On August 10, 2021 Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders with high unmet medical need, reported financial results for the second quarter 2021, and provided an update on its clinical programs (Press release, Equillium, AUG 10, 2021, View Source [SID1234586229]).
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"The second quarter of the year was highlighted by positive data from our Phase 1b EQUATE study in acute graft-versus-host disease," said Bruce Steel, chief executive officer at Equillium. "These data were critical for achieving a positive outcome from our End-of-Phase 1 meeting with the FDA and accelerating our plans to immediately advance to a single, pivotal Phase 3 clinical study. This strategy, if successful, may position itolizumab to become the first approved therapy to treat patients with acute graft-versus-host disease in the first-line setting."
Corporate & Clinical Highlights Since Beginning of Q2 2021:
Announced positive topline results from the EQUATE study in first-line treatment of acute graft-versus-host disease presented at the 2021 Virtual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), and plans to initiate a Phase 3 pivotal study following an End-of-Phase 1 meeting with the FDA
Itolizumab continues to demonstrate favorable safety and efficacy profile
Rapid and durable complete responses resulted in clinically meaningful reduction in corticosteroid use
Data support clinical advancement of itolizumab in first-line treatment of aGVHD
Presented multiple posters at the 104th annual meeting of the American Association of Immunologists; research highlighted:
Itolizumab’s novel mechanism of action and its effect on modulating T cell responses through inhibition of the CD6-ALCAM pathway
Development of a pharmacodynamic biomarker assay to monitor target engagement and fate of CD6 on T cells in patients treated with itolizumab
Upcoming Catalysts:
EQUALISE Phase 1b study: interim data from Type B patients (lupus nephritis) expected 2H 2021
EQUIP Phase 1b study: topline data in uncontrolled asthma expected 2H 2021
Initiate pivotal study in first-line aGVHD expected Q4 2021
Second Quarter 2021 Financial Results
Research and development (R&D) expenses for the second quarter of 2021 were $6.0 million, compared with $3.9 million for the same period in 2020. The increase was driven by greater employee compensation and benefit expenses primarily related to increased headcount, an increase in clinical development expenses primarily related to the EQUATE and EQUALISE studies, as well as greater consulting, overhead, and non-clinical research expenses.
General and administrative (G&A) expenses for the second quarter of 2021 were $2.9 million, compared with $2.7 million for the same period in 2020. The increase was driven by greater employee compensation and benefits primarily related to increased headcount, partially offset by a decrease in non-cash stock-based compensation mainly due to retention option grants issued to certain officers and directors in the second quarter of 2020.
Net loss for the second quarter of 2021 was $9.2 million, or $(0.31) per basic and diluted share, compared with a net loss of $6.5 million, or $(0.37) per basic and diluted share for the same period in 2020. The increase in net loss was largely attributable to greater operating expenses.
Cash used in operations for the second quarter of 2021 was $7.0 million compared to $7.9 million in the first quarter of 2021.
Cash, cash equivalents and short-term investments totaled $97.6 million as of June 30, 2021, compared to $104.1 million as of March 31, 2021. Equillium believes that its cash and investments will be sufficient to fund its currently planned operations into 2023.
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.