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]

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].