Achieve Life Sciences, Inc. (ACHV) Q3 2024 Earnings Call Transcript Summary
Achieve Life Sciences, Inc. (ACHV) Q3 2024 Earnings Call Transcript Summary
The following is a summary of the Achieve Life Sciences, Inc. (ACHV) Q3 2024 Earnings Call Transcript:
以下是 Achieve Life Sciences, Inc. (ACHV) 2024年第三季度业绩会议呼叫记录摘要:
Financial Performance:
财务业绩:
Achieve Life Sciences reported a net loss of $12.5 million for Q3 2024, compared to a net loss of $7.1 million in the same quarter the previous year.
The company's cash, cash equivalents, restricted cash, and short-term investments as of September 30, 2024, stood at $42.9 million, down from $61.3 million the previous quarter.
Achieve successfully completed a debt refinancing agreement with SVB, securing up to $20 million, split across three tranches, to support future activities including potential NDA submission.
Achieve Life Sciences报告2024年第三季度净损失1250万美元,与去年同期710万美元的净损失相比。
截至2024年9月30日,该公司的现金、现金等价物、受限制的现金和短期投资为4290万美元,较上一季度的6130万美元下降。
Achieve成功与SVb完成了一项债务再融资协议,获得了高达2000万美元,分三个Tranche支持未来活动,包括潜在的NDA提交。
Business Progress:
业务进展:
Achieve Life Sciences received FDA breakthrough therapy designation for cytisinicline for e-cigarette or vaping cessation.
The company is preparing for NDA submission for smoking cessation, targeting Q2 2025, and plans to commence a Phase 3 clinical trial for vaping cessation by Q3 2025.
Successfully enrolled 479 participants in the ORCA-OL safety trial for cytisinicline, completing enrollment ahead of expectations.
Achieve focuses on advancing cytisinicline as a promising treatment for nicotine dependence, supported by digital and innovative commercial strategies for market launch.
Achieve Life Sciences因烟草碱丁烷抗烟或戒烟获得FDA突破性疗法认定。
公司正在为戒烟NDA提交做准备,计划在2025年第二季度,同时计划在2025年第三季度开始进行戒烟的第三阶段临床试验。
ORCA-OL安全试验的赛替尼克林参与人数已成功招募479名,提前完成了招募任务。
Achieve专注于推进赛替尼克林作为治疗尼古丁依赖的有前途的选择,并借助数字化和创新的商业策略支持市场推出。
Opportunities:
机会:
Achieve Life Sciences is gearing up for the commercial launch of cytisinicline, capitalizing on the significant unmet need in smoking and vaping cessation.
The breakthrough therapy designation received for vaping cessation allows for enhanced interaction with FDA, potentially accelerating cytisinicline's approval and market entry.
Planned expansion into vaping cessation and exploration of adolescent and possibly nicotine pouch use cases provide multiple avenues for growth.
Achieve Life Sciences正为赛替尼克林的商业推出做准备,利用吸烟和吸蒸汽戒断领域存在的重大未满足需求。
获得用于吸蒸汽戒断的突破性疗法认定使得与FDA的互动增强,有望加速赛替尼克林的批准和市场准入。
计划扩展至吸蒸汽戒烟,并探索青少年及可能的尼古丁袋用例提供了多条增长途径。
Risks:
风险:
The continued elevation of operating expenses as Achieve progresses with its ORCA-OL study and prepares for NDA submission and commercial rollout poses a financial strain.
The potential for high patient discontinuation rates in long-term trials could impact study outcomes and regulatory approval paths.
随着Achieve在ORCA-OL研究上的进展和为NDA提交以及商业推出做准备,营业费用持续上升,造成了财务压力。
长期试验中患者辍学率高的潜在可能会影响研究结果和监管批准路径。
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译文内容由第三方软件翻译。