Summary of Athira Pharma Conference Call - December 18, 2025 Company Overview - **Company**: Athira Pharma (NasdaqGS:ATHA) - **Focus**: Development of innovative therapies for diseases with unmet medical needs, specifically in oncology and neurology Key Points Discussed Transformative Acquisition - Athira announced the acquisition of rights to develop and commercialize **lasofoxifene**, a potential treatment for metastatic breast cancer, which diversifies its pipeline with a late-stage program [5][15][16] - The acquisition is expected to enhance Athira's mission to deliver transformative therapies for patients [5][14] Lasofoxifene Overview - Lasofoxifene is currently in a pivotal phase III clinical trial targeting **ER-positive HER2-negative metastatic breast cancer**, which represents about 70% of all breast cancer cases [15][16] - The global market for metastatic ER-positive HER2-negative breast cancer is projected to grow from **$10.9 billion in 2025 to over $15.9 billion by 2029** [15] - Lasofoxifene has shown promising clinical activity, achieving **13 months of progression-free survival (PFS)** in combination therapy during phase II trials [20][26] Clinical Data and Mechanism - Lasofoxifene demonstrated an **83% reduction in new-onset primary wild-type estrogen receptor-positive breast cancer** in previous studies [19] - It modulates the estrogen receptor rather than degrading it, providing tissue selectivity and sparing healthy estrogen receptors in critical tissues [19][21] - The drug has shown **significant efficacy against ESR1 mutations**, which occur in over 40% of patients and are a major mechanism of resistance in breast cancer treatments [20][21] ATH-1105 for ALS - Athira is also advancing **ATH-1105**, a potential treatment for **Amyotrophic Lateral Sclerosis (ALS)**, which affects approximately **33,000 patients in the U.S.** [37] - ATH-1105 modulates the hepatocyte growth factor (HGF) system, which is critical for neuronal health [38] - Preclinical studies have shown that ATH-1105 preserves motor function and reduces neurodegeneration in ALS models [39][40] Financial and Strategic Positioning - Athira raised **$90 million** to support its development programs, with the potential for an additional **$146 million** through warrants [46] - The financing positions the company to reach critical data readouts across both programs by the end of **2027** [46] - Athira aims to achieve peak annual U.S. sales for lasofoxifene approaching **$1 billion** if approved [35] Market Opportunity - The global breast cancer market is approximately **$55 billion**, with the second-line breast cancer segment in the U.S. exceeding **$5-$6 billion annually** [34] - Lasofoxifene's favorable tolerability profile and unique attributes position it as a potential leading therapy in this market [35][36] Conclusion - Athira is committed to advancing its promising development programs for lasofoxifene and ATH-1105, addressing significant unmet needs in metastatic breast cancer and ALS [45] - The company is optimistic about its future and the potential impact of its therapies on patient outcomes [47]

Core Insights - Natera, Inc. and MEDSIR are collaborating on the MiRaDoR study, a phase II clinical trial focused on HR+/HER2- breast cancer, which accounts for approximately 70% of all breast cancer cases globally [1][2] - The study aims to evaluate the efficacy of various therapeutic approaches using Signatera Genome to monitor circulating-tumor DNA (ctDNA) levels as a predictive marker of treatment response [2][3] - Enrollment for the MiRaDoR trial is currently underway, with several sites in the U.K. active and further expansions expected in Europe by 2026 [3] Study Design and Objectives - The MiRaDoR study will enroll up to 60 patients who are Signatera-positive without evidence of disease recurrence, assigning them to one of four treatment arms [2][6] - The primary endpoint is the proportion of patients achieving a 90% decrease or clearance in baseline ctDNA after three months of treatment, with follow-up testing at 6, 9, and 12 months [2] - The trial will compare the effectiveness of specific therapy combinations against standard endocrine treatment [2] Company Background - Natera is recognized as a leader in cell-free DNA and precision medicine, focusing on oncology, women's health, and organ health, with a commitment to integrating personalized genetic testing into standard care [4] - MEDSIR specializes in oncology research and clinical trial management, operating in Spain and the U.S., and aims to promote independent research through strategic partnerships [8]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-016 江苏恒瑞医药股份有限公司 关于药品临床试验进展的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，江苏恒瑞医药股份有限公司（以下简称"公司"）自主研发的羟乙磺 酸达尔西利片联合内分泌治疗在激素受体（HR）阳性、人表皮生长因子受体 2 （HER2）阴性女性乳腺癌辅助治疗中的一项多中心、随机、双盲的Ⅲ期临床试验 （研究方案编号：SHR6390-Ⅲ-303），首次期中分析主要终点达到统计学显著性。 研究结果显示，达尔西利联合内分泌治疗，较安慰剂联合内分泌治疗，可显著降 低患者复发风险，提高患者无侵袭性疾病生存期（IDFS）[1]。公司已于近期向国 家药品监督管理局药品审评中心递交上市前沟通交流申请。 一、 药品的基本情况 药品名称：羟乙磺酸达尔西利片 剂型：片剂 二、 药品的临床试验情况 达尔西利已于国内获批两项适应症，即本品适用于激素受体（HR）阳性、人 表皮生长因子受体 2（HER2）阴性局部晚期或转移性乳腺癌患者：1.与芳香化酶 抑制剂联合使 ...