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ALXO

ALX ONCOLOGY HOLDINGS INC

ALX ONCOLOGY HOLDINGS INC Q4 FY2025 earnings call

February 27, 2026 · fiscal period ended 2025-12

EPS · actual vs est

/ $-0.38

Revenue · actual vs est

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Summary

Generated 2026-02-27

Management highlights

• Jason Lettmann welcomed Barbara Klencke as permanent CMO, highlighted her experience. • Reviewed Q4 2025 and year-to-date accomplishments, focus on execution. • EVO has data from various combos and tumor types, MOA validated. • ALX 2004 in phase 1 trial with progress. • Barbara Klencke detailed clinical data for EVO in HER2-positive gastric and breast cancer, and hematologic malignancy. • Harish Shantharam discussed financials, cash position, milestones including biomarker analysis readout, safety data for ALX 2004, and top-line data for EVO phase 2 breast trial.

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Segment performance

For EVO: Treated over 750 patients to date. In HER2-positive gastric cancer, randomized study showed 65% response rate in CD47 tumors subset, median DOR over 2 years, median PFS 18.4 months, median OS 17 months. In HER2-positive breast cancer phase 2 study, responders were predominantly CD47 overexpressors. Launched phase 2 ASPEN-9 breast trial, expect top-line data for 80 patients in mid-2027. In hematologic malignancy, indolent non-Hodgkin’s lymphoma patients achieved 92% complete response rate with EVO combo. For ALX 2004: Cleared first two dose cohorts, 4 mg/kg dose in phase 1 trial, expect full safety data in second half of 2026.

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Guidance

• Full biomarker analysis readout from phase 1/2 trial evaluating EVO in advanced HER2-positive breast cancer patients to be presented at ESMO Breast Conference in May 2026. • ALX 2004 safety data from dose-escalation phase anticipated in 2026. • Top-line data from ongoing phase 2 ASPEN breast cancer trial for 80 patients anticipated in 2027. • Cash and investments sufficient to fund operating expenses through 2028.

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Q&A highlights

Q: Confirm interim look at 80-patient readout for ASPEN-9, rationale behind upsizing to 120 patients, change in primary endpoint, feedback from investigators on biomarker approach, enrollment trends in ASPEN breast.

A: Correct, guiding to 80-patient full data in mid-2027. Upsizing to ensure robust numbers of patients in various segments. Primary endpoint changed to response rate in CD47 high population. Investigators excited about biomarker selection strategy.

Q: Safe to expect up to four dose levels tested for ALX 2004?

A: Reasonable, progressed from 1 mg/kg to 4 mg/kg without DLTs, expect to get to four doses.

Q: Expected ratio of CD47 high versus low expression in ASPEN-9, impact of chemo options on CD47 expression, monitoring of ILD and skin tox for ALX 2004?

A: Roughly half of population expected to be CD47 high. No major concern about chemo options impacting CD47 expression. Monitor ILD via CT scans, skin tox via regular clinic exams.

Q: CD47 cut point for ASPEN-9, handling of borderline cases with insufficient tissue?

A: Anticipate CD47 expression to be different across tumor types, will run study to understand cut point. Missing tissue not expected to be significant issue as CD47 is relatively stable, IHC is standard assay

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Key numbers

Reported versus consensus

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MetricReportedConsensusDeltaPrior year
EPS$-0.38
Revenue

Transcript

February 27, 2026

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