UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2022
OR
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from _____ to _____
Commission
File Number: 001-40901
LUCID
DIAGNOSTICS INC.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
82-5488042
(State or Other Jurisdiction
of
(IRS Employer
Incorporation or Organization)
Identification No.)
One Grand Central Place
60 E. 42nd Street
Suite 4600
New York , NY 10165
10165
(Address of Principal
Executive Offices)
(Zip Code)
(212)
949-4319
(Registrant’s
Telephone Number, Including Area Code)
Securities
registered under Section 12(b) of the Exchange Act:
Title
of each Class
Trading
Symbol(s)
Name
of each Exchange on which Registered
Common Stock, $0.001 par value per share
LUCD
The NASDAQ Stock Market
LLC
Securities
registered under Section 12(g) of the Exchange Act: None
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically Interactive Data File required to be submitted pursuant to Rule 405
of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was
required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”
, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large Accelerated filer
☐
Accelerated filed
☐
Non-accelerated filer
☒
Smaller reporting company
☒
Emerging growth company
☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to section 13(c) of the Exchange Act ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of August 10, 2022 there were 38,568,462 shares of the registrant’s Common Stock, par value $0.001 per share, issued (with such
number of shares inclusive of shares of common stock underlying unvested restricted stock awards granted under the Lucid Diagnostics
Inc. 2018 Long-Term Incentive Equity Plan as of such date).
TABLE
OF CONTENTS
Page
Part I - Financial Information
Item 1.
Financial Statements
Condensed Consolidated Balance Sheets (unaudited) as of June 30, 2022 and December 31, 2021
1
Condensed Consolidated Statements of Operations (unaudited) for the three and six months ended June 30, 2022 and 2021
2
Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) (unaudited) for the three and six months ended June 30, 2022 and 2021
3
Condensed Consolidated Statements of Cash Flows (unaudited) for the six months ended June 30, 2022 and 2021
5
Notes to Unaudited Condensed Consolidated Financial Statements
6
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
21
Item 4.
Controls and Procedures
34
Part II - Other Information
Item 1.
Legal Proceedings
35
Item 5.
Other Information
35
Item 6.
Exhibits
35
Signature
36
Exhibit Index
37
i
Part
I. Financial Information
Item
1. Financial Statements
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
( a
majority-owned subsidiary of PAVmed Inc. )
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands except number of shares and per share data - unaudited)
June 30, 2022
December 31, 2021
Assets:
Current assets:
Cash
$ 32,679
$ 53,656
Accounts receivable
—
200
Prepaid expenses, deposits, and other current assets
3,196
3,447
Total current assets
35,875
57,303
Fixed assets, net
1,266
971
Operating lease right-of-use assets
2,080
—
Intangible assets, net
4,456
—
Other assets
1,724
725
Total assets
$ 45,401
$ 58,999
Liabilities, Preferred Stock and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 2,406
$ 1,490
Accrued expenses and other current liabilities
1,245
1,113
Operating lease liabilities - current portion
798
—
Purchase consideration payable
1,000
—
Due To: PAVmed Inc. - MSA Fee and operating expenses
2,429
1,657
Total current liabilities
7,878
4,260
Long-term liabilities
Operating lease liabilities, less current portion
1,282
—
Total long-term liabilities
1,282
—
Total liabilities
9,160
4,260
Commitments and contingencies
-
Stockholders’ Equity:
Preferred stock, $ 0.001 par value, 20,000,000 shares authorized; no shares issued and outstanding as of June 30, 2022 and December 31, 2021
—
—
Common stock, $ 0.001 par value, 100,000,000 shares authorized; 35,994,667 and 34,917,907 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively
36
35
Additional paid-in capital
105,003
96,608
Accumulated deficit
( 68,798 )
( 41,904 )
Total Stockholders’ Equity
36,241
54,739
Total Liabilities and Stockholders’ Equity
$ 45,401
$ 58,999
See
accompanying notes to the unaudited condensed consolidated financial statements.
1
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
( a
majority-owned subsidiary of PAVmed Inc. )
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(in
thousands except number of shares and per share data - unaudited)
2022
2021
2022
2021
Three Months Ended June 30,
Six Months Ended June 30,
2022
2021
2022
2021
Revenue
$ —
$ —
$ 189
$ —
Cost of revenue
—
—
369
—
Gross profit (loss)
—
—
( 180 )
—
Operating expenses:
Sales and marketing
3,873
1,021
7,191
1,710
General and administrative
7,311
3,122
13,202
4,334
Research and development
3,440
1,873
6,321
3,625
Total operating expenses
14,624
6,016
26,714
9,669
Loss from operations
( 14,624
)
( 6,016 )
( 26,894 )
( 9,669 )
Other income (expense):
Interest expense - Senior Unsecured Promissory Note
—
( 147 )
—
( 147 )
Other income (expense), net
—
( 147 )
—
( 147 )
Loss before provision for income tax
( 14,624 )
( 6,163 )
( 26,894 )
( 9,816 )
Provision for income taxes
—
—
—
—
Net loss
$ ( 14,624 )
$ ( 6,163 )
$ ( 26,894 )
$ ( 9,816 )
Net loss per share - basic and diluted
$ ( 0.41 )
$ ( 0.44 )
$ ( 0.76 )
$ ( 0.70 )
Weighted average common shares outstanding, basic and diluted
35,760,492
14,114,707
35,443,526
14,114,707
See
accompanying notes to the unaudited condensed consolidated financial statements.
2
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
( a
majority-owned subsidiary of PAVmed Inc. )
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
for
the THREE AND SIX MONTHS ENDED June 30, 2022
(in
thousands except number of shares and per share data - unaudited)
Shares
Amount
Additional Paid-In Capital
Accumulated Deficit
Total
Common Stock
Shares
Amount
Additional Paid-In Capital
Accumulated Deficit
Total
Balance as of March 31, 2022
35,171,796
$ 35
$ 100,630
$ ( 54,174 )
$ 46,491
Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan
705,500
1
501
—
502
Stock-based compensation - Lucid Diagnostics Inc.
—
—
3,553
—
3,553
Stock-based compensation - PAVmed Inc.
—
—
290
—
290
CapNostics, LLC transfer
—
—
( 210 )
—
( 210 )
APA-RDx - Installment Payment
117,371
—
239
—
239
Net Loss
—
—
—
( 14,624 )
( 14,624 )
Balance as of June 30, 2022
35,994,667
$ 36
$ 105,003
$ ( 68,798 )
$ 36,241
Common Stock
Shares
Amount
Additional Paid-In Capital
Accumulated Deficit
Total
Balance as of December 31, 2021
34,917,907
$ 35
$ 96,608
$ ( 41,904 )
$ 54,739
Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan
959,389
1
687
—
688
Stock-based compensation - Lucid Diagnostics Inc.
—
—
7,091
—
7,091
Stock-based compensation - PAVmed Inc.
—
—
588
—
588
CapNostics, LLC transfer
—
—
( 210 )
—
( 210 )
APA-RDx - Installment Payment
117,371
—
239
—
239
Net loss
—
—
—
( 26,894 )
( 26,894 )
Balance as of June 30, 2022
35,994,667
$ 36
$ 105,003
$ ( 68,798 )
$ 36,241
See
accompanying notes to the unaudited condensed consolidated financial statements.
3
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
( a
majority-owned subsidiary of PAVmed Inc. )
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
for
the THREE AND SIX MONTHS ENDED June 30, 2021
(in
thousands except number of shares and per share data - unaudited)
Common Stock
Shares
Amount
Additional Paid-In Capital
Accumulated Deficit
Total
Balance as of March 31, 2021
14,114,707
$ 10
$ 1,103
$ ( 17,479 )
$ ( 16,366 )
Stock-based compensation - Lucid Diagnostics Inc.
—
—
2,526
—
2,526
Stock-based compensation - PAVmed Inc.
—
—
53
—
53
Net loss
—
—
—
( 6,163 )
( 6,163 )
Balance as of June 30, 2021
14,114,707
$ 10
$ 3,682
$ ( 23,642 )
$ ( 19,950 )
Common Stock
Shares
Amount
Additional Paid-In Capital
Accumulated Deficit
Total
Balance as of December 31, 2020
14,114,707
$ 10
$ 298
$ ( 13,826 )
$ ( 13,518 )
Stock-based compensation - Lucid Diagnostics Inc.
—
—
3,328
—
3,328
Stock-based compensation - PAVmed Inc.
—
—
56
—
56
Net Loss
—
—
—
( 9,816 )
( 9,816 )
Balance as of June 30, 2021
14,114,707
$ 10
$ 3,682
$ ( 23,642 )
$ ( 19,950 )
See
accompanying notes to the unaudited condensed consolidated financial statements.
4
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
( a
majority-owned subsidiary of PAVmed Inc. )
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in
thousands except number of shares and per share data - unaudited)
2022
2021
Six Months Ended June 30,
2022
2021
Cash flows from operating activities
Net loss
$ ( 26,894 )
$ ( 9,816 )
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation and amortization expense
728
3
Stock-based compensation - Lucid Diagnostics Inc.
7,091
3,328
Stock-based compensation - PAVmed Inc.
588
56
APA-RDx: Issue common stock - settle installment payment
239
—
Changes in operating assets and liabilities:
Accounts receivable
200
—
Prepaid expenses and other current assets
( 748 )
( 515 )
Accounts payable
916
( 517 )
Accrued expenses and other current liabilities
132
( 26 )
Due To: PAVmed Inc. - operating expenses, employee related costs, MSA Fee
( 1,333 )
1,731
Due To: PAVmed Inc. - Interest Expense - Senior Unsecured Promissory Note
—
147
Net cash flows used in operating activities
( 19,081 )
( 5,609 )
Cash flows from investing activities
Purchase of equipment
( 384 )
( 10 )
Payments - Acquisition
( 2,200 )
—
Net cash flows used in investing activities
( 2,584 )
( 10 )
Cash flows from financing activities
Proceeds – exercise of stock options
688
—
Proceeds – Due To: PAVmed Inc. - working capital cash advances
—
7,739
Net cash flows provided by financing activities
688
7,739
Net increase (decrease) in cash
( 20,977 )
2,120
Cash, beginning of period
53,656
111
Cash, end of period
$ 32,679
$ 2,231
See
accompanying notes to the unaudited condensed consolidated financial statements.
5
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
( a
majority-owned subsidiary of PAVmed Inc. )
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(amounts
in these accompanying notes are presented in thousands, except number of shares and per-share amounts.)
Note
1 — Summary Description of the Company
Lucid
Diagnostics Inc. and Subsidiaries, referred to herein as “Lucid Diagnostics” or the “Company” is comprised of
Lucid Diagnostics Inc. and its wholly-owned subsidiaries, inclusive of LucidDx Labs, Inc. and CapNostics LLC. Lucid Diagnostics Inc.
is a majority-owned subsidiary of PAVmed Inc., as discussed below.
The
Company operates in one segment as a commercial-stage medical diagnostics technology company focused on the millions of patients with
gastroesophageal reflux disease - “GERD” - which is also known variously as chronic heartburn, acid reflux or simply reflux
- who are at risk for developing esophageal precancer and cancer, specifically highly lethal esophageal adenocarcinoma (“EAC”).
Lucid
Diagnostics Inc. entered into a patent license agreement with Case Western Reserve University (“CWRU”), captioned the Amended
and Restated License Agreement, dated August 23, 2021 (“Amended CWRU License Agreement”). The Amended CWRU License Agreement
is a successor to and replaced in its entirety the previous CWRU License Agreement, dated May 12, 2018. The Amended CWRU License Agreement
terminates upon the expiration of certain related patents, or on May 12, 2038 in countries where no such patents exist, or upon expiration
of any exclusive marketing rights granted by the FDA or other U.S. government agency, whichever comes later.
The
Amended CWRU License Agreement (as did the predecessor CWRU License Agreement) provides for the exclusive worldwide license of the intellectual
property rights for the proprietary technologies of two distinct technology components - the “EsoCheck Cell Collection Device”
referred to as “EsoCheck®”; and a panel of proprietary methylated DNA biomarkers, a laboratory developed test (“LDT”),
referred to as “EsoGuard®”; and together are collectively referred to as the “EsoGuard Technology”. See the
Company’s consolidated financial statements for the year ended December 31, 2021, Note 3, Patent License Agreement - Case Western
Reserve University , as included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 as filed with
the SEC on April 6, 2022, for a further discussion of the Amended CWRU License Agreement.
On
February 25, 2022, LucidDx Labs, Inc. entered into an asset purchase agreement (“APA”) with ResearchDx, Inc. (“RDx”),
an unrelated third-party - “APA-RDx”. Under the APA-RDx, LucidDx Labs Inc. acquired certain assets from RDx to be combined
with LucidDx Labs Inc. purchased and leased property and equipment to establish a Company-owned Commercial Lab Improvements Act (“CLIA”)
certified, College of American Pathologists (“CAP”) accredited commercial clinical laboratory capable of performing the EsoGuard®
Esophageal DNA assay, inclusive of DNA extraction, next generation sequencing (“NGS”) and specimen storage. See Note 6, Asset
Purchase Agreement and Management Services Agreement, for a further discussion of the APA-RDx.
Since
its inception, the Company has advanced the proprietary technologies underlying EsoGuard and EsoCheck from the academic research laboratory
to commercial diagnostics tests and devices with scalable manufacturing capacity. The Company is presently focused on expanding commercialization
across multiple sales channels, including: the communication and education of medical practitioners and clinicians of the EsoGuard LDT;
and establishing “Lucid Diagnostics Test Centers” for the collection of cell samples using EsoCheck. Additionally, the Company
is developing expanded clinical evidence to support recommendation of our products in professional society guidelines and insurance reimbursement
adoption by government and private insurers. Further, the Company is also pursuing development of other products and services, including
EsoCure™, an esophageal ablation device. The ability of the Company to generate revenue depends upon the Company’s ability
to successfully advance the commercialization of EsoGuard, while also completing the clinical studies, its product and service development,
and the necessary regulatory approval thereof. There are no assurances, however, the Company will be able to obtain an adequate level
of financial resources required for the long-term commercialization and development of its products and services.
6
Note
1 — Summary Description of the Company - continued
Prior
to its initial public offering (“IPO”) of its common stock, the operations of the Company were funded by PAVmed Inc.,
inclusive of providing working capital cash advances and the payment of certain operating expenses on-behalf-of the Company. Additionally,
certain operations of Lucid Diagnostics Inc. continue to be managed by personnel of PAVmed Inc., for which Lucid Diagnostics Inc. incurs
expense according to the provisions of a Management Services Agreement between Lucid Diagnostics Inc. and PAVmed Inc. See Note 4, Related
Party Transactions , for information with respect to the Management Services Agreement; and Note 5, Due To PAVmed Inc. , for
further information with respect to amounts owed to PAVmed Inc. by Lucid Diagnostics Inc.
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 expects to continue to experience recurring losses from operations
and will continue to fund its operations with debt and equity financing transactions. Notwithstanding, however, with the cash on-hand
as of the date hereof and committed equity sources of financing, the Company expects to be able to fund its operations and meet its financial
obligations as they become due for the one year period from the date of the issue of the Company’s unaudited condensed consolidated
financial statements, as included herein in this Quarterly Report on Form 10-Q for the period ended June 30, 2022.
Note
2 — 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, 2021 as filed with the SEC on April 6, 2022, except as otherwise noted herein below.
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements of Lucid Diagnostics Inc. and 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. Lucid Diagnostics Inc. is a majority-owned
consolidated subsidiary of PAVmed Inc., which has a majority equity ownership interest and has financial control of Lucid Diagnostics
Inc. The Company manages its operations as a single operating segment for the purposes of assessing performance and making operating
decisions.
All
amounts in the accompanying unaudited condensed consolidated financial statements and these notes thereto are presented in thousands
of dollars, if not otherwise noted as being presented in millions of dollars, except for shares and per share amounts.
Use
of Estimates
In
preparing the 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 liabilities and the disclosure of contingent losses, as of the date of
the consolidated financial statements, as well as the reported amounts of revenue and expenses during the reporting period. Significant
estimates in these (unaudited) condensed consolidated financial statements include those related to the estimated fair value of 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.
7
Note
2 — Summary of Significant Accounting Policies - continued
Significant
Accounting Policies - Continued
Leases
The
Company adopted FASB ASC Topic 842, Leases , (“ASC 842”) effective December 31, 2021, with such adoption not having
an effect on the Company’s consolidated financial statements.
All
significant lease agreements and contractual agreements with embedded lease agreements are accounted for under the provisions of ASC
842, wherein, if the contractual arrangement: involves the use of a distinct identified asset; provides for the right to substantially
all the economic benefits from the use of the asset throughout the contractual period; and, provides for the right to direct the use
of the asset. A lease agreement is accounted for as either a finance lease (generally with respect real estate) or an operating lease
(generally with respect to equipment). Under both a finance lease and an operating lease, the Company recognizes as of the lease commencement
date a lease right-of-use (“ROU”) asset and a corresponding lease payment liability.
A
lease ROU asset represents the Company’s right to use an underlying asset for the lease term, and the lease liability represents
its contractual obligation to make lease payments. The lease ROU asset is measured at the lease commencement date as the present value
of the future lease payments plus initial direct costs incurred. The Company recognizes lease expense of the amortization of the lease
ROU asset for an operating lease on a straight-line basis over the lease term; and for financing leases on a straight-line basis unless
another basis is more representative of the pattern of economic benefit. The operating ROU asset also includes any lease incentives received
for improvements to leased property, when the improvements are lessee owned. For improvements to leased property that are lessor owned,
the Company includes amounts the Company incurred for the improvements as ROU assets which are amortized on a straight-line basis over
the life of the lease.
The
lease liability is measured at the lease commencement date with the discount rate generally based on the Company’s incremental
borrowing rate (to the extent the lease implicit rate is not known nor determinable), with interest expense recognized using the interest
method for financing leases.
Certain
leases may include options to extend or terminate the agreement. The Company does not assume renewals in determination of the lease term
unless the renewals are deemed to be reasonably certain at lease commencement. As well, an option to terminate is considered unless it
is reasonably certain the Company will not exercise the option. The Company elected the practical expedient to not recognize a lease
ROU asset and lease payment liability for leases with a term of twelve months or less (“short-term leases”), resulting in
the aggregate lease payments being recognized on a straight line basis over the lease term. The Company’s leases with a commencement
date prior to January 1, 2022 were short-term leases and therefore did not require recording a ROU asset or lease liability at December
31, 2021. Additionally, the Company elected the practical expedient to not separate lease and non-lease components.
8
Note
3 — Revenue from Contracts with Customers
Revenue
is recognized when the satisfaction of the performance obligation occurs, which is when the delivery of product and /or the provision
of service is rendered, and is measured as the amount of estimated consideration expected to be realized. In the period ended June 30,
2022, the Company recognized revenue under the EsoGuard Commercialization Agreement, dated August 1, 2021, as discussed below.
EsoGuard
Commercialization Agreement
The
Company entered into the EsoGuard Commercialization Agreement, dated August 1, 2021, with its CLIA certified commercial laboratory service
provider, ResearchDx Inc. (“RDx”), an unrelated third-party. The EsoGuard Commercialization Agreement was on a month-to-month
basis and was terminated on February 25, 2022 upon the execution of an asset purchase agreement (“APA”) dated February 25,
2022, between LucidDx Labs Inc., a wholly-owned subsidiary of Lucid Diagnostics Inc., and RDx, with such agreement further discussed
in Note 6, Asset Purchase Agreement and Management Services Agreement .
Revenue
Recognized
In
the six months ended June 30, 2022, the Company recognized total revenue of $ 189 , under the EsoGuard Commercialization Agreement, which
represents the minimum fixed monthly fee of $ 100 for the period January 1, 2022 to the February 25, 2022 termination date as discussed
above, The monthly fee was deemed to be collectible for such period as RDx has timely paid the applicable respective monthly fee.
Cost
of Revenue
The
cost of revenue recognized with respect to the revenue recognized under the EsoGuard Commercialization Agreement for the period January
1, 2022 to February 25, 2022 totaled $ 369 , inclusive of employee related costs of personnel engaged in the delivery of the administration
to patients of the EsoCheck cell sample collection procedure, EsoCheck devices and EsoGuard mailers (cell sample shipping costs) distributed
to medical practitioners’ locations and the Lucid Test Centers; Lucid Test Centers operating expenses, including rent expense and
supplies; and royalty fees incurred under the Amended CWRU License Agreement.
9
Note
4 — Related Party Transactions
Case
Western Reserve University and Physician Inventors - CWRU License Agreement
Case
Western Reserve University (“CWRU”) and each of the three physician inventors of the intellectual property licensed
under the Amended CWRU License Agreement (“Physician Inventors”) each hold a minority equity ownership interest in Lucid
Diagnostics Inc. The expenses incurred with respect to the Amended CWRU License Agreement and the three Physician Inventors, as
classified in the accompanying consolidated statement of operations for the periods indicated are summarized as follows:
Schedule
of Incurred Expenses of Minority Shareholders
2022
2021
2022
2021
Three Months Ended
June 30,
Six Months Ended
June 30,
2022
2021
2022
2021
Cost of Revenue
CWRU – Royalty Fee
$ —
$ —
$ 9
$ —
Cost of Revenue
-
-
369
-
General and Administrative Expense
Stock-based compensation expense – Physician Inventors’ restricted stock awards
272
273
544
364
General and administrative Expense
7,311
3,122
13,202
4,334
Research and Development Expense
CWRU License Agreement - reimbursement of patent legal fees
209
113
209
113
Fees - Physician Inventors’ consulting agreements
10
1
18
14
Sponsored research agreement
—
—
3
—
Stock-based compensation expense – Physician Inventors’ stock options
52
52
99
58
Research and development Expense
3,440
1,873
6,321
3,625
Total Related Party Expenses
$ 543
$ 439
$ 882
$ 549
10
Note 4 — Related Party Transactions - continued
PAVmed
Inc. - Management Services Agreement
The
Company’s daily operations of are managed by personnel employed by PAVmed Inc., for which Lucid Diagnostics Inc. incurs a
service fee, referred to as the “MSA Fee”, according to the provisions of a Management Services Agreement
(“MSA”) with PAVmed Inc. The MSA does not have a termination date, but may be terminated by the Lucid Diagnostics Inc.
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 Inc. personnel to the Company, with any such change in the MSA Fee being subject to approval of the
boards of directors of each of Lucid Diagnostics Inc. and PAVmed Inc.. In this regard, subsequent to June 30, 2022, on August 11,
2022, the respective Company’s boards of directors approved a sixth amendment to the MSA to increase the MSA Fee to $ 550 per
month from $ 390 per
month, with such increase effective on a prospective basis commencing July 1, 2022. Pursuant to the sixth amendment, the parties
agreed PAVmed Inc. may elect to receive payment of the monthly MSA Fee in cash or in shares of common stock of the Company, with
such shares valued at the volume weighted average price (“VWAP”) during the final ten trading days of the applicable
month (subject to a floor price of $ 0.70
per share). However, in no event will PAVmed Inc. be entitled to receive under the MSA, as amended, more than 7,709,836 shares of
common stock the Company (representing 19.99% of our outstanding shares of common stock as of immediately prior to the execution of
the sixth amendment). The shares that may be issued under the MSA, as amended, are being offered and sold in transactions exempt
from registration under the Securities Act of 1933, as amended, in reliance on the exemption afforded under Section 4(a)(2) thereof.
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 Unaudited Condensed Statement of Operations
2022
2021
2022
2021
Three Months Ended
June 30,
Six Months Ended
June 30,
2022
2021
2022
2021
Cost of Revenues
$ —
$ —
$ —
$ —
Sales & Marketing
200
296
383
619
General & Administrative
644
348
1,284
618
Research & Development
326
226
673
403
Total MSA Fee
$ 1,170
$ 870
$ 2,340
$ 1,640
The
classification of the MSA Fee as presented above is based on the PAVmed Inc. classification of employee salary expense. In this regard,
PAVmed Inc. classifies employee salary expense as cost-of-revenue for employees engaged in service delivery under the EsoGuard Commercialization
Agreement, and sales and marketing expenses for employees performing sales, marketing, and reimbursement activities and functions, general
and administrative, and research and development except for those employees who are engaged in product and services engineering development
and design and /or clinical trials activities, for which such employee salary is classified as research and development expense.
Other
Related Party Transactions
Lucid
Diagnostics Inc. previously entered into a consulting agreement with Stanley N. Lapidus, effective June 2020 with such consulting agreement
providing for compensation on a contractual rate per hour for consulting services provided. In July 2021, Mr. Lapidus was appointed as
Vice Chairman of the Board of Directors of Lucid Diagnostics Inc. Lucid Diagnostics Inc. recognized general and administrative expense
of $ 8 and $ 14 in the three and six months ended June 30, 2021 in connection with the consulting agreement.
11
Note
5 — Due To PAVmed Inc.
The
aggregate Due To: PAVmed Inc. for the periods indicated is summarized as follows:
Schedule
of Senior Unsecured Promissory Note
CapNostics, LLC Transfer
PAVmed Inc. OBO Payments
Employee-
Related Costs
MSA Fees
Total
Balance - December 31, 2021
$ —
$ 620
$ 1,037
$ —
$ 1,657
MSA fees
—
—
—
2,340
2,340
On Behalf Of (OBO) activities
—
646
—
—
646
ERC - Payroll & Benefits
—
—
4,459
—
4,459
CapNostics, LLC transfer
2,105
—
—
—
2,105
Cash payments to PAVmed Inc.
—
( 1,230 )
( 5,208 )
( 2,340 )
( 8,778 )
Balance - June 30, 2022
$ 2,105
$ 36
$ 288
$ —
$ 2,429
CapNostics,
LLC
On
October 5, 2021, PAVmed Subsidiary Corp, a wholly-owned subsidiary of PAVmed Inc., acquired 100 % of
the outstanding membership interest of CapNostics, LLC (“CapNostics”), an unrelated third-party, for total (gross)
purchase consideration of approximately $ 2.1 million
in cash, paid at the closing of the transaction. Subsequently, effective April 1, 2022, PAVmed Subsidiary Corp and the Company
entered into an agreement pursuant to which PAVmed Subsidiary Corp assigned to Lucid Diagnostics Inc. 100 % of
the membership interest in CapNostics, LLC, resulting in the recognition by the Company principally of an acquired defensive
technology intangible asset, and a $ 2.1 million
payment obligation Due To: PAVmed Inc. Additionally,
Lucid Diagnostics Inc. was also assigned on a prospective basis effective April 1, 2022, the consulting agreement with the previous
principal owner of CapNostics, LLC. The transfer was accounted for as entities under common control. See Note 9 - Intangibles
Assets, with respect to the transferred intangible asset.
EsoCure License Agreement with PAVmed Inc.
EsoCure
has been in development as an esophageal ablation device by PAVmed Inc., with the intent to allow a clinician to treat dysplastic BE
before it can progress to EAC, a highly lethal esophageal cancer, and to do so without the need for complex and expensive capital
equipment. In April 2022, following the approval from both the Company’s and PAVmed Inc.’s boards of directors, the
companies entered into an intercompany license agreement (“EsoCure License Agreement”), pursuant to which the Company
was granted the rights to commercialize EsoCure, a technology under development intended for the treatment of dysplastic
Barrett’s Esophagus. The EsoCure License Agreement, includes a royalty arrangement whereby the Company will pay PAVmed Inc. a 5 %
royalty on all EsoCure sales up to $ 100 million
per calendar year, and an 8.0 %
royalty on annual sales in excess of $ 100
million per calendar year. The Company is obligated to reimburse PAVmed Inc. for any ongoing development costs and cumulative patent
expenses associated with the licensed technology.
12
Note
6 — Asset Purchase Agreement and Management Services Agreement
Asset
Purchase Agreement - ResearchDx Inc.
Through
its wholly-owned subsidiary, LucidDx Labs Inc., the Company entered into an asset purchase agreement (“APA”) dated
February 25, 2022, with ResearchDx, Inc. (“RDx”), an unrelated third-party - “APA-RDx”. Under the APA-RDx,
LucidDx Labs Inc. acquired certain assets from RDx which were combined with LucidDx Labs Inc. purchased and leased property and
equipment to establish a Company-owned CLIA certified, CAP accredited commercial clinical laboratory capable of performing the
EsoGuard® Esophageal DNA assay, inclusive of DNA extraction, next generation sequencing (“NGS”) and specimen
storage. Prior to February 25, 2022, RDx provided such laboratory services at its owned CLIA-certified, CAP-accredited clinical
laboratory.
The
total purchase price consideration payable under the APA-RDx is a face value of $ 3,200 comprised
of three contractually specified periodic payments. The APA-RDx is being accounted for as an asset acquisition, with the recognition
of an intangible asset of approximately $ 3,200 , which is included in “Intangible assets, net” on the accompanying
unaudited condensed consolidated balance sheet, as further discussed in Note 9, Intangible Assets, net . In the three and six
months ended June 30, 2022, a total of $ 2,200
of cash was paid with respect to the periodic payments. Subsequent to June 30, 2022, in July 2022, $ 1,000
of cash was paid with respect to the remaining unpai d
balance of the periodic payments.
Additionally,
the APA-RDx requires the Company to pay a total of $ 3,000 to be paid as twelve (12) equal installment payments commencing May 25, 2022
and then on each three month anniversary thereof, inclusive of a final installment payment on February 25, 2025, with such installment payments recognized as current period expense as incurred. In the three and six
months ended June 30, 2022, as provided for in the APA-RDx, an installment payment was settled by the issue of 117,371 shares of common
stock of Lucid Diagnostics Inc., with such shares having a fair value of $ 239 (with the fair value measured as the quoted closing price
on the date the shares were issued), which was recognized as a current period expense included in general and administrative expenses
in the accompanying unaudited condensed consolidated statement of operations.
The
APA-RDx provides for each of an acceleration and a cancellation of the remaining unpaid installment payments, summarized as follows:
●
The
payment of the remaining unpaid installment payments will be accelerated as immediately due and payable as of the date the “MSA-RDx”
(as such agreement is discussed below) is either terminated by LucidDx Labs Inc. or if it is terminated by mutual agreement between the Company
and RDx.
●
The payment of the remaining unpaid installment payments will be cancelled if the MSA-RDx is
terminated by LucidDx Labs Inc. for cause, defined as the occurrence of any one of: (i) a material breach by RDx which is not cured
within thirty days of LucidDx Labs Inc. written notice; (ii) RDx becomes insolvent and /or bankrupt; or (ii)
RDx fails to comply with applicable statutes, is barred from participating in federal health care programs, or by
action of changes in law or regulation, or by action of judicial interpretation of law, or by judicial civil proceedings
decisions.
Management
Services Agreement - Research Dx Inc
LucidDx
Labs Inc. and RDx entered into a separate management services agreement (“MSA-RDx”), dated and effective February 25, 2022,
with such agreement having a term of three
years commencing on the agreement’s effective
date, and an initial fee of $ 150
per quarter. The MSA-RDx provides for the cancellation
of the remaining unpaid installment payments upon termination of the MSA-RDx for any reason or no reason by either party thereto.
13
Note
7 — 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, 2022
December 31, 2021
Advanced payments to service providers and suppliers
$ 588
$ 260
Prepaid insurance
546
1,578
Deposits
1,782
1,116
EsoCheck cell collection supplies
215
434
EsoGuard mailer supplies
65
59
Total prepaid expenses, deposits and other current assets
$ 3,196
$ 3,447
Note
8 — Leases
During
the six months ended June 30, 2022, the Company entered into additional lease agreements that have commenced and are classified
as operating leases and short-term leases, including for each of: a commercial clinical laboratory and additional Lucid Test Centers.
The
Company’s future lease payments as of June 30, 2022, 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
2022 (remainder of year)
$ 463
2023
927
2024
883
2025
8
Total lease payments
$ 2,281
Less: imputed interest
( 201 )
Present value of lease liabilities
$ 2,080
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
Six Months Ended June 30,
2022
2021
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows from operating leases
$ 453
$ —
Non-cash investing and financing activities
Right-of-use assets obtained in exchange for new operating lease liabilities
$ 2,448
$ —
Weighted-average remaining lease term - operating leases (in years)
2.48
—
Weighted-average discount rate - operating leases
7.875 %
— %
As
of June 30, 2022, the Company’s right-of-use assets from operating leases are $ 2,080 , which are reporting in right-of-use assets
- operating leases in the unaudited condensed consolidated balance sheets. As of June 30, 2022, the Company has outstanding operating
lease obligations of $ 2,080 , of which $ 798 is reported in operating lease liabilities, current portion and $ 1,282 is reporting in operating
lease liabilities less current portion in the Company’s unaudited condensed consolidated balance sheets. The Company did not have
operating leases as of December 31, 2021. 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.
14
Note
9 — Intangibles Assets, net
Intangible
assets, less accumulated amortization, consisted of the following as of:
Schedule
of Intangible Assets Accumulated Amortization
Estimated Useful Life
June 30, 2022
Defensive technology
60 months
$ 2,105
Laboratory licenses and certifications and laboratory information management
software (“LIMSDx”)
24 months
3,200
Total Intangible assets
5,305
Less Accumulated Amortization
( 849 )
Intangible Assets, net
$ 4,456
The
defensive technology intangible asset of $ 2.1
million (and approximately $ 0.2
million of accumulated amortization) was recognized by the Company as of the April 1, 2022 effective date of the intercompany
transfer of CapNostics, LLC to the Company from PAVmed Subsidiary Corp (a wholly-owned subsidiary of PAVmed Inc.). The transfer was
accounted for as entities under common control. The defensive technology intangible asset was recognized by PAVmed Subsidiary Corp
upon its acquisition of CapNostics, LLC, an unrelated third-party, for total purchase consideration paid on the October 5, 2021
acquisition date of approximately $ 2.1
million in cash. The CapNostics LLC transaction was accounted for as an asset acquisition, resulting in the recognition of the
defensive technology intangible asset. The defensive technology intangible asset is being amortized on a straight-line basis over an
expected useful life 60
months commencing on the acquisition date. See Note 5, Due To: PAVmed Inc. , with respect to the transfer of the
corresponding $ 2.1
million payment obligation Due To: PAVmed Inc.
As
noted in Note 6, Asset Purchase Agreement and Management Services Agreement , the asset purchase agreement between the Company
and ResearchDx Inc. (“APA-RDx”), is being accounted for as an asset acquisition. The intangible assets recognized under the
APA-RDx are the laboratory licenses and certifications, (inclusive of a CLIA certification, CAP accreditation, and clinical laboratory
licenses for five (5) U.S. States transfer to the Company from RDx), and a laboratory information management software (“LIMSDx”)
perpetual-use royalty-free license granted under the APA-RDx, with such intangible asset having a useful life of twenty-four months commencing
on the APA-RDx February 25, 2022 transaction date.
Amortization
expense of the intangible assets discussed above was $ 639 and $ 0 for the three and six month periods ended June 30, 2022 and 2021,
respectively, and is included in general and administrative expenses in the accompanying unaudited condensed consolidated statements
of operations. As of June 30, 2022, 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
2022 (remainder of year)
$ 1,010
2023
2,021
2024
688
2025
421
2026
316
Total
$ 4,456
15
Note
10 — Stock-Based Compensation
Lucid
Diagnostics Inc. 2018 Long-Term Incentive Equity Plan
The
Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan (“Lucid Diagnostics Inc. 2018 Equity Plan”) is separate and apart
from the PAVmed Inc. 2014 Equity Plan discussed below. The Lucid Diagnostics Inc. 2018 Equity Plan is designed to enable Lucid Diagnostics
Inc. to offer employees, officers, directors, and consultants, as defined, an opportunity to acquire shares of common stock of Lucid
Diagnostics Inc. The types of awards that may be granted under the Lucid Diagnostics Inc. 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 Inc. board of directors.
A
total of 9,144,000 shares of common stock of Lucid Diagnostics Inc. are reserved for issuance under the Lucid Diagnostics Inc. 2018 Equity
Plan, with 3,932,802 shares available for grant as of June 30, 2022. The share reservation is not diminished by a total of 423,300 stock
options and 50,000 restricted stock awards granted outside the Lucid Diagnostics Inc. 2018 Equity Plan, as of June 30, 2022.
Lucid
Diagnostics Inc. Stock Options
Lucid
Diagnostics Inc. stock options granted under the Lucid Diagnostics Inc. 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)
Outstanding stock options at December 31, 2021
1,419,242
$ 0.73
7.0
Granted (1)
2,107,500
$ 3.82
Exercised
( 959,389 )
$ 0.72
Forfeited
( 107,687 )
$ 4.45
Outstanding stock options at June 30, 2022 (2)
2,459,666
$ 3.22
9.0
Vested and exercisable stock options at June 30, 2022
741,869
$ 1.90
7.4
(1)
Stock options granted under the
Lucid Diagnostics Inc. 2018 Equity Plan and those granted outside such plan generally vest ratably over twelve quarters, with the
vesting commencing with the grant date quarter-end, and have a ten-year contractual term from date-of-grant.
(2)
The outstanding stock options presented in the table
above, are inclusive of 423,300 stock options granted outside the Lucid Diagnostics Inc. 2018 Equity Plan. as of June 30, 2022 and
December 31, 2021.
See
Note 4, Related Party Transactions , for a summary of the stock-based compensation expense recognized with respect to the stock
options granted under the Lucid Diagnostics Inc. 2018 Equity Plan to the Physician Inventors.
16
Note
10 — Stock-Based Compensation - continued
Lucid
Diagnostics Inc. Restricted Stock Awards
Lucid
Diagnostics Inc. restricted stock awards granted under the Lucid Diagnostics Inc. 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, 2021
1,940,740
$ 12.76
Granted
320,000
4.53
Vested
—
—
Forfeited
—
—
Unvested restricted stock awards as of June 30, 2022 (1)
2,260,740
$ 11.59
(1)
The unvested
restricted stock awards presented in the table above, are inclusive of 50,000 restricted stock awards granted outside the Lucid Diagnostics
Inc. 2018 Equity Plan. as of June 30, 2022 and December 31, 2021.
On
January 7, 2022, 320,000 restricted stock awards were granted under the Lucid Diagnostics Inc 2018 Equity Plan, with such restricted
stock awards having a single vesting date on January 7, 2025, and an aggregate grant date fair value of approximately $ 1.4 million, measured
as the grant date closing price of Lucid Diagnostics Inc. common stock, with such aggregate estimated 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 restricted
stock awards are subject to forfeiture if the requisite service period is not completed.
PAVmed
Inc. 2014 Equity Plan
The
PAVmed Inc. 2014 Long-Term Incentive Equity Plan (the “PAVmed Inc. 2014 Equity Plan”), is separate and apart from the Lucid
Diagnostics Inc. 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 Inc. 2018 Equity Plan and the PAVmed Inc. 2014
Equity Plan, for the periods indicated, was as follows:
Schedule
of Stock-Based Compensation Expense
2022
2021
2022
2021
Three
Months Ended June 30,
Six
Months Ended June 30,
2022
2021
2022
2021
Lucid Diagnostics Inc 2018 Equity Plan – sales and marketing expenses
$ 214
$ —
$ 480
$ —
Lucid Diagnostics Inc 2018 Equity Plan - general and administrative expense
3,313
2,505
6,514
3,294
Lucid Diagnostics Inc 2018 Equity Plan - research and development expenses
26
22
97
34
PAVmed Inc 2014 Equity Plan - sales and marketing expenses
161
—
336
—
PAVmed Inc 2014 Equity Plan - general and administrative expenses
77
—
145
—
PAVmed Inc 2014 Equity Plan - research and development expenses
52
53
107
56
Total stock-based compensation expense
$ 3,843
$ 2,580
$ 7,679
$ 3,384
The
stock-based compensation expense, as presented above, is inclusive of: stock options and restricted stock awards granted under the Lucid
Diagnostics Inc. 2018 Equity Plan to employees of PAVmed Inc., the Physician Inventors , and members of the board of directors of Lucid
Diagnostics Inc., as well as the stock options granted under the PAVmed Inc. 2014 Equity Plan to the Physician Inventors.
17
Note
10 — Stock-Based Compensation - continued
As
of June 30, 2022, 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 Inc. 2018 Equity Plan and the PAVmed Inc. 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 Inc. 2018 Equity Plan
Stock Options
$ 4,030
2.6
Restricted Stock Awards
$ 10,873
1.0
PAVmed Inc. 2014 Equity Plan
Stock Options
$ 1,869
1.9
Restricted Stock Awards
$ 226
1.5
Stock-based
compensation expense recognized with respect to stock options granted under the Lucid Diagnostics Inc. 2018 Equity Plan was based on
a weighted average estimated fair value of such stock options of $1.48 per share during the period ended June 30, 2022. The stock-based
compensation was calculated using the following weighted average Black-Scholes valuation model assumptions:
Schedule of Stock-based Compensation Valuation Assumptions
Six Months Ended
June 30,
2022
Expected term of stock options (in years)
5.7
Expected stock price volatility
71 %
Risk free interest rate
3.0 %
Expected dividend yield
— %
Lucid
Diagnostics, Inc Employee Stock Purchase Plan (“ESPP”)
The
Lucid Diagnostics Inc Employee Stock Purchase Plan (“Lucid Diagnostics Inc ESPP”), initial six-month stock purchase period
is April 1, 2022 to September 30, 2022. The Lucid Diagnostics Inc. ESPP has a total reservation of 500,000 shares of common stock for
which all shares are available-for-issue as of June 30, 2022.
18
Note
11 — Stockholders’ Equity
Lucid
Diagnostics Inc. Common Stock
As
of June 30, 2022 and December 31, 2021, there were 35,994,667 and 34,917,907 shares of common stock issued and outstanding, respectively.
As of June 30, 2022, PAVmed Inc. holds 27,927,190 shares, representing a majority-interest equity ownership and PAVmed Inc. has a controlling
financial interest in Lucid Diagnostics Inc.
Committed
Equity Facility - March 28, 2022
On
March 28, 2022, Lucid Diagnostics, Inc. 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 Lucid Diagnostics Inc. 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. As of June 30, 2022, there were no shares of common stock issued under the committed equity facility. Subsequent
to June 30, 2022, as of August 10, 2022, under the committed equity facility, a total of 308,152
shares of common stock of the Company were issued
for proceeds of approximately $ 927 .
In
connection with the execution of the agreement for the committed equity facility, the Company paid Cantor $ 1.0
million as consideration for its irrevocable commitment to purchase the shares upon the terms and subject to the satisfaction of the
conditions set forth in such agreement. In addition, pursuant to the agreement, we agreed to reimburse Cantor for certain of its
expenses. The Company also entered into a registration rights agreement with Cantor. The Company has the right to terminate the
agreement at any time after initial satisfaction of the conditions to Cantor’s obligation to purchase shares under the
facility, at no cost or penalty, upon three trading days’ prior written notice.
19
Note
12 — Net Loss Per Share
The
“Net loss per share basic and diluted” for the respective periods indicated - is as follows:
Schedule
of Basic and Fully Diluted Net Loss Per Share
2022
2021
2022
2021
Three Months Ended
June 30,
Six Months Ended
June 30,
2022
2021
2022
2021
Numerator
Net loss
$ ( 14,624 )
$ ( 6,163 )
$ ( 26,894 )
$ ( 9,816 )
Denominator
Weighted average common shares outstanding, basic and diluted
35,760,492
14,114,707
35,443,526
14,114,707
Loss per share
Net loss per share - basic and diluted
$ ( 0.41 )
$ ( 0.44 )
$ ( 0.76 )
$ ( 0.70 )
Basic
weighted-average number of shares of common stock outstanding for the periods ended June 30, 2022 and 2021 include the shares of the
Company issued and outstanding during such periods, each on a weighted average basis. The basic weighted average number of shares common
stock outstanding excludes common stock equivalent incremental shares, while diluted weighted average number of shares outstanding includes
such incremental shares. However, as the Company was in a loss position for all periods presented, basic and diluted weighted average
shares outstanding are the same, as the inclusion of the incremental shares would be anti-dilutive. The common stock equivalents excluded
from the computation of diluted weighted average shares outstanding are as follows:
Schedule
of Anti-dilutive Securities Excluded from Computation of Diluted Earnings Per Share
June 30,
2022
2021
Stock options
2,459,666
1,399,242
Unvested restricted stock awards
2,260,740
1,552,100
Total
4,720,406
2,951,342
20
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The
following discussion and analysis of our unaudited condensed consolidated financial condition and results of operations should be read
together with our Annual Report on Form 10-K for the year ended December 31, 2021 (the “Form 10-K”), as filed with the Securities
and Exchange Commission (the “SEC”). We are a majority-owned consolidated subsidiary of PAVmed Inc. (“PAVmed”).
Unless
the context otherwise requires, references herein to “we”, “us”, and “our”, and to the “Company”
or “Lucid Diagnostics” are to Lucid Diagnostics Inc and its subsidiaries LucidDx Labs Inc. (“LucidDx Labs”) and
CapNostics, LLC.
FORWARD-LOOKING
STATEMENTS
This
Quarterly Report on Form 10-Q (this “Form 10-Q”), including the following discussion and analysis of our (unaudited) condensed
consolidated financial condition and results of operations, contains forward-looking statements that involve substantial risks and uncertainties.
All statements, other than statements of historical facts, contained in this Form 10-Q, including statements regarding our future results
of operations and financial position, business strategy and plans and objectives of management for future operations, are forward-looking
statements. The words “may,” “will,” “should,” “expects,” “plans,” “anticipates,”
“could,” “intends,” “target,” “projects,” “contemplates,” “believes,”
“estimates,” “predicts,” “potential” or “continue” or the negative of these terms or
other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these
identifying words. Forward-looking statements are not guarantees of future performance and the Company’s actual results may differ
significantly from the results discussed in the forward-looking statements. Factors that might cause such differences include, but are
not limited to, those discussed in Item 1A of Part I of the Form 10-K under the heading “Risk Factors.”
Important
factors that may affect our actual results include:
●
our limited operating history;
●
our financial performance, including our ability to
generate revenue;
●
our ability to obtain regulatory approval for the commercialization
of our products;
●
our ability of our products to achieve market acceptance;
●
our success in retaining or recruiting, or changes
required in, our officers, key employees or directors;
●
our potential ability to obtain additional financing
when and if needed;
●
our ability to protect our intellectual property;
●
our ability to complete strategic acquisitions;
●
our ability to manage growth and integrate acquired
operations;
●
the potential liquidity and trading of our securities;
●
regulatory and operational risks;
●
cybersecurity risks;
●
risks related to SARS-CoV-2 /COVID-19 pandemic;
●
the impact of the material weakness identified by our
management; and
●
our estimates regarding expenses, future revenue, capital
requirements and needs for additional financing.
In
addition, our forward-looking statements do not reflect the potential impact of any future financings, acquisitions, mergers, dispositions,
joint ventures or investments we may make.
We
may not actually achieve the plans, intentions, and /or expectations disclosed in our forward-looking statements, and you should not
place undue reliance on our forward-looking statements. You should read this Form 10-Q and the Form 10-K, and the documents we have filed
as exhibits to this Form 10-Q and the Form 10-K, completely and with the understanding our actual future results may be materially different
from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information,
future events or otherwise, except as required by applicable law.
21
Overview
We
are a commercial-stage, cancer prevention, medical diagnostics technology company focused on the millions of patients with long-standing
gastroesophageal reflux disease (“GERD”) who are at risk of developing esophageal precancer and cancer, specifically highly
lethal esophageal adenocarcinoma (“EAC”), which is expected to lead to approximately 16,000 U.S. deaths per year.
We
believe that our lead products, 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 screening tool to prevent
EAC deaths, through early detection of esophageal precancer in at-risk GERD patients.
●
EsoGuard is
a DNA test performed on surface esophageal cells collected with EsoCheck in a brief noninvasive office procedure which has been shown
to be over 90% sensitive and specific at detecting Barrett’s Esophagus (“BE”), a precancerous condition of the
esophagus and all conditions along the BE-EAC spectrum. (Moinova, et al. Sci Transl
Med. 2018 Jan 17;10(424): eaao5848).
●
EsoCheck
is a United States Food and Drug Administration FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter
capable of sampling surface esophageal cells in a less than five-minute office procedure. We believe its proprietary
Collect+Protect™ technology makes it the only noninvasive esophageal cell collection device capable of anatomically targeted
and protected sampling to prevent dilution and contamination during device withdrawal.
EsoGuard
is commercialized in the U.S. as a laboratory developed test (“LDT”). It was previously performed by our unrelated
third-party commercial clinical laboratory service partner ResearchDx Inc. (“RDx”), at their Clinical Laboratory
Improvement Amendments (“CLIA”) certified commercial clinical laboratory, located in Irvine, CA. Beginning in March
2022, the EsoGuard LDT has been performed at our own CLIA-certified commercial clinical laboratory, located in Lake Forest, CA. RDx
also manufactures our EsoGuard Specimen Kits. EsoCheck is commercialized in the U.S. as a 510(k) cleared esophageal cell collection
device currently manufactured for us by our contract manufacturing partner, Sage Product Development Inc., located in Foxborough,
MA. We are in the process of transferring EsoCheck manufacturing to Coastline International Inc., a high-volume manufacturer
headquartered in San Diego, CA with plants in Mexico. Both EsoGuard and EsoCheck have completed the CE Mark certification process.
EsoGuard, us ed with EsoCheck was granted FDA Breakthrough
Device designation and requires the completion of an international multicenter pre-market approval (“PMA”) clinical
trial to be able to submit EsoGuard to the FDA for approval as an in vitro diagnostic device (“IVD”). Presently, the
Company is focusing its clinical trial efforts and resources towards supporting insurance reimbursement adoption by government and
private insurers. Consequently, with the Company prioritizing shorter term clinical utility studies to facilitate widespread
insurance adoption, the completion of the BE-1 EsoGuard screening (as described below) study will be delayed indefinitely. The
Company expects to complete the EsoGuard BE-2 case control study (as described below) in due course.
The
EsoGuard PLA code 0114U secured final Medicare payment determination of $1,938.01, effective January 1, 2021. We are awaiting Medicare
local coverage determination. We are also aggressively pursuing EsoGuard U.S. private payor payment and coverage as well as payment in
Europe.
We
are working to expand EsoGuard commercialization across multiple channels by building a direct sales and marketing team targeting primary
care physicians, specialists, institutions and consumers. To assure sufficient testing capacity and geographic coverage, as part of this
expansion, we are building our own network of Lucid Test Centers, staffed by Lucid-employed clinical personnel, where patients can undergo
the EsoCheck procedure and have the sample sent for EsoGuard testing. We have also established an EsoGuard Telemedicine Program, in partnership
with UpScript, LLC, an independent third-party telemedicine provider, that can accommodate EsoGuard self-referrals from direct-to-consumer
marketing.
22
Overview - continued
In connection
with our efforts to expand our presence in the diagnostic market, we are also developing EsoCure as an Esophageal Ablation Device, with
the intent to allow a clinician to treat dysplastic BE before it can progress to EAC, a highly lethal esophageal cancer, and to do so
without the need for complex and expensive capital equipment. As described below, we recently entered into a license agreement with our
parent company, PAVmed Inc., pursuant to which we were granted the rights to commercialize EsoCure. A successful pre-clinical feasibility
animal study of EsoCure has been completed, demonstrating excellent, controlled circumferential ablation of the esophageal mucosal lining.
An acute and survival animal study of EsoCure™ Esophageal Ablation Device has also been completed, demonstrating successful direct
thermal balloon catheter ablation of esophageal lining through the working channel of a standard endoscope. We plan to conduct additional
development work and animal testing of EsoCure to support a future FDA 510(k) submission.
We
are a majority owned subsidiary of PAVmed. We are party to an amended and restated patent license agreement with CWRU, dated August 23,
2021 (“Amended CWRU License Agreement”), which provides for the exclusive worldwide license of the intellectual property
rights for the proprietary technologies underlying EsoCheck and EsoGuard.
Recent
Developments
Business
Clinical
Guideline Update - ACG and AGA
In April 2022, the American College
of Gastroenterology (“ACG”) updated its clinical guideline to support esophageal precancer (“Barrett’s Esophagus”-
or “BE”) screening to prevent highly lethal EAC utilizing our EsoGuard® DNA Test on samples collected with our EsoCheck®
Cell Collection Device. The clinical guideline reiterates the ACG’s long-standing recommendation for esophageal precancer screening
in at-risk patients with GERD, commonly known as chronic heartburn, acid reflux or simply reflux. In its Recommendation 5, the ACG suggests
a single screening endoscopy in patients with chronic GERD symptoms and 3 or more additional risk factors for BE, including male sex,
age greater than 50 years, White race, tobacco smoking, obesity, and family history of BE or EAC in a first-degree relative. Furthermore,
and importantly for the first time, the clinical guideline also endorses nonendoscopic biomarker screening as an acceptable alternative
to costly and invasive endoscopy by stating in its Recommendation 6 that the ACG suggests that a swallowable, nonendoscopic capsule device
combined with a biomarker is an acceptable alternative to endoscopy for screening for BE. The clinical guideline specifically mentions
EsoCheck, along with the Company’s EsophaCap® device, as such swallowable, nonendoscopic esophageal cell collection devices,
as well as methylated DNA biomarkers such as EsoGuard. The summary of evidence for this recommendation cites the seminal NIH-funded multicenter,
case-control study published in 2018 in Science Translational Medicine, which demonstrated that EsoGuard is highly accurate at detecting
esophageal precancer and cancer, including on samples collected with EsoCheck.
In July 2022, the American Gastroenterology
Association (“AGA”) published updated clinical guidance that mirrors the same furnished by the ACG as described above ,
endorsing the use of non-invasive screening tools like our EsoCheck® Cell Collection Device, which is cited in its guideline,
as an acceptable alternative to endoscopy to directly address the need for noninvasive screening tools that are easy to administer,
patient friendly, and cost-effective for the detection of BE. The clinical practice update by the AGA also significantly expands the target
population for esophageal precancer screening, including for EsoGuard and EsoCheck, by recommending, for the first time, screening in
at-risk patients without symptoms of reflux. The AGA does so by adding a history of chronic GERD as merely an additional,
seventh, risk factor to the six risk factors for BE and EAC that have traditionally identified at-risk symptomatic patients recommended
for screening. As a result, chronic symptomatic GERD is no longer a mandatory prerequisite and asymptomatic patients with three of the
other six risk factors (e.g., male sex, age greater than 50 years, White race, tobacco smoking, obesity, and family history of BE) are
now considered appropriate for screening.
23
Recent Developments - continued
Business - continued
Local
Coverage Determination Update - CMS
In April 2022, a proposed Local
Coverage Determination (“LCD”) DL39256, entitled “Molecular Testing for Detection of Upper Gastrointestinal Metaplasia,
Dysplasia, and Neoplasia” was published on the Center for Medicare and Medicaid Services (“CMS”) website by MAC Palmetto
GBA. The proposed LCD is a further step in our efforts to secure Medicare coverage and payment for EsoGuard.
The
proposed LCD, which the CMS website explicitly characterizes as a “work in progress” for “public review,” outlines
criteria that MolDX expects upper gastrointestinal precancer and cancer molecular diagnostic tests to meet. These criteria include active
GERD with at least two risk factors, as well as evidence of analytic validity, clinical validity, and clinical utility. Although it found
that no currently existing test has fulfilled all these criteria, it indicated that it will “monitor the evidence and will provide
coverage based on the pertinent literature and society recommendations.” Notably, the proposed LCD pre-dated, and therefore does
not include consideration of, the most recent ACG clinical guideline update endorsing swallowable, nonendoscopic capsule devices combined
with a biomarker, such as EsoCheck and EsoGuard. The publication of the proposed LCD included a written comment period that extended
through May 14, 2022. MolDX held an open meeting on May 10, 2022, during which stakeholders and other interested parties had the opportunity
to address the proposed LCD.
We
have used the written comment process and the open meeting to bring to MolDX essential information that was not incorporated into the
proposed LCD. These include: the updated ACG clinical guideline; the fact that EsoGuard’s published performance is at or above
accepted performance criteria for detection of lower gastrointestinal cancers in approved and currently effective Medicare coverage determinations;
and data from ongoing clinical utility studies Lucid and clinical investigators are performing. A final LCD will not be issued until
the MAC has had the opportunity to assess and consider the comments and input from the written comment period and the open meeting.
Following
the MAC Palmetto GBA release of a proposed LCD, Noridian Healthcare Solutions published a proposed LCD entitled Molecular Testing for
Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia DL39262. The proposed LCD mirrors the MAC Palmetto GBA proposed
LCD. We have used the Noridian Healthcare Solutions open meeting held on May 26, 2022, and the written comment period that ended on June
11, 2022 to bring the same essential information that we provided to the MAC Palmetto GBA to maintain consistency in our approach and
advocate appropriately.
EsoGuard
BE-1 and BE-2 Clinical Trials
In 2021 Lucid Diagnostics Inc. began conducting two concurrent clinical
trials, including each of: the “EsoGuard screening study” (“BE-1”); and the “EsoGuard case-control study”
(“BE-2”), to expand the clinical evidence for the technologies and to support a United States Food and Drug Administration
(“FDA”) pre-market approval (“PMA”) of the use of EsoGuard and EsoCheck as an in-vitro diagnostic medical device
(“IVD”). However, in light of the recently published proposed Local Coverage Determination (“LCD”) DL39256, the
recently updated AGA guidance, and the ACG update to its clinical guideline that supports screening to prevent highly lethal esophageal
cancer (“EAC”) utilizing our EsoGuard® DNA Test on samples collected with our EsoCheck® Cell Collection Device, the
Company has determined to prioritize its clinical trial efforts and resources towards supporting studies that will help secure insurance
reimbursement adoption by government and private insurers. Consequently, we have decided to delay for the time being the BE-1 trial while
continuing to enroll GERD patients with a previous diagnosis of nondysplastic BE, low-grade dysplasia, high-grade dysplasia, or EAC in
the BE-2 case-control study through Q2 2023.
24
Recent Developments - continued
Business - continued
MediNcrease
Health Plans
In May 2022 LucidDx Labs, Inc.
entered into a participating provider agreement with MediNcrease Health Plans, LLC (“MediNcrease”). A national directly-contracted,
multi-specialty PPO provider network with over 8 million lives covered through its clients and payers, which include regional and national
health plans, insurance companies, third party administrators, self-insured employer groups, municipalities, unions and other entities
involved in the management of medical claims. Pursuant to the agreement, persons covered by MediNcrease clients and payers will have in-network
access to our EsoGuard® DNA test. The agreement provides rates of reimbursement as a percent of charges for services rendered to such
covered persons by LucidDx Labs, including the performance of the EsoGuard® DNA test.
In
June and July 2022, LucidDx Labs Inc. continued to expand its in-network base by entering into participating provider agreements
with Galaxy Health Network, Three Rivers Provider Network, and Prime Health Services (collectively, “the PPOs”), as well
as Alivio Health. The PPOs cover millions of lives through the provider networks they have compiled for their clients, including
third-party administrators, insurance companies, self-insured companies, corporations, and government entities to access, while
Alivio provides its clients access to its specialized diagnostic laboratory network. Pursuant to the agreement, persons covered by
the PPOs will have in-network access to our EsoGuard® DNA test. The agreements provides rates of reimbursement as a percentage
of charges for services rendered to such covered persons by LucidDx Labs, including the performance of the EsoGuard test.
Company-Owned
Commercial Clinical Laboratory
Through
our wholly-owned subsidiary, LucidDx Labs Inc., we entered into an asset purchase agreement (“APA”) dated February 25,
2022, with ResearchDx, Inc. (“RDx”), an unrelated third-party - “APA-RDx”. Under the APA-RDx, LucidDx Labs
Inc. acquired certain assets from RDx which were combined with LucidDx Labs purchased and leased property and equipment to establish
a Company-owned CLIA certified, CAP accredited commercial clinical laboratory capable of performing the EsoGuard® Esophageal DNA
assay, inclusive of DNA extraction, next generation sequencing (“NGS”) and specimen storage. Prior to consummation of
the APA-RDx, RDx provided such laboratory services to us at its owned CLIA-certified, CAP-accredited clinical laboratory.
25
Recent Developments - continued
Business - continued
Third-Party
Payor Billing and Revenue Cycle Management
As part of the transition to
our own Company-owned commercial clinical laboratory, we also contracted with a revenue cycle management (“RCM”) service provider
to submit third-party reimbursement claims on our behalf. The RCM service provider will have complete oversight of payer claims, appeals
processes, patient billing, online payment collection, and claims tracking. With the appropriate licenses and certifications for billing
and credentialing secured, and our recently having put in place the necessary back office systems, claims for approximately 1,000 tests
performed since the establishment of our own lab are now being processed, including 850 tests in the three months ended June 30, 2022
(although not having yet secured reimbursed rates from Medicare and Medicaid, the Company does not know the amount per claim it will receive
from payors). Refer to Note 3 of our Condensed Consolidated Financial Statements for more information on Revenue from Contracts
with Customers. Presently, recognized revenue for GAAP purposes is subject to actual amounts collected during the period.
Accordingly, since the RCM began submitting claims processed from our own lab subsequent to June 30, 2022, there were no collections during
the three months ended June 30, 2022.
EsoCure License Agreement with PAVmed Inc.
EsoCure has been in development
as an esophageal ablation device by PAVmed. In April 2022, following the approval from both ours and the PAVmed Inc. boards of directors,
we and PAVmed Inc. entered into an intercompany license agreement (“EsoCure License Agreement”), pursuant to which we were
granted the rights to commercialize EsoCure. The EsoCure License Agreement, includes a royalty arrangement whereby we will pay PAVmed
Inc. a 5% royalty on all EsoCure sales up to $100 million per calendar year, and an 8.0% royalty on annual sales in excess of $100 million
per calendar year. We are obligated to reimburse PAVmed Inc. for any ongoing development costs and cumulative patent expenses associated
with the licensed technology.
CapNostics,
LLC
On October 5, 2021, PAVmed Subsidiary Corp, a wholly-owned
subsidiary of PAVmed Inc., acquired 100% of the outstanding membership interest of CapNostics, LLC (“CapNostics”), an unrelated
third-party, for total (gross) purchase consideration of approximately $2.1 million in cash, paid at the closing of the transaction. Subsequently,
Lucid Diagnostics Inc. and PAVmed Subsidiary Corp entered into an agreement, effective April 1, 2022, pursuant to which PAVmed Subsidiary
Corp assigned to Lucid Diagnostics Inc. 100% of the membership interest in CapNostics, LLC, inclusive of an acquired defensive technology
intangible asset, and a $2.1 million payment obligation Due To: PAVmed Inc. Additionally, Lucid Diagnostics Inc. was also assigned on a prospective basis effective April 1, 2022, the consulting
agreement with the previous principal owner of CapNostics, LLC.
26
Results
of Operations
Overview
Revenue
Revenue was recognized with respect to the EsoGuard
Commercialization Agreement, dated August 1, 2021, between the Company and ResearchDx Inc. (“RDx”), a CLIA certified commercial
laboratory service provider. On February 25, 2022, the EsoGuard Commercialization Agreement was terminated upon the execution of an Asset
Purchase Agreement between the Company’s wholly-owned subsidiary LucidDx Labs Inc. and RDx.
Cost
of revenue
The
cost of revenue recognized with respect to the revenue recognized under the EsoGuard Commercialization Agreement is inclusive of: a royalty
fee incurred under the Amended CWRU License Agreement; the MSA Fee (as defined and discussed herein below) allocated to cost of revenue,
which is principally employee related costs of PAVmed employees engaged in the administration to patients of the EsoCheck cell sample
collection procedure (principally at the LUCID Test Centers); the EsoCheck devices and EsoGuard mailers (cell sample shipping costs)
distributed to medical practitioners locations and the LUCID Test Centers; and LUCID Test Centers operating expenses, including rent
expense and supplies.
Sales
and marketing expenses
Sales
and marketing expenses consist primarily of the portion of the MSA Fee allocated to sales and marketing expenses, which are principally
employee related costs of PAVmed employees, as well as advertising and promotion expenses. We anticipate our sales and marketing expenses
will increase in the future, as we anticipate an increase in payroll and related expenses related to the roll-out of our commercial sales
and marketing operations as we execute on our business strategy.
General
and administrative expenses
General
and administrative expenses consist primarily of professional fees, accounting and legal services, consultants and expenses associated
with obtaining and maintaining patents within our intellectual property portfolio, along with the portion of the MSA Fee allocated to
general and administrative expenses.
We
anticipate our general and administrative expenses will increase in the future, as we anticipate an increase in the MSA Fee allocated
to general and administrative expense, related to continued expansion of our overall business operations. We also anticipate expenses
related to being a public company, including professional services fees for legal, accounting, tax, audit, employees involved in third-party
payor reimbursement contract negotiations and regulatory services associated with maintaining compliance as a public company, along with
insurance premiums, investor relations, and other corporate expenses.
27
Results of Operations - continued
Overview - continued
Research
and Development Expenses
Research
and development expenses are recognized in the period they are incurred and consist principally of internal and external expenses incurred
for the development of our technologies and conducting clinical trials, including:
●
consulting
costs charged to us by various external contract research organizations we contract with to conduct preclinical studies and engineering
studies;
●
costs associated with regulatory filings;
●
patent license fees;
●
cost of laboratory supplies and acquiring, developing,
and manufacturing preclinical prototypes;
●
product design engineering studies;
●
fees associated with conducting clinical trials for
our EsoGuard diagnostic assay; and
●
MSA Fee allocated to research and development, as such
MSA Fee are discussed below.
We
plan to incur research and development expenses for the foreseeable future as we continue the development of our existing products as
well as new innovations. Our research and development activities are focused principally on obtaining FDA approvals and developing product
improvements or extending the utility of the lead products in our pipeline, including EsoCheck and EsoGuard.
Presentation
of Dollar Amounts
All
dollar amounts in this Management’s Discussion and Analysis of Financial Condition and Results of Operations are presented in thousands
of dollars, if not otherwise indicated as being presented as dollars in millions, except for the number of shares and per share amounts.
28
Results
of Operations - continued
Three
months ended June 30, 2022 as compared to three months ended June 30, 2021
The
Company did not recognize revenue nor cost of revenue during the three months ended June 30, 2022 and June 30, 2021.
Sales
and marketing expenses
In
the three months ended June 30, 2022, sales and marketing costs were approximately $3.9 million, compared to $1.0 million for the corresponding
period in the prior year. The net increase of $2.9 million was principally related to:
●
approximately
$2.5 million increase in compensation related costs, including stock-based compensation of approximately $0.4 million in stock based
compensation with respect to restricted stock awards (“RSA”) grants under the Lucid Diagnostics Inc. 2018 Equity Plan to Lucid Diagnostics and PAVmed employees and non-employees,
and an increase in stock options granted corresponding with the increase in the number of employees principally related to an increase
in headcount;
●
approximately
$0.5 million increase in outside professional services related to EsoCheck, EsoGuard and consulting and professional services fees;
and
●
approximately $0.1 million
decrease in the MSA fee allocation from PAVmed related to the growth and expansion of our business and the services incurred
through PAVmed.
General
and administrative expenses
In
the three months ended June 30, 2022, general and administrative costs were approximately $7.3 million, compared to $3.1 million for
the corresponding period in the prior year. The net increase of $4.2 million was principally related to:
●
approximately
$0.5 million increase in compensation related costs, including stock-based compensation of approximately $0.2 million with respect to restricted stock awards (“RSA”) grants under the Lucid Diagnostics Inc. 2018 Equity Plan to
Lucid Diagnostics and PAVmed employees and non-employees, and an increase in stock options granted corresponding with the increase
in the number of employees principally related to an increase in headcount;
●
approximately
$2.1 million increase in consulting services related to patents, regulatory compliance, legal processes for contract review,
transition of public relations and investor relations firms, and public company expenses;
●
approximately $0.6 million of amortization expense related to our intangible
assets;
●
approximately $0.3 million
increase in the MSA fees, after allocation, from PAVmed related to the growth and expansion of our business and the services incurred
through PAVmed; and
●
approximately $0.7 million
increase in general business expenses.
Research
and development expenses
In
the three months ended June 30, 2022, research and development costs were approximately $3.4 million, compared to $1.9 million for the
corresponding period in the prior year. The net increase of $1.5 million was principally related to:
●
approximately
$1.4 million increase in development costs, particularly in clinical trial activities and outside professional and consulting fees
with respect to EsoCheck, EsoCure and EsoGuard; and
●
approximately $0.1 million
increase in the MSA fee allocation from PAVmed related to the growth and expansion of our business and the services incurred
through PAVmed.
See
our accompanying unaudited condensed consolidated financial statements for each of: Note 4 , Related Party Transactions, for a
discussion of the consulting fee expense and stock based compensation expense recognized with respect to the Physician Inventors consulting
agreements and stock options and restricted stock awards; and the MSA between Lucid Diagnostics and PAVmed; and Note 11 , Stock-Based
Compensation , for information regarding each of the Lucid Diagnostics 2018 Equity Plan and the PAVmed Inc. 2014 Equity Plan.
29
Results
of Operations - continued
Six
months ended June 30, 2022 as compared to six months ended June 30, 2021
Revenue
In the six months ended June
30, 2022, revenue was $0.2 million as compared to no revenue in the corresponding period in the prior year. The $0.2 million increase
relates to our EsoGuard Commercialization Agreement, dated August 1, 2021, which resulted in revenue recognition of $0.1 million per month
commencing August 2021 and ending February 2022 upon the February 25, 2022 termination date of such agreement.
Cost
of revenue
In
the six months ended June 30, 2022, cost of revenue was approximately $0.4 million, compared to no cost of revenue in the corresponding
period in the prior year. The $0.4 million increase principally relates to costs associated with the EsoGuard Commercialization Agreement
noted above.
Sales
and marketing expenses
In
the six months ended June 30, 2022, sales and marketing costs were approximately $7.2 million, compared to $1.7 million for the corresponding
period in the prior year. The net increase of $5.5 million was principally related to:
●
approximately
$4.8 million increase in compensation related costs, including stock-based compensation of approximately $0.8 million in stock based
compensation with respect to restricted stock awards (“RSA”) grants under the Lucid Diagnostics Inc. 2018 Equity Plan to Lucid Diagnostics and PAVmed employees and non-employees,
and an increase in stock options granted corresponding with the increase in the number of employees principally related to an increase
in headcount;
●
approximately $0.9 million
increase in outside professional services related to EsoCheck, EsoGuard and consulting and professional services fees; and
●
approximately $0.2 million
decrease in the MSA fee allocation from PAVmed related to the growth and expansion of our business and the services incurred
through PAVmed.
General
and administrative expenses
In
the six months ended June 30, 2022, general and administrative costs were approximately $13.2 million, compared to $4.3 million for the
corresponding period in the prior year. The net increase of $8.9 million was principally related to:
●
approximately
$2.0 million increase in compensation related costs, including stock-based compensation of approximately $1.6 million in stock based
compensation with respect to restricted stock awards (“RSA”) grants under the Lucid Diagnostics Inc. 2018 Equity Plan to Lucid Diagnostics and PAVmed employees and non-employees,
and an increase in stock options granted corresponding with the increase in the number of employees principally related to an increase
in headcount;
●
approximately $4.1 million
increase in consulting services related to patents, regulatory compliance, legal processes for contract review, transition of public
relations and investor relations firms, and public company expenses; and
●
approximately $0.6 million of amortization expense related to our intangible
assets;
●
approximately $0.7 million
increase in the MSA fees, after allocation, from PAVmed related to the growth and expansion of our business and the services incurred
through PAVmed; and
●
approximately $1.5 million
increase general business expenses.
30
Results of Operations - continued
Six months ended June 30, 2022 as compared to six months ended June
30, 2021 - continued
Research
and development expenses
In
the six months ended June 30, 2022, research and development costs were approximately $6.3 million, compared to $3.6 million for the
corresponding period in the prior year. The net increase of $2.7 million was principally related to:
●
approximately
$2.2 million increase in development costs, particularly in clinical trial activities and outside professional and consulting fees
with respect to EsoCheck, EsoCure and EsoGuard;
●
approximately $0.2 million
increase in compensation related costs and related to expanded clinical and engineering staff; and
●
approximately $0.3 million
increase in the MSA fee allocation from PAVmed related to the growth and expansion of Lucid’s business and the services incurred
through PAVmed.
See
our accompanying unaudited condensed consolidated financial statements for each of: Note 4 , Related Party Transactions, for a
discussion of the consulting fee expense and stock based compensation expense recognized with respect to the Physician Inventors consulting
agreements and stock options and restricted stock awards; and the MSA between Lucid Diagnostics and PAVmed; and Note 11 , Stock-Based
Compensation , for information regarding each of the Lucid Diagnostics 2018 Equity Plan and the PAVmed Inc. 2014 Equity Plan.
31
Liquidity
and Capital Resources
Our
current operational activities are principally focused on the commercialization of EsoGuard. We are presently focused on expanding commercialization
across multiple sales channels, including: the communication and education of medical practitioners and clinicians of the EsoGuard LDT;
and establishing “Lucid Diagnostics Test Centers” for the collection of cell samples using EsoCheck. Additionally, we are
developing expanded clinical evidence to support recommendation of our products in professional society guidelines and insurance reimbursement
adoption by government and private insurers. Further, the Company is also pursuing development of other products and services, including
EsoCure™, an esophageal ablation device.
The
ability of the Company to generate revenue depends upon the Company’s ability to successfully advance the commercialization of
EsoGuard, while also completing the clinical studies, its product and service development, and the necessary regulatory approval thereof.
There are no assurances, however, the Company will be able to obtain an adequate level of financial resources required for the long-term
commercialization and development of its products and services.
Prior
to our initial public offering (“IPO”) of our common stock in October 2021, our operations were funded by PAVmed Inc., inclusive
of providing working capital cash advances and the payment of certain operating expenses on-our-behalf. Additionally, certain operations
of Lucid Diagnostics Inc. continue to be managed by personnel of PAVmed Inc., for which we incur expense according to the provisions
of a Management Services Agreement between us and PAVmed Inc.
We
are subject to all of the risks and uncertainties typically faced by medical device and diagnostic companies that devote substantially
all of their efforts to the commercialization of their initial product and services and ongoing research and development activities and
conducting clinical trials. We expect to continue to experience recurring losses from operations and will continue to fund our operations
with debt and equity financing transactions. Notwithstanding, however, with the cash on-hand as of the date hereof and committed equity
sources of financing, the Company expects to be able to fund its operations and meet its financial obligations as they become due for
the one year period from the date of the issue of the Company’s unaudited condensed consolidated financial statements, as included
herein in this Quarterly Report on Form 10-Q for the period ended June 30, 2022.
Committed
Equity Facility - March 28, 2022
On
March 28, 2022, we 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 our common stock from time to time at our
request. While there are distinct differences, the committed equity facility is structured similarly to a traditional at-the-market equity
facility, insofar as it allows us to raise primary equity capital on a periodic basis at prices based on the existing market price. As
of June 30, 2022, there were no shares of common stock issued under the committed equity facility. Subsequent to June 30, 2022, as of
August 10, 2022, under the committed equity facility, a total of 308,152 shares of common stock of the Company were issued for proceeds
of approximately $927.
Due
To: PAVmed Inc.
Since
our inception in May 2018 through our IPO in October 2021, our operations were funded by PAVmed providing working capital cash advances
and the payment by PAVmed of certain operating expenses on-our-behalf. Additionally, our daily operations have been and continue to be
principally managed by personnel employed by PAVmed, for which we incur a MSA Fee expense according to the provisions of the MSA discussed
above.
As
of June 30, 2022, we had a Due To: PAVmed Inc. payment obligation liability of an aggregate of approximately $2.4 million payable for
the transfer of CapNostics LLC, and for reimbursement of employee related costs and certain operating expenses paid by PAVmed Inc. on
our behalf. See our accompanying unaudited condensed consolidated financial statements Note 5, Due To PAVmed Inc.
32
Critical
Accounting Policies and Significant Judgments and Estimates
The
discussion and analysis of our (unaudited) financial condition and consolidated results of operations is based on our unaudited
condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in
the United States of America (“U.S. GAAP”). The preparation of these unaudited condensed consolidated financial
statements requires us to make estimates and assumptions affecting the reported amounts of assets, liabilities, and equity, along
with the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements
and the reported amounts of expenses during the corresponding periods. In accordance with U.S. GAAP, we base our estimates on
historical experience and on various other assumptions we believe are reasonable under the circumstances. Actual results may differ
from these estimates under different assumptions or conditions. Our critical accounting policies are as disclosed in the
Company’s annual report on Form 10-K for the year ended December 31, 2021 as filed with the SEC on April 6, 2022, except as
otherwise noted in Note 2, Summary of Significant Accounting Policies and Recent Accounting Standards Updates , of our
unaudited condensed consolidated financial statements included herein in this Form 10-Q.
33
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our principal executive officer and our principal financial officer, evaluated the effectiveness
of our disclosure controls and procedures as of June 30, 2022. Based on such evaluation, our principal executive officer and principal
financial officer concluded our disclosure controls and procedures (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act)
were effective as of such date to provide reasonable assurance the information required to be disclosed by us in the reports we file
or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s
rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure information
required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management,
including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required
disclosure.
Changes
to Internal Controls Over Financial Reporting
There
has been no change in our internal controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange
Act) that occurred during our fiscal quarter ended June 30, 2022 that has materially affected, or is reasonably likely to materially
affect, our internals control over financial reporting.
34
Part
II - Other Information
Item
1. Legal Proceedings
In
the ordinary course of our business, particularly as it begins commercialization of its products, the Company may be subject to certain
other legal actions and claims, including product liability, consumer, commercial, tax and governmental matters, which may arise from
time to time. Except as otherwise noted herein, the Company does not believe it is currently a party to any other pending legal proceedings.
Notwithstanding, legal proceedings are subject-to inherent uncertainties, and an unfavorable outcome could include monetary damages,
and excessive verdicts can result from litigation, and as such, could result in a material adverse impact on the Company’s business,
financial position, results of operations, and /or cash flows. Additionally, although the Company has specific insurance for certain
potential risks, the Company may in the future incur judgments or enter into settlements of claims which may have a material adverse
impact on the Company’s business, financial position, results of operations, and /or cash flows.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
See the disclosure under Item 5 below, which is incorporated
herein by reference, for a description of the shares issuable under the sixth amendment to our Management Services Agreement with PAVmed
Inc. In addition, effective as of May 25, 2022, we issued 117,371 shares of our common stock to an entity designated by RDx, in satisfaction
of a $250,000 installment payment due under the asset purchase agreement dated February 25, 2022, between LucidDx Labs Inc. (a wholly-owned
subsidiary of Lucid Diagnostics Inc.) and ResearchDx Inc. (“RDx”), and unrelated third-party - referred to as “APA-RDx”.
See the Current Report on Form 8-K filed by us with the SEC on March 3, 2022, which is incorporated herein by reference, for a fuller
description of the APA-RDx and the installment payments thereunder. The shares of our common stock are being offering pursuant to the
APA-RDx in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended, for the
sale of securities not involving a public offering.
On
October 14, 2021, we completed our initial public offering (“IPO”) of our common stock under an effective registration
statement on Form S-1 (SEC File No. 333-259721). As of June 30, 2022, of the net proceeds of $64.4 million, approximately $31.7
million has been used, in a manner consistent with the use of proceeds set forth in the prospectus for our IPO, as follows:
approximately $3.9 million of net repayments due to PAVmed Inc.; approximately $3.4 million for the purchase of our laboratory
equipment, software, and its operating expenses; and 24.4 million of working capital expenditures. None of the proceeds have been paid to any of our directors,
officers, 10% stockholders, or affiliates, other than as described above.
Item
5. Other Information
The Company’s daily operations of are managed by
personnel employed by PAVmed Inc., for which Lucid Diagnostics Inc. incurs a service fee, referred to as the “MSA Fee”, according
to the provisions of a Management Services Agreement (“MSA”) with PAVmed Inc. The MSA does not have a termination date, but
may be terminated by the Lucid Diagnostics Inc. 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 Inc. personnel to the Company, with any such change in the MSA Fee being subject to approval of the Lucid Diagnostics Inc.
and PAVmed Inc. boards of directors. In this regard, subsequent to June 30, 2022, in August 2022, the boards of directors of Lucid
Diagnostics Inc. and PAVmed Inc. approved a sixth amendment to the MSA to increase the MSA Fee to $550 per month from $390 per
month, with such increase effective on a
prospective basis commencing July 1, 2022. Pursuant to the sixth amendment, the parties agreed PAVmed Inc. may elect to receive
payment of the monthly MSA Fee in cash or in shares of our common stock, with such shares valued at the volume weighted average
price (“VWAP”) during the final ten trading days of the applicable month (subject to a floor price of
$0.70 per share). However, in no event will PAVmed Inc. be entitled to receive under the MSA, as amended, more than 7,709,836 shares
of our common stock (representing 19.99% of our outstanding shares of common stock as of immediately prior to the execution of the
sixth amendment). The shares that may be issued under the MSA, as amended, are being offered and sold in transactions exempt from
registration under the Securities Act of 1933, as amended, in reliance on the exemption afforded under Section 4(a)(2) thereof.
Item
6. Exhibits
The
exhibits filed as part of this Quarterly Report on Form 10-Q are set forth in the “ Exhibit Index ” below.
35
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized.
Lucid Diagnostics Inc.
August 15, 2022
By:
/s/ Dennis
M McGrath
Dennis M McGrath
Chief Financial Officer
(Principal Financial and Accounting Officer)
36
EXHIBIT
INDEX
Incorporation
by Reference
Exhibit
No.
Description
Form
Exhibit
No.
Date
2.1‡
Asset Purchase Agreement, dated as of February 25, 2022, by and among LucidDx Labs Inc., Lucid Diagnostics Inc. and ResearchDx, Inc. ‡
8-K
2.1
3/3/2022
10.1
Amended and Restated 2018 Long-Term Incentive Equity Plan.
DEF 14A
Annex A
5/2/2022
10.2
Employee Stock Purchase Plan.
DEF 14A
Annex B
5/2/2022
31.1
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
*
31.2
Certification of Principal Financial and Accounting Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
*
32.1
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
*
32.2
Certification of Principal Financial and Accounting Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
*
101.INS
Inline XBRL Instance Document
*
101.CAL
Inline XBRL Taxonomy Extension Schema
*
101.DEF
Inline XBRL Taxonomy Extension Calculation Linkbase
*
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase
*
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase
*
104
Cover Page Interactive Data File (embedded within the
Inline XBRL document)
*
*
Filed herewith.
‡
Certain exhibits and schedules have been omitted pursuant to Item 601(b)(10) of Regulation S-K. The registrant hereby undertakes to furnish
supplementally a copy of any omitted exhibit or schedule upon request by the Securities and Exchange Commission.
37
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.