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]

Highlights society guidelines recommending non-endoscopic biomarker testing, such as Lucid's EsoGuard Esophageal DNA Test, as an acceptable alternative to endoscopy NEW YORK, March 20, 2025 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company"), a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM), today announced that a recent update to the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncol ...

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]

Core Insights - Lucid Diagnostics Inc. is collaborating with a consortium of academic medical centers to conduct a five-year clinical study on esophageal precancer detection, supported by an $8 million NIH grant [1][2][3] - The study aims to evaluate the effectiveness of Lucid's EsoCheck and EsoGuard technologies in detecting Barrett's Esophagus among at-risk individuals without GERD symptoms [2][3] - The research will involve 800 patients across five centers, focusing on improving detection rates in a population that is currently underserved by existing screening guidelines [2][3] Company Overview - Lucid Diagnostics is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc., focusing on patients at risk of esophageal precancer and cancer due to GERD [4] - The company's EsoGuard Esophageal DNA Test and EsoCheck Esophageal Cell Collection Device are the first commercially available tools aimed at early detection of esophageal precancer [4] Research Significance - Nearly half of prevalent esophageal cancer cases occur in patients without GERD symptoms, highlighting the need for improved screening methods [3] - The study is expected to significantly expand the target population for EsoGuard testing, potentially impacting esophageal cancer-related mortality rates [3]

Company Overview - Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc. [2] - The company focuses on patients with gastroesophageal reflux disease (GERD), who are at risk of developing esophageal precancer and cancer [2] - Lucid's EsoGuard® Esophageal DNA Test is the first and only commercially available tool aimed at preventing cancer through early detection of esophageal precancer [2] Compliance Notification - Lucid Diagnostics received a written notification from Nasdaq indicating eligibility for a 180-day extension to regain compliance with the $1.00 minimum bid price requirement [4] - The company must maintain a closing bid price of at least $1.00 per share for a minimum of ten consecutive business days during the extension period [1][4] - The deadline to meet this requirement is June 16, 2025 [4]