Kezar Life Sciences Reports First Quarter 2019 Financial Results and Provides Business Update
- Phase 1b systemic lupus erythematosus (SLE) top-line data release and Phase 2 lupus nephritis (LN) initiation on track in Q2 2019
- Site selection underway for Phase 2 trial of KZR-616 for the treatment of dermatomyositis (DM) and polymyositis (PM)—trial on track to begin in 2H 2019
FDAaccepts Investigational New Drug (IND) Application for KZR-616 for the treatment of autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP)—trial to begin in 2H 2019
- Nomination of oncology clinical candidate from protein secretion program planned before year end
“The entire team at Kezar is excited to build on last year’s momentum and advance both of our programs in 2019,” said
First Quarter and Recent Clinical and Business Highlights
The United States Food and Drug Administration( FDA) accepted an IND for KZR-616 for the treatment of AIHA and ITP. A Phase 2 trial for these indications in addition to a Phase 2 trial in DM and PM are anticipated to begin 2H 2019.
- Our SLE and LN program is advancing with enrollment continuing in the open-label dose escalation Phase 1b portion in SLE patients. We expect to report data from the first two cohorts of this portion at a major medical conference later this quarter in addition to initiating the Phase 2 portion of the trial in patients with active, proliferative LN.
- Our protein secretion program (Sec61 translocon modulation) was showcased in two poster presentations at the
American Association for Cancer Research(AACR) in Atlanta, GAon April 2, 2019. We remain on track to nominate a first clinical candidate in oncology before the end of the year.
- In April of this year, we continued to strengthen the depth and breadth of our management team with the appointment of
Mark Schilleras Vice President of Legal Affairs.
- Cash, cash equivalents and marketable securities totaled $101.1 million as of March 31, 2019, compared to $107.4 million as of December 31, 2018. The decrease in cash, cash equivalents and marketable securities was primarily attributable to cash used by the Company in operations to advance its clinical stage programs as well as preclinical research and development.
- Research and development expenses for the first quarter of 2019 increased by
$2.3 million to $5.9 millionfrom $3.6 millionin the first quarter of 2018. This increase was primarily related to advancing both the KZR-616 clinical program across indications and the protein secretion preclinical program.
- General and administrative expenses for the first quarter of 2019 increased by
$0.9 million to $2.4 millionfrom $1.5 millionin the first quarter of 2018. The increase was primarily due to an increase in stock-based compensation, personnel expenses, and costs related to operating as a public company.
- Net loss for the first quarter of 2019 was $7.6 million, or $0.40 per basic and diluted common share, compared to a net loss of $4.9 million, or $6.53 per basic and diluted common share, for the first quarter of 2018.
- Total shares outstanding were 19.1 million as of
March 31, 2019. Additionally, there were 2.8 million outstanding options granted to purchase common stock at a $7.73 weighted average exercise price as of March 31, 2019.
KZR-616 is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Nonclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Phase 1a clinical trial results in healthy volunteers provide evidence that KZR-616 potentially avoids adverse effects caused by currently marketed non-selective proteasome inhibitors, which we believe prevent them from being utilized as a chronic treatment in autoimmune disorders. A Phase 1b trial in systemic lupus erythematosus (SLE) is currently underway, with a Phase 2 trial in lupus nephritis (LN) expected to initiate during the second quarter of 2019. Phase 2 trials in dermatomyositis (DM), polymyositis (PM), autoimmune hemolytic anemia (AIHA), and immune thrombocytopenia (ITP) are expected to commence the second half of 2019.
Cautionary Note on Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “should,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Kezar’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, (i) projected financing needs, (ii) the discovery and development of new product candidates, (iii) the design, progress, timing, scope and results of clinical trials, (iv) the anticipated timing of disclosure of results of clinical trials, (v) the likelihood data will support future development and (vi) the likelihood of obtaining regulatory approval of Kezar’s product candidates. Factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Kezar’s filings with the
SVP, Strategy & External Affairs
|KEZAR LIFE SCIENCES, INC.|
|Selected Balance Sheet Data|
|March 31, 2019||December 31, 2018|
|Cash, cash equivalents and marketable securities||$||101,134||$||107,432|
|Total current liabilities||4,758||3,337|
|Total stockholders' equity||102,145||108,797|
|KEZAR LIFE SCIENCES, INC.|
|Condensed Consolidated Statement of Operations|
|(In thousands except share and per share data)|
|Three Months Ended|
|Research and development||$||5,927||$||3,572|
|General and administrative||2,382||1,514|
|Total operating expenses||8,309||5,086|
|Loss from operations||(8,309||)||(5,086||)|
|Net loss per common share, basic and diluted||$||(0.40||)||$||(6.53||)|
|Weighted-average shares used to compute net loss
per common share, basic and diluted
Source: Kezar Life Sciences, Inc.