On May 12, 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 first quarter 2022 and provided an update on its corporate development and clinical programs (Press release, Equillium, MAY 12, 2022, View Source [SID1234614348]).
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"It’s been a transformative start to the year, leading to significant enhancements in how we are building value going forward," said Bruce Steel, chief executive officer at Equillium. "Since the beginning of the year we announced the acquisition of Bioniz Therapeutics, adding two first-in-class therapeutic candidates to our pipeline and an underlying novel drug discovery platform. This enables us to further expand our approach to business development and partnering efforts and significantly adds to our future operational milestones and pending data catalysts. In March we also announced the initiation of our Phase 3 EQUATOR study of itolizumab in first-line acute graft-versus-host disease and look forward to interim data from the Phase 1b EQUALISE study of itolizumab in patients with lupus nephritis expected mid-year."
Clinical Highlights Since the Beginning of Q1 2022:
Initiated Phase 3 EQUATOR study of itolizumab in first-line acute graft-versus-host disease (aGVHD), a randomized, double-blind global pivotal study assessing the efficacy and safety of itolizumab versus placebo as a first-line therapy for aGVHD in combination with corticosteroids that will enroll up to 200 patients. The primary endpoint assessment is complete response rate at Day 29, with key secondary endpoints of overall response rate at Day 29 and durability of complete response rate from Day 29 through Day 99.
Published data in the Journal of Clinical Investigation confirming the role of T cells activated by the CD6-ALCAM pathway in the development of lupus nephritis.
Corporate Highlights Since the Beginning of Q1 2022:
Acquired Bioniz Therapeutics, a privately held clinical-stage biotechnology company, significantly expanding the company’s pipeline of novel immunomodulatory drug candidates, including two first-in-class clinical-stage assets (EQ101 & EQ102) and a proprietary product discovery platform. Lead assets are multi-specific inhibitors of key disease-driving, clinically validated cytokine targets aimed at addressing unmet needs across a range of immuno-inflammatory indications.
Appointed Barbara Troupin, M.D., formerly of Myokardia, ERX Pharmaceuticals, Aquinox and Apricus Biosciences to Equillium’s board of directors.
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 initiation expected in 2H 2022, anticipated to include normal healthy volunteers and celiac disease patients
First Quarter 2022 Financial Results
Research and development (R&D) expenses for the first quarter of 2022 were $10.8 million, compared with $5.9 million for the same period in 2021. The increase was primarily due to greater clinical development expenses, driven by start-up expenses related to the EQUATOR study, greater employee compensation and benefit expenses driven by increased headcount, greater non-clinical research costs, and transaction costs associated with the Bioniz acquisition.
Acquired in-process research and development (IPR&D) expenses for the first quarter of 2022 were $23.0 million resulting from the accounting for the Bioniz acquisition. Those IPR&D expenses were comprised of $22.5 million in non-cash expense associated with the fair value of the equity consideration and $0.5 million for the net liabilities acquired. There were no IPR&D expenses in the first quarter of 2021.
General and administrative (G&A) expenses for the first quarter of 2022 were $3.5 million, compared with $2.8 million for the same period in 2021. The increase was primarily due to greater employee compensation and benefits, greater legal fees and consulting expenses.
Net loss for the first quarter of 2022 was $37.4 million, or $(1.17) per basic and diluted share, compared with a net loss of $9.0 million, or $(0.33) per basic and diluted share for the same period in 2021. The increase in net loss was largely attributable to greater operating expenses, especially the acquired IPR&D expenses.
Cash used in operations for the first quarter of 2022 was $12.1 million compared to $10.2 million in the fourth quarter of 2021. Key drivers of the quarter-over-quarter increase in cash used in operations include the 2021 annual bonuses that were paid in the first quarter of 2022, increased payments related to non-clinical research, and payments related to the Bioniz acquisition, partially offset by our annual directors and officers insurance premiums which were paid in the fourth quarter of 2021.
Cash, cash equivalents and short-term investments totaled $68.8 million as of March 31, 2022, compared to $80.7 million as of December 31, 2021. Of that $11.9 million reduction in cash and investments in the first quarter of 2022, approximately $1.0 million was estimated to be one-time costs related to the Bioniz acquisition transaction. Equillium believes that its cash and investments will be sufficient to fund 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.