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T2 Biosystems Announces Letter of Intent to Enter Strategic Partnership for Lyme Disease

T2 Biosystems Announces Letter of Intent to Enter Strategic Partnership for Lyme Disease

T2 Biosystems宣布签订莱姆病战略合作伙伴关系的意向书
T2 Biosystems ·  05/07 00:00
Advances plan to launch T2Lyme Panel for detection of early Lyme disease
Advances计划启动用于检测早期莱姆病的T2Lyme小组

Filed Pursuant to Rule 433
Issuer Free Writing Prospectus dated May 6, 2024
Relating to Preliminary Prospectus dated May 6, 2024
Registration No. 333-278866

根据第 433 条提交
2024 年 5 月 6 日的发行人免费写作招股说明书
与 2024 年 5 月 6 日的初步招股说明书有关
注册号 333-278866

LEXINGTON, Mass., May 07, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has signed a non-binding letter of intent ("LOI") to enter into a strategic partnership with ECO Laboratory, a Massachusetts-based clinical laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA).

马萨诸塞州列克星敦,2024年5月7日(GLOBE NEWSWIRE)——快速检测败血症致病原体和抗生素耐药基因领域的领导者T2 Biosystems, Inc.(纳斯达克股票代码:TTOO)今天宣布,它已签署一份不具约束力的意向书(“LOI”),与总部位于马萨诸塞州的获得临床实验室改进修正案(CLIA)认证的临床实验室ECO实验室建立战略合作伙伴关系)。

ECO Laboratory was founded by Karen Weeks, who has been at the forefront of Lyme disease research and testing for decades. She is co-author of extensive publications pertaining to tick-borne diseases, including The New England Journal of Medicine and The Journal of Infectious Diseases. While supervising the Virology Department at the Massachusetts Department of Public Health, and working directly with Allen Steere, MD at Tufts University Medical Center, Ms. Weeks developed the Lyme Antibody Capture Immunoassay, which remains one of the most sensitive serology tests available for Lyme disease. In 1990, Ms. Weeks co-founded IMUGEN, Inc., the premier laboratory for the diagnosis of Lyme disease and many other tick-borne diseases, which was acquired by Oxford Immunotec in 2016.

ECO 实验室由凯伦·威克斯创立,她几十年来一直站在莱姆病研究和测试的最前沿。她是有关蜱传疾病的大量出版物的合著者,包括《新英格兰医学杂志》和《传染病杂志》。在监督马萨诸塞州公共卫生部病毒学系并直接与塔夫茨大学医学中心医学博士艾伦·斯蒂尔合作期间,Weeks女士开发了莱姆抗体捕获免疫测定,它仍然是目前可用于莱姆病的最敏感的血清学测试之一。1990年,Weeks女士与他人共同创立了IMUGEN, Inc.,这是诊断莱姆病和许多其他蜱传疾病的首要实验室,于2016年被牛津免疫技术公司收购。

"We look forward to entering into a strategic partnership with ECO Laboratory and its founder Karen Weeks, who has significant experience and expertise in the Lyme diagnostic market," stated John Sperzel, Chairman and CEO of T2 Biosystems. "Together, we plan to launch the T2Lyme Panel as a Laboratory Developed Test (LDT), for the detection or early Lyme disease, and build the premier Lyme testing laboratory in the United States."

T2 Biosystems董事长兼首席执行官约翰·斯珀泽尔表示:“我们期待与ECO Laboratory及其创始人凯伦·威克斯建立战略合作伙伴关系,他们在莱姆诊断市场拥有丰富的经验和专业知识。”“我们计划共同推出T2Lyme Panel作为实验室开发测试(LDT),用于检测早期莱姆病,并在美国建造首屈一指的莱姆测试实验室。”

The T2Lyme Panel is a direct-from-blood molecular diagnostic test designed for the early detection of Borrelia burgdorferi, the bacterium that causes Lyme disease in the United States. Lyme disease is the leading vector-borne disease in America, with an estimated 3.4 million tests performed each year.

T2Lyme Panel 是一项直接来自血液的分子诊断测试,专为早期发现 Borrelia burgdorferi,在美国引起莱姆病的细菌。莱姆病是美国主要的病媒传播疾病,估计每年进行340万次检测。

The current diagnostic process is a two-tiered antibody test algorithm that relies on the presence of antibodies and can only be used accurately four to eight weeks after infection. If left untreated, the bacteria may spread throughout the body and become much harder to eradicate and treat effectively. Although early symptoms of Lyme disease are similar to the flu, Borrelia burgdorferi infections can lead to chronic, debilitating disease. To address this critical unmet need, we have developed a highly sensitive diagnostic test for the detection of early Lyme disease, with an analytical sensitivity that is in line with our FDA-cleared sepsis tests. We believe our test will detect Lyme disease within the first 30 days after infection, compared to antibody tests that can take 30-60 days after infection. We are finalizing internal validation and verification, and we expect to be in position for a product launch during the third quarter of 2024.

目前的诊断过程是一种两级抗体测试算法,它依赖于抗体的存在,只能在感染后四到八周内准确使用。如果不进行治疗,细菌可能会扩散到全身,变得更加难以根除和有效治疗。尽管莱姆病的早期症状与流感相似, Borrelia burgdorferi 感染可导致慢性、使人衰弱的疾病。为了解决这一未得到满足的关键需求,我们开发了一种用于检测早期莱姆病的高灵敏度诊断测试,其分析灵敏度与美国食品药品管理局批准的败血症测试一致。我们相信,我们的测试将在感染后的前30天内检测出莱姆病,而抗体测试可能在感染后30-60天内检测出来。我们正在完成内部验证和验证,预计将在2024年第三季度推出产品。

The Company expects to announce details regarding the strategic partnership with ECO Laborator when the definitive agreement has been executed.

该公司预计将在最终协议执行后公布有关与ECO Laborator战略合作伙伴关系的细节。

About T2 Biosystems

关于 T2 生物系统

T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems' products include the T2Dx Instrument, the T2Bacteria Panel, the T2Candida Panel, the T2Resistance Panel, and the T2Biothreat Panel, and are powered by the proprietary T2 Magnetic Resonance (T2MR) technology. T2 Biosystems has an active pipeline of future products, including the U.S. T2Resistance Panel, the Candida auris test, and the T2Lyme Panel.

T2 Biosystems是快速检测诱发败血症的病原体和抗生素耐药基因领域的领导者,致力于通过帮助临床医生比以往任何时候都更快地有效治疗患者来改善患者护理和降低护理成本。T2 Biosystems的产品包括T2Dx仪器、T2Baceria Panel、T2Candida Panel、T2Resistance Panel和T2Biothreat Panel,由专有的T2磁共振(T2MR)技术提供支持。T2 Biosystems拥有一系列活跃的未来产品,包括美国T2抗药小组、耳念珠菌测试和T2Lyme试剂盒。

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements about the Company's ability to regain compliance with the listing requirements of the Nasdaq Capital market, as well as statements that include the words "expect," "may," "should," "anticipate," and similar statements of a future or forward-looking nature. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials; (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes; (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission, or SEC, on April 1, 2024, and other filings the Company makes with the SEC from time to time, including our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company's silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

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本新闻稿包含1995年《私人证券诉讼改革法》所指的前瞻性陈述。本新闻稿中包含的所有与历史事实无关的陈述均应被视为前瞻性陈述,包括但不限于关于公司恢复遵守纳斯达克资本市场上市要求的能力的陈述,以及包含 “期望”、“可能”、“应该”、“预期” 等字样的陈述以及具有未来或前瞻性质的类似陈述。这些前瞻性陈述基于管理层当前的预期。这些陈述既不是承诺也不是保证,但涉及已知和未知的风险、不确定性和其他重要因素,这些因素可能导致实际结果、业绩或成就与前瞻性陈述所表达或暗示的任何未来业绩、业绩或成就存在重大差异,包括但不限于:(i) 无法 (a) 实现承诺、合同或产品的预期收益;(b) 成功执行战略优先事项;(c) 将产品推向市场;(d) 扩大产品的使用或采用率;(e) 获取客户证言;(f)准确预测增长假设;(g)实现预期收入;(h)产生预期的运营支出水平;或(i)增加客户设施的高风险患者人数;(ii)早期数据无法预测最终结果;(iii)未能在预期的时间范围内或根本没有提交或获得预期的FDA申请或许可;或(iv)第1A项下讨论的因素。公司于2024年4月1日向美国证券交易委员会(SEC)提交的截至2023年12月31日年度的10-K表年度报告中的 “风险因素”,以及公司不时向美国证券交易委员会提交的其他文件,包括我们的10-Q表季度报告和8-K表最新报告。这些和其他重要因素可能导致实际业绩与本新闻稿中前瞻性陈述所示的结果存在重大差异。任何此类前瞻性陈述均代表管理层截至本新闻稿发布之日的估计。尽管除非法律要求,否则公司可能会选择在未来的某个时候更新此类前瞻性陈述,但它不承担任何更新此类前瞻性陈述的义务,即使随后发生的事件导致其观点发生变化。因此,任何人都不应假设公司在一段时间内的沉默意味着实际事件是按照此类前瞻性陈述中明示或暗示的方式发生的。不应将这些前瞻性陈述视为本新闻稿发布之日后任何日期的公司观点。

Investor Contact:
Philip Trip Taylor, Gilmartin Group
ir@T2Biosystems.com
415-937-5406

投资者联系人:
菲利普·特里普泰勒,吉尔马丁集团
ir@T2Biosystems.com
415-937-5406

T2 Biosystems, Inc. has filed a registration statement for a Form S-1 (including a preliminary prospectus) with the Securities and Exchange Commission, or the SEC, for the public offering. Before you invest, you should read the Preliminary Prospectus and the other documents T2 Biosystems, Inc. has filed with the SEC for more complete information about T2 Biosystems, Inc. and the public offering. You may get these documents for free by visiting EDGAR on the SEC web site at www.sec.gov. Alternatively, T2 BioSystems, Inc., A.G.P. or any dealer participating in the public offering will arrange to send you the Preliminary Prospectus if you request it by contacting A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060.

T2 Biosystems, Inc.已向美国证券交易委员会(SEC)提交了公开发行S-1表格(包括初步招股说明书)的注册声明。在投资之前,您应该阅读初步招股说明书和T2 Biosystems, Inc.向美国证券交易委员会提交的其他文件,以获取有关T2 Biosystems, Inc.和公开募股的更多完整信息。您可以通过访问美国证券交易委员会网站上的EDGAR免费获得这些文件 www.sec.gov。或者,如果您通过联系纽约州纽约麦迪逊大道590号28楼的A.G.P./Alliance Global Partners或致电(212)624-2060索取初步招股说明书,T2 BioSystems, Inc.、A.G.P. 或任何参与公开募股的交易商将安排向您发送初步招股说明书。

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Source: T2 Biosystems, Inc.

来源:T2 Biosystems, Inc.

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