Sign in

You're signed outSign in or to get full access.

TB

TuHURA Biosciences, Inc./NV (HURA)·Q3 2025 Earnings Summary

Executive Summary

  • Pre-revenue quarter; reported net loss of $7.10M and EPS of $-0.14, modestly better than S&P Global consensus EPS of $-0.15; revenue remained $0 as expected *.
  • Guidance timelines were pushed out: IFx‑2.0 Phase 3 topline moved from 2H 2026 to Q1 2027; TBS‑2025 Phase 2 initiation slipped from 2H 2025 to Q1 2026 .
  • Liquidity tightened: cash fell to $2.70M with Q3 operating cash outflow of ~$11.1M*; management disclosed substantial doubt about going concern and executed a $3.0M bridge loan; an up-to-$50M ATM was filed but awaits S-3 effectiveness .
  • Strategic visibility improved via ASH oral/poster acceptances on Delta Opioid Receptor (DOR) and leadership hire (VP Immunology), supporting the immuno-oncology platform narrative .

Values retrieved from S&P Global for starred items.

What Went Well and What Went Wrong

What Went Well

  • Phase 3 SPA-backed trial for IFx‑2.0 in first-line MCC is underway; CEO emphasized potential to satisfy both accelerated and regular approval “without the need to conduct a post-approval confirmatory trial” .
  • Scientific validation: ASH accepted an oral and two posters on DOR biology; management highlighted DOR as “a novel shared target” to overcome resistance and enable immune-modulating ADCs .
  • Organization strengthened: appointment of Michael Turner, Ph.D., as VP Immunology (20+ years industry experience), bolstering discovery and translational capabilities .

What Went Wrong

  • Timelines slipped: IFx‑2.0 Phase 3 topline now Q1 2027 (vs 2H 2026 prior); TBS‑2025 Phase 2 now Q1 2026 (vs 2H 2025 prior), delaying key catalysts .
  • Cash burn and runway risk: Q3-end cash $2.70M; nine-month operating cash outflow $22.1M; management flagged “substantial doubt” about going concern over next 12 months .
  • Dilution/funding overhang: filed $50M ATM and executed a $3.0M bridge loan; equity and warrant activity remains active, indicating continued external financing reliance .

Financial Results

MetricQ1 2025Q2 2025Q3 2025
Revenue ($USD Millions)$0.00 $0.00 $0.00
Net Loss ($USD Millions)$(6.66)*$(9.52)*$(7.10)
EPS ($USD)$-0.15*$-0.21*$-0.14
Research & Development ($USD Millions)$4.60 $4.90 $4.97
Total Operating Expenses ($USD Millions)$7.02 $5.98*$6.73

Values retrieved from S&P Global for starred items.

Liquidity & Cash Burn KPIsQ1 2025Q2 2025Q3 2025
Cash & Equivalents ($USD Millions)$6.22 $8.51 $2.70
Cash from Operations ($USD Millions)$(4.74)*$(6.25)*$(11.09)*

Values retrieved from S&P Global for starred items.

Capitalization KPIQ1 2025Q2 2025Q3 2025
Shares Outstanding (Millions)43.7 49.9 51.2

Note: Company operates in a single segment (cancer treatment); no revenue and no segment breakdown .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
IFx‑2.0 Phase 1b/2a MCCUP preliminary resultsQ2/Q1 2026Q1 2026 topline Q2 2026 preliminary results Delayed
IFx‑2.0 Phase 3 enrollment completionQ4 2026Not specifiedQ4 2026 completion of enrollment New milestone
IFx‑2.0 Phase 3 topline results2H 2026 vs Q1 20272H 2026 topline Q1 2027 topline Delayed
TBS‑2025 Phase 2 initiation (mut NPM1 AML + menin inhibitor)Q1 20262H 2025 initiation Q1 2026 initiation Delayed
Lead DOR inhibitor selection for ADCQ1 20262025 non-clinical data presentations Q1 2026 lead selection; Q3 2026 in vivo PoC Refined/Delayed
ATM ProgramOngoingNoneFiled $50M ATM (pending S-3 effectiveness) New

Earnings Call Themes & Trends

No Q3 2025 earnings call transcript was available; themes below reflect press releases and 10‑Q MD&A .

TopicPrevious Mentions (Q2 and Q1)Current Period (Q3 2025)Trend
IFx‑2.0 clinical progressPhase 3 initiated; MCCUP 1b/2a initiated Phase 3 underway under SPA; MCCUP results targeted Q2 2026 Continued execution; timeline extended
TBS‑2025 (VISTA mAb)Acquisition of Kineta; plan to start Ph2 in 2H 2025 Protocol submission Q4 2025; Ph2 start Q1 2026 Slight delay; advancing to Ph2
DOR platform visibility2025 non-clinical data target ASH oral/posters accepted; TAM/MDSC targeting highlighted Strengthening scientific validation
Funding/liquidityEquity financing ($12.5M) and warrants; index inclusion Cash $2.70M; bridge loan $3.0M; $50M ATM filed; going concern flagged Increased funding need; dilution overhang
Regulatory/processPartial clinical hold lifted; SPA in place SPA reiterated; FDA/government shutdown risk disclosure Stable regulatory path; macro risk noted
Organization/talentBoard/leadership hires VP Immunology hire (Michael Turner, Ph.D.) Building R&D capabilities

Management Commentary

  • “This accelerated, registration-directed trial, conducted under an SPA Agreement with the FDA, has the potential, if successful, to satisfy the requirements for both accelerated and regular approval without the need to conduct a post-approval confirmatory trial.” – James Bianco, M.D., CEO .
  • “We are on track to submit our proposed Phase 2 plan to FDA next month and initiate the Phase 2 randomized study in the first quarter of next year.” – James Bianco, M.D., CEO .
  • “We believe that the DOR represents a novel shared target for pharmacologic intervention to overcome resistance to cancer immunotherapies… to create a new class of immune-modulating ADCs.” – James Bianco, M.D., CEO .

Q&A Highlights

No Q3 2025 earnings call transcript was available; no Q&A themes or clarifications to report. Management commentary is derived from the earnings press release and 10‑Q .

Estimates Context

MetricConsensus (Q3 2025)Actual (Q3 2025)Surprise
EPS ($USD)$-0.15*$-0.14 Beat by $0.01
Revenue ($USD Millions)$0.00*$0.00 In line
EPS – # of Estimates1*——
Revenue – # of Estimates3*——

Values retrieved from S&P Global for starred items.

Interpretation: With no revenue and a single EPS estimate, the modest EPS beat likely reflects lower-than-expected operating expense run-rate and grant income offset; however, cash burn and delayed timelines are the dominant drivers for estimate revisions and valuation .

Key Takeaways for Investors

  • The platform is advancing under FDA SPA with meaningful potential regulatory efficiency, but topline timelines were pushed out (IFx‑2.0 Q1 2027), extending the path to value inflection .
  • Liquidity is tight (cash $2.70M; nine-month CFO $(22.1)M), with substantial doubt about going concern; short-term trading likely hinges on S‑3 effectiveness and ATM utilization/dilution expectations .
  • Near-term catalysts: ASH presentations (Dec 6–9) on DOR biology and MCC program updates; potential protocol submission for TBS‑2025 in Q4 2025 .
  • Strategic optionality: bridge loan and ATM provide funding paths; watch for partnering or grant inflows to reduce dilution risk .
  • Expense discipline matters: Operating expenses were $6.73M in Q3; any deceleration could support EPS vs micro-consensus while preserving runway .
  • Pipeline breadth is a differentiator (IFx‑2.0, TBS‑2025, DOR ADCs), but execution risk and macro/regulatory timing remain elevated; monitor enrollment progress and manufacturing scaling .
  • For medium-term thesis, the SPA-backed MCC program and DOR ADC concept offer asymmetric upside if timelines are met and capital is secured; interim data in 2026/2027 will be decisive .

Appendix: Additional Data

  • Balance Sheet snapshot (Q3 2025): Cash & equivalents $2.70M; Total assets $25.70M; Total liabilities $8.92M; Equity $16.78M .
  • Cash flows (9M 2025): CFO $(22.07)M; CFI $(1.31)M; CFF $13.42M .
  • Share count (as of Nov 12, 2025): 51,258,085 common shares outstanding .
  • ATM status: S‑3 filed Nov 3; not yet declared effective; no sales until effective .

Values retrieved from S&P Global for starred items.