Equillium Q2 2024 Financial Results and Recent Highlights

Equillium Inc., a clinical-stage biotechnology company dedicated to developing innovative therapies for autoimmune and inflammatory disorders, has disclosed its financial results for the second quarter of 2024 and shared updates on its ongoing corporate and clinical activities.

CEO Bruce Steel highlighted a positive interim assessment from the Independent Data Monitoring Committee (IDMC) for the Phase 3 EQUATOR study, which showed no safety or futility issues. Consequently, the study will continue as planned. Equillium has shared this data with Ono Pharmaceutical, which has until the end of October 2024 to decide whether to acquire rights to itolizumab. If Ono opts in, Equillium stands to receive a substantial one-time payment of approximately $35 million, extending its financial runway significantly. Further, Equillium could earn up to $101.4 million from clinical, regulatory, and commercialization milestones, along with continued reimbursement for itolizumab-related expenses.

Additionally, Equillium is progressing its multi-cytokine assets. Following encouraging Phase 2 results for EQ101 in alopecia areata patients, the company is preparing for a Phase 2b placebo-controlled study to optimize dosage and transition from intravenous to subcutaneous delivery. Simultaneously, the company is advancing EQ302, an orally available bi-specific inhibitor, with plans to begin Phase 1 clinical trials in the latter half of next year.

Key milestones achieved since the second quarter of 2024 include:
- Initiating Ono Pharmaceutical's option period following positive topline data from the Phase 1b EQUALISE study in lupus nephritis patients.
- Announcing positive Phase 2 study results for EQ101 in alopecia areata patients, where 29% of participants with moderate to severe disease achieved a SALT (Severity Alopecia Tool) score of ≤20.
- Presenting a poster at the American Association of Immunologists' annual meeting, demonstrating itolizumab’s mechanism in modulating T cell activity.

Anticipated milestones in the near future are:
- Ono’s decision on exercising its option by the end of October 2024.
- Transitioning EQ101 to subcutaneous delivery and starting a Phase 2 dose optimization study in 2025.
- Initiating a Phase 1 study for EQ302 in the second half of 2025.

From a financial perspective, Equillium reported revenues of $13.9 million for Q2 2024, up from $9.1 million in the same period the previous year. This revenue primarily stems from itolizumab development funding and amortization of an upfront payment from the Asset Purchase Agreement with Ono. Research and development expenses increased to $10.8 million due to higher costs associated with itolizumab, whereas general and administrative expenses remained steady at $3.1 million. Equillium posted a net income of $0.5 million for Q2 2024, a significant improvement from a net loss of $3.3 million in Q2 2023.

As of June 30, 2024, Equillium held $33.3 million in cash, cash equivalents, and short-term investments, up from $32.3 million as of March 31, 2024. This increase was driven by receiving their 2023 Australian tax credit claim and itolizumab development payments from Ono. Operating activities generated $0.7 million in cash during the second quarter. Equillium believes that its current cash reserves are sufficient to fund operations for the next 12 months, provided there are no further stock repurchases and discretionary spending adjustments are made if Ono does not exercise its option.

Equillium's multi-cytokine platform aims to create selective therapies that block pathogenic cytokines while preserving beneficial signaling, offering a targeted approach to treat autoimmune and inflammatory diseases. Their main assets include EQ101 and EQ302, each targeting specific cytokines for different delivery methods, and itolizumab, a monoclonal antibody targeting the CD6-ALCAM pathway, which is under evaluation for treating acute graft-versus-host disease and lupus nephritis.

Equillium continues to capitalize on its in-depth immunobiology knowledge to develop treatments that address critical unmet medical needs in the domain of autoimmune and inflammatory diseases.