ALX ONCOLOGY HOLDINGS INC Q2 FY2025 earnings call

Key managerial messages include: New data from ASPEN-06 trial shows CD47 expression as a key predictive biomarker for evorpacept, with high CD47 expression patients deriving greater benefit. Modified Phase II breast cancer trial to use CD47 and HER2 biomarker-driven strategy. Novel EGFR-targeted ADC, ALX2004, set to enter clinic soon. Partnered UMBRELLA study with Sanofi in multiple myeloma completed phase, moving to dose optimization. Cash runway extended to Q1 2027 by prioritizing efforts and managing clinical spend.

Forward-looking statements include: Cash runway extended to Q1 2027. Clinical trial spend decline as legacy evorpacept trials close out. ALX2004 on track to dose first patient later this month.

Q: Do you need to meet with FDA to finalize trial design changes for ASPEN-Breast? Or are there any other barriers to implementing the biomarker strategy in the trial?

A: We did submit the amendment for the ASPEN-Breast study to FDA and are ready to go; no holdup from FDA.

Q: Could you just frame for us investigator feedback on the CD47 biomarker approach? How you think that it could affect enrollment trends?

A: Enthusiasm is high; clinician feedback has been great, and it's a unique story for patients progressing on ENHERTU.

Q: Just on the interim look for ASPEN-Breast in Q3 next year. Maybe just frame for us what kind of data you would need to see to give you confidence to continue pursuing that biomarker approach in breast or other tumor types?

A: Looking for response rates in the high 30s or greater, associated with durability.

Q: Can you clarify if you intend to pursue a registrational path with the current Phase II study or you will need to run a separate study to support registration?

A: Goal is to use data for decision-making; accelerated approval path possible if data is compelling.

Q: How do you address contribution of components question for the study?

A: Study is HERCEPTIN and single-agent chemotherapy of dealer's choice; Evo is the added component.

Q: Did you look at this correlation between CD47 expression and response in any of the other studies with evorpacept? And then if so, did the data replicate?

A: Actively looking at other data sets, but need to be cautious across different mechanisms; more to come.

Q: I have a quick follow-up on the 10% IHC3 cutoff. Sounded like this biomarker analysis was prespecified, but this threshold wasn't. If you could clarify quickly, am I understanding this correctly? And when you make the protocol change to the breast cancer study, would you prespecify a threshold? Or will that be dependent on the data analysis?

A: Biomarker analysis was prespecified, cutoff wasn't; protocol change doesn't predefine a threshold yet, will depend on data analysis.