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- **CD47 Biomarker Breakthrough**: 65% ORR in CD47 high gastric cancer patients vs. 26% control, validating targeted IL-2 strategy.
- **Pipeline Momentum**: ALX2004 Phase I ADC enrolling, with 2026 interim data and $2B market potential.
- **Financial Strength**: $67M cash runway to Q1 2027, supporting dual Phase II/III milestones.
- **Strategic Focus**: Evorpacept breast cancer trial targeting 80 patients, with 35%+ ORR vs. 20% control arm.

**【CEO Summary Section】**
- Q3 2025 revenue growth driven by CD47 biomarker validation in gastric cancer trials, with 65% ORR in CD47 high patients vs. 26% in control arm.
- Evorpacept Phase II breast cancer trial expected to dose first patient in Q4 2025, targeting CD47 high HER2+ patients post ENHERTU failure.
- ALX2004 EGFR-targeted ADC enrolling in Phase I trial, with first patient dosed in August 2025 and interim safety data expected H1 2026.
- Cash balance of $67M, providing runway to Q1 2027.

**【CFO Financial Commentary】**
- GAAP net income of $420M, with strong cost control and 5% YoY operating expense reduction.
- Evorpacept CD47 high biomarker strategy validated in 7,000+ patients, showing 2x survival benefit in CD47 high vs. low groups.
- ALX2004 Phase I trial demonstrating 1mg/kg safety profile with no EGFR-related toxicity.

**【Q&A Highlights】**
- CD47 high cutoff defined as IHC3+ in ≥10% tumor cells, with 50-60% of HER2+ patients meeting threshold post ENHERTU.
- Companion diagnostic development in collaboration with partners, targeting Phase III readiness.
- Evorpacept breast cancer trial targeting 80 patients, with 35-40% ORR benchmark vs. 20% control arm.
- ALX2004 EGFR ADC Phase I trial progressing to 2mg/kg cohort, with $2B-$4B market potential in EGFR+ solid tumors.
- CD47 overexpression identified as resistance mechanism post ENHERTU, positioning evorpacept as first-line salvage therapy.


ALX Oncology Holdings Inc. (ALXO) Q3 2025 Earnings Call Transcript

- **CD47 Biomarker Breakthrough**: Evorpacept achieves 65% ORR in CD47-high/HER2-positive gastric cancer patients, driving a biomarker-driven strategy for breast cancer expansion.
- **$2-4B Market Opportunity**: 20,000 addressable breast cancer patients with CD47-high/HER2-positive status, targeting post-ENHERTU relapse.
- **ALX2004 Milestone**: First patient dosing in Q3 2023, with safety data expected mid-2024.
- **Extended Cash Runway**: $270M+ cash to Q1 2027, supporting key programs without dilution.

**【CEO Opening Remarks】**
- Announced new data from the ASPEN-06 trial showing CD47 expression as a predictive biomarker for evorpacept efficacy in HER2-positive gastric cancer.
- Highlighted the potential to expand evorpacept into breast cancer and other CD47-overexpressing tumor types.
- Updated guidance on extended cash runway to Q1 2027, enabling focus on key programs (evorpacept in breast cancer and ALX2004).

**【CMO Clinical Update】**
- In ASPEN-06, CD47-high patients achieved 65% ORR vs. 26% in the control arm (p < 0.05), with durable responses across DOR, PFS, and OS.
- Amended Phase II breast cancer trial to prioritize CD47-high/HER2-positive patients, with interim data expected Q3 2026.
- Preclinical data shows CD47 upregulation in HER2-positive breast cancer post-ENHERTU treatment, supporting biomarker-driven strategy.

**【CFO Financial Update】**
- Extended cash runway to Q1 2027 by halting the evorpacept colon cancer program and optimizing clinical trial spend.
- ALX2004 on track to dose first patient in Q3 2023, with initial safety data expected H1 2024.
- Focus on high-value data milestones, including CD47 biomarker validation and ALX2004 proof-of-concept.

**【Q&A Highlights】**
- FDA has approved the amended ASPEN-Breast trial protocol, with no regulatory barriers to implementation.
- Clinicians express enthusiasm for CD47 biomarker strategy, citing unmet need in post-ENHERTU breast cancer.
- Interim data from ASPEN-Breast will focus on response rates ≥40%, with durability as a secondary endpoint.
- CD47 cutoff thresholds will be determined post hoc based on ASPEN-06 data, with no prespecified value in the breast trial.

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