UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2025
OR
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from _____ to _____
Commission
File Number: 001-40901
LUCID
DIAGNOSTICS INC.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
82-5488042
(State
or Other Jurisdiction of
(IRS
Employer
Incorporation
or Organization)
Identification
No.)
360
Madison Avenue
25th
Floor
New
York , NY
10017
(Address
of Principal Executive Offices)
(Zip
Code)
(917)
813-1828
(Registrant’s
Telephone Number, Including Area Code)
Securities
registered pursuant to Section 12(b) of the Exchange Act:
Title
of each Class
Trading
Symbol(s)
Name
of each Exchange on which Registered
Common
Stock, $0.001 par value per share
LUCD
The
NASDAQ Stock Market LLC
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically Interactive Data File required to be submitted pursuant to Rule 405
of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was
required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”
, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
Accelerated filer
☐
Accelerated
filed
☐
Non-accelerated
filer
☒
Smaller
reporting company
☒
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(c) of the Exchange Act ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of June 30, 2025 and August 8, 2025 there were 108,411,028
and 108,477,495 , respectively, shares of the
registrant’s Common Stock, par value $ 0.001
per share, issued and outstanding (with such number of shares inclusive of shares of common stock underlying unvested restricted
stock awards granted under the Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan as of such date).
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
$ 31,123
$ 22,358
Accounts receivable
373
45
Inventory
505
341
Prepaid expenses, deposits, and other current assets
1,832
2,404
Total current assets
33,833
25,148
Fixed assets, net
948
1,062
Operating lease right-of-use assets
2,238
2,637
Intangible assets, net
526
736
Other assets
1,125
1,132
Total assets
$ 38,670
$ 30,715
Liabilities, Preferred Stock and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable
$ 833
$ 1,241
Accrued expenses and other current liabilities
2,422
2,829
Operating lease liabilities, current portion
871
854
Senior Secured Convertible Notes - at fair value
25,300
18,600
Total current liabilities
29,426
23,524
Operating lease liabilities, less current portion
1,382
1,800
Total liabilities
30,808
25,324
Commitments and contingencies (Note 8)
-
-
Stockholders’ Equity (Deficit):
Preferred stock, $ 0.001 par value, 20,000,000 shares authorized; Series B and Series B-1 Convertible Preferred Stock, issued and outstanding 54,419 at June 30, 2025 and December 31, 2024
54,419
54,419
Common stock, $ 0.001 par value, 300,000,000 shares authorized as of June 30, 2025 and December 31, 2024, respectively; 101,826,788 and 63,071,950 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively
102
63
Additional paid-in capital
201,013
154,675
Accumulated deficit
( 247,672 )
( 203,766 )
Total Stockholders’ Equity (Deficit)
7,862
5,391
Total Liabilities and Stockholders’ Equity (Deficit)
$ 38,670
$ 30,715
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
$ 1,163
$ 976
$ 1,991
$ 1,977
Operating expenses:
Cost of revenue
1,563
1,614
3,114
3,269
Sales and marketing
4,007
4,210
8,076
8,404
General and administrative
5,617
4,867
11,779
8,937
Amortization of acquired intangible assets
105
105
210
477
Research and development
1,255
1,372
2,683
2,873
Total operating expenses
12,547
12,168
25,862
23,960
Operating loss
( 11,384 )
( 11,192 )
( 23,871 )
( 21,983 )
Other income (expense):
Interest income
110
107
176
175
Interest expense
( 6 )
( 6 )
( 14 )
( 18 )
Change in fair value - Senior Secured Convertible Note
6,841
599
( 7,638 )
890
Debt extinguishments loss - Senior Secured Convertible Note
—
( 513 )
—
( 681 )
Other income (expense), net
6,945
187
( 7,476 )
366
Loss before provision for income tax
( 4,439 )
( 11,005 )
( 31,347 )
( 21,617 )
Provision for income taxes
—
—
—
—
Net loss attributable to Lucid Diagnostics Inc.
$ ( 4,439 )
$ ( 11,005 )
$ ( 31,347 )
$ ( 21,617 )
Less: Deemed dividend on Series A and Series A-1 Convertible Preferred Stock
—
—
—
( 7,496 )
Less: Series B and Series B-1 Convertible Preferred Stock dividends earned
$ ( 3,449 )
$ —
( 12,559 )
—
Net loss attributable to Lucid Diagnostics Inc. common stockholders
$ ( 7,888 )
$ ( 11,005 )
$ ( 43,906 )
$ ( 29,113 )
Net loss per share attributable to Lucid Diagnostics Inc. common stockholders - basic and diluted
$ ( 0.08 )
$ ( 0.23 )
$ ( 0.52 )
$ ( 0.62 )
Weighted average common shares outstanding, basic and diluted
98,989,161
48,212,040
83,976,182
46,613,362
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
54,419
54,419
84,374,455
$ 84
$ 179,904
$ ( 239,784 )
$ ( 5,377 )
Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan
—
—
8,998
—
11
—
11
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan
—
—
—
—
1,142
—
1,142
Stock-based compensation - PAVmed Inc. 2014 Equity Plan
—
—
—
—
1
—
1
Issuance - At-The-Market Facility, net of deferred financing charges
—
—
215,421
—
274
—
274
Issuance - Interest payment paid in stock
—
—
48,954
1
75
—
76
Issuance - Confidentially Marketed Public Offering, net of fees
—
—
14,375,000
14
16,160
—
16,174
Issuance - Dividend on Series B and Series B-1 Preferred Stock
—
—
2,803,960
3
3,446
( 3,449 )
—
Net loss
—
—
—
—
—
( 4,439 )
( 4,439 )
Balance as of June 30, 2025
54,419
$ 54,419
101,826,788
$ 102
$ 201,013
$ ( 247,672 )
$ 7,862
Preferred Stock
Common Stock
Additional Paid-In
Accumulated
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Balance as of December 31, 2024
54,419
$ 54,419
63,071,950
$ 63
$ 154,675
$ ( 203,766 )
$ 5,391
Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan
—
—
10,891
—
13
—
13
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan
—
—
—
—
2,092
—
2,092
Stock-based compensation - PAVmed Inc. 2014 Equity Plan
—
—
—
—
82
—
82
Issuance - At-The-Market Facility, net of deferred financing charges
—
—
215,421
—
274
—
274
Purchase - Employee Stock Purchase Plan
—
—
203,051
—
141
—
141
Issuance - Interest payment paid in stock
—
—
89,722
1
106
—
107
Issuance - Registered Direct Offering, net of fees
—
—
13,939,330
14
14,921
—
14,935
Issuance - Confidentially Marketed Public Offering, net of fees
—
—
14,375,000
14
16,160
—
16,174
Issuance - Dividend on Series B and Series B-1 Preferred Stock
—
—
9,921,423
10
12,549
( 12,559 )
—
Net loss
—
—
—
—
—
( 31,347 )
( 31,347 )
Balance as of June 30, 2025
54,419
$ 54,419
101,826,788
$ 102
$ 201,013
$ ( 247,672 )
$ 7,862
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
44,285
44,285
46,747,062
$ 47
$ 136,411
$ ( 168,849 )
$ 11,894
Stock-based compensation - Lucid Diagnostics Inc.
—
—
—
—
1,106
—
1,106
Stock-based compensation - PAVmed Inc.
—
—
—
—
95
—
95
Conversions - Senior Secured Convertible Note
—
—
2,117,883
2
1,852
—
1,854
Issuance through sale - Series B-1 Preferred Stock
11,634
11,634,000
—
—
—
—
11,634
Issue common stock - vendor service agreement
—
—
480,000
—
401
—
401
Net loss
—
—
—
—
—
( 11,005 )
( 11,005 )
Balance as of June 30, 2024
55,919
$ 55,919
49,344,945
$ 49
$ 139,865
$ ( 179,854 )
$ 15,979
Preferred Stock
Common Stock
Additional Paid-In
Accumulated
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Balance as of December 31, 2023
18,625
$ 18,625
42,329,864
$ 42
$ 129,763
$ ( 150,741 )
$ ( 2,311 )
Balance
18,625
$ 18,625
42,329,864
$ 42
$ 129,763
$ ( 150,741 )
$ ( 2,311 )
Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan
—
—
3,333
—
4
—
4
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan
—
—
—
—
1,850
—
1,850
Stock-based compensation - Lucid Diagnostics Inc.
—
—
—
—
1,850
—
1,850
Stock-based compensation - PAVmed Inc. 2014 Equity Plan
—
—
—
—
285
—
285
Stock-based compensation - PAVmed Inc.
—
—
—
—
285
—
285
Vest - restricted stock awards
—
—
26,912
—
—
—
—
Conversions - Senior Secured Convertible Note
—
—
2,661,181
3
2,538
—
2,541
Issuance - At-The-Market Facility, net of financing charges
—
—
—
—
—
—
—
Purchase - Employee Stock Purchase Plan
—
—
511,884
1
352
—
353
Issuance - Series A-1 Preferred Stock
5,670
5,670
—
—
—
—
5,670
Exchange - Series A and Series A-1 Preferred Stock
( 24,295 )
( 24,295 )
—
—
—
( 7,496 )
( 31,791 )
Issuance through exchange - Series B Preferred Stock
31,790
31,790
—
—
—
—
31,790
Issuance through sale- Series B and Series B-1 Preferred Stock
24,129
24,129
—
—
—
—
24,129
Issuance - Due To: PAVmed Inc. Settlement in Common Stock
—
—
3,331,771
3
4,672
—
4,675
Issue common stock - vendor service agreement
—
—
480,000
—
401
—
401
Net loss
—
—
—
—
—
( 21,617 )
( 21,617 )
Balance as of June 30, 2024
55,919
$ 55,919
49,344,945
$ 49
$ 139,865
$ ( 179,854 )
$ 15,979
Balance
55,919
$ 55,919
49,344,945
$ 49
$ 139,865
$ ( 179,854 )
$ 15,979
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
$ ( 31,347 )
$ ( 21,617 )
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation and amortization expense
443
730
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan
2,092
1,850
Stock-based compensation - PAVmed Inc. 2014 Equity Plan
82
285
Change in fair value - Senior Secured Convertible Note
7,638
( 890 )
Debt extinguishment loss - Senior Secured Convertible Note
—
681
Amortization of common stock payment for vendor service agreement
147
113
Changes in operating assets and liabilities:
Accounts receivable
( 328 )
( 115 )
Prepaid expenses and other current assets
( 942 )
625
Accounts payable
( 408 )
( 243 )
Accrued expenses and other current liabilities
( 407 )
( 1,114 )
Due To: PAVmed Inc. - operating expenses, employee related costs, MSA Fee
16
( 4,399 )
Net cash flows used in operating activities
( 23,014 )
( 24,094 )
Cash flows from investing activities
Purchase of equipment
( 118 )
( 37 )
Net cash flows used in investing activities
( 118 )
( 37 )
Cash flows from financing activities
Proceeds – issue of preferred stock
—
29,798
Proceeds – issue of common stock - Registered Direct Offering, net of fees
14,935
—
Proceeds – issue of common stock - Confidentially Marketed Public Offering, net of fees
16,174
—
Proceeds – issue of Senior Secured Convertible Notes
360
—
Proceeds – issue of common stock – At-The-Market Facility
274
—
Proceeds – exercise of stock options
13
4
Proceeds – issue common stock – Employee Stock Purchase Plan
141
353
Net cash flows provided by financing activities
31,897
30,155
Net increase in cash
8,765
6,024
Cash, beginning of period
22,358
18,896
Cash, end of period
$ 31,123
$ 24,920
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 $ 1.2 million and $ 2.0 million of revenue for the three and six months ended June 30,
2025, respectively, however the Company expects to continue to experience recurring losses and to generate negative cash flows from operating
activities in the near future.
The
Company incurred a net loss attributable to its common stockholders of approximately $ 43.9
million and had net cash flows used in operating activities
of approximately $ 23.0
million for the six months ended June 30, 2025. As of
June 30, 2025, the Company had working capital of approximately $ 4.4
million, with such working capital inclusive of the 2024 Convertible
Notes (as defined below) classified as a current liability of approximately $ 25.3
million and approximately $ 31.1
million of cash.
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 $ 1,163 and $ 1,991 , respectively, resulting from
the delivery of patient EsoGuard test results. Revenue recognized from customer contracts deemed to include a variable consideration
transaction price is limited to the unconstrained portion of the variable consideration. The Company’s revenue for the three and
six months ended June 30, 2024 was $ 976 and $ 1,977 , respectively, resulting from the delivery of patient EsoGuard test results.
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 $ 1,563 and $ 3,114 , respectively, primarily related to costs
for our laboratory operations and EsoCheck device supplies. The Company’s cost of revenue for the three and six months ended June 30,
2024 was $ 1,614 and $ 3,269 , respectively, primarily related to costs for our laboratory operations and EsoCheck device supplies.
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
6,300
—
—
6,300
ERC - Benefits
—
771
—
771
On Behalf Of (OBO) activities
—
—
288
288
Cash payments to PAVmed Inc.
( 6,300 )
( 771 )
( 288 )
( 7,359 )
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
165
127
$ 329
$ 253
General & Administrative
2,252
1,803
4,505
3,607
Research & Development
733
570
1,466
1,140
Total MSA Fee
$ 3,150
$ 2,500
$ 6,300
$ 5,000
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
$ 476
$ 581
Prepaid insurance
220
443
Deposits
1,136
1,020
Subscribed amounts due from investors
—
360
Total prepaid expenses, deposits and other current assets
$ 1,832
$ 2,404
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)
$ 512
2026
998
2027
942
2028
19
2029
—
Total lease payments
$ 2,471
Less: imputed interest
( 218 )
Present value of lease liabilities
$ 2,253
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
$ 529
$ 598
Non-cash investing and financing activities
Right-of-use assets obtained in exchange for new operating lease liabilities
$ 34
$ 2,285
Weighted-average remaining lease term - operating leases (in years)
2.47
3.33
Weighted-average discount rate - operating leases
7.925 %
7.875 %
As
of June 30, 2025 and December 31, 2024, the Company’s right-of-use assets from operating leases were $ 2,238 and $ 2,637 , respectively,
which are reported in operating lease right-of-use assets in the unaudited condensed consolidated balance sheets. As of June 30,
2025 and December 31, 2024, the Company had outstanding operating lease obligations of $ 2,253 and $ 2,654 , respectively, of which $ 871
and $ 854 , respectively, are reported in operating lease liabilities, current portion and $ 1,382 and $ 1,800 , respectively, are reported
in operating lease liabilities less current portion in the Company’s unaudited condensed consolidated balance sheets. The Company
calculates its incremental borrowing rates for specific lease terms, as a function of the financing
terms the Company would likely receive on the open market.
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 Using 1
Level-1
Inputs
Level-2
Inputs
Level-3 Inputs
Total
June 30, 2025
2024 Convertible Notes 1
$ —
$ —
$ 25,300
$ 25,300
Totals 1
$ —
$ —
$ 25,300
$ 25,300
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
$ —
$ —
$ 18,600
$ 18,600
Totals 1
$ —
$ —
$ 18,600
$ 18,600
Fair value of liability 1
$ —
$ —
$ 18,600
$ 18,600
1 There were no transfers
between the respective Levels during the six months ended June 30, 2025.
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 $ 21.975 million
face value principal (“2024 Convertible Notes”). The convertible notes are accounted for under the fair value option (“FVO”)
election, wherein, the financial instruments are initially measured at their issue date estimated fair value and subsequently remeasured
at estimated fair value on a recurring basis at each reporting period date.
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
$ 25,300
$ 18,600
Face value principal payable
$ 21,975
$ 21,975
Required rate of return
29.50 %
29.00 %
Conversion Price
$ 1.00
$ 1.00
Value of common stock
$ 1.15
$ 0.819
Expected term (years)
4.40
4.90
Volatility
40.00 %
40.00 %
Risk free rate
3.69 %
4.28 %
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
November 22, 2029
12.000 %
$ 1.00
$ 21,975
$ 25,300
Balance as of June 30, 2025
$ 21,975
$ 25,300
Contractual Maturity Date
Stated Interest Rate
Conversion Price per Share
Face Value Principal Outstanding
Fair Value
2024 Convertible Notes
November 22, 2029
12.000 %
$ 1.00
$ 21,975
$ 18,600
Balance as of December 31, 2024
$ 21,975
$ 18,600
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
$ 32,800
$ —
Non-installment payments – common stock
( 75 )
—
Non-installment payments – cash
( 584 )
—
Change in fair value
( 6,841 )
6,841
Fair Value at June 30, 2025
$ 25,300
-
Other Income (Expense) - Change in fair value – three months ended June 30, 2025
$ 6,841
2024 Convertible Notes
Other Income (expense)
Fair Value - December 31, 2024
$ 18,600
$ —
Non-installment payments – common stock
( 107 )
—
Non-installment payments – cash
( 831 )
—
Change in fair value
7,638
( 7,638 )
Fair Value at June 30, 2025
$ 25,300
-
Other Income (Expense) - Change in fair value – six months ended June 30, 2025
$ ( 7,638 )
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
$ 13,140
$ —
Installment repayments – common stock
( 1,125 )
—
Non-installment payments – common stock
( 216 )
—
Change in fair value
( 599 )
599
Fair Value at June 30, 2024
$ 11,200
-
Other Income (Expense) - Change in fair value – three months ended June 30, 2024
$ 599
March 2023 Senior Convertible Note
Other Income (expense)
Fair Value - December 31, 2023
$ 13,950
$ —
Fair Value - Beginning Balance
$ 13,950
$ —
Installment repayments – common stock
( 1,208 )
—
Non-installment payments – common stock
( 652 )
—
Change in fair value
( 890 )
890
Fair Value at June 30, 2024
$ 11,200
-
Fair Value - Ending Balance
$ 11,200
-
Other Income (Expense) - Change in fair value – six months ended June 30, 2024
$ 890
14
Note
10 — Debt - continued
2024 Senior Convertible Note
On
November 22, 2024, the Company closed on the sale of $ 21.975 million in principal amount of Senior Secured Convertible Notes (collectively,
the “2024 Convertible Notes”), in a private placement, to certain accredited investors (the “2024 Note Investors”).
The sale of the 2024 Convertible Notes was completed pursuant to the terms of that certain Securities Purchase Agreement, dated as of
November 12, 2024 (the “2024 SPA”), between the Company and the 2024 Note Investors. The Company realized gross proceeds
of $ 21.975 million and, after giving effect to the repayment in full of the March 2023 Senior Convertible Note, net proceeds of $ 18.3
million from the sale of the 2024 Convertible Notes. As of December 31, 2024 there was an approximately $ 0.4 million subscription receivable
in respect of the 2024 Convertibles Notes, which was reflected in prepaid expenses, deposits, and other current assets on the Company’s
consolidated balance sheets as of such date. As of June 30, 2025, the Company had received the entire $ 0.4 million receivable.
Each
2024 Convertible Note has a 12.0 %
annual stated interest rate, a contractual maturity date of five
years from the date of issuance, and a contractual conversion price of $ 1.00
per share of the Company’s common stock (subject to (i) in the event of certain issuances of additional securities by the
Company at a price per share less than the then applicable conversion price, adjustment to such lower price per share, and (ii)
customary proportionate adjustment upon any stock split, stock dividend, stock combination, recapitalization or other similar
transaction). The Company held a stockholder meeting on June 18, 2025 at which the stockholders approved the issuance of the shares
issuable upon conversion of the Notes in excess of any primary market limitations.
Under
the 2024 Convertible Notes, the Company is subject to certain customary affirmative and negative covenants regarding the incurrence of
indebtedness, the existence of liens, the repayment of indebtedness and the making of investments, the payment of cash in respect of
dividends, distributions or redemptions, the transfer of assets, the maturity of other indebtedness, transactions with affiliates, and
the consummation of fundamental transactions where the aggregate consideration payable in respect thereof, as determined on a per share
of the Company’s common stock basis, has a fair market value that is less than $1.50, among other customary matters. Under the
2024 Convertible Notes, the Company is subject to a financial covenant requiring that the amount of its available cash equal or exceed
$5.0 million at all times that at least 25% of the principal amount of 2024 Convertible Notes issued are outstanding . The Company was
in compliance with all covenants as of June 30, 2025.
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 18,342,201 shares of common stock of Lucid Diagnostics are reserved for issuance under the Lucid Diagnostics 2018 Equity Plan,
with 1,001,663 shares available for grant as of June 30, 2025. The share reservation is not diminished by a total of 523,300 stock
options and 50,000 restricted stock awards granted outside the Lucid Diagnostics 2018 Equity Plan, as of June 30, 2025. In January
2025, the number of shares available for grant was increased by 4,018,163 in accordance with the evergreen provisions of the plan.
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
8,646,758
$ 1.68
8.1
$ 199
Granted (1)
1,471,000
$ 1.46
Exercised
( 10,891 )
$ 1.23
Forfeited
( 274,837 )
$ 1.48
Outstanding stock options at June 30, 2025 (3)
9,832,030
$ 1.66
7.8
$ 446
Vested and exercisable stock options at June 30, 2025
6,019,811
$ 1.87
7.2
$ 373
(1) Stock
options granted under the Lucid Diagnostics 2018 Equity Plan and those granted outside such
plan generally vest one-third in one year then ratably over the next eight quarters, and
have a ten-year contractual term from date-of-grant.
(2) The
intrinsic value is computed as the difference between the quoted price of the Lucid Diagnostics
common stock on each of June 30, 2025 and December 31, 2024 and the exercise price of
the underlying Lucid Diagnostics stock options, to the extent such quoted price is greater
than the exercise price.
(3) The
outstanding stock options presented in the table above are inclusive of 523,300 stock options
granted outside the Lucid Diagnostics 2018 Equity Plan, as of June 30, 2025 and December
31, 2024.
On
February 20, 2025, the Compan y granted 1,321,000 stock
options to employees under the Lucid Diagnostics Inc 2018 Equity Plan with a weighted average
exercise price of $ 1.49 . Each option will vest one-third on December 31, 2025 and then ratably over the next eight quarters.
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
3,897,440
$ 5.77
Granted
2,686,800
1.49
Vested
—
—
Forfeited
—
—
Unvested restricted stock awards as of June 30, 2025
6,584,240
$ 4.02
On
February 20, 2025, a total of 2,686,800 restricted stock awards were granted to employees, management and directors under the Lucid Diagnostics
2018 Equity Plan, with such restricted stock awards having an aggregate fair value of approximately $ 4.0 million, which was measured
using the grant date quoted closing price per share of Lucid Diagnostics Inc. common stock, with the fair value recognized as stock-based
compensation expense ratably on a straight-line basis over the vesting period, which is commensurate with the service period. The vesting
of the restricted stock awards vest on a single vest date of May 20, 2028. The restricted stock awards are subject to forfeiture if the
requisite service period is not completed.
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
$ 38
$ 33
$ 71
$ 58
Lucid Diagnostics 2018 Equity Plan – sales and marketing
245
326
466
597
Lucid Diagnostics 2018 Equity Plan - general and administrative
740
609
1,341
937
Lucid Diagnostics 2018 Equity Plan - research and development
119
138
214
258
PAVmed 2014 Equity Plan - cost of revenue
—
11
38
22
PAVmed 2014 Equity Plan - sales and marketing
—
39
19
118
PAVmed 2014 Equity Plan - general and administrative
1
1
1
4
PAVmed 2014 Equity Plan - research and development
—
44
24
141
Total stock-based compensation expense
$ 1,143
$ 1,201
$ 2,174
$ 2,135
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
$ 3,089
1.8
Restricted Stock Awards
$ 4,603
2.1
PAVmed 2014 Equity Plan
Stock Options
$ 4
1.5
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 $ 0.93 per share and $ 0.80 per share during the six months ended June 30, 2025
and 2024, respectively, calculated using the following weighted average Black-Scholes valuation model assumptions:
Schedule
of Stock-based Compensation Valuation Assumptions
2025
2024
Six Months Ended June 30,
2025
2024
Expected term of stock options (in years)
5.8
5.7
Expected stock price volatility
68 %
74 %
Risk free interest rate
4.4 %
4.4 %
Expected dividend yield
— %
— %
Lucid
Diagnostics Inc Employee Stock Purchase Plan (“Lucid ESPP”)
A
total of 203,051 shares and 511,884 shares of common stock of Lucid Diagnostics were purchased for proceeds of approximately $ 141 and
$ 353 on March 31, 2025 and 2024, respectively, under the Lucid ESPP. The Lucid ESPP has a total reservation of 2,500,000 shares of common
stock of which 1,056,779 shares are available for issue as of June 30, 2025.
Note
12 — Stockholders’ Equity
Series
B Preferred Stock Offering and Exchange
As of June 30, 2025 and December
31, 2024, there were 44,285 shares of Series B Convertible Preferred Stock, classified in permanent equity, issued and outstanding.
18
Note
12 — Stockholders’ Equity - continued
Each
holder of Series B Preferred Stock (i) was entitled to receive, and did receive, a dividend on or about March 13, 2025 equal to 20% of
the number of shares of Common Stock issuable upon conversion of the Series B Preferred Stock then held by such holder on March 13, 2025,
and (ii) will be entitled to receive a dividend on or about March 13, 2026 equal to a number of shares of Common Stock equal to 20% of
the number of shares of Common Stock issuable upon conversion of the Series B Preferred Stock then held by such holder on March 13, 2026.
A holder that voluntarily converts its Series B Preferred Stock prior to March 13, 2026 will not receive the dividend that accrues on
such date with respect to such converted Series B Preferred Stock. The holders of the Series B Preferred Stock also will be entitled
to dividends equal, on an as-if-converted to shares of Common Stock basis, to and in the same form as dividends actually paid on shares
of the Common Stock when, as, and if such dividends are paid on shares of the Common Stock . The Company issued in the aggregate 7,117,463
common shares, with such shares having a fair value of approximately $ 9.1 million at the time of issuance, in satisfaction of the March
13, 2025 Series B Preferred Stock dividend.
Series
B-1 Preferred Stock Offering
As of June 30, 2025 and December
31, 2024, there were 10,134 shares of Series B-1 Convertible Preferred Stock, classified in permanent equity, issued and outstanding.
Each
holder of Series B-1 Preferred Stock (i) was entitled to receive, and did receive, a dividend on or about May 6, 2025 equal to 20%
of the number of shares of Common Stock issuable upon conversion of the Series B-1 Preferred Stock then held by such holder on May
6, 2025, and (ii) will be entitled to receive a dividend on or about May 6, 2026 equal to a number of shares of Common Stock equal
to 20% of the number of shares of Common Stock issuable upon conversion of the Series B-1 Preferred Stock then held by such holder
on May 6, 2026. A holder that voluntarily converts its Series B-1 Preferred Stock prior to May 6, 2026 will not receive the dividend
that accrues on such date with respect to such converted Series B-1 Preferred Stock. The holders of the Series B-1 Preferred Stock
also will be entitled to dividends equal, on an as-if-converted to shares of Common Stock basis, to and in the same form as
dividends actually paid on shares of the Common Stock when, as, and if such dividends are paid on shares of the Common
Stock . The Company issued in the aggregate 2,803,960 common
shares, with such shares having a fair value of approximately $ 3.5
million at the time of issuance, in satisfaction of the May 6, 2025 Series B-1 Preferred Stock dividend.
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 13,939,330 shares of its common stock at a price of $ 1.10 per share in a registered
direct offering. The net proceeds of the offering, after deducting approximately $ 0.4 million of placement agent’s fees and other
expenses, was approximately $ 14.9 million.
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 in a confidentially marketed public offering. The net proceeds of the offering, after deducting approximately $ 1.1 million
of the placement agent’s fees and other expenses, was approximately $ 16.2
million.
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 $ 50 million of the Company’s common stock from time to time at the request
of the Company. While there are distinct differences, the facility is structured similarly to a traditional at-the-market equity facility,
insofar as it allows the Company to raise primary equity capital on a periodic basis at prices based on the existing market price. Cumulatively
a total of 680,263 shares of Lucid Diagnostics’ common stock were issued for net proceeds of approximately $ 1.8 million, after a
4 % discount, as of June 30, 2025. This facility terminated on August 1, 2025, which is the first of the month following the 36-month
anniversary of the effective date of the registration statement for the same. Upon termination any remaining deferred financing fees were
expensed.
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 their at-the-market equity facility for net
proceeds of approximately $ 0.3 million,
after payment of 3 %
commissions.
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
$ ( 4,439 )
$ ( 11,005 )
$ ( 31,347 )
$ ( 21,617 )
Deemed dividend on Series A and Series A-1 Convertible Preferred Stock
—
—
—
( 7,496 )
Series B and Series B-1 Convertible Preferred Stock dividends earned
( 3,449 )
—
( 12,559 )
—
Net loss attributable to Lucid Diagnostics Inc. common stockholders
$ ( 7,888 )
$ ( 11,005 )
$ ( 43,906 )
$ ( 29,113 )
Denominator
Weighted average common shares outstanding, basic and diluted
98,989,161
48,212,040
83,976,182
46,613,362
Net loss per share (1)
Net loss per share - basic and diluted
$ ( 0.08 )
$ ( 0.23 )
$ ( 0.52 )
$ ( 0.62 )
(1) - Convertible Preferred
Stock would potentially be considered a participating security under the two-class method of calculating net loss per share. However,
the Company has incurred net losses to-date, and as such holders are not contractually obligated to share in the losses, there is no
impact on the Company’s net loss per share calculation for the periods indicated.
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
9,832,030
8,744,626
Unvested restricted stock awards
6,584,240
3,897,440
Preferred stock
49,607,115
51,682,378
Total
66,023,385
64,324,444
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 one reportable segment. Further, the CODM reviews and utilizes functional expenses (cost of revenues, sales and marketing,
research and development, and general and administrative) at the consolidated level to manage the Company’s operations. The Company’s
significant segment expenses and other segment items align with the financial statements line items presented in its the unaudited condensed
consolidated statements of operations.
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.
23
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.
24
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.
25
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.
26
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.
27
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
28
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.
29
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.
30
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) adopted or
terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement” (as those terms are defined
in Item 408 of Regulation S-K).
Item
6. Exhibits
The
exhibits filed as part of this Quarterly Report on Form 10-Q are set forth in the “ Exhibit Index ” below.
31
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)
32
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.
33
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.