Item 1. Financial Statements
Item
1. Financial Statements
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARY
(a
majority-owned subsidiary of PAVmed Inc.)
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands except number of shares and per share data - unaudited)
March 31, 2022
December 31, 2021
Assets:
Current assets:
Cash
$ 47,919
$ 53,656
Accounts receivable
89
200
Prepaid expenses, deposits, and other current assets
4,324
3,447
Total current assets
52,332
57,303
Fixed assets, net
1,095
971
Operating lease right-of-use assets
2,224
—
Intangible assets, net
5,714
—
Other assets
695
725
Total assets
$ 62,060
$ 58,999
Liabilities, Preferred Stock and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 4,462
$ 1,490
Accrued expenses and other current liabilities
2,226
1,113
Operating lease liabilities, current portion
769
—
Contingent purchase consideration payable
4,887
—
Due To: PAVmed Inc. - MSA Fee and operating expenses
1,770
1,657
Total current liabilities
14,114
4,260
Long-term liabilities
Operating lease liabilities, less current portion
1,455
—
Total long-term liabilities
1,455
—
Total liabilities
15,569
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 March 31, 2022 and December 31, 2021
—
—
Common stock, $ 0.001 par value, 100,000,000 shares authorized; 35,171,796 and 34,917,907 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively
35
35
Additional paid-in capital
100,630
96,608
Accumulated deficit
( 54,174 )
( 41,904 )
Total Stockholders’ Equity
46,491
54,739
Total Liabilities and Stockholders’ Equity
$ 62,060
$ 58,999
See
accompanying notes to the unaudited condensed consolidated financial statements.
1
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARY
(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
Three Months Ended March 31,
2022
2021
Revenue
$ 189
$ —
Cost of revenue
369
—
Gross profit (loss)
( 180 )
—
Operating expenses:
Sales and marketing
3,318
689
General and administrative
5,718
1,212
Research and development
2,881
1,752
Total operating expenses
11,917
3,653
Loss from operations
( 12,097 )
( 3,653 )
Other income (expense):
Change in fair value - contingent consideration payable
( 173 )
—
Other income (expense), net
( 173 )
—
Loss before provision for income tax
( 12,270 )
( 3,653 )
Provision for income taxes
—
—
Net loss
$ ( 12,270 )
$ ( 3,653 )
Net loss per share - basic and diluted
$ ( 0.35
)
$ ( 0.26 )
Weighted average common shares outstanding, basic and diluted
35,123,039
14,114,437
See
accompanying notes to the unaudited condensed consolidated financial statements.
2
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARY
(a
majority-owned subsidiary of PAVmed Inc.)
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
for
the THREE MONTHS ENDED March 31, 2022 and 2021
(in
thousands except number of shares and per share data - unaudited)
Shares
Amount
Capital
Deficit
Total
Common Stock
Additional Paid-In
Accumulated
Shares
Amount
Capital
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
253,889
—
187
—
187
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan
—
—
3,537
—
3,537
Stock-based compensation - PAVmed Inc. 2014 Equity Plan
—
—
298
—
298
Net Loss
—
—
—
( 12,270 )
( 12,270 )
Balance as of March 31, 2022
35,171,796
$ 35
$ 100,630
$ ( 54,174 )
$ 46,491
Shares
Amount
Capital
Deficit
Total
Common Stock
Additional Paid-In
Accumulated
Shares
Amount
Capital
Deficit
Total
Balance as of December 31, 2020
14,114,707
$ 10
$ 298
$ ( 13,826 )
$ ( 13,518 )
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan
—
—
802
—
802
Stock-based compensation - PAVmed Inc. 2014 Equity Plan
—
—
3
—
3
Net loss
—
—
—
( 3,653 )
( 3,653 )
Balance as of March 31, 2021
14,114,707
$ 10
$ 1,103
$ ( 17,479 )
$ ( 16,366 )
See
accompanying notes to the unaudited condensed consolidated financial statements.
3
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARY
(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
Three Months Ended March 31,
2022
2021
Cash flows from operating activities
Net loss
$ ( 12,270 )
$ ( 3,653 )
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation expense
24
3
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan
3,537
802
Stock-based compensation - PAVmed Inc. 2014 Equity Plan
298
3
Fair value adjustment to contingent consideration payable
173
—
Changes in operating assets and liabilities:
Accounts receivable
111
—
Prepaid expenses and other current assets
168
104
Accounts payable
1,958
( 1,269 )
Accrued expenses and other current liabilities
112
( 108 )
Due To: PAVmed Inc. - operating expenses paid on-behalf-of Lucid Diagnostics Inc.
( 510 )
33
Due To: PAVmed Inc. - Management Services Agreement Fee
—
770
Due To: PAVmed Inc. - Employee Related Costs
623
—
Net cash flows used in operating activities
( 5,776 )
( 3,315 )
Cash flows from investing activities
Purchase of equipment
( 148 )
( 9 )
Net cash flows used in investing activities
( 148 )
( 9 )
Cash flows from financing activities
Proceeds – exercise of stock options
187
—
Proceeds – Due To: PAVmed Inc. - working capital cash advances
—
3,300
Net cash flows provided by financing activities
187
3,300
Net increase (decrease) in cash
( 5,737 )
( 24 )
Cash, beginning of period
53,656
111
Cash, end of period
$ 47,919
$ 87
See
accompanying notes to the unaudited condensed consolidated financial statements.
4
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARY
(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
The
accompanying unaudited condensed consolidated financial statements are those of Lucid Diagnostics Inc. (“Lucid Diagnostics”
or “the Company”), which was incorporated in the State of Delaware on May 8, 2018. 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 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 Note
3, Patent License Agreement – Case Western Reserve University, for a discussion of the Amended CWRU License Agreement.
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 Up and until February
25, 2022, delivery of the collected cell samples were sent to ResearchDX Inc. (“RDx”), a CLIA certified commercial
laboratory service provider, for the performance of the EsoGuard LDT. See LucidDx Labs, Inc. and Asset Purchase Agreement-February
2022 below. Additionally, the Company is conducting two concurrent clinical trials, including each of: the “EsoGuard screening
study” (“ESOGUARD-BE-1”); and the “EsoGuard case control study” (“ESOGUARD-BE-2”), 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”). Further, the Company is developing expanded clinical evidence to support
recommendation of our products in professional society guidelines.
5
Note 1 — Summary Description of the Company - continued
Since
its inception and through the date of the Company’s IPO on October 14, 2021, the operations of Lucid Diagnostics Inc. have been
funded by PAVmed Inc. providing working capital cash advances and the payment by PAVmed Inc. of certain operating expenses on-behalf-of
Lucid Diagnostics Inc. Additionally, the daily operations of Lucid Diagnostics Inc. continue to be managed by personnel employed by 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 5, Related Party Transactions , for information with respect to the Management Services Agreement;
and Note 6, 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 and medical device 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 other debt and equity committed sources of capital with Lucid and its parent company, PAVmed, the Company expects
to be able to fund its future operations for one year 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 March 31, 2022.
Lucid
Diagnostics Inc. Initial Public Offering - October 14, 2021
On
October 14, 2021, Lucid Diagnostics Inc. completed an initial public offering (“IPO”) of its common stock under an effective
registration statement on Form S-1 (SEC File No. 333-259721), wherein a total of 5.0 million IPO shares of common stock were issued,
with such total IPO shares inclusive of 571,428 IPO shares issued to PAVmed Inc., at an IPO price of $ 14.00 per share, resulting gross
proceeds of $ 70.0 million, before underwriting fees of $ 4.9 million, and approximately $ 0.7 million of offering costs incurred by the
Company.
LucidDx Labs Inc.
In
December 2021, Lucid Diagnostics, Inc. formed a new wholly owned subsidiary, LucidDx Labs Inc., principally to construct and operate
a Company-owned Commercial Lab Improvements Act (“CLIA”) certified, College of American Pathologists (“CAP”)
accredited commercial clinical laboratory.
On February 25, 2022, LucidDx
Labs, Inc., entered into an asset purchase agreement (“APA”) with ResearchDx, Inc. (“RDx”), an unrelated third-party
- “RDx APA”. Under the RDx APA, 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 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. See Note 7, Acquisitions - Asset Purchase Agreement - Research Dx Inc. , for a further discussion of the
RDx APA.
6
Note
2 — Summary of Significant Accounting Policies and Recent Accounting Standards Updates
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 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 subsidiary, LucidDx Labs Inc.
All intercompany transactions and balances have been eliminated in consolidation. Lucid Diagnostics Inc. (“the Company”)
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 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 consolidated financial statements include those related to the estimated fair value of stock-based equity awards and
contingent consideration. Other significant estimates include 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.
Contingent
Consideration
Contingent
Consideration relates to the potential payment for an acquisition that is contingent upon the achievement of the acquired business meeting
certain milestones. The Company records contingent consideration at fair value at the date of acquisition based on the consideration
expected to be transferred. For potential payments related to milestone achievements, the Company estimated the
fair value based on the probability of achievement of such milestones. The assumptions utilized in the calculation of the acquisition
date fair value include probability of success and the discount rates. Contingent consideration involves certain assumptions requiring
significant judgment and actual results may differ from assumed and estimated amounts. Contingent consideration is remeasured each reporting
period, and subsequent changes in fair value, including accretion for the passage of time, are recognized within other income (expense),
net in the Company’s unaudited condensed consolidated statements of operations.
7
Note
2 — Summary of Significant Accounting Policies and Recent Accounting Standards Updates - continued
Recent
Accounting Standards Updates Adopted
Effective
December 31, 2021, the Company adopted FASB ASC Topic 842, Leases, (“ASC 842”). ASC 842 established a right-of-use (“ROU”)
model requiring a lessee to recognize a ROU asset and a lease liability for all leases with terms greater-than 12 months. Leases are
classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement.
The Company’s adoption of ASC 842 did not have an effect on the Company’s consolidated financial statements. See Note 9,
Leases.
Note
3 — Patent License Agreement - Case Western Reserve University
The Company has a patent license
agreement with CWRU which provides for each of patent fees reimbursement payments, milestone payments and royalty payments - each as
discussed below. For further details of this agreement, see Note 3 of the Company’s Consolidated Financial Statements in the Company’s
Form 10-K for the year ended December 31, 2021.
Lucid
Diagnostics Inc. is responsible for reimbursement of certain CWRU billed patent fees. See Note 5, Related Party Transactions ,
for patent fee reimbursement payments paid to CWRU in the periods ended March 31, 2022 and 2021.
The
CWRU License Agreement contained milestones for
which a $ 75
research and development expense was recognized
and paid with respect to the achievement of the regulatory milestone related to FDA clearance of EsoCheck. The CWRU License Agreement
was amended effective February 12, 2021 such that a regulatory milestone related to FDA PMA submission of a licensed product
(“PMA Milestone”) is included in the Amended CWRU License Agreement, and is the sole remaining unachieved milestone, for
which a $ 200 milestone
payment would be payable to CWRU upon its achievement.
8
Note
3 — Patent License Agreement - Case Western Reserve University - continued
Under
the Amended CWRU License Agreement, the Company is required to pay a royalty fee to CWRU with respect to the “Licensed Products”
(as defined in the CWRU License Agreement) of a percentage of “Net Sales”, as defined in the Amended CWRU License Agreement,
as follows: 5.0% of Net Sales up to $100.0 million per year; and 8.0% of Net Sales of $100.0 million or greater per year, with such amounts
subject-to a minimum annual royalty fee. The Company recorded a royalty expense of $ 10 for the three months ended March 31, 2022
Note
4 — 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 March 31,
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 initial term
was on a month-to-month basis and was terminated on February 25, 2022 upon the execution of the RDx APA. See Note 7, Acquisitions
- Asset Purchase Agreement - Research Dx Inc. , for a further discussion of the RDx APA.
Revenue
Recognized
In
the three months ended March 31, 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 employees 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
5 — 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 CWRU License Agreement (“Physician Inventors”) each hold equity ownership minority interests in Lucid Diagnostics Inc.
The expenses incurred with respect to the 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
Three Months Ended March 31,
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
91
General and Administrative Expense
5,718
1,212
Research and Development Expense
CWRU License Agreement - reimbursement of patent legal fees
—
—
Fees - Physician Inventors’ consulting agreements
8
13
Sponsored research agreement
3
—
Stock-based compensation expense – Physician Inventors’ stock options
46
6
Research and Development Expense
2,881
1,752
Total Related Party Expenses
$ 338
$ 110
Lucid
Diagnostics Inc. entered into consulting agreements with each of the three Physician Inventors, with each such consulting agreement providing
for compensation on a contractual rate per hour for consulting services provided, and an expiration date of May 12, 2024, upon the agreements’
renewal effective May 12, 2021. Additionally, as discussed below, each of the Physician Inventors have been granted stock options under
the PAVmed Inc. 2014 Long-Term Incentive Equity Plan, and stock options and restricted stock awards under the Lucid Diagnostics Inc.
2018 Long-Term Incentive Equity Plan.
Under
each of their respective (initial) consulting agreements with Lucid Diagnostics Inc., the three Physician Inventors were each granted
25,000 stock options under the PAVmed Inc. 2014 Equity Plan, with a grant date of May 12, 2018, an exercise price of $ 1.59 per share
of common stock of PAVmed Inc., vesting ratably on a quarterly basis commencing June 30, 2018 and ending March 31, 2021, and a contractual
period of ten years from the date of grant. As of March 31, 2021, such stock options were fully vested and exercisable. Subsequent to
March 31, 2021, each of the Physician Inventors were granted 50,000 stock options under the PAVmed Inc. 2014 Equity Plan, with a grant
date of June 21, 2021, an exercise price of $ 6.41 per share of common stock of PAVmed Inc., vesting ratably on a quarterly basis commencing
June 30, 2021 and ending March 31, 2024, and a contractual period of ten years from the date of grant.
On
March 1, 2021, restricted stock awards were granted under the Lucid Diagnostics Inc. 2018 Equity Plan to each of the three Physician
Inventors, with such restricted stock awards having a single vesting date of March 1, 2023, with the fair value of such restricted stock
awards 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.
10
Note
5 — Related Party Transactions - continued
PAVmed
Inc. - Management Services Agreement
The
daily operations of Lucid Diagnostics Inc. 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 quarterly basis and is subject-to periodic adjustment corresponding with changes in the number of PAVmed Inc.
employees providing services to Lucid Diagnostics Inc., with the change in the MSA Fee approved by each of the Lucid Diagnostics Inc.
and PAVmed Inc. board of directors.
Lucid
Diagnostics Inc. recognized MSA Fee expense of $ 1,170 and $ 770
in the periods ended March 31, 2022 and 2021,
respectively. 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
Three Months Ended March 31,
2022
2021
Cost of Revenues
$ —
$ —
Sales & Marketing
183
323
General & Administrative
640
270
Research & Development
347
177
Total MSA Fee
$ 1,170
$ 770
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 $ 6 in
the period ended March 31, 2021 in connection with the consulting agreement.
11
Note
6 — Due To PAVmed Inc.
The
aggregate Due To: PAVmed Inc., inclusive of the Senior Unsecured Promissory Note, for the periods indicated is summarized as follows:
Schedule of Senior Unsecured Promissory Note
Working Capital Cash Advances
PAVmed Inc. OBO Payments
Employee-Related
Costs
MSA Fees
Total
Balance - December 31, 2021
$ —
$ 620
$ 1,037
$ —
$ 1,657
MSA fees
—
—
—
1,170
1,170
On Behalf Of (OBO) activities
—
153
—
—
153
ERC - Payroll & Benefits
—
—
2,122
—
2,122
Cash payments to PAVmed Inc.
—
( 662 )
( 1,500 )
( 1,170 )
( 3,332 )
Balance - March 31, 2022
$ —
$ 111
$ 1,659
$ —
$ 1,770
Prior
to the Company’s initial public offering (IPO), it
principally financed its operations through working capital cash advances from PAVmed Inc. and the periodic payment of certain operating
expenses by PAVmed Inc. on-behalf-of Lucid Diagnostics Inc. (the “PAVmed Inc. OBO Payments”). Additionally, the daily operations
of Lucid Diagnostics Inc. are managed by personnel employed by PAVmed Inc., for which the Company incurs expense according to the provisions
of a Management Services Agreement (the “MSA”) between the Company and PAVmed Inc (the “MSA Fee”). See
Note 5 , Related Party Transactions , for further information regarding the MSA.
12
Note
7 — Acquisitions
Asset
Purchase Agreement - ResearchDx Inc.
On
February 25, 2022, LucidDx Labs, Inc., entered into an asset purchase agreement (“APA”) with ResearchDx, Inc. (“RDx”),
an unrelated third-party - “RDx APA”. Under the RDx APA, 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 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 RDx APA, RDx provided such laboratory services at its owned CLIA-certified, CAP-accredited laboratory.
As of March 31, 2022, the
Company’s preliminary analysis is the RDx APA transaction is a business combination, resulting in the recognition
and measurement of a preliminary purchase consideration in accordance with the valuation methodology described in Note
2, Summary of Significant Accounting Policies and Recent Accounting Standards Updates .
Under
the terms of the RDx APA, LucidDx Labs Inc. will pay RDx an aggregate purchase price of up to $ 6.2
million for the acquired assets. The total
of $ 6.2
million is comprised of non-contingent purchase
consideration of $ 1.0
million (included in “Accrued expenses
and other liabilities” in the accompanying unaudited condensed consolidated balance sheets, as of March 31, 2022), and contingent
purchase consideration of a total of $ 5.2
million face value, with such contingent purchase
consideration having a preliminary $ 4,714
initial estimated fair value
as of the transaction date. The preliminary $ 5,714
purchase consideration (inclusive of both
the non-contingent and contingent purchase consideration discussed above) is unallocated as of March 31, 2022, and as such is included
in intangible assets in the accompanying unaudited consolidated balance sheet. The preliminary estimated fair value of the contingent
purchase price consideration and the identification and estimated fair value of acquired assets are subject-to further revision.
Concurrent with the RDx
APA, LucidDx Labs Inc. and RDx also entered into a management services agreement (“RDx MSA”), with a term of three
years , and a total of approximately $ 1.8
million payable in equal quarterly payments.
Pro Forma Information.
The
RDx APA transaction impact for purposes of pro forma financial statement disclosures would have primarily impacted the Company’s
EsoGuard Commercialization Agreement with RDx, summarized as follows:
Schedule
of Business Acquisition Pro Forma Information
Three Months Ended March 31,
2022
2021
Revenue
As reported
$ 189
$ —
Pro forma
$ —
$ —
Net Loss
As reported
$ ( 12,270 )
$ ( 3,653 )
Pro forma
$ ( 12,459 )
$ ( 3,653 )
Basic and diluted net loss per share
As reported
$ ( 0.35 )
$ ( 0.26 )
Pro forma
$ ( 0.35 )
$ ( 0.26 )
13
Note
8 — 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
March 31, 2022
December 31, 2021
Advanced payments to service providers and suppliers
$ 259
$ 260
Prepaid insurance
1,052
1,578
Deposits
1,668
1,116
Deferred financing charges
1,014
—
EsoCheck cell collection supplies
266
434
EsoGuard mailer supplies
65
59
Total prepaid expenses, deposits and other current assets
$ 4,324
$ 3,447
Note
9 — Leases
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
2022
2021
Three Months Ended March 31,
2022
2021
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows from operating leases
$ 224
$ —
Non-cash investing and financing activities
Right-of-use assets obtained in exchange for new operating lease liabilities
$ 2,404
$ —
Weighted-average remaining lease term - operating leases (in years)
2.72
—
Weighted-average discount rate - operating leases
7.875 %
— %
As
of March 31, 2022, the Company’s right-of-use assets from operating leases are $ 2,224 ,
which are reporting in right-of-use assets - operating leases in the unaudited condensed consolidated balance sheets. As of March 31,
2022, the Company has outstanding operating lease obligations of $ 2,224 ,
of which $ 769 is
reported in operating lease liabilities, current portion and $ 1,455
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
10 — Financial
Instruments Fair Value Measurements
Recurring
Fair Value Measurements
The
fair value hierarchy table for the reporting dates noted is as follows:
Schedule
of Fair value Measurement on Recurring Basis
Level-1 Inputs
Level-2 Inputs
Level-3 Inputs
Total
Fair Value Measurement on a Recurring Basis at Reporting
Date Using (1)
Level-1 Inputs
Level-2 Inputs
Level-3 Inputs
Total
March 31, 2022
Contingent consideration payable (1)
$ —
$ —
$ 4,887
$ 4,887
Totals (1)
$ —
$ —
$ 4,887
$ 4,887
(1) As noted above,
as presented in the fair value hierarchy table, Level-1 represents quoted prices in active markets for identical items, Level-2 represents
significant other observable inputs, and Level-3 represents significant unobservable inputs. There were no transfers between the respective
Levels during the period ended March 31, 2022.
Fair
value measurements of contingent consideration
The
Company recorded $ 4.9
million, which is the fair value, of contingent
consideration related to the RDx acquisition. The Company is required to make contingent consideration payments of up to $ 5.2
million related to the RDx APA agreement. The
contingent agreement is based on achieving milestones to obtain certain certifications and licensing rights. The Company estimated
the fair value on a probability based model that assessed achievement of such milestones. The model used present
value factors, that applied probability ranges of 94 - 99 % , a discount rate of 7.875 % and achievement times ranging from one
month to six months to achieve the respective milestones.
The
final settlement of contingent consideration liabilities for the acquisition could vary from current estimates based on
the actual results of the financial measures described above. This liability is considered to be a Level 3 financial liability that is
re-measured each reporting period. The change in fair value of contingent consideration for these acquisitions is included in other income
(expense), net.
The
following table presents a reconciliation of the liability measured at fair value on a recurring basis using significant unobservable
inputs (Level 3):
Schedule
of Reconciliation of Liability Measured at Fair Value Recurring Basis Using Unobservable Inputs
March 31, 2022
Fair value of contingent consideration at the date of acquisition
$ 4,714
Payments
—
Change in fair value of contingent consideration
173
Contingent consideration payable
$ 4,887
As
of December 31, 2021 there were no fair value measurements.
15
Note
11 — 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 5,644,000 shares of common stock of Lucid Diagnostics Inc. are reserved for issuance under the Lucid Diagnostics Inc. 2018 Equity
Plan, with 733,541 shares available for grant as of March 31, 2022. The share reservation is not diminished by a total of 473,300 Lucid
Diagnostics Inc. stock options and restricted stock awards granted outside the Lucid Diagnostics Inc. 2018 Equity Plan, as of March 31,
2022.
Lucid
Diagnostics Inc. 2018 Equity Plan - Stock Options
Stock
options issued and outstanding under the Lucid Diagnostics Inc. 2018 Equity Plan and including Lucid Diagnostics stock options granted
outside the plan is 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)
1,760,000
$ 4.16
Exercised
( 253,889 )
$ 0.74
Forfeited
( 60,926 )
$ 4.61
Outstanding stock options at March 31, 2022
2,864,427
$ 2.75
6.9
Vested and exercisable stock options at March 31, 2022
1,277,026
$ 0.99
3.3
(1) Stock
options granted under the Lucid Diagnostics Inc. 2018 Equity Plan generally vest ratably
over twelve quarters, with the vesting commencing with the grant date quarter, and have a
ten-year contractual term from date-of-grant.
See
Note 5, 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
11 — Stock-Based Compensation - continued
Lucid
Diagnostics Inc. 2018 Equity Plan – Restricted Stock Awards
A
summary of restricted stock award activity is 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
1,890,740
$ 12.94
Granted
320,000
4.53
Vested
—
—
Forfeited
—
—
Unvested restricted stock awards as of March 31, 2022
2,210,740
$ 11.07
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).
The
three Physician Inventors were each granted 25,000 stock options under the PAVmed Inc. 2014 Equity Plan, with a grant date of May 12,
2018, an exercise price of $ 1.59 per share of common stock of PAVmed Inc., vesting ratably on a quarterly basis commencing June 30, 2018
and ending March 31, 2021, and a contractual period of ten years from the date of grant. Additionally, the three Physician Inventors
were each granted 50,000 stock options under the PAVmed Inc. 2014 Equity Plan, with a grant date of June 21, 2021, an exercise price
of $ 6.41 per share of common stock of PAVmed Inc., vesting ratably on a quarterly basis commencing June 30, 2021 and ending March 31,
2024, and a contractual period of ten years from the date of grant. See Note 5, Related Party Transactions , for a summary of the
stock-based compensation expense recognized with respect to the stock options granted under the PAVmed Inc. 2014 Equity Plan to the Physician
Inventors.
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
Three Months Ended March 31,
2022
2021
Lucid Diagnostics Inc 2018 Equity Plan – sales and marketing expenses
$ 265
$ —
Lucid Diagnostics Inc 2018 Equity Plan - general and administrative expense
3,201
789
Lucid Diagnostics Inc 2018 Equity Plan - research and development expenses
71
13
PAVmed Inc 2014 Equity Plan - sales and marketing expenses
175
—
PAVmed Inc 2014 Equity Plan - general and administrative expenses
68
—
PAVmed Inc 2014 Equity Plan - research and development expenses
55
3
Total stock-based compensation expense
$ 3,835
$ 805
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 (as discussed above), 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 (as discussed above).
17
Note
11 — Stock-Based Compensation - continued
As
of March 31, 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
$ 4,660
2.7
Restricted Stock Awards
$ 14,080
1.3
PAVmed Inc. 2014 Equity Plan
Stock Options
$ 2,317
2.1
Restricted Stock Awards
$ 264
1.7
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 $ 2.95 per share during the year ended March 31, 2022. There were no
stock-based awards granted under the Lucid Diagnostics Inc. 2018 Equity Plan during the period ended March 31, 2021. The stock-based
compensation was calculated using the following weighted average Black-Scholes valuation model assumptions:
Schedule of Stock-based Compensation Valuation Assumptions
2022
Three Months Ended March 31,
2022
Expected term of stock options (in years)
5.6
Expected stock price volatility
86 %
Risk free interest rate
1.7 %
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 March 31, 2022.
18
Note
12 — Stockholders’ Equity
Lucid
Diagnostics Inc. Common Stock
There
were 35,171,796 and 34,917,907 shares of common stock issued and outstanding as of March 31, 2022 and December 31, 2021, respectively.
As of March 31, 2022, PAVmed Inc. holds 27,927,190 shares, representing a majority-interest equity ownership and 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.
In
connection with the execution of the agreement for the committed equity facility, the Company agreed to pay 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
13 — 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
Three Months Ended March 31,
2022
2021
Numerator
Net loss
$ ( 12,270 )
$ ( 3,653 )
Denominator
Weighted average common shares outstanding, basic and diluted
35,123,039
14,114,437
Loss per share
Net loss per share - basic and diluted
$ ( 0.35
)
$ ( 0.26 )
Basic
weighted-average number of shares of common stock outstanding for the periods ended March 31, 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
Three Months Ended March 31,
2022
2021
Lucid Diagnostics Inc. 2018 Equity Plan:
Stock options
3,287,727
1,145,353
Unvested restricted stock awards
2,260,740
1,467,440
Total
5,548,467
2,612,793
The total of stock options and unvested restricted stock awards presented in the table above, are inclusive of 423,300 stock options as
of March 31, 2022 and 2021, and 50,000 restricted stock awards as of March 31, 2022, granted outside the Lucid Diagnostics Inc. 2018 Equity
Plan.
Note
14 — Subsequent Events
CapNostics,
LLC
On
October 5, 2021, PAVmed Subsidiary Corporation, a wholly-owned subsidiary of PAVmed Inc., acquired all of the outstanding common stock
of CapNostics, LLC (“CapNostics”) for total (gross) purchase consideration of approximately $ 2.1
million of cash, paid at the closing of the transaction.
In April 2022, following the approval from both the PAVmed and Lucid board of directors, the respective companies entered
into an agreement to transfer the CapNostics, LLC assets from PAVmed to Lucid as well as transferring the consulting agreement
with the previous principal owner of CapNostics, LLC. The transfer price is $ 2.1
million for the assets.
EsoCure
EsoCure
has been in development as an Esophageal Ablation Device by PAVmed, 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 PAVmed and Lucid board of directors have the Companies entered
into an intercompany license between PAVmed and Lucid such that Lucid will be granted the rights to commercialize EsoCure for the treating
dysplastic Barrett’s Esophagus, including a royalty arrangement whereby Lucid will pay PAVmed a 5 %
royalty on all EsoCure sales up to $ 100
million per calendar year, and 8% above that
threshold. Lucid will obligated to fund ongoing development costs and cumulative patent expenses. EsoCure will become part of an integrated
suite of Lucid products addressing BE-EAC.
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.