[10-Q] Lucid Diagnostics Inc. Quarterly Earnings Report
Lucid Diagnostics (LUCD) is a commercial-stage cancer-prevention diagnostics company selling the EsoGuard test with EsoCheck sampling. For the three and six months ended June 30, 2025 the company recognized $1.16 million and $1.99 million of revenue, respectively, while reporting a net loss attributable to common stockholders of $7.9 million for the quarter and $43.9 million for the six months. Operating activities used $23.0 million of cash in the first half of 2025, leaving $31.1 million of cash and approximately $4.4 million of working capital as of June 30, 2025.
Key balance sheet and financing items include total assets of $38.7 million, stockholders' equity of $7.9 million, and Senior Secured Convertible Notes with $21.975 million face value carried at fair value of $25.3 million (conversion price $1.00; 12% stated interest). Management discloses substantial doubt about going concern absent increased reimbursement, revenue growth or additional financing. Recent developments include two equity raises in March and April 2025 netting ~$31.0 million, an ATM up to $25.0 million, Highmark coverage in New York effective May 26, 2025, MolDx LCD reconsideration (CAC on Sept 4, 2025), multiple peer-reviewed publications, and an $8.0 million NIH R01 award to CWRU investigators.
Lucid Diagnostics (LUCD) è una società commerciale attiva nella diagnostica per la prevenzione del cancro che commercializza il test EsoGuard con il prelievo EsoCheck. Nei tre e sei mesi chiusi il 30 giugno 2025 la società ha registrato ricavi per 1,16 milioni di dollari e 1,99 milioni di dollari rispettivamente, riportando una perdita netta attribuibile agli azionisti ordinari di 7,9 milioni di dollari nel trimestre e di 43,9 milioni nei sei mesi. Le attività operative hanno assorbito 23,0 milioni di dollari di cassa nella prima metà del 2025, lasciando 31,1 milioni di dollari di liquidità e circa 4,4 milioni di capitale circolante al 30 giugno 2025.
Punti chiave di bilancio e finanziamento includono attività totali per 38,7 milioni di dollari, patrimonio netto degli azionisti di 7,9 milioni e Senior Secured Convertible Notes con valore nominale di 21,975 milioni di dollari contabilizzate al fair value di 25,3 milioni di dollari (prezzo di conversione 1,00$; tasso d'interesse nominale 12%). La direzione segnala dubbi sostanziali sulla continuità aziendale in assenza di maggiori rimborsi, crescita dei ricavi o finanziamenti aggiuntivi. Sviluppi recenti comprendono due aumenti di capitale a marzo e aprile 2025 che hanno raccolto circa 31,0 milioni, un'offerta ATM fino a 25,0 milioni, la copertura Highmark nello stato di New York effettiva dal 26 maggio 2025, la riconsiderazione del MolDx LCD (CAC il 4 settembre 2025), più pubblicazioni peer-reviewed e un finanziamento NIH R01 da 8,0 milioni assegnato a ricercatori della CWRU.
Lucid Diagnostics (LUCD) es una empresa comercial de diagnóstico para la prevención del cáncer que comercializa la prueba EsoGuard con el muestreo EsoCheck. En los tres y seis meses cerrados el 30 de junio de 2025 la compañía reconoció ingresos por 1,16 millones de dólares y 1,99 millones de dólares, respectivamente, y reportó una pérdida neta atribuible a los accionistas comunes de 7,9 millones de dólares en el trimestre y de 43,9 millones en el semestre. Las actividades operativas consumieron 23,0 millones de dólares de efectivo en la primera mitad de 2025, dejando 31,1 millones de dólares en caja y aproximadamente 4,4 millones de capital de trabajo al 30 de junio de 2025.
Elementos clave del balance y financiación incluyen activos totales por 38,7 millones de dólares, patrimonio neto de los accionistas de 7,9 millones y Senior Secured Convertible Notes con un valor nominal de 21,975 millones de dólares contabilizadas a valor razonable de 25,3 millones de dólares (precio de conversión 1,00$; interés nominal 12%). La dirección declara dudas sustanciales sobre la continuidad de la empresa en ausencia de mayores reembolsos, crecimiento de ingresos o financiación adicional. Desarrollos recientes incluyen dos aumentos de capital en marzo y abril de 2025 que recaudaron aproximadamente 31,0 millones, una oferta ATM de hasta 25,0 millones, la cobertura de Highmark en Nueva York vigente desde el 26 de mayo de 2025, la reconsideración del MolDx LCD (CAC el 4 de septiembre de 2025), múltiples publicaciones revisadas por pares y una subvención NIH R01 de 8,0 millones otorgada a investigadores de CWRU.
Lucid Diagnostics(LUCD)는 EsoCheck 샘플링과 함께 EsoGuard 검사를 판매하는 상업화 단계의 암 예방 진단 회사입니다. 2025년 6월 30일 종료된 3개월 및 6개월 기간 동안 회사는 각각 116만 달러 및 199만 달러의 수익을 인식했으며, 분기 기준 보통주주 귀속 순손실은 790만 달러, 6개월 누계 순손실은 4,390만 달러를 보고했습니다. 영업활동으로 2025년 상반기에 2,300만 달러의 현금이 사용되어 2025년 6월 30일 기준 현금 잔액은 3,110만 달러, 운전자본은 약 440만 달러였습니다.
대차대조표와 자금조달의 주요 항목으로는 총자산 3,870만 달러, 자본총계 790만 달러, 액면가 2,197.5만 달러인 Senior Secured Convertible Notes가 공정가치 2,530만 달러로 계상되어 있다는 점(전환가격 1.00달러, 명목이자율 12%)이 있습니다. 경영진은 상환 확대, 매출 성장 또는 추가 자금 조달이 없을 경우 계속기업 존속에 대해 상당한 의문을 제기하고 있습니다. 최근 동향으로는 2025년 3월 및 4월 두 차례 주식 발행으로 약 3,100만 달러를 순수령한 점, 최대 2,500만 달러 규모의 ATM, 2025년 5월 26일부터 유효한 뉴욕 Highmark 보장, MolDx LCD 재심사(2025년 9월 4일 CAC), 다수의 동료검토(피어리뷰) 논문, 그리고 CWRU 연구진에 수여된 800만 달러 규모의 NIH R01 연구보조금 등이 있습니다.
Lucid Diagnostics (LUCD) est une société de diagnostics en phase commerciale spécialisée dans la prévention du cancer, commercialisant le test EsoGuard avec le prélèvement EsoCheck. Pour les trois et six mois clos au 30 juin 2025, la société a reconnu des revenus de 1,16 million de dollars et 1,99 million de dollars, respectivement, tout en enregistrant une perte nette attribuable aux actionnaires ordinaires de 7,9 millions de dollars pour le trimestre et de 43,9 millions de dollars pour les six mois. Les activités opérationnelles ont consommé 23,0 millions de dollars de trésorerie au premier semestre 2025, laissant 31,1 millions de dollars de liquidités et environ 4,4 millions de fonds de roulement au 30 juin 2025.
Les éléments clés du bilan et du financement incluent un actif total de 38,7 millions de dollars, des capitaux propres de 7,9 millions et des Senior Secured Convertible Notes d'une valeur nominale de 21,975 millions de dollars comptabilisées à la juste valeur de 25,3 millions de dollars (prix de conversion 1,00$; taux d'intérêt nominal 12%). La direction fait état de doutes importants sur la continuité d'exploitation en l'absence d'une hausse des remboursements, d'une croissance des revenus ou d'un financement supplémentaire. Parmi les développements récents figurent deux augmentations de capital en mars et avril 2025 ayant rapporté environ 31,0 millions, une offre ATM jusqu'à 25,0 millions, la prise en charge par Highmark dans l'État de New York effective le 26 mai 2025, la réexamen du MolDx LCD (CAC le 4 septembre 2025), plusieurs publications évaluées par des pairs et une subvention NIH R01 de 8,0 millions attribuée à des chercheurs de la CWRU.
Lucid Diagnostics (LUCD) ist ein kommerzielles Diagnostikunternehmen zur Krebsprävention, das den EsoGuard-Test mit der EsoCheck-Probenentnahme vertreibt. Für die drei bzw. sechs Monate zum 30. Juni 2025 erzielte das Unternehmen Umsatzerlöse in Höhe von 1,16 Mio. USD bzw. 1,99 Mio. USD und meldete einen dem Stammkapitalinhaber zurechenbaren Nettoverlust von 7,9 Mio. USD für das Quartal bzw. 43,9 Mio. USD für das Halbjahr. Die operative Tätigkeit verbrauchte im ersten Halbjahr 2025 23,0 Mio. USD an Barmitteln, sodass zum 30. Juni 2025 noch 31,1 Mio. USD an liquiden Mitteln und rund 4,4 Mio. USD an Umlaufkapital vorhanden waren.
Wesentliche Bilanz- und Finanzierungspositionen umfassen Gesamtvermögen von 38,7 Mio. USD, Eigenkapital der Aktionäre von 7,9 Mio. USD sowie Senior Secured Convertible Notes mit einem Nennwert von 21,975 Mio. USD, die zum beizulegenden Zeitwert von 25,3 Mio. USD bilanziert sind (Umwandlungspreis 1,00 USD; ausgewiesener Zinssatz 12 %). Das Management äußert erhebliche Zweifel an der Fortführungsprognose, sofern nicht höhere Vergütungen, Umsatzwachstum oder zusätzliche Finanzmittel erzielt werden. Zu den aktuellen Entwicklungen zählen zwei Kapitalerhöhungen im März und April 2025 mit Nettoerlösen von rund 31,0 Mio. USD, ein ATM-Angebot (bis zu 25,0 Mio. USD), die Highmark-Deckung in New York ab 26. Mai 2025, die Überprüfung des MolDx LCD (CAC am 4. September 2025), mehrere begutachtete Fachveröffentlichungen und ein NIH R01-Zuschuss in Höhe von 8,0 Mio. USD an Forscher der CWRU.
- Clinical performance reported: EsoGuard sensitivity ~90% and NPV ~99% (stated across precancer-to-cancer spectrum).
- Payer progress: Highmark issued positive coverage in New York effective May 26, 2025; MolDx LCD reconsideration submitted with CAC on Sept 4, 2025.
- NIH R01 award of $8.0 million to CWRU investigators to study EsoCheck/EsoGuard in an expanded at-risk population.
- Financings closed: March 2025 Registered Direct ($14.9M net) and April 2025 Offering ($16.2M net) provided ~$31.0M net proceeds.
- Market access tool: ATM facility entered May 30, 2025 for up to $25.0M; company sold shares through ATM in H1 2025.
- Index inclusion: Added to Russell 2000 and Russell 3000 on June 27, 2025.
- Going concern disclosure: management states substantial doubt about ability to continue as a going concern absent reimbursement, revenue growth, or additional capital.
- High cash burn: Net cash used in operating activities of ~$23.0M for the six months ended June 30, 2025.
- Large accumulated deficit of ~$247.7M as of June 30, 2025.
- Significant convertible debt: 2024 Convertible Notes face value $21.975M carried at fair value $25.3M with 12% stated interest and conversion price $1.00, creating dilution/refinancing risk and a cash covenant ($5.0M threshold).
- Potential dilution: ~9.83M stock options outstanding and ~6.58M unvested restricted shares plus convertible preferred and note conversion features could significantly increase share count.
Insights
TL;DR Persistent losses and heavy operating cash burn create material liquidity risk despite recent financings.
Lucid reported $1.99 million of revenue for six months vs. $1.98 million prior year and consumed $23.0 million of operating cash in H1 2025. Cash of $31.1 million and working capital of ~$4.4 million provide a limited runway given the six-month burn rate and the company’s disclosure of substantial doubt about going concern. The $21.975 million 2024 Convertible Notes (fair value $25.3 million) carry a 12% coupon and a covenant requiring available cash >=$5.0 million while at least 25% of notes remain outstanding, which is a near-term covenant to monitor. Recent equity proceeds (~$31.0 million net from March and April offerings) materially improved liquidity, but continued negative operating cash flows, large unrecognized stock-based compensation, and convertible securities present dilution and refinancing risks that are material to shareholders.
TL;DR Clinical evidence, payer actions, and large NIH study materially strengthen commercialization prospects.
EsoGuard/EsoCheck are supported by peer-reviewed publications claiming ~90% sensitivity and ~99% NPV across the precancer-to-cancer spectrum, and recent clinical utility data (ENVET-BE) showing a 2.4x to 2.7x increase in diagnostic yield versus literature benchmarks. Highmark issued positive coverage in New York (effective May 26, 2025) and Lucid submitted a MolDx reconsideration with a CAC scheduled for September 4, 2025, which could expand Medicare access if favorable. The $8.0 million NIH R01 award to CWRU investigators to study EsoGuard in asymptomatic at-risk populations further validates the technology and may support future payer coverage and guideline uptake. These clinical and payer milestones are material to commercial adoption if sustained.
Lucid Diagnostics (LUCD) è una società commerciale attiva nella diagnostica per la prevenzione del cancro che commercializza il test EsoGuard con il prelievo EsoCheck. Nei tre e sei mesi chiusi il 30 giugno 2025 la società ha registrato ricavi per 1,16 milioni di dollari e 1,99 milioni di dollari rispettivamente, riportando una perdita netta attribuibile agli azionisti ordinari di 7,9 milioni di dollari nel trimestre e di 43,9 milioni nei sei mesi. Le attività operative hanno assorbito 23,0 milioni di dollari di cassa nella prima metà del 2025, lasciando 31,1 milioni di dollari di liquidità e circa 4,4 milioni di capitale circolante al 30 giugno 2025.
Punti chiave di bilancio e finanziamento includono attività totali per 38,7 milioni di dollari, patrimonio netto degli azionisti di 7,9 milioni e Senior Secured Convertible Notes con valore nominale di 21,975 milioni di dollari contabilizzate al fair value di 25,3 milioni di dollari (prezzo di conversione 1,00$; tasso d'interesse nominale 12%). La direzione segnala dubbi sostanziali sulla continuità aziendale in assenza di maggiori rimborsi, crescita dei ricavi o finanziamenti aggiuntivi. Sviluppi recenti comprendono due aumenti di capitale a marzo e aprile 2025 che hanno raccolto circa 31,0 milioni, un'offerta ATM fino a 25,0 milioni, la copertura Highmark nello stato di New York effettiva dal 26 maggio 2025, la riconsiderazione del MolDx LCD (CAC il 4 settembre 2025), più pubblicazioni peer-reviewed e un finanziamento NIH R01 da 8,0 milioni assegnato a ricercatori della CWRU.
Lucid Diagnostics (LUCD) es una empresa comercial de diagnóstico para la prevención del cáncer que comercializa la prueba EsoGuard con el muestreo EsoCheck. En los tres y seis meses cerrados el 30 de junio de 2025 la compañía reconoció ingresos por 1,16 millones de dólares y 1,99 millones de dólares, respectivamente, y reportó una pérdida neta atribuible a los accionistas comunes de 7,9 millones de dólares en el trimestre y de 43,9 millones en el semestre. Las actividades operativas consumieron 23,0 millones de dólares de efectivo en la primera mitad de 2025, dejando 31,1 millones de dólares en caja y aproximadamente 4,4 millones de capital de trabajo al 30 de junio de 2025.
Elementos clave del balance y financiación incluyen activos totales por 38,7 millones de dólares, patrimonio neto de los accionistas de 7,9 millones y Senior Secured Convertible Notes con un valor nominal de 21,975 millones de dólares contabilizadas a valor razonable de 25,3 millones de dólares (precio de conversión 1,00$; interés nominal 12%). La dirección declara dudas sustanciales sobre la continuidad de la empresa en ausencia de mayores reembolsos, crecimiento de ingresos o financiación adicional. Desarrollos recientes incluyen dos aumentos de capital en marzo y abril de 2025 que recaudaron aproximadamente 31,0 millones, una oferta ATM de hasta 25,0 millones, la cobertura de Highmark en Nueva York vigente desde el 26 de mayo de 2025, la reconsideración del MolDx LCD (CAC el 4 de septiembre de 2025), múltiples publicaciones revisadas por pares y una subvención NIH R01 de 8,0 millones otorgada a investigadores de CWRU.
Lucid Diagnostics(LUCD)는 EsoCheck 샘플링과 함께 EsoGuard 검사를 판매하는 상업화 단계의 암 예방 진단 회사입니다. 2025년 6월 30일 종료된 3개월 및 6개월 기간 동안 회사는 각각 116만 달러 및 199만 달러의 수익을 인식했으며, 분기 기준 보통주주 귀속 순손실은 790만 달러, 6개월 누계 순손실은 4,390만 달러를 보고했습니다. 영업활동으로 2025년 상반기에 2,300만 달러의 현금이 사용되어 2025년 6월 30일 기준 현금 잔액은 3,110만 달러, 운전자본은 약 440만 달러였습니다.
대차대조표와 자금조달의 주요 항목으로는 총자산 3,870만 달러, 자본총계 790만 달러, 액면가 2,197.5만 달러인 Senior Secured Convertible Notes가 공정가치 2,530만 달러로 계상되어 있다는 점(전환가격 1.00달러, 명목이자율 12%)이 있습니다. 경영진은 상환 확대, 매출 성장 또는 추가 자금 조달이 없을 경우 계속기업 존속에 대해 상당한 의문을 제기하고 있습니다. 최근 동향으로는 2025년 3월 및 4월 두 차례 주식 발행으로 약 3,100만 달러를 순수령한 점, 최대 2,500만 달러 규모의 ATM, 2025년 5월 26일부터 유효한 뉴욕 Highmark 보장, MolDx LCD 재심사(2025년 9월 4일 CAC), 다수의 동료검토(피어리뷰) 논문, 그리고 CWRU 연구진에 수여된 800만 달러 규모의 NIH R01 연구보조금 등이 있습니다.
Lucid Diagnostics (LUCD) est une société de diagnostics en phase commerciale spécialisée dans la prévention du cancer, commercialisant le test EsoGuard avec le prélèvement EsoCheck. Pour les trois et six mois clos au 30 juin 2025, la société a reconnu des revenus de 1,16 million de dollars et 1,99 million de dollars, respectivement, tout en enregistrant une perte nette attribuable aux actionnaires ordinaires de 7,9 millions de dollars pour le trimestre et de 43,9 millions de dollars pour les six mois. Les activités opérationnelles ont consommé 23,0 millions de dollars de trésorerie au premier semestre 2025, laissant 31,1 millions de dollars de liquidités et environ 4,4 millions de fonds de roulement au 30 juin 2025.
Les éléments clés du bilan et du financement incluent un actif total de 38,7 millions de dollars, des capitaux propres de 7,9 millions et des Senior Secured Convertible Notes d'une valeur nominale de 21,975 millions de dollars comptabilisées à la juste valeur de 25,3 millions de dollars (prix de conversion 1,00$; taux d'intérêt nominal 12%). La direction fait état de doutes importants sur la continuité d'exploitation en l'absence d'une hausse des remboursements, d'une croissance des revenus ou d'un financement supplémentaire. Parmi les développements récents figurent deux augmentations de capital en mars et avril 2025 ayant rapporté environ 31,0 millions, une offre ATM jusqu'à 25,0 millions, la prise en charge par Highmark dans l'État de New York effective le 26 mai 2025, la réexamen du MolDx LCD (CAC le 4 septembre 2025), plusieurs publications évaluées par des pairs et une subvention NIH R01 de 8,0 millions attribuée à des chercheurs de la CWRU.
Lucid Diagnostics (LUCD) ist ein kommerzielles Diagnostikunternehmen zur Krebsprävention, das den EsoGuard-Test mit der EsoCheck-Probenentnahme vertreibt. Für die drei bzw. sechs Monate zum 30. Juni 2025 erzielte das Unternehmen Umsatzerlöse in Höhe von 1,16 Mio. USD bzw. 1,99 Mio. USD und meldete einen dem Stammkapitalinhaber zurechenbaren Nettoverlust von 7,9 Mio. USD für das Quartal bzw. 43,9 Mio. USD für das Halbjahr. Die operative Tätigkeit verbrauchte im ersten Halbjahr 2025 23,0 Mio. USD an Barmitteln, sodass zum 30. Juni 2025 noch 31,1 Mio. USD an liquiden Mitteln und rund 4,4 Mio. USD an Umlaufkapital vorhanden waren.
Wesentliche Bilanz- und Finanzierungspositionen umfassen Gesamtvermögen von 38,7 Mio. USD, Eigenkapital der Aktionäre von 7,9 Mio. USD sowie Senior Secured Convertible Notes mit einem Nennwert von 21,975 Mio. USD, die zum beizulegenden Zeitwert von 25,3 Mio. USD bilanziert sind (Umwandlungspreis 1,00 USD; ausgewiesener Zinssatz 12 %). Das Management äußert erhebliche Zweifel an der Fortführungsprognose, sofern nicht höhere Vergütungen, Umsatzwachstum oder zusätzliche Finanzmittel erzielt werden. Zu den aktuellen Entwicklungen zählen zwei Kapitalerhöhungen im März und April 2025 mit Nettoerlösen von rund 31,0 Mio. USD, ein ATM-Angebot (bis zu 25,0 Mio. USD), die Highmark-Deckung in New York ab 26. Mai 2025, die Überprüfung des MolDx LCD (CAC am 4. September 2025), mehrere begutachtete Fachveröffentlichungen und ein NIH R01-Zuschuss in Höhe von 8,0 Mio. USD an Forscher der CWRU.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
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| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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TABLE OF CONTENTS
| Page | ||
| Part I - Financial Information | ||
| Item 1. | Financial Statements | 1 |
| Condensed Consolidated Balance Sheets (unaudited) as of June 30, 2025 and December 31, 2024 | 1 | |
| Condensed Consolidated Statements of Operations (unaudited) for the three and six months ended June 30, 2025 and 2024 | 2 | |
| Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) (unaudited) for the three and six months ended June 30, 2025 and 2024 | 3 | |
| Condensed Consolidated Statements of Cash Flows (unaudited) for the six months ended June 30, 2025 and 2024 | 5 | |
| Notes to Unaudited Condensed Consolidated Financial Statements | 6 | |
| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 22 |
| Item 4. | Controls and Procedures | 30 |
| Part II - Other Information | ||
| Item 1. | Legal Proceedings | 31 |
| Item 5. | Other Information | 31 |
| Item 6. | Exhibits | 31 |
| Signature | 32 | |
| Exhibit Index | 33 |
| i |
Part I - Financial Information
Item 1. Financial Statements
LUCID DIAGNOSTICS INC.
and SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands except number of shares and per share data - unaudited)
| June 30, 2025 | December 31, 2024 | |||||||
| Assets: | ||||||||
| Current assets: | ||||||||
| Cash | $ | $ | ||||||
| Accounts receivable | ||||||||
| Inventory | ||||||||
| Prepaid expenses, deposits, and other current assets | ||||||||
| Total current assets | ||||||||
| Fixed assets, net | ||||||||
| Operating lease right-of-use assets | ||||||||
| Intangible assets, net | ||||||||
| Other assets | ||||||||
| Total assets | $ | $ | ||||||
| Liabilities, Preferred Stock and Stockholders’ Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses and other current liabilities | ||||||||
| Operating lease liabilities, current portion | ||||||||
| Senior Secured Convertible Notes - at fair value | ||||||||
| Total current liabilities | ||||||||
| Operating lease liabilities, less current portion | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (Note 8) | - | - | ||||||
| Stockholders’ Equity (Deficit): | ||||||||
| Preferred stock, $ | ||||||||
| Common stock, $ | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total Stockholders’ Equity (Deficit) | ||||||||
| Total Liabilities and Stockholders’ Equity (Deficit) | $ | $ | ||||||
See accompanying notes to the unaudited condensed consolidated financial statements.
| 1 |
LUCID DIAGNOSTICS INC.
and SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands except number of shares and per share data - unaudited)
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenue | $ | $ | $ | $ | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenue | ||||||||||||||||
| Sales and marketing | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Amortization of acquired intangible assets | ||||||||||||||||
| Research and development | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Operating loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | ||||||||||||||||
| Interest expense | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Change in fair value - Senior Secured Convertible Note | ( | ) | ||||||||||||||
| Debt extinguishments loss - Senior Secured Convertible Note | — | ( | ) | — | ( | ) | ||||||||||
| Other income (expense), net | ( | ) | ||||||||||||||
| Loss before provision for income tax | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Provision for income taxes | — | — | — | — | ||||||||||||
| Net loss attributable to Lucid Diagnostics Inc. | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Less: Deemed dividend on Series A and Series A-1 Convertible Preferred Stock | — | — | — | ( | ) | |||||||||||
| Less: Series B and Series B-1 Convertible Preferred Stock dividends earned | $ | ( | ) | $ | — | ( | ) | — | ||||||||
| Net loss attributable to Lucid Diagnostics Inc. common stockholders | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Net loss per share attributable to Lucid Diagnostics Inc. common stockholders - basic and diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Weighted average common shares outstanding, basic and diluted | ||||||||||||||||
See accompanying notes to the unaudited condensed consolidated financial statements.
| 2 |
LUCID DIAGNOSTICS INC.
and SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
for the THREE AND SIX MONTHS ENDED June 30, 2025
(in thousands except number of shares and per share data - unaudited)
| Shares | Amount | Shares | Amount | Capital | Deficit | Total | ||||||||||||||||||||||
| Preferred Stock | Common Stock | Additional Paid-In | Accumulated | |||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Deficit | Total | ||||||||||||||||||||||
| Balance as of March 31, 2025 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||
| Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan | — | — | — | — | ||||||||||||||||||||||||
| Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan | — | — | — | — | — | |||||||||||||||||||||||
| Stock-based compensation - PAVmed Inc. 2014 Equity Plan | — | — | — | — | — | |||||||||||||||||||||||
| Issuance - At-The-Market Facility, net of deferred financing charges | — | — | — | — | ||||||||||||||||||||||||
| Issuance - Interest payment paid in stock | — | — | — | |||||||||||||||||||||||||
| Issuance - Confidentially Marketed Public Offering, net of fees | — | — | — | |||||||||||||||||||||||||
| Issuance - Dividend on Series B and Series B-1 Preferred Stock | — | — | ( | ) | — | |||||||||||||||||||||||
| Net loss | — | — | — | — | — | ( | ) | ( | ) | |||||||||||||||||||
| Balance as of June 30, 2025 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
| Preferred Stock | Common Stock | Additional Paid-In | Accumulated | |||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Deficit | Total | ||||||||||||||||||||||
| Balance as of December 31, 2024 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
| Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan | — | — | — | — | ||||||||||||||||||||||||
| Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan | — | — | — | — | — | |||||||||||||||||||||||
| Stock-based compensation - PAVmed Inc. 2014 Equity Plan | — | — | — | — | — | |||||||||||||||||||||||
| Issuance - At-The-Market Facility, net of deferred financing charges | — | — | — | — | ||||||||||||||||||||||||
| Purchase - Employee Stock Purchase Plan | — | — | — | — | ||||||||||||||||||||||||
| Issuance - Interest payment paid in stock | — | — | — | |||||||||||||||||||||||||
| Issuance - Registered Direct Offering, net of fees | — | — | — | |||||||||||||||||||||||||
| Issuance - Confidentially Marketed Public Offering, net of fees | — | — | — | |||||||||||||||||||||||||
| Issuance - Dividend on Series B and Series B-1 Preferred Stock | — | — | ( | ) | — | |||||||||||||||||||||||
| Net loss | — | — | — | — | — | ( | ) | ( | ) | |||||||||||||||||||
| Balance as of June 30, 2025 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
See accompanying notes to the unaudited condensed consolidated financial statements.
| 3 |
LUCID DIAGNOSTICS INC.
and SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
for the THREE AND SIX MONTHS ENDED June 30, 2024
(in thousands except number of shares and per share data - unaudited)
| Preferred Stock | Common Stock | Additional Paid-In | Accumulated | |||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Deficit | Total | ||||||||||||||||||||||
| Balance as of March 31, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||
| Stock-based compensation - Lucid Diagnostics Inc. | — | — | — | — | — | |||||||||||||||||||||||
| Stock-based compensation - PAVmed Inc. | — | — | — | — | — | |||||||||||||||||||||||
| Conversions - Senior Secured Convertible Note | — | — | — | |||||||||||||||||||||||||
| Issuance through sale - Series B-1 Preferred Stock | — | — | — | — | ||||||||||||||||||||||||
| Issue common stock - vendor service agreement | — | — | — | — | ||||||||||||||||||||||||
| Net loss | — | — | — | — | — | ( | ) | ( | ) | |||||||||||||||||||
| Balance as of June 30, 2024 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
| Preferred Stock | Common Stock | Additional Paid-In | Accumulated | |||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Deficit | Total | ||||||||||||||||||||||
| Balance as of December 31, 2023 | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
| Balance | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||
| Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan | — | — | — | — | ||||||||||||||||||||||||
| Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan | — | — | — | — | — | |||||||||||||||||||||||
| Stock-based compensation - Lucid Diagnostics Inc. | — | — | — | — | — | |||||||||||||||||||||||
| Stock-based compensation - PAVmed Inc. 2014 Equity Plan | — | — | — | — | — | |||||||||||||||||||||||
| Stock-based compensation - PAVmed Inc. | — | — | — | — | — | |||||||||||||||||||||||
| Vest - restricted stock awards | — | — | — | — | — | — | ||||||||||||||||||||||
| Conversions - Senior Secured Convertible Note | — | — | — | |||||||||||||||||||||||||
| Issuance - At-The-Market Facility, net of financing charges | — | — | — | — | — | — | — | |||||||||||||||||||||
| Purchase - Employee Stock Purchase Plan | — | — | — | |||||||||||||||||||||||||
| Issuance - Series A-1 Preferred Stock | — | — | — | — | ||||||||||||||||||||||||
| Exchange - Series A and Series A-1 Preferred Stock | ( | ) | ( | ) | — | — | — | ( | ) | ( | ) | |||||||||||||||||
| Issuance through exchange - Series B Preferred Stock | — | — | — | — | ||||||||||||||||||||||||
| Issuance through sale- Series B and Series B-1 Preferred Stock | — | — | — | — | ||||||||||||||||||||||||
| Issuance - Due To: PAVmed Inc. Settlement in Common Stock | — | — | — | |||||||||||||||||||||||||
| Issue common stock - vendor service agreement | — | — | — | — | ||||||||||||||||||||||||
| Net loss | — | — | — | — | — | ( | ) | ( | ) | |||||||||||||||||||
| Balance as of June 30, 2024 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
| Balance | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
See accompanying notes to the unaudited condensed consolidated financial statements.
| 4 |
LUCID DIAGNOSTICS INC.
and SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands except number of shares and per share data - unaudited)
| 2025 | 2024 | |||||||
| Six Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities | ||||||||
| Depreciation and amortization expense | ||||||||
| Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan | ||||||||
| Stock-based compensation - PAVmed Inc. 2014 Equity Plan | ||||||||
| Change in fair value - Senior Secured Convertible Note | ( | ) | ||||||
| Debt extinguishment loss - Senior Secured Convertible Note | — | |||||||
| Amortization of common stock payment for vendor service agreement | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | ( | ) | ( | ) | ||||
| Prepaid expenses and other current assets | ( | ) | ||||||
| Accounts payable | ( | ) | ( | ) | ||||
| Accrued expenses and other current liabilities | ( | ) | ( | ) | ||||
| Due To: PAVmed Inc. - operating expenses, employee related costs, MSA Fee | ( | ) | ||||||
| Net cash flows used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchase of equipment | ( | ) | ( | ) | ||||
| Net cash flows used in investing activities | ( | ) | ( | ) | ||||
| Cash flows from financing activities | ||||||||
| Proceeds – issue of preferred stock | — | |||||||
| Proceeds – issue of common stock - Registered Direct Offering, net of fees | — | |||||||
| Proceeds – issue of common stock - Confidentially Marketed Public Offering, net of fees | — | |||||||
| Proceeds – issue of Senior Secured Convertible Notes | — | |||||||
| Proceeds – issue of common stock – At-The-Market Facility | — | |||||||
| Proceeds – exercise of stock options | ||||||||
| Proceeds – issue common stock – Employee Stock Purchase Plan | ||||||||
| Net cash flows provided by financing activities | ||||||||
| Net increase in cash | ||||||||
| Cash, beginning of period | ||||||||
| Cash, end of period | $ | $ | ||||||
See accompanying notes to the unaudited condensed consolidated financial statements.
| 5 |
LUCID DIAGNOSTICS INC.
and SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(amounts in these accompanying notes are presented in thousands, except number of shares and per-share amounts.)
Note 1 — The Company
Description of the Business
Lucid Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company. Lucid is focused on the millions of patients with gastroesophageal reflux disease (GERD), also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer.
EsoGuard is a bisulfite-converted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck. Cell samples, including those collected with EsoCheck, as discussed below, are sent to our laboratory, for testing and analyses using our proprietary EsoGuard NGS DNA assay.
EsoCheck is an FDA 510(k) cleared and CE Mark certified noninvasive swallowable balloon capsule catheter device designed for in-office targeted sampling of surface esophageal cells in a less than two minute long office procedure. It consists of a vitamin sized semi-rigid plastic capsule tethered to a thin silicone catheter from which a soft inflatable silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal.
EsoGuard and EsoCheck are based on patented technology licensed by Lucid from Case Western Reserve University (“CWRU”). EsoGuard and EsoCheck have been developed to provide an accurate, non-invasive, patient-friendly test for the early detection of EAC and Barrett’s Esophagus (“BE”), including dysplastic BE and related precursors to EAC in patients with chronic GERD.
Note 2 — Liquidity and Going Concern
The Company’s management is required to assess an entity’s ability to continue as a going concern within one year of the date of the financial statements being issued. In each reporting period, including interim periods, an entity is required to assess conditions known and reasonably knowable as of the financial statement issuance date to determine whether it is probable an entity will not meet its financial obligations within one year from the financial statement issuance date. Substantial doubt about an entity’s ability to continue as a going concern exists when conditions and events, considered in the aggregate, indicate it is probable the entity will be unable to meet its financial obligations as they become due within one year after the date the financial statements are issued.
The
Company has financed its operations principally through public and private issuances of its common stock, preferred stock, and debt.
The Company is subject to all of the risks and uncertainties typically faced by medical device and diagnostic companies that devote substantially
all of their efforts to the commercialization of their initial product and services and ongoing research and development activities and
conducting clinical trials. The Company generated $
The
Company incurred a net loss attributable to its common stockholders of approximately $
The Company’s ability to continue operations 12 months beyond the issuance of the financial statements, will depend upon generating substantial revenue that is conditioned upon obtaining positive third-party reimbursement coverage for its EsoGuard Esophageal DNA Test from both government and private health insurance providers, and increasing revenue through cash pay and contracted revenue programs that target, among others, concierge medicine practices and self-insured employers, and on its ability to raise additional capital through various potential sources including equity and/or debt financings or refinancing existing debt obligations. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the accompanying unaudited condensed consolidated financial statements are issued.
| 6 |
Note 3 — Summary of Significant Accounting Policies
Significant Accounting Policies
The Company’s significant accounting policies are as disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on March 24, 2025, except as otherwise noted herein below.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements of the Company and its subsidiaries have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”), and applicable rules and regulations of the United States Securities and Exchange Commission (“SEC”), and include the accounts of the Company and its wholly-owned subsidiaries. All intercompany transactions and balances have been eliminated in consolidation. The Company is a non-consolidated subsidiary of PAVmed, which has the ability to exercise significant influence over the Company. The Company manages its operations as a single operating segment for the purposes of assessing performance and making operating decisions.
As permitted under SEC rules, certain footnotes or other financial information normally required by U.S. GAAP have been condensed or omitted. The balance sheet as of December 31, 2024 has been derived from audited consolidated financial statements at such date. The accompanying unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements, and in the opinion of management, include all adjustments, consisting only of routine recurring adjustments, necessary for a fair statement of the Company’s unaudited condensed consolidated financial information.
The unaudited condensed consolidated results of operations for the three and six months ended June 30, 2025 are not necessarily indicative of the consolidated results to be expected for the year ending December 31, 2025 or for any other interim period or for any other future periods. The accompanying unaudited condensed consolidated financial statements and related unaudited condensed consolidated financial information should be read in conjunction with the Company’s audited consolidated financial statements and related notes thereto as of and for the year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K as filed with the SEC on March 24, 2025.
All amounts in the accompanying unaudited condensed consolidated financial statements and the notes thereto are presented in thousands of dollars, if not otherwise noted as being presented in millions of dollars, except for shares and per share amounts.
Use of Estimates
In preparing the unaudited condensed consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and the determination of corresponding carrying value reserves, if any, and liabilities and the disclosure of contingent losses, as of the date of the unaudited condensed consolidated financial statements, as well as the reported amounts of revenue and expenses during the reporting period. Significant estimates in these unaudited condensed consolidated financial statements include those related to the estimated fair value of debt obligations, stock-based equity awards and intangible assets. Other significant estimates include the estimated incremental borrowing rate, the provision or benefit for income taxes and the corresponding valuation allowance on deferred tax assets. Additionally, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. On an ongoing basis, the Company evaluates its estimates and assumptions. The Company bases its estimates on historical experience and on various other assumptions believed to be reasonable. Due to inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these estimates.
Revenue Recognition
Revenues are recognized when the satisfaction of the performance obligation occurs, in an amount that reflects the consideration the Company expects to collect in exchange for those services. The Company’s revenue is primarily generated by its laboratory testing services utilizing its EsoGuard Esophageal DNA tests. The services are completed upon release of a patient’s test result to the ordering healthcare provider. Revenue recognized is inclusive of both variable consideration in connection with an individual patient’s third-party insurance coverage policy and fixed consideration in connection with a contracted services arrangement with an unrelated third party legal entity. To determine revenue recognition for the arrangements that the Company determines are within the scope of ASC 606, Revenue from Contracts with Customers, the Company performs the following five steps: (1) identify the contract(s) with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract and (5) recognize revenue when (or as) the entity satisfies a performance obligation.
| 7 |
Note 3 — Summary of Significant Accounting Policies - continued
The key aspects considered by the Company include the following:
Contracts—The Company’s customer is primarily the patient, but the Company does not enter into a formal reimbursement contract with a patient. The Company establishes a contract with a patient in accordance with other customary business practices, which is the point in time an order is received from a provider and a patient specimen has been returned to the laboratory for testing. Payment terms are a function of a patient’s existing insurance benefits, including the impact of coverage decisions with Center for Medicare & Medicaid Services (“CMS”) and applicable reimbursement contracts established between the Company and payers. The Company’s consideration can be deemed variable or fixed depending on the structure of specific payer contracts, and the Company considers collection of such consideration to be probable to the extent that it is unconstrained.
Performance obligations—A performance obligation is a promise in a contract to transfer a distinct good or service (or a bundle of goods or services) to the customer. The Company’s contracts have a single performance obligation, which is satisfied upon rendering of services, which culminates in the release of a patient’s test result to the ordering healthcare provider. The Company elects the practical expedient related to the disclosure of unsatisfied performance obligations, as the duration of time between providing testing supplies, the receipt of a sample, and the release of a test result to the ordering healthcare provider is far less than one year.
Transaction price—The transaction price is the amount of consideration that the Company expects to collect in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes). The consideration expected to be collected from a contract with a customer may include fixed amounts, variable amounts, or both.
If the consideration derived from the contracts is deemed to be variable, the Company estimates the amount of consideration to which it will be entitled in exchange for the promised goods or services. The Company limits the amount of variable consideration included in the transaction price to the unconstrained portion of such consideration. In other words, the Company recognizes revenue up to the amount of variable consideration that is not subject to a significant reversal until additional information is obtained or the uncertainty associated with the additional payments or refunds is subsequently resolved.
When the Company does not have significant historical experience or that experience has limited predictive value, the constraint over estimates of variable consideration may result in no revenue being recognized upon delivery of patient EsoGuard test results to the ordering healthcare provider. As such, the Company recognizes revenue up to the amount of variable consideration not subject to a significant reversal until additional information is obtained or the uncertainty associated with additional payments or refunds, if any, is subsequently resolved. Differences between original estimates and subsequent revisions, including final settlements, represent changes in estimated expected variable consideration, with the change in estimate recognized in the period of such revised estimate. With respect to a contracted service arrangement, the fixed consideration revenue is recognized on an as-billed basis upon delivery of the laboratory test report with realization of such fixed consideration deemed probable based upon actual historical experience.
Allocate transaction price—The transaction price is allocated entirely to the performance obligation contained within the contract with a customer on the basis of the relative standalone selling prices of each distinct good or service.
Practical Expedients—The Company does not adjust the transaction price for the effects of a significant financing component, as at contract inception, the Company expects the collection cycle to be one year or less.
Fair Value Option (“FVO”) Election
Under a Securities Purchase Agreement dated November 12, 2024, the Company issued Senior Secured Convertible Notes dated November 22, 2024, referred to herein as the “2024 Convertible Notes”, which are accounted under the “fair value option election” as discussed below.
Under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 815, Derivative and Hedging, (“ASC 815”), a financial instrument containing embedded features and/or options may be required to be bifurcated from the financial instrument host and recognized as separate derivative asset or liability, with the bifurcated derivative asset or liability initially measured at estimated fair value as of the transaction issue date and then subsequently remeasured at estimated fair value as of each reporting period balance sheet date.
Alternatively, FASB ASC Topic 825, Financial Instruments, (“ASC 825”) provides for the “fair value option” (“FVO”) election. In this regard, ASC 825-10-15-4 provides for the FVO election (to the extent not otherwise prohibited by ASC 825-10-15-5) to be afforded to financial instruments, wherein the financial instrument is initially measured at estimated fair value as of the transaction issue date and then subsequently remeasured at estimated fair value as of each reporting period balance sheet date, with changes in the estimated fair value recognized as other income (expense) in the statement of operations. The estimated fair value adjustment of the 2024 Convertible Note, including the component related to accrued interest, is presented in a single line item within other income (expense) in the accompanying unaudited condensed consolidated statement of operations (as provided for by ASC 825-10-50-30(b)). Further, as required by ASC 825-10-45-5, to the extent a portion of the fair value adjustment is attributed to a change in the instrument-specific credit risk, such portion would be recognized as a component of other comprehensive income (“OCI”) (for which there was no such adjustment with respect to the 2024 Convertible Notes).
See Note 9, Financial Instruments Fair Value Measurements, with respect to the FVO election; and Note 10, Debt, for a discussion of the 2024 Senior Convertible Notes.
| 8 |
Note 3 — Summary of Significant Accounting Policies - continued
Recently Adopted Accounting Pronouncements
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740)—Improvements to Income Tax Disclosures (“ASU 2023-09”), which is intended to enhance the transparency and decision usefulness of income tax disclosures. The amendments in ASU 2023-09 provide for enhanced income tax information primarily through changes to the rate reconciliation and income taxes paid information. ASU 2023-09 is effective for the Company prospectively to all annual periods beginning after December 15, 2024. Early adoption is permitted. The guidance was adopted by the Company effective January 1, 2025, on a prospective basis. The Company does not expect the standard to have a significant impact on its consolidated financial statements in the 2025 Annual Report on Form 10-K.
Recent Accounting Standards Updates Not Yet Adopted
In November 2024, the FASB issued ASU No. 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. This update enhances financial statement disclosures by requiring public business entities to disclose specified information about certain costs and expenses including the amounts of (a) purchases of inventory, (b) employee compensation, (c) depreciation, and (d) intangible asset amortization included in each relevant expense caption. The update also requires disclosure of certain amounts that are already required to be disclosed under current GAAP, disclosure of a qualitative description of the amounts remaining in relevant expense captions that are not separately disaggregated quantitatively, and disclosure of the total amount of selling expenses and, in annual reporting periods, an entity’s definition of selling expenses. The amendments in this update may be applied either prospectively or retrospectively and are effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating the potential impact of this guidance on its unaudited condensed consolidated financial statements.
In October 2023, the FASB issued ASU No. 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. This update modifies the disclosure or presentation requirements of a variety of topics in the Accounting Standards Codification to conform with certain SEC amendments in Release No. 33-10532, Disclosure Update and Simplification. The amendments in this update should be applied prospectively, and the effective date for each amendment will be the date on which the SEC’s removal of that related disclosure from Regulation S-X or S-K becomes effective. However, if the SEC has not removed the related disclosure from its regulations by June 30, 2027, the amendments will be removed from the Codification and not become effective. Early adoption is prohibited. The Company is currently evaluating the potential impact this update will have on its unaudited condensed consolidated financial statements and disclosures.
Note 4 — Revenue from Contracts with Customers
Revenue Recognized
In
the three and six months ended June 30, 2025, the Company recognized revenue of $
Cost of Revenue
The cost of revenues principally includes the costs related to the Company’s laboratory operations (excluding estimated costs associated with research activities), the costs related to the EsoCheck cell collection device, cell sample mailing kits and license royalties.
In
the three and six months ended June 30, 2025, the cost of revenue was $
| 9 |
Note 5 — Related Party Transactions
The aggregate Due To: PAVmed Inc. for the period indicated is summarized as follows:
Schedule of Due To: PAVmed Inc
| MSA Fees | Employee-Related Costs | PAVmed Inc. OBO Payments | Total | |||||||||||||
| Balance - December 31, 2024 | $ | — | $ | — | $ | — | $ | — | ||||||||
| MSA fees | — | — | ||||||||||||||
| ERC - Benefits | — | — | ||||||||||||||
| On Behalf Of (OBO) activities | — | — | ||||||||||||||
| Cash payments to PAVmed Inc. | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Balance - June 30, 2025 | $ | — | $ | — | $ | — | $ | — | ||||||||
PAVmed - Management Services Agreement
The Company’s daily operations are also managed in part by personnel employed by PAVmed, for which the Company incurs a service fee, referred to as the “MSA Fee”, according to the provisions of a Management Services Agreement (“MSA”) with PAVmed. The MSA does not have a termination date, but may be terminated by the Company’s board of directors. The MSA Fee is charged on a monthly basis and is subject to periodic adjustment corresponding with changes in the services provided by PAVmed personnel to the Company, with any such change in the MSA Fee being subject to approval of the boards of directors of each of the Company and PAVmed. Currently, under the terms of PAVmed’s outstanding convertible debt, PAVmed is required to elect to receive such payments in cash.
The MSA Fee expense classification in the unaudited condensed consolidated statement of operations for the periods noted is as follows:
Schedule of MSA Fee Expense Classification in Statements of Operations
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Sales & Marketing | $ | $ | ||||||||||||||
| General & Administrative | ||||||||||||||||
| Research & Development | ||||||||||||||||
| Total MSA Fee | $ | $ | $ | $ | ||||||||||||
The classification of the MSA Fee as presented above is based on the PAVmed classification of employee salary expense and other operating expenses. In this regard, PAVmed classifies employee salary expense as sales and marketing expenses for employees performing sales, sales support and marketing activities, research and development expenses for those employees who are engaged in product and services engineering development and design and /or clinical trials activities, and other employees and activities classified as general and administrative.
| 10 |
Note 6 — Prepaid Expenses, Deposits, and Other Current Assets
Prepaid expenses and other current assets consisted of the following as of:
Schedule of Prepaid Expenses and Other Current Assets
| June 30, 2025 | December 31, 2024 | |||||||
| Advanced payments to service providers and suppliers | $ | $ | ||||||
| Prepaid insurance | ||||||||
| Deposits | ||||||||
| Subscribed amounts due from investors | — | |||||||
| Total prepaid expenses, deposits and other current assets | $ | $ | ||||||
Note 7 — Leases
The Company’s future lease payments as of June 30, 2025, which are presented as operating lease liabilities, current portion and operating lease liabilities, less current portion on the Company’s unaudited condensed consolidated balance sheets are as follows:
Schedule of Future Lease Payments of Operating Lease Liabilities
| 2025 (remainder of year) | $ | |||
| 2026 | ||||
| 2027 | ||||
| 2028 | ||||
| 2029 | — | |||
| Total lease payments | $ | |||
| Less: imputed interest | ( | ) | ||
| Present value of lease liabilities | $ |
Supplemental disclosure of cash flow information related to the Company’s cash and non-cash activities with its leases are as follows:
Schedule of Cash Flow Supplemental Information
| 2025 | 2024 | |||||||
| Six Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Cash paid for amounts included in the measurement of lease liabilities | ||||||||
| Operating cash flows from operating leases | $ | $ | ||||||
| Non-cash investing and financing activities | ||||||||
| Right-of-use assets obtained in exchange for new operating lease liabilities | $ | $ | ||||||
| Weighted-average remaining lease term - operating leases (in years) | ||||||||
| Weighted-average discount rate - operating leases | % | % | ||||||
As
of June 30, 2025 and December 31, 2024, the Company’s right-of-use assets from operating leases were $
| 11 |
Note 8 — Commitment and Contingencies
Other Matters
In the ordinary course of Lucid’s business, particularly as it begins commercialization of its products, the Company may be subject to certain other legal actions and claims, including product liability, consumer, commercial, tax and governmental matters, which may arise from time to time. The Company is not aware of any such pending legal or other proceedings that are reasonably likely to have a material impact on the Company. Notwithstanding, legal proceedings are subject to inherent uncertainties, and an unfavorable outcome could include monetary damages, and excessive verdicts can result from litigation, and as such, could result in a material adverse impact on the Company’s business, financial position, results of operations, and/or cash flows. Additionally, although the Company has specific insurance for certain potential risks, the Company may in the future incur judgments or enter into settlements of claims which may have a material adverse impact on the Company’s business, financial position, results of operations, and /or cash flows.
Note 9 — Financial Instruments Fair Value Measurements
Recurring Fair Value Measurements
The fair value hierarchy table for the reporting date noted is as follows:
Schedule of Financial Liabilities Measured at Fair Value on Recurring Basis
Level-1 Inputs | Level-2 Inputs | Level-3 Inputs | Total | |||||||||||||
Fair Value Measurement on a Recurring Basis at Reporting Date Using1 | ||||||||||||||||
Level-1 Inputs | Level-2 Inputs | Level-3 Inputs | Total | |||||||||||||
| June 30, 2025 | ||||||||||||||||
| 2024 Convertible Notes | 1 | $ | — | $ | — | $ | $ | |||||||||
| Totals | 1 | $ | — | $ | — | $ | $ | |||||||||
Level-1 Inputs | Level-2 Inputs | Level-3 Inputs | Total | |||||||||||||
| Level-1 Inputs | Level-2 Inputs | Level-3 Inputs | Total | |||||||||||||
| December 31, 2024 | ||||||||||||||||
| 2024 Convertible Notes | 1 | $ | — | $ | — | $ | $ | |||||||||
| Totals | 1 | $ | — | $ | — | $ | $ | |||||||||
| Fair value of liability | 1 | $ | — | $ | — | $ | $ | |||||||||
| 1 |
| 12 |
Note 9 — Financial Instruments Fair Value Measurements - continued
As
discussed in Note 10, Debt, the Company issued Senior Secured Convertible Notes dated November 22, 2024 with a $
The estimated fair value of the financial instruments classified within the Level 3 category was determined using both observable inputs and unobservable inputs. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in fair value attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in unobservable long- dated volatilities) inputs.
The estimated fair value of the 2024 Convertible Notes as of each June 30, 2025 and December 31, 2024 was computed using a Monte Carlo simulation of the present value of its cash flows using a synthetic credit rating analysis and a required rate-of-return, using the following assumptions:
Schedule of Fair Value Assumption Used
| 2024 Convertible Notes: June 30, 2025 | 2024 Convertible Notes: December 31, 2024 | |||||||
| Fair Value | $ | $ | ||||||
| Face value principal payable | $ | $ | ||||||
| Required rate of return | % | % | ||||||
| Conversion Price | $ | $ | ||||||
| Value of common stock | $ | $ | ||||||
| Expected term (years) | ||||||||
| Volatility | % | % | ||||||
| Risk free rate | % | % | ||||||
| Dividend yield | — | % | — | % | ||||
The estimated fair values reported utilized the Company’s common stock price along with certain Level 3 inputs (as discussed in the table above), in the development of Monte Carlo simulation models, discounted cash flow analyses, and /or Black-Scholes valuation models. The estimated fair values are subjective and are affected by changes in inputs to the valuation models and analyses, including the Company’s common stock price, the Company’s dividend yield, the risk-free rates based on U.S. Treasury security yields, and certain other Level-3 inputs including, assumptions regarding the estimated volatility in the value of the Company’s common stock price and the volatility of similar entities within the medical device industry. Changes in these assumptions can materially affect the estimated fair values.
Note 10 — Debt
The fair value and face value principal outstanding of the 2024 Convertible Notes as of the dates indicated are as follows:
Summary of Outstanding Debt
| Contractual Maturity Date | Stated Interest Rate | Conversion Price per Share | Face Value Principal Outstanding | Fair Value | ||||||||||||||
| 2024 Convertible Notes | % | $ | $ | $ | ||||||||||||||
| Balance as of June 30, 2025 | $ | $ | ||||||||||||||||
| Contractual Maturity Date | Stated Interest Rate | Conversion Price per Share | Face Value Principal Outstanding | Fair Value | ||||||||||||||
| 2024 Convertible Notes | % | $ | $ | $ | ||||||||||||||
| Balance as of December 31, 2024 | $ | $ | ||||||||||||||||
| 13 |
Note 10 — Debt - continued
The changes in the fair value of debt during the three and six months ended June 30, 2025 is as follows:
Schedule of Changes in Fair Value of Debt
| 2024 Convertible Notes | Other Income (expense) | |||||||
| Fair Value - March 31, 2025 | $ | $ | — | |||||
| Non-installment payments – common stock | ( | ) | — | |||||
| Non-installment payments – cash | ( | ) | — | |||||
| Change in fair value | ( | ) | ||||||
| Fair Value at June 30, 2025 | $ | - | ||||||
| Other Income (Expense) - Change in fair value – three months ended June 30, 2025 | $ | |||||||
| 2024 Convertible Notes | Other Income (expense) | |||||||
| Fair Value - December 31, 2024 | $ | $ | — | |||||
| Non-installment payments – common stock | ( | ) | — | |||||
| Non-installment payments – cash | ( | ) | — | |||||
| Change in fair value | ( | ) | ||||||
| Fair Value at June 30, 2025 | $ | - | ||||||
| Other Income (Expense) - Change in fair value – six months ended June 30, 2025 | $ | ( | ) | |||||
The changes in the fair value of debt during the three and six months ended June 30, 2024 is as follows:
| March 2023 Senior Convertible Note | Other Income (expense) | |||||||
| Fair Value - March 31, 2024 | $ | $ | — | |||||
| Installment repayments – common stock | ( | ) | — | |||||
| Non-installment payments – common stock | ( | ) | — | |||||
| Change in fair value | ( | ) | ||||||
| Fair Value at June 30, 2024 | $ | - | ||||||
| Other Income (Expense) - Change in fair value – three months ended June 30, 2024 | $ | |||||||
| March 2023 Senior Convertible Note | Other Income (expense) | |||||||
| Fair Value - December 31, 2023 | $ | $ | — | |||||
| Fair Value - Beginning Balance | $ | $ | — | |||||
| Installment repayments – common stock | ( | ) | — | |||||
| Non-installment payments – common stock | ( | ) | — | |||||
| Change in fair value | ( | ) | ||||||
| Fair Value at June 30, 2024 | $ | - | ||||||
| Fair Value - Ending Balance | $ | - | ||||||
| Other Income (Expense) - Change in fair value – six months ended June 30, 2024 | $ | |||||||
| 14 |
Note 10 — Debt - continued
2024 Senior Convertible Note
On
November 22, 2024, the Company closed on the sale of $
Each
2024 Convertible Note has a
Under
the 2024 Convertible Notes,
The Company agreed that it would file with the SEC a resale registration statement on Form S-3 covering the resale of all shares of the Company’s common stock issuable upon conversion of the 2024 Convertible Notes. Such filing was made, as required under the notes, on May 22, 2025.
| 15 |
Note 11 — Stock-Based Compensation
Lucid Diagnostics 2018 Long-Term Incentive Equity Plan
The Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan (“Lucid Diagnostics 2018 Equity Plan”) is separate and apart from the PAVmed 2014 Equity Plan discussed below. The Lucid Diagnostics 2018 Equity Plan is designed to enable Lucid Diagnostics to offer employees, officers, directors, and consultants, an opportunity to acquire shares of common stock of Lucid Diagnostics. The types of awards that may be granted under the Lucid Diagnostics 2018 Equity Plan include stock options, stock appreciation rights, restricted stock, and other stock-based awards subject to limitations under applicable law. All awards are subject to approval by the Lucid Diagnostics compensation committee.
A
total of
Lucid Diagnostics Stock Options
Lucid Diagnostics stock options granted under the Lucid Diagnostics 2018 Equity Plan and stock options granted outside such plan are summarized as follows:
Schedule of Stock Options Issued and Outstanding Activities
| Number of Stock Options | Weighted Average Exercise Price | Remaining Contractual Term (Years) | Intrinsic Value(2) | |||||||||||||
| Outstanding stock options at December 31, 2024 | $ | $ | ||||||||||||||
| Granted(1) | $ | |||||||||||||||
| Exercised | ( | ) | $ | |||||||||||||
| Forfeited | ( | ) | $ | |||||||||||||
| Outstanding stock options at June 30, 2025(3) | $ | $ | ||||||||||||||
| Vested and exercisable stock options at June 30, 2025 | $ | $ | ||||||||||||||
| (1) | |
| (2) | |
| (3) |
On
February 20, 2025, the Company granted
Lucid Diagnostics Restricted Stock Awards
Lucid Diagnostics restricted stock awards granted under the Lucid Diagnostics 2018 Equity Plan and restricted stock awards granted outside such plan are summarized as follows:
Schedule of Restricted Stock Award Activity
| Number of Restricted Stock Awards | Weighted Average Grant Date Fair Value | |||||||
| Unvested restricted stock awards as of December 31, 2024 | $ | |||||||
| Granted | ||||||||
| Vested | — | — | ||||||
| Forfeited | — | — | ||||||
| Unvested restricted stock awards as of June 30, 2025 | $ | |||||||
On
February 20, 2025, a total of
| 16 |
Note 11 — Stock-Based Compensation - continued
PAVmed Inc. 2014 Equity Plan
The PAVmed 2014 Long-Term Incentive Equity Plan (the “PAVmed 2014 Equity Plan”), is separate and apart from the Lucid Diagnostics 2018 Equity Plan (as such equity plan is discussed above).
Stock-Based Compensation Expense
The stock-based compensation expense recognized by the Company for both the Lucid Diagnostics 2018 Equity Plan and the PAVmed 2014 Equity Plan, for the periods indicated, was as follows:
Schedule of Stock-Based Compensation Expense
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Lucid Diagnostics 2018 Equity Plan – cost of revenue | $ | $ | $ | $ | ||||||||||||
| Lucid Diagnostics 2018 Equity Plan – sales and marketing | ||||||||||||||||
| Lucid Diagnostics 2018 Equity Plan - general and administrative | ||||||||||||||||
| Lucid Diagnostics 2018 Equity Plan - research and development | ||||||||||||||||
| PAVmed 2014 Equity Plan - cost of revenue | — | |||||||||||||||
| PAVmed 2014 Equity Plan - sales and marketing | — | |||||||||||||||
| PAVmed 2014 Equity Plan - general and administrative | ||||||||||||||||
| PAVmed 2014 Equity Plan - research and development | — | |||||||||||||||
| Total stock-based compensation expense | $ | $ | $ | $ | ||||||||||||
The stock-based compensation expense, as presented above, is inclusive of: stock options and restricted stock awards granted under the Lucid Diagnostics 2018 Equity Plan to employees of PAVmed, the physician inventors of the technology licensed under the Amended CWRU License Agreement, and members of the board of directors of Lucid Diagnostics, as well as the stock options granted under the PAVmed 2014 Equity Plan to the physician inventors.
As of June 30, 2025, unrecognized stock-based compensation expense and weighted average remaining requisite service period with respect to stock options and restricted stock awards issued under each of the Lucid Diagnostics 2018 Equity Plan and the PAVmed 2014 Equity Plan, as discussed above, is as follows:
Schedule of Unrecognized Compensation Expense and Weighted Average Remaining Service Period
| Unrecognized Expense | Weighted Average Remaining Service Period (Years) | |||||||
| Lucid Diagnostics 2018 Equity Plan | ||||||||
| Stock Options | $ | |||||||
| Restricted Stock Awards | $ | |||||||
| PAVmed 2014 Equity Plan | ||||||||
| Stock Options | $ | |||||||
| 17 |
Note 11 — Stock-Based Compensation - continued
Stock-based
compensation expense recognized with respect to stock options granted under the Lucid Diagnostics 2018 Equity Plan was based on a weighted
average estimated fair value of such stock options of $
Schedule of Stock-based Compensation Valuation Assumptions
| 2025 | 2024 | |||||||
| Six Months Ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| Expected term of stock options (in years) | ||||||||
| Expected stock price volatility | % | % | ||||||
| Risk free interest rate | % | % | ||||||
| Expected dividend yield | — | % | — | % | ||||
Lucid Diagnostics Inc Employee Stock Purchase Plan (“Lucid ESPP”)
A
total of
Note 12 — Stockholders’ Equity
Series B Preferred Stock Offering and Exchange
As of June 30, 2025 and December
31, 2024, there were
| 18 |
Note 12 — Stockholders’ Equity - continued
Series B-1 Preferred Stock Offering
As of June 30, 2025 and December
31, 2024, there were
Lucid Diagnostics Common Stock
On June 21, 2024, the Company received a notice from the Listing Qualifications Department of Nasdaq stating that, for the prior 30 consecutive business days (through June 20, 2024), the closing bid price of the Company’s common stock had been below the minimum of $1 per share required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). The notification letter stated that the Company would be afforded 180 calendar days (until December 18, 2024) to regain compliance, which grace period was extended by an additional 180 calendar days (until June 16, 2025).
On February 24, 2025, the Company received a notice from the Listing Qualifications Department of Nasdaq stating that the closing bid price of the Company’s common stock had been above the minimum of $1 per share for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) for ten consecutive trading days (through February 21, 2025) and accordingly, the Company had regained compliance with this listing requirement.
| 19 |
Note 12 — Stockholders’ Equity - continued
March 2025 Registered Direct Offering
On
March 5, 2025, the Company closed on the sale of
April 2025 Confidentially Marketed Public Offering
On
April 11, 2025, the Company closed on the sale of
Committed Equity Facility and ATM Facility
On March 28, 2022, the Company
entered into a committed equity facility with an affiliate of Cantor Fitzgerald (“Cantor”). Under the terms of the committed
equity facility, Cantor has committed to purchase up to $
On
May 30, 2025, the Company entered into an “at-the-market offering” (“ATM”) for up to $
| 20 |
Note 13 — Net Loss Per Share
The Net loss per share basic and diluted for the respective periods indicated is as follows:
Schedule of Net Loss Per Share Basic and Diluted
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Numerator | ||||||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Deemed dividend on Series A and Series A-1 Convertible Preferred Stock | — | — | — | ( | ) | |||||||||||
| Series B and Series B-1 Convertible Preferred Stock dividends earned | ( | ) | — | ( | ) | — | ||||||||||
| Net loss attributable to Lucid Diagnostics Inc. common stockholders | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Denominator | ||||||||||||||||
| Weighted average common shares outstanding, basic and diluted | ||||||||||||||||
| Net loss per share (1) | ||||||||||||||||
| Net loss per share - basic and diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| (1) |
Basic weighted-average number of shares of common stock outstanding for the six months ended June 30, 2025 and 2024 include the shares of the Company issued and outstanding during such periods, each on a weighted average basis. The basic weighted average number of shares common stock outstanding excludes common stock equivalent incremental shares, while diluted weighted average number of shares outstanding includes such incremental shares. However, as the Company was in a loss position for all periods presented, basic and diluted weighted average shares outstanding are the same, as the inclusion of the incremental shares would be anti-dilutive. The common stock equivalents excluded from the computation of diluted weighted average shares outstanding are as follows:
Schedule of Common Stock Equivalents Excluded from Computation of Diluted Earnings Per Share
| 2025 | 2024 | |||||||
| June 30, | ||||||||
| 2025 | 2024 | |||||||
| Stock options | ||||||||
| Unvested restricted stock awards | ||||||||
| Preferred stock | ||||||||
| Total | ||||||||
Note 14 — Segment Information
Lucid’s
Chief Executive Officer is the Chief Operating Decision Maker (“CODM”). The CODM uses consolidated net income(loss) to assess
segment profit or loss, allocate resources and assess performance. The Company manages the business activities on a consolidated basis
and operates in
During the three and six months ended June 30, 2025 and 2024 revenues resulting from the delivery of patient EsoGuard test results was concentrated in the United States. The measure of segment assets is reported on the balance sheet as total consolidated assets, and concentrated in the United States.
| 21 |
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our unaudited condensed consolidated financial condition and results of operations should be read together with our Annual Report on Form 10-K for the year ended December 31, 2024 (the “Form 10-K”), as filed with the Securities and Exchange Commission (the “SEC”).
Unless the context otherwise requires, (i) “we”, “us”, and “our”, and the “Company”, “Lucid” and “Lucid Diagnostics” refer to Lucid Diagnostics Inc. and its subsidiaries LucidDx Labs Inc. (“LucidDx Labs”) and CapNostics, LLC (“CapNostics”), (ii) “FDA” refers to the Food and Drug Administration, (iii) “510(k)” refers to a premarket notification, submitted to the FDA by a manufacturer pursuant to § 510(k) of the Food, Drug and Cosmetic Act and 21 CFR § 807 subpart E, (iv) “CLIA” refers to the Clinical Laboratory Improvement Amendments of 1988 and associated regulations set forth in 42 CFR § 493, (v) “CE Mark” refers to a “Conformité Européenne” Mark, a mark indicating that a product such as a medical device conforms to the essential requirements of the relevant European directive, and (vi) “LDT” refers to a diagnostic test, defined by the FDA as “an IVD that is intended for clinical use and designed, manufactured and used within a single laboratory,” which is generally subject only to self-certification of analytical validity under the CMS CLIA program.
FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (this “Form 10-Q”), including the discussion and analysis of our unaudited condensed consolidated financial condition and results of operations, contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Form 10-Q, including statements regarding our future results of operations and financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements are not guarantees of future performance and the Company’s actual results may differ significantly from those expressed or implied in the forward-looking statements. Factors that might cause such differences include, but are not limited to, those discussed in Item 1A of Part I of the Form 10-K under the heading “Risk Factors.”
Important factors that may affect our actual results include:
| ● | our limited operating history; | |
| ● | our financial performance, including our ability to generate revenue; | |
| ● | our ability to obtain regulatory approval for the commercialization of our products; | |
| ● | the risk that the FDA will cease to exercise enforcement discretion with respect to LDTs, like EsoGuard; | |
| ● | the ability of our products to achieve market acceptance; | |
| ● | our success in retaining or recruiting, or changes required in, our officers, key employees or directors; | |
| ● | our potential ability to obtain additional financing when and if needed; | |
| ● | our ability to protect our intellectual property; | |
| ● | our ability to complete strategic acquisitions; | |
| ● | our ability to manage growth and integrate acquired operations; | |
| ● | the potential liquidity and trading of our securities; | |
| ● | our regulatory and operational risks; | |
| ● | cybersecurity risks; | |
| ● | risks related to the COVID-19 pandemic and other health-related emergencies; | |
| ● | risks related to our relationship with PAVmed; and | |
| ● | our estimates regarding expenses, future revenue, capital requirements and needs for additional financing. |
In addition, our forward-looking statements do not reflect the potential impact of any future financings, acquisitions, mergers, dispositions, joint ventures or investments we may make.
We may not actually achieve the results, plans and/or objectives disclosed in our forward-looking statements, and the intended or expected results, developments and/or other events disclosed in our forward-looking statements may not actually occur, and accordingly you should not place undue reliance on our forward-looking statements. You should read this Quarterly Report on Form 10-Q and the documents we have filed as exhibits to this Form 10-Q and the Form 10-K completely and with the understanding our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
| 22 |
Overview
We are a commercial-stage, cancer prevention medical diagnostics technology company focused on the millions of patients who are at risk of developing esophageal precancer and cancer, specifically highly lethal esophageal adenocarcinoma (“EAC”).
We believe that our flagship product, the EsoGuard Esophageal DNA Test, performed on samples collected with the EsoCheck Esophageal Cell Collection Device, constitutes the first and only commercially available diagnostic test capable of serving as a widespread tool for the early detection of esophageal precancer, including Barrett’s Esophagus (“BE”), in at-risk patients. Early detection of esophageal precancer allows patients to undergo appropriate monitoring and treatment, as indicated by clinical practice guidelines, in an effort to prevent progression to esophageal cancer.
EsoGuard is a bisulfite-converted targeted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck. It quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay has been evaluated in multiple studies, demonstrating sensitivity of ~90% for detecting disease along the full esophageal precancer to cancer spectrum, with a negative predictive value (NPV) of ~99%. Sensitivity and NPV remain very high even for detecting early precancer, which is unprecedented for a molecular diagnostic test.
EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than two minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. We believe this proprietary Collect+Protect™ technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling.
EsoGuard and EsoCheck are based on patented technology licensed by Lucid from Case Western Reserve University (“CWRU”). EsoGuard and EsoCheck have been developed to provide an accurate, non-invasive, patient-friendly test for the early detection of EAC and BE, including dysplastic BE and related precursors to EAC in patients with gastroesophageal reflux disease (“GERD”), commonly known as chronic heartburn, acid reflux, or just reflux.
Recent Developments
Medicare Coverage
In November 2024, we submitted to MolDx our complete clinical evidence package in support of a request for reconsideration of the non-coverage language in the LCD to secure Medicare coverage for EsoGuard. The EsoGuard clinical evidence package included six new peer-reviewed publications: three clinical validation studies (two in the intended use population, one case control), two clinical utility studies, and one analytical validation study. The current LCD provides clear coverage criteria consistent with the American College of Gastroenterology (ACG) guidelines for esophageal precancer testing. The package was submitted as part of a request for reconsideration of the non-coverage language in the LCD to secure Medicare coverage for EsoGuard.
As part of the LCD reconsideration process, MolDX-participating Medicare Administrative Contractors are scheduled to convene a Contractor Advisory Committee (CAC) Meeting regarding the LCD on September 4, 2025.
Clinical Study Publications
In April 2025, the Company’s fifth peer-reviewed clinical utility manuscript, “Enhancing the Diagnostic Yield of EGD for Diagnosis of Barrett’s Esophagus Through Methylated DNA Biomarker Triage,” was published in Gastroenterology & Hepatology. This manuscript presents clinical utility data from the ENVET-BE study, which is the second to assess the clinical utility of EsoGuard in a real-world screening population. The ENVET-BE study analyzed 209 EsoGuard-positive patients who underwent biomarker triage and confirmatory EGD in the 2023 calendar year, to test the hypothesis that EGDs performed on patients who first triage positive on EsoGuard have higher diagnostic yield than screening EGDs alone. The yield of screening EGDs was estimated by literature-established disease prevalence (10.6%). A 2.4-fold increase in BE detection compared with the performance goal was observed for the full study population. In the cohort meeting American College of Gastroenterology (ACG) criteria for BE screening, the diagnostic yield was increased by 2.7-fold.
On August 1, 2025, the American Journal of Gastroenterology e-published (ahead of printing) the manuscript “Nonendoscopic Detection of Barrett’s Esophagus in Patients Without GERD Symptoms.” This investigator-initiated pilot study evaluated EsoGuard in 120 patients without GERD symptoms, but who met American Gastroenterological Association (AGA) BE screening criteria. Of 34 EsoGuard-positive patients, 27 underwent EGD, confirming BE in 9 cases (PPV: 33%). Of 86 EsoGuard-negative patients, 22 volunteered for EGD, with zero BE cases (NPV: 100%). This is the first study to assess EsoGuard in this expanded risk group and informed the design of a larger, ongoing NIH R01-funded study.
ATM Facility
On May 30, 2025, the Company entered into an “at-the-market offering” (“ATM”) for up to $25.0 million of its common stock that may be offered and sold under a Controlled Equity Offering Agreement between the Company and Maxim Group LLC.
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Recent Developments - continued
April 2025 Confidentially Marketed Public Offering
On April 11, 2025, the Company closed on the sale of 14,375,000 shares of its common stock at a price of $1.20 per share (the “April 2025 Offering”). The net proceeds of the April 2025 Offering, after deducting the estimated placement agent’s fees and other expenses of $1.2 million, was approximately $16.1 million. The Company intends to use the net proceeds from the April 2025 Offering for working capital and other general corporate purposes.
March 2025 Registered Direct Offering
On March 5, 2025, the Company closed on the sale of 13,939,330 shares of its common stock at a price of $1.10 per share (the “Offering”). The net proceeds of the Offering, after deducting the estimated placement agent’s fees and other expenses of $0.4 million, was approximately $14.9 million. The Company intends to use the net proceeds from the Offering for working capital and other general corporate purposes.
Russell 2000® and 3000® Indexes
On June 27, 2025, the Company was added to the Russell 2000® Index and the Russell 3000® Index, following the 2025 annual reconstitution by FTSE Russell.
Hoag Comprehensive Esophageal Precancer Testing Program Using EsoGuard
On June 18, 2025, the Company announced that Hoag, a nationally recognized regional healthcare delivery network, launched a comprehensive, integrated esophageal precancer testing program using the Company’s EsoGuard® Esophageal DNA Test. The Company will partner with Hoag to offer EsoGuard testing across its digestive health, primary care, and concierge medicine programs.
NCCN Clinical Practice Guidelines Update
In March 2025, we announced that a recent update to the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) focused on Esophageal and Esophagogastric Junction Cancers (Version 1.2025) has added a new section on BE screening. The NCCN Guidelines® now reference professional society guidelines on BE screening, including the most recent ACG clinical guideline discussed above, which recommends non-endoscopic biomarker testing, such as EsoGuard performed on samples collected with EsoCheck, as an acceptable alternative to invasive upper endoscopy to detect esophageal precancer.
Highmark Reimbursement Approval
On March 13, 2025, the Company announced that Highmark Blue Cross Blue Shield, an independent licensee of the Blue Cross and Blue Shield Association, has issued a positive coverage policy for non-invasive screening of esophageal precancer and cancer in New York state. The new policy, which became effective as of May 26, 2025, covers EsoGuard in patients who meet established criteria for esophageal precancer testing consistent with professional society guidelines.
CWRU NIH Grant Related to EsoGuard and EsoCheck
On February 27, 2025, the Company announced that principal investigators from Case Western Reserve University (CWRU) and University Hospitals (UH), were awarded an $8 million National Institutes of Health (NIH) R01 grant to conduct a five-year clinical study designed to evaluate esophageal precancer detection using EsoCheck and EsoGuard among at-risk individuals without symptoms of chronic gastroesophageal reflux disease (GERD). The study, “A Clinical Trial of Cancer Prevention by Biomarker Based Detections of Barrett’s Esophagus and Its Progression,” aims to evaluate the effectiveness of EsoCheck and EsoGuard in detecting esophageal precancer (Barrett’s Esophagus or BE) to prevent esophageal cancer (EAC) within a non-GERD at-risk population. To accomplish this aim, 800 patients without GERD symptoms who meet the American Gastroenterological Association’s (AGA) risk criteria for screening will be recruited across five participating research centers: University Hospitals, University of Colorado, Johns Hopkins University, University of North Carolina, and Cleveland Clinic.
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Results of Operations
Overview
Revenue
The Company recognized revenue resulting from the delivery of patient EsoGuard test results when the Company considered the collection of such consideration to be probable to the extent that it is unconstrained.
Cost of revenue
Cost of revenues recognized from the delivery of patient EsoGuard test results includes costs related to EsoCheck device usage, shipment of test collection kits, royalties and the cost of services to process tests and provide results to physicians. We incur expenses for tests in the period in which the activities occur, therefore, gross margin as a percentage of revenue may vary from quarter to quarter due to costs being incurred in one period that relate to revenues recognized in a later period.
We expect that the gross margin for our services will continue to fluctuate and be affected by EsoGuard test volume, our operating efficiencies, patient compliance rates, payer mix, the levels of reimbursement, and payment patterns of payers and patients.
Sales and marketing expenses
Sales and marketing expenses consist primarily of salaries and related costs for employees engaged in sales, sales support and marketing activities, as well as the portion of the MSA Fee (as defined in Note 5, Related Party Transactions, to our accompanying unaudited condensed consolidated financial statements) allocated to sales and marketing expenses, which are principally costs related to PAVmed employees who are performing services for the Company. We anticipate our sales and marketing expenses will increase in the future, to the extent we expand our commercial sales and marketing operations as resources permit and insurance reimbursement coverage for our EsoGuard test expands.
General and administrative expenses
General and administrative expenses consist primarily of professional fees for accounting, tax, audit and legal services (including those fees incurred as a result of our being a public company), consulting fees, employees costs involved in third-party payor reimbursement contract negotiations and consulting fees, expenses associated with obtaining and maintaining patents within our intellectual property portfolio, and certain employee costs, along with the portion of the MSA Fee allocated to general and administrative expenses.
We anticipate our general and administrative expenses will increase in the future to the extent our business operations grow. Furthermore, we anticipate continued expenses related to being a public company, including fees and expenses for audit, legal, regulatory, tax-related services, insurance premiums and investor relations costs associated with maintaining compliance as a public company.
Research and development expenses
Research and development expenses are recognized in the period they are incurred and consist principally of internal and external expenses incurred for the development of our technologies and conducting clinical trials, including:
| ● | costs associated with submission of regulatory filings; | |
| ● | cost of laboratory supplies and acquiring, developing, and manufacturing preclinical prototypes; and | |
| ● | the portion of the MSA Fee allocated to research and development. |
We plan to incur research and development expenses for the foreseeable future as we continue the development of our existing products as well as new innovations. Our research and development activities, including our clinical trials, are focused principally on facilitating insurer reimbursement, encouraging physician adoption and developing product improvements or extending the utility of the lead products in our pipeline, including EsoCheck and EsoGuard.
Other Income and Expense, net
Other income and expense, net, consists principally of changes in fair value of our convertible note and losses on extinguishment of debt upon repayment of such convertible note.
Presentation of Dollar Amounts
All dollar amounts in this Management’s Discussion and Analysis of Financial Condition and Results of Operations are presented as dollars in millions, except for share and per share amounts.
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Results of Operations - continued
The three months ended June 30, 2025 as compared to the three months ended June 30, 2024
Revenue
In the three months ended June 30, 2025, revenue was $1.2 million as compared to $1.0 million for the corresponding period in the prior year. The $0.2 million increase principally relates to the increase in the consideration received for the performance of the EsoGuard Esophageal DNA Tests.
Cost of revenue
In the three months ended June 30, 2025, the cost of revenue remained relatively level at approximately $1.6 million, as compared to the corresponding period in the prior year.
Sales and marketing expenses
In the three months ended June 30, 2025, sales and marketing costs were approximately $4.0 million as compared to $4.2 million for the corresponding period in the prior year. The net decrease of $0.2 million was principally related to a decrease in compensation costs.
General and administrative expenses
In the three months ended June 30, 2025, general and administrative costs were approximately $5.6 million as compared to $4.9 million for the corresponding period in the prior year. The net increase of $0.7 million was principally related to:
| ● | approximately $0.4 million increase related to the amended MSA with PAVmed due to the growth and expansion of our business and the services incurred through PAVmed; and | |
| ● | approximately $0.3 million increase in stock-based compensation related costs. |
Research and development expenses
In the three months ended June 30, 2025, research and development costs were approximately $1.3 million, compared to $1.4 million for the corresponding period in the prior year. The net decrease of $0.1 million was principally related to a decrease in development costs, particularly in clinical trial activities and outside professional and consulting fees.
Amortization of Acquired Intangible Assets
In the three months ended June 30, 2025, the amortization of acquired intangible assets remained relatively level at approximately $0.1 million, as compared to the corresponding period in the prior year.
Other Income and Expense
Change in fair value of convertible debt
In the three months ended June 30, 2025, the change in the fair value of our convertible notes was approximately $6.8 million of income, related to the 2024 Senior Convertible Notes (as defined in Note 10, Debt, to our accompanying unaudited condensed consolidated financial statements). The 2024 Senior Convertible Notes was initially measured at the notes’ issue-date estimated fair value and is subsequently remeasured at estimated fair value as of each reporting period date.
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Results of Operations - continued
The three months ended June 30, 2025 as compared to three months ended June 30, 2024 - continued
Loss on Debt Extinguishment
The Company did not incur debt extinguishment loss in the three months ended June 30, 2025.
In the three months ended June 30, 2024, a debt extinguishment loss in the aggregate of approximately $0.5 million was recognized in connection with our March 2023 Senior Convertible Note as discussed below.
| ● | In the three months ended June 30, 2024, approximately $1.1 million of principal repayments along with approximately $0.2 million of interest expense thereon, were settled through the issuance of 2,117,883 shares of common stock of the Company, with such shares having a fair value of approximately $1.9 million (with such fair value measured as the quoted closing price of the common stock of the Company on the respective conversion date). The conversions resulted in a debt extinguishment loss of $0.5 million in the three months ended June 30, 2025. |
See Note 10, Debt, to our accompanying unaudited condensed consolidated financial statements, for additional information with respect to the 2024 Senior Convertible Notes.
The six months ended June 30, 2025 as compared to six months ended June 30, 2024
Revenue
In the six months ended June 30, 2025, revenue remained relatively level at $2.0 million, as compared to the corresponding period in the prior year.
Cost of revenue
In the six months ended June 30, 2025, the cost of revenue was approximately $3.1 million as compared to $3.3 million for the corresponding period in the prior year. The net decrease of $0.2 million was principally related to:
| ● | approximately $0.4 million decrease in the manufacturing costs associated with the EsoCheck devices and EsoGuard Esophageal DNA Tests; and | |
| ● | approximately $0.2 million increase in compensation related costs. |
Sales and marketing expenses
In the six months ended June 30, 2025, sales and marketing costs were approximately $8.1 million as compared to $8.4 million for the corresponding period in the prior year. The net decrease of $0.3 million was principally related to:
| ● | approximately $0.2 million decrease in stock-based compensation; and | |
| ● | approximately $0.1 million decrease related to third-party facility related expenses. |
General and administrative expenses
In the six months ended June 30, 2025, general and administrative costs were approximately $11.8 million as compared to $8.9 million for the corresponding period in the prior year. The net increase of $2.9 million was principally related to:
| ● | approximately $1.6 million increase related to third-party professional fees, primarily due to financing related costs; | |
| ● | approximately $0.9 million increase related to the amended MSA with PAVmed due to the growth and expansion of our business and the services incurred through PAVmed; and | |
| ● | approximately $0.4 million increase in stock-based compensation costs. |
Research and development expenses
In the six months ended June 30, 2025, research and development costs were approximately $2.7 million, compared to $2.9 million for the corresponding period in the prior year. The net decrease of $0.2 million was principally related to:
| ● | approximately $0.3 million increase related to the amended MSA with PAVmed due to the growth and expansion of our business and the services incurred through PAVmed; | |
| ● | approximately $0.3 million decrease in development costs, particularly in clinical trial activities; and | |
| ● | approximately $0.2 million decrease in stock-based compensation. |
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Results of Operations - continued
The six months ended June 30, 2025 as compared to six months ended June 30, 2024 - continued
Amortization of Acquired Intangible Assets
The amortization of acquired intangible assets was approximately $0.2 million in the six months ended June 30, 2025, as compared to $0.5 million for the corresponding period in the prior year. The decrease of $0.3 million in the current period was due to certain acquired intangible assets being fully amortized in February 2024.
Other Income and Expense
Change in fair value of convertible debt
In the six months ended June 30, 2025 and 2024, the change in the fair value of our convertible note was approximately $7.6 million of expense and $0.9 million of income, respectively, related to the 2024 Convertible Notes and the March 2023 Senior Convertible Note (as defined in Note 10, Debt, to our accompanying unaudited condensed consolidated financial statements). The 2024 Convertible Notes and March 2023 Senior Convertible Note were initially measured at their respective issue date estimated fair value and subsequently remeasured at estimated fair value as of each reporting period date. The Company initially recognized a $0.8 million fair value remeasurement as a non-cash expense on the issue date.
Loss on Debt Extinguishment
The Company did not incur debt extinguishment loss in the six months ended June 30, 2025.
In the six months ended June 30, 2024, a debt extinguishment loss in the aggregate of approximately $0.7 million was recognized in connection with our March 2023 Senior Convertible Note as discussed below.
| ● | In the six months ended June 30, 2024, approximately $1.2 million of principal repayments along with approximately $0.7 million of interest expense thereon, were settled through the issuance of 2,661,181 shares of common stock of the Company, with such shares having a fair value of approximately $2.5 million (with such fair value measured as the quoted closing price of the common stock of the Company on the respective conversion date). The conversions resulted in a debt extinguishment loss of $0.7 million in the six months ended June 30, 2024. |
See Note 10, Debt, to our accompanying unaudited condensed consolidated financial statements, for additional information with respect to the 2024 Convertible Notes.
Deemed Dividend on Series A and Series A-1 Convertible Preferred Stock Exchange Offer
The fair value of the consideration given in the form of the issue of 31,790 shares of Series B Convertible Preferred Stock, with such fair value recognized as the carrying value of such issued shares of Series B Convertible Preferred Stock, as compared to the carrying value of the extinguished Series A and Series A-1 Convertible Preferred Stock (carrying value of $24.3 million), resulting in an excess of fair value of $7.5 million recognized as a deemed dividend charged to accumulated deficit in the unaudited condensed consolidated balance sheet on March 13, 2024, with such deemed dividend included as a component of net loss attributable to common stockholders, summarized as follows:
| Series B Convertible Preferred Stock Issuance and Series A/A-1 Exchange Offer ($ in thousands) | March 13, 2024 | |||
| Fair Value - 31,790 shares of Series B Preferred Stock issued in exchange for Series A and Series A-1 Preferred Stock | $ | 31,790 | ||
| Less: Carrying value related to Series A and Series A-1 Preferred Stock Exchanged for Series B Preferred Stock (of 24,295 shares) | (24,294 | ) | ||
| Deemed Dividend Charged to Accumulated Deficit | $ | 7,496 | ||
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Liquidity and Capital Resources
Our current operational activities are principally focused on the commercialization of EsoGuard. We are pursuing commercialization across multiple sales channels, including: the communication to and education of medical practitioners and clinicians regarding EsoGuard; the establishment of Lucid Test Centers for the collection of cell samples using EsoCheck; use of our mobile testing unit; ongoing #CheckYourFoodTube testing days; and our direct contracting strategic initiative (including in the concierge medicine and employer markets sectors). Additionally, we are developing expanded clinical evidence to support insurance reimbursement adoption by government and private insurers. Further, as resources permit, the Company also intends to pursue development of other products and services.
Our ability to generate revenue depends upon our ability to successfully advance the commercialization of EsoGuard, including significantly expanding insurance reimbursement coverage. There are no assurances, however, we will be able to obtain an adequate level of financial resources required for the long-term commercialization and development of our products and services.
We are subject to all of the risks and uncertainties typically faced by medical device and diagnostic companies that devote substantially all of their efforts to the commercialization of their initial products and services. We experienced a net loss of approximately $31.3 million and used approximately $23.0 million of cash in operations during the six months ended June 30, 2025. Financing activities provided $31.9 million of cash during the six months ended June 30, 2025. We ended the quarter with cash on-hand of $31.1 million as of June 30, 2025. We expect to continue to experience recurring losses and negative cash flow from operations, and will continue to fund our operations with debt and/or equity financing transactions, which in accordance with management’s plans may include conversions of our existing debt to equity and refinancing our existing debt obligations to extend the maturity date. The Company’s ability to continue operations 12 months beyond the issuance of the financial statements will depend upon generating substantial revenue that is conditioned on obtaining positive third-party reimbursement coverage for its EsoGuard Esophageal DNA Test from both government and private health insurance providers, increasing revenue through contracting directly with self-insured employers, and upon raising additional capital through various potential sources including equity and/or debt financings or refinancing existing debt obligations. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the accompanying unaudited condensed consolidated financial statements are issued.
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Liquidity and Capital Resources - continued
March 2025 Registered Direct Offering
On March 5, 2025, the Company closed on the sale of 13,939,330 shares of its common stock at a price of $1.10 per share (the “Offering”). The net proceeds of the Offering, after deducting the estimated placement agent’s fees and other expenses of $0.4 million, was approximately $14.9 million. The Company intends to use the net proceeds from the Offering for working capital and other general corporate purposes.
April 2025 Confidentially Marketed Public Offering
On April 11, 2025, the Company closed on the sale of 14,375,000 shares of its common stock at a price of $1.20 per share (the “April 2025 Offering”). The net proceeds of the April 2025 Offering, after deducting the estimated placement agent’s fees and other expenses of $1.1 million, was approximately $16.2 million. The Company intends to use the net proceeds from the April 2025 Offering for working capital and other general corporate purposes.
ATM Facility
On May 30, 2025, the Company entered into an “at-the-market offering” (“ATM”) for up to $25.0 million of its common stock that may be offered and sold under a Controlled Equity Offering Agreement between the Company and Maxim Group LLC. In the six months ended June 30, 2025, the Company sold 215,421 shares through its at-the-market equity facility for net proceeds of approximately $0.3 million, after payment of 3% commissions.
Critical Accounting Estimates
The discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the amounts reporting in our unaudited condensed consolidated financial statements and accompanying notes. On an ongoing basis, we evaluate our estimates and judgements. In accordance with U.S. GAAP, we base our estimates on historical experience and on various other factors that are believed to be appropriate under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. Our critical accounting estimates are as disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on March 24, 2025. There have been no material changes to our critical accounting estimates in the six months ended June 30, 2025.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our principal executive officer and our principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2025. Based on such evaluation, our principal executive officer and principal financial officer concluded our disclosure controls and procedures (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) were effective as of such date to provide reasonable assurance the information required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure information required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
Changes to Internal Controls Over Financial Reporting
There has been no change in internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during our fiscal quarter ended June 30, 2025 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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Part II - Other Information
Item 1. Legal Proceedings
In the ordinary course of the Company’s business, particularly as it begins commercialization of its products, the Company may be subject to certain other legal actions and claims, including product liability, consumer, commercial, tax and governmental matters, which may arise from time to time. The Company is not aware of any such pending legal or other proceedings that are reasonably likely to have a material impact on the Company. Notwithstanding, legal proceedings are subject to inherent uncertainties, and an unfavorable outcome could include monetary damages, and excessive verdicts can result from litigation, and as such, could result in a material adverse impact on the Company’s business, financial position, results of operations, and /or cash flows. Additionally, although the Company has specific insurance for certain potential risks, the Company may in the future incur judgments or enter into settlements of claims which may have a material adverse impact on the Company’s business, financial position, results of operations, and /or cash flows.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Except as previously disclosed in our current and periodic reports filed prior to the date of this Form 10-Q, we did not sell any unregistered securities or repurchase any of our securities during the three months ended June 30, 2025. The equity dividends described in Note 12, Preferred Stock, to our accompanying unaudited condensed consolidated financial statements (which were previously disclosed in a current report filed prior to the date of this Form 10-Q) were exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), pursuant to Section 4(a)(2) of the Securities Act, as transactions not involving public offerings.
As long as the 2024 Convertible Notes are outstanding, we may not, directly or indirectly, redeem, or declare or pay any cash dividend or cash distribution on, any of our securities without the prior express written consent of a majority-in-interest of the holders of the 2024 Convertible Notes (subject to limited exceptions). Furthermore, our common stock is junior to our preferred stock with respect to certain in-kind dividends payable to the holders of such preferred stock.
Item 5. Other Information
During
the fiscal quarter ended June 30, 2025, none of our directors or officers (as defined in Rule 16a-1 under the Exchange Act)
Item 6. Exhibits
The exhibits filed as part of this Quarterly Report on Form 10-Q are set forth in the “Exhibit Index” below.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Lucid Diagnostics Inc. | ||
| August 12, 2025 | By: | /s/ Dennis M McGrath |
| Dennis M McGrath | ||
| Chief Financial Officer | ||
| (Principal Financial and Accounting Officer) | ||
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EXHIBIT INDEX
| Incorporation by Reference | ||||||||
| Exhibit No. | Description | Form | Exhibit No. | Date | ||||
| 1.1 | Sales Agreement (ATM Facility) | 8-K | 1.1 | 5/30/2025 | ||||
| 31.1 | Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | * | ||||||
| 31.2 | Certification of Principal Financial and Accounting Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | * | ||||||
| 32.1 | Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | * | ||||||
| 32.2 | Certification of Principal Financial and Accounting Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | * | ||||||
| 101.INS | Inline XBRL Instance Document | * | ||||||
| 101.CAL | Inline XBRL Taxonomy Extension Schema | * | ||||||
| 101.DEF | Inline XBRL Taxonomy Extension Calculation Linkbase | * | ||||||
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase | * | ||||||
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase | * | ||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | * | ||||||
* Filed herewith.
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FAQ
What were Lucid Diagnostics (LUCD) revenues for Q2 and the six months ended June 30, 2025?
How much cash did LUCD have and what was operating cash flow in H1 2025?
What is the status of Lucid's 2024 Convertible Notes?
Did Lucid receive any payer coverage or reimbursement developments?
What clinical or research milestones support EsoGuard/EsoCheck?
How did Lucid strengthen liquidity in 2025?
