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Dec 31, 2024
Equillium Q4 2024 Earnings Report
Equillium reported its financial results for the fourth quarter and full year 2024, highlighting topline data from the Phase 3 EQUATOR study and progress with FDA designations.
Key Takeaways
Equillium reported Q4 2024 revenue of $4.4 million, a decrease from $9.2 million in Q4 2023. The company's net loss for the quarter was $5.8 million, or $(0.16) per share, compared to a net loss of $2.3 million, or $(0.07) per share, in the same period last year. Despite not meeting primary endpoints in the EQUATOR study, itolizumab showed statistically significant and clinically meaningful benefits in longer-term outcomes, leading to a Breakthrough Therapy designation request and a planned FDA meeting.
Q4 2024 revenue was $4.4 million, down from $9.2 million in Q4 2023.
Net loss for Q4 2024 was $5.8 million, or $(0.16) per share, compared to a net loss of $2.3 million, or $(0.07) per share, in Q4 2023.
Itolizumab's Phase 3 EQUATOR study did not meet Day 29 primary endpoints but showed statistically significant and clinically meaningful benefits in longer-term outcomes.
Equillium submitted a request for Breakthrough Therapy designation and plans to submit a biologics license application in the first half of 2026, pending FDA feedback.
Equillium
Equillium
Forward Guidance
Equillium anticipates feedback from the FDA regarding Breakthrough Therapy designation and Accelerated Approval pathway for itolizumab by May 2025, with a potential Biologics License Application submission in the first half of 2026. The company believes its current cash and cash equivalents can fund operations into Q3 2025.
Positive Outlook
- Feedback from the FDA on Breakthrough Therapy designation and Accelerated Approval pathway for itolizumab expected by May 2025.
- Potential submission of a Biologics License Application for itolizumab in first-line aGVHD during the first half of 2026, if FDA feedback is positive and additional capital is raised.
- Itolizumab has already received Orphan Drug and Fast Track designations for aGVHD.
- Positive topline data from Phase 2 study evaluating itolizumab in moderate to severe ulcerative colitis, demonstrating clinical efficacy and generally good tolerability.
- Cash, cash equivalents and short-term investments are expected to fund operations into the third quarter of 2025.
Challenges Ahead
- Itolizumab's Phase 3 EQUATOR study did not meet Day 29 outcomes of complete response, the primary endpoint.
- Submission of a Biologics License Application is subject to raising additional capital.
- Actual results may differ materially from forward-looking statements due to risks and uncertainties.
- Risks include Equillium's ability to raise additional capital on acceptable terms, or at all.
- Risks related to performing clinical and pre-clinical studies, and whether results will validate and support safety and efficacy of product candidates.