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$152 million Series B financing by private placement to select investors, co-led by Life Sciences at Goldman Sachs Alternatives and TCGX, with participation from Omega Funds, EQT Life Sciences, Perceptive Advisors, Kalehua Capital, and existing investors Medicxi and Droia
通过私募方式向精选投资者完成1.52亿美元B轮融资,由高盛另类投资旗下生命科学部门与TCGX联合领投,Omega Funds、EQT Life Sciences、Perceptive Advisors、Kalehua Capital以及现有投资者Medicxi和Droia参与投资。
Provides the company with capital needs through potential U.S. regulatory approval of engasertib
通过engasertib在美国获得监管批准的可能性,为公司提供资金需求。
Marks the company's transition into pivotal-stage development with initiation of the global Phase 3 HEROIC study evaluating engasertib, a once daily oral medication, in patients with moderate-to-severe hereditary hemorrhagic telangiectasia (HHT)
标志着公司进入关键阶段的发展,启动了全球III期HEROIC研究,评估每日一次口服药物engasertib在中重度遗传性出血性毛细血管扩张症(HHT)患者中的疗效
BASEL, Switzerland and LINCOLNSHIRE, Ill.
瑞士巴塞尔和美国伊利诺伊州林肯郡
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,
Aug. 11, 2026
2026年8月11日
/PRNewswire/ -- Vaderis Therapeutics, a clinical-stage biopharmaceutical company focused on developing targeted therapies for rare vascular diseases, today announced the closing of a private $152 million Series B financing and initiation of HEROIC, the company's global Phase 3 clinical study evaluating engasertib (VAD044) in patients with hereditary hemorrhagic telangiectasia (HHT)..
/美通社/ -- 专注于开发罕见血管疾病靶向疗法的临床阶段生物制药公司Vaderis Therapeutics今日宣布,完成1.52亿美元的私募B轮融资,并启动HEROIC研究。这是一项全球性III期临床试验,旨在评估engasertib(VAD044)在遗传性出血性毛细血管扩张症(HHT)患者中的疗效。
Together, these milestones mark a significant step forward in the development of engasertib, an investigational oral allosteric AKT inhibitor. Engasertib is positioned to become the first approved therapy specifically developed for people living with HHT, a rare genetic vascular disorder that currently has no approved treatment options worldwide..
这些里程碑共同标志着engasertib(一种在研的口服变构AKT抑制剂)的研发取得了重大进展。Engasertib有望成为首款专为遗传性出血性毛细血管扩张症(HHT)患者批准的疗法。HHT是一种罕见的遗传性血管疾病,目前全球范围内尚无获批的治疗方案。
The Series B financing, supported by both new and existing investors, reflects strong confidence in the potential of engasertib to address significant unmet needs in HHT. The proceeds from the financing are expected to fund the company's planned operations through regulatory submissions and potential U.S.
本轮B轮融资得到了新老投资者的共同支持,反映出市场对engasertib在解决遗传性出血性毛细血管扩张症(HHT)领域重大未满足需求方面的潜力充满信心。融资所得资金预计将用于支持公司按计划开展运营,直至完成监管申报并潜在进入美国市场。
regulatory approval..
监管批准..
Following the closing, Vaderis' Board of Directors comprises Giovanni Mariggi of Medicxi, Colin Walsh of Goldman Sachs Alternatives, Giuliano Marostica of TCGX, Francesco Draetta of Omega Funds, Nick Williams of Medicxi, Azmi Nabulsi, President and Chief Executive Officer of Vaderis, and Rahul Ballal, who serves as an independent director..
交易完成后,Vaderis 的董事会成员包括:来自 Medicxi 的 Giovanni Mariggi、来自高盛另类投资(Goldman Sachs Alternatives)的 Colin Walsh、来自 TCGX 的 Giuliano Marostica、来自 Omega Funds 的 Francesco Draetta、来自 Medicxi 的 Nick Williams、Vaderis 总裁兼首席执行官 Azmi Nabulsi,以及担任独立董事的 Rahul Ballal。
The financing and initiation of HEROIC follows publication of positive proof-of-concept and long-term extension data for engasertib in
HEROIC 研究的融资和启动紧随 engasertib 的阳性概念验证数据及长期扩展数据的公布之后
The New England Journal of Medicine
新英格兰医学杂志
, which demonstrated clinically meaningful and sustained improvements across multiple measures of disease in patients with HHT. These data established the scientific foundation for advancing engasertib into pivotal development and its potential to address the significant unmet needs of patients living with HHT..
,这在遗传性出血性毛细血管扩张症(HHT)患者中展现出具有临床意义且持续的多项疾病指标改善。这些数据为将engasertib推进至关键性开发阶段奠定了科学基础,并彰显了其满足HHT患者重大未竟医疗需求的潜力。
'Today represents a defining moment for HHT patients,' said Azmi Nabulsi, MD, MPH, President and Chief Executive Officer of Vaderis Therapeutics. 'Closing this financing and initiating HEROIC as the first Phase 3 study utilizing a molecule specifically developed for HHT marks an exciting new chapter.
“今天对遗传性出血性毛细血管扩张症(HHT)患者而言是一个具有决定性意义的时刻,”Vaderis Therapeutics 总裁兼首席执行官 Azmi Nabulsi 博士、公共卫生硕士表示。“完成此次融资并启动 HEROIC 研究——这是首个利用专为 HHT 开发的分子进行的 III 期临床试验——标志着一个令人振奋的新篇章。”
This milestone reflects the dedication of our patients, investigators, study teams, and advocacy organizations, to whom we extend our deepest gratitude. We are also thankful to our investors for their confidence and support, which have been essential in bringing us to this point.'.
这一里程碑体现了我们的患者、研究者、研究团队以及倡导组织的奉献精神,我们向他们致以最诚挚的感谢。我们也感谢投资者们的信任与支持,这对我们取得今天的成就至关重要。
'Having partnered with Vaderis since its inception, Medicxi has seen the company consistently translate cutting-edge science into meaningful clinical progress,' said Giovanni Mariggi, co-founder and Partner, Medicxi and Chairman of Vaderis Therapeutics. 'The advancement of engasertib into Phase 3 represents the culmination of years of disciplined execution, scientific innovation and close collaboration with the HHT community.
“自Vaderis成立之初便与其合作,Medicxi见证了该公司持续将前沿科学转化为具有临床意义的进展,”Medicxi联合创始人兼合伙人、Vaderis Therapeutics董事长Giovanni Mariggi表示。“Engasertib进入III期临床试验,标志着多年来的严谨执行、科学创新以及与遗传性出血性毛细血管扩张症(HHT)社群紧密合作的成果。”
Building on the important contributions of clinicians and scientists that have advanced the field, we are proud to continue supporting Vaderis as it pioneers a regulatory pathway for therapies specifically developed for HHT, while working to bring the first such treatment to patients..
在临床医生和科学家为推动该领域发展所作出的重要贡献基础上,我们自豪地继续支持Vaderis,使其在为遗传性出血性毛细血管扩张症(HHT)专门开发的疗法监管路径方面发挥先锋作用,同时努力将首款此类治疗药物带给患者。
'Vaderis has generated compelling clinical evidence supporting targeted AKT inhibition as a novel treatment approach for HHT,' said Colin Walsh, PhD, Managing Director, Life Sciences at Goldman Sachs Alternatives. 'The company's strong scientific foundation, disciplined execution and clear focus on addressing a significant unmet medical need gave us conviction in both the financing and the Phase 3 program.'.
“Vaderis 已生成令人信服的临床证据,支持将靶向 AKT 抑制作为遗传性出血性毛细血管扩张症(HHT)的一种新型治疗方法。”高盛另类投资生命科学部门董事总经理 Colin Walsh 博士表示。“该公司坚实的科学基础、严谨的执行力以及对解决重大未满足医疗需求的明确关注,使我们对此次融资及其三期临床试验计划充满信心。”
'We are pleased to partner with Vaderis and a high-quality investor syndicate to advance engasertib through this important stage of development,' added Giuliano Marostica, Managing Partner, TCGX.
TCGX管理合伙人朱利亚诺·马罗斯蒂卡补充道:“我们很高兴与Vaderis及一个高质量的投资者联盟合作,共同推动engasertib在这一关键开发阶段取得进展。”
Phase 3 HEROIC Study Now Underway
HEROIC研究第三期现已启动
HEROIC is a global, randomized, double-blind, placebo-controlled Phase 3 clinical study designed to evaluate the efficacy and safety of once-daily oral engasertib in patients with moderate-to-severe HHT. The study is expected to enroll patients across sites in North America, South America and Europe..
HEROIC 是一项全球性、随机、双盲、安慰剂对照的 III 期临床研究,旨在评估每日一次口服 engasertib 在中重度遗传性出血性毛细血管扩张症(HHT)患者中的疗效和安全性。该研究预计将在北美、南美和欧洲的多个中心招募患者。
'HHT remains a serious, lifelong disease that places a substantial burden on patients, yet there are still no approved therapies,' said Hanny Al-Samkari, MD, Associate Professor of Medicine at Harvard Medical School, The Peggy S. Blitz Endowed Chair in Hematology/Oncology at Mass General Brigham Cancer Institute, and Principal Investigator of the HEROIC study.
“遗传性出血性毛细血管扩张症(HHT)仍然是一种严重的终身性疾病,给患者带来沉重负担,然而目前尚无获批的疗法。”哈佛大学医学院医学副教授、麻省总医院布里格姆癌症研究所佩吉·S·布利茨血液学/肿瘤学讲席教授、HEROIC研究主要研究者汉尼·阿尔-萨姆卡里博士表示。
'As the Principal Investigator of HEROIC, I believe this study has been thoughtfully designed to rigorously evaluate engasertib in a larger patient population and confirm the encouraging findings from the earlier proof-of-concept study.'.
“作为HEROIC研究的主要研究者,我认为本研究经过精心设计,旨在更大规模的患者人群中严格评估engasertib,并验证早期概念验证研究中令人鼓舞的结果。”
About Engasertib (VAD044)
关于 Engasertib (VAD044)
Engasertib is an investigational oral selective allosteric inhibitor of AKT1/2 being developed for the treatment of hereditary hemorrhagic telangiectasia (HHT), a rare genetic vascular disorder characterized by recurrent bleeding and arteriovenous malformations. By targeting dysregulated signaling pathways implicated in vascular malformations, engasertib is designed to address the underlying pathophysiology of disease..
Engasertib 是一种在研的口服选择性 AKT1/2 变构抑制剂,正在开发用于治疗遗传性出血性毛细血管扩张症(HHT),这是一种罕见的遗传性血管疾病,以反复出血和动静脉畸形为特征。通过靶向与血管畸形相关的失调信号通路,Engasertib 旨在解决该疾病的潜在病理生理机制。
Engasertib has not been approved for use in any country for any indication.
Engasertib 尚未在任何国家获批用于任何适应症。
About HHT
关于HHT
Hereditary hemorrhagic telangiectasia (HHT) is a rare genetic vascular disorder (prevalence ~1 in 3,800) characterized by recurrent severe epistaxis, anemia, and visceral arteriovenous malformations (AVMs). Despite the significant disease burden, there are currently no approved therapies for HHT globally..
遗传性出血性毛细血管扩张症(HHT)是一种罕见的遗传性血管疾病(患病率约为1/3,800),其特征为复发性严重鼻出血、贫血以及内脏动静脉畸形(AVMs)。尽管该病负担沉重,但目前全球范围内尚无获批的HHT治疗药物。
About Vaderis Therapeutics
关于Vaderis Therapeutics
Vaderis Therapeutics is a science-driven biopharmaceutical company focused on discovering and advancing transformative treatments for rare vascular diseases. By targeting the underlying pathophysiology, the company aims to bring first-in-class targeted therapies to patients in need. Vaderis is headquartered in Basel, Switzerland with a U.S.
Vaderis Therapeutics 是一家科学驱动的生物制药公司,专注于发现和推进针对罕见血管疾病的变革性疗法。通过针对基础病理生理机制,该公司旨在为有需要的患者带来首创的靶向疗法。Vaderis 总部位于瑞士巴塞尔,并在美国设有分支机构。
subsidiary in Lincolnshire, Illinois. For more information, visit .
位于伊利诺伊州林肯郡的子公司。欲了解更多信息,请访问。
www.vaderis.com
www.vaderis.com
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。
Forward-Looking Statement
前瞻性陈述
This press release contains forward-looking statements regarding the development, regulatory review, and potential approval of engasertib and related programs, the anticipated initiation, timing, and execution of clinical trials, the expected use of proceeds from the financing, and the company's anticipated operational runway.
本新闻稿包含有关engasertib及相关项目的开发、监管审查和潜在批准,临床试验的预期启动、时间安排和执行,融资所得款项的预期用途,以及公司预期运营资金存续期的前瞻性陈述。
By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements, including due to risks, uncertainties, and the inherent complexities of clinical development, regulatory review, financing activities, manufacturing, and other factors..
前瞻性陈述就其性质而言,涉及多种风险、不确定性和假设,这些因素可能导致实际结果或事件与前瞻性陈述所明示或暗示的内容存在重大差异,包括由于临床开发、监管审查、融资活动、生产制造以及其他因素所带来的风险、不确定性及固有复杂性。
This press release does not constitute an offer or solicitation for the purchase or disposal of, trading or any transaction in any securities of Vaderis Therapeutics in any jurisdiction.
本新闻稿不构成在任何司法管辖区对Vaderis Therapeutics任何证券的购买、处置、交易或进行任何交易的要约或招揽。
Medical Information
医疗信息
Engasertib has not been approved for use in any country for any indication. Information in this press release is for medical and scientific reference only and is not intended to promote, recommend, or suggest use of this product. The safety and efficacy of engasertib have not been established by any regulatory authority..
Engasertib 尚未在任何国家获得任何适应症的批准使用。本新闻稿中的信息仅供医学和科学参考,无意推广、推荐或建议使用本产品。Engasertib 的安全性和有效性尚未得到任何监管机构的确认。
SOURCE Vaderis Therapeutics AG
来源:Vaderis Therapeutics AG
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