Financial Data and Key Metrics Changes - The company reported total revenues of approximately $598 million for Q3 2025, which included Cabozantinib franchise net product revenues of approximately $543 million, reflecting a year-over-year growth of about 14% from $478 million in Q3 2024 [7][13] - Non-GAAP net income for Q3 2025 was approximately $217.9 million, or $0.81 per share basic, compared to $193.6 million GAAP net income, or $0.72 per share basic [14][15] - Cash and marketable securities at the end of Q3 2025 were approximately $1.6 billion, with share repurchases totaling approximately $99 million during the quarter [15][16] Business Line Data and Key Metrics Changes - The Cabozantinib business maintained its leadership position as the top TKI for RCC, with net product revenues growing to approximately $543 million in Q3 2025 [7][28] - Demand in neuroendocrine tumors grew about 50% quarter-over-quarter, contributing approximately 6% of total demand for Cabozantinib in Q3 2025 [8][31] - The company expects to exceed $100 million in revenue for the neuroendocrine tumor indication in 2025 [8][32] Market Data and Key Metrics Changes - The Cabozantinib franchise net product revenues generated globally were approximately $739 million in Q3 2025, compared to $653 million in Q3 2024 [7] - Cabometyx's TRX volume grew 21% in Q3 2025 relative to Q3 2024, outpacing the market basket growth rate of 13% [29] - Cabometyx achieved a new patient market share of over 40% in the second-line plus neuroendocrine tumors segment [31] Company Strategy and Development Direction - The company aims to build a best-in-class, multi-franchise oncology business, focusing on improving the standard of care for cancer patients [6] - Zanzalintinib is positioned as the next oncology franchise opportunity, with seven ongoing and soon-to-start pivotal trials [9][12] - The company plans to expedite the build-out of its GI sales team to support the growth of the Cabozantinib neuroendocrine tumor indication and prepare for Zanzalintinib's launch [8][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong performance of the Cabozantinib business and the potential of Zanzalintinib to eclipse it [6][9] - The company is optimistic about the regulatory approval process for Zanzalintinib, especially following positive results from the Stellar-303 trial [10][20] - Management highlighted the importance of capital allocation and plans to repurchase shares when undervalued, with an additional $750 million share repurchase program authorized [12][15] Other Important Information - Susan Hubbard, EVP of Public Affairs and Investor Relations, announced her retirement after more than 35 years in the biopharma industry [38] - Andrew Peters will take over investor relations responsibilities, reflecting a strategic move within the company [39] Q&A Session Summary Question: Can you summarize the post-ESMO feedback on Zanzalintinib results? - Management noted positive feedback from physicians regarding the overall survival benefit and the introduction of an immune checkpoint inhibitor in a significant tumor type [41][43] Question: Why is Sunitinib the right control for the Stellar-304 study? - Management explained that Sunitinib is a standard of care in the setting and has a relevant target profile, making it a suitable comparator [47][49] Question: How does the Stellar-303 initial data set expectations for the NLM cut? - Management indicated that the study's design allowed for a broader analysis, and they expect results for the non-liver metastases subgroup to mature around mid-year 2026 [51][54] Question: What is the clinical trial contribution for Cabozantinib in Q3? - There were no clinical trial sales reported in the quarter [58] Question: Is there a risk to the Stellar-303 trial approval? - Management refrained from commenting on external opinions regarding Cabozantinib's usefulness [62] Question: How is the NET launch performing relative to Lutathera? - Management expressed confidence in the strong performance of Cabozantinib in the NET market, indicating a favorable position compared to Lutathera [85]

Financial Data and Key Metrics Changes - For Q3 2025, total revenues were approximately $598 million, including Cabozantinib franchise net product revenues of approximately $543 million, which represents a year-over-year growth of about 14% from $478 million in Q3 2024 [5][12] - Gross-to-net for the Cabozantinib franchise was 30.4%, with expectations to maintain around 30% for the year [12] - GAAP net income for Q3 2025 was approximately $193.6 million, or $0.72 per share basic, and $0.69 per share diluted, while non-GAAP net income was approximately $217.9 million, or $0.81 per share basic, and $0.78 per share diluted [14][15] - Cash and marketable securities at the end of Q3 2025 were approximately $1.6 billion, with share repurchases totaling approximately $99 million during the quarter [15] Business Line Data and Key Metrics Changes - The Cabozantinib business showed strong performance, with net product revenues growing to approximately $543 million in Q3 2025, driven by robust demand and revenue growth [5][12] - The demand for Cabozantinib in neuroendocrine tumors grew about 50%, contributing approximately 6% of total business in Q3 2025, with expectations to exceed $100 million in revenue for this indication in 2025 [6][32] - Zanzalintinib is advancing with seven ongoing pivotal trials, focusing on expanding its indications and combinations, with positive results from the Stellar-303 trial in colorectal cancer [8][10] Market Data and Key Metrics Changes - Cabozantinib maintained its leadership position as the top TKI for renal cell carcinoma (RCC), with a greater than 40% new patient share in the oral second-line plus segment [5][6] - The Cabometyx business continued to grow, with TRX volume increasing by 21% in Q3 2025 compared to Q3 2024, outpacing the market basket growth rate of 13% [29] - The market for neuroendocrine tumors is viewed positively, with Cabometyx rapidly becoming the market leader in this segment, achieving over 40% new patient share for oral therapies [32] Company Strategy and Development Direction - The company aims to build a best-in-class, multi-franchise oncology business, focusing on improving the standard of care for cancer patients [4] - There is a strong emphasis on expanding the GI sales team to accelerate growth in the Cabozantinib neuroendocrine tumor indication and prepare for the Zanzalintinib launch [6][37] - The company is committed to managing capital allocation effectively while advancing R&D and commercial priorities, with plans to repurchase shares when undervalued [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong performance of the Cabozantinib business and the potential of Zanzalintinib to become a significant oncology franchise [4][8] - The company is optimistic about the regulatory approval process for Zanzalintinib, particularly following the positive results from the Stellar-303 trial [10][24] - Management highlighted the importance of the upcoming R&D day for sharing further details on pipeline developments and strategic initiatives [11][27] Other Important Information - The company announced a new share repurchase program totaling $750 million, authorized by the board, which will expire at the end of 2026 [15] - Susan Hubbard, EVP of Public Affairs and Investor Relations, announced her retirement, with Andrew Peters taking over her responsibilities [39][40] Q&A Session Summary Question: Summary of post-ESMO feedback on Zanzalintinib results - Management noted positive feedback from physicians regarding the overall survival benefit and the potential of Zanzalintinib as a chemo-free option in a fragmented market [42][44] Question: Rationale for using Sunitinib as a control in Stellar-304 - Management explained that Sunitinib is a standard of care in the setting and provides a relevant comparator due to its extensive use [49][50] Question: Expectations for the NLM cut from Stellar-303 - Management indicated that the study design allowed for a combined analysis, and results for the non-liver metastases subgroup are expected around mid-2026 [52][56] Question: Impact of Merck's LITESPARK-011 on Zanzalintinib - Management expressed confidence that ongoing trials with Merck will continue and emphasized the collaboration's potential [59][62] Question: Concerns regarding Stellar-303 trial approval - Management refrained from commenting on external opinions but maintained confidence in the trial's outcomes [64] Question: Strategy for NET population and potential cannibalization with Zanzalintinib - Management highlighted the distinct positioning of Zanzalintinib and the ongoing growth potential for Cabozantinib in the NET space [67][69]

Core Viewpoint - The company, Heng Rui Medicine, announced that its subsidiary, Shanghai Shengdi Pharmaceutical Co., Ltd., has received a "Notice of Acceptance" from the National Medical Products Administration for the new indication application of its drug, Adebali monoclonal antibody injection [1] Group 1: Product Information - Adebali monoclonal antibody injection is a humanized anti-PD-L1 monoclonal antibody developed by the company, which can specifically bind to the PD-L1 molecule to block the PD-1/PD-L1 pathway that leads to tumor immune tolerance, thereby reactivating the immune system's anti-tumor activity [1] - Similar products available in the market include Atezolizumab (brand name: Tecentriq), Avelumab (brand name: Bavencio), and Durvalumab (brand name: Imfinzi), which have been approved for sale in the United States, with Atezolizumab and Durvalumab also approved in China [1] Group 2: Market Context - The combined global sales of Atezolizumab, Avelumab, and Durvalumab are approximately $9.648 billion for the year 2024 [1] - The cumulative research and development investment for the Adebali monoclonal antibody injection project has reached approximately 939 million yuan [1]

Group 1 - Company subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd., Shanghai Hengrui Medicine Co., Ltd., and Shanghai Shengdi Medicine Co., Ltd. received approval from the National Medical Products Administration for clinical trials of SHR-A2102 and Adebeli monoclonal antibody injection [1] - SHR-A2102 is a targeted antibody-drug conjugate (ADC) developed by the company, targeting Nectin-4, with a payload of topoisomerase I inhibitor (TOP1i) [1] - Nectin-4 is highly expressed in tumors, correlating with tumor progression and poor prognosis; currently, there is one similar product approved globally, Enfortumab vedotin, with projected global sales of approximately $1.949 billion in 2024 [1] Group 2 - Adebeli monoclonal antibody injection is a humanized anti-PD-L1 monoclonal antibody that reactivates the immune system's anti-tumor activity by blocking the PD-1/PD-L1 pathway [2] - Adebeli monoclonal antibody injection (brand name: Ailili) was approved for use in first-line treatment of extensive-stage small cell lung cancer in March 2023; similar products include Atezolizumab, Avelumab, and Durvalumab, with combined projected global sales of approximately $9.648 billion in 2024 [2] - The cumulative R&D investment for Adebeli monoclonal antibody injection is approximately 901.3 million yuan [2]

Core Viewpoint - Heng Rui Medicine's subsidiary has two products, SHR-A1811 and Abedilizumab, included in the list of proposed breakthrough therapies by the National Medical Products Administration, marking the ninth inclusion for SHR-A1811 [1] Group 1: Market Context - Breast cancer is the second most common malignant tumor globally, with approximately 2.297 million new cases reported in 2022 [1] - In China, breast cancer accounts for 15.6% of all malignant tumors, with around 357,000 new cases and 75,000 deaths in 2022 [2] - Triple-negative breast cancer (TNBC) represents 10%-15% of all breast cancer cases, predominantly affecting younger women and exhibiting high invasiveness and poor prognosis [2] Group 2: Product Information - SHR-A1811 is an injectable drug that targets HER2-positive tumors, approved for use in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received prior systemic therapy [3] - The global sales of similar products, Kadcyla and Enhertu, are projected to reach approximately $6.557 billion in 2024 [3] - The total R&D investment for SHR-A1811 has reached approximately 1.259 billion yuan [3] Group 3: Competitive Landscape - Abedilizumab is a humanized anti-PD-L1 monoclonal antibody, approved for first-line treatment of extensive-stage small cell lung cancer [4] - Similar products like Atezolizumab, Avelumab, and Durvalumab are projected to have a combined global sales of approximately $9.648 billion in 2024 [4] - The total R&D investment for Abedilizumab has reached approximately 901 million yuan [4]

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of four drugs, indicating a significant advancement in its oncology pipeline [1][2][3][4] Group 1: Drug Approvals and Clinical Trials - The company and its subsidiaries have been granted clinical trial approval for SHR-8068 injection, Adebali monoclonal antibody injection, Bevacizumab injection, and Apatinib mesylate tablets [1][2][3][4] - SHR-8068 is a fully human anti-CTLA-4 monoclonal antibody aimed at enhancing anti-tumor immune effects, with a cumulative R&D investment of approximately 214 million yuan [1] - Adebali monoclonal antibody injection, a humanized anti-PD-L1 monoclonal antibody, was approved in March 2023 for first-line treatment of extensive-stage small cell lung cancer, with a cumulative R&D investment of about 887 million yuan [2] - Bevacizumab injection, a humanized anti-VEGF monoclonal antibody, was approved in June 2021, with a cumulative R&D investment of around 345 million yuan [3] - Apatinib mesylate tablets have been approved for three indications, with a cumulative R&D investment of approximately 587 million yuan [4] Group 2: Market Potential and Competitors - The global sales of similar products for SHR-8068, including Ipilimumab and Tremelimumab, are projected to be approximately 3.271 billion USD in 2024 [1] - The combined global sales for Adebali's competitors, Atezolizumab, Avelumab, and Durvalumab, are estimated to be around 9.648 billion USD in 2024 [2] - Bevacizumab's global sales are projected to be about 5.655 billion USD in 2024 [3] - The global sales for Apatinib's competitors, including Sorafenib, Sunitinib, and Pazopanib, are expected to total approximately 543 million USD in 2024 [4]

Core Insights - Tempest Therapeutics has received approval from the National Medical Products Administration (NMPA) in China to initiate a pivotal trial for amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab for the treatment of unresectable or metastatic hepatocellular carcinoma (HCC) [1][2][3] Company Overview - Tempest Therapeutics is a clinical-stage biotechnology company focused on developing targeted and immune-mediated therapeutics for cancer treatment [8] - The company is headquartered in Brisbane, California, and has a diverse portfolio of small molecule product candidates [8] Drug Development - Amezalpat is an oral, small molecule, selective PPAR⍺ antagonist that shows promise in treating cancer by targeting tumor cells and modulating the tumor microenvironment [7] - The planned Phase 3 study will be a global, blinded, 1:1 randomized trial comparing amezalpat plus atezolizumab and bevacizumab against a placebo combination for first-line treatment of HCC [3] - The company has received agreement from both the FDA and EMA on the study design and statistical plan for the Phase 3 trial [3] Hepatocellular Carcinoma (HCC) Insights - HCC is an aggressive cancer with over 900,000 new diagnoses globally each year, and it is projected to become the third leading cause of cancer death by 2030 [4] - The highest incidence and mortality rates of HCC are found in East Asia, with increasing rates in Europe and the US [4] - Chronic liver diseases, including hepatitis B and C, NAFLD, NASH, and cirrhosis, account for 90% of HCC cases [5] Clinical Trial Context - The ongoing global randomized Phase 1b/2 study of amezalpat in combination with atezolizumab and bevacizumab has shown clinical superiority in overall survival compared to the standard of care [7] - Early-stage HCC patients face a 70-80% recurrence rate post-surgery, which is associated with poorer prognosis [6]

Company Overview - Tempest Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing first-in-class targeted and immune-mediated therapeutics for cancer treatment [1][8] - The company is headquartered in Brisbane, California, and has a diverse portfolio of small molecule product candidates [8] Drug Development and Designations - The European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to amezalpat (TPST-1120), an oral, small molecule, selective PPAR⍺ antagonist for hepatocellular carcinoma (HCC) [1][6] - Earlier in the year, the FDA also granted ODD and Fast Track Designation (FTD) to amezalpat for the same indication, highlighting the urgent need for new treatment options [2][6] - Amezalpat has shown positive outcomes in a global randomized Phase 1b/2 clinical study, demonstrating a six-month improvement in median overall survival (OS) with a hazard ratio (HR) of 0.65 when combined with standard-of-care therapies [2][4] Disease Context - Hepatocellular carcinoma (HCC) is an aggressive cancer with over 900,000 new diagnoses globally each year, projected to become the third leading cause of cancer death by 2030 [3] - The majority of HCC cases are linked to chronic liver diseases, with a high recurrence rate of 70-80% even after early-stage diagnosis [3][4] Mechanism of Action - Amezalpat is designed to target tumor cells directly while also modulating immune suppressive cells and angiogenesis within the tumor microenvironment [4] - The drug has shown clinical superiority across multiple study endpoints, including overall survival in both the entire population and key subpopulations compared to standard care [4][6] Regulatory Benefits - The EMA's ODD provides benefits such as potential 10 years of market exclusivity following regulatory approval in the EU, reduced regulatory fees, and a centralized EU approval process [7]

Core Viewpoint - Galmed Pharmaceuticals has initiated a research collaboration with Virginia Commonwealth University to explore the potential of Aramchol in overcoming drug resistance in gastrointestinal cancers, particularly colorectal and hepatocellular cancers, aiming to enhance treatment efficacy against these aggressive tumors [1][5]. Group 1: Collaboration Details - The collaboration involves VCU scientists studying Aramchol in preclinical models, focusing on its ability to prevent or reverse resistance to standard therapies such as targeted kinase inhibitors and chemotherapies [1][2]. - The project is based on recent research highlighting the role of lipid metabolic pathways, specifically Stearoyl-CoA Desaturase 1 (SCD1), in driving drug resistance in GI tumors [2][5]. - Galmed will provide funding and Aramchol materials, while VCU will conduct the studies, leveraging its expertise in cancer biology and drug resistance [7]. Group 2: Market Implications - This partnership marks a strategic expansion for Galmed beyond its historical focus on fibrotic liver diseases into oncology, targeting a significant market with high unmet needs [4][5]. - Aramchol is the most clinically advanced SCD1 inhibitor, with a strong safety profile demonstrated in previous trials, presenting a unique opportunity in cancer treatment [4][5]. - The collaboration aims to generate proof-of-concept data that could lead to further clinical development in oncology, potentially expanding Galmed's pipeline and enhancing its commercial prospects [6][7]. Group 3: Clinical Context - A significant proportion of patients with advanced hepatocellular carcinoma (HCC) do not benefit from current second-line therapies due to drug resistance, with most developing resistance within six months [3][6]. - Targeting lipid metabolism with Aramchol is seen as a promising strategy to overcome resistance to tyrosine kinase inhibitors (TKIs), which are pivotal in treating advanced HCC [6][3]. - The collaboration aims to develop safe drug combinations that can block and circumvent drug resistance in HCC, addressing a critical need in cancer treatment [3][6].

江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 阿得贝利单抗注射液是公司自主研发的人源化抗 PD-L1 单克隆抗体，能通过 特异性结合 PD-L1 分子从而阻断导致肿瘤免疫耐受的 PD-1/PD-L1 通路，重新激 活免疫系统的抗肿瘤活性，从而达到治疗肿瘤的目的。国外有同类产品 Atezolizumab （ 商 品 名 ： Tecentriq ） 、 Avelumab( 商品名： Bavencio) 和 Durvalumab(商品名：Imfinzi)于美国获批上市销售，其中 Atezolizumab 和 Durvalumab 已在中国获批上市。国内有康宁杰瑞/思路迪药业的恩沃利单抗、基 石药业的舒格利单抗和正大天晴药业的贝莫苏拜单抗等同类产品获批上市。公司 阿得贝利单抗注射液（商品名：艾瑞利）已于 2023 年 3 月获批上市，获批的适 应症为与卡铂和依托泊苷联合用于广泛期小细胞肺癌患者的一线治疗。经查询， 2023 年 Atezolizumab、Avelumab 和 Durvalumab 全球销售额合计约为 89.85 亿 美元。截至目前，阿得贝利单抗注射液相关项目累计研发投入约 78,47 ...