Orca Bio Raises $250M to Scale High-Precision Cell Therapy Technology

Menlo Park-based Orca Bio has secured $250 million in aggregate equity capital to propel the commercial launch of its lead cell therapy, Orca-T. This financing includes a recently closed Series F led by Lightspeed Venture Partners and is bolstered by an expanded $100 million credit facility from Silicon Valley Bank. The infusion of capital arrives just months before the FDA target action date of April 6, 2026, positioning the firm for a significant transition from clinical research to a commercial entity.

To ensure a seamless rollout, the company is scaling its operations and establishing new manufacturing capacity on the East Coast. These facilities will complement existing Sacramento operations to address the logistical challenges of high-precision cell therapies that require rapid turnaround times. Strengthening this infrastructure is critical for reaching leukemia patients across the United States immediately following potential regulatory approval.

Orca Bio differentiates itself through a proprietary platform that utilizes high-speed, single-cell precision to engineer personalized donor grafts. While traditional transplants involve a raw mixture of cells, this technology allows for the precise sorting of regulatory and conventional T-cells to maximize cancer-fighting effects. By leveraging computational precision and advanced sorting tech, the company aims to solve the decades-long challenge of graft-versus-host disease.

Beyond the initial launch, the new funds will accelerate clinical trials for patients who cannot tolerate standard, high-intensity chemotherapy. The SERENE-T and Orca-Q programs are currently evaluating treatments in reduced intensity and nonmyeloablative settings. These studies, tracked via ClinicalTrials.gov, seek to provide safer, curative options for older populations or those with significant co-morbidities who were previously excluded from traditional transplant therapies. CEO Nate Fernhoff noted that the current financial strength provides the necessary runway to redefine treatment across various blood cancers and autoimmune diseases. With the PDUFA date looming, the company is focused on establishing Orca-T as a new standard of care. Investors see this milestone as a validation of the transformative potential inherent in high-precision immunotherapy.