Item 9A. Controls and Procedures
Item 9A. 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 December 31, 2024. 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.
Management’s Report on Internal Control
Over Financial Reporting
Our management is responsible
for establishing and maintaining an adequate system of internal control over financial reporting, as such term is defined in Exchange
Act Rules 13(a)-15(f). Our system of internal control over financial reporting is designed to provide reasonable assurance regarding
the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting
principles generally accepted in the U.S.
Our internal control over financial
reporting includes those policies and procedures that:
● pertain to the maintenance of records,
in reasonable detail, accurately and fairly reflect our transactions and dispositions of
our assets;
● provide reasonable assurance our
transactions are recorded as necessary to permit preparation of our financial statements
in accordance with accounting principles generally accepted in the U.S., and our receipts
and expenditures are being made only in accordance with authorizations of our management
and our directors; and
● provide reasonable assurance regarding
prevention or timely detection of unauthorized acquisition, use, or disposition of our assets
could have a material effect on the financial statements.
Due to its inherent limitations,
a system of internal control over financial reporting can provide only reasonable assurance and may not prevent or detect all misstatements.
Further, because of changes in conditions, effectiveness of internal controls over financial reporting may vary over time. Our system
contains self-monitoring mechanisms, so actions will be taken to correct deficiencies as they are identified.
Our management conducted an evaluation
of the effectiveness of the system of internal control over financial reporting based on the framework in Internal Control-Integrated
Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this evaluation, our management
concluded our system of internal control over financial reporting was effective as of December 31, 2024.
This Form 10-K does not include
an attestation report of our independent registered public accounting firm regarding internal control over financial reporting. Management’s
report was not subject to attestation by our registered public accounting firm pursuant to the rules of the SEC to permit us to provide
only management’s report in this Form 10-K.
Changes to Internal Controls Over Financial Reporting
There has been no change in our
internal controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during
the quarter ended December 31, 2024 that has materially affected, or is reasonably likely to materially affect, our internal controls
over financial reporting.
Item 9B. Other Information
During the fiscal quarter ended
December 31, 2024, 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 9C. Disclosure Regarding Foreign Jurisdictions
that Prevent Inspections
Not applicable.
62
PART III
Item 10. Directors, Executive Officers and
Corporate Governance
The information required by this
Item 10 is incorporated by reference to our Proxy Statement for the 2025 Annual Meeting of Stockholders to be filed with the Securities
and Exchange Commission within 120 days of the fiscal year ended December 31, 2024.
Item 11. Executive Compensation
The information required by this
Item 11 is incorporated by reference to our Proxy Statement for the 2025 Annual Meeting of Stockholders to be filed with the Securities
and Exchange Commission within 120 days of the fiscal year ended December 31, 2024.
Item 12. Security Ownership of Certain Beneficial
Owners and Management and Related Stockholder Matters
The information required by this
Item 12 is incorporated by reference to our Proxy Statement for the 2025 Annual Meeting of Stockholders to be filed with the Securities
and Exchange Commission within 120 days of the fiscal year ended December 31, 2024.
Item 13. Certain Relationships and Related
Transactions, and Director Independence
The information required by this
Item 13 is incorporated by reference to our Proxy Statement for the 2025 Annual Meeting of Stockholders to be filed with the Securities
and Exchange Commission within 120 days of the fiscal year ended December 31, 2024.
Item 14. Principal Accounting Fees and Services
The information required by this
Item 14 is incorporated by reference to our Proxy Statement for the 2025 Annual Meeting of Stockholders to be filed with the Securities
and Exchange Commission within 120 days of the fiscal year ended December 31, 2024.
63
PART IV
Item 15. Exhibits and Financial Statement Schedules
(a)
The following documents filed as a part of the report:
(1)
The following financial statements:
Report of Independent Registered Public Accounting
Firm (PCAOB ID #688)
Consolidated Balance Sheets
Consolidated Statements of Operations
Consolidated Statements of Changes in Stockholders’
Equity (Deficit)
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
(2)
The financial statement schedules:
Schedules other than those listed above are omitted for the reason
they are not required or are not applicable, or the required information is shown in the financial statements or notes thereto. Columns
omitted from schedules filed have been omitted because the information is not applicable.
(3)
The following exhibits:
Incorporation by Reference
Exhibit No.
Description
Form
Exhibit No.
Date
2.1‡
Asset Purchase Agreement, dated as of February 25, 2022, by and among LucidDx Labs Inc., Lucid Diagnostics Inc. and ResearchDx, Inc.
8-K
2.1
3/3/2022
3.1.1
Amended and Restated Certificate of Incorporation
S-1/A
3.1
10/7/2021
3.1.2
Amendment to Amended and Restated Certificate of Incorporation
8-K
3.1
6/21/2023
3.1.3
Form of Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock
8-K
3.1
3/14/2024
3.1.4
Form of Certificate of Designation of Preferences, Rights and Limitations of Series B-1 Convertible Preferred Stock
8-K
3.1
5/7/2024
3.2
Amended and Restated Bylaws
S-1/A
3.2
10/7/2021
4.1
Description of Registrant’s Securities
*
4.2
Common Stock Certificate
S-1/A
4.1
10/7/2021
4.3
Form of 2024 Convertible Note
8-K
4.1
11/29/2024
10.1#
Lucid Diagnostics Inc. Amended and Restated 2018 Long-Term Incentive Equity Plan.
S-8
2/10/2023
10.2.1†
Amended and Restated License Agreement, dated as of August 23, 2021, by and between Case Western Reserve University and Lucid Diagnostics Inc.
S-1/A
10.2
10/1/2021
10.2.2†
First Amendment to Amended and Restated License Agreement, dated as of February 15, 2024, by and between Case Western Reserve University and Lucid Diagnostics Inc.
*
10.2.3
Second Amendment to Amended and Restated License Agreement, dated as of November 7, 2024, by and between Case Western Reserve University and Lucid Diagnostics Inc.
*
10.3
License Agreement, dated as of May 20, 2019, by and between PAVmed Inc. and Lucid Diagnostics Inc.
S-1/A
10.3
10/1/2021
10.4.1
Management Services Agreement, dated as of May 12, 2018, by and between PAVmed Inc. and Lucid Diagnostics Inc.
S-1/A
10.4.1
10/7/2021
10.4.2
Amendment to Management Services Agreement, dated as of March 1, 2019, by and between PAVmed Inc. and Lucid Diagnostics Inc.
S-1/A
10.4.2
10/7/2021
10.4.3
Second Amendment to Management Services Agreement, dated as of June 5, 2019, by and between PAVmed Inc. and Lucid Diagnostics Inc.
S-1/A
10.4.3
10/7/2021
10.4.4
Third Amendment to Management Services Agreement, dated as of July 20, 2020, by and between PAVmed Inc. and Lucid Diagnostics Inc.
S-1/A
10.4.4
10/7/2021
10.4.5
Fourth Amendment to Management Services Agreement, dated as of February 1, 2021, by and between PAVmed Inc. and Lucid Diagnostics Inc.
S-1/A
10.4.5
10/7/2021
10.4.6
Fifth Amendment to Management Services Agreement, dated as of November 10, 2021, by and between PAVmed Inc. and Lucid Diagnostics Inc.
10-K
10.4.6
3/14/2023
10.4.7
Sixth Amendment to Management Services Agreement, dated as of August 11, 2022, by and between PAVmed Inc. and Lucid Diagnostics Inc.
8-K
10.1
12/2/2022
10.4.8
Seventh Amendment to Management Services Agreement, dated as of May 9, 2023, by and between PAVmed Inc. and Lucid Diagnostics Inc.
10-Q
10.7
5/15/2023
10.4.9
Eighth Amendment to Management Services Agreement, dated as of March 22, 2024, by and between PAVmed Inc. and Lucid Diagnostics Inc.
10-K
10.4.9
3/25/2024
10.4.10
Ninth Amendment to Management Services Agreement, dated as of August 6, 2024, by and between PAVmed Inc. and Lucid Diagnostics Inc.
10-Q
10.2
8/12/2024
10.5
Payroll and Benefit Expense Reimbursement Agreement, dated as of November 30, 2022, by and between PAVmed Inc. and Lucid Diagnostics Inc.
8-K
10.2
12/2/2022
64
Incorporation by Reference
Exhibit No.
Description
Form
Exhibit No.
Date
10.6#
Form of Stock Option Agreement.
10-K
10.9
3/14/2023
10.7#
Form of Indemnification Agreement.
S-1/A
10.9
10/8/2021
10.8
Quality & Manufacturing Master Services Agreement, dated as of September 1, 2021, by and between Coastline International, Inc. and Lucid Diagnostics Inc.
S-1/A
10.11
10/1/2021
10.9#
Form of Restricted Stock Agreement.
S-1/A
10.12#
10/8/2021
10.10#
Employment Agreement with Lishan Aklog, M.D.
8-K
10.1
1/20/2022
10.11#
Employment Agreement with Dennis M. McGrath
8-K
10.2
1/20/2022
10.12.1#
Employment Agreement with Shaun O’Neil
8-K
10.1
3/23/2022
10.12.2#
Amendment to Employment Agreement with Shaun O’Neil
10-K
10.12.2
3/25/2024
10.13#
Employment Agreement with Michael Gordon
10-K
10.16
3/14/2023
10.14.1‡
Common Stock Purchase Agreement, dated as of March 28, 2022, by and between CF Principal Investments LLC and Lucid Diagnostics Inc.
8-K
10.1
4/1/2022
10.14.2‡
Registration Rights Agreement, dated as of March 28, 2022, by and between CF Principal Investments LLC and Lucid Diagnostics Inc.
8-K
10.2
4/1/2022
10.15
Controlled Equity Offering SM , dated as of November 23, 2022, by and between Cantor Fitzgerald & Co. and Lucid Diagnostics Inc.
S-3
1.2
11/23/2022
10.16.1‡
Form of Securities Purchase Agreement (2024 Convertible Notes)
8-K
10.1
11/29/2024
10.16.2
Form of Registration Rights Agreement (2024 Convertible Notes)
8-K
10.2
11/29/2024
10.16.3
Form of Guaranty (2024 Convertible Notes)
8-K
10.3
11/29/2024
10.16.4‡
Form of Security Agreement (2024 Convertible Notes)
8-K
10.4
11/29/2024
10.17.1
Exchange Agreement, dated as of March 13, 2024, by and between Lucid Diagnostics Inc. and the purchasers of Series B Preferred Stock party thereto
8-K
10.1
3/14/2024
10.17.2
Registration Rights Agreement, dated as of March 13, 2024, by and between Lucid Diagnostics Inc. and the purchasers of Series B Preferred Stock party thereto
8-K
10.2
3/14/2024
10.18
Registration Rights Agreement, dated as of May 6, 2024, by and between Lucid Diagnostics Inc. and the purchasers of Series B-1 Preferred Stock party thereto
8-K
10.2
5/6/2024
10.19#
Lucid Diagnostics Inc. Employee Stock Purchase Plan
S-8
10.1
3/15/2022
14.1
Code of Ethics
10-K
14.1
3/14/2023
19.1
Insider Trading Policy
*
21.1
List of Subsidiaries
*
23.1
Consent of Marcum LLP
*
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.
*
97.1
Form of Compensation Clawback Policy
10-K
97.1
3/25/2024
101
Inline XBRL Document Set for the consolidated financial statements and accompanying notes in Part
II, Item 8, “Financial Statements and Supplementary Data” of this Annual Report on Form 10-K.
*
104
Inline XBRL for the cover page of this Annual Report on Form 10-K, included in the Exhibit 101
Inline XBRL Document Set.
*
* Filed herewith.
# Indicates management contract or compensatory plan.
† Certain confidential portions of this exhibit
were omitted by means of marking such portions with asterisks because the identified confidential portions (i) are not material and (ii)
would be competitively harmful if publicly disclosed.
‡ Certain exhibits and schedules have been
omitted pursuant to Item 601(b)(10) of Regulation S-K. The registrant hereby undertakes to furnish a copy of any omitted exhibit or schedule
upon request by the Securities and Exchange Commission.
Item 16. Form 10-K Summary
None
65
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
Lucid Diagnostics Inc.
March 24, 2025
By:
/s/ Dennis M. McGrath
Dennis M. McGrath
Chief Financial Officer
(Principal Financial and Accounting Officer)
Pursuant to the requirements
of the Securities Exchange Act of 1934, as amended, the report has been signed by the following persons on behalf of the Registrant and
in the capacities and on the dates indicated. Each person whose signature appears below hereby authorizes both Lishan Aklog, M.D. and
Dennis M. McGrath or either of them acting in the absence of the others, as his or her true and lawful attorney-in-fact and agent, with
full power of substitution and re-substitution for him or her and in his or her name, place and stead, in any and all capacities to sign
any and all amendments to this report, and to file the same, with all exhibits thereto and other documents in connection therewith, with
the United States Securities and Exchange Commission.
Signature
Title
Date
/s/ Lishan Aklog, M.D.
Chairman of the Board of Directors
March 24, 2025
Lishan Aklog, M.D.
Chief Executive Officer
(Principal Executive Officer)
/s/ Dennis M. McGrath
Chief Financial Officer
March 24, 2025
Dennis M. McGrath
(Principal Financial and Accounting Officer)
/s/ Stanley N. Lapidus
Vice Chairman
March 24, 2025
Stanley N. Lapidus
Director
/s/ Debra J. White
Director
March 24, 2025
Debra J. White
/s/ James L. Cox, M.D.
Director
March 24, 2025
James L. Cox, M.D.
/s/ Jacque J. Sokolov, M.D.
Director
March 24, 2025
Jacque J. Sokolov, M.D.
/s/ Ronald M. Sparks
Director
March 24, 2025
Ronald M. Sparks
/s/ Dennis A. Matheis
Director
March 24, 2025
Dennis A. Matheis
66
LUCID DIAGNOSTICS INC.
and SUBSIDIARIES
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Financial Statements
Page
Report of Independent Registered
Public Accounting Firm (PCAOB ID # 688 )
F-2
Consolidated Balance Sheets
as of December 31, 202 4 and
202 3
F-3
Consolidated Statements
of Operations for the years ended December 31, 202 4
and 202 3
F-4
Consolidated Statements
of Changes in Stockholders’ Equity (Deficit) for the years ended December 31, 202 4
and 202 3
F-5
Consolidated Statements
of Cash Flows for the years ended December 31, 202 4
and 202 3
F-6
Notes to Consolidated Financial
Statements
F-7
F- 1
REPORT OF INDEPENDENT REGISTERED
PUBLIC ACCOUNTING FIRM
To the Stockholders and Board of Directors of
Lucid Diagnostics, Inc.
Opinion on the Financial Statements
We
have audited the accompanying consolidated balance sheets of Lucid Diagnostics Inc. and Subsidiaries (the “Company”) as
of December 31, 2024 and 2023, the related consolidated statements of operations, changes in stockholders’ equity (deficit)
and cash flows for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as
the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the
financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of
the two years in the period ended December 31, 2024, in conformity with accounting principles generally accepted in the United
States of America.
Explanatory Paragraph – Going Concern
The accompanying financial statements
have been prepared assuming that the Company will continue as a going concern. As more fully described in Note 2, the Company has incurred significant losses and needs to raise additional funds to meet its obligations and sustain its
operations. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in
regard to these matters are also described in Note 2. The financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our
audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards
of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial
statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well
as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Marcum LLP
Marcum LLP
We have served as the Company’s auditor since
2019.
New York, NY
March 24, 2025
F- 2
LUCID DIAGNOSTICS INC.
and SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(in thousands except number of shares and per share
data)
December 31, 2024
December 31, 2023
Assets:
Current assets:
Cash
$ 22,358
$ 18,896
Accounts receivable
45
45
Inventory
341
278
Prepaid expenses, deposits, and other current assets
2,404
2,854
Total current assets
25,148
22,073
Fixed assets, net
1,062
1,334
Operating lease right-of-use assets
2,637
1,307
Intangible assets, net
736
1,424
Other assets
1,132
1,132
Total assets
$ 30,715
$ 27,270
Liabilities, Preferred Stock and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable
$ 1,241
$ 1,146
Accrued expenses and other current liabilities
2,829
3,841
Operating lease liabilities, current portion
854
1,106
Senior Secured Convertible Notes - at fair value
18,600
13,950
Due To: PAVmed Inc. - MSA Fee and operating expenses
—
9,339
Total current liabilities
23,524
29,382
Operating lease liabilities, less current portion
1,800
199
Total liabilities
25,324
29,581
Commitments and contingencies
-
-
Stockholders’ Equity:
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 December 31, 2024 and Series A and Series A-1
Convertible Preferred Stock, shares issued and outstanding 18,625 at December 31, 2023
54,419
18,625
Common stock, $ 0.001 par value, 300,000,000 and 200,000,000 shares authorized as of
December 31, 2024 and December 31, 2023, respectively; 63,071,950 and 42,329,864 shares issued and outstanding
as of December 31, 2024 and December 31, 2023, respectively
63
42
Additional paid-in capital
154,675
129,763
Accumulated deficit
( 203,766 )
( 150,741 )
Total Stockholders’ Equity (Deficit)
5,391
( 2,311 )
Total Liabilities and Stockholders’ Equity (Deficit)
$ 30,715
$ 27,270
See accompanying notes to the consolidated financial
statements.
F- 3
LUCID DIAGNOSTICS INC.
and SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands except number of shares and per share
data)
Years
Ended December 31,
2024
2023
Revenue
$ 4,346
$ 2,428
Operating expenses:
Cost of revenue
7,099
5,979
Sales and marketing
16,463
16,404
General and administrative
20,156
19,254
Amortization of acquired intangible assets
688
2,021
Research and development
5,992
7,252
Total operating expenses
50,398
50,910
Operating loss
( 46,052 )
( 48,482 )
Other income (expense):
Interest income
322
424
Interest expense
( 26 )
( 416 )
Change in fair value - Senior Secured Convertible Note
5,394
( 2,980 )
Loss on issue and offering costs - Senior Secured Convertible Note
—
( 1,186 )
Debt extinguishments loss - Senior Secured Convertible Note
( 5,167 )
( 26 )
Other income (expense), net
523
( 4,184 )
Loss before provision for income tax
( 45,529 )
( 52,666 )
Provision for income taxes
—
—
Net loss attributable to Lucid Diagnostics Inc.
$ ( 45,529 )
$ ( 52,666 )
Less: Deemed dividend on Series A and Series A-1 Convertible Preferred Stock
( 7,496 )
—
Net loss attributable to Lucid Diagnostics Inc. common stockholders
$ ( 53,025 )
$ ( 52,666 )
Net loss per share attributable to Lucid Diagnostics Inc. common stockholders -
basic and diluted
$ ( 1.05 )
$ ( 1.26 )
Weighted average common shares outstanding, basic and diluted
50,515,773
41,756,129
See accompanying notes to the consolidated financial
statements.
F- 4
LUCID DIAGNOSTICS INC.
and SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’
EQUITY (DEFICIT)
for the YEARS ENDED December 31, 2024 and
2023
(in thousands except number of shares and per share
data)
Preferred Stock
Common Stock
Additional Paid-In
Accumulated
Shares
Amount
Shares
Amount
Capital
Deficit
Total
Balance as of December 31, 2022
—
$ —
40,518,792
$ 41
$ 121,081
$ ( 98,075 )
$ 23,047
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan
—
—
—
—
5,762
—
5,762
Stock-based compensation - PAVmed Inc. 2014 Equity Plan
—
—
—
—
1,060
—
1,060
Vest - restricted stock awards
—
—
303,980
—
—
—
—
Conversions - Senior Secured Convertible Note
—
—
115,388
—
166
—
166
Issuance common stock - APA-RDx - Termination payment
—
—
553,436
—
713
—
713
Issuance - At-The-Market Facility, net of financing charges
—
—
230,068
1
283
—
284
Purchase - Employee Stock Purchase Plan
—
—
508,200
—
551
—
551
Issuance - Series A and Series A-1 Preferred Stock
18,625
18,625
—
—
—
—
18,625
Issue common stock - vendor service agreement
—
—
100,000
—
147
—
147
Net loss
—
—
—
—
—
( 52,666 )
( 52,666 )
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
—
—
—
—
4,183
—
4,183
Stock-based compensation - PAVmed Inc. 2014 Equity Plan
—
—
—
—
351
—
351
Vest - restricted stock awards
—
—
26,912
—
—
—
—
Conversions - Senior Secured Convertible Note
—
—
13,866,867
14
13,468
—
13,482
Purchase - Employee Stock Purchase Plan
—
—
647,940
1
446
—
447
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 and Series B-1 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
Conversions - Series B Preferred Stock
( 1,500 )
( 1,500 )
2,075,263
2
1,498
—
—
Issuance - Due To: PAVmed Inc. Settlement in Common Stock
—
—
3,331,771
3
4,672
—
4,675
Issue common stock - vendor service agreement
—
—
790,000
1
640
—
641
Transfer of intellectual property from PAVmed Inc.
—
—
—
—
( 350 )
—
( 350 )
Net loss
—
—
—
—
—
( 45,529 )
( 45,529 )
Balance as of December 31, 2024
54,419
$ 54,419
63,071,950
$ 63
$ 154,675
$ ( 203,766 )
$ 5,391
Balance
54,419
$ 54,419
63,071,950
$ 63
$ 154,675
$ ( 203,766 )
$ 5,391
See accompanying notes to the
consolidated financial statements.
F- 5
LUCID DIAGNOSTICS INC.
and SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands except number of shares and per share
data)
Years Ended December 31,
2024
2023
Cash flows from operating activities
Net loss
$ ( 45,529 )
$ ( 52,666 )
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation and amortization expense
1,167
2,499
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan
4,183
5,762
Stock-based compensation - PAVmed Inc. 2014 Equity Plan
351
1,060
Change in fair value - Senior Secured Convertible Note
( 5,394 )
2,980
Loss on issue - Senior Secured Convertible Note
—
1,111
Debt extinguishment loss - Senior Secured Convertible Note
5,167
26
APA-RDx: Issue common stock - termination payment
—
713
Amortization of common stock payment for vendor service agreement
346
23
Changes in operating assets and liabilities:
Accounts receivable
—
( 28 )
Prepaid expenses and other current assets
1,159
( 1,160 )
Accounts payable
96
89
Accrued expenses and other current liabilities
( 1,012 )
2,394
Due To: PAVmed Inc. - operating expenses, employee related costs,
MSA Fee
( 4,674 )
4,380
Net cash flows used in operating activities
( 44,140 )
( 32,817 )
Cash flows from investing activities
Purchase of equipment
( 296 )
( 221 )
Purchase of intellectual property from PAVmed Inc.
( 350 )
—
Net cash flows used in investing activities
( 646 )
( 221 )
Cash flows from financing activities
Proceeds – issue of preferred stock
29,798
18,625
Proceeds – issue of Senior Secured Convertible Notes
21,615
10,000
Payment – repayment of Senior Secured Convertible Note
( 3,616 )
—
Proceeds – issue of common stock – At-The-Market Facility
—
284
Proceeds – exercise of stock options
4
—
Proceeds – issue common stock – Employee Stock Purchase Plan
447
551
Net cash flows provided by financing activities
48,248
29,460
Net increase (decrease) in cash
3,462
( 3,578 )
Cash, beginning of period
18,896
22,474
Cash, end of period
$ 22,358
$ 18,896
See accompanying notes to the consolidated financial
statements.
F- 6
LUCID DIAGNOSTICS INC.
and SUBSIDIARIES
NOTES TO 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. (“Lucid”,
“Lucid Diagnostics” or the “Company”) is a commercial-stage, cancer prevention medical diagnostics technology
company focused on the millions of patients with gastroesophageal reflux disease (“GERD”), also known as chronic heartburn,
acid reflux or simply reflux, who are at risk of developing esophageal precancer and cancer, specifically highly lethal esophageal adenocarcinoma
(“EAC”). Lucid is a non-consolidated subsidiary of PAVmed Inc. (“PAVmed”).
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 a FDA 510(k) and
CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than a
five-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, when inflated, 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.
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 $ 4.3 million of revenue for the year ended December 31, 2024, 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 Lucid Diagnostics Inc common stockholders of approximately $ 53.0 million and had net cash flows used in operating activities
of approximately $ 44.1 million for the year ended December 31, 2024. As of December 31, 2024, the Company had working
capital of approximately $ 1.6 million, with such working capital inclusive of the 2024 Convertible Notes classified as a current liability
of approximately $ 18.6 million and approximately $ 22.4 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, increasing revenue through contracting directly with 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 consolidated financial statements are issued.
F- 7
Note 3 — Summary
of Significant Accounting Policies
Significant Accounting Policies
Basis of Presentation
The accompanying consolidated
financial statements 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, LucidDx Labs Inc and CapNostics LLC. 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.
All amounts in the accompanying
consolidated financial statements and these 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 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 liabilities and the disclosure of contingent losses, as of the date of the consolidated financial statements, as
well as the reported amounts of revenue and expenses during the reporting period. Significant estimates in these consolidated financial
statements include those related to the estimated of 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.
Cash
The Company maintains its cash
at a major financial institution with high credit quality. At times, the balance of its cash deposits may exceed federally insured limits.
The Company has not experienced losses on deposits with commercial banks and financial institutions which exceed federally insured limits.
F- 8
Note 3 — Summary of Significant Accounting
Policies - continued
Offering Costs
Offering costs consist of certain
legal, accounting, and other advisory fees incurred related to the Company’s efforts to raise debt and equity capital. Offering
costs in connection with equity financing are recognized as either an offset against the financing proceeds to extent the underlying
security is equity classified or a current period expense to extent the underlying security is liability classified or for which the
fair value option is elected. Offering costs, lender fees, and warrants issued in connection with debt financing, to the extent the fair
value option is not elected, are recognized as debt discount, which reduces the reported carrying value of the debt, with the debt discount
amortized as interest expense, generally over the contractual term of the debt agreement, to result in a constant rate of interest. Offering
costs associated with in-process capital financing are accounted for as deferred offering costs.
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.
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. However, when a patient is considered self-pay, the
Company requires payment from the patient prior to the commencement of the Company’s performance obligations. 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.
F- 9
Note 3 — Summary of Significant Accounting
Policies - continued
Inventory
The Company carries test supply
inventories to support our laboratory activities. The inventories are carried at the lower of weighted average cost and net realizable
value and expensed through cost of sales as the supplies are used.
Fixed Assets
Fixed assets are stated at cost
and depreciated using the straight-line method over the assets’ estimated useful lives. Additions and improvements are capitalized,
including direct and indirect costs incurred to validate equipment and bring to working conditions. The costs for maintenance and repairs
are expensed as incurred.
Leases
The Company adopted FASB ASC
Topic 842, Leases , (“ASC 842”) effective December 31, 2021. All significant lease agreements and contractual agreements
with embedded lease agreements are accounted for under the provisions of ASC 842, wherein, if the contractual arrangement: involves the
use of a distinct identified asset; provides for the right to substantially all the economic benefits from the use of the asset throughout
the contractual period; and provides for the right to direct the use of the asset. A lease agreement is accounted for as either a finance
lease or an operating lease. Under both a finance lease and an operating lease, the Company recognizes as of the lease commencement date
a lease right-of-use (“ROU”) asset and a corresponding lease payment liability.
A lease ROU asset represents
the Company’s right to use an underlying asset for the lease term, and the lease liability represents its contractual obligation
to make lease payments. The lease ROU asset is measured at the lease commencement date as the present value of the future lease payments
plus initial direct costs incurred. The Company recognizes lease expense of the amortization of the lease ROU asset for an operating
lease on a straight-line basis over the lease term; and for financing leases on a straight-line basis unless another basis is more representative
of the pattern of economic benefit. The operating ROU asset also includes any lease incentives received for improvements to leased property,
when the improvements are lessee-owned. For improvements to leased property that are lessor-owned, the Company includes amounts the Company
incurred for the improvements as ROU assets which are amortized on a straight-line basis over the life of the lease.
The lease liability is measured
at the lease commencement date with the discount rate generally based on the Company’s incremental borrowing rate (to the extent
the lease implicit rate is not known nor determinable), with interest expense recognized using the interest method for financing leases.
Certain leases may include options
to extend or terminate the agreement. The Company does not assume renewals in determination of the lease term unless the renewals are
deemed to be reasonably certain at lease commencement. As well, an option to terminate is considered unless it is reasonably certain
the Company will not exercise the option. The Company elected the practical expedient to not recognize a lease ROU asset and lease payment
liability for leases with a term of twelve months or less (“short-term leases”), resulting in the aggregate lease payments
being recognized on a straight line basis over the lease term. The Company’s leases with a commencement date prior to January 1,
2022 were short-term leases and therefore did not require recording a ROU asset or lease liability at December 31, 2021. Additionally,
the Company elected the practical expedient to not separate lease and non-lease components.
Intangible Assets
Purchased intangible assets are
recorded at cost and depreciated using the straight-line method over the assets’ estimated useful life. See Note 9, Intangible
Assets, net , for further information with respect to purchased intangible assets.
Impairment - Long Lived Assets
The Company reviews its long-lived
assets, including intangible assets with finite lives, for recoverability whenever events or changes in circumstances indicate the carrying
amount of the assets may not be fully recoverable. The Company evaluates assets for potential impairment by comparing estimated future
undiscounted net cash flows to the carrying amount of the asset. If the carrying amount of the assets exceeds the estimated future undiscounted
cash flows, impairment is measured based on the difference between the carrying amount of the assets and fair value which is generally
an expected present value cash flow technique. The assessment and determination of the existence of an impairment indicator comprises
measurable operating performance criteria as well as qualitative factors deemed relevant and appropriate to such evaluation.
F- 10
Note 3 — Summary of Significant Accounting
Policies - continued
Stock-Based Compensation
Stock-based awards are made to
members of the board of directors of the Company, the Company’s employees and non-employees, under each of the Lucid Diagnostics
2018 Equity Plan and the PAVmed 2014 Equity Plan. The Company accounts for stock-based compensation in accordance with the provisions
of FASB ASC Topic 718, Stock Compensation (“ASC 718”).
The grant-date estimated fair
value of the stock-based award is recognized on a straight-line basis over the requisite service period, which is generally the vesting
period of the respective stock-based award, with such straight-line recognition adjusted, as applicable, so the cumulative expense recognized
is at-least equal-to-or-greater-than the estimated fair value of the vested portion of the respective stock-based award as of the reporting
date.
The Company uses the Black-Scholes
valuation model to estimate the fair value of stock options granted under both the PAVmed 2014 Equity Plan and the Lucid Diagnostics
2018 Equity Plan, which requires the Company to make certain weighted-average valuation estimates and assumptions for stock-based awards,
principally as follows:
● With respect to the PAVmed 2014
Equity Plan, the expected stock price volatility is based on the historical stock price volatility
of PAVmed common stock over the period commensurate with the expected term with respect to
stock options granted to the board of directors and employees in the years ended December 31,
2024 and 2023;
● With respect to stock options granted
under the Lucid Diagnostics 2018 Equity Plan, the expected stock price volatility is based
on the historical stock price volatility of Lucid Diagnostics common stock and the volatilities
of similar entities within the medical device industry over the period commensurate with
the expected term with respect to stock options granted to employees in the years ended December 31,
2024 and 2023;
● The risk-free interest rate is based
on the interest rate payable on U.S. Treasury securities in effect at the time of grant for
a period commensurate with either the expected term or the remaining contractual term, as
applicable, of the stock option; and,
● The expected dividend yield is based
on annual dividends of $ 0.00 as there have not been dividends paid to-date, and there is
no plan to pay dividends for the foreseeable future.
The price per share of Lucid
Diagnostics common stock used in the computation of estimated fair value of stock options and restricted stock awards granted under the
Lucid Diagnostics 2018 Equity Plan is its quoted closing price per share.
The price per share of PAVmed
common stock used in the computation of estimated fair value of stock options and restricted stock awards granted under the PAVmed 2014
Equity Plan is its quoted closing price per share.
Financial Instruments Fair Value Measurements
FASB ASC Topic 820, Fair Value
Measurement , (ASC 820) defines fair value as the price which would be received to sell an asset or paid to transfer a liability in
an orderly transaction between market participants at a transaction measurement date. The ASC 820 three-tier fair value hierarchy prioritizes
the inputs used in the valuation methodologies, as follows:
Level 1 Valuations based
on quoted prices for identical assets and liabilities in active markets.
Level 2 Valuations based
on observable inputs other than quoted prices included in Level 1, such as quoted prices
for similar assets or liabilities in active markets, quoted prices for identical or similar
assets and liabilities in markets which are not active, or other inputs observable or can
be corroborated by observable market data.
Level 3 Valuations based
on unobservable inputs reflecting the Company’s own assumptions, consistent with reasonably
available assumptions made by other market participants. These valuations require significant
judgment.
As of December 31, 2024
and 2023, the carrying values of cash, and accounts payable, approximate their respective fair value due to the short-term nature of
these financial instruments.
F- 11
Note 3 — Summary of Significant Accounting
Policies - continued
Fair Value Option (“FVO”) Election
Under a Securities Purchase Agreement
dated March 13, 2023, the Company issued a Senior Secured Convertible Note dated March 21, 2023, referred to herein as the “March
2023 Senior Convertible Note”, which was accounted under the “fair value option election” as discussed below.
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 March 2023
Senior Convertible Note and the 2024 Convertible Notes are presented in a single line item within other income (expense) in the accompanying
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 March 2023
Senior Convertible Note and the 2024 Convertible Notes).
See Note 11, Financial Instruments
Fair Value Measurements , with respect to the FVO election; and Note 12, Debt , for a discussion of the March 2023 Senior Convertible
Note and the 2024 Convertible Notes.
Research and Development Expenses
Research and development expenses
are recognized as incurred and include the salary and stock-based compensation of employees engaged in product research and development
activities, and the costs related to the Company’s various contract research service providers, suppliers, engineering studies,
supplies, and outsourced testing and consulting fees, as well as depreciation expense and rental costs for equipment used in research
and development activities, and fees incurred for access to certain facilities of contract research service providers.
Patent Costs and Purchased Patent License Rights
Patent related costs in connection
with filing and prosecuting patent applications and patents filed by the Company are expensed as incurred and are included in the line
item captioned “general and administrative expenses” in the accompanying consolidated statements of operations. Patent fee
reimbursement expense incurred under the patent license agreement agreements are included in the line item captioned “general
and administrative” expenses in the accompanying consolidated statements of operations.
The Company has entered into
agreements with third parties to acquire technologies for potential commercial development. Such agreements generally require an initial
payment by the Company when the contract is executed. The purchase of patent license rights for use in research and development activities,
including product development, are expensed as incurred and are classified as research and development expense. Additionally, the Company
may be obligated to make future royalty payments in the event the Company commercializes the technology and achieves a certain sales
volume, which is included in cost of revenues in the accompanying consolidated statements of operations. In accordance with Financial Accounting Standards Board (“FASB”) Accounting Standard Codification (“ASC”)
Topic 730, “Research and Development”, (“ASC 730”), expenditures for research and development, including upfront
licensing fees and milestone payments associated with products not yet been approved by the United States Food and Drug Administration
(“FDA”), are charged to research and development expense as incurred. Future contract milestone and /or royalty payments
will be recognized as expense when achievement of the milestone is determined to be probable and the amount of the corresponding milestone
can be objectively estimated.
F- 12
Note 3 — Summary of Significant Accounting
Policies - continued
Income Taxes
The Company accounts for income
taxes using the asset and liability method, as required by FASB ASC Topic 740, Income Taxes, (ASC 740). Current tax liabilities or receivables
are recognized for estimated income tax payable and/or refundable for the current year. Deferred tax assets and deferred tax liabilities
are recognized for estimated future tax consequences attributable to differences between the financial statement carrying amounts of
existing assets and liabilities and their respective tax basis, along with net operating loss and tax credit carryforwards. Deferred
tax assets and deferred tax liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which
those temporary differences are expected to be recovered or settled. Changes in deferred tax assets and deferred tax liabilities are
recorded in the provision for income taxes.
Under ASC 740, a “more-likely-than-not”
criterion is applied when assessing the estimated realization of deferred tax assets through their utilization to reduce future taxable
income, or with respect to a deferred tax asset for tax credit carryforward, to reduce future tax expense. A valuation allowance is established,
when necessary, to reduce deferred tax assets, net of deferred tax liabilities, when the assessment indicates it is more-likely-than-not,
the full or partial amount of the net deferred tax asset will not be realized. As a result of the evaluation of the positive and negative
evidence bearing upon the estimated realizability of net deferred tax assets, and based on a history of operating losses, it is more-likely-than-not
the deferred tax assets will not be realized, and therefore a valuation allowance reserve equal to the full amount of the deferred tax
assets, net of deferred tax liabilities, has been recognized as a charge to income tax expense as of December 31, 2024 and 2023.
The Company recognizes the benefit
of an uncertain tax position it has taken or expects to take on its income tax return if such a position is more-likely-than-not to be
sustained upon examination by the taxing authorities, with the tax benefit recognized being the largest amount having a greater than
50% likelihood of being realized upon ultimate settlement. As of December 31, 2024, the Company does no t have any unrecognized tax
benefits resulting from uncertain tax positions.
The Company’s policy is
to record interest and penalties related to income taxes as part of its income tax provision. There were no amounts accrued for penalties
or interest as of December 31, 2024 and December 31, 2023 or recognized during the years ended December 31, 2024 and 2023.
The Company is not aware of any issues under review to potentially result in significant payments, accruals, or material deviations from
its position.
Net Loss Per Share
The net loss per share is computed
by dividing each respective net loss by the number of “basic weighted average common shares outstanding” and “diluted
weighted average shares outstanding” for the reporting period indicated. The basic weighted-average shares common shares outstanding
are computed on a weighted average based on the number of days the shares of common stock of the Company are issued and outstanding during
the respective reporting period indicated. The diluted weighted average common shares outstanding are the sum of the basic weighted-average
common shares outstanding plus the number of common stock equivalents’ incremental shares on an if-converted basis, computed using
the treasury stock method, computed on a weighted average based on the number of days the incremental shares would potentially be issued
and outstanding during the periods indicated, if dilutive. The Company’s common stock equivalents include convertible debt, convertible
preferred stock, stock options and unvested restricted stock awards granted under the Lucid Diagnostics 2018 Long-Term Incentive Equity
Plan.
Notwithstanding, as the Company
has a net loss for each reporting period presented, only the basic weighted average common shares outstanding are used to compute the
basic and diluted net loss per share for each reporting period presented.
JOBS Act EGC Accounting Election
The Company is an “emerging
growth company” or “EGC”, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”).
Under the JOBS Act, an EGC can delay adopting new or revised accounting standards issued after the enactment of the JOBS Act until such
time as those standards apply to private companies. The Company has irrevocably elected to avail itself of this exemption from new or
revised accounting standards, and, therefore, will not be subject to the same new or revised accounting standards as public companies
who are not an EGC.
F- 13
Note 3 — Summary of Significant Accounting
Policies - continued
Recently Adopted Accounting Pronouncements
In November 2023, the FASB issued
ASU No. 2023-07, Segment Reporting (Topic 280)—Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which
require public companies disclose significant segment expenses and other segment items on an annual and interim basis and to provide
in interim periods all disclosures about a reportable segment’s profit or loss and assets that are currently required annually.
The guidance is effective for public entities for fiscal years beginning after December 15, 2023, and interim periods within fiscal years
beginning after December 15, 2024. Early adoption is permitted. The guidance was adopted by the Company on January 1, 2024. The adoption
of the ASU did not change the way that the Company identifies its reportable segments and, as a result, did not have a material impact
on the Company’s segment-related disclosures. Refer to Note 17, Segment Information for further information on the Company’s
reportable segment.
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 consolidated financial statements.
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 Company does not
expect the standard to have a significant impact on its 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 of this guidance on its consolidated financial statements and disclosures.
Note 4 — Revenue
from Contracts with Customers
Revenue Recognized
In the year ended December 31,
2024, the Company recognized revenue of $ 4,346 , 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 year ended December 31, 2023 was $ 2,428 , 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 year ended December 31,
2024, the cost of revenue was $ 7,099 , primarily related to costs for our laboratory operations and EsoCheck device supplies. The Company’s
cost of revenue for the year ended December 31, 2023 was $ 5,979 , primarily related to costs for our laboratory operations and EsoCheck
device supplies.
F- 14
Note 5 — Related
Party Transactions
The aggregate Due To: PAVmed
Inc. for the period indicated is summarized as follows:
Schedule of Due To: PA Vmed Inc
MSA Fees
Employee-Related Costs
PAVmed Inc. OBO Payments
Total
Balance - December 31, 2022
$ 1,650
$ 3,026
$ 284
$ 4,960
MSA fees
9,000
—
—
9,000
ERC - Payroll & Benefits
—
1,828
—
1,828
On Behalf Of (OBO) activities
—
—
1,035
1,035
Cash payments to PAVmed Inc.
( 4,500 )
( 1,691 )
( 1,293 )
( 7,484 )
Balance - December 31, 2023
$ 6,150
$ 3,163
$ 26
$ 9,339
MSA Fees
Employee-Related Costs
PAVmed Inc. OBO Payments
Total
Balance - December 31, 2023
$ 6,150
$ 3,163
$ 26
$ 9,339
MSA fees
11,300
—
—
11,300
ERC - Benefits
—
1,888
—
1,888
On Behalf Of (OBO) activities
—
—
779
779
Cash payments to PAVmed Inc.
( 15,800 )
( 2,026 )
( 805 )
( 18,631 )
Payment to PAVmed Inc. settled in LUCD stock
( 1,650 )
( 3,025 )
—
( 4,675 )
Balance - December 31, 2024
$ —
$ —
$ —
$ —
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. In March 2024, PAVmed and the Company were authorized
by their respective boards of directors to enter, and they did enter, into an eighth amendment to the MSA. Under this amendment, the
monthly fee due from the Company to PAVmed was increased from $ 750 to $ 833 , effective January 1, 2024. In August 2024, PAVmed and the
Company were authorized by their respective boards of directors to enter, and they did enter, into a ninth amendment to the MSA. Under
this amendment, the monthly fee due from the Company to PAVmed was increased from $ 833 to $ 1,050 , effective July 1, 2024. During the
year ended December 31, 2023, MSA fees were $ 750 per month. Currently, under the terms of PAVmed’s outstanding convertible debt,
PAVmed is required to elect to receive such payments in cash.
On January 26, 2024, PAVmed elected
to receive payment of $ 4,675 of fees and reimbursements due from Lucid, through the issuance of 3,331,771 shares of Lucid Diagnostics
common stock.
The MSA Fee expense classification
in the consolidated statement of operations for the periods noted is as follows:
Schedule of MSA Fee Expense Classification in Statements of Operations
Years Ended December 31,
2024
2023
Sales & Marketing
$ 581
$ 436
General & Administrative
8,113
6,350
Research & Development
2,606
2,214
Total MSA Fee
$ 11,300
$ 9,000
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.
Transfer of Intellectual Property from PAVmed
On September 27, 2024, the Company
entered into an Assignment of Patent Rights with PAVmed, pursuant to which PAVmed assigned certain patent rights to the Company related
to the EsoCheck device. In consideration of the assignment the Company agreed to pay PAVmed a $ 350 assignment fee.
F- 15
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
December 31, 2024
December 31, 2023
Advanced payments to service providers and suppliers
$ 581
$ 266
Prepaid insurance
443
607
Deposits
1,020
1,981
Subscribed amounts due from investors
360
—
Total prepaid expenses, deposits and other current assets
$ 2,404
$ 2,854
Note 7 — Fixed Assets
Fixed assets, less accumulated depreciation, consisted
of the following as of:
Schedule
of Fixed Assets
Estimated Useful Life
December 31, 2024
December 31, 2023
Computer and office equipment
2 - 5 years
$ 269
$ 252
Laboratory equipment
3 - 7 years
1,765
1,702
Furniture and fixtures
3 - 5 years
145
146
Leasehold improvements
- (1)
30
1
Total Fixed Assets
2,209
2,101
Less Accumulated Depreciation
( 1,147 )
( 767 )
Total Fixed Assets, net
$ 1,062
$ 1,334
(1) Lesser of remaining lease
term or estimated useful life.
Depreciation expense of $ 479 and $ 478 for the years
ended December 31, 2024 and 2023, respectively, is included in general and administrative expenses in the accompanying consolidated
statements of operations.
Note 8 — Leases
During the year ended December 31,
2024, the Company entered into additional lease agreements that have commenced and are classified as operating leases, including in June
2024, the Company exercised a renewal option to extend the lease term on its central laboratory in California for an additional three
years, through December 31, 2027. The aggregate (undiscounted) rent payments are approximately $ 2.6 million over the extended lease term.
The components of lease expense
were as follows:
Schedule
of Components of Lease Expense
Year Ended December 31,
2024
2023
Operating lease cost
$ 1,168
$ 1,214
Short-term lease cost
74
87
Variable lease cost
62
58
Total lease cost
$ 1,304
$ 1,359
F- 16
Note 8 — Leases - continued
The Company’s future lease
payments as of December 31, 2024, which are presented as operating lease liabilities, current portion and operating lease liabilities,
less current portion on the Company’s consolidated balance sheets are as follows:
Schedule
of Future Lease Payments of Operating Lease Liabilities
2025
$ 1,025
2026
979
2027
940
2028
19
2029
—
Total lease payments
$ 2,963
Less: imputed interest
( 309 )
Present value of lease liabilities
$ 2,654
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
Years Ended December 31,
2024
2023
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows from operating leases
$ 1,148
$ 1,207
Non-cash investing and financing activities
Right-of-use assets obtained in exchange for new operating lease liabilities
$ 2,347
$ 380
Weighted-average remaining lease term - operating leases (in years)
2.95
1.39
Weighted-average discount rate - operating leases
7.875 %
7.875 %
As of December 31, 2024
and December 31, 2023, the Company’s right-of-use assets from operating leases were $ 2,637 and $ 1,307 , respectively, which are
reported in operating lease right-of-use assets in the consolidated balance sheets. As of December 31, 2024 and December 31, 2023,
the Company had outstanding operating lease obligations of $ 2,654 and $ 1,305 , respectively, of which $ 854 and $ 1,106 , respectively, are
reported in operating lease liabilities, current portion and $ 1,800 and $ 199 , respectively, are reported in operating lease liabilities
less current portion in the Company’s consolidated balance sheets. The Company calculates its incremental borrowing rates for specific
lease terms, used to discount future lease payments, as a function of the financing terms the Company would likely receive on the open
market.
F- 17
Note 9 — Intangible
Assets, net
Intangible assets, less accumulated
amortization, consisted of the following as of:
Schedule of Intangible Assets
Estimated Useful Life
December 31, 2024
December 31, 2023
Defensive technology
60 months
$ 2,105
$ 2,105
Laboratory licenses and certifications and laboratory information management software
24 months
3,200
$ 3,200
Total Intangible assets
5,305
5,305
Less Accumulated Amortization
( 4,569 )
( 3,881 )
Intangible Assets, net
$ 736
$ 1,424
Amortization expense of the intangible
assets discussed above was $ 688 and $ 2,021 for the years ended December 31, 2024 and 2023, respectively, and is included in amortization
of acquired intangible assets in the accompanying consolidated statements of operations. As of December 31, 2024, the estimated
future amortization expense associated with the Company’s finite-lived intangible assets for each of the five succeeding fiscal
years is as follows:
Schedule of Future Amortization Expense
2025
$ 421
2026
315
Total
$ 736
Note 10 — Accrued Expenses and Other
Current Liabilities
Accrued expenses and other current liabilities consisted
of the following items as of:
Schedule of Accrued Expenses and Other Current Liabilities
December 31, 2024
December 31, 2023
Compensation and Employee Benefits
$ 1,479
$ 1,178
CWRU Amended License Agreement - Royalty fee
64
96
Operating expenses
869
2,018
Other
417
549
Total accrued expenses and other current liabilities
$ 2,829
$ 3,841
Note 11 — 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
Fair Value Measurement
on a Recurring Basis at Reporting Date Using 1
Level-1 Inputs
Level-2 Inputs
Level-3 Inputs
Total
December 31, 2024
2024 Convertible Notes
$ —
$ —
$ 18,600
$ 18,600
Totals
$ —
$ —
$ 18,600
$ 18,600
Level-1 Inputs
Level-2 Inputs
Level-3 Inputs
Total
December 31, 2023
March 2023 Senior Convertible Note
$ —
$ —
$ 13,950
$ 13,950
Totals
$ —
$ —
$ 13,950
$ 13,950
1 There were no transfers between the respective Levels during the year ended December 31,
2024.
As discussed in Note 12, Debt ,
the Company issued a Senior Secured Convertible Note dated March 21, 2023 with a $ 11.1 million face value principal (“March 2023
Senior Convertible Note”). The convertible note is accounted for under the fair value option (“FVO”) election,
wherein, the financial instrument is initially measured at its issue date estimated fair value and subsequently remeasured at estimated
fair value on a recurring basis at each reporting period date.
F- 18
Note 11 — Financial Instruments Fair Value
Measurements - continued
As discussed in Note 12, 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 November 22, 2024 and December 31, 2024, and the March 2023 Senior Convertible Note as of December
31, 2023 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
March 2023 Senior Convertible Note:
December 31, 2023
2024 Convertible Notes:
November 22, 2024
2024 Convertible Notes:
December 31, 2024
Fair Value
$ 13,950
$ 21,975
$ 18,600
Face value principal payable
$ 11,019
$ 21,975
$ 21,975
Required rate of return
10.00 %
28.50 %
29.00 %
Conversion Price
$ 5.00
$ 1.00
$ 1.00
Value of common stock
$ 1.10
$ 1.00
$ 0.819
Expected term (years)
1.22
5.00
4.90
Volatility
60.00 %
40.00 %
40.00 %
Risk free rate
4.56 %
4.21 %
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 12 — 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
$ 18,600
Balance as of December 31, 2024
$ 21,975
$ 18,600
The fair value and face value
principal outstanding of the March 2023 Senior Convertible Note (redeemed on November 22, 2024) as of December 31, 2023:
Contractual Maturity Date
Stated Interest Rate
Conversion Price per Share
Face Value Principal Outstanding
Fair Value
March 2023 Senior Convertible Note
March 21, 2025
7.875 %
$ 5.00
$ 11,019
$ 13,950
Balance as of December 31, 2023
$ 11,019
$ 13,950
F- 19
Note 12 — Debt - continued
The changes in the fair value
of debt during the year ended December 31, 2024 is as follows:
Schedule of Changes in Fair Value of Debt
March 2023 Senior Convertible Note
2024 Convertible Notes
Sum of Balance Sheet Fair Value Components
Other Income (expense)
Fair Value - December 31, 2023
$ 13,950
$ —
$ 13,950
$ —
Face value principal – issue date
—
21,975
21,975
$ —
Fair value adjustment – issue date
Installment repayments – common stock
( 8,365 )
—
( 8,365 )
—
Non-installment payments – common stock
( 912 )
—
( 912 )
—
Change in fair value
( 2,019 )
( 3,375 )
( 5,394 )
5,394
Principal repayments - cash
( 2,654 )
—
( 2,654 )
—
Fair Value at December 31, 2024
$ —
$ 18,600
$ 18,600
—
Other Income (Expense) - Change in fair value – year ended December 31, 2024
$ 5,394
The changes in the fair value
of debt during the year ended December 31, 2023 is as follows:
March 2023 Senior Convertible Note
Other Income (expense)
Fair Value - December 31, 2022
$ —
$ —
Fair Value - Beginning Balance
$ —
$ —
Face value principal – issue date
11,111
$ —
Fair value adjustment – issue date
789
( 789 )
Installment repayments – common stock
( 92 )
—
Non-installment payments – common stock
( 49 )
—
Change in fair value
2,191
( 2,191 )
Fair Value at December 31, 2023
$ 13,950
—
Fair Value - Ending Balance
$ 13,950
—
Other Income (Expense) - Change in fair value – year ended December 31, 2023
$ ( 2,980 )
F- 20
Note 12 — Debt - continued
March 2023 Senior Secured Convertible Note
Lucid Diagnostics entered into
a Securities Purchase Agreement (“SPA”) dated March 13, 2023, with an accredited institutional investor (“Investor”,
“Lender”, and /or “Holder”), wherein Lucid agreed to sell, and the Investor agreed to purchase, an aggregate
of $ 11.1 million face value principal of debt.
Under the SPA, Lucid issued in
a registered direct offering under its effective shelf registration statement a Senior Secured Convertible Note dated March 21, 2023,
referred to herein as the “March 2023 Senior Convertible Note”, with such note having a $ 11.1 million face value principal,
a 7.875 % annual stated interest rate, a contractual conversion price of $ 5.00 per share of the Company’s common stock (subject
to standard adjustments in the event of any stock split, stock dividend, stock combination, recapitalization or other similar transaction),
and a contractual maturity date of March 21, 2025 . The March 2023 Senior Convertible Note may be converted into shares of common stock
of the Company at the Holder’s election.
The March 2023 Senior Convertible
Note proceeds were $ 9.925 million after deducting a $ 1.186 million lender fee and offering costs. The lender fee and offering costs were
recognized as of the March 21, 2023 issue date as a current period expense in other income (expense) in the Company’s consolidated
statement of operations.
During the period from March
21, 2023 to September 20, 2023, the Company was required to pay interest expense only (on the $ 11.1
million face value principal), at 7.875 %
per annum, computed on a 360 day year. The Company paid cash interest expense of $ 391
for the year ended December 31, 2023. Commencing September 21, 2023, and then on each of the successive first and tenth trading
day of each month thereafter through to and including March 14, 2025 (each referred to as an “Installment Date”); and on
the March 21, 2025 maturity date, the Company will be required to make a principal repayment of $ 292 together with accrued interest thereon,
with such 38 payments referred to herein as the “Installment Amount”, settled in shares of common stock of the Company, subject
to customary equity conditions, including minimum share price and volume thresholds, or at the election of the Company, in cash, in whole
or in part.
In addition to the Installment Amount repayments, the Holder was able to elect to accelerate the conversion of
future Installment Amount repayments, and interest thereon, subject to certain restrictions, as defined, utilizing the then current
conversion price of the most recent Installment Date conversion price.
The payment of all amounts due and
payable under this senior convertible note was guaranteed by all of Lucid Diagnostics’ subsidiaries; and the obligations under this
senior convertible note were secured by all of the assets of Lucid Diagnostics and its subsidiaries.
Lucid was subject to certain customary
affirmative and negative covenants regarding the rank of the note, along with the incurrence of further 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, and transactions with affiliates, among other customary matters.
Lucid was subject to financial covenants requiring: (i) a minimum of $5.0 million of available cash at all times;
(ii) the ratio of (a) the outstanding principal amount of the total senior convertible notes outstanding, accrued and unpaid interest
thereon and accrued and unpaid late charges to (b) the Company’s average market capitalization over the prior ten trading days,
as of the last day of any fiscal quarter commencing with September 30, 2023, to not exceed 30%; and (iii) the Company’s market capitalization
to at no time be less than $30 million.
The March 2023 Senior Convertible
Note installment payments were payable in shares of Lucid Diagnostics common stock at a conversion price that was the lower of the contractual
conversion price and 82.5% of the two lowest VWAPs during the last 10 trading days preceding the date of conversion, subject to a conversion
price floor of $0.30. The notes are also subject to certain provisions that may require redemption upon the occurrence of an event of default,
a change of control, or certain equity issuances.
In the year ended December 31,
2024, approximately $ 8,365 of principal repayments along with approximately $ 912 of interest expense thereon, were settled through the
issuance of 13,866,867 shares of common stock of the Company, with such shares having a fair value of approximately $ 13,482 (with such
fair value measured as the respective conversion date quoted closing price of the common stock of the Company). The conversions resulted
in debt extinguishment losses of $ 4,205 in the year ended December 31, 2024. In addition to principal payments through conversions,
the Company redeemed the March 2023 Senior Convertible Note for $ 3,616 , which included an additional $ 962 of debt extinguishment loss in the year ended
December 31, 2024.
November 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 approximately $ 0.4 million of subscription receivable currently included
in prepaid expenses, deposits, and other current assets on the Company’s consolidated balance sheets. Subsequent to December 31,
2024, the Company received the entire $ 0.4 million of subscription receivable.
The material terms of the 2024
Convertible Notes, upon issuance, are as follows:
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 will hold a stockholder meeting no later than June 30, 2025 to solicit the stockholder approval of the
issuance of the conversion shares (and payment in kind of interest on the Notes).
The principal of the 2024 Convertible
Notes does not amortize in installments over the term of the notes. The entire principal amount of the notes is due on the maturity date.
The accrued interest on the 2024 Convertible Notes is paid quarterly in cash or, at the election of the holder, shares of the Company’s
common stock, at a price based on the then current market price.
F- 21
Note 12 — Debt - continued
Each 2024 Convertible Note is
convertible into shares of the Company’s common stock at the holder’s election at any time and from time to time after the
6-month anniversary of issuance. In addition, each 2024 Convertible Note converts into shares of the Company’s common stock, subject
to customary beneficial ownership and primary market limitations, (i) at the election of the holder upon the consummation by the Company
of certain fundamental transactions (in which case all interest that would have accrued through maturity would also convert into shares
of the Company’s common stock), or (ii) at the Company’s election at any time after the six-month anniversary of the issuance
of such note, upon written notice given to the holder thereof, if the VWAP of the Company’s common stock has been at least $ 10.00
per share (subject to adjustment in the event of stock splits, stock dividends, and similar transactions) on 20 out of any 30 consecutive
trading days. The Company is not permitted to voluntarily repurchase, redeem or prepay any 2024 Convertible Note, other than during the
last 6 months prior to maturity thereof.
The 2024 Convertible Notes are
secured by a lien on all the Company’s present and future tangible and intangible property and assets.
The 2024 Convertible Notes
are subject to acceleration upon consummation of a fundamental transaction, upon default of the Case Western Reserve University
Amended and Restated License Agreement, upon failure to obtain a positive Medicare coverage decision with respect to its EsoGuard
product by the 18-month anniversary of issuance, and upon certain other customary events of default. Upon default the interest rate would increase to 18 %.
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 December 31, 2024.
Certain of the investors in the
purchase and sale of the 2024 Convertible Notes have the collective right to designate one individual to be appointed to the Company’s
board of directors, subject to certain limitations and subject to the policies and procedures of the Company’s nominating and corporate
governance committee.
The Company agreed that it
will, within 120 days following the closing of the offering of the 2024 Convertible Notes, 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. Subsequent to December 31, 2024, on March 14, 2025, a majority-in-interest of the holders of the 2024 Convertible
Notes agreed to extend this filing deadline to 180 days following such closing.
The holders of the 2024 Convertible
Notes have the right, based on their ownership interest in the Company assuming the conversion of all such notes, to participate in subsequent
equity or debt financings or issuances by the Company (subject to customary exceptions).
Note 13 — 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 14,324,038 shares
of common stock of Lucid Diagnostics are reserved for issuance under the Lucid Diagnostics 2018 Equity Plan, with 866,463 shares available
for grant as of December 31, 2024. 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 December 31, 2024. 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.
F- 22
Note 13 — Stock-Based Compensation -
continued
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, 2022
2,565,377
$ 3.14
8.3
-
Granted (1)
3,618,000
$ 1.32
Exercised
—
$ —
Forfeited
( 678,994 )
$ 2.75
Outstanding stock options at December 31, 2023
5,504,383
$ 2.00
8.5
$ 765
Granted (1)
3,733,000
$ 1.21
Exercised
( 3,333 )
$ 1.31
Forfeited
( 587,292 )
$ 1.59
Outstanding stock options at December 31, 2024 (3)
8,646,758
$ 1.68
8.1
$ 199
Vested and exercisable stock options at December 31, 2024
4,918,408
$ 2.02
7.5
$ 198
(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 December 31, 2024 and December 31, 2023 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 December 31, 2024 and 2023.
On February 22, 2024, the Company
granted 2,895,000 stock options to employees and directors under the Lucid Diagnostics Inc 2018 Equity Plan with a weighted average exercise
price of $ 1.25 . Each option will vest one-third after one year then ratably over the next eight quarters.
Subsequent to December 31, 2024,
on February 20, 2025, the Company granted 1,306,000 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, 2022
2,091,420
$ 11.44
Granted
550,000
1.29
Vested
( 303,980 )
11.95
Forfeited
—
—
Unvested restricted stock awards as of December 31, 2023
2,337,440
$ 8.99
Granted
1,600,000
1.03
Vested
( 26,912 )
4.56
Forfeited
( 13,088 )
4.56
Unvested restricted stock awards as of December 31, 2024
3,897,440
$ 5.77
In May 2024, a total of 1,600,000
restricted stock awards were granted to management under the Lucid Diagnostics 2018 Equity Plan, with such restricted stock awards having
an aggregate fair value of approximately $ 1.5 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, 2026. The restricted stock awards are subject to forfeiture if the requisite service period is not completed.
Subsequent to December 31, 2024,
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.
F- 23
Note 13 — 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
2024
2023
Years
Ended December 31,
2024
2023
Lucid Diagnostics 2018 Equity Plan – cost of revenue
$ 120
$ 63
Lucid Diagnostics 2018 Equity Plan – sales and marketing
1,221
948
Lucid Diagnostics 2018 Equity Plan - general and administrative
2,325
4,455
Lucid Diagnostics 2018 Equity Plan - research and development
517
296
PAVmed 2014 Equity Plan - cost of revenue
44
37
PAVmed 2014 Equity Plan - sales and marketing
144
463
PAVmed 2014 Equity Plan - general and administrative
5
173
PAVmed 2014 Equity Plan - research and development
158
387
Total stock-based compensation expense
$ 4,534
$ 6,822
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.
F- 24
Note 13 — Stock-Based Compensation -
continued
As of December 31, 2024,
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
$ 3,016
1.8
Restricted Stock Awards
$ 1,565
1.3
PAVmed 2014 Equity Plan
Stock Options
$ 86
1.5
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 $ 0.79 per share and $ 0.88 per share during the years ended December 31, 2024 and 2023, respectively,
calculated using the following weighted average Black-Scholes valuation model assumptions:
Schedule
of Stock-based Compensation Valuation Assumptions
2024
2023
Year Ended December 31,
2024
2023
Expected term of stock options (in years)
5.7
5.6
Expected stock price volatility
73 %
74 %
Risk free interest rate
4.3 %
3.9 %
Expected dividend yield
— %
— %
Lucid Diagnostics Inc Employee Stock Purchase Plan (“Lucid ESPP”)
A total of 511,884 shares and
231,987 shares of common stock of Lucid Diagnostics were purchased for proceeds of approximately $ 353 and $ 276 on March 31, 2024 and
2023, respectively, under the Lucid ESPP. A total of 136,056 and 276,213 shares of common stock of Lucid Diagnostics were purchased for
proceeds of approximately $ 94 and $ 275 on September 30, 2024 and 2023, respectively, under the Lucid ESPP. The Lucid ESPP has a total
reservation of 1,500,000 shares of common stock of which 259,830 shares are available for issue as of December 31, 2024. In January
2025, the number of shares available for issue was increased by 1,000,000 in accordance with the evergreen provisions of the plan.
Note 14 — Stockholders’
Equity
Series B Preferred Stock Offering and Exchange
On March 13, 2024, the Company
entered into subscription agreements (each, a “Series B Subscription Agreement”) and exchange agreements (each, a “Series
B Exchange Agreement”) with certain accredited investors (collectively, the “Series B Investors”), which agreements
provided for (i) the sale to the Series B Investors of 12,495 shares of newly designated Series B Convertible Preferred Stock, par value
$ 0.001 per share (the “Series B Preferred Stock”), at a purchase price of $ 1,000 per share, and (ii) the exchange by the
Series B Investors of 13,625 shares of Lucid Series A Convertible Preferred Stock, par value $ 0.001 per share (the “Series A Preferred
Stock”), and 10,670 shares of Lucid Series A-1 Convertible Preferred Stock, par value $ 0.001 per share (the “Series A-1 Preferred
Stock”), held by them for 31,790 shares of Series B Preferred Stock (collectively, the “Series B Offering and Exchange”).
Prior to the execution of the Series B Subscription Agreements and the Series B Exchange Agreements, the Company entered into subscription
agreements with certain of the Series B Investors providing for the sale to such investors of 5,670 shares of Series A-1 Preferred Stock,
at a purchase price of $ 1,000 per share, which shares the investors immediately agreed to exchange for shares of Series B Preferred Stock
pursuant to the Series B Exchange Agreements (and are included in the 10,670 shares of Series A-1 Preferred Stock set forth above). Each
share of the Series B Preferred Stock has a stated value of $ 1,000 and a conversion price of $ 1.2444 . The terms of the Series B Preferred
Stock also include a one times preference on liquidation and a right to receive dividends equal to 20 % of the number of shares of our
common stock into which such Series B Preferred Stock is convertible, payable on the one-year and two-year anniversary of the issuance
date. 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 Series B Preferred Stock is a voting security. The aggregate gross proceeds of these transactions
were $ 18.2 million (inclusive of $ 5.7 million of aggregate gross proceeds from the sale of the Series A-1 Preferred Stock that was immediately
exchanged for Series B Preferred Stock in the transactions).
F- 25
Note 14 — Stockholders’ Equity - continued
As a result of 100% of the then-outstanding
shares of Series A Preferred Stock and Series A-1 Preferred Stock being exchanged for shares of Series B Preferred Stock in the Series
B Offering and Exchange, no shares of Series A Preferred Stock or Series A-1 Preferred Stock remain outstanding.
In connection with the issuance,
the Company filed a Certificate of Designation of Preferences, Rights and Limitations of the Series B Preferred Stock with the Secretary
of State of the State of Delaware (the “Certificate of Designation”). The key terms of the Series B Preferred Stock are as
follows:
Each share of Series B Preferred
Stock is convertible at the option of the holder, subject to certain beneficial ownership limitations into such number of shares of the
Company’s common stock, equal to the number of Series B Preferred Shares to be converted, multiplied by the stated value of $ 1,000
(the “Stated Value”), divided by the conversion price in effect at the time of the conversion. The initial conversion price
is $ 1.2444 , subject to adjustment in the event of stock splits, stock dividends, and similar transactions. The Series B Preferred Stock
is convertible into shares of our common stock at any time at the option of the holder from and after the six-month anniversary of its
issuance, and automatically converts into shares of our common stock on March 13, 2026, the second anniversary of its issuance at a conversion
price of $ 1.2444 , and the Series B Preferred Stock is a voting security (subject to applicable ownership limitations). In addition, the
Series B Preferred Stock issued in exchange for Series A Preferred Stock and Series A-1 Preferred Stock may be converted, at the election
of the Company at any time after the six-month anniversary of the issuance of such shares of Series B Preferred Stock, upon written notice
given to the holders of such shares, if the volume weight average price of our common stock has been at least $ 8.00 per share (subject
to adjustment in the event of stock splits, stock dividends, and similar transactions) on 20 out of 30 consecutive trading days ending
within 15 trading days prior to the date on which such notice is given (subject to certain limited exceptions) (a “VWAP-Based Mandatory
Conversion”).
The Series B Preferred Stock
will be senior to the Common Stock and any other class of the Company’s capital stock that is not by its terms senior to or pari
passu with the Series B Preferred Stock.
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.
In the event of any voluntary
or involuntary liquidation, dissolution or winding up of the Company (or any Deemed Liquidation Event as defined in the Certificate of
Designation), the holders of shares of Series B Preferred Stock then outstanding will be entitled to be paid out of the assets of the
Company available for distribution to its stockholders, before any payment shall be made to the holders of Common Stock by reason of
their ownership thereof, an amount per share equal to the greater of (i) the Stated Value, plus any dividends accrued but unpaid thereon,
or (ii) such amount per share as would have been payable had all shares of Series B Preferred Stock been converted into Common Stock
immediately prior to such event.
The Series B Preferred Stock
is a voting security (subject to applicable ownership limitations).
The Company will not effect any
conversion of the Series B Preferred Stock, and a holder will not have the right to receive dividends or convert any portion of the Series
B Preferred Stock, to the extent that, after giving effect to the receipt of dividends or the conversion, the holder (together with such
holder’s affiliates, and any persons acting as a group together with such holder or any of the holder’s affiliates) would
beneficially own in excess of 4.99% of the Company’s outstanding common stock (or, upon election of the holder, 9.99% of the Company’s
outstanding common stock).
The Company and the investors
in the offering also executed a registration rights agreement (the “Series B Registration Rights Agreement”), pursuant to
which the Company agreed to file a registration statement covering the resale of the shares of Common Stock issuable pursuant to the
Series B Preferred Stock. The Company filed such registration statement on Form S-3 with the SEC (file number 333-280650), which filing
became effective on July 18, 2024, covering the resale of the shares of Common Stock issuable pursuant to the Series B and Series B-1
Preferred Stock.
Series B-1 Preferred Stock Offering
On May 6, 2024, the Company issued
approximately 11,634 shares of newly designated Series B-1 Convertible Preferred Stock (the “Series B-1 Preferred Stock”).
The terms of the Series B-1 Preferred Stock are substantially identical to the terms of the Series B Preferred Stock, except that the
Series B-1 Preferred Stock has a conversion price of $ 0.7228 and is not subject to a VWAP-Based Mandatory Conversion. The aggregate gross
proceeds from the sale of shares in such offering were $ 11.6 million.
In the year ended December 31,
2024, investors of the Series B-1 Preferred Stock converted 1,500 shares of Series B-1 Preferred Stock at the agreed upon conversion
price of $ 0.7228 for 2,075,263 shares of the Company’s common stock.
F- 26
Note 14 — Stockholders’ Equity - continued
Series A Preferred Stock Offering
On March 7, 2023, the Company
issued 13,625 shares of newly designated Series A Convertible Preferred Stock, par value $ 0.001 per share (the “Series A Preferred
Stock”). The terms of the Series A Preferred Stock were substantially identical to the terms of the Series B-1 Preferred Stock,
except that the Series A Preferred Stock had a conversion price of $ 1.394 and was not a voting security. The aggregate gross proceeds
from the sale of shares in such offering were $ 13.6 million.
As noted above, on March 13,
2024, 100% of the then-outstanding shares of Series A Preferred Stock were exchanged for shares of Series B Preferred Stock in the Series
B Preferred Stock Offering and Exchange. As a result, no shares of Series A Preferred Stock remain outstanding.
Series A-1 Preferred Stock Offering
On October 17, 2023, the Company
issued 5,000 shares of newly designated Series A-1 Convertible Preferred Stock (the “Series A-1 Preferred Stock”). The terms
of the Series A-1 Preferred Stock were substantially identical to the terms of the Series A Preferred Stock, except that the Series A-1
Preferred Stock has a conversion price of $ 1.2592 . The aggregate gross proceeds from the sale of shares in such offering were $ 5.0 million.
On March 13, 2024, the Company
issued an additional 5,670 shares of Series A-1 Preferred Stock.
As noted above, on March 13,
2024, 100% of the then-outstanding shares of Series A-1 Preferred Stock were exchanged for shares of Series B Preferred Stock in the
Series B Preferred Stock Offering and Exchange. As a result, no shares of Series A-1 Preferred Stock remain outstanding.
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 $ 24,294 ), resulting in an excess of fair value of $ 7.5 million recognized as
a deemed dividend charged to accumulated deficit in the 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:
Schedule
of Net Loss Attributable to Common Stockholders
Series B Convertible Preferred Stock Issuance and Series A/A-1 Exchange Offer
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
Lucid Diagnostics Common Stock
In July 2024, the Company received
shareholder approval to amend its certificate of incorporation, as amended, to increase the total number of shares of common stock the
Company is authorized to issue by 100 million shares from 200 million shares to 300 million shares. An amendment effecting such change
was filed with the Secretary of State of Delaware on July 23, 2024.
Additionally in July 2024, the
Company’s shareholders approved, for purposes of Listing Rule 5635 of The Nasdaq Stock Market LLC (“Nasdaq”) the issuance
of shares of the Company’s common stock under the Series B Convertible Preferred Stock (“Series B Preferred Stock”)
sold by the Company in a private offering in March 2024 and the Series B-1 Convertible Preferred Stock (“Series B-1 Preferred Stock”)
sold by the Company in a private offering in May 2024. Each of the Series B and Series B-1 Preferred Stock is a voting security. On any
matter to be acted upon or considered by the stockholders of the Company, each holder shall be entitled to vote on an “as converted”
basis after applying the beneficial ownership limitations described in the Series B and B-1 Preferred Stock Offering above.
As of December 31, 2024
and December 31, 2023, there were 63,071,950 and 42,329,864 shares of common stock issued and outstanding, respectively. On September
10, 2024, following preferred equity transactions completed by the Company earlier in 2024 and the termination of voting proxies entered
into between PAVmed and certain shareholders of the Company, PAVmed’s voting interest in the Company was reduced to less than 50.0%,
resulting in the loss of a controlling financial interest. However, PAVmed retains the ability to exercise significant influence over
Lucid. As of December 31, 2024, PAVmed holds 31,302,444 shares of the Company’s common stock.
On January 26, 2024, PAVmed elected
to receive payment of $ 4,675 of fees and reimbursements due from Lucid, through the issuance of 3,331,771 shares of Lucid Diagnostics
common stock. Substantially all of such shares were distributed by PAVmed to its shareholders on February 15, 2024.
F- 27
Note 14 — Stockholders’ Equity - continued
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.
In the year ended December 31,
2024, the Company issued 790,000 shares of common stock to vendors in exchange for $ 641 of agreed upon services, which is included in
general and administrative operating expenses on the Company’s consolidated statement of operations.
Subsequent to December 31, 2024,
on March 5, 2025, the Company closed on the sale of 13,939,331 shares of its common stock at a price of $ 1.10 per share. The net proceeds
of the offering, after deducting the estimated placement agent’s fees and other expenses, was approximately $ 14.5 million.
Also subsequent to December 31, 2024, on or about March 13, 2025, the Company issued 7,117,463 shares of its common
stock as a dividend to the holders of its Series B Preferred Stock (in accordance with the terms of such preferred stock), which shares
represent 20 % of the number of shares of Common Stock issuable upon conversion of the Series B Preferred Stock then held by such holders
on March 13, 2025.
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 December 31, 2024. This facility terminates 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.
In November 2022, the Company
entered into an “at-the-market offering” (“ATM”) for up to $ 6.5 million of its common stock that may be offered
and sold under a Controlled Equity Offering Agreement between the Company and Cantor. Cumulatively a total of 230,068 shares of Lucid
Diagnostics’ common stock were issued through the at-the-market equity facility for net proceeds of approximately $ 0.3 million,
after payments of 3 % commissions, as of December 31, 2024. Effective as of March 4, 2025, the Company terminated the prospectus
supplement for the “at-the-market offering”. The Company will not make any sales of common stock in such offering unless
and until a new prospectus or prospectus supplement is filed.
Note 15 — Income Taxes
Income tax (benefit) expense
for respective periods noted is as follows:
Schedule
of Income Tax (Benefit) Expense
2024
2023
Years Ended December 31,
2024
2023
Current
Federal, State and Local
$ —
$ —
Deferred
Federal
( 8,033 )
( 9,281 )
State and Local
( 2,173 )
( 6,897 )
Current and Deferred tax (benefit) expense
( 10,206 )
( 16,178 )
Less: Valuation allowance reserve
10,206
16,178
Income tax (benefit) expense
$ —
$ —
F- 28
Note 15 — Income Taxes - continued
The reconciliation of the federal
statutory income tax rate to the effective income tax rate for the respective period noted is as follows:
Schedule
of Reconciliation of Federal Statutory Income Tax Rate
2024
2023
Years Ended December 31,
2024
2023
U.S. federal statutory rate
21.0 %
21.0 %
U.S. state and local income taxes, net of federal benefit
6.1 %
6.4 %
Permanent differences
( 1.9 )%
( 1.3 )%
Tax credits
0.4 %
1.5 %
Revaluation of state deferred taxes
0.8 %
— %
Federal deferred true-up
( 0.8 )%
( 0.7 )%
State deferred true-up
( 3.2 )%
3.8 %
Valuation allowance
( 22.4 )%
( 30.7 )%
Effective tax rate
— %
— %
The tax effects of temporary
differences which give rise to the net deferred tax assets for the respective period noted is as follows:
Schedule
of Net Deferred Tax Assets
2024
2023
Years Ended December 31,
2024
2023
Deferred Tax Assets
Net operating loss
$ 39,472
$ 29,059
Debt issue costs
—
55
Stock-based compensation expense
7,659
7,984
Accrued expenses
154
111
Depreciation & amortization
755
790
Lease liabilities
736
—
Research and development expenditures
3,107
3,109
Research and development tax credit carryforwards
1,225
1,062
Deferred tax assets
$ 53,108
$ 42,170
Deferred Tax Liabilities
Operating leases right-of-use assets
( 732 )
—
Deferred Tax Liabilities
$ ( 732 )
$ —
Deferred tax assets, net of deferred tax liabilities
52,376
42,170
Less: valuation allowance
( 52,376 )
( 42,170 )
Deferred tax assets, net after valuation allowance
$ —
$ —
F- 29
Note 15 — Income Taxes - continued
Deferred tax assets and deferred
tax liabilities resulting from temporary differences are measured using enacted tax rates expected to apply to taxable income in the
years in which those temporary differences are expected to be recovered or settled. The effect of the change in the tax rate is recognized
as income or expense in the period the change in tax rate is enacted.
As required by FASB ASC Topic
740, Income Taxes, (“ASC 740”), a “more-likely-than-not” criterion is applied when assessing the estimated realization
of deferred tax assets through their utilization to reduce future taxable income, or with respect to a deferred tax asset for tax credit
carryforward, to reduce future tax expense. A valuation allowance is established, when necessary, to reduce deferred tax assets, net
of deferred tax liabilities, when the assessment indicates it is more-likely-than-not, the full or partial amount of the net deferred
tax asset will not be realized. Accordingly, the Company evaluated the positive and negative evidence bearing upon the estimated realizability
of the net deferred tax assets, and based on the Company’s history of operating losses, concluded it is more-likely-than-not the
deferred tax assets will not be realized, and therefore recognized a valuation allowance reserve equal to the full amount of the deferred
tax assets, net of deferred tax liabilities, as of December 31, 2024 and 2023.
Lucid Diagnostics has federal
and state net operating loss (“NOL”) carryforwards, available to reduce future taxable income, if any, as of December 31,
2024 and 2023, as follows: federal NOL carryforward of approximately $ 144.8
million and $ 103.5
million, respectively, with such federal NOL carryforward not having a statutory expiration date; and state NOL carryforward of
approximately $ 134.6 million and $ 103.5
million, respectively, with such state NOL carryforward having statutory expiration
dates commencing in 2037 . The Company has not yet conducted a formal analysis and the NOL carryforward may be subject-to limitation
under U.S. Internal Revenue Code (“IRC”) Section 382 (provided there was a greater than 50% ownership change, as computed
under such IRC Section 382).
As of October 14, 2021,
Lucid Diagnostics filed its Federal income tax returns on a stand-alone legal entity basis but filed combined unitary state tax
returns with PAVmed. As of September 10, 2024, Lucid Diagnostics no longer qualifies to be included in PAVmed’s combined
unitary state tax returns and will file on a stand-alone legal entity basis. For all periods presented, the deferred tax asset net
of valuation allowance, income tax expense and /or an uncertain tax position, if any; is
determined based on Lucid Diagnostics stand-alone legal entity assumed filing of separate income tax returns in all jurisdictions.
The Company files income tax
returns in the United States in federal and applicable state and local jurisdictions. The Company’s tax filings for the years 2018
and thereafter each remain subject to examination by taxing authorities. The Company’s policy is to record interest and penalties
related to income taxes as part of its income tax provision. The Company has not recognized any penalties or interest related to its
income tax provision.
F- 30
Note 16 — 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
2024
2023
Years Ended December 31,
2024
2023
Numerator
Net loss
$ ( 45,529 )
$ ( 52,666 )
Deemed dividend on Series A and Series A-1 Convertible Preferred Stock
( 7,496 )
—
Net loss attributable to Lucid Diagnostics Inc. common stockholders
$ ( 53,025 )
$ ( 52,666 )
Denominator
Weighted average common shares outstanding, basic and diluted
50,515,773
41,756,129
Net loss per share (1)
Net loss per share - basic and diluted
$ ( 1.05 )
$ ( 1.26 )
(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 years ended December 31, 2024 and 2023 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 years 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
2024
2023
December 31,
2024
2023
Stock options
8,646,758
5,504,383
Unvested restricted stock awards
3,897,440
2,337,440
Preferred stock
49,607,115
13,744,812
Total
62,151,313
21,586,635
Note 17 — 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 consolidated statements of operations.
During the years ended December
31, 2024 and 2023 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.
F- 31