Kezar Life Sciences Q2 2024 Financial Results and Business Update

Kezar Life Sciences, Inc., a clinical-stage biotech firm specializing in innovative small molecule therapies for immune-mediated diseases and cancer, has released its financial results for the second quarter ending June 30, 2024, along with a business update. The company noted significant progress in its clinical programs, notably the completion of patient enrollment for the PORTOLA trial.

Chris Kirk, PhD, the Co-founder and CEO of Kezar, expressed enthusiasm about the rapid enrollment and upcoming data from the PORTOLA trial. The trial aims to assess zetomipzomib as a treatment for autoimmune hepatitis (AIH) and is expected to yield topline results in the first half of 2025. Kirk emphasized the importance of this milestone in addressing the unmet medical needs of AIH patients.

The company's flagship product, zetomipzomib, is a selective immunoproteasome inhibitor being evaluated in multiple clinical trials. The PALIZADE trial, a Phase 2b study, is exploring the efficacy and safety of zetomipzomib in patients with active lupus nephritis (LN). This global, placebo-controlled trial is set to enroll 279 patients who will be randomized into three groups receiving either 30 mg, 60 mg of zetomipzomib, or a placebo weekly for 52 weeks. The primary endpoint is to achieve a complete renal response by Week 37. Kezar anticipates reporting topline data from this trial by mid-2026.

In collaboration with Everest Medicines, the first patient in China has been dosed as part of the PALIZADE trial, highlighting the company's efforts to expand globally. This partnership aims to develop and commercialize zetomipzomib in Greater China, South Korea, and Southeast Asia.

The PORTOLA trial, a Phase 2a study, is targeting patients with AIH who are non-responsive to standard treatments or have relapsed. Enrollment is complete with 24 patients who will receive either 60 mg of zetomipzomib or a placebo over 24 weeks. The primary endpoint is the achievement of a complete biochemical response by Week 24. Results for this trial are expected in the first half of 2025.

Kezar also provided an update on KZR-261, a broad-spectrum Sec61 translocon inhibitor. The KZR-261-101 Phase 1 trial aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity in patients with advanced or metastatic solid tumors. Despite halting new enrollment to reallocate resources to zetomipzomib development, the study has enrolled 61 patients to date. Preliminary results show consistent pharmacokinetics and dose-dependent inhibition of Sec61 in patient blood samples. Full results will be presented at a future medical conference.

Financially, Kezar reported a decrease in cash, cash equivalents, and marketable securities to $164.2 million as of June 30, 2024, down from $201.4 million at the end of 2023. This decline is attributed to operational costs for advancing clinical programs. Research and development expenses for Q2 2024 were $16.3 million, a reduction from $21.0 million in Q2 2023, primarily due to a strategic restructuring to focus on clinical-stage programs. General and administrative expenses also saw a slight decrease to $5.6 million.

Kezar incurred restructuring and impairment charges amounting to $1.5 million, mainly from vacated office space. The net loss for Q2 2024 was $21.5 million compared to $24.3 million in Q2 2023. As of June 30, 2024, Kezar had 72.9 million shares of common stock outstanding.

In summary, Kezar Life Sciences is making significant strides in its clinical programs, particularly with zetomipzomib, which holds promise for treating serious immune-mediated diseases. The company continues to optimize its financial and operational strategies to support the advancement of its clinical pipeline.

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