Lucid Diagnostics(LUCD)
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Lucid Diagnostics(LUCD) - 2025 Q2 - Quarterly Report
2025-08-12 21:29
Revenue and Financial Performance - The Company recognized revenue from the delivery of EsoGuard test results, with gross margin expected to fluctuate based on test volume and operating efficiencies [124][126]. - Revenue for the three months ended June 30, 2025, was $1.2 million, a 20% increase from $1.0 million in the same period of 2024, primarily due to higher consideration for EsoGuard Esophageal DNA Tests [135]. - Cost of revenue for the three months ended June 30, 2025, remained stable at approximately $1.6 million, unchanged from the prior year [136]. - The company experienced a net loss of approximately $31.3 million and used approximately $23.0 million of cash in operations during the six months ended June 30, 2025 [154]. - The company ended the quarter with cash on hand of $31.1 million as of June 30, 2025 [154]. - The company closed on the sale of 13,939,330 shares of common stock at $1.10 per share on March 5, 2025, generating net proceeds of approximately $14.9 million [156]. - The Company raised approximately $16.1 million from the sale of 14,375,000 shares at $1.20 per share in April 2025, intended for working capital [117]. - The company entered into an "at-the-market offering" for up to $25.0 million of its common stock, selling 215,421 shares for net proceeds of approximately $0.3 million in the six months ended June 30, 2025 [158]. Clinical and Research Developments - EsoGuard demonstrated a sensitivity of approximately 90% for detecting disease across the esophageal precancer to cancer spectrum, with a negative predictive value (NPV) of around 99% [109]. - The Company submitted a clinical evidence package to secure Medicare coverage for EsoGuard, which included six new peer-reviewed publications [112]. - A comprehensive esophageal precancer testing program using EsoGuard was launched by Hoag, a recognized healthcare delivery network [120]. - The Company received a positive coverage policy from Highmark Blue Cross Blue Shield for EsoGuard in New York state, effective May 26, 2025 [122]. - An $8 million NIH R01 grant was awarded to evaluate esophageal precancer detection using EsoCheck and EsoGuard among at-risk individuals without GERD symptoms [123]. - The diagnostic yield of Barrett's Esophagus detection increased by 2.4-fold in a study analyzing EsoGuard-positive patients compared to established performance goals [114]. Expenses and Operational Costs - General and administrative expenses are anticipated to increase as business operations grow, including costs related to being a public company [129]. - Sales and marketing expenses decreased to approximately $4.0 million in the three months ended June 30, 2025, down from $4.2 million, reflecting a net decrease of 4.8% primarily due to lower compensation costs [137]. - General and administrative expenses increased to approximately $5.6 million for the three months ended June 30, 2025, up from $4.9 million, marking a 14.3% increase attributed to various factors including research and development [138]. - Research and development costs for the three months ended June 30, 2025, were approximately $1.3 million, a slight decrease of 7.1% from $1.4 million in the prior year [138]. Market and Index Inclusion - The Company was added to the Russell 2000® and 3000® Indexes on June 27, 2025, following the annual reconstitution by FTSE Russell [119]. Other Financial Metrics - The change in fair value of convertible notes resulted in approximately $6.8 million of income for the three months ended June 30, 2025 [140].
Lucid Diagnostics to Hold a Business Update Conference Call and Webcast on August 13, 2025
Prnewswire· 2025-07-30 12:01
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]. Upcoming Conference Call - Lucid Diagnostics will host a business update conference call and webcast on August 13, 2025, at 8:30 AM ET [1]. - The call will feature Lishan Aklog, M.D., the Chairman and CEO, providing a business update and overview of the company's operations and growth strategy [1]. - Dennis McGrath, the CFO, will discuss the company's second quarter 2025 financial results during the call [1]. Access Information - The webcast will be available on the investor relations section of the company's website [2]. - U.S.-based callers can access the conference call by dialing 1-800-836-8184, while international listeners should dial 1-646-357-8785 [2]. - A replay of the conference call will be available for 30 days on the investor relations section of the company's website [3]. Product Information - Lucid's EsoGuard® Esophageal DNA Test is the first and only commercially available tool designed for early detection of esophageal precancer in at-risk patients [4]. - The test is performed on samples collected using the EsoCheck® Esophageal Cell Collection Device, which involves a brief, noninvasive office procedure [4].
MolDX to Convene Expert Medical Panel on Medicare Local Coverage Determination (LCD) for Lucid Diagnostics' EsoGuard® Esophageal DNA Test
Prnewswire· 2025-07-16 11:31
Group 1 - Lucid Diagnostics Inc. announced a virtual public meeting on September 4, 2025, to discuss the reconsideration of Local Coverage Determination (LCD) L39256 for its EsoGuard® Esophageal DNA Test [1] - The meeting will involve Medicare Administrative Contractors and medical experts, focusing on the clinical literature related to esophageal precancer testing [2] - Lucid's CEO expressed optimism about the meeting's potential to lead to a positive Medicare coverage policy outcome, citing broad consensus in the GI community regarding the clinical utility of EsoGuard [2] Group 2 - Lucid Diagnostics is a commercial-stage company focused on cancer prevention, specifically targeting patients with gastroesophageal reflux disease (GERD) at risk of esophageal precancer [3] - The EsoGuard® Esophageal DNA Test is designed for early detection of esophageal precancer through a noninvasive procedure, representing a significant advancement in cancer prevention tools [3]
Major California Health System Launches Comprehensive Esophageal Precancer Testing Program Using Lucid Diagnostics' EsoGuard® Esophageal DNA Test
Prnewswire· 2025-06-18 16:02
Core Viewpoint - Lucid Diagnostics has partnered with Hoag to enhance access to EsoGuard esophageal precancer testing, aiming to combat the rising incidence of esophageal cancer in Orange County [1][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 EsoGuard® Esophageal DNA Test is the first and only commercially available tool designed for early detection of esophageal precancer in at-risk patients, performed through a non-invasive office procedure [3]. Partnership Details - Hoag has launched a comprehensive esophageal precancer testing program using Lucid's EsoGuard test, integrating it into its digestive health, primary care, and concierge medicine programs [1]. - The partnership is seen as a significant milestone in expanding access to EsoGuard within large healthcare systems, with expectations that it will serve as a model for other health systems [2]. Industry Context - The incidence of esophageal cancer has increased tenfold over the past four decades, highlighting the need for effective screening methods [2]. - The EsoGuard test offers a 3-minute non-endoscopic procedure aimed at identifying at-risk patients, which is critical for early intervention and potentially saving lives [2]. Hoag Overview - Hoag is a nonprofit regional healthcare delivery system in Orange County, California, recognized for its comprehensive personalized care and consisting of 1,800 physicians, 17 urgent care facilities, and two award-winning hospitals [5]. - It is ranked as the highest hospital in Orange County by U.S. News & World Report and is known for its specialized services in various health areas, including cancer and digestive health [5].
Lucid Diagnostics(LUCD) - 2025 FY - Earnings Call Transcript
2025-06-18 16:00
Financial Data and Key Metrics Changes - The meeting confirmed that a majority of shares were represented, constituting a quorum for the voting process [9] - The preliminary vote tallies indicated that management nominees were elected as directors and the issuance of common stock under the senior secured convertible notes was approved [20] Business Line Data and Key Metrics Changes - The proposal to approve the issuance of shares under the senior secured convertible notes was discussed, with a majority of shares voting in favor [14][16] Market Data and Key Metrics Changes - No specific market data or key metrics were provided during the meeting Company Strategy and Development Direction and Industry Competition - The company is focused on maintaining compliance with Nasdaq listing rules and ensuring proper governance through the election of board members and the appointment of auditors [10][17] Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook during this meeting Other Important Information - The meeting was conducted via live webcast, allowing stockholders to vote and submit questions [3][4] - The final vote tallies will be disclosed in public filings with the SEC after the meeting [20] Q&A Session Summary - No questions were submitted during the meeting, and management indicated that they would respond to appropriate questions after the meeting [21]
Lucid Diagnostics Inc. (LUCD) Q1 2025 Business Update Call Transcript
Seeking Alpha· 2025-05-14 17:51
Core Viewpoint - Lucid Diagnostics Inc. provided a business update and financial results for Q1 2025 during a conference call, highlighting key developments and future outlooks for the company [1][2][3]. Group 1: Company Overview - The conference call featured key participants including Matt Riley (Senior Director of Investor Relations), Dr. Lishan Aklog (Chairman and CEO), and Dennis McGrath (CFO) [1][3]. - The press release detailing the business update and financial results is accessible on Lucid's official website [3]. Group 2: Financial Results - Specific financial metrics and performance indicators were likely discussed during the call, although detailed figures are not provided in the available text [1][2][3].
Lucid Diagnostics Inc. (LUCD) Reports Q1 Loss, Lags Revenue Estimates
ZACKS· 2025-05-14 14:16
Core Viewpoint - Lucid Diagnostics Inc. reported a quarterly loss of $0.16 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.09, marking an earnings surprise of -77.78% [1][2] Financial Performance - The company posted revenues of $0.83 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 36.31%, compared to revenues of $1 million in the same quarter last year [2] - Over the last four quarters, Lucid Diagnostics has not surpassed consensus EPS estimates and has topped revenue estimates only once [2] Stock Performance - Lucid Diagnostics shares have increased approximately 45.4% since the beginning of the year, significantly outperforming the S&P 500's gain of 0.1% [3] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.08 on revenues of $1.4 million, and for the current fiscal year, it is -$0.32 on revenues of $7 million [7] - The estimate revisions trend for Lucid Diagnostics is currently favorable, resulting in a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] Industry Context - The Medical - Instruments industry, to which Lucid Diagnostics belongs, is currently in the top 32% of over 250 Zacks industries, suggesting a positive outlook for stocks within this sector [8]
Lucid Diagnostics(LUCD) - 2025 Q1 - Earnings Call Transcript
2025-05-14 13:32
Financial Data and Key Metrics Changes - The company reported revenue of $800,000 for the first quarter, which fell short of expectations due to external headwinds and a greater concentration of testing through healthcare events [8][27] - The cash balance at the end of the first quarter was $25.2 million, which does not include the net proceeds from a recent public offering that raised approximately $16.1 million, bringing pro forma cash to over $41 million [23][11] - The non-GAAP net loss for the first quarter was $11.2 million, slightly higher than the trailing average of $10.8 million, with a non-GAAP net loss per share of $0.16 [29][28] Business Line Data and Key Metrics Changes - The company performed 3,034 EsoGuard tests in the first quarter, exceeding the target range of 2,500 to 3,000 tests [7] - The company doubled the number of contracts in its concierge medicine program and employer contracts in the first quarter [9][10] - The average allowable amount per test from adjudicated claims was approximately $13.62, with a median at the Medicare rate of $19.38 [32] Market Data and Key Metrics Changes - The company is experiencing delays in cash collections primarily from United Healthcare due to a national issue with a new claims processing system [27] - The percentage of Medicare volume is currently estimated at 10-15%, with a goal to increase this to 40% once Medicare coverage is secured [60][61] Company Strategy and Development Direction - The company is focused on driving commercialization of EsoGuard and enhancing long-term shareholder value, with a strong emphasis on securing Medicare coverage [5][6] - The company is actively engaging with regional commercial insurers to secure EsoGuard coverage and has seen positive developments with Highmark Blue Cross Blue Shield of New York [14][15] - The company is also targeting cash pay and contracted programs with concierge medicine practices and employers to diversify revenue streams [10][81] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the imminent Medicare coverage decision and believes it will significantly enhance commercialization efforts [38][40] - The company is preparing for a potential increase in test volumes and revenue once Medicare coverage is secured, while also managing cash burn effectively [70][82] - Management highlighted the importance of ongoing clinical studies to support expanded indications for EsoGuard, particularly in asymptomatic patients [44][46] Other Important Information - The company has secured a significant NIH grant for a larger study to replicate initial positive findings regarding EsoGuard's effectiveness in patients without GERD symptoms [46] - The company is actively involved in legislative efforts to promote biomarker testing coverage, although it acknowledges the challenges in translating state mandates into payer reimbursements [84][85] Q&A Session Summary Question: Impact of weather on Q1 volumes - Management indicated that there was no evidence that weather impacted volumes, noting a shift towards larger testing events which can create lumpier revenue [35][36] Question: Status of Medicare coverage discussions - Management confirmed ongoing engagement with the Medicare group and expressed confidence in the upcoming decision based on previous discussions [38][39] Question: Future studies related to EsoGuard - Management stated that additional data from the NIH study will be crucial for expanding clinical indications and market opportunities [41][46] Question: Trends in Medicare mix - Management noted that the current Medicare volume is lower than desired but plans to increase this significantly post-approval [60][61] Question: Marketing strategies for concierge medicine - Management explained that they are optimizing patient-facing materials and processes to effectively market EsoGuard within concierge practices [72][73] Question: Legislative efforts for biomarker testing - Management is actively engaged in legislative efforts to promote biomarker testing coverage but does not expect it to be a complete solution [84][85]
Lucid Diagnostics(LUCD) - 2025 Q1 - Earnings Call Transcript
2025-05-14 13:30
Financial Data and Key Metrics Changes - The company reported revenue of $800,000 for Q1 2025, which fell short of expectations due to external headwinds and a greater concentration of testing through healthcare events [8][28] - The cash balance at the end of Q1 was $25.2 million, which does not include the net proceeds from a recent public offering that added approximately $16.1 million, bringing pro forma cash to over $41 million [11][23] - The non-GAAP net loss for Q1 was $11.2 million, slightly higher than the trailing average, with a non-GAAP net loss per share of $0.16 [30] Business Line Data and Key Metrics Changes - The company performed 3,034 EsoGuard tests in Q1, exceeding the target range of 2,500 to 3,000 tests [7] - The company doubled the number of contracts in its concierge medicine program and employer contracts in the first quarter [9][10] - The quarterly test mix included larger testing events, which are more efficient but can lead to lumpier revenue recognition [37] Market Data and Key Metrics Changes - The company is experiencing delays in cash collections from United Healthcare due to a national issue with a new claims processing system, affecting revenue recognition [28] - Approximately 10-15% of the test volume is currently Medicare-related, with plans to increase this to 40% post-Medicare approval [60] Company Strategy and Development Direction - The company is focused on expanding its commercial efforts through concierge medicine and employer contracts while awaiting Medicare coverage [6][10] - The recent NCI-sponsored study showed EsoGuard's effectiveness in detecting esophageal precancer in patients without GERD symptoms, potentially expanding the target market by 70% [12][45] - The company is actively engaging with regional commercial insurers to secure EsoGuard coverage and has seen positive developments with Highmark Blue Cross Blue Shield [14][18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about securing Medicare coverage soon, which is expected to accelerate commercialization efforts [19][41] - The company is well-positioned financially to navigate any delays in Medicare coverage due to recent capital raises [70] - There is a growing understanding in the GI community regarding the importance of screening asymptomatic patients, which could lead to expanded market opportunities [44][45] Other Important Information - The company has a robust pipeline of regional plans and is leveraging new clinical guidelines to drive positive policy coverage decisions [16][17] - The company is preparing for a comprehensive EsoGuard testing program in partnership with a major health system, which includes a concierge medicine component [9][63] Q&A Session Summary Question: Impact of weather on Q1 volumes and expectations for Q2 - Management indicated that weather was not a factor in Q1 volumes and expects to maintain similar volume levels until broader coverage is achieved [36] Question: Status of Medicare coverage discussions - Management confirmed ongoing discussions with the Palmetto GBA group and expressed confidence in the imminent decision regarding Medicare coverage [38][41] Question: Future studies and data investment for EsoGuard - Management highlighted the importance of the ongoing NIH study to replicate initial findings and support expanded indications for EsoGuard [42][48] Question: Trends in Medicare mix and expectations - The current Medicare volume is around 10-15%, with plans to increase this significantly post-approval [60] Question: Visibility for large testing events for the rest of the year - The company has a strong pipeline for large testing events, primarily driven by fire departments and self-insured employers [96]
Lucid Diagnostics(LUCD) - 2025 Q1 - Quarterly Results
2025-05-14 12:20
Exhibit 99.1 Lucid Diagnostics Provides Business Update and Reports First Quarter 2025 Financial Results Processed 3,034 EsoGuard tests and recognized revenue of $0.8 million in 1Q25 Secured capital to extend runway well past key upcoming reimbursement milestones; ended 1Q25 with over $40 million in proforma cash Conference call and webcast to be held today, May 14, at 8:30 AM EDT NEW YORK, May 14, 2025 - Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention ...