About this content About William Farrington William kickstarted his career as a researcher and reporter for a global legal publication, covering everything from public law to M&A. Before moving to Proactive Investors, he worked as a reporter for a major fintech company with a focus on cryptocurrency and blockchain technology. Harking from Queensland, Australia, William obtained first-class honours in journalism and media from Birkbeck University before going on to complete an MA in creative and critical ...

ATH-1105 is an orally delivered, positive modulator of the neurotrophic HGF system that is currently in a Phase 1 clinical trial with completion expected by year end 2024 and commencement of dosing of ALS patients expected in 2025  Company announces cost containment measures in alignment with focus on advancing ATH-1105 BOTHELL, Wash., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a clinical stage biopharmaceutical company focused on developing small molecules to restore neuronal he ...

Shares of Athira Pharma, Inc. (ATHA) plunged 72.2% in after-hours trading on Sep 3 after the company announced disappointing top-line data from the phase II/III LIFT-AD study evaluating its pipeline candidate, fosgonimeton, for the treatment of mild-to-moderate Alzheimer’s disease (AD).The LIFT-AD study investigated once-daily fosgonimeton (40 mg) subcutaneous injection versus placebo over a treatment period of 26 weeks in mild-to-moderate AD patients.The study did not meet the primary endpoint which was th ...

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...

药物研发和临床试验 - 公司专注于开发小分子治疗药物，利用神经营养性肝细胞生长因子(HGF)系统来修复神经元健康并减缓神经退行性疾病[112] - 公司的主要药物候选物fosgonimeton正在进行LIFT-AD II/III期临床试验，评估其在轻度至中度阿尔茨海默病患者中的疗效[113,115] - LIFT-AD临床试验的主要终点指标为全局统计检验(GST)，综合评估认知和功能两个共同主要次要终点[115] - 公司根据ACT-AD试验结果,调整LIFT-AD试验设计,聚焦于未服用乙酰胆碱酯酶抑制剂的患者,并选择40mg剂量进行进一步开发[115] - LIFT-AD试验已于2024年1月完成入组,预计2024年第三季度公布试验结果[115] - 公司还为LIFT-AD和ACT-AD试验设立了开放标签延长试验(OLEX),允许符合条件的患者接受长达48个月的fosgonimeton治疗[116] 财务状况 - 公司目前主要通过股权融资获得运营资金,截至2024年6月30日共筹集约4.074亿美元[122] - 公司预计未来会持续亏损,主要用于推进药物候选物的临床开发、扩大管线、建立商业化能力等[123] - 公司预计未来12个月内现有现金、现金等价物和投资将足以支持其运营费用和资本支出需求[125] - 截至2024年6月30日，公司现金、现金等价物和投资总额为9180万美元[157] - 公司预计现有资金可支持未来至少12个月的运营[159] - 公司需要筹集大量额外资金以支持药品候选物的开发[159] - 2023年1月公司与Cantor Fitzgerald和BTIG签订了最高7500万美元的ATM股权融资协议[159] - 公司未来资金需求取决于临床试验进展、监管审批、商业化活动等多方面因素[160-161] 研发费用 - 研发费用主要包括直接成本和间接成本,其中直接成本包括实验室材料和供应品、外包研究和制造、临床试验成本等,间接成本包括人员相关费用和设施费用等[128][129][130] - 研发费用预计将持续增加,主要由于继续投资于药物候选物的研发、临床试验规模扩大、知识产权维护等[131][132][133][134] - 研发费用增加500万美元，主要由于ATH-1105项目的临床试验成本增加330万美元[151] 一般及行政费用 - 一般及行政费用主要包括人员相关费用和第三方费用,预计未来将持续增加以支持业务增长[135][136] - 一般及行政费用减少620万美元，主要由于法律费用、业务发展费用、专业服务费用等的减少[152] 其他收益 - 公司过去获得了150万美元的NIH赠款,该赠款已全部确认[137] - 2023年6月30日获得的政府补助收入为20万美元，2024年6月30日无政府补助收入[153] - 其他收益净额主要包括现金、现金等价物和投资的利息收入,随着现金余额的减少预计将有所下降[138] - 其他收益净额减少130万美元，主要由于持有至到期的债务证券折价摊销收益和可供出售证券利息收益的减少[154]

临床试验进展 - 公司正在进行一项针对轻度至中度阿尔茨海默病患者的2/3期LIFT-AD临床试验，预计在2024年第三季度公布试验的顶线数据[1][3][7] - LIFT-AD试验的主要终点指标是全局统计检验(GST)，这是一个综合认知(ADAS-Cog11)和功能(ADCS-ADL23)指标的复合指标，反映了整体疾病负担[8] - 公司正在进行一项ATH-1105的1期临床试验，评估其在健康受试者中的安全性、耐受性和药代动力学，预计在2024年底完成[10][11] - ATH-1105在多个ALS动物模型中显示出在神经和运动功能、炎症和神经变性生物标志物以及生存率方面的统计学显著改善[11] 财务状况 - 公司2024年第二季度的现金、现金等价物和投资总额为9180万美元[14] - 2024年第二季度研发费用为2220万美元，主要由ATH-1105项目费用增加所致[15] - 2024年第二季度一般及行政费用为590万美元，较上年同期下降[16]

Topline data from completed Phase 2/3 LIFT-AD clinical trial of fosgonimeton as a potential treatment for mild-to-moderate Alzheimer’s disease targeted for September 2024 Phase 2/3 LIFT-AD data to be presented in an oral presentation at CTAD in October 2024 Phase 1 clinical trial of ATH-1105 underway for the potential treatment of amyotrophic lateral sclerosis (ALS) BOTHELL, Wash., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused ...

Fosgonimeton mitigated amyloid-β-induced toxicity, lowered pTau levels and reduced disruption of protein clearance mechanisms that may contribute to pTau pathology Fosgonimeton treatment, alone and in combination with lecanemab, protected cultures of primary neurons from the toxic effects of amyloid-β BOTHELL, Wash., July 31, 2024 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ:ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow n ...