ALX Oncology (ALXO) 44th Annual J.P. Morgan Healthcare Conference summary

Program highlights and strategic focus

• Advanced two differentiated clinical-stage programs: Evorpacept (CD47 inhibitor) and ALX 2004 (EGFR-targeted ADC), both showing strong progress in trials and multiple clinical milestones expected in 2026.

• Collaborations with Jazz and Sanofi further validated Evorpacept’s efficacy in combination therapies, including bispecifics and hematologic malignancies.

• Aspen breast trial is actively enrolling, targeting post-Enhertu HER2-positive patients, with interim data expected in Q3 2026.

• Projected cash runway extends into Q1 2027, supporting key milestones such as ALX2004 safety data and ASPEN-Breast trial results.

• Partnerships and internal R&D optimization are central to advancing both assets.

Clinical data and biomarker-driven approach

• Evorpacept demonstrated validated mechanism and safety, with focus on breast cancer, multiple myeloma, and high response rates in HER2-positive gastric and breast cancer, especially in CD47-overexpressing subgroups.

• Rituxan/Evorpacept combinations in lymphoma demonstrated high complete response rates, up to 92% in first-line settings.

• Safety profile across 750+ patients is manageable and reversible, with adverse events comparable to control arms.

• Evorpacept blocks CD47-SIRPA interaction, enhancing macrophage-mediated phagocytosis, and its inactive Fc design minimizes toxicity.

• CD47 overexpression is a negative prognostic biomarker, supporting patient selection strategies.

Market opportunity and trial design

• HER2-positive breast cancer post-Enhertu represents a $2–$4 billion market, with 20,000 addressable patients in the U.S.

• Aspen breast trial is an 80-patient, single-arm study with primary endpoint of response rate; interim data expected Q3 2026.

• Future plans include a phase III randomized trial, likely in CD47-selected patients, to support registration.

• Multiple myeloma collaboration with Sanofi (Sarclisa) is progressing, with positive data supporting advancement.

• ALX2004 phase 1 trial enrolling in multiple EGFR-expressing solid tumors, with potential for accelerated approval.