Key Takeaways from Kezar Life Sciences (KZR) 2025 Conference Company Overview - **Company**: Kezar Life Sciences - **Focus**: Development of zetomipsumab (Zito), the first selective inhibitor of the immunoproteosome in clinical development, targeting autoimmune hepatitis (AIH) [5][6] Industry Context - **Market Opportunity**: Approximately 100,000 patients in the United States suffer from AIH, with no new treatments in over three decades [5][6] - **Competitive Landscape**: No other drugs currently in development for AIH; Novartis discontinued its Phase II study last year [6] Core Product Insights - **Mechanism of Action**: Zito modulates immune responses without inducing cell depletion or immunosuppression, targeting all arms of the immune system [7][8] - **Clinical Data**: - In the Portola study, over 30% of Zito patients achieved steroid-free remission, a significant improvement compared to the placebo group [14][15] - Median duration of response for complete remission was just under 7 months, exceeding expectations [15] Safety and Regulatory Considerations - **Partial Clinical Hold**: The company is under a partial clinical hold due to safety concerns from a lupus nephritis study, which resulted in fatalities [20][22] - **Safety Profile**: Zito showed a favorable safety profile in AIH patients compared to lupus nephritis patients, with no disease flares reported in the AIH study [24][32] Future Development Plans - **Next Steps**: The company plans to submit a comprehensive safety summary to the FDA to lift the partial clinical hold and initiate a pivotal study for AIH [25][39] - **Study Design**: The pivotal study is expected to be similar to the Portola study, focusing on steroid-dependent second-line AIH patients [41][42] Market Potential and Pricing Strategy - **Addressable Patient Population**: Estimated 40,000 to 60,000 second-line AIH patients in the U.S. [56] - **Pricing Strategy**: Comparable to drugs for primary biliary cholangitis, potentially around $150,000 per year, leading to a blockbuster market opportunity [58] Intellectual Property and Exclusivity - **Patent Expiration**: Current composition of matter patent for Zito is expected to expire in 2039, with potential for orphan drug designation providing additional market exclusivity [61][62] Financial Position - **Cash Reserves**: The company reported $114 million in cash, sufficient to navigate key inflection points and fund upcoming trials [64] Key Inflection Points - **Upcoming Milestones**: - Lifting of the clinical hold - Alignment with the FDA on the next trial design - Potential partnerships for global market expansion [63][59] Conclusion Kezar Life Sciences is positioned to address a significant unmet need in the treatment of autoimmune hepatitis with its innovative drug Zito. The company is navigating regulatory challenges while preparing for pivotal studies that could unlock substantial market potential.

Kezar Life Sciences, Inc. (KZR) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the system ...

Financial Performance - The company reported a net loss of $16.6 million for the three months ended March 31, 2025, compared to a net loss of $21.7 million for the same period in 2024, reflecting a decrease of $5.1 million [118]. - Total operating expenses for the three months ended March 31, 2025, were $17.7 million, down from $23.7 million in the same period of 2024, a decrease of $6.0 million [118]. - Net cash used in operating activities for Q1 2025 was $17.2 million, compared to $22.9 million in Q1 2024, indicating a decrease of 25% [133][134]. - The net loss for Q1 2025 was $16.6 million, with non-cash charges of $2.5 million, including $2.8 million for stock-based compensation [134]. Research and Development - Research and development expenses decreased to $12.2 million for the three months ended March 31, 2025, down from $17.2 million in the same period of 2024, primarily due to a $3.4 million reduction in clinical expenses [111][119]. - The company is focusing its clinical development efforts on zetomipzomib for the treatment of autoimmune diseases, having discontinued development of KZR-261 and the PALIZADE trial [114]. Financial Position - The accumulated deficit as of March 31, 2025, was $451.1 million, indicating significant ongoing operating losses since inception [105][124]. - The company had $114.4 million in cash, cash equivalents, and marketable securities as of March 31, 2025, which is expected to meet projected operating requirements for at least the next 12 months [123][125]. - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $114.4 million [143]. - The average maturity of cash equivalents and marketable securities was approximately three months, with the longest maturity being nine months [143]. - The company maintains a diversified investment portfolio with a maximum credit exposure limit of 10% to any one issuer, except for U.S. Treasury and Federal Agencies [145]. - Approximately $0.6 million of cash and marketable securities were located in Australia, with expenses generally denominated in U.S. dollars [146]. - A 10% change in current exchange rates would not have a material effect on the company's consolidated financial results [146]. Funding and Financing - The company has no products approved for commercial sale and does not expect to generate revenue from product sales in the near future [107][108]. - The company has a loan agreement with Oxford Finance providing up to $50.0 million in borrowing capacity, with the initial tranche of $10.0 million funded [126]. - Future funding requirements will depend on various factors, including the progress and costs of clinical trials, regulatory approvals, and the ability to attract and retain qualified personnel [128]. - The company requires additional financing to fund working capital and pay obligations, with no committed external sources of funding currently available [132]. - Interest income decreased by $1.0 million to $1.4 million for the three months ended March 31, 2025, compared to $2.4 million in the same period of 2024, primarily due to a decrease in cash equivalents and marketable securities [121]. Cash Flow - Cash provided by investing activities was $13.7 million in Q1 2025, down from $20.4 million in Q1 2024, primarily due to maturities of marketable securities [137]. - Net cash used in financing activities for Q1 2025 was $1.3 million, primarily from loan repayments, with no financing activities reported in Q1 2024 [138].

Financial Performance - Cash, cash equivalents, and marketable securities totaled $114.4 million as of March 31, 2025, down from $132.2 million as of December 31, 2024, primarily due to cash used in operations[9] - Net loss for Q1 2025 was $16.6 million, or $2.27 per basic and diluted common share, compared to a net loss of $21.7 million, or $2.98 per basic and diluted common share, for Q1 2024[9] - Total stockholders' equity decreased to $103.1 million as of March 31, 2025, from $116.9 million as of December 31, 2024[12] - Total operating expenses for Q1 2025 were $17.6 million, down from $23.7 million in Q1 2024[13] Research and Development - Research and development (R&D) expenses for Q1 2025 decreased by $5.0 million to $12.2 million, compared to $17.2 million in Q1 2024, due to decreased clinical activities following the termination of the PALIZADE trial[9] - In the PORTOLA Phase 2a clinical trial, 36% of zetomipzomib-treated patients achieved a complete biochemical response and clinically significant steroid taper, compared to 0% of placebo patients[5] - The median duration of response in zetomipzomib patients achieving a complete response was 27.6 weeks, with no disease flares reported during the study[5] - The PORTOLA trial enrolled 24 patients, randomized (2:1) to receive 60 mg of zetomipzomib or placebo for 24 weeks[8] - The median urine protein-to-creatinine ratio (UPCR) was reduced by 79% from baseline in patients receiving 60 mg of zetomipzomib[6] General and Administrative Expenses - General and administrative (G&A) expenses for Q1 2025 decreased by $1.1 million to $5.4 million compared to $6.5 million in Q1 2024, primarily due to reduced legal and professional service expenses[9]

Kezar Life Sciences (KZR) Q4 2024 Earnings Call March 25, 2025 08:00 AM ET Company Participants Christopher Kirk - CEO & Co-FounderCraig Lammert - Associate Professor of MedicineGideon Hirschfield - ProfessorMatt Phipps - Group Head - Biotechnology Conference Call Participants Divya Rao - AnalystMaury Raycroft - Equity Research AnalystDerek Archila - AnalystMitchell Kapoor - Director, Senior Biotechnology Analyst Operator Good day, everyone. My name is Shell, and I will be your conference operator today. At ...

Financial Data and Key Metrics Changes - The Portola trial enrolled 24 patients, with 21 in a prespecified subgroup on steroid therapy. 36% of patients receiving zetomipsemib achieved complete biochemical remission by week 24 compared to none in the placebo arm [4][16] - The safety profile of zetomipsemib was favorable, with most treatment-emergent adverse events being grade one and two, primarily related to injection site reactions [5][19] Business Line Data and Key Metrics Changes - The trial demonstrated that responses to zetomipsemib were durable, with no flares reported for patients achieving complete remission [4][16] - 20 patients completed the double-blind treatment period, with 16 eligible for the open-label extension, indicating ongoing interest and potential for further data collection [11][12] Market Data and Key Metrics Changes - Autoimmune hepatitis affects nearly 100,000 patients in the United States, with a significant unmet need for effective treatments [5][21] - The trial results suggest that zetomipsemib could transform the treatment landscape for autoimmune hepatitis, a disease with limited therapeutic options [7][21] Company Strategy and Development Direction - The company aims to respond to the FDA regarding the partial clinical hold on the Portola study and plans to align with regulatory bodies for potential registrational studies [51] - Future studies may mandate steroid tapering as a key endpoint, reflecting a commitment to improving treatment protocols for autoimmune hepatitis [62] Management's Comments on Operating Environment and Future Outlook - Management emphasized the need for new agents in autoimmune hepatitis, highlighting the poor treatment options currently available [21][22] - The data from the Portola study is seen as a significant step forward, with the potential for zetomipsemib to be a novel and effective therapy for complex autoimmune disorders [22][49] Other Important Information - The trial included an open-label extension for patients, with ongoing data collection expected to provide further insights into the long-term efficacy and safety of zetomipsemib [11][12] - The demographics of the patient population were typical for autoimmune hepatitis, with a slight majority being older, white, and female [12][14] Q&A Session Summary Question: Concerns with zetomipsemib and lupus nephritis - Craig Lammert noted that injection site reactions were minor and manageable, with no significant safety concerns observed in the Portola study [57][60] Question: Biochemical remission without steroid taper - Christopher Kirk explained that the protocol suggested but did not mandate steroid tapering, with future studies possibly requiring it [62] Question: Infection rates in placebo vs. zetomipsemib arms - Kirk mentioned that overall infection rates were consistent across trials, and the reduced infection rate in the zetomipsemib arm should be interpreted cautiously [70][72] Question: Clinical meaningfulness of data in refractory patients - Craig Lammert highlighted the importance of reducing liver test abnormalities and corticosteroid dependency as significant clinical outcomes for patients [80] Question: Designing an optimal phase three study - Kirk acknowledged the lack of regulatory precedent and emphasized the need for alignment with the FDA on trial design and endpoints [85] Question: Impact of disease duration on therapy responsiveness - Kirk clarified that the duration of disease was balanced between the two arms, with no statistical difference noted [89]

Core Viewpoint - Kezar Life Sciences, Inc. (KZR) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook driven by an upward trend in earnings estimates [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which significantly influence stock price movements [2][4]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in buying or selling pressure that affects stock prices [4]. Company Performance Indicators - For the fiscal year ending December 2024, Kezar Life Sciences is expected to earn -$1.20 per share, reflecting an 8.4% change from the previous year [8]. - Over the past three months, the Zacks Consensus Estimate for Kezar Life Sciences has increased by 3.2%, indicating a positive trend in earnings expectations [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating [9][10]. - The upgrade of Kezar Life Sciences to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

& KEZAR Selective Targets. Broad Impact. Uniquely Powerful Approaches to Tackling the Toughest Diseases Corporate Overview September 2021 www.kezarlifesciences.com Forward-Looking Statements Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "should," "expect," "plan," "anticipate," "target," and similar expressions (as well as other words or expressions referencing future events or circums ...

Revolutionizing the Treatment of Autoimmune Disorders and Malignancies Corporate Presentation September 2020 Forward-Looking Statements Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "should," "expect," "plan," "anticipate," "target," and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statem ...

Financial Data and Key Metrics Changes - Cash, cash equivalents, and marketable securities totaled $157.5 million as of June 30, 2020, compared to $78.2 million as of December 31, 2019, primarily due to net proceeds from public offerings [37] - Net loss for Q2 2020 was $9.5 million or $0.22 per share, compared to a net loss of $8.7 million or $0.46 per share for Q2 2019 [39] Business Line Data and Key Metrics Changes - Research and development expenses for Q2 2020 increased by $200,000 to $7.1 million compared to $6.9 million in Q2 2019, mainly due to advancing the protein secretion pre-clinical program [38] - General and administrative expenses for Q2 2020 increased by $300,000 to $2.7 million compared to $2.4 million in Q2 2019, primarily due to increased personnel expenses [38] Market Data and Key Metrics Changes - The company is focusing on the development of KZR-616 for severe autoimmune diseases and KZR-261 for solid tumors, with ongoing clinical trials impacted by COVID-19 [11][14] Company Strategy and Development Direction - The company aims to pioneer small molecule approaches against novel targets, with a focus on KZR-616 and KZR-261, to address severe autoimmune diseases and cancers [14][41] - The strategy includes reevaluating clinical development plans in light of new data and the ongoing pandemic, with a commitment to patient safety and effective treatment [12][18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of their drug candidates and the ongoing commitment to advancing clinical programs despite challenges posed by COVID-19 [9][41] - The company is well-capitalized with a strong balance sheet, providing a runway to achieve its goals [15][37] Other Important Information - The MARINA study has been withdrawn due to a lack of patient enrollment and the need for protocol amendments [30] - The company plans to submit an IND for KZR-261 in Q1 2021 and initiate a first-in-human clinical trial shortly thereafter [34][55] Q&A Session Summary Question: What factors contributed to better tolerability on Cohort 2c? - Better tolerability was due to a combination of moving to a lyophilized formulation, step-up dosing, and supportive measures for patients [43] Question: Does the new formulation make the drug more stable? - The new formulation does not change stability but simplifies the formulation by removing an excipient that could cause adverse reactions [45] Question: When can we expect another update from the Stage 1b MISSION study? - An interim update is expected by the end of the year, with initial data anticipated in the first half of 2021 [50] Question: How has the PRESIDIO timeline been impacted by COVID-19? - Enrollment has slowed, pushing the completion timeline from the end of 2021 to mid-2022, but data integrity is not expected to be affected [51] Question: What is the rationale for the 50% reduction in proteinuria as a primary endpoint? - A 50% reduction in proteinuria is a standard measure of renal response based on past clinical trials [58] Question: Why was the MARINA study withdrawn? - The study was withdrawn due to a high screening failure rate and the need for a more inclusive protocol [59][77]