Core Insights - Lucid Diagnostics has formed a strategic partnership with VITALExam to enhance access to its EsoGuard® Esophageal DNA Test for firefighters at risk of esophageal precancer [1][2] - The partnership aims to drive revenue through fully-contracted CheckYourFoodTube Precancer Testing Events, starting with an event at Tuscaloosa Fire Rescue [1][2] - Firefighters face a 62% increased risk of developing esophageal cancer and a 39% increased risk of dying from it, highlighting the need for early detection [3] 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 esophageal precancer and cancer [4] - The EsoGuard® Esophageal DNA Test is the first and only commercially available tool designed for early detection of esophageal precancer in at-risk patients [4] Partnership Details - The partnership with VITALExam is expected to enhance the health of first responders by integrating EsoGuard into their wellness programs [2] - VITALExam provides comprehensive medical care for first responders, including cancer screenings and physical assessments, utilizing advanced technology [2]

Financial Data and Key Metrics Changes - Revenue for Q3 2024 was $1.2 million, representing a 20% increase quarter-on-quarter and a 50% increase year-on-year, marking a record quarterly revenue for the company [8][42] - Test volume for Q3 was 2,787, with a trailing three-month total of approximately 3,500 tests, the largest since the company's inception [42][43] - The quarterly burn rate was $10.4 million, consistent with the previous quarters, and included $7.3 million from ongoing operations [35] Business Line Data and Key Metrics Changes - The company has expanded its direct contracting initiatives, including the "Check Your Food Tube" events, which have tested over 7,000 firefighters with EsoGuard [9][10] - EsoGuard's gross margin per test remains over 90%, with a substantial commercial opportunity targeting approximately 30 million at-risk patients [15][16] Market Data and Key Metrics Changes - The total addressable market for EsoGuard is approximately $60 billion, with Medicare pricing established at $1,938 [15] - The company has seen a significant increase in claims submitted, with nearly 2,800 claims submitted in Q3, reflecting just under $7 million in pro forma revenue [49][50] Company Strategy and Development Direction - The company is focused on securing Medicare coverage for EsoGuard, having completed a comprehensive clinical evidence package and held productive meetings with the CMS [10][20] - Strategic initiatives include targeting concierge medicine and employer markets to drive contractually guaranteed revenue [22][27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the upcoming submission for Medicare coverage, anticipating it to be a first-half event for next year [80] - The company is confident in its data package for both Medicare and commercial payers, which is expected to facilitate broader coverage discussions [88] Other Important Information - Cash at the end of Q3 was $14.5 million, with plans to increase cash runway by more than a quarter through new convertible note agreements [31][33] - The company has maintained a flat sales team headcount while focusing on revenue-driving programs [16][59] Q&A Session Summary Question: What caused the sequential decline in test volume in Q3? - Management noted that July had fewer large events due to summer, but volumes picked up in August and September, with October showing strong results [56][57] Question: Will Q4 be a record volume quarter? - Management indicated that while October was strong, holiday periods in December could affect volume predictability, but overall adoption is expanding [58][60] Question: What is the strategy for concierge medicine? - The company is entering the concierge medicine market, leveraging data and experience from previous employer market efforts to engage with practices [62][66] Question: What is the timeline for submitting the data package for Medicare coverage? - Management expects to submit the data package soon, with a high level of confidence in the outcome [79][80] Question: How will marketing strategy change with Medicare coverage? - The company plans to direct resources towards the Medicare population, which could increase revenue from that segment significantly [86][87] Question: How does pricing work in the concierge market? - Pricing will start at $2,500, with negotiations based on what practices believe their patients will pay, as this is a cash-pay model [84][85]

Nasdaq: LUCD Q3 2024 Business Update November 13, 2024 Lishan Aklog MD Dennis McGrath Chairman & CEO CFO Disclaimer ▪ 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 events discussed in forwardlooking statements. ▪ Factors that might cause or contribute to such differences include, but are not limited to, those discussed in "Risk Fa ...

Financial Performance - EsoGuard revenue for Q3 2024 was $1.2 million, representing a 20% sequential increase from Q2 2024 and a 50% increase year-over-year from Q3 2023[5]. - Operating expenses for Q3 2024 were approximately $12.9 million, including stock-based compensation expenses of $1.2 million[9]. - GAAP net loss attributable to common stockholders for Q3 2024 was approximately $12.4 million, or $(0.25) per common share[9]. - Non-GAAP adjusted loss for Q3 2024 was approximately $10.1 million, or $(0.20) per common share[10]. - As of September 30, 2024, the company had cash and cash equivalents of $14.5 million, down from $18.9 million as of December 31, 2023[11]. - The company entered into subscription agreements for $21.75 million of five-year Senior Secured Convertible Notes, expecting to increase its cash runway by approximately $13.2 million[11]. Clinical and Product Development - The clinical laboratory performed 2,787 commercial EsoGuard tests in Q3 2024, with a record of over 1,400 tests in October 2024, contributing to the largest three-month total in the company's history[5]. - The EsoGuard BE-1 clinical validation study was accepted for peer-reviewed publication, completing the clinical evidence package for Medicare coverage submission[6]. - EsoGuard is the first and only commercially available test for early detection of esophageal precancer in at-risk GERD patients, with over 90% sensitivity and specificity[21]. - EsoCheck is a noninvasive device that collects esophageal cell samples in under three minutes, utilizing proprietary Collect+Protect™ technology[22]. - The updated clinical practice guidelines endorse non-endoscopic biomarker tests as an acceptable alternative to invasive endoscopy for esophageal precancer screening[20]. Market and Strategic Initiatives - The company is expanding its direct contracting initiative with multiple programs aimed at driving near-term revenue growth[7]. - A Notice of Allowance for a key patent underlying EsoGuard was received, enhancing the company's intellectual property position[8]. - Lucid Diagnostics is focused on the millions of GERD patients at risk of esophageal precancer and cancer, aiming to prevent cancer deaths through early detection[23]. - Lucid Diagnostics is a subsidiary of PAVmed Inc., emphasizing its commitment to cancer prevention through innovative diagnostic solutions[23]. Industry Context and Challenges - The incidence of esophageal adenocarcinoma (EAC) has increased by 500% over the past four decades in the U.S., highlighting the urgent need for effective screening[20]. - Less than 10% of recommended GERD patients undergo traditional invasive endoscopic screening, indicating a significant gap in early detection[19]. - The company faces risks including market acceptance, regulatory approvals, and funding needs, which could impact future operations[25]. - Lucid Diagnostics disclaims any obligation to update forward-looking statements, reflecting the inherent uncertainties in their business[25].

Financial Performance - For the three months ended September 30, 2024, revenue was $1.2 million, an increase of 50% compared to $0.8 million for the same period in 2023[159]. - For the nine months ended September 30, 2024, revenue was $3.1 million, a significant increase of 121.4% compared to $1.4 million for the same period in 2023[167]. - The company experienced a net loss of approximately $34.0 million and used approximately $34.3 million of cash in operations during the nine-month period ended September 30, 2024[180]. - As of September 30, 2024, the company had cash on hand of $14.5 million and expects to continue experiencing recurring losses and negative cash flow from operations[180]. Expenses - The cost of revenue for the same period was approximately $1.7 million, up from $1.6 million, with a net increase of $0.1 million primarily due to increased third-party professional and IT-related expenses[160]. - Sales and marketing expenses for the three months ended September 30, 2024, were approximately $4.1 million, an increase of 7.9% from $3.8 million in the prior year[161]. - General and administrative expenses increased to approximately $5.4 million from $4.3 million, reflecting a net increase of $1.1 million primarily due to growth and expansion of business operations[161]. - Research and development expenses for the three months ended September 30, 2024, were approximately $1.7 million, compared to $1.6 million for the same period in the prior year, indicating a slight increase[162]. - The cost of revenue for the nine months ended September 30, 2024, was approximately $5.0 million, up from $4.5 million, with a net increase of $0.5 million attributed to various factors including increased compensation-related costs[168]. - Sales and marketing costs for the nine months ended September 30, 2024, were approximately $12.5 million, a slight increase of 4.2% from $12.0 million in the prior year[169]. - General and administrative costs decreased to approximately $14.3 million from $15.0 million, reflecting a net decrease of $0.7 million primarily due to a reduction in stock-based compensation[170]. - Research and development costs for the nine months ended September 30, 2024, were approximately $4.5 million, down from $5.3 million, indicating a decrease of $0.8 million[171]. Capital and Financing - The Company increased its authorized shares from 200,000,000 to 300,000,000, approved at the annual stockholders meeting[139]. - The Company plans to redeem the March 2023 Senior Convertible Note and has entered into a securities purchase agreement for 12.0% senior secured convertible notes due 2029[142]. - The company raised $18.16 million through the Series B Preferred Stock offering, selling 12,495 shares at a purchase price of $1,000 per share[181]. - The company issued approximately 11,634 shares of Series B-1 Preferred Stock, raising gross proceeds of $11.6 million[183]. - The company entered into a committed equity facility allowing for the purchase of up to $50 million of its common stock, with net proceeds of approximately $1.8 million raised as of September 30, 2024[190]. - The company is subject to financial covenants under the March 2023 Senior Convertible Note, requiring available cash to equal or exceed $5.0 million at all times[185]. Product Development and Market Strategy - EsoGuard Esophageal DNA Test demonstrates approximately 90% sensitivity and ~99% negative predictive value for detecting esophageal precancer and cancer[128]. - EsoGuard's recent study showed sensitivity of ~88% and negative predictive value of ~99% for Barrett's Esophagus detection, with specificity at ~81%[132]. - The Company received a Notice of Allowance for a patent covering its method of using methylation of the CCNA1 gene, a key component of EsoGuard[139]. - EsoCheck is an FDA 510(k) and CE Mark cleared device for noninvasive esophageal cell sampling, enhancing the diagnostic process[129]. - The Company has developed proprietary technology for targeted esophageal cell collection, ensuring contamination-free sampling[129]. - The Company is focused on expanding its market presence in cancer prevention diagnostics, particularly for esophageal adenocarcinoma[126]. - The company plans to pursue the development of other products and services as resources permit, focusing on the commercialization of EsoGuard[179]. - The company is actively working to expand insurance reimbursement coverage for its EsoGuard Esophageal DNA Test, which is critical for revenue generation[179]. Compliance and Regulatory - The Company aims to regain compliance with Nasdaq listing standards by addressing the closing bid price issue below $1 per share[138]. - The Company has increased the monthly fee in its management services agreement with PAVmed from $0.83 million to $1.05 million[133]. - The company expects to complete the issuance of the November 2024 Senior Convertible Notes and the redemption of the March 2023 Senior Convertible Note by the end of the Optional Redemption Notice Period[188].

Request for insurance coverage aims to enhance early detection and treatment of esophageal precancer to prevent highly lethal esophageal cancer NEW YORK, Aug. 13, 2024 /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 the American Foregut Society (AFS), a leading society of gastroenterologists and surgeons collaborating to improve patient outcome ...

Real-world data confirms utility of EsoGuard as a non-invasive triage tool to significantly increase positive yield of invasive upper endoscopy NEW YORK, Aug. 6, 2024 /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 the release of new real-world data from its ENVET-BE study supporting the clinical utility of the EsoGuard® Esophageal DNA test as a no ...

NEW YORK, Aug. 5, 2024 /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 management will participate in the following upcoming investor conferences: 9th Annual Needham Virtual MedTech & Diagnostics 1x1 Conference Dates: August 12-13, 2024 Canaccord Genuity 44th Annual Growth Conference Fireside Chat: Tuesday, August 13, 2024, at 1:30 PM ET The ...

Conference Call and Webcast at 8:30AM Eastern Time Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company's website at luciddx.com. For more information, please visit www.luciddx.com and for more information about its parent company PAVmed, please visit www.pavmed.com. The webcast will be available at the investor relations section of the Company's website at luciddx.com. Alternatively, to access the conference call by telepho ...

"Our commercial and clinical teams remain relentlessly focused on expanding awareness of, demand for and access to EsoGuard esophageal precancer testing at physician offices, integrated health systems and #CheckYourFoodTube testing events," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. About Lucid Diagnostics This press release includes forward-looking statements that involve risk and uncertainties. Forward-looking statements are any statements that are not historical facts. Such fo ...