
T2 Biosystems Pre-Releases 3Q23 Results; Announces Additional FDA Submission for Sepsis Test
T2 Biosystems, Inc. (NASDAQ: TTOO) has released its preliminary unaudited financial results for the third quarter ending September 30, 2023, and provided several business highlights including it’s 510(k) submission for FDA approval for Acinetobacter baumannii (A. baumannii) on its T2Bacteria Panel for sepsis patients. Total preliminary revenue in the 3Q23 is expected to be $1.5 million, a 60% decrease YoY, attributed to a reduction in BARDA revenue and a sepsis test backorder. One analyst who covers the stock had a quarterly estimate of $2.6 million. The company noted that it secured contracts for 5 T2Dx Instruments in the third quarter, and successfully installed 7 T2Dx Instruments for a European distributor. In September the company received FDA 510(k) clearance for the T2Biothreat™ Panel and it is anticipating an FDA submission for its T2Resistance Panel in Q124.
Cash and liquidity has been concern for investors as with most small cap med-tech companies but the company strengthened its balance sheet in the quarter by converting $10 million in term loan debt in exchange for shares of T2 Biosystems equity. The company ended September with cash and cash equivalents were $24.3.
Looking ahead to the 4th quarter, the company expects a sequential quarterly increase of 60% in sepsis and related product revenue for Q4 2023 and guided to total revenue of $2.4 million. Additionally, the company regained compliance with Nasdaq market value and recently enacted a 1 for 100 reverse stock split to comply with Nasdaq’s minimum bid price rule.
T2 Biosystems also announced the company has submitted a 510(k) premarket notification to the FDA to expand the pathogens detected on the FDA-cleared T2Bacteria® Panel to include A. baumannii. A. baumannii can cause bloodstream infections, particularly in critically ill patients. The inclusion of A. baumannii is expected to increase the detection capabilities of the T2Bacteria Panel to cover about 75% of common sepsis-causing bacterial pathogens found in bloodstream infections. The World Health Organization has recognized A. baumannii as a critically important bacteria in need of improved prevention and therapeutic approaches due to its resistance to antibiotics, including carbapenems, which can lead to high mortality rates.