Marker Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update
August 14 2023 - 4:30PM
Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage
immuno-oncology company focusing on developing next-generation T
cell-based immunotherapies for the treatment of hematological
malignancies and solid tumor indications, today reported corporate
updates and financial results for the second quarter ended June 30,
2023.
“The second quarter of 2023 proved to be a
highly beneficial time at Marker from an operational and clinical
standpoint, and I am excited by our comprehensive strategic
advancements,” commented Dr. Juan F. Vera, the new President and
Chief Executive Officer of Marker Therapeutics. “Importantly, we
extended our cash runway through 2025 by an agreement with Cell
Ready, a newly formed contract development and manufacturing
organization (CDMO). In exchange for certain cell manufacturing
assets, Cell Ready provided Marker with approximately $19 million
in cash and Cell Ready will absorb approximately $11 million of
Marker’s overhead expense annually while simultaneously ensuring
that Marker’s manufacturing and research and development (R&D)
needs will be fully met. As a result, we are now able to
aggressively and strategically advance our unique multiTAA-specific
T cell therapies toward meaningful clinical milestones.”
Dr. Vera added, “Our R&D work has yielded
non-clinical evidence for our multiTAA-specific T cell programs. In
May, we reported compelling, non-clinical data for the MT-601
product candidate in lymphoma cells that highlighted the potential
merit of multiTAA-specific T cell therapy in patients with
CD19-directed CAR T cell refractory lymphoma. Shortly after, the
first patient, who has relapsed following multiple therapies,
including anti-CD19 CAR T treatment, was treated in our Phase 1,
multicenter (“APOLLO”) clinical trial.”
“We also continue to progress the MT-401 program
in patients suffering from Acute Myeloid Leukemia (AML). In June,
we announced positive, non-clinical, in vitro data that
demonstrated enhanced MT-401-induced tumor killing in an AML cell
line after standard-of-care treatment with hypomethylating agents
(HMA), suggesting a synergistic effect of HMA boosting the
anti-tumor response of MT-401,” said Dr. Vera. “As a result of this
work, Marker was awarded a $2 million grant from the National
Institutes of Health (NIH) Small Business Innovation Research
(SBIR) program to support the development and investigation of
MT-401 for the treatment of AML patients following standard-of-care
therapy with HMA. On the regulatory front, we reached a significant
milestone by receiving Orphan Drug Designation for MT-401 in July
from the European Medicines Agency (EMA), which validates the
potential therapeutic impact of MT-401 in patients with AML and
potentially provides an expedited development pathway.”
“Having made these broad-based advances in the
second quarter, the new management team and I believe that Marker’s
future has never been brighter. These advances position Marker to
unlock significant value. To this end, we are finalizing an updated
clinical development plan, which we expect to unveil in the coming
months,” concluded Dr. Vera.
Recent Clinical and Operational Highlights:
MT-401 (Acute Myeloid Leukemia)
- Marker reported non-clinical data
showing enhanced anti-tumor activity of MT-401 in AML cells
following HMA exposure.
- Based on non-clinical data, Marker
was awarded a $2 million grant from the NIH SBIR program to support
clinical investigation of MT-401 after HMA administration.
- After receiving Orphan Drug
Designation (ODD) from the U.S. Food and Drug Administration (FDA),
Marker was granted ODD from the Committee for Orphan Medicinal
Products of the EMA for the treatment of AML patients.
- Marker reported non-clinical
proof-of-concept data for MT-401 in an Off-the-Shelf (OTS) setting
and provided an update on clinical readiness for the OTS program.
The U.S. FDA has cleared the clinical protocol to investigate
MT-401 OTS in patients with relapsed AML. Marker has implemented a
patient cellular inventory and anticipates the first AML patient to
be treated with MT-401 OTS during the first half of 2024.
MT-601 (Lymphoma)
- Marker provided non-clinical data
demonstrating the anti-tumor activity of MT-601 in anti-CD19 CAR T
resistant lymphoma cells, indicating the potential clinical benefit
of MT-601 in patients with CAR T refractory lymphoma.
- Initiation of the Phase 1 APOLLO
trial (clinicaltrials.gov Identifier: NCT05798897) for treatment of
patients with lymphoma who have relapsed after, or are ineligible
for, anti-CD19 CAR T cell therapy. First patient with lymphoma was
treated with MT-601 at a 200 million cell dose level and showed no
treatment-related adverse events, suggesting a similar favorable
safety profile and tolerability of multiTAA-specific T cell
products as observed in previous clinical studies.
MT-601 (Pancreatic)
- Investigational New Drug (IND)
application cleared by U.S. FDA for multicenter Phase 1 trial of
MT-601 in patients with metastatic pancreatic cancer in combination
with first-line chemotherapy.
- Clinical advancement will be
pending additional financial support from non-dilutive grant
activities.
Executive Leadership
- Appointed Juan Vera, M.D.,
President and Chief Executive Officer and Monic Stuart, M.D., MPH,
Chief Medical Officer, whose combined experience will significantly
aid Marker in advancing its clinical programs.
Strategic and Financial Partnerships
- On June 26, 2023, Marker completed
the previously announced non-dilutive transaction with Cell Ready,
under which Cell Ready purchased certain cell manufacturing assets
from Marker for approximately $19 million in cash. Marker
anticipates that the cost savings from the transaction, including
the assumption of facility leases by Cell Ready and the hiring by
Cell Ready of over 50 of Marker’s employees in its manufacturing,
R&D, quality and regulatory affairs functions, will result in a
reduction of Marker’s operating expenses by approximately $11
million annually, and should extend Marker’s cash runway into the
fourth quarter of 2025.
- In April 2022, Marker entered into
a service agreement with Wilson Wolf Manufacturing Corporation
(Wilson Wolf Agreement). Pursuant to the Wilson Wolf Agreement,
Marker received an additional $1 million in May 2023 as the work
was completed within one year from the onset of the agreement,
achieving the agreed milestone.
Second Quarter 2023 Financial Highlights:
-
Cash Position: At June 30, 2023, Marker had
cash and cash equivalents of $18.1 million.
-
R&D Expenses: Research and development
expenses from continuing operations were $2.4 million for
the quarter ended June 30, 2023, compared to $2.9
million for the quarter ended June 30, 2022.
-
G&A Expenses: General and administrative
expenses from continuing operations were $2.5 million for
the quarter ended June 30, 2023, compared to $3.1
million for the quarter ended June 30, 2022.
-
Net Income (Loss): Marker reported net income
of $2.5 million for the quarter ended June 30, 2023,
compared to a net loss of ($9.2) million for the quarter
ended June 30, 2022.
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. The cell
therapy technology Marker has in place 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 the T cells, Marker believes that its 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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HTTPS://WWW.MARKERTHERAPEUTICS.COM/EMAIL-ALERTS.
Forward-Looking Statements
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 Marker’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 of our product candidates; our ability to recognize
the benefits of the Cell Ready transaction; anticipated cost
savings as a result of the Cell Ready transaction; and our future
operating expenses and capital expenditure requirements, including
our anticipated cash runway. 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 Marker’s
most recent Form 10-K, 10-Q and other SEC filings which are
available through EDGAR at WWW.SEC.GOV. Marker assumes no
obligation to update its forward-looking statements whether as a
result of new information, future events or otherwise, after the
date of this press release except as may be required by law.
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Marker
Therapeutics, Inc.Condensed Consolidated Balance
Sheets(Unaudited) |
|
|
|
|
|
June
30, |
|
December
31, |
|
|
2023 |
|
|
|
2022 |
|
ASSETS |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
18,122,086 |
|
|
$ |
11,782,172 |
|
Prepaid expenses and deposits |
|
2,087,462 |
|
|
|
1,849,239 |
|
Other receivables |
|
1,746,100 |
|
|
|
2,402,004 |
|
Current assets of discontinued operations |
|
- |
|
|
|
585,840 |
|
Total current assets |
|
21,955,648 |
|
|
|
16,619,255 |
|
Non-current
assets of discontinued operations |
|
|
|
17,802,929 |
|
Total assets |
$ |
21,955,648 |
|
|
$ |
34,422,184 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable and accrued liabilities |
$ |
2,660,616 |
|
|
$ |
2,521,193 |
|
Current liabilities of discontinued operations |
|
260,280 |
|
|
|
5,260,616 |
|
Total current liabilities |
|
2,920,896 |
|
|
|
7,781,809 |
|
Non-current
liabilities of discontinued operations |
|
- |
|
|
|
7,039,338 |
|
Total
liabilities |
|
2,920,896 |
|
|
|
14,821,147 |
|
|
|
|
|
Stockholders' equity: |
|
|
|
Preferred stock - $0.001 par value, 5 million shares authorized and
0 shares issued and outstanding at June 30, 2023 and December 31,
2022, respectively |
|
- |
|
|
|
- |
|
Common stock, $0.001 par value, 30 million shares authorized, 8.8
million and 8.4 million shares issued and outstanding as of June
30, 2023 and December 31, 2022, respectively |
|
8,799 |
|
|
|
8,406 |
|
Additional paid-in capital |
|
449,526,789 |
|
|
|
447,641,680 |
|
Accumulated deficit |
|
(430,500,836 |
) |
|
|
(428,049,049 |
) |
Total
stockholders' equity |
|
19,034,752 |
|
|
|
19,601,037 |
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
21,955,648 |
|
|
$ |
34,422,184 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Marker
Therapeutics, Inc.Condensed Consolidated
Statements of Operations(Unaudited) |
|
|
|
|
|
|
|
|
|
For the
Three Months Ended |
|
For the Six
Months Ended |
|
June 30, |
|
June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
Grant income |
$ |
762,658 |
|
|
$ |
790,508 |
|
|
$ |
1,996,995 |
|
|
$ |
1,754,830 |
|
Total
revenues |
|
762,658 |
|
|
|
790,508 |
|
|
|
1,996,995 |
|
|
|
1,754,830 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
2,377,993 |
|
|
|
2,923,877 |
|
|
|
5,754,492 |
|
|
|
6,194,241 |
|
General and administrative |
|
2,518,725 |
|
|
|
3,135,168 |
|
|
|
4,686,044 |
|
|
|
6,486,465 |
|
Total
operating expenses |
|
4,896,718 |
|
|
|
6,059,045 |
|
|
|
10,440,536 |
|
|
|
12,680,706 |
|
Loss from
operations |
|
(4,134,060 |
) |
|
|
(5,268,537 |
) |
|
|
(8,443,541 |
) |
|
|
(10,925,876 |
) |
Other income (expenses): |
|
|
|
|
|
|
|
Arbitration settlement |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(118,880 |
) |
Interest income |
|
35,080 |
|
|
|
35,786 |
|
|
|
119,734 |
|
|
|
38,902 |
|
Loss from
continuing operations |
|
(4,098,980 |
) |
|
|
(5,232,751 |
) |
|
|
(8,323,807 |
) |
|
|
(11,005,854 |
) |
Discontinued operations: |
|
|
|
|
|
|
|
Loss from discontinued operations before income taxes |
|
(2,179,657 |
) |
|
|
(4,011,437 |
) |
|
|
(2,922,406 |
) |
|
|
(8,148,842 |
) |
Gain on disposal of discontinued operations |
|
8,794,426 |
|
|
|
- |
|
|
|
8,794,426 |
|
|
|
- |
|
Income
(loss) from discontinued operations |
|
6,614,769 |
|
|
|
(4,011,437 |
) |
|
|
5,872,020 |
|
|
|
(8,148,842 |
) |
Net
income (loss) |
$ |
2,515,789 |
|
|
$ |
(9,244,188 |
) |
|
$ |
(2,451,787 |
) |
|
$ |
(19,154,696 |
) |
|
|
|
|
|
|
|
|
Net earnings
(loss) per share, basic and diluted: |
|
|
|
|
|
|
|
Loss from continuing operations |
$ |
(0.47 |
) |
|
$ |
(0.63 |
) |
|
$ |
(0.95 |
) |
|
$ |
(1.32 |
) |
Income (loss) from discontinued operations |
$ |
0.75 |
|
|
$ |
(0.48 |
) |
|
$ |
0.67 |
|
|
$ |
(0.98 |
) |
Net earnings (loss) per share |
$ |
0.29 |
|
|
$ |
(1.11 |
) |
|
$ |
(0.28 |
) |
|
$ |
(2.30 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average number of common shares outstanding, |
|
|
|
|
|
|
|
Basic and diluted |
|
8,798,956 |
|
|
|
8,359,205 |
|
|
|
8,760,209 |
|
|
|
8,335,119 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Marker
Therapeutics, Inc.Condensed Consolidated
Statements of Cash Flows(Unaudited) |
|
|
|
For the Six
Months Ended |
|
June 30, |
|
|
2023 |
|
|
|
2022 |
|
Cash
Flows from Operating Activities: |
|
|
|
Net loss |
$ |
(2,451,787 |
) |
|
$ |
(19,154,696 |
) |
Less: gain (loss) from discontinued operations, net of tax |
|
5,872,020 |
|
|
|
(8,148,842 |
) |
Net loss from continuing operations |
|
(8,323,807 |
) |
|
|
(11,005,854 |
) |
Reconciliation of net loss to net cash used in operating
activities: |
|
|
|
Stock-based compensation |
|
539,858 |
|
|
|
1,986,402 |
|
Changes in operating assets and liabilities: |
|
|
|
Prepaid expenses and deposits |
|
(238,223 |
) |
|
|
(309,254 |
) |
Other receivables |
|
655,904 |
|
|
|
(627,392 |
) |
Accounts payable and accrued expenses |
|
197,030 |
|
|
|
(1,061,562 |
) |
Deferred revenue |
|
- |
|
|
|
(1,146,186 |
) |
Net cash used in operating activities - continuing operations |
|
(7,169,238 |
) |
|
|
(12,163,846 |
) |
Net cash used in operating activities - discontinued
operations |
|
(5,775,680 |
) |
|
|
(856,922 |
) |
Net cash used in operating activities |
|
(12,944,918 |
) |
|
|
(13,020,768 |
) |
Cash
Flows from Investing Activities: |
|
|
|
Net cash provided by (used in) investing activities - discontinued
operations |
|
18,664,122 |
|
|
|
(4,718,428 |
) |
Net cash provided by (used in) investing activities |
|
18,664,122 |
|
|
|
(4,718,428 |
) |
Cash
Flows from Financing Activities: |
|
|
|
Proceeds from issuance of common stock, net |
|
619,974 |
|
|
|
63,573 |
|
Proceeds from stock options exercise |
|
736 |
|
|
|
- |
|
Net cash provided by financing activities |
|
620,710 |
|
|
|
63,573 |
|
Net increase
(decrease) in cash, cash equivalents and restricted cash (1) |
|
6,339,914 |
|
|
|
(17,675,623 |
) |
|
|
|
|
Cash, cash
equivalents and restricted cash at beginning of the period (1) |
|
11,782,172 |
|
|
|
43,497,331 |
|
Cash
and cash equivalents at end of the period |
$ |
18,122,086 |
|
|
$ |
25,821,708 |
|
|
|
|
|
(1) As of June 30, 2022 and December 31, 2021, the Company had $0
and $1,146,186 of restricted cash, respectively. |
|
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ContactsTIBEREND STRATEGIC ADVISORS,
INC.InvestorsDaniel Kontoh-Boateng(862)
213-1398DBOATENG@TIBEREND.COM
MediaCasey McDonald(646) 577-8520CMCDONALD@TIBEREND.COM
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