Summary of Lucid Diagnostics Conference Call Company Overview - **Company**: Lucid Diagnostics (NasdaqCM: LUCD) - **Industry**: Medical diagnostics, specifically focusing on esophageal cancer detection through the EsoGuard test Key Points and Arguments 1. **Positive Outcome of MOLDEX CAC Meeting**: The recent Contractor Advisory Committee (CAC) meeting was overwhelmingly positive, with broad clinician support for EsoGuard, exceeding expectations [4][5][6] 2. **Clinical Need and Evidence**: There is a strong clinical need for EsoGuard, supported by a robust body of clinical evidence. Medical experts unanimously agreed that Medicare should cover the test for detecting precancerous conditions [5][6][8] 3. **EsoGuard's Performance**: EsoGuard has a 99% negative predictive value, making it a reliable rule-out test for esophageal precancer and cancer. The test is designed to avoid unnecessary endoscopies for the majority of patients [16][20][24] 4. **Consensus on Clinical Validity**: The test performs well across various conditions, including short-segment Barrett's esophagus, which is critical as a significant portion of the target population has this condition [22][24] 5. **Unmet Screening Needs**: Only about 10% of eligible patients currently undergo screening for esophageal cancer, compared to 40-50% for colorectal cancer. Increasing this percentage could save thousands of lives annually [51][54] 6. **Patient Compliance**: EsoGuard has shown to improve patient compliance for follow-up endoscopies, with 85% of patients referred for endoscopy actually undergoing the procedure [32][33] 7. **Guidelines and Support**: Major gastroenterology societies support non-endoscopic testing like EsoGuard, which aligns with established guidelines for managing patients with precancerous conditions [36][38] 8. **Next Steps for Coverage**: The publication of a draft Local Coverage Determination (LCD) is expected, indicating a move towards Medicare coverage for EsoGuard. This is seen as a significant milestone for the company [44][46][49] Additional Important Insights 1. **Real-World Clinical Experience**: Primary care physicians and gastroenterologists shared their positive experiences with EsoGuard, emphasizing its utility in practice and the ease of incorporating it into patient care [39][40][61] 2. **Addressing Endoscopy Deserts**: The discussion highlighted the challenges faced by patients in rural areas who lack access to endoscopy services, underscoring the need for non-invasive testing options like EsoGuard [27][64] 3. **Future Opportunities**: There is potential for expanding the use of EsoGuard to asymptomatic patients, supported by ongoing research and grants [58][60] 4. **Marketing and Implementation**: The company has been actively marketing EsoGuard to primary care physicians, emphasizing its non-invasive nature and the importance of early detection in high-risk populations [59][61] This summary encapsulates the key discussions and insights from the Lucid Diagnostics conference call, focusing on the company's strategic direction, clinical evidence, and the potential impact of EsoGuard in the medical diagnostics landscape.

Summary of Lucid Diagnostics (LUCD) Conference Call Company Overview - **Company**: Lucid Diagnostics Inc. - **Industry**: Cancer prevention and diagnostics - **Product**: EsoGuard® molecular diagnostic test for detecting esophageal precancer non-invasively in office settings [1][4] Key Points and Arguments 1. **Medicare Coverage Progress**: - Lucid Diagnostics is in the late stages of securing Medicare coverage for the EsoGuard® test, having worked closely with the Multi-X group for several years [4][5] - A recent multi-jurisdictional Contractor Advisory Committee meeting provided clinical context to the evidence submitted, which included multiple studies on clinical validity and utility [5][6] 2. **Clinical Validity and Utility**: - The test has a negative predictive value of 99% and a positive predictive value that enhances patient compliance for endoscopy [6][7] - Patients with a positive EsoGuard test have double the compliance rate for endoscopy, leading to a nearly threefold increase in diagnostic yield [7][8] 3. **Impact of Esophageal Cancer**: - Esophageal cancer is highlighted as a significant health issue, with a high mortality rate, emphasizing the need for effective early detection [9][10] 4. **Next Steps for Coverage**: - The next milestone is the publication of a draft Local Coverage Determination (LCD), which indicates a positive direction towards coverage [19][20] - Following the draft, there will be a 45-day comment period before finalization [23] 5. **Commercialization Strategy**: - Lucid Diagnostics plans to target Medicare patients more aggressively, as historically only 10-15% of their patients were Medicare beneficiaries [24][25] - The company is also engaging with commercial payers and has begun securing contracts with regional plans [26][27] 6. **Sales Force and Operational Efficiency**: - The company intends to maintain a cautious approach with its existing sales force while ensuring operational efficiency [29] - The Medicare payment rate is set at $1,938, with a cost of goods at $1,200, providing a favorable margin for the business [30] 7. **Patient Awareness and Education**: - Lucid Diagnostics is focused on educating patients about the link between heartburn and esophageal cancer, which is crucial for driving test adoption [34][36] - The company has plans for direct-to-consumer marketing once broader coverage is achieved [35] 8. **Future Research and Development**: - Ongoing clinical studies, including a significant NIH study, aim to expand market opportunities for the EsoGuard test [39] - The company is exploring potential markets in Europe, particularly the UK, where there is growing awareness of esophageal cancer [41] 9. **Key Catalysts for Next Year**: - Securing Medicare coverage and increasing the proportion of Medicare patients to align with the target population [42] Additional Important Content - The meeting included discussions with leading medical experts, emphasizing the importance of clinical context in diagnostics [6][18] - Anecdotal evidence from physicians highlighted the effectiveness of the EsoGuard test in identifying precancerous conditions, showcasing its potential life-saving impact [10][11]

Core Points - Lucid Diagnostics Inc. will host a conference call on September 8, 2025, at 8:30 AM ET to discuss the recent Contractor Advisory Committee meeting regarding the reconsideration of Local Coverage Determination for its EsoGuard® Esophageal DNA Test [1][2] - The EsoGuard® test is aimed at patients with GERD who are at risk of developing esophageal precancer and cancer, utilizing a noninvasive procedure for early detection [4] Company Overview - Lucid Diagnostics is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc. [4] - The company focuses on early detection of esophageal precancer in at-risk patients through its EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device [4]

Company Overview - Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc. [3] - The company focuses on patients with GERD (chronic heartburn) who are at risk of developing esophageal precancer and cancer [3]. Product Information - Lucid's flagship product is the EsoGuard® Esophageal DNA Test, which is performed using the EsoCheck® Esophageal Cell Collection Device [3]. - These tools are designed for the early detection of esophageal precancer in at-risk patients, aiming to prevent esophageal cancer and related deaths [3]. Upcoming Event - Lishan Aklog, M.D., Chairman and CEO of Lucid, will participate in a fireside chat at the Cantor Global Healthcare Conference 2025 on September 5, 2025, at 8:35 AM EDT [1][2]. - The event will be available via live and archived webcast, accessible through the company's Investor Relations section [2].

Core Insights - PAVmed Inc. has provided a business update highlighting its financial results and developments within its subsidiaries, Lucid Diagnostics and Veris Health, for the second quarter of 2025 [1][4] Financial Performance - Lucid Diagnostics recognized $1.2 million in revenue from 2,756 EsoGuard® tests processed in Q2 2025 [7] - The company strengthened its balance sheet with a public offering that netted approximately $16.1 million, extending its financial runway into 2026 [7] - PAVmed reported a net loss attributable to common stockholders of approximately $13.3 million for the three months ended June 30, 2025, translating to a loss of $(0.74) per diluted share [10] Business Developments - Lucid initiated patient testing under a new commercial insurance coverage policy from Highmark Blue Cross Blue Shield, effective May 26, 2025 [7] - Veris Health completed a $2.5 million direct equity financing, allowing it to fund the development of its implantable physiological monitor through FDA clearance [7] - Veris is advancing towards regulatory clearance for its implantable monitor and is integrating with The Ohio State's James Cancer Hospital for commercial deployment [7] Strategic Partnerships and Initiatives - PAVmed is actively evaluating new opportunities to leverage its platform and diversify its portfolio, including discussions with academic medical centers [7] - Lucid partnered with Hoag to launch a comprehensive EsoGuard esophageal precancer testing program [7] Conference Call Information - A conference call and webcast were scheduled for August 14, 2025, to discuss the business update and financial results [2][3]

Summary of Lucid Diagnostics Conference Call Company Overview - **Company**: Lucid Diagnostics - **Founded**: 2018 - **Technology**: Focuses on detecting precancerous conditions for esophageal cancer, which is the second most deadly cancer [3][4] Industry Context - **Esophageal Cancer**: High mortality rate; early detection is crucial for prevention [4][5] - **Target Population**: Patients with heartburn and at least three out of six risk factors (e.g., over 50, white male, obese, smoker, family history) have about a 10% chance of having precancer [6] Core Technology and Testing Method - **Testing Method**: Non-invasive molecular test using a swallowable balloon capsule to collect samples from the lower esophagus [7][8] - **Performance Metrics**: - 99% negative predictive value [9] - 80% of patients can avoid invasive tests [10] - Approximately 40,000 tests performed to date [11] Financial and Coverage Insights - **Medicare Payment**: Established at $19.38 in 2021; ongoing efforts to secure coverage from Medicare and commercial payers [12] - **Current Testing Volume**: Approximately 2,756 tests in the latest quarter, a decrease from previous quarters due to waiting for coverage [14][15] - **Claim Denials**: About 83% of claims were denied in the quarter, primarily due to lack of medical policy coverage [20][21] Strategic Focus - **Coverage Strategy**: Engaging with payers to secure coverage; significant focus on building a clinical evidence package [12][19] - **Regional Plans**: Increased engagement with regional commercial plans, which are more willing to discuss coverage [24] - **Health System Partnerships**: Long-term partnerships with health systems to integrate testing into broader cancer prevention programs [25][26] Future Outlook - **Medicare Coverage Anticipation**: Expecting to secure Medicare coverage soon, which will allow for increased test volume and revenue growth [30][72] - **Market Opportunity**: Approximately 30 million patients recommended for screening, with 40-50% being Medicare age [30] - **Revenue Growth**: Anticipated solid revenue growth next year, with plans to ramp up operations post-Medicare approval [70][72] Competitive Landscape - **Comparison with Other Tests**: Lucid's test is positioned as more effective than sponge-based devices and blood tests for detecting precancerous conditions [82][88] - **Partnership Potential**: Opportunities for collaboration with other companies in the space to enhance market reach [81] Conclusion - **Growth Potential**: Lucid Diagnostics is poised for significant growth with the anticipated Medicare coverage and increasing commercial payer engagement, targeting a substantial market opportunity in esophageal cancer prevention [90][91]

Company Performance - Lucid Diagnostics Inc. reported a quarterly loss of $0.1 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.09, representing an earnings surprise of -11.11% [1] - The company posted revenues of $1.16 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 29.22%, compared to revenues of $0.98 million a year ago [2] - Over the last four quarters, Lucid Diagnostics has not surpassed consensus EPS estimates, but it has topped consensus revenue estimates twice [2] Stock Movement and Outlook - Lucid Diagnostics shares have increased approximately 21.8% since the beginning of the year, outperforming the S&P 500's gain of 9.6% [3] - The company's future stock performance will largely depend on management's commentary during the earnings call and the earnings outlook [4][6] - The current consensus EPS estimate for the upcoming quarter is -$0.09 on $1 million in revenues, and for the current fiscal year, it is -$0.41 on $5 million in revenues [7] Industry Context - The Medical - Instruments industry, to which Lucid Diagnostics belongs, is currently ranked in the bottom 39% of over 250 Zacks industries, indicating potential challenges ahead [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact Lucid Diagnostics' stock performance [5]

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $1,200,000, representing a 40% increase from Q1 and matching the previous quarterly high [10][43] - Cash at the end of Q2 was $31,100,000, with a quarterly burn rate of $10,300,000, slightly better than the average burn rate of the previous four quarters [40][41] - Non-GAAP net loss for Q2 was $9,900,000, an improvement of $1,200,000 sequentially [46] Business Line Data and Key Metrics Changes - EtherCAT test volume for Q2 was 2,756 tests, within the target range of 2,500 to 3,000 tests per quarter [8] - The company invoiced nearly $7,000,000 for 2,756 tests, recognizing revenue of approximately $1,200,000, which reflects a 40% sequential increase and a 19% year-over-year increase [43][48] Market Data and Key Metrics Changes - Approximately 40% of the revenue recognized in Q2 was from claims submitted in prior quarters, indicating a lag in revenue collection due to the reimbursement process [48] - The pending Medicare approval decision impacts 40% to 50% of the addressable patient population, significantly affecting future revenue recognition [45] Company Strategy and Development Direction - The company is focused on securing Medicare coverage for EsoGuard, viewing the upcoming CAC meeting as a critical step towards achieving this goal [6][19] - Strategic partnerships, such as the one with HOGUE health system, are being leveraged to enhance commercial execution and expand market reach [10][11] - The company aims to increase its Medicare patient volume significantly once coverage is secured, with proactive steps already being taken to prepare for commercialization [37][60] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the upcoming CAC meeting, viewing it as a strong indicator of progress towards a positive Medicare coverage policy outcome [7][20] - The company is confident in its clinical evidence and the utility of its tests, expecting positive feedback from the expert opinions during the CAC meeting [33][55] - Management highlighted the importance of the recent Highmark Blue Cross Blue Shield coverage policy as a precedent for engaging with other commercial payers [14][78] Other Important Information - The company completed a public offering that netted $16,100,000, strengthening its balance sheet and extending its runway into 2026 [16][40] - A pilot study published in the American Journal of Gastroenterology showed promising results for EsoGuard, indicating potential for a larger addressable market [17][19] Q&A Session Summary Question: Insights on the multi-jurisdictional CAC meeting - Management indicated that the coordinated effort among Medicare contractors is a positive sign, suggesting they are in the late stages of the coverage determination process [52][54] Question: Percentage of business from Medicare - Currently, Medicare accounts for about 10% to 15% of testing volume, with plans to increase this significantly post-Medicare coverage approval [58][60] Question: Timing expectations post-CAC meeting - Management expects a draft LCD to be published relatively quickly after the CAC meeting, with a hopeful timeline for finalization in early 2026 [71][72] Question: Feedback from MolDX regarding the CAC meeting - Management emphasized the importance of the CAC meeting for supplementing clinical evidence with expert opinions, which is crucial for achieving consensus among the MACs [88][89]

Financial Performance - Processed 2,756 EsoGuard tests and recognized revenue of $1.2 million for Q2 2025[5] - Ended Q2 2025 with over $30 million in proforma cash, extending runway into 2026[7] - Operating expenses for Q2 2025 were approximately $12.5 million, including stock-based compensation of $1.1 million[7] - GAAP net loss attributable to common stockholders was approximately $7.9 million, or $(0.08) per share[7] - Non-GAAP adjusted loss for Q2 2025 was approximately $9.9 million, or $(0.10) per share[7] - Strengthened balance sheet with a public offering netting approximately $16.1 million in proceeds[7] Market Developments - Initiated patient testing under the first positive commercial insurance coverage policy for EsoGuard from Highmark Blue Cross Blue Shield effective May 26, 2025[7] - Joined the Russell 2000 and Russell 3000 Indexes effective June 27, 2025, enhancing visibility to institutional investors[7] - A study published in the American Journal of Gastroenterology supports EsoGuard's effectiveness, indicating a potential market opportunity increase of up to 70%[7] - Upcoming MolDx CAC meeting on September 4, 2025, to discuss Medicare coverage for EsoGuard[5] Risks and Challenges - Lucid Diagnostics' management acknowledges risks and uncertainties that could impact future results, including stock price volatility and market conditions[16] - The company faces challenges in research and development, particularly regarding the costs and timelines for regulatory submissions[16] - Regulatory authorities' satisfaction with clinical and preclinical study designs and results is crucial for product clearance[16] - Market acceptance of Lucid Diagnostics' products post-clearance is a significant factor for future success[16] - The ability to raise additional funding as needed is essential for ongoing operations and development[16] - New risks and uncertainties may arise, complicating accurate predictions of future performance[16] - The company disclaims any obligation to update or revise forward-looking statements based on changes in expectations or circumstances[16]

Core Insights - Lucid Diagnostics Inc. reported a revenue of $1.2 million for EsoGuard tests in Q2 2025, processing a total of 2,756 tests, and ended the quarter with over $30 million in proforma cash, extending its financial runway into 2026 [1][6][9] - A significant Multi-Jurisdictional Contractor Advisory Committee (CAC) meeting regarding Medicare Local Coverage Determination (LCD) for EsoGuard is scheduled for September 4, 2025, which is seen as a critical step towards securing positive Medicare coverage [1][4][6] - The company has strengthened its balance sheet through a public offering, netting approximately $16.1 million in proceeds, and has initiated patient testing under a new commercial insurance coverage policy from Highmark Blue Cross Blue Shield [4][6][9] Business Highlights - The upcoming MolDx CAC meeting is viewed as a major milestone for Lucid, with expectations of strong support from medical experts for the clinical utility of EsoGuard [4] - Lucid has partnered with Hoag to launch a comprehensive EsoGuard testing program, enhancing access for at-risk patients [6] - A study sponsored by the National Cancer Institute (NCI) has shown that EsoGuard effectively detects esophageal precancer in patients without GERD symptoms, potentially increasing market opportunities by up to 70% [6] Financial Results - For the three months ended June 30, 2025, Lucid reported revenues of $1.2 million, with operating expenses of approximately $12.5 million, leading to a GAAP net loss of about $7.9 million or $(0.08) per share [9][10] - The non-GAAP adjusted loss for the same period was approximately $9.9 million or $(0.10) per share, reflecting the impact of stock-based compensation and other non-cash expenses [9][10] - Cash and cash equivalents stood at $31.1 million as of June 30, 2025, compared to $22.4 million at the end of 2024, indicating improved liquidity [9]