On May 13, 2021 Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, reported financial results for the first quarter 2021, and provided an update on its clinical development programs (Press release, Equillium, MAY 13, 2021, View Source [SID1234579928]).
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"During the quarter, we announced the first of multiple data catalysts across three indications expected in 2021 for itolizumab, highlighting its potential broad therapeutic utility," said Bruce Steel, chief executive officer at Equillium. "Data from the Type A group of patients in the Phase 1b EQUALISE study, our first from subcutaneous delivery, showed favorable safety and tolerability results in systemic lupus erythematosus patients. It also demonstrated a dose-dependent reduction in the pharmacodynamic marker of CD6 expression on effector T cells, and that these results were consistent with the promising data generated from intravenous dosing of itolizumab in the EQUATE study in acute graft-versus-host disease (aGVHD). We now look ahead to the EQUATE study where we expect to announce topline data before the end of this quarter, followed by regulatory feedback on our proposed pivotal study in first-line treatment of aGVHD in mid-2021. In the second half of the year we expect to announce data from the Type B group of patients with lupus nephritis in the EQUALISE study along with data from the EQUIP study in uncontrolled asthma."
2021 Year-to-Date Corporate & Clinical Highlights:
Announced favorable data from the Type A group of patients with systemic lupus erythematosus in the EQUALISE study, where itolizumab:
Was found to be safe and well tolerated
Demonstrated a dose-dependent reduction of cell surface CD6 expression on effector T cells, a leading indicator of drug activity, consistent with its mechanism of action
Demonstrated changes in pharmacodynamic markers observed with subcutaneous dosing were consistent with intravenous dosing of itolizumab
Presented positive interim data from the EQUATE study in patients with acute graft-versus-host disease at the following conferences:
2021 Transplantation and Cellular Therapy Meetings Digital Experience
European Society for Blood and Marrow Transplantation
Completed a registered direct offering with Decheng Capital on February 5, 2021, which raised $29.9 million in net proceeds, strengthening Equillium’s balance sheet and extending its expected cash runway into the second half of 2023
Strengthened the company’s leadership, including the following additions since the beginning of this year:
Dolca Thomas, M.D., appointed as executive vice president of research and development and chief medical officer
Y. Katherine Xu, Ph.D., partner at Decheng Capital, appointed to Equillium’s board of directors
Upcoming Catalysts:
EQUATE Phase 1b study: topline data in first-line aGVHD, 1H 2021
Regulatory feedback on proposed pivotal study in first-line aGVHD, mid-2021
Initiate pivotal study in first-line aGVHD, 2H 2021*
EQUALISE Phase 1b study: interim data from Type B patients (lupus nephritis), 2H 2021
EQUIP Phase 1b study: topline data in uncontrolled asthma, 2H 2021
*Proposed protocol & timeline for site initiation contingent on regulatory review
First Quarter 2021 Financial Results
Research and development (R&D) expenses for the first quarter of 2021 were $5.9 million, compared with $4.7 million for the same period in 2020. The increase in the first quarter of 2021 compared to the same period in 2020 was driven by an increase in clinical development expenses, primarily related to the EQUATE and EQUALISE studies as well as purchases of drug product from Equillium’s collaboration partner, Biocon, for Equillium’s ongoing clinical trials, greater headcount expenses, and greater research and translational science expenses. Those increases were partially offset by a reduction in overhead costs, primarily travel, and lower consulting expenses.
General and administrative (G&A) expenses for the first quarter of 2021 were $2.8 million, compared with $2.7 million for the same period in 2020. The increase in the first quarter of 2021 compared to the same period in 2020 was driven by greater headcount expenses, partially offset by lower consulting expenses, legal fees, and travel expenses.
Net loss for the first quarter of 2021 was $9.0 million, or $(0.33) per basic and diluted share, compared with a net loss of $7.8 million, or $(0.45) per basic and diluted share for the same period in 2020. The increase in net loss was largely attributable to increased research and development expenses.
Cash used in operations for the first quarter of 2021 was $7.9 million compared to $8.3 million in the fourth quarter of 2020.
Cash, cash equivalents and short-term investments totaled $104.1 million as of March 31, 2021, compared to $82.2 million as of December 31, 2020. The increase was due to the registered direct offering with Decheng Capital in February 2021, which raised $29.9 million in net proceeds. Equillium believes that its cash and investments will be sufficient to fund its currently planned operations into the second half of 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.