ALX Oncology Holdings (NasdaqGS:ALXO) Conference November 19, 2025 06:30 AM ET Company ParticipantsJason Lettmann - CEOHarish Shantharam - CFOConference Call ParticipantsRoger Song - Senior Equity Research AnalystRoger SongGood morning, everyone. Welcome to Jefferies London Healthcare Conference 2025. My name is Roger Song, one of the senior analysts covering SIMCA Biotech in the U.S.. It is my pleasure to have a fireside chat with the next company, ALX Oncology. Welcome, Jason and Harish.Jason LettmannThan ...

Core Insights - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment and improving patient survival [1][3] - The company will participate in two significant healthcare conferences: the Jefferies Global Healthcare Conference in London and the Piper Sandler 37th Annual Global Healthcare Conference in New York [1][2] Conference Details - Jefferies Global Healthcare Conference: - Format: Fireside Chat - Date: November 19, 2025 - Time: 11:30 AM GMT / 6:30 AM EST - Location: London, UK [2] - Piper Sandler 37th Annual Global Healthcare Conference: - Format: Fireside Chat - Date: December 3, 2025 - Time: 9:30 AM EST - Location: New York, NY [2] Company Pipeline - ALX Oncology's lead candidate, evorpacept, is positioned as a potential cornerstone therapy in immuno-oncology and is undergoing multiple clinical trials across various cancer indications [3] - The second candidate, ALX2004, is an EGFR-targeted antibody-drug conjugate that began Phase 1 trials in August 2025 [3]

Core Insights - ALX Oncology Holdings Inc. is a clinical-stage biotechnology company focused on developing novel cancer therapies aimed at extending patients' lives [3] - The company will participate in two significant healthcare conferences: the Jefferies Global Healthcare Conference in London and the Piper Sandler 37 Annual Global Healthcare Conference in New York [1][2] Conference Details - Jefferies Global Healthcare Conference: - Format: Fireside Chat - Date: November 19, 2025 - Time: 11:30 AM GMT / 6:30 AM EST - Location: London, UK [2] - Piper Sandler 37 Annual Global Healthcare Conference: - Format: Fireside Chat - Date: December 3, 2025 - Time: 9:30 AM EST - Location: New York, NY [2] Company Pipeline - ALX Oncology's lead candidate, evorpacept, is being evaluated in multiple clinical trials across various cancer indications and is positioned as a cornerstone therapy for future immuno-oncology developments [3] - The second candidate, ALX2004, is an EGFR-targeted antibody-drug conjugate that began Phase 1 trials in August 2025 [3]

Q3 2025 Results November 7, 2025 NASDAQ GS ALXO Certain information set forth in this presentation contains "forward-looking information", under applicable laws collectively referred to herein as forward-looking statements. Except for statements of historical fact, information contained herein constitutes forward-looking statements and includes, but is not limited to the (i) results and cost and timing of our product development activities and clinical trials; (ii) completion of the Company's clinical trial ...

Core Insights - ALX Oncology reported financial results for Q3 2025, highlighting advancements in its clinical pipeline and financial position [1][3][13] Financial Performance - Cash, cash equivalents, and investments as of September 30, 2025, were $66.5 million, sufficient to fund operations into Q1 2027 [13][18] - R&D expenses for Q3 2025 were $17.4 million, a decrease from $26.5 million in Q3 2024, primarily due to reduced stock-based compensation and clinical development costs [13][16] - GAAP net loss for Q3 2025 was $22.1 million, or $0.41 per share, compared to a net loss of $30.7 million, or $0.58 per share, in Q3 2024 [13][16] Clinical Developments - Data from the ASPEN-06 trial showed that evorpacept combined with trastuzumab, ramucirumab, and paclitaxel achieved a 65.0% objective response rate in HER2-positive gastric cancer patients with high CD47 expression [5][6] - The Phase 2 ASPEN-09-Breast Cancer trial is set to begin enrollment in Q4 2025, evaluating evorpacept's efficacy based on CD47 expression levels [4][8] - The Phase 1 trial for ALX2004, an EGFR-targeted antibody-drug conjugate, is currently enrolling patients and is on track to deliver initial safety data in the first half of 2026 [4][9] Upcoming Milestones - Initial safety data for ALX2004 is expected in 1H 2026, with interim data for ASPEN-09-Breast Cancer anticipated in Q3 2026 [4][7] - The company appointed Barbara Klencke, M.D., as Chief Medical Officer, bringing over 30 years of experience in oncology drug development [4][8]

Core Insights - ALX Oncology plans to report its third quarter 2025 financial results and provide a business update on November 7, 2025, before market open [1] - The company will highlight data on CD47 overexpression as a potential predictive biomarker for evorpacept in HER2+ gastric cancer during the Society for Immunotherapy of Cancer (SITC) Annual Meeting [1][3] Financial Results Announcement - The financial results will be discussed in a teleconference scheduled for November 7, 2025, at 5:30 a.m. PT / 8:30 a.m. ET [2] - Access to the conference call can be made via phone or through a live audio webcast available on the company's website [2] Clinical Development - Evorpacept, the lead therapeutic candidate of ALX Oncology, is being evaluated in multiple ongoing clinical trials across various cancer indications [4] - The second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate that entered Phase 1 trials in August 2025 [4] Upcoming Presentation - A poster presentation titled "CD47 expression as a predictive biomarker for evorpacept in HER2-positive gastric/gastroesophageal cancer" will be presented at SITC on November 8, 2025 [3]

Core Insights - ALX Oncology is advancing ALX2004, a novel antibody-drug conjugate (ADC) targeting EGFR-expressing solid tumors, with promising preclinical data supporting its potential as a first-in-class treatment [1][2][6] - The ongoing Phase 1 trial for ALX2004 aims to evaluate its safety, tolerability, and preliminary efficacy, with initial safety data expected in the first half of 2026 [1][3] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with a pipeline that includes ALX2004 and evorpacept [5][6] - The company utilizes proprietary technology for drug design, specifically a topoisomerase I inhibitor payload and linker platform, to enhance the therapeutic window of its ADCs [2][6] Clinical Trial Details - The Phase 1 trial (NCT07085091) for ALX2004 is an open-label multicenter study targeting patients with advanced or metastatic EGFR-expressing solid tumors [3] - Enrollment for the trial began in August 2025, and the company is on track to deliver initial safety data in early 2026 [2][3] Presentation Highlights - ALX Oncology presented extensive preclinical data and trial design for ALX2004 at the 2025 AACR-NCI-EORTC International Conference, showcasing its potential to innovate within the EGFR-targeting ADC class [1][4] - The poster presentations included detailed information on the anti-tumor activity and toxicity profile of ALX2004, emphasizing its differentiated mechanism of action [2][4]

Core Viewpoint - ALX Oncology has appointed Dr. Barbara Klencke as Interim Chief Medical Officer, succeeding Dr. Alan Sandler, who will return to the Board of Directors [1][2][5] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with a pipeline that includes evorpacept and ALX2004 [3] - Evorpacept is positioned as a cornerstone therapy in immuno-oncology and is currently undergoing multiple clinical trials across various cancer indications [3] - ALX2004 is a novel EGFR-targeted antibody-drug conjugate that entered Phase 1 clinical trials in August 2025 [3] Leadership Changes - Dr. Klencke brings over 30 years of experience in oncology and has previously served as CMO at Sierra Oncology, contributing to its acquisition by GlaxoSmithKline [2][5] - The transition aims to enhance the execution of the company's development strategy for its clinical programs [2]

Core Insights - ALX Oncology is participating in two significant healthcare conferences in New York, showcasing its commitment to advancing cancer therapies [1][2]. Group 1: Conference Participation - ALX Oncology leadership will engage in the Cantor Global Healthcare Conference on September 3, 2025, featuring a fireside chat and one-on-one meetings [2]. - The H.C. Wainwright 27th Annual Global Investment Conference will take place on September 9, 2025, with a focus on one-on-one meetings [2]. - Webcasts for both conferences will be available on ALX Oncology's website, with replays archived for up to 90 days [2]. Group 2: Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies aimed at treating cancer and improving patient survival [3]. - The lead therapeutic candidate, evorpacept, is being evaluated in multiple clinical trials across various cancer indications, indicating its potential as a cornerstone therapy in immuno-oncology [3]. - ALX2004, the second pipeline candidate, is an EGFR-targeted antibody-drug conjugate that entered Phase 1 trials in August 2025, highlighting the company's innovative approach to cancer treatment [3].

Core Insights - ALX2004 is a potential best- and first-in-class antibody-drug conjugate (ADC) designed for treating EGFR-expressing solid tumors, with components optimized to maximize the therapeutic window [1][4] - The first patient has been dosed in the Phase 1 clinical trial for ALX2004, marking a significant milestone for ALX Oncology [2][3] - Initial safety data from the trial is expected in the first half of 2026 [1][3] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment [6] - The company’s lead candidate, evorpacept, is being evaluated in multiple clinical trials across various cancer indications [6] Clinical Trial Details - The Phase 1 clinical trial (NCT07085091) is an open-label multicenter study targeting advanced or metastatic EGFR-expressing solid tumors, including non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and colorectal cancer [3][5] - The trial consists of a Phase 1a dose escalation followed by a Phase 1b dose expansion [3] Preclinical Data - Preclinical studies indicate that ALX2004 has a differentiated linker-payload construct, demonstrating superior stability and dose-dependent anti-tumor activity [5] - The preclinical model findings suggest a favorable safety profile, with no EGFR-related skin toxicity or payload-related interstitial lung disease observed at clinically relevant doses [5]