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T2 Biosystems Unveils T2Lyme Launch Plans and Provides Additional Business Updates

T2 Biosystems Unveils T2Lyme Launch Plans and Provides Additional Business Updates

T2 Biosystems公佈了T2Lyme的發佈計劃並提供了更多業務更新
T2 Biosystems ·  03/20 00:00
Anticipates commercial launch of the T2Lyme Panel in the third quarter of 2024
預計T2Lyme面板將於2024年第三季度商業推出

LEXINGTON, Mass., March 20, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) (the "Company"), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced plans for the T2Lyme Panel commercial launch and provided recent business updates.

馬薩諸塞州列剋星敦,2024年3月20日(GLOBE NEWSWIRE)——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T2 Biosystems, Inc.(納斯達克股票代碼:TTOO)(“公司”)今天宣佈了T2Lyme Panel商業發佈的計劃,並提供了最新的業務最新情況。

Recent Highlights

近期亮點

  • Announced plans to commercialize the T2Lyme Panel in the third quarter of 2024 as a laboratory developed test (LDT) without the need to be run on the T2Dx Instrument providing throughput improvements and cost of goods advantages. The Company is currently in discussions with potential LDT partners and plans to provide early Lyme disease results to U.S. reference laboratories nationwide.
  • Announced a new publication in Journal of Clinical Microbiology highlighting the clinical benefits and performance of the T2Resistance Panel, including demonstrating high accuracy, faster detection times, and the positive impact of faster test results on clinical interventions.
  • Engaged Dr. Robin Robinson as a strategic advisor to aid in commercialization of the T2Biothreat Panel. Dr. Robinson is the former Director of the Biomedical Advanced Research and Development Authority (BARDA) and former Deputy Assistant Secretary for Preparedness and Response (ASPR).
  • Received extension from the Nasdaq Hearings Panel to regain compliance with $35 million Market Value of Listed Securities requirement as set forth in Nasdaq Listing Rule 5550(b)(2) on or before May 20, 2024.
  • 宣佈計劃在2024年第三季度將T2Lyme面板作爲實驗室開發的測試(LDT)商業化,無需在T2Dx上運行 可提高吞吐量和提高商品成本優勢的儀器。該公司目前正在與潛在的LDT合作伙伴進行討論,並計劃向全國範圍內的美國參考實驗室提供萊姆病的早期結果。
  • 宣佈了新出版物 的雜誌 臨床微生物學 重點介紹T2Resistance Panel的臨床益處和性能,包括證明高準確性、更快的檢測時間以及更快的測試結果對臨床干預措施的積極影響。
  • 聘請羅賓遜博士擔任戰略顧問,以協助T2Biothreat小組的商業化。羅賓遜博士是生物醫學高級研究與發展局(BARDA)的前任董事和前負責備災和反應的副助理部長(ASPR)。
  • 在2024年5月20日當天或之前,獲得納斯達克聽證小組的延期,以恢復遵守納斯達克上市規則5550(b)(2)中規定的3500萬美元上市證券市值要求。

"Recently, we have made significant progress on our three corporate priorities that we believe positions us for a strong future. Specifically, the anticipated launch of the T2Lyme Panel in the third quarter, new data validating the clinical benefits of the T2Resistance Panel and increasing commercial support and U.S. Government engagement on the T2Biothreat Panel each represent potential material growth catalysts," stated John Sperzel, Chairman and CEO of T2 Biosystems. "We continue to prioritize our Nasdaq listing and advance the review of strategic alternatives which are both intended to increase shareholder value."

“最近,我們在三項公司優先事項上取得了重大進展,我們認爲這爲我們走向美好的未來奠定了基礎。具體而言,預計將在第三季度推出T2Lyme小組、證實T2Resistance小組臨床益處的新數據、不斷增加的商業支持以及美國政府對T2Biothreat小組的參與都代表了潛在的材料增長催化劑,” T2 Biosystems董事長兼首席執行官約翰·斯珀澤爾表示。“我們將繼續優先考慮在納斯達克上市,並推進對戰略替代方案的審查,這兩者都旨在增加股東價值。”

Reiterated 2024 Financial Outlook
The Company continues to expect full year 2024 total sepsis and related product revenue of $10.0 million to $11.0 million, representing growth of 49% to 64%, compared to $6.7 million in 2023. The Company's 2024 revenue guidance consists entirely of sepsis and related product revenue and does not include potential sales of the T2Lyme Panel or the T2Biothreat Panel.

重申2024年財務展望
該公司繼續預計,2024年全年敗血症和相關產品總收入爲1,000萬至1,100萬美元,增長49%至64%,而2023年爲670萬美元。該公司2024年的收入指引完全由敗血症和相關產品收入組成,不包括T2Lyme面板或T2Biothreat小組的潛在銷售。

Webcast and Conference Call Information
The Company's management team will host a conference call today, March 20, 2024, beginning at 8:30 am ET. Investors interested in listening to the call may do so by dialing 888-506-0062 for domestic callers or 973-528-0011 for International callers and using conference ID 688651 approximately five minutes prior to the start time. A live and recorded webcast of the call will be available on the "Investors" section of the Company's website at www.t2biosystems.com.

網絡直播和電話會議信息
公司的管理團隊將於今天,即2024年3月20日,美國東部時間上午8點30分開始舉行電話會議。有興趣收聽電話會議的投資者可以在開始前大約五分鐘撥打888-506-0062或撥打973-528-0011(國際來電者撥打973-528-0011),並使用會議編號688651。電話會議的網絡直播和錄製的網絡直播將在公司網站的 “投資者” 欄目上播出 www.t2biosystems.com

About T2 Biosystems
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. For more information, please visit www.t2biosystems.com.

關於 T2 生物系統
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,T2Bertia 小組,T2Candida 面板,T2Restance 面板和 T2Biothreat Panel,由專有的 T2 磁共振 (T2MR) 提供動力) 技術。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。欲了解更多信息,請訪問 www.t2biosystems.com

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 regarding the likelihood that the T2Lyme Panel will be launched in the third quarter of 2024, the ability of the Company to provide T2Lyme results to U.S. reference laboratories nationwide, the likelihood that the growing dataset for T2Resistance will be a catalyst for increased adoption in countries where the T2Resistance Panel is currently available for purchase, and the likelihood that increasing commercial support and U.S. Government engagement represents a material future growth catalyst, 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, 2022, filed with the U.S. Securities and Exchange Commission, or SEC, on March 31, 2023, 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T2Lyme小組可能於2024年第三季度啓動、公司向美國全國參考實驗室提供T2Lyme結果的能力、不斷增長的T2Resistance數據集可能成爲目前可使用T2Resistance面板的國家越來越多采用的催化劑的陳述購買,以及增加商業支持和美國政府參與可能是未來的實質性增長催化劑,以及包含 “期望”、“可能”、“應該”、“預期” 等詞語以及具有未來或前瞻性質的類似陳述的陳述。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2023年3月31日向美國證券交易委員會(SEC)提交的截至2022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隨着時間的推移保持沉默意味着實際事件如此類前瞻性陳述中所明示或暗示的那樣得到證實。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

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Source: T2 Biosystems, Inc.

來源:T2 Biosystems, Inc.

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