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]

Financial Data and Key Metrics Changes - The company reported a total cash balance of $67 million, which is expected to provide runway into Q1 2027, allowing the company to achieve upcoming value-enhancing data milestones for both ALX-2004 and evorpacept [6][44]. Business Line Data and Key Metrics Changes - Significant advances were made in both evorpacept and ALX-2004 clinical programs during Q3 2025, with a focus on evorpacept's potential as a targeted oncology therapy [4][12]. - The phase two clinical trial in breast cancer is on track to dose its first patient in Q4 2025, based on strong data supporting a CD47 and HER2 biomarker-driven strategy [5][12]. Market Data and Key Metrics Changes - The addressable patient population for HER2-positive breast cancer in the second-plus-line setting is approximately 48,000, with an estimated 20,000 patients being both HER2 positive and CD47 high, representing a market opportunity of $2 billion to $4 billion [38]. Company Strategy and Development Direction - The company is pursuing a focused development strategy for evorpacept in combination with anticancer antibodies, leveraging the consistent proof of concept seen in various clinical studies [13][44]. - ALX-2004 is positioned to redefine standard care across a range of EGFR-expressing cancers, with a strong emphasis on optimizing safety and efficacy [39][44]. Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the potential of evorpacept to drive substantial benefits for patients with high CD47 expression, emphasizing the importance of this biomarker in future trials [11][44]. - The company remains focused on delivering solutions for patients with unmet needs in both HER2-positive breast cancer and EGFR-expressing cancers [44][45]. Other Important Information - The company highlighted the unique mechanism of action of evorpacept, which is designed to block the CD47 signal that cancer cells use to evade immune detection, thus enhancing the effectiveness of anticancer therapies [15][44]. - ALX-2004 has shown promising preclinical data, indicating a differentiated safety profile and potential efficacy across various cancer types [40][41]. Q&A Session Summary Question: How to correlate CD47 positivity with expression cutoffs in gastric data? - Management noted strong scientific concordance across different indications, with approximately 50% of patients expected to be CD47 high based on multiple studies [46][47]. Question: Companion diagnostic development plans? - The company is working with partners for companion diagnostics, utilizing a research-use assay for both gastric and breast cancer studies [48]. Question: Efficacy data in breast cancer trials? - Management highlighted a 56% overall response rate in patients post-Enhertu, which is significantly higher than expected benchmarks [51][52]. Question: Expectations for interim data and patient numbers? - The company anticipates good outcome data in the evorpacept trial, aiming for a response rate of 35%-40% in the breast cancer setting [56].

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 Insights - ALX Oncology is set to present updated data from its Phase 2 ASPEN-06 trial, focusing on evorpacept as a treatment for HER2-positive gastric cancer, at the SITC 40th Annual Meeting in November 2025 [1][2] - The trial evaluates evorpacept in combination with HERCEPTIN, CYRAMZA, and paclitaxel for patients with advanced gastric cancer who have previously undergone treatment [1][3] Company Overview - ALX Oncology is a clinical-stage biotechnology company dedicated to developing novel cancer therapies aimed at extending patient lives [4] - The lead candidate, evorpacept, is being assessed in various clinical trials across multiple cancer indications, indicating its potential as a cornerstone therapy in immuno-oncology [4] - The second pipeline candidate, ALX2004, is an EGFR-targeted antibody-drug conjugate that began Phase 1 trials in August 2025 [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].