Lucid Diagnostics(LUCD) - 2024 Q4 - Annual Report

EsoGuard Test Performance - The EsoGuard Esophageal DNA Test has a sensitivity of approximately 90% for detecting disease across the esophageal precancer to cancer spectrum, with a negative predictive value (NPV) of around 99%[348] - EsoGuard demonstrated a sensitivity of approximately 88% and a negative predictive value of 99% for detecting Barrett's Esophagus (BE) in a multi-center study[354] Clinical Studies and Coverage - The ENVET-BE clinical utility study showed that confirmatory upper endoscopy (EGD) in EsoGuard-positive patients had a diagnostic yield 2.4 times higher than expected for screening EGD alone, based on a cohort of 199 patients[353] - The Company submitted a clinical evidence package to secure Medicare coverage for EsoGuard, which included six new peer-reviewed publications[351] - Highmark Blue Cross Blue Shield issued a positive coverage policy for EsoGuard in New York state, covering patients who meet established criteria for esophageal precancer testing[355] - A $8 million NIH grant was awarded to evaluate esophageal precancer detection using EsoCheck and EsoGuard among at-risk individuals without GERD symptoms[356] Financial Performance - Revenue for the year ended December 31, 2024, was $4.3 million, an increase of $1.9 million compared to $2.4 million in the prior year, primarily driven by the EsoGuard Esophageal DNA Test[384] - Cost of revenue for the year ended December 31, 2024, was approximately $7.1 million, up from $6.0 million in the prior year, reflecting a $1.1 million increase[385] - Sales and marketing expenses for the year ended December 31, 2024, were approximately $16.5 million, a slight increase of $0.1 million compared to $16.4 million in the prior year[385] - General and administrative expenses for the year ended December 31, 2024, were approximately $20.2 million, an increase of $0.9 million from $19.3 million in the prior year[386] - Research and development expenses for the year ended December 31, 2024, were approximately $6.0 million, down from $7.3 million in the prior year, reflecting a decrease of $1.3 million[386] - The company experienced a net loss of approximately $45.5 million and used approximately $44.1 million of cash in operations during the year ended December 31, 2024[396] - The company ended the year with cash on-hand of $22.4 million as of December 31, 2024[396] Capital Raising Activities - The Company closed on the sale of 13,939,331 shares of common stock at $1.10 per share, resulting in net proceeds of approximately $14.5 million for working capital and corporate purposes[366] - The Company raised $21.975 million from the sale of 12.0% Senior Secured Convertible Notes due 2029, with net proceeds of $18.3 million after repaying a previous note[370] - The aggregate gross proceeds from the Series B Offering and Exchange were $18.16 million[397] - The Company closed the sale of $21.975 million in principal amount of 12.0% Senior Secured Convertible Notes due 2029, realizing net proceeds of $18.3 million after repaying the March 2023 Senior Convertible Note[403][404] - A total of 680,263 shares have been issued through the committed equity facility for net proceeds of approximately $1.8 million as of December 31, 2024[407] Management and Operational Changes - The Company increased the monthly fee under its management services agreement with PAVmed from $0.83 million to $1.05 million, effective July 1, 2024[362] - The monthly fee due from the Company to PAVmed was increased from $750 to $1,050 effective July 1, 2024, under the Management Services Agreement[409] - The Company issued 3,331,771 shares of common stock to PAVmed in exchange for approximately $4.7 million of fees and reimbursements accrued under the Management Services Agreement[410] - As of December 31, 2024, the Company had no accrued obligations under the payroll and benefit expense reimbursement agreement, reflecting a payment obligation liability of approximately $0.0 million[410] Regulatory and Accounting Updates - The Company received a Notice of Allowance for a patent application covering its method of using methylation of the cyclin-A1 gene for detecting esophageal precancer and cancer[357] - The Company adopted ASU No. 2023-07 on January 1, 2024, which requires enhanced segment disclosures, with no significant impact on its consolidated financial statements[419] - The Company is evaluating the potential impact of ASU No. 2024-03, effective after December 15, 2026, which requires detailed expense disaggregation disclosures[420] - The Company does not have any off-balance sheet arrangements[423] - The Company does not have any quantitative and qualitative disclosures about market risk applicable[424] Other Financial Metrics - The change in fair value of the convertible note resulted in approximately $5.4 million of income for the year ended December 31, 2024[390] - A debt extinguishment loss of approximately $5.2 million was recognized in connection with the March 2023 Senior Convertible Note for the year ended December 31, 2024[392]