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Financial Performance - The company reported a net loss of $41.5 million for the nine months ended September 30, 2025, compared to a net loss of $63.5 million for the same period in 2024, reflecting a decrease of $22.0 million [134]. - Total operating expenses for the nine months ended September 30, 2025, were $43.9 million, down from $69.0 million in 2024, representing a decrease of $25.1 million [134]. - The net loss for the nine months ended September 30, 2025, was $41.5 million, with an accumulated deficit of $476.0 million as of the same date [142]. - Cash used in operating activities was $39.8 million for the nine months ended September 30, 2025, compared to $57.4 million for the same period in 2024 [154]. - The company anticipates additional losses in the future as it evaluates strategic alternatives and manages discretionary spending [145]. Research and Development - Research and development expenses decreased by $21.0 million for the nine months ended September 30, 2025, primarily due to a reduction in clinical expenses from the termination of the PALIZADE trial and completion of the PORTOLA trial [135]. - Research and development expenses for the three months ended September 30, 2025, were $6.9 million, down from $16.2 million in 2024, a decrease of $9.3 million [129]. - The FDA removed the partial clinical hold on the PORTOLA Phase 2a clinical trial for zetomipzomib in July 2025, but a proposed registrational trial for relapsed and refractory autoimmune hepatitis was not aligned with the FDA [113][114]. Expenses and Charges - General and administrative expenses for the three months ended September 30, 2025, decreased by $0.9 million to $4.8 million compared to $5.7 million in 2024 [131]. - Restructuring and impairment charges decreased by $1.5 million for the nine months ended September 30, 2025, compared to the same period in 2024 [137]. - Interest income decreased by $1.0 million for the three months ended September 30, 2025, primarily due to a decrease in cash equivalents and lower interest rates [132]. - Interest income decreased by $3.1 million for the nine months ended September 30, 2025, primarily due to lower cash equivalents and interest rates [139]. Strategic Initiatives - The company is exploring strategic alternatives, including a restructuring plan and workforce reduction, to maximize stockholder value [115]. - The company reduced its workforce by approximately 70% as part of cost reduction efforts, estimating cash expenditures of about $6.0 million [144]. - The company has no committed external sources of funding and may need to pursue financing through equity offerings, debt financings, and collaborations [152]. Cash and Investments - As of September 30, 2025, the company had $90.2 million in cash, cash equivalents, and marketable securities, with an average maturity of approximately two months [141]. - Net cash provided by investing activities was $40.9 million for the nine months ended September 30, 2025, primarily from maturities of marketable securities [157]. - The company repaid $6.3 million under the Loan Agreement with Oxford Finance in October 2025, fully satisfying the outstanding amount [146].

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--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 announced two presentations from the completed Phase 2a PORTOLA clinical trial in patients with autoimmune hepatitis (AIH) at The Liver Meeting 2025 held by the American Association for the Study of Liver Disease (AASLD) and taking place November 7-11, in Washington, DC. ...

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Artiva Biotherapeutics, Inc. (ARTV) has increased by 124% to $6.22 [3] - Akanda Corp. (AKAN) is up 39% at $3.10 [3] - Kezar Life Sciences, Inc. (KZR) has risen 38% to $5.80 [3] - Carbon Revolution Public Limited Company (CREV) is also up 38% at $5.15 [3] - Safe & Green Holdings Corp. (SGBX) has increased by 28% to $3.96 [3] - Achieve Life Sciences, Inc. (ACHV) is up 23% at $3.80 [3] - Revolution Medicines, Inc. (RVMD) has risen 8% to $53.90 [3] - Erayak Power Solution Group Inc. (RAYA) is up 8% at $5.76 [3] - ProQR Therapeutics N.V. (PRQR) has increased by 7% to $3.00 [3] - Bio Green Med Solution, Inc. (BGMS) is up 6% at $4.04 [3] Premarket Losers - American Rebel Holdings, Inc. (AREB) has decreased by 41% to $2.09 [4] - Sadot Group Inc. (SDOT) is down 25% at $5.35 [4] - AVITA Medical, Inc. (RCEL) has fallen 24% to $4.04 [4] - Soluna Holdings, Inc. (SLNH) is down 23% at $3.22 [4] - American Battery Technology Company (ABAT) has decreased by 17% to $4.70 [4] - CID HoldCo, Inc. (DAIC) is down 17% at $2.16 [4] - Pinnacle Food Group Limited (PFAI) has fallen 12% to $3.12 [4] - OnKure Therapeutics, Inc. (OKUR) is down 12% at $2.52 [4] - Whitehawk Therapeutics, Inc. (WHWK) has decreased by 12% to $2.29 [4] - Aqua Metals, Inc. (AQMS) is down 7% at $14.50 [4]

Group 1: CSX Corp Performance - CSX Corp reported third-quarter revenue of $3.59 billion, exceeding analyst estimates of $3.58 billion [1] - The company achieved adjusted earnings of 44 cents per share, surpassing analyst expectations of 43 cents per share [1] - Following the earnings report, CSX shares increased by 4.2% to $37.51 in pre-market trading [1] Group 2: Other Stocks in Pre-Market Trading - Artiva Biotherapeutics Inc gained 98.6% to $5.50 after receiving FDA Fast Track Designation for AlloNK [4] - Safe & Green Holdings Corp surged 38.8% to $4.27 after completing Phase 1 of its intelligent wellsite monitoring system [4] - Kezar Life Sciences Inc rose 36% to $5.67 following a regulatory update on its Zetomipzomib program [4] - INVO Fertility Inc tumbled 34.6% to $0.92 after a significant rise of over 85% the previous day [4] - American Battery Technology Co shares dipped 19.8% to $4.55 after a 37% decline on Thursday due to the termination of a grant by the Department of Energy [4]

Date of Report (Date of earliest event reported): October 16, 2025 __________________________________________________________ Kezar Life Sciences, Inc. (Exact name of Registrant as Specified in Its Charter) __________________________________________________________ (State or Other Jurisdiction of Incorporation) Delaware 001-38542 47-3366145 (Commission File Number) (IRS Employer UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 __________________________________________________________ ...

Company Overview - Verrica Pharmaceuticals Inc. (NASDAQ:VRCA) is focused on developing and commercializing treatments for skin diseases, with its lead product candidate, VP-102, targeting molluscum contagiosum [1] Financial Performance - VRCA has a Return on Invested Capital (ROIC) of -166.93%, significantly lower than its Weighted Average Cost of Capital (WACC) of 17.69%, indicating inefficiencies in capital utilization [2][6] - The ROIC to WACC ratio for VRCA is -9.44, further emphasizing the challenge in generating sufficient returns to cover its cost of capital [2] Comparative Analysis - Y-mAbs Therapeutics (YMAB) has a ROIC of -27.64% and a WACC of 6.11%, resulting in a ROIC to WACC ratio of -4.53, making it the least inefficient among its peers [3][5] - Scholar Rock Holding Corporation (SRRK) shows a ROIC of -109.48% against a WACC of 5.32%, leading to a ROIC to WACC ratio of -20.57, indicating similar inefficiencies as VRCA [4] - Crinetics Pharmaceuticals (CRNX) and Kezar Life Sciences (KZR) also exhibit negative ROIC to WACC ratios of -6.99 and -10.94, respectively, highlighting broader challenges within the sector [4][5] Sector Insights - All companies analyzed, including VRCA, are currently operating at a loss relative to their cost of capital, with Y-mAbs Therapeutics managing its capital more effectively than its peers [5][6]

Core Viewpoint - Kezar Life Sciences, Inc. (KZR) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system tracks the Zacks Consensus Estimate, which reflects EPS estimates from sell-side analysts for the current and following years, highlighting the importance of earnings revisions in stock valuation [1][4]. - A strong correlation exists between changes in earnings estimates and near-term stock price movements, primarily due to institutional investors adjusting their valuations based on these estimates [4][6]. Recent Developments for Kezar Life Sciences - For the fiscal year ending December 2025, Kezar Life Sciences is expected to earn -$7.22 per share, which remains unchanged from the previous year, but analysts have raised their estimates by 3.4% over the past three months [8]. - The upgrade to Zacks Rank 2 places Kezar Life Sciences in the top 20% of Zacks-covered stocks, suggesting potential for higher stock prices in the near term [10]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a proven track record of Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [7][9]. - The system maintains a balanced distribution of "buy" and "sell" ratings, ensuring that only the top 5% of stocks receive a "Strong Buy" rating, indicating superior earnings estimate revisions [9][10].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q _______________________________________________________________________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission Fil ...

[Kezar Life Sciences Reports Second Quarter 2025 Financial Results and Provides Business Update](index=1&type=section&id=Kezar%20Life%20Sciences%20Reports%20Second%20Quarter%202025%20Financial%20Results%20and%20Provides%20Business%20Update) Kezar Life Sciences announced its Q2 2025 financial results and provided updates on clinical development and regulatory progress for zetomipzomib [Company Announcement & CEO Statement](index=1&type=section&id=Company%20Announcement%20%26%20CEO%20Statement) Kezar Life Sciences reported Q2 2025 financial results and business updates, with CEO Chris Kirk highlighting zetomipzomib's clinical development and regulatory submission progress for autoimmune hepatitis - Kezar Life Sciences, a clinical-stage biotechnology company, reported financial results for the second quarter ended June 30, 2025, and provided a business update on August 13, 2025[1](index=1&type=chunk)[2](index=2&type=chunk) - CEO Chris Kirk stated the company is on track with clinical development and regulatory submission for zetomipzomib in autoimmune hepatitis, proposing a registration-enabling study and anticipating a Type C meeting with the FDA[3](index=3&type=chunk) [Business Update](index=1&type=section&id=Business%20Update) This section details the clinical and regulatory advancements for zetomipzomib, corporate personnel changes, and upcoming medical conference presentations [Zetomipzomib Clinical & Regulatory Progress](index=1&type=section&id=Zetomipzomib%20Clinical%20%26%20Regulatory%20Progress) Kezar achieved significant milestones for zetomipzomib, including FDA's removal of a partial clinical hold on the PORTOLA Phase 2a trial for autoimmune hepatitis (AIH) and the submission of a Type C meeting request to discuss the AIH development plan - FDA removed partial clinical hold on PORTOLA Phase 2a trial evaluating zetomipzomib for autoimmune hepatitis (AIH) in July[5](index=5&type=chunk)[6](index=6&type=chunk) - Submitted Type C meeting request to the FDA to meet during Q4 2025 to discuss the AIH development plan for zetomipzomib[5](index=5&type=chunk)[6](index=6&type=chunk) - Submitted a complete response to the FDA Division of Rheumatology and Transplant Medicine with a request to remove the clinical hold on zetomipzomib in lupus nephritis[7](index=7&type=chunk) - PORTOLA Phase 2a trial results in relapsed or refractory AIH patients showed **36% (5 of 14) achieved a complete biochemical response (CR)** and clinically significant steroid taper to 5 mg/day or less by 6 months, compared to 0 of 7 placebo patients[6](index=6&type=chunk) - The median duration of response in zetomipzomib patients achieving CR was **27.6 weeks**, with no disease flares reported during the study[6](index=6&type=chunk) - A favorable safety profile was observed during the 6-month blinded treatment period[6](index=6&type=chunk) [Corporate & Personnel Updates](index=2&type=section&id=Corporate%20%26%20Personnel%20Updates) Zung To was promoted to Chief Development Officer in June 2025, bringing 35 years of industry experience and leading Kezar's development strategy - Zung To was promoted to Chief Development Officer in June 2025, bringing **35 years of industry experience**, including over 20 years in senior leadership roles in clinical development[8](index=8&type=chunk) [Medical Conference Presentations](index=2&type=section&id=Medical%20Conference%20Presentations) PORTOLA Phase 2a data and biomarker data have been selected for oral and poster presentations, respectively, at The Liver Meeting® 2025 in November - An abstract featuring PORTOLA Phase 2a data has been selected for an oral presentation at The Liver Meeting® 2025 (November 7-11, Washington, DC)[5](index=5&type=chunk)[10](index=10&type=chunk) - An abstract featuring PORTOLA biomarker data has been selected for poster presentation at The Liver Meeting® 2025[10](index=10&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) This section presents Kezar's second quarter 2025 financial performance, including key income statement and balance sheet data [Summary of Q2 2025 Financial Performance](index=2&type=section&id=Summary%20of%20Q2%202025%20Financial%20Performance) Kezar reported a net loss of $13.7 million for Q2 2025, an improvement from $21.5 million in Q2 2024, driven by decreased R&D, G&A, and restructuring expenses Key Financial Highlights (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (Millions) | | :-------------------------------- | :----------------- | :----------------- | :---------------- | | Cash, Cash Equivalents & Marketable Securities (as of period end) | $100.8 | $132.2 (Dec 31, 2024) | $(31.4) | | Research & Development (R&D) Expenses | $9.6 | $16.3 | $(6.7) | | General & Administrative (G&A) Expenses | $5.0 | $5.6 | $(0.6) | | Restructuring & Impairment Charges | $0.0 | $1.5 | $(1.5) | | Net Loss | $(13.7) | $(21.5) | $7.8 | | Net Loss per Share (Basic & Diluted) | $(1.87) | $(2.96) | $1.09 | - The decrease in R&D expenses was primarily due to reduced clinical activities from trial completion and closeout, lower personnel costs (including non-cash stock-based compensation), and decreased facility-related expenses[11](index=11&type=chunk) - The decrease in G&A expenses was mainly attributable to lower non-cash stock-based compensation and personnel-related expenses[11](index=11&type=chunk) - Restructuring and impairment charges decreased due to an impairment charge in 2024 related to a vacated floor in the company's leased office facility[11](index=11&type=chunk) [Selected Balance Sheets Data](index=3&type=section&id=Selected%20Balance%20Sheets%20Data) As of June 30, 2025, Kezar's cash, cash equivalents, and marketable securities totaled $100.8 million, a decrease from December 31, 2024, with all major balance sheet items also decreasing Selected Balance Sheets Data (as of June 30, 2025 vs. December 31, 2024) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | Change | | :----------------------------------- | :------------ | :---------------- | :----- | | Cash, cash equivalents and marketable securities | $100,849 | $132,245 | $(31,396) | | Total assets | $109,123 | $144,682 | $(35,559) | | Total current liabilities | $14,365 | $20,329 | $(5,964) | | Total noncurrent liabilities | $2,972 | $7,437 | $(4,465) | | Total stockholders' equity | $91,786 | $116,916 | $(25,130) | [Summary of Operations Data](index=3&type=section&id=Summary%20of%20Operations%20Data) For Q2 2025, total operating expenses decreased significantly to $14.6 million, resulting in a reduced net loss of $13.7 million, with similar trends observed for the six-month period Summary of Operations Data (Three Months Ended June 30) | Metric (in thousands) | Q2 2025 | Q2 2024 | Change | | :------------------------------------------ | :------ | :------ | :----- | | Research and development | $9,583 | $16,298 | $(6,715) | | General and administrative | $5,016 | $5,603 | $(587) | | Restructuring and impairment charges | $0 | $1,482 | $(1,482) | | Total operating expenses | $14,599 | $23,383 | $(8,784) | | Loss from operations | $(14,599) | $(23,383) | $8,784 | | Interest income | $1,197 | $2,237 | $(1,040) | | Interest expense | $(302) | $(401) | $99 | | Net loss | $(13,704) | $(21,547) | $7,843 | | Net loss per common share, basic and diluted | $(1.87) | $(2.96) | $1.09 | | Weighted-average shares used to compute net loss per common share, basic and diluted | 7,311,032 | 7,284,587 | 26,445 | Summary of Operations Data (Six Months Ended June 30) | Metric (in thousands) | H1 2025 | H1 2024 | Change | | :------------------------------------------ | :------ | :------ | :----- | | Research and development | $21,763 | $33,470 | $(11,707) | | General and administrative | $10,465 | $12,142 | $(1,677) | | Restructuring and impairment charges | $0 | $1,482 | $(1,482) | | Total operating expenses | $32,228 | $47,094 | $(14,866) | | Loss from operations | $(32,228) | $(47,094) | $14,866 | | Interest income | $2,617 | $4,690 | $(2,073) | | Interest expense | $(649) | $(801) | $152 | | Net loss | $(30,260) | $(43,205) | $12,945 | | Net loss per common share, basic and diluted | $(4.14) | $(5.93) | $1.79 | | Weighted-average shares used to compute net loss per common share, basic and diluted | 7,308,360 | 7,282,289 | 26,071 | [About Kezar Life Sciences](index=3&type=section&id=About%20Kezar%20Life%20Sciences) This section provides an overview of Kezar Life Sciences as a clinical-stage biopharmaceutical company and its lead product candidate, zetomipzomib [Company Overview](index=3&type=section&id=Company%20Overview) Kezar Life Sciences is a clinical-stage biopharmaceutical company developing novel small molecule therapeutics for immune-mediated diseases, with zetomipzomib as its lead product candidate for autoimmune hepatitis - Kezar Life Sciences is a clinical-stage biopharmaceutical company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases[12](index=12&type=chunk) - Zetomipzomib, a selective immunoproteasome inhibitor, is currently being evaluated for autoimmune hepatitis and has the potential to address multiple chronic immune-mediated diseases[12](index=12&type=chunk) [Cautionary Note on Forward-looking Statements](index=3&type=section&id=Cautionary%20Note%20on%20Forward-looking%20Statements) This section provides a disclaimer regarding forward-looking statements, outlining inherent risks and uncertainties that may affect actual results [Forward-looking Statements Disclaimer](index=3&type=section&id=Forward-looking%20Statements%20Disclaimer) This section serves as a disclaimer, indicating that the press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially - The press release contains forward-looking statements regarding clinical development programs, regulatory submission plans for zetomipzomib in AIH, and the likelihood of obtaining regulatory approval[13](index=13&type=chunk) - These statements involve risks and uncertainties, such as unexpected safety or efficacy data, difficulties in clinical trials, changes in competition or the regulatory environment, and the timing of the regulatory approval process, which could cause actual results to differ materially[13](index=13&type=chunk) - Kezar assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, except as required by law[13](index=13&type=chunk)