Financial Data and Key Metrics Changes - The company reported a non-GAAP loss of $9.4 million for Q1 2024, reflecting a $500,000 sequential improvement compared to Q4 2023 and a $400,000 improvement year-over-year [15][37] - Revenue for Q1 2024 was just over $1 million, flat compared to Q4 2023 but representing a 124% increase year-over-year [38][95] - The average quarterly burn rate for the trailing four quarters was $9.5 million, with Q1 2024 burn including $7 million from ongoing operations and $2.5 million from a management services agreement [37][67] Business Line Data and Key Metrics Changes - Test volume for Q1 2024 was 2,420 tests, a 10% increase quarter-over-quarter and a 31% increase year-over-year [38][95] - The gross margin at current volumes is approximately 90%, facilitating the business's ability to generate revenue [97] - The company has implemented a streamlined telehealth operation to enhance testing efficiency, particularly during high-volume health events [7][95] Market Data and Key Metrics Changes - The total addressable market opportunity for the company's tests is approximately $50 billion, with over 30 million patients at risk for esophageal cancer [6] - The average allowed amount for out-of-network claims remains stable at just under the Medicare rate of $1,938 per test [76][99] - Approximately 75% of claims submitted have been adjudicated, with nearly half resulting in an allowable amount by insurance companies [128] Company Strategy and Development Direction - The company is focused on securing medical policy coverage with regional plans and engaging in direct contracting with self-insured entities [60][80] - The company plans to ramp up its direct contracting initiatives during the second half of the year, targeting large groups of patients [79] - The company is actively pursuing biomarker legislation states to enhance coverage opportunities [9][80] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the upcoming MolDX pre-submission meeting scheduled for July 17, which aims to secure coverage for EsoGuard [60][116] - The management highlighted the importance of improving revenue cycle management processes, including prior authorization programs to reduce denials [67][76] - The company is confident in its technology's ability to detect pre-cancer effectively, which is critical for impacting cancer death rates [64][77] Other Important Information - The company completed a $29.8 million Series B preferred stock offering, strengthening its balance sheet and extending its operational runway [75][76] - The company has not experienced any device failures with EsoCheck in over 10,000 tests, contrasting with issues faced by competitors [68][84] - The company is preparing for a significant presence at the upcoming DDW meeting, which is a major event in the gastroenterology field [47][98] Q&A Session Summary Question: What are the expectations for the upcoming MolDX pre-submission meeting? - The meeting aims to review data with the MolDX group for a technical assessment seeking coverage of EsoGuard under Medicare [108] Question: Can you provide an update on the reimbursement landscape? - Approximately 75% of claims submitted have been adjudicated, with nearly half resulting in allowable amounts, indicating progress in the reimbursement process [128] Question: How does the company view the competitive landscape, especially with recent recalls in the industry? - The company believes that recent issues faced by competitors, such as the Cytosponge recall, may provide a competitive advantage for its products [119][120]

Part I - Financial Information This section provides Lucid Diagnostics Inc.'s unaudited condensed consolidated financial statements and management's discussion and analysis for the three months ended March 31, 2024 [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents Lucid Diagnostics Inc.'s unaudited condensed consolidated financial statements for Q1 2024 and 2023, including balance sheets, statements of operations, equity changes, cash flows, and detailed notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity at specific points in time | Metric (in thousands) | March 31, 2024 | December 31, 2023 | | :-------------------- | :------------- | :---------------- | | Total Assets | $32,048 | $27,270 | | Total Liabilities | $20,154 | $29,581 | | Total Stockholders' Equity (Deficit) | $11,894 | $(2,311) | - Total assets increased by **$4,778 thousand**, driven by a rise in cash from **$18,896 thousand** to **$24,769 thousand**[9](index=9&type=chunk) - Total liabilities decreased significantly by **$9,427 thousand**, primarily due to a reduction in 'Due To: PAVmed Inc.' and the Senior Secured Convertible Note[9](index=9&type=chunk) - Stockholders' Equity shifted from a deficit of **$(2,311) thousand** to a positive **$11,894 thousand**[9](index=9&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section outlines the company's financial performance over a period, detailing revenues, expenses, and net loss | Metric (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------- | :-------------------------------- | :-------------------------------- | | Revenue | $1,001 | $446 | | Total Operating Expenses | $11,793 | $14,763 | | Operating Loss | $(10,792) | $(14,317) | | Net Loss attributable to Lucid Diagnostics Inc. | $(10,612) | $(16,247) | | Net Loss per share (basic and diluted) | $(0.40) | $(0.40) | - Revenue increased by **124.4%** year-over-year[11](index=11&type=chunk) - Total operating expenses decreased by **20.1%** due to lower general and administrative expenses and research and development[11](index=11&type=chunk) - The net loss attributable to Lucid Diagnostics Inc. improved by **34.6%** from **$(16,247) thousand** to **$(10,612) thousand**, despite a deemed dividend on preferred stock in 2024[11](index=11&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(Deficit)) This section details the changes in the company's equity over time, including preferred stock, common stock, and accumulated deficit | Metric (in thousands) | Balance as of Dec 31, 2023 | Balance as of Mar 31, 2024 | | :-------------------- | :------------------------- | :------------------------- | | Preferred Stock Amount | $18,625 | $44,285 | | Common Stock Amount | $42 | $47 | | Additional Paid-In Capital | $129,763 | $136,411 | | Accumulated Deficit | $(150,741) | $(168,849) | | Total Stockholders' Equity (Deficit) | $(2,311) | $11,894 | - The company's total stockholders' equity significantly improved from a deficit of **$(2,311) thousand** at December 31, 2023, to a positive **$11,894 thousand** at March 31, 2024[13](index=13&type=chunk) - This was primarily driven by the issuance of Series B Preferred Stock (**$44,285 thousand**) and settlement of 'Due To: PAVmed Inc.' in common stock (**$4,675 thousand**), partially offset by a net loss and a deemed dividend on preferred stock exchange[13](index=13&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes the cash inflows and outflows from operating, investing, and financing activities for the period | Metric (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------- | :-------------------------------- | :-------------------------------- | | Net Cash Flows Used in Operating Activities | $(12,612) | $(7,120) | | Net Cash Flows Used in Investing Activities | $(37) | $(17) | | Net Cash Flows Provided by Financing Activities | $18,522 | $24,185 | | Net Increase (Decrease) in Cash | $5,873 | $17,048 | | Cash, End of Period | $24,769 | $39,522 | - Cash used in operating activities increased significantly from **$(7,120) thousand** in Q1 2023 to **$(12,612) thousand** in Q1 2024[15](index=15&type=chunk) - Cash provided by financing activities decreased from **$24,185 thousand** to **$18,522 thousand**, primarily due to lower proceeds from the issue of preferred stock and convertible notes compared to the prior year[15](index=15&type=chunk) - Despite increased operating cash burn, the company ended Q1 2024 with **$24,769 thousand** in cash, an increase of **$5,873 thousand** for the quarter[15](index=15&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations of significant accounting policies, financial instruments, and other relevant disclosures supporting the financial statements [Note 1 — The Company](index=8&type=section&id=Note%201%20%E2%80%94%20The%20Company) This note describes Lucid Diagnostics Inc.'s business, its focus on early detection of esophageal precancer, and its flagship products - Lucid Diagnostics Inc. is a commercial-stage medical diagnostics technology company focused on early detection of esophageal precancer and cancer (EAC) in GERD patients[16](index=16&type=chunk) - Its flagship product, EsoGuard Esophageal DNA Test, performed with the EsoCheck Esophageal Cell Collection Device, is presented as the first and only commercially available diagnostic test for widespread early detection of esophageal precancer[17](index=17&type=chunk) - EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device utilizing proprietary Collect+Protect™ technology for targeted cell sampling[19](index=19&type=chunk) [Note 2 — Liquidity and Going Concern](index=9&type=section&id=Note%202%20%E2%80%94%20Liquidity%20and%20Going%20Concern) This note addresses the company's financial viability, highlighting its current liquidity position and ability to continue operations - The Company generated **$1.0 million** in revenue for Q1 2024 but does not expect positive cash flows from operating activities in the near future[23](index=23&type=chunk) - Lucid incurred a net loss of approximately **$18.1 million** and used **$12.6 million** in operating cash flows for Q1 2024[24](index=24&type=chunk) - As of March 31, 2024, working capital was approximately **$7.6 million**, including **$24.8 million** in cash[24](index=24&type=chunk) - These factors raise substantial doubt about the Company's ability to continue as a going concern within one year, contingent on generating substantial revenue from third-party reimbursement and raising additional capital[25](index=25&type=chunk) [Note 3 — Summary of Significant Accounting Policies](index=9&type=section&id=Note%203%20%E2%80%94%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and methods used in preparing the financial statements, including revenue recognition and fair value measurements - The financial statements are prepared in accordance with U.S. GAAP and SEC rules, consolidating the Company and its wholly-owned subsidiaries, with all intercompany transactions eliminated[27](index=27&type=chunk) - Revenue is primarily generated from EsoGuard Esophageal DNA tests, recognized upon release of patient test results to healthcare providers, with consideration being variable or fixed depending on payer contracts[32](index=32&type=chunk)[33](index=33&type=chunk) - The March 2023 Senior Secured Convertible Note is accounted for under the fair value option (FVO) election, with changes in fair value recognized in the statement of operations[40](index=40&type=chunk)[42](index=42&type=chunk) [Note 4 — Revenue from Contracts with Customers](index=13&type=section&id=Note%204%20%E2%80%94%20Revenue%20from%20Contracts%20with%20Customers) This note details the company's revenue recognition policies and the sources of its revenue from customer contracts | Metric (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------- | :-------------------------------- | :-------------------------------- | | Revenue | $1,001 | $446 | | Cost of Revenue | $1,656 | $1,338 | - Revenue recognized from EsoGuard test results increased by **124.4%** year-over-year[48](index=48&type=chunk)[50](index=50&type=chunk) - Cost of revenue increased by **23.8%** primarily due to laboratory operations and EsoCheck device supplies[48](index=48&type=chunk)[50](index=50&type=chunk) [Note 5 — Related Party Transactions](index=13&type=section&id=Note%205%20%E2%80%94%20Related%20Party%20Transactions) This note discloses transactions between the company and its related parties, including fees and settlements with PAVmed Inc | Metric (in thousands) | Balance - Dec 31, 2023 | Balance - Mar 31, 2024 | | :-------------------- | :--------------------- | :--------------------- | | Total Due To: PAVmed Inc. | $9,339 | $1,871 | - The MSA Fee with PAVmed Inc. increased to **$833 thousand** per month effective January 1, 2024, from **$750 thousand** per month in Q1 2023[52](index=52&type=chunk) - On January 26, 2024, PAVmed elected to receive payment of **$4,675 thousand** in fees and reimbursements through the issuance of **3,331,771 shares** of Lucid Diagnostics common stock[53](index=53&type=chunk) [Note 6 — Prepaid Expenses, Deposits, and Other Current Assets](index=15&type=section&id=Note%206%20%E2%80%94%20Prepaid%20Expenses,%20Deposits,%20and%20Other%20Current%20Assets) This note provides details on the company's prepaid expenses, deposits, and other short-term assets | Metric (in thousands) | March 31, 2024 | December 31, 2023 | | :-------------------- | :------------- | :---------------- | | Total prepaid expenses, deposits and other current assets | $2,355 | $2,854 | - Prepaid expenses, deposits, and other current assets decreased by **$499 thousand** from December 31, 2023, to March 31, 2024, primarily due to reductions in prepaid insurance and deposits[55](index=55&type=chunk) [Note 7 — Leases](index=15&type=section&id=Note%207%20%E2%80%94%20Leases) This note describes the company's lease arrangements, including right-of-use assets and lease liabilities | Metric (in thousands) | March 31, 2024 | December 31, 2023 | | :-------------------- | :------------- | :---------------- | | Operating lease right-of-use assets | $1,039 | $1,307 | | Total lease payments | $1,088 | N/A | | Present value of lease liabilities | $1,038 | $1,305 | - The company's operating lease right-of-use assets and lease liabilities decreased from December 31, 2023, to March 31, 2024[56](index=56&type=chunk)[58](index=58&type=chunk) - Future lease payments total **$1,088 thousand**, with the majority due in the remainder of 2024[56](index=56&type=chunk)[58](index=58&type=chunk) [Note 8 — Intangible Assets, net](index=16&type=section&id=Note%208%20%E2%80%94%20Intangible%20Assets,%20net) This note provides information on the company's intangible assets, including their amortization and net carrying value | Metric (in thousands) | March 31, 2024 | December 31, 2023 | | :-------------------- | :------------- | :---------------- | | Total Intangible assets | $5,305 | $5,305 | | Less Accumulated Amortization | $(4,253) | $(3,881) | | Intangible Assets, net | $1,052 | $1,424 | - Net intangible assets decreased by **$372 thousand** due to amortization expense[59](index=59&type=chunk) - Amortization expense for Q1 2024 was **$372 thousand**, down from **$505 thousand** in Q1 2023, as some assets became fully amortized[59](index=59&type=chunk)[144](index=144&type=chunk) [Note 9 — Financial Instruments Fair Value Measurements](index=17&type=section&id=Note%209%20%E2%80%94%20Financial%20Instruments%20Fair%20Value%20Measurements) This note explains the valuation methodologies and assumptions used for financial instruments measured at fair value | Metric (in thousands) | March 31, 2024 | December 31, 2023 | | :-------------------- | :------------- | :---------------- | | March 2023 Senior Convertible Note (Fair Value) | $13,140 | $13,950 | - The March 2023 Senior Convertible Note is classified as a Level 3 financial instrument and its fair value is determined using a Monte Carlo simulation with both observable and unobservable inputs[61](index=61&type=chunk)[62](index=62&type=chunk) | Valuation Assumption | March 31, 2024 | December 31, 2023 | | :------------------- | :------------- | :---------------- | | Required rate of return | 9.80% | 10.00% | | Conversion Price | $5.00 | $5.00 | | Value of common stock | $0.81 | $1.41 | | Expected term (years) | 0.97 | 1.22 | | Volatility | 55.00% | 60.00% | | Risk free rate | 4.93% | 4.56% | [Note 10 — Debt](index=18&type=section&id=Note%2010%20%E2%80%94%20Debt) This note details the company's debt obligations, including convertible notes, their terms, and related transactions | Metric (in thousands) | March 31, 2024 | December 31, 2023 | | :-------------------- | :------------- | :---------------- | | March 2023 Senior Convertible Note (Face Value Principal) | $10,936 | $11,019 | | March 2023 Senior Convertible Note (Fair Value) | $13,140 | $13,950 | - The March 2023 Senior Convertible Note has a face value principal of **$11.1 million**, a **7.875%** annual interest rate, a **$5.00** conversion price, and matures on March 21, 2025[66](index=66&type=chunk) - In Q1 2024, approximately **$83 thousand** of principal and **$436 thousand** of interest were settled by issuing **543,298 common shares**, resulting in a **$167 thousand** debt extinguishment loss[75](index=75&type=chunk) - The company is subject to financial covenants, including maintaining a minimum of **$5.0 million** in available cash and a market capitalization of at least **$30 million**, with which it was in compliance as of March 31, 2024[73](index=73&type=chunk) [Note 11 — Stock-Based Compensation](index=19&type=section&id=Note%2011%20%E2%80%94%20Stock-Based%20Compensation) This note describes the company's stock-based compensation plans, including expense recognition and outstanding awards | Metric (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------- | :-------------------------------- | :-------------------------------- | | Total stock-based compensation expense | $933 | $3,208 | - Total stock-based compensation expense decreased significantly from **$3,208 thousand** in Q1 2023 to **$933 thousand** in Q1 2024, primarily due to a large decrease in general and administrative stock-based compensation[83](index=83&type=chunk) - As of March 31, 2024, **8,332,713 stock options** were outstanding with a weighted average exercise price of **$1.74**, and **2,297,440 unvested restricted stock awards** were outstanding[79](index=79&type=chunk)[81](index=81&type=chunk) [Note 12 — Stockholders' Equity](index=23&type=section&id=Note%2012%20%E2%80%94%20Stockholders'%20Equity) This note provides details on the company's equity structure, including preferred and common stock issuances, and deemed dividends - On March 13, 2024, the Company issued **44,285 shares** of Series B Convertible Preferred Stock for **$18.1 million** and exchanged all outstanding Series A and Series A-1 Preferred Stock for Series B Preferred Stock[86](index=86&type=chunk)[101](index=101&type=chunk) - The Series B Preferred Stock has a stated value of **$1,000 per share**, an initial conversion price of **$1.2444**, and includes dividend rights and a one-time liquidation preference[87](index=87&type=chunk)[89](index=89&type=chunk)[90](index=90&type=chunk) - A deemed dividend of **$7,495 thousand** was recognized and charged to accumulated deficit on March 13, 2024, due to the Series B Preferred Stock issuance and exchange[102](index=102&type=chunk) - Subsequent to March 31, 2024, on May 6, 2024, the Company issued **11,634 shares** of Series B-1 Convertible Preferred Stock for **$11.6 million**, with similar terms to Series B but a conversion price of **$0.7228**[94](index=94&type=chunk)[95](index=95&type=chunk) [Note 13 — Net Loss Per Share](index=26&type=section&id=Note%2013%20%E2%80%94%20Net%20Loss%20Per%20Share) This note presents the calculation of basic and diluted net loss per share, including factors affecting dilutive securities | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :----- | :-------------------------------- | :-------------------------------- | | Net loss attributable to Lucid Diagnostics Inc. common stockholders | $(18,108) | $(16,247) | | Weighted average common shares outstanding, basic and diluted | 45,014,410 | 40,970,504 | | Net loss per share - basic and diluted | $(0.40) | $(0.40) | - Net loss per share remained at **$(0.40)** for both periods, despite a higher net loss attributable to common stockholders in Q1 2024 due to a **$7,496 thousand** deemed dividend on preferred stock[108](index=108&type=chunk) - Common stock equivalents, including stock options, unvested restricted stock awards, and preferred stock, were excluded from diluted EPS calculation as their inclusion would be anti-dilutive due to the company's net loss position[109](index=109&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's analysis of Lucid Diagnostics Inc.'s financial condition and operational results for Q1 2024, covering business overview, recent developments, detailed financial performance, liquidity, and critical accounting estimates [Overview](index=28&type=section&id=Overview) This section introduces Lucid Diagnostics Inc.'s business, its flagship product EsoGuard, and its role in early detection of esophageal precancer - Lucid Diagnostics is a commercial-stage medical diagnostics company focused on early detection of esophageal precancer and cancer (EAC) in at-risk patients[117](index=117&type=chunk) - The flagship product, EsoGuard Esophageal DNA Test, performed with the EsoCheck Esophageal Cell Collection Device, is positioned as the first and only widespread diagnostic tool for early detection of esophageal precancer, including Barrett's Esophagus (BE)[118](index=118&type=chunk) - EsoGuard demonstrated high analytical sensitivity (**97%**), specificity (**95%**), and accuracy (**98%**), with clinical validation showing **84%** sensitivity and **86%** specificity for BE detection[119](index=119&type=chunk) [Recent Developments](index=29&type=section&id=Recent%20Developments) This section highlights key business and financing events that have occurred recently, impacting the company's operations and capital structure [Business](index=29&type=section&id=Business) This section details recent operational and regulatory updates, including changes to the MSA with PAVmed and FDA's LDT rule impact - The management services agreement (MSA) with PAVmed was amended to increase the monthly fee to **$0.83 million**, effective January 1, 2024[122](index=122&type=chunk) - PAVmed elected to receive approximately **$4.7 million** in fees and reimbursements through the issuance of **3,331,771 shares** of Lucid's common stock on January 26, 2024[123](index=123&type=chunk) - The FDA's final rule on LDTs will not immediately impact Lucid's regulatory strategy, as EsoGuard was marketed prior to May 6, 2024, and is NYS CLEP-approved, thus remaining under continued enforcement discretion[124](index=124&type=chunk) [Financing](index=29&type=section&id=Financing) This section outlines recent capital-raising activities, including preferred stock offerings and their impact on the company's financial position - On March 13, 2024, the company completed a Series B Preferred Stock offering and exchange, raising **$18.16 million** and converting all Series A and A-1 Preferred Stock into Series B Preferred Stock[126](index=126&type=chunk)[127](index=127&type=chunk) - Subsequent to March 31, 2024, on May 6, 2024, the company issued Series B-1 Convertible Preferred Stock, raising an additional **$11.6 million**, concluding its Board-approved **$30 million** preferred stock offering[128](index=128&type=chunk)[129](index=129&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) This section provides a comparative analysis of the company's financial performance for the three months ended March 31, 2024, versus 2023 [The three months ended March 31, 2024 as compared to three months ended March 31, 2023](index=33&type=section&id=The%20three%20months%20ended%20March%2031,%202024%20as%20compared%20to%20three%20months%20ended%20March%2031,%202023) This section offers a detailed comparative analysis of key financial metrics and their changes between the two periods [Revenue](index=33&type=section&id=Revenue) This section analyzes the company's revenue performance, highlighting growth drivers and key contributing factors | Metric (in millions) | Q1 2024 | Q1 2023 | | :------------------- | :------ | :------ | | Revenue | $1.0 | $0.4 | - Revenue increased by **$0.6 million**, or **150%**, primarily due to increased EsoGuard Esophageal DNA Test performance in the company's CLIA laboratory[141](index=141&type=chunk) [Cost of revenue](index=33&type=section&id=Cost%20of%20revenue) This section examines the changes in the costs directly associated with generating revenue, including supplies and compensation | Metric (in millions) | Q1 2024 | Q1 2023 | | :------------------- | :------ | :------ | | Cost of revenue | $1.7 | $1.3 | - Cost of revenue increased by **$0.4 million**, or **30.8%**, mainly due to higher EsoCheck and EsoGuard supplies costs and increased compensation-related costs, including stock-based compensation[142](index=142&type=chunk) [Sales and marketing expenses](index=33&type=section&id=Sales%20and%20marketing%20expenses) This section details the trends and drivers behind the company's sales and marketing expenditures | Metric (in millions) | Q1 2024 | Q1 2023 | | :------------------- | :------ | :------ | | Sales and marketing expenses | $4.2 | $4.1 | - Sales and marketing expenses increased by **$0.1 million**, or **2.4%**, primarily due to higher compensation-related costs from changes in headcount, bonus structure, and travel expenses[142](index=142&type=chunk) [General and administrative expenses](index=33&type=section&id=General%20and%20administrative%20expenses) This section analyzes the changes in general and administrative costs, including stock-based compensation and professional fees | Metric (in millions) | Q1 2024 | Q1 2023 | | :------------------- | :------ | :------ | | General and administrative expenses | $4.1 | $6.9 | - General and administrative expenses decreased by **$2.8 million**, or **40.6%**, mainly due to a **$2.4 million** decrease in stock-based compensation and a **$0.9 million** decrease in third-party professional fees, partially offset by a **$0.3 million** increase from the amended MSA with PAVmed[143](index=143&type=chunk)[146](index=146&type=chunk) [Research and development expenses](index=33&type=section&id=Research%20and%20development%20expenses) This section reviews the company's research and development expenditures, focusing on changes in clinical trial and consulting costs | Metric (in millions) | Q1 2024 | Q1 2023 | | :------------------- | :------ | :------ | | Research and development expenses | $1.5 | $1.9 | - Research and development expenses decreased by **$0.4 million**, or **21.1%**, primarily due to a reduction in development costs, particularly in clinical trial activities and outside professional and consulting fees related to EsoCure[143](index=143&type=chunk) [Amortization of Acquired Intangible Assets](index=33&type=section&id=Amortization%20of%20Acquired%20Intangible%20Assets) This section discusses the amortization expense related to acquired intangible assets and factors influencing its change | Metric (in millions) | Q1 2024 | Q1 2023 | | :------------------- | :------ | :------ | | Amortization of acquired intangible assets | $0.4 | $0.5 | - Amortization expense decreased by **$0.1 million**, or **20%**, as certain acquired intangible assets were fully amortized in February 2024[144](index=144&type=chunk) [Other Income and Expense](index=33&type=section&id=Other%20Income%20and%20Expense) This section covers non-operating income and expenses, including fair value adjustments of financial instruments - The change in fair value of the March 2023 Senior Convertible Note resulted in **$0.3 million** of income in Q1 2024, compared to an initial **$0.8 million** non-cash expense recognized on the issue date in Q1 2023[145](index=145&type=chunk) [Loss on Issue and Offering Costs - Senior Secured Convertible Note](index=34&type=section&id=Loss%20on%20Issue%20and%20Offering%20Costs%20-%20Senior%20Secured%20Convertible%20Note) This section details the costs and losses incurred in connection with the issuance of the Senior Secured Convertible Note - In Q1 2023, the company recognized **$1.2 million** in lender fees and offering costs related to the March 2023 Senior Convertible Note; no such costs were incurred in Q1 2024[147](index=147&type=chunk) [Loss on Debt Extinguishment](index=34&type=section&id=Loss%20on%20Debt%20Extinguishment) This section explains the loss recognized from the settlement of debt obligations through the issuance of common stock - A debt extinguishment loss of approximately **$0.2 million** was recognized in Q1 2024 due to the settlement of principal and interest repayments of the March 2023 Senior Convertible Note through the issuance of common stock[148](index=148&type=chunk) [Deemed Dividend on Series A and Series A-1 Convertible Preferred Stock Exchange Offer](index=34&type=section&id=Deemed%20Dividend%20on%20Series%20A%20and%20Series%20A-1%20Convertible%20Preferred%20Stock%20Exchange%20Offer) This section describes the deemed dividend recognized due to the exchange of preferred stock and its impact on accumulated deficit | Metric (in millions) | March 13, 2024 | | :------------------- | :------------- | | Deemed Dividend Charged to Accumulated Deficit | $7.5 | - A **$7.5 million** deemed dividend was recognized and charged to accumulated deficit on March 13, 2024, as a result of the Series B Convertible Preferred Stock issuance and the exchange of Series A and A-1 Preferred Stock[149](index=149&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its short-term and long-term financial obligations, including cash position and future funding needs - The company's current operations focus on commercializing EsoGuard through various sales channels and developing expanded clinical evidence for insurance reimbursement[150](index=150&type=chunk) - Lucid experienced a net loss of approximately **$10.6 million** and used **$12.6 million** in operating cash flows in Q1 2024, ending the quarter with **$24.8 million** in cash[152](index=152&type=chunk) - The company expects continued losses and negative cash flow, necessitating future debt and/or equity financing to fund operations and address existing convertible debt obligations, raising substantial doubt about its ability to continue as a going concern[152](index=152&type=chunk)[153](index=153&type=chunk) - The company has raised approximately **$29.8 million** from Series B and Series B-1 Preferred Stock offerings, concluding its Board-approved **$30 million** preferred stock offering[129](index=129&type=chunk)[154](index=154&type=chunk)[156](index=156&type=chunk) [Critical Accounting Estimates](index=38&type=section&id=Critical%20Accounting%20Estimates) This section discusses the significant judgments and assumptions used in preparing the financial statements that could materially affect reported results - The company's financial statements rely on estimates and assumptions, particularly for fair value of debt obligations, stock-based equity awards, intangible assets, incremental borrowing rates, and income taxes[31](index=31&type=chunk) - Management's assessment of the company's going concern ability also involves estimating future cash flows[31](index=31&type=chunk) - There have been no material changes to critical accounting policies and estimates in Q1 2024[166](index=166&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the evaluation of the company's disclosure controls and procedures and reports on any changes to internal controls over financial reporting during the quarter [Evaluation of Disclosure Controls and Procedures](index=38&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section reports on management's assessment of the effectiveness of the company's disclosure controls and procedures - Management, including the principal executive and financial officers, concluded that disclosure controls and procedures were effective as of March 31, 2024, providing reasonable assurance that required information is recorded, processed, summarized, and reported timely[167](index=167&type=chunk) [Changes to Internal Controls Over Financial Reporting](index=38&type=section&id=Changes%20to%20Internal%20Controls%20Over%20Financial%20Reporting) This section discloses any material changes to the company's internal controls over financial reporting during the quarter - There were no changes in internal control over financial reporting during the fiscal quarter ended March 31, 2024, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[168](index=168&type=chunk) Part II - Other Information This section provides additional disclosures not covered in the financial statements, including legal proceedings, equity sales, and other relevant information [Item 1. Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) This section addresses potential legal actions and claims the company may face in the ordinary course of business, particularly during commercialization - The company is not aware of any pending legal or other proceedings that are reasonably likely to have a material impact on its business, financial position, results of operations, or cash flows[170](index=170&type=chunk) - Legal proceedings are subject to inherent uncertainties, and an unfavorable outcome could result in monetary damages or excessive verdicts, potentially having a material adverse impact[170](index=170&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports on any unregistered sales of equity securities and the use of proceeds during the reporting period - On March 22, 2024, the company approved the issuance of a three-year option to acquire **100,000 common shares** at an exercise price of **$1.50 per share** to an investor relations firm, exempt from registration requirements under Section 4(a)(2) of the Securities Act[171](index=171&type=chunk) - No other unregistered securities were sold, and no securities were repurchased during the three months ended March 31, 2024, beyond what was previously disclosed[172](index=172&type=chunk) [Item 5. Other Information](index=39&type=section&id=Item%205.%20Other%20Information) This section provides other information not covered elsewhere in the report - During the fiscal quarter ended March 31, 2024, none of the company's directors or officers adopted or terminated a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement"[173](index=173&type=chunk) [Item 6. Exhibits](index=39&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of this Quarterly Report on Form 10-Q - The exhibit index includes various documents such as Certificates of Designation for Series B and B-1 Preferred Stock, Exchange Agreements, Registration Rights Agreements, and certifications required by the Sarbanes-Oxley Act[181](index=181&type=chunk)

EsophaCap device recalled due to recent publication of serious device failures Lucid Diagnostics' EsoCheck® unaffected by recall and remains the gold standard for non-endoscopic cell collection NEW YORK, May 9, 2024 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), announced that the legacy EsophaCap sponge-on-a-string (SOS) esophage ...

Final closing yields total gross proceeds of $29.8 million from offering Mr. Matheis serves as President and CEO of Sentara Health, one of the largest not-for-profit integrated health systems in the U.S., which encompasses hospitals, a physician group, and an affiliated health plan NEW YORK, May 7, 2024 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAV ...

Conference Call and Webcast at 8:30AM Eastern Time NEW YORK, May 2, 2024 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ), today announced that it will host a business update conference call and webcast on Monday, May 13, 2024, at 8:30 AM ET. During the call, Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer, will provide a busine ...

NEW YORK, April 29, 2024 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM), is partnering with the Esophageal Cancer Action Network (ECAN) to highlight Esophageal Cancer Awareness Month. ECAN, a leading patient advocacy organization focused on increasing esophageal cancer education, advocacy, awareness, and research, was founded 15 years ago by Mindy M ...

[FORM 10-K Filing Information](index=1&type=section&id=FORM%2010-K) [Registrant Information](index=1&type=section&id=Registrant%20Information) LUCID DIAGNOSTICS INC. filed its 2023 Form 10-K, is incorporated in Delaware, trades on NASDAQ (LUCD), and is classified as a non-accelerated, smaller reporting, and emerging growth company - Registrant: **LUCID DIAGNOSTICS INC.**[2](index=2&type=chunk) - Fiscal Year End: **December 31, 2023**[2](index=2&type=chunk) Securities Registered | Title of each Class | Trading Symbol(s) | Name of each Exchange on which Registered | | :------------------ | :---------------- | :---------------------------------------- | | Common Stock, $0.001 par value per share | LUCD | The NASDAQ Stock Market LLC | - Filer Status: **Non-accelerated filer, Smaller reporting company, Emerging growth company**[6](index=6&type=chunk) [Market Value and Shares Outstanding](index=2&type=section&id=Market%20Value%20and%20Shares%20Outstanding) As of June 30, 2023, non-affiliate voting stock market value was approximately **$14.4 million**, with **48,244,798 common shares outstanding** as of March 21, 2024 - Aggregate market value of voting stock held by non-affiliates (as of June 30, 2023): Approximately **$14.4 million** (based on 10,331,863 shares at $1.39/share)[6](index=6&type=chunk) - Shares of Common Stock issued and outstanding (as of March 21, 2024): **48,244,798 shares**[7](index=7&type=chunk) [Documents Incorporated by Reference](index=2&type=section&id=Documents%20Incorporated%20by%20Reference) Portions of the 2024 annual meeting proxy statement are incorporated by reference into Part III of this Form 10-K, to be filed within 120 days after December 31, 2023 - Portions of the 2024 annual meeting of stockholders' definitive proxy statement are incorporated by reference into Part III of this Form 10-K[9](index=9&type=chunk) [Forward-Looking Statements](index=4&type=section&id=FORWARD-LOOKING%20STATEMENTS) [Disclaimer and Risk Factors](index=4&type=section&id=Disclaimer%20and%20Risk%20Factors) This Form 10-K contains forward-looking statements with significant risks, including limited operating history, revenue generation, regulatory approvals, and financing, and the company disclaims any obligation to update them - Forward-looking statements are not guarantees of future performance and actual results may differ significantly[13](index=13&type=chunk) - Key factors that may affect actual results include: limited operating history, ability to generate revenue, regulatory approval, market acceptance, financing, intellectual property, cybersecurity, and risks related to PAVmed[13](index=13&type=chunk)[16](index=16&type=chunk) - The company does not assume any obligation to update forward-looking statements, except as required by applicable law[15](index=15&type=chunk) [Part I](index=5&type=section&id=PART%20I) [Item 1. Business](index=5&type=section&id=Item%201.%20Business) Lucid Diagnostics is a commercial-stage medical diagnostics company focused on early detection of esophageal precancer and cancer in GERD patients using EsoGuard and EsoCheck, actively commercializing and expanding clinical evidence [Background and Overview](index=5&type=section&id=Background%20and%20Overview) - Lucid Diagnostics Inc. is a commercial-stage medical diagnostics technology company focused on patients with GERD at risk of esophageal precancer and cancer (EAC)[17](index=17&type=chunk) - Flagship product: EsoGuard Esophageal DNA Test, performed on samples collected with EsoCheck Esophageal Cell Collection Device, is positioned as the first and only commercially available diagnostic test for widespread early detection of esophageal precancer[18](index=18&type=chunk) - EsoGuard is a bisulfite-converted targeted next-generation sequencing (NGS) DNA assay, quantifying methylation at 31 sites on Vimentin (VIM) and Cyclin A1 (CCNA1) genes[19](index=19&type=chunk) EsoGuard Analytical and Clinical Validation Results | Metric | Result | | :---------------------- | :----- | | Analytical Sensitivity | ~97% | | Analytical Specificity | ~95% | | Analytical Accuracy | ~98% | | Inter-assay Precision | 100% | | Intra-assay Precision | 100% | | Clinical Sensitivity (for BE) | 84% (95% CI 76-90%) | | Clinical Specificity (for BE) | 86% (95% CI 81-91%) | | Positive Predictive Value (PPV) | ~42% | | Negative Predictive Value (NPV) | ~98% | - EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device for sampling surface esophageal cells in a less than five-minute office procedure, featuring proprietary Collect+Protect™ technology[20](index=20&type=chunk) - EsoGuard and EsoCheck are based on patented technology licensed from Case Western Reserve University (CWRU)[21](index=21&type=chunk) [Market Opportunity](index=5&type=section&id=Market%20Opportunity) - In 2023, approximately **20,000 U.S. GERD patients** are projected to be diagnosed with EAC, and **16,000 will die** from it, making it the second most lethal cancer in the U.S. with over **80% mortality** within five years of diagnosis[22](index=22&type=chunk) - The U.S. incidence of EAC has increased **500%** over the past four decades[22](index=22&type=chunk) - The American Gastroenterology Association (AGA) expanded the target population for esophageal precancer screening in July 2022 to an estimated **30 million U.S. individuals** with at least 3 established risk factors for BE[23](index=23&type=chunk) - EsoGuard's total addressable U.S. market opportunity approximates **$60 billion**, based on an effective Medicare payment of **$1,938** and **30 million patients**[23](index=23&type=chunk) - Less than **10%** of at-risk patients recommended for screening undergo traditional invasive upper gastrointestinal endoscopy (EGD)[23](index=23&type=chunk) - EsoGuard, with EsoCheck, is believed to be the missing element for widespread early detection of esophageal precancer and cancer in at-risk patients[25](index=25&type=chunk) [Clinical Guidelines for At-Risk Population](index=7&type=section&id=Clinical%20Guidelines%20for%20At-Risk%20Population) - The American College of Gastroenterology (ACG) suggests a single screening endoscopy for patients with chronic GERD symptoms and **3+ risk factors** (male sex, age >50, White race, tobacco smoking, obesity, family history of BE or EAC)[26](index=26&type=chunk) - An April 2022 ACG guideline update endorses nonendoscopic biomarker screening, specifically mentioning EsoCheck and methylated DNA biomarkers like EsoGuard, as an acceptable alternative to endoscopy for BE[27](index=27&type=chunk) - In July 2022, the American Gastroenterology Association (AGA) updated its guidance, endorsing non-endoscopic cell collection tools like EsoCheck and expanding the target population to include at-risk patients without GERD symptoms by adding chronic GERD history as a seventh risk factor[28](index=28&type=chunk) [Commercialization](index=7&type=section&id=Commercialization) - Commercialization efforts target primary care and GI physicians, aiming to expand the funnel of BE-EAC patients for EGD surveillance and treatment[29](index=29&type=chunk) - Testing access is provided through Lucid Test Centers (in AZ, CA, CO, FL, ID, IL, NV, OH, OR, TX, UT), a satellite test center program (in physician offices or via Lucid Mobile Testing Unit), and CheckYourFoodTube Precancer Testing Events (e.g., with fire departments)[30](index=30&type=chunk)[31](index=31&type=chunk)[32](index=32&type=chunk) - A Direct Contracting Strategic Initiative (DCSI) was launched in March 2023 to engage self-insured employers and unions, resulting in a contract with Ancira Automotive Group in August 2023[33](index=33&type=chunk) - An EsoGuard Telemedicine Program, in partnership with UpScript, LLC, accommodates self-referrals from direct-to-consumer marketing[34](index=34&type=chunk) [Reimbursement and Market Access](index=7&type=section&id=Reimbursement%20and%20Market%20Access) - In December 2019, EsoGuard secured 'gapfill' determination for PLA code 0114U through the CMS CLFS process[35](index=35&type=chunk) - In October 2020, CMS granted EsoGuard a final Medicare payment determination of **$1,938.01**, effective January 1, 2021[36](index=36&type=chunk) - A final Local Coverage Determination (LCD) L39256, 'Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia,' became effective in May 2023, outlining criteria for future coverage that MolDX expects tests to meet; EsoGuard is expected to be submitted for Technical Assessment under this LCD later in 2024[38](index=38&type=chunk) - The company is actively pursuing commercial insurer payment and coverage, having received out-of-network commercial insurance payments for EsoGuard, which accounts for the vast majority of revenue to date[39](index=39&type=chunk) - State laws mandating coverage of comprehensive biomarker testing are being reviewed to expand EsoGuard access[40](index=40&type=chunk) [Clinical Utility and Clinical Trials](index=9&type=section&id=Clinical%20Utility%20and%20Clinical%20Trials) - Demonstrating EsoGuard's clinical utility is crucial for Medicare and private payor payment/coverage and physician understanding[41](index=41&type=chunk) - Ongoing efforts include expanding the EsoGuard and EsoCheck evidence portfolio with clinical utility, validity, and analytical validity data[42](index=42&type=chunk) - Planned publications for H1 2024 include results from the 'Multi-center, Single-arm EsoGuard clinical validation study' (BE-1), real-world experience of EsoCheck, EsoGuard analytical validation studies by LucidDx Labs, and real-world outcomes from EsoGuard-positive patients[42](index=42&type=chunk) - The CLinical Utility of EsoGuard study (CLUE) completed enrollment in late 2023, with full results expected mid-2024; interim results from PREVENT and PREVENT-Firefighter (FF) registries are also expected[43](index=43&type=chunk) - The 'EsoGuard case-control study' (BE-2) resumed enrollment in 2023 and will continue through 2024[44](index=44&type=chunk) [Manufacturing](index=9&type=section&id=Manufacturing) - EsoCheck is manufactured by Coastline International and Sage Product Development, with Coastline having a current capacity of up to **25,000 units per year** and exponential scaling capacity[45](index=45&type=chunk) - EsoGuard Specimen Kits are manufactured by Path-Tec[45](index=45&type=chunk) - Warehousing, logistics, fulfillment, and customer support are managed by HealthLink International and Path-Tec[45](index=45&type=chunk) [License Agreement](index=10&type=section&id=License%20Agreement) - Lucid holds an exclusive worldwide right to use EsoGuard and EsoCheck intellectual property from CWRU under the Amended CWRU License Agreement[46](index=46&type=chunk) CWRU License Agreement Royalty Payments | Net Sales per Year | Royalty Rate | | :----------------- | :----------- | | < $100 million | 5% | | > $100 million | 8% | CWRU License Agreement Minimum Annual Royalty Payments | Net Sales per Year | Minimum Annual Royalty | | :----------------- | :--------------------- | | N/A (post-first commercial sale) | $50,000 | | > $25 million | $150,000 | | > $50 million | $300,000 | | > $100 million | $600,000 | - One remaining milestone payment of **$200,000** is due upon FDA PMA submission of a licensed product[46](index=46&type=chunk) - The license agreement terminates upon the expiration of the last-to-expire licensed patent or May 12, 2038, whichever is later[46](index=46&type=chunk) [Regulatory](index=11&type=section&id=Regulatory) - EsoCheck received FDA 510(k) clearance in June 2019 for adults, expanded in 2022 for pediatric populations, and received CE Mark certification in May 2021[47](index=47&type=chunk)[49](index=49&type=chunk) - EsoGuard was commercialized as a Laboratory Developed Test (LDT) after analytical validity documentation in December 2019 and received CE Mark self-certification in June 2021[47](index=47&type=chunk)[49](index=49&type=chunk) - EsoGuard received FDA 'Breakthrough Device Designation' in February 2020 as an in-vitro diagnostic (IVD) medical device, expediting development and review[48](index=48&type=chunk) - In October 2023, FDA proposed a policy to phase out general enforcement discretion for LDTs, intending to finalize it by April 2024; Lucid plans to implement QS requirements and submit a premarket submission for EsoGuard[50](index=50&type=chunk)[51](index=51&type=chunk) - The longer-term strategy is to secure a specific FDA clearance or approval for EsoGuard with EsoCheck as an IVD device[52](index=52&type=chunk) [Laboratory Operations](index=11&type=section&id=Laboratory%20Operations) - On February 25, 2022, Lucid's wholly-owned subsidiary, LucidDx Labs Inc., acquired assets to operate its own CLIA-certified, CAP-accredited clinical laboratory in Lake Forest, CA[53](index=53&type=chunk) - LucidDx Labs launched EsoGuard 2.0 in November 2023, which uses multiplexing for both genes on a single DNA sample, demonstrating improved sensitivity, specificity, and lower costs[54](index=54&type=chunk) [Competition](index=13&type=section&id=Competition) - The U.S. market for esophageal cancer and precancer testing is large, with over **30 million at-risk individuals**[57](index=57&type=chunk) - EsoGuard competes with procedure-based detection (e.g., upper endoscopy) and other testing technologies (e.g., multi-cancer early detection products)[57](index=57&type=chunk) - EsoCheck competes with other esophageal cell collection devices, such as EndoSign (Cyted) and Cytosponge, which are 'sponge-on-a-string' devices that, unlike EsoCheck, lack anatomically targeted and protected sampling[57](index=57&type=chunk) - Future competition may arise from 'liquid biopsy' tests for early cancer detection and other unproven technologies like breath tests and oral tests[57](index=57&type=chunk)[172](index=172&type=chunk)[173](index=173&type=chunk) [EsoCure](index=13&type=section&id=EsoCure) - The EsoCure Esophageal Ablation Device is a novel technology for treating dysplastic BE without complex capital equipment[59](index=59&type=chunk) - Lucid licensed commercialization rights for EsoCure from PAVmed in March 2022, with a **5% royalty** on sales up to **$100 million** and **8%** above that threshold[60](index=60&type=chunk) - PAVmed completed pre-clinical feasibility and acute/survival animal studies for EsoCure, demonstrating controlled circumferential ablation[61](index=61&type=chunk) [Our Relationship with PAVmed](index=13&type=section&id=Our%20Relationship%20with%20PAVmed) - Lucid is a majority-owned subsidiary of PAVmed, which holds approximately **70.1% of voting power** as of December 31, 2023, and **64.9%** as of March 21, 2024[62](index=62&type=chunk)[63](index=63&type=chunk) - Lucid depends on PAVmed for various management, technical, R&D, legal, accounting, and administrative services under a Management Services Agreement (MSA) and a Payroll Benefits and Expense Reimbursement Agreement (PBERA)[62](index=62&type=chunk)[64](index=64&type=chunk) - PAVmed can elect to settle Lucid's obligations under MSA and PBERA by issuing Lucid's stock instead of cash[64](index=64&type=chunk) [Recent Events](index=14&type=section&id=Recent%20Events) - In January 2024, PAVmed elected to receive **$4.7 million** in fees and reimbursements by issuing **3,331,771 shares** of Lucid's common stock[65](index=65&type=chunk) - In March 2024, the MSA with PAVmed was amended, increasing the monthly fee from **$0.75 million to $0.83 million**, effective January 1, 2024; PAVmed may receive payment in cash or common stock, subject to a **$0.70 floor price** and a maximum of **9,644,135 shares**[66](index=66&type=chunk) - On March 13, 2024, Lucid completed a Series B Offering and Exchange, selling **12,495 shares** of Series B Convertible Preferred Stock for **$1,000/share** and exchanging all outstanding Series A and A-1 Preferred Stock for **31,790 shares** of Series B Preferred Stock; aggregate gross proceeds were **$18.16 million**[68](index=68&type=chunk) - Each Series B Preferred Stock has a stated value of **$1,000**, a conversion price of **$1.2444**, a one-time liquidation preference, and a right to receive dividends equal to **20%** of common stock convertible shares on the one-year and two-year anniversaries[68](index=68&type=chunk) - In October 2023, Lucid sold **5,000 shares** of Series A-1 Preferred Stock for **$5.0 million**, which were later exchanged for Series B Preferred Stock[70](index=70&type=chunk) [Intellectual Property](index=15&type=section&id=Intellectual%20Property) - Lucid's business relies on proprietary medical device and diagnostic technologies, including EsoCheck and EsoGuard, protected by **20 domestic and foreign patents**[71](index=71&type=chunk) Earliest Patent Expiration Dates | Technology | Year | | :--------- | :--- | | EsoCheck | May 2034 | | EsoGuard | August 2024 | - Pending patent applications for EsoGuard are positioned to provide protection until at least **2037**[71](index=71&type=chunk) - The company protects its proprietary rights through patents, trademarks (e.g., Lucid Diagnostics™, LUCID™, EsoCheck®, EsoGuard®, Collect + Protect®), trade secrets, know-how, and confidentiality agreements[73](index=73&type=chunk)[77](index=77&type=chunk)[78](index=78&type=chunk) [Health Insurance Coverage and Reimbursement](index=17&type=section&id=Health%20Insurance%20Coverage%20and%20Reimbursement) - Successful commercialization depends on adequate coverage and reimbursement from governmental authorities, private health insurers, and other third-party payors[79](index=79&type=chunk) - Third-party payors are implementing initiatives to restrict technology use to those meeting clinical evidentiary requirements and regularly update reimbursement amounts and methodologies[80](index=80&type=chunk) [Government Regulation](index=17&type=section&id=Government%20Regulation) [Key U.S. Regulation](index=17&type=section&id=Key%20U.S.%20Regulation) - Medical devices, including IVD products like EsoGuard and traditional devices like EsoCheck, are subject to extensive FDA regulation under the Federal Food, Drug, and Cosmetic Act and/or the Public Health Service Act[82](index=82&type=chunk)[83](index=83&type=chunk) - FDA defines an LDT as an IVD product designed, manufactured, and used within a single laboratory, for which FDA has generally not enforced premarket review requirements[84](index=84&type=chunk) - EsoCheck received FDA 510(k) clearance in June 2019 (for adults) and 2022 (expanded to adolescents); EsoGuard was commercialized as an LDT after analytical validity documentation in December 2019[85](index=85&type=chunk) - FDA proposed a policy in October 2023 to phase out enforcement discretion for LDTs, intending to finalize by April 2024, requiring LDTs to generally fall under the same enforcement approach as other IVDs[87](index=87&type=chunk)[88](index=88&type=chunk) - EsoGuard received FDA 'Breakthrough Device Designation' in February 2020, which expedites development and review and may lead to an expedited Medicare coverage pathway[90](index=90&type=chunk) - Medical devices are classified into Class I, II, or III, with higher classifications requiring greater controls and more extensive approval processes (e.g., PMA for Class III)[92](index=92&type=chunk) - Clinical trials for investigational devices must comply with FDA requirements, potentially requiring an Investigational Device Exemption (IDE) application and IRB approval[96](index=96&type=chunk) - Post-approval, products are subject to ongoing regulatory requirements including Quality Systems Regulation (QSR), labeling, adverse event reporting, and cGMP for manufacturing[98](index=98&type=chunk)[99](index=99&type=chunk) - The company's CLIA-certified laboratory is subject to U.S. and state laws and regulations, including certification requirements and standards for quality assurance and control[100](index=100&type=chunk) [Other U.S. Healthcare Regulation](index=23&type=section&id=Other%20U.S.%20Healthcare%20Regulation) - Business practices are restricted by federal and state laws, including anti-kickback, false claims, data privacy and security, and transparency laws (e.g., Physician Payment Sunshine Act)[103](index=103&type=chunk)[106](index=106&type=chunk) - The Federal Anti-Kickback Statute prohibits offering/receiving remuneration to induce purchasing or recommending services reimbursable by federal healthcare programs, with a stricter intent standard under the Affordable Care Act[108](index=108&type=chunk)[109](index=109&type=chunk) - The Federal False Claims Act prohibits knowingly presenting false or fraudulent claims to the federal government or making false statements material to such claims[110](index=110&type=chunk) - The Foreign Corrupt Practices Act (FCPA) prohibits payments to foreign officials to obtain or retain business and requires accurate accounting records[113](index=113&type=chunk) - The Health Insurance Portability and Accountability Act (HIPAA) establishes comprehensive protection for the privacy and security of health information, applicable to certain company activities and interactions with patients[115](index=115&type=chunk) - The federal 'Stark' law prohibits physician self-referrals to entities (like laboratories) with which they have ownership or compensation arrangements for Medicare-reimbursable tests[117](index=117&type=chunk) [International Regulation](index=26&type=section&id=International%20Regulation) - To market products outside the U.S., the company must comply with varying regulatory requirements of other countries and jurisdictions[118](index=118&type=chunk) - EsoCheck received CE Mark certification under MDD, and EsoGuard completed CE Mark self-certification under IVDD, allowing marketing in CE Mark European countries[119](index=119&type=chunk) - MDD and IVDD have been replaced by stricter MDR and IVDR, respectively, requiring EsoGuard and EsoCheck to undergo recertification, which is difficult to predict in terms of cost, time, and risk[120](index=120&type=chunk)[121](index=121&type=chunk)[122](index=122&type=chunk) - The UK's departure from the EU (Brexit) necessitates securing UKCA mark certification for EsoGuard and EsoCheck before their CE Mark certifications expire in the UK[123](index=123&type=chunk) [Other Laws](index=26&type=section&id=Other%20Laws) - The company must comply with Occupational Safety and Health Administration (OSHA) requirements for laboratories and hazardous chemicals[126](index=126&type=chunk) - Commercialization activities are subject to regulations from the Department of Transportation, U.S. Postal Service, and CDC regarding specimen transportation[127](index=127&type=chunk) - Compliance with environmental provisions has had no material effect on the Diagnostics business, with no material capital expenditures for environmental control facilities in 2023 and 2022[128](index=128&type=chunk) [Employees](index=28&type=section&id=Employees) - As of March 21, 2024, Lucid has **70 full-time employees**, including executive officers[129](index=129&type=chunk) - The company reimburses PAVmed for certain payroll and benefit-related expenses for its employees, which may be settled in common stock[129](index=129&type=chunk) [Corporate Information](index=28&type=section&id=Corporate%20Information) - Lucid Diagnostics Inc. was incorporated in Delaware on **May 8, 2018**[130](index=130&type=chunk) - Corporate offices are located at 360 Madison Avenue, 25th Floor, New York, NY 10017[130](index=130&type=chunk) [Available Information](index=28&type=section&id=Available%20Information) - Periodic reports and registration statements filed with the SEC (10-K, 10-Q, 8-K) are available free of charge on the company's website (www.luciddx.com)[131](index=131&type=chunk) - Reports filed by executive officers, directors, and 10% stockholders under Section 16 of the Exchange Act are also available on the website[132](index=132&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) Lucid Diagnostics faces significant financial, business, regulatory, intellectual property, and stock ownership risks, including ongoing losses, going concern doubts, dilution, intense competition, and dependence on PAVmed [Risks Associated with Our Financial Condition](index=29&type=section&id=Risks%20Associated%20with%20Our%20Financial%20Condition) - The company has incurred operating losses since inception, with net losses of **$52.7 million** in 2023 and **$56.2 million** in 2022, and expects continued losses[145](index=145&type=chunk) - There is substantial doubt about the company's ability to continue as a going concern beyond March 2025, as noted in its financial statements and auditor's report, requiring additional capital funding[148](index=148&type=chunk) - Issuance of convertible securities (e.g., Series B Preferred Stock convertible into up to **49,822,240 common shares**) and future equity/debt offerings could significantly dilute existing stockholders and potentially cause a change in control[149](index=149&type=chunk)[150](index=150&type=chunk)[155](index=155&type=chunk) - Servicing indebtedness, including the March 2023 Senior Convertible Note, requires significant cash flow, and restrictive covenants could adversely affect liquidity and operations[158](index=158&type=chunk)[162](index=162&type=chunk) [Risks Associated with Our Business](index=29&type=section&id=Risks%20Associated%20with%20Our%20Business) - With a limited operating history and no significant revenues to date, there is little basis to evaluate the ability to achieve business objectives[166](index=166&type=chunk) - The company faces competition from existing procedure-based technologies, other diagnostic tests (e.g., 'sponge-on-a-string' devices, liquid biopsies), and potential new technologies, some from companies with greater resources[167](index=167&type=chunk)[169](index=169&type=chunk)[172](index=172&type=chunk)[176](index=176&type=chunk) - Substantially all revenues are expected from EsoGuard and EsoCheck, making the business highly dependent on their market acceptance, regulatory status, and competition[177](index=177&type=chunk) - High dependence on the CWRU license agreement means termination or disputes could prevent commercialization[178](index=178&type=chunk) - Products may not achieve market acceptance due to factors like effectiveness, reliability, safety, physician adoption, reimbursement, and marketing efforts[179](index=179&type=chunk) - Estimates of total addressable markets may be incorrect, potentially impairing sales growth[181](index=181&type=chunk) - Reliance on third-party manufacturers and a single laboratory facility for EsoGuard testing poses risks to capacity, timely production, and operational continuity[184](index=184&type=chunk)[186](index=186&type=chunk)[189](index=189&type=chunk) - Labor shortages, turnover, and cost increases, as well as disruptions in courier delivery services, could adversely affect operations and customer satisfaction[192](index=192&type=chunk)[194](index=194&type=chunk) [Risks Associated with Healthcare Regulation, Billing and Reimbursement, and Product Safety and Effectiveness](index=31&type=section&id=Risks%20Associated%20with%20Healthcare%20Regulation%2C%20Billing%20and%20Reimbursement%2C%20and%20Product%20Safety%20and%20Effectiveness) - Inadequate reimbursement from private or governmental third-party payors, or delays in obtaining coverage decisions, could materially hinder commercialization of EsoGuard and EsoCheck[204](index=204&type=chunk)[205](index=205&type=chunk)[209](index=209&type=chunk) - The proposed FDA policy to phase out enforcement discretion for LDTs could require EsoGuard to undergo FDA premarket review, a complex and resource-intensive process[212](index=212&type=chunk)[218](index=218&type=chunk) - Failure to maintain CLIA-certification or comply with federal/state laws regulating clinical laboratories could prevent EsoGuard testing and commercialization[214](index=214&type=chunk)[216](index=216&type=chunk) - Jointly marketing EsoGuard with EsoCheck as a combined product without FDA approval as an IVD device could lead to enforcement actions and severe business impact[217](index=217&type=chunk) - Clinical trials are expensive, time-consuming, and may not yield results supporting product claims or could reveal adverse side effects, delaying commercialization[226](index=226&type=chunk)[230](index=230&type=chunk) - Ongoing regulatory obligations post-approval, including cGMP compliance and potential recalls, could result in significant expenses and penalties[235](index=235&type=chunk)[237](index=237&type=chunk)[267](index=267&type=chunk) - Promoting devices for unapproved ('off-label') uses or engaging in other non-compliant activities could lead to recalls, fines, and reputational damage[238](index=238&type=chunk)[239](index=239&type=chunk) - Operation of Lucid Test Centers and telemedicine partnerships are subject to complex federal and state regulations, with non-compliance risking sanctions and fines[244](index=244&type=chunk)[247](index=247&type=chunk)[249](index=249&type=chunk)[251](index=251&type=chunk) - Billing complexities in the diagnostic industry, including varying payor requirements and potential for non-coverage, may hinder payment collection for EsoGuard tests[259](index=259&type=chunk)[260](index=260&type=chunk) - Product liability lawsuits, even without merit, could result in substantial liabilities, decreased demand, and reputational harm[269](index=269&type=chunk) - Compliance with HIPAA security, privacy, and breach notification regulations increases costs and risks of fines or penalties from data breaches[271](index=271&type=chunk)[273](index=273&type=chunk) [Risks Associated with Our Intellectual Property and Technology Infrastructure](index=33&type=section&id=Risks%20Associated%20with%20Our%20Intellectual%20Property%20and%20Technology%20Infrastructure) - Inability to protect or enforce intellectual property rights (patents, trademarks, trade secrets) for EsoGuard and EsoCheck technology could impair competitive position, as patents may expire, be challenged, or circumvented[274](index=274&type=chunk)[275](index=275&type=chunk) - The company may be subject to costly intellectual property infringement claims by third parties, diverting management attention and potentially resulting in liability or requiring product redesigns[280](index=280&type=chunk)[281](index=281&type=chunk) - Failures in information technology (IT) systems, including security breaches, cyberattacks, or data loss, could disrupt operations, research, and commercialization efforts, leading to financial and reputational damage[283](index=283&type=chunk)[287](index=287&type=chunk) [Risks Associated with Our Relationship with PAVmed](index=33&type=section&id=Risks%20Associated%20with%20Our%20Relationship%20with%20PAVmed) - PAVmed owns a majority of Lucid's voting stock (**70.1%** as of Dec 31, 2023; **64.9%** as of Mar 21, 2024), allowing it to control actions requiring a stockholder vote and potentially creating conflicts of interest[288](index=288&type=chunk)[289](index=289&type=chunk) - If PAVmed's debt is accelerated due to default, it could lose voting control of Lucid, potentially transferring control to its debtholders[292](index=292&type=chunk) - Lucid's certificate of incorporation waives certain rights regarding business opportunities presented to PAVmed-affiliated officers/directors, meaning such opportunities may not be presented to Lucid[293](index=293&type=chunk)[294](index=294&type=chunk) - Dependence on PAVmed for management and administrative services under the MSA means that if these services are insufficient or if the MSA terminates, establishing independent systems could be costly and disruptive[295](index=295&type=chunk)[296](index=296&type=chunk) [Risks Associated with Ownership of Our Common Stock](index=33&type=section&id=Risks%20Associated%20with%20Ownership%20of%20Our%20Common%20Stock) - Lack of research or unfavorable research from securities/industry analysts could lead to a decline in stock price and trading volume[299](index=299&type=chunk)[301](index=301&type=chunk) - The common stock may be delisted from Nasdaq if listing requirements are not met, limiting investor transactions and potentially subjecting the company to additional trading restrictions[302](index=302&type=chunk)[303](index=303&type=chunk) - The stock price is likely to be volatile, influenced by broad market factors, industry trends, retail investor sentiment, and trading dynamics, potentially leading to substantial losses for stockholders[303](index=303&type=chunk)[305](index=305&type=chunk) - The company does not intend to pay cash dividends on common stock in the foreseeable future, meaning any gain will solely depend on stock appreciation[306](index=306&type=chunk) - Operating as a public company incurs significant legal, accounting, and compliance costs, requiring substantial management time[307](index=307&type=chunk) - Failure to establish and maintain effective internal control over financial reporting could erode investor confidence and significantly depress the stock price[310](index=310&type=chunk)[311](index=311&type=chunk) - As an 'emerging growth company,' reduced reporting requirements might make common stock less attractive to some investors, potentially affecting trading market and stock price[313](index=313&type=chunk) - Provisions in corporate charter documents and Delaware law (e.g., staggered board, no cumulative voting, Section 203) could make an acquisition more difficult and prevent changes in management[315](index=315&type=chunk)[317](index=317&type=chunk)[321](index=321&type=chunk) [Item 1B. Unresolved Staff Comments](index=40&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company has no unresolved staff comments from the SEC - Not applicable[322](index=322&type=chunk) [Item 1C. Cybersecurity](index=40&type=section&id=Item%201C.%20Cybersecurity) Lucid Diagnostics' audit committee oversees cybersecurity risks, managed by third-party CyberTeam, which identifies, assesses, and mitigates threats, with no material incidents currently known [Governance](index=80&type=section&id=Governance) - The board administers cybersecurity risk oversight through its audit committee, which discusses major risk exposures with management, counsel, and auditors[323](index=323&type=chunk) - Techneto, Inc. d/b/a CyberTeam, a third-party vendor with over **25 years of experience**, is retained to identify, assess, and manage cybersecurity threats, reporting directly to the president and COO[324](index=324&type=chunk) - CyberTeam provides periodic updates on the cybersecurity program and material risks to the board and executive leadership[325](index=325&type=chunk) [Risk Management and Strategy](index=80&type=section&id=Risk%20Management%20and%20Strategy) - Senior management, supported by CyberTeam, monitors cybersecurity events and trends, assessing potential impacts; third-party partners handling confidential information are generally required to notify of cybersecurity incidents[326](index=326&type=chunk) - CyberTeam tracks and mitigates cybersecurity risks and incidents, overseeing remediation plans[327](index=327&type=chunk) - Cybersecurity risks are integrated into the overall risk management process through regular meetings with executive leadership and, when appropriate, the board and audit committee[328](index=328&type=chunk) - Currently, the company is not aware of any cybersecurity threats or incidents that have materially affected or are reasonably likely to materially affect the Company[329](index=329&type=chunk) [Item 2. Property](index=40&type=section&id=Item%202.%20Property) Lucid Diagnostics leases corporate offices in New York, a **21,019 sq ft** CLIA laboratory in California, and approximately **15,048 sq ft** across multiple Lucid Test Centers, with current space deemed adequate for operations - Corporate offices are located at 360 Madison Avenue, 25th Floor, New York, NY 10017, leased through PAVmed Inc. until **February 1, 2031**[330](index=330&type=chunk) - The company leases a CLIA laboratory in California (**21,019 sq ft**) with a term expiring **December 31, 2024**[331](index=331&type=chunk) - Lucid Test Centers are leased in Arizona, California, Colorado, Florida, Idaho, Illinois, Nevada, Ohio, Texas, and Utah, totaling approximately **15,048 sq ft**[331](index=331&type=chunk) [Item 3. Legal Proceedings](index=40&type=section&id=Item%203.%20Legal%20Proceedings) Lucid Diagnostics may face ordinary course legal actions, but is currently unaware of any pending proceedings likely to have a material business impact - The company may be subject to material legal actions (e.g., intellectual property, contract, privacy, professional liability, employee-related matters) in the ordinary course of business[203](index=203&type=chunk)[332](index=332&type=chunk) - Currently, the company is not aware of any pending legal or other proceedings that are reasonably likely to have a material impact[333](index=333&type=chunk) [Item 4. Mine Safety Disclosures](index=40&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company is not subject to Dodd-Frank Section 1503(a) disclosure requirements as it does not own or operate mines - Not applicable[334](index=334&type=chunk) [Part II](index=41&type=section&id=PART%20II) [Item 5. Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=41&type=section&id=Item%205.%20Market%20for%20Registrants%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Lucid Diagnostics' common stock (LUCD) trades on Nasdaq, with **48,244,798 shares outstanding** as of March 21, 2024; no common stock cash dividends are anticipated, but Series B Preferred Stock dividends are payable in common stock [Market for Common Equity](index=82&type=section&id=Market%20for%20Common%20Equity) - Common stock is traded on the Nasdaq Capital Market under the symbol '**LUCD**'[336](index=336&type=chunk) [Holders](index=82&type=section&id=Holders) - As of March 21, 2024, there were **48,244,798 shares** of common stock issued, held by an estimated **256 holders of record**[337](index=337&type=chunk) [Dividends](index=82&type=section&id=Dividends) - The company has not paid cash dividends on common stock to date and does not anticipate paying them in the foreseeable future, intending to retain earnings for business growth[338](index=338&type=chunk) - Payment of common stock dividends is restricted while the Senior Convertible Note is outstanding and is junior to preferred stock dividends[339](index=339&type=chunk) - Holders of Series B Preferred Stock are entitled to dividends payable in common stock (**20%** of convertible shares) on March 13, 2025, and March 13, 2026[340](index=340&type=chunk) [Recent Sales of Unregistered Securities and Use of Proceeds](index=82&type=section&id=Recent%20Sales%20of%20Unregistered%20Securities%20and%20Use%20of%20Proceeds) - No unregistered securities were sold or repurchased during the fiscal year ended December 31, 2023, except as previously disclosed in 8-K and 10-Q reports and as detailed in the recent financing section[341](index=341&type=chunk) [Item 6. [Reserved]](index=41&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved and contains no information - This item is reserved[342](index=342&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=42&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Lucid Diagnostics, a commercial-stage medical diagnostics company, focuses on EsoGuard and EsoCheck commercialization and regulatory approvals, but faces significant losses and going concern doubts, necessitating further capital raises and managing expenses via PAVmed agreements [Overview](index=83&type=section&id=Overview) - Lucid Diagnostics is a commercial-stage medical diagnostics technology company focused on early detection of highly lethal esophageal adenocarcinoma (EAC) in GERD patients[345](index=345&type=chunk) - The flagship product, EsoGuard Esophageal DNA Test, performed with EsoCheck Esophageal Cell Collection Device, is designed for widespread early detection of esophageal precancer[346](index=346&type=chunk) - EsoGuard is a bisulfite-converted targeted next-generation sequencing (NGS) DNA assay, and EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device[347](index=347&type=chunk)[348](index=348&type=chunk) - Both products are based on patented technology licensed from Case Western Reserve University (CWRU) for accurate, non-invasive, patient-friendly early detection of EAC and Barrett's Esophagus (BE)[349](index=349&type=chunk) [Recent Developments](index=84&type=section&id=Recent%20Developments) - In January 2024, PAVmed elected to receive **$4.7 million** in fees and reimbursements by issuing **3,331,771 shares** of Lucid's common stock[350](index=350&type=chunk) - In March 2024, the MSA with PAVmed was amended, increasing the monthly fee from **$0.75 million to $0.83 million**, effective January 1, 2024[350](index=350&type=chunk) - On March 13, 2024, Lucid completed a Series B Offering and Exchange, selling **12,495 shares** of Series B Convertible Preferred Stock for **$1,000/share** and exchanging all outstanding Series A and A-1 Preferred Stock for **31,790 shares** of Series B Preferred Stock; aggregate gross proceeds were **$18.16 million**[351](index=351&type=chunk) - As a result, no Series A or A-1 Preferred Stock remains outstanding[352](index=352&type=chunk) - In October 2023, Lucid sold **5,000 shares** of Series A-1 Preferred Stock for **$5.0 million**, which were later exchanged for Series B Preferred Stock[353](index=353&type=chunk) [Results of Operations](index=85&type=section&id=Results%20of%20Operations) - Revenue is recognized upon delivery of patient EsoGuard test results when collection is probable and unconstrained; cost of revenue includes EsoCheck device usage, shipment, royalties, and processing costs[354](index=354&type=chunk)[355](index=355&type=chunk) - Sales and marketing expenses primarily consist of salaries and allocated MSA fees, expected to increase with commercial expansion[358](index=358&type=chunk) - General and administrative expenses include professional fees, consulting, patent maintenance, and allocated MSA fees, expected to increase with business growth and public company compliance[359](index=359&type=chunk)[360](index=360&type=chunk) - Research and development expenses include regulatory filings, patent license fees, laboratory supplies, and allocated MSA fees, expected to continue for product development and clinical trials[361](index=361&type=chunk)[362](index=362&type=chunk) Key Financial Results (2023 vs. 2022) | Metric | Year Ended Dec 31, 2023 ($M) | Year Ended Dec 31, 2022 ($M) | Change ($M) | Change (%) | | :------------------------------------- | :--------------------------- | :--------------------------- | :---------- | :--------- | | Revenue | 2.4 | 0.4 | 2.0 | 500.0% | | Cost of revenue | 6.0 | 3.6 | 2.4 | 66.7% | | Sales and marketing expenses | 16.4 | 16.1 | 0.3 | 1.9% | | General and administrative expenses | 19.3 | 24.0 | (4.7) | (19.6%) | | Amortization of acquired intangible assets | 2.0 | 1.6 | 0.4 | 25.0% | | Research and development expenses | 7.3 | 11.3 | (4.0) | (35.4%) | | Operating loss | (48.5) | (56.3) | 7.8 | (13.9%) | | Net loss | (52.7) | (56.2) | 3.5 | (6.2%) | | Change in fair value - Senior Secured Convertible Note | (3.0) | — | (3.0) | N/A | | Loss on issue and offering costs - Senior Secured Convertible Note | (1.2) | — | (1.2) | N/A | - The **$2.0 million** increase in revenue in 2023 was principally due to the EsoGuard test performed in the company's own CLIA laboratory, following the termination of the EsoGuard Commercialization Agreement with RDx in February 2022[364](index=364&type=chunk) - The **$2.4 million** increase in cost of revenue was primarily due to a **$1.6 million** increase in EsoCheck and EsoGuard supplies costs and a **$0.8 million** increase in compensation-related costs[365](index=365&type=chunk)[368](index=368&type=chunk) - The **$4.7 million** decrease in general and administrative costs was principally due to an **$8.3 million** decrease in stock-based compensation, partially offset by a **$3.3 million** increase related to the amended MSA with PAVmed[365](index=365&type=chunk)[368](index=368&type=chunk) - The **$4.0 million** decrease in research and development costs was principally due to a **$5.5 million** decrease in development costs, particularly in clinical trial activities and outside professional/consulting fees for EsoCure[366](index=366&type=chunk)[368](index=368&type=chunk) [Liquidity and Capital Resources](index=89&type=section&id=Liquidity%20and%20Capital%20Resources) - Current operational activities focus on EsoGuard commercialization across multiple channels (medical practitioners, Lucid Test Centers, mobile units, direct contracting, telemedicine) and expanding clinical evidence for insurance reimbursement[372](index=372&type=chunk) - The company incurred a net loss of **$52.7 million** and used **$32.8 million** in cash from operations in 2023, ending the year with **$18.9 million cash on hand**[374](index=374&type=chunk) - Negative working capital of **$7.3 million** as of December 31, 2023, including a **$14.0 million** Senior Secured Convertible Note classified as a current liability, raises substantial doubt about the company's ability to continue as a going concern beyond March 2025[374](index=374&type=chunk)[472](index=472&type=chunk)[473](index=473&type=chunk) - Future operations depend on generating substantial revenue from reimbursement, direct employer contracts, and raising additional capital through equity/debt financings or refinancing existing debt[374](index=374&type=chunk) - In March 2024, the Series B Offering and Exchange generated **$18.16 million** in gross proceeds, with all Series A and A-1 Preferred Stock exchanged for Series B Preferred Stock[375](index=375&type=chunk)[376](index=376&type=chunk) - The March 2023 Senior Secured Convertible Note (face value **$11.1 million**) was issued for **$9.925 million** net proceeds, with a **7.875% annual interest rate** and a **$5.00 conversion price**, maturing **March 21, 2025**[378](index=378&type=chunk)[379](index=379&type=chunk)[380](index=380&type=chunk) - The company is subject to financial covenants for the Senior Convertible Note, including maintaining at least **$5.0 million** in available cash and specific market capitalization ratios, which it was in compliance with as of December 31, 2023[380](index=380&type=chunk) - A committed equity facility with Cantor (up to **$50 million**) and an 'at-the-market offering' (up to **$6.5 million**) provide mechanisms for raising primary equity capital[382](index=382&type=chunk)[383](index=383&type=chunk) - Intercompany agreements with PAVmed (MSA and PBERA) govern services and expense reimbursements, with PAVmed electing to receive **$4.7 million** in January 2024 via common stock issuance[384](index=384&type=chunk)[386](index=386&type=chunk) [Critical Accounting Policies and Estimates](index=93&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) - Revenue is recognized when performance obligations are satisfied (delivery of test results), reflecting expected consideration, which can be variable or fixed[389](index=389&type=chunk)[390](index=390&type=chunk)[391](index=391&type=chunk)[392](index=392&type=chunk) - The company elected the Fair Value Option (FVO) for the March 2023 Senior Secured Convertible Note, measuring it at estimated fair value at issuance and subsequently at each reporting period, with changes recognized in the statement of operations[397](index=397&type=chunk)[399](index=399&type=chunk) - Stock-based compensation expense for awards under Lucid Diagnostics 2018 Equity Plan and PAVmed 2014 Equity Plan is recognized on a straight-line basis over the vesting period, using the Black-Scholes valuation model[402](index=402&type=chunk)[403](index=403&type=chunk)[404](index=404&type=chunk) [Recent Accounting Standards Updates](index=97&type=section&id=Recent%20Accounting%20Standards%20Updates) - The company adopted ASU No. 2016-13 (Financial Instruments-Credit Losses) on **January 1, 2023**, with no impact on consolidated financial statements[407](index=407&type=chunk) - The company is evaluating the impact of ASU No. 2023-09 (Income Taxes) and ASU No. 2023-07 (Segment Reporting), effective for fiscal years beginning after **December 15, 2024**, and **December 15, 2023**, respectively[408](index=408&type=chunk)[409](index=409&type=chunk) - ASU No. 2023-06 (Disclosure Improvements) modifies disclosure requirements to conform with SEC amendments, with prospective application and early adoption prohibited[410](index=410&type=chunk) [Off-Balance sheet arrangements](index=97&type=section&id=Off-Balance%20sheet%20arrangements) - The company does not have any off-balance sheet arrangements[411](index=411&type=chunk) [Item 7A. Quantitative and Qualitative Disclosure About Market Risk](index=50&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) The company has no material market risk exposure requiring quantitative and qualitative disclosure - Not applicable[412](index=412&type=chunk) [Item 8. Financial Statements and Supplementary Data](index=50&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) Consolidated financial statements and the independent registered public accounting firm's report are incorporated by reference - Consolidated financial statements and the report of the independent registered public accounting firm are incorporated by reference[413](index=413&type=chunk) [Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=50&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) There have been no changes in or disagreements with accountants on accounting and financial disclosure - None[414](index=414&type=chunk) [Item 9A. Controls and Procedures](index=51&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2023, with no material changes reported during Q4 2023 [Evaluation of Disclosure Controls and Procedures](index=98&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - Management, with the participation of the principal executive officer and principal financial officer, concluded that disclosure controls and procedures were effective as of **December 31, 2023**[415](index=415&type=chunk) [Management's Report on Internal Control Over Financial Reporting](index=98&type=section&id=Management's%20Report%20on%20Internal%20Control%20Over%20Financial%20Reporting) - Management is responsible for establishing and maintaining an adequate system of internal control over financial reporting[416](index=416&type=chunk) - Based on an evaluation using the COSO framework (2013), management concluded that the system of internal control over financial reporting was effective as of **December 31, 2023**[418](index=418&type=chunk) - The Form 10-K does not include an attestation report from the independent registered public accounting firm regarding internal control over financial reporting, as permitted for emerging growth companies[419](index=419&type=chunk) [Changes to Internal Controls Over Financial Reporting](index=98&type=section&id=Changes%20to%20Internal%20Controls%20Over%20Financial%20Reporting) - No change in internal controls over financial reporting occurred during the quarter ended **December 31, 2023**, that materially affected, or is reasonably likely to materially affect, internal controls[420](index=420&type=chunk) [Item 9B. Other Information](index=51&type=section&id=Item%209B.%20Other%20Information) This section reports no adoption or termination of Rule 10b5-1 trading plans by directors or officers during Q4 2023 [Rule 10b5-1 Trading Plans](index=98&type=section&id=Rule%2010b5-1%20Trading%20Plans) - None of the directors or officers adopted or terminated a 'Rule 10b5-1 trading arrangement' or 'non-Rule 10b5-1 trading arrangement' during the fiscal quarter ended **December 31, 2023**[421](index=421&type=chunk) [Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=51&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) The company has no disclosures regarding foreign jurisdictions that prevent inspections - Not applicable[422](index=422&type=chunk) [Part III](index=52&type=section&id=PART%20III) [Item 10. Directors, Executive Officers and Corporate Governance](index=52&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information for this item is incorporated by reference from the 2024 Annual Meeting of Stockholders' definitive proxy statement - Information is incorporated by reference to the Proxy Statement for the 2024 Annual Meeting of Stockholders[424](index=424&type=chunk) [Item 11. Executive Compensation](index=52&type=section&id=Item%2011.%20Executive%20Compensation) Information for this item is incorporated by reference from the 2024 Annual Meeting of Stockholders' definitive proxy statement - Information is incorporated by reference to the Proxy Statement for the 2024 Annual Meeting of Stockholders[425](index=425&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=52&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information for this item is incorporated by reference from the 2024 Annual Meeting of Stockholders' definitive proxy statement - Information is incorporated by reference to the Proxy Statement for the 2024 Annual Meeting of Stockholders[426](index=426&type=chunk) [Item 13. Certain Relationships and Related Transactions and Director Independence](index=52&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%20and%20Director%20Independence) Information for this item is incorporated by reference from the 2024 Annual Meeting of Stockholders' definitive proxy statement - Information is incorporated by reference to the Proxy Statement for the 2024 Annual Meeting of Stockholders[427](index=427&type=chunk) [Item 14. Principal Accountant Fees and Services](index=52&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information for this item is incorporated by reference from the 2024 Annual Meeting of Stockholders' definitive proxy statement - Information is incorporated by reference to the Proxy Statement for the 2024 Annual Meeting of Stockholders[428](index=428&type=chunk) [Part IV](index=53&type=section&id=PART%20IV) [Item 15. Exhibits and Financial Statement Schedules](index=53&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists financial statements, schedules, and exhibits filed with the Form 10-K, including the Independent Registered Public Accounting Firm's Report and Consolidated Financial Statements - Includes the Report of Independent Registered Public Accounting Firm, Consolidated Balance Sheets, Statements of Operations, Changes in Stockholders' Equity (Deficit), Cash Flows, and Notes to Consolidated Financial Statements[433](index=433&type=chunk)[445](index=445&type=chunk) - Lists various exhibits, including the Asset Purchase Agreement, Amended and Restated Certificate of Incorporation, Bylaws, Form of Senior Secured Convertible Note, Equity Plans, License Agreements, Management Services Agreements, and certifications[434](index=434&type=chunk) [Item 16. Form 10-K Summary](index=55&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company has not provided a summary of its Form 10-K - None[438](index=438&type=chunk) [Financial Statements](index=105&type=section&id=FINANCIAL%20STATEMENTS) [Report of Independent Registered Public Accounting Firm](index=106&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) Marcum LLP issued an unqualified opinion on Lucid Diagnostics' 2023 and 2022 consolidated financial statements, but included an explanatory paragraph regarding substantial doubt about the company's going concern ability due to recurring losses and funding needs - Marcum LLP issued an unqualified opinion on the consolidated financial statements for 2023 and 2022, stating they present fairly the financial position and results of operations[447](index=447&type=chunk) - An explanatory paragraph highlights substantial doubt about the company's ability to continue as a going concern due to recurring losses, negative cash flows from operations, and the need to raise additional capital[448](index=448&type=chunk) - The company is not required to have, nor was the auditor engaged to perform, an audit of its internal control over financial reporting[450](index=450&type=chunk) [Consolidated Balance Sheets](index=107&type=section&id=Consolidated%20Balance%20Sheets) Consolidated balance sheets show total assets decreased from **$32.5 million** in 2022 to **$27.3 million** in 2023, while total liabilities increased from **$9.5 million** to **$29.6 million**, shifting stockholders' equity to a **$2.3 million deficit** Consolidated Balance Sheet Summary (in thousands) | Account | Dec 31, 2023 | Dec 31, 2022 | | :------------------------------------------ | :----------- | :----------- | | **Assets:** | | | | Cash | $18,896 | $22,474 | | Total current assets | $22,073 | $24,356 | | Fixed assets, net | $1,334 | $1,592 | | Intangible assets, net | $1,424 | $3,445 | | Total assets | $27,270 | $32,509 | | **Liabilities:** | | | | Senior Secured Convertible Note - at fair value | $13,950 | — | | Due To: PAVmed Inc. - MSA Fee and operating expenses | $9,339 | $4,960 | | Total current liabilities | $29,382 | $8,425 | | Total liabilities | $29,581 | $9,462 | | **Stockholders' Equity (Deficit):** | | | | Preferred stock | $18,625 | — | | Accumulated deficit | $(150,741) | $(98,075) | | Total Stockholders' Equity (Deficit) | $(2,311) | $23,047 | - Cash decreased by **$3.578 million** from **$22.474 million** in 2022 to **$18.896 million** in 2023[454](index=454&type=chunk) - Total liabilities increased significantly by **$20.119 million**, primarily due to the recognition of the Senior Secured Convertible Note (**$13.950 million**) and an increase in Due To: PAVmed Inc. (**$4.379 million**)[454](index=454&type=chunk) - Stockholders' Equity shifted from a positive **$23.047 million** in 2022 to a deficit of **$2.311 million** in 2023, driven by the net loss and preferred stock issuances[454](index=454&type=chunk) [Consolidated Statements of Operations](index=108&type=section&id=Consolidated%20Statements%20of%20Operations) Lucid Diagnostics reported a net loss of **$52.7 million** in 2023, an improvement from **$56.2 million** in 2022, with revenue increasing from **$0.4 million** to **$2.4 million**, while operating expenses decreased, but new convertible note expenses impacted the overall loss Consolidated Statements of Operations Summary (in thousands) | Account | 2023 | 2022 | | :------------------------------------------ | :----- | :----- | | Revenue | $2,428 | $377 | | Cost of revenue | $5,979 | $3,614 | | Sales and marketing | $16,404 | $16,134 | | General and administrative | $19,254 | $23,974 | | Amortization of acquired intangible assets | $2,021 | $1,649 | | Research and development | $7,252 | $11,257 | | Total operating expenses | $50,910 | $56,628 | | Operating loss | $(48,482) | $(56,251) | | Interest income | $424 | $88 | | Interest expense | $(416) | $(8) | | Change in fair value - Senior Secured Convertible Note | $(2,980) | — | | Loss on issue and offering costs - Senior Secured Convertible Note | $(1,186) | — | | Net loss | $(52,666) | $(56,171) | | Net loss per share - basic and diluted | $(1.26) | $(1.55) | - Revenue increased by **$2.051 million (544%)** from **$0.377 million** in 2022 to **$2.428 million** in 2023[457](index=457&type=chunk) - Net loss improved by **$3.505 million (6.2%)** from **$56.171 million** in 2022 to **$52.666 million** in 2023[457](index=457&type=chunk) - General and administrative expenses decreased by **$4.720 million (19.7%)** from **$23.974 million** in 2022 to **$19.254 million** in 2023[457](index=457&type=chunk) - Research and development expenses decreased by **$4.005 million (35.6%)** from **$11.257 million** in 2022 to **$7.252 million** in 2023[457](index=457&type=chunk) - New expenses in 2023 include a **$2.980 million** change in fair value and **$1.186 million** loss on issue and offering costs for the Senior Secured Convertible Note[457](index=457&type=chunk) [Consolidated Statements of Changes in Stockholders' Equity (Deficit)](index=109&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(Deficit)) Lucid Diagnostics' total stockholders' equity shifted from a **$23.047 million** positive balance in 2022 to a **$2.311 million deficit** in 2023, primarily due to a **$52.666 million net loss**, partially offset by **$18.625 million** from preferred stock and **$6.822 million** in stock-based compensation Consolidated Statements of Changes in Stockholders' Equity (Deficit) Summary (in thousands) | Item | 2023 | 2022 | | :------------------------------------------ | :----- | :----- | | Balance as of December 31, 2021 | $54,739 | $54,739 | | Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan | $5,762 | $13,859 | | Stock-based compensation - PAVmed Inc. 2014 Equity Plan | $1,060 | $1,132 | | Issuance - Series A and Series A-1 Preferred Stock | $18,625 | — | | Net loss | $(52,666) | $(56,171) | | Balance as of December 31, 2023 | $(2,311) | $23,047 | - Total Stockholders' Equity (Deficit) decreased by **$25.358 million**, from **$23.047 million** in 2022 to **$(2.311) million** in 2023[460](index=460&type=chunk) - The issuance of Series A and Series A-1 Preferred Stock contributed **$18.625 million** to equity in 2023[460](index=460&type=chunk) - Accumulated deficit increased from **$(98.075) million** in 2022 to **$(150.741) million** in 2023 due to the net loss[460](index=460&type=chunk) [Consolidated Statements of Cash Flows](index=110&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) In 2023, Lucid Diagnostics used **$32.8 million** in operating cash, provided **$29.5 million** from financing (preferred stock, convertible note), and used **$0.2 million** in investing, resulting in a net cash decrease of **$3.6 million** and ending with **$18.9 million** cash Consolidated Statements of Cash Flows Summary (in thousands) | Cash Flow Activity | 2023 | 2022 | | :------------------------------------------ | :----- | :----- | | Net cash flows used in operating activities | $(32,817) | $(29,685) | | Net cash flows used in investing activities | $(221) | $(4,108) | | Net cash flows provided by financing activities | $29,460 | $2,611 | | Net increase (decrease) in cash | $(3,578) | $(31,182) | | Cash, end of period | $18,896 | $22,474 | - Net cash used in operating activities increased by **$3.132 million (10.5%)** from **$29.685 million** in 2022 to **$32.817 million** in 2023[462](index=462&type=chunk) - Net cash provided by financing activities significantly increased by **$26.849 million (1028%)** from **$2.611 million** in 2022 to **$29.460 million** in 2023, driven by preferred stock and convertible note issuances[462](index=462&type=chunk) - Cash at the end of the period decreased by **$3.578 million**, from **$22.474 million** in 2022 to **$18.896 million** in 2023[462](index=462&type=chunk) [Notes to Consolidated Financial Statements](index=111&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) These notes detail Lucid Diagnostics' business, fin

Lucid Diagnostics Inc. (NASDAQ:LUCD) Q3 2023 Results Conference Call November 14, 2023 8:30 AM ET Company Participants Michael Parks - VP, IR Dr. Lishan Aklog - Chairman, CEO Dennis McGrath - EVP, CFO Conference Call Participants Kyle Mikson - Canaccord Ross Osborn - Cantor Fitzgerald Mike Matson - Needham & Co Ed Woo - Ascendiant Capital Operator Good morning, and welcome to the Lucid Diagnostics Third Quarter 2023 Business Update Conference Call. All participants will be in a listen-only mode. [Operator I ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) OR ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 001-40901 LUCID DIAGNOSTICS INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 82-5488042 (State or ...

Financial Data and Key Metrics Changes - The company reported a net loss per share improvement from $0.40 to $0.27, reflecting a $4.9 million decrease in sequential net loss [59][88] - Non-GAAP operating expenses for Q2 2023 were $9.7 million, showing an 11.3% sequential decrease [58][87] - Revenue for Q2 reflects actual cash collections and invoiced EsoGuard tests, with a significant increase in collections for third-party reimbursement claims, tripling compared to the previous quarter [56][86] Business Line Data and Key Metrics Changes - EsoGuard test volume grew by 20% quarter-on-quarter to 2,200 tests, marking consistent double-digit growth over six quarters [5][35] - The company achieved a 99% technical success rate for the EsoCheck cell collection procedure [37] - The first direct employer contract was executed, offering EsoGuard as an employee benefit at 12 locations [6][44] Market Data and Key Metrics Changes - The split between commercial and Medicare/Medicaid claims is approximately 82% commercial and 17% Medicare/Medicaid [89] - The average allowed payment for adjudicated claims is now just under $1,900, indicating an increase in payment rates [90] Company Strategy and Development Direction - The company is focusing on expanding its geographic reach through satellite test centers and high-volume testing events [14][41] - There is an emphasis on improving revenue cycle management and engaging with commercial payers to enhance coverage and payment processes [20][74] - The company plans to continue enrolling patients in clinical utility studies to support payer engagement and demonstrate the test's impact on medical decision-making [76][132] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trajectory, citing improved engagement with medical directors and a robust pipeline of accounts [68][120] - The company anticipates that the upgraded revenue cycle management will lead to better claims processing and payments, positively impacting revenue recognition [144][125] - Management highlighted the importance of clinical utility data in discussions with payers, indicating ongoing efforts to enhance this aspect [72][75] Other Important Information - The company has a laboratory capacity to perform over 10,000 tests per quarter, indicating sufficient capacity to meet current demand [12] - The EsoGuard study reported a 100% detection rate for cancer and over 80% for pre-cancer, showcasing the test's effectiveness [29][51] Q&A Session Summary Question: Can you quantify the volume that was lost during the period in May and June? - The total volume during that period was a little over 2,000 tests, but no claims were lost as they were submitted later [92][93] Question: How long until you can shift from billing on collections to submissions? - The timeline is uncertain and depends on the predictability of payment likelihood based on historical data [102][104] Question: What is the expected timing for the peer-reviewed publication of the clinical utility studies? - The goal is to submit data for peer review by the end of the month, with ongoing enrollment expected [111][112] Question: Were there any large events in Q2 that may not occur again in Q3? - There were no significant events that would risk the sequential volume growth trajectory, as growth has been strong across various channels [129][130]