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ALX Oncology Holdings Inc 2025年度报告

2026-04-20 美股财报 有梦想的人不睡觉
报告封面

Dear Fellow Shareholders, 2025 was a year of strong execution and meaningful scientific progress for ALX across both of ourprograms. I am pleased to report that our clinical development timelines remain firmly on track and that weare entering the next 12-18 months with more confidence in where our science is headed, and what it can dofor patients. The recent financing in Q1 ’26 also gives us strength in our balance sheet to execute on ourongoing clinical trials and move towards key milestones across both our programs. Evorpacept: Strong Confidence Built Over 800+ Patient Experience Based on our learnings from over 800 patients across more than a dozen clinical trials we are prioritizingevorpacept development in combination with anti-cancer antibodies that directly induce antibody-dependentcellular phagocytosis (ADCP), the primary proposed mechanism of action for evorpacept. The mechanism ofcombining evorpacept with Fc active antibodies has been validated across 5 different cohorts in multipletumor settings. This data validates our approach and will continue to anchor our go-forward strategy. CD47 as Biomarker: Two Datasets, One Consistent Story In November 2025 at the Society for Immunotherapy of Cancer conference, we shared biomarker data fromour HER2 positive gastric study, showing a compelling clinical response across all efficacy measures inHER2+ gastric cancer patients with high CD47 expression. Shortly after, top-line data from the Phase 1study of evorpacept and zanidatamab breast cancer trial delivered a second independent validation, whereresponders were largely restricted to CD47 over expressers. Across two datasets, there is one consistentbiomarker story. ASPEN-Breast Ph2 Trial: On Track for Mid 2027 Readout These findings sharpen our conviction in ASPEN-Breast, our Phase 2 trial in HER2-positive breast cancerevaluating patient responses by CD47 level. Site activations are progressing globally at a strong pace andenrollment is tracking to plan. We continue to expect top line data for 80 patients in mid 2027. With over50,000 patients in this setting, Evorpacept has the potential to be both a best in class and first-class option –and the only therapy designed to directly address CD47 expression in this population to date. ALX2004: Progressing Per Plan Our novel Epidermal Growth Factor Receptor (EGFR) targeted Antibody-Drug Conjugate (ADC), ALX2004is also advancing well and on track. We have cleared the first two dose cohorts in our phase 1 dose escalationstudy targeting EGFR over expressing tumors in Lung, Head & Neck, Colorectal and Esophageal cancers.We expect full safety data from the dose escalation cohort in the second half of 2026. Given thedifferentiated design built to overcome some of the traditional EGFR toxicities that have constrained priorEGFR ADCs, we believe ALX2004 has the potential to address significant gaps in the standard of care inmultiple cancers. What It All Means for Patients The patients our programs target have often exhausted standard options. We are excited with the potentialthat both our programs have to offer for these patients. I look forward to sharing more at our annual Investor Meeting and am deeply grateful for your continuedsupport and partnership. Jason LettmannChief Executive Officer Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YESնNOշ Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90days. YESշNOն Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). YESշNOնIndicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 ofthe Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act.ն If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect thecorrection of an error to previously issued financial statements.ն SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Ann