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MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that the Company accepted offers from multiple leading biotech institutional and individual investors to purchase an aggregate of approximately 10.35 million shares of the Company’s common stock at $22.70 per share, the closing price on Wednesday, September 11, 2024, for aggregate gross proceeds to the Company of approximately $235 million.
迈阿密--(商业新闻短讯)--Summit Therapeutics Inc.(纳斯达克代码:SMMT)(“Summit”,“we”或“公司”)今天宣布,该公司接受了多家领先的生物技术机构和个人投资者的报价,以每股22.70美元(2024年9月11日星期三的收盘价)购买该公司普通股约1035万股,总收益约为2.35亿美元。
The capital raise was completed without bankers’ fees..
此次融资是在没有银行手续费的情况下完成的。。
All of Summit’s Section 16 officers participated in the capital raise. A total of $79 million was raised by insiders, including Robert W. Duggan, Dr. Maky Zanganeh, Manmeet S. Soni, and Bhaskar Anand, as well as Jeff Huber, a member of the Board of Directors, who invested via a controlled entity. The remaining $156 million was raised with multiple leading biopharma institutional investors..
Summit第16部门的所有官员都参与了此次融资。。剩下的1.56亿美元是由多家领先的生物制药机构投资者筹集的。。
Summit intends to use the net proceeds to advance, in part, the clinical development of ivonescimab, including in non-small cell lung cancer and in settings outside of lung cancer by leveraging the data that will be presented at ESMO, which may include, but is not limited to, colorectal cancer, and triple-negative breast cancer, in addition to working capital needs and general corporate purposes..
Summit计划利用净收益部分推进ivonescimab的临床开发,包括在非小细胞肺癌和肺癌以外的环境中,通过利用ESMO将提供的数据,除了营运资金需求和一般企业用途之外,还可能包括但不限于结直肠癌和三阴性乳腺癌。。
The securities described above have not been registered under the Securities Act of 1933, as amended. Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act.
上述证券尚未根据经修订的《1933年证券法》进行登记。因此,这些证券不得在美国发售或出售,除非根据有效的注册声明或《证券法》注册要求的适用豁免。
Summit has agreed to file a registration statement with the Securities and Exchange Commission (SEC) registering the resale of the shares of common stock following the closing of the securities purchase agreement..
Summit已同意向美国证券交易委员会(SEC)提交一份登记声明,登记在证券购买协议结束后普通股的转售情况。。
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction..
本新闻稿不构成出售或招揽购买这些证券的要约,也不构成在根据任何该等司法管辖区的证券法注册或取得资格之前,在任何州或其他司法管辖区出售这些证券是非法的。。
About Ivonescimab
Ivonescimab
Ivonescimab, known as SMT112 in Summit’s license territories, the United States, Canada, Europe, Japan, Latin America, including Mexico and all countries in Central America, South America, and the Caribbean, the Middle East, and Africa, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule.
Ivonescimab在Summit的许可区域,美国,加拿大,欧洲,日本,拉丁美洲(包括墨西哥和中美洲,南美洲,加勒比,中东和非洲的所有国家)被称为SMT112,在中国和澳大利亚被称为AK112,是一种新型的,潜在的一流研究性双特异性抗体,它将通过阻断PD-1的免疫疗法的作用与阻断VEGF相关的抗血管生成作用结合成一个分子。
Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF..
当同时存在PD-1和VEGF时,Ivonescimab以多倍的更高亲和力显示出与每个预期靶标的独特协同结合。。
This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro (Zhong, et al, SITC, 2023).
这可以区分ivonescimab,因为与体内正常组织相比,肿瘤组织和肿瘤微环境(TME)中PD-1和VEGF的表达(存在)可能更高。Ivonescimab的四价结构(四个结合位点)使TME具有更高的亲和力(多重结合相互作用的累积强度),在体外VEGF存在下对PD-1的结合亲和力增加了18倍以上,并且在体外PD-1存在下对VEGF的结合亲和力增加了4倍以上(Zhong等,SITC,2023)。
This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days (Zhong, et al, SITC, 2023), is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets..
这种四价结构,分子的有意新颖设计,以及将这两个靶标引入具有协同结合特性的单一双特异性抗体中,有可能将ivonescimab导向肿瘤组织而不是健康组织。。。
Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 1,800 patients have been treated with ivonescimab in clinical studies globally.
Ivonescimab由Akeso Inc.(香港交易所代码:9926.HK)设计,目前正在进行多个III期临床试验。在全球临床研究中,已有1800多名患者接受了ivonescimab治疗。
Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multi-regional Phase III clinical trials, HARMONi and HARMONi-3, with a plan to initiate HARMONi-7 in early 2025.
Summit已开始在非小细胞肺癌(NSCLC)中开发ivonescimab的临床开发,并于2023年开始参加两项多区域III期临床试验HARMONi和HARMONi-3,计划于2025年初启动HARMONi-7。
HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib)..
HARMONi是一项III期临床试验,旨在评估ivonescimab联合化疗与安慰剂加化疗相比,对EGFR突变,局部晚期或转移性非鳞状非小细胞肺癌患者进行治疗后,用第三代EGFR TKI(例如osimertinib)治疗进展。。
HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic squamous NSCLC.
HARMONi-3是一项III期临床试验,旨在评估ivonescimab联合化疗与pembrolizumab联合化疗治疗一线转移性鳞状NSCLC患者的疗效。
HARMONi-7 is a planned Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 TPS > 50%).
HARMONi-7是一项计划进行的III期临床试验,旨在评估与pembrolizumab单药治疗相比,ivonescimab单药治疗具有高PD-L1表达(PD-L1 TPS>50%)的一线转移性NSCLC患者。
In addition, Akeso has recently had positive read-outs in two single-region (China), randomized Phase III clinical trials for ivonescimab in NSCLC, HARMONi-A and HARMONi-2.
此外,Akeso最近在两个单区域(中国)的非小细胞肺癌,HARMONi-A和HARMONi-2的ivonescimab随机III期临床试验中获得了积极的结果。
HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.
。
HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression (PD-L1 TPS >1%).
HARMONi-2是一项III期临床试验,评估局部晚期或转移性非小细胞肺癌患者PD-L1表达阳性(PD-L1 TPS>1%)的单药治疗依伐昔单抗对单药治疗pembrolizumab的影响。
Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024.
Ivonescimab是一种研究性疗法,未经Summit许可区域(包括美国和欧洲)的任何监管机构批准。Ivonescimab于2024年5月被批准在中国上市。
About Summit Therapeutics
关于Summit Therapeutics
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs..
Summit Therapeutics Inc.是一家生物制药肿瘤公司,专注于患者,医生,护理人员和社会友好药物疗法的发现,开发和商业化,旨在改善生活质量,延长潜在寿命,并解决严重未满足的医疗需求。。
Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol 'SMMT'). We are headquartered in Miami, Florida, and we have additional offices in Menlo Park, California, and Oxford, UK.
Summit成立于2003年,我们的股票在纳斯达克全球市场(代号“SMMT”)上市。我们的总部位于佛罗里达州的迈阿密,在加利福尼亚州的门洛帕克和英国的牛津都设有办事处。
For more information, please visit https://www.smmttx.com and follow us on X @SMMT_TX.
有关更多信息,请访问https://www.smmttx.com并在X@SMMT\U TX上关注我们。
Summit Forward-looking Statements
峰会前瞻性声明
Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc., the intended use of the net proceeds from the private placements, the Company's anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected proceeds and uses thereof, and other statements containing the words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'would,' and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.
本新闻稿中关于公司未来预期、计划和前景的任何声明,包括但不限于关于公司候选产品的临床和临床前开发、与Akeso Inc.合作的进入和行动、私募净收益的预期用途、公司的预期支出和现金跑道、公司候选产品的治疗潜力、公司候选产品的潜在商业化、临床试验数据的启动、完成和可用性的时间、潜在的上市批准申请提交、潜在的收购、先前在市场股权发售计划(“ATM计划”)中披露的声明、预期收益及其用途的声明以及其他包含“预期”,“相信”,“继续”,“可能”,“估计”,“预期”,“打算”,“可能”,“计划”,“潜力,“预测”、“项目”、“应该”、“目标”、“将会”和类似表述构成了1995年《私人证券诉讼改革法案》含义内的前瞻性陈述。
Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent i.
由于各种重要因素,包括公司在ATM计划下出售普通股的能力、影响资本市场的条件、一般经济、行业或政治条件,包括我们对与ivonescimab开发和商业化活动有关的基础数据的评估结果、与监管机构(包括食品和药物管理局)的讨论结果、固有的不确定性,实际结果可能与此类前瞻性声明所示的结果存在重大差异。
Summit Therapeutics and the Summit Therapeutics logo are trademarks of Summit Therapeutics Inc. Copyright 2024, Summit Therapeutics Inc. All Rights Reserved.
Summit Therapeutics和Summit Therapeutics徽标是Summit Therapeutics Inc.的商标。版权所有2024,Summit Therapeutics Inc.保留所有权利。