Item 1. Financial Statements
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
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.