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MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that the Company received and accepted an unsolicited offer from an institutional investor to purchase 22,222,222 shares of the Company’s common stock at $9.00 per share, a premium to the closing price on Friday, May, 31, 2024, for aggregate gross proceeds to the Company of approximately $200.0 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,该公司收到并接受了机构投资者的主动要约,以每股9.00美元的价格收购2222222股该公司的普通股,这是对2024年5月31日星期五收盘价的溢价,该公司的总收益约为2亿美元。。
Summit intends to use the net proceeds to advance the clinical development of ivonescimab, and for working capital and general corporate purposes.
Summit打算将净收益用于推进ivonescimab的临床开发,并用于营运资本和一般企业目的。
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 and shares of common stock issuable within 60 days of 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60天内转售普通股和可发行普通股的股份。。
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。。
Expansion of Ivonescimab License Territories
扩大Ivonescimab许可区域
In addition, Summit announced an expansion of its license territories for ivonescimab via an amendment of the collaboration and in-license agreement with Akeso, Inc. (Akeso, HKEX Code: 9926.HK). Under the terms of the expanded agreement, Summit’s license territories for ivonescimab will include Latin America, including Mexico and all countries in Central America and South America, in addition to the Middle East and Africa.
此外,Summit宣布通过修订与Akeso,Inc.(Akeso,HKEX代码:9926.HK)的合作和许可协议,扩大其ivonescimab的许可区域。根据扩大协议的条款,Summit对ivonescimab的许可区域将包括拉丁美洲,包括墨西哥和中美洲和南美洲的所有国家,以及中东和非洲。
This expansion adds to the territory licensed by Summit, which previously included the United States, Canada, Japan, and Europe..
这一扩张增加了Summit许可的领土,之前包括美国、加拿大、日本和欧洲。。
“Both parties are strengthening their bond with the intent to bring ivonescimab to as many patients as possible around the world who can potentially benefit from this novel anti-cancer therapy,” stated Dr. Maky Zanganeh, Chief Executive Officer and President of Summit. “Therefore, we are thrilled to be expanding our collaboration agreement with Akeso; we are incredibly proud of our growing partnership as our shared mission and vision can help rapidly progress the development of ivonescimab.”.
Summit首席执行官兼总裁Maky Zanganeh博士表示:“双方正在加强联系,旨在将ivonescimab带给世界各地尽可能多的患者,这些患者可能会从这种新型抗癌疗法中受益。”。“因此,我们很高兴能够扩大与Akeso的合作协议;我们对不断增长的合作伙伴关系感到无比自豪,因为我们共同的使命和愿景可以帮助快速推进ivonescimab的发展。”。
In exchange for these rights, the total deal value is worth up to $70 million. Consistent with the original governing collaboration agreement are the remaining provisions, including royalty payments, manufacturing provisions, and other business terms. The amendment also strengthens the partnership for both parties by increasing the mutual data sharing benefits for all trials involving ivonescimab worldwide, which may help facilitate clinical development and regulatory approval processes in various regions..
作为这些权利的交换,这笔交易的总价值高达7000万美元。与原始管辖合作协议一致的是其余条款,包括特许权使用费、制造条款和其他商业条款。该修正案还通过增加全球所有涉及ivonescimab的试验的相互数据共享利益,加强了双方的合作伙伴关系,这可能有助于促进各个地区的临床开发和监管审批流程。。
Conference Call
电话会议
Summit Therapeutics Inc. will host a conference call to discuss recent updates related to ivonescimab, including data released at ASCO, on Monday June 3, 2024, before the market opens.
Summit Therapeutics Inc.将于2024年6月3日(周一)在市场开放前召开电话会议,讨论与ivonescimab相关的最新更新,包括ASCO发布的数据。
Summit will host a live webcast of the conference call at 8:00am ET, which will be accessible through our website www.smmttx.com, and can also be accessed via the following link: https://events.q4inc.com/attendee/130822402.
Summit将于美国东部时间上午8:00主持电话会议的在线直播,可通过我们的网站www.smmttx.com访问,也可通过以下链接访问:https://events.q4inc.com/attendee/130822402.
The dial-in information for US attendees is toll-free at (800) 715-9871. Additionally, all attendees may access through the toll number, (646) 307-1963. The Conference ID is 4259251.
美国与会者的拨入信息可拨打(800)715-9871免费电话。此外,所有与会者都可以通过收费电话号码(646)307-1963访问。会议ID为4259251。
An archived edition of the webcast will be available on our website later in the day on Monday.
周一晚些时候,我们的网站将提供网络广播的存档版本。
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,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单一分子。
Ivonescimab displays unique cooperative binding to each of its intended targets with higher affinity when in the presence of both PD-1 and VEGF..
当存在PD-1和VEGF时,Ivonescimab以更高的亲和力显示出与其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 tumor microenvironment 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)能够在肿瘤微环境中实现更高的亲和力(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,1 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。该设计的目的是,除了与这些目标相关的副作用和安全性概况外,还有6至7天的半衰期1,以改善先前确定的疗效阈值。。
Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 1,600 patients have been treated with ivonescimab in clinical studies globally. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two Phase III clinical trials, HARMONi and HARMONi-3..
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1600多名患者接受了ivonescimab治疗。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III期临床试验HARMONi和HARMONi-3。。
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。
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 @summitplc.
有关更多信息,请访问https://www.smmttx.com并在X@summitplc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., including the expected benefits of the amendment to the collaboration and license agreement, the expected timing of the closing of the private placement of the Company’s shares of common stock, the intended use of the net proceeds from the private placement, 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 use 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.合作的进入和行动的声明,包括合作和许可协议修订的预期收益、公司普通股私募关闭的预期时间、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,以及可能提交营销批准申请、潜在收购、,关于先前在市场股权发行计划(“ATM计划”)中披露的声明、预期用途收益及其用途,以及包含“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”等字样的其他声明,构成1995年《私人证券诉讼改革法》含义内的前瞻性声明。
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 wi.
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wi相关基础数据的评估结果,实际结果可能与此类前瞻性声明所示结果存在重大差异。