On November 10, 2021 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, reported financial results for the third quarter ended September 30, 2021 (Press release, TapImmune, NOV 10, 2021, View Source [SID1234595108]).
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"This quarter, we continued our momentum in advancing Marker’s Phase 2 trial of MT-401, Marker’s lead MultiTAA-specific T cell therapy, for the treatment of post-transplant acute myeloid leukemia, or AML," said Peter L. Hoang, President & CEO of Marker Therapeutics. "We are pleased to announce that the first patients in Marker’s Phase 2 AML trial have been dosed with study drug. Further, we are on track to enroll the first 20 patients of the trial in the fourth quarter, with the first data readout expected in the first quarter of 2022. We look forward to providing year-end updates in a conference call and webcast early next year."
PROGRAM UPDATES
The Company continues to enroll patients and activate clinical sites across the U.S. in Marker’s Phase 2 trial of MT-401, its lead MultiTAA-specific T cell product candidate, for the treatment of post-transplant AML. The trial is expected to enroll approximately 120 patients in the adjuvant setting and 40 patients with active disease at approximately 20 clinical sites.
BUSINESS UPDATES
The Company’s new cGMP manufacturing facility in Houston, Texas is fully operational and is supporting ongoing operations. The facility will also manufacture Marker’s MultiTAA-specific T cell products for future hematological and solid tumor trials, in addition to producing the potential commercial supply of any products, if approved.
In August, the Company announced that it received notice of a Product Development Research award totaling approximately $13.1 million from the Cancer Prevention and Research Institute of Texas (CPRIT) to support the Company’s Phase 2 AML trial.
ANTICIPATED PROGRAM MILESTONES
AML Trial Milestones
Enrollment of first 20 patients of the Phase 2 AML trial expected in Q4 2021
Topline readout of Group 2 active disease anticipated in Q1 2022
THIRD QUARTER 2021 FINANCIAL RESULTS
Cash Position and Guidance: At September 30, 2021, Marker had cash and cash equivalents of $48.7 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses and capital expenditure requirements into the first quarter of 2023.
R&D Expenses: Research and development expenses were $6.8 million for the quarter ended September 30, 2021 compared to $4.8 million for the quarter ended September 30, 2020. The increase was primarily attributable to increases in clinical trial and sponsored research expenses and headcount-related expenses due to growth of research and development operations.
G&A Expenses: General and administrative expenses were $3.2 million for the quarter ended September 30, 2021 compared to $2.6 million for the quarter ended September 30, 2020.
Net Loss: Marker reported a net loss of $12.4 million for the quarter ended September 30, 2021, compared to a net loss of $7.4 million for the quarter ended September 30, 2020.