On November 12, 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 third quarter 2019 and recent business highlights (Press release, Equillium, NOV 12, 2019, View Source [SID1234550975]).
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"With the recent initiation of the EQUALISE trial in lupus nephritis and ongoing studies in uncontrolled asthma and aGVHD, we are concurrently running clinical studies of itolizumab in three indications where effective treatments are lacking for patients," said Dan Bradbury, chairman and chief executive officer of Equillium. "As we continue to efficiently execute our clinical programs, we anticipate important data readouts next year that may establish the foundation for broadly developing itolizumab in severe autoimmune and inflammatory disorders for patients in urgent need of novel treatments."
Business Highlights:
Secured a term loan for up to $20 million that, together with cash on-hand, is expected to provide sufficient resources to fund currently planned development programs into the second half of 2021 and through anticipated initial data readouts
Obtained exclusive rights to negotiate third-party licensing rights to develop and commercialize itolizumab in select major markets outside of North America
Initiated Phase 1b EQUALISE proof-of-concept trial evaluating itolizumab for the treatment of lupus nephritis
Continued to advance itolizumab in Phase 1b development for both the treatment of uncontrolled asthma and the frontline treatment of aGVHD
Upcoming Milestones
Itolizumab initial data from the Phase 1b:
EQUIP trial in uncontrolled asthma expected in 2H 2020
EQUATE trial in aGVHD expected in 2H 2020
EQUALISE trial in lupus nephritis – systemic lupus erythematosus (SLE) cohort expected in 2H 2020, lupus nephritis cohort expected in 1H 2021
Third Quarter 2019 Financial Results
Research and development (R&D) expenses. Total R&D expenses for the three months ended September 30, 2019 were $4.2 million, compared with $1.2 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 EQUIP, EQUATE 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 September 30, 2019 were $2.1 million, compared with $1.0 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 September 30, 2019 was $6.0 million, or $(0.35) per basic and diluted share, compared with a net loss of approximately $4.9 million, or $(0.44) per basic and diluted share, for the same period in 2018.
Cash and cash equivalents. As of September 30, 2019, Equillium reported total cash, cash equivalents and short-term investments of $62.2 million, compared to $65.9 million as of December 31, 2018. The amount of cash and investments at September 30, 2019 included approximately $9.9 million of net proceeds from the initial advancement from the term loan.