ALX ONCOLOGY HOLDINGS INC Q3 FY2025 earnings call

Key points include: Significant advances in evorpacept and ALX2004 clinical programs. Data from the ASPEN-06 trial demonstrated CD47 expression as a key predictive biomarker for evorpacept in HER2-positive gastric cancer patients, with high CD47 expression patients showing greater benefit across efficacy markers. The Phase II breast cancer trial for evorpacept is on track to dose the first patient in Q4 2025. ALX-2004 is in the Phase I trial with the first patient dosed in August 2025, and initial safety data is expected in the first half of 2026. There is a partner program with Sanofi Sarclisa in multiple myeloma in the dose optimization phase. Dr. Peter Schmidt from Barts Cancer Institute provided views on evorpacept data in HER2-positive metastatic breast cancer.

Reported a total cash balance of $67 million, with cash expected to provide runway into the first quarter of 2027. Clinical programs for evorpacept and ALX2004 made significant advances, but no specific financial revenue contribution percentages for product segments are provided as the focus is on clinical progress.

Evorpacept in the ASPEN-Breast study is expected to have the first patient dosed in Q4 2025 and interim data in Q3 2026. ALX2004, which had the first patient dosed in August 2025, continues to progress well and is expected to have initial safety data in the first half of 2026.

Q: How to correlate the CD47 positivity shown on Slide 30 with the CD47 expression cutoffs shown in the gastric data?

A: There is a strong scientific basis behind CD47, with promising concordance across indications. In gastric, it was roughly 50-50 in the CD47 high group, and in breast, literature studies show around 50% of patients have CD47 high expression.

Q: Thoughts on companion diagnostic development for evorpacept?

A: Testing was done with a partner for the gastric study, and the same plan is in place for breast. Work is ongoing with partners to operationalize the process prior to the initiation of a Phase III trial for a companion diagnostic.

Q: Data on CD47 high vs low in breast cancer trials and historical breast cancer retrospective studies?

A: In the zani study, evorpacept shows strong response in the CD47 high group. Benchmark data in broad HER2 positive vs CD47 cutoff, and gastric data compares favorably to benchmarks.

Q: Interims next year for the EGFR ADC and breast cancer program, including patient numbers and win views?

A: ALX2004 Phase I trial is moving fast, with initial safety data expected in the first half of 2026. The evorpacept breast trial expects a response rate in the range of 35%-40%, doubling traditional benchmarks.