Lucid Diagnostics Inc.

Previous wording

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.

Current wording

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 local coverage determination, or “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, or “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.

Previous wording

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.

Current wording

As part of the LCD reconsideration process, MolDx-participating Medicare Administrative Contractors convened a Contractor Advisory Committee, or “CAC,” Meeting regarding the LCD on September 4, 2025. At the meeting, eleven experts, including physicians across multiple specialties (GI, primary care, pathology), major society guideline co-authors (ACG, AGA (as defined below)) and industry leaders (American Foregut Society, American Society for Gastrointestinal Endoscopy), participated in this extensive discussion of the unmet clinical need with respect to early detection of esophageal precancer and the strength of the EsoGuard clinical validity and clinical utility data.

Previous wording

On August 1, 2025, theAmerican 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.

Current wording

On August 1, 2025, theAmerican Journal of Gastroenterology e-published 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.

Previous wording

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.

Current wording

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, 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.

Previous wording

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.

Current wording

In the three months ended September 30, 2025, revenue remained relatively level at $1.2 million as compared to the corresponding period in the prior year.

Previous wording

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.

Current wording

In the three months ended September 30, 2025, the cost of revenue remained relatively level at approximately $1.7 million, as compared to the corresponding period in the prior year.

Previous wording

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.

Current wording

In the three months ended September 30, 2025, sales and marketing costs were approximately $4.3 million as compared to $4.1 million for the corresponding period in the prior year. The net increase of $0.2 million was principally related to an increase in third-party professional services and consulting costs.

Previous wording

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:

Current wording

In the three months ended September 30, 2025, general and administrative costs were approximately $5.6 million as compared to $5.4 million for the corresponding period in the prior year. The net increase of $0.2 million was principally related to:

Previous wording

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.

Current wording

In the three months ended September 30, 2025, research and development costs were approximately $1.3 million, compared to $1.7 million for the corresponding period in the prior year. The net decrease of $0.4 million was principally related to a decrease in development costs, particularly in clinical trial activities and outside professional and consulting fees.

Previous wording

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.

Current wording

In the three months ended September 30, 2025, the sequential decrease in the fair value of our convertible notes of approximately $2.3 million is reflected as other income in the Statement of Operations, (see Note 10,Debt, to our accompanying unaudited condensed consolidated financial statements). The 2024 Convertible Notes were initially measured at the issue-date estimated fair value and are subsequently remeasured at estimated fair value as of each reporting period end date.

Previous wording

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.

Current wording

In the three months ended September 30, 2024, a debt extinguishment loss in the aggregate of approximately $0.4 million was recognized in connection with our March 2023 Senior Convertible Note as discussed below.

Previous wording

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.

Current wording

In the nine months ended September 30, 2025, revenue was $3.2 million, as compared to $3.1 million for the corresponding period in the prior year. The $0.1 million increase principally relates to the increase in the consideration received for the performance of the EsoGuard Esophageal DNA Tests.

Previous wording

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:

Current wording

In the nine months ended September 30, 2025, the cost of revenue was approximately $4.8 million as compared to $5.0 million for the corresponding period in the prior year. The net decrease of $0.2 million was principally related to:

Previous wording

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:

Current wording

In the nine months ended September 30, 2025, sales and marketing costs were approximately $12.4 million as compared to $12.5 million for the corresponding period in the prior year. The net decrease of $0.1 million was principally related to:

Previous wording

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:

Current wording

In the nine months ended September 30, 2025, general and administrative costs were approximately $17.4 million as compared to $14.3 million for the corresponding period in the prior year. The net increase of $3.1 million was principally related to:

Previous wording

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:

Current wording

In the nine months ended September 30, 2025, research and development costs were approximately $4.0 million, compared to $4.5 million for the corresponding period in the prior year. The net decrease of $0.5 million was principally related to:

Previous wording

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.

Current wording

The amortization of acquired intangible assets was approximately $0.3 million in the nine months ended September 30, 2025, as compared to $0.6 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.

Previous wording

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.

Current wording

In the nine months ended September 30, 2025 and 2024, the change in the fair value of our convertible note was approximately $5.3 million of expense and $0.6 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.

Previous wording

The Company did not incur debt extinguishment loss in the six months ended June 30, 2025.

Current wording

The Company did not incur debt extinguishment loss in the nine months ended September 30, 2025.

Previous wording

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.

Current wording

In the nine months ended September 30, 2024, a debt extinguishment loss in the aggregate of approximately $1.1 million was recognized in connection with our March 2023 Senior Convertible Note as discussed below.

Previous wording

See Note 10*, Debt*, to our accompanying unaudited condensed consolidated financial statements, for additional information with respect to the 2024 Senior Convertible Notes.

Current wording

See Note 10*, Debt*, to our accompanying unaudited condensed consolidated financial statements, for additional information with respect to the 2024 Convertible Notes.

Previous wording

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.

Current wording

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 $41.7 million and used approximately $33.9 million of cash in operations during the nine months ended September 30, 2025. Financing activities provided $59.0 million of cash during the nine months ended September 30, 2025. We ended the quarter with cash on-hand of $47.3 million as of September 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.

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

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 nine months ended September 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.

Previous wording

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.

Current wording

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 nine months ended September 30, 2025.