Kezar Life Sciences Q1 2024 Financial Results and Business Update

Kezar Life Sciences, Inc., a biotech company based in South San Francisco, has released its financial results for the first quarter ending on March 31, 2024, and shared an update on its ongoing clinical programs. The company, which focuses on developing innovative small molecule therapeutics to address unmet needs in immune-mediated diseases and cancer, reported several significant developments in their clinical trials.

Chris Kirk, Kezar’s Co-Founder and CEO, highlighted the progress made in clinical execution, particularly in the PALIZADE and PORTOLA trials. He also expressed anticipation for the initial results from the KZR-261 study’s dose escalation and expansion phases expected later this year.

Zetomipzomib, one of Kezar's lead candidates, is a selective immunoproteasome inhibitor under investigation in two key trials:

1. PALIZADE: This Phase 2b trial involves patients with active lupus nephritis (LN). The global, placebo-controlled, randomized, double-blind study aims to evaluate the efficacy and safety of two dose levels of zetomipzomib. A total of 279 patients will be enrolled and randomly assigned to receive either 30 mg or 60 mg of zetomipzomib, or a placebo, administered subcutaneously once weekly for 52 weeks. The primary endpoint is achieving a complete renal response at Week 37, with a urine protein-to-creatine ratio of 0.5 or less without the need for rescue medications.

2. PORTOLA: This Phase 2a trial is for patients with autoimmune hepatitis (AIH) who are not responding adequately to standard treatments. It is a placebo-controlled, randomized, double-blind trial with a target enrollment of 24 patients. Participants will receive either 60 mg of zetomipzomib or a placebo in addition to background corticosteroid therapy for 24 weeks. The primary endpoint is the normalization of ALT and AST levels with a successful steroid taper by Week 24.

Additionally, Kezar is progressing with KZR-261, a broad-spectrum Sec61 translocon inhibitor, in its Phase 1 trial. The study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of KZR-261, along with its preliminary anti-tumor activity in patients with locally advanced or metastatic solid malignancies. The dose escalation phase has identified a maximum tolerated dose of 80 mg/m², with dose expansion currently focusing on melanoma patients at 60 mg/m². To date, KZR-261 has shown dose-proportional exposure without signs of accumulation upon repeated dosing.

Financially, Kezar reported cash, cash equivalents, and marketable securities amounting to $179.8 million as of March 31, 2024, a decrease from $201.4 million on December 31, 2023. This reduction primarily reflects operational cash usage to advance clinical-stage programs.

For the first quarter of 2024, research and development expenses were $17.2 million, a decrease from $18.3 million in the same period the previous year. This reduction is attributed to the company's strategic restructuring in October 2023, which prioritized clinical-stage programs and reduced costs related to personnel and early-stage research. General and administrative expenses, however, rose slightly to $6.5 million, largely due to increases in non-cash stock-based compensation and personnel-related expenses, offset by reduced legal and professional service costs.

The net loss for the first quarter of 2024 stood at $21.7 million, or $0.30 per share, compared to a net loss of $22.2 million, or $0.31 per share, in the first quarter of 2023. The total number of common stock shares outstanding as of March 31, 2024, was 72.8 million, with options to purchase an additional 15.6 million shares at an average exercise price of $2.27 per share and 0.2 million restricted stock units.

Kezar Life Sciences continues to advance its mission to develop novel therapeutics, with ongoing trials and financial resources positioning it to address significant unmet medical needs in immunology and oncology.

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