Risk Factors Update Summary

• Total revenues were concentrated with 29% from top 2 customers in 2023.
• Expectation of future losses and inability to utilize net operating losses against profitability. This may impact financial stability.
• Obtained FDA 510(k) clearance for T2Biothreat Panel. Received $11.0 million in BARDA contract revenue in 2023.
• Increased focus on compliance with debt instruments, future capital needs, and ability to raise additional funds.
• Revenue from BARDA contract decreased from 50% in 2022 to less than 10% in 2023.
• Addition of risks related to fluctuations in demand for raw materials and supplies, impacting production and costs.
• Expanded CE mark to T2Resistance panels in November 2019. Recorded $2.5 million impairment charges in 2023.
• Federal net operating loss carryforwards decreased from $273.7 million in 2022 to $256 million in 2023.
• Increased total employees from 113 in 2023 to 158 in 2023. Incurred net losses of $62.0 million in 2023.
• Pending U.S. patent applications increased from over 15 in 2022 to over 40 in 2023.
• Emphasis on the impact of cybersecurity risks, including ransomware, phishing, and data breaches on information technology systems.
• Chief Executive Officer and Chief Financial Officer identified material weaknesses in internal controls in 2023.
• Introduction of risks related to recruiting, training, and retaining key personnel, crucial for operational success.
• The FDA issued a final rule to amend the QSR to align with ISO: 13485.
• Inclusion of risks associated with manufacturing interruptions and backlogs in order fulfillment, affecting product delivery.
• The EU In Vitro Diagnostic Medical Devices Regulation replaced the EU In Vitro Diagnostic Medical Devices Directive.
• Addition of risks related to market volatility impacting stock price and market acceptance of common stock.