On August 15, 2022 Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need, reported financial results for the second quarter 2022 and provided an update on its clinical development programs (Press release, Equillium, AUG 15, 2022, View Source [SID1234618356]).
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"The second quarter focused largely on the execution of our development programs with itolizumab and our plans to advance the clinical development of our new multi-cytokine inhibitors, EQ101 and EQ102," said Bruce Steel, chief executive officer at Equillium. "We are actively preparing to initiate a Phase 2 clinical study of EQ101 in alopecia areata and a Phase 1 SAD/MAD study of EQ102 – both of which are on track to commence during the second half of this year. At the same time, we continue to enroll our recently initiated Phase 3 EQUATOR study in acute graft-versus-host disease and look forward to the pending interim data from the Phase 1b EQUALISE study of itolizumab in patients with lupus nephritis."
Program Highlights Since the Beginning of Q2 2022:
Presented translational and clinical data demonstrating itolizumab’s impact on effector T cell function in acute graft-versus-host disease (aGVHD) and treatment associated with high rates of overall clinical response in the treatment of aGVHD at the Transplantation & Cellular Meetings of the American Society of Transplantation and Cellular Therapy, and the 48th Annual Meeting of the European Society for Blood and Marrow Transplantation
Announced data confirming CD6 as a target to prevent pathogenic T cell recruitment into inflamed organs and that itolizumab-induced reduction of CD6 from T effector cells promotes the development and activity of T regulatory cells at the 48th Annual Meeting of the European Society for Blood and Marrow Transplantation, and IMMUNOLOGY2022, the annual meeting of The American Association of Immunologists
Introduced data from the company’s multi-cytokine inhibitor technology and platform focusing on the design and development of multi-specific cytokine inhibitors, and the importance of targeting biological synergy to optimize therapeutic outcomes at the 3rd Annual Cytokine-Based Drug Development Summit
Anticipated Upcoming Milestones & Catalysts:
Itolizumab – EQUALISE Phase 1b study: interim data from the Type B part of the study in patients with lupus nephritis expected mid-2022
EQ101 – Phase 2 study in alopecia areata initiation expected 2H 2022
EQ102 – Phase 1 study in normal healthy volunteers (NHV) and celiac disease patients expected to initiate in 2H 2022
Second Quarter 2022 Financial Results
Research and development (R&D) expenses for the second quarter of 2022 were $9.5 million, compared with $6.0 million for the same period in 2021. The increase was primarily due to greater clinical development expenses, driven by start-up costs related to the Phase 3 EQUATOR study.
General and administrative (G&A) expenses for the second quarter of 2022 were $4.1 million, compared with $2.9 million for the same period in 2021. The increase was primarily due to higher legal fees related to business development activities and greater employee compensation and consulting costs.
Net loss for the second quarter of 2022 was $14.1 million, or $(0.41) per basic and diluted share, compared with a net loss of $9.2 million, or $(0.31) per basic and diluted share for the same period in 2021. The increase in net loss was largely attributable to greater operating expenses.
Cash used in operations for the second quarter of 2022 was $11.3 million compared to $12.1 million in the first quarter of 2022. Key drivers of the quarter-over-quarter decrease in cash used in operations include payments made in the first quarter of 2022 related to 2021 annual bonuses and the Bioniz acquisition.
Cash, cash equivalents and short-term investments totaled $57.6 million as of June 30, 2022, compared to $68.8 million as of March 31, 2022. Equillium believes that its cash and investments, together with its existing and available committed equity line, are sufficient to fund its operations for at least the next 12 months.
About Itolizumab
Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.
About Multi-Cytokine Platform: EQ101 & EQ102
Our proprietary multi-cytokine platform (MCP) generates rationally designed composite peptides that selectively block key cytokines at the shared receptor level targeting pathogenic cytokine redundancies and synergies while preserving non-pathogenic signaling. This approach provides multi-cytokine inhibition at the receptor level and is expected to avoid the broad immuno-suppression and off-target safety liabilities that may be associated with other therapeutic classes, such as JAK inhibitors. Many immune-mediated diseases are driven by the same combination of dysregulated cytokines, and we believe identifying the key cytokines for these diseases will allow us to target and develop customized treatment strategies for multiple autoimmune and inflammatory diseases.
Current MCP assets include EQ101, a first-in-class, tri-specific inhibitor of IL-2, IL-9 and IL-15, and EQ102, a first-in-class, selective inhibitor of IL-15 and IL-21.