Lucid Diagnostics Inc. (Nasdaq: LUCD) 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, 2023.
Business Update Highlights
“Lucid had a strong start in the first quarter of 2023, with robust sequential growth in EsoGuard testing volume,” said Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer. “We attribute this progress to our relentless focus on EsoGuard commercial expansion, including the growing popularity and utilization of our satellite Lucid Test Center (sLTC) program, a broad expansion of #CheckYourFoodTube Precancer Detection Events (#CYFT) and growing awareness of EsoGuard as a much-needed widespread screening tool that is highly effective in detecting esophageal precancer in a sizeable at-risk patient population.”
Highlights from the first quarter and recent weeks:
- Lucid’s CLIA-certified clinical laboratory performed 1,841 commercial EsoGuard® Esophageal DNA Tests in the 1Q23, which represents a 57 percent increase sequentially from 4Q22 and a 245 percent annual increase from 1Q22.
- Satellite Lucid Test Center (sLTC) activity, whereby Lucid clinicians collect samples at physician offices or high-volume testing events, continues to increase rapidly, representing 51 percent of all samples collected in 1Q23, up from 31 percent in 4Q22.
- In January, Lucid launched its #CheckYourFoodTube Precancer Detection Event (#CYFT Event) program, bringing EsoGuard testing directly to at-risk patients at high-volume testing day events. Since the inaugural event, Lucid has held additional events across the country during the first quarter and recent weeks. These events have identified patients with suspected esophageal precancer based on a positive EsoGuard result, including some less than 40 years of age, who will undergo appropriate monitoring and treatment, as indicated by clinical practice guidelines, to prevent progression to esophageal cancer.
- Lucid and its collaborators presented compelling new data at the Digestive Disease Week® (DDW) 2023 conference. EsoGuard demonstrated excellent esophageal precancer and cancer detection performance, including in the most prevalent and challenging precancer subgroup—short segment non-dysplastic Barrett’s Esophagus. In addition, EsoCheck cell collection achieved 98 percent technical success and high DNA yields in real-world study of 1,483 patients.
- In the first quarter and recent weeks, Medicare Administrative Contractors Palmetto GBA MolDX and Noridian Healthcare Solutions published foundational Future Effective Local Coverage Determinations (“LCD”), both titled “Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia“.
Financial Results
- For the three months ended March 31, 2023, EsoGuard related revenues were $0.4 million, compared to $0.2 million as of March 31, 2022. Operating expenses were approximately $14.8 million, including stock-based compensation expenses of $3.2 million. GAAP net loss attributable to common stockholders was approximately $16.2 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 preliminary non-GAAP adjusted loss for the three months ended March 31, 2023, was approximately $9.8 million or $(0.24) per common share.
- Lucid had cash and cash equivalents of $39.5 million as of March 31, 2023, compared to $22.5 million as of December 31, 2022.
- In March, the Company received $13.6 million from the sale of non-voting Series A Convertible Preferred Stock, which may not be converted until September 2023 and not until March 2025 without surrendering the right to an annual dividend.
- Also in March, the Company entered into a securities purchase agreement for Series A Convertible Notes with an aggregated principal amount of $11.1 million, which may not be converted below the stated $5.00 conversion price until September 2023. The proceeds of these offerings will extend the Company’s cash runway into 2024, through near-term commercial milestones, including expanded reimbursement.
- The unaudited financial results for the three months ended March 31, 2023, were filed with the SEC on Form 10-Q on May 15, 2023, and are 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.
About EsoGuard and EsoCheck
Millions of patients with GERD are at risk of developing esophageal precancer and a highly lethal form of esophageal cancer (“EAC”). Over 80 percent of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The mortality rate is high even in those diagnosed with early stage EAC. The U.S. incidence of EAC has increased 500 percent over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease. All EAC is believed to arise from esophageal precancer, which occurs in approximately 5 percent to 15 percent of at-risk GERD patients. Early esophageal precancer can be monitored for progression to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer.
