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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宣佈簽訂萊姆病戰略合作伙伴關係的意向書
T2 Biosystems ·  05/07 00:00
Advances plan to launch T2Lyme Panel for detection of early Lyme disease
Advances計劃啓動用於檢測早期萊姆病的T2Lyme小組

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

根據第 433 條提交
2024 年 5 月 6 日的發行人免費寫作招股說明書
與 2024 年 5 月 6 日的初步招股說明書有關
註冊號 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).

馬薩諸塞州列剋星敦,2024年5月7日(GLOBE NEWSWIRE)——快速檢測敗血症致病原體和抗生素耐藥基因領域的領導者T2 Biosystems, Inc.(納斯達克股票代碼:TTOO)今天宣佈,它已簽署一份不具約束力的意向書(“LOI”),與總部位於馬薩諸塞州的獲得臨床實驗室改進修正案(CLIA)認證的臨床實驗室ECO實驗室建立戰略合作伙伴關係)。

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 實驗室由凱倫·威克斯創立,她幾十年來一直站在萊姆病研究和測試的最前沿。她是有關蜱傳疾病的大量出版物的合著者,包括《新英格蘭醫學雜誌》和《傳染病雜誌》。在監督馬薩諸塞州公共衛生部病毒學系並直接與塔夫茨大學醫學中心醫學博士艾倫·斯蒂爾合作期間,Weeks女士開發了萊姆抗體捕獲免疫測定,它仍然是目前可用於萊姆病的最敏感的血清學測試之一。1990年,Weeks女士與他人共同創立了IMUGEN, Inc.,這是診斷萊姆病和許多其他蜱傳疾病的首要實驗室,於2016年被牛津免疫技術公司收購。

"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董事長兼首席執行官約翰·斯珀澤爾表示:“我們期待與ECO Laboratory及其創始人凱倫·威克斯建立戰略合作伙伴關係,他們在萊姆診斷市場擁有豐富的經驗和專業知識。”“我們計劃共同推出T2Lyme Panel作爲實驗室開發測試(LDT),用於檢測早期萊姆病,並在美國建造首屈一指的萊姆測試實驗室。”

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 是一項直接來自血液的分子診斷測試,專爲早期發現 Borrelia burgdorferi,在美國引起萊姆病的細菌。萊姆病是美國主要的病媒傳播疾病,估計每年進行340萬次檢測。

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.

目前的診斷過程是一種兩級抗體測試算法,它依賴於抗體的存在,只能在感染後四到八週內準確使用。如果不進行治療,細菌可能會擴散到全身,變得更加難以根除和有效治療。儘管萊姆病的早期症狀與流感相似, Borrelia burgdorferi 感染可導致慢性、使人衰弱的疾病。爲了解決這一未得到滿足的關鍵需求,我們開發了一種用於檢測早期萊姆病的高靈敏度診斷測試,其分析靈敏度與美國食品藥品管理局批准的敗血症測試一致。我們相信,我們的測試將在感染後的前30天內檢測出萊姆病,而抗體測試可能在感染後30-60天內檢測出來。我們正在完成內部驗證和驗證,預計將在2024年第三季度推出產品。

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

該公司預計將在最終協議執行後公佈有關與ECO Laborator戰略合作伙伴關係的細節。

About T2 Biosystems

關於 T2 生物系統

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是快速檢測誘發敗血症的病原體和抗生素耐藥基因領域的領導者,致力於通過幫助臨床醫生比以往任何時候都更快地有效治療患者來改善患者護理和降低護理成本。T2 Biosystems的產品包括T2Dx儀器、T2Baceria Panel、T2Candida Panel、T2Resistance Panel和T2Biothreat Panel,由專有的T2磁共振(T2MR)技術提供支持。T2 Biosystems擁有一系列活躍的未來產品,包括美國T2抗藥小組、耳念珠菌測試和T2Lyme試劑盒。

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.

前瞻性陳述
本新聞稿包含1995年《私人證券訴訟改革法》所指的前瞻性陳述。本新聞稿中包含的所有與歷史事實無關的陳述均應被視爲前瞻性陳述,包括但不限於關於公司恢復遵守納斯達克資本市場上市要求的能力的陳述,以及包含 “期望”、“可能”、“應該”、“預期” 等字樣的陳述以及具有未來或前瞻性質的類似陳述。這些前瞻性陳述基於管理層當前的預期。這些陳述既不是承諾也不是保證,但涉及已知和未知的風險、不確定性和其他重要因素,這些因素可能導致實際結果、業績或成就與前瞻性陳述所表達或暗示的任何未來業績、業績或成就存在重大差異,包括但不限於:(i) 無法 (a) 實現承諾、合同或產品的預期收益;(b) 成功執行戰略優先事項;(c) 將產品推向市場;(d) 擴大產品的使用或採用率;(e) 獲取客戶證言;(f)準確預測增長假設;(g)實現預期收入;(h)產生預期的運營支出水平;或(i)增加客戶設施的高風險患者人數;(ii)早期數據無法預測最終結果;(iii)未能在預期的時間範圍內或根本沒有提交或獲得預期的FDA申請或許可;或(iv)第1A項下討論的因素。公司於2024年4月1日向美國證券交易委員會(SEC)提交的截至2023年12月31日年度的10-K表年度報告中的 “風險因素”,以及公司不時向美國證券交易委員會提交的其他文件,包括我們的10-Q表季度報告和8-K表最新報告。這些和其他重要因素可能導致實際業績與本新聞稿中前瞻性陳述所示的結果存在重大差異。任何此類前瞻性陳述均代表管理層截至本新聞稿發佈之日的估計。儘管除非法律要求,否則公司可能會選擇在未來的某個時候更新此類前瞻性陳述,但它不承擔任何更新此類前瞻性陳述的義務,即使隨後發生的事件導致其觀點發生變化。因此,任何人都不應假設公司在一段時間內的沉默意味着實際事件是按照此類前瞻性陳述中明示或暗示的方式發生的。不應將這些前瞻性陳述視爲本新聞稿發佈之日後任何日期的公司觀點。

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

投資者聯繫人:
菲利普·特里普泰勒,吉爾馬丁集團
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.已向美國證券交易委員會(SEC)提交了公開發行S-1表格(包括初步招股說明書)的註冊聲明。在投資之前,您應該閱讀初步招股說明書和T2 Biosystems, Inc.向美國證券交易委員會提交的其他文件,以獲取有關T2 Biosystems, Inc.和公開募股的更多完整信息。您可以通過訪問美國證券交易委員會網站上的EDGAR免費獲得這些文件 www.sec.gov。或者,如果您通過聯繫紐約州紐約麥迪遜大道590號28樓的A.G.P./Alliance Global Partners或致電(212)624-2060索取初步招股說明書,T2 BioSystems, Inc.、A.G.P. 或任何參與公開募股的交易商將安排向您發送初步招股說明書。

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Source: T2 Biosystems, Inc.

來源:T2 Biosystems, Inc.

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