Original from: Lucid Diagnostics

 

Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), today provided a business update for the Company and presented financial results for the three months ended September 30, 2024.

 

Business Update Highlights

"The third quarter and recent weeks have been a transformational period for Lucid, including two key milestones announced last week," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "We are now fully armed with a complete body of outstanding clinical data to go along with a renewed commercial focus on programs designed to drive near-term revenue. Our team is ready to make our final push towards broad reimbursement, including our upcoming submission formally seeking Medicare coverage of EsoGuard. We are energized by the vast clinical and market opportunity before us as we seek to expand patient access to our groundbreaking technologies to detect esophageal precancer, and drive shareholder value."

 

Highlights from the third quarter and recent weeks:

· For the quarter, EsoGuard® Esophageal DNA Test revenue was $1.2M, which represents a 20 percent increase sequentially from 2Q24 and a 50 percent annual increase from 3Q23.

 

· Lucid's CLIA-certified clinical laboratory performed 2,787 commercial EsoGuard tests in 3Q24. Additionally, for the month of October, the lab performed a single-month record of more than 1,400 tests, contributing to the largest three-month total in the Company's history.

 

· ESOGUARD BE-1 clinical validation study accepted for peer-reviewed publication in the American Journal of Gastroenterology. This publication completes Lucid's clinical evidence package for submission to formally seek Medicare coverage.

 

· Company leveraging complete clinical evidence package to expand direct contracting initiative with multiple programs focused on driving near-term revenue growth, including a shift to fully-contracted #CYFT Precancer Testing Events, broadening employer markets activity, and a new foray into the concierge medicine sector.

 

· Met with CMS Medicare Administrative Contractor (MAC) Palmetto GBA's Molecular Diagnostics Program (MolDX) to discuss EsoGuard clinical evidence package for upcoming submission for Medicare coverage.

 

· Peer-reviewed publication of EsoGuard analytical validation study, demonstrating excellent analytical accuracy, repeatability, and reproducibility of the assay.

 

· Received Notice of Allowance for key patent underlying EsoGuard.

 

Financial Results

· For the three months ended September 30, 2024, EsoGuard related revenues were $1.2 million. Operating expenses were approximately $12.9 million, which included stock-based compensation expenses of $1.2 million. GAAP net loss attributable to common stockholders was approximately $12.4 million or $(0.25) per common share.

 

· As shown below and for the purpose of illustrating the effect of stock-based compensation and other non-cash income and expenses on the Company's financial results, the Company's non-GAAP adjusted loss for the three months ended September 30, 2024 was approximately $10.1 million or $(0.20) per common share.

 

· Lucid had cash and cash equivalents of $14.5 million as of September 30, 2024, compared to $18.9 million as of December 31, 2023. As of November 12, the Company has entered into subscription agreements with long-term accredited investors to purchase $21.75 million of five-year Senior Secured Convertible Notes. The Company gave notice to the existing convertible note holder that it is exercising its right to redeem the existing notes. Upon closing of the subscription agreements and completing the redemption of the existing notes, the company expects to increase its cash runway by approximately $13.2 million.

 

· The unaudited financial results for the three and nine months ended September 30, 2024, were filed with the SEC on Form 10-Q on November 12, 2024, and available at www.luciddx.com or www.sec.gov.

 

Lucid Non-GAAP Measures

 

· To supplement our unaudited financial results presented in accordance with U.S. generally accepted accounting principles (GAAP), management provides certain non-GAAP financial measures of the Company's financial results. These non-GAAP financial measures include net loss before interest, taxes, depreciation, and amortization (EBITDA), and non-GAAP adjusted loss, which further adjusts EBITDA for stock-based compensation expense and other non-cash income and expenses, if any. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted loss are not recognized terms under U.S. GAAP.

 

· Non-GAAP financial measures are presented with the intent of providing greater transparency to the information used by us in our financial performance analysis and operational decision-making. We believe these non-GAAP financial measures provide meaningful information to assist investors, shareholders, and other readers of our unaudited financial statements in making comparisons to our historical financial results and analyzing the underlying performance of our results of operations. These non-GAAP financial measures are not intended to be, and should not be, a substitute for, considered superior to, considered separately from, or as an alternative to, the most directly comparable GAAP financial measures.

 

· Non-GAAP financial measures are provided to enhance readers' overall understanding of our current financial results and to provide further information for comparative purposes. Management believes the non-GAAP financial measures provide useful information to management and investors by isolating certain expenses, gains, and losses that may not be indicative of our core operating results and business outlook. Specifically, the non-GAAP financial measures include non-GAAP adjusted loss, and its presentation is intended to help the reader understand the effect of the loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, the loss on debt extinguishment, and the corresponding accounting for non-cash charges on financial performance. In addition, management believes non-GAAP financial measures enhance the comparability of results against prior periods.

 

· A reconciliation to the most directly comparable GAAP measure of all non-GAAP financial measures included in this press release for the three and nine months ended September 30, 2024, and 2023 are as follows:

 

 

Source: Lucid Diagnostics Provides Business Update and Third Quarter 2024 Financial Results