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SOUTH SAN FRANCISCO, Calif. - Kezar Life Sciences, Inc. (NASDAQ:KZR), a biotechnology firm focused on developing treatments for immune-mediated diseases, today reported positive topline results from its PORTOLA Phase 2a clinical trial of zetomipzomib in patients with autoimmune hepatitis (AIH). Additionally, the company released its financial results for the fourth quarter and year-end 2024. According to InvestingPro data, the company, currently valued at approximately $45 million, appears undervalued based on its Fair Value analysis, despite facing profitability challenges.
The PORTOLA trial, which was not powered for efficacy, showed promising outcomes for AIH patients treated with zetomipzomib, a selective immunoproteasome inhibitor. The trial enrolled 24 patients, with a primary efficacy endpoint of achieving a complete biochemical response (CR) by Week 24, along with a reduction in steroid dosage to 5 mg/day or less. Results indicated that 31.3% (5 of 16) of zetomipzomib patients reached both CR and the targeted steroid taper, compared to 12.5% (1 of 8) in the placebo group. The median duration of response for zetomipzomib patients achieving a CR was 27.6 weeks, with no disease flares reported during the study.
In a subgroup analysis of 21 patients who were on steroid-based therapy at screening, 35.7% (5 of 14) of those treated with zetomipzomib achieved a CR and steroid taper to 5 mg/day or less, while none in the placebo group did. The safety profile was favorable, with the most common treatment-emergent adverse events being injection site reactions and systemic injection reactions, both generally mild to moderate in severity.
Financially, Kezar reported a decrease in cash, cash equivalents, and marketable securities to $132 million as of December 31, 2024, down from $201.4 million the previous year. This decline was primarily due to operational costs advancing clinical-stage programs. Research and development expenses for the year decreased by $20 million to $65.7 million, reflecting a strategic restructuring to prioritize clinical-stage programs and reduced early-stage research spending. General and administrative expenses also saw a decrease, attributed to lower legal, professional service expenses, and non-cash stock-based compensation. InvestingPro analysis reveals the company maintains a strong current ratio of 7.65, with more cash than debt on its balance sheet, though it’s quickly burning through available funds. Subscribers to InvestingPro can access 8 additional key financial tips about KZR’s financial health.
The net loss for 2024 was $83.7 million or $11.49 per basic and diluted common share, an improvement from a net loss of $101.9 million in 2023. The company highlighted that these financial results are based on a press release statement.
Kezar’s CEO, Chris Kirk, expressed optimism about the trial results and the potential for zetomipzomib to offer a new treatment option for AIH patients. The company plans to continue discussions with the FDA to advance the clinical development of zetomipzomib.
For further details, Kezar will host a conference call and webcast today at 8:00 a.m. ET to discuss the PORTOLA trial results.
In other recent news, Kezar Life Sciences announced its preliminary financial results for the year ending December 31, 2024. The company estimates its year-end cash, cash equivalents, and marketable securities to total approximately $132.2 million. These figures are preliminary and have not yet been audited, with the final results expected to follow the completion of year-end financial closing procedures. In another development, William Blair upgraded Kezar’s stock rating from Market Perform to Outperform. This upgrade was influenced by the positive outlook on Kezar’s product, zetomipzomib, particularly following the PALIZADE Phase IIb clinical trial results for lupus nephritis. Analysts at William Blair noted that the safety concerns from the trial were not as severe as anticipated. The upcoming PORTOLA trial results are anticipated to be a crucial moment for Kezar, with a favorable risk/reward scenario expected. These developments reflect a period of significant activity and potential for Kezar Life Sciences.
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