New data evaluating Orca-T® with reduced intensity conditioning for the treatment of hematological malignancies in patients 60 to 75 years of age

Clinical findings of Orca-Q® with and without the use of GvHD prophylaxis in patients with hematological malignancies including AML, ALL and MDS

Expanded feasibility data on the combination of Orca-T and an allogeneic CAR-T (OrCAR-T™) in patients with high-risk B-ALL

Additional presentations will highlight overall survival and non-relapse mortality with Orca-T versus PTCy, and additional subsets from the pivotal Phase 3 study including relapse-free survival and patient-reported outcomes

Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced that new clinical data will be presented in three oral and three poster sessions at the American Society of Hematology (ASH) Annual Meeting from December 6-9 in Orlando, FL. The presentations will span its pipeline of investigational allogeneic T-cell immunotherapies for the treatment of multiple hematological malignancies including Orca-T, Orca-Q and the Orca-T and allogeneic CAR-T combination therapy, OrCAR-T.

“Our ongoing clinical evaluation of our pipeline across diverse patient populations, conditioning regimens and donor types underscores our commitment to advancing care for people with blood cancer,” said Nate Fernhoff, Ph.D., co-founder and chief executive officer of Orca Bio. “We look forward to presenting new and expanded evidence from the pivotal Phase 3 study of our lead T-cell immunotherapy, Orca-T, along with data highlighting the potential of our next-generation candidate, Orca-Q, to enable treatment without GvHD prophylaxis. Overall, these findings mark meaningful progress toward our goal of delivering our high-precision approach to more patients who may benefit.”

The ASH abstracts are now available at www.hematology.org. Details of the Orca Bio oral and poster presentations follow:

Oral Session: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Toxicities: Improving Outcomes by Decreasing Transplant-Related Complications

Title: Allogeneic HSC and Regulatory T cell (Orca-T) Engineered Cell Therapy Following Reduced Intensity Conditioning: Results of a Single Center Phase 1 Study

Abstract Number: 111

Date and Time: December 6, 2025 at 10:00 AM EST

Location: OCCC - Chapin Theater (320)

Oral Session: 732. Allogeneic Transplantation: Disease Response and Comparative Treatment Studies: Biologic Predictors and Novel Platforms Integrating CAR T with Transplant

Title: Superior Efficacy and Persistence of Orca-T-Allogeneic CAR19/22 Versus Autologous CAR19/22 in High-Risk Adult B-ALL

Abstract Number: 514

Date and Time: December 7, 2025 at 10:15 AM EST

Location: OCCC - Chapin Theater (320)

Oral Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: GVHD Prevention: Post-transplant cyclophosphamide and beyond

Title: Preliminary Safety and Efficacy of Myeloablative Orca-Q with Tacrolimus or without GVHD Prophylaxis for Treatment of Advanced Hematologic Malignancies

Abstract Number: 932

Date and Time: December 8, 2025 at 3:00 PM EST

Location: OCCC - W331

Poster Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster I

Title: Orca-T Improves cGVHD-free Survival in Patients with a Broad Range of Demographic and Clinical Variables: Results of Randomized, Phase 3 Trial

Abstract Number: 2477

Date and Time: December 6, 2025 at 5:30 PM - 7:30 PM EST

Location: OCCC - West Halls B3-B4

Poster Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster I

Title: Orca-T Demonstrates Favorable Quality of Life and Healthcare Resource Use Compared to Standard AlloHSCT plus Tac/MTX for GVHD Prevention in a Randomized Phase 3 Clinical Trial (Precision-T)

Abstract Number: 2473

Date and Time: December 6, 2025 at 5:30 PM - 7:30 PM EST

Location: OCCC - West Halls B3-B4

Poster Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster III

Title: Observational Comparison of Orca-T to Registry-Based Post-Transplant Cyclophosphamide Patients using Matched Unrelated Donor

Abstract Number: 6029

Date and Time: December 8, 2025 at 6:00 PM - 8:00 PM EST

Location: OCCC - West Halls B3-B4

About Orca-T

Orca-T is an investigational allogeneic T-cell immunotherapy being evaluated for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration (FDA). The Biologics License Application (BLA) for Orca-T is currently under Priority Review with the FDA with a PDUFA target action date of April 6, 2026.

About Orca-Q

Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy under evaluation in clinical trials for the treatment of multiple hematologic malignancies, including in patients with haploidentical and mismatched donors. Orca-Q is a proprietary composition of stem cells combined with specific T-cell subsets derived from healthy donors and engineered by Orca Bio’s high-precision platform.

About Orca Bio

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of blood cancer and autoimmune diseases. The company’s manufacturing platform uses single-cell precision to create personalized cell therapy products intended to replace a patient’s diseased blood and immune system with a healthy one. At Orca Bio, we are on a mission to redefine what’s possible for patients by transforming the field of curative allogeneic cell therapy. For more information, visit www.orcabio.com.

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