On March 26, 2020 Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe autoimmune and inflammatory disorders, reported financial results for the fourth quarter and full-year ended December 31, 2019 and provided an update on its clinical development programs (Press release, Equillium, MAR 26, 2020, View Source [SID1234555870]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"COVID-19 and the global response to combat this pandemic may have unprecedented consequences to the healthcare system, including the ability to conduct clinical studies," said Bruce Steel, chief executive officer of Equillium. "In an abundance of caution to protect patients, caregivers, clinical site staff, company employees and contractors at this critical juncture, we have paused enrollment in the EQUIP trial for uncontrolled asthma and the EQUALISE trial for lupus nephritis. Our decision was not based on any safety events related to itolizumab and is in alignment with the FDA’s guidance on the conduct of clinical trials during the COVID-19 pandemic issued March 20, 2020. The demands on medical institutions and the ability of clinicians to execute clinical studies during this global crisis were also considerations in our decision. As a result, we are suspending guidance on when we anticipate reporting initial data from these studies. We will continue to monitor the situation and are working closely with our partners and focusing on being operationally prepared to restart these trials when appropriate."
"We are continuing to enroll patients in the EQUATE study for patients with acute graft-versus-host disease (aGVHD) given the acute life-threatening severity of the disease. We are maintaining guidance that we anticipate reporting initial data from the EQUATE study during the second half of 2020. We also reiterate guidance that our cash on hand is sufficient to fund operations into the second half of 2021; this runway may be extended depending on the timing of restarting enrollment of the EQUIP and EQUALISE trials."
"We have made significant advances over the last year in the development of itolizumab in multiple indications. We eagerly await initial results from our aGVHD study where we believe itolizumab represents a potentially life-saving treatment for these severely ill patients. Additionally, depending on the course of COVID-19, we look forward to recommencing our studies in lupus nephritis and uncontrolled asthma to elucidate the potential of itolizumab as a novel therapeutic option for patients across a range of severe immuno-inflammatory diseases."
2019 Business Highlights:
Initiated three Phase 1b proof-of-concept clinical trials of itolizumab:
EQUATE trial in aGVHD
EQUIP trial in uncontrolled asthma
EQUALISE trial in lupus nephritis
Received fast track designation from the Food and Drug Administration (FDA) for the treatment with itolizumab in patients with aGVHD and lupus nephritis
Received orphan drug designations from the FDA for both the prevention and treatment of aGVHD
Expanded exclusive license agreement with Biocon Limited for itolizumab to include the territories of Australia and New Zealand, and obtained exclusive representation rights to third-party licensing rights to develop and commercialize itolizumab in select major markets outside of North America
Secured a term debt facility for up to $20 million with Silicon Valley Bank and Oxford Finance LLC
Upcoming Catalysts:
Initial data from the Phase 1b part of the EQUATE trial in aGVHD expected in 2H 2020
Fourth Quarter 2019 Financial Results
Research and development (R&D) expenses. Total R&D expenses for the three months ended December 31, 2019 were $5.4 million, compared with $2.5 million for the same period in 2018. The increase in R&D expenses was primarily driven by the ramp-up of clinical development activities associated with the EQUIP, EQUATE and EQUALISE clinical trials, increased headcount expenses, and preclinical research and translational science activities to support Equillium’s clinical development programs.
General and administrative (G&A) expenses. Total G&A expenses for the three months ended December 31, 2019 were $2.2 million, compared with $1.7 million for the same period in 2018. The increase in G&A expenses was primarily driven by additional costs related to increased headcount expenses, costs related to being a public company, offset by lower legal fees.
Net loss. Net loss for the three months ended December 31, 2019 was $7.6 million, or $(0.44) per basic and diluted share, compared with a net loss of $5.0 million, or $(0.31) per basic and diluted share for the same period in 2018.
Full-Year 2019 Financial Results
Research and development (R&D) expenses. Total R&D expenses for the year ended December 31, 2019 were $17.6 million, compared with $4.9 million for the year ended December 31, 2018. The increase in R&D expenses was primarily driven by the initiation and ramp-up of clinical development activities associated with the EQUIP, EQUATE and EQUALISE clinical trials, increased headcount expenses, and preclinical research and translational science activities to support Equillium’s clinical development programs.
General and administrative (G&A) expenses. Total G&A expenses for the year ended December 31, 2019 were $9.1 million, compared with $3.7 million for the year ended December 31, 2018. The increase in G&A expenses was primarily driven by additional costs related to increased headcount expenses, costs related to being a public company, and legal and other professional fees.
Net loss. Net loss for the year ended December 31, 2019 was $25.6 million, or $(1.47) per basic and diluted share, compared with a net loss of $13.3 million, or $(1.09) per basic and diluted share for the year ended December 31, 2018.
Cash, cash equivalents and short-term investments. Equillium held cash, cash equivalents and short-term investments totaling approximately $53.1 million at December 31, 2019, compared to $65.9 million at December 31, 2018.