Kezar Life Sciences(KZR) - 2025 Q2 - Quarterly Results

Kezar Life Sciences Reports Second Quarter 2025 Financial Results and Provides Business Update Kezar Life Sciences announced its Q2 2025 financial results and provided updates on clinical development and regulatory progress for zetomipzomib Company Announcement & CEO Statement 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][2] - 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] Business Update This section details the clinical and regulatory advancements for zetomipzomib, corporate personnel changes, and upcoming medical conference presentations Zetomipzomib Clinical & Regulatory Progress 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][6] - Submitted Type C meeting request to the FDA to meet during Q4 2025 to discuss the AIH development plan for zetomipzomib[5][6] - 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] - 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] - The median duration of response in zetomipzomib patients achieving CR was 27.6 weeks, with no disease flares reported during the study[6] - A favorable safety profile was observed during the 6-month blinded treatment period[6] Corporate & Personnel Updates 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] Medical Conference Presentations 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][10] - An abstract featuring PORTOLA biomarker data has been selected for poster presentation at The Liver Meeting® 2025[10] Financial Results This section presents Kezar's second quarter 2025 financial performance, including key income statement and balance sheet data Summary of Q2 2025 Financial Performance 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] - The decrease in G&A expenses was mainly attributable to lower non-cash stock-based compensation and personnel-related expenses[11] - 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] Selected Balance Sheets Data 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 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 This section provides an overview of Kezar Life Sciences as a clinical-stage biopharmaceutical company and its lead product candidate, zetomipzomib Company Overview 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] - Zetomipzomib, a selective immunoproteasome inhibitor, is currently being evaluated for autoimmune hepatitis and has the potential to address multiple chronic immune-mediated diseases[12] Cautionary Note on Forward-looking Statements This section provides a disclaimer regarding forward-looking statements, outlining inherent risks and uncertainties that may affect actual results Forward-looking Statements Disclaimer 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] - 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] - Kezar assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, except as required by law[13]