TuHURA Files IND for TBS-2025 in AML, a Minor Step Amid High-Risk Pipeline Expansion

What happened

TuHURA Biosciences has filed an Investigational New Drug Application for TBS-2025, a VISTA-inhibiting antibody, to be studied with a menin inhibitor in relapsed/refractory AML with mutNPM1. This aligns with the company's multi-platform strategy, as TBS-2025 was acquired via the Kineta merger and represents one of three technology pillars highlighted in the DeepValue report. However, TuHURA remains a development-stage company with no product revenue, ongoing operating losses, and a disclosed need for substantial additional funding, which casts doubt on its ability to sustain multiple clinical programs. The IND filing is a regulatory formality that does not address core risks like the Phase 3 trial for IFx-2.0 in Merkel cell carcinoma or imminent financing challenges. Thus, while it shows pipeline activity, it underscores the speculative nature of TuHURA's early-stage assets in a competitive oncology landscape.

Implication

Investors should view this news as a minor operational update that doesn't change the company's precarious financial position, with only $8.5 million in cash as of June 2025 and a need for more funding. The primary value driver remains the Phase 3 trial of IFx-2.0 under an accelerated approval pathway, which faces regulatory scrutiny and competitive pressure. Integration costs from the Kineta merger and potential selling pressure from former shareholders add to the overhang, as noted in the DeepValue report. Early-stage programs like TBS-2025 require significant time and capital to advance, with no guarantee of clinical success or regulatory approval. Therefore, this filing reinforces the need for cautious monitoring of enrollment progress, financing events, and any safety signals that could impact the broader pipeline.

Thesis delta

The DeepValue report frames TuHURA as a speculative, high-risk investment dependent on Phase 3 IFx-2.0 execution and timely financing. This IND filing for TBS-2025 expands the early-stage pipeline but does not shift the core thesis, as it introduces no new catalysts or mitigants to the funding and regulatory risks. It merely underscores the company's strategy of diversifying across modalities without addressing the immediate need for clinical validation and capital.