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ALX Oncology Q1 2025 Earnings Report
ALX Oncology reported its first quarter 2025 financial results and provided a corporate update.
Key Takeaways
ALX Oncology reported a net loss of $30.8 million for Q1 2025, an improvement from the $35.6 million net loss in Q1 2024, primarily due to lower R&D expenses. The company's cash runway has been extended into Q4 2026.
ALX Oncology is on track to initiate Phase 2 ASPEN-Breast and Phase 1 ASPEN-CRC studies in mid-2025.
IND clearance was received from the U.S. FDA for ALX2004, with clinical program initiation expected mid-year.
The company will not pursue a U.S. registrational path in gastric cancer for evorpacept due to FDA feedback.
Cash, cash equivalents, and investments totaled $107.0 million as of March 31, 2025, extending the cash runway into Q4 2026.
ALX Oncology
ALX Oncology
Forward Guidance
ALX Oncology anticipates initiating new clinical trials and expects data milestones across its three clinical programs in 2026, with its cash runway extended into Q4 2026.
Positive Outlook
- On track to initiate Phase 2 ASPEN-Breast and Phase 1 ASPEN-CRC studies in mid-2025.
- IND clearance received for ALX2004, paving the way for mid-year clinical program initiation.
- Company to host a webcast focused on ALX2004 research program on May 20.
- Data milestones expected across Company's three clinical programs in 2026.
- Cash runway has been extended into Q4 2026.
Challenges Ahead
- Company will not pursue U.S. registrational path in gastric cancer for evorpacept due to FDA feedback.
- Accelerated approval pathway for ASPEN-06 is not feasible due to standard-of-care evolving to ENHERTU®.
- A Phase 3 versus ENHERTU® trial would be needed for regulatory approval of evorpacept in second-line HER2-positive gastric cancer.
- Decision to discontinue evaluation of evorpacept in combination with PADCEV® in urothelial cancer.
- The addition of evorpacept to PADCEV® did not meet the bar for improved efficacy in the ASPEN-07 trial.