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ALX ONCOLOGY HOLDINGS INC (ALXO)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 delivered disciplined execution: GAAP net loss improved to $22.1M with EPS of $0.41 vs $0.58 in Q3 2024, driven by lower R&D and G&A; non-GAAP net loss was $19.6M .
  • Cash, cash equivalents and investments were $66.5M; the company reiterated runway into Q1 2027, sufficient to reach ALX2004 initial safety data (1H 2026) and ASPEN-09-Breast interim (Q3 2026) .
  • Clinical narrative strengthened: ASPEN-06 exploratory analysis showed evorpacept markedly improves ORR, DOR, PFS (HR=0.39) and OS (HR=0.63) in HER2+ gastric cancer with CD47-high expression; management is pivoting to a CD47 biomarker-driven strategy in HER2+ breast cancer (ASPEN-09) .
  • Estimates context: Q3 EPS of $0.41 missed Wall Street consensus of $0.3725*, while revenue was in-line at $0.0* given the clinical-stage profile (no product revenue). Stock catalysts: SITC data validation of CD47 biomarker, ASPEN-09 FPI in Q4 2025, ALX2004 dose escalation progress .

What Went Well and What Went Wrong

What Went Well

  • Validated CD47-high biomarker: Evorpacept + TRP achieved 65.0% ORR vs 26.1% control, DOR 25.5 vs 8.4 months, PFS 18.4 vs 7.0 months (HR=0.39), and OS 17.0 vs 9.9 months (HR=0.63) in retained HER2+ gastric cancer with CD47-high expression .
  • Clear strategic focus: Company discontinued PD‑1 combination paths (ASPEN‑03/04 didn’t meet primary endpoints) and prioritized combinations that induce ADCP (e.g., trastuzumab, rituximab) to align with evorpacept’s mechanism .
  • Pipeline momentum: ASPEN‑09 on track for FPI in Q4 2025; ALX2004 cleared first cohort (1 mg/kg) with no DLTs and is enrolling the 2 mg/kg cohort; initial safety data expected 1H 2026 .

Quotes:

  • “The magnitude of benefit…was double or even triple” in CD47-high patients; median PFS 18.4 months vs 7 months, HR 0.39 .
  • “We are currently enrolling the second dose cohort at 2mg/kg after clearing the dose 1 cohort” (ALX2004) .
  • “Cash is expected to provide us runway into the first quarter of 2027” .

What Went Wrong

  • PD‑1 combinations underperformed: ASPEN‑03/04 did not meet primary endpoints; company will not pursue evorpacept + PD‑1 inhibitors further .
  • Sequential cash draw: Cash declined to $66.5M from $83.5M in Q2 and $107.0M in Q1 as operations continued, though runway extended through Q1 2027 .
  • R&D reductions reflect pipeline reprioritization: R&D was cut YoY by $9.0M on lower stock comp, personnel, clinical material manufacturing, and preclinical costs (offset by $2.5M milestone), highlighting caution on spend and slowed breadth of programs .

Financial Results

Income Statement and EPS Trends

MetricQ3 2024Q1 2025Q2 2025Q3 2025
GAAP Net Loss ($USD Millions)$30.7 $30.8 $25.9 $22.1
Non-GAAP Net Loss ($USD Millions)$23.7 $25.5 $23.7 $19.6
Net Loss per Share (EPS, $USD)$0.58 $0.58 $0.49 $0.41
R&D Expense ($USD Millions)$26.5 $23.9 $18.0 $17.4
G&A Expense ($USD Millions)$6.1 $7.9 $5.5 $5.1

Liquidity

MetricQ1 2025Q2 2025Q3 2025
Cash, Cash Equivalents & Investments ($USD Millions)$107.0 $83.5 $66.5

EPS vs Wall Street Consensus (S&P Global)

MetricQ3 2025 ActualQ3 2025 ConsensusQ4 2025 Consensus
EPS ($USD)$0.41 $0.3725*$0.35*
Revenue ($USD Millions)0.0*0.0*0.0*
# EPS Estimates—4*3*
# Revenue Estimates—4*4*

Values retrieved from S&P Global.*

KPIs (Operating Discipline and Program Milestones)

KPIQ1 2025Q2 2025Q3 2025
Cash Runway GuidanceInto Q4 2026 Into Q1 2027 Into Q1 2027
ALX2004 Clinical StatusIND cleared; mid-2025 start First dosing Aug 2025; Phase 1 underway 2 mg/kg cohort; initial safety data 1H 2026
ASPEN-09 (HER2+ Breast)Mid-2025 start plan Design amended; FPI Q4 2025 FPI Q4 2025; interim Q3 2026

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayCorporateQ4 2026 Q1 2027 Raised runway (extended)
ASPEN-09 FPIQ4 2025Mid-2025 plan Q4 2025 on track Slipped to Q4; now on track
ASPEN-09 InterimQ3 20262H 2026 Q3 2026 Narrowed to Q3
ALX2004 initial safety1H 20261H 2026 1H 2026 Maintained
PD‑1 combinationsMultiEvaluating Not pursuing (ASPEN‑03/04 failed) Lowered/terminated
ASPEN‑CRCCRCStart mid-2025 Paused to extend runway Lowered/paused

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
CD47 biomarker validationPre-planned ASPEN‑06 analysis indicated CD47‑high benefit; full data in Q4 Strong ORR/DOR/PFS/OS gains in CD47‑high gastric; biomarker to drive breast strategy Strengthening; central to strategy
PD‑1 combosASPEN‑03/04 topline negative; signals manageable safety Formal decision to discontinue PD‑1 combos De‑prioritized
HER2+ breast strategyMid‑2025 start; combo with trastuzumab + chemo Single‑arm, CD47 stratification; FPI Q4 2025; KOL endorsement Clarified, biomarker‑driven
EGFR ADC (ALX2004)IND cleared; start mid‑2025 First cohort cleared; 2 mg/kg dosing; safety update 1H 2026 Positive early execution
Cash disciplineWorkforce reduction and reprioritization extended runway to Q4 2026 Runway extended to Q1 2027 Further extended
Regulatory/macroFDA feedback: gastric AA not feasible; pivot away from U.S. gastric registration Comparator context vs DESTINY‑Gastric04; favorability in CD47‑high Repositioned program focus

Management Commentary

  • “Patients with high CD47 expression derived the greatest benefit across all key efficacy markers…response rates, duration of response, median PFS, and overall survival” .
  • “We are currently enrolling the second dose cohort at 2mg/kg after clearing the dose 1 cohort…we look forward to providing…initial safety data…in the first half of next year” .
  • “Cash is expected to provide us runway into the first quarter of 2027…to achieve value‑enhancing data milestones for both ALX‑2004 and evorpacept” .
  • KOL perspective: “There is significant unmet need post T‑DXd…evorpacept has a different mode of action…safety profile…more favorable compared to ADCs” .

Q&A Highlights

  • Companion diagnostic strategy: ALXO is using an IHC research-use assay in ASPEN‑09; working with partners to operationalize a CDx path ahead of Phase 3 .
  • CD47‑high prevalence and cutoffs: Literature suggests ~50% CD47‑high across HER2+; consistent with gastric data and supports trial feasibility .
  • Breast efficacy bar: Management targets 35–40% ORR vs real-world 15–20% post‑ENHERTU with trastuzumab+chemo backbones; gastric data guides expectations .
  • ALX2004 near‑term goals: Clear safety questions in Phase 1 dose escalation; early progress with rapid cohort advancement .

Estimates Context

  • Q3 EPS of $0.41 vs consensus $0.3725* was a modest miss, consistent with ongoing clinical investments and lower interest income vs prior year .
  • Revenue remained in-line at $0.0*, reflecting the clinical-stage, non-commercial profile; estimate counts were limited (EPS: 4, revenue: 4)*.
  • Forward quarter (Q4 2025) consensus implies similar EPS trajectory at $0.35*, with no product revenue expected*. Values retrieved from S&P Global.*

Key Takeaways for Investors

  • The CD47‑high biomarker is emerging as a potent differentiation vector; ASPEN‑09 is a key 2026 catalyst to translate gastric biomarker success to HER2+ breast .
  • Strategic focus away from PD‑1 combinations removes underperforming paths and concentrates capital on ADCP‑aligned combinations and the EGFR ADC .
  • Runway into Q1 2027 reduces near‑term financing risk and aligns with multiple readouts (ALX2004 1H 2026; ASPEN‑09 Q3 2026) .
  • Near-term catalysts: SITC data proliferation, ASPEN‑09 FPI in Q4 2025, ALX2004 dose escalation updates; watch for companion diagnostic development clarity .
  • Tactical trading: Expect sentiment volatility around biomarker generalizability to breast; upside if early ASPEN‑09 responses track toward the 35–40% bar management outlined .
  • Medium-term thesis: If CD47‑high selection consistently drives superior outcomes, evorpacept could anchor a first‑in‑class targeted IO approach in HER2+ tumors; ALX2004 offers optionality across EGFR‑expressing cancers .
Sources: Q3 2025 8‑K and press release **[1810182_0001193125-25-271112_alxo-20251107.htm:1]** **[1810182_0001193125-25-271112_alxo-ex99_1.htm:3]** **[1810182_f4ed154928e7459cbdbf968a1f111f0b_4]**-**[1810182_f4ed154928e7459cbdbf968a1f111f0b_8]**; Q3 2025 earnings call transcript **[0001810182_2270627_1]**-**[0001810182_2270627_14]**; Q2 2025 8‑K and press release **[1810182_0000950170-25-107277_alxo-ex99_1.htm:0]**-**[1810182_0000950170-25-107277_alxo-ex99_1.htm:5]** **[1810182_bbab1d44f0404911bf58eee1cba1006c_1]**-**[1810182_bbab1d44f0404911bf58eee1cba1006c_9]**; Q1 2025 8‑K **[1810182_0000950170-25-066440_alxo-ex99_1.htm:0]**-**[1810182_0000950170-25-066440_alxo-ex99_1.htm:5]**.