2022 CLINICAL AND REGULATORY HIGHLIGHTS

2022 CORPORATE AND FINANCIAL HIGHLIGHTS

HOUSTON, March 22, 2023 (GLOBE NEWSWIRE) -- 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."

Mr. 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 programs.”

MT-401 PHASE 2 ARTEMIS (AML)

New manufacturing process for MT-401:

Adjuvant Patients:

Marker continues to see promising data with MRD+ patients:

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 (Lymphoma)

MT-601 (Pancreatic):

FISCAL YEAR 2022 FINANCIAL RESULTS

Cash 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.

R&D 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.

G&A 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.

Net 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

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 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 http://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.

Contacts

Investors

Tiberend Strategic Advisors, Inc. Daniel Kontoh-Boateng (862) 213-1398 dboateng@tiberend.com

Media

Tiberend Strategic Advisors, Inc. Jason Rando/Casey McDonald (917)-930-6346/ (646) 577-8520 jrando@tiberend.com/cmcdonald@tiberend.com

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2023-03-22 | NDAQ:MRKR | Press Release | Marker Therapeutics Inc. - Stockhouse