Item 1. Financial Statements
Item
1. Financial Statements
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
(a
subsidiary of PAVmed Inc.)
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands except number of shares and per share data - unaudited)
June
30, 2024
December
31, 2023
Assets:
Current
assets:
Cash
$ 24,920
$ 18,896
Accounts
receivable
160
45
Inventory
683
278
Prepaid
expenses, deposits, and other current assets
2,184
2,854
Total
current assets
27,947
22,073
Fixed
assets, net
1,050
1,334
Operating
lease right-of-use assets
3,037
1,307
Intangible
assets, net
947
1,424
Other
assets
1,132
1,132
Total
assets
$ 34,113
$ 27,270
Liabilities,
Preferred Stock and Stockholders’ Equity (Deficit)
Current
liabilities:
Accounts
payable
$ 903
$ 1,146
Accrued
expenses and other current liabilities
2,727
3,841
Operating
lease liabilities, current portion
884
1,106
Senior
Secured Convertible Note - at fair value
11,200
13,950
Due
To: PAVmed Inc. - MSA Fee and operating expenses
266
9,339
Total
current liabilities
15,980
29,382
Operating
lease liabilities, less current portion
2,154
199
Total
liabilities
18,134
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 June 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 shares authorized; 49,344,945 and 42,329,864 shares issued and outstanding as of June 30, 2024
and December 31, 2023, respectively
49
42
Additional
paid-in capital
139,865
129,763
Accumulated
deficit
( 179,854 )
( 150,741 )
Total
Stockholders’ Equity (Deficit)
15,979
( 2,311 )
Total
Liabilities and Stockholders’ Equity (Deficit)
$ 34,113
$ 27,270
See
accompanying notes to the unaudited condensed consolidated financial statements.
3
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
(a
subsidiary of PAVmed Inc.)
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(in
thousands except number of shares and per share data - unaudited)
2024
2023
2024
2023
Three
Months Ended
June
30,
Six
Months Ended
June
30,
2024
2023
2024
2023
Revenue
$ 976
$ 159
$ 1,977
$ 605
Operating
expenses:
Cost
of revenue
1,614
1,549
3,269
2,887
Sales
and marketing
4,210
4,032
8,404
8,159
General
and administrative
4,867
3,830
8,937
10,730
Amortization
of acquired intangible assets
105
505
477
1,010
Research
and development
1,372
1,827
2,873
3,719
Total
operating expenses
12,168
11,743
23,960
26,505
Operating
loss
( 11,192 )
( 11,584 )
( 21,983 )
( 25,900 )
Other
income (expense):
Interest
income
107
136
175
214
Interest
expense
( 6 )
( 223 )
( 18 )
( 257 )
Change
in fair value - Senior Secured Convertible Note
599
290
890
( 499 )
Loss
on issue and offering costs - Senior Secured Convertible Note
—
—
—
( 1,186 )
Debt
extinguishments loss - Senior Secured Convertible Note
( 513 )
—
( 681 )
—
Other
income (expense), net
187
203
366
( 1,728 )
Loss
before provision for income tax
( 11,005 )
( 11,381 )
( 21,617 )
( 27,628 )
Provision
for income taxes
—
—
—
—
Net
loss attributable to Lucid Diagnostics Inc.
$ ( 11,005 )
$ ( 11,381 )
$ ( 21,617 )
$ ( 27,628 )
Less:
Deemed dividend on Series A and Series A-1 Convertible Preferred Stock
—
—
( 7,496 )
—
Net
loss attributable to Lucid Diagnostics Inc. common stockholders
$ ( 11,005 )
$ ( 11,381 )
$ ( 29,113 )
$ ( 27,628 )
Net
loss per share attributable to Lucid Diagnostics Inc. common stockholders - basic and diluted
$ ( 0.23 )
$ ( 0.27 )
$ ( 0.62 )
$ ( 0.67 )
Weighted
average common shares outstanding, basic and diluted
48,212,040
41,833,823
46,613,362
41,404,547
See
accompanying notes to the unaudited condensed consolidated financial statements.
4
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
(a
subsidiary of PAVmed Inc.)
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
for
the THREE AND SIX MONTHS ENDED June 30, 2024
(in
thousands except number of shares and per share data - unaudited)
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 March 31, 2024
44,285
44,285
46,747,062
$ 47
$ 136,411
$ ( 168,849 )
$ 11,894
Stock-based
compensation - Lucid Diagnostics Inc. 2018 Equity Plan
—
—
—
—
1,106
—
1,106
Stock-based
compensation - PAVmed Inc. 2014 Equity Plan
—
—
—
—
95
—
95
Conversions
- Senior Secured Convertible Note
—
—
2,117,883
2
1,852
—
1,854
Issuance
- Series B-1 Preferred Stock
11,634
11,634
—
—
—
—
11,634
Issue
common stock - vendor service agreement
—
—
480,000
—
401
—
401
Net
loss
—
—
—
—
—
( 11,005 )
( 11,005 )
Balance
as of June 30, 2024
55,919
$ 55,919
49,344,945
$ 49
$ 139,865
$ ( 179,854 )
$ 15,979
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
—
—
—
—
1,850
—
1,850
Stock-based
compensation - PAVmed Inc. 2014 Equity Plan
—
—
—
—
285
—
285
Vest
- restricted stock awards
—
—
26,912
—
—
—
—
Conversions
- Senior Secured Convertible Note
—
—
2,661,181
3
2,538
—
2,541
Purchase
- Employee Stock Purchase Plan
—
—
511,884
1
352
—
353
Issuance
- Series A-1 Preferred Stock
5,670
5,670
—
—
—
—
5,670
Exchange
- Series A and Series A-1 Preferred Stock
( 24,295 )
( 24,295 )
—
—
—
( 7,496 )
( 31,791 )
Issuance
- Series B and Series B-1 Preferred Stock
55,919
55,919
—
—
—
—
55,919
Issuance
- Due To: PAVmed Inc. Settlement in Common Stock
—
—
3,331,771
3
4,672
—
4,675
Issue
common stock - vendor service agreement
—
—
480,000
401
—
401
Net
loss
—
—
—
—
—
( 21,617 )
( 21,617 )
Balance
as of June 30, 2024
55,919
$ 55,919
49,344,945
$ 49
$ 139,865
$ ( 179,854 )
$ 15,979
5
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
(a
subsidiary of PAVmed Inc.)
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
for
the THREE AND SIX MONTHS ENDED June 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 March 31, 2023
13,625
13,625,000
41,753,603
$ 42
$ 125,561
$ ( 114,322 )
$ 24,906
Stock-based
compensation - Lucid Diagnostics Inc.
—
—
—
—
1,165
—
1,165
Stock-based
compensation - PAVmed Inc.
—
—
—
—
234
—
234
Issue
common stock - vendor service agreement
—
—
100,000
—
147
—
147
Net
loss
—
—
—
—
—
( 11,381 )
( 11,381 )
Balance
as of June 30, 2023
13,625
$ 13,625
41,853,603
$ 42
$ 127,107
$ ( 125,703 )
$ 15,071
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
—
—
—
—
3,982
—
3,982
Stock-based
compensation - PAVmed Inc. 2014 Equity Plan
—
—
—
—
625
—
625
Vest
- restricted stock awards
—
—
219,320
—
—
—
—
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
—
—
231,987
—
276
—
276
Issuance
- Series A Preferred Stock
13,625
13,625
—
—
—
—
13,625
Issue
common stock - vendor service agreement
—
—
100,000
—
147
—
147
Net
loss
—
—
—
—
—
( 27,628 )
( 27,628 )
Balance
as of June 30, 2023
13,625
$ 13,625
41,853,603
$ 42
$ 127,107
$ ( 125,703 )
$ 15,071
Balance
13,625
$ 13,625
41,853,603
$ 42
$ 127,107
$ ( 125,703 )
$ 15,071
See
accompanying notes to the unaudited condensed consolidated financial statements.
6
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
(a
subsidiary of PAVmed Inc.)
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in
thousands except number of shares and per share data - unaudited)
2024
2023
Six
Months Ended June 30,
2024
2023
Cash
flows from operating activities
Net
loss
$ ( 21,617 )
$ ( 27,628 )
Adjustments
to reconcile net loss to net cash used in operating activities
Depreciation
and amortization expense
730
1,245
Stock-based
compensation - Lucid Diagnostics Inc. 2018 Equity Plan
1,850
3,982
Stock-based
compensation - PAVmed Inc. 2014 Equity Plan
285
625
Change
in fair value - Senior Secured Convertible Note
( 890 )
499
Loss
on issue - Senior Secured Convertible Note
—
1,111
Debt
extinguishment loss - Senior Secured Convertible Note
681
—
APA-RDx:
Issue common stock - termination payment
—
713
Amortization
of common stock payment for vendor service agreement
113
23
Changes
in operating assets and liabilities:
Accounts
receivable
( 115 )
( 18 )
Prepaid
expenses and other current assets
625
( 1,120 )
Accounts
payable
( 243 )
( 419 )
Accrued
expenses and other current liabilities
( 1,114 )
1,193
Due
To: PAVmed Inc. - operating expenses, employee related costs, MSA Fee
( 4,399 )
5,737
Net
cash flows used in operating activities
( 24,094 )
( 14,057 )
Cash
flows from investing activities
Purchase
of equipment
( 37 )
( 32 )
Net
cash flows used in investing activities
( 37 )
( 32 )
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
353
276
Net
cash flows provided by financing activities
30,155
24,185
Net
increase (decrease) in cash
6,024
10,096
Cash,
beginning of period
18,896
22,474
Cash,
end of period
$ 24,920
$ 32,570
See
accompanying notes to the unaudited condensed consolidated financial statements.
7
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
(a
subsidiary of PAVmed Inc.)
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 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 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 $ 1.0 million and $ 2.0 million of revenues for the three and six month periods ended
June 30, 2024, respectively, however the Company does not expect to generate positive cash flows from operating activities in the near
future.
The
Company incurred a net loss attributable to Lucid Diagnostics Inc common stockholders of approximately $ 29.1 million and had net cash
flows used in operating activities of approximately $ 24.1 million for the six month period ended June 30, 2024. As of June 30, 2024,
the Company had working capital of approximately $ 12.0 million, with such working capital inclusive of the Senior Secured Convertible
Note classified as a current liability of approximately $ 11.2 million and approximately $ 24.9 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.
8
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 consolidated subsidiary
of PAVmed, which has financial control of 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 six months ended June 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.
9
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.
10
Note
3 — Summary of Significant Accounting Policies - continued
Reclassifications
Certain
prior-year amounts have been reclassified to conform to the current year presentation, which includes presenting costs of revenue within
operating expenses on the statements of operations, in the unaudited condensed consolidated financial statements and accompanying notes
to the unaudited condensed consolidated financial statements. The impact of the reclassifications made to prior year amounts is not material
and did not affect net loss.
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 does not expect the standard to have a significant impact
on its unaudited condensed consolidated financial statements.
In
October 2023, the FASB issued ASU No. 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure
Update and Simplification Initiative. This update modifies the disclosure or presentation requirements of a variety of topics in the
Accounting Standards Codification to conform with certain SEC amendments in Release No. 33-10532, Disclosure Update and Simplification.
The amendments in this update should be applied prospectively, and the effective date for each amendment will be the date on which the
SEC’s removal of that related disclosure from Regulation S-X or S-K becomes effective. However, if the SEC has not removed the
related disclosure from its regulations by June 30, 2027, the amendments will be removed from the Codification and not become effective.
Early adoption is prohibited. The Company is currently evaluating the impact this update will have on its unaudited condensed consolidated
financial statements and disclosures.
Note
4 — Revenue from Contracts with Customers
Revenue
Recognized
In
the three and six month periods ended June 30, 2024, the Company recognized revenue of $ 976 and $ 1,977 , respectively, resulting from
the delivery of patient EsoGuard test results. Revenue recognized from customer contracts deemed to include a variable consideration
transaction price is limited to the unconstrained portion of the variable consideration. The Company’s revenue for the three and
six month periods ended June 30, 2023 was $ 159 and $ 605 , respectively, resulting from the delivery of patient EsoGuard test results.
Cost
of Revenue
The
cost of revenues principally includes the costs related to the Company’s laboratory operations (excluding estimated costs associated
with research activities), the costs related to the EsoCheck cell collection device, cell sample mailing kits and license royalties.
In
the three and six month periods ended June 30, 2024, the cost of revenue was $ 1,614 and $ 3,269 , respectively, primarily related to costs
for our laboratory operations and EsoCheck device supplies. The Company’s cost of revenue for the three and six month periods ended
June 30, 2023 was $ 1,549 and $ 2,887 , respectively, primarily related to costs for our laboratory operations and EsoCheck device supplies.
11
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
5,000
—
—
5,000
ERC
- Benefits
—
913
—
913
On
Behalf Of (OBO) activities
—
—
341
341
Cash
payments to PAVmed Inc.
( 9,500 )
( 889 )
( 263 )
( 10,652 )
Payment
to PAVmed Inc. settled in LUCD stock
( 1,650 )
( 3,025 )
—
( 4,675 )
Balance
- June 30, 2024
$ —
$ 162
$ 104
$ 266
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.
The respective companies’ boards of directors approved an amendment to the MSA to increase the MSA Fee to $ 833 per month, effective
January 1, 2024. During the six months ended June 30, 2023, MSA fees were $ 750 per month.
Subsequent
to June 30, 2024, in August 2024, the respective companies’ boards of directors approved the Company to 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.
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
June
30,
Six
Months Ended
June
30,
2024
2023
2024
2023
Sales
& Marketing
127
109
$ 253
$ 218
General
& Administrative
1,803
1,554
3,607
3,108
Research
& Development
570
587
1,140
1,174
Total
MSA Fee
$ 2,500
$ 2,250
$ 5,000
$ 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.
Note
6 — Prepaid Expenses, Deposits, and Other Current Assets
Prepaid
expenses and other current assets consisted of the following as of:
Schedule of Prepaid Expenses and Other Current Assets
June
30, 2024
December
31, 2023
Advanced
payments to service providers and suppliers
$ 563
$ 266
Prepaid
insurance
266
607
Deposits
1,355
1,981
Total
prepaid expenses, deposits and other current assets
$ 2,184
$ 2,854
12
Note
7 — Leases
During
the six months ended June 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 June 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)
$ 562
2025
1,016
2026
952
2027
913
2028
1
Total
lease payments
$ 3,444
Less:
imputed interest
( 406 )
Present
value of lease liabilities
$ 3,038
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
Six
Months Ended June 30,
2024
2023
Cash
paid for amounts included in the measurement of lease liabilities
Operating
cash flows from operating leases
$ 598
$ 583
Non-cash
investing and financing activities
Right-of-use
assets obtained in exchange for new operating lease liabilities
$ 2,285
$ 321
Weighted-average
remaining lease term - operating leases (in years)
3.33
1.80
Weighted-average
discount rate - operating leases
7.875 %
7.875 %
As
of June 30, 2024 and December 31, 2023, the Company’s right-of-use assets from operating leases were $ 3,037 and $ 1,307 , respectively,
which are reported in operating lease right-of-use assets in the unaudited condensed consolidated balance sheets. As of June 30, 2024
and December 31, 2023, the Company had outstanding operating lease obligations of $ 3,038 and $ 1,305 , respectively, of which $ 884 and
$ 1,106 , respectively, are reported in operating lease liabilities, current portion and $ 2,154 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.
13
Note
8 — Intangible Assets, net
Intangible
assets, less accumulated amortization, consisted of the following as of:
Schedule of Intangible Assets
Estimated
Useful Life
June
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
( 4,358 )
( 3,881 )
Intangible
Assets, net
$ 947
$ 1,424
Amortization
expense of the intangible assets discussed above was $ 105 and $ 505 for the three month periods ended June 30, 2024 and 2023, respectively,
and $ 477 and $ 1,010 for the six month periods ended June 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 June 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)
$ 210
2025
421
2026
316
Total
$ 947
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
June
30, 2024
March
2023 Senior Convertible Note
$ —
$ —
$ 11,200
$ 11,200
Totals
$ —
$ —
$ 11,200
$ 11,200
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 six months ended June 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.
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.
1
There were no transfers between the respective Levels during the six months ended June 30, 2024.
14
Note
9 — Financial Instruments Fair Value Measurements - continued
The
estimated fair value of the March 2023 Senior Convertible Note as of each of June 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:
June 30, 2024
March
2023 Senior Convertible Note:
December 31, 2023
Fair
Value
$ 11,200
$ 13,950
Face
value principal payable
$ 9,811
$ 11,019
Required
rate of return
10.00 %
10.00 %
Conversion
Price
$ 5.00
$ 5.00
Value
of common stock
$ 0.82
$ 1.41
Expected
term (years)
0.72
1.22
Volatility
60.00 %
60.00 %
Risk
free rate
5.09 %
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
$ 9,811
$ 11,200
Balance
as of June 30, 2024
$ 9,811
$ 11,200
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
15
Note
10 — Debt - continued
The
changes in the fair value of debt during the three and six month periods ended June 30, 2024 is as follows:
Schedule of Changes in Fair Value of Debt
March
2023 Senior Convertible Note
Other
Income (expense)
Fair
Value - March 31, 2024
$ 13,140
$ —
Face value principal – issue date
Fair value adjustment – issue date
Installment
repayments – common stock
( 1,125 )
—
Non-installment
payments – common stock
( 216 )
—
Change
in fair value
( 599 )
599
Fair
Value at June 30, 2024
$ 11,200
-
Other
Income (Expense) - Change in fair value – three months ended June 30, 2024
-
$ 599
March
2023 Senior Convertible Note
Other
Income (expense)
Fair
Value - December 31, 2023
$ 13,950
$ —
Installment
repayments – common stock
( 1,208 )
—
Non-installment
payments – common stock
( 652 )
—
Change
in fair value
( 890 )
890
Fair
Value at June 30, 2024
$ 11,200
-
Other
Income (Expense) - Change in fair value – six months ended June 30, 2024
-
$ 890
The
changes in the fair value of debt during the three and six month periods ended June 30, 2023 is as follows:
March
2023 Senior Convertible Note
Other
Income (expense)
Fair
Value - March 31, 2023
$ 11,900
$ —
Change
in fair value
( 290 )
290
Fair
Value at June 30, 2023
$ 11,610
-
Other
Income (Expense) - Change in fair value – three months ended June 30, 2023
-
$ 290
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 )
Change
in fair value
( 290 )
290
Fair
Value at June 30, 2023
$ 11,610
-
Fair Value - Ending Balance
$ 11,610
-
Other
Income (Expense) - Change in fair value – six months ended June 30, 2023
-
$ ( 499 )
16
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 $ 219 and $ 243 for the three
and six months ended June 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 June 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 six month periods ended June 30, 2024, approximately $ 1,125
and $ 1,208 ,
respectively, of principal repayments along with approximately $ 215
and $ 652 ,
respectively, of interest expense thereon, were settled through the issuance of 2,117,883
and 2,661,181
shares, respectively, of common stock of the
Company, with such shares having a fair value of approximately $ 1,854
and $ 2,541 ,
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 $ 512
and $ 681
in the three and six month periods ended June
30, 2024, respectively. Subsequent to June 30, 2024, as of August 8, 2024, approximately $ 375
of principal repayments along with approximately
$ 80
of interest expense thereon, were settled through
the issuance of 747,909
shares of common stock of the Company, with such
shares having a fair value of approximately $ 619
(with such fair value measured as the respective
conversion date quoted closing price of the common stock of the Company).
17
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 768,595 shares available for grant as of June 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 June 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)
3,519,000
$ 1.23
Exercised
( 3,333 )
$ 1.31
Forfeited
( 275,424 )
$ 1.63
Outstanding
stock options at June 30, 2024 (3)
8,744,626
$ 1.70
8.6
$ 199
Vested
and exercisable stock options at June 30, 2024
3,082,590
$ 2.26
7.3
$ 199
(1)
Stock options granted under the Lucid Diagnostics 2018 Equity
Plan and those granted outside such plan generally vest one-third in one year then ratably over the next eight quarters, and have a ten-year
contractual term from date-of-grant.
(2)
The intrinsic value is computed as the difference between the
quoted price of the Lucid Diagnostics common stock on each of June 30, 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 June 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.
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 June 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.
18
Note
11 — Stock-Based Compensation - continued
PAVmed
Inc. 2014 Equity Plan
The
PAVmed 2014 Long-Term Incentive Equity Plan (the “PAVmed 2014 Equity Plan”), is separate and apart from the Lucid Diagnostics
2018 Equity Plan (as such equity plan is discussed above).
Stock-Based
Compensation Expense
The
stock-based compensation expense recognized by the Company for both the Lucid Diagnostics 2018 Equity Plan and the PAVmed 2014 Equity
Plan, for the periods indicated, was as follows:
Schedule
of Stock-Based Compensation Expense
2024
2023
2024
2023
Three
Months Ended
June
30,
Six
Months Ended
June
30,
2024
2023
2024
2023
Lucid
Diagnostics 2018 Equity Plan – cost of revenue
$ 33
$ 16
$ 58
$ 28
Lucid
Diagnostics 2018 Equity Plan – sales and marketing
326
247
597
470
Lucid
Diagnostics 2018 Equity Plan - general and administrative
609
836
937
3,348
Lucid
Diagnostics 2018 Equity Plan - research and development
138
66
258
136
PAVmed
2014 Equity Plan - cost of revenue
11
9
22
16
PAVmed
2014 Equity Plan - sales and marketing
39
120
118
253
PAVmed
2014 Equity Plan - general and administrative
1
8
4
164
PAVmed
2014 Equity Plan - research and development
44
97
141
192
Total
stock-based compensation expense
$ 1,201
$ 1,399
$ 2,135
$ 4,607
The
stock-based compensation expense, as presented above, is inclusive of: stock options and restricted stock awards granted under the Lucid
Diagnostics 2018 Equity Plan to employees of PAVmed, the physician inventors of the technology licensed under the Amended CWRU License
Agreement, and members of the board of directors of Lucid Diagnostics, as well as the stock options granted under the PAVmed 2014 Equity
Plan to the physician inventors.
As
of June 30, 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
$ 4,665
2.1
Restricted
Stock Awards
$ 2,305
1.8
PAVmed
2014 Equity Plan
Stock
Options
$ 152
1.9
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 $ 0.80 per share and $ 0.87 per share during the six month periods ended June 30,
2024 and 2023, respectively, calculated using the following weighted average Black-Scholes valuation model assumptions:
Schedule
of Stock-based Compensation Valuation Assumptions
Six
Months Ended June 30,
2024
2023
Expected
term of stock options (in years)
5.7
5.6
Expected
stock price volatility
74 %
75 %
Risk
free interest rate
4.4 %
3.7 %
Expected
dividend yield
— %
— %
19
Note
11 — Stock-Based Compensation - continued
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. The Lucid ESPP has a total reservation of 1,500,000 shares of common
stock of which 395,886 shares are available for issue as of June 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 issued 44,285 shares of newly designated Series B Convertible Preferred Stock, par value $ 0.001 (the “Series
B Preferred Stock”), to accredited investors at a purchase price of $ 1,000 per share, for aggregate gross proceeds to the Company
of $ 18.1 million. In connection with the offering, 100% of the then-outstanding shares of Series A Preferred Stock and 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 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.
20
Note
12 — Stockholders’ Equity - continued
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 are not subject to a VWAP-Based Mandatory Conversion.
The aggregate gross proceeds from the sale of shares in such offering were $ 11.6 million.
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 44,285 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 both the newly issued
Series B Convertible Preferred Stock (fair value of $ 12,495 ) and 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 - 44,285 shares of Series B Preferred Stock issued
$ 44,285
Less:
Fair value related to newly issued Series B Preferred Stock (of 12,495 shares)
( 12,495 )
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
21
Note
12 — Stockholders’ Equity - continued
Lucid
Diagnostics Common Stock
Subsequent
to June 30, 2024, 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
and also subsequent to June 30, 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 June 30, 2024 and December 31, 2023, there were 49,344,945 and 42,329,864 shares of common stock issued and outstanding, respectively.
As of June 30, 2024, PAVmed holds 31,302,444 shares and maintains a controlling financial and voting interest in the Company.
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.
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.
Committed
Equity Facility and ATM Facility
On
March 28, 2022, the Company entered into a committed equity facility with an affiliate of Cantor Fitzgerald (“Cantor”). Under
the terms of the committed equity facility, Cantor has committed to purchase up to $ 50 million of the Company’s common stock from
time to time at the request of the Company. While there are distinct differences, the facility is structured similarly to a traditional
at-the-market equity facility, insofar as it allows the Company to raise primary equity capital on a periodic basis at prices based on
the existing market price. Cumulatively a total of 680,263 shares of Lucid Diagnostics’ common stock were issued for net proceeds
of approximately $ 1.8 million, after a 4 % discount, as of June 30, 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 June 30, 2024.
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
Three
Months Ended
June
30,
Six
Months Ended
June
30,
2024
2023
2024
2023
Numerator
Net
loss
$ ( 11,005 )
$ ( 11,381 )
$ ( 21,617 )
$ ( 27,628 )
Deemed
dividend on Series A and Series A-1 Convertible Preferred Stock
—
—
( 7,496 )
—
Net
loss attributable to Lucid Diagnostics Inc. common stockholders
$ ( 11,005 )
$ ( 11,381 )
$ ( 29,113 )
$ ( 27,628 )
Denominator
Weighted
average common shares outstanding, basic and diluted
48,212,040
41,833,823
46,613,362
41,404,547
Net
loss per share (1)
Net
loss per share - basic and diluted
$ ( 0.23 )
$ ( 0.27 )
$ ( 0.62 )
$ ( 0.67 )
(1) - Convertible Preferred
Stock would potentially be considered a participating security under the two-class method of calculating net loss per share. However,
the Company has incurred net losses to-date, and as such holders are not contractually obligated to share in the losses, there is no
impact on the Company’s net loss per share calculation for the periods indicated.
Basic
weighted-average number of shares of common stock outstanding for the six month periods ended June 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
June
30,
2024
2023
Stock
options
8,744,626
4,949,962
Unvested
restricted stock awards
3,897,440
1,872,100
Preferred
stock
51,682,378
13,695,850
Total
64,324,444
20,517,912
22
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.