neldaleucel (MT-601) / Marker Therap, Baylor College of Medicine - LARVOL DELTA

MT-601 demonstrates favorable safety and durable responses in relapsed or refractory (r/r) non-Hodgkin lymphoma (NHL) (ASH 2025) - P1 | "Subsequent pts received standard doses of a LD regimen (Flu/Cy or bendamustine wasallowed per protocol) and a single infusion of MT-601. Preliminary safety and efficacy data from the APOLLO study demonstrates a favorable safety profile anddurable objective responses in r/r NHL pts treated with MT-601. Unlike genetically modified celltherapies, our approach uses endogenous T cells and appears to have low rates of Grade 1 CRS (6%) andno ICANS noted thus far. The favorable safety profile may allow for inclusion of heavily pre-treated ptsnot normally considered for more toxic cell therapies and safe outpatient administration of MT-601."

Clinical • IO biomarker • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • BIRC5 • CTAG1B • MAGEA4 • PRAME • WT1

Safety and efficacy of MT-601 in relapsed or refractory (r/r) Hodgkin lymphoma (ASH 2025) - P1 | "HL pts received standard dosesof a lymphodepletion chemotherapy (LDC) regimen (Flu/Cy or bendamustine was allowed per protocol)for three consecutive days (Day -5 to Day -3) before infusion of MT-601 (MT-601 doses: 200 x106 cells n=3; 300 x106 cells n=2; 400 x106 cells n=4). Initial disease assessment was conducted 8 weeks post MT-601infusion.The 9 HL pts (female n=4; male n=5) had a median age of 43 (range 30-75) and had undergone a medianof 8 prior lines of therapy, with all 9 pts having received prior brentuximab, PD-1 and HSCT (autologousn=5; allogeneic n=2; autologous and allogeneic n=2)...These preliminary findings from the Phase 1 APOLLO study demonstrate that MT-601 has a favorablesafety profile and early objective responses in heavily pre-treated HL pts. The encouraging tolerability ina population with limited treatment options supports the potential of MT-601 to address a significantunmet medical need and warrants further clinical examination. We will..."

Clinical • IO biomarker • B Cell Lymphoma • Bone Marrow Transplantation • Hodgkin Lymphoma • Immunology • Lymphoma • Non-Hodgkin’s Lymphoma • Primary Immunodeficiency • BIRC5 • CTAG1B • MAGEA4 • PD-1 • PRAME • WT1

Marker Therapeutics…announced that data from the Phase 1 APOLLO study will be presented in two posters at the 67th American Society of Hematology (ASH) Annual Meeting… (GlobeNewswire) - "Among patients with Non-Hodgkin lymphoma (NHL), including those who relapsed after anti-CD19 directed CAR-T cell therapy, the objective response rate (ORR) was 66% (8 out of 12) with 50% achieving a complete response (CR). Responses were durable, ranging from 3 to 24 months, with five patients remaining in remission for 6 months or longer, including three patients with responses exceeding 12 months. In Hodgkin lymphoma (HL), the ORR was 78% (7 out of 9), with 11% achieving a CR."

P1 data • Hodgkin Lymphoma • Non-Hodgkin’s Lymphoma

TACTOPS: TAA Specific Cytotoxic T Lymphocytes in Patients With Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=37 | Completed | Sponsor: Baylor College of Medicine | Trial completion date: May 2027 ➔ Jul 2025 | Active, not recruiting ➔ Completed

Trial completion • Trial completion date • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Marker Therapeutics Provides Update on Phase 1 APOLLO Study Highlighting Encouraging Overall Response Rates in Relapsed Lymphoma (GlobeNewswire) - "Ongoing Phase 1 APOLLO study investigating MT-601 in patients with relapsed B cell lymphoma showed 66% of Non-Hodgkin Lymphoma (NHL) patients achieving objective response rates, with 50% demonstrating complete response (CR). Favorable safety profile observed in study participants....'We...anticipate to provide another data update in the first half of 2026'."

P1 data • Hodgkin Lymphoma • Non-Hodgkin’s Lymphoma

Marker Therapeutics and Cellipont Bioservices Announce Collaboration to Advance cGMP Manufacturing of MT-601, a Multi-Antigen Recognizing T Cell Therapy for Patients with Lymphoma (GlobeNewswire) - "Marker Therapeutics...announced a collaboration with Cellipont Bioservices, a leading cell therapy Contract Development and Manufacturing Organization (CDMO), for current good manufacturing practice (cGMP) manufacturing of MT-601, Marker’s lead Multi-Antigen Recognizing (MAR)-T cell therapy. MT-601 is currently being investigated in the Phase 1 APOLLO study in patients with lymphoma who relapsed after anti-CD19 chimeric antigen receptor (CAR)-T cell therapy or for whom anti-CD19 CAR-T cell therapy is not an option.....Under the agreement, Cellipont will provide technology transfer and cGMP manufacturing services to support the scale-up and production of MT-601 for Marker’s APOLLO study. The collaboration between Marker and Cellipont is designed to accelerate clinical supply and lay the foundation for a potential pivotal trial and commercial readiness."

Licensing / partnership • Hodgkin Lymphoma • Non-Hodgkin’s Lymphoma

Marker Therapeutics Reports that Lymphodepletion Improves the Expansion and Persistence of Multi-Antigen Recognizing T Cells in Patients with Lymphoma (GlobeNewswire) - P1 | N=79 | APOLLO (NCT05798897) | Sponsor: Marker Therapeutics, Inc. | "Today, Marker provides data demonstrating preliminary evidence that lymphodepletion supports the expansion and persistence of MT-601 in vivo. Using T Cell Receptor (TCR) sequencing as an immunomonitoring strategy, the Company has evidence suggesting that MT-601 MAR-T cell clones in the drug product expanded and persisted at significantly higher levels in patients receiving lymphodepletion compared to patients who did not undergo the conditioning regimen....The Company believes that the enhanced in vivo expansion and persistence of MT-601 may positively influence the clinical anti-tumor activity of MT-601 in the ongoing APOLLO study....This upward trend reflects growing momentum and is expected to meaningfully expand the magnitude of the clinical data set, which the Company plans to present later this year."

P1 data • Lymphoma

Marker Therapeutics pops on receiving $9.5M grant to advance lead asset (MSN News) - "Marker Therapeutics...shares popped 11% Tuesday morning after the immuno-oncology company won a $9.5M grant from the Cancer Prevention & Research Institute of Texas (CPRIT) to support the clinical investigation of its lead asset, MT-601, in patients with metastatic pancreatic cancer....The latest grant is intended to support the company’s Phase 1 PANACEA study evaluating the safety and tolerability of MT-601 in patients with metastatic pancreatic cancer. Marker Therapeutics (MRKR) has been awarded over $30M in non-dilutive funding from governmental institutions to-date. It recently bagged a $2M grant from the NIH Small Business Innovation Research program to explore MT-601 in patients with pancreatic cancer....Marker will use these funds to advance the drug candidate in pancreatic cancer and anticipates clinical program initiation in 2025."

Financing • New trial • Pancreatic Cancer

Marker Therapeutics Reports Year-End 2024 Corporate and Financial Results (GlobeNewswire) - "MT-601 (Lymphoma): The Company is enrolling additional study participants in the Phase 1 APOLLO trial and expects to report further data in the second half of 2025; MT-601 (Pancreatic): Clinical program launch is anticipated in the second half of 2025."

New trial • P1 data • Trial status • Lymphoma • Pancreatic Cancer

Marker Therapeutics Provides a Clinical Update on MT-601 in Patients with Lymphoma (GlobeNewswire) - P1 | N=79 | APOLLO (NCT05798897) | Sponsor: Marker Therapeutics, Inc. | "...Phase 1 APOLLO study, with a data cutoff date of September 10....Key findings from the APOLLO study include: Safety: Infusion of MT-601 was well tolerated in all study participants, with no observation of immune-effector cell associated neurotoxicity syndrome (ICANS) and one reported Grade 1 cytokine release syndrome (CRS). No dose limiting toxicities (DLTs) have been reported to date; Efficacy: In the first dose cohort, 7 out of 9 patients achieved objective responses (78%) at first response assessment, with 4 patients demonstrating complete response (CR; 44.4%)...Time in Follow-Up: Long-term follow-up of 6 to 12 months is currently available for three patients....Ongoing follow-up visits are being conducted to assess the durability of responses. All study participants are monitored closely to ensure comprehensive data collection and patient safety."

Cytokine release syndrome • P1 data • Lymphoma

Marker Therapeutics Announces $16.1 Million Private Placement (GlobeNewswire) - "Marker Therapeutics, Inc...announced it has entered into a securities purchase agreement for a private placement resulting in gross proceeds of $16.1 million, before deducting placement agent fees and other expenses....Proceeds from the financing will, among other uses, support the clinical advancement of the Company’s Phase 1 APOLLO study investigating MT-601, a multi-antigen recognizing (MAR) T cell product (formerly known as multiTAA-specific T cells), in patients with lymphoma who have relapsed after anti-CD19 chimeric antigen receptor (CAR)-T cell therapy or where anti-CD19 CAR-T cells are not an option."

Financing • Lymphoma

Marker Therapeutics Awarded $9.5 Million Grant from the Cancer Prevention & Research Institute of Texas (CPRIT) to Support the Investigation of MT-601 in Patients with Pancreatic Cancer (GlobeNewswire) - "Marker Therapeutics, Inc...announced that the Company has been awarded a $9.5 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT) to support the clinical investigation of MT-601 in patients with metastatic pancreatic cancer. The CPRIT grant is intended to support the Company’s Phase 1 PANACEA study (clinicaltrials.gov Identifier: NCT06549751) evaluating the safety and tolerability of MT-601, a multi-tumor associated antigen (multiTAA)-specific T cell product, in patients with metastatic pancreatic cancer....Including this CPRIT grant, the Company has been awarded over $30 million in non-dilutive funding from governmental institutions including FDA, NIH and CPRIT....Together with the $9.5 million from CPRIT, Marker will use these funds to advance MT-601 in pancreatic cancer and anticipates clinical program initiation in 2025."

Financing • Pancreatic Cancer

Marker Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Updates (GlobeNewswire) - "PROGRAM UPDATES & EXPECTED MILESTONES: (i) MT-601 (Lymphoma):...The Company is enrolling additional study participants in the Phase 1 APOLLO trial and expects to provide an update on safety and durability during the fourth quarter of 2024...; (ii) MT-601 (Pancreatic):...The Company expects to start the clinical program of MT-601 in patients with metastatic pancreatic cancer in 2025...; (iii) MT-401-OTS (Acute Myeloid Leukemia or Myelodysplastic Syndrome): The Company...anticipates clinical program initiation during the first half of 2025."

New trial • P1 data • Acute Myelogenous Leukemia • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Pancreatic Cancer

Marker Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Updates (GlobeNewswire) - "PROGRAM UPDATES & EXPECTED MILESTONES: (i) MT-601 (Lymphoma):...The Company is enrolling additional study participants in the Phase 1 APOLLO trial and expect to provide an update on safety and durability during the third quarter....(ii) MT-401-OTS (Acute Myeloid Leukemia or Myelodysplastic Syndrome):...The Company...anticipates the clinical program initiation of MT-401-OTS during the fourth quarter of 2024."

Enrollment status • New trial • P1 data • Acute Myelogenous Leukemia • Hodgkin Lymphoma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma

PANACEA: MT-601 Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Marker Therapeutics, Inc.

Metastases • New P1 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Marker Therapeutics Awarded $2 Million Grant from NIH in Support of Phase 1 Study Investigating MT-601 in CAR-Relapsed Patients with Non-Hodgkin’s Lymphoma (GlobeNewswire) - "Marker Therapeutics...announced that the Company has been awarded a $2 million grant from the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program to support the clinical investigation of MT-601 in patients with non-Hodgkin’s lymphoma (NHL) who have relapsed following anti-CD19 chimeric antigen receptor (CAR) T cell therapy. The SBIR grant has been awarded based in part on Marker’s preliminary clinical data in patients with lymphoma...as well as non-clinical data demonstrating the anti-tumor activity of MT-601 on anti-CD19 CAR resistant lymphoma cells....The proceeds of the grant will support the nationwide multi-center Phase 1 APOLLO study...evaluating the safety and efficacy of MT-601, a multi-tumor associated antigen (multiTAA)-specific T cell product, in patients with relapsed NHL including those previously treated with anti-CD19 CAR-T cell therapy."

Financing • Non-Hodgkin’s Lymphoma

APOLLO: Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma (clinicaltrials.gov) - P1 | N=79 | Recruiting | Sponsor: Marker Therapeutics, Inc. | N=37 ➔ 79

Enrollment change • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Marker Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Updates (GlobeNewswire) - "MT-601 (Lymphoma): The Company is enrolling additional patients in the Phase 1 APOLLO trial and expects to report further data in the second half of 2024."

P1 data • Trial status • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Principal Investigator from City of Hope National Medical Center Invited to Present Clinical Data from Marker Therapeutics APOLLO Study at 11th Global Summit on Hematologic Malignancies (GlobeNewswire) - P1 | N=37 | APOLLO (NCT05798897) | Sponsor: Marker Therapeutics, Inc. | "Dr. Shouse’s presentation included data from two additional study participants that have been treated at City of Hope. One of the study participants had transformed follicular NHL and failed a total of 12 lines of therapy including mosunetuzumab (bispecific antibody) for follicular NHL, and Yescarta (anti-CD19 CAR T cell therapy) after transformation into DLBCL. At the time of MT-601 administration, only follicular NHL persisted after the last treatment. Eight weeks after initial infusion with MT-601, this study participant achieved a CR and remains in CR three months following treatment with MT-601....When evaluated at eight weeks post-treatment, the study participant was in partial response with all lesions decreasing in size including one that has completely resolved."

P1 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Marker Therapeutics Reports Year-End 2023 Corporate and Financial Results (GlobeNewswire) - "MT-601 (Lymphoma):...The Company is enrolling additional patients in the Phase 1 APOLLO trial and expects to report further data in the first half of 2024."

P1 data • Non-Hodgkin’s Lymphoma

Marker Therapeutics Receives Approval from United States Adopted Name (USAN) Council and International Nonproprietary Names (INN) Expert Committee for 'Neldaleucel' as Nonproprietary Name for MT-601 (GlobeNewswire) - "Marker Therapeutics, Inc...announced today that the United States Adopted Names (USAN) Council, and the World Health Organization (WHO) International Nonproprietary Names (INN) expert committee has approved 'neldaleucel' as the nonproprietary (generic) name for MT-601, a multi-tumor associated antigen (multiTAA)-specific T cell product candidate for the treatment of patients with lymphoma....The adoption of the name neldaleucel is a step forward for continued advancements of multiTAA therapies Marker is developing."

Commercial • Hematological Malignancies • Lymphoma • Oncology

Marker Therapeutics Receives Approval from United States Adopted Name (USAN) Council and International Nonproprietary Names (INN) Expert Committee for “Neldaleucel” as Nonproprietary Name for MT-601 (GlobeNewswire) - "Marker Therapeutics, Inc...announced today that the United States Adopted Names (USAN) Council, and the World Health Organization (WHO) International Nonproprietary Names (INN) expert committee has approved 'neldaleucel' as the nonproprietary (generic) name for MT-601, a multi-tumor associated antigen (multiTAA)-specific T cell product candidate for the treatment of patients with lymphoma....The adoption of the name neldaleucel is a step forward for continued advancements of multiTAA therapies Marker is developing."

Commercial • Hematological Malignancies • Lymphoma • Oncology

Marker Therapeutics Announces Clinical Program Updates and Pipeline Prioritization (GlobeNewswire) - "The Company today announced the prioritization of MT-601 in chimeric antigen receptor (CAR) relapse patients with lymphoma (APOLLO; clinicaltrials.gov identifier: NCT05798897). This strategic decision was made based on 1) the Company’s promising non-clinical and clinical data using the multiTAA technology in lymphoma, and 2) the lack of an approved treatment for patients who experience relapse after treatment with CD19 CAR T (up to 60% within a year; Chong EA et al, N Engl J Med, 2021), which is a clear unmet medical need and provides an opportunity for accelerated product development."

Clinical • Non-Hodgkin’s Lymphoma

Marker Therapeutics Announces Sustained Complete Response in First Lymphoma Patient Treated with MT-601 following CAR T Relapse (GlobeNewswire) - P1 | N=37 | APOLLO (NCT05798897) | Sponsor: Marker Therapeutics, Inc. | "Marker Therapeutics, Inc...today reported a clinical update on the APOLLO study. The Phase 1 APOLLO study is investigating MT-601, a multi-tumor associated antigen (multiTAA)-specific T cell product, for the treatment of patients with lymphoma who have failed or are ineligible to receive anti-CD19 CAR T cell therapy...Marker reports today that six months following the initial treatment with MT-601 the study participant has maintained complete response to treatment....This APOLLO study participant relapsed within 90 days after CAR T cell therapy, yet maintained a complete response for at least six months after treatment with MT-601, suggesting that MT-601 is more durable compared to CAR T cells in this study participant....'We will continue to monitor long-term treatment effects and durability of response and look forward to treating additional participants in this Phase 1 study.'"

P1 data • Trial status • Hematological Malignancies • Lymphoma • Oncology

Marker Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Updates (GlobeNewswire) - "Marker Therapeutics, Inc...today reported corporate updates and financial results for the third quarter ended September 30, 2023...Marker is treating and evaluating additional patients in the Phase 1 APOLLO trial and anticipates reporting additional data in the first half of 2024."

P1 data • Hematological Malignancies • Lymphoma • Oncology