MRKR Overview

Biotech Stocks Performance: Several small-cap biotech and healthcare companies saw notable gains in after-hours trading, driven by recent corporate updates and clinical milestones.

Inspira Technologies Update: Inspira Technologies Oxy B.H.N. Ltd. rose 5.88% following a recent agreement for a registered direct offering and a Standby Equity Purchase Agreement, despite no new news on the day.

MediciNova's Clinical Trial Success: MediciNova, Inc. advanced 4.83% after successfully completing patient enrollment in its Phase 2 OXTOX study, which evaluates MN-166 for preventing chemotherapy-induced peripheral neuropathy.

DiaMedica's FDA Meeting: DiaMedica Therapeutics Inc. gained 2.89% after a productive pre-IND meeting with the FDA regarding its study of DM199 in preeclampsia, with an additional non-clinical study requested.

Clinical Study Results: The APOLLO study reported a 66% objective response rate and a 50% complete response rate for MT-601 in relapsed Non-Hodgkin lymphoma patients, demonstrating a favorable safety profile with no dose-limiting toxicities observed.

New Treatment Initiatives: Marker Therapeutics treated the first patient in the RAPID study, exploring Off-the-Shelf MAR-T cells for Acute Myeloid Leukemia and Myelodysplastic Syndrome, while also launching a clinical program for MT-601 in metastatic pancreatic cancer.

Manufacturing Collaboration: The company established a cGMP manufacturing partnership with Cellipont Bioservices to enhance production capabilities for MT-601, supporting clinical supply and future pivotal trials.

Financial Position: Marker Therapeutics raised approximately $10 million, extending its cash runway into 2026, with a reported net loss of $2 million for the third quarter of 2025, reflecting a decrease in research and development expenses compared to the previous year.

Study Overview: The Phase 1 APOLLO study is investigating MT-601, a Multi-Antigen Recognizing (MAR)-T cell therapy, in patients with relapsed B cell lymphomas, showing promising preliminary efficacy data with an objective response rate of 66% in Non-Hodgkin lymphoma and 78% in Hodgkin lymphoma.

Safety Profile: MT-601 demonstrated a robust safety profile with no dose limiting toxicities or immune-effector cell associated neurotoxicity syndrome reported, and only two participants experienced mild cytokine release syndrome.

Upcoming Presentations: Data from the APOLLO study will be presented in two posters at the 67th American Society of Hematology Annual Meeting from December 6-9, 2025, highlighting the safety and efficacy of MT-601 in relapsed or refractory lymphomas.

Company Background: Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company focused on developing next-generation T cell-based therapies for hematological malignancies and solid tumors, with a commitment to operational excellence and patient outcome improvement.

Clinical Study Update: Marker Therapeutics provided an update on the Phase 1 APOLLO study of MT-601, a MAR-T cell product for lymphoma patients who have relapsed after anti-CD19 CAR-T therapy or are not eligible for it.

Efficacy Results: The study reported a 66% objective response rate in Non-Hodgkin Lymphoma (NHL) patients, with 50% achieving complete responses. Hodgkin Lymphoma (HL) patients showed a 78% response rate, indicating MT-601's effectiveness across different lymphoma types.

Safety Profile: No dose-limiting toxicities were observed at the highest dose tested, and the treatment was well tolerated with minimal adverse events, including only two Grade 1 cytokine release syndrome cases.

Future Updates: Marker Therapeutics plans to provide additional data updates in the first half of 2026, while their stock price has seen a decline of 14.28% to $1.08 at the time of publication.

Study Results: The Phase 1 APOLLO study of MT-601 in patients with relapsed B cell lymphoma reported a 66% objective response rate, with 50% achieving complete response, demonstrating promising efficacy.

Safety Profile: The treatment exhibited a favorable safety profile, with no dose limiting toxicities or severe neurotoxicity observed, and only mild cytokine release syndrome events reported.

Next Steps: The study will proceed to a dose expansion phase to evaluate MT-601 at a maximum dose in patients with Diffuse Large B Cell Lymphoma (DLBCL) who are ineligible for CAR-T therapy.

Webcast Announcement: A live webcast is scheduled to discuss the clinical results and updates from the study, allowing attendees to engage through a Q&A feature.