T2 Biosystems, Inc - TTOO STOCK NEWS

T2 Biosystems (NASDAQ:TTOO), a company specializing in rapid detection of sepsis-causing pathogens and antibiotic resistance genes, has announced it will release its third quarter 2024 financial results after market close on Thursday, November 14, 2024. The company will host a conference call at 4:30 p.m. Eastern Time to discuss the results and provide business updates. Investors can access the call via webcast at www.t2biosystems.com or by dialing 877-545-0320 (US/Canada) or 973-528-0002 (International) using passcode 903508.

T2 Biosystems, a leader in rapid sepsis pathogen and antibiotic resistance gene detection, has announced a business update call scheduled for October 10, 2024, at 4:30pm ET. The call will provide additional details on recent developments and address select shareholder questions submitted in advance to ir@T2Biosystems.com.

Investors can access the call through:

• A live and archived webcast at www.t2biosystems.com (Investors page, Events & Presentations section)
• Dialing 1-888-506-0062 (US/Canada) or 1-973-528-0011 (International) with passcode 702677

Participants are advised to dial in approximately ten to five minutes before the start time.

T2 Biosystems (NASDAQ: TTOO) and Prxcision have announced a co-marketing collaboration to combat antimicrobial resistance (AMR) and improve sepsis treatment. The partnership aims to combine T2 Biosystems' rapid, direct-from-blood diagnostics with Prxcision's AI-powered pRxcision® platform to provide faster pathogen identification and real-time treatment guidance.

This collaboration is expected to revolutionize sepsis management by enabling clinicians to detect pathogens within hours and make informed treatment decisions quickly. The integrated solution aims to prevent antibiotic misuse, reduce resistance, and potentially save lives by addressing the critical time factor in sepsis treatment, where each hour of delay can increase mortality risk by up to 8%.

The partnership is positioned to drive product adoption and create growth opportunities in the healthcare market by offering hospitals a comprehensive tool to improve patient outcomes and reduce costs associated with AMR and sepsis management.

T2 Biosystems (NASDAQ: TTOO) has entered into a multi-year exclusive U.S. agreement with Cardinal Health (NYSE: CAH) for the distribution of its FDA-cleared direct-from-blood diagnostics for rapid sepsis detection. The agreement covers the T2Dx® Instrument, T2Bacteria® Panel, and T2Candida® Panel. This collaboration is expected to significantly expand T2 Biosystems' access to the U.S. hospital market.

T2 Biosystems' technology can detect sepsis-causing pathogens directly from blood in 3-5 hours, without waiting for blood culture results. The T2Bacteria Panel detects six pathogens responsible for nearly 75% of U.S. bacterial bloodstream infections, while the T2Candida Panel detects five Candida species accounting for up to 95% of U.S. Candida bloodstream infections. Both panels demonstrate high sensitivity and specificity.

T2 Biosystems (NASDAQ: TTOO) announced preliminary unaudited financial results for Q3 2024, reporting a 35% increase in total revenue compared to the prior year period. Key highlights include:

- Total revenue of $2.0 million
- Sepsis test panel revenue of $1.6 million, up 42% year-over-year
- Executed contracts for 11 T2Dx® Instruments
- Expanded international distribution to Malaysia and Indonesia
- Received FDA clearance for T2Candida® Panel for pediatric patients
- Advanced T2Resistance® Panel toward FDA 510(k) submission

The company expects Q4 2024 total sepsis product revenue of $2.5 million to $3.5 million, representing growth of 49% to 109% compared to Q4 2023.

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.