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TuHURA Biosciences, Inc./NV (HURA)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 was execution-heavy: TuHURA initiated its SPA-backed Phase 3 trial of IFx-2.0 in first-line MCC, completed the Kineta acquisition (adding VISTA mAb TBS-2025), and closed $12.5M equity financing plus $3.0M in warrant proceeds, positioning the company to advance multiple programs .
  • Financially, losses widened as planned with increased R&D to support Phase 3 startup: R&D rose to $4.9M vs $2.8M YoY; six-month operating cash outflow was ($10.9)M vs ($8.9)M YoY; shares outstanding increased to ~49.9M with financing and the Kineta merger .
  • EPS missed S&P Global consensus: Q2 2025 EPS was ($0.21)* vs ($0.135)* expected; revenue remains n/a for a development-stage profile, with sell-side modeling $0.00* [GetEstimates Q2 2025].
  • Near-term catalysts: Phase 3 site activations/enrollment update by YE 2025; MCCUP Phase 1b/2a topline in Q1 2026; Phase 3 topline in 2H 2026; initiation of TBS-2025 Phase 2 in r/r NPM1-mut AML in 2H 2025 .

What Went Well and What Went Wrong

  • What Went Well

    • Phase 3 initiation under FDA SPA (single trial can potentially satisfy accelerated and full approval without a post-approval confirmatory study if PFS is met): “if successful, has the potential to both meet and satisfy the requirements for both accelerated and full approval without the need to conduct a post-accelerated approval confirmatory trial” .
    • Strategic expansion via Kineta acquisition; TBS-2025 advances to randomized Phase 2 in r/r NPM1-mut AML in 2H 2025, creating synergies with TuHURA’s ADC/APC platforms .
    • Strengthened balance sheet: $12.5M private placement closed, plus $3.0M warrant proceeds; Russell 3000/2000 inclusion raises visibility .

  • What Went Wrong

    • Operating losses increased with R&D acceleration for Phase 3: Q2 R&D $4.9M vs $2.8M YoY; six-month operating cash outflows ($10.9)M vs ($8.9)M YoY .
    • EPS missed S&P Global consensus on higher operating spend supporting trial initiations (Q2 EPS ($0.21)* vs ($0.135)* cons.) [GetEstimates Q2 2025].
    • TBS-2025 Phase 2 guidance broadened from a specific “Q3 2025” start to “2H 2025,” modestly widening the window .

Financial Results

P&L snapshot (periods oldest → newest)

MetricQ2 2024Q1 2025Q2 2025
Net Income (Loss) ($USD)($5.27M)*($6.66M)*($9.52M)*
Diluted EPS - Continuing Ops ($)($0.4323)*($0.1536)*($0.2138)*
  • Values marked with * retrieved from S&P Global.

Operating investment and liquidity

MetricQ2 2024Q1 2025Q2 2025
R&D Expense ($USD)$2.8M $4.6M $4.9M
Cash & Equivalents ($USD)n/a$6.22M $8.51M
Basic Shares Outstanding (approx.)n/a43.7M 49.9M

YTD operating cash flow

Metric6M 20246M 2025
Cash from Operations ($USD)($8.9M) ($10.9M)

Q2 2025 vs S&P Global consensus

MetricConsensusActualBeat/Miss
EPS ($)($0.135)*($0.21)*Miss
Revenue ($USD)$0.00*n/an/a
  • Values marked with * retrieved from S&P Global.

Notes:

  • No product revenue was disclosed in company press materials; sell-side models assume $0.00* revenue for Q2 2025 [GetEstimates Q2 2025].
  • Net loss and EPS are shown to track operating intensity as programs scale; absent revenue/margins, R&D cadence is the main driver .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
IFx-2.0 Phase 3 trial initiation (1L MCC, SPA)Q2 2025Initiation anticipated in Q2 2025 Initiated June 2025 Achieved
IFx-2.0 Phase 3 topline2H 2026n/a2H 2026 New
IFx-2.0 MCCUP Phase 1b/2a toplineQ4 2025–Q1 2026End Q4 2025 or early Q1 2026 Q1 2026 Narrowed window
TBS-2025 (VISTA) Phase 2 start (r/r NPM1-mut AML)2025Q3 2025 start 2H 2025 start Window broadened/slightly later
Equity financing2025$12.5M private placement announced Financing completed + $3.0M warrant proceeds Achieved
Index inclusion2025n/aAdded to Russell 3000/2000 as of 6/27/25 New

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024)Previous Mentions (Q1 2025)Current Period (Q2 2025)Trend
FDA/SPA & registrational strategySPA secured; single Phase 3 potential path outlined Anticipated hold lift and Phase 3 initiation in Q2 Partial hold removed; Phase 3 initiated under SPA Improving
Program execution (IFx-2.0)Plan to initiate Phase 3 in Q2 2025 Phase 3 initiation expected Q2 Phase 3 initiated; YE enrollment update planned Advancing
Pipeline expansion (VISTA/ADC/APC)Plan to acquire Kineta; expand ADC/APC Close Kineta in Q2; initiate Phase 2 in Q3 Kineta acquired; Phase 2 planned 2H 2025 Advancing (timeline broadened)
Financing/runway$36M raised in 2024; plan for 2025 needs Private placement announced ($12.5M) Financing completed + $3.0M warrants; tranche milestones met Strengthened
Visibility/indexationn/an/aAdded to Russell 3000/2000 Improving awareness

Management Commentary

  • “Conducted under an SPA Agreement with the FDA, the Phase 3 trial is a single randomized placebo-controlled trial that, if successful, has the potential to both meet and satisfy the requirements for both accelerated and full approval without the need to conduct a post-accelerated approval confirmatory trial.” — James Bianco, M.D., President & CEO .
  • “We recently bolstered our development pipeline with the acquisition of Kineta and their novel VISTA inhibiting antibody, TBS-2025… We plan to advance TBS-2025 into a randomized Phase 2 trial in… NPM1-mutated AML… in the second half of this year.” .
  • On Phase 3 significance: “a significant milestone… for the 40% to 50% of patients with advanced or metastatic MCC who may not respond to first line treatment with Keytruda” .

Q&A Highlights

  • An earnings call transcript for Q2 2025 was not located in our transcripts corpus for August 2025; key details above are drawn from the company’s 8-K press release and related Q2 press releases .

Estimates Context

  • Q2 2025 vs S&P Global consensus: EPS ($0.21)* vs ($0.135), a miss; consensus revenue modeled at $0.00 (development-stage) [GetEstimates Q2 2025].

  • Forward implications: Higher R&D (Q2 $4.9M vs $2.8M YoY) to support Phase 3 and MCCUP studies may keep near-term EPS below prior expectations unless offset by operating discipline or financing mix; however, execution milestones (Phase 3 progress, TBS-2025 Phase 2 start) are likely the primary drivers of estimate revisions and stock narrative near term .

  • Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Execution quarter: Phase 3 initiation under SPA and Kineta acquisition materially de-risk operational timelines and broaden the late-stage pipeline .
  • Near-term stock catalysts: Phase 3 site activations/enrollment updates by YE 2025; initiation of TBS-2025 Phase 2 in 2H 2025; MCCUP Phase 1b/2a topline in Q1 2026 .
  • Financing reduces near-term funding overhang: $12.5M completed plus $3.0M warrants; tranche triggers tied to FDA and Phase 3 progress achieved .
  • Index inclusion (Russell 3000/2000) may broaden the shareholder base and liquidity into 2H 2025 .
  • Earnings optics will reflect R&D-driven loss profile; R&D rose to $4.9M (Q2) to support clinical execution, with six-month operating cash outflows of ($10.9)M .
  • Estimate alignment: Expect near-term EPS models to reflect higher operating spend and share count (49.9M at 6/30/25) while valuation sensitivity skews to clinical readouts and regulatory milestones rather than near-term P&L .
  • Risk/reward: Key risks include trial timelines, regulatory outcomes, and financing needs through pivotal milestones; key upside lies in successful Phase 3 ORR and PFS outcomes enabling accelerated and potentially full approval without a separate confirmatory trial .

Footnotes

  • Values marked with * are retrieved from S&P Global (Capital IQ).