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$240 million private placement financing led by RA Capital Management with significant participation by Bain Capital Life Sciences as well as BVF Partners and Canaan Partners to fund Phase 2b clinical trial
由RA Capital Management牵头的2.4亿美元私募融资,贝恩资本生命科学以及BVF Partners和Canaan Partners的大力参与,为2b期临床试验提供资金
CD388, which is active against all strains of influenza A and B, is being developed for pre-exposure prophylactic treatment
CD388对所有甲型和乙型流感病毒株都有活性,正在开发用于暴露前预防性治疗
Company to host business strategy update conference call and webcast today at 4:30 PM ET
美国东部时间今天下午4:30,公司将主持商业战略更新电话会议和网络广播
SAN DIEGO, April 24, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced that it has entered into a definitive agreement with Johnson & Johnson1 to reacquire the exclusive global development and commercial rights to CD388, which is in development for the prevention of all strains of influenza A and B..
2024年4月24日,圣地亚哥(环球通讯社)--Cidara Therapeutics,Inc.(纳斯达克:CDTX),一家生物技术公司,使用其专有的Cloudbreak®平台开发药物Fc结合物(DFC)免疫疗法,旨在挽救生命并提高面临严重疾病的患者的护理标准,今天宣布,它已与Johnson&Johnson1达成明确协议,重新获得CD388的独家全球开发和商业权利,CD388正在开发中,用于预防所有甲型和乙型流感毒株。
Concurrent with the acquisition, Cidara closed a definitive agreement for the sale of preferred stock in a private placement led by RA Capital Management, with significant participation from Bain Capital Life Sciences, Biotech Value Fund (BVF), and Canaan Partners. The private placement provides $240 million in gross proceeds that will be used by Cidara to develop CD388 as a universal preventative against seasonal and pandemic influenza A and B, beginning with a Phase 2b clinical trial in the upcoming Northern Hemisphere influenza season.
在收购的同时,Cidara达成了一项最终协议,以RA Capital Management为首的私募方式出售优先股,贝恩资本生命科学、生物技术价值基金(BVF)和加拿大合作伙伴参与了此次私募。此次私募提供了2.4亿美元的总收益,Cidara将用于开发CD388,作为预防季节性和大流行性甲型和乙型流感的通用预防药物,从即将到来的北半球流感季节的2b期临床试验开始。
The proceeds from the private placement fund the upfront payment under the agreement with Johnson & Johnson and are expected to provide runway beyond topline data from CD388’s Phase 2b trial..
私募基金的收益是根据与强生公司的协议支付的预付款,预计将提供CD388 2b期试验的topline数据。
CD388 is a long-acting antiviral investigational drug invented and developed by Cidara that became the subject of an exclusive worldwide license and collaboration agreement established with Johnson & Johnson in April 2021. In September 2023, Johnson & Johnson delivered to Cidara an Election to Proceed Notice and associated milestone payment for CD388 before beginning a process to transfer its rights and obligations under the agreement to another entity..
CD388是一种由Cidara发明和开发的长效抗病毒研究药物,已成为2021年4月与强生公司签订的全球独家许可和合作协议的主题。2023年9月,强生公司在开始将其在本协议下的权利和义务转让给另一个实体之前,向Cidara提交了一份关于CD388的选举继续通知和相关里程碑付款。
In connection with the private placement, Laura Tadvalkar, Ph.D., Managing Director at RA Capital Management, Ryan Spencer, and James Merson, Ph.D. have been appointed to Cidara’s board of directors, while David Gollaher, Ph.D. and Timothy Franson, M.D. will be stepping down. “I thank David and Tim for their invaluable contributions, which have helped facilitate this opportunity for Cidara,” said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Cidara..
就私募而言,RA Capital Management董事总经理LauraTadvalkar博士、Ryan Spencer博士和James Merson博士已被任命为Cidara董事会成员,而David Gollaher博士和Timothy Franson博士将辞职。Cidara总裁兼首席执行官Jeffrey Stein博士说:“我感谢David和Tim的宝贵贡献,他们为Cidara创造了这个机会。”
Dr. Stein continued, “This reacquisition of CD388, along with the capital to advance it through Phase 2b development, is transformational for Cidara and especially for those who could benefit from a long-acting, universal preventative against all forms of influenza. In our Phase 2b study later this year, we will evaluate the efficacy and safety of CD388 in providing season-long, universal protection from influenza.
斯坦博士继续说:“CD388的重新获得,以及通过2b期开发推进CD388的资金,对于Cidara来说是一个转变,特别是对于那些可能受益于长效,普遍预防各种形式流感的人。在我们今年晚些时候的2b期研究中,我们将评估CD388在提供季节性,普遍预防流感方面的有效性和安全性。
We believe that CD388 may have significant advantages beyond and in addition to flu vaccines, with the potential for universal protection even in the absence of a robust immune response and without the requirement for seasonal influenza strain prediction.”.
我们认为,CD388除了流感疫苗之外,还可能具有显着的优势,即使在没有强大的免疫反应且不需要季节性流感病毒株预测的情况下,也可能具有普遍保护的潜力。”
All responsibility for future development, manufacturing, and commercialization activities of CD388 will be assumed by Cidara. In exchange for reacquiring the exclusive global development and commercial rights to CD388, Johnson & Johnson has received from Cidara a one-time upfront payment of $85 million and is eligible to receive potential additional development, regulatory, and commercial milestone payments..
CD388未来的开发、制造和商业化活动的所有责任将由Cidara承担。作为重新获得CD388的独家全球开发和商业权利的交换,强生公司已从加拿大国际开发署获得8500万美元的一次性预付款,并有资格获得潜在的额外开发、监管和商业里程碑付款。
“We have followed the development of CD388 over time with great interest,” said Dr. Tadvalkar. “As stage-agnostic company builders, we were excited to catalyze this reacquisition and financing – and to leverage the company-building capabilities of our RAVen incubator to support Cidara.”
Tadvalkar博士说:“随着时间的推移,我们对CD388的发展产生了极大的兴趣。”。“作为不分阶段的公司建设者,我们很高兴能够促进这种重新收购和融资,并利用我们的RAVen孵化器的公司建设能力来支持Cidara。”
“The support from this top-tier syndicate of new and existing investors highlights our enthusiasm and potential for CD388, the most advanced member of our Cloudbreak DFC pipeline and the new focus of the company,” added Dr. Stein. “We expect that the capital infusion from this financing, together with existing cash and the expected near-term cost savings associated with our recently announced divestiture of rezafungin to Mundipharma, positions us well to execute on the CD388 development program and advance the key assets in our pipeline.”.
Stein博士补充道:“这家由新投资者和现有投资者组成的顶级财团的支持突显了我们对CD388的热情和潜力,CD388是我们Cloudbreak DFC管道中最先进的成员,也是公司的新重点。”。“我们预计,此次融资带来的资金注入,加上现有现金以及与我们最近宣布的将rezafungin剥离给Mundipharma相关的预期短期成本节约,使我们能够很好地执行CD388开发计划,并推进我们管道中的关键资产。”
Conference Call and Webcast Details
电话会议和网络广播详细信息
Cidara will host a business strategy update conference call and webcast today, Wednesday, April 24, 2024, at 4:30 PM ET. Details can be found below.
Cidara将于今天,2024年4月24日星期三,美国东部时间下午4:30主持商业战略更新电话会议和网络广播。详情见下文。
AboutCD388
关于CD388
CD388 is an investigational drug-Fc conjugate (DFC) comprised of multiple copies of a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. DFCs are not vaccines or monoclonal antibodies but are low molecular weight biologics which are designed to function as long-acting small molecule inhibitors.
CD388是一种研究药物Fc缀合物(DFC),由多个拷贝的有效小分子神经氨酸酶抑制剂组成,该抑制剂与人抗体的专有Fc片段稳定缀合。DFC不是疫苗或单克隆抗体,而是低分子量生物制剂,旨在作为长效小分子抑制剂发挥作用。
CD388 was designed to provide universal protection against all known strains of seasonal and pandemic influenza with the potential to provide season-long protection with a single subcutaneous or intramuscular administration. Importantly, because CD388 is not a vaccine, its activity is not reliant on an immune response and thereby is expected to be efficacious in individuals regardless of immune status.
CD388旨在提供针对所有已知季节性和大流行性流感病毒株的通用保护,并有可能通过单次皮下或肌肉注射提供季节性保护。重要的是,由于CD388不是疫苗,其活性不依赖于免疫反应,因此无论免疫状态如何,预计对个体都有效。
AboutCidaraTherapeutics
关于Cidara Therapeutics
Cidara is developing immunotherapeutics designed to help improve the standard of care for patients facing serious diseases. The Company’s portfolio comprises new approaches aimed at transforming existing treatment and prevention paradigms, including DFCs from its proprietary Cloudbreak® platform targeting oncologic, viral and autoimmune diseases.
Cidara正在开发免疫疗法,旨在帮助改善面临严重疾病的患者的护理标准。该公司的投资组合包括旨在改变现有治疗和预防模式的新方法,包括针对肿瘤,病毒和自身免疫性疾病的专有Cloudbreak®平台的DFC。
Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com..
Cidara总部位于加利福尼亚州圣地亚哥。欲了解更多信息,请访问www.cidara.com。
About RA Capital
关于RA Capital
RA Capital Management is a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare, life sciences, and planetary health companies. RA Capital forms and funds innovative companies, from private seed rounds to public follow-on financings, allowing management teams to drive value creation from inception through commercialization.
RA Capital Management是一家多阶段投资管理公司,致力于对公共和私人医疗保健、生命科学和行星健康公司进行循证投资。RA Capital成立并资助创新公司,从私人种子轮到公共后续融资,允许管理团队从一开始就通过商业化推动价值创造。
RA Capital's knowledge engine is guided by our TechAtlas internal research division, and our in-house RAVen incubator offers experienced entrepreneurs a collaborative and comprehensive company creation platform to explore both the novel and the re-imagined. For more information, please visit www.racap.com..
RA Capital的知识引擎由我们的TechAtlas内部研究部门指导,我们的内部RAVen孵化器为经验丰富的企业家提供了一个协作和全面的公司创建平台,以探索新颖和重新想象的事物。有关更多信息,请访问www.racap.com。
Forward-LookingStatements
前瞻性陈述
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
本新闻稿包含经修订的《1933年证券法》第27A节和经修订的《1934年证券交易法》第21E节所指的“前瞻性声明”,此类前瞻性声明是根据1995年《私人证券诉讼改革法》的安全港条款做出的。
“Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to the proceeds from the private placement being expected to provide runway beyond topline data from CD388’s Phase 2b trial; the reported transactions being transformational for Cidara; whether CD388 may have significant advantages beyond and in addition to flu vaccines; and Cidara’s ability to execute on the CD388 development program and advance the key assets in its pipeline.
“前瞻性陈述”描述未来的期望、计划、结果或策略,通常在前面加上“预期”、“预期”、“可能”、“计划”或“意愿”等词。本版本中的前瞻性声明包括但不限于与私募收益相关的声明,该私募收益有望提供CD388 2b期试验的topline数据之外的跑道;所报告的交易对Cidara来说是转型的;除了流感疫苗之外,CD388是否可能具有显着的优势;以及Cidara执行CD388开发计划并推进其管道中关键资产的能力。
Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s pre-clinical or clinical trials, delays in action by regulatory authorities, and obstacles on the enrollment of patients or other aspects of CD388 development.
此类声明受到多种风险和不确定性的影响,这些风险和不确定性可能导致未来的情况、事件或结果与前瞻性声明中预测的情况、事件或结果产生重大差异,例如Cidara临床前或临床试验的意外延迟或负面结果,监管机构的行动延迟,以及患者登记或CD388开发的其他方面的障碍。
These and other risks are identified under the caption “Risk Factors” in Cidara’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on manageme.
这些风险和其他风险在加拿大国际开发署截至2023年12月31日的10-K表年度报告以及随后向美国证券交易委员会提交的其他文件中的“风险因素”标题下确定。本新闻稿中包含的所有前瞻性声明仅在发布之日发表,并以manageme为基础。