Core Viewpoint - Lucid Diagnostics Inc. has announced a public offering of 12,500,000 shares at a price of $1.20 per share, aiming to raise approximately $15 million for working capital and general corporate purposes [1][2]. Company Overview - Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc. The company focuses on patients with gastroesophageal reflux disease (GERD), who are at risk of developing esophageal precancer and cancer [6]. Offering Details - The offering includes a 45-day option for underwriters to purchase an additional 1,875,000 shares at the public offering price [1]. - The gross proceeds from the offering are expected to be around $15 million, excluding any proceeds from the underwriters' option [2]. - The offering is expected to close on or about April 11, 2025, subject to customary closing conditions [2]. Underwriters - Canaccord Genuity LLC is acting as the sole bookrunner for the offering, while Maxim Group LLC is serving as co-manager [3]. Regulatory Information - The offering is made pursuant to a shelf registration statement on Form S-3, which was declared effective by the Securities and Exchange Commission on December 6, 2022 [4]. - A prospectus supplement will be filed with the SEC, and the securities may only be offered by means of a written prospectus [4].

Company Overview - Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc. The company focuses on patients with gastroesophageal reflux disease (GERD), who are at risk of developing esophageal precancer and cancer [5]. Offering Details - Lucid Diagnostics announced its intention to offer shares of common stock through an underwritten public offering, with plans to grant underwriters a 45-day option to purchase additional shares. Proceeds from the offering are expected to support working capital and general corporate purposes [1]. - Canaccord Genuity LLC is acting as the sole bookrunner for the offering, while Maxim Group LLC is serving as co-manager [2]. Regulatory Information - The offering is being made pursuant to a shelf registration statement on Form S-3, which was declared effective by the Securities and Exchange Commission on December 6, 2022. A prospectus supplement will be filed with the SEC [3].

NEW YORK, April 3, 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 Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer, will participate in a fireside chat at the 24th Annual Needham Virtual Healthcare Conference on Thursday, April 10, 2025 at 11:00 AM EDT. The fireside chat will be webcast live and can be accessed by visitin ...

Core Insights - Lucid Diagnostics Inc. has launched a campaign titled "Embrace the Future" to promote its EsoCheck® Esophageal Cell Collection Device, coinciding with Esophageal Cancer Awareness Month and the upcoming Digestive Disease Week (DDW) Conference [1] - The EsoCheck device has demonstrated outstanding performance in nearly 30,000 patients, showcasing a pristine safety record and high patient satisfaction, with a procedure time of less than three minutes [2] - EsoCheck, when used with Lucid's EsoGuard® Esophageal DNA Test, has achieved an unprecedented negative predictive value (NPV) of approximately 99% in detecting esophageal precancer [2] Company Overview - Lucid Diagnostics 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 [4] - The company's EsoGuard® Esophageal DNA Test, performed on samples collected via the EsoCheck device, is the first and only commercially available tool aimed at preventing cancer through early detection of esophageal precancer in at-risk patients [4] Industry Context - Esophageal Cancer Awareness Month serves as a reminder of the approximately 16,000 annual deaths in the U.S. due to esophageal cancer, which is now considered preventable with modern technologies [3] - The traditional "sponge-on-a-string" (SOS) devices used for cell collection have been criticized for their poor performance and safety issues, leading to multiple FDA recalls, while EsoCheck offers a targeted and safe alternative [3]

Financial Performance - Recognized EsoGuard revenue of $1.2 million in Q4 2024, compared to $1.04 million in Q4 2023, marking a 15% year-over-year growth[10] - Operating expenses for Q4 2024 were approximately $13.6 million, including stock-based compensation expenses of $1.2 million[5] - GAAP net loss attributable to common stockholders was approximately $11.5 million or $(0.20) per common share for Q4 2024[5] - Non-GAAP adjusted loss for Q4 2024 was approximately $10.9 million or $(0.19) per common share[8] - Pro forma cash, including the first quarter 2025 common stock financing, is approximately $36.9 million at the start of 2025[8] - Completed a $22 million convertible debt refinancing and a $15.3 million common stock financing, yielding a total of $32.8 million in net proceeds[6] Product Performance and Development - Processed a record 4,042 EsoGuard tests in Q4 2024, representing a 45% sequential increase and an 84% annual increase[6] - EsoGuard is the first and only commercially available test for esophageal precancer screening, endorsed by updated clinical practice guidelines[15] - The EsoGuard assay demonstrated over 90% sensitivity and specificity in detecting esophageal precancer and cancer based on a study of 408 patients[16] - EsoCheck is a noninvasive device that collects esophageal cell samples in under three minutes, utilizing proprietary Collect+Protect™ technology[17] - Lucid Diagnostics targets millions of GERD patients at risk for esophageal precancer and cancer, aiming to prevent cancer deaths through early detection[18] - The EsoGuard test is based on Next Generation Sequencing (NGS) and quantifies methylation at 31 sites on two genes[16] Regulatory and Market Developments - Secured first positive commercial insurance coverage policy for EsoGuard from Highmark Blue Cross Blue Shield, establishing a precedent for additional coverage decisions[6] - Updated National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines now includes EsoGuard as an acceptable alternative for esophageal precancer screening[6] - Case Western Reserve University and University Hospitals received an $8 million NIH grant to study EsoGuard for expanded indications, potentially increasing the total addressable market beyond $60 billion[6] Company Overview and Strategy - The company is a subsidiary of PAVmed Inc., focusing on cancer prevention medical diagnostics[18] - Lucid Diagnostics emphasizes the importance of screening, as fewer than 10% of at-risk patients currently undergo traditional screening[14] - Lucid Diagnostics plans to continue advancing its products through regulatory submissions and market expansion efforts[20] Risks and Challenges - Lucid Diagnostics faces risks including stock price volatility, regulatory uncertainties, and market acceptance of its products[20] - The company has a CLIA-certified, CAP-accredited laboratory for conducting EsoGuard tests[17]

Financial Data and Key Metrics Changes - The company generated approximately $1.2 million in revenue for Q4 2024, reflecting a 15% increase compared to the same quarter last year [36][42]. - Test volume exceeded 4,000 tests in Q4, representing a record quarterly test volume and significantly higher than the target of 2,500 to 3,000 tests per quarter [9][36]. - The cash at year-end December 31, 2024, was $22.4 million, which, when combined with a recent $15 million financing, gives pro forma cash of about $37 million [30]. Business Line Data and Key Metrics Changes - The company has restructured its commercial team to focus on revenue-driving activities, including a concierge medicine cash-pay program that has signed 20 contracts in a few weeks [10][27]. - The EsoGuard test has been included in the NCCN Clinical Practice Guidelines, which is expected to drive positive policy coverage decisions from commercial payers [11][12]. Market Data and Key Metrics Changes - The total addressable market for EsoGuard is estimated at $60 billion, based on 30 million patients recommended for testing by existing guidelines [18]. - The company is actively engaging with payers across the country, having submitted claims to 400 payers and having numerous conversations with them [131]. Company Strategy and Development Direction - The company aims to enhance long-term shareholder value by focusing on expanding reimbursement and driving revenue through new sales channels [7][19]. - The strategic focus includes direct contracting with employers and a cash-pay program targeting concierge medicine practices [25][26]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting significant advancements in sales channels and reimbursement milestones that set the stage for a pivotal year in 2025 [8][28]. - The company is confident about the upcoming decision from the MolDX group regarding Medicare coverage, expecting a draft LCD that reflects a positive update [96]. Other Important Information - The company has received an $8 million NIH grant to study EsoGuard for expanded indications, which could significantly increase the total addressable market [15][69]. - The NCCN's inclusion of EsoGuard in its guidelines is seen as a powerful tool for securing positive policy coverage from commercial payers [102]. 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 [49][50]. Question: Why was the effective ASP lower than expected? - The lower ASP was attributed to the timing of payments rather than a direct reflection on payment rates, with a backlog of claims affecting revenue recognition [56][60]. Question: Can you size the opportunity from the $8 million NIH grant? - The opportunity is significant, with an estimated additional 20 million patients recommended for screening without GERD symptoms [69][70]. Question: What happens if Medicare coverage is approved? - Upon approval, the company plans to aggressively target Medicare patients and expects to submit a backlog of claims [88][120]. Question: How will NCCN inclusion help the company? - Inclusion in NCCN guidelines is expected to serve as a stamp of approval that will aid in discussions with commercial payers [102].

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 ...

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]