Orca Bio Appoints Bijan Nejadnik, M.D., as Chief Medical Officer

Press release

Menlo Park, CA

May 18, 2026

Orca Bio Appoints Bijan Nejadnik, M.D., as Chief Medical Officer 

MENLO PARK, CA, May 18, 2026  Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced the appointment of Bijan Nejadnik, M.D., as Chief Medical Officer (CMO). Dr. Nejadnik is a veteran biopharmaceutical executive with over 20 years of experience spearheading global medical and regulatory strategy. 

 

Concurrent with this appointment, J. Scott McClellan, M.D., Ph.D., will transition from his role as CMO to assume the newly created role of Chief Development Officer, where he will lead the strategic expansion of Orca Bio’s robust pipeline and oversee the advancement of next-generation programs into the clinic. 

 

“We are thrilled to welcome Dr. Nejadnik whose rare expertise in bridging complex clinical innovation with successful global regulatory outcomes will be instrumental as we transition into a commercial-stage company,” said Nate Fernhoff, Ph.D., co-founder and Chief Executive Officer of Orca Bio. “His leadership will be vital in building a world-class medical organization, driving our late-stage clinical strategy and partnering closely with the medical community to bring our high-precision therapies to every patient in need.” 

 

Dr. Nejadnik joins Orca Bio from Tanabe Pharma, where he served as CMO and Head of R&D and Regulatory Affairs. His career is marked by a distinguished track record of leading cross-functional organizations to navigate the path from early-stage biologics to global commercialization. He has overseen multiple successful regulatory submissions, securing approvals from the U.S Food and Drug Administration (FDA), European Medicines Agency (EMA), and Pharmaceuticals and Medical Devices Agency (PMDA). 

 

Beyond his clinical and regulatory roles, Dr. Nejadnik has served as a Board Director and senior officer for several biotech innovators, where he was a key architect of corporate strategy, capital formation and strategic M&A. His clinical oversight spans early- to late-stage clinical trials across oncology, immunotherapy and cell-based therapies. Earlier in his career, he held academic appointments at Johns Hopkins, Cornell and Stanford. He holds an M.D. with honors from the Catholic University of Louvain in Belgium. 

 

“The team at Orca Bio has made extraordinary strides towards redefining the standard of care for allogeneic stem cell transplant through its high-precision platform,” said Dr. Nejadnik. “I am eager to build on this momentum, furthering our clinical innovation to ensure our pipeline meets the highest bar of scientific excellence while simultaneously building the medical infrastructure necessary to broaden patient access to these potentially life-changing therapies.” 

 

“Our platform has the potential to redefine treatment across a vast array of diseases by replacing diseased blood and immune systems,” Dr. Fernhoff continued. “Realizing that potential requires dedicated strategic oversight to prioritize and advance our next wave of therapies. We are fortunate to have Dr. McClellan’s leadership and expertise focused on shaping and constructing a pipeline that will bring Orca Bio’s approach to even more patients who could benefit.” 

 

“It has been a privilege to lead our clinical efforts through the development of Orca-T, and I am excited to now dedicate my focus to the next chapter of Orca Bio’s growth,” said Dr. McClellan. “I look forward to working closely with Dr. Nejadnik and the rest of the leadership team as we accelerate our broader pipeline and explore the full potential of our high-precision platform to treat blood cancers and autoimmune diseases.” 

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

Orca Bio Corporate Overview
Orca Bio Announces U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to Orca-Q® for the Treatment of High-Risk Hematologic Malignancies

Press release

Menlo Park, CA

April 28, 2026

Orca Bio Announces U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to Orca-Q® for the Treatment of High-Risk Hematologic Malignancies 

RMAT designation based on promising preliminary Phase 1 clinical data, including positive outcomes across overall survival, acute and chronic GVHD and non-relapse mortality 
Phase 1 trial was recently expanded to include additional cohorts of patients receiving reduced intensity or non-myeloablative conditioning with either matched, 7/8 mismatched or haploidentical donors  
New clinical findings and longer follow-up data expected in 2026 

MENLO PARK, CA, April 28, 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 granted Regenerative Medicine Advanced Therapy (RMAT) designation to Orca-Q, Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy for the treatment of high-risk hematologic malignancies.

"The FDA’s RMAT designation for Orca-Q recognizes the significant unmet need for patients with serious hematologic malignancies and validates the promising clinical findings from our ongoing Phase 1 study,” said Nate Fernhoff, Ph.D., co-founder and chief executive officer at Orca Bio. “As this is our second cell therapy candidate to receive RMAT status, we have experienced firsthand how this program can support accelerated development and enhanced communication with the FDA. With our newly expanded Phase 1 study continuing to enroll patients and additional data expected later this year, we remain focused on advancing our high-precision approach to deliver an important new treatment to patients with blood cancer.”  

 

The RMAT application included data from the ongoing Phase 1 clinical trial (NCT03802695) evaluating Orca-Q for the treatment of hematologic malignancies across six treatment cohorts, including in patients with haploidentical donors, and in patients receiving non-myeloablative or reduced intensity conditioning. Clinical findings demonstrated durability and encouraging outcomes across key metrics, including overall survival, acute and chronic graft versus host disease (GVHD) and non-relapse mortality. Enrollment is ongoing, with new data expected to be presented at upcoming scientific congresses. Additional details can be found on www.ClinicalTrials.gov.  

 

RMAT designation is a specialized FDA program created to accelerate the development and review of promising new therapies, including cell therapies, intended to treat serious or life-threatening conditions. To qualify, a therapy must demonstrate preliminary clinical evidence suggesting the potential to address unmet medical needs. This designation provides important opportunities during the drug development process, including increased FDA guidance and eligibility for priority and rolling reviews, as well as accelerated approval pathways. By streamlining these regulatory milestones, the program aims to bring transformative innovations to patients more quickly. 

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

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

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 SessionOS14 | 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 TimeWednesday, March 25 at 08:30 AM – 08:39 AM CET 

LocationN107 

 

Oral SessionOS14 | Graft Manipulation and Conditioning   

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

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

Location: N107 

 

Oral SessionOS12 | Acute GVHD - Clinical 

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

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

Location: N101-102 

 

Poster Session: A 

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

 Presentation IDA038 

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

LocationPavilion 9 

 

Poster Session: A 

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

 Presentation IDA145 

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

LocationPavilion 9 

 

Poster Session: A 

TitlePreliminary Safety and Efficacy of Myeloablative Orca-Q in Patients with Haploidentical Donors 

 Presentation IDA043 

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

LocationPavilion 9 

 

Poster Session: A 

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

 Presentation IDA085 

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

LocationPavilion 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

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

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 TimeWednesday, February 4, 3:15 PM - 3:30 PM MST 

Location: Ballroom AB 

 

Oral SessionSession 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 TimeThursday, February 5, 3:15 PM - 3:30 PM MST 

Location: Ballroom AB 

 

Poster SessionMyeloid Neoplasms Including Relapse – Clinical 

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

 Presentation ID: 534  

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

Location: Poster Hall AB 

 

Poster SessionCell and Gene Therapy – Clinical 

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

 Presentation ID: 161 

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

Location: Poster Hall AB 

 

Poster SessionGVHD Clinical – Prevention and Treatment 

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

 Presentation ID: 366 

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

Location: Poster Hall AB 

 

Poster SessionGVHD Clinical – Prevention and Treatment 

TitlePreliminary Safety and Efficacy of Myeloablative Orca-Q in Patients with Haploidentical Donors 

 Presentation ID: 345 

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

Location: Poster Hall AB  

 

Poster SessionConditioning Regimens 

TitleSingle 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 TimeThursday, February 5, 6:30 PM - 8:00 PM MST 

Location: Poster Hall AB 

 

Poster SessionHealth Services and Barriers to Access 

TitleOrca-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 TimeThursday, February 5, 6:30 PM - 8:00 PM MST 

Location: Poster Hall AB 

 

Poster SessionHealth Services and Barriers to Access 

TitleCost-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 TimeThursday, 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

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:

Corporate Communications

Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com