Equillium Announces Q4 & Full-Year 2024 Results, Corporate & Clinical Updates
Equillium, Inc., a clinical-stage biotechnology company specializing in immunobiology, has reported its financial results for the fourth quarter and full year 2024, alongside recent corporate and clinical developments. The company continues its mission to develop novel therapeutics for severe autoimmune and inflammatory disorders.
“This morning, following considerable efforts by our clinical team, we announced topline data from the Phase 3 EQUATOR study evaluating itolizumab in first-line treatment of acute graft-versus-host disease,” said Bruce Steel, chief executive officer at Equillium. “While the study did not meet Day 29 outcomes of complete response—our primary endpoint—and overall response rate, itolizumab demonstrated statistically significant and clinically meaningful benefits in important longer-term outcomes.
These include complete response at Day 99, duration of complete response, and failure-free survival. Given these results and prior FDA guidance, we have submitted a request for Breakthrough Therapy designation and secured a meeting with the FDA to discuss potential Accelerated Approval for itolizumab in first-line treatment of aGVHD. The FDA has already granted Orphan Drug and Fast Track designations for this indication. We anticipate FDA feedback by May 2025 and, contingent upon securing additional funding, plan to submit a biologics license application in the first half of 2026.”
Recent Corporate & Clinical Highlights:
- Announced topline data from the Phase 3 EQUATOR study in first-line acute graft-versus-host disease (aGVHD), demonstrating a favorable safety and tolerability profile, along with meaningful longer-term outcomes. While no significant difference was observed in complete response (CR) and overall response rate (ORR) at Day 29 between itolizumab and placebo, key statistically significant or clinically meaningful benefits included:
- Median duration of CR: 336 days for itolizumab vs. 72 days for placebo (p = 0.017)
- Median failure-free survival: 154 days for itolizumab vs. 70 days for placebo (p = 0.043)
- CR at Day 99: 44.9% for itolizumab vs. 28.6% for placebo (p = 0.035)
- Positive trend in overall survival: 24.4% mortality rate for itolizumab vs. 32.5% for placebo
- Similar rates of steroid tapering, primary disease relapse, and chronic graft-versus-host disease in both treatment groups
- Announced positive topline data from a Phase 2 study evaluating itolizumab in moderate to severe ulcerative colitis (UC). After 12 weeks of treatment, itolizumab achieved a clinical remission rate of 23.3% compared to 20.0% for adalimumab and 10.0% for placebo. Additionally, itolizumab reached a key secondary endpoint of endoscopic remission at 16.7%, matching adalimumab and outperforming placebo (6.7%). The drug was well tolerated, aligning with previous clinical experiences.
- Presented data on the dual and synergistic signaling of IL-15 and IL-21—targets of EQ302—highlighting the benefits of inhibiting or activating both cytokines to regulate aggressive T and NK cell responses. These pathways are implicated in multiple inflammatory diseases.
Upcoming Milestones:
- Itolizumab: Anticipated FDA feedback on Breakthrough Therapy designation request and review of EQUATOR study data for potential Accelerated Approval by May 2025.
Financial Results for Q4 and Full Year 2024:
Revenue:
- Q4 2024: $4.4 million, compared to $9.2 million in Q4 2023.
- Full Year 2024: $41.1 million, compared to $36.1 million in 2023.
- Revenue was primarily from itolizumab development funding and amortization of the upfront payment from Ono Pharmaceutical related to the terminated Asset Purchase Agreement.
Research & Development (R&D) Expenses:
- Q4 2024: $7.3 million, down from $9.2 million in Q4 2023.
- Full Year 2024: $37.4 million, a slight increase from $37.0 million in 2023.
- Increased expenses were attributed to preclinical and clinical development and consulting, partially offset by lower employee compensation.
General & Administrative (G&A) Expenses:
- Q4 2024: $1.8 million, down from $3.2 million in Q4 2023.
- Full Year 2024: $11.9 million, down from $13.6 million in 2023.
- Decrease due to lower employee compensation, audit and tax professional fees, consulting, and overhead costs.
Net Loss:
- Q4 2024: $5.8 million ($0.16 per share), compared to $2.3 million ($0.07 per share) in Q4 2023.
- Full Year 2024: $8.1 million ($0.23 per share), compared to $13.3 million ($0.38 per share) in 2023.
- Improved net loss position driven by higher revenue and lower operating expenses, partially offset by reduced other income and increased tax expense.
Cash & Investments:
- As of December 31, 2024: $22.6 million, down from $40.9 million in 2023.
- Current cash reserves expected to fund operations into Q3 2025, based on assumptions that may be subject to change.
Equillium remains committed to advancing its immunobiology-driven drug development pipeline, leveraging innovative therapies to address critical unmet needs in autoimmune and inflammatory diseases.
