Press release

Investor Relations

Joshua Murray

Orca-T Results in High GVHD-Free and Relapse-Free Survival Following Myeloablative Conditioning for Hematological Malignancies: Results of a Single Center Phase 2 and a Multicenter Phase 1b Study

Orca Bio to Present New Clinical Data on Orca-T at the 63rd American Society of Hematology Annual Meeting

Oral and poster presentations will include one-year follow-up data from an expanded group of patients and an analysis of treatment outcomes in patients with myelofibrosis

MENLO PARK, CA, November 4, 2021 – Orca Bio, a clinical-stage biotechnology company developing purified, high-precision cell therapies for cancer, autoimmune and genetic blood disorders, today announced that new data will be presented from a single-center Phase 2 trial and a multi-center Phase 1b trial at the American Society of Hematology (ASH) Annual Meeting. Specifically, pooled data from patients treated with Orca-T, an investigational high-precision cell therapy product being studied in patients with hematologic malignancies, will be shared in an oral presentation. Additionally, results of Orca-T in a subset of patients with myelofibrosis from those same trials will be shared in a poster presentation.

“Our clinical experience with Orca-T has grown significantly over the past year and we are pleased to present data on an expanded group of patients who now have one year of follow-up with Orca-T,” said Ivan Dimov, Ph.D., cofounder and chief executive officer of Orca Bio. “We look forward to presenting these important findings at ASH as we continue to work to deliver on our promise of maximizing patient survival while minimizing the compromise of toxicities to enable better outcomes.”

The ASH abstracts are now available at www.hematology.org.

Details of the Orca Bio presentations follow:

Abstract Number: 98

Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Prevention of graft vs. host disease after allogeneic hematopoietic cell transplantation

Presentation Date: Saturday, December 11, 2021, at 9:45 AM EST

Location: Georgia World Congress Center, B302-B303

Poster Presentation: Outcomes for Myelofibrosis Patients Following Myeloablative Allogeneic Stem Cell Transplantation Using the Orca-T Graft from HLA-Matched Related and Unrelated Donors

Abstract Number: 1819

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

Presentation Date: Saturday, December 11, 2021, at 5:30 PM – 7:30 PM EST

Location: Georgia World Congress Center, Hall B5

About Orca Bio

Orca Bio is a late-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders. Our investigational therapies are designed to deliver better survival rates with dramatically fewer risks than the standard of care. At Orca Bio, we hope to not only replace patients' blood and immune systems with healthy ones, but restore their quality of life. For more information, visit www.orcabio.com and follow Orca Bio on Twitter: @orcabio.

Contact:

Corporate Communications

Kelsey Grossman

Investor Relations

Joshua Murray

Orca Bio to Present Clinical Data on Its High-Precision Cell Therapies at the 66th American Society of Hematology Annual Meeting

Long-term survival data with Orca-T will be presented for the first time in patients with AML, ALL and MDS

Early feasibility data on the combination of Orca-T and an allogeneic CAR-T in patients with high-risk B-ALL will be shown

A third oral presentation will highlight patient outcomes with Orca-Q without the use of any graft versus host disease (GvHD) prophylaxis in patients with hematologic malignancies

MENLO PARK, CA, November 5, 2024 – 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 sessions at the American Society of Hematology (ASH) Annual Meeting from December 7-10 in San Diego, CA.

Three-year survival data with Orca Bio’s lead investigational allogeneic T-cell immunotherapy, Orca-T, will be presented from the multicenter Phase 1b clinical trial of patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and high-risk myelodysplastic syndrome (MDS). Additionally, initial feasibility, safety and efficacy data from an investigator-sponsored trial evaluating the combination of Orca-T with allogeneic CD19/CD22-CAR-T cells in patients with high-risk B-cell acute lymphoblastic leukemia (B-ALL) will be shared. In a third oral session, data from a multicenter Phase 1 clinical trial will be presented from patients treated with Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy, Orca-Q, in patients with hematologic malignancies without the use of any post-treatment graft versus host disease (GvHD) prophylaxis.

“We are pleased to present exciting new data from our lead clinical programs for patients with blood cancers, including three-year follow-up with Orca-T, our lead cell therapy candidate currently being evaluated in a pivotal Phase 3 clinical trial,” said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio. “We also look forward to debuting the results of patients treated with Orca-Q without the use of any GvHD prophylaxis. Overall, these findings represent important progress toward our goal of delivering our high-precision approach to more patients who could potentially benefit.”

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

Oral Session: 732. Allogeneic Transplantation: Disease Response and Comparative Treatment Studies: Finding the Ideal Donor and Graft: Going Beyond HLA

Title: Observational Comparison of Overall Survival between Phase 1b Orca-T and Registry-Based Post-Transplant Cyclophosphamide Patients

Abstract Number: 694

Date and Time: Sunday, December 8, 2024 at 5:15 PM PT

Location: San Diego Convention Center, Room 6A

Oral Session: 704. Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: B Cell-directed CAR T Cell Therapies for ALL and for Autoimmunity

Title: Safe and Effective Combination of Donor-Derived, Allogeneic CD19/CD22-CAR T Cells with Myeloablative Graft-Engineered Allo-HCT for High-Risk B-ALL

Abstract Number: 679

Date and Time: Sunday, December 8, 2024 at 4:30 PM PT

Location: Marriott Marquis San Diego Marina, Marriott Grand Ballroom 2-4

Oral Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Monitoring, Understanding and Optimizing GVHD Interventions

Title: Preliminary Safety and Efficacy of Myeloablative Orca-Q with No GvHD Prophylaxis for Treatment of Advanced Hematologic Malignancies

Abstract Number: 382

Date and Time: Saturday, December 7, 2024 at 4:45 PM PT

Location: San Diego Convention Center, Room 6CF

About Orca-T

Orca-T is an investigational allogeneic T-cell immunotherapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies. Orca-T is comprised of highly purified regulatory T-cells, CD34+ stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors. Orca-T is currently being evaluated in a pivotal Phase 3 clinical trial which has completed enrollment at leading transplant centers across the U.S. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.

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 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 cancer and autoimmune diseases. Our investigational products are designed to replace a patient’s diseased blood and immune system with a healthy one, with the goal of improving outcomes with fewer risks than the standard of care. Our manufacturing platform uses single-cell precision to create proprietary, uniquely-defined products that have the potential to transform allogeneic cell therapy. At Orca Bio, our mission is to make curative cell therapies both more effective and safer, and in doing so, push past the field’s current boundaries and redefine its future. For more information, visit www.orcabio.com.

Contact:

Corporate Communications

Kelsey Grossman

Investor Relations

Joshua Murray

Orca Bio Expands Manufacturing Capabilities to Develop and Commercialize its Precision Cell Therapies

New state-of-the art manufacturing facility is designed to enable the reliable production of Orca Bio's investigational cell therapies from late-stage clinical development through potential commercialization

The 100,000-square-foot facility is located in Metro Air Park, Sacramento

MENLO PARK, CA, September 8, 2022 – Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, today announced the expansion of its current manufacturing capabilities with the construction of a new 100,000-square-foot commercial facility in Sacramento, CA. This facility will support the late-stage clinical development and commercialization of Orca Bio’s precision cell therapies, including Orca-T, which is currently being evaluated in a Phase 3 registrational trial.

“The new state-of-the-art facility represents critical infrastructure to enable the advancement of our pipeline and the future commercial availability of our potentially life-saving products,” said Jeroen Bekaert, Ph.D., co-founder and chief operating officer of Orca Bio. “With the capacity to manufacture approximately 3,000 cell therapy products per year, the facility will allow us to scale to meet future demand. Investing in our manufacturing capabilities is essential to our mission of delivering a cure without compromise while ensuring timely access to the patients who need it, when they need it.”

The new facility is strategically located in Sacramento's newly developed Metro Air Park next to the Sacramento International Airport, enabling direct shipping access to transplant centers across the U.S. It is also in close proximity to Orca Bio's existing clinical manufacturing building. The facility is uniquely tailored to manufacture precision cell therapies designed to replace cancerous blood and immune systems with healthy ones. It touts modular production suites, which are adjustable for future growth, quality control laboratories, warehouse space and offices. The construction began in August of 2021 and is scheduled to be completed later this year. The facility is expected to be fully validated and operational in the first half of 2023.

“Throughout the clinical development of our products, we have demonstrated the ability to reliably manufacture and deliver high-precision cell therapies with rapid turnaround times, regardless of donor and patient location,” said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio. “This new facility will further enhance our capabilities to deliver our therapies urgently and seamlessly to patients at scale, while meeting the highest quality and regulatory standards.”

Orca Bio’s unique approach uses precision cell selection technology to identify the less than 1% of the 100 billion donor cells that potentially contain therapeutic benefits for patients. These cells are then manufactured into potentially curative cell therapies designed to maximize efficacy of treatment and significantly limit treatment-related risks. Orca Bio recently announced Precision-T, its pivotal Phase 3 study evaluating Orca-T for the treatment of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and high-risk myelodysplastic syndromes (MDS), is open for enrollment at leading transplant centers across the U.S.

About Orca-T

Orca-T is an investigational high-precision allogeneic cellular therapy consisting of infusions containing regulatory T-cells, conventional T-cells and CD34+ stem cells derived from peripheral blood from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and is being studied to treat multiple hematologic malignancies.

About Orca Bio

Orca Bio is a clinical-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders. Our investigational therapies are designed to deliver better survival rates with dramatically fewer risks than standard allogeneic stem cell transplants, like graft versus host disease and other debilitating transplant-related toxicities. At Orca Bio, we hope to not only replace patients' blood and immune systems with healthy ones, but restore their quality of life. For more information, visit www.orcabio.com and follow Orca Bio on Twitter: @OrcaBio.

Contact:

Corporate Communications

Kelsey Grossman

Investor Relations

Joshua Murray

Orca Bio to Present at the 43rd Annual J.P. Morgan Healthcare Conference

MENLO PARK, CA, January 6, 2025 – Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced that Ivan Dimov, Ph.D., Orca Bio’s co-founder and chief executive officer, will present at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA.

The company presentation will take place on Monday, January 13, 2025, at 8:00AM PST at the Westin St. Francis in the Golden Gate Room on the 32nd floor.

About Orca Bio

Contact:

Corporate Communications

Kelsey Grossman

Investor Relations

Joshua Murray

ir@orcabio .com

Orca Bio to Present New Clinical Data on Its High-Precision Cell Therapies at the 67th American Society of Hematology Annual Meeting

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

MENLO PARK, CA, November 3, 2025 – 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 under evaluation 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.

Trademarks or registered trademarks used in this press release are the property of their respective owners.

Contact:

Corporate Communications

Kelsey Grossman

Investor Relations

Joshua Murray

Orca Bio to Present New Clinical Data on Orca-T at the European Hematology Association 2022 Congress

MENLO PARK, CA, May 12, 2022 – Orca Bio, a clinical-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, today announced that new clinical data on its lead investigational high-precision cell therapy, Orca-T, will be shared in an oral presentation at the hybrid European Hematology Association (EHA) Congress from June 9-17, 2022, in Vienna, Austria.

Oral Session: Clinical Studies in Transplantation

Title: Orca-T, an Engineered Allograft, Results in High GVHD-Free and Relapse-Free Survival Following Myeloablative Conditioning for Hematological Malignancies

Abstract Number: S237

Date and Time: Sunday, June 12, at 11:30–12:45 CEST / 5:30AM–6:45AM EDT

Location: Hall Stolz 1-2

The presentation will highlight results from the single-center Phase 2 and multi-center Phase 1b trials of Orca-T in patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myelodysplastic syndromes (MDS). Data included in the abstract will be updated at the time of presentation.

The oral session will take place in Vienna and will be livestreamed on the EHA Congress platform.

About Orca Bio

Orca Bio is a late-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders. Our investigational therapies are designed to deliver better survival rates with dramatically fewer risks than the standard of care. At Orca Bio, we hope to not only replace patients' blood and immune systems with healthy ones, but restore their quality of life. For more information, visit www.orcabio.com and follow Orca Bio on Twitter: @orcabio.

Contact:

Corporate Communications

Kelsey Grossman

Investor Relations

Joshua Murray

Orca Bio to Present Positive Clinical Data on Orca-T at the 50th Annual Meeting of the EBMT

Presentations include data from an expanded group of older patients treated with Orca Bio’s investigational high-precision cell therapy, Orca-T, and reduced intensity conditioning

MENLO PARK, CA, April 11, 2024 – Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders, today announced new data will be presented during the 50th Annual Meeting of the EBMT in Glasgow, United Kingdom.

Specifically, results from a single-center open-label Phase 1 clinical trial of an expanded group of older patients (n=20) treated with Orca Bio’s lead investigational high-precision cell therapy, Orca-T, and a reduced intensity conditioning (RIC) regimen will be presented. Preliminary data with Orca-T and RIC in patients with hematologic malignancies showed encouraging rates of relapse-free survival (77%). With a median follow-up of 9.65 months, no patients have experienced relapse to date (0%), demonstrating the curative potential for Orca-T in this historically challenging to treat patient group. An earlier dataset evaluating Orca-T and RIC in this population was presented at the 2023 American Society of Hematology (ASH) Annual Meeting.

A second presentation will highlight findings from a non-randomized retrospective analysis comparing Orca-T plus single-agent tacrolimus with a standard of care allogeneic stem cell transplant (alloHSCT) plus post-transplant cyclophosphamide (PTCy)-based graft versus host disease (GvHD) prophylaxis in patients with hematologic malignancies receiving myeloablative conditioning (MAC). When compared to the historical PTCy cohort in this patient population, Orca-T offered potentially favorable rates of relapse-free survival, non-relapse mortality and overall survival. These data were previously presented at the 2024 Tandem Meetings, Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR).

“At Orca Bio, we continue to build clinical evidence to support the profile of Orca-T and its potential to expand life-saving treatment to patients while also reducing treatment-related risks,” said Scott McClellan, M.D., Ph.D., chief medical officer at Orca Bio. “We look forward to joining top healthcare professionals from around the world at EBMT and sharing the latest findings that support the potential for Orca-T to offer a new curative solution for providers and their patients.”

The EBMT abstracts are available at https://www.ebmt.org/.

Details of the Orca Bio presentations follow:

Title: Phase 1 Trial Results for Patients with Advanced Hematologic Malignancies Treated with Orca-T Cell Therapy with Reduced Intensity Conditioning and Single Agent Tacrolimus

Poster Code: A121

Date and Time: Monday, April 15, 2024 at 18:00 BST

Location: Hall 3 North

Title: A Retrospective Analysis Comparing Orca-T to Post-Transplant Cyclophosphamide Based Allogeneic Hematopoietic Stem Cell Transplant in Patients with Matched Unrelated Donors Receiving Myeloablative Conditioning

Poster Code: A107

Date and Time: Monday, April 15, 2024 at 18:00 BST

Location: Hall 3 North

About Orca-T

Orca-T is an investigational high-precision allogeneic cell therapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies. Orca-T includes infusions containing regulatory T-cells, CD34+ stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors. Orca-T is currently being evaluated in a pivotal Phase 3 clinical trial at leading transplant centers across the U.S. and has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.

About Orca Bio

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders. Our investigational products are designed to safely replace a patient’s diseased blood and immune system with a healthy one, delivering significantly better outcomes with dramatically fewer risks than the standard of care. Our manufacturing platform uses single-cell precision to create proprietary, uniquely-defined products that have the potential to transform allogeneic cell therapy. At Orca Bio, our mission is to make curative cell therapies both more effective and safer, and in doing so, push past the field’s current boundaries and redefine its future. For more information, visit www.orcabio.com and follow Orca Bio on Twitter: @OrcaBio.

Contact:

Corporate Communications

Kelsey Grossman

Investor Relations

Joshua Murray