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TuHURA Secures $50 Million Credit Line, $6.3 Million Cash, and FDA Orphan Nod for IFx-2.0

TuHURA Biosciences secures a $50 million credit line, reports $6.3 million cash, and receives FDA orphan drug designation for melanoma therapy IFx-2.0.

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TuHURA Secures $50 Million Credit Line, $6.3 Million Cash, and FDA Orphan Nod for IFx-2.0
Source: IrOriginal source

TL;DR: TuHURA Biosciences secured a $50 million credit line from its biggest shareholder, holds $6.3 million in cash, and received FDA orphan drug status for its lead therapy IFx-2.0 targeting advanced melanoma.

Context TuHURA Biosciences is a Phase 3 immuno‑oncology company developing treatments to overcome resistance to cancer immunotherapy. Its lead candidate, IFx-2.0, is an innate immune agonist being tested in melanoma and Merkel cell carcinoma. The company also advances TBS-2025, a VISTA‑inhibiting antibody for acute myeloid leukemia.

Key Facts - The company obtained a $50 million non‑equity credit facility from its largest stockholder, usable as needed to fund operations beyond the anticipated top‑line data for IFx-2.0. The facility carries a 12 % annual interest rate on drawn amounts, with monthly interest payments and principal repayment due April 21, 2031. - As of March 31, 2026, TuHURA reported $6.3 million in cash and cash equivalents. - The FDA granted orphan drug designation to IFx-2.0 for the treatment of stage IIB to stage IV cutaneous melanoma. The designation rests on Phase 1 data showing the drug was safe with no serious dose‑limiting toxicities and provided clinical benefit in patients whose melanoma had progressed after checkpoint inhibitor therapy. - CEO Dr. James Bianco said the financing will support upcoming milestones, including an FDA meeting to discuss the IND and development plan for TBS-2025 and the initiation of Phase 3 enrollment for IFx-2.0.

What It Means The credit facility extends TuHURA’s cash runway into 2028, reducing immediate financing pressure while it advances late‑stage trials. The orphan drug status for IFx-2.0 may qualify the therapy for tax credits, fee waivers, and seven years of market exclusivity if approved, potentially accelerating patient access to a new melanoma option. Investors should note the 12 % interest cost on any drawn funds, which will affect future earnings if the facility is heavily used.

What to Watch Next Monitor the FDA meeting scheduled for TBS-2025’s IND discussion and the start of Phase 3 enrollment for IFx-2.0, as updates will clarify timelines for pivotal data readouts and potential partnership opportunities.

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