Revenue and Financial Performance - The Company recognized revenue from the delivery of EsoGuard test results, with gross margin expected to fluctuate based on test volume and operating efficiencies [126]. - Revenue for the three months ended September 30, 2025, remained relatively level at $1.2 million compared to the same period in 2024 [137]. - For the nine months ended September 30, 2025, revenue was $3.2 million, an increase from $3.1 million in the same period in 2024 [145]. - The company experienced a net loss of approximately $41.7 million and used approximately $33.9 million of cash in operations during the nine months ended September 30, 2025 [155]. - The company ended the quarter with cash on hand of $47.3 million as of September 30, 2025 [155]. - The Company was in compliance with all financial covenants as of September 30, 2025 [161]. Expenses - Cost of revenue for the same period was approximately $1.7 million, also remaining relatively level year-over-year [138]. - Sales and marketing expenses increased to approximately $4.3 million in Q3 2025, up from $4.1 million in Q3 2024, reflecting a net increase of $0.2 million [139]. - General and administrative expenses rose to approximately $5.6 million in Q3 2025, compared to $5.4 million in Q3 2024, marking a net increase of $0.2 million [140]. - Research and development costs decreased to approximately $1.3 million in Q3 2025 from $1.7 million in Q3 2024, a net decrease of $0.4 million [140]. - General and administrative costs for the nine months ended September 30, 2025, were approximately $17.4 million, up from $14.3 million in the prior year, reflecting a net increase of $3.1 million [147]. Clinical and Regulatory Developments - EsoGuard demonstrated a sensitivity of approximately 90% for detecting disease across the esophageal precancer to cancer spectrum, with a negative predictive value (NPV) of around 99% [108]. - The Company submitted a clinical evidence package to secure Medicare coverage for EsoGuard, which included six new peer-reviewed publications [111]. - The ENVET-BE study showed a 2.4-fold increase in Barrett's Esophagus (BE) detection compared to the performance goal, with a 2.7-fold increase in the cohort meeting ACG criteria [114]. - Highmark Blue Cross Blue Shield issued a positive coverage policy for EsoGuard in New York state, effective May 26, 2025 [123]. - An $8 million NIH grant was awarded to evaluate esophageal precancer detection using EsoCheck and EsoGuard among at-risk individuals without GERD symptoms [124]. - EsoCheck is an FDA 510(k) and CE Mark cleared device that allows for non-invasive sampling of esophageal cells in under two minutes [109]. Capital and Stock Transactions - The Company closed on the sale of 28,750,000 shares at $1.00 per share in September 2025, raising approximately $27.0 million for working capital [116]. - The company closed on the sale of 28,750,000 shares of common stock at a price of $1.00 per share in September 2025, generating net proceeds of approximately $27.0 million [158]. Operational Insights - The Company anticipates an increase in sales and marketing expenses as it expands commercial operations and insurance reimbursement coverage for EsoGuard [129]. - The MSA Fee incurred by the Company is currently $1.05 million per month [162]. - There have been no material changes to the Company's critical accounting estimates in the nine months ended September 30, 2025 [163].
Lucid Diagnostics(LUCD) - 2025 Q3 - Quarterly Report