ALX Oncology Holdings (ALXO) investor relations material

Strategic program updates

• Focus shifted to combining evorpacept with anti-cancer antibodies, deprioritizing checkpoint inhibitor combinations, based on clinical potency observed in breast cancer studies.

• Evorpacept demonstrated strong clinical activity in HER2-positive cancers, especially when combined with Fc-active antibodies like Herceptin and Zanidatamab.

• Phase 2 gastric cancer trial showed 41% ORR for evorpacept plus TRP, with even higher response rates in patients retaining HER2 positivity and high CD47 expression.

• FDA did not grant accelerated approval for gastric cancer due to Enhertu’s availability, prompting a strategic pivot to breast cancer and partnership opportunities, especially in Asia.

• Companion diagnostic development for CD47 is underway, with integration into ongoing and future clinical trials.

Clinical trial design and biomarker strategy

• Current phase 2 breast cancer trial evaluates evorpacept plus Herceptin and chemo, stratified by CD47 expression, with interim data expected Q3 2026.

• Protocol amendments incorporated CD47 and HER2 as biomarkers, aiming to identify optimal CD47 cut points for future phase 3 studies.

• Regulatory feedback on the amended protocol was standard, with further FDA discussions planned as data matures in late 2026–2027.

• Future phase 3 studies may use predictive biomarkers for patient selection and ctDNA for HER2 confirmation.

ALX2004 ADC program and competitive positioning

• ALX2004, an EGFR-targeted ADC, was developed in-house with unique epitope and linker payload, aiming to overcome past failures in the field.

• Phase 1 trial targets four tumor types: non-small cell lung, colorectal, head and neck, and esophageal cancers.

• Safety data expected in H1 2026, with efficacy data to follow; initial dose escalation has progressed smoothly.

• Asset is positioned as first-in-class in the U.S., with differentiation from China-based competitors.