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Kezar Life Sciences, Inc. (KZR) SEC Filing 10-K Annual report for the fiscal year ending Monday, December 31, 2018

Kezar Life Sciences, Inc.

CIK: 1645666 Ticker: KZR

Exhibit 99.1

Kezar Life Sciences Reports Fourth Quarter and Year End 2018 Financial Results and Provides Business Update

 

Phase 1b SLE top-line data and Phase 2 LN initiation in Q2 2019

 

Phase 2 trials in up to four additional autoimmune indications to begin 2H 2019

 

First clinical candidate nomination for protein secretion program in 2019

SOUTH SAN FRANCISCO, Calif., March 26, 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 fourth quarter and full year 2018 financial results and business highlights.

“This past year was pivotal for Kezar, and I’m proud of the tremendous progress our team has accomplished,” said John Fowler, Chief Executive Officer. “We successfully completed our IPO, creating a strong capital base, and we are rapidly advancing KZR-616, our first-in-class selective immunoproteasome inhibitor for patients living with severe and underserved autoimmune diseases. We look forward to sharing results from the initial two cohorts from the Phase 1b portion of our trial in lupus patients and initiating our Phase 2 trial in lupus nephritis (LN) in the second quarter of 2019. We are also pleased to announce the planned expansion of our KZR-616 clinical program with additional Phase 2 trials commencing in up to four new indications later this year, including dermatomyositis and polymyositis. Lastly, our ongoing discovery efforts in protein secretion are progressing well, and we anticipate nominating our first oncology clinical candidate before the end of the year.”

Fourth Quarter and Recent Clinical and Business Highlights

 

Our systemic lupus erythematosus (SLE) and LN program is advancing with enrollment continuing in the open-label dose escalation Phase 1b portion in SLE patients. We plan to initiate the Phase 2 portion of the trial in patients with active, proliferative LN and expect to report data from the first two cohorts of the Phase 1b portion in the second quarter of 2019.

 

 

We initiated a Phase 1, randomized, double-blind, placebo controlled, single and multiple ascending dose trial to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunomodulatory activity of a new lyophilized formulation of KZR-616.  This formulation of KZR-616 has the potential to improve the ease of drug administration, transportation and storage, which we believe may result in increased patient adoption in a commercial setting.  Additionally, data from this trial may support development and potential regulatory approval.

 

 

Clinical development efforts are underway to initiate trials in up to four additional autoimmune diseases of high unmet need beginning in the second half of 2019, with the first two diseases being dermatomyositis and polymyositis.

 

 

The protein secretion program (Sec61 translocon modulation) also advanced during the fourth quarter which will be showcased in two poster presentations at the American Association for Cancer Research (AACR) in Atlanta, GA on April 2, 2019. We remain on track to nominate a first clinical candidate in oncology this year.


The following information was filed by Kezar Life Sciences, Inc. (KZR) on Tuesday, March 26, 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-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside this 10-K Annual Report

Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statement Of Redeemable Convertible Preferred Stock And Stockholders' Equity (Deficit)
Consolidated Statement Of Redeemable Convertible Preferred Stock And Stockholders' Equity (Deficit) (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Comprehensive Loss
Consolidated Statements Of Operations
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)
Cash Equivalents And Marketable Securities
Cash Equivalents And Marketable Securities (Tables)
Cash Equivalents And Marketable Securities - Additional Information (Details)
Cash Equivalents And Marketable Securities - Summary Of Amortized Cost And Estimated Fair Value Of Available-For-Sale Securities By Contractual Maturity (Details)
Cash Equivalents And Marketable Securities - Summary Of Financial Assets And Liabilities Measured And Recognized At Fair Value On Recurring Basis (Details)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Additional Information (Details)
Commitments And Contingencies - Summary Of Future Minimum Lease Payments (Details)
Defined Contribution Plan
Defined Contribution Plan - Additional Information (Details)
Income Taxes
Income Taxes (Tables)
Income Taxes - Additional Information (Details)
Income Taxes - Schedule Of Components Of Deferred Tax Assets And Liabilities (Details)
Income Taxes - Schedule Of Domestic And Foreign Components Of Net Loss (Details)
Income Taxes - Schedule Of Effective Tax Rate Of Provision For Income Taxes Differs From Federal Statutory Rate (Details)
License Agreement
License Agreement - Additional Information (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)
Redeemable Convertible Preferred Stock
Redeemable Convertible Preferred Stock - Additional Information (Details)
Selected Quarterly Financial Information (Unaudited)
Selected Quarterly Financial Information (Unaudited) (Tables)
Selected Quarterly Financial Information (Unaudited) - Schedule Of Selected Quarterly Financial Information (Unaudited) (Details)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Additional Information (Details)
Stock-Based Compensation - Fair Value Of Employee Stock Options Granted Is Calculated Using Black Scholes Option Pricing Model With Weighted Average Assumptions (Details)
Stock-Based Compensation - Stock-Based Compensation Recognized (Details)
Stock-Based Compensation - Summarizes Of Activity Of Nonvested Restricted Stock (Details)
Stock-Based Compensation - Summary Of Activity Under Stock Option Plan And Related Information (Details)
Stock-Based Compensation - Unrecognized Stock-Based Compensation Cost And Estimated Weighted Average Amortization Period (Details)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)
Summary Of Significant Accounting Policies - Additional Information (Details)
Summary Of Significant Accounting Policies - Schedule Of Reconciliation Of Cash, Cash Equivalents And Restricted Cash (Detail)
Summary Of Significant Accounting Policies - Summary Of Financial Assets Measured At Fair Value On Recurring Basis (Details)
Ticker: KZR
CIK: 1645666
Form Type: 10-K Annual Report
Accession Number: 0001564590-19-009369
Submitted to the SEC: Tue Mar 26 2019 5:01:30 PM EST
Accepted by the SEC: Tue Mar 26 2019
Period: Monday, December 31, 2018
Industry: Pharmaceutical Preparations

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