ALX Oncology (ALXO) H.C. Wainwright 28th Annual Global Investment Conference summary

Pipeline progress and clinical strategy

• Advancing two internally developed programs, evorpacept (CD47 blocker) and ALX2004 (EGFR-directed TOP1i ADC), toward key inflection points in 2026 and 2027.

• Evorpacept leverages a unique mechanism separating "don't eat me" and "eat me" signals, showing improved safety and efficacy in over 800 patients.

• ALX2004 is in phase I dose escalation across four high EGFR-expressing tumor types, with safety and dose data expected in the second half of 2024.

• Both programs aim to be ready for registration-level studies within 12 months.

• Active research continues, with potential new pipeline disclosures as programs mature toward IND.

Clinical data and biomarker insights

• CD47 expression has emerged as a predictive biomarker in both gastric and HER2-positive breast cancer studies.

• ASPEN-09 phase II study in HER2-experienced, HER2-positive breast cancer expects topline data in mid-2027.

• Prior studies showed strong benefit in CD47-high populations, with ORR improvements and durable responses.

• Biomarker-driven approach may allow for smaller, more targeted phase III trials.

• Companion diagnostic development is underway with Roche, using standard IHC techniques.

ALX2004 program specifics

• ALX2004 uses a novel matuzumab epitope to minimize EGFR-related toxicities, with no on-target skin toxicities seen in preclinical studies.

• Dose escalation has reached above 4 mg/kg, aiming to define the therapeutic window and show early activity.

• Focus is on lung, head and neck, and esophageal cancers, with colorectal as a challenging but included indication.

• Benchmarking against other TOP1i ADCs, with 4–5 mg/kg as the likely optimal dose range.

• U.S.-only trial sites at top academic centers, enrolling late-line patients.