Orca Bio Secures $350M to Launch New Era of Leukemia Cell Therapy

MENLO PARK, CA – January 09, 2026 – As the clock ticks down to a pivotal FDA decision, late-stage biotechnology firm Orca Bio has armed itself with a $350 million war chest to prepare for the potential commercial launch of its revolutionary leukemia treatment, Orca-T. The financing, a combination of new equity and credit, signals strong investor confidence as the company stands on the cusp of potentially transforming the standard of care for patients with life-threatening blood cancers.

The company announced it had raised $250 million in a Series F financing round led by Lightspeed Venture Partners, supplemented by an amended credit facility with Silicon Valley Bank providing up to $100 million in liquidity. This infusion of capital is timed strategically, with the U.S. Food and Drug Administration's Prescription Drug User Fee Act (PDUFA) target action date for Orca-T set for April 6, 2026. If approved, Orca-T would become the first high-precision, allogeneic T-cell immunotherapy for treating several types of leukemia and myelodysplastic syndromes.

A New Standard in Cell Therapy?

For decades, the most effective curative option for many blood cancer patients has been the allogeneic hematopoietic stem cell transplant (alloHSCT), where a patient’s diseased blood and immune system is replaced with cells from a healthy donor. However, this life-saving procedure carries a significant risk of a severe complication known as graft-versus-host disease (GvHD), where the new donor cells attack the patient’s body.

Orca Bio aims to solve this paradox with Orca-T. The therapy is a custom-formulated mixture of immune cells derived from a donor, manufactured with single-cell precision to retain therapeutic T-cells that fight cancer while removing the specific cell populations that cause GvHD. The goal is to deliver the curative power of a transplant without the debilitating side effects.

The BLA submission for Orca-T is backed by compelling data from the pivotal Phase 3 Precision-T study. The trial demonstrated that Orca-T achieved a statistically significant improvement in its primary endpoint: survival free of moderate-to-severe chronic GvHD. At the one-year mark, an impressive 78% of patients receiving Orca-T were alive and free of this severe complication, compared to just 38% of those who received the conventional transplant.

Furthermore, the data pointed to better overall outcomes and a gentler patient experience. The estimated one-year overall survival was 94% for the Orca-T group versus 83% for the standard-of-care arm. Patients treated with Orca-T also experienced a lower incidence of severe acute GvHD (6% vs. 17%) and a dramatically lower rate of non-relapse mortality (3% vs. 13%). These clinical benefits translated into faster recoveries, fewer ICU stays, and a lower likelihood of rehospitalization, suggesting a profound improvement in quality of life. These results underpinned the FDA's decision to grant the therapy Priority Review and Regenerative Medicine Advanced Therapy (RMAT) designation.

“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, in a recent statement. “We are uniquely positioned to bring our first high-precision therapy to leukemia patients in the U.S.”

Expanding Access Beyond Traditional Transplants

While the impending decision on Orca-T captures the spotlight, Orca Bio is simultaneously advancing a broader mission: making curative cell therapies accessible to more patients. The high-dose chemotherapy and radiation used in traditional myeloablative conditioning (MAC) regimens are too toxic for many older patients or those with other health conditions, effectively excluding them from transplant options.

To address this major unmet need, the company is actively enrolling patients in two new clinical programs evaluating its therapies in less harsh reduced intensity conditioning (RIC) and nonmyeloablative (NMA) settings.

“While myeloablative conditioning offers the best chance to eradicate disease with a traditional allogeneic stem cell transplant, the high toxicity levels carry significant risks,” noted Scott McClellan, M.D., Ph.D., Orca Bio's chief medical officer. “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.”

The new SERENE-T Phase 2 study will evaluate Orca-T in AML and MDS patients undergoing RIC or NMA conditioning. In parallel, the company has expanded its Phase 1b study of Orca-Q, its second-generation immunotherapy. Early data for Orca-Q has already shown remarkable promise, demonstrating rapid immune reconstitution and an 85% one-year overall survival rate with a low risk of infection. Critically, some patient groups achieved these outcomes without the need for any post-transplant GvHD prophylaxis drugs, pointing toward a future where the transplant process is not only safer during conditioning but also less reliant on long-term immunosuppression.

Building a Commercial Powerhouse

Bringing a revolutionary cell therapy to market requires more than just strong clinical data; it demands a robust and scalable manufacturing and logistics network. Orca Bio is using its new capital to fortify this crucial infrastructure. The company has been building out a 100,000-square-foot commercial manufacturing facility in Sacramento, California, designed to produce up to 3,000 cell therapy products annually.

The press release also revealed plans for adding East Coast manufacturing capacity. This bi-coastal strategy is critical for cell therapies, where the "vein-to-vein" time—the window from donor cell collection to patient infusion—is a race against the clock. Orca-T, for example, must be delivered within 72 hours. Having manufacturing sites on both coasts will reduce shipping times, enhance supply chain resilience, and ensure more equitable and timely access for patients across the United States. By investing heavily in in-house manufacturing, Orca Bio is taking direct control of product quality and sidestepping the manufacturing bottlenecks that have plagued the broader cell and gene therapy industry.

Investor Confidence in a Competitive Field

The $250 million equity round, led by a top-tier firm like Lightspeed Venture Partners, is a significant vote of confidence not just in Orca Bio, but in the future of high-precision cell therapy. Lightspeed has a history of backing transformative biotech companies, including Forty Seven (acquired by Gilead) and Guardant Health. Their leadership in this late-stage round underscores a belief that Orca Bio is well-positioned to succeed in an increasingly competitive landscape populated by players like Allogene Therapeutics and Caribou Biosciences.

Further bolstering its financial standing is the amended credit facility with Silicon Valley Bank. The bank's collapse in 2023 sent shockwaves through the biotech sector, but its continued ability to provide substantial credit lines under new ownership with First Citizens Bank demonstrates a return to stability and a sustained commitment to funding life science innovation.

With its finances secured, its manufacturing capacity scaling, and a potential blockbuster therapy awaiting an FDA verdict, Orca Bio is poised for a watershed moment. The coming months will determine if its high-precision approach can redefine the treatment paradigm for thousands of patients battling blood cancers, turning the hope of a safer cure into a clinical reality.