On August 12, 2019 Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe autoimmune and inflammatory disorders with high unmet medical need, reported financial results for the second quarter 2019, and recent business highlights (Press release, Equillium, AUG 12, 2019, View Source [SID1234538621]).
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"Since our last quarterly update, we took significant steps forward in the clinical development of our lead therapeutic candidate, itolizumab, with the initiation of the Phase 1b EQUIP proof-of-concept trial for the treatment of uncontrolled asthma, and acceptance of our IND application by the FDA for the treatment of lupus nephritis," stated Daniel Bradbury, chairman and chief executive officer of Equillium. "With two clinical trials now up and running, and a third trial in lupus nephritis planned to commence later this year, we are well positioned to establish the broad clinical utility of itolizumab on our path toward helping improve the lives of patients with severe immuno-inflammatory disorders. We look forward to several important clinical milestones through the end of 2020."
Business Highlights:
Initiated the EQUIP Phase 1b proof-of-concept trial evaluating itolizumab for the treatment of uncontrolled moderate to severe asthma
IND application accepted by the FDA for a Phase 1b proof-of-concept trial of itolizumab for the treatment of lupus nephritis
Continued to advance the Phase 1b portion of the EQUATE trial evaluating itolizumab for the frontline treatment of acute graft-versus-host disease (aGVHD)
Expanded Scientific and Clinical Advisory Team with the appointments of Tom Daniel, M.D., Brian Kotzin, M.D. and Larry Steinman, M.D.
Upcoming Milestones:
Planned initiation of the EQUALISE trial – a Phase 1b proof-of-concept trial of itolizumab for the treatment of lupus nephritis during the second half of 2019
Data from the Phase 1b portion of the EQUATE aGVHD trial expected during the first quarter of 2020
Data from the EQUIP Phase 1b proof-of-concept trial of itolizumab for the treatment of uncontrolled moderate to severe asthma expected in the second half of 2020
Second Quarter 2019 Financial Results
Research and development (R&D) expenses. Total R&D expenses for the three months ended June 30, 2019 were $4.3 million, compared with $0.5 million for the same period in 2018. The increase in R&D expenses was primarily driven by additional costs related to regulatory and clinical development activities associated with the EQUATE, EQUIP and EQUALISE clinical trials, increased headcount expenses, and preclinical research activities to support Equillium’s clinical development program.
General and administrative (G&A) expenses. Total G&A expenses for the three months ended June 30, 2019 were $2.2 million, compared with $0.6 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 and legal and professional fees.
Net loss. Net loss for the three months ended June 30, 2019 was $6.1 million, or $0.35 per common share (basic and diluted), compared with a net loss of approximately $1.8 million, or $0.16 per common share (basic and diluted), for the same period in 2018.
Cash and cash equivalents. As of June 30, 2019, Equillium reported total cash, cash equivalents and short-term investments of $56.9 million, compared to $65.9 million as of December 31, 2018.