Lucid Diagnostics Inc. Q3 FY2025 earnings call

• MolDx CAC meeting on September 4 went well with strong consensus on nearing positive Medicare coverage outcome, leading to a successful subsequent financing in September.
• Third quarter test volume was 2,841 tests and revenue was ~$1.2 million, in line with the previous quarter. Volume was within the targeted range for maintaining engagement with commercial payers.
• Strengthened and scaled market access infrastructure to drive payer engagement and secure broader commercial insurance coverage and expanded patient access. Strengthened the market access leadership team.
• Holding the first firefighter esophageal cancer prevention summit next week, with a strong partnership with fire departments across the country.
• Completed an underwritten public offering of common stock in September, netting approximately $27 million in proceeds, bolstering the balance sheet to $47 million in pro forma cash by quarter-end.
• For Medicare, next steps include publication of a draft local coverage determination (LCD), a 45-day public comment period, and then publication of a final LCD. Positive progress with CCLA meeting and comments from MolDx and Meridian medical directors.
• Active engagement with commercial payers, with opportunities to link EsoGuard coverage to existing guidelines for endoscopy, and positive conversations with UnitedHealthcare leading to potential contracting discussions.

In the third quarter, Lucid Diagnostics Inc. had a test volume of 2,841 tests and revenue of approximately $1.2 million. Both the revenue and the volume were in line with the last quarter (second quarter of 2025). The volume was within the target range of approximately 2,500 to 3,000 tests per quarter needed to maintain ongoing engagement with commercial payers. Revenue contribution details weren't explicitly broken down by product segment beyond the overall financials.

• Expectation that after CAC meeting, a draft LCD will be published soon and the process from draft to final LCD is seen as a formality.
• Anticipation of seeing positive coverage policies from commercial payers sooner rather than later while awaiting Medicare process conclusion.
• Continued focus on driving Medicare testing and increasing the portion of Medicare-eligible patients in the target population, with the team already starting to shift emphasis to pursue this.

Forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from statements made. Factors that could cause actual results to differ are described in the disclaimer and in filings with the SEC, including risks in Part 1, Item 1A entitled Risk Factors in the most recent annual report on Form 10-K and subsequent updates in quarterly reports on Form 10-Q and Forms 8-K.

Q: Could you share more about the CCLA meeting and the process from draft LCD to final?

A: The CCLA meeting was a regular scheduled meeting where Danielle, the new head of market access attended. It was a general meeting with MolDx leaders present. Responses from MolDx were positive and consistent with internal conversations. The process from draft LCD to final is seen as a formality as the draft is a reconsideration of an existing final policy and the public comment period is expected to be a formality.

Q: What's the outlook for commercial payers and when might we see positive coverage policies?

A: There is a lot of activity with commercial payers, including positive conversations. We are seeing positive movement and expect to start seeing positive coverage policies from small and large payers sooner rather than later while awaiting the Medicare process conclusion. EsoGuard fits within the existing paradigm of endoscopy and related procedures covered by payers, which helps in these conversations.

Q: How is the team handling the shift to targeting Medicare patients and what about test volume?

A: The team has been making a concerted push to target Medicare patients. We are not increasing total test volume but shifting the mix. The process of targeting Medicare patients is going well, and we are seeing some success. The team is focused on maintaining test volume while shifting the portion towards Medicare-eligible patients.

Q: Can you talk about the NIH study on asymptomatic GERD patients and its impact?

A: The NIH study is enrolling well with two parallel studies. There's no target date for the readout yet. The study is an opportunity to expand the target population long-term, but we are not dependent on its results for near-term inroads into the existing target population which is based on symptomatic patients and existing guidelines.