T2 Biosystems Stock Price, News & Analysis

T2 Biosystems (NASDAQ: TTOO) highlighted a recent article in The Lancet titled 'Changing the Culture of Blood Culture'. The article discusses the limitations of traditional blood culture methods and the potential of rapid, culture-independent diagnostics to improve health outcomes and strengthen global response to infectious diseases.

Key points from the article include:

• Weaknesses of blood culture, such as poor sensitivity and time-consuming process
• Ideal characteristics of culture-independent diagnostics, including rapid results and accuracy
• The need for changes in reimbursement practices and funding for new diagnostic technologies
• The importance of integrating rapid diagnostics into antimicrobial-stewardship programs

T2 Biosystems, as the only provider of FDA-cleared direct-from-blood diagnostics for rapid pathogen detection, aligns with the article's emphasis on advancing diagnostic technologies in infectious disease management.

T2 Biosystems (NASDAQ:TTOO) has successfully defended a key patent for its direct-from-whole blood detection method in the European Union. The opposition, filed in May 2023 by bioMerieux and an undisclosed party, challenged T2 Biosystems' European Patent No. 3 443 124. This patent is important to the company's intellectual property portfolio for detecting pathogens directly from whole blood samples.

The European Patent Office's Opposition Division held a public hearing on September 19, 2024, ruling in favor of T2 Biosystems. This decision maintains the company's strong IP position in pathogen detection technology. John Sperzel, Chairman and CEO, expressed confidence in the broad scope of their IP portfolio and stated their intention to continue defending against future challenges while advancing their technology, commercial platform, and product pipeline.

T2 Biosystems (NASDAQ:TTOO) has received FDA clearance to market its T2Candida® Panel for pediatric patients, expanding its market to over 200 children's hospitals in the U.S. The T2Candida Panel is the only FDA-cleared diagnostic test that can detect sepsis-causing Candida species directly from blood in 3-5 hours, without waiting for blood culture results. It detects five Candida species that account for up to 95% of all Candida bloodstream infections in the U.S.

Studies show that the T2Candida Panel detects Candida species significantly faster and with greater sensitivity than blood culture-based diagnostics. A study at Bambino Gesù hospital found that the panel provided results 121.8 hours faster than blood culture and detected additional infections missed by traditional methods. This clearance allows T2 Biosystems to improve outcomes and reduce costs for pediatric patients through faster targeted antifungal treatment.

T2 Biosystems (NASDAQ:TTOO) has provided updates on its new product development pipeline, focusing on direct-from-blood diagnostic tests for antimicrobial resistance, pediatric Candida infections, Lyme disease, and Candida auris. Key highlights include:

1. Finalizing a 510(k) application for the T2Resistance® Panel, planned for Q4 2024 FDA submission.
2. Pending FDA clearance for expanded use of the T2Candida® Panel for pediatric Candida infections.
3. Plans to submit a 510(k) for expanded use of the T2Bacteria® Panel for pediatric bacterial infections.
4. Decision to build or buy a laboratory for launching the T2Lyme™ Panel as a Laboratory Developed Test.
5. Pursuing non-dilutive funding for a Candida auris diagnostic test.

The company expects to launch multiple new products in 2024 and 2025, with three pipeline products having received FDA Breakthrough Device designation.

T2 Biosystems (NASDAQ:TTOO), a leader in rapid sepsis detection, announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The company's management will host one-on-one meetings on September 11, 2024. Investors can access a virtual presentation on-demand through T2 Biosystems' website starting September 9, 2024, at 7:00 am ET.

This conference participation highlights T2 Biosystems' commitment to engaging with investors and showcasing its innovative technology in sepsis detection. The company's presence at this global investment event could potentially impact its stock performance and investor relations.

T2 Biosystems (NASDAQ:TTOO), a leader in rapid sepsis pathogen and antibiotic resistance gene detection, has announced its participation in two upcoming investor conferences in August 2024:

• The Canaccord Genuity Annual Growth Conference in Boston, MA, where management will host a fireside chat on August 14, 2024, at 10:30am ET.
• The Sidoti Micro-Cap Conference, with virtual participation and a management presentation scheduled for August 15, 2024, at 1:00pm ET.

Interested parties can access live and recorded webcasts of these presentations on the "Investors" section of T2 Biosystems' website at www.t2biosystems.com.

T2 Biosystems (NASDAQ:TTOO) announced its Q2 2024 financial results, highlighting record quarterly and first half sepsis test revenue, with 27% and 25% growth respectively compared to the prior year. The company achieved total revenue of $2.0 million, all from sepsis product sales. T2 Biosystems executed contracts for 2 T2Dx® Instruments outside the U.S. and signed multiple international distribution agreements. The company also strengthened its balance sheet by converting $30.0 million of term loan debt and raised $8.0 million through a private placement stock sale.

Key pipeline developments include completing clinical studies for the T2Lyme Panel, submitting a 510(k) for pediatric testing with the T2Candida® Panel, and advancing the T2Resistance Panel toward FDA submission. The company reiterated its 2024 financial outlook, expecting full year sepsis product revenue of $10.0 million to $11.0 million, representing 49% to 64% growth compared to 2023.

T2 Biosystems (NASDAQ:TTOO) has announced a territory exclusive distribution agreement for Malaysia and Indonesia, expanding its international commercial presence. This agreement allows T2 Biosystems to sell its T2Dx® Instrument and related test panels through the newly appointed distributor. The expansion follows recent entry into Hong Kong and Macau, marking four new territories in Asia Pacific in the past month.

The move aims to address the critical issue of sepsis in these regions, where studies have shown high mortality rates in intensive care units. T2 Biosystems' technology enables rapid detection of sepsis-causing pathogens and antibiotic resistance genes in hours, potentially improving patient care and enabling faster targeted therapy.

T2 Biosystems (NASDAQ:TTOO), a leader in rapid sepsis pathogen and antibiotic resistance gene detection, has announced its second quarter 2024 financial results and business updates will be reported on July 29, 2024, after market close. The company will host a conference call at 4:30 p.m. Eastern Time on the same day.

Investors can access the call by dialing 1-888-506-0062 (US/Canada) or 1-973-528-0011 (International) with passcode 109834. A live and archived webcast will also be available on the company's website in the Investors section under Events & Presentations.