ALX Oncology Holdings Inc. reports company news around a clinical-stage oncology pipeline led by evorpacept, an investigational CD47 inhibitor designed to address a cancer immune-evasion signal. Updates commonly cover clinical data presentations, biomarker analyses involving CD47 expression, and studies of evorpacept combinations in HER2-positive cancers, including breast and gastric cancer settings.
The company also reports development activity for ALX2004, an EGFR-targeted antibody-drug conjugate for EGFR-expressing solid tumors. Other recurring updates include quarterly financial results, research and development spending, cash runway commentary, registered offerings of common stock and pre-funded warrants, leadership appointments, investor conference participation, and Nasdaq inducement equity grants.
ALX Oncology (Nasdaq: ALXO) reported Q3 2025 results and a corporate update on Nov 7, 2025. Key clinical highlights from an ASPEN-06 exploratory analysis showed strong benefit for evorpacept in retained HER2-positive, CD47-high gastric cancer: ORR 65.0% vs 26.1%, median DOR 25.5 vs 8.4 months, PFS 18.4 vs 7.0 months (HR 0.39), and OS 17.0 vs 9.9 months (HR 0.63).
ALX remains on track to start Phase 2 ASPEN-09-Breast Cancer enrollment in Q4 2025 with interim data expected Q3 2026. Phase 1 ALX2004 is enrolling (dose cohort 2 at 2 mg/kg) with initial safety data expected in 1H 2026. Q3 cash, cash equivalents and investments were $66.5 million, funding operations into Q1 2027. The company appointed Barbara Klencke, M.D., as interim CMO and will host a webcast on Nov 7, 2025.
ALX Oncology (Nasdaq: ALXO) will report third quarter 2025 financial results and provide a business update on Friday, November 7, 2025 before market open, followed by a teleconference and live webcast at 5:30 a.m. PT / 8:30 a.m. ET.
The company said it will review upcoming data presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting highlighting a full data set showing CD47 overexpression as a potential predictive biomarker for response to evorpacept in HER2-positive gastric/gastroesophageal cancer. A poster (abstract 496) will be presented at SITC on November 8, 2025 and available as an eposter on November 7; presenter: Dr. Zev A. Wainberg.
Webcast and archived replay will be available on the company investor website.
ALX Oncology (NASDAQ: ALXO) presented preclinical data and the Phase 1 trial design for ALX2004, an EGFR-targeted antibody-drug conjugate, at the 2025 AACR-NCI-EORTC conference on October 23, 2025.
The company reported a robust preclinical package supporting differentiation in the EGFR-ADC class, described ALX2004’s matuzumab-derived EGFR antibody, proprietary Top1i payload and linker designed to improve on-target delivery and bystander effect, and confirmed the ongoing first-in-human study (NCT07085091) for advanced/metastatic EGFR-expressing solid tumors.
Enrollment began in August 2025 and initial safety data is anticipated in H1 2026.
ALX Oncology (Nasdaq: ALXO) will present updated Phase 2 ASPEN-06 data at the SITC 40th Annual Meeting (Nov 5–9, 2025) in National Harbor, MD. The poster reports that CD47 expression is a predictive biomarker for response to evorpacept in previously treated HER2-positive gastric and gastroesophageal junction cancer.
ASPEN-06 tested evorpacept combined with trastuzumab, ramucirumab, and paclitaxel. Poster details: Title "CD47 expression as a predictive biomarker for evorpacept in HER2-positive gastric/gastroesophageal cancer from the Phase 2 randomized ASPEN-06 trial," First Author Zev A. Wainberg, M.D., Abstract 496, presented Saturday, November 8, 2025, 10:00 a.m.–6:35 p.m. ET in Poster Hall (Exhibit Halls AB).
ALX Oncology (NASDAQ:ALXO) announced a significant leadership change as Dr. Barbara Klencke, a current board member, has been appointed as Interim Chief Medical Officer (CMO), replacing Dr. Alan Sandler who will return to his position on the company's Board of Directors.
Dr. Klencke brings over 30 years of experience in oncology and drug development, with notable achievements including serving as CMO at Sierra Oncology until its GSK acquisition in 2022. She will oversee the development of ALX's evorpacept and ALX2004 clinical programs, focusing on the company's CD47 blocker and EGFR-targeted antibody-drug conjugate (ADC) pipeline.
ALX Oncology (NASDAQ:ALXO), a clinical-stage biotech company focused on cancer therapies, has announced its participation in two upcoming investor conferences in September 2025. The company will attend the Cantor Global Healthcare Conference on September 3, featuring a fireside chat at 9:45 AM ET, and the H.C. Wainwright 27th Annual Global Investment Conference on September 9.
Both events will be held in New York and will include one-on-one meetings. Webcasts of the presentations will be available on ALX Oncology's website and archived for up to 90 days.
ALX Oncology (NASDAQ:ALXO) has initiated its Phase 1 clinical trial of ALX2004, a potential first-in-class antibody-drug conjugate (ADC) targeting EGFR-expressing solid tumors. The first patient has been dosed in the open-label multicenter study (NCT07085091).
The trial will evaluate ALX2004 in patients with advanced or metastatic solid tumors, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC), and colorectal cancer (CRC). The study comprises Phase 1a dose escalation, dose exploration, and Phase 1b dose expansion portions.
ALX2004 features an optimized design with an affinity-tuned EGFR antibody and proprietary topoisomerase I inhibitor payload. Preclinical data has shown superior stability, dose-dependent activity, and a favorable safety profile without significant EGFR-related skin toxicity. Initial safety data is expected in the first half of 2026.
ALX Oncology (NASDAQ:ALXO) reported significant advances in its clinical programs during Q2 2025. A key highlight was the identification of CD47 expression as a predictive biomarker in HER2+ gastric cancer patients, where CD47-high patients showed a 65% objective response rate with evorpacept combination therapy versus 26% in the control group.
The company has updated its ASPEN-Breast trial design to a single-arm study incorporating CD47 biomarker strategy, with interim data expected in Q3 2026. Additionally, ALX2004, their novel ADC candidate for EGFR-expressing tumors, is set to begin patient dosing in August 2025.
Financially, ALX reported $83.5 million in cash as of June 30, 2025, extending runway into Q1 2027. Q2 net loss was $25.9 million ($0.49 per share), improved from $39.4 million in Q2 2024.
ALX Oncology (NASDAQ: ALXO), a clinical-stage biotechnology company focused on developing cancer therapies, has scheduled its second quarter 2025 financial results announcement for August 12, 2025, after market close.
The company will host a conference call and webcast at 1:30 PM PT / 4:30 PM ET on the same day. Investors can access the event through a webcast or by dialing 1-877-407-0752 (US) or +1-201-389-0912 (International). Presentation slides and an archived recording will be available on the company's website.