On November 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 third quarter 2021, and provided an update on its clinical programs (Press release, Equillium, NOV 10, 2021, View Source [SID1234595095]).

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"Following positive topline data from the EQUATE study, we started the third quarter by announcing our plans to advance itolizumab into a pivotal clinical study in first-line acute graft-versus-host disease, which we anticipate commencing early in the new year," said Bruce Steel, chief executive officer at Equillium. "Recent strategic activity in the GVHD therapeutic segment demonstrates industry’s recognition of the high unmet medical need for effective treatments for patients suffering from this deadly disease, and we believe our pivotal study could position itolizumab to become the first approved therapy to treat patients with acute GVHD in the first-line setting. We are also encouraged by the reductions in proteinuria observed in the subgroup data from the Type A portion of the EQUALISE study in patients with systemic lupus erythematosus, without lupus nephritis, that had elevated baseline urine protein/creatinine and albumin/creatinine ratios. Based on the Type A data we amended the protocol in the Type B portion to include newly diagnosed patients in addition to refractory patients and selected the 1.6 mg/kg dose. As a result of these protocol enhancements and due to challenges in patient recruitment amid the ongoing global pandemic, we now expect to announce interim data from the Type B portion of the study in patients with lupus nephritis mid-year 2022. We look forward to initiating our pivotal study in first-line acute GVHD early in the new year and presenting topline data from our EQUIP study in moderate to severe asthma before the end of this year."

Corporate & Clinical Highlights Since Beginning of Q3 2021:

Announced plans to initiate a pivotal study in first-line acute graft-versus-host disease (aGVHD) following positive topline results from the EQUATE study and an End-of-Phase 1 meeting with the FDA
Reported additional data from the EQUALISE study’s Type A systemic lupus erythematosus (SLE) patients, without lupus nephritis, that had elevated baseline urine protein/creatinine and albumin/creatinine ratios, demonstrating a mean decrease of 42% and 54%, respectively, at Day 57 following two doses of itolizumab
Presented multiple posters at the American College of Rheumatology (ACR), the American Society of Nephrology (ASN) and the American College of Allergy, Asthma and Immunology (ACAAI)
ASN & ACR
Sustained decrease in proteinuria observed in subgroup of SLE patients, without lupus nephritis, following two doses of itolizumab
Itolizumab was safe and well tolerated at doses ranging from 0.4 to 2.4 mg/kg
Dose dependent decreases in inflammatory marker CD6 following itolizumab administration
ACAAI
◦ Itolizumab was well tolerated in patients with moderate to severe uncontrolled asthma

Upcoming Catalysts:

EQUIP Phase 1b study: topline data in uncontrolled asthma expected Q4 2021
Initiate pivotal study in first-line aGVHD expected early 2022
EQUALISE Phase 1b study: interim data from Type B lupus nephritis patients expected mid-2022
Upcoming Catalysts:

EQUIP Phase 1b study: topline data in uncontrolled asthma expected Q4 2021
Initiate pivotal study in first-line aGVHD expected early 2022
EQUALISE Phase 1b study: interim data from Type B lupus nephritis patients expected mid-2022
Third Quarter 2021 Financial Results

Research and development (R&D) expenses for the third quarter of 2021 were $7.0 million, compared with $4.2 million for the same period in 2020. The increase was driven by greater clinical development expenses related to EQUIP primarily resulting from a lower R&D Tax Incentive benefit from the Australian Taxation Office and by start-up expenses related to our planned pivotal study in aGVHD, partially offset by lower costs related to a Phase 3 COVID-19 clinical trial that we decided not to commence. Greater employee compensation and benefit expenses driven by increased headcount and greater overhead expenses and costs related to our non-clinical research activities also contributed to the increase in R&D expense.

General and administrative (G&A) expenses for the third quarter of 2021 were $2.9 million, compared with $2.3 million for the same period in 2020. The increase was driven by greater employee compensation and benefit expenses primarily related to increased headcount and by greater overhead expenses, partially offset by a decrease in consulting expenses.

Net loss for the third quarter of 2021 was $10.3 million, or $(0.35) per basic and diluted share, compared with a net loss of $6.6 million, or $(0.31) 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 third quarter of 2021 was $7.0 million compared to $7.0 million in the second quarter of 2021.

Cash, cash equivalents and short-term investments totaled $90.7 million as of September 30, 2021, compared to $97.6 million as of June 30, 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 signaling pathway to selectively downregulate pathogenic T effector cells while preserving T regulatory cells critical for maintaining a balanced immune response. 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.