Dustin Scaringe

Asked about the specific performance metrics for Wave to be released at ECCMID, the FDA approval timeline for the isolates menu following the initial gram-negative panel, and for guidance on company spending and cash burn expectations for the upcoming year.

Answer

The company plans to release Wave data at ECCMID, including metrics like essential agreement, categorical agreement, and time-to-result. The menu strategy post-gram-negative PBC is to focus on gram-positive PBC (expected approval in 2025), followed by gram-negative and gram-positive isolates. Significant cash burn reductions are expected, particularly in R&D (about $2M savings per quarter), as Wave moves into clinical trials, with Q4's spend serving as a good baseline for 2024 modeling.

Inquired about the launch timeline and success metrics for EndoCheck, confidence in the finalization of the CMS rule for OvaWatch and its impact on longitudinal monitoring pricing, the outlook for 2024 volume and ASP, and the company's cash burn and runway.

Answer

The company maintains its EndoCheck launch timeline for year-end with a broader rollout in Q1 2024. They are highly confident the CMS pricing for OvaWatch will be finalized and do not expect it to affect the longitudinal product. No guidance for 2024 was provided. The company reiterated its H2 2023 cash burn guidance and mentioned its focus on managing cash and exploring funding options, including existing equity lines.