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]

[Filing Information](index=1&type=section&id=Filing%20Information) This section details the filing information for Lucid Diagnostics Inc.'s Quarterly Report (Form 10-Q) for Q2 2023 - The document is a Quarterly Report (Form 10-Q) for Lucid Diagnostics Inc. for the period ended June 30, 2023[1](index=1&type=chunk)[2](index=2&type=chunk) Registrant Filer Status | Filer Status | Designation | | :------------- | :---------- | | Large Accelerated filer | ☐ | | Accelerated filed | ☐ | | Non-accelerated filer | ☒ | | Smaller reporting company | ☒ | | Emerging growth company | ☒ | - As of August 10, 2023, there were **43,725,703 shares** of the registrant's Common Stock outstanding[5](index=5&type=chunk) [Part I - Financial Information](index=3&type=section&id=Part%20I%20-%20Financial%20Information) [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 and comprehensive notes for the period ended June 30, 2023 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2023 | December 31, 2022 | Change | | :----------------------------------- | :-------------- | :---------------- | :----- | | Total Assets | $42,486 | $32,509 | +$9,977 | | Cash | $32,570 | $22,474 | +$10,096 | | Total Current Liabilities | $26,683 | $8,425 | +$18,258 | | Senior Secured Convertible Note - at fair value | $11,610 | — | +$11,610 | | Due To: PAVmed Inc. | $10,697 | $4,960 | +$5,737 | | Total Stockholders' Equity | $15,071 | $23,047 | -$7,976 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Condensed Consolidated Statements of Operations Highlights (in thousands) | Metric | 3 Months Ended June 30, 2023 | 3 Months Ended June 30, 2022 | 6 Months Ended June 30, 2023 | 6 Months Ended June 30, 2022 | | :----------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Revenue | $159 | $— | $605 | $189 | | Cost of revenue | $1,549 | $— | $2,887 | $369 | | Operating loss | $(11,584) | $(14,628) | $(25,900) | $(26,899) | | Net loss | $(11,381) | $(14,624) | $(27,628) | $(26,894) | | Net loss per share - basic and diluted | $(0.27) | $(0.41) | $(0.67) | $(0.76) | - The company's revenue significantly increased in Q2 2023 and H1 2023, while operating loss decreased for both periods compared to the prior year, but net loss increased for the six-month period[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)) Changes in Stockholders' Equity (Deficit) Highlights (in thousands) | Metric | 6 Months Ended June 30, 2023 | | :----------------------------------- | :--------------------------- | | Balance as of December 31, 2022 | $23,047 | | Issuance - Series A Preferred Stock | $13,625 | | Stock-based compensation - Lucid Diagnostics Inc. | $3,982 | | Stock-based compensation - PAVmed Inc. | $625 | | Net loss | $(27,628) | | Balance as of June 30, 2023 | $15,071 | - Total Stockholders' Equity decreased from **$23,047k** at December 31, 2022, to **$15,071k** at June 30, 2023, primarily due to the net loss, partially offset by the issuance of Series A Preferred Stock[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Metric | 6 Months Ended June 30, 2023 | 6 Months Ended June 30, 2022 | | :----------------------------------- | :--------------------------- | :--------------------------- | | Net cash flows used in operating activities | $(14,057) | $(19,081) | | Net cash flows used in investing activities | $(32) | $(2,584) | | Net cash flows provided by financing activities | $24,185 | $688 | | Net increase (decrease) in cash | $10,096 | $(20,977) | | Cash, end of period | $32,570 | $32,679 | - Cash provided by financing activities significantly increased in H1 2023, leading to a net increase in cash, contrasting with a net decrease in the prior year[19](index=19&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [Note 1 — Summary Description of the Company](index=9&type=section&id=Note%201%20%E2%80%94%20Summary%20Description%20of%20the%20Company) - Lucid Diagnostics is a commercial-stage medical diagnostics technology company focused on early detection of esophageal precancer (EAC) in GERD patients[21](index=21&type=chunk)[22](index=22&type=chunk) - Its flagship product, the EsoGuard Esophageal DNA Test, performed on samples collected with the EsoCheck Esophageal Cell Collection Device, is the first and only commercially available diagnostic test for early detection of esophageal precancer[22](index=22&type=chunk)[23](index=23&type=chunk)[24](index=24&type=chunk) - The company expects recurring losses but anticipates funding operations for one year from the report date with current cash and committed equity sources[26](index=26&type=chunk) [Note 2 — Summary of Significant Accounting Policies](index=10&type=section&id=Note%202%20%E2%80%94%20Summary%20of%20Significant%20Accounting%20Policies) - The financial statements are prepared in accordance with U.S. GAAP, are unaudited, and consolidate the Company and its wholly-owned subsidiaries, with PAVmed Inc. as the majority owner[29](index=29&type=chunk) - Revenue is primarily from EsoGuard Esophageal DNA tests, recognized upon release of patient test results to the ordering healthcare provider, considering variable and fixed consideration[34](index=34&type=chunk)[35](index=35&type=chunk)[39](index=39&type=chunk) - The company elected the 'fair value option' (FVO) for the March 2023 Senior Secured Convertible Note, measuring it at fair value at issuance and subsequently, with changes recognized in the statement of operations[46](index=46&type=chunk)[48](index=48&type=chunk) - The adoption of ASU No. 2016-13 (Financial Instruments-Credit Losses) on January 1, 2023, did not have a material impact on the condensed consolidated financial statements[51](index=51&type=chunk) [Note 3 — Revenue from Contracts with Customers](index=14&type=section&id=Note%203%20%E2%80%94%20Revenue%20from%20Contracts%20with%20Customers) Revenue and Cost of Revenue (in thousands) | Metric | 3 Months Ended June 30, 2023 | 3 Months Ended June 30, 2022 | 6 Months Ended June 30, 2023 | 6 Months Ended June 30, 2022 | | :---------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Revenue | $159 | $— | $605 | $189 | | Cost of Revenue | $1,549 | $— | $2,887 | $369 | - The increase in revenue in 2023 is primarily due to the delivery of patient EsoGuard test results from the Company's own CLIA laboratory, following the termination of the EsoGuard Commercialization Agreement with ResearchDx Inc. (RDx) in February 2022[53](index=53&type=chunk) - Cost of revenue in 2023 is principally related to laboratory operations and EsoCheck device supplies, reflecting the shift to in-house testing[54](index=54&type=chunk)[55](index=55&type=chunk) [Note 4 — Related Party Transactions](index=15&type=section&id=Note%204%20%E2%80%94%20Related%20Party%20Transactions) Related Party Expenses (in thousands) | Expense Category | 3 Months Ended June 30, 2023 | 3 Months Ended June 30, 2022 | 6 Months Ended June 30, 2023 | 6 Months Ended June 30, 2022 | | :----------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | CWRU – Royalty Fees (Cost of Revenue) | $10 | $— | $34 | $9 | | Stock-based compensation – Physician Inventors (G&A) | $— | $272 | $180 | $544 | | Amended CWRU – License Agreement - reimbursement of patent legal fees (R&D) | $— | $209 | $389 | $209 | | Fees - Physician Inventors' consulting agreements (R&D) | $9 | $10 | $10 | $18 | | Stock-based compensation – Physician Inventors' stock options (R&D) | $52 | $52 | $105 | $99 | | **Total Related Party Expenses** | **$71** | **$543** | **$718** | **$882** | - The Management Services Agreement (MSA) Fee with PAVmed Inc. increased to **$750k per month**, effective January 1, 2023, from **$390k per month** in Q2 2022[58](index=58&type=chunk) MSA Fee Expense Classification (in thousands) | Expense Category | 3 Months Ended June 30, 2023 | 3 Months Ended June 30, 2022 | 6 Months Ended June 30, 2023 | 6 Months Ended June 30, 2022 | | :----------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Sales & Marketing | $109 | $183 | $218 | $383 | | General & Administrative | $1,554 | $640 | $3,108 | $1,284 | | Research & Development | $587 | $347 | $1,174 | $673 | | **Total MSA Fee** | **$2,250** | **$1,170** | **$4,500** | **$2,340** | [Note 5 — Due To PAVmed Inc.](index=16&type=section&id=Note%205%20%E2%80%94%20Due%20To%20PAVmed%20Inc.) Due To: PAVmed Inc. (in thousands) | Component | Balance - December 31, 2022 | 6 Months Ended June 30, 2023 Activity | Balance - June 30, 2023 | | :----------------------------------- | :-------------------------- | :------------------------------------ | :---------------------- | | MSA Fees | $1,650 | $4,500 | $6,150 | | Employee Related Costs (ERC) | $3,026 | $922 | $3,948 | | On Behalf Of (OBO) payments | $284 | $601 | $599 | | Cash payments to PAVmed Inc. | — | $(286) | — | | **Total Due To: PAVmed Inc.** | **$4,960** | **$5,737** | **$10,697** | - The aggregate liability to PAVmed Inc. significantly increased by **$5,737k** to **$10,697k** as of June 30, 2023, primarily driven by accrued MSA fees and employee-related costs[60](index=60&type=chunk) [Note 6 — Asset Purchase Agreement and Management Services Agreement](index=16&type=section&id=Note%206%20%E2%80%94%20Asset%20Purchase%20Agreement%20and%20Management%20Services%20Agreement) - The Company acquired certain assets from ResearchDx Inc. (RDx) on February 25, 2022, to establish its own CLIA-certified laboratory, recognizing an intangible asset of approximately **$3,200k**[61](index=61&type=chunk)[62](index=62&type=chunk) - The management services agreement with RDx was terminated on February 10, 2023, with remaining payment obligations of **$713k** settled by issuing **553,436 shares** of the Company's common stock[63](index=63&type=chunk)[64](index=64&type=chunk) [Note 7 — Prepaid Expenses, Deposits, and Other Current Assets](index=17&type=section&id=Note%207%20%E2%80%94%20Prepaid%20Expenses,%20Deposits,%20and%20Other%20Current%20Assets) Prepaid Expenses, Deposits, and Other Current Assets (in thousands) | Asset Category | June 30, 2023 | December 31, 2022 | | :----------------------------------- | :-------------- | :---------------- | | Advanced payments to service providers and suppliers | $344 | $371 | | Prepaid insurance | $171 | $52 | | Deposits | $2,587 | $1,331 | | EsoCheck cell collection supplies | $39 | $59 | | EsoGuard mailer supplies | $3 | $52 | | **Total prepaid expenses, deposits and other current assets** | **$3,144** | **$1,865** | - Total prepaid expenses, deposits, and other current assets increased by **$1,279k**, primarily due to a significant increase in deposits[65](index=65&type=chunk) [Note 8 — Leases](index=17&type=section&id=Note%208%20%E2%80%94%20Leases) - The Company entered into additional operating lease agreements for Lucid Test Centers during the six months ended June 30, 2023[66](index=66&type=chunk) Future Lease Payments and Lease Liabilities (in thousands) | Metric | Amount (June 30, 2023) | | :----------------------------------- | :--------------------- | | Total lease payments | $1,958 | | Present value of lease liabilities | $1,831 | | Operating lease right-of-use assets | $1,835 | | Weighted-average remaining lease term | 1.80 years | | Weighted-average discount rate | 7.875% | [Note 9 — Intangible Assets, net](index=18&type=section&id=Note%209%20%E2%80%94%20Intangible%20Assets,%20net) Intangible Assets, net (in thousands) | Asset Category | June 30, 2023 | December 31, 2022 | | :----------------------------------- | :-------------- | :---------------- | | Defensive technology | $2,105 | $2,105 | | Laboratory licenses and certifications and LIMS software | $3,200 | $3,200 | | Total Intangible assets | $5,305 | $5,305 | | Less Accumulated Amortization | $(2,870) | $(1,860) | | **Intangible Assets, net** | **$2,435** | **$3,445** | Amortization Expense (in thousands) | Period | 2023 | 2022 | | :--------------------------- | :--- | :--- | | 3 Months Ended June 30 | $505 | $639 | | 6 Months Ended June 30 | $1,010 | $639 | - Net intangible assets decreased by **$1,010k** due to amortization of defensive technology (60-month useful life) and laboratory licenses/software (24-month useful life)[68](index=68&type=chunk)[69](index=69&type=chunk)[70](index=70&type=chunk) [Note 10 — Financial Instruments Fair Value Measurements](index=19&type=section&id=Note%2010%20%E2%80%94%20Financial%20Instruments%20Fair%20Value%20Measurements) - The March 2023 Senior Convertible Note is classified as a **Level 3 financial instrument** and is measured at fair value using a Monte Carlo simulation[71](index=71&type=chunk)[72](index=72&type=chunk)[74](index=74&type=chunk) March 2023 Senior Convertible Note Fair Value and Assumptions | Metric | March 21, 2023 | June 30, 2023 | | :------------------- | :------------- | :------------ | | Fair Value | $11,900k | $11,610k | | Value of common stock | $1.54 | $1.39 | | Expected term (years) | 2.00 | 1.73 | | Volatility | 75.00% | 70.00% | | Risk free rate | 4.09% | 4.89% | - A **$290k income** was recognized in Q2 2023 due to a decrease in the fair value of the convertible note[74](index=74&type=chunk)[76](index=76&type=chunk) [Note 11 — Debt](index=20&type=section&id=Note%2011%20%E2%80%94%20Debt) - The March 2023 Senior Secured Convertible Note has a **$11.1 million face value principal**, a **7.875% annual interest rate**, a **$5.00 conversion price**, and matures on March 21, 2025[76](index=76&type=chunk)[78](index=78&type=chunk) - Net proceeds from the note were **$9.925 million** after deducting **$1.186 million** in lender fees and offering costs[79](index=79&type=chunk) - The note includes financial covenants requiring a minimum of **$5.0 million** in available cash, a debt-to-market capitalization ratio not exceeding **30%** (commencing Sept 30, 2023), and a market capitalization of at least **$30 million**; the Company was in compliance as of June 30, 2023[85](index=85&type=chunk)[163](index=163&type=chunk) [Note 12 — Stock-Based Compensation](index=21&type=section&id=Note%2012%20%E2%80%94%20Stock-Based%20Compensation) Total Stock-Based Compensation Expense (in thousands) | Period | 2023 | 2022 | | :--------------------------- | :--- | :--- | | 3 Months Ended June 30 | $1,399 | $3,844 | | 6 Months Ended June 30 | $4,607 | $7,679 | - Total stock-based compensation expense decreased significantly in both the three and six months ended June 30, 2023, compared to the prior year[94](index=94&type=chunk) Unrecognized Stock-Based Compensation Expense (in thousands) as of June 30, 2023 | Plan/Award Type | Unrecognized Expense | Weighted Average Remaining Service Period (Years) | | :----------------------------------- | :------------------- | :---------------------------------------------- | | Lucid Diagnostics 2018 Equity Plan - Stock Options | $4,129 | 2.3 | | Lucid Diagnostics 2018 Equity Plan - Restricted Stock Awards | $1,141 | 1.1 | | PAVmed 2014 Equity Plan - Stock Options | $861 | 2.0 | [Note 13 — Stockholders' Equity](index=24&type=section&id=Note%2013%20%E2%80%94%20Stockholders'%20Equity) - On March 7, 2023, the Company issued **13,625 shares** of Series A Convertible Preferred Stock for aggregate gross proceeds of **$13.625 million**, with an initial conversion price of **$1.394 per share**[98](index=98&type=chunk) - Shareholders approved an increase in authorized common stock to **200 million shares** in June 2023[105](index=105&type=chunk) - As of June 30, 2023, PAVmed holds **31,302,420 shares**, representing a majority-interest equity ownership in the Company[105](index=105&type=chunk) - Under the Committed Equity Facility, **680,263 shares** were issued for **$1.8 million** net proceeds cumulatively as of June 30, 2023; under the ATM Facility, **230,068 shares** were sold for **$0.3 million** net proceeds in H1 2023[106](index=106&type=chunk)[107](index=107&type=chunk) [Note 14 — Net Loss Per Share](index=26&type=section&id=Note%2014%20%E2%80%94%20Net%20Loss%20Per%20Share) Net Loss Per Share (Basic and Diluted) | Period | 3 Months Ended June 30, 2023 | 3 Months Ended June 30, 2022 | 6 Months Ended June 30, 2023 | 6 Months Ended June 30, 2022 | | :----------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Net loss per share - basic and diluted | $(0.27) | $(0.41) | $(0.67) | $(0.76) | - Basic and diluted net loss per share are identical because the Company was in a loss position, making the inclusion of common stock equivalents anti-dilutive[108](index=108&type=chunk) - Common stock equivalents excluded from diluted EPS increased significantly to **20,517,912** at June 30, 2023, primarily due to preferred stock[108](index=108&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) Management discusses Lucid Diagnostics Inc.'s financial condition, operational results, business developments, financing, and liquidity for the periods ended June 30, 2023 [Overview](index=27&type=section&id=Overview) - Lucid Diagnostics is a commercial-stage medical diagnostics company focused on the early detection of esophageal precancer (EAC) in patients with gastroesophageal reflux disease (GERD)[115](index=115&type=chunk) - The flagship product, EsoGuard Esophageal DNA Test, used with the EsoCheck Esophageal Cell Collection Device, is designed for non-invasive, early detection of esophageal precancer and Barrett's Esophagus (BE)[116](index=116&type=chunk)[118](index=118&type=chunk)[119](index=119&type=chunk)[120](index=120&type=chunk) - EsoGuard demonstrated over **90% sensitivity and specificity** in detecting esophageal precancer and conditions along the BE-EAC spectrum in a 408-patient study[118](index=118&type=chunk) [Recent Developments](index=29&type=section&id=Recent%20Developments) [Business Developments](index=29&type=section&id=Business%20Developments) - Lucid is accelerating clinical utility data collection through planned retrospective analysis of San Antonio firefighter data (results H2 2023), a virtual-patient randomized controlled trial (results 2023), a multi-center observational study, and a patient registry[121](index=121&type=chunk) - The company completed its first CheckYourFoodTube Precancer Testing Event with the San Antonio Fire Department in January 2023, testing **391 at-risk members**, and has expanded these events to other fire departments and launched a mobile testing unit in June 2023[122](index=122&type=chunk)[123](index=123&type=chunk)[124](index=124&type=chunk) - A Direct Contracting Strategic Initiative was launched in March 2023 to engage self-insured employers and unions, resulting in a contract with Ancira Automotive Group in August 2023[125](index=125&type=chunk) - Transitioned to a new revenue cycle management provider in May 2023, leading to improved speed of collections, claim submission, payment percentage, and data for appeals[126](index=126&type=chunk) [Financing Developments](index=29&type=section&id=Financing%20Developments) - On March 7, 2023, Lucid completed a Series A Preferred Stock offering, raising **$13.625 million** in gross proceeds from the sale of **13,625 shares**[128](index=128&type=chunk) - A private placement of a Senior Secured Convertible Note with a face value of **$11.1 million** was completed on March 13, 2023, yielding **$9.925 million** in net proceeds after fees[130](index=130&type=chunk)[131](index=131&type=chunk) - In the six months ended June 30, 2023, the company sold **230,068 shares** through its at-the-market (ATM) equity facility for net proceeds of approximately **$0.3 million**[133](index=133&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) [Revenue](index=32&type=section&id=Revenue_MD%26A) Revenue (in millions) | Period | 2023 | 2022 | | :--------------------------- | :--- | :--- | | 3 Months Ended June 30 | $0.2 | $0.0 | | 6 Months Ended June 30 | $0.6 | $0.2 | - Revenue increased significantly due to the Company performing EsoGuard tests in its own CLIA laboratory after the termination of the EsoGuard Commercialization Agreement with RDx in February 2022[135](index=135&type=chunk)[144](index=144&type=chunk)[151](index=151&type=chunk) [Cost of Revenue](index=32&type=section&id=Cost%20of%20Revenue_MD%26A) Cost of Revenue (in millions) | Period | 2023 | 2022 | | :--------------------------- | :--- | :--- | | 3 Months Ended June 30 | $1.5 | $0.0 | | 6 Months Ended June 30 | $2.9 | $0.4 | - The increase in cost of revenue is primarily due to increased laboratory facility and operations costs, EsoCheck and EsoGuard supplies costs, and compensation-related costs associated with the Company's own CLIA laboratory operations[145](index=145&type=chunk)[152](index=152&type=chunk) [Sales and Marketing Expenses](index=32&type=section&id=Sales%20and%20Marketing%20Expenses_MD%26A) Sales and Marketing Expenses (in millions) | Period | 2023 | 2022 | | :--------------------------- | :--- | :--- | | 3 Months Ended June 30 | $4.0 | $3.9 | | 6 Months Ended June 30 | $8.2 | $7.2 | - Sales and marketing expenses increased due to higher compensation-related costs from increased headcount, partially offset by a decrease in third-party marketing expenses[145](index=145&type=chunk)[152](index=152&type=chunk) [General and Administrative Expenses](index=32&type=section&id=General%20and%20Administrative%20Expenses_MD%26A) General and Administrative Expenses (in millions) | Period | 2023 | 2022 | | :--------------------------- | :--- | :--- | | 3 Months Ended June 30 | $3.8 | $6.7 | | 6 Months Ended June 30 | $10.3 | $12.6 | - General and administrative expenses decreased primarily due to lower stock-based compensation and reduced expenses from the termination of the MSA-RDx, despite an increase in the amended MSA with PAVmed[146](index=146&type=chunk)[153](index=153&type=chunk) [Research and Development Expenses](index=32&type=section&id=Research%20and%20Development%20Expenses_MD%26A) Research and Development Expenses (in millions) | Period | 2023 | 2022 | | :--------------------------- | :--- | :--- | | 3 Months Ended June 30 | $1.8 | $3.4 | | 6 Months Ended June 30 | $4.1 | $6.3 | - Research and development expenses decreased mainly due to a reduction in development costs, particularly for clinical trial activities and EsoCure, partially offset by increased compensation and amended MSA fees[147](index=147&type=chunk)[154](index=154&type=chunk) [Amortization of Acquired Intangible Assets](index=35&type=section&id=Amortization%20of%20Acquired%20Intangible%20Assets_MD%26A) Amortization of Acquired Intangible Assets (in millions) | Period | 2023 | 2022 | | :--------------------------- | :--- | :--- | | 3 Months Ended June 30 | $0.5 | $0.6 | | 6 Months Ended June 30 | $1.0 | $0.6 | - Amortization expense for acquired intangible assets remained relatively stable in the three-month period and increased in the six-month period[11](index=11&type=chunk) [Other Income and Expense](index=35&type=section&id=Other%20Income%20and%20Expense_MD%26A) - The change in fair value of the March 2023 Senior Convertible Note resulted in **$0.3 million of income** in Q2 2023 but a **$0.5 million expense** for the six months ended June 30, 2023, due to an initial **$0.8 million non-cash expense** on the issue date[148](index=148&type=chunk)[155](index=155&type=chunk) - The Company recognized approximately **$1.2 million** in lender fees and offering costs related to the March 2023 Senior Convertible Note in the six months ended June 30, 2023[156](index=156&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) - Lucid's current operational activities are focused on commercializing EsoGuard through multiple sales channels and expanding clinical evidence to support insurance reimbursement[157](index=157&type=chunk) - The company experienced a net loss of **$27.6 million** and used **$14.1 million** in cash from operations for the six months ended June 30, 2023, but financing activities provided **$24.2 million**[159](index=159&type=chunk) - As of June 30, 2023, the company had **$32.6 million** in cash on hand and expects to fund operations and meet financial obligations for one year from the report date with existing cash and committed equity sources[159](index=159&type=chunk) - The company was in compliance with all financial covenants of the March 2023 Senior Secured Convertible Note as of June 30, 2023, including minimum cash and market capitalization requirements[163](index=163&type=chunk) - The liability 'Due To: PAVmed Inc.' was approximately **$10.7 million** as of June 30, 2023, primarily from MSA fees and payroll/benefit reimbursements[169](index=169&type=chunk) [Item 4. Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluated the effectiveness of disclosure controls and procedures, confirming their efficacy with no material changes to internal controls during the quarter ended June 30, 2023 - Disclosure controls and procedures were evaluated and deemed effective as of June 30, 2023[172](index=172&type=chunk) - No material changes to internal controls over financial reporting occurred during the fiscal quarter ended June 30, 2023[173](index=173&type=chunk) [Part II - Other Information](index=42&type=section&id=Part%20II%20-%20Other%20Information) [Item 1. Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no material pending legal proceedings, while acknowledging inherent uncertainties and potential for future claims - 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, and/or cash flows[175](index=175&type=chunk) - Legal proceedings are subject to inherent uncertainties, and an unfavorable outcome could result in a material adverse impact[175](index=175&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=42&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered securities were sold in Q2 2023, and $57.5 million of IPO proceeds have been utilized for repayments, laboratory expenses, and working capital - No unregistered securities were sold or repurchased during the three months ended June 30, 2023[176](index=176&type=chunk) - Of the **$64.4 million** net proceeds from the October 2021 IPO, approximately **$57.5 million** has been used as of June 30, 2023[177](index=177&type=chunk) - Proceeds were used for approximately **$5.3 million** in net repayments to PAVmed Inc., **$5.0 million** for laboratory equipment/expenses, and **$47.2 million** for working capital expenditures[177](index=177&type=chunk) [Item 5. Other Information](index=42&type=section&id=Item%205.%20Other%20Information) This section confirms no additional information is reported - No other information is reported under this item[178](index=178&type=chunk) [Item 6. Exhibits](index=42&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including key agreements and certifications - Exhibit 10.1: Seventh Amendment to Management Services Agreement, dated May 9, 2023, between PAVmed Inc. and Lucid Diagnostics Inc.[185](index=185&type=chunk) - Exhibits 31.1, 31.2, 32.1, 32.2: Certifications of Principal Executive Officer and Principal Financial and Accounting Officer pursuant to the Sarbanes-Oxley Act of 2002[185](index=185&type=chunk) - Exhibits 101.INS, 101.CAL, 101.DEF, 101.LAB, 101.PRE, 104: Inline XBRL documents[185](index=185&type=chunk) [Signature](index=43&type=section&id=Signature) - The report was signed by Dennis M McGrath, Chief Financial Officer (Principal Financial and Accounting Officer) of Lucid Diagnostics Inc., on August 14, 2023[184](index=184&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ 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 Oth ...

Lucid Diagnostics Inc. (NASDAQ:LUCD) Q4 2022 Earnings Conference Call March 14, 2023 8:30 AM ET Company Participants Michael Parks - Vice President, Investor Relations Dr. Lishan Aklog - Chairman and CEO Dennis McGrath - Chief Financial Officer Conference Call Participants Kyle Mikson - Canaccord Genuity Ross Osborn - Cantor Fitzgerald Mike Matson - Needham & Co. Mark Massaro - BTIG Edward Woo - Ascendiant Capital Operator Welcome to the Lucid Diagnostics Business Update and Fourth Quarter 2022 Financial Re ...