FDA Removes Manufacturing-Related Partial Clinical Hold On TuHURA's Phase 3 Accelerated Approval Trial For IFx-2.0, Allowing Trial To Proceed As Agreed To Under Previously Announced SPA Agreement With FDA

Company anticipates initiating its Phase 3 accelerated approval trial of IFx-Hu2.0 as adjunctive therapy with Keytruda® (pembrolizumab) as first-line treatment for advanced and metastatic Merkel cell carcinoma (MCC), conducted under Special Protocol Assessment (SPA) Agreement with U.S. Food and Drug Administration (FDA), later in June 2025

Resolution of partial clinical hold unlocks second tranche of funds from $12.5 million PIPE financing announced on June 3, 2025

TAMPA, Fla., June 9, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced that the FDA has removed the manufacturing-related partial clinical hold on the Company's Phase 3 accelerated approval trial for IFx-2.0, thereby allowing the trial to proceed as agreed to under the previously announced SPA Agreement with the FDA.