KZR Kezar Life Sciences Inc

 

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 12, 2024

 

 

Kezar Life Sciences, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-38542	47-3366145
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
4000 Shoreline Court, Suite 300
South San Francisco, California				94080
(Address of Principal Executive Offices)				(Zip Code)

 

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:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.001 par value		KZR		The Nasdaq Stock Market LLC
Preferred Share Purchase Rights		N/A		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company 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. ☐

 

 

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Item 2.02 Results of Operations and Financial Condition.

On November 12, 2024, Kezar Life Sciences, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended September 30, 2024. 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 under this Item 2.02 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

 

Exhibit No.		Description
99.1		Press release of the Company, dated November 12, 2024
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

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SIGNATURES

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.

			KEZAR LIFE SCIENCES, INC.
Date:	November 12, 2024	By:	/s/ Marc L. Belsky
			Marc L. Belsky Chief Financial Officer and Secretary

 

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Kezar Life Sciences Reports Third Quarter 2024 Financial Results and Provides Business Update

SOUTH SAN FRANCISCO, Calif.—November 12, 2024 — Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, today reported financial results for the third quarter ended September 30, 2024, and provided a business update.

“The team at Kezar has made great progress towards completing the double-blind portion of the PORTOLA trial as we prepare for a data release in first half of 2025,” said Chris Kirk, PhD, Kezar’s Chief Executive Officer. “There are currently no approved drugs for the treatment of autoimmune hepatitis, and we are focused on bringing zetomipzomib to patients living with this life-threatening disease. In addition, we are working to understand the safety events that occurred in the PALIZADE trial in lupus nephritis, including deaths that occurred in both the placebo and drug arms, so that we can provide patients and physicians appropriate guidance during our ongoing and future clinical trials.”

Zetomipzomib: Selective Immunoproteasome Inhibitor

PORTOLA – Phase 2a clinical trial of zetomipzomib in patients with AIH (ClinicalTrials.gov: NCT05569759)

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PALIZADE – Phase 2b clinical trial of zetomipzomib in patients with active lupus nephritis (LN) (ClinicalTrials.gov: NCT05781750)

MISSION – Kezar will present results from the open-label Phase 1b/2 MISSION trial in patients with systemic lupus erythematosus (SLE) with or without LN showing zetomipzomib demonstrated improvements in SLE/LN disease measures and biomarkers in patients with highly active SLE or nephrotic range proteinuria at the upcoming American College of Rheumatology (ACR) Convergence 2024, which is taking place November 14 – 19, 2024, in Washington, D.C.

Business Updates

In October, Kezar effected a one-for-ten reverse stock split of its outstanding shares of common stock (Reverse Stock Split) to regain compliance with the minimum bid price requirement of $1.00 per share required to maintain continued listing on The Nasdaq Capital Market. The Reverse Stock Split reduced the number of shares of Kezar’s outstanding common stock from 72,962,220 shares to 7,296,222 shares, subject to adjustment due to the issuance of full shares in lieu of fractional shares.

Financial Results

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About Kezar Life Sciences

Kezar Life Sciences is a clinical-stage biopharmaceutical company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases. Zetomipzomib, a selective immunoproteasome inhibitor, is currently being evaluated in a Phase 2a clinical trial for autoimmune hepatitis. This product candidate also has the potential to address multiple chronic immune-mediated diseases. For more information, visit www.kezarlifesciences.com, and follow us on LinkedIn, Facebook, Twitter and Instagram.

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,” “can,” “should,” “expect,” “believe,” “potential,” “anticipate” 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 that could cause Kezar’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the design, initiation, progress, timing, scope and results of clinical trials, the enrollment and expected timing of reporting topline data from our clinical trials, the likelihood that data will support future development and therapeutic potential, the association of data with treatment outcomes and the likelihood of obtaining regulatory approval of Kezar’s product candidates. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during clinical studies, difficulties enrolling and conducting our clinical trials, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, 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 “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.

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KEZAR LIFE SCIENCES, INC.
Selected Balance Sheets Data
(In thousands)
		September 30, 2024		December 31, 2023
		(unaudited)
Cash, cash equivalents and marketable securities		$ 148,388		$ 201,372
Total assets		164,086		221,235
Total current liabilities		20,429		17,744
Total noncurrent liabilities		9,608		15,921
Total stockholders' equity		134,049		187,570

 

Summary of Operations Data
(In thousands except share and per share data)

 

	Three Months Ended				Nine Months Ended
	September 30				September 30
	2024		2023		2024		2023
	(unaudited)				(unaudited)
Collaboration revenue	$ -		$ 7,000		$ -		$ 7,000
Operating expenses:
Research and development	16,242		23,738		49,712		63,055
General and administrative	5,706		8,789		17,848		20,780
Impairment charge	-		-		1,482		-
Total operating expenses	21,948		32,527		69,042		83,835
Loss from operations	(21,948)		(25,527)		(69,042)		(76,835)
Interest income	2,038		2,820		6,728		8,376
Interest expense	(403)		(396)		(1,204)		(1,151)
Net loss	$ (20,313)		$ (23,103)		$ (63,518)		$ (69,610)
Net loss per common share, basic and diluted	$ (2.78)		$ (3.18)		$ (8.72)		$ (9.60)
Weighted-average shares used to compute net loss per common share, basic and diluted (1)	7,296,222		7,268,165		7,286,967		7,249,188

 

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Investor and Media Contact:

Gitanjali Jain

Senior Vice President, Investor Relations and External Affairs

Kezar Life Sciences, Inc.

gjain@kezarbio.com

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v3.24.3

Document And Entity Information	Nov. 12, 2024
Document Information [Line Items]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 12, 2024
Entity Registrant Name	Kezar Life Sciences, Inc.
Entity Central Index Key	0001645666
Entity Emerging Growth Company	false
Entity File Number	001-38542
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	47-3366145
Entity Address, Address Line One	4000 Shoreline Court, Suite 300
Entity Address, City or Town	South San Francisco
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94080
City Area Code	650
Local Phone Number	822-5600
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Common Stock
Document Information [Line Items]
Title of 12(b) Security	Common Stock, $0.001 par value
Trading Symbol	KZR
Security Exchange Name	NASDAQ
Preferred Share Purchase Rights
Document Information [Line Items]
Title of 12(b) Security	Preferred Share Purchase Rights
No Trading Symbol Flag	true
Security Exchange Name	NASDAQ

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