Orca Bio to Present Clinical Data on TREGZI™ and Its Clinical Pipeline at the 14th Annual Meeting of the Society of Hematologic Oncology

Data outline infection events with TREGZI vs conventional alloHSCT from the pivotal Precision-T Phase 3 Trial

Additional presentations will highlight the preliminary profile of Orca-Q^® in patients with haploidentical donors and the design of the Serene-T trial of TREGZI in older patients with hematologic malignancies

MENLO PARK, Calif.--(BUSINESS WIRE)--Orca Bio, a commercial-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced that three clinical data and study updates have been accepted for presentation and publication at the 14th Annual Meeting of the Society of Hematologic Oncology from September 9 -12 in Houston, Texas.

The presentations will include data on TREGZI™, the company’s recently approved precision-engineered cell therapy for allogenic transplant in adults with hematologic malignancies, as well as an encore presentation on Orca Bio’s investigational allogeneic T-cell immunotherapy, Orca-Q ^®.

“Our presence at the Society of Hematologic Oncology comes at an important time as it gives us the opportunity to share additional information on the profile of our recently approved therapy, TREGZI, to the hematology community,” said Nate Fernhoff, Ph.D., co-founder and chief executive officer of Orca Bio. “As a company committed to redefining what’s possible in curative allogeneic cell therapy, we’re also pleased to share updates coming out of our clinical development program.”

Details of the Orca Bio presentations follow:

Title: Clinical Overview of Infection Events with Orca-T^® vs Conventional Allogeneic Hematopoietic Stem Cell Transplantation in the Precision-T Phase 3 Study
Presentation ID: CT 594
Date and Time: September 9, 2026 at 6:25-7:55pm CT
Location: Hall B3, George R. Brown Convention Center

Title: Preliminary Safety and Efficacy of Myeloablative Orca-Q in Patients with Haploidentical Donors
Presentation ID: CT 931
Date and Time: September 9, 2026 at 6:25-7:55pm CT
Location: Hall B3, George R. Brown Convention Center

Title: SERENE-T: A Phase 2 Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome
Accepted for publication in Clinical Lymphoma, Myeloma and Leukemia as part of the SOHO 2026 meeting proceedings supplement

Following the presentations, copies will be available on the Scientific Publications section of the Company’s website.

About TREGZI™

TREGZI™ is the first-and-only FDA approved precision-cell therapy for allogeneic transplant in adults with hematologic malignancies to improve survival free of cGVHD. It is indicated for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host-disease-free survival, in the treatment of adults with hematological malignancies.

TREGZI is a personalized treatment manufactured for each individual patient using living cells from a matched donor. TREGZI uses hematopoietic stem and progenitor cells (HSPCs) to reconstitute the immune system, highly purified regulatory T cells (Tregs) to suppress GVHD and conventional T cells (Tcons) to accelerate immune reconstitution and produce graft-versus-leukemia (GVL) activity.

The FDA approval of TREGZI was based on the results of Precision-T, a randomized, open-label, multi-center study that evaluated the safety, efficacy and tolerability of TREGZI compared with conventional allogeneic hematopoietic stem cell transplant (alloHSCT).

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 commercial-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.