On August 14, 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, reported corporate updates and financial results for the second quarter ended June 30, 2023 (Press release, Marker Therapeutics, AUG 14, 2023, View Source [SID1234634393]).

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"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."

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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.

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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.

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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.