Patient reported outcomes with Orca-T^® from the pivotal Precision-T Phase 3 study will be presented including quality of life and rates of rehospitalizations compared to conventional alloHSCT

Data evaluating the use of Orca-T with reduced intensity conditioning versus PTCy for the treatment of hematologic malignancies will be shared

Additional presentations will highlight the manufacturing and nationwide distribution data reported on Orca–T and clinical findings of Orca-Q^® in patients with haploidentical donors

Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced that clinical data will be presented in seven oral and poster sessions at the 52nd Annual Meeting of the EBMT from March 22-25 in Madrid.

The encore presentations will include data on the company's pipeline of investigational allogeneic T-cell immunotherapies for the treatment of multiple hematologic malignancies, including Orca-T and Orca-Q.

“Our participation at this year’s meeting of the EBMT provides an important opportunity to engage directly with the global transplant community as we continue our shared efforts to advance the field of allogeneic stem cell transplant,” said Nate Fernhoff, Ph.D., co-founder and chief executive officer of Orca Bio. “As we progress toward the potential FDA approval of Orca-T, the strength and consistency of our data reinforce our commitment to delivering a new therapy for patients with blood cancer. We look forward to being in Madrid to connect with clinicians and partners from around the world and to participate in scientific exchange focused on improving patient outcomes.”

The EBMT abstracts are now available at www.ebmt.org/annual-meeting-2026. Details of the Orca Bio presentations follow:

Oral Session: OS14 | Graft Manipulation and Conditioning
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)
Date and Time: Wednesday, March 25 at 08:30 AM – 08:39 AM CET
Location: N107

Oral Session: OS14 | Graft Manipulation and Conditioning
Title: Clinical Outcomes in Orca-T and Registry-Based Post-Transplant Cyclophosphamide Patients: An Observational Comparison
Date and Time: Wednesday, March 25 at 08:39 AM – 08:48 AM CET
Location: N107

Oral Session: OS12 | Acute GVHD - Clinical
Title: Cost-Effectiveness of Orca-T vs Allo-HCT with Conventional GVHD Prophylaxis for the Treatment of Advanced Hematologic Malignancies in the United States
Date and Time: Tuesday, March 24 at 2:39 PM – 2:48 PM CET
Location: N101-102

Poster Session: A
Title: Interim Clinical Outcomes in Orca-T with Reduced Intensity Conditioning: An Observational Comparison to Registry-Based Post-Transplant Cyclophosphamide Patients
Presentation ID: A038
Date and Time: Monday, March 23 at 6:00 PM – 7:00 PM CET
Location: Pavilion 9

Poster Session: A
Title: Scalable Manufacturing and Nationwide Distribution of Orca-T: A Precision-Engineered Allogeneic Immune Cell Therapy
Presentation ID: A145
Date and Time: Monday, March 23 at 6:00 PM – 7:00 PM CET
Location: Pavilion 9

Poster Session: A
Title: Preliminary Safety and Efficacy of Myeloablative Orca-Q in Patients with Haploidentical Donors
Presentation ID: A043
Date and Time: Monday, March 23 at 6:00 PM – 7:00 PM CET
Location: Pavilion 9

Poster Session: A
Title: Clinical Outcomes in Myelodysplastic Syndrome Patients Treated with Orca-T or Post-Transplant Cyclophosphamide Patients: A Registry-Based Comparison
Presentation ID: A085
Date and Time: Monday, March 23 at 6:00 PM – 7:00 PM CET
Location: Pavilion 9

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 peripheral blood 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 being evaluated 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 proprietary, uniquely-defined products designed 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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“Our participation at this year’s meeting of the EBMT provides an important opportunity to engage directly with the global transplant community as we continue our shared efforts to advance the field of allogeneic stem cell transplant.”