On March 27, 2019 Equillium, Inc. (Nasdaq: EQ), a 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 fourth quarter and full-year ended December 31, 2018, and recent business highlights (Press release, Equillium, MAR 27, 2019, View Source [SID1234534706]).
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Business Highlights:
Completed a successful initial public offering in October 2018 resulting in gross proceeds of $71.6 million
Received FDA Fast Track designation and Orphan Drug designations for EQ001 for both the prevention and treatment of acute graft-versus-host disease (aGVHD)
Initiated the Phase 1b portion of the EQUATE trial for the frontline treatment of aGVHD
Announced plans to develop EQ001 for the treatment of lupus nephritis with a Phase 1b proof-of-concept clinical trial expected to commence in the second half of 2019
"The progress that we made during 2018, highlighted by our successful initial public offering in October, sets the stage for continued advancement of our pipeline this year with three clinical trials of our lead therapeutic candidate, EQ001, beginning with our EQUATE trial in aGVHD that commenced earlier this month," said Daniel Bradbury, chairman and chief executive officer of Equillium. "The recent announcement that we are exploring the clinical utility of EQ001 in lupus nephritis, in addition to aGVHD and uncontrolled moderate to severe asthma, leverages our research into the role of CD6-ALCAM pathway in immuno-inflammatory diseases, and represents a natural expansion of our pipeline targeting this potentially promising pathway. As we progress through 2019, we have line-of-sight to multiple potentially value-creating data catalysts beginning early next year, and believe we are well positioned to introduce a new class of therapeutic that can transform the lives of patients suffering from these serious and underserved medical conditions."
Upcoming Milestones:
Planned initiation of Phase 1b EQUIP proof-of-concept trial evaluating EQ001 for the treatment of uncontrolled moderate to severe asthma by the end of the second quarter of 2019
Planned initiation of Phase 1b proof-of-concept trial evaluating EQ001 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, approximately 12 months following initiation
Fourth Quarter 2018 Financial Results
Research and development (R&D) expenses. Total R&D expenses for the three months ended December 31, 2018 were $2.5 million, compared with $0.5 million for the same period in 2017. The increase in R&D expenses was primarily driven by additional costs related to increased headcount, regulatory and clinical activity, 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 December 31, 2018 were $1.7 million, compared with $0.2 million for the same period in 2017. The increase in G&A expenses was primarily driven by increased headcount and other costs associated with supporting the increased level of clinical and corporate activities as Equillium transitioned to a public company.
Net loss. Total net loss for the three months ended December 31, 2018 was $5.0 million, compared with a net loss of $1.1 million for the same period in 2017.
Full-Year 2018 Financial Results
Research and development (R&D) expenses. Total R&D expenses for the year ended December 31, 2018 were $4.9 million, compared with approximately $1.3 million for the period March 16, 2017 (inception) through December 31, 2017. The increase in R&D expenses was primarily driven by additional costs related to increased headcount, regulatory and clinical activity, and preclinical research activities to support Equillium’s clinical development program.
General and administrative (G&A) expenses. Total G&A expenses for the year ended December 31, 2018 were $3.7 million, compared with $0.4 million for the period March 16, 2017 (inception) through December 31, 2017. The increase in G&A expenses was primarily driven by increased headcount and other costs incurred during the fourth quarter of 2018 associated with supporting the increased level of clinical and corporate activities as Equillium transitioned to a public company.
Net loss. Total net loss for the year ended December 31, 2018 was $13.3 million, compared with a net loss of $2.3 million for the period March 16, 2017 (inception) through December 31, 2017.
Cash, cash equivalents and short-term investments. Equillium held cash, cash equivalents and short-term investments totaling approximately $65.9 million at December 31, 2018, compared to $7.1 million at December 31, 2017. The increase was due to Equillium’s initial public offering in October 2018, partially offset by cash used in operations during 2018.