Lucid Diagnostics Inc. (LUCD) came out with a quarterly loss of $0.19 per share versus the Zacks Consensus Estimate of a loss of $0.15. This compares to loss of $0.23 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -26.67%. A quarter ago, it was expected that this company would post a loss of $0.16 per share when it actually produced a loss of $0.20, delivering a surprise of -25%.Over the last four quarters, the company has no ...

Nasdaq: LUCD Q4 2024 Business Update Lishan Aklog, M.D. Chairman & CEO Highlights ▪ Commercial Execution Record quarterly test volume 4 – 4Q24 Revenue $1.2M – 4Q24 EsoGuard test volume 4,042: +45% Quarterly March 24, 2025 Lishan Aklog MD Dennis McGrath Chairman & CEO CFO Disclaimer 2 ▪ This presentation may contain certain forward-looking statements related to or Lucid Diagnostics Inc. (the "Company") that involve risks and uncertainties. ▪ Actual results and events may differ significantly from results and ...

Financial Data and Key Metrics Changes - The company generated $1,200,000 in revenue for the fourth quarter, reflecting a 15% increase compared to the same quarter last year [27][28] - Test volume exceeded 4,000 tests in the fourth quarter, representing a record quarterly test volume [7][28] - The quarterly burn rate was $10,100,000, lower than the average burn rate of $11,000,000 for the preceding four quarters [25] Business Line Data and Key Metrics Changes - The EsoGuard sales channels have seen significant advancements, with a focus on expanding coverage and reimbursement [6][9] - The concierge medicine cash pay program has signed 20 contracts within a few weeks of launch, indicating strong initial traction [8][20] Market Data and Key Metrics Changes - The company has submitted claims to 400 payers, with ongoing conversations with numerous commercial payers [94] - The NCCN guidelines now include a section on screening for esophageal precancer, which is expected to influence positive policy coverage decisions from commercial payers [10][70] Company Strategy and Development Direction - The company is focused on driving revenue through expanded sales channels, including direct contracting with employers and concierge medicine [14][19] - The recent positive insurance coverage policy from Highmark Blue Cross Blue Shield is seen as a precedent for future engagements with commercial payers [9][81] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for significant growth in test volume and revenue in the second half of the year, particularly with the expected Medicare coverage [22][60] - The company is confident in its ability to scale operations and target the Medicare population effectively once coverage is secured [59][61] Other Important Information - The company secured an $8,000,000 NIH grant to study EsoGuard for expanded indications, which could significantly increase the total addressable market [12][48] - The balance sheet was strengthened through long-term debt refinancing and a registered direct common stock offering, extending the runway well past key reimbursement milestones [11][24] Q&A Session Summary Question: How should we think about the volume metric going forward? - Management advised to remain conservative on test volume expectations, focusing more on revenue rather than just volume [36][37] Question: Why was the effective ASP lower than expected? - The lower ASP was attributed to the timing of payments rather than a direct reflection of payment rates [42][44] Question: Can you size the opportunity from the $8,000,000 NIH grant? - The opportunity is significant, potentially adding 20 million patients to the screening recommendations [48][50] Question: What happens if Medicare coverage is secured? - The company plans to aggressively target the Medicare population and expects to submit a backlog of claims [60][86] Question: How will NCCN inclusion help the company? - Inclusion in NCCN guidelines is expected to serve as a powerful tool in discussions with commercial payers [70][72]

Core Insights - Lucid Diagnostics Inc. reported a record 4,042 EsoGuard tests processed in Q4 2024, marking a 45% sequential increase and an 84% annual increase [1] - The company recognized EsoGuard revenue of $1.2 million in Q4 2024 [1] - Significant advancements in EsoGuard's commercial coverage and sales channels are expected to drive revenue growth in the second half of 2025 [4] Business Highlights - The company secured over 20 new cash-pay concierge medicine contracts through a new sales channel [1] - Lucid Diagnostics achieved its first agreement to pay for EsoGuard under state biomarker legislation [1] - The CEO emphasized the potential for broader payor coverage for EsoGuard, positioning the company to capitalize on a large clinical and market opportunity [4] Financial Results - For Q4 2024, EsoGuard related revenues were $1.2 million, with operating expenses around $13.6 million, including $1.2 million in stock-based compensation [7] - The GAAP net loss attributable to common stockholders was approximately $11.5 million, or $(0.20) per common share [7] - As of December 31, 2024, the company had cash and cash equivalents of $22.4 million, with pro forma cash estimated at $36.9 million at the start of 2025 [7] EsoGuard and EsoCheck Overview - EsoGuard is a DNA methylation assay designed to detect esophageal precancer in patients with gastroesophageal reflux disease (GERD) [12][14] - The test has shown over 90% sensitivity and specificity in detecting esophageal precancer and cancer [15] - EsoCheck is a noninvasive device for collecting esophageal cell samples, facilitating the EsoGuard testing process [16]

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]

Core Insights - The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines to include non-endoscopic biomarker testing, such as Lucid's EsoGuard Esophageal DNA Test, as an acceptable alternative to invasive endoscopy for detecting esophageal precancer [1][2] Company Overview - Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company focused on patients with gastroesophageal reflux disease (GERD) who are at risk of developing esophageal precancer and cancer [3] - The EsoGuard Esophageal DNA Test is designed for early detection of esophageal precancer in at-risk patients and is performed using the EsoCheck Esophageal Cell Collection Device, which allows for a noninvasive office procedure [3] Industry Impact - The alignment of NCCN Guidelines with multiple gastroenterology society guidelines on Barrett's Esophagus (BE) screening is expected to positively influence commercial insurance policy coverage decisions, thereby expanding access to EsoGuard testing [2]

Core Insights - The ENVET-BE clinical utility study confirms the effectiveness of EsoGuard as a non-invasive triage tool that significantly increases the positive yield of invasive upper endoscopy for detecting esophageal precancer [1][2] - EsoGuard testing demonstrated a 2.4-fold increase in the overall positive diagnostic yield for Barrett's Esophagus (BE) compared to the expected yield from screening EGD alone, with nearly three-fold higher yield in patients meeting ACG screening criteria [2] Company Overview - Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc., focusing on patients with gastroesophageal reflux disease (GERD) who are at risk of developing esophageal precancer and cancer [3] - The company's EsoGuard Esophageal DNA Test is the first and only commercially available tool designed for early detection of esophageal precancer in at-risk patients [3]

Core Insights - Highmark Blue Cross Blue Shield has issued a positive coverage policy for Lucid Diagnostics' EsoGuard® Esophageal DNA Test, which will cover non-invasive screening for esophageal precancer and cancer in New York state [1][2] - This decision is seen as a landmark event for Lucid, potentially influencing other commercial insurers to adopt similar coverage policies and validating the strength of Lucid's clinical evidence [2] - Lucid Diagnostics focuses on patients with gastroesophageal reflux disease (GERD) who are at risk of developing esophageal precancer and cancer, with its EsoGuard® test being the first commercially available tool aimed at early detection [3] Company Overview - Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc. [3] - The company aims to prevent cancer and cancer deaths through early detection of esophageal precancer in at-risk patients, utilizing its EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device [3]

Core Viewpoint - Lucid Diagnostics Inc. is set to host a business update conference call on March 24, 2025, to discuss its operations and financial results, highlighting its growth strategy in cancer prevention diagnostics [1][2]. Company Overview - Lucid Diagnostics Inc. is a commercial-stage medical diagnostics company focused on cancer prevention, specifically targeting patients with gastroesophageal reflux disease (GERD) who are at risk of esophageal precancer and cancer [4]. - The company offers the EsoGuard® Esophageal DNA Test, which is the first and only commercially available tool aimed at early detection of esophageal precancer in at-risk patients [4]. Financial Update - During the upcoming conference call, the Chief Financial Officer will present the financial results for the fourth quarter of 2024, providing insights into the company's financial performance [1].

Company Overview - Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc. [4] - The company focuses on patients with gastroesophageal reflux disease (GERD), who are at risk of developing esophageal precancer and cancer [4] - Lucid's EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device are the first and only commercially available tools aimed at preventing cancer through early detection [4] Recent Financial Activity - The company announced the closing of a registered direct offering of 13,939,331 shares of common stock at a purchase price of $1.10 per share [1] - Gross proceeds from this offering are approximately $15.3 million, with around $0.8 million in placement agent's fees and other expenses [2] - Canaccord Genuity acted as the sole placement agent for this offering [2] Use of Proceeds - The net proceeds from the offering will be used for working capital and other general corporate purposes [2]