ALX Oncology (ALXO) Status Update summary

Strategic vision and development priorities

• Focused on advancing evorpacept through multiple FDA registration paths, prioritizing combinations with anti-cancer antibodies, checkpoint inhibitors, and ADCs, targeting large oncology markets.

• Launching new clinical trials in breast and colorectal cancer, with first patient dosing expected mid-2025, and expanding into additional tumor types and combinations.

• Aggressive cost-cutting and prioritization, including a 30% reduction in force and decreased preclinical investments, have extended the cash runway into Q4 2026.

• New guidance provided on upcoming data catalysts over the next 12–18 months, including key readouts and regulatory milestones.

Clinical and preclinical program updates

• Evorpacept demonstrated robust activity and favorable safety in six clinical studies, including positive randomized data in gastric, breast, and hematologic cancers.

• Multiple registration paths are being pursued: ASPEN-06 (gastric), ASPEN-Breast, ASPEN-CRC, and ASPEN-03/04 (HNSCC), with several studies launching or reading out in 2025 and 2026.

• New phase 2 trials in breast and colorectal cancer will use fresh biopsies and ctDNA for patient selection, aiming for meaningful ORR improvements over benchmarks.

• ALX2004, a differentiated EGFR-targeted ADC, is set for IND submission in Q1 2025, with early safety data expected in 1H 2026.

Market opportunity and commercial outlook

• Evorpacept’s broad combineability with blockbuster oncology drugs positions it for significant commercial impact, targeting over 100,000 patients in breast and colorectal cancer alone.

• The mechanism of action enables synergy with established therapies, offering a favorable safety profile and potential expansion into earlier lines of treatment.

• Partnerships, such as with Sanofi in multiple myeloma, further expand the addressable market and development opportunities.