Press release

Investor Relations

Joshua Murray

ir@orcabio .com

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

Contact:

Corporate Communications

Kelsey Grossman

Investor Relations

Joshua Murray

Orca Bio to Present at the 42nd Annual J.P. Morgan Healthcare Conference

MENLO PARK, CA, Jan. 3 – 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 Ivan Dimov, Ph.D., Orca Bio’s co-founder and chief executive officer, will present at the 42nd Annual J.P. Morgan Healthcare Conference.

The company presentation will take place on Monday, January 8, 2024, at 2:00PM PST at the Westin St. Francis in the Golden Gate Room on the 32nd floor.

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

ir@orcabio .com

Orca Bio to Present Positive Clinical Outcomes with Orca-T in Patients with AML at 2024 ASCO Annual Meeting

Relapse-free survival and overall survival were 82.5% and 100% at 12 months, respectively, in 37 patients with AML, an aggressive form of blood cancer

Non-relapse mortality at 12 months was 0%

Orca-T is currently being evaluated in a pivotal Phase 3 clinical trial at leading treatment centers across the U.S.

MENLO PARK, CA, May 23, 2024 – Orca Bio, a biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced it will present new data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, from May 31–June 4. The presentation will highlight outcomes of its lead investigational allogeneic T-cell immunotherapy, Orca-T, in patients with acute myeloid leukemia (AML).

AML is an aggressive form of blood cancer and the most common acute leukemia in adults. There are an estimated 20,800 new diagnoses and nearly 11,200 deaths in the U.S. each year.

“Today, only a fraction of adults diagnosed with AML undergo curative treatment with standard of care allogeneic hematopoietic stem cell transplant due to the serious and life-threatening risks often associated with it,” said Rawan Faramand, M.D., assistant member of Blood and Marrow Transplant and Cellular Immunotherapy at Moffitt Cancer Center. “These new findings suggest Orca-T has the potential to offer a cure with low rates of treatment-related mortality, and could provide an important option for patients with AML. With its goal of alleviating the tradeoff between the risk of relapse and the risk of toxicities observed with standard of care stem cell transplant, this novel approach has the potential to expand curative treatment to many more patients.”

A new subanalysis from the ongoing multi-center Phase 1b single-arm trial evaluated outcomes with Orca-T among a subgroup of 37 patients with AML who had a median age of 51 years and median follow-up of 14 months. All patients received myeloablative conditioning (MAC) with busulfan, fludarabine and thiotepa (BFT), followed by Orca-T and single-agent graft versus host disease (GvHD) prophylaxis with tacrolimus. At 12 months, results found relapse-free survival was 82.5% (95% CI: 65.0, 91.7) and non-relapse mortality was 0%. Overall survival was 100% (95% CI: 100, 100) at 12 months. The safety profile of Orca-T in this subgroup was consistent with the larger Phase 1b population with no new safety signals identified. Across all patients, 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 at ASCO for the first time and share the latest findings that support the potential for Orca-T to offer a curative solution and fulfill a significant unmet need for patients with AML,” said Scott McClellan, M.D., Ph.D., chief medical officer at Orca Bio. “These data continue to advance our mission of expanding potentially life-saving treatment to patients and their providers who face limited viable options today.”

Details of the Orca Bio presentation follow:

Title: Treatment of Acute Myeloid Leukemia with Orca-T

Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Abstract Number: 6552

Poster Code: 111

Date and Time: June 3, 2024, from 9AM - 12PM CDT

Location: Oncology Professionals Hall

The ASCO abstracts are available at https://conferences.asco.org/am/abstracts.

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 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 X: @OrcaBio.

Contact:

Corporate Communications

Kelsey Grossman

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

ir@orcabio .com

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 Announces Completion of Patient Enrollment for the Precision-T Phase 3 Study of Orca-T

Precision-T over-enrolled with 187 total patients at 19 clinical trial sites across the U.S.

Topline results expected in 1H 2025

MENLO PARK, CA, June 5, 2024 – Orca Bio, a biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced that it has completed enrollment in the pivotal Precision-T Phase 3 clinical study.

A randomized, open-label multicenter study, Precision-T (NCT05316701) is evaluating the safety and efficacy of Orca Bio’s lead investigational allogeneic T-cell immunotherapy, Orca-T, compared to a standard of care allogeneic hematopoietic stem cell transplant (alloHSCT) in patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and high-risk myelodysplastic syndrome (MDS). Orca-T is a donor-derived product designed to replace a patient’s diseased blood and immune system with a healthy one.

“Completing enrollment in our multicenter Phase 3 study of Orca-T is an important milestone toward our ultimate goal of delivering a potentially life-saving product to patients who have long had to settle for a standard of care that carries significant risks,” said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio. “We’re immensely grateful to the patients, their families and the trial site investigators who participated in our study, and look forward to sharing pivotal data in the near future with the broader blood cancer community.”

The primary endpoint of the Precision-T study is the rate of survival free from moderate-to-severe chronic graft versus host disease (GvHD). Secondary endpoints include time to moderate-to-severe chronic GvHD, graft-versus-host-disease and relapse-free survival (GRFS) and overall survival. Topline results from the study are expected in the first half of 2025. The study has enrolled 187 patients, exceeding the original target of 174 patients.

Orca-T is designed to deliver improved outcomes for patients while overcoming the limitations of standard alloHSCT, which carries the risk of serious complications and treatment-related mortality. Orca-T uses highly purified regulatory T cells with the goal of reducing the tradeoff between the risk of relapse and the risk of serious toxicity, a primary objective of the cell therapy field. Orca-T has demonstrated promising results in early single-arm trials which were recently presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting the Annual Meeting of the EBMT, the 2024 Tandem Meetings of ASTCT® and CIBMTR® and the American Society of Hematology (ASH) Annual Meeting.

More information about the Precision-T study can be found at www.precisiontstudy.com or www.clinicaltrials.gov.

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 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 X: @OrcaBio.

Contact:

Corporate Communications

Kelsey Grossman

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