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Lucid Diagnostics Provides Business Update and First Quarter 2024 Financial Results
Quarterly EsoGuard® test volume increased 10 percent
Strengthened balance sheet following completion of $29.8 million Series B Preferred Stock Offering
MolDX pre-submission meeting scheduled for July 17, 2024
Conference call and webcast to be held today, May 13th at 8:30 AM EDT
NEW YORK, May 13, 2024 /PRNewswire/ -- Lucid Diagnostics Inc. (NASDAQ:LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company, and majority-owned 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 March 31, 2024.
Conference Call and Webcast
The webcast will take place on Monday, May 13, 2024, at 8:30 AM and will be accessible in the investor relations section of the Company's website at luciddx.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184 and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name "Lucid Diagnostics Business Update" to join.
Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company's website at luciddx.com.
Business Update Highlights
"I am very pleased with the excellent progress Lucid has made on multiple fronts during the first quarter and recent weeks and look forward to exciting very near-term milestones for our business," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "We strengthened our balance sheet closing an approximately $30 million preferred stock financing to long-term investors that extends our runway well past these milestones. Our EsoGuard commercial execution continues to deliver results as we drive towards expanded private and public coverage, as well as direct contracting. We look forward to our MolDX pre-submission meeting scheduled for mid-July where we will have the opportunity to present our now robust clinical evidence base for EsoGuard as we seek coverage under its Local Coverage Determination (LCD). We believe we have line of sight to Medicare coverage."
Highlights from the first quarter and recent weeks:
For the quarter, EsoGuard® revenue was $1.0M, which was flat compared to 4Q23 and represents a 124 percent annual increase from 1Q23.
Lucid's CLIA-certified clinical laboratory performed 2,420 commercial EsoGuard Esophageal DNA Tests in 1Q24, which represents a 10 percent increase sequentially from 4Q23 and a 31 percent annual increase from 1Q23.
Continuous revenue cycle management improvements, including prior authorization appeals, physician advocacy, etc., while maintaining stable out-of-network allowed amounts averaging ~$1,800.
Strengthened balance sheet by completing $29.8 million Series B Preferred Stock Offering.
Peer-reviewed publication of positive data from landmark National Cancer Institute (NCI)-sponsored clinical validation study of EsoGuard esophageal precancer testing demonstrating unprecedented early cancer detection. The publication of data strengthens EsoGuard's clinical data supporting ongoing engagement to secure commercial and Medicare payor coverage.
Secured July 17, 2024 MolDX pre-submission meeting to review data for technical assessment (TA) seeking EsoGuard coverage under its foundational Local Coverage Determination (LCD).
Robust pipeline of direct contracting engagements with benefits brokers, third-party administrators, and self-insured entities.
Actively executing on aggressive market access strategy focused on securing medical policy coverage with regional plans in biomarker legislation states and pilots with national plans.
Financial Results
For the three months ended March 31, 2024, EsoGuard related revenues were $1.0 million. Operating expenses were approximately $11.8 million, which included stock-based compensation expenses of $0.9 million. GAAP net loss attributable to common stockholders was approximately $18.1 million or $(0.40) 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 March 31, 2024 was approximately $9.4 million or $(0.21) per common share.
Lucid had cash and cash equivalents of $24.8 million as of March 31, 2024, compared to $18.9 million as of December 31, 2023. Subsequent to March 31, 2024, the Company completed an issuance of Convertible Preferred Stock Series B-1 resulting in gross proceeds of approximately $11.6 million.
The unaudited financial results for the three months ended March 31, 2024, were filed with the SEC on Form 10-Q on May 13, 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 months ended March 31, 2024, and 2023 are as follows:
Condensed consolidated statements of operations (unaudited)
(in thousands except per-share amounts)
For the ...