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ALX ONCOLOGY HOLDINGS INC (ALXO)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 was a pivotal strategic quarter: ALX refined evorpacept’s development around a biomarker-driven strategy after an exploratory analysis showed materially higher responses in CD47-high, HER2+ patients; cash runway extended into Q1 2027, and ASPEN-CRC was paused to focus resources on ASPEN-Breast and ALX2004 .
  • EPS came in at ($0.49) GAAP vs S&P Global consensus of -$0.45, a modest miss; net loss narrowed year over year and sequentially on lower R&D and G&A, partially offset by a $3.2M impairment tied to preclinical workforce reductions *.
  • Clinical signals strengthened: ASPEN-06 ORR was 65% with evorpacept+TRP in CD47-high, confirmed HER2+ gastric cancer vs 26% for TRP alone, with favorable DOR/PFS/OS; ASPEN-Breast transitioned to a single‑arm design with CD47/HER2 stratification to accelerate a registrational path .
  • Near-term catalysts: ASPEN‑06 full biomarker dataset in Q4 2025; first patient dosed in ALX2004 Phase 1 in August; ASPEN‑Breast FPI in Q4 2025; ASPEN‑Breast interim in Q3 2026 .
  • Stock reaction catalyst: a clear biomarker-led strategy, runway extension, and pause of lower-priority programs could reframe expectations; investors should focus on Q4 biomarker data, ALX2004 safety in 1H26, and ASPEN-Breast interim efficacy in Q3 2026 .

What Went Well and What Went Wrong

What Went Well

  • Biomarker-driven efficacy: In CD47-high, confirmed HER2+ gastric patients (n=43), evorpacept+TRP achieved 65% ORR vs 26% for TRP; CD47-low still showed benefit (39% vs 25%), and DOR/PFS/OS favored evorpacept, supporting a targeted strategy in breast and other tumors .
  • Cost discipline extended runway: Cash runway moved from Q4 2026 to Q1 2027 as resources were reallocated to ASPEN-Breast and ALX2004 (and ASPEN‑CRC paused), enabling multiple 2026 readouts without incremental financing assumptions .
  • Clear strategic messaging and execution: “We are excited to share data demonstrating the potential of CD47 expression as a predictive biomarker…[and] extended our cash runway into the first quarter of 2027,” said CEO Jason Lettmann, highlighting a plan to reach key inflection points while dosing the first ALX2004 patient in August .

What Went Wrong

  • EPS modestly missed consensus: GAAP net loss per share ($0.49) vs S&P Global Primary EPS consensus of -$0.45, reflecting limited revenue generation and the biotech’s R&D cadence; impairment of $3.2M added to quarterly loss *.
  • Regulatory headwinds in gastric: FDA feedback (Q1) made accelerated approval for ASPEN‑06 infeasible vs evolving SOC (ENHERTU), pushing ALX to forego a U.S. registrational path in gastric and reconsider partnering options .
  • Program deprioritizations: ASPEN‑CRC was paused; urothelial PADCEV combo discontinued due to insufficient efficacy improvement; checkpoint inhibitor combos (ASPEN‑03/04) did not meet primary endpoints, consolidating focus to anti‑cancer antibody combinations .

Financial Results

MetricQ4 2024Q1 2025Q2 2025
GAAP Net Loss ($USD Millions)$29.2 $30.8 $25.9
GAAP Net Loss Per Share ($)($0.55) ($0.58) ($0.49)
R&D Expense ($USD Millions)$23.5 $23.9 $18.0
G&A Expense ($USD Millions)$7.1 $7.9 $5.5
Impairment ($USD Millions)——$3.175
Total Operating Expenses ($USD Millions)$30.6 $31.8 $26.6
MetricDec 31 2024Mar 31 2025Jun 30 2025
Cash, Cash Equivalents & Investments ($USD Millions)$131.3 $107.0 $83.5
Total Assets ($USD Millions)$147.8 $120.9 $95.3
Total Liabilities ($USD Millions)$34.2 $32.6 $30.9
Stockholders’ Equity ($USD Millions)$113.6 $88.3 $64.4
MetricQ4 2024Q1 2025Q2 2025
GAAP EPS (Actual) ($)($0.55) ($0.58) ($0.49)
Primary EPS Consensus Mean ($)-0.6415*-0.4842*-0.4506*

Values retrieved from S&P Global.*

KPIs (Clinical efficacy signals):

PopulationORR TRP Alone (%)ORR Evorpacept+TRP (%)mDOR Control (months)mDOR Evorpacept (months)
ITT (HER2+ gastric/GEJ)26.6 41.3 9.1 15.7
Confirmed HER2+ by fresh biopsy or ctDNA24.5 48.9 9.1 15.7
Confirmed HER2+, CD47-high26 65 ——
Confirmed HER2+, CD47-low25 39 ——

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCorporateInto Q4 2026 Into Q1 2027 Raised/extended
ASPEN‑Breast FPITrial startMid‑2025 Q4 2025 Delayed
ASPEN‑Breast InterimData2H 2026 (interim) Q3 2026 Narrowed/timed
ALX2004 First PatientTrial startMid‑2025 August 2025 Timed/maintained
ASPEN‑CRCProgramPhase 1 start mid‑2025 Paused Lowered/paused
ASPEN‑06 CD47 DataReadoutNot previously setQ4 2025 New milestone

Earnings Call Themes & Trends

TopicQ4 2024 (Q‑2)Q1 2025 (Q‑1)Q2 2025 (Current)Trend
Biomarker-driven CD47 strategyEmphasis on evorpacept efficacy in HER2+ gastric; foundational data presented at ASCO GI FDA feedback re: gastric path; strategic prioritization to antibody combinations CD47-high predictive biomarker; ASPEN‑Breast single‑arm with CD47/HER2 stratification Strengthening focus on biomarker targeting
Regulatory/legal (gastric)Momentum from ASPEN‑06 randomized data FDA: accelerated approval infeasible vs ENHERTU; no U.S. Phase 3 pursuit Pursue targeted approach and consider partnerships; data update in Q4 Pivot away from U.S. gastric registrational path
R&D execution/prioritizationLeadership adds; plan to extend runway Workforce reduction; runway to Q4 2026 Pause ASPEN‑CRC; runway to Q1 2027 Opex discipline and focus on highest ROI
ALX2004 ADC programAnnounced and planned IND IND cleared; mid‑year initiation plan First patient dosing in August; initial safety in 1H26 On-track execution
Breast program (HER2+)Promising zanidatamab combo data at SABCS 2024 ASPEN‑Breast design as randomized with Herceptin + chemo Shift to single-arm with biomarker evaluation; interim Q3 2026 Design optimized to accelerate registrational path
PartnershipsJazz (zanidatamab) outcomes presented Lilly supplies CYRAMZA for ASPEN‑06; Sanofi program ongoing Sanofi moves to dose optimization in MM cohort Progressing collaborations

Management Commentary

  • “We are excited to share data demonstrating the potential of CD47 expression as a predictive biomarker … [and] extended our cash runway into the first quarter of 2027, solidly positioning us to achieve multiple data milestones across our pipeline.” — Jason Lettmann, CEO .
  • “The Phase 1 trial of our highly‑differentiated, ADC candidate, ALX2004, … has best‑in‑class potential for the treatment of EGFR‑expressing solid tumors and we anticipate dosing the first patient this month.” — Jason Lettmann, CEO .
  • Call highlight: “There is evidence that CD47 expression increases with subsequent therapy lines, potentially as a resistance mechanism.” — Management on Q&A .

Q&A Highlights

  • Clarifications on biomarker-led strategy: thresholding and stratifying by CD47 and HER2 to maximize evorpacept benefit in post‑ENHERTU breast cancer; single‑arm design aimed to enable a rapid, registrational path .
  • Clinical efficacy context: ITT ORR 41.3% with evorpacept+TRP vs 26.6% control; CD47‑high subset ORR 65% vs 26%; breast cohort with zanidatamab showed 55.6% ORR in centrally confirmed HER2+ patients .
  • Financial runway and prioritization: runway extension to Q1 2027 underpins ALX2004 and ASPEN‑Breast milestones; ASPEN‑CRC pause reallocates resources to programs with strongest probability-adjusted value .

Estimates Context

  • Q2 2025 EPS: GAAP ($0.49) vs S&P Global consensus -$0.4506 → modest miss, driven largely by limited revenue and impairment charges despite disciplined R&D and G&A reductions *.
  • Revenue consensus was $0.0; the company operates with no product revenue, consistent with clinical-stage status [GetEstimates]*.
  • Prior quarters: Q1 2025 EPS (GAAP $0.58) vs consensus -$0.4842; Q4 2024 (GAAP $0.55) vs consensus -$0.6415; modelers may need to adjust OpEx trajectories lower given pipeline prioritization and workforce actions * *.

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • The CD47-high biomarker read-through is the core equity story: evorpacept’s magnitude of benefit is strongest in CD47-high, confirmed HER2+ patients, structurally improving registrational odds in breast and supporting cross‑tumor expansion .
  • Strategy pivot should compress timelines and capital intensity: ASPEN‑Breast single-arm design and program focus raise the likelihood of a faster, biomarker-driven path to registration; watch Q3 2026 interim .
  • Near-term de‑risking catalysts: (1) ASPEN‑06 full biomarker dataset in Q4 2025; (2) ALX2004 Phase 1 initial safety in 1H 2026; both are critical for sentiment and valuation inflections .
  • Financial positioning improved: runway into Q1 2027 allows ALX to reach multiple data readouts without near-term capital; expect opex trends to remain disciplined post reprioritizations .
  • Trading lens: Q4 biomarker data could be a catalyst; downside is limited by opex control, upside depends on durability signals and alignment of biomarker thresholds with clinical outcomes .
  • Medium-term thesis: If ASPEN‑Breast interim shows strong ORR/DOR in CD47‑high post‑ENHERTU patients, evorpacept could open a $2–4B HER2+ 2L+ market (management discussion) and support earlier-line expansion .
  • Risk monitor: Regulatory pathway in gastric deprioritized; continued execution on CD47 stratification and ALX2004 safety profile is essential to maintain momentum .