497,331 |
|
|
$ |
21,352,382 |
|
|
|
|
|
Investors and Media Contacts
Marker Therapeutics:
Neda SafarzadehVice President/Head of Investor
Relations, PR & Marketing(713)
400-6451Investor.Relations@markertherapeutics.com
Solebury Trout:
MediaAmy
BonannoAbonanno@soleburytrout.com
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