Kezar Life Sciences, Inc. (KZR) 10-Q Quarterly Report August 2021

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE) – May 12, 2021 – Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today announced its first quarter 2021 financial results and corporate highlights.

“Last quarter saw excellent execution by the Kezar team across both of our programs. We look forward to sharing data this June from the completed Phase 1b portion of the MISSION study of KZR-616 in SLE patients, followed by an interim review of the Phase 2 portion of MISSION in LN patients in the fourth quarter. Our conviction continues to deepen that immunoproteasome inhibition has the potential to be a powerful, differentiated treatment approach for patients with autoimmune diseases,” said John Fowler, Kezar’s Co-founder and Chief Executive Officer. “In addition, we are on track to submit an IND for KZR-261, our first-in-class protein secretion inhibitor, in mid-2021 and commence a Phase 1 study in solid tumors shortly thereafter.”

Clinical Highlights & Updates

KZR-616: Selective Immunoproteasome Inhibitor

MISSION – Phase 1b/2 clinical trial in patients with systemic lupus erythematous (SLE) and lupus nephritis (LN), respectively (NCT03393013)

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The last patient from the MISSION Phase 1b completed treatment in February 2021, and final clinical data from this 25-week safety and tolerability study of up to 75 mg weekly of KZR-616 in 47 patients with SLE will be presented during the European Congress of Rheumatology (EULAR 2021) in June.

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The amended Phase 2 open-label portion of the MISSION trial in patients with active, proliferative lupus nephritis opened for enrollment in August 2020 and is actively recruiting. The primary efficacy endpoint for the trial is the proportion of patients achieving a renal response measured by a 50% or greater reduction in urine protein to creatinine ratio (UPCR) at six months.

Interim data are expected in late 2021, and topline data are expected in the first half of 2022.

PRESIDIO – Phase 2 clinical trial in patients with dermatomyositis (DM) and polymyositis (PM) (NCT04033926)

The following information was filed by Kezar Life Sciences, Inc. (KZR) on Wednesday, May 12, 2021 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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Inside Kezar Life Sciences, Inc.'s 10-Q Quarterly Report:

Other - Other Highlight
If such a disruption occurs, we could experience an inability to access additional capital, which could in the future negatively affect our operations.

Financial - Expense Highlight
We expect to continue to incur significant expenses and increasing operating losses for at least the next several years.
Financial - Expense Highlight
The increase was primarily due to an increase of $0.4 million in stock-based compensation, an increase of $0.4 million in personnel and recruiting expenses due to an increase in headcount and salaries, an increase of $0.1 million in directors and officers liability insurance, and an increase of $0.1 million in facilities related expenses.
Financial - Expense Highlight
The increase was primarily due to an increase of $0.9 million in stock-based compensation and an increase of $0.5 million in personnel and recruiting expenses due to an increase in headcount and salaries, an increase of $0.2 million in directors and officers liability insurance, and an increase of $0.2 million in facilities related expenses.
Financial - Cash Flow Highlight
We have incurred operating losses and experienced negative operating cash flows since our inception and anticipate that we will continue to incur losses for at least the foreseeable future.
Other - Other
The safety and tolerability of...Read more
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Costs for certain development activities...Read more
Other - Other
Further, our operating plan may...Read more
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The following table summarizes our...Read more
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18 General and Administrative Expenses...Read more
Other - Other
Improvement in key biomarkers indicating...Read more
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Improvement in disease activity generally...Read more
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In September 2020, we entered...Read more
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We will incur additional expenses...Read more
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General and administrative expenses increased...Read more
Other - Other
Our net losses were $41.7...Read more
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There can be no assurance...Read more
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Interest income decreased by $0.3...Read more
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Interest income decreased by $0.7...Read more
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We observed encouraging trends in...Read more
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Personnel costs consist of salaries,...Read more
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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 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: 0001564590-21-043979
Submitted to the SEC: Thu Aug 12 2021 4:13:42 PM EST
Accepted by the SEC: Thu Aug 12 2021
Period: Wednesday, June 30, 2021
Industry: Pharmaceutical Preparations

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Kezar Life Sciences, Inc. (KZR) SEC Filing 10-Q Quarterly Report for the period ending Wednesday, June 30, 2021

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