ALX Oncology Q2 2025 slides: biomarker strategy shows promise as cash runway extends

Introduction & Market Context

ALX Oncology Holdings (NASDAQ:ALXO) presented its Q2 2025 results on August 12, 2025, highlighting its focused development strategy around evorpacept, a CD47-targeting immunotherapy, and ALX2004, a new EGFR-targeted antibody-drug conjugate (ADC). The company’s stock closed at $0.61, near its 52-week low of $0.40, despite presenting promising biomarker data that could strengthen its clinical development pathway.

CEO Jason Lettmann led the presentation, emphasizing the company’s refined strategy focusing on biomarker-driven patient selection to improve clinical outcomes and development efficiency. This approach comes as ALX Oncology works to maximize its cash runway while advancing its most promising programs.

Quarterly Performance Highlights

ALX Oncology reported several key accomplishments during Q2 2025, including new biomarker data from its ASPEN-06 trial in gastric cancer, completion of dose escalation in a Sanofi-sponsored trial, and preparations for its first patient enrollment in the ALX2004 Phase 1 trial.

As shown in the following summary of key accomplishments:

The company has strategically focused its resources on evorpacept in the ASPEN-Breast trial and the development of ALX2004, while pausing the ASPEN-CRC program. This prioritization has extended the company’s cash runway into Q1 2027, providing additional time to reach key clinical milestones.

Clinical Development Strategy

The most significant development highlighted in the presentation was the identification of CD47 expression as a predictive biomarker for evorpacept efficacy. In the ASPEN-06 trial evaluating evorpacept in combination with trastuzumab, ramucirumab, and paclitaxel (TRP) in HER2-positive gastric cancer, patients with high CD47 expression showed substantially better outcomes.

The data clearly demonstrates the impact of CD47 expression on treatment response:

In patients with confirmed HER2-positive and CD47-high expression, the objective response rate (ORR) was 65% with evorpacept plus TRP compared to just 26% with TRP alone, a statistically significant difference (p<0.05). This finding is pivotal for the company’s development strategy, as it suggests that patient selection based on CD47 expression could significantly improve clinical outcomes.

ALX Oncology is applying these insights to its breast cancer program, where CD47 is also overexpressed in HER2-positive disease. The company presented data showing that CD47 is upregulated in response to treatment with trastuzumab deruxtecan (ENHERTU), suggesting that CD47 may be a key mechanism of resistance to current therapies.

The company’s rationale for targeting CD47-high breast cancer is supported by multiple studies:

Pipeline and Development Updates

ALX Oncology is advancing evorpacept in HER2-positive breast cancer with an updated trial design incorporating CD47 expression as a biomarker. The company estimates that HER2-positive and CD47-high second-line and later breast cancer represents approximately 20,000 addressable patients and a $2-4 billion market opportunity.

As illustrated in the company’s commercial opportunity assessment:

In addition to evorpacept, ALX Oncology is developing ALX2004, a potentially best-in-class EGFR-targeted ADC. The company highlighted the differentiated design of ALX2004, which includes an antibody with tuned affinity to maximize therapeutic window and a Top1i payload engineered for enhanced bystander effect with improved linker stability.

The company’s development plan for ALX2004 is progressing:

Financial Position and Outlook

ALX Oncology reported $84 million in cash, cash equivalents, and investments as of June 30, 2025. By focusing resources on its most promising programs and pausing the ASPEN-CRC trial, the company has extended its cash runway into Q1 2027, providing sufficient funding to reach key clinical milestones in 2026.

The company outlined its upcoming catalysts and financial runway:

Key upcoming milestones include an update on ASPEN-06 CD47 expression data in Q4 2025, initial safety data for ALX2004 in the first half of 2026, and an interim data readout from the ASPEN-Breast trial in Q3 2026.

Despite the promising clinical data and extended cash runway, ALX Oncology’s stock remains near its 52-week low, suggesting investor caution regarding the company’s clinical development programs or broader market challenges facing small-cap biotech companies. The company’s focus on biomarker-driven patient selection could potentially de-risk its clinical programs and improve the probability of success, but investors appear to be waiting for more definitive clinical outcomes before reassessing the company’s prospects.

Full presentation:

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