Orca Bio Announces FDA Review Extension of BLA for Orca-T for the Treatment of Hematologic Malignancies

Press release

Menlo Park, CA

April 1, 2026

Orca Bio Announces FDA Review Extension of BLA for Orca-T for the Treatment of Hematologic Malignancies 

New PDUFA Target Action Date of July 6, 2026 allows FDA additional time to complete its review 

MENLO PARK, CA, April 1, 2026 – Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline of its Biologics License Application (BLA) for Orca-T for the treatment of patients with hematologic malignancies. The new Prescription Drug User Fee Act (PDUFA) target action date is July 6, 2026. 

 

The extension follows Orca Bio's recent submission of updated chemistry, manufacturing and controls (CMC) information in response to requests from the FDA as part of the standard review process. The FDA classified the submission as a Major Amendment (MA) to the BLA, which extends the review by three months. Importantly, the FDA has not requested any additional clinical data. Orca Bio believes that the updated information submitted in the amendment does not affect the benefit-risk conclusions of the BLA. 

 

"We appreciate the frequent engagement with the FDA throughout the review process,” said Nate Fernhoff, co-founder and chief executive officer at Orca Bio. “Our continued focus is on preparing for the potential approval and commercial launch of Orca-T. We remain committed to working with the Agency, physicians and the broader blood cancer community to deliver this important therapy to patients with hematologic malignancies as quickly as possible.”  

 

The BLA for Orca-T was granted Priority Review by the FDA and Orca-T previously received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation. 

About Orca-T

Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified hematopoietic stem cells, regulatory T-cells and conventional T-cells derived from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration (FDA).  

About Orca Bio

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of blood cancer and autoimmune diseases. The company’s manufacturing platform uses single-cell precision to create personalized cell therapy products intended to replace a patient’s diseased blood and immune system with a healthy one. At Orca Bio, we are on a mission to redefine what’s possible for patients by transforming the field of curative allogeneic cell therapy. For more information, visit www.orcabio.com.  

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

Contact:

Corporate Communications

Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com

Visit our newsroom
Orca Bio to Present Clinical Data on Its Pipeline of High-Precision Cell Therapies at the 52nd Annual Meeting of the EBMT

Press release

Menlo Park, CA

March 2, 2026

Orca Bio to Present Clinical Data on Its Pipeline of High-Precision Cell Therapies at the 52nd Annual Meeting of the EBMT 

Patient reported outcomes with Orca-T® from the pivotal Precision-T Phase 3 study will be presented including quality of life and rates of rehospitalizations compared to conventional alloHSCT 
Data evaluating the use of Orca-T with reduced intensity conditioning versus PTCy for the treatment of hematologic malignancies will be shared  
Additional presentations will highlight the manufacturing and nationwide distribution data reported on Orca–T and clinical findings of Orca-Q® in patients with haploidentical donors 

MENLO PARK, CA, March 2, 2026 – Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced that clinical data will be presented in seven oral and poster sessions at the 52nd Annual Meeting of the EBMT from March 22-25 in Madrid. 

 

The encore presentations will include data on the company's pipeline of investigational allogeneic T-cell immunotherapies for the treatment of multiple hematologic malignancies, including Orca-T and Orca-Q. 

 

“Our participation at this year’s meeting of the EBMT provides an important opportunity to engage directly with the global transplant community as we continue our shared efforts to advance the field of allogeneic stem cell transplant,” said Nate Fernhoff, Ph.D., co-founder and chief executive officer of Orca Bio. “As we progress toward the potential FDA approval of Orca-T, the strength and consistency of our data reinforce our commitment to delivering a new therapy for patients with blood cancer. We look forward to being in Madrid to connect with clinicians and partners from around the world and to participate in scientific exchange focused on improving patient outcomes.” 

 

The EBMT abstracts are now available at www.ebmt.org/annual-meeting-2026. Details of the Orca Bio presentations follow: 

 

Oral Session: OS14 | Graft Manipulation and Conditioning   

Title: Orca-T Demonstrates Favorable Quality of Life and Healthcare Resource Use Compared to Standard AlloHSCT plus Tac/MTX for GVHD Prevention in a Randomized Phase 3 Clinical Trial (Precision-T) 

Date and Time: Wednesday, March 25 at 08:30 AM – 08:39 AM CET 

Location: N107 

 

Oral Session: OS14 | Graft Manipulation and Conditioning   

Title: Clinical Outcomes in Orca-T and Registry-Based Post-Transplant Cyclophosphamide Patients: An Observational Comparison 

Date and Time: Wednesday, March 25 at 08:39 AM – 08:48 AM CET 

Location: N107 

 

Oral Session: OS12 | Acute GVHD - Clinical 

Title: Cost-Effectiveness of Orca-T vs Allo-HCT with Conventional GVHD Prophylaxis for the Treatment of Advanced Hematologic Malignancies in the United States 

Date and Time: Tuesday, March 24 at 2:39 PM – 2:48 PM CET 

Location: N101-102 

 

Poster Session: A 

Title: Interim Clinical Outcomes in Orca-T with Reduced Intensity Conditioning: An Observational Comparison to Registry-Based Post-Transplant Cyclophosphamide Patients 

 Presentation ID: A038 

Date and Time: Monday, March 23 at 6:00 PM – 7:00 PM CET 

Location: Pavilion 9 

 

Poster Session: A 

Title: Scalable Manufacturing and Nationwide Distribution of Orca-T: A Precision-Engineered Allogeneic Immune Cell Therapy 

 Presentation ID: A145 

Date and Time: Monday, March 23 at 6:00 PM – 7:00 PM CET 

Location: Pavilion 9 

 

Poster Session: A 

Title: Preliminary Safety and Efficacy of Myeloablative Orca-Q in Patients with Haploidentical Donors 

 Presentation ID: A043 

Date and Time: Monday, March 23 at 6:00 PM – 7:00 PM CET 

Location: Pavilion 9 

 

Poster Session: A 

Title: Clinical Outcomes in Myelodysplastic Syndrome Patients Treated with Orca-T or Post-Transplant Cyclophosphamide Patients: A Registry-Based Comparison 

 Presentation ID: A085 

Date and Time: Monday, March 23 at 6:00 PM – 7:00 PM CET 

Location: Pavilion 9 

About Orca-T

Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration (FDA). The Biologics License Application (BLA) for Orca-T is currently under Priority Review with the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of April 6, 2026.   

About Orca-Q

Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies, including in patients with haploidentical and mismatched donors. Orca-Q is a proprietary composition of stem cells combined with specific T-cell subsets derived from healthy donors and engineered by Orca Bio’s high-precision platform.  

About Orca Bio

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of blood cancer and autoimmune diseases. The company’s manufacturing platform uses single-cell precision to create personalized cell therapy products intended to replace a patient’s diseased blood and immune system with a healthy one. At Orca Bio, we are on a mission to redefine what’s possible for patients by transforming the field of curative allogeneic cell therapy. For more information, visit www.orcabio.com.  

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

Contact:

Corporate Communications

Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com

Visit our newsroom
Orca Bio Presents New Data at the 2026 Tandem Meetings of ASTCT® and CIBMTR® Reinforcing Orca-T® as a Durable, High-Precision Cell Therapy for Hematological Malignancies

Press release

Menlo Park, CA

February 5, 2026

Orca Bio Presents New Data at the 2026 Tandem Meetings of ASTCT® and CIBMTR® Reinforcing Orca-T® as a Durable, High-Precision Cell Therapy for Hematological Malignancies 

New retrospective analysis showed Orca-T with reduced intensity conditioning (RIC) demonstrated favorable OS, RFS and GRFS compared to PTCy  
Company announced first patients dosed in the Phase 2 SERENE-T study evaluating Orca-T with RIC 
Orca-T demonstrated superior OS and RFS with reduced non-relapse mortality in patients with myelodysplastic syndromes compared to PTCy-based transplants  
New manufacturing and distribution report found 100% of Orca-T products were distributed within 70 hours vein-to-vein time with consistent purity  
Patients with haploidentical donors treated with Orca-Q® showed promising outcomes in survival, GVHD and relapse-free survival   

MENLO PARK, CA, Feb. 5, 2026 – Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced new clinical data presented at the 2026 Tandem Meetings of ASTCT® and CIBMTR® from February 4-7 in Salt Lake City. 

 

Orca-T with Reduced Intensity Conditioning  

“Patients undergoing reduced intensity conditioning allogeneic stem cell transplantation often face a tradeoff between tolerability and long-term disease control,” said Caspian Oliai, MD, medical director of the UCLA Bone Marrow Transplantation Stem Cell Processing Center, and primary investigator on the SERENE-T Phase 2 study. “The clinical evidence being generated today, which suggests Orca-T may improve key outcomes by reducing GVHD without increasing infection risk or relapse rate, provides a strong foundation for our ongoing evaluation of Orca-T in this setting. The dosing of the first patients in the Phase 2 SERENE‑T study further strengthens this initial momentum, representing a meaningful step forward in expanding the investigation of Orca‑T for patients undergoing reduced intensity conditioning.” 

 

SERENE-T (NCT07216443) is a new multicenter, open-label Phase 2 trial evaluating the safety, tolerability and efficacy of Orca-T, Orca Bio’s lead investigational allogeneic T-cell immunotherapy, in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) undergoing reduced intensity conditioning (RIC) or non-myeloablative conditioning (NMA). The first patients were treated this year at Vanderbilt University, UCLA and Oregon Health & Science University (OHSU) - Knight Cancer Institute. The study continues to enroll patients with plans to open at additional transplant centers across the U.S. 

 

A new analysis compared outcomes from the single-center, open-label Phase 1 investigator-sponsored trial evaluating Orca-T versus a historical cohort of patients from the CIBMTR registry who received a conventional allogeneic hematopoietic stem cell transplant (alloHSCT) with post-transplant cyclophosphamide (PTCy). All patients were aged 60-75 (median 68 years), had a 7/8 or 8/8 human leukocyte antigen (HLA)-matched donor, and were given a RIC for the treatment of AML, acute lymphoblastic leukemia (ALL), MDS or myeloproliferative neoplasm (MPN). 

 

Patients receiving Orca-T (n=53) compared with PTCy (n=587) demonstrated improved: 

  • Overall survival at one year (OS; 88% vs 72%) and two years (84% vs 61%) 
  • Relapse-free survival at one year (RFS; 82% vs 61%) and two years (79% vs 53%) 
  • Graft-versus-host-disease relapse-free survival at one year (GRFS; 72% vs 54%) and two years (72% vs 45%) 
  • Relapse rates at one and two years (9.7% vs 23%, 9.7% vs 30%) and non-relapse mortality at one and two years (NRM; 8% vs 16%, 12% vs 17%).  

At one year, rates of Grade 3-4 acute and moderate-to-severe chronic graft versus host disease (aGVHD, cGVHD) were 0% and 10% with Orca-T, respectively, compared to 6% and 10% with PTCy. At two years, rates of cGVHD were 10% with Orca-T and 12% with PTCy. 

 

Orca-T Versus PTCy in Patients with Myelodysplastic Syndromes 

 

A post-hoc analysis of patients aged 18-65 with MDS compared pooled results from the Phase 3 Precision-T study and the Phase 1b study of Orca-T to a historical cohort from the CIBMTR registry of patients who received a conventional alloHSCT and PTCy in the myeloablative conditioning (MAC) HLA-matched setting. Patients with MDS who were treated with Orca-T (n=25) demonstrated higher one-, two- and three-year OS of 100% compared to the PTCy cohort (n=95) with 80%, 70% and 62%, respectively. At one year, the Orca-T arm showed RFS of 95% versus 64% with PTCy and NRM of 0% versus 9.9%, respectively. Notably, these trends were observed across subgroups including age and donor type. 

 

A similar analysis was conducted across multiple hematologic malignancies, including MDS, AML and ALL with consistent results. In this post-hoc analysis, Orca-T (n=164) demonstrated higher OS compared to PTCy (n=380) at one, two and three years (94% vs 82%, 85% vs 73% and 82% vs 65%, respectively). At one year, RFS was 78% with Orca-T compared with 70% with PTCy, while NRM was 2.7% versus 7.7%, respectively. These findings were consistent with the results observed in a subgroup of patients over 50 years of age. 

 

Reliable Manufacturing and Nationwide Distribution of Orca-T 

 

A manufacturing and distribution analysis from the Phase 3 and Phase 1b Orca-T studies conducted between December 2019 and September 2024 reported on the production of 243 clinical cell therapies, including 215 from single-day and 28 from two-day collections. Overall, 100% of products were delivered to transplant centers across the U.S. within 70 hours, with 99% infused within 72 hours. Product quality was consistent across all three Orca-T components: hematopoietic stem cells, regulatory T-cells and conventional T-cells. 

 

These results demonstrate the feasibility of reliably manufacturing and distributing Orca-T at scale while maintaining high product purity within a controlled logistics framework, supporting multicenter clinical studies and potential future commercial application. 

 

“These data continue to reinforce the strength of Orca-T across both clinical outcomes and operational execution,” said Nate Fernhoff, Ph.D., co-founder and chief executive officer at Orca Bio. “The consistency of these results, along with our ability to reliably manufacture and deliver Orca-T across the U.S., highlights the potential of this therapy to make a meaningful difference for patients with hematologic malignancies. As we move toward a potential launch later this year, we remain focused on executing with the same level of commitment and rigor to support patients, clinicians and transplant centers.” 

 

Orca-Q for Patients with Haploidentical Donors 

 

New findings from the ongoing Phase 1 study of Orca-Q, Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy, evaluated 39 patients with AML, ALL or MDS and a haploidentical donor who received MAC with Bu/Flu/Thiotepa (BFT), TBI/Flu/Thio (TFT) or TBI/Flu. All patients engrafted by Day +19 (median 11 days) and demonstrated encouraging rates of OS at one, two and three years (80%, 77% and 77%, respectively). Patients demonstrated RFS of 77% and GRFS of 72%, with low incidences of Grade 3-4 aGVHD at Day +180 and moderate-to-severe cGVHD at one year (8.1% and 0%, respectively). Outcomes were further improved in the TFT subgroup (n=14) across OS (85%), RFS (85%), GRFS (85%), aGVHD (0%) and cGVHD (0%). 


About Orca-T

Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration (FDA). The Biologics License Application (BLA) for Orca-T is currently under Priority Review with the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of April 6, 2026.   

About Orca-Q

Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies, including in patients with haploidentical and mismatched donors. Orca-Q is a proprietary composition of stem cells combined with specific T-cell subsets derived from healthy donors and engineered by Orca Bio’s high-precision platform.  

About Orca Bio

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of blood cancer and autoimmune diseases. The company’s manufacturing platform uses single-cell precision to create personalized cell therapy products intended to replace a patient’s diseased blood and immune system with a healthy one. At Orca Bio, we are on a mission to redefine what’s possible for patients by transforming the field of curative allogeneic cell therapy. For more information, visit www.orcabio.com.  

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

Contact:

Corporate Communications

Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com

Visit our newsroom
Orca Bio to Present New Clinical Data on Its High-Precision Cell Therapies at the 2026 Tandem Meetings of ASTCT® and CIBMTR®

Press release

Menlo Park, CA

January 21, 2026

Orca Bio to Present New Clinical Data on Its High-Precision Cell Therapies at the 2026 Tandem Meetings of ASTCT® and CIBMTR®

New data evaluating Orca-T® with reduced intensity conditioning versus PTCy for the treatment of hematological malignancies 
Orca-T outcomes in patients with myelodysplastic syndromes to be presented for the first time; includes retrospective comparison to PTCy 
Additional presentations will highlight the combination of Orca-T and an allogeneic CAR-T (OrCAR-T™), manufacturing and nationwide distribution data reported on Orca–T and clinical findings of Orca-Q® in patients with haploidentical donors 

MENLO PARK, CA, Jan. 21, 2026 – 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 two oral and seven poster sessions at the 2026 Tandem Meetings of ASTCT and CIBMTR from February 4-7 in Salt Lake City, UT. 

 

The presentations will include data on the company's pipeline of investigational allogeneic T-cell immunotherapies for the treatment of multiple hematological malignancies, including Orca-T, Orca-Q and the Orca-T and allogeneic CAR-T combination therapy, OrCAR-T. 

 

“Our presentations at this year’s Tandem Meetings reflect the growing body of evidence supporting the use of Orca-T as a precision-engineered cellular immunotherapy administered through an allogeneic stem cell transplant,” said Nate Fernhoff, Ph.D., co-founder and chief executive officer of Orca Bio. “From new data in myelodysplastic syndromes, to evaluations in reduced intensity conditioning, and a report on our ability to reliably distribute our products to patients nationwide, these findings represent our ongoing efforts to improve outcomes for the transplant community. We look forward to engaging with our peers and partners to discuss how these advancements can help redefine the treatment landscape for patients with blood cancer.” 

 

The Tandem abstracts are now available at www.tandemmeetings.com. Details of the Orca Bio presentations follow: 

 

Oral Session: Session A - Clinical Progress in GVHD Prevention, Risk Stratification, and Treatment 

Title: Interim Clinical Outcomes in Orca-T with Reduced Intensity Conditioning: An Observational Comparison to Registry-Based Post-Transplant Cyclophosphamide Patients 

Presentation ID: 7 

Date and Time: Wednesday, February 4, 3:15 PM - 3:30 PM MST 

Location: Ballroom AB 

 

Oral Session: Session E - Acute Lymphoid Leukemias: Advances in CAR T and Transplant Approaches 

Title: Mature Outcomes from the Phase I Trial of Orca-T and Allogeneic CD19/CD22 CAR-T cells for Adults with High-Risk B-ALL 

 Presentation ID: 31 

Date and Time: Thursday, February 5, 3:15 PM - 3:30 PM MST 

Location: Ballroom AB 

 

Poster Session: Myeloid Neoplasms Including Relapse – Clinical 

Title: Clinical Outcomes in Myelodysplastic Syndrome Patients Treated with Orca-T or Post-Transplant Cyclophosphamide Patients: A Registry-Based Comparison 

 Presentation ID: 534  

Date and Time: Thursday, February 5, 6:30 PM - 8:00 PM MST 

Location: Poster Hall AB 

 

Poster Session: Cell and Gene Therapy – Clinical 

Title: Scalable Manufacturing and Nationwide Distribution of Orca-T: A Precision-Engineered Allogeneic Immune Cell Therapy  

 Presentation ID: 161 

Date and Time: Thursday, February 5, 6:30 PM - 8:00 PM MST 

Location: Poster Hall AB 

 

Poster Session: GVHD Clinical – Prevention and Treatment 

Title: Clinical Outcomes in Orca-T and Registry-Based Post-Transplant Cyclophosphamide Patients: An Observational Comparison 

 Presentation ID: 366 

Date and Time: Thursday, February 5, 6:30 PM - 8:00 PM MST 

Location: Poster Hall AB 

 

Poster Session: GVHD Clinical – Prevention and Treatment 

Title: Preliminary Safety and Efficacy of Myeloablative Orca-Q in Patients with Haploidentical Donors 

 Presentation ID: 345 

Date and Time: Thursday, February 5, 6:30 PM - 8:00 PM MST 

Location: Poster Hall AB  

 

Poster Session: Conditioning Regimens 

Title: Single Center Phase 1b Study of Orca-T Following Escalated Doses of Total Marrow and Lymphoid Irradiation (TMLI) in Patients with Acute Leukemia or MDS 

 Presentation ID: 172 

Date and Time: Thursday, February 5, 6:30 PM - 8:00 PM MST 

Location: Poster Hall AB 

 

Poster Session: Health Services and Barriers to Access 

Title: Orca-T Demonstrates Favorable Quality of Life and Healthcare Resource Use Compared to Standard AlloHSCT Plus Tac/MTX for GVHD Prevention in a Randomized phase 3 Clinical Trial (Precision-T) 

 Presentation ID: 402 

Date and Time: Thursday, February 5, 6:30 PM - 8:00 PM MST 

Location: Poster Hall AB 

 

Poster Session: Health Services and Barriers to Access 

Title: Cost-Effectiveness of Orca-T Vs Allo-HCT with Conventional GVHD Prophylaxis for the Treatment of Advanced Hematologic Malignancies in the United States 

 Presentation ID: 401 

Date and Time: Thursday, February 5, 6:30 PM - 8:00 PM MST 

Location: Poster Hall AB 

About Orca-T

Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration (FDA). The Biologics License Application (BLA) for Orca-T is currently under Priority Review with the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of April 6, 2026.   

About Orca Bio

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of blood cancer and autoimmune diseases. The company’s manufacturing platform uses single-cell precision to create personalized cell therapy products intended to replace a patient’s diseased blood and immune system with a healthy one. At Orca Bio, we are on a mission to redefine what’s possible for patients by transforming the field of curative allogeneic cell therapy. For more information, visit www.orcabio.com.  

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

Contact:

Corporate Communications

Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com

Visit our newsroom
Orca Bio Announces $250M in Aggregate Financing in Preparation for Potential Commercialization

Press release

Menlo Park, CA

January 9, 2026

Orca Bio Announces $250M in Aggregate Financing in Preparation for Potential Commercialization 

Series F, closed in December 2025, builds on recent financing activity to support launch readiness leading up to the Orca-T ® PDUFA date of April 6, 2026 
Funding also enables pipeline advancements including new and expanded clinical programs evaluating Orca-T and Orca-Q® in reduced intensity and nonmyeloablative conditioning settings 

MENLO PARK, CA, Jan. 9, 2026 – Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced the completion of a Series F financing round in December 2025 led by Lightspeed Venture Partners. With $250M in new equity capital from its two most recent financing rounds, along with a 2025 amendment to its Silicon Valley Bank credit facility providing up to $100M in additional liquidity, Orca Bio possesses the financial strength to scale its commercial operations and advance its clinical pipeline.  

 

The proceeds will be used to ensure commercial readiness as the company approaches the April 6, 2026 Prescription Drug User Fee Act (PDUFA) target action date for Orca-T, Orca Bio’s lead investigational allogeneic T-cell immunotherapy. The funding will help strengthen the company’s infrastructure to support future commercial scale, including the addition of East Coast manufacturing capacity to complement its Sacramento, CA operations. The capital will also support the accelerated advancement of Orca Bio’s pipeline across multiple clinical programs designed to expand treatment to more patients in need. 

 

“Our financial position is a powerful validation of Orca-T's transformative potential and reflects our commitment to pioneering a new standard in cell therapy,” said Nate Fernhoff, Ph.D., co-founder and chief executive officer at Orca Bio. “With the resources and infrastructure now in place, we are uniquely positioned to bring our first high-precision therapy to leukemia patients in the U.S. This milestone not only solidifies our anticipated commercial launch but also provides the runway to advance our promising pipeline as we seek to redefine treatment across multiple life-threatening blood cancer and autoimmune diseases.” 

 

In parallel to commercialization efforts, Orca Bio remains focused on advancing its pipeline of high-precision cell therapies. The company progressed two clinical programs designed to evaluate Orca-T and Orca-Q in both the reduced intensity conditioning (RIC) and nonmyeloablative (NMA) settings for patients who may not be candidates to receive a traditional myeloablative conditioning (MAC) regimen. 

 

“While myeloablative conditioning offers the best chance to eradicate disease with a traditional allogeneic stem cell transplant, the high toxicity levels carry significant risks, particularly for older patients or those with co-morbidities,” said Scott McClellan, M.D., Ph.D., chief medical officer at Orca Bio. “Less intensive conditioning regimens are safer for patients who are not candidates for myeloablative conditioning. Through these new studies, we aim to evaluate if Orca-T and Orca-Q can bring safer, curative interventions to a broader population of blood cancer patients.” 

  • SERENE-T Phase 2 Study: SERENE-T (NCT07216443) is a new multicenter, open-label Phase 2 trial evaluating the safety, tolerability and efficacy of Orca-T in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) undergoing RIC or NMA. 
  • Expanded Phase 1b Study of Orca-Q: The first patients have been treated in the expanded Phase 1b study (NCT03802695​) which now includes three additional cohorts of patients receiving RIC or NMA with either matched related or unrelated, 7/8 mismatched unrelated or haploidentical related donors. Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy for patients with AML, MDS or mixed phenotype acute leukemia (MPAL).  


Both studies are now enrolling with plans to open at additional centers across the U.S. For more information, visit ClinicalTrials.gov. 

About Orca-T

Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration (FDA). The Biologics License Application (BLA) for Orca-T is currently under Priority Review with the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of April 6, 2026.   

About Orca Bio

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of blood cancer and autoimmune diseases. The company’s manufacturing platform uses single-cell precision to create personalized cell therapy products intended to replace a patient’s diseased blood and immune system with a healthy one. At Orca Bio, we are on a mission to redefine what’s possible for patients by transforming the field of curative allogeneic cell therapy. For more information, visit www.orcabio.com.  

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

Contact:

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Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com

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Orca Bio to Present at the 44th Annual J.P. Morgan Healthcare Conference

Press release

Menlo Park, CA

January 5, 2026

Orca Bio to Present at the 44th Annual J.P. Morgan Healthcare Conference 

MENLO PARK, CA, Jan. 5, 2026 – Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced that Nate Fernhoff, Ph.D., Orca Bio’s co-founder and chief executive officer, will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, CA. 

 

The company presentation will take place on Monday, January 12, 2026, at 7:30AM 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 high-precision cell therapies for the treatment of blood cancer and autoimmune diseases. The company’s manufacturing platform uses single-cell precision to create personalized cell therapy products intended to replace a patient’s diseased blood and immune system with a healthy one. At Orca Bio, we are on a mission to redefine what’s possible for patients by transforming the field of curative allogeneic cell therapy. For more information, visit www.orcabio.com.  

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

Contact:

Corporate Communications

Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com

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Orca Bio Announces Orca-T® Phase 3 Data Published in Blood Demonstrate Significant Improvement in Survival Free from Chronic Graft versus Host Disease in Patients with Hematological Malignancies

Press release

Menlo Park, CA

December 15, 2025

Orca Bio Announces Orca-T® Phase 3 Data Published in Blood Demonstrate Significant Improvement in Survival Free from Chronic Graft versus Host Disease in Patients with Hematological Malignancies 

Results from the Precision-T study showed Orca-T significantly improved survival free from chronic GvHD in patients with AML, ALL and MDS compared to a conventional allogeneic hematopoietic stem cell transplant  
New findings demonstrate fewer rehospitalizations due to safety events and reduced rates of non-relapse mortality  
Orca-T is the first Treg-based immunotherapy to demonstrate an improvement in patient outcomes including overall survival and GvHD and relapse-free survival (GRFS) in these conditions 
Orca-T is being evaluated under Priority Review by the U.S. Food and Drug Administration (FDA) with a target action date of April 6, 2026 

MENLO PARK, CA, Dec. 15, 2025 – Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced the publication of the Precision-T Phase 3 study results of its lead investigational allogeneic T-cell immunotherapy, Orca-T, in Blood, a journal of the American Society of Hematology (ASH). The study compared Orca-T to a conventional allogeneic hematopoietic stem cell transplant (alloHSCT) in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL). These results were first presented on April 2, 2025, at the 51st Annual Meeting of The EBMT in Florence, Italy, and further analyses were presented at the 67th ASH Annual Meeting on December 6, 2025. 

 

In the randomized Precision-T study, Orca-T plus single-agent tacrolimus (TAC) demonstrated a significant improvement in the primary endpoint of survival free from moderate-to-severe chronic graft versus host disease (cGFS) compared to alloHSCT plus tacrolimus/methotrexate (TAC/MTX). The rate for patients who received Orca-T was 78% (95% CI: 65%, 87%) compared to 38.4% (95% CI: 26%, 51%) for patients who received an alloHSCT (HR 0.26; p<0.00001), an improvement driven by a reduction in moderate-to-severe chronic graft versus host disease (cGvHD) and fewer patient deaths.  

 

“Today, treating patients with serious blood cancers using conventional allogeneic stem cell transplants often forces a difficult risk–benefit trade-off, as clinicians work to cure the disease while avoiding life-threatening complications like GvHD,” said lead author Everett Meyer, M.D., Ph.D., hematologist and associate professor of medicine in Blood and Marrow Transplantation and Cellular Therapy at Stanford Medicine. “The Precision-T results showed that Orca-T can meaningfully shift that balance, delivering improved GvHD-free survival alongside less toxicity, including fewer serious infections and lower non-relapse mortality. Orca-T has the potential to become an important new therapy for patients and a valuable new option for the providers who care for them.” 

In the study, all patients (n=187) with a median age of 43.6 years (range 19-65 years) were randomized 1:1 to Orca-T plus TAC or alloHSCT plus TAC/MTX. Patients across both groups received myeloablative conditioning 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. Additional results from the Precision-T study at one year include: 

  • A secondary endpoint of cumulative incidence of moderate-to-severe cGvHD was 12.6% (95% CI: 5%, 23%) and 44.0% (95% CI: 31%, 56%) in the Orca-T and alloHSCT arms, respectively (HR 0.19; p<0.00002). 
  • The overall survival (OS), another secondary endpoint, was 93.7% (95% CI: 86%, 97%) in the Orca-T arm and 83.2% (95% CI: 73%, 90%) in the alloHSCT arm (HR 0.49; p=0.11823). 
  • A secondary endpoint of GvHD and relapse-free survival (GRFS) was 63.1% and 30.9% with Orca-T and alloHSCT (p<0.001 in a post hoc analysis), respectively. 
  • The cumulative incidence of non-relapse mortality (NRM) was 3.4% (95% CI: 0.9%, 8.8%) for Orca-T versus 13.2% (95% CI: 6.8%, 21.6%) for alloHSCT (HR 0.27 [95% CI: 0.08, 0.93]; p=0.03 in a post hoc analysis).  


Additional safety findings were consistent with previous studies. The cumulative incidence for grade III or IV acute GvHD at day +180 was reduced with Orca-T with 6.2% (95% CI: 2.3, 12.9) versus 16.5% (95% CI: 9.4, 25.3) with alloHSCT (HR 0.37 [95% CI: 0.13, 1.02]; p=0.044 in a post hoc analysis). Grade 3+ infections were less common with Orca-T, with a one-year estimated incidence of 8.4% (95% CI: 3.6%, 16%) for Orca-T and 16.1% (95% CI: 9.2%, 25%) for alloHSCT. 

 

An exploratory endpoint evaluated health-related quality of life (HRQoL) and hospitalization patterns and found Orca-T delivered marked improvements over conventional alloHSCT. In the data presented at ASH 2025, patients receiving Orca-T experienced faster recovery to, and higher improvement above, baseline HRQoL, fewer ICU stays, lower likelihood of rehospitalization and higher rehospitalization-free survival, suggesting better early post-treatment recovery and a lower burden of GvHD symptoms.   

 

Rehospitalizations due to adverse events occurred less frequently among Orca-T recipients (27.3% [24] vs. 45.7% [43]), with fewer total hospitalization days per patient (30.6 vs. 40.8). Rehospitalization-free survival at 18 months was also significantly improved with Orca-T, reaching 66.4% (95% CI: 54.0, 76.2) compared to 33.8% (95% CI: 18.5, 49.9) for conventional alloHSCT (p=0.0096 in a post hoc analysis; HR 0.53 [0.32, 0.86]). 

 

“As the first Treg-based immunotherapy to show improved outcomes for patients with acute leukemias and myelodysplastic syndrome compared with a conventional transplant, Orca-T has the potential to become a new standard of care,” said Nate Fernhoff, Ph.D., co-founder and chief executive officer at Orca Bio. “The Phase 3 results published in Blood underscore our ability to potentially redefine how blood cancers are treated today. We look forward to continuing to work closely with the FDA on the review of our application with the goal of making Orca-T available to patients who need it.” 

 

The safety and efficacy of Orca-T have not been determined by any regulatory authority. Orca-T is currently being evaluated under Priority Review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of April 6, 2026. 

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 under evaluation for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration (FDA). The Biologics License Application (BLA) for Orca-T is currently under Priority Review with the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of April 6, 2026.   

About Orca Bio

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of blood cancer and autoimmune diseases. The company’s manufacturing platform uses single-cell precision to create personalized cell therapy products intended to replace a patient’s diseased blood and immune system with a healthy one. At Orca Bio, we are on a mission to redefine what’s possible for patients by transforming the field of curative allogeneic cell therapy. For more information, visit www.orcabio.com.  

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

Contact:

Corporate Communications

Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com

Visit our newsroom
Orca Bio Presents New Clinical Data on its Pipeline of High-Precision Cell Therapies including Orca-Q® Without GvHD Prophylaxis and Orca-T/CAR-T Combination Therapy at the 67th ASH Annual Meeting

Press release


Menlo Park, CA

December 8, 2025

Orca Bio Presents New Clinical Data on its Pipeline of High-Precision Cell Therapies including Orca-Q® Without GvHD Prophylaxis and Orca-T/CAR-T Combination Therapy at the 67th ASH Annual Meeting 

Orca-Q, Orca Bio’s second investigational allogeneic T-cell immunotherapy, showed low rates of acute and chronic GvHD, infections and non-relapse mortality with and without GvHD prophylaxis 

Orca-T plus CAR-T combination therapy, OrCAR-T™, showed improved relapse and overall survival rates compared to autologous CAR19/22 treatment in patients with B-ALL 

MENLO PARK, CA, December 8, 2025 – Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced positive new data from its pipeline of allogeneic T-cell immunotherapies at the 67th American Society of Hematology (ASH) Annual Meeting. 

 

Orca-Q with and Without the Use of GvHD Prophylaxis 

 

A subset of the multi-center Phase 1 clinical trial evaluated Orca-Q, Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy, in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), myelofibrosis (MF), myelodysplastic syndrome (MDS) and mixed phenotype acute leukemia (MPAL) with HLA-matched related and unrelated donors. New data evaluating Orca-Q with and without the use of pharmacological graft versus host disease (GvHD) prophylaxis showed encouraging outcomes including rapid neutrophil recovery and low rates of acute and chronic GvHD, relapse and non-relapse mortality (NRM).  

 

“Controlling alloreactivity and reducing GvHD following a conventional stem cell transplant typically requires multi-agent immunosuppression. However, this can impair immune reconstitution and increase the risk of organ toxicity, infection and relapse,” said presenting author Samer Srour, M.D., Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center. “In these new findings, Orca-Q demonstrated encouraging outcomes even without the use of any pharmacological GvHD prophylaxis. While ongoing enrollment is important to further validate these results, the data suggest that Orca-Q may be able to control alloreactivity and potentially offer a platform to improve transplant outcomes through controlling GvHD and infection and reducing non-relapse mortality without increasing the risk of relapse.” 

 

Patients on Arm A received Orca-Q and single-agent tacrolimus (tac, n=18) while patients on Arm C received Orca-Q and no immune suppression (n=26). Median time to neutrophil engraftment was 15 days for patients who received tac and 11 days for patients who did not. Orca-Q was well-tolerated with 94% overall survival (OS) at one year for patients with tac and 87% for patients without tac. At one year, GvHD-and-relapse-free survival (GRFS) was 77% with tac and 79% without tac, and NRM was 6% and 0% with tac and without tac, respectively. Relapse-free survival (RFS) at one year was 88% with tac and 87% without tac. At Day 180, moderate-to-severe chronic GvHD was 12% with tac and 0% without tac. Grade 3-4 acute GvHD was 8% and 6% with and without tac, respectively. 

 

Importantly, Orca-Q patients treated without GvHD prophylaxis demonstrated more rapid immune reconstitution and improved control of infections. Specifically, BMT CTN Grade 2+ infections at one year were 33% with tac and 17% without tac.  

 

Orca-T and CAR-T Combination Treatment Versus Autologous CAR-T 

 

A second oral presentation compared the results from two separate Phase 1 trials in adults with high-risk relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL). The first trial evaluated OrCAR-T (n=16), a treatment that combines Orca-T and allogeneic CD19/CD22 CAR-T cells, and the second trial evaluated an autologous CD19/22 (n=17). At 18 months, progression-free survival (PFS) and OS were 100% and 100% with OrCAR-T, and 38.5% and 77% in the autologous cohort. Toxicities were mild across both cohorts, with no grade 3-4 CAR-related toxicities reported. At a median follow-up of 2.5 years, there were no relapses or patient deaths with OrCAR-T and seven deaths with autologous, six from refractory B-ALL.  

 

“Among adults with B-ALL, CAR-T therapy is often followed by a consolidative allogeneic transplant to achieve long-term remission,” said Lori Muffly, M.D., associate professor in the Division of Blood and Marrow Transplantation-Cellular Therapies at Stanford Health Care. “Emerging data showing improved progression-free survival in patients with a prior transplant has prompted interest in exploring whether combining a high-precision allogeneic therapy like Orca-T with CAR-T cells could provide a feasible, all-in-one treatment. While these findings are early, they suggest this approach has the potential to benefit patients across a range of hematologic diseases.” 

 

“Our team is encouraged by these new findings from our broader pipeline programs, including results that highlight the potential to eliminate the need for GvHD prophylaxis while preserving immune reconstitution with Orca-Q,” said Nate Fernhoff, Ph.D., co-founder and chief executive officer at Orca Bio. “The durability of Orca-T when combined with CAR-T therapy exemplifies how our high-precision approach may be applied to expand treatment options both within and beyond hematologic malignancies. Overall, these results reinforce our continued focus on advancing our pipeline to bring this high-precision platform to more patients who could potentially benefit.” 

About Orca-Q

Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy under evaluation in clinical trials for the treatment of multiple hematologic malignancies, including in patients with haploidentical and mismatched donors. Orca-Q is a proprietary composition of stem cells combined with specific T-cell subsets derived from healthy donors and engineered by Orca Bio’s high-precision platform.   

About Orca Bio

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of blood cancer and autoimmune diseases. The company’s manufacturing platform uses single-cell precision to create personalized cell therapy products intended to replace a patient’s diseased blood and immune system with a healthy one. At Orca Bio, we are on a mission to redefine what’s possible for patients by transforming the field of curative allogeneic cell therapy. For more information, visit www.orcabio.com. 

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

Contact:

Corporate Communications

Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com


Visit our newsroom