false 0001799011 0001799011 2025-11-12 2025-11-12 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 8-K

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Date of Report (Date of earliest event reported): November 12, 2025

 

LUCID DIAGNOSTICS INC.
(Exact Name of Registrant as Specified in Charter)

 

Delaware   001-40901   82-5488042

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

360 Madison Avenue, 25th Floor, New York, New York   10017
(Address of Principal Executive Offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (917) 813-1828

 

N/A
(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425).
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12).
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)).
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)).

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, Par Value $0.001 Per Share   LUCD   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 

 

 

 

Item 2.02 Results of Operations and Financial Condition.

 

On November12, 2025, Lucid Diagnostics Inc. (the “Company”) issued a press release announcing financial results for its fiscal quarter ended September 30, 2025 and providing a business update. A copy of the press release is attached to this report as Exhibit 99.1 and is incorporated herein by reference.

 

Item 7.01.Regulation FD Disclosure.

 

The disclosure set forth under Item 2.02 is incorporated herein by reference.

 

The information furnished under Items 2.02 and 7.01, including the exhibit related thereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any disclosure document of the Company, except as shall be expressly set forth by specific reference in such document.

 

Item 9.01.Financial Statements and Exhibits.

 

(d) Exhibits:

 

Exhibit No.   Description
99.1   Press release.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

2

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: November 12, 2025 LUCID DIAGNOSTICS INC.
     
  By: /s/ Dennis McGrath
    Dennis McGrath
    Chief Financial Officer

 

3

 

 

Exhibit 99.1

 

Lucid Diagnostics Provides Business Update and Reports Third Quarter 2025 Financial Results

 

Processed 2,841 EsoGuard® tests and recognized 3Q25 revenue of $1.2 million, ending quarter with over $47 million in proforma cash and extending runway through 2026 and well past upcoming reimbursement milestones

 

Multi-Jurisdictional Contractor Advisory Committee (CAC) meeting on Medicare Local Coverage Determination (LCD) for Lucid’s EsoGuard yielded unanimous expert consensus supporting Medicare coverage

 

Conference call and webcast to be held today, November 12, at 8:30 AM EST

 

NEW YORK, November 12, 2025 - Lucid Diagnostics Inc. (Nasdaq: LUCD) (“Lucid” or the “Company”) a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM) (“PAVmed”), today provided a business update for the Company and reported financial results for the three months ended September 30, 2025.

 

Conference Call and Webcast

 

The webcast will take place on Wednesday, November 12, 2025, at 8:30 AM and will be accessible in the investor relations section of the Company’s website at luciddx.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184 and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name “Lucid Diagnostics Business Update” to join.

 

Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company’s website at luciddx.com.

 

Business Highlights

 

“The overwhelmingly positive MolDx CAC meeting in September—with medical experts unanimously supporting Medicare coverage for EsoGuard—further reinforces our confidence that we are now firmly in the final stages of achieving this transformative coverage milestone,” said Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer. “Our strengthened balance sheet, continued commercial execution, targeted initiatives aimed at the Medicare population, and a new world-class market access team driving payor engagement have us well-prepared to accelerate EsoGuard commercialization as Medicare coverage and other upcoming reimbursement milestones are secured.”

 

 
 

 

Processed 2,841 EsoGuard® Esophageal DNA Tests in 3Q25.
   
Recognized $1.2 million in EsoGuard revenue for 3Q25.
   
MolDX-participating Medicare Administrative Contractors (MACs) convened a Contractor Advisory Committee (CAC) meeting on September 4, 2025, where medical experts unanimously supported Medicare coverage for EsoGuard. The meeting represented a key step in the final stages of the Local Coverage Determination (LCD) reconsideration process previously requested by Lucid.
   
Strengthened balance sheet with underwritten public offering of common stock, netting approximately $27.0 million in proceeds; ended 3Q25 with over $47 million in proforma cash, extending runway through 2026.
   
Appointed Danielle Scelfo as Senior Vice President, Market Access & Government Affairs to strengthen and scale Lucid’s market access infrastructure and lead rapidly expanding reimbursement activities focused on payor engagement, broad insurance coverage, and patient access.
   
Firefighter Esophageal Cancer Prevention Summit scheduled for November 19–20, focused on advancing cancer prevention through early detection in the fire service and bolstering the pipeline of contracted #CheckYourFoodTube precancer testing events.

 

Financial Results

 

For the three months ended September 30, 2025, EsoGuard related revenues were $1.2 million. Operating expenses were approximately $13.0 million, which included stock-based compensation expenses of $1.2 million. GAAP net loss attributable to common stockholders was approximately $10.4 million or $(0.10) per common share.
   
As shown below and for the purpose of illustrating the effect of stock-based compensation and other non-cash income and expenses on the Company’s financial results, the Company’s non-GAAP adjusted loss for the three months ended September 30, 2025 was approximately $10.3 million or $(0.10) per common share.
   
Lucid had cash and cash equivalents of $47.3 million as of September 30, 2025, compared to $22.4 million as of December 31, 2024. During the quarter ended September 30, 2025, the Company completed a Confidentially Marketed Public Offering resulting in net proceeds of approximately $27.0 million.
   
The unaudited financial results for the three and nine months ended September 30, 2025, were filed with the SEC on Form 10-Q on November 12, 2025, and available at www.luciddx.com or www.sec.gov.

 

 
 

 

Lucid Non-GAAP Measures

 

To supplement our unaudited financial results presented in accordance with U.S. generally accepted accounting principles (GAAP), management provides certain non-GAAP financial measures of the Company’s financial results. These non-GAAP financial measures include net loss before interest, taxes, depreciation, and amortization (EBITDA), and non-GAAP adjusted loss, which further adjusts EBITDA for stock-based compensation expense and other non-cash income and expenses, if any. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted loss are not recognized terms under U.S. GAAP.
   
Non-GAAP financial measures are presented with the intent of providing greater transparency to the information used by us in our financial performance analysis and operational decision-making. We believe these non-GAAP financial measures provide meaningful information to assist investors, shareholders, and other readers of our unaudited financial statements in making comparisons to our historical financial results and analyzing the underlying performance of our results of operations. These non-GAAP financial measures are not intended to be, and should not be, a substitute for, considered superior to, considered separately from, or as an alternative to, the most directly comparable GAAP financial measures.
   
 Non-GAAP financial measures are provided to enhance readers’ overall understanding of our current financial results and to provide further information for comparative purposes. Management believes the non-GAAP financial measures provide useful information to management and investors by isolating certain expenses, gains, and losses that may not be indicative of our core operating results and business outlook. Specifically, the non-GAAP financial measures include non-GAAP adjusted loss, and its presentation is intended to help the reader understand the effect of the loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, the loss on debt extinguishment, and the corresponding accounting for non-cash charges on financial performance. In addition, management believes non-GAAP financial measures enhance the comparability of results against prior periods.
   
A reconciliation to the most directly comparable GAAP measure of all non-GAAP financial measures included in this press release for the three and nine months ended September 30, 2025, and 2024 are as follows:

 

 
 

 

Condensed consolidated statements of operations (unaudited)

 

(in thousands except per-share amounts)  For the three months ended
September 30,
   For the nine months ended
September 30,
 
   2025   2024   2025   2024 
                 
Revenue  $1,211   $1,172   $3,202   $3,149 
                     
Operating expenses   12,970    12,866    38,831    36,826 
Other (Income) expense   (1,362)   677    6,115    311 
Net Loss   (10,397)   (12,371)   (41,744)   (33,988)
Net income (loss) per common share, basic and diluted  $(0.10)  $(0.25)  $(0.59)  $(0.87)
Net loss attributable to common stockholders   (10,397)   (12,371)   (54,303)   (41,484)
Preferred Stock dividends and deemed dividends           12,559    7,496 
Net income (loss) as reported   (10,397)   (12,371)   (41,744)   (33,988)
Adjustments:                    
Depreciation and amortization expense1   220    215    663    945 
Interest expense, net2   (99)   (80)   (260)   (237)
EBITDA   (10,276)   (12,236)   (41,341)   (33,280)
                     
Other non-cash or financing related expenses:                    
Stock-based compensation expense3   1,152    1,228    3,326    3,363 
Operating expenses issued in stock1   87    135    234    248 
Change in FV convertible debt2   (2,341)   322    5,297    (568)
Debt extinguishments loss - Senior Secured Convertible Note2       435        1,116 
Equity issuance cost extinguishment  $1,078   $   $1,078   $ 
Non-GAAP adjusted (loss)  $(10,300)  $(10,116)  $(31,406)  $(29,121)
Basic and Diluted shares outstanding   108,176    50,374    92,131    47,876 
Non-GAAP adjusted (loss) income per share  $(0.10)  $(0.20)  $(0.34)  $(0.61)

 

1 Included in general and administrative expenses in the financial statements.

 

2 Included in other income and expenses.

 

3 Stock-based compensation (“SBC”) expense included in operating expenses is detailed as follows in the table below by category within operating expenses for the non-GAAP Net operating expenses:

 

 

 

 

Reconciliation of GAAP Operating Expenses to Non-GAAP Net Operating Expenses

 

(in thousands except per-share amounts)  For the three months ended
September 30,
   For the nine months ended
September 30,
 
   2025   2024   2025   2024 
Cost of revenues  $1,697   $1,684   $4,810   $4,954 
Stock-based compensation expense3   (43)   (41)   (152)   (121)
Net cost of revenues   1,654    1,643    4,658    4,833 
                     
Amortization of intangible assets   105    105    316    582 
                     
Sales and marketing   4,291    4,056    12,367    12,459 
Stock-based compensation expense3   (268)   (351)   (753)   (1,066)
Net sales and marketing   4,023    3,705    11,614    11,393 
                     
General and administrative   5,605    5,355    17,383    14,292 
Depreciation expense   (115)   (110)   (347)   (363)
Operating expenses issued in stock   (87)   (135)   (234)   (248)
Stock-based compensation expense3   (718)   (700)   (2,060)   (1,640)
Net general and administrative   4,685    4,410    14,742    12,041 
                     
Research and development   1,272    1,666    3,955    4,539 
Stock-based compensation expense3   (123)   (136)   (361)   (536)
Net research and development   1,149    1,530    3,594    4,003 
                     
Total operating expenses   12,970    12,866    38,831    36,826 
Depreciation and amortization expense   (220)   (215)   (663)   (945)
Operating expenses issued in stock   (87)   (135)   (234)   (248)
Stock-based compensation expense3   (1,152)   (1,228)   (3,326)   (3,363)
Net operating expenses  $11,511   $11,288   $34,608   $32,270 

 

About Lucid Diagnostics

 

Lucid Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. Lucid is focused on the millions of patients with GERD, also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer. Lucid’s EsoGuard® Esophageal DNA Test, performed on samples collected in a brief, noninvasive office procedure with its EsoCheck® Esophageal Cell Collection Device - the first and only commercially available tools designed with the goal of preventing esophageal cancer and cancer deaths through widespread, early detection of esophageal precancer in at-risk patients.

 

For more information, please visit luciddx.com and for more information about its parent company PAVmed, please visit pavmed.com.

 

 

 

 

Forward-Looking Statements

 

This press release includes forward-looking statements that involve risk and uncertainties. Forward-looking statements are any statements that are not historical facts. Such forward-looking statements, which are based upon the current beliefs and expectations of Lucid Diagnostics’ management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of Lucid Diagnostics’ common stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance Lucid Diagnostics’ products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from Lucid Diagnostics’ clinical and preclinical studies; whether and when Lucid Diagnostics’ products are cleared by regulatory authorities; market acceptance of Lucid Diagnostics’ products once cleared and commercialized; Lucid Diagnostics’ ability to raise additional funding as needed; and other competitive developments. These factors are difficult or impossible to predict accurately and many of them are beyond Lucid Diagnostics’ control. In addition, new risks and uncertainties may arise from time to time and are difficult to predict. For a further list and description of these and other important risks and uncertainties that may affect Lucid Diagnostics’ future operations, see Part I, Item 1A, “Risk Factors,” in Lucid Diagnostics’ most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Report on Form 10-Q filed by Lucid Diagnostics after its most recent Annual Report. Lucid Diagnostics disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.

 

Investor and Media Contact

 

Matt Riley
PAVmed and Lucid Diagnostics
[email protected]