PAVmed(US:PAVM)2025-03-24 21:22Clinical Evidence and Research - EsoGuard submitted a complete clinical evidence package to secure Medicare coverage, including six new peer-reviewed publications[348]. - EsoGuard demonstrated a 2.4-fold higher diagnostic yield for Barrett's Esophagus (BE) compared to expected yield from screening EGD alone, based on a cohort of 199 EsoGuard-positive patients[350]. - EsoGuard's sensitivity and negative predictive value for detecting BE were approximately 88% and 99%, respectively[352]. - Lucid received an $8 million NIH grant for a five-year clinical study evaluating EsoCheck and EsoGuard among at-risk individuals without GERD symptoms[354]. - Veris was awarded a $1.8 million NIH grant to optimize the Veris Cancer Care Platform for underserved cancer patients[356]. - EsoGuard is now referenced in the NCCN Guidelines as an acceptable alternative to invasive upper endoscopy for detecting esophageal precancer[349]. - A pilot program for the Veris Cancer Care Platform has been launched in collaboration with a National Cancer Institute-Designated Comprehensive Cancer Center[360]. - Research and development efforts will focus on the Veris Cancer Care Platform and other products in the pipeline as resources permit[394]. Financial Performance - Revenue for the year ended December 31, 2024, was $3.0 million, an increase of 20% compared to $2.5 million in the prior year, primarily driven by the EsoGuard Esophageal DNA Test[399]. - Cost of revenue decreased to $4.8 million in 2024 from $6.4 million in 2023, a reduction of 25% attributed to the limited inclusion of Lucid's results post-deconsolidation[400]. - The Company experienced net income before noncontrolling interests of approximately $28.4 million in 2024, while using approximately $33.6 million of cash in operations[414]. - Financing activities provided $31.3 million of cash during the year ended December 31, 2024[414]. - The Company ended the year with cash on-hand of $1.2 million as of December 31, 2024[414]. Stock and Shareholder Activities - The Company generated gross proceeds of $2.37 million from the sale of 2,574,350 shares of common stock and pre-funded warrants[361]. - The Company received shareholder approval to increase the total number of authorized shares from 50 million to 250 million on January 15, 2025[379]. - Lucid closed on the sale of 13,939,331 shares at $1.10 per share, generating net proceeds of approximately $14.5 million for working capital[380][381]. - The company raised a total of $18.16 million from the sale of 12,495 shares of Lucid Series B Preferred Stock at $1,000 per share and the exchange of existing preferred shares[422]. - The company issued approximately 11,634 shares of Lucid Series B-1 Preferred Stock, generating gross proceeds of $11.6 million, with a conversion price of $0.7228[424]. - The company realized gross proceeds of $21.95 million from the issuance of November 2024 Senior Convertible Notes, which were used to fully repay the Lucid March 2023 Senior Convertible Note[428]. - In the year ended December 31, 2024, the company sold 1,032,298 shares through its at-the-market equity facility for net proceeds of approximately $1.3 million[429]. - Cumulatively, the company issued 680,263 shares of common stock for net proceeds of approximately $1.8 million under a committed equity facility as of December 31, 2024[430]. - The company entered into an "at-the-market offering" for up to $6.5 million of its common stock, resulting in net proceeds of approximately $0.3 million from 230,068 shares sold as of December 31, 2024[431]. - The company issued 1,084,366 shares of common stock in satisfaction of approximately $1.4 million of principal repayments and $0.1 million of interest expense in 2024[415]. Compliance and Regulatory Matters - The Company regained compliance with Nasdaq's continued listing standard, maintaining at least $2.5 million in stockholders' equity[366]. - The Company achieved compliance through the exchange of $22.3 million in secured convertible notes for Series C Preferred Stock and a reduction in operating expenses due to the deconsolidation of Lucid[368]. - As of December 31, 2024, the company was in compliance with the Financial Tests, which require available cash to equal or exceed $8.0 million and market capitalization to be no less than $75 million[420]. - The company is subject to financial covenants under the Lucid March 2023 Senior Convertible Note, requiring available cash to equal or exceed $5.0 million and market capitalization to be no less than $30 million[427]. - The company has a Debt to Market Cap Ratio Test that should not exceed 30% based on the outstanding principal amount of notes and average market capitalization[420]. Expenses and Cost Management - The Company increased the monthly management services fee to Lucid from $0.83 million to $1.05 million[359]. - The Company anticipates a decrease in sales and marketing expenses due to the deconsolidation of Lucid, which will no longer be included in its operating results[391]. - Sales and marketing expenses decreased to approximately $11.6 million in 2024 from $17.6 million in 2023, a reduction of $6.0 million[401]. - General and administrative expenses were approximately $24.5 million in 2024, down from $30.9 million in 2023, reflecting a decrease of $6.4 million[401]. - Research and development costs fell to approximately $5.9 million in 2024 compared to $14.3 million in 2023, a decrease of $8.4 million[402]. Changes in Accounting Standards - The company adopted ASU No. 2023-07 for segment reporting, effective January 1, 2024, which did not materially impact its segment-related disclosures[441]. - The FASB issued ASU No. 2023-09 in December 2023, aimed at enhancing income tax disclosures, effective for annual periods beginning after December 15, 2024[443]. - ASU 2023-09 includes changes to rate reconciliation and income taxes paid information, but the company does not expect a significant impact on its consolidated financial statements[443]. - In October 2023, the FASB issued ASU No. 2023-06, which modifies disclosure requirements in response to the SEC's Disclosure Update and Simplification Initiative[444]. - The effective date for ASU 2023-06 amendments will align with the SEC's removal of related disclosures, with a potential removal of amendments if not enacted by June 30, 2027[444]. - The company is currently evaluating the potential impact of ASU 2023-06 on its consolidated financial statements[444]. Miscellaneous - The change in fair value of convertible debt resulted in approximately $0.5 million of income in 2024, compared to $6.0 million of expense in 2023[403]. - A gain on deconsolidation of Lucid Diagnostics was recognized at $72.3 million in 2024, with the value of the Company's shares in Lucid at $25.1 million[408]. - The outstanding principal balance of the September 2022 Senior Convertible Note was approximately $6.6 million after the exchange agreement[371]. - The conversion price for the September 2022 Convertible Note was reset to $1.068, with the maturity date extended to December 31, 2025[372]. - A deemed dividend of $7.5 million was recognized on the exchange of Lucid Series A and Series A-1 Convertible Preferred Stock for Series B Preferred Stock on March 13, 2024[412]. - The company does not have any off-balance sheet arrangements[446]. - There are no applicable quantitative and qualitative disclosures about market risk[447].