T2 Biosystems, Inc. (NASDAQ:TTOO) Q1 2023 Earnings Conference Call May 23, 2023 8:30 AM ET

Company Participants

Philip Taylor - Gilmartin Group

John Sperzel - President, CEO & Chairman

John Sprague - CFO

Brett Giffin - Chief Commercial Officer

Conference Call Participants

Kyle Mikson - Canaccord Genuity

Mark Massaro - BTIG

Benjamin Haynor - Alliance Global Partners

Operator

Greetings. Welcome to the T2 Biosystems, Inc. First Quarter 2023 Earnings Conference Call. [Operator Instructions].

I will now turn the conference over to your host, Trip Taylor. You may begin.

Philip Taylor

Thank you, operator. I would like to remind everyone that comments made by management today and answers to questions will include forward-looking statements. Those include statements related to T2 Biosystems' future financial and operating results and plans for developing and marketing new products. Forward-looking statements are based on estimates and assumptions as of today and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied by these statements, including the risks and uncertainties described in T2 Biosystems' annual report on Form 10-K filed with the SEC on March 31, 2023, and other filings the company makes with the SEC from time to time. The company undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law.

With that, I would like to turn the call over to Chairman and CEO, John Sperzel. John?

John Sperzel

Thank you for joining our first quarter 2023 earnings and business update call. Today, I will start by addressing two press releases that we issued earlier this morning, then discuss our performance during the first quarter, including the progress we have made across our three corporate priorities as outlined in our first quarter earnings press release. I will then turn the call over to John Sprague, our Chief Financial Officer, who will review our first quarter financial results and our outlook for 2023, before I provide closing remarks and we open the call for questions and answers.

This morning, we issued a press release announcing an FDA 510(k) submission for the T2Biothreat panel, a product that we developed in collaboration with the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority, or BARDA.

The FDA submission marks an important milestone in our commitment to protect Americans from the threat of deliberate or naturally occurring outbreaks of Biothreat pathogens, and follows the recently completed U.S. clinical evaluation that demonstrated very high sensitivity and specificity, including 350 contrive positive samples and over 470 negative blood samples from both healthy and federal subjects.