UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended September 30, 2024
OR
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from _____ to _____
Commission
File Number: 001-40901
LUCID
DIAGNOSTICS INC.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
82-5488042
(State
or Other Jurisdiction of
(IRS
Employer
Incorporation
or Organization)
Identification
No.)
360
Madison Avenue
25th
Floor
New
York , NY
10017
(Address
of Principal Executive Offices)
(Zip
Code)
(917)
813-1828
(Registrant’s
Telephone Number, Including Area Code)
Securities
registered pursuant to Section 12(b) of the Exchange Act:
Title
of each Class
Trading
Symbol(s)
Name
of each Exchange on which Registered
Common
Stock, $0.001 par value per share
LUCD
The
NASDAQ Stock Market LLC
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically Interactive Data File required to be submitted pursuant to Rule 405
of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was
required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller
reporting company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated
filer” , “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange
Act.
Large
Accelerated filer
☐
Accelerated
filed
☐
Non-accelerated
filer
☒
Smaller
reporting company
☒
Emerging
growth company
☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to section 13(c) of the Exchange Act ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of September 30, 2024 and November 8, 2024 there were 55,495,158 and 59,342,479 , respectively, shares of the registrant’s
Common Stock, par value $ 0.001 per share, issued and outstanding (with such number of shares inclusive of shares of common stock underlying
unvested restricted stock awards granted under the Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan as of such date).
TABLE
OF CONTENTS
Part I - Financial Information
Page
Item
1.
Financial Statements
Condensed Consolidated Balance Sheets (unaudited) as of September 30, 2024 and December 31, 2023
1
Condensed Consolidated Statements of Operations (unaudited) for the three and nine months ended September 30, 2024 and 2023
2
Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) (unaudited) for the three and nine months ended September 30, 2024 and 2023
3
Condensed Consolidated Statements of Cash Flows (unaudited) for the nine months ended September 30, 2024 and 2023
5
Notes to Unaudited Condensed Consolidated Financial Statements
6
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
24
Item
4.
Controls and Procedures
34
Part II - Other Information
Item
1.
Legal Proceedings
35
Item
5.
Other Information
35
Item
6.
Exhibits
35
Signature
36
Exhibit Index
37
i
Part
I - Financial Information
Item
1. Financial Statements
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands except number of shares and per share data - unaudited)
September 30, 2024
December 31, 2023
Assets:
Current assets:
Cash
$ 14,489
$ 18,896
Accounts receivable
39
45
Inventory
651
278
Prepaid expenses, deposits, and other current assets
1,645
2,854
Total current assets
16,824
22,073
Fixed assets, net
940
1,334
Operating lease right-of-use assets
2,860
1,307
Intangible assets, net
842
1,424
Other assets
1,132
1,132
Total assets
$ 22,598
$ 27,270
Liabilities, Preferred Stock and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable
$ 1,135
$ 1,146
Accrued expenses and other current liabilities
2,006
3,841
Operating lease liabilities, current portion
855
1,106
Senior Secured Convertible Note - at fair value
10,200
13,950
Due To: PAVmed Inc. - MSA Fee and operating expenses
53
9,339
Total current liabilities
14,249
29,382
Operating lease liabilities, less current portion
2,011
199
Total liabilities
16,260
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 55,919 at September 30, 2024 and Series A and Series A-1 Convertible Preferred Stock, shares issued and outstanding 18,625 at December 31, 2023
55,919
18,625
Common stock, $ 0.001
par value, 300,000,000
and 200,000,000 shares authorized as of September 30, 2024 and December 31, 2023, respectively; 51,597,718
and 42,329,864
shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively
52
42
Additional paid-in capital
142,592
129,763
Accumulated deficit
( 192,225 )
( 150,741 )
Total Stockholders’ Equity (Deficit)
6,338
( 2,311 )
Total Liabilities and Stockholders’ Equity (Deficit)
$ 22,598
$ 27,270
See
accompanying notes to the unaudited condensed consolidated financial statements.
1
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(in
thousands except number of shares and per share data - unaudited)
2024
2023
2024
2023
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
Revenue
$ 1,172
$ 783
$ 3,149
$ 1,388
Operating expenses:
Cost of revenue
1,684
1,634
4,954
4,522
Sales and marketing
4,056
3,837
12,459
11,996
General and administrative
5,355
4,320
14,292
15,049
Amortization of acquired intangible assets
105
505
582
1,516
Research and development
1,666
1,615
4,539
5,334
Total operating expenses
12,866
11,911
36,826
38,417
Operating loss
( 11,694 )
( 11,128 )
( 33,677 )
( 37,029 )
Other income (expense):
Interest income
81
116
256
330
Interest expense
( 1 )
( 149 )
( 19 )
( 405 )
Change in fair value - Senior Secured Convertible Note
( 322 )
( 3,021 )
568
( 3,520 )
Loss on issue and offering costs - Senior Secured Convertible Note
—
—
—
( 1,186 )
Debt extinguishments loss - Senior Secured Convertible Note
( 435 )
( 26 )
( 1,116 )
( 26 )
Other income (expense), net
( 677 )
( 3,080 )
( 311 )
( 4,807 )
Loss before provision for income tax
( 12,371 )
( 14,208 )
( 33,988 )
( 41,836 )
Provision for income taxes
—
—
—
—
Net loss attributable to Lucid Diagnostics Inc.
$ ( 12,371 )
$ ( 14,208 )
$ ( 33,988 )
$ ( 41,836 )
Less: Deemed dividend on Series A and Series A-1 Convertible Preferred Stock
—
—
( 7,496 )
—
Net loss attributable to Lucid Diagnostics Inc. common stockholders
$ ( 12,371 )
$ ( 14,208 )
$ ( 41,484 )
$ ( 41,836 )
Net loss per share attributable to Lucid Diagnostics Inc. common stockholders - basic and diluted
$ ( 0.25 )
$ ( 0.34 )
$ ( 0.87 )
$ ( 1.01 )
Weighted average common shares outstanding, basic and diluted
50,374,146
41,862,805
47,876,015
41,558,979
See
accompanying notes to the unaudited condensed consolidated financial statements.
2
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
for
the THREE AND NINE MONTHS ENDED September 30, 2024
(in
thousands except number of shares and per share data - unaudited)
Shares
Amount
Shares
Amount
Additional Paid-In Capital
Accumulated Deficit
Total
Preferred Stock
Common Stock
Shares
Amount
Shares
Amount
Additional Paid-In Capital
Accumulated Deficit
Total
Balance as of June 30, 2024
55,919
55,919
49,344,945
$ 49
$ 139,865
$ ( 179,854 )
$ 15,979
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan
—
—
—
—
1,185
—
1,185
Stock-based compensation - PAVmed Inc. 2014 Equity Plan
—
—
—
—
43
—
43
Conversions - Senior Secured Convertible Note
—
—
2,116,717
3
1,755
—
1,758
Purchase - Employee Stock Purchase Plan
—
—
136,056
—
94
—
94
Transfer of intellectual property from PAVmed Inc.
—
—
—
—
( 350
)
—
( 350
)
Net loss
—
—
—
—
—
( 12,371 )
( 12,371 )
Balance as of September 30, 2024
55,919
$ 55,919
51,597,718
$ 52
$ 142,592
$ ( 192,225 )
$ 6,338
Shares
Amount
Shares
Amount
Additional Paid-In Capital
Accumulated Deficit
Total
Preferred Stock
Common Stock
Shares
Amount
Shares
Amount
Additional Paid-In Capital
Accumulated Deficit
Total
Balance as of December 31, 2023
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
—
—
—
—
3,034
—
3,034
Stock-based compensation - PAVmed Inc. 2014 Equity Plan
—
—
—
—
329
—
329
Vest - restricted stock awards
—
—
26,912
—
—
—
—
Conversions - Senior Secured Convertible Note
—
—
4,777,898
6
4,293
—
4,299
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
Issuance - Due To: PAVmed Inc. Settlement in Common Stock
—
—
3,331,771
3
4,672
—
4,675
Issue common stock - vendor service agreement
—
—
480,000
401
—
401
Transfer of intellectual property from PAVmed Inc.
—
—
—
—
( 350
)
—
( 350 )
Net loss
—
—
—
—
—
(33,988 )
(33,988 )
Balance as of September 30, 2024
55,919
$ 55,919
51,597,718
$ 52
$ 142,592
$ ( 192,225 )
$ 6,338
See
accompanying notes to the unaudited condensed consolidated financial statements.
3
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
for
the THREE AND NINE MONTHS ENDED September 30, 2023
(in
thousands except number of shares and per share data - unaudited)
Shares
Amount
Shares
Amount
Additional Paid-In Capital
Accumulated Deficit
Total
Preferred Stock
Common Stock
Shares
Amount
Shares
Amount
Additional Paid-In Capital
Accumulated Deficit
Total
Balance as of June 30, 2023
13,625
13,625
41,853,603
$ 42
$ 127,107
$ ( 125,703 )
$ 15,071
Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan
—
—
—
—
—
—
—
Stock-based compensation - Lucid Diagnostics Inc.
—
—
—
—
1,032
—
1,032
Stock-based compensation - PAVmed Inc.
—
—
—
—
220
—
220
Vest - restricted stock awards
—
—
84,660
—
—
—
—
Conversions - Senior Secured Convertible Note
—
—
115,388
—
166
—
166
CapNostics, LLC
—
—
—
—
—
—
—
APA-RDx - Installment Payment
—
—
—
—
—
—
—
Issuance - Committed Equity Facility, net of deferred financing charges
—
—
—
—
—
—
—
Purchase - Employee Stock Purchase Plan
—
—
276,213
—
275
—
275
Issue common stock - vendor service agreement
—
—
—
—
—
—
—
Net loss
—
—
—
—
—
( 14,208 )
( 14,208 )
Balance as of September 30, 2023
13,625
$ 13,625
42,329,864
$ 42
$ 128,800
$ ( 139,911 )
$ 2,556
Shares
Amount
Shares
Amount
Additional Paid-In Capital
Accumulated Deficit
Total
Preferred Stock
Common Stock
Shares
Amount
Shares
Amount
Additional Paid-In Capital
Accumulated Deficit
Total
Balance as of December 31, 2022
—
$ —
40,518,792
$ 41
$ 121,081
$ ( 98,075 )
$ 23,047
Balance
—
$ —
40,518,792
$ 41
$ 121,081
$ ( 98,075 )
$ 23,047
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan
—
—
—
—
5,014
—
5,014
Stock-based compensation - PAVmed Inc. 2014 Equity Plan
—
—
—
—
845
—
845
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 Preferred Stock
13,625
13,625
—
—
—
—
13,625
Issue common stock - vendor service agreement
—
—
100,000
—
147
—
147
Net loss
—
—
—
—
—
( 41,836 )
( 41,836 )
Balance as of September 30, 2023
13,625
$ 13,625
42,329,864
$ 42
$ 128,800
$ ( 139,911 )
$ 2,556
Balance
13,625
$ 13,625
42,329,864
$ 42
$ 128,800
$ ( 139,911 )
$ 2,556
See
accompanying notes to the unaudited condensed consolidated financial statements.
4
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in
thousands except number of shares and per share data - unaudited)
2024
2023
Nine Months Ended September 30,
2024
2023
Cash flows from operating activities
Net loss
$ ( 33,988 )
$ ( 41,836 )
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation and amortization expense
945
1,870
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan
3,034
5,014
Stock-based compensation - PAVmed Inc. 2014 Equity Plan
329
845
Change in fair value - Senior Secured Convertible Note
( 568 )
3,520
Loss on issue - Senior Secured Convertible Note
—
1,111
Debt extinguishment loss - Senior Secured Convertible Note
1,116
26
APA-RDx: Issue common stock - termination payment
—
713
Amortization of common stock payment for vendor service agreement
248
23
Changes in operating assets and liabilities:
Accounts receivable
7
( 4 )
Prepaid expenses and other current assets
1,065
( 1,262 )
Accounts payable
( 10 )
( 62 )
Accrued expenses and other current liabilities
( 1,836 )
1,878
Due To: PAVmed Inc. - operating expenses, employee related costs, MSA Fee
( 4,611 )
5,326
Net cash flows used in operating activities
( 34,269 )
( 22,838 )
Cash flows from investing activities
Purchase of equipment
( 37 )
( 46 )
Purchase of intellectual property from PAVmed Inc.
( 350 )
—
Net cash flows used in investing activities
( 387 )
( 46 )
Cash flows from financing activities
Proceeds – issue of preferred stock
29,798
13,625
Proceeds – issue of Senior Convertible Note
—
10,000
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
30,249
24,460
Net increase (decrease) in cash
( 4,407 )
1,576
Cash, beginning of period
18,896
22,474
Cash, end of period
$ 14,489
$ 24,050
See
accompanying notes to the unaudited condensed consolidated financial statements.
5
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(amounts
in these accompanying notes are presented in thousands, except number of shares and per-share amounts.)
Note
1 — The Company
Description
of the Business
Lucid
Diagnostics Inc. (“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”).
The
Company believes that its flagship product, the EsoGuard Esophageal DNA Test, performed on samples collected with the EsoCheck Esophageal
Cell Collection Device, constitutes the first and only commercially available diagnostic test capable of serving as a widespread testing
tool for the early detection of esophageal precancer in at-risk GERD patients.
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. The Company believes that this proprietary Collect+Protect™ technology
makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling.
EsoGuard
and EsoCheck are based on patented technology licensed by Lucid from Case Western Reserve University (“CWRU”). EsoGuard and
EsoCheck have been developed to provide an accurate, non-invasive, patient-friendly test for the early detection of EAC and Barrett’s
Esophagus (“BE”), including dysplastic BE and related precursors to EAC in patients with chronic GERD.
Note
2 — Liquidity and Going Concern
The
Company’s management is required to assess an entity’s ability to continue as a going concern within one year of the date
of the financial statements being issued. In each reporting period, including interim periods, an entity is required to assess conditions
known and reasonably knowable as of the financial statement issuance date to determine whether it is probable an entity will not meet
its financial obligations within one year from the financial statement issuance date. Substantial doubt about an entity’s ability
to continue as a going concern exists when conditions and events, considered in the aggregate, indicate it is probable the entity will
be unable to meet its financial obligations as they become due within one year after the date the financial statements are issued.
The
Company has financed its operations principally through public and private issuances of its common stock, preferred stock, and debt.
The Company is subject to all of the risks and uncertainties typically faced by medical device and diagnostic companies that devote substantially
all of their efforts to the commercialization of their initial product and services and ongoing research and development activities and
conducting clinical trials. The Company generated $ 1.2 million and $ 3.1 million of revenues for the three and nine month periods ended
September 30, 2024, respectively, however the Company expects to continue to experience recurring losses and to generate negative cash flows from operating activities in the
near future.
The
Company incurred a net loss attributable to Lucid Diagnostics Inc common stockholders of approximately $ 41.5 million and had net cash
flows used in operating activities of approximately $ 34.3 million for the nine month period ended September 30, 2024. As of September
30, 2024, the Company had working capital of approximately $ 2.6 million, with such working capital inclusive of the Senior Secured Convertible
Note classified as a current liability of approximately $ 10.2 million and approximately $ 14.5 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 unaudited condensed consolidated financial statements are issued.
6
Note
3 — Summary of Significant Accounting Policies
Significant
Accounting Policies
The
Company’s significant accounting policies are as disclosed in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2023 as filed with the SEC on March 25, 2024, except as otherwise noted herein below.
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements of the Company and its subsidiaries have been prepared in accordance
with accounting principles generally accepted in the United States of America (“U.S. GAAP”), and applicable rules and regulations
of the United States Securities and Exchange Commission (“SEC”), and include the accounts of the Company and its wholly-owned
subsidiaries. All intercompany transactions and balances have been eliminated in consolidation. The Company is a non-consolidated subsidiary
of PAVmed, which has the ability to exercise significant influence over the Company. The Company manages its operations as a single operating segment for the purposes
of assessing performance and making operating decisions.
As
permitted under SEC rules, certain footnotes or other financial information normally required by U.S. GAAP have been condensed or omitted.
The balance sheet as of December 31, 2023 has been derived from audited consolidated financial statements at such date. The accompanying
unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated
financial statements, and in the opinion of management, include all adjustments, consisting only of routine recurring adjustments, necessary
for a fair statement of the Company’s unaudited condensed consolidated financial information.
The
unaudited condensed consolidated results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative
of the consolidated results to be expected for the year ending December 31, 2024 or for any other interim period or for any other future
periods. The accompanying unaudited condensed consolidated financial statements and related unaudited condensed consolidated financial
information should be read in conjunction with the Company’s audited consolidated financial statements and related notes thereto
as of and for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K as filed with the SEC on March
25, 2024.
All
amounts in the accompanying unaudited condensed consolidated financial statements and the notes thereto are presented in thousands of
dollars, if not otherwise noted as being presented in millions of dollars, except for shares and per share amounts.
Use
of Estimates
In
preparing the unaudited condensed consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates
and assumptions that affect the reported amounts of assets and the determination of corresponding carrying value reserves, if any, and
liabilities and the disclosure of contingent losses, as of the date of the unaudited condensed consolidated financial statements, as
well as the reported amounts of revenue and expenses during the reporting period. Significant estimates in these unaudited condensed
consolidated financial statements include those related to the estimated fair value of debt obligations, stock-based equity awards and
intangible assets. Other significant estimates include the estimated incremental borrowing rate, the provision or benefit for income
taxes and the corresponding valuation allowance on deferred tax assets. Additionally, management’s assessment of the Company’s
ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. On an ongoing
basis, the Company evaluates its estimates and assumptions. The Company bases its estimates on historical experience and on various other
assumptions believed to be reasonable. Due to inherent uncertainty involved in making estimates, actual results reported in future periods
may be affected by changes in these estimates.
Revenue
Recognition
Revenues
are recognized when the satisfaction of the performance obligation occurs, in an amount that reflects the consideration the Company expects
to collect in exchange for those services. The Company’s revenue is primarily generated by its laboratory testing services utilizing
its EsoGuard Esophageal DNA tests. The services are completed upon release of a patient’s test result to the ordering healthcare
provider. Revenue recognized is inclusive of both variable consideration in connection with an individual patient’s third-party
insurance coverage policy and fixed consideration in connection with a contracted services arrangement with an unrelated third party
legal entity. To determine revenue recognition for the arrangements that the Company determines are within the scope of ASC 606, Revenue
from Contracts with Customers, the Company performs the following five steps: (1) identify the contract(s) with a customer, (2) identify
the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance
obligations in the contract and (5) recognize revenue when (or as) the entity satisfies a performance obligation.
7
Note
3 — Summary of Significant Accounting Policies - continued
The
key aspects considered by the Company include the following:
Contracts —The
Company’s customer is primarily the patient, but the Company does not enter into a formal reimbursement contract with a patient.
The Company establishes a contract with a patient in accordance with other customary business practices, which is the point in time an
order is received from a provider and a patient specimen has been returned to the laboratory for testing. Payment terms are a function
of a patient’s existing insurance benefits, including the impact of coverage decisions with Center for Medicare & Medicaid
Services (“CMS”) and applicable reimbursement contracts established between the Company and payers. 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.
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 is 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, including the component related to accrued interest, is presented in a single line item within other
income (expense) in the accompanying unaudited condensed consolidated statement of operations (as provided for by ASC 825-10-50-30(b)).
Further, as required by ASC 825-10-45-5, to the extent a portion of the fair value adjustment is attributed to a change in the instrument-specific
credit risk, such portion would be recognized as a component of other comprehensive income (“OCI”) (for which there was no
such adjustment with respect to the March 2023 Senior Convertible Note).
See
Note 9, Financial Instruments Fair Value Measurements , with respect to the FVO election; and Note 10, Debt , for a discussion
of the March 2023 Senior Convertible Note.
8
Note
3 — Summary of Significant Accounting Policies - continued
Recent
Accounting Standards Updates Not Yet Adopted
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 unaudited condensed consolidated financial statements.
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 is
applied retrospectively to all periods presented in the financial statements, unless it is impracticable. The Company is currently
evaluating the impact this update will have on its unaudited condensed consolidated financial statements and disclosures,
however the company does not expect the standard to have a significant impact.
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 impact this update will have on its unaudited condensed consolidated
financial statements and disclosures.
Note
4 — Revenue from Contracts with Customers
Revenue
Recognized
In
the three and nine month periods ended September 30, 2024, the Company recognized revenue of $ 1,172 and $ 3,149 , respectively, resulting
from the delivery of patient EsoGuard test results. Revenue recognized from customer contracts deemed to include a variable consideration
transaction price is limited to the unconstrained portion of the variable consideration. The Company’s revenue for the three and
nine month periods ended September 30, 2023 was $ 783 and $ 1,388 , respectively, resulting from the delivery of patient EsoGuard test results.
Cost
of Revenue
The
cost of revenues principally includes the costs related to the Company’s laboratory operations (excluding estimated costs associated
with research activities), the costs related to the EsoCheck cell collection device, cell sample mailing kits and license royalties.
In
the three and nine month periods ended September 30, 2024, the cost of revenue was $ 1,684 and $ 4,954 , respectively, primarily related
to costs for our laboratory operations and EsoCheck device supplies. The Company’s cost of revenue for the three and nine month
periods ended September 30, 2023 was $ 1,634 and $ 4,522 , respectively, primarily related to costs for our laboratory operations and EsoCheck
device supplies.
9
Note
5 — Related Party Transactions
The
aggregate Due To: PAVmed Inc. for the period indicated is summarized as follows:
Schedule of Due To: PA Vmed Inc
MSA Fees
Employee-Related Costs
PAVmed Inc. OBO Payments
Total
Balance - December 31, 2023
$ 6,150
$ 3,163
$ 26
$ 9,339
MSA fees
8,150
—
—
8,150
ERC - Benefits
—
1,411
—
1,411
On Behalf Of (OBO) activities
—
—
598
598
Cash payments to PAVmed Inc.
( 12,650 )
( 1,537 )
( 583 )
( 14,770 )
Payment to PAVmed Inc. settled in LUCD stock
( 1,650 )
( 3,025 )
—
( 4,675 )
Balance - September 30, 2024
$ —
$ 12
$ 41
$ 53
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 nine months ended September 30, 2023, MSA fees were $ 750
per month.
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 unaudited condensed consolidated statement of operations for the periods noted is as follows:
Schedule of MSA Fee Expense Classification in Statements of Operations
2024
2023
2024
2023
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
Sales & Marketing
164
109
$ 417
$ 218
General & Administrative
2,253
1,554
5,860
3,108
Research & Development
733
587
1,873
1,174
Total MSA Fee
$ 3,150
$ 2,250
$ 8,150
$ 4,500
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.
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
September 30, 2024
December 31, 2023
Advanced payments to service providers and suppliers
$ 389
$ 266
Prepaid insurance
49
607
Deposits
1,207
1,981
Total prepaid expenses, deposits and other current assets
$ 1,645
$ 2,854
10
Note
7 — Leases
During
the nine months ended September 30, 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
Company’s future lease payments as of September 30, 2024, which are presented as operating lease liabilities, current portion and
operating lease liabilities, less current portion on the Company’s unaudited condensed consolidated balance sheets are as follows:
Schedule of Future Lease Payments of Operating Lease Liabilities
2024 (remainder of year)
$ 266
2025
1,025
2026
979
2027
940
2028
19
Total lease payments
$ 3,229
Less: imputed interest
( 363 )
Present value of lease liabilities
$ 2,866
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
2024
2023
Nine Months Ended September 30,
2024
2023
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows from operating leases
$ 889
$ 894
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)
3.17
1.58
Weighted-average discount rate - operating leases
7.875 %
7.875 %
As
of September 30, 2024 and December 31, 2023, the Company’s right-of-use assets from operating leases were $ 2,860 and $ 1,307 , respectively,
which are reported in operating lease right-of-use assets in the unaudited condensed consolidated balance sheets. As of September 30,
2024 and December 31, 2023, the Company had outstanding operating lease obligations of $ 2,866 and $ 1,305 , respectively, of which $ 855
and $ 1,106 , respectively, are reported in operating lease liabilities, current portion and $ 2,011 and $ 199 , respectively, are reported
in operating lease liabilities less current portion in the Company’s unaudited condensed consolidated balance sheets. The Company
calculates its incremental borrowing rates for specific lease terms, used to discount future lease payments, as a function of the financing
terms the Company would likely receive on the open market.
11
Note
8 — Intangible Assets, net
Intangible
assets, less accumulated amortization, consisted of the following as of:
Schedule of Intangible Assets
Estimated Useful Life
September 30, 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
( 4,463 )
( 3,881 )
Intangible Assets, net
$ 842
$ 1,424
Amortization
expense of the intangible assets discussed above was $ 105
and $ 505
for the three month periods ended September 30,
2024 and 2023, respectively, and $ 582
and $ 1,516
for the nine month periods ended September 30,
2024 and 2023, respectively, and is included in amortization of acquired intangible assets in the accompanying unaudited condensed consolidated
statements of operations. As of September 30, 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
2024 (remainder of year)
$ 105
2025
421
2026
316
Total
$ 842
Note
9 — Financial Instruments Fair Value Measurements
Recurring
Fair Value Measurements
The
fair value hierarchy table for the reporting date noted is as follows:
Schedule of Financial Liabilities Measured at Fair Value on Recurring Basis
Fair Value Measurement on a Recurring Basis at Reporting Date Using 1
Level-1 Inputs
Level-2 Inputs
Level-3 Inputs
Total
September 30, 2024
March 2023 Senior Convertible Note
$ —
$ —
$ 10,200
$ 10,200
Totals
$ —
$ —
$ 10,200
$ 10,200
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 nine months ended September 30, 2024.
As
discussed in Note 10, 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 ASC 825-10-15-4 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.
12
Note
9 — Financial Instruments Fair Value Measurements - continued
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 March 2023 Senior Convertible Note as of each of September 30, 2024 and December 31, 2023 were 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:
September 30, 2024
March 2023 Senior Convertible Note:
December 31, 2023
Fair Value
$ 10,200
$ 13,950
Face value principal payable
$ 8,669
$ 11,019
Required rate of return
9.20 %
10.00 %
Conversion Price
$ 5.00
$ 5.00
Value of common stock
$ 0.82
$ 1.41
Expected term (years)
0.47
1.22
Volatility
60.00 %
60.00 %
Risk free rate
4.33 %
4.56 %
Dividend yield
— %
— %
The
estimated fair values reported utilized the Company’s common stock price along with certain Level 3 inputs (as discussed in the
table above), in the development of Monte Carlo simulation models, discounted cash flow analyses, and /or Black-Scholes valuation models.
The estimated fair values are subjective and are affected by changes in inputs to the valuation models and analyses, including the Company’s
common stock price, the Company’s dividend yield, the risk-free rates based on U.S. Treasury security yields, and certain other
Level-3 inputs including, assumptions regarding the estimated volatility in the value of the Company’s common stock price and the
volatility of similar entities within the medical device industry. Changes in these assumptions can materially affect the estimated fair
values.
Note
10 — Debt
The
fair value and face value principal outstanding of the March 2023 Senior Convertible Note 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
March 2023 Senior Convertible Note
March 21, 2025
7.875 %
$ 5.00
$ 8,669
$ 10,200
Balance as of September 30, 2024
$ 8,669
$ 10,200
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
13
Note
10 — Debt - continued
The
changes in the fair value of debt during the three and nine month periods ended September 30, 2024 is as follows:
Schedule of Changes in Fair Value of Debt
March 2023 Senior Convertible Note
Other Income (expense)
Fair Value - June 30, 2024
$ 11,200
$ —
Face value principal – issue date
-
-
Fair value adjustment – issue date
-
-
Installment repayments – common stock
( 1,142 )
—
Non-installment payments – common stock
( 180 )
—
Change in fair value
322
( 322 )
Fair Value at September 30, 2024
$ 10,200
-
Other Income (Expense) - Change in fair value – three months ended September 30, 2024
$ ( 322 )
March 2023 Senior Convertible Note
Other Income (expense)
Fair Value - December 31, 2023
$ 13,950
$ —
Installment repayments – common stock
( 2,350 )
—
Non-installment payments – common stock
( 832 )
—
Change in fair value
( 568 )
568
Fair Value at September 30, 2024
$ 10,200
-
Other Income (Expense) - Change in fair value – nine months ended September 30, 2024
$ 568
The
changes in the fair value of debt during the three and nine month periods ended September 30, 2023 is as follows:
March 2023 Senior Convertible Note
Other Income (expense)
Fair Value - June 30, 2023
$ 11,610
$ —
Installment repayments – common stock
( 92 )
—
Non-installment payments – common stock
( 49 )
—
Change in fair value
3,021
( 3,021 )
Fair Value at September 30, 2023
$ 14,490
-
Other Income (Expense) - Change in fair value – three months ended September 30, 2023
$ ( 3,021 )
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
2,731
( 2,731 )
Fair Value at September 30, 2023
$ 14,490
-
Fair Value - Ending Balance
$ 14,490
-
Other Income (Expense) - Change in fair value – nine months ended September 30, 2023
$ ( 3,520 )
14
Note
10 — 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 unaudited condensed 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 $ 149 and $ 391 for the three
and nine months ended September 30, 2023, respectively.
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 may 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 is guaranteed by all of Lucid Diagnostics’ subsidiaries;
and the obligations under this senior convertible note are secured by all of the assets of Lucid Diagnostics and its subsidiaries.
Lucid
is 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
is 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. As of September 30, 2024, the Company was in compliance, and as of the date hereof, the Company is in compliance, with
the Financial Tests.
The
March 2023 Senior Convertible Note installment payments may be made in shares of Lucid Diagnostics common stock at a conversion price
that is 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 three and nine month periods ended September 30, 2024, approximately $ 1,142 and $ 2,350 , respectively, of principal repayments along
with approximately $ 180 and $ 832 , respectively, of interest expense thereon, were settled through the issuance of 2,116,717 and 4,777,898
shares, respectively, of common stock of the Company, with such shares having a fair value of approximately $ 1,755 and $ 4,293 , respectively,
(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 $ 435 and $ 1,116 in the three and nine month periods ended September 30, 2024, respectively.
Subsequent to September 30, 2024, as of November 8, 2024, approximately $ 2,415 of principal repayments along with approximately
$ 63 of interest expense thereon, were settled through the issuance of 3,847,321 shares of common stock of the Company, with such shares having
a fair value of approximately $ 3,680 (with such fair value measured as the respective conversion date quoted closing price of the common
stock of the Company).
15
Note 10 — Debt - continued
March 2023 Senior Convertible Note Refinancing
On November 8, 2024, the Company
gave notice to the holder of the March 2023 Senior Convertible Note that it was exercising its right pursuant to such note to redeem the
same for the redemption price specified in such note (the “Optional Redemption Price”). Pursuant to the terms of the March
2023 Senior Convertible Note, the Company has not less than ten business days, and not more than twenty business days, from the date of
the notice (the “Optional Redemption Notice Period”) to pay the Optional Redemption Price.
To finance the payment of
the Optional Redemption Price, the Company has entered into a securities purchase agreement with certain accredited investors (the “2024
Note Investors”). Under the agreement, subject to customary closing conditions, the Company has agreed to issue, and each 2024
Note Investor has agreed to purchase, 12.0 %
senior secured convertible notes due 2029 (collectively, the “November 2024 Senior Convertible Notes”). As of the date hereof,
the aggregate commitments of the 2024 Note Investors exceed the Lucid Optional Redemption Price. Subsequent to September 30, 2024, as
of the date hereof, the Company has received cash proceeds of $ 7.7
million to date related to subscription agreements for the November 2024 Senior Convertible Notes.
The Company expects to complete the issuance of the November 2024 Senior Convertible Notes and the redemption of
the March 2023 Senior Convertible Note on or prior to the end of the Optional Redemption Notice Period.
16
Note
11 — Stock-Based Compensation
Lucid
Diagnostics 2018 Long-Term Incentive Equity Plan
The
Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan (“Lucid Diagnostics 2018 Equity Plan”) is separate and apart
from the PAVmed 2014 Equity Plan discussed below. The Lucid Diagnostics 2018 Equity Plan is designed to enable Lucid Diagnostics to offer
employees, officers, directors, and consultants, an opportunity to acquire shares of common stock of Lucid Diagnostics. The types of
awards that may be granted under the Lucid Diagnostics 2018 Equity Plan include stock options, stock appreciation rights, restricted
stock, and other stock-based awards subject to limitations under applicable law. All awards are subject to approval by the Lucid Diagnostics
compensation committee.
A
total of 14,324,038 shares of common stock of Lucid Diagnostics are reserved for issuance under the Lucid Diagnostics 2018 Equity Plan,
with 850,672 shares available for grant as of September 30, 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 September 30, 2024. In January
2024, the number of shares available for grant was increased by 2,680,038 in accordance with the evergreen provisions of the plan.
Lucid
Diagnostics Stock Options
Lucid
Diagnostics stock options granted under the Lucid Diagnostics 2018 Equity Plan and stock options granted outside such plan are summarized
as follows:
Schedule
of Stock Options Issued and Outstanding Activities
Number of Stock Options
Weighted Average Exercise Price
Remaining Contractual Term (Years)
Intrinsic Value (2)
Outstanding stock options at December 31, 2023
5,504,383
$ 2.00
8.5
$ 765
Granted (1)
3,604,000
$ 1.22
Exercised
( 3,333 )
$ 1.31
Forfeited
( 442,501 )
$ 1.63
Outstanding stock options at September 30, 2024 (3)
8,662,549
$ 1.69
8.3
$ 197
Vested and exercisable stock options at September 30, 2024
3,654,937
$ 2.19
7.2
$ 197
(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 September 30, 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 September 30, 2024 and December 31, 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.
17
Note 11 — Stock-Based Compensation -
continued
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, 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 September 30, 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.
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
2024
2023
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
Lucid Diagnostics 2018 Equity Plan – cost of revenue
$ 30
$ 16
$ 88
$ 44
Lucid Diagnostics 2018 Equity Plan – sales and marketing
328
228
925
697
Lucid Diagnostics 2018 Equity Plan - general and administrative
699
721
1,635
4,069
Lucid Diagnostics 2018 Equity Plan - research and development
128
67
386
204
PAVmed 2014 Equity Plan - cost of revenue
11
10
33
26
PAVmed 2014 Equity Plan - sales and marketing
23
106
141
359
PAVmed 2014 Equity Plan - general and administrative
1
7
5
170
PAVmed 2014 Equity Plan - research and development
8
97
150
290
Total stock-based compensation expense
$ 1,228
$ 1,252
$ 3,363
$ 5,859
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.
18
Note 11 — Stock-Based Compensation -
continued
As
of September 30, 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
$ 3,798
2.0
Restricted Stock Awards
$ 1,935
1.6
PAVmed 2014 Equity Plan
Stock Options
$ 109
1.7
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 nine month periods ended September
30, 2024 and 2023, respectively, calculated using the following weighted average Black-Scholes valuation model assumptions:
Schedule
of Stock-based Compensation Valuation Assumptions
2024
2023
Nine Months Ended September 30,
2024
2023
Expected term of stock options (in years)
5.7
5.6
Expected stock price volatility
73 %
75 %
Risk free interest rate
4.3 %
3.7 %
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 September 30,
2024. In January 2024, our board authorized an increase in the number of shares available for issue by 500,000 .
Note
12 — 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 $ 18.1 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).
19
Note 12 — 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.
The
holders of Series B Preferred Stock will be entitled to dividends payable as follows: (i) 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, 2025, and (ii) 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, 2025 or March 13, 2026, as the case may be, 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.
20
Note 12 — 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 unaudited condensed consolidated balance sheet on March 13, 2024, with such deemed dividend included as
a component of net loss attributable to common stockholders, summarized as follows:
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 September 30, 2024 and December 31, 2023, there were 51,597,718 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 September 30, 2024, PAVmed holds 31,302,444 shares.
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.
21
Note 12 — 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, and that the Company could be eligible
for additional time. The Company intends to consider all available options to regain compliance with the Nasdaq listing standards.
In the nine months ended September 30,
2024, the Company issued 480,000 shares of common stock to vendors in exchange for $ 401 of agreed upon services, which is included in
general and administrative operating expenses on the Company’s unaudited condensed consolidated statement of operations.
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 September 30, 2024.
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 September 30, 2024.
22
Note
13 — Net Loss Per Share
The
Net loss per share basic and diluted for the respective periods indicated is as follows:
Schedule
of Net Loss Per Share Basic and Diluted
2024
2023
2024
2023
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
Numerator
Net loss
$ ( 12,371 )
$ ( 14,208 )
$ ( 33,988 )
$ ( 41,836 )
Deemed dividend on Series A and Series A-1 Convertible Preferred Stock
—
—
( 7,496 )
—
Net loss attributable to Lucid Diagnostics Inc. common stockholders
$ ( 12,371 )
$ ( 14,208 )
$ ( 41,484 )
$ ( 41,836 )
Denominator
Weighted average common shares outstanding, basic and diluted
50,374,146
41,862,805
47,876,015
41,558,979
Net loss per share (1)
Net loss per share - basic and diluted
$ ( 0.25 )
$ ( 0.34 )
$ ( 0.87 )
$ ( 1.01 )
(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 nine month periods ended September 30, 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
September 30,
2024
2023
Stock options
8,662,549
4,957,215
Unvested restricted stock awards
3,897,440
1,787,440
Preferred stock
51,682,378
13,683,647
Total
64,242,367
20,428,302
23
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The
following discussion and analysis of our unaudited condensed consolidated financial condition and results of operations should be read
together with our Annual Report on Form 10-K for the year ended December 31, 2023 (the “Form 10-K”), as filed with the Securities
and Exchange Commission (the “SEC”).
Unless
the context otherwise requires, (i) “we”, “us”, and “our”, and the “Company”, “Lucid”
and “Lucid Diagnostics” refer to Lucid Diagnostics Inc. and its subsidiaries LucidDx Labs Inc. (“LucidDx Labs”)
and CapNostics, LLC (“CapNostics”), (ii) “FDA” refers to the Food and Drug Administration, (iii) “510(k)”
refers to a premarket notification, submitted to the FDA by a manufacturer pursuant to § 510(k) of the Food, Drug and Cosmetic Act
and 21 CFR § 807 subpart E, (iv) “CLIA” refers to the Clinical Laboratory Improvement Amendments of 1988 and associated
regulations set forth in 42 CFR § 493, (v) “CE Mark” refers to a “Conformité Européenne” Mark,
a mark indicating that a product such as a medical device conforms to the essential requirements of the relevant European directive,
and (vi) “LDT” refers to a diagnostic test, defined by the FDA as “an IVD that is intended for clinical use and designed,
manufactured and used within a single laboratory,” which is generally subject only to self-certification of analytical validity
under the CMS CLIA program.
FORWARD-LOOKING
STATEMENTS
This
Quarterly Report on Form 10-Q (this “Form 10-Q”), including the following discussion and analysis of our unaudited condensed
consolidated financial condition and results of operations, contains forward-looking statements that involve substantial risks and uncertainties.
All statements, other than statements of historical facts, contained in this Form 10-Q, including statements regarding our future results
of operations and financial position, business strategy and plans and objectives of management for future operations, are forward-looking
statements. The words “may,” “will,” “should,” “expects,” “plans,” “anticipates,”
“could,” “intends,” “target,” “projects,” “contemplates,” “believes,”
“estimates,” “predicts,” “potential” or “continue” or the negative of these terms or
other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these
identifying words. Forward-looking statements are not guarantees of future performance and the Company’s actual results may differ
significantly from those expressed or implied in the forward-looking statements. Factors that might cause such differences include, but
are not limited to, those discussed in Item 1A of Part I of the Form 10-K under the heading “Risk Factors.”
Important
factors that may affect our actual results include:
● our
limited operating history;
● our
financial performance, including our ability to generate revenue;
● our
ability to obtain regulatory approval for the commercialization of our products;
● the
risk that the FDA will cease to exercise enforcement discretion with respect to LDTs, like
EsoGuard;
● the
ability of our products to achieve market acceptance;
● our
success in retaining or recruiting, or changes required in, our officers, key employees or
directors;
● our
potential ability to obtain additional financing when and if needed;
● our
ability to protect our intellectual property;
● our
ability to complete strategic acquisitions;
● our
ability to manage growth and integrate acquired operations;
● the
potential liquidity and trading of our securities;
● our
regulatory and operational risks;
● cybersecurity
risks;
● risks
related to the COVID-19 pandemic and other health-related emergencies;
● risks
related to our relationship with PAVmed; and
● our
estimates regarding expenses, future revenue, capital requirements and needs for additional
financing.
In
addition, our forward-looking statements do not reflect the potential impact of any future financing, acquisitions, mergers, dispositions,
joint ventures or investments we may make.
We
may not actually achieve the results, plans and/or objectives disclosed in our forward-looking statements, and the intended or expected
developments and/or other events disclosed in our forward-looking statements may not actually occur, and accordingly you should not place
undue reliance on our forward-looking statements. You should read this Form 10-Q and the documents we have filed as exhibits to this
Form 10-Q and the Form 10-K completely and with the understanding our actual future results may be materially different from what we
expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events
or otherwise, except as required by applicable law.
24
Overview
We
are a commercial-stage, cancer prevention medical diagnostics technology company focused on the millions of patients who are at risk
of developing esophageal precancer and cancer, specifically highly lethal esophageal adenocarcinoma (“EAC”).
We
believe that our flagship product, the EsoGuard Esophageal DNA Test, performed on samples collected with the EsoCheck Esophageal Cell
Collection Device, constitutes the first and only commercially available diagnostic test capable of serving as a widespread tool for
the early detection of esophageal precancer, including Barrett’s Esophagus (“BE”), in at-risk patients. Early detection
of esophageal precancer allows patients to undergo appropriate monitoring and treatment, as indicated by clinical practice guidelines,
in an effort to prevent progression to esophageal cancer.
EsoGuard
is a bisulfite-converted targeted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck.
It quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay has been evaluated in multiple studies,
demonstrating sensitivity of ~90% for detecting disease along the full esophageal precancer to cancer spectrum, with a negative predictive
value (NPV) of ~99%. Sensitivity and NPV remain very high even for detecting early precancer, which is unprecedented for a molecular
diagnostic test .
EsoCheck
is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells
in a less than 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 to gently swab surface esophageal cells. When vacuum suction is applied,
the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted
region during device withdrawal. We believe this proprietary Collect+Protect™ technology makes EsoCheck the only noninvasive esophageal
cell collection device capable of such anatomically targeted and protected sampling.
EsoGuard
and EsoCheck are based on patented technology licensed by Lucid from Case Western Reserve University (“CWRU”). EsoGuard and
EsoCheck have been developed to provide an accurate, non-invasive, patient-friendly test for the early detection of EAC and BE, including
dysplastic BE and related precursors to EAC in patients with gastroesophageal reflux disease (“GERD”), commonly known as chronic heartburn, acid reflux, or just reflux.
Recent
Developments
Business
American Journal of Gastroenterology Publication
On November 7, 2024, the Company
announced that its manuscript for its multi-center ESOGUARD BE-1 study has been accepted for publication in The American Journal of Gastroenterology,
the official journal of the American College of Gastroenterology (ACG). This is the fourth publication presenting clinical validation
data for the Company’s EsoGuard® Esophageal DNA Test, and the second to demonstrate its performance in an intended-use screening
population. Consistent with previous studies, EsoGuard showed high sensitivity and negative predictive value in detecting esophageal precancer
(Barrett’s Esophagus or BE). With the acceptance for publication, the Company believes we now have a complete clinical evidence package
to submit our data to the MolDX program and formally seek Medicare coverage.
The prospective, multi-center study
presented data from a cohort of patients who met ACG guideline criteria for esophageal precancer screening and underwent non-endoscopic
EsoGuard testing followed by traditional upper endoscopy. EsoGuard sensitivity and negative predictive value for detecting BE were approximately
88% and 99%, respectively. Specificity and positive predictive value were approximately 81% and 30%, respectively. No serious adverse
events were reported.
Intercompany
Agreements with PAVmed
On
August 6, 2024, PAVmed and the Company entered into a ninth amendment to the management services agreement between PAVmed and Lucid (“MSA”)
to increase the monthly fee thereunder from $0.83 million per month to $1.05 million per month, effective as of July 1, 2024.
On
March 22, 2024, PAVmed and the Company entered into an eighth amendment to the MSA to increase the monthly fee thereunder from $0.75
million per month to $0.83 million per month, effective as of January 1, 2024. The amendment also reset the maximum number of shares
issuable under the agreement to 19.99% of the shares outstanding as of the date of the amendment.
On
January 26, 2024, in accordance with the MSA and the payroll, benefits and expense reimbursement agreement between PAVmed and Lucid (“PBERA”),
PAVmed elected to receive payment of approximately $4.7 million of fees and reimbursements accrued under the MSA and the PBERA through
the issuance of 3,331,771 shares of Lucid’s common stock.
FDA
Enforcement Discretion
In
April 2024, FDA published the final rule under which FDA intends to phase out its general enforcement discretion approach for LDTs so
that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs (the proposed rule was
published in October 2023). In the final rule, FDA has expanded the categories of LDTs that will be eligible for continued enforcement
discretion, which categories include LDTs first marketed prior to May 6, 2024 and LDTs approved by New York State’s Clinical Laboratory
Evaluation Program (“NYS CLEP”). As EsoGuard was marketed prior to the cutoff date, and is also NYS CLEP-approved, EsoGuard will remain
under continued enforcement discretion from FDA’s premarket review requirements and quality systems requirements (except for record-keeping).
As such, there is no immediate impact from the final rule on Lucid’s regulatory strategy.
Appointment
of Dennis Matheis to Board of Directors
On
May 6, 2024, the board of directors of the Company appointed Dennis Matheis as a Class C director of the Company (and he was
subsequently re-elected to the board, together with the incumbent Class C directors of the Company, at the Company’s annual
shareholders meeting held on July 23, 2024). In connection with his joining the board, Mr. Matheis received a grant of an option to
acquire 241,500 shares of the Company’s common stock pursuant to the Company’s Amended and Restated 2018 Long-Term
Incentive Equity Plan in accordance with the Company’s existing compensation policy for non-employee directors.
25
Recent
Developments - continued
Business
- continued
NASDAQ
Notice
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, and that the Company could be eligible
for additional time. The Company intends to consider all available options to regain compliance with the Nasdaq listing standards.
Authorized
Shares Increase
On
July 23, 2024, the Company filed an amendment to its Certificate of Incorporation to effectuate an increase in its authorized shares
from 200,000,000 to 300,000,000. Such increase was approved at the annual meeting
of the Company’s stockholders held the same day.
Lucid IP Matters
On October 15, 2024, the Company
announced that it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent application covering
its proprietary method of using methylation of the cyclin-A1 (CCNA1) gene to help detect esophageal precancer and cancer, a key component
of its EsoGuard® Esophageal DNA Test.
EsoGuard utilizes next-generation
sequencing (NGS) to assess DNA methylation at 31 sites on two genes, vimentin (VIM) and cyclin-A1 (CCNA1). Such methylation has been shown
to be strongly associated with conditions along the spectrum from early esophageal precancer (non-dysplastic Barrett’s Esophagus or BE),
to late precancer (dysplastic BE), to cancer (esophageal adenocarcinoma). Although VIM methylation had been previously associated with
gastrointestinal neoplasias, the association of CCNA1 methylation with esophageal neoplasia is novel and appears to be more specific.
Financing
March
2023 Senior Convertible Note Refinancing
On
November 8, 2024, the Company gave notice to the holder of the March 2023 Senior Convertible Note that it was exercising its right pursuant
to such note to redeem the same for the redemption price specified in such note (the “Optional Redemption Price”). Pursuant
to the terms of the March 2023 Senior Convertible Note, the Company has not less than ten business days, and not more than twenty business
days, from the date of the notice (the “Optional Redemption Notice Period”) to pay the Optional Redemption Price.
To
finance the payment of the Optional Redemption Price, the Company has entered into a securities purchase agreement with certain accredited
investors (the “2024 Note Investors”). Under the agreement, subject to customary closing conditions, the Company has agreed
to issue, and each 2024 Note Investor has agreed to purchase, 12.0% senior secured convertible notes due 2029 (collectively, the “November
2024 Senior Convertible Notes”). As of the date hereof, the aggregate commitments of the 2024 Note Investors exceed the Optional
Redemption Price.
The
Company expects to complete the issuance of the November 2024 Senior Convertible Notes and the redemption of the March 2023 Senior Convertible Note on or prior
to the end of the
Optional Redemption Notice Period, although there can be no assurance that such issuance and redemption will be completed
during such period, if at all.
Series
B and Series B-1 Preferred Stock Offerings
On
March 13, 2024, we 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 our 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 our Series A Convertible Preferred Stock, par value $0.001 per share (the “Series
A Preferred Stock”), and 10,670 shares of our 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, we 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 $18.16 million (inclusive of $5.67 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).
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.
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. The aggregate gross proceeds from the sale of shares
in such offering were $11.6 million.
The
aggregate gross proceeds from the issuances of the Series B Preferred Stock and Series B-1 Preferred Stock were approximately $29.8 million.
26
Results
of Operations
Overview
Revenue
The
Company recognized revenue resulting from the delivery of patient EsoGuard test results when the Company considered the collection of
such consideration to be probable to the extent that it is unconstrained.
Cost
of revenue
Cost
of revenues recognized from the delivery of patient EsoGuard test results includes costs related to EsoCheck device usage, shipment of
test collection kits, royalties and the cost of services to process tests and provide results to physicians. We incur expenses for tests
in the period in which the activities occur, therefore, gross margin as a percentage of revenue may vary from quarter to quarter due
to costs being incurred in one period that relate to revenues recognized in a later period.
We
expect that the gross margin for our services will continue to fluctuate and be affected by EsoGuard test volume, our operating efficiencies,
patient compliance rates, payer mix, the levels of reimbursement, and payment patterns of payers and patients.
Sales
and marketing expenses
Sales
and marketing expenses consist primarily of salaries and related costs for employees engaged in sales, sales support and marketing activities,
as well as the portion of the MSA Fee (as defined in Note 5, Related Party Transactions , to our accompanying unaudited condensed
consolidated financial statements) allocated to sales and marketing expenses, which are principally costs related to PAVmed employees
who are performing services for the Company. We anticipate our sales and marketing expenses will increase in the future, to the extent
we expand our commercial sales and marketing operations as resources permit and insurance reimbursement coverage for our EsoGuard test
expands.
General
and administrative expenses
General
and administrative expenses consist primarily of professional fees for accounting, tax, audit and legal services (including those fees
incurred as a result of our being a public company), consulting fees, expenses associated with obtaining and maintaining patents within
our intellectual property portfolio, and certain employee costs, along with the portion of the MSA Fee allocated to general and administrative
expenses.
We
anticipate our general and administrative expenses will increase in the future to the extent our business operations grow. Furthermore,
we anticipate continued expenses related to being a public company, including fees and expenses for audit, legal, regulatory, tax-related
services, insurance premiums and investor relations costs associated with maintaining compliance as a public company.
Research
and development expenses
Research
and development expenses are recognized in the period they are incurred and consist principally of internal and external expenses incurred
for the development of our technologies and conducting clinical trials, including:
● costs
associated with regulatory filings;
● patent
license fees;
● cost
of laboratory supplies and acquiring, developing, and manufacturing preclinical prototypes;
and
● the
portion of the MSA Fee allocated to research and development.
We
plan to incur research and development expenses for the foreseeable future as we continue the development of our existing products as
well as new innovations. Our research and development activities, including our clinical trials, are focused principally on facilitating
insurer reimbursement, encouraging physician adoption and developing product improvements or extending the utility of the lead products
in our pipeline, including EsoCheck and EsoGuard.
Other
Income and Expense, net
Other
income and expense, net, consists principally of changes in fair value of our convertible note and losses on extinguishment of debt upon
repayment of such convertible note.
Presentation
of Dollar Amounts
All
dollar amounts in this Management’s Discussion and Analysis of Financial Condition and Results of Operations are presented as dollars
in millions, except for share and per share amounts.
27
Results
of Operations - continued
The
three months ended September 30, 2024 as compared to the three months ended September 30, 2023
Revenue
In
the three months ended September 30, 2024, revenue was $1.2 million as compared to $0.8 million for the corresponding period in the prior
year. The $0.4 million increase principally relates to the increase in volume of our EsoGuard Esophageal DNA Tests performed in our CLIA laboratory for the period and the consideration received for the performance of the EsoGuard Esophageal DNA Tests.
Cost
of revenue
In
the three months ended September 30, 2024, the cost of revenue was approximately $1.7 million as compared to $1.6 million for the corresponding
period in the prior year. The net increase of $0.1 million was principally related to:
● approximately
$0.2 million decrease in manufacturing costs associated with the EsoCheck devices and EsoGuard
Esophageal DNA Tests;
● approximately
$0.2 million increase in third party professional and IT related expenses; and
● approximately
$0.1 million increase in compensation and stock-based compensation costs.
Sales
and marketing expenses
In
the three months ended September 30, 2024, sales and marketing costs were approximately $4.1 million as compared to $3.8 million for
the corresponding period in the prior year. The net increase of $0.3 million was principally related to:
● approximately
$0.3 million increase in compensation and stock-based compensation costs.
General
and administrative expenses
In
the three months ended September 30, 2024, general and administrative costs were approximately $5.4 million as compared to $4.3 million
for the corresponding period in the prior year. The net increase of $1.1 million was principally related to:
● approximately
$0.6 million increase related to the amended MSA with PAVmed due to the growth and expansion
of our business and the services incurred through PAVmed;
● approximately
$0.4 million increase in compensation related costs; and
● approximately
$0.1 million increase in third-party professional services related to investor relations
and other third-party professional services.
Research
and development expenses
In
the three months ended September 30, 2024, research and development costs were approximately $1.7 million, compared to $1.6 million for
the corresponding period in the prior year. The net increase of $0.1 million was principally related to:
● approximately
$0.1 million increase in development costs, particularly in clinical trial activities and
outside professional and consulting fees.
Amortization
of Acquired Intangible Assets
The
amortization of acquired intangible assets was approximately $0.1 million in the three months ended September 30, 2024, as compared to
$0.5 million for the corresponding period in the prior year. The decrease of $0.4 million in the current period was due to certain acquired
intangible assets being fully amortized in February 2024.
Other
Income and Expense
Change
in fair value of convertible debt
In
the three months ended September 30, 2024, the change in the fair value of our convertible note was approximately $0.3 million of expense,
related to the March 2023 Senior Convertible Note (as defined in Note 10, Debt , to our accompanying unaudited condensed consolidated
financial statements). The March 2023 Senior Convertible Note was initially measured at its issue-date estimated fair value and subsequently
remeasured at estimated fair value as of each reporting period date. The Company initially recognized a $0.8 million fair value non-cash
expense on the issue date.
28
Results
of Operations - continued
The
three months ended September 30, 2024 as compared to three months ended September 30, 2023 - continued
Loss
on Debt Extinguishment
In
the three months ended September 30, 2024, a debt extinguishment loss in the aggregate of approximately $0.4 million was recognized in
connection with our March 2023 Senior Convertible Note as discussed below.
● In
the three months ended September 30, 2024, approximately $1.1 million of principal repayments
along with approximately $0.2 million of interest expense thereon, were settled through the
issuance of 2,116,717 shares of common stock of the Company, with such shares having a fair
value of approximately $1.8 million (with such fair value measured as the quoted closing
price of the common stock of the Company on the respective conversion date). The conversions
resulted in a debt extinguishment loss of $0.4 million in the three months ended September
30, 2024. The Company incurred less than $0.1 million of debt extinguishment losses in the
three months ended September 30, 2023.
See
Note 10 , Debt , to our accompanying unaudited condensed consolidated financial statements, for additional information with respect
to the March 2023 Senior Convertible Note.
The
nine months ended September 30, 2024 as compared to nine months ended September 30, 2023
Revenue
In
the nine months ended September 30, 2024, revenue was $3.1 million as compared to $1.4 million for the corresponding period in the prior
year. The $1.7 million increase principally relates to the revenue for our EsoGuard Esophageal DNA Test performed in our CLIA laboratory
for the period and the consideration received for the performance of the EsoGuard Esophageal DNA Test.
Cost
of revenue
In
the nine months ended September 30, 2024, the cost of revenue was approximately $5.0 million as compared to $4.5 million for the corresponding
period in the prior year. The $0.5 million increase was principally related to:
● approximately
$0.3 million decrease in manufacturing costs associated with the EsoCheck devices and EsoGuard
Esophageal DNA Tests;
● approximately
$0.3 million increase in compensation related costs, including stock-based compensation;
● approximately
$0.3 million increase in third party professional fees and IT services; and
● approximately
$0.2 million increase in the CLIA laboratory supplies required to perform the EsoGuard Esophageal
DNA tests and in royalty costs for the test.
Sales
and marketing expenses
In
the nine months ended September 30, 2024, sales and marketing costs were approximately $12.5 million as compared to $12.0 million for
the corresponding period in the prior year. The net increase of $0.5 million was principally related to:
● approximately
$0.4 million increase in compensation related costs principally as a result of changes in
headcount and bonus structure and travel expenses; and
● approximately
$0.1 million increase related to the amended MSA with PAVmed due to the growth and expansion
of our business and the services incurred through PAVmed.
General
and administrative expenses
In
the nine months ended September 30, 2024, general and administrative costs were approximately $14.3 million as compared to $15.0 million
for the corresponding period in the prior year. The net decrease of $0.7 million was principally related to:
● approximately
$2.6 million decrease in stock-based compensation;
● approximately
$1.1 million increase related to the amended MSA with PAVmed due to the growth and expansion
of our business and the services incurred through PAVmed;
● approximately
$0.9 million increase in compensation costs; and
● approximately
$0.1 million decrease in third-party professional fees, expenses related to the termination
of the management services agreement with our former laboratory provider, and expenses for finance and legal services.
Research
and development expenses
In
the nine months ended September 30, 2024, research and development costs were approximately $4.5 million, compared to $5.3 million for
the corresponding period in the prior year. The net decrease of $0.8 million was principally related to:
● approximately
$0.8 million decrease in development costs, particularly in clinical trial activities and
outside professional and consulting fees.
29
Results
of Operations - continued
The
nine months ended September 30, 2024 as compared to nine months ended September 30, 2023 - continued
Amortization
of Acquired Intangible Assets
The
amortization of acquired intangible assets was approximately $0.6 million in the nine months ended September 30, 2024, as compared to
$1.5 million for the corresponding period in the prior year. The decrease of $0.9 million in the current period was due to certain acquired
intangible assets being fully amortized in February 2024.
Other
Income and Expense
Change
in fair value of convertible debt
In
the nine months ended September 30, 2024, the change in the fair value of our convertible note was approximately $0.6 million of income,
related to the March 2023 Senior Convertible Note (as defined in Note 10 , Debt , to our accompanying unaudited condensed consolidated
financial statements). The March 2023 Senior Convertible Note was initially measured at its issue date estimated fair value and subsequently
remeasured at estimated fair value as of each reporting period date. The Company initially recognized a $0.8 million fair value remeasurement
as a non-cash expense on the issue date.
Loss
on Issue and Offering Costs - Senior Secured Convertible Note
In
the nine months ended September 30, 2023, in connection with the issue of the March 2023 Senior Convertible Note, we recognized a total
of approximately $1.2 million of lender fee and offering costs paid by us. The Company did not incur lender fees and offering costs in
the nine months ended September 30, 2024 .
Loss
on Debt Extinguishment
In
the nine months ended September 30, 2024, a debt extinguishment loss in the aggregate of approximately $1.1 million was recognized in
connection with our March 2023 Senior Convertible Note as discussed below.
● In
the nine months ended September 30, 2024, approximately $2.4 million of principal repayments
along with approximately $0.8 million of interest expense thereon, were settled through the
issuance of 4,777,898 shares of common stock of the Company, with such shares having a fair
value of approximately $4.3 million (with such fair value measured as the quoted closing
price of the common stock of the Company on the respective conversion date). The conversions
resulted in a debt extinguishment loss of $1.1 million in the nine months ended September
30, 2024. The Company incurred less than $0.1 million of debt extinguishment losses in the
nine months ended September 30, 2023.
See
Note 10 , Debt , to our accompanying unaudited condensed consolidated financial statements, for additional information with respect
to the March 2023 Senior Convertible Note.
Deemed
Dividend on Series A and Series A-1 Convertible Preferred Stock Exchange Offer
The
fair value of the consideration given in the form of the issue of 31,790 shares of Series B Convertible Preferred Stock, with such fair
value recognized as the carrying value of such issued shares of Series B Convertible Preferred Stock, as compared to the carrying value of the extinguished Series A and Series A-1
Convertible Preferred Stock (carrying value of $24.3 million), resulting in an excess of fair value of $7.5 million recognized as a deemed
dividend charged to accumulated deficit in the unaudited condensed consolidated balance sheet on March 13, 2024, with such deemed dividend
included as a component of net loss attributable to common stockholders, summarized as follows:
Series B Convertible Preferred Stock Issuance and Series A/A-1 Exchange Offer
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
30
Liquidity
and Capital Resources
Our
current operational activities are principally focused on the commercialization of EsoGuard. We are pursuing commercialization
across multiple sales channels, including: the communication to and education of medical practitioners and clinicians regarding
EsoGuard; the establishment of Lucid Test Centers for the collection of cell samples using EsoCheck; use of our mobile testing unit;
ongoing #CheckYourFoodTube testing days; and our direct contracting strategic initiative (including in the concierge medicine and employer markets sectors). Additionally, we are developing expanded
clinical evidence to support insurance reimbursement adoption by government and private insurers. Further, as resources permit, the
Company also intends to pursue development of other products and services.
Our
ability to generate revenue depends upon our ability to successfully advance the commercialization of EsoGuard, including significantly
expanding insurance reimbursement coverage, while also completing the clinical studies, product and service development, and necessary
regulatory approval thereof. There are no assurances, however, we will be able to obtain an adequate level of financial resources required
for the long-term commercialization and development of our products and services.
We
are subject to all of the risks and uncertainties typically faced by medical device and diagnostic companies that devote
substantially all of their efforts to the commercialization of their initial products and services, to ongoing research and
development activities, and to conducting clinical trials. We experienced a net loss of approximately $34.0 million and used
approximately $34.3 million of cash in operations during the nine month period ended September 30, 2024. Financing activities
provided $30.2 million of cash during the nine month period ended September 30, 2024. We ended the quarter with cash on-hand of
$14.5 million as of September 30, 2024. We expect to continue to experience recurring losses and negative cash flow from operations,
and will continue to fund our operations with debt and/or equity financing transactions, which in accordance with management’s
plans may include conversions of our existing debt to equity and refinancing our existing debt obligations to extend the maturity
date. The Company’s ability to continue operations 12 months beyond the issuance of the financial statements will depend upon
generating substantial revenue that is conditioned on obtaining positive third-party reimbursement coverage for its EsoGuard
Esophageal DNA Test from both government and private health insurance providers, increasing revenue through contracting directly
with self-insured employers, and upon raising additional capital through various potential sources including equity and/or debt
financings or refinancing existing debt obligations. These factors raise substantial doubt about the Company’s ability to
continue as a going concern within one year after the date the accompanying unaudited condensed consolidated financial statements
are issued.
Preferred
Stock Offerings
On
March 13, 2024, we entered into the Series B Subscription Agreements and Series B Exchange Agreements with the Series B Investors, which
agreements provided for (i) the sale to the Series B Investors of 12,495 shares of our newly designated 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 our Series A Preferred Stock
and 10,670 shares of our Series A-1 Preferred Stock held by them for 31,790 shares of Series B Preferred Stock. Prior to the execution
of the Series B Subscription Agreements and the Series B Exchange Agreements, we 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 $18.16 million (inclusive
of $5.67 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).
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.
On
May 6, 2024, the Company issued approximately 11,634 shares of newly designated 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. The aggregate gross proceeds from the sale of shares in such offering were $11.6 million.
Private
Placement - Securities Purchase Agreement
Effective
as of March 13, 2023, we entered into a Securities Purchase Agreement (the “Note SPA”) with an accredited institutional
investor, pursuant to which we agreed to sell, and the investor agreed to purchase the March 2023 Senior Convertible Note with a
face value principal of $11.1 million. We issued the March 2023 Senior Convertible Note on March 21, 2023 pursuant to the Note SPA.
The March 2023 Senior Convertible Note proceeds were $9.925 million after deducting a $1.186 million lender fee and offering
costs.
31
Liquidity
and Capital Resources - continued
The
March 2023 Senior Convertible Note has 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 the two-year anniversary of the date of issuance. The principal of
the March 2023 Senior Convertible Note and accrued interest thereon is convertible at the option of the holder into the Company’s
common stock at the contractual conversion price. In addition, the principal of the March 2023 Senior Convertible Note amortizes over
18 months commencing six months after its issuance. The amortization payments and accrued interest on the March 2023 Senior Convertible
Note are payable in shares of the Company’s common stock (subject to the satisfaction of certain customary equity conditions and
except for interest payable prior to September 21, 2023), at prices based on the then current market price.
Under
the March 2023 Senior Convertible Note, 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, and transactions
with affiliates, among other customary matters. Under the March 2023 Senior Convertible Note, the Company is also subject to
financial covenants requiring that (i) the amount of the Company’s available cash shall equal or exceed $5.0 million at all
times, (ii) the ratio of (a) the outstanding principal amount of the notes issued under the Note SPA, accrued and unpaid interest
thereon and accrued and unpaid late charges, as of the last day of any fiscal quarter commencing with September 30, 2023 to (b) the
Company’s average market capitalization over the prior ten trading days, shall not exceed 30%, and (iii) the Company’s
market capitalization shall at no time be less than $30 million (the “Financial Tests”). As of September 30, 2024, the
Company was in compliance, and as of the date hereof, the Company is in compliance, with the Financial Tests.
During
the nine month period ended September 30, 2024, approximately $2.4 million of principal repayments along with approximately $0.8 million
of interest expense thereon, were settled through the issuance of 4,777,898 shares of common stock of the Company, with such shares having
a fair value of approximately $4.3 million (with such fair value measured as the respective conversion date quoted closing price of the
common stock of the Company).
March 2023 Senior Convertible Note Refinancing
On November 8, 2024, the
Company gave notice to the holder of the March 2023 Senior Convertible Note that it was exercising its right pursuant to such note
to redeem the same for the Optional Redemption Price specified in such note. Pursuant to the terms of the March 2023 Senior
Convertible Note, the Company has not less than ten business days, and not more than twenty business days, from the date of the
notice (which we sometimes refer to as the “Optional Redemption Notice Period”) to pay the Optional Redemption
Price.
To finance the payment of
the Optional Redemption Price, the Company has entered into a securities purchase agreement with the 2024 Note Investors. Under the
agreement, subject to customary closing conditions, the Company has agreed to issue, and each 2024 Note Investor has agreed to
purchase, the November 2024 Senior Convertible Notes, which are 12.0% senior secured convertible notes due 2029. As of the date hereof, the aggregate commitments of the 2024 Note Investors
exceed the Lucid Optional Redemption Price.
The Company expects to complete
the issuance of the November 2024 Senior Convertible Notes and the redemption of the March 2023 Senior Convertible Note on or prior to
the end of the Optional Redemption Notice Period, although there can be no assurance that such issuance and redemption will be completed
during such period, if at all
32
Liquidity and Capital Resources - continued
The Company expects to complete
the issuance of the November 2024 Senior Convertible Notes and the redemption of the March 2023 Senior Convertible Note on or prior to
the end of the Optional Redemption Notice Period, although there can be no assurance that such issuance and redemption will be completed
during such period, if at all.
Committed
Equity Facility and ATM Facility
In
March 2022, we entered into a committed equity facility with a Cantor affiliate. Under the terms of the committed equity facility, the
Cantor affiliate has committed to purchase up to $50 million of our common stock from time to time at our request. While there are distinct
differences, the committed equity facility is structured similarly to a traditional at-the-market equity facility, insofar as it allows
us 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 common stock of the Company have been issued through our committed equity facility for net proceeds of approximately $1.8 million, after a 4% discount, as of September
30, 2024.
In
November 2022, Lucid Diagnostics also entered into an “at-the-market offering” for up to $6.5 million of its common stock
that may be offered and sold under a Controlled Equity Offering Agreement between Lucid Diagnostics and Cantor. Cumulatively, a total
of 230,068 shares of the Company have been issued through our at-the-market equity facility for net proceeds of approximately $0.3 million,
after payment of 3% commissions, as of September 30, 2024.
Intercompany
Agreements with PAVmed
From
our inception in May 2018 through our initial public offering in October 2021, our operations were funded by PAVmed providing
working capital cash advances and by PAVmed paying certain operating expenses on our behalf. Additionally, our daily operations have
been and continue to be conducted in part by personnel employed by PAVmed, for which we incur an MSA Fee expense. 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 Company and PAVmed boards of
directors. In March 2024, PAVmed and the Company were authorized by their respective boards of directors to enter, and they did
enter, into a eighth amendment to the MSA. Under this amendment, the monthly fee due from the Company to PAVmed was increased from
$750 to $833, effective Janaury 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. Pursuant
to the MSA, as amended, PAVmed may elect to receive payment of the monthly MSA Fee in cash or in shares of our common stock,
with such shares valued at the volume weighted average price (“VWAP”) during the final ten trading days of the
applicable month (subject to a floor price of $0.70 per share). However, in no event will PAVmed be entitled to receive under the
MSA, as amended, from and after the date of the eighth amendment to the MSA, more than 9,644,135 shares of our common stock
(representing 19.99% of our outstanding shares of common stock as of immediately prior to the execution of the eighth
amendment).
As
of September 30, 2024, we had a Due To: PAVmed Inc. payment obligation liability of approximately $0.1 million, which liability is primarily
comprised of our obligations under a payroll and benefit expense reimbursement agreement (the “PBERA”) and the MSA, as well
other operating expenses paid by PAVmed on our behalf. See our accompanying unaudited condensed consolidated financial statements Note
5 , Related Party Transactions. In accordance with the MSA and the PBERA, on January 26, 2024, PAVmed elected to receive payment
of approximately $4.7 million of fees and reimbursements accrued under the MSA and the PBERA through the issuance of 3,331,771 shares
of the Company’s common stock.
33
Critical
Accounting Estimates
The
discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial
statements, which have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S.
GAAP”). The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions
that affect the amounts reporting in our unaudited condensed consolidated financial statements and accompanying notes. On an ongoing
basis, we evaluate our estimates and judgements. In accordance with U.S. GAAP, we base our estimates on historical experience and on
various other factors that are believed to be appropriate under the circumstances. Actual results may differ from these estimates under
different assumptions or conditions. Our critical accounting policies are as disclosed in the Company’s Annual Report on Form 10-K
for the year ended December 31, 2023 as filed with the SEC on March 25, 2024. There have been no material changes to our critical accounting
policies and estimates in the nine months ended September 30, 2024.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our principal executive officer and our principal financial officer, evaluated the effectiveness
of our disclosure controls and procedures as of September 30, 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.
Changes
to Internal Controls Over Financial Reporting
There
has been no change in internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act)
that occurred during our fiscal quarter ended September 30, 2024 that has materially affected, or is reasonably likely to materially
affect, our internal control over financial reporting.
34
Part
II - Other Information
Item
1. Legal Proceedings
In
the ordinary course of our business, particularly as it begins commercialization of its products, the Company may be subject to certain
other legal actions and claims, including product liability, consumer, commercial, tax and governmental matters, which may arise from
time to time. The Company is not aware of any such pending legal or other proceedings that are reasonably likely to have a material impact
on the Company. Notwithstanding, legal proceedings are subject to inherent uncertainties, and an unfavorable outcome could include monetary
damages, and excessive verdicts can result from litigation, and as such, could result in a material adverse impact on the Company’s
business, financial position, results of operations, and /or cash flows. Additionally, although the Company has specific insurance for
certain potential risks, the Company may in the future incur judgments or enter into settlements of claims which may have a material
adverse impact on the Company’s business, financial position, results of operations, and /or cash flows.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
On
May 29, 2024, the Company approved the issuance to an investor relations firm it had engaged 150,000 unregistered shares of the Company’s
common stock. The offer and sale of the shares of common stock is exempt from the registration requirements of the Securities Act of
1933, as amended (the “Securities Act”), pursuant to Section 4(a)(2) of the Securities Act, as a transaction not involving
a public offering.
Except
as set forth above and as previously disclosed in our current reports on Form 8-K filed prior to the date of this Form 10-Q and in the
Annual Report, we did not sell any unregistered securities or repurchase any of our securities during the three months ended September
30, 2024.
See
Part I, Item 2 under the caption “ Liquidity and Capital Resources ” for a description of limitations on the payment
of dividends.
Item
5. Other Information
During
the fiscal quarter ended September 30, 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).
The information set forth
in Part I, Item 2 in the first paragraph under the caption “ Recent Developments — Business — Intercompany
Agreements with PAVmed ” is incorporated herein by reference.
The information set forth in Part I, Item 2 under the caption “Recent Developments — Financing — March 2023 Senior Convertible
Note Refinancing” is incorporated herein by reference.
Item
6. Exhibits
The
exhibits filed as part of this Quarterly Report on Form 10-Q are set forth in the “ Exhibit Index ” below.
35
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized.
Lucid
Diagnostics Inc.
November
12, 2024
By:
/s/
Dennis M McGrath
Dennis
M McGrath
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
36
EXHIBIT
INDEX
Incorporation
by Reference
Exhibit
No.
Description
Form
Exhibit
No.
Date
3.1
Form of Certificate of Designation of Preferences, Rights and Limitations of Series B-1 Preferred Stock.
8-K
3.1
5/7/2024
3.2
Certificate of Amendment to Certificate of Incorporation, dated July 23, 2024.
8-K
3.1
7/23/2024
10.1
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
31.1
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
*
31.2
Certification of Principal Financial and Accounting Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
*
32.1
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
*
32.2
Certification of Principal Financial and Accounting Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
*
101.INS
Inline
XBRL Instance Document
*
101.CAL
Inline
XBRL Taxonomy Extension Schema
*
101.DEF
Inline
XBRL Taxonomy Extension Calculation Linkbase
*
101.LAB
Inline
XBRL Taxonomy Extension Label Linkbase
*
101.PRE
Inline
XBRL Taxonomy Extension Presentation Linkbase
*
104
Cover
Page Interactive Data File (embedded within the Inline XBRL document)
*
*
Filed herewith.
37
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.