Orca Bio Secures $250 Million in Financing

MENLO PARK &&num;8212&semi; Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, has completed a Series F financing round led by Lightspeed Venture Partners&period; With &dollar;250 million 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 &dollar;100 million in additional liquidity, Orca Bio possesses the financial strength to scale its commercial operations and advance its clinical pipeline&period;&NewLine;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&period; 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&period; 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&period;&NewLine;&OpenCurlyDoubleQuote;Our financial position is a powerful validation of Orca-T&&num;8217&semi;s transformative potential and reflects our commitment to pioneering a new standard in cell therapy,” said Nate Fernhoff, Ph&period;D&period;, co-founder and chief executive officer at Orca Bio&period; &OpenCurlyDoubleQuote;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&period;S&period; 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&period;”&NewLine;In parallel to commercialization efforts, Orca Bio remains focused on advancing its pipeline of high-precision cell therapies&period; 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&period;&NewLine;&OpenCurlyDoubleQuote;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&period;D&period;, Ph&period;D&period;, chief medical officer at Orca Bio&period; &OpenCurlyDoubleQuote;Less intensive conditioning regimens are safer for patients who are not candidates for myeloablative conditioning&period; 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&period;”&NewLine;<ul class="bwlistdisc">&NewLine;<li>SERENE-T Phase 2 Study&colon; 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&period;</li>&NewLine;<li>Expanded Phase 1b Study of Orca-Q&colon; The first patients have been treated in the expanded Phase 1b study (NCT03802695&ZeroWidthSpace;) 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&period; Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy for patients with AML, MDS or mixed phenotype acute leukemia (MPAL)&period;</li>&NewLine;</ul>&NewLine;Both studies are now enrolling with plans to open at additional centers across the U&period;S&period;&NewLine;

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