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ALX ONCOLOGY HOLDINGS INC (ALXO)·Q1 2025 Earnings Summary

Executive Summary

  • ALX Oncology’s Q1 2025 print was operationally focused: no revenue, GAAP net loss of $30.8M ($0.58/share) improved YoY on lower R&D, and cash/investments of $107.0M with runway extended into Q4 2026 .
  • Management pivoted its strategy: will not pursue a U.S. registrational path in gastric cancer after FDA feedback on ASPEN-06 and is prioritizing evorpacept combos with anti-cancer antibodies plus the newly cleared ALX2004 EGFR-ADC; Phase 2 ASPEN-Breast, Phase 1 ASPEN-CRC, and ALX2004 Phase 1 are slated to start mid-2025 .
  • Q1 lacked a conference call; the company pre-announced it would not host one, and instead held an R&D webcast on ALX2004 with detailed program design and timelines .
  • Estimate context: S&P Global “Primary EPS” was a slight beat versus consensus (Actual -$0.477 vs -$0.484), but GAAP EPS was -$0.58; limited coverage and non-GAAP normalization likely explain the difference. Expect modest estimate revisions focused on OpEx trajectory and timeline catalysts into 2026 (S&P Global values)*.

What Went Well and What Went Wrong

  • What Went Well

    • Clear strategic focus and pipeline prioritization: evorpacept combinations with anti-cancer antibodies (HERCEPTIN in breast, ERBITUX in colorectal) and the ALX2004 IND clearance, with all three programs targeting mid-2025 starts and 2026 data readouts. “We are now hyper-focused on pursuing the validated mechanism of action for evorpacept in combination with anti-cancer antibodies and delivering data… in 2026.”
    • Cash discipline: runway extended into Q4 2026 through reprioritization; Q1 cash, cash equivalents and investments were $107.0M .
    • Positive final Phase 1 data in B-NHL (evorpacept + R2): 83% CR in indolent R/R B-NHL vs 34% historical CR with R2 alone; Phase 2 previously untreated cohort is fully enrolled .

  • What Went Wrong

    • FDA feedback removed the accelerated approval path in gastric cancer for ASPEN-06; the company will not pursue a U.S. Phase 3 registrational study versus ENHERTU, and is considering partnerships for gastric cancer .
    • ASPEN-03/04 (pembrolizumab combos) did not meet primary endpoints; efficacy did not support advancing those PD-1 combinations into registration despite manageable safety .
    • Urothelial cancer program (PADCEV combo, ASPEN-07) discontinued after final analysis failed to show improved efficacy, narrowing the near-term multi-indication optionality .

Financial Results

Q/Q progression (oldest → newest)

MetricQ3 2024Q4 2024Q1 2025
GAAP Net Loss ($M)$(30.7) $(29.2) $(30.8)
GAAP EPS (basic & diluted)$(0.58) $(0.55) $(0.58)
Total Operating Expenses ($M)$32.6 $30.6 $31.8
R&D Expense ($M)$26.5 $23.5 $23.9
G&A Expense ($M)$6.1 $7.1 $7.9
Cash, Cash Equivalents & Investments ($M)$162.6 $131.3 $107.0

YoY comparison (Q1 2024 vs Q1 2025)

MetricQ1 2024Q1 2025
GAAP Net Loss ($M)$(35.6) $(30.8)
GAAP EPS (basic & diluted)$(0.71) $(0.58)
R&D Expense ($M)$31.7 $23.9
G&A Expense ($M)$6.0 $7.9

Estimate comparison (S&P Global, Q1 2025)

MetricConsensusActualDelta
Primary EPS (SPGI)*-$0.484 (5 est.)*-$0.477*+$0.007*
Revenue (SPGI)*$0.0 (4 est.)*n/a (no revenue)in line*

Notes: No product revenue reported; ALXO is a clinical-stage biotech. GAAP to non-GAAP reconciliation provided for net loss, but no non-GAAP EPS disclosed in the release .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
U.S. registrational path (Gastric, ASPEN-06)2025+Q3’24: Phase 3 initiation mid-2025 envisioned ; Q4’24: regulatory guidance pending in Q2’25 FDA feedback: accelerated approval not feasible; Phase 3 vs ENHERTU needed; ALXO will not pursue U.S. registrational path; may seek partners Lowered/Withdrawn
Cash runwayMulti-yearInto Q4 2026 (Q4’24) Into Q4 2026 reaffirmed (Q1’25) Maintained
ASPEN-Breast startMid-2025Planned mid-2025 (Q4’24) On track mid-2025 Maintained
ASPEN-CRC startMid-2025Planned mid-2025 (Q4’24) On track mid-2025 Maintained
ALX2004 IND/Phase 12025–2026IND planned Mar’25 (Q4’24) IND cleared; Phase 1 to start mid-2025; initial safety data 1H 2026 Raised/De-risked
Urothelial (PADCEV combo)2025Update 1H 2025 (Q4’24) Discontinued after final analysis Lowered/Terminated

Earnings Call Themes & Trends

(“Previous Mentions” summarize Q3’24 and Q4’24 press releases; no Q1’25 earnings call was hosted)

TopicPrevious Mentions (Q3’24, Q4’24)Current Period (Q1’25)Trend
Pipeline prioritization to antibody combosEmphasis on evorpacept combos; ASPEN-06 gastric data; breadth across indications Hyper-focus on evorpacept + anti-cancer antibodies; ASPEN-Breast and ASPEN-CRC starting mid-2025 Sharpened focus
Regulatory path in gastric (ASPEN-06)Q3’24: contemplated Phase 3 mid-2025; Q4’24: regulatory guidance pending FDA: accelerated approval not feasible; no U.S. Phase 3 pursuit; partnering optionality Negative inflection
ALX2004 EGFR-ADCQ4’24: IND planned Mar’25 IND cleared; Phase 1 mid-2025; safety data 1H 2026; deep design rationale via webcast De-risked, progressing
PD-1 combinations (ASPEN-03/04)Topline results pending 1H’25 Did not meet primary endpoints; no registrational path Negative outcome
Cash discipline/runwayQ3’24: well into Q1’26; Q4’24: into Q4’26 via optimization Runway into Q4’26 reaffirmed Stable
Partnerships/ExternalSanofi SARCLISA combo initiated (RRMM) Multiple myeloma combo ongoing; partnering optionality noted Ongoing

Management Commentary

  • “We are now hyper-focused on pursuing the validated mechanism of action for evorpacept in combination with anti-cancer antibodies and delivering data in breast cancer… colorectal cancer… as well as from ALX2004, in 2026.” — Jason Lettmann, CEO .
  • On ALX2004 safety-first and design rigor: “The primary goal… is going to be safety, but we do anticipate seeing efficacy along the way… [We] designed all components of this ADC with an optimized, validated payload and antibody to maximize its potential…” — Management at ALX2004 webcast .
  • On capital strategy: “We have cash well into Q4 of next year… Our goal is to deliver data on this capital… we continue to assess options… both in terms of equity as well as pharma.” — CEO at webcast Q&A .

Q&A Highlights

  • Safety and dose-escalation for ALX2004: Management emphasized safety as the primary early objective, with initial safety dataset anticipated in 1H 2026; efficacy may emerge during escalation in selected EGFR-high tumor types .
  • Tumor selection strategy: Study avoids all-comer design, focusing on four EGFR-overexpressing tumors historically sensitive to EGFR mAbs to increase probability of early signals .
  • Capital allocation/runway: The company aims to deliver catalysts on existing cash into Q4 2026 while maintaining optionality for equity and pharma partnerships; Sanofi-collaboration continues in multiple myeloma .
  • Note: ALXO did not host a Q1 2025 earnings teleconference; investor communications occurred via press releases and the May 20 ALX2004 webcast .

Estimates Context

  • S&P Global Q1 2025 “Primary EPS” was a slight beat: Actual -$0.477 vs Consensus -$0.484 (5 est.); revenue consensus $0 with no product revenue reported (S&P Global values)*.
  • GAAP EPS was -$0.58, reflecting stock-based compensation and other items; the SPGI “Primary EPS” framework likely normalizes some non-cash items, explaining the delta (S&P Global values)*.
  • Given OpEx reductions YoY (R&D down ~$7.8M) and discontinued programs, street models may further trim near-term R&D while shifting valuation focus to 2026 catalysts (ALX2004 safety readout; ASPEN-Breast/CRC interim data) .

Key Takeaways for Investors

  • The thesis pivots from a near-term gastric registrational path to a 2026 catalyst stack focused on evorpacept antibody combinations and ALX2004’s safety readout, de-risked by IND clearance .
  • Cash runway into Q4 2026 provides a window to deliver multiple data points without immediate financing, though optionality for partnerships and capital remains on the table .
  • Discontinuations (PD-1 HNSCC programs; PADCEV urothelial) remove lower-probability/less-differentiated shots and refocus resources, albeit at the cost of breadth .
  • Watch near-term execution: mid-2025 FPI for ASPEN-Breast/CRC and ALX2004 Phase 1 start; any delays could impact sentiment given the 2026 catalyst concentration .
  • The key stock drivers now hinge on: (1) clean ALX2004 safety/PK and early signs in EGFR-high tumors, and (2) evorpacept combo signals with HERCEPTIN and ERBITUX supporting the “antibody combo” thesis .
  • With no Q1 call, use the May 20 webcast materials for qualitative color; further investor events (e.g., Jefferies conference) may offer incremental updates before mid-2025 trial initiations .

Additional Q1 2025 documents reviewed:

  • Q1 2025 8-K 2.02 and press release (financials and corporate update) .
  • ALX2004 webcast press releases and remarks (program design, timelines) .
  • Conference participation notice (Jefferies) .

Prior two quarters for trend analysis:

  • Q4 2024 8-K (financials, ASPEN-06 update, runway to Q4’26, IND plan for ALX2004) .
  • Q3 2024 8-K (financials, ASPEN-06 topline, SARCLISA combo initiation) .

Footnote: *Values retrieved from S&P Global.