ALX Oncology(US:ALXO)2025-11-07 14:30Financial 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].