T2 Biosystems Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced preliminary unaudited financial and operational results for the second quarter 2023.
Recent Financial and Operational Highlights (unaudited)
- Achieved second quarter total revenue of $2.0 million, comprised entirely of product revenue.
- Achieved sepsis test panel revenue of $1.3 million, representing an increase of 7% compared to the prior year period, despite ending the second quarter with a $0.4 million sepsis test backorder.
- Executed contracts for 11 T2Dx® Instruments during the second quarter, including 4 in the U.S. and 7 internationally.
- Secured multi-year contract with a European distributor for 7 T2Dx Instruments and sepsis test panels for Poland – including T2Bacteria® Panel, T2Candida® Panel, and T2Resistance® Panel.
- Implemented a restructuring program in May 2023, including a workforce reduction of nearly 30%.
- Strengthened balance sheet by converting $10.0 million, or approximately 20%, of term loan debt with CRG Servicing LLC (“CRG”) in exchange for 48,345,798 shares of T2 Biosystems common stock and Series B Convertible Preferred Stock convertible into 93,297,259 shares of common stock.
- Completed Nasdaq listing compliance hearing and a response is expected within 30 days.
- Cash and cash equivalents totaled $16.1 million as of June 30, 2023, including $18.5 million of net proceeds from the sale of shares through the ATM facility in the second quarter.
Recent Pipeline and Clinical Highlights
- Completed patient enrollment in the U.S. clinical trial for the T2Resistance Panel.
- Filed FDA submission for T2Biothreat™ Panel, a direct-from-blood diagnostic test that runs on the FDA-cleared T2Dx Instrument and detects six biothreat pathogens identified as threats by CDC.
- Submitted for FDA Breakthrough Device Designation for a direct-from-blood diagnostic test to detect Candida auris, a multidrug-resistant fungal pathogen identified by CDC as an urgent threat.
- Established a clinical collaboration with Vanderbilt University Medical Center to implement the T2Bacteria Panel and assess its impact on antibiotic usage and clinical interventions.
“We achieved a number of significant milestones during the second quarter, including record demand for our sepsis test panels, the second largest sepsis-driven instrument order in company history, the FDA 510(k) submission for the T2Biothreat Panel, and the FDA Breakthrough Device Designation application for our Candida auris test,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “In addition, we recently strengthened our balance sheet through sales of common stock and the conversion of $10 million of debt to equity, extending our cash runway to pursue strategic initiatives.”
The Company’s second quarter 2023 financial results are preliminary and are subject to the completion of the audit of the Company’s second quarter 2023 financial statements. Complete second quarter 2023 financial results will be announced in August.
2023 Financial Outlook
The Company now expects full year 2023 total sepsis and related product revenue of $9.5 million to $10.5 million, representing growth of 13% to 25%, compared to $8.4 million in 2022.
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