UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
November 8, 2018
KEZAR LIFE SCIENCES, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
001-38542 |
47-3366145 |
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(state or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
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4000 Shoreline Court, Suite 300 South San Francisco, California |
94080 |
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(Address of principal executive offices) |
(Zip Code) |
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Registrant's telephone number, including area code: (650) 822-5600
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b–2 of the Securities Exchange Act of 1934 (§ 240.12b–2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 2.02. Results of Operations and Financial Condition.
On November 8, 2018, Kezar Life Sciences, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2018. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information provided in this Form 8-K, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit No. |
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Description |
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99.1 |
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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KEZAR LIFE SCIENCES, INC. |
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By: |
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/s/ Marc L. Belsky |
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Marc L. Belsky |
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Chief Financial Officer and Secretary |
Dated: November 8, 2018
Exhibit 99.1
Kezar Life Sciences Reports Third Quarter 2018 Financial Results and Provides Business Update
SOUTH SAN FRANCISCO, Calif., 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, today announced its third quarter 2018 business highlights and financial results.
“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
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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. |
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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
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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. |
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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. |
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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. |
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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. |
About Kezar Life Sciences
Based in South San Francisco, Kezar Life Sciences is a clinical-stage biotechnology company committed to revolutionizing treatments for patients with autoimmune diseases and cancer. Kezar is translating its innovative research on the immunoproteasome and protein secretion pathways to advance novel therapeutic approaches. KZR-616, a first-in-class immunoproteasome inhibitor, is currently in a Phase 1b trial, with a Phase 2 trial in lupus nephritis patients expected to initiate during the first half of 2019. Kezar is also poised to expand its development programs throughout 2019 with plans to initiate multiple Phase 2 trials of KZR-616, in up to four additional autoimmune indications, and to nominate an initial clinical candidate for the treatment of cancer from its protein secretion program. For more information, visit www.kezarlifesciences.com.
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,” “expect,” “plan,” “anticipate,” “estimate,” “intend” 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 statements regarding (i) the timing of initiation, progress and scope of clinical trials for Kezar’s product candidates; and (ii) the timing of program updates and data disclosures. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical site activation rates or clinical trial enrollment rates that are lower than expected, changes in expected or existing competition, 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 U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Kezar assumes no obligation to update any forward-looking statements
contained herein to reflect any change in expectations, even as new information becomes available.
CONTACTS:
Alex Gray, Burns McClellan, Inc., on behalf of Kezar Life Sciences
212-213-0006
agray@burnsmc.com
KEZAR LIFE SCIENCES, INC.
(unaudited, in thousands)
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September 30, 2018 |
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December 31, 2017 |
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Cash, cash equivalents and marketable securities |
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$ |
112,755 |
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$ |
51,033 |
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Total assets |
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120,267 |
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54,222 |
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Total current liabilities |
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3,502 |
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1,484 |
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Total stockholders' equity (deficit) |
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114,127 |
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(25,687 |
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KEZAR LIFE SCIENCES, INC.
Condensed Consolidated Statements of Operations
(unaudited, in thousands, except share and per share amounts)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2018 |
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2017 |
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2018 |
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2017 |
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Operating expenses: |
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Research and development |
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$ |
4,664 |
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$ |
1,557 |
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$ |
13,463 |
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$ |
4,833 |
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General and administrative |
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1,600 |
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635 |
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4,837 |
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1,497 |
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Total operating expenses |
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6,264 |
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2,192 |
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18,300 |
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6,330 |
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Loss from operations |
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(6,264 |
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(2,192 |
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(18,300 |
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(6,330 |
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Interest income |
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601 |
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112 |
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915 |
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113 |
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Net loss |
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$ |
(5,663 |
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$ |
(2,080 |
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$ |
(17,385 |
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$ |
(6,217 |
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Net loss per common share, basic and diluted |
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$ |
(0.30 |
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$ |
(3.31 |
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$ |
(2.38 |
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$ |
(10.92 |
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Weighted-average shares used to compute net loss per common share, basic and diluted |
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18,955,384 |
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628,435 |
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7,319,012 |
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569,417 |
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