Press release

Investor Relations

Joshua Murray

Orca Bio Presents Data Demonstrating its Lead Investigational High-Precision Cell Therapy Orca-T Significantly Improved Relapse-Free Survival at 64th Annual Meeting

Orca Bio Presents Data Demonstrating its Lead Investigational High-Precision Cell Therapy Orca-T Significantly Improved Relapse-Free Survival at 64th ASH Annual Meeting

Updated data from Phase 1b/2 trials include 151 patients with acute myeloid leukemia, acute lymphocytic leukemia, myelodysplastic syndromes and other hematologic malignancies

Relapse-free survival was 87% at one year in a group of 71 patients who received the preferred conditioning regimen being used in the Precision-T Phase 3 Study of Orca-T

Data also showed improved graft-versus-host disease-free, relapse-free survival rates and overall survival rates at one year with Orca-T compared to standard of care

Precision-T is ongoing and enrolling patients at transplant centers across the U.S.

MENLO PARK, CA, Dec. 10, 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 presented updated positive clinical data on its lead investigational cell therapy, Orca-T, during an oral presentation at the 64th American Society of Hematology (ASH) Annual Meeting.

The data demonstrated a significant improvement in relapse-free survival (RFS) at one year with 87% in 71 patients who received Orca-T and busulfan, fludarabine, and thiotepa (BFT) conditioning. BFT is the preferred conditioning regimen used in Precision-T, the ongoing Phase 3 pivotal study of Orca-T. Additionally, across all 151 patients, there was an increase in graft-versus-host disease, relapse-free survival (GRFS) rates and overall survival rates at one year with Orca-T compared to an independent cohort.

“Today, providers must balance treatment decisions with the goal of fighting cancer while minimizing toxicities. With a standard allogeneic transplant, highly myeloablative conditioning regimens can lead to reduced rates of patient relapse, but can also increase rates of non-relapse mortality,” said Everett Meyer, M.D., Ph.D., primary investigator. “It is encouraging to see that the use of Orca-T across multiple hematological malignancies resulted in a remarkable improvement in relapse-free and overall survival while lowering the rate of serious toxicities compared to standard of care allogeneic hematopoietic stem cell transplants.”

The results of the patient subgroup conditioned with BFT were presented today along with pooled results from the single-center Phase 2 and multi-center Phase 1b trials from 151 patients treated with Orca-T with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndromes (MDS) and other hematological malignancies. For comparison purposes, an independent Center for International Blood and Marrow Transplant Research (CIBMTR)-based cohort was identified consisting of patients with AML, ALL or MDS who received a standard of care allogeneic hematopoietic stem cell transplant.

Results demonstrated that patients conditioned with BFT and treated with Orca-T experienced:

87% RFS at one year among all groups, including minimal residual disease positive acute leukemia patients.
81% GRFS at one year.
0% non-relapse mortality and only 5% moderate-to-severe chronic GvHD at one year.
94% overall survival (OS) at one year.

In pooled results from all patients treated with Orca-T, patients experienced:

70% GRFS at one year compared to 21% in the CIBMTR-based cohort.
4% non-relapse mortality at one year compared to 10% in the CIBMTR-based cohort.

88% OS at one year compared to 68% in the CIBMTR-based cohort.

Importantly, Orca-T was manufactured reliably and delivered with vein-to-vein times of 72 hours or less across the U.S.

“These relapse-free and overall survival rates from more than 150 patients treated with Orca-T are very encouraging, and we are extremely pleased to see the strong results of patients who were given the preferred conditioning regimen used in our pivotal Phase 3 trial,” said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio. “These new data continue to reinforce the potential of this high-precision cell therapy to become a better treatment option for patients and transplant physicians. We remain laser-focused on advancing Orca-T through Precision-T and ultimately on delivering the therapy to more patients in need.”

The full presentation is available on www.orcabio.com.

About Orca-T

About Orca Bio

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Corporate Communications

Investor Relations

Joshua Murray

Orca Bio’s Orca-T® Meets Primary Endpoint in the Pivotal Precision-T Phase 3 Clinical Study for Hematologic Malignancies

Orca Bio to present efficacy and safety data with Orca-T compared to conventional hematopoietic stem cell transplant (alloHSCT) at the 51st Annual Meeting of the EBMT

MENLO PARK, CA, February 10, 2025 – Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced it will present positive results from the pivotal Phase 3 Precision-T study (NCT05316701) of its investigational allogeneic T-cell immunotherapy, Orca-T, in people with hematologic malignancies at the 51st Annual Meeting of the EBMT held March 30-April 2, 2025 in Florence, Italy.

The randomized Precision-T study evaluated the safety, efficacy and tolerability of Orca-T in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL) compared to a conventional allogeneic hematopoietic stem cell transplant (alloHSCT). The Precision-T study met the protocol-specified primary endpoint of a statistically significant improvement in survival free of moderate-to-severe chronic graft versus host disease (cGvHD) with Orca-T versus alloHSCT.

Session details follow:

Oral Session: OS15 Oral Session 15 | GVHD (II)

Title: Orca-T® Demonstrates Improved Survival Free of Chronic GVHD Compared to Conventional Allogeneic Hematopoietic Stem Cell Transplant: A Randomized Phase 3 Trial in Advanced Hematologic Malignancies

Date and Time: April 2, 2025 at 10:30AM CEST

Location: Michelangelo (S-1)

“The Precision-T study marks a critical milestone in our mission to redefine the treatment landscape for patients facing aggressive blood cancers like AML, MDS and ALL, and we eagerly await the opportunity to share the results at EBMT,” said Ivan Dimov, Ph.D., co-founder and chief executive officer at Orca Bio. “We look forward to discussing the Phase 3 findings with the FDA as we advance toward our ultimate goal of bringing Orca-T to the patients who need it most.”

“The annual meeting of the EBMT is one of the largest and most prestigious international congresses for exchanging groundbreaking clinical advancements in the cell therapy space,” said Everett Meyer, M.D., Ph.D., presenting author and primary investigator, hematologist, associate professor of medicine of Blood and Marrow Transplantation and Cellular Therapy at Stanford Health Care. “I am excited and honored to present efficacy and safety data from the pivotal Phase 3 Precision-T study."

Information on two additional oral sessions accepted for presentation at EBMT follow:

Oral Session: OS03 Oral Session 3 | ATMP Preclinical and Clinical

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

Date and Time: March 31, 2025 at 2:30PM CEST

Location: Cavaniglia 2

Oral Session: OS01 Oral Session 1 | Viral Infections

Title: Differential Immune Reconstitution Profiles Between Orca-T® and CD34 Allograft Recipients Provide Insight for Control of Viral Infections

Date and Time: March 31, 2025 at 2:30PM CEST

Location: Roma (S1)

The program for the 51st Annual Meeting of the EBMT is now available at https://www.ebmt.org/annual-meeting-2025.

About Precision-T

Precision-T (NCT05316701) is a randomized, open-label multi-center study that evaluated the safety, efficacy and tolerability of Orca Bio’s lead investigational allogeneic T-cell immunotherapy, Orca-T, compared to conventional allogeneic hematopoietic stem cell transplant (alloHSCT). Orca Bio received guidance from the U.S. Food and Drug Administration on the design of Precision-T, which evaluated Orca-T in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL). There are 19 leading treatment centers participating in the trial, which enrolled 187 patients across the U.S.

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 Precision-T, 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 Bio

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer and autoimmune diseases. Our 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.

Contact:

Corporate Communications

Kelsey Grossman

Investor Relations

Joshua Murray

Orca Bio Announces Positive Results from the Pivotal Phase 3 Study of Investigational Orca-T® Compared to Allogeneic Stem Cell Transplant for the Treatment of Hematologic Malignancies

Precision-T study met the primary endpoint of a statistically significant improvement in survival free of moderate-to-severe chronic graft versus host disease (cGvHD), showing 78% with Orca-T versus 38% with conventional allogeneic stem cell transplant (alloHSCT) at one year (HR 0.26, p<0.00001)

Overall survival with Orca-T was 94% compared to 83% with alloHSCT at one year, and the cumulative incidence of moderate-to-severe cGvHD was 13% versus 44%, respectively

Orca Bio is preparing to submit these findings in a BLA to the U.S. FDA in 2025

Results will be presented at the 51st Annual Meeting of the EBMT

MENLO PARK, CA, March 17, 2025 – Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced positive results from the pivotal Phase 3 Precision-T study of Orca-T, its lead investigational allogeneic T-cell immunotherapy, in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL). Orca-T is manufactured using highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors.

In the randomized Precision-T study, Orca-T met the primary endpoint of a statistically significant improvement in survival free of moderate-to-severe chronic graft versus host disease (cGvHD) with Orca-T. At one year, the rate for patients who received Orca-T was 78% compared to 38% for patients who received a conventional allogeneic hematopoietic stem cell transplant (alloHSCT). Patients in the Orca-T group achieved an estimated overall survival (OS) of 94% compared to 83% in the alloHSCT arm at one year.

"Today, treating patients with serious blood cancers using allogeneic stem cell transplants requires a difficult risk-benefit trade-off as clinicians aim to cure the disease while avoiding potentially deadly treatment-related toxicities, like GvHD," said presenting author Everett Meyer, M.D., Ph.D., hematologist and associate professor of medicine in Blood and Marrow Transplantation and Cellular Therapy at Stanford Health Care. "The Precision-T study showed double the rate of survival free from GvHD with Orca-T versus a conventional transplant, a relapse-free survival rate of 76% and no new safety concerns. These findings are highly encouraging and provide compelling new evidence as we work to solve for the critical factors contributing to the needs of this patient population."

Precision-T Study Results

In the study, all patients (n=187) with a median age of 43.5 years (range 19-65 years) were randomized 1:1 to Orca-T plus single-agent tacrolimus (TAC) or alloHSCT plus TAC methotrexate (TAC/MTX). Patients across both groups received myeloablative conditioning (MAC) and used a related or unrelated matched donor. Patients had a median follow-up time of 11.4 months (range 0.2-24.3 months) across both arms. Key results from the Precision-T study at one year are summarized below:

The primary endpoint of survival free of cGvHD was 78% (95% CI: 65%, 87%) in the Orca-T arm (n=93) and 38% (95% CI: 26%, 51%) in the alloHSCT arm (n=94) (HR 0.26; p<0.00001).
An interim analysis of the secondary endpoint of OS was 94% (95% CI: 86%, 97%) in the Orca-T arm and 83% (95% CI: 73%, 90%) in the alloHSCT arm (HR 0.49; p=0.11823).
An additional secondary endpoint of cumulative incidence of moderate-to-severe cGvHD was 13% (95% CI: 5%, 23%) and 44% (95% CI: 31%, 56%) in the Orca-T and alloHSCT arms, respectively (HR 0.19; p<0.00002).

Exploratory endpoints at one year include the rate of relapse-free survival which was 76% and 74% in the Orca-T and alloHSCT arms, respectively (HR 0.80, p=0.49). The cumulative incidence of non-relapse mortality was 3% in the Orca-T arm and 13% in the alloHSCT arm. Additionally, the cumulative incidence of Grade 3 or 4 acute GvHD was 6% and 17% in the Orca-T and alloHSCT arms, respectively.

No new safety issues were identified with Orca-T. Grade ≥ 4 infections per CTCAE scoring were noted in 6% and 10% of patients in the Orca-T and alloHSCT arms, respectively.

Orca-T was manufactured in Orca Bio’s centralized GMP facility and delivered to patients at 19 treatment centers across the U.S., with all infusions occurring within a vein-to-vein time of 72 hours or less.

“Approximately 46,000 people are diagnosed with AML, ALL and MDS in the U.S. each year, but only a fraction of them receive an allogeneic stem cell transplant within the current paradigm,” said Rawan Faramand, M.D., Blood and Marrow Transplant and Cellular Immunotherapy, Moffitt Cancer Center. “Additional treatment options are needed, and the introduction of a cell therapy like Orca-T that leverages a precision-based approach could pave the way for a new standard of care for patients with various hematologic malignancies.”

“These exciting results underscore Orca Bio’s vision of transforming the treatment landscape for patients living with serious blood cancers, potentially standardizing curative treatment for diseases like AML, ALL and MDS,” said Ivan Dimov, Ph.D., co-founder and chief executive officer at Orca Bio. “We are working closely with the FDA and expect to submit a Biologics License Application this year. These results support the validity of our high-precision platform as we continue to advance our robust pipeline of allogeneic cell therapies for the treatment of hematologic malignancies, autoimmune diseases and beyond.”

Orca Bio is grateful to the patients and families, donors and trial site investigators who participated in the Precision-T study.

The complete results will be presented on April 2, 2025, at the 51st Annual Meeting of The EBMT in Florence, Italy.

About Precision-T

About Orca-T

Orca-T is an investigational allogeneic T-cell immunotherapy being evaluated for the treatment of multiple hematologic malignancies. Orca-T is composed 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 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.

About Orca Bio

Contact:

Corporate Communications

Kelsey Grossman

Investor Relations

Joshua Murray

Orca Bio Presents Three-Year Survival Data with Orca-T® in Patients with Hematological Malignancies at the 66th ASH Annual Meeting

Three-year overall survival with Orca-T allogeneic T-cell immunotherapy was 86% for patients with AML, ALL and MDS compared to 67% in a non-randomized historical cohort of post-transplant cyclophosphamide (PTCy)

Reduced non-relapse mortality and increased relapse-free survival seen with Orca-T compared to PTCy at one-year

In a second oral presentation, early feasibility data were presented on the combination of Orca-T and allogeneic CAR-T cells in patients with high-risk B-ALL

Orca-T is being evaluated in a pivotal Phase 3 clinical trial versus a conventional allogeneic stem cell transplant with data expected in the first half of 2025

MENLO PARK, CA, December 8, 2024 – Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today presented positive long-term data on its lead investigational allogeneic T-cell immunotherapy, Orca-T, at the 66th American Society of Hematology (ASH) Annual Meeting.

Three-Year Survival Data with Orca-T vs PTCy

The results of a three-year follow-up analysis with Orca-T plus single-agent tacrolimus (TAC) showed encouraging overall survival (OS) in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and high-risk myelodysplastic syndrome (MDS). These results also showed an improvement when compared to a historical cohort of patients receiving an allogeneic stem cell transplant (alloHSCT) with post-transplant cyclophosphamide (PTCy)-based graft versus host disease (GvHD) prophylaxis.

“With the current standard of care, physicians must carefully balance the risk of relapse with the risk of toxicities when treating patients with serious hematological malignancies, as both impact overall survival,” said presenting author Caspian Oliai, MD, medical director of the UCLA Bone Marrow Transplantation Stem Cell Processing Center. “The preliminary results with Orca-T have been promising, and now observational outcomes show sustained improvement in comparison to a similar cohort of patients who received a conventional alloHSCT with PTCy at one, two and three years. These data add to the growing body of evidence suggesting Orca-T could potentially offer an important new treatment option for patients.”

This analysis from the multicenter Phase 1b clinical trial evaluated a subset of patients (n=77) who received Orca-T with TAC. These outcomes were compared to patients from a CIBMTR literature-based cohort (n=293) who received alloHSCT with a PTCy-based GvHD prophylaxis regimen. All patients across both groups received myeloablative conditioning (MAC) and used a related or unrelated fully matched donor. These subsets of patients were selected based on disease, disease status and conditioning regimens that most closely resemble the patients enrolled in the ongoing pivotal Phase 3 clinical trial evaluating Orca-T.

The analysis included patients who had a median follow-up time of 33 months (range 5-54 months) and 24 months (range 0-53 months) in the Orca-T Phase 1b and PTCy cohorts, respectively. The OS at 12, 24 and 36 months (p=0.0021) are summarized in the table below:

	Phase 1b Orca-T plus TAC OS	AlloHSCT with PTCy OS
1 Year	96% (range 88%-99%; 95% CI)	82% (range 78%-87%; 95% CI)
2 Year	88% (range 78%-94%; 95% CI)	73% (range 68%-79%; 95% CI)
3 Year	86% (range 73-92%; 95% CI)	67% (range 61%-74%; 95% CI)

Further analyses of these patient subsets found Orca-T may reduce non-relapse mortality (NRM) and increase relapse-free survival (RFS) compared to PTCy. At one year, NRM was 1.4% in the Orca-T group and 7.4% in the PTCy cohort. The rate of RFS at one year was 83% and 71% for patients receiving Orca-T and PTCy, respectively. Results also found that age had no significant impact on OS at one year. For patients receiving Orca-T, OS was 95% (88%-100%) in patients under the age of 50 and 97% (92%-100%) in patients over the age of 50. For patients in the PTCy cohort, OS was 86% (81%-92%) in patients under the age of 50 and 77% (70%-85%) in patients over the age of 50.

Across all patients in the Phase 1b trial, Orca-T was manufactured reliably and delivered with vein-to-vein times of 72 hours or less across the U.S.

“We’re pleased to present positive long-term follow-up data for Orca-T as these findings provide valuable insight into how the cell therapy performs over extended periods of time,” said Scott McClellan, MD, PhD, chief medical officer at Orca Bio. “As we eagerly await the results of our pivotal Phase 3 clinical trial evaluating Orca-T in a similar patient population, we are one step closer to gathering the information needed for BLA submission and toward potentially making a significant difference for patients.”

Combining Orca Bio Approach with CAR-T Technology

A second oral presentation highlighted initial feasibility, safety and efficacy data from an investigator-sponsored Phase 1 clinical trial evaluating OrCAR-T, a platform that combines the Orca Bio technology with CAR-T technology. This presentation highlighted data following treatment with Orca-T and allogeneic CD19/CD22 CAR-T cells in patients with high-risk B-cell acute lymphoblastic leukemia (B-ALL).

B-ALL remains incurable for many patients despite treatment with an alloHSCT or autologous CAR-T cells, which can also lead to serious complications including GvHD, infections and CAR-related toxicities. Preliminary results for 10 patients treated with OrCAR-T who reached the primary endpoint of 42 days post-treatment showed neutrophil and platelet engraftment at 14 days. At a median follow up of 381 days (range 61-762 days, including 6 patients with >12 months of follow-up) across three dose escalation levels (1x106 CAR+ cells/kg; 2x106 CAR+ cells/kg; 3x106 CAR+ cells/kg), there were no cases of acute or chronic GvHD, no grade 3 or greater cytokine release syndrome and no neurotoxicity observed.

These early findings suggest a single treatment that combines a high-precision cell therapy like Orca-T with specific CAR-T cells has the potential to benefit patients with a range of hematologic diseases.

About Orca-T

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 Presents Clinical Results on Use of Orca-Q without GvHD Prophylaxis in Patients with Hematological Malignancies at the 66th ASH Annual Meeting

Orca Bio Presents Clinical Results on Use of Orca-Q® without GvHD Prophylaxis in Patients with Hematological Malignancies at the 66th ASH Annual Meeting

Orca-Q allogeneic T-cell immunotherapy with no GvHD prophylaxis in patients with matched donors demonstrated low rates of GvHD and non-relapse mortality

MENLO PARK, CA, December 7, 2024 – Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today presented clinical findings on the use of Orca-Q, its investigational second-generation allogeneic T-cell immunotherapy, without the use of any graft versus host disease (GvHD) prophylaxis in patients with diverse hematological conditions at the 66th American Society of Hematology (ASH) Annual Meeting.

Preliminary data from a subset of the multicenter Phase 1 clinical trial of Orca-Q in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML) and myelofibrosis (MF) showed encouraging patient outcomes without the use of GvHD prophylaxis, including low rates of GvHD, infection and non-relapse mortality (NRM) in patients with fully matched donors.

“With a conventional allogeneic stem cell transplant, patients typically receive a mix of strong immunosuppressive drugs to control GvHD. These can also lead to poor immune reconstitution and increase the risk of infections, organ damage and relapse,” said presenting author Mehrdad Abedi, MD, hematologist and professor of Medicine at UC Davis Comprehensive Cancer Center. “The possibility of achieving a cure without the need for preventative agents could expand the treatment landscape for patients with hematologic malignancies. While additional data is needed, these early findings suggest Orca-Q without GvHD prophylaxis may have the potential to transform our treatment approach.”

This analysis evaluated 14 patients enrolled in the HLA-identical donor dose expansion arm who received myeloablative conditioning (MAC) with Orca-Q and either busulfan, fludarabine and thiotepa (BFT) or total body irradiation-based conditioning (TBI). Across all patients, the median time to engraftment of neutrophils and platelets was 11 days and rates of GvHD and serious infections were low. In the subgroup of patients who received Orca-Q and BFT, there was no chronic GvHD of any grade and two cases of grade 2 acute GvHD. There were no cases of non-relapse mortality (NRM) reported across all 14 patients. Relapse-free survival (RFS) and overall survival (OS) were both 85% among all patients, and both 90% in the BFT population. GvHD-free, relapse-free survival (GRFS) was 77% and 90% across all patients and in the BFT group, respectively.

Across all patients, Orca-Q was manufactured reliably and delivered with vein-to-vein times of 72 hours or less across the U.S.

“Our team is inspired by the possibility of developing a product that could eliminate the need for GvHD prophylaxis while preserving safety and efficacy, a concept representing a significant advancement for hematology and beyond,” said Nate Fernhoff, PhD, co-founder and chief scientific officer at Orca Bio. “We are highly encouraged by these preliminary data which provide an early glimpse into the future therapeutic potential of Orca-Q.”

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

Contact:

Corporate Communications

Kelsey Grossman

Investor Relations

Joshua Murray

ir@orcabio.com

Orca Bio Announces Leadership Updates

Co-founder and Chief Scientific Officer of Orca Bio, Nate Fernhoff, Ph.D., has been appointed Chief Executive Officer

Co-founder and Chief Operating Officer of Orca Bio, Jeroen Bekaert, Ph.D., has been appointed President

Company is accelerating investment in manufacturing and commercial infrastructure in preparation for planned 2025 BLA to the U.S. FDA

MENLO PARK, CA, May 3, 2025 – Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced leadership updates including the appointment of co-founder and Chief Scientific Officer Nate Fernhoff, Ph.D., as Chief Executive Officer (CEO), succeeding Ivan Dimov, Ph.D. In addition, co-founder and Chief Operating Officer, Jeroen Bekaert, Ph.D., has assumed the role of President at Orca Bio.

“I am honored and humbled to serve as CEO as we progress toward our vision of transforming the treatment landscape for patients living with blood cancer,” said Dr. Fernhoff. “Following the positive Phase 3 results for Orca-T, we remain focused on a 2025 BLA submission and ensuring commercial readiness. In parallel, we are advancing our pipeline of groundbreaking cell therapies that leverage the same high-precision platform to potentially offer new and innovative treatments to more patients who could benefit.”

Dr. Fernhoff continued, “I’m fortunate to continue to partner with Jeroen in his new role as President where he will oversee operations across all areas of the organization. Since co-founding Orca Bio, Jeroen has played an integral part in guiding the company from its inception through multiple phases of clinical development and organizational growth.”

After reporting positive Phase 3 clinical data on its lead investigational allogeneic T-cell immunotherapy, Orca-T, Orca Bio continues to scale its U.S. manufacturing infrastructure and operations to ensure consistent and reliable delivery of its products. This includes activating new production lines in its state-of-the-art commercial manufacturing facility to increase capacity and support future demand. The company is also strengthening the commercial organization with the addition of leaders who have successful cell therapy launch expertise across commercial operations, market access and stakeholder engagement.

Nate Fernhoff, Ph.D., Co-Founder and Chief Executive Officer

Dr. Fernhoff is the CEO and co-founder of Orca Bio. In his previous role as Chief Scientific Officer, Dr. Fernhoff led the advancement of Orca Bio’s robust pipeline of high-precision cell therapies and is one of the inventors of Orca-Q, an investigational allogeneic T-cell immunotherapy for patients with high-risk blood disease. Prior to Orca Bio, Dr. Fernhoff was a Ruth L. Kirchstein National Research Service Award (NRSA) Postdoctoral Scholar in the Irving Weissman laboratory at Stanford University. He holds a Ph.D. in molecular and cell biology from the University of California, Berkeley, and bachelor’s degrees in biological sciences and mathematics from Stanford University. Dr. Fernhoff has several publications in peer-reviewed journals, as well as patents and patent applications. He currently serves on the board of the ML4 Foundation.

Jeroen Bekaert, Ph.D., Co-Founder, President and Chief Operating Officer

Dr. Bekaert is the President and co-founder of Orca Bio where he oversees the operational activities across all company functions. Before joining Orca Bio, Dr. Bekaert was the head of Merck KGaA’s innovation center in Silicon Valley, where he was responsible for shaping and onboarding science and technology opportunities from universities and emerging biotech companies across Merck KGaA’s pharma and life science sectors. Prior to this, Dr. Bekaert held a variety of positions of increasing responsibility in Johnson & Johnson’s Supply Chain group, most recently as director, worldwide engineering and technical operations, overseeing the EMEA portfolio. Dr. Bekaert started his career as a researcher at the Los Alamos National Laboratory in New Mexico. He holds a master’s and Ph.D. in computer science engineering from Ghent University. He was a Gustave Boël-Sofina Fellow and also holds a master’s degree in management from Stanford Graduate School of Business.

About Orca Bio

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of 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.

Contact:

Corporate Communications

Kelsey Grossman

Investor Relations

Joshua Murray

Orca Bio Announces Updated Orca-T Clinical Data Presented at the 2021 TCT (Transplantation & Cellular Therapy) Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT) and Center for International Blood & Marrow Transplant Research (CIBMTR)

Orca Bio Announces Updated Orca-T Clinical Data Presented at the 2021 TCT (Transplantation & Cellular Therapy) Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT) and Center for International Blood & Marrow Transplant Research (CIBMTR)

Orca-T (n=50) with single-agent graft versus host disease (GvHD) prophylaxis when compared with a cohort of patients who received a standard-of-care (SOC) hematopoietic stem cell transplant (HSCT) (n=144) and a 2-agent GvHD prophylaxis demonstrated:

Improved 1-year GvHD-free and Relapse-Free Survival (GRFS) (75% vs 31%
Decreased incidence of grade 2+ acute GvHD (aGvHD) at 100 days (10% vs 30%)
Decreased chronic GvHD (cGvHD) at 365 days (3% vs 46%)

MENLO PARK, CA, February 11, 2021 – Orca Bio, a clinical-stage biotechnology company developing high-precision investigational cell therapies, today announced updated clinical data from its first-generation investigational therapy Orca-T, which was presented at the 2021 TCT Meetings of ASTCT and CIBMTR by Everett Meyer, MD, PhD, Assistant Professor of Medicine, Blood and Marrow Transplantation at Stanford University.I

Results from multicenter (NCT04013685) and single-center (NCT01660607) phase I/II trials showed that patients receiving Orca-T (n=50) with single-agent GvHD prophylaxis demonstrated improved 1-year GvHD-free and Relapse-Free Survival (GRFS) (75% vs 31%) when compared with a cohort of patients who received a standard-of-care (SOC) hematopoietic stem cell transplant (HSCT) (n=144) and 2-agent GvHD prophylaxis.

As of the data cut-off, Orca-T plus single-agent GvHD prophylaxis was well-tolerated in the clinical trial, with a decreased incidence of grade 2+ acute GvHD (at 100 days: 10% vs 30%) and chronic GvHD (at 365 days: 3% vs 46%). The high-precision investigational cellular products continue to be successfully manufactured and scaled in a central facility and were delivered to patients at multiple clinical sites with a vein-to-vein time of less than 72 hours. The presentation can be viewed on the Orca Bio website.

“Orca-T continues its groundbreaking performance in our phase 1b clinical trial where it is under investigation to improve survival by preventing transplant-related mortality, aGvHD, and cGvHD,” said Nate Fernhoff, PhD, Chief Scientific Officer at Orca Bio.

“Orca-T continues its groundbreaking performance in our phase 1b clinical trial where it is under investigation to improve survival by preventing transplant-related mortality, aGvHD, and cGvHD."

Nate Fernhoff, PhD, Chief Scientific Officer at Orca Bio.

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.

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Joshua Murray

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