Kezar Life Sciences, Inc. (KZR) 10-Q Quarterly Report Tue May 07 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

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FDA accepts 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

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Nomination of oncology clinical candidate from protein secretion program planned before year end

SAN FRANCISCO, Calif., May 7, 2019 -- 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 first quarter 2019 financial results and corporate highlights.

“The entire team at Kezar is excited to build on last year’s momentum and advance both of our programs in 2019,” said John Fowler, Kezar’s Chief Executive Officer. “Our strategy of evaluating KZR-616 in Phase 2 trials across multiple autoimmune indications is underway, building our case around the broad therapeutic potential of immunoproteasome inhibition. Pursuant to that goal, we look forward to reporting the first in patient data for KZR-616 at a major medical conference later this quarter. In addition, our novel protein secretion program continues to progress, with our first oncology clinical candidate anticipated to be selected this year.”

First Quarter and Recent Clinical and Business Highlights

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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.

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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.

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Our protein secretion program (Sec61 translocon modulation) was showcased in two poster presentations at the American Association for Cancer Research (AACR) in Atlanta, GA on April 2,

The following information was filed by Kezar Life Sciences, Inc. (KZR) on Tuesday, May 7, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Kezar Life Sciences, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2019 10-K Annual Report includes:

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Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Material Contracts, Statements, Certifications & more

Kezar Life Sciences, Inc. provided additional information to their SEC Filing as exhibits

Exhibit 10.1: Material Contract

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Ticker: KZR
CIK: 1645666
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-19-016498
Submitted to the SEC: Tue May 07 2019 4:09:55 PM EST
Accepted by the SEC: Tue May 07 2019
Period: Sunday, March 31, 2019
Industry: Pharmaceutical Preparations

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Kezar Life Sciences, Inc. (KZR) SEC Filing 10-Q Quarterly report for the period ending Sunday, March 31, 2019

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