Item 1. Financial Statements
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
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.