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Investor Relations

Joshua Murray

Orca Bio Presents Positive Data Demonstrating the Potential for Orca-T and Orca-Q to Expand Treatment to Additional Patient Groups at the 65th ASH Annual Meeting

Orca-T, Orca Bio’s lead investigational high-precision cell therapy, showed similar results in older patients undergoing myeloablative conditioning as seen in younger patients across disease control, non-relapse mortality and overall survival

Orca-T in older patients given a reduced intensity conditioning regimen demonstrated curative potential with no incidence of relapse and encouraging relapse-free survival

Orca-T showed positive results in patients with intermediate to high-risk myelodysplastic syndrome

Orca-Q, Orca Bio’s second investigational high-precision cell therapy, showed encouraging data in graft-versus-host-disease-free and relapse-free survival in patients with a haploidentical donor without the use of post-transplant cyclophosphamide

MENLO PARK, CA, Dec. 9, 2023 – 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 positive new data that suggest its investigational high-precision cell therapies, Orca-T and Orca-Q, have the potential to deliver improved clinical outcomes across different age ranges, donor types and conditioning regimens relative to existing standard of care allogeneic hematopoietic stem cell transplants (alloHSCT). The results presented at the 65th American Society of Hematology (ASH) Annual Meeting showed promising data with the use of Orca Bio’s cell therapies across several patient groups where there is significant unmet medical need.

Orca-T in Older Patients with Myeloablative Conditioning

Results highlighted in an oral presentation showed Orca-T’s ability to deliver similar outcomes in older patients undergoing myeloablative conditioning (MAC) as younger patients. Notably, Orca-T delivered similar results across disease control, non-relapse mortality (NRM) and overall survival (OS).

“While the use of MAC offers the best chance of a cure, it also increases life-threatening complications in older patients receiving standard of care alloHSCT,” said presenting author Caspian Oliai, M.D., medical director of the UCLA Bone Marrow Transplantation Stem Cell Processing Center. “These latest findings suggest a cell therapy like Orca-T, which has the potential to offer a cure while reducing toxicity and lowering treatment-related mortality, may allow older patients to better tolerate MAC. This approach could expand curative treatment to older patients who might not be offered a MAC regimen today, and potentially provide physicians with an important new option in our ongoing efforts to balance the risk of relapse with transplant-related side effects.”

In a subgroup analysis, 64 patients from Orca Bio’s ongoing multi-center Phase 1b clinical trial who received Orca-T and busulfan, fludarabine and thiotepa (BFT) conditioning for the treatment of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), mixed phenotype leukemia, chronic myeloid leukemia (CML) and myelodysplastic syndromes (MDS) were divided into two age groups: 18-54 years of age (n=39), and 55 years of age and older (n=25). With a median follow-up of 12 months, the following outcomes were reported:

Relapse-free survival (RFS) was 84.8% in younger patients and 82.3% in older patients.
NRM was 0% in both groups.
OS was 100% and 95.5% in the younger and older patient groups, respectively.
Events of grade 3-4 acute graft versus host disease (GvHD) and moderate-to-severe chronic GvHD were low across the younger group (0 and 3, respectively) and older group (1 and 3, respectively).

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

Orca-T in Older Patients with Reduced Intensity Conditioning

Additional data from a single-center open-label Phase 1 clinical trial presented at ASH looked at the outcomes of older patients treated with Orca-T and a reduced intensity conditioning (RIC). These patients were found to be unfit for a MAC regimen due to the significant risks associated with it, particularly in older age. At 12 months, patients treated with a RIC Orca-T (n=15) saw no observable compromise in curative outcomes, with no patients experiencing relapse (0%). Patients also saw encouraging RFS (79%) and a low incidence of both grade 3-4 acute and chronic GvHD (0% and 7%, respectively).

Collectively, these findings support the potential for Orca-T to treat older patients with hematological malignancies, whether they are given a MAC or RIC regimen, with no new safety signals reported.

Orca-T in Patients with MDS

New data was also presented on the performance of Orca-T in patients with intermediate to high-risk MDS. Current treatments for MDS aren’t often curative, and many patients relapse or become resistant to first-line treatment. There remains an unmet need for new, more effective but tolerable strategies to manage MDS.

In this subgroup from the ongoing multi-center Phase 1b clinical trial, Orca-T demonstrated promising results in this patient population (n=16). At one year, RFS with Orca-T was 94%. No patients experienced grade 3-4 acute GvHD, and moderate-to-severe chronic GvHD occurred in two patients. The rates of NRM and OS with Orca-T were 0% and 94%, respectively.

Orca-T is currently being evaluated in a pivotal Phase 3 clinical study for the treatment of AML, ALL and MDS at leading transplant centers across the U.S.

Orca-Q for Patients with Haploidentical Donors

In an oral presentation, Orca Bio shared updated data from a multi-center Phase 1 clinical trial of its second high-precision cell therapy, Orca-Q, in patients with a haploidentical donor without the use of post-transplant cyclophosphamide (PTCy).

“Orca-Q is a first-in-class therapy that has the potential to improve patient outcomes and reduce the risk of graft versus host disease without the use of PTCy,” said presenting author Samer Srour, M.D., M.S., Department of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center. “While PTCy has increased the use of haploidentical HSCTs, it can bring a myriad of risks and toxicities that we didn’t experience with Orca-Q. These updated results in an expanded group of patients continue to support Orca-Q’s promise to overcome the challenges of haploidentical stem cell transplant by providing a solution where patients and physicians may no longer have to compromise between the risk of relapse and the risk of GvHD.”

The positive outcomes from an expanded group of 33 patients with AML, ALL and CML support Orca-Q as a potential treatment option for patients with a haploidentical donor. With a median of 375 days follow-up, updated safety and efficacy data include:

No patients experienced moderate-to-severe chronic GvHD (0%).
There was one event of grade 3 acute GvHD and no grade 4 acute GvHD.
NRM was 9%.
RFS, GRFS and OS at one year were 82%.

Additionally, no new safety signals were identified. The estimated incidence of CTCAE grade 2 and greater than grade 3 infections at one year were 9% and 15%, respectively.

“At Orca Bio, we understand the challenges providers face in achieving the right balance in offering blood cancer patients the best option for a cure with optimal quality of life,” said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio. “We are pleased to present these latest findings at ASH that add to our growing body of clinical evidence which underscore the potential of our novel high-precision platform to expand potentially life-saving treatment to more patient groups who could benefit.”

The full ASH presentations will be made available on www.orcabio.com.

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-Q

Orca-Q is an investigational high-precision allogeneic cell therapy being evaluated in clinical trials for the treatment of hematologic malignancies 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. Orca-Q has the potential to improve patient outcomes and reduce the risks of toxicities without the use of post-transplant cyclophosphamide (PTCy) in patients unable to identify a full human leukocyte antigen (HLA) match.

About Orca Bio

Contact:

Corporate Communications

Kelsey Grossman

Investor Relations

Joshua Murray

Orca Bio to Present Positive Clinical Data on its Novel High-Precision Cell Therapies at the 65th American Society of Hematology Annual Meeting

The first oral presentation will demonstrate the performance of Orca-T in patients over 55 years of age compared with younger patients

A second oral presentation will highlight Orca-Q, Orca Bio’s high-precision cell therapy for patients with haploidentical donors

Additional poster presentations include outcomes in patients with high-risk myelodysplastic syndrome treated with Orca-T and results of Orca-T in patients undergoing reduced intensity conditioning

MENLO PARK, CA, November 2, 2023 – 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 that new data will be presented at the American Society of Hematology (ASH) Annual Meeting from December 9-12 in San Diego, CA. Specifically, an oral presentation will highlight the outcomes of myeloablative Orca-T, Orca Bio’s lead investigational high-precision cell therapy, in patients over the age of 55. A second oral presentation will share updated results in an expanded group of patients with haploidentical donors treated with Orca Bio’s second investigational high-precision cell therapy, Orca-Q.

Orca Bio will also present two posters highlighting the results of patients with high-risk myelodysplastic syndrome who were treated with Orca-T, and the outcomes of patients treated with Orca-T who received reduced intensity conditioning.

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

Oral Session: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment and Acute Toxicities: Optimizing Conditioning Regimens for Lymphoid Malignancies and Fanconi Anemia

Title: Optimizing Outcomes with Myeloablative Conditioning in Older Patients: Efficacy and Safety of Precision Engineered Orca-T in Patients > 55 Years Old with Hematologic Malignancies

Abstract Number: 230

Date and Time: Saturday, December 9, 2023 at 2:15 PM PT

Location: Marriott Marquis, Marriott Grand Ballroom 5-6

Oral Session: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Novel Approaches to Enhance Cellular Therapies and Immune Responses in Leukemias and Lymphomas

Title: Safety and Efficacy of Orca-Q with Haploidentical Donors for the Treatment of Advanced Hematologic Malignancies Without the Use of Post-Transplant Cyclophosphamide

Abstract Number: 773

Date and Time: Monday, December 11, 2023 at 11:30 AM PT

Location: San Diego Convention Center, Room 6CF

Poster Session: 732. Allogeneic Transplantation: Disease Response and Comparative Treatment Studies

Title: High Disease-Free Survival in Patients with High-Risk MDS Treated with Orca-T

Abstract Number: 2230

Date and Time: Saturday, December 9, 2023 at 5:30 PM PT

Location: San Diego Convention Center, Halls G-H

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

Title: Phase 1 Trial Results for Patients with Advanced Hematologic Malignancies Undergoing Reduced Intensity Allogeneic HCT with Orca-T Donor Cell Therapy Product and Single Agent Tacrolimus

Abstract Number: 3560

Date and Time: Sunday, December 10, 2023 at 6:00 PM PT

Location: San Diego Convention Center, Halls G-H

About Orca-T

Orca-T is an investigational high-precision allogeneic cell therapy for the treatment of multiple hematological 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-Q

Orca-Q is an investigational high-precision allogeneic cell therapy designed to treat hematological malignancies 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. Orca-Q has the potential to improve patient outcomes and reduce the risks of toxicities without the use of post-transplant cyclophosphamide (PTCy) in patients unable to identify a full human leukocyte antigen (HLA) match.

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

Orca Bio Presents Positive Data Reinforcing Clinical Profile of Orca-T and Orca-Q at 2023 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR

Three oral presentations showcase clinical evidence for Orca Bio’s promising pipeline of early- and late-stage high-precision cell therapies

Orca-T demonstrated high relapse-free survival in recipients with fully matched donors and early potential in patients with mismatched donors

Orca-Q showed improved graft-versus-host disease-free, relapse-free survival in patients with haploidentical donors

MENLO PARK, CA, February 16, 2023 – 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 data from the company’s investigational high-precision cell therapy programs, Orca-T and Orca-Q, were presented in three oral presentations at the 2023 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR.

Positive data on Orca-T was presented from the single-center Phase 2 and multi-center Phase 1b trials of patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndromes (MDS) and other hematological malignancies. Outcomes with Orca-T appeared to be further enhanced in patients who received a conditioning regimen of busulfan, fludarabine and thiotepa (BFT). At 12 months, the 71 patients in the Orca-T BFT subgroup reported no non-relapse mortality (0%), and high rates of relapse-free survival (87%), graft-versus-host disease-free, relapse-free survival (GRFS) (81%) and overall survival (94%). These data were previously presented at the 64th American Society of Hematology (ASH) Annual Meeting in December 2022.

In a second oral presentation, new data highlighted how expanding the donor pool may help address disparities in access to transplant. Today, approximately 70% of blood cancer patients do not have access to a fully matched related donor, and the likelihood of a patient finding a matched unrelated donor in the U.S. is as low as 29% for some ethnic backgrounds. While the use of human leukocyte antigen (HLA) mismatched donors has increased access to treatment for these patients undergoing allogeneic hematopoietic stem cell transplant (alloHSCT), clinical outcomes have also been associated with significantly worse overall survival, disease-free survival, treatment-related mortality and acute graft versus host disease (aGvHD). In a small cohort (n=8), Orca-T demonstrated promising results in patients with HLA mismatched (7/8) donors, including no cases of severe GvHD or non-relapse mortality and 100% overall survival to date. While this early data is encouraging, more studies of Orca-T in this patient population are ongoing and will provide additional clinical data in this setting.

"As we continue to enroll patients in our pivotal Phase 3 trial of Orca-T, we are extremely encouraged by its continued potential to improve relapse-free and overall survival rates,” said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio. “Beyond its promise to enhance outcomes and reduce deadly, transplant-related risks, this early evidence that Orca-T may improve clinical outcomes in patients who can’t find a fully matched donor is an important step toward our ultimate goal of offering a safe and effective treatment to all patients who may benefit.”

Orca Bio also presented findings from a Phase 1 multi-center trial of its second investigational cell therapy, Orca-Q, showing that patients with haploidentical – or half-matched – allogeneic hematopoietic stem cell donors, experienced no moderate-to-severe chronic GvHD (0%) and an improved GRFS rate (75%). Orca-Q is a proprietary composition of enriched CD34+ stem cells combined with specific T cell subsets derived from haploidentical donors. Unlike standard of care haploidentical alloHSCT, Orca-Q does not require post-transplant cyclophosphamide (PTCy). These data were also previously presented at the ASH Annual Meeting.

“A haploidentical stem cell transplant is currently the only curative treatment option available for the majority of blood cancer patients who lack a matched donor, but providers often find themselves balancing the risk of relapse and the risk of debilitating side effects like GvHD, infections and other toxicities,” said Samer Srour, M.D., Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center. “These interim findings show patients treated with Orca-Q experienced improved outcomes with significantly fewer transplant-related toxicities, suggesting this novel cell therapy could help to address this critical unmet medical need.”

Links to the abstracts follow:

Oral Presentation Title: Precision-Engineered Cell Therapy Orca-T Demonstrates High Relapse-Free Survival at 1 Year While Reducing Graft-Versus-Host Disease and Toxicity

Oral Presentation Title: Orca-T, a High-Precision Cell Therapy, for the Treatment of Hematologic Malignancies in Patients with 7/8 Mismatch Donors

Oral Presentation Title: Orca-Q Demonstrates Favorable GvHD-and-Relapse-Free Survival with Haploidentical Donors without Post-Transplant Cyclophosphamide

Poster Presentation Title: Estimating the Current and Future Costs and Health Outcomes of Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HCT)

About Orca-T

Orca-T is an investigational high-precision allogeneic cell 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 hematological malignancies.

About Orca-Q

Orca-Q is Orca Bio’s second investigational high-precision allogeneic cell therapy to enter clinical development for hematological malignancies. Orca-Q is a proprietary composition of enriched CD34+ stem cells combined with specific T cell subsets derived from haploidentical donors that are purified through Orca Bio’s high-precision platform. Orca-Q is a therapy that has the potential to improve patient outcomes and reduce the risks of graft versus host disease, without the use of post-transplant cyclophosphamide (PTCy) in patients for whom a full human leukocyte antigen (HLA) match cannot be found.

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 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 41st Annual J.P. Morgan Healthcare Conference

MENLO PARK, CA, Jan. 6, 2023 – 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 that Ivan Dimov, Ph.D., Orca Bio’s co-founder and chief executive officer, will present at the 41st Annual J.P. Morgan Healthcare Conference.

The company presentation will take place on Monday, January 9, 2023, at 7:30 AM PST at the Westin St. Francis in the Mission Bay Room on the 32nd floor.

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 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

Investor Relations

Joshua Murray

Orca Bio Presents Encouraging Interim Clinical Data on Orca-Q in Haploidentical Allogeneic Hematopoietic Stem Cell Transplants at 64th ASH Annual Meeting

Orca Bio Presents Encouraging Interim Clinical Data on Orca-Q in Haploidentical Allogeneic Hematopoietic Stem Cell Transplants at 64th Annual ASH Meeting

Orca-Q is Orca Bio's investigational high-precision cell therapy designed to overcome the challenges of haploidentical allogeneic hematopoietic stem cell transplant (alloHSCT)

Interim multi-center Phase 1 clinical trial results show that Orca-Q improved graft-versus-host disease-free, relapse-free survival in haploidentical alloHSCT compared to standard of care, without the use of post-transplant cyclophosphamide

MENLO PARK, CA, Dec. 12, 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 that interim clinical data from its Phase 1 multi-center trial of its second investigational cell therapy, Orca-Q, were unveiled in an oral presentation at the 64^th American Society of Hematology (ASH) Annual Meeting.

The data from the ongoing clinical trial show that Orca-Q reduced the incidence and severity of graft versus host disease (GvHD) and improved graft-versus-host disease-free, relapse-free survival (GRFS) rates in 26 patients matched to haploidentical allogeneic hematopoietic stem cell donors. Unlike standard of care haploidentical allogeneic stem cell transplant (alloHSCT), Orca-Q does not require post-transplant cyclophosphamide (PTCy).

“Patients and transplant physicians are in urgent need of a novel treatment option that improves the chances of survival and the quality of that survival. This is the key limitation of haploidentical transplant, which is currently the only treatment option for the vast majority of blood cancer patients in need of a transplant,” said Amandeep Salhotra, M.D., associate professor, Division of Leukemia, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope. “These results suggest Orca-Q’s promise to overcome this serious challenge by offering a novel investigational high-precision cell therapy with the potential to significantly improve patient outcomes and reduce serious transplant-related risks.”

Orca-Q is an investigational high-precision cell therapy that is a proprietary composition of enriched CD34+ stem cells combined with specific T cell subsets. The findings presented at ASH are from patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndromes (MDS) and chronic myeloid leukemia (CML) who were matched to haploidentical allogeneic donors, defined as matched across at least 4/8 but fewer than 7/8 human leukocyte antigen (HLA) loci. Historical controls from the literature of patients who received standard of care haploidentical alloHSCT with PTCy GvHD prophylaxis were used for comparison purposes^1,2,3,4.

Interim results from the Phase 1 single-arm, open-label trial showed:

A reduction of grade 2-4 acute GvHD (aGvHD) at 6 months as compared to literature controls (13% vs 21-63%), with only one patient developing grade 3 aGvHD and no incidence of grade 4 aGvHD.

No patients experienced moderate-to-severe chronic GvHD (cGvHD), compared to 24%-33% in the literature control. There was only one case of mild cGvHD.
GRFS was 75% at one year after Orca-Q, which compares favorably to a GRFS of 46% in patients in the literature control.

Patients treated with Orca-Q also experienced a low adverse event profile, suggesting Orca-Q has the potential to offer a new treatment option for patients undergoing haploidentical alloHSCT.

Today, approximately 70% of blood cancer patients do not have access to a fully matched related donor. Haploidentical transplant, which uses healthy, blood-forming cells from a partially matched donor to replace the unhealthy ones, is one of the few treatment options currently available to those without a fully matched donor. However, its use remains significantly limited because of the conditioning regimens that are required. Haploidentical transplant patients receiving higher intensity myeloablative conditioning treatments have a higher risk of cGvHD post-transplant, while patients receiving lower intensity pre-transplant conditioning have a greater risk of relapse.

“These interim results from our second clinical program demonstrate Orca-Q’s potential to overcome the challenges of haploidentical alloHSCT by providing a solution with which patients and physicians may no longer have to compromise between the risk of relapse and the risk of GvHD,” said Scott McClellan, M.D., Ph.D., chief medical officer of Orca Bio. “This novel approach, along with our growing body of clinical evidence demonstrating Orca-T’s improved GvHD and relapse-free survival rates in patients with HLA-matched donors, underscore the potential of our high-precision platforms to deliver cell therapies that can greatly expand the number of patients who receive life-saving treatment, whether their donor is a full or partial match.”

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

About Orca-Q

Orca-Q is Orca Bio's second investigational high-precision allogeneic cellular therapy to enter clinical development for hematological malignancies. Orca-Q is a proprietary composition of enriched CD34+ stem cells combined with specific T cell subsets derived from haploidentical—or partially matched—donors that are purified through Orca Bio's high-precision platform. Orca-Q is a first-in-class therapy that has the potential to improve patient outcomes and reduce the risks of graft versus host disease, without the use of post-transplant cyclophosphamide (PTCy) in patients for whom a full human leukocyte antigen (HLA) match cannot be found.

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 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 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.

1 Gooptu, M, et al. Blood. 2021; 138 (3): 273–282.

2 Sanz, J, et al. J Hematol Oncol. 2020; 13:46.

3 Baker, M, et al. Biol Blood Marrow Transplant. 2016; 22; 2047-2055.

4 Sanz, J, et al. J Hematol Oncol. 2020; 13:46.

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Corporate Communications

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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

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 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

Investor Relations

Joshua Murray

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

Orca Bio to Present Four Abstracts at the 64th American Society of Hematology Annual Meeting, Including Updated Relapse-Free Survival Data with Orca-T and the First Clinical Data for Orca-Q

Oral presentation to highlight impressive results with Orca-T on relapse-free survival (RFS) at one year in the Phase 1b/2 clinical trials

Oral presentation will detail first data readout of Orca-Q in haploidentical allogeneic transplant demonstrating favorable graft-versus-host disease and relapse-free survival (GRFS) at one year in patients with hematologic malignancies

Poster presentation will demonstrate the mechanism of action of Orca-T for blood and immune reconstitution

Poster presentation to show the health economic benefit to the US healthcare system of doubling the number of patients able to achieve GRFS

MENLO PARK, CA, November 3, 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 that new clinical data will be presented at the American Society of Hematology (ASH) Annual Meeting from December 10-13. Specifically, an oral presentation will include new data on relapse-free survival with Orca Bio’s lead investigational high-precision cell therapy, Orca-T. Additionally, results from Orca Bio’s Phase 1 clinical trial of its second investigational cell therapy, Orca-Q, in patients with haploidentical donors will be presented for the first time in an oral presentation.

Orca Bio will also share two poster presentations featuring data on immune reconstitution and elevated regulatory T cell frequencies in patients treated with Orca-T, as well as an analysis of the cost burden of allogeneic hematopoietic cell transplants and the potential value of addressing this unmet need.

Oral presentations:

Title: Precision-Engineered Cell Therapy Orca-T Demonstrates High Relapse-Free Survival at 1 Year While Reducing Graft-Versus-Host Disease and Toxicity

Abstract Number: 265
Date and time: Saturday, December 10, 2022, at 2 p.m. CST
Location: 391-392, Ernest N. Morial Convention Center

Presenter: Everett Meyer, M.D., Ph.D., Associate Professor of Medicine, Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford Health Care

Title: Orca-Q Demonstrates Favorable GvHD-and Relapse-Free Survival in Haploidentical Transplants without Post-Transplant Cyclophosphamide
Abstract Number: 769

Date and time: Monday, December 12, 2022, at 10:30 a.m. CST
Location: 252-254, Ernest N. Morial Convention Center

Presenter: Amandeep Salhotra, M.D., Associate Professor, Division of Leukemia, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope

Poster Presentations:

Title: Rapid Immune Reconstitution and Elevated Regulatory T Cell Frequencies in Patients Treated with Orca-T
Abstract Number: 3408

Date and time: Sunday, December 11, 2022, from 6 p.m. – 8 p.m. CST
Location: Hall D, Ernest N. Morial Convention Center

Title: Estimating the Lifetime Medical Cost Burden of an Allogeneic Hematopoietic Cell Transplantation Patient and the Value of Addressing the Unmet Need
Abstract Number: 4865
Date and time: Monday, December 12, 2022, from 6 p.m. – 8 p.m. CST
Location: Hall D, Ernest N. Morial Convention Center

About Orca-T

About Orca-Q

Orca-Q is an investigational allogeneic cellular therapy consisting of a single infusion containing a proprietary composition of stem and immune cells derived from peripheral blood from either related or unrelated matched, unmatched or haploidentical donors. Orca-Q is currently being studied to treat multiple hematologic malignancies in alternative donor settings, with and without GvHD prophylaxis.

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.

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Joshua Murray