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Lucid Diagnostics(LUCD) - 2023 Q2 - Quarterly Report
2023-08-14 20:45
[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)
Lucid Diagnostics(LUCD) - 2023 Q1 - Quarterly Report
2023-05-15 20:25
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(LUCD) - 2022 Q4 - Earnings Call Transcript
2023-03-14 18:18
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 ...
Lucid Diagnostics(LUCD) - 2022 Q4 - Annual Report
2023-03-13 22:36
Revenue and Financial Performance - Lucid Diagnostics Inc. reported a revenue of $13.625 million from the sale of 13,625 shares of Series A preferred stock, with each share having a stated value of $1,000 and a conversion price of $1.394[350]. - For the year ended December 31, 2022, revenue was $0.4 million, a decrease of 20% from $0.5 million in the prior year, primarily due to the termination of the EsoGuard Commercialization Agreement[368]. - Cost of revenue increased significantly to approximately $3.6 million in 2022 from $0.6 million in the prior year, reflecting a $3.0 million increase[369]. - Sales and marketing expenses rose to approximately $16.1 million in 2022, up from $5.3 million in the previous year, marking a net increase of $10.8 million[369]. - General and administrative expenses increased to approximately $23.7 million in 2022, compared to $12.8 million in the prior year, a net increase of $10.9 million[369]. - Research and development expenses were approximately $11.5 million in 2022, an increase of $2.2 million from $9.3 million in the prior year[371]. Clinical Trials and Product Development - Lucid is conducting multiple clinical trials, including a study with 500 patients and a virtual-patient randomized controlled trial with 100-200 participants, with results expected in 2023[343]. - EsoGuard achieved over 90% sensitivity and specificity in detecting esophageal precancer in a multicenter study involving 408 patients[340]. - The EsoCheck device, a noninvasive swallowable capsule, allows for surface esophageal cell sampling in under five minutes, enhancing patient experience[341]. - The company plans to continue incurring research and development expenses for existing products and new innovations, focusing on obtaining FDA approvals and facilitating insurer reimbursement[364][366]. - The company is expanding commercialization of EsoGuard across multiple sales channels and establishing Lucid Diagnostics Test Centers[374]. Agreements and Financial Instruments - The termination of the MSA-RDx agreement resulted in a net savings of $2.725 million for the company, reducing future earnout payments and management fees[347]. - The March 2023 Senior Secured Convertible Note has a face value of $11.1 million and a 7.875% annual interest rate, with a contractual conversion price of $5.00 per share[351][352]. - The company entered into a Securities Purchase Agreement to sell a Senior Secured Convertible Note with a face value of $11.1 million, with a 7.875% annual interest rate[379][380]. - As of March 7, 2023, the company entered into subscription agreements for the sale of 13,625 shares of Series A preferred stock, generating gross proceeds of $13.625 million[378]. Stock-Based Compensation and Accounting Policies - The Company recognizes research and development expenses as incurred, including salaries, stock-based compensation, and costs related to contract research service providers[392]. - Stock-based awards are made under the Lucid Diagnostics Inc. 2018 Equity Plan and the PAVmed Inc. 2014 Equity Plan, with fair value recognized on a straight-line basis over the requisite service period[393]. - The estimated fair value of stock options is calculated using the Black-Scholes model, with historical stock price volatility and risk-free interest rates factored in[395]. - The Company adopted ASU 2020-06 effective January 1, 2021, which simplified accounting for certain financial instruments, but it did not affect the consolidated financial statements[398]. - The Company adopted FASB ASC Topic 842, requiring recognition of right-of-use assets and lease liabilities for leases over 12 months, effective December 31, 2021[400]. Other Financial Obligations and Risks - As of December 31, 2022, the Company had a payment obligation liability of approximately $5.0 million to PAVmed Inc. for employee-related costs and operating expenses[389]. - There are no off-balance sheet arrangements reported by the Company[401]. - The Company has not disclosed any quantitative and qualitative market risk information as it is not applicable[402].
Lucid Diagnostics(LUCD) - 2022 Q3 - Earnings Call Transcript
2022-11-15 02:50
Lucid Diagnostics Inc. (NASDAQ:LUCD) Q3 2022 Earnings Conference Call November 14, 2022 4:30 PM ET Company Participants Adrian Miller - Vice President-Investor Relations Lishan Aklog - Chairman & Chief Executive Officer Dennis McGrath - Chief Financial Officer Conference Call Participants Mike Matson - Needham & Company Ross Osborn - Cantor Fitzgerald Ed Woo - Ascendiant Capital Greetings, and welcome to Lucid Diagnostics Third Quarterly Update Conference Call and Webcast. At this time, all participants are ...
Lucid Diagnostics(LUCD) - 2022 Q3 - Quarterly Report
2022-11-14 21:08
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 September 30, 2022 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 ...
Lucid Diagnostics(LUCD) - 2022 Q2 - Earnings Call Transcript
2022-08-16 01:57
Lucid Diagnostics Inc. (NASDAQ:LUCD) Q2 2022 Earnings Conference Call August 15, 2022 4:30 PM ET Company Participants Adrian Miller - Vice President-Investor Relations Lishan Aklog - Chairman & Chief Executive Officer Dennis McGrath - Chief Financial Officer Conference Call Participants Ross Osborn - Cantor Fitzgerald Mike Matson - Needham & Company Ed Woo - Ascendiant Capital Mark Massaro - BTIG Operator Greetings, and welcome to Lucid Diagnostics Second Quarter 2020 Business Update Conference Call. At thi ...
Lucid Diagnostics(LUCD) - 2022 Q2 - Quarterly Report
2022-08-15 22:11
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 June 30, 2022 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 Othe ...
Lucid Diagnostics(LUCD) - 2022 Q1 - Quarterly Report
2022-05-16 21:18
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, 2022 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(LUCD) - 2022 Q1 - Earnings Call Transcript
2022-05-12 01:18
Lucid Diagnostics Inc. (NASDAQ:LUCD) Q1 2022 Earnings Conference Call May 11, 2022 4:30 PM ET Company Participants Adrian Miller – Vice President-Investor Relations Lishan Aklog – Chairman and Chief Executive Officer Dennis McGrath – Chief Financial Officer Conference Call Participants Ross Osborn – Cantor Fitzgerald Ed Woo – Ascendiant Capital Kyle Mikson – Canaccord Operator Greetings, welcome to the Lucid Diagnostics Business Update Conference Call. At this time, all participants are in a listen-only mod ...