Kezar Life Sciences Reports Third Quarter 2019 Financial Results and Provides Business Update
- Additional data from the ongoing Phase 1b portion of the MISSION study to be presented at the 2019 ACR/ARP Meeting in
- Phase 2 MISSION, PRESIDIO, and MARINA trials with KZR-616 are progressing
- KZR-261 nominated as the first oncology clinical candidate from the Protein Secretion Program
- Protein Secretion Program to be featured in oral and poster presentations at
“I commend our team’s continued execution across our clinical and preclinical programs here at Kezar. Our three Phase 2 trials with KZR-616 in severe autoimmune diseases are progressing on track, and we look forward to disclosing additional data from our MISSION study at the ACR meeting next week”, 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.
October 1, 2019, we presented a corporate and strategic update, including a protocol amendment for the Phase 2 portion of the MISSION study (NCT03393013). The updated protocol is designed to generate more robust and meaningful data around the safety and efficacy of KZR-616 in lupus nephritis, including the evaluation of three dose levels of KZR-616 (administered with background medication) for a treatment period of six months.
- The Phase 1b portion of the MISSION study is ongoing and additional data will be presented during a poster session at the 2019
American College of Rheumatology (ACR) Meetingin Atlanta, GAon November 12, 2019.
KZR-261 – Protein Secretion Program
- Our research and discovery efforts targeting the protein secretion pathway have progressed significantly, and today, we announce the nomination of KZR-261 as our first oncology clinical candidate. KZR-261 has demonstrated broad anti-tumor activity in preclinical models of both solid and hematologic malignancies, and we have initiated laboratory studies and manufacturing activities towards an Investigational New Drug (IND) filing for a Phase 1 study in solid tumors, which we anticipate occurring in Q1 2021.
- Additionally, this novel program and pathway will be featured in four separate presentations during two major medical and scientific conferences: the
Society for Immunotherapy of Cancer( SITC) and the 61st American Society of Hematology Meeting & Exposition(ASH). The abstract titles are summarized below.
- Abstract Number: 815
Title: Targeting multiple immune checkpoint proteins with novel small molecule inhibitors of Sec61-dependent cotranslational translocation
Friday, November 8, 2019
Poster Session: Novel Single-Agent Immunotherapies
- Abstract Number: 408
Title: Blocking Protein Secretion with Novel Small Molecule Inhibitors of Sec61 Represents a Potential Treatment Strategy Against Hematologic Malignancies
Sunday, December 8, 2019
Oral Session: 802. Chemical Biology and Experimental Therapeutics: Novel Compounds and Mechanisms of Action
- Abstract Number: 805
Title: Protein Translocation Inhibitors Overcome Cytokine-Induced Glucocorticoid Resistance in T-Cell Acute Lymphoblastic Leukemia
Monday, December 9, 2019
Oral Session: 605. Molecular Pharmacology, Drug Resistance—Lymphoid and Other
- Abstract Number: 2076
Title: Proteomic Profiling and Mechanistic Investigating of a Novel Anti-Cancer Small Molecule Inhibitor of Sec61
Saturday, December 7, 2019
5:30 PM - 7:30 PM
Poster Session: 802. Chemical Biology and Experimental Therapeutics: Poster I
- Cash, cash equivalents and marketable securities totaled $85.2 million as of September 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 third quarter of 2019 increased by
$2.4 million to $7.1 millioncompared to $4.7 millionin the third quarter of 2018. This increase was primarily related to advancing both the KZR-616 clinical program in multiple indications and the protein secretion preclinical program.
- General and administrative expenses for the third quarter of 2019 increased by
$1.0 million to $2.6 millioncompared to $1.6 millionin the third 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 third quarter of 2019 was $9.1 million, or $0.48 per basic and diluted common share, compared to a net loss of $5.7 million, or $0.30 per basic and diluted common share, for the third quarter of 2018.
- Total shares outstanding were 19.1 million as of
September 30, 2019. Additionally, there were outstanding options to purchase 3.3 million shares of common stock at a weighted average exercise price of $7.39per share as of September 30, 2019.
KZR-616 is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical 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 are underway for the treatment of lupus nephritis (MISSION study), dermatomyositis and polymyositis (PRESIDIO study), and autoimmune hemolytic anemia and immune thrombocytopenia (MARINA study).
KZR-261, a novel, first-in-class protein secretion inhibitor, is the first clinical candidate to be nominated from our research and discovery efforts targeting protein secretion pathways as potential therapies for oncology, immuno-oncology and autoimmune indications. KZR-261 is a broad-spectrum anti-tumor agent that acts through direct interaction and inhibition of Sec61 activity. The compound was discovered at Kezar through a medicinal chemistry campaign in which several scaffolds were progressed through the company’s proprietary work flow of Sec61 modulation. As a result, Kezar has established a unique and broad library of protein secretion inhibitors and a strong patent position around KZR-261 and its analogs. KZR-261 has demonstrated several encouraging features that lend to its potential to be a new anti-cancer agent for the treatment of solid and hematologic malignancies. IND-enabling studies are currently underway, and an IND filing in solid tumors is expected in Q1 2021.
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,” “expect,” “believe” 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 that could cause Kezar’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about 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. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, and unexpected litigation or other disputes. Other 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|
|September 30, 2019||December 31, 2018|
|Cash, cash equivalents and marketable securities||$||85,243||$||107,432|
|Total current liabilities||5,327||3,337|
|Total stockholders' equity||86,497||108,797|
|KEZAR LIFE SCIENCES, INC.|
|Condensed Consolidated Statements of Operations|
|(In thousands except share and per share data)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||$||7,080||$||4,664||$||19,932||$||13,463|
|General and administrative||2,601||1,600||7,413||4,837|
|Total operating expenses||9,681||6,264||27,345||18,300|
|Loss from operations||(9,681||)||(6,264||)||(27,345||)||(18,300||)|
|Net loss per common share, basic and diluted||($||0.48||)||($||0.30||)||($||1.34||)||($||2.38||)|
|Weighted-average shares used to compute net loss per common share, basic and diluted||19,095,870||18,955,384||19,070,937||7,319,012|
Source: Kezar Life Sciences, Inc.