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Kezar Life Sciences, Inc. (KZR) SEC Filing 10-Q Quarterly report for the period ending Wednesday, September 30, 2020

Kezar Life Sciences, Inc.

CIK: 1645666 Ticker: KZR

Exhibit 99.1

Kezar Life Sciences Reports Third-Quarter 2020 Financial Results and Provides Business Updates

 

FDA grants two Orphan Drug Designations to KZR-616 for the treatment of Dermatomyositis (DM) and Polymyositis (PM)

 

KZR-616 clinical and pre-clinical data continues to support its potential to positively affect multiple drivers of immune-mediated diseases

 

KZR-261 IND submission on-track for Q1 2021

SOUTH SAN FRANCISCO, Calif., November 5, 2020

-- 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 third-quarter 2020 financial results and corporate highlights.

“The third quarter of 2020 saw continued momentum for Kezar, punctuated by the U.S. FDA granting Orphan Drug Designations for our lead candidate KZR-616 for the treatment of polymyositis and dermatomyositis,” said John Fowler, Kezar’s Co-Founder and Chief Executive Officer. “In addition, our presentations at a number of medical and scientific meetings this fall highlight the compelling therapeutic potential of our two highly novel programs in immunoproteasome inhibition and the protein secretion pathway. With each step forward, our conviction deepens that Kezar’s novel small molecule approaches autoimmunity and oncology could have profound impacts on a wide array of diseases with high unmet need.”

Clinical Highlights & Updates

KZR-616: Selective Immunoproteasome Inhibitor

KZR-616 is currently being evaluated for the treatment of severe autoimmune diseases.

 

In October 2020, Orphan Drug Designations (ODD) were granted for KZR-616 in both dermatomyositis (DM) and polymyositis (PM) by the U.S. Food and Drug Administration (FDA). Both orphan diseases are autoimmune inflammatory myopathies that are chronic and debilitating diseases characterized by marked morbidity and mortality. The estimated prevalence of DM and PM in the United States is up to 71,000 and 51,000, respectively. Orphan Drug Designation can provide certain benefits for the development of KZR-616, including a period of marketing exclusivity for the first marketing application, if approved for the designated indication, certain tax credits and waiver of certain administrative fees.

 

The MISSION Phase 2 trial in patients with active, proliferative lupus nephritis (LN) opened for enrollment under a new protocol in August 2020. The primary efficacy endpoint for the trial is the number of patients achieving a renal response measured by a 50% or greater reduction in urine protein to creatinine ratio (UPCR) at six months.

 

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Interim data are expected in late 2021, and topline data are expected in the first half of 2022. To allow for responding patients to continue treatment with KZR-616, a 12-month extension study will also be made available.  


The following information was filed by Kezar Life Sciences, Inc. (KZR) on Thursday, November 5, 2020 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 2020 10-K Annual Report includes:

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Inside Kezar Life Sciences, Inc.'s 10-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Document And Entity Information
Condensed Consolidated Balance Sheets
Condensed Consolidated Balance Sheets (Parenthetical)
Condensed Consolidated Statements Of Cash Flows (Unaudited)
Condensed Consolidated Statements Of Comprehensive Loss (Unaudited)
Condensed Consolidated Statements Of Operations (Unaudited)
Condensed Consolidated Statements Of Stockholders' Equity
Condensed Consolidated Statements Of Stockholders' Equity (Parenthetical)
Available-For-Sale Securities
Available-For-Sale Securities (Tables)
Available-For-Sale Securities - Additional Information (Details)
Available-For-Sale Securities - Summary Of Amortized Cost And Estimated Fair Value Of Available-For-Sale Securities By Contractual Maturity (Details)
Available-For-Sale Securities - Summary Of Available-For-Sale Securities Recorded In Cash And Cash Equivalents Or Marketable Securities (Details)
Available-For-Sale Securities - Summary Of Gross Unrealized Losses And Fair Value By Major Security Type For Available-For-Sale Securities In Unrealized Loss Position (Details)
Balance Sheet Components
Balance Sheet Components (Tables)
Balance Sheet Components - Accrued Liabilities (Details)
Balance Sheet Components - Additional Information (Details)
Balance Sheet Components - Property And Equipment (Details)
Fair Value Measurements
Fair Value Measurements (Tables)
Fair Value Measurements - Summary Of Financial Assets Measured At Fair Value On Recurring Basis (Details)
Income Taxes
Income Taxes - Additional Information (Details)
Lease
Lease (Tables)
Lease - Additional Information (Details)
Lease - Details Of Right-Of-Use Assets And Lease Liabilities (Details)
Net Loss Per Share
Net Loss Per Share (Tables)
Net Loss Per Share - Anti-Dilutive Outstanding Shares Of Common Stock Equivalents Excluded From Computation Of Diluted Net Loss Per Share (Details)
Net Loss Per Share - Calculation Of Basic And Diluted Net Loss Per Share (Details)
Organization And Description Of The Business
Organization And Description Of The Business - Additional Information (Details)
Pre-Funded Warrants
Pre-Funded Warrants (Tables)
Pre-Funded Warrants - Additional Information (Details)
Pre-Funded Warrants - Summary Of Pre-Funded Warrants Outstanding (Details)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Additional Information (Details)
Stock-Based Compensation - Fair Value Of Stock Options Granted Is Calculated Using Black Scholes Option Pricing Model With Range Of Assumptions (Details)
Stock-Based Compensation - Stock-Based Compensation Expense Recognized (Details)
Stock-Based Compensation - Summary Of Activity Under Stock Option Plans And Related Information (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)

Material Contracts, Statements, Certifications & more

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

Ticker: KZR
CIK: 1645666
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-20-051314
Submitted to the SEC: Thu Nov 05 2020 4:13:03 PM EST
Accepted by the SEC: Thu Nov 05 2020
Period: Wednesday, September 30, 2020
Industry: Pharmaceutical Preparations

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