Full Press Release Details
Marker Therapeutics Reports Fiscal Year 2022
Corporate and Financial Results
2022 CLINICAL AND REGULATORY HIGHLIGHTS
2022 CORPORATE AND FINANCIAL HIGHLIGHTS
TX - March 22, 2023 - 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 fiscal year 2022 financial results and provided updates for its clinical development programs.
"2022 was a critical year for Marker Therapeutics
as we advanced the company on several fronts, including key enhancements to our multiTAA clinical development pipeline and strategic initiatives,
including with Wilson Wolf, to leverage our differentiated manufacturing capabilities to generate alternative sources of funding for our
clinical programs," said Peter L. Hoang, President and Chief Executive Officer at Marker Therapeutics. "We believe these initiatives
will unlock multiple value building opportunities for Marker throughout 2023. We continue to advance our MT-401 Phase 2 ARTEMIS clinical
trial and are encouraged by recent data involving measurable residual disease (MRD) positive patients, which suggest MT-401 produced with
our new T cell manufacturing process could be well suited for this underserved subset of patients with AML. We anticipate reporting a
more expansive data readout from the MRD positive group in the second half of 2023.
Hoang continued: "We also made considerable progress with our MT-601 program, securing FDA clearance for INDs in non-Hodgkin lymphoma
and pancreatic cancer. We have initiated enrollment for the lymphoma Phase 1 clinical study of MT-601 and expect to report topline data
in early 2024 and expect to initiate enrollment for the pancreatic study by the fourth quarter of 2023. We continue to be energized
by the manufacturing services agreement with Wilson Wolf and believe we are on track to earn the additional $1 million bonus provided
for in the agreement. Additionally, we see the potential to build on the success of this project with additional revenue-generating opportunities
whereby we leverage our unique expertise in technical operations to provide the company with non-dilutive capital to fund our clinical
MT-401 PHASE 2 ARTEMIS (AML)
New manufacturing process for MT-401:
Marker continues to see promising data with MRD+
Measurable residual disease is an important biomarker
in hematological malignancies, such as AML, that is used for prognostic, predictive and monitoring assessments. This term refers to a
small number of malignant cancer cells remaining in a patient's body after completion of therapy, despite the absence of clinical and
radiological evidence of disease. MRD detection relies on highly sensitive laboratory techniques, such as next-generation sequencing,
polymerase chain reaction (PCR), or flow cytometry. The assessment is crucial in AML management as it can provide prognostic information
and guide therapeutic decisions, such as the need for additional treatment or close surveillance. Importantly, MRD is a transitional phase
prior to development of frank relapse and considered a negative prognostic factor. Thus, the achievement of MRD negativity, defined as
the absence of detectable malignant cells, is a favorable prognostic factor and an important treatment goal in AML.
The standard first-line treatment for the last
decade had been combination chemotherapy using cytarabine and an anthracycline. However, approximately half of the patients eventually
relapse. Eligible patients subsequently proceed to hematopoietic stem cell transplantation (HSCT), but disease relapse after transplant
is frequent and remains a major cause of death. To date, there is no approved therapy for post-transplant MRD+ patients, highlighting
the need for novel therapies. Therefore, the positive clinical responses observed in MRD+ patients treated with MT-401 may provide a more
effective approach to treatment.
"Our ARTEMIS trial showed promising clinical
responses in post-transplant MRD positive patients highlighting the potential benefit of our multiTAA-specific T cell therapy in patients
where no treatments have been approved," said Dr. Juan F. Vera, Chief Scientific Officer and Chief Operating Officer of Marker Therapeutics.
"We will continue to track the patients' disease status and look forward to investigating MT-401 in a larger patient population."
Dr. Vera continued: "Our improved T cell
manufacturing process used for multiTAA-specific T cells enables a 9-day ex vivo T cell production, providing a fast turnaround for patient
treatment to reach MRD positive patients before relapse."
Frank Relapse Patients:
MT-601 (Pancreatic):
FISCAL YEAR 2022 FINANCIAL RESULTS
Position and Guidance: At December 31, 2022, Marker had cash and cash equivalents of $11.8 million. The Company believes that
its existing cash, cash equivalents and restricted cash will fund its operating expenses and capital expenditure requirements into the
third quarter of 2023.
Expenses: Research and development expenses were $26.1 million for the year ended December 31, 2022, compared
to $27.8 million for the year ended December 31, 2021.
Expenses: General and administrative expenses were $12.8 million for the year ended December 31, 2022, compared
to $12.9 million for the year ended December 31, 2021.
Loss: Marker reported a net loss of $29.9 million for the year ended December 31, 2022, compared to a net loss of
$41.9 million for the year ended December 31, 2021.
About Marker's Phase 2 ARTEMIS Trial
The multicenter Phase 2 AML study is evaluating
the clinical efficacy of MT-401 in patients with AML following an allogeneic stem-cell transplant in both the adjuvant and active disease
setting. In the adjuvant setting, approximately 150 patients will be randomized 1:1 to either MT-401 at 90 days post-transplant versus
standard-of-care observation, while approximately 40 patients with active disease will receive MT-401 as part of the single-arm group.
The primary objectives of the trial are to evaluate
relapse-free survival in the adjuvant group and determine the complete remission rate and duration of complete remission in active disease
patients. Additional objectives include, for the adjuvant group, overall survival and graft-versus-host disease relapse-free survival
while additional objectives for the active disease group include overall response rate, duration of response, progression-free survival,
and overall survival.
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 Statements
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 collaboration with Wilson
Wolf Manufacturing Corporation; 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
| December 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 11,782,172 | $ | 42,351,145 | ||||
| Restricted cash | - | 1,146,186 | ||||||
| Prepaid expenses and deposits | 2,435,079 | 2,484,634 | ||||||
| Other receivables | 2,402,004 | 237 | ||||||
| Total current assets | 16,619,255 | 45,982,202 | ||||||
| Non-current assets: | ||||||||
| Property, plant and equipment, net | 12,323,143 | 10,096,861 | ||||||
| Construction in progress | - | 2,225,610 | ||||||
| Right-of-use assets, net | 5,479,786 | 9,830,461 | ||||||
| Total non-current assets | 17,802,929 | 22,152,932 | ||||||
| Total assets | $ | 34,422,184 | $ | 68,135,134 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 4,704,611 | $ | 11,134,913 | ||||
| Related party deferred revenue | 2,500,000 | - | ||||||
| Deferred revenue | - | 1,146,186 | ||||||
| Lease Liability | 577,198 | 620,490 | ||||||
| Total current liabilities | 7,781,809 | 12,901,589 | ||||||
| Non-current liabilities: | ||||||||
| Lease liability, net of current portion | 7,039,338 | 11,247,950 | ||||||
| Total non-current liabilities | 7,039,338 | 11,247,950 | ||||||
| Total liabilities | 14,821,147 | 24,149,539 | ||||||
| Stockholders' equity: | ||||||||
| Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at December 31, 2022 and 2021, respectively | - | - | ||||||
| Common stock, $0.001 par value, 30 million and 15 million shares authorized, 8.4 million and 8.3 million shares issued and outstanding as of December 31, 2022 and 2021, respectively | 8,406 | 8,308 | ||||||
| Additional paid-in capital | 447,641,680 | 442,095,642 | ||||||
| Accumulated deficit | (428,049,049 | ) | (398,118,355 | ) | ||||
| Total stockholders' equity | 19,601,037 | 43,985,595 | ||||||
| Total liabilities and stockholders' equity | $ | 34,422,184 | $ | 68,135,134 |
Marker Therapeutics, Inc.
Consolidated Statements of Operations