Marker Therapeutics Reports Third Quarter 2020 Operating and Financial Results

Initiated first Marker-sponsored study, a Phase 2 trial of MT-401 for the treatment of post-transplant acute myeloid leukemia, and enrolled the first patient in the safety lead-in portion

Received alternate reagent and expect to submit required data to enable removal of partial clinical hold for IND for MT-401 by Q1 2021

Company to host conference call and webcast today at 5:00 PM EST

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 third quarter ended September 30, 2020.

“This quarter, our Company reached a significant milestone by initiating our first Marker-sponsored study—a Phase 2 trial of zelenoleucel or MT-401, our lead MultiTAA-specific T cell product candidate for the treatment of post-transplant acute myeloid leukemia,” said Peter L. Hoang, President & CEO of Marker Therapeutics. “We have enrolled the first patient in the safety lead-in portion of the trial, and are in the process of scheduling the donor in order to manufacture the product.”

Continued Mr. Hoang: “During this unprecedented time, we have made significant progress by enrolling additional clinical sites for our AML trial, advancing our manufacturing process, reducing production time by 50% and improving the potency of our MT-401 product, and entering the final phase of the construction of our new in-house cGMP manufacturing facility. I am extremely proud of the dedication and resolve that our team has shown during these challenging months. I want to acknowledge their hard work across the organization that went into achieving these milestones.”

PROGRAM UPDATES

MT-401: Multi-Antigen Targeted (MultiTAA)-Specific T Cell Product Candidate for AML

Phase 2 AML Trial

The Company initiated the safety lead-in portion of its Phase 2 study of zelenoleucel (MT-401) in patients with acute myeloid leukemia (AML) following an allogeneic stem cell transplant in both the adjuvant and active disease settings. The Company anticipates treating the first patient by Q1 2021. The safety lead-in is expected to enroll a total of six patients: three of which will be treated with MT-401 manufactured with a legacy reagent, and the remaining three to be treated with study drug manufactured with a new reagent from an alternate supplier.
Marker has activated four clinical sites and is in the start-up phase with additional clinical sites to enroll patients for the safety lead-in portion of the AML trial. The Company has also received commitments from additional clinical sites to participate in the Phase 2 AML trial following the safety lead-in phase and anticipates activating a total of approximately 20 sites.

The study remains on partial clinical hold pending the review of final data and subsequent acceptance of certificates of analysis for the new reagent by the U.S. FDA. The Company received the remaining reagent from the alternate supplier in Q3 2020 and is currently conducting the comparability analyses between the previous and new reagents, as required by FDA. Marker intends to submit all required data to FDA by Q1 2021 to enable removal of the partial clinical hold.

Over the past year, the Company has continued to streamline and simplify the MT-401 manufacturing process. The technical improvements include a 50% reduction in manufacturing time, a 95% reduction in the number of required operator interventions, and significant improvement in the consistency and reproducibility of the manufacturing process, while yielding a significant increase in the number of T cells available for patient administration. The Company expects the new process to yield a measurably improved product, with superior T cell phenotype and antigen specificity as compared to the original process. The new process improvements have been updated in the CMC section of the IND and will be used for all patients in the Marker AML clinical trial.

BUSINESS UPDATES

  • Construction of the cGMP manufacturing facility has entered its final phase. The facility, located in Houston near the George Bush Intercontinental Airport, will be used to support the manufacture of study drug for Marker’s Phase 2 AML trial and for future hematological and solid tumor trials, in addition to the potential commercialization of any approved products. The construction is expected to be completed by year-end with clinical activities to be initiated in the first half of 2021.

THIRD QUARTER 2020 FINANCIAL RESULTS

Cash Position and Guidance: At September 30, 2020, Marker had cash and cash equivalents of $27.0 million. The Company raised $2.2 million through the previously executed $30 million common stock purchase agreement with Aspire Capital Fund, LLC. The remaining $27.8 million available to Marker from Aspire Capital along with current cash available, funds operations into Q1 2022.

R&D Expenses: Research and development expenses were $4.8 million for the quarter ended September 30, 2020, compared to $3.1 million for the quarter ended September 30, 2019.

G&A Expenses: General and administrative expenses were $2.6 million for the quarter ended September 30, 2020, compared to $2.5 million for the quarter ended September 30, 2019.

Net Loss: Marker reported a net loss of $7.4 million for the quarter ended September 30, 2020, compared to a net loss of $5.5 million for the quarter ended September 30, 2019.

Conference Call and Webcast
The Company will host a webcast and conference call to discuss its third quarter 2020 financial results and provide a corporate update today at 5:00 PM EST.

The webcast will be accessible in the Investors section of the Company’s website at markertherapeutics.com. Individuals can participate in the conference call by dialing 877-407-8913 (domestic) or 201-689-8201 (international) and referring to the “Marker Therapeutics Third Quarter 2020 Earnings Call.”

The archived webcast will be available for replay on the Marker website following the event.

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 Statement Disclaimer
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 impact of the COVID-19 pandemic; the timing, conduct and success of our clinical trials, as well as clinical trials conducted by our collaborators; our manufacturing processes and our ability to use our in-house manufacturing facility to support clinical and commercial demand. 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

Marker Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)

Marker Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)

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