TuHURA Biosciences, Inc./NV (HURA)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 was operationally focused: TuHURA initiated a Phase 1b/2a MCCUP study, reaffirmed plans to start the SPA-backed Phase 3 IFx‑Hu2.0 + pembrolizumab trial in Q2 2025, and guided to lifting a manufacturing-related partial clinical hold in the coming weeks -.
• Operating expenses rose year over year as R&D scaled (R&D $4.6M vs $3.6M; G&A $2.4M vs $1.0M), consistent with the ramp to Phase 3 and broader pipeline build-out .
• EPS missed S&P Global consensus: Q1 2025 diluted EPS of -$0.15 vs -$0.11 consensus; revenue not reported (pre-revenue) and consensus stood at $0.0*.
• Near-term stock catalysts: lifting of the partial clinical hold, Phase 3 first-line MCC start in Q2 2025, Kineta acquisition closing in Q2 2025, and initial MCCUP feasibility/safety readout by late Q4 2025/early Q1 2026 - -.

What Went Well and What Went Wrong

What Went Well

• Initiated Phase 1b/2a MCCUP trial (IFx‑Hu2.0 + pembrolizumab) to address ~30% of MCC patients who present without cutaneous lesions, potentially expanding the addressable population .
  • “Up to 30% of patients with MCC present without primary lesions in the skin… this trial will not only provide safety, feasibility, and efficacy data, but may also expand the potential number of addressable patients who may benefit from IFx‑Hu2.0.” — CEO James Bianco, M.D. .
• Stayed on track for SPA-backed single Phase 3 accelerated approval trial in first-line advanced/metastatic MCC in Q2 2025; company expects the partial clinical hold to be lifted in the coming weeks - -.
• Advanced pipeline synergies: targeted Q2 closing of Kineta acquisition and movement of VISTA inhibitor (KVA12123) into Phase 2 AML in Q3 2025; AACR data highlighted >90% VISTA receptor occupancy, supporting mechanism rationale - .

What Went Wrong

• No product revenue and an EPS miss vs consensus driven by higher operating expenses as programs scale; diluted EPS of -$0.15 vs -$0.11 consensus*.
• Partial clinical hold on Phase 3 (CMC-related) was still in place at quarter-end (resolution anticipated in Q2), creating some execution risk on timing .
• Higher G&A (+$1.4M YoY) alongside R&D growth (+$1.0M YoY) raises the cash burn profile ahead of key milestones and the Kineta close, which remains “subject to financing and other conditions” - .

Financial Results

P&L Trend (oldest → newest)

• Notes: Company did not disclose revenue in the Q1 release; pre-revenue biotech. OpEx and EPS reflect scale-up for Phase 3 readiness . Values with “*” retrieved from S&P Global.

Operating Expense Detail (YoY)

Liquidity and Cash Flow (oldest → newest)

• Values with “*” retrieved from S&P Global. Shares outstanding as of March 31, 2025 .

Estimates vs. Actuals (Q1 2025)

• Values with “*” retrieved from S&P Global.

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “TuHURA has had an impressive start to 2025… We recently initiated our Phase 1b/2a study of IFx‑Hu2.0… We are also moving towards initiating our Phase 3 accelerated approval trial… and anticipate the lifting of the manufacturing-related partial clinical hold in the coming weeks.” — James Bianco, M.D., President & CEO -.
• “If feasibility and safety is demonstrated for IFx‑Hu2.0 and Keytruda when radiologically administered to deep‑seated tumors, we plan to extend enrollment to a variety of non‑MCC cancers… If successful, this trial could expand the potential benefit of IFx‑Hu2.0 to a wide variety of cancers.” — James Bianco, M.D. .
• “We continue to assemble an exciting late-stage pipeline through our pending acquisition of Kineta… and its VISTA inhibitor antibody, KVA12123… [with] Phase 2 trial in NPM1‑mutated AML.” — James Bianco, M.D. - -.

Q&A Highlights

• Not applicable: no earnings call transcript was available in the document set for Q1 2025 (we relied on the 8‑K and press releases) - -.

Estimates Context

• EPS: Q1 2025 diluted EPS of -$0.15 vs S&P Global consensus of -$0.11 (miss of -$0.04)*.
• Revenue: Consensus was $0.0 and the company did not report revenue for the quarter*.
• With OpEx scaling (R&D +$1.0M YoY; G&A +$1.4M YoY), estimates may need to reflect a higher near-term burn ahead of the Phase 3 start and Kineta close .
• Values with “*” retrieved from S&P Global.

Key Takeaways for Investors

• Near-term regulatory and execution catalysts (partial hold lift; Q2 Phase 3 start) are likely the primary stock drivers over the next 1–2 months .
• The MCCUP Phase 1b/2a opens an additional path to demonstrate feasibility in non‑cutaneous disease and could broaden IFx‑Hu2.0 applicability if positive .
• Pipeline breadth continues to build: Kineta VISTA mAb Phase 2 in AML now targeted for Q3 2025, adding hematologic exposure and a mechanistically complementary checkpoint program -.
• S&P Global consensus EPS was missed in Q1, reflecting higher OpEx as programs scale; watch quarterly burn and financing updates given the merger close is “subject to financing” -*.
• AACR poster readouts (VISTA >90% receptor occupancy; IFx‑Hu2.0 immune activation) provide supportive mechanistic validation for the strategy .
• Execution bar: Timely CMC resolution and on‑time Phase 3 initiation are critical to sustaining momentum and narrative into 2H 2025 .
• Positioning: Trading setups may hinge on confirmation of the hold lift/Phase 3 FPI and clarity on Kineta close; positive confirmations could de‑risk timelines and reset sentiment.

Footnote: Values marked with “*” were retrieved from S&P Global.

References: Q1 2025 press release and 8‑K (including Exhibit 99.1) - -; Phase 1b/2a initiation press release -; FY 2024 press release -; November 25, 2024 development pathway 8‑K -.