On November 8, 2018 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing novel small molecule therapeutics to treat unmet needs in autoimmunity and cancer, reported its third quarter 2018 business highlights and financial results (Press release, Kezar Life Sciences, NOV 8, 2018, View Source [SID1234531020]).
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"During the third quarter of 2018 we continued to execute on our strategy of developing our first-in-class selective immunoproteasome inhibitor for patients with severe autoimmune diseases. Enrollment continues in KZR-616-002, our Phase 1b/2 trial in lupus (SLE) and lupus nephritis (LN), with top-line results from the initial two cohorts of the Phase 1b expected in the first half of 2019," said John Fowler, CEO of Kezar. "In the same timeframe we plan to begin enrolling the Phase 2 portion of the trial, focused exclusively on LN, a serious disease with high medical and economic burden and no approved drugs. Plans to initiate trials in up to four additional autoimmune indications with high unmet need are also on track for 2019."
Business Highlights
Enrollment of patients with SLE with or without nephritis to the open-label dose escalation Phase 1b portion of the clinical trial KZR-616-002 (NCT03393013), continued in the third quarter. This trial will include a randomized, placebo-controlled Phase 2 portion in patients with active, proliferative LN.
Ongoing drug discovery efforts in the protein secretion program (Sec61 translocon modulation) advanced in the third quarter. Continued progress with the medicinal chemistry campaign and preclinical studies could lead to nomination of a first clinical candidate for oncology in 2019.
Financial Results
Cash Position. Cash, cash equivalents and marketable securities totaled $112.8 million as of September 30, 2018, compared to $51.0 million as of December 31, 2017. The increase in cash, cash equivalents and marketable securities was primarily attributable to IPO proceeds, net of cash used by the Company in operations to advance its clinical stage programs as well as preclinical research and development.
R&D Expenses. Research and development expenses for the third quarter of 2018 increased by $3.1 million to $4.7 million from $1.6 million in the third quarter of 2017. This increase was primarily related to advancing both the KZR-616 clinical program and the protein secretion preclinical program.
G&A Expenses. General and administrative expenses for the third quarter of 2018 increased by $1.0 million to $1.6 million from $0.6 million in the third quarter of 2017. This increase was primarily related to increases in personnel, professional services and insurance incurred because of becoming a public company.
Net Loss. Net loss for the third quarter of 2018 was $5.7 million, or $0.30 per basic and diluted common share, compared to a net loss of $2.1 million, or $3.31 per basic and diluted common share, for the third quarter of 2017.
Shares Outstanding. Total shares outstanding were 19.1 million as of September 30, 2018. Additionally, there were 2.2 million options granted to purchase common stock at a $3.70 weighted average exercise price as of September 30, 2018.