Marker Therapeutics Reports Q1 2022 Operating and Financial Results
May 13 2022 - 7:00AM
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, 2022.
“2022 has already been an exciting year for Marker as we
reported encouraging initial results from the six-patient safety
lead-in portion of our Phase 2 AML trial—including elimination of
MRD in one MRD positive patient—and announced plans for
Company-sponsored trials of our second cell therapy product
candidate, MT-601, in pancreatic cancer and lymphoma,”
said Peter L. Hoang, Marker’s President and Chief Executive
Officer. “We also implemented a new MultiTAA-specific T cell
therapy manufacturing process, details of which were presented at
the 2022 International Society for Cell & Gene Therapy (ISCT)
annual meeting. After completing enrollment of the first 20
patients in the Phase 2 AML trial last year, we anticipate
reporting topline data from the active disease group in the main
phase of the trial next quarter.”
PROGRAM UPDATES AND EXPECTED MILESTONES
Acute Myeloid Leukemia (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)
based on peripheral blood analysis at Week 32 in one MRD positive
patient and induced epitope spreading across multiple
AML-associated antigens in that patient.
- Enrollment of the first 20 patients of the main Phase 2 stage
of the AML trial was completed in Q4 2021. Topline readout of Group
2 active disease is anticipated in Q2 2022.
- Marker announced in February 2022 that it is
developing 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 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
2023.
Additional Clinical Programs (MT-601)
- 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.
- Marker announced in February 2022 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.
BUSINESS UPDATES
- In April 2022, the Company announced that it entered into a
services agreement with Wilson Wolf Manufacturing Corporation. The
agreement includes an $8.0 million upfront cash payment by Wilson
Wolf to Marker in exchange for services relating to Marker’s
expertise in the manufacture of cell therapies. Wilson Wolf has
agreed to pay Marker an additional $1.0 million if the certain
work, as defined in the services agreement, is completed within one
year from the onset of the services agreement.
FIRST QUARTER 2022 FINANCIAL RESULTS
Cash Position and Guidance: At March 31, 2022,
Marker had cash, cash equivalents and restricted cash of $28.8
million.
R&D Expenses: Research and development
expenses were $7.0 million for the quarter ended March 31, 2022,
compared to $5.6 million for the quarter ended March 31, 2021.
G&A Expenses: General and administrative
expenses were $3.7 million for the quarter ended March 31, 2022,
compared to $3.1 million for the quarter ended March 31, 2021.
Net Loss: Marker reported a net loss of $9.9
million for the quarter ended March 31, 2022, compared to a net
loss of $8.8 million for the quarter ended March 31, 2021.
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; our ability to use our manufacturing
facilities to support clinical and commercial demand; the timing
and use of the CPRIT award; 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.Condensed
Consolidated Balance
Sheets(Unaudited) |
|
|
|
March 31, |
|
December 31, |
|
|
|
2022 |
|
|
|
2021 |
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
28,637,217 |
|
|
$ |
42,351,145 |
|
Restricted cash |
|
|
181,864 |
|
|
|
1,146,186 |
|
Prepaid expenses and deposits |
|
|
2,196,225 |
|
|
|
2,484,634 |
|
Other receivables |
|
|
2,185 |
|
|
|
237 |
|
Total current assets |
|
|
31,017,491 |
|
|
|
45,982,202 |
|
Non-current assets: |
|
|
|
|
Property, plant and equipment, net |
|
|
10,276,936 |
|
|
|
10,096,861 |
|
Construction in progress |
|
|
4,089,135 |
|
|
|
2,225,610 |
|
Right-of-use assets, net |
|
|
9,572,572 |
|
|
|
9,830,461 |
|
Total non-current assets |
|
|
23,938,643 |
|
|
|
22,152,932 |
|
|
|
|
|
|
Total assets |
|
$ |
54,956,134 |
|
|
$ |
68,135,134 |
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
7,348,680 |
|
|
$ |
11,134,913 |
|
Lease liability |
|
|
683,969 |
|
|
|
620,490 |
|
Deferred revenue |
|
|
181,864 |
|
|
|
1,146,186 |
|
Total current liabilities |
|
|
8,214,513 |
|
|
|
12,901,589 |
|
Non-current liabilities: |
|
|
|
|
Lease liability, net of current portion |
|
|
11,035,857 |
|
|
|
11,247,950 |
|
Total non-current liabilities |
|
|
11,035,857 |
|
|
|
11,247,950 |
|
|
|
|
|
|
Total liabilities |
|
|
19,250,370 |
|
|
|
24,149,539 |
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
Preferred stock - $0.001 par value, 5 million shares authorized and
0 shares issued and outstanding at March 31, 2022 and December 31,
2021, respectively |
|
|
- |
|
|
|
- |
|
Common stock, $0.001 par value, 150 million shares authorized, 83.5
million and 83.1 million shares issued and outstanding as of March
31, 2022 and December 31, 2021, respectively |
|
|
83,451 |
|
|
|
83,079 |
|
Additional paid-in capital |
|
|
443,651,176 |
|
|
|
442,020,871 |
|
Accumulated deficit |
|
|
(408,028,863 |
) |
|
|
(398,118,355 |
) |
Total stockholders' equity |
|
|
35,705,764 |
|
|
|
43,985,595 |
|
|
|
|
|
|
Total liabilities and stockholders' equity |
|
$ |
54,956,134 |
|
|
$ |
68,135,134 |
|
Marker Therapeutics, Inc.Condensed
Consolidated Statements of
Operations(Unaudited) |
|
|
|
For the Three Months Ended |
|
|
March 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Revenues: |
|
|
|
|
Grant income |
|
$ |
964,322 |
|
|
$ |
- |
|
Total revenues |
|
|
964,322 |
|
|
|
- |
|
Operating expenses: |
|
|
|
|
Research and development |
|
$ |
7,026,066 |
|
|
$ |
5,643,029 |
|
General and administrative |
|
|
3,733,001 |
|
|
|
3,137,958 |
|
Total operating expenses |
|
|
10,759,067 |
|
|
|
8,780,987 |
|
Loss from operations |
|
|
(9,794,745 |
) |
|
|
(8,780,987 |
) |
Other income (expenses): |
|
|
|
|
Arbitration settlement |
|
|
(118,880 |
) |
|
|
- |
|
Interest income |
|
|
3,117 |
|
|
|
1,537 |
|
Net loss |
|
$ |
(9,910,508 |
) |
|
$ |
(8,779,450 |
) |
|
|
|
|
|
Net loss per share, basic and diluted |
|
$ |
(0.12 |
) |
|
$ |
(0.16 |
) |
Weighted average number of common shares outstanding, basic and
diluted |
|
|
83,107,649 |
|
|
|
56,470,247 |
|
Marker Therapeutics, Inc.Condensed
Consolidated Statements of Cash
Flows(Unaudited) |
|
|
|
For the Three Months Ended |
|
|
March 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Cash Flows from Operating Activities: |
|
|
|
|
Net loss |
|
$ |
(9,910,508 |
) |
|
$ |
(8,779,450 |
) |
Reconciliation of net loss to net cash used in operating
activities: |
|
|
|
|
Depreciation and amortization |
|
|
576,331 |
|
|
|
502,743 |
|
Stock-based compensation |
|
|
1,630,677 |
|
|
|
1,377,038 |
|
Amortization of right-of-use assets |
|
|
257,889 |
|
|
|
251,626 |
|
Changes in operating assets and liabilities: |
|
|
|
|
Prepaid expenses and deposits |
|
|
288,409 |
|
|
|
95,000 |
|
Other receivables |
|
|
(1,948 |
) |
|
|
(308 |
) |
Accounts payable and accrued expenses |
|
|
(3,953,976 |
) |
|
|
(1,482,473 |
) |
Deferred revenue |
|
|
(964,322 |
) |
|
|
- |
|
Lease liability |
|
|
(148,614 |
) |
|
|
(64,329 |
) |
Net cash used in operating activities |
|
|
(12,226,062 |
) |
|
|
(8,100,153 |
) |
Cash Flows from Investing Activities: |
|
|
|
|
Purchase of property and equipment |
|
|
(826,583 |
) |
|
|
(442,277 |
) |
Cash used for construction in progress |
|
|
(1,625,605 |
) |
|
|
(958,965 |
) |
Net cash used in investing activities |
|
|
(2,452,188 |
) |
|
|
(1,401,242 |
) |
Cash Flows from Financing Activities: |
|
|
|
|
Proceeds from issuance of common stock, net |
|
|
- |
|
|
|
52,656,588 |
|
Net cash provided by financing activities |
|
|
- |
|
|
|
52,656,588 |
|
Net (decrease) increase in cash, cash equivlants and restricted
cash |
|
|
(14,678,250 |
) |
|
|
43,155,193 |
|
|
|
|
|
|
Cash, cash equivalents and restricted cash at beginning of the
period |
|
|
43,497,331 |
|
|
|
21,352,382 |
|
Cash, cash equivalents and restricted cash at end of the
period |
|
$ |
28,819,081 |
|
|
$ |
64,507,575 |
|
|
|
|
|
|
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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