Kezar Life Sciences Reports Second Quarter 2019 Financial Results and Provides Business Update
- Promising data reported from the Phase 1b portion of MISSION, a first-in-patient study of KZR-616; Phase 2 portion of MISSION in LN patients has been initiated
- Phase 2 PRESIDIO and MARINA trials have been initiated evaluating KZR-616 in DM, PM, AIHA, and ITP patients
- Nomination of first oncology clinical candidate from protein secretion program on track before year end
Niti Goel, MD, Chief Medical Officer, will depart to pursue new professional opportunities following a transition period
“I’m proud of the tremendous progress made by the team over the quarter, culminating with the first-in-patient data reported with KZR-616,” said
Recent Clinical and Business Highlights
KZR-616 (Selective Immunoproteasome Inhibitor)
The Phase 1b/2 MISSION study in systemic lupus erythematosus (SLE) patients with and without nephritis is currently ongoing.
- We reported promising data with KZR-616 in patients with SLE at the European League Against Rheumatism (EULAR) 2019 Annual Meeting. Initial data were reported from 3 cohorts of the open-label dose escalation portion of the trial (Phase 1b). The study met its objectives by establishing the safety and tolerability of KZR-616 and identifying doses to advance into our Phase 2 clinical trials.
- Enrollment to the Phase 1b portion of the MISSION study is ongoing and updated data from cohorts testing step-up dosing to a 60 mg dose are expected in Q4 2019.
- The Phase 2 portion of the MISSION study, which is evaluating KZR-616 for the treatment of lupus nephritis (LN), was initiated.
- We recently initiated the PRESIDIO study (NCT04033926). This is a Phase 2 randomized, double-blind, placebo-controlled, crossover, multicenter study to evaluate the safety, tolerability, efficacy, PK and PD of treatment with KZR-616 in patients with active dermatomyositis (DM) or polymyositis (PM). The trial is expected to enroll 24 patients with either DM or PM.
- We recently initiated the MARINA study (NCT04039477). MARINA is a Phase 2 randomized, dose-blind, multicenter study to evaluate the safety and efficacy of KZR-616 in the treatment of patients with autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP). The trial is expected to enroll 40 patients with either AIHA or ITP.
Protein Secretion Program (Sec61 translocon modulation)
- Our research and discovery efforts targeting the protein secretion pathway as a potential therapy for oncology indications is progressing well, and we remain on track to nominate a first clinical candidate before the end of the year.
Kezar announced today that
“On behalf of the Executive Team and Board of Directors, I would like to sincerely thank Niti for her contributions during her tenure at Kezar,” said
- Cash, cash equivalents and marketable securities totaled $93.4 million as of June 30, 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 second quarter of 2019 increased by
$1.7 million to $6.9 millionfrom $5.2 millionin the second 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 second quarter of 2019 increased by
$0.7 million to $2.4 millionfrom $1.7 millionin the second quarter of 2018. The increase was primarily due to an increase in personnel expenses and costs related to operating as a public company.
- Net loss for the second quarter of 2019 was $8.7 million, or $0.46 per basic and diluted common share, compared to a net loss of $6.8 million, or $3.31 per basic and diluted common share, for the second quarter of 2018.
- Total shares outstanding were 19.1 million as of
June 30, 2019. Additionally, there were outstanding options to purchase 2.9 million shares of common stock at a $8.02 weighted average exercise price as of June 30, 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. Phase 2 trials have commenced for the treatment of lupus nephritis (MISSION study), dermatomyositis and polymyositis (PRESIDIO study), and autoimmune hemolytic anemia and immune thrombocytopenia (MARINA study).
About Protein Secretion
We are conducting research and discovery efforts targeting protein secretion pathways as potential therapies for oncology and immuno-oncology indications. In mammalian cells, the secretion of proteins such as cytokines and the expression of cell surface transmembrane proteins such as cytokine receptors involve a process called cotranslational translocation. For most proteins, this process occurs via the Sec61 translocon, a highly conserved multi-subunit protein complex found in the membrane of the endoplasmic reticulum of all cells. Inhibition of the Sec61 translocon with small molecules blocks the secretion of some or all proteins, which can result in several physiologic outcomes, including altered cellular function, inhibition of cytokine release and/or cell death. We believe this platform has the potential to yield oral small molecule alternatives to currently marketed biologic therapeutics, to act as cytotoxic anti-cancer agents or to block the secretion of novel targets of interest in immuno-oncology or inflammation.
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, the design, progress, timing, scope and results of clinical trials, the anticipated timing of disclosure of results of clinical trials, the likelihood data will support future development, the association of data with treatment outcomes, the likelihood of obtaining regulatory approval of Kezar’s product candidates, and the discovery and development of new 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 Sheets Data|
|June 30, 2019||December 31, 2018|
|Cash, cash equivalents and marketable securities||$||93,423||$||107,432|
|Total current liabilities||4,735||3,337|
|Total stockholders' equity||94,603||108,797|
|KEZAR LIFE SCIENCES, INC.|
|Condensed Consolidated Statements of Operations|
|(In thousands except share and per share data)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Research and development||$||6,925||$||5,228||$||12,852||$||8,800|
|General and administrative||2,430||1,722||4,812||3,236|
|Total operating expenses||9,355||6,950||17,664||12,036|
|Loss from operations||(9,355||)||(6,950||)||(17,664||)||(12,036||)|
|Net loss per common share, basic and diluted||($||0.46||)||($||3.31||)||($||0.86||)||($||8.35||)|
|Weighted-average shares used to compute net loss per common share, basic and diluted||19,073,830||2,044,027||19,058,263||1,404,392|
Source: Kezar Life Sciences, Inc.