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Dogwood Therapeutics, Inc. (DWTX)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 was dominated by a one-time acquired IPR&D charge tied to the SP16 licensing deal, driving net loss/EPS to $(15.7)M/$(8.20) vs S&P Global consensus EPS of $(1.58), a significant miss; revenue remained $0 as expected. The step-up in R&D to $14.5M included ~$12.0M acquired IPR&D, the primary driver of the delta . Consensus estimates from S&P Global: EPS $(1.58); revenue $0.0.
  • Execution on clinical milestones remained solid: Halneuron Phase 2b reached 100 patients enrolled (80 completed), with prespecified interim analysis on track for Q4 2025; final 200-patient data targeted for H2 2026 .
  • Strategic expansion: secured an exclusive, worldwide, royalty-free license to develop/commercialize SP16 (LRP1 agonist) for cancer-related pain in an all-stock transaction; SP16 Phase 1b (CINP) to commence post-FDA consult and is fully funded by NCI .
  • Liquidity: cash of $10.1M at 9/30/25 and runway through Q1 2026, reiterated from prior quarters and supported by earlier balance-sheet actions (debt-to-equity conversion and equity raise in Q1) .

What Went Well and What Went Wrong

What Went Well

  • Clinical execution: “recruitment of 100 patients in our ongoing Halneuron Phase 2b trial,” with 80 completions; interim analysis remains on track for Q4 2025 and final 200-patient readout expected H2 2026 . CEO: “The Company continues to execute at a high level…” .
  • Portfolio expansion: exclusive global, royalty-free license for SP16 adds a synergistic, complementary asset for cancer-related pain; SP16 Phase 1b to start after FDA consultation and is fully funded by NCI .
  • Cost discipline in G&A: G&A declined to $1.3M from $1.8M YoY, driven by lower legal/accounting fees and public company costs (partially offset by higher personnel) .

What Went Wrong

  • EPS miss vs consensus: Q3 diluted EPS of $(8.20) vs S&P Global consensus of $(1.58)*, driven by ~$12.0M acquired IPR&D expense recognized in R&D tied to the SP16 license .
  • Elevated R&D: R&D rose to $14.5M vs $0.5M YoY, primarily the acquired IPR&D ($12.0M) plus higher clinical and CMC costs for Halneuron Phase 2b, amplifying the quarterly loss .
  • Continued pre-revenue status: no product revenue this quarter (and in prior quarters), leaving the equity story fully reliant on clinical and regulatory catalysts (e.g., Q4 interim analysis) .

Financial Results

P&L and Per-Share – Quarterly Trend (oldest → newest)

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Revenue ($)$0 $0 $0 $0
Research & Development ($)$535,162 $2,436,998 $2,569,943 $14,521,342
General & Administrative ($)$1,766,010 $1,992,928 $1,353,172 $1,287,783
Total Operating Expenses ($)$2,301,172 $4,429,926 $3,923,115 $15,809,125
Net Loss Attributable to Common ($)$(2,280,684) $(12,181,614) $(3,807,353) $(15,744,616)
Net Loss per Share, Basic & Diluted ($)$(2.05) $(8.45) $(1.99) $(8.20)
Weighted Avg Shares (Basic & Diluted)1,110,317 1,441,535 1,911,128 1,919,433

Notes: Q3 R&D increase primarily reflects ~$12.0M acquired IPR&D tied to the SP16 licensing; higher Phase 2b clinical and development costs also contributed . G&A decreased YoY on lower legal/accounting and public company costs .

Consensus vs Actuals (Q3 2025)

MetricS&P Global ConsensusActual Q3 2025
Revenue ($)$0.0*$0
Primary EPS ($)$(1.58)*$(8.20)
  • The EPS shortfall vs consensus reflects a one-time ~$12.0M acquired IPR&D charge recognized in R&D tied to the SP16 license .

Balance Sheet Snapshot (oldest → newest)

MetricDec 31, 2024Mar 31, 2025Jun 30, 2025Sep 30, 2025
Cash and Equivalents ($)$14,847,949 $17,539,004 $13,402,809 $10,126,710
Total Assets ($)$94,308,246 $96,984,688 $96,692,527 $91,992,613
Total Liabilities ($)$30,027,223 $14,235,733 $14,151,904 $14,607,504
Stockholders’ Equity ($)$(10,124,339) $7,086,931 $6,878,599 $7,258,152

KPIs and Operational Milestones

KPIQ1 2025Q2 2025Q3 2025
Halneuron Phase 2b – Patients EnrolledDosing commenced 52 enrolled 100 enrolled; 80 completed
Discontinuation Rate (first cohort)—5.8% in first 38 completions —
Interim Analysis Timing (CINP Phase 2b)Q4 2025 Q4 2025 (on track) Q4 2025 (on track)
Final Data (200 patients)——H2 2026
Cash RunwayThrough Q1 2026 Through Q1 2026 Through Q1 2026
Pipeline Expansion——SP16 license (exclusive, worldwide, royalty-free)
SP16 Phase 1b Plan/Funding——To start post-FDA consult; fully funded by NCI

Segment breakdown: Not applicable (no revenue) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Halneuron CINP Phase 2b Interim AnalysisQ4 2025Q4 2025 (Q1/Q2 reaffirmations) Q4 2025 (on track) Maintained
Halneuron CINP Phase 2b Final 200-pt DataH2 2026—H2 2026 New
Cash RunwayLiquidityThrough Q1 2026 Through Q1 2026 Maintained
SP16 (LRP1 agonist) ProgramPhase 1b (CINP)—Start post-FDA consultation; fully funded by NCI New

No revenue, margin, tax, or opex dollar guidance provided in the filings/press releases reviewed .

Earnings Call Themes & Trends

Note: No Q3 2025 earnings call transcript was furnished via 8-K; themes below reflect press releases and filings.

TopicPrevious Mentions (Q1–Q2 2025)Current Period (Q3 2025)Trend
R&D execution and enrollmentDosing commenced (Q1) ; 52 enrolled, low discontinuation 5.8% (Q2) 100 enrolled; 80 completed; interim Q4 2025; final H2 2026 Positive progress (on timelines)
Regulatory/designationsHalneuron fast track (reiterated) Fast track reiterated for CINP; SP16 Phase 1b after FDA consult Steady regulatory momentum
Pipeline expansion/licensing—Exclusive, worldwide, royalty-free SP16 license (all stock) Expanded pain pipeline
Funding/liquidityDebt-to-equity conversion; $4.8M equity raise; runway Q1’26 (Q1) Cash $10.1M; runway Q1’26 reaffirmed Stable runway reiterated
Safety/tolerabilityLow discontinuation 5.8% in early completers (Q2) No new safety/tolerability disclosures beyond prior Unchanged disclosures

Management Commentary

  • CEO Greg Duncan (Q3): “The Company continues to execute at a high level, including recruitment of 100 patients in our ongoing Halneuron Phase 2b trial and the addition of… SP16… a novel, first-in-class development candidate for cancer related pain… we look forward to… an update on our interim analysis… in Q4 2025… final data… in the second half of 2026” .
  • CMO Michael Gendreau (Q2, reiterating mechanism relevance): “The NaV 1.7 sodium channel plays a fundamental role in pain transmission… modulation… is likely to be applicable to… chronic and acute pain… Congenital Insensitivity to Pain… illustrates the critical role NaV 1.7… as a pain treatment target” .

Q&A Highlights

  • No Q3 2025 earnings call transcript was furnished via 8-K; no Q&A highlights were available in the company’s Q3 press release or associated filings .

Estimates Context

  • S&P Global consensus (Q3 2025): EPS $(1.58); revenue $0.0. Actual: EPS $(8.20), revenue $0. The EPS miss was largely attributable to a one-time ~$12.0M acquired IPR&D expense recognized within R&D tied to the SP16 license, which materially increased operating expenses in the quarter .
  • Implication: While consensus anticipated a loss (pre-revenue biotech), the magnitude was not aligned with the acquired IPR&D timing. Investors may normalize results by excluding this non-recurring IPR&D charge when assessing underlying burn and runway .
    Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Near-term catalyst: Halneuron Phase 2b prespecified interim analysis due Q4 2025; positive data could be a major stock driver; final 200-patient data expected H2 2026 .
  • Large EPS miss reflects accounting for acquired IPR&D ($12.0M) and higher clinical spend, not a change in revenue trajectory (still $0); focus on operating cadence ex-one-time items .
  • Strategic breadth increased with SP16 (exclusive, worldwide, royalty-free); Phase 1b (CINP) is fully NCI-funded, limiting incremental cash burn for this program’s start-up .
  • Liquidity: $10.1M cash and reiterated runway through Q1 2026; balance-sheet actions earlier in 2025 improved equity (e.g., debt conversion, equity raise) .
  • Operational momentum: enrollment milestones achieved (100 enrolled; 80 completed), low discontinuation in earlier cohorts, and steady regulatory posture (fast track) bolster the Halneuron program’s execution narrative .
  • Risk framing: binary readouts (Q4 interim, H2 2026 final) and continued pre-revenue status keep the story catalyst-driven and sensitive to clinical outcomes .

Citations:

  • Q3 2025 8-K and press release (financial results, pipeline updates, financial tables):
  • Q2 2025 8-K and press release (prior-quarter results, enrollment/tolerability, tables):
  • Q1 2025 8-K and press release (trend analysis, liquidity actions, tables):
  • SP16 licensing 8-K (transaction details, rights, funding):

S&P Global estimates disclaimer: Values retrieved from S&P Global.*