Zetomipzomib

SHANGHAI, March 25, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative medicines and vaccines, today announced its financial results for the full year ended December 31, 2024, along with a corporate update. "In 2024, Everest continued to strength the execution of our 'Dual-Engine' strategy, having evolved from a license-in model to a balanced approach that combines in-house discovery with global partnerships and in-licensing, with a focus on high-value programs and the development of first-in-class or best-in-class assets," commented Rogers Yongqing Luo, CEO of Everest Medicines. "Our total revenue reached RMB706.7 million, representing a 461% year-over-year increase and exceeding our revenue guidance of RMB700 million. Operating expenses as a percentage of revenue decreased significantly by 562%. Notably, our non-IFRS net loss narrowed by 25%, and our gross margin, excluding non-cash items, reached 83%. We ended the year with a strong cash balance of RMB1.6 billion. Importantly, we achieved commercial-level profitability for the full year of 2024. The highlight of our commercial execution in 2024 was the successful launch of NEFECON® in mainland China in May, marking the beginning of a new era in the treatment of IgA nephropathy (IgAN). The product generated RMB353.4 million in revenue for the year, representing a year-over-year increase of 1,581%. NEFECON® was also included in China's National Reimbursement Drug List (NRDL), helping to address a significant unmet medical need among Chinese patients. In addition, it received regulatory approvals in Singapore, Hong Kong SAR, Taiwan region, and South Korea during 2024, expanding its regional footprint in Asia. We also delivered robust growth with XERAVA® (eravacycline), a first-in-class fluorocycline antibiotic, which generated RMB352.8 million in revenue in 2024, representing a 256% year-on-year increase. This strong performance was driven by its differentiated clinical profile and rising market demand. In our autoimmune portfolio, we achieved significant progress with VELSIPITY® (etrasimod), which received regulatory approvals in Macau SAR and Singapore in April 2024. The product was subsequently commercially launched in December in Guangdong province under the 'Hong Kong and Macau Medicine and Equipment Connect' policy. In parallel, New Drug Applications (NDAs) for VELSIPITY® have been officially accepted in both mainland China and Hong Kong in December 2024." "We continued to advance our pipeline of assets with global rights, focusing on creating value in high-potential therapeutic areas. EVER001, a covalent reversible BTK inhibitor, delivered positive results from the preliminary analysis of our Phase 1b/2a trial and is progressing steadily through global development. We also achieved a major milestone by advancing our mRNA platform from early-stage research into global clinical development, underscoring both our innovation capabilities and the strategic potential of our AI-powered mRNA technology. EVM16, our personalized therapeutic mRNA cancer vaccine, completed first patient dosing in an investigator-initiated clinical trial (IIT) in March 2025. EVM14, our off-the-shelf tumor-associated antigen (TAA) vaccine, received Investigational New Drug (IND) approval from the U.S. FDA, and we plan to submit an IND application to China's NMPA in the first half of this year. The in vivo CAR-T program is expected to achieve preclinical candidate milestone later this year. These programs are supported by our commercial-scale, GMP-compliant manufacturing facility in Jiashan, Zhejiang, which provides integrated R&D, production, and commercialization capabilities across mRNA and other pipeline platforms. In 2025, we will continue to enhance our commercial excellence and advance our first-in-class and best-in-class assets with global rights to maximize synergies. A key priority will be accelerating the sales of NEFECON®, leveraging its unique position as the only approved IgAN therapy in China and successfully included in the NRDL. With global rights to EVER001, we will actively explore partnership opportunities outside of China to leverage international expertise and optimize commercial value, while further enhancing Everest's global visibility and presence. Our 'Dual-Engine' strategy has entered a new chapter. Under the Board's guidance, Everest will leverage its established efficient commercial platform to solidify our position in key therapeutic areas, advance innovation on our mRNA platform, and strive to become a leading biopharma in the Asia-Pacific region by 2030—delivering greater value for shareholders and breakthrough therapies for patients worldwide." Luo concluded. Recent Key Product Highlights and Anticipated Milestones RENAL PRODUCTS PORTFOLIO Nefecon® 2024 - In March 2024, the Company's partner Calliditas Therapeutics AB ("Calliditas") (which was acquired by Asahi Kasei Corporation in September 2024 ) announced the U.S. FDA has granted an Orphan Drug exclusivity period of seven years for NEFECON®, expiring in December 2030 based on Calliditas obtaining full approval for this drug product in December 2023. - In March 2024, the Singapore Health Sciences Authority ("HSA") approved NEFEGAN®, known in other Everest territories as NEFECON®, for the treatment of primary IgAN in adults at risk of disease progression. Singapore marks the third region in Everest territories that received NDA approval after Macau and mainland China. - In April 2024, Calliditas published additional sub-analyses of NEFECON®'s Phase 3 NefIgArd study. One of the sub-analyses showed that during the 2-year period (9 months of treatment with NEFECON®, followed by a 15-month observation period after discontinuation), significant benefits in estimated glomerular filtration rate ("eGFR") were observed regardless of baseline UPCR levels (<0.8 g/g or ≥0.8 g/g). This study also showed that patients with UPCR <0.8 g/g who received NEFECON® achieved an eGFR slope of -0.25 mL/min/1.73 m3 per year, supporting the treatment target of <1 ml/min/1.73 m3 per year with the objective to avoid kidney failure in their lifetime. Another sub-analyses demonstrated that, irrespective of baseline UPCR levels and use of rescue medication, time to confirmed 30% eGFR reduction or kidney failure was significantly delayed. - In April 2024, Calliditas announced that the global open-label extension (OLE) study to the Phase 3 NefIgArd study showed a treatment response consistent with the NefIgArd study for the endpoints of urine protein to creatinine ratio ("UPCR") and eGFRat 9 months in all IgAN patients, including those who had previously received NEFECON® in the NefIgArd study. The safety data after 9 months of treatment or retreatment with Nefecon® in patients who completed the NefIgArd study were consistent with previously reported safety data. - In May 2024, the Hong Kong Department of Health had approved NEFECON® for the treatment of primary IgAN in adults at risk of disease progression. Hong Kong marks the fourth region in Everest territories where Nefecon® has received NDA approval after Singapore, Macau and mainland China. - In May 2024, Everest announced the successful launch of NEFECON® in mainland China, which has the highest prevalence of primary glomerular diseases in the world. The commercialization of NEFECON® in the Chinese market represents a significant milestone for Everest and a breakthrough for IgAN patients in China. The first prescription of NEFECON® was issued through an internet hospital, enhancing speed and convenience of delivering medication to patients and improving accessibility to the treatment. - In June 2024, Calliditas announced an additional efficacy analysis of NEFECON® in IgAN at the 61st European Renal Association Congress. An anchored matching-adjusted indirect comparison (MAIC) was performed to estimate the relative effect of NEFECON® or sparsentan on the absolute eGFR change from baseline at 9, 12, and 24 months, with common comparators of optimized renin-angiotensin system inhibition for NefIgArd and irbesartan from the phase 3 PROTECT study. Using patient-level data from NefIgArd and trial-level data from PROTECT, the study demonstrated that treatment with NEFECON® 16 mg/day for 9 months was associated with greater eGFR benefit compared with continuous treatment with sparsentan 400 mg/day over 2 years. - In July 2024, China's NMPA accepted the submission of a supplemental New Drug Application seeking full approval of NEFECON® based on the complete clinical data from the global Phase 3 NeflgArd study. - In September 2024, NEFECON® was included in the "KDIGO 2024 Clinical Practice Guideline for the Management of Immunoglobulin A Nephrophthy (IgAN) and Immunoglobulin A Vasculitis (IgAV)" draft for public review. The draft guideline notes that NEFECON® is the only treatment to date proven to reduce the levels of pathogenic forms of IgA and IgA immune complexes and recommends treatment with a 9-month course of NEFECON® for IgAN patients who are at risk of progressive kidney function loss. - In October 2024, the Taiwan Food and Drug Administration approved NEFECON® indicated "to reduce the loss of kidney function in adult patients with primary IgAN who are at risk for disease progression". Taiwan was the fifth region in Everest Medicines' authorized area to approve NEFECON® after Macau, Mainland China, Singapore, and Hong Kong. - In October 2024, "Kidney 360" magazine published the complete two-year subpopulation data from Chinese patients in the Phase 3 NefIgArd clinical trial of NEFECON® under the title "Efficacy and Safety of Nefecon in Patients with Immunoglobulin A Nephropathy from Mainland China: 2-Year NefIgArd Trial Results". The article states that during the 2-year treatment and observation period, the Chinese subpopulation data showed improvements in kidney protection, proteinuria reduction, and microhematuria that were numerically greater than the outcomes of global population. - In October 2024, additional analyses of the NefIgArd study for NEFECON® were presented at the 2024 American Society of Nephrology Kidney Week (ASN Kidney Week 2024). One of the analyses showed that the ability of NEFECON® to specifically modulate pathogenic Gd-IgA1 production in the GALT while leaving systemic IgA responses and total IgA and IgG levels unchanged, supports its use as a generally well tolerated, targeted, locally-acting treatment option for IgAN. Another analysis demonstrated that real-world use of NEFECON® was well-tolerated and can reduce loss of kidney function in patients who receive ≥9 months of treatment. - In November 2024, NEFECON® received full approval from the Ministry of Food and Drug Safety ("MFDS") in South Korea, indicated for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g). - In November 2024, NEFECON® was included in NRDL in mainland China which takes effect on January 1st, 2025. NEFECON®'s inclusion in the NRDL acknowledges its significant clinical value in improving patient care and with approximately 5 million IgAN patients in China and over 100,000 newly diagnosed patients annually, there is a significant unmet clinical demand in the country. - In December 2024, the first prescription for NEFECON® was issued at Hong Kong Gleneagles Hospital, marking a new era for the targeted treatment of IgAN in the region. It represents the third commercial launch of NEFECON® in the year, following its launch in Mainland China and Singapore. 2025 - On January 1, 2025, with the official implementation of the latest update of NRDL, NRDL pricing now applies to NEFECON® which will benefit more IgAN patients. NEFECON® is the only approved treatment for primary IgAN in adults at risk of disease progression in China. - In March 2025, the HSA has granted full approval of NEFEGAN® indicated "to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g)". - We expect to commercially launch NEFECON® in Taiwan region and South Korea in 2025. - We expect to receive NEFECON® full approval from NMPA in 2025. - We expect inclusion of NEFECON® in the KDIGO 2025 guidelines as well as in the first Chinese guideline for IgAN in 2025.® EVER001 is a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor with potentially best-in-class characteristics for the treatment of autoimmune renal diseases. Compared to covalent irreversible BTK inhibitors, EVER001 offers improved selectivity while maintaining high potency, thereby potentially avoiding many of the side effects associated with earlier-generation BTK inhibitors. Everest Medicines holds global rights to EVER001 for the treatment of renal diseases. 2024 - In December 2024, Everest announced positive results in the ongoing Phase 1b/2a clinical trial for the treatment of pMN with EVER001. In an analysis of the data available as of September 13th, 2024, we observed that of the patients in the low-dose cohort who have completed 36 weeks of treatment, 9 out of 11 (81.8%) achieved overall clinical remission and 10 out of 11 (91%) achieved immunological complete remission (ICR). In the high dose cohort, 6 out of 7 (85.7%) patients achieved overall clinical remission and all patients achieved ICR by week 24. EVER001 was generally safe and well tolerated. No clinically significant adverse events typically associated with earlier-generation BTK inhibitors, such as bleeding, arrhythmia, severe infection, leukopenia, thrombocytopenia, or severe liver function impairment, were reported. 2025 - We expect to report one-year follow up data of the Phase 1b/2a clinical trial in 2025. INFECTIOUS DISEASE PORTFOLIO XERAVA® (eravacycline) 2024 - In January 2024, eravacycline's clinical breakpoint was officially approved by the Expert Committee of the National Health Commission on Antimicrobial Susceptibility Testing and Standard Research (ChinaCAST) for clinical use in China. - In November 2024, data on eravacycline (XERAVA®), were presented in Los Angeles, California at IDWeek 2024. The first study evaluated the in vitro antimicrobial activity of eravacycline against Carbapenem-resistant Acinetobacter baumannii (CRAB). Using the recently approved, ChinaCAST breakpoint of 1 µg/mL the results showed a high susceptibility rate of eravacycline against CRAB. The second study evaluated the in vitro activity of eravacycline against 23,127 global clinical isolates of major Gram-positive and Gram-negative bacteria, including drug-resistant strains collected from various regions such as Asia, Europe, and North America from 2018 to 2022. Since its approval in 2018, eravacycline has consistently maintained a high level of susceptibility against clinically relevant pathogens across diverse geographic regions and infection sites which supports eravacycline's use in treating complicated intra-abdominal infections caused by both Gram-negative and Gram-positive bacteria. - In November 2024, in a real-world clinical evaluation led by the National Health Commission's Expert Committee on Clinical Use of Antimicrobials and Evaluation of Antimicrobial Resistance, the final report showed that the overall efficacy rate of eravacycline treatment for 3 days was 91.1%, and the overall treatment efficacy rate at the end of treatment was 90.1%. Cefepime-taniborbactam is an investigational agent that is a combination of cefepime, a fourth-generation cephalosporin, and the novel beta-lactamase inhibitor (BLI), taniborbactam, that exhibits broad coverage of both serine- and metallo-beta-lactamases. In combination with cefepime, taniborbactam is under development as a new treatment option for patients with serious bacterial infections caused by difficult-to-treat drug resistant gram-negative pathogens, including carbapenem-resistant Enterobacterales (CRE) and carbapenem-resistant or multidrug-resistant Pseudomonas aeruginosa (CRPA/MDR-PA). 2024 - In February 2024, The New England Journal of Medicine ("NEJM") published the results of the CERTAIN-1 Phase 3 clinical study of the investigational agent cefepime-taniborbactam for the treatment of adult patients with complicated urinary tract infections ("cUTI"), including acute pyelonephritis. The results showed that cefepime-taniborbactam was superior to meropenem for the treatment of complicated UTI that included acute pyelonephritis, with a similar safety profile to meropenem. 2025 - We expect to submit an NDA for cefepime-taniborbactam in cUTI to China NMPA in 2025. AUTOIMMUNE DISEASE PORTFOLIO VELSIPITY® (etrasimod) 2024 - In February 2024, our licensing partner Pfizer Inc. announced that the European Commission ("EC") granted marketing authorization for VELSIPITY® in the European Union to treat patients 16 years of age and older with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent. - In March 2024, the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China, accepted Everest's NDA for VELSIPITY® for the treatment of adult patients with moderately to severely active UC. In April, the bureau approved the NDA, marking the first approval of VELSIPITY® in Everest territories. - In July 2024, Everest announced positive topline data results of the maintenance period from a multi-center Phase 3 clinical trial of VELSIPITY® in Asia for the treatment of subjects with moderately-to-severely active UC. The data of maintenance treatment confirmed that, after 40 weeks of treatment of 2mg once-daily VELSIPITY or placebo, VELSIPITY® demonstrated significant clinical and statistical improvements over placebo in the primary and all key secondary endpoints (p<0.0001), and other secondary endpoints (including mucosal healing and endoscopic normalization, both p<0.0001). The safety profile of VELSIPITY® was consistent with previous studies, with no new safety signals observed. - In October 2024, Everest announced that, through the "Hong Kong and Macau Medicine and Equipment Connect" policy, VELSIPITY® was officially been approved for patients with moderately to severely active UC by the Guangdong Provincial Medical Products Administration and the first prescription for VELSIPITY® was written at Foshan Fosun Chancheng Hospital in Guangdong in December. VELSIPITY® is now Everest's third commercialized product. - In November 2024, the full induction period data results from a multi-center Phase 3 clinical trial of VELSIPITY® in Asia on the treatment of moderately to severely active UC with etrasimod was presented in an oral presentation at the 32nd United European Gastroenterology Week (UEGW 2024). The induction period results showed that all primary and key secondary efficacy endpoints in the etrasimod treatment group achieved statistically significant and clinically meaningful improvements compared to the placebo group. The treatment differences in clinical remission, endoscopic improvement, and clinical response rates were 20.4%, 28.6%, and 32.0%, respectively (all P-values <0.0001). Patients treated with etrasimod achieved clinically meaningful and statistically significant improvements in mucosal healing (P<0.0001) and endoscopic normalization (P=0.0003). - In December 2024, the Department of Health of the Government of the Hong Kong Special Administrative Region, China, accepted Everest's NDA for VELSIPITY® for the treatment of adult patients with moderately to severely active UC. - In December 2024, the first prescription of VELSIPITY® in Macau was issued at Kiang Wu Hospital and VELSIPITY® was included in the Catalog of Pharmaceutical and Medical Devices Imported from Hong Kong and Macau for the Nine Municipalities in Guangdong Province within the Guangdong-Hong Kong-Macau Greater Bay Area, published by the Guangdong Provincial Medical Products Administration and Health Commission of Guangdong Province. - In December 2024, the NMPA of China accepted the NDA for VELSIPITY® for the treatment of patients with moderately to severely active UC. We expect to receive NDA approval in 2026. 2025 - In February 2025, Everest announced the presentation of maintenance data from its multi-center Phase 3 clinical trial of etrasimod in Asia at the 20th European Crohn's and Colitis Organization Congress (ECCO 2025). The results demonstrated that treatment with etrasimod 2 mg resulted in a clinically meaningful and statistically significant improvement in the primary and all secondary endpoints at the end of maintenance period. A statistically significant greater proportion of etrasimodtreated patients achieved clinical remission at Week 40 compared with placebo. A statistically significant greater proportion of etrasimod-treated patients achieved endoscopic improvement and clinical response at week 40 compared with placebo. Other secondary endpoints of mucosal healing, endoscopic normalization, and histological remission also significantly favored patients treated with etrasimod compared with placebo. Notably, mucosal healing as measured by a central read endoscopic subscore ≤1 (excluding friability) with a Geboes Index score <2.0, was achieved in 51.9% of the etrasimod treated patients compared to 8.8% in the placebo group (2-sided p-value <0.0001). The safety profile of etrasimod during the maintenance period was consistent with previous studies, with no new safety findings observed. - In March 2025, Everest announced the launch of a construction project for etrasimod's local production at Jiashan factory. The project is expected to achieve an annual production capacity of 50 million tablets upon full operation. The planned supply regions include mainland China, Hong Kong, Macau, Taiwan, South Korea, and Singapore, covering Everest's licensing regions in Asia. - We expect to receive VELSIPITY® NDA approval in UC in Hong Kong in 2025. - We expect to submit NDA for VELSIPITY® in UC in Taiwan region and South Korea in 2025. - We will continue to expand VELSIPITY®'s accessibility in the Greater Bay area through the "Hong Kong and Macau Medicine and Equipment Connect" policy in 2025. Zetomipzomib is a novel, first-in-class, selective immunoproteasome inhibitor currently being evaluated for immune- mediated disorders. It was licensed from Kezar Life Sciences in 2023. Everest and Kezar collaborate on the development of zetomipzomib in autoimmune diseases such as autoimmune hepatitis. - In February 2024, Everest announced that the Center for Drug Evaluation ("CDE") of China's NMPA approved Kezar's IND application for initiation of the Phase 2b PALIZADE trial in China of zetomipzomib in patients with lupus nephritis ("LN"). - In July 2024, Everest announced that the first patient had been dosed in China with zetomipzomib in the global Phase 2b PALIZADE trial for the treatment of active LN. - In September 2024, PALIZADE was placed on clinical hold following the recommendation of the Independent Data Monitoring Committee. In October, Kezar made the strategic decision to terminate the PALIZADE trial and focus clinical development efforts on zetomipzomib in autoimmune hepatitis (AIH). - Zetomipzomib is currently being tested in PORTOLA, a placebo-controlled, randomized, double-blind Phase 2a clinical trial evaluating the efficacy and safety of the molecule in patients with AIH. AIH is a rare chronic disease in which the immune system attacks the liver and causes inflammation and tissue damage, severely impacting patients' physical health and quality of life. The study has completed enrollment of 24 patients, and Kezar expects to report topline results in 1H 2025. mRNA PLATFORM Everest has built end-to-end capabilities across its proprietary mRNA platform. Our R&D team is developing multiple mRNA-based therapeutic products including personalized cancer vaccines, tumor-associated antigen vaccines, immunomodulatory cancer vaccines, in vivo CAR-T program, as well as next generation lipid nanoparticle ("LNP") delivery systems to enhance cell-mediated immune response. Our mRNA manufacturing facility in Jiashan, Zhejiang Province in China is designed to comply with global good manufacturing practice ("GMP") standards and is able to produce at clinical- and commercial-scale. Everest owns full global intellectual property rights to its mRNA therapeutic programs. In 2024, the Company advanced its self-developed mRNA pipeline products, the first of which is EVM16, a novel personalized therapeutic mRNA cancer vaccine independently developed by Everest. It contains neoantigens with high immunogenicity potential, predicted based on the unique tumor mutations of each patient using Everest's proprietary AI-based neoantigen prediction algorithm, EVER-NEO-1. The vaccine is designed to encode dozens of tumor neoantigens. This platform will be an important part of our discovery efforts going forward. 2024 - In Feb. 2024, Everest announced the termination of the collaboration and license agreements with Providence Therapeutics Holdings Inc. Everest continues to develop its own therapeutic vaccine products utilizing the mRNA platform. - In August 2024, Everest announced the launch of an IIT for a personalized mRNA cancer vaccine, EVM16, under the study EVM16CX01, at the Peking University Cancer Hospital and Fudan University's Cancer Hospital. This trial is designed to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 injection as a monotherapy and in combination with PD-1 antibody for patients with advanced or recurrent solid tumors. EVM16CX01 is the first-in-human ("FIH") trial for EVM16. 2025 - In March 2025, Everest announced that the first patient has been dosed with the Company's internally developed personalized mRNA cancer vaccine EVM16 at Peking University Cancer Hospital in the investigator-initiated clinical trial (IIT) EVM16CX01. - In March 2025, the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for EVM14, a TAA vaccine. EVM14 is Everest's first internally developed mRNA therapeutic vaccine to receive FDA IND approval, marking a significant milestone in the Company's efforts to develop innovative mRNA therapeutics in oncology. - We expect to submit IND application for EVM14 in China in 2025. PRODUCT PIPELINE Everest has built a strong product pipeline across renal, anti-infective, and autoimmune diseases that are all potentially first-in-class treatment or best-in-class assets. These programs encompass short-term, mid-term and long-term opportunities which are collectively expected to generate significant revenue growth for the Company and create value for its shareholders. Pipeline Outlook 2025 promises to be a year of important data readouts and significant advancement in our best-in-class programs which carry global rights. In 2024 we were pleased to report positive data from a preliminary analysis of a Phase 1b/2a clinical trial of EVER001, a novel BTK Inhibitor for the treatment of primary membranous nephropathy. We expect to advance this trial further in 2025 and plan to report one-year follow-up data in the second half of 2025. Among our self-developed programs, the first patients have been dosed in our IIT for personalized cancer vaccine and preliminary data on safety and immunogenicity are expected this year. In parallel, we have received FDA's IND approval for EVM14, our off-the-shelf TAA cancer vaccine. We also plan to submit IND application to China's NMPA for EVM14 in the first half of this year. It marks the first U.S. IND submission and approval for Everest, and the first IND applications for Everest's self-developed pipeline. With respect to our late-stage programs, we plan to submit the NDA for cefepime-taniborbactam to the NMPA in mainland China for the treatment of cUTI in 2025. We will also submit NDAs for VELSIPITY® in South Korea and Taiwan and expect to receive NDA approval for this product in Hong Kong in the second half of the year. Commercialization Our commercial organization continued to flourish in 2024 as we launched and grew three commercial products, NEFECON®, XERAVA®, and VELSIPITY®. In our renal franchise, our team successfully launched our leading drug product, NEFECON® in mainland China in May 2024. We employed a broad array of sales channels, including traditional in-person detailing of hospitals as well as the innovative channel of online prescribing, to meet the urgent and significant unmet needs of an estimated 5 million IgAN patients. Our 150-person sales team had penetrated more than 600-700 hospitals by the end-of 2024, which encompass over 60% of the addressable IgAN population. To further broaden IgAN patient access, NEFECON® was included in China's 2024 NRDL which went into effect on January 1, 2025. We expect this significantly increased affordability to drive rapid penetration of NEFECON® throughout its patient population. Another highlight for NEFECON® in 2024 was its inclusion in the "KDIGO 2024 Clinical Practice Guideline for the Management of Immunoglobulin A Nephrophthy (IgAN) and Immunoglobulin A Vasculitis (IgAV)" draft for public review. The draft guideline points out that NEFECON® is the only treatment to date proven to reduce the levels of pathogenic forms of IgA and IgA immune complexes and recommends treatment with a 9-month course of NEFECON® for patients who are at risk of progressive kidney function loss with IgAN. It also suggests that many patients may need either repeated 9-month treatment cycles or a reduced-dose maintenance regimen in order to produce a sustained clinical response in terms of proteinuria reduction or stabilization of eGFR. The safety and efficacy of repeated treatment was also supported by our partner Calliditas' global OLE study which showed consistent treatment response across endpoints of UPCR and eGFR at 9 months across all IgAN patients, including those who had previously received NEFECON® in the NefIgArd study. In our anti-infective portfolio, Everest continued to grow XERAVA® sales through deeper penetration of our covered core hospitals and we began partnering with Contract Sales Organizations to benefit patients outside of our core target hospitals, although we still anticipate our own commercial team to generate the majority of sales for XERAVA®. Eravacycline's clinical breakpoint was officially approved by ChinaCAST for clinical use in China, and more than 100 hospitals in China have already adopted the new breakpoint in 2024, facilitating wider use of the drug in clinical practice. Inclusion of eravacycline in the Catalogue of Hierarchical Management of Clinical Application of Antimicrobial Drugs in Shanghai, Beijing and Guangdong last year underscores recognition of the drug's clinical benefits by China's key opinion leaders. In addition, eravacycline was included into The Surgical Infection Society Guidelines on the Management of Intra-Abdominal Infection: 2024 Update and China's Clinical Diagnosis and Treatment Guidelines for Multidrug-resistant Bacterial Infections in Renal Transplantation, Infectious Diseases Society of America 2024 Guidance on the Treatment of Antimicrobial-Resistant Gram-Negative Infections and Chinese Expert Consensus on the Diagnosis and Treatment of Pneumonia in the Elderly (2024 Edition). Inclusion in these guidelines is expected to broaden physician awareness of XERAVA® while also encouraging broader product utilization. With the accumulation of clinical experience and the conduct of clinical studies by Chinese doctors, the following articles were published in 2024. These publications have significantly enhanced awareness and provided more references for broader clinical applications. We were pleased to have launched our first autoimmune therapeutic, VELSIPITY® which was approved in Macau in April and in Singapore in May, and successfully launched for sales in those regions. Under the "Hong Kong and Macau Medicine and Equipment Connect" policy ("the Connect Policy"), VELSITPITY® was qualified for early access in nine cities in Guangdong province and its first prescription was written at Foshan Fosun Chancheng Hospital in December. To date, VELSIPITY® has been made available at five designated medical institutions in Guangdong (First Affiliated Hospital of Sun Yat-sen University, Foshan Fosun Chancheng Hospital, Shenzhen Hospital of Southern Medical University, Guangzhou United Family Healthcare and Shenzhen Qianhai Shekou Free Trade Zone Hospital) to benefit patients in mainland China with urgent needs for advanced innovative medicines in UC. In 2025 we will continue to build on the strong commercial foundation established in 2024. In our renal franchise, we will work to rapidly ramp NEFECON® sales after its inclusion on the NRDL which makes the medicine much more affordable and broadly accessible to patients. We are targeting rapid progress in NRDL implementation through either hospital listing or dual-channel pharmacies in the first quarter of 2025. We are also aiming to expand our list of core coverage hospitals to about 800 in 2025, which includes over 80% of the potential NEFECON® market with about 200 sales representatives. Everest also anticipates official inclusion of NEFECON® in the 2025 revised Kidney Disease Improving Global Outcomes (KDIGO) guidelines as well as the first Chinese guideline for IgAN as a first-line treatment for IgAN patients. This is expected to help further grow our sales volumes by giving treating physicians an industry standard reference which instills in them more confidence in NEFECON®. While we focus on maximizing the NRDL opportunity in mainland China, we also plan to expand availability of this first-in-disease medication to more IgAN patients across other valuable Asian regions including Taiwan and South Korea. Within our anti-infective portfolio, we will continue to drive penetration of XERAVA® among our core hospitals by enhancing doctors' awareness, which would lead to more prescriptions at hospitals with significant growth potential. We will also drive early and appropriate use of XERAVA® to establish the medicine as a fundamental option in empirical multi-drug resistant bacteria infection therapy. In addition to our own sales network, we will further optimize promotion through the contract sales organization model in non-core markets where we believe XERAVA® prescription can be broadened. VELSIPITY® is our newest launch and in 2025, while we will facilitate the NDA review by NMPA with approval expected in 2026, we will also accelerate its availability in designated medical institutions under the Connect Policy for early access to VELSIPITY® in mainland China. Additionally, VELSIPITY®'s real-world study is planned in Greater Bay to provide physicians with more clinical guidance with the product. Discovery 2024 marked a remarkable year of progress in our mRNA platform as we started the first in-human trial with an investigator-initiated program for our personalized cancer vaccine, EVM16 in two top cancer hospitals in China. EVM16 is independently developed by Everest which contains neoantigens with high immunogenicity potential, predicted based on the unique tumor mutations of each patient using Everest's proprietary AI-based neoantigen prediction algorithm, EVER-NEO-1. The vaccine is designed to encode dozens of tumor neoantigens, and uses an LNP delivery system to efficiently deliver neoantigen-encoded mRNA in vivo, activating neoantigen-specific tumor-killing T cells and inhibiting tumor growth. In preclinical studies, vaccination with EVM16 stimulated a strong neoantigen-specific T cell response in different mouse models and showed significant tumor growth inhibition in the syngeneic B16F10 mouse melanoma model. EVER-NEO-1, the AI-based neoantigen prediction algorithm developed in-house by Everest, can identify the majority of reported tumor neoantigens, as well as several previously unreported neoantigens. Furthermore, the neoantigen prediction capability of EVER-NEO-1 was shown to be either comparable to or superior to leading industry algorithms in multiple independent validation studies. We are expecting a catalyst-rich 2025 with a preliminary human data readout from EVM16, for which we achieved first patient dosing in March. Additionally, we have received U.S. FDA's IND approval for EVM14, our off-the-shelf tumor-associated antigen vaccine, marking Everest's first internally discovered program and the first mRNA therapeutic cancer vaccine to be cleared for global clinical development. With IND application to China's NMPA expected in the first half of this year, this asset is designed to treat various cancers, including non-small cell lung cancer and head and neck cancer. In preclinical studies, EVM14 induced a dosedependent antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic tumor models. Lastly, the in vivo CAR-T program is also expected to achieve preclinical candidate milestone later this year, which may create a pathway to future global partnership opportunities. Business Development With the promising data generated by EVER001, our most advanced product with global rights, we will look to potentially engage in out-licensing activities to create value for all our early-stage assets with global rights. For these assets, we plan to pursue global partnership opportunities and seek ways to maximize shareholder value with entities who have global expertise and deals that offer attractive economics. Our business development strategy for in-licensing remains focused on first-in-class or best-in-class assets in less crowded, high value therapeutic areas such as renal diseases, autoimmune disorders, and anti-infective categories. We intend to leverage the strength of our existing commercial platforms to pursue commercial-stage or near-commercial-stage assets in China to create operational synergies and build scale. In parallel, we plan to evaluate earlier-stage assets with global rights, where we can deliver clinical proof-of-concept results and build substantial shareholder value. Financial Highlights IFRS Numbers: Revenue for the year ended 31 December 2024 increased significantly by RMB580.7 million, or 461%, to RMB706.7 million, compared with RMB125.9 million for the year ended 31 December 2023. The revenue growth was primarily driven by the strong ramp up of XERAVA® sales and the successful launch of NEFECON® in mainland China. Additionally, in markets outside of Mainland China, XERAVA® sales continued to build in Hong Kong and Singapore, NEFECON® was successfully launched in Hong Kong and Singapore, and VELSIPITY® was first launched in Macau and made available in Guangdong province through the "Hong Kong and Macau Medicines and Equipment Connect" policy. Gross profit margin rose from 72.7% for the year ended 31 December 2023 to 74.6% for the year ended 31 December 2024. Excluding the amortisation of intangible assets, the gross profit margin increased from 79.9% in 2023 to 82.9% in 2024. The improvement was mainly due to the commercial launch of NEFECON® and the optimisation of product costs. R&D expenses for the year ended 31 December 2024 amounted to RMB528.0 million, decreasing slightly from RMB540.1 million for the year ended 31 December 2023. The Company remains committed to strategic R&D investments across various product pipelines to support long-term sustainable growth. General and administrative expenses increased by RMB84.9 million, from RMB165.2 million for the year ended 31 December 2023 to RMB250.1 million for the year ended 31 December 2024. This increase was primarily due to higher remuneration expenses and professional service expenses in order to support the Company's business expansion and continued pipeline growth. Distribution and selling expenses increased by RMB276.7 million from RMB231.4 million for the year ended 31 December 2023 to RMB508.1 million for the year ended 31 December 2024, primarily due to expansion of the commercial team and additional commercial activities, which helped the successful launch of new products and encouraged the growth of existing product sales. Our commercial operational efficiency increased as commercialization expenses-to-sales ratio decreased by 111.9%, with our continued efforts to build a more efficient and focused commercialization model. The ratio of total operating expenses (including general and administrative expenses, research and development expenses, and distribution and selling expenses) to sales decreased by 561.8%, showing operational efficiency improvement. Net loss for the year increased by RMB196.9 million from RMB844.5 million for the year ended 31 December 2023 to RMB1,041.4 million for the year ended 31 December 2024. This increase was primarily due to a one-time, non-recurring impairment loss from an intangible asset related to mRNA COVID-19 vaccines in the first half of 2024. Excluding this impairment loss of an intangible asset, net loss narrowed by RMB107.5 million, from RMB792.5 million for the year ended 31 December 2023 to RMB685.0 million for the year ended 31 December 2024. This was primarily due to the strong product sales and improvements in operational efficiency. Cash and cash equivalents and bank deposits amounted to RMB1,603.3 million as of 31 December 2024. Non-IFRS Measure: Adjusted loss for the year narrowed by RMB176.1 million, from RMB713.6 million for the year ended 31 December 2023 to RMB537.6 million for the year ended 31 December 2024, primarily excluding the one-time and non-recurring loss on impairment of an intangible asset, and non-cash expenses of share-based compensation and amortization of intangible assets. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at . Forward-Looking Statements: This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law. SOURCE Everest Medicines WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, today reported positive topline results from the PORTOLA Phase 2a clinical trial evaluating zetomipzomib, a novel, first-in-class selective immunoproteasome inhibitor, in patients with autoimmune hepatitis (AIH) and reported fourth quarter and year end 2024 financial results. “We are pleased to announce these exciting results from the PORTOLA trial, the first successful randomized study in treatment-refractory AIH,” said Chris Kirk, CEO and co-founder of Kezar. “We are encouraged by the safety and efficacy data in this difficult-to-treat patient population, specifically durable and steroid-sparing remissions experienced by patients treated with zetomipzomib. We are eager to work with the FDA Division of Hepatology and Nutrition to remove the partial clinical hold and align on an appropriate trial design to demonstrate the clinical benefit of zetomipzomib in AIH. I’d like to thank the team at Kezar, the physicians and staff at our clinical trial sites, and most importantly, the patients and their caregivers, for their participation, sacrifice and hard work.” “I am impressed by the totality of efficacy and safety data from the PORTOLA study,” said Gideon Hirschfield, Chair of Autoimmune Liver Disease Research and Director of the Francis Family Liver Clinic, at the Toronto General Hospital. “Zetomipzomib represents a potent and targeted therapy for patients, and I believe these results will positively contribute to the design of a registrational trial of zetomipzomib in AIH, where patients are in need of better treatment options.” PORTOLA is a placebo-controlled, randomized, double-blind Phase 2a clinical trial evaluating the efficacy and safety of zetomipzomib in patients with AIH that are insufficiently responding to standard of care or have relapsed from a previous CR. The trial enrolled 24 patients, randomized (2:1) to receive 60 mg of zetomipzomib or placebo in addition to background therapy for 24 weeks, with a protocol-suggested steroid taper. All patients were required to receive a starting daily steroid dose of 20-40 mg/day of prednisone (or budesonide equivalent) and physicians were encouraged to taper daily steroid usage to 5 mg/day consistent with AIH treatment guidelines established by the American Association for the Study of Liver Diseases (AASLD). The primary efficacy endpoint of PORTOLA, which was not powered for efficacy, evaluated the proportion of patients who achieved a CR by Week 24, measured as normalization of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and Immunoglobulin G (IgG) values (if elevated at baseline), with steroid dose levels not higher than baseline. A key secondary endpoint was the proportion of patients who achieved a CR by Week 24 with a steroid dose of 5 mg/day or less. The PORTOLA trial included a pre-specified subgroup analysis of patients who were on steroid-based therapy at the time of screening, which represents a patient population with unmet medical needs for a potential future registrational study. Additional exploratory endpoints included changes in histologic assessment of AIH as measured in biopsies taken within six months of screening and repeated at Week 24 of the trial. Summary of Topline Results PORTOLA enrolled 24 patients as the ITT population. Consistent with the AASLD treatment goals, zetomipzomib treatment resulted in higher rates of complete biochemical responses (CR) combined with reduction of steroid dosage to 5 mg/day or less, compared to placebo. In the ITT population: Without regard to steroid taper, 50.0% (8 of 16) of zetomipzomib patients achieved a CR, compared to 37.5% (3 of 8) of placebo patients. 31.3% (5 of 16) of zetomipzomib patients achieved both a CR and steroid taper to 5 mg/day or less, compared to 12.5% (1 of 8) of placebo patients. 18.8% (3 of 16) of zetomipzomib patients achieved both a CR and complete steroid withdrawal to zero mg/day, compared to 0% (0 of 8) of placebo patients. Median duration of response in zetomipzomib patients achieving a CR was 27.6 weeks (including the ongoing open-label extension), and no disease flares were reported in any zetomipzomib-treated patient achieving CR. Disease flares were defined as a sustained increase in ALT values to 25% above the CR value or 1.25-fold higher than the upper limit of normal for more than one week and requiring a restart or increase in steroid dose. In the pre-specified subgroup analysis, 21 of the 24 patients entered the study on a steroid-based therapy at the time of screening. One patient in the placebo arm and two patients in the zetomipzomib arm were not receiving steroids at screening. All patients on study were required to initiate treatment with an initial prednisone dose of 20–40 mg/day. Of the 21 patients in this subgroup analysis: Median steroid use at screening was 20 mg/day for patients enrolled in the zetomipzomib arm, compared to 10 mg/day in the placebo arm, indicating that the zetomipzomib-treated arm was more refractory than the placebo arm. Without regard to steroid taper, 57.1% (8 of 14) of zetomipzomib patients achieved a CR, compared to 28.6% (2 of 7) of placebo patients. 35.7% (5 of 14) of patients on the zetomipzomib arm achieved a CR and steroid taper to 5 mg/day or less, compared to 0% (0 of 7) of placebo patients. 21.4% (3 of 14) of patients on the zetomipzomib arm achieved a CR and complete steroid withdrawal to zero mg/day, compared to 0% (0 of 7) of placebo patients. Safety Treatment-emergent adverse events (TEAEs) were seen in all patients, with injection site reactions (ISRs) being the most commonly reported TEAE in both arms. Systemic injection reactions (SIRs), with onset occurring 8 to 24 hours post-dose and usually resolving within 48 hours, were all Grade 1 and Grade 2. SIRs are a protocol-defined set of specific adverse events (AEs) consisting of one or more of the following signs/symptoms: hypotension, tachycardia, nausea, vomiting, dizziness, headache, pyrexia, rigors and/or chills. Three patients experienced treatment-emergent serious adverse events (SAEs): one in the placebo arm, a Grade 3 variceal bleeding with hematemesis and atrial fibrillation; and two in the zetomipzomib arm, a Grade 3 fever occurring after the Week 24 liver biopsy, and a Grade 3 influenza infection that fully resolved during study. All SAEs were considered unrelated to study treatment, and all three patients completed the double-blind treatment period. Infectious AEs were reported in 85.7% (6 of 7) of patients in the placebo arm and 56.3% (9 of 16) of patients in the zetomipzomib arm. One patient discontinued from the placebo arm for a UTI requiring antibiotic treatment prior to receiving a dose on study, and three patients discontinued on the zetomipzomib arm for a Grade 1 fatigue, Grade 2 hives and a Grade 2 AIH disease flare. The safety population (n=23) includes all patients who received at least one dose of study treatment: Placebo Zetomipzomib n=7 n=16 Adverse Events in Double-blind Treatment Period n (%) n (%) Participants with at least 1 Treatment Emergent Adverse Event (TEAE) 7 (100.0) 16 (100.0) Most common TEAE: Injection Site Reaction (ISR) 4 (57.1) 15 (93.8) Systemic Injection Reaction (SIR) 1 (14.3) 12 (75.0) TEAE leading to study drug discontinuation 0 (0) 3 (18.8) Grade 3 TEAE (no Grade 4 or 5 TEAEs reported) 1 (14.3) 3 (18.8) Serious TEAE 1 (14.3) 2 (12.5) Infectious TEAE 6 (85.7) 9 (56.3) Grade ≥3 Infectious TEAE 0 (0) 1 (6.3) Opportunistic Infections 0 (0) 0 (0) Death 0 (0) 0 (0) Financial Results Cash, cash equivalents and marketable securities totaled $132.2 million as of December 31, 2024, compared to $201.4 million as of December 31, 2023. The decrease was primarily attributable to cash used in operations to advance clinical-stage programs. Revenue decreased by $7.0 million in 2024 compared to 2023 due to the October 2023 upfront payment received under the collaboration and license agreement with Everest Medicines. Research and development (R&D) expenses for the fourth quarter of 2024 decreased by $6.6 million to $16.0 million, compared to $22.6 million in the fourth quarter of 2023. Full year R&D expenses decreased by $20.0 million to $65.7 million in 2024, compared to $85.7 million in 2023. This decrease was primarily due to the Company’s strategic restructuring in October 2023 to prioritize its clinical-stage programs, reducing personnel-related costs and spending in its early-stage research activities, and a $5.0 million milestone payment made in 2023 under Kezar’s exclusive license agreement with Onyx Therapeutics. The decrease was partially offset by the increased clinical trial costs related to the PALIZADE and PORTOLA trials. General and administrative (G&A) expenses for the fourth quarter of 2024 decreased by $0.3 million to $5.5 million compared to $5.8 million in the fourth quarter of 2023. Full year G&A expenses decreased by $3.1 million to $23.4 million in 2024, compared to $26.5 million in 2023. The decrease was primarily due to a decrease in legal and professional service expenses and non-cash stock-based compensation. Restructuring and impairment charges decreased by $4.7 million to $1.5 million in 2024, compared to $6.2 million in 2023. The decrease was primarily related to one-time severance-related costs made in 2023 and higher impairment costs recognized in 2023 than 2024 on the right-of-use asset for the vacated floor in the leased office facility and certain equipment no longer utilized. Net loss for the fourth quarter of 2024 was $20.2 million, or $2.77 per basic and diluted common share, compared to a net loss of $32.3 million, or $4.44 per basic and diluted common share, for the fourth quarter of 2023. Net loss for 2024 was $83.7 million, or $11.49 per basic and diluted common share, compared to a net loss of $101.9 million, or $14.04 per basic and diluted common share in 2023. The weighted-average shares used to compute net loss per basic and diluted common share have been retroactively adjusted to reflect the one-for-ten reverse stock split completed on October 29, 2024. Total shares of common stock outstanding was 7.3 million shares as of December 31, 2024, after taking into effect the one-for-ten reverse stock split completed on October 29, 2024. Conference Call and Webcast Kezar Life Sciences will host a webcast and conference call today, March 25, 2025, at 8:00 a.m. ET to discuss topline results from the PORTOLA Phase 2a clinical trial. To access the live audio webcast with slides and dial-in information as needed, please register here: https://kezar-life-sciences-portola-phase-2a-topline-results.open-exchange.net/. A live webcast of the event can also be found on the Kezar website at https://ir.kezarlifesciences.com/news-events/events-presentations. A replay of the event will be available for 90 days following the presentation. About Zetomipzomib Zetomipzomib is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from completed clinical trials provide evidence that zetomipzomib exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases. About Autoimmune Hepatitis Autoimmune hepatitis (AIH) is a rare chronic disease in which the immune system attacks the liver and causes inflammation and tissue damage, severely impacting patients’ physical health and quality of life. Lifelong maintenance therapy is required to avoid relapse and burdensome adverse effects. If left untreated, AIH can lead to cirrhosis, liver failure and hepatocellular carcinoma. In the United States, AIH affects approximately 100,000 individuals, with incidence rates increasing. The cause of this condition remains unclear, with females affected four times as often as males. Currently, standard of care treatment for AIH is chronic, immunosuppressive treatment with corticosteroids that frequently cause life-altering side effects, including diabetes, osteoporotic fractures and cataracts. There is a significant need for treatment regimens that reduce or remove the need for chronic immunosuppression from use of corticosteroids. About Kezar Life Sciences Kezar Life Sciences is a clinical-stage biopharmaceutical company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases. Zetomipzomib, a selective immunoproteasome inhibitor, is currently being evaluated in a Phase 2a clinical trial for autoimmune hepatitis. This product candidate also has the potential to address multiple chronic immune-mediated diseases. For more information, visit www.kezarlifesciences.com, and follow us on LinkedIn, Facebook, Twitter and Instagram. Cautionary Note on Forward-looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “can,” “should,” “expect,” “believe,” “potential,” “anticipate” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Kezar’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Kezar’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the design, initiation, progress, timing, scope and results of ongoing and potential future clinical trials, preliminary nature of topline data from our clinical trials, the likelihood that data will support future development and therapeutic potential, the association of data with treatment outcomes, expectations regarding the removal of the partial clinical hold in the PORTOLA trial and the initiation of a registrational trial of zetomipzomib in AIH, and the likelihood of obtaining regulatory approval of zetomipzomib. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during clinical studies, difficulties enrolling and conducting our clinical trials, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Kezar’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” contained therein. Except as required by law, Kezar assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. KEZAR LIFE SCIENCES, INC. Selected Balance Sheets Data (In thousands) December 31, 2024 December 31, 2023 Cash, cash equivalents and marketable securities $ 132,245 $ 201,372 Total assets 144,682 221,235 Total current liabilities 20,329 17,744 Total noncurrent liabilities 7,437 15,921 Total stockholders' equity 116,916 187,570 Summary of Operations Data (In thousands except share and per share data) Three Months Ended Year Ended December 31 December 31 2024 2023 2024 2023 Collaboration revenue $ - $ - $ - $ 7,000 Operating expenses: Research and development 16,030 22,643 65,742 85,697 General and administrative 5,545 5,759 23,393 26,540 Impairment charge (12 ) 6,187 1,470 6,187 Total operating expenses 21,563 34,589 90,605 118,424 Loss from operations (21,563 ) (34,589 ) (90,605 ) (111,424 ) Interest income 1,734 2,728 8,462 11,104 Interest expense (389 ) (399 ) (1,593 ) (1,550 ) Net loss $ (20,218 ) $ (32,260 ) $ (83,736 ) $ (101,870 ) Net loss per common share, basic and diluted $ (2.77 ) $ (4.44 ) $ (11.49 ) $ (14.04 ) Weighted-average shares used to compute net loss per common share, basic and diluted (1) 7,300,007 7,273,696 7,290,245 7,255,365 (1) Shares outstanding have been retroactively adjusted to reflect the one-for-ten reverse stock split completed on October 29, 2024.