Orca Bio announced it has raised $250 million in new equity financing and expanded access to debt capital as the late-stage biotech prepares for a potential U.S. commercialization of its lead cell therapy candidate, Orca-T, with an FDA action date set for April 6, 2026.
The Menlo Park, California-based company said its latest fundraising includes a Series F round that closed in December 2025 and was led by Lightspeed Venture Partners. Orca Bio described the $250 million figure as aggregate new equity capital from its two most recent financing rounds. In addition, the company said it amended its Silicon Valley Bank credit facility in 2025, providing up to $100 million in additional liquidity.
The funding will be directed toward launch readiness for Orca-T, an investigational allogeneic T-cell immunotherapy, including investments to scale commercial operations and strengthen infrastructure for future commercial supply. The company said it plans to add East Coast manufacturing capacity to complement its Sacramento, California, operations.
Alongside commercialization preparation, Orca Bio said it is advancing its pipeline of “high-precision” cell therapies, including new and expanded clinical programs evaluating Orca-T and a second-generation candidate, Orca-Q, in reduced-intensity and nonmyeloablative conditioning settings. Those approaches are intended for patients who may not be able to tolerate traditional myeloablative conditioning regimens used in allogeneic stem cell transplant protocols.
The company highlighted two studies it said are now enrolling: SERENE-T, a multicenter open-label Phase 2 trial evaluating Orca-T in patients with acute myeloid leukemia and myelodysplastic syndromes undergoing reduced-intensity or nonmyeloablative conditioning; and an expanded Phase 1b study of Orca-Q that now includes additional cohorts spanning multiple donor types and conditioning approaches in patients with acute myeloid leukemia, myelodysplastic syndromes, or mixed phenotype acute leukemia. Orca Bio said the Orca-Q study has already treated its first patients in the expansion and that both trials are expected to open at additional U.S. centers.
Orca Bio said its manufacturing platform uses “single-cell precision” to create cell therapy products intended to replace a patient’s diseased blood and immune system with a healthy one, targeting blood cancers and autoimmune diseases.
KEY QUOTES:
“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. 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.”
Nate Fernhoff, Ph.D., Co-Founder and Chief Executive Officer, Orca Bio
“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. 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.”
Scott McClellan, M.D., Ph.D., Chief Medical Officer, Orca Bio
