UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2022
OR
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from _____ to _____
Commission
File Number: 001-37685
PAVMED
INC.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
47-1214177
(State
or Other Jurisdiction of
(IRS
Employer
Incorporation
or Organization)
Identification
No.)
One
Grand Central Place
60
E. 42nd Street
Suite
4600
New
York , NY 10165
10165
(Address
of Principal Executive Offices
(Zip
Code)
(212)
949-4319
(Registrant’s
Telephone Number, Including Area Code)
Securities
registered under Section 12(b) of the Exchange Act:
Title
of each Class
Trading
Symbol(s)
Name
of each Exchange on which Registered
Common
Stock, $0.001 par value per share
PAVM
The
NASDAQ Stock Market LLC
Series
Z Warrants, each to purchase one share of Common Stock
PAVMZ
The
NASDAQ Stock Market LLC
Securities
registered under Section 12(g) of the Exchange Act: None
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically Interactive Data File required to be submitted pursuant to Rule 405
of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was
required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”
, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
Accelerated filer
☐
Accelerated
filed
☐
Non-accelerated
filer
☒
Smaller
reporting company
☒
Emerging
growth company
☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to section 13(c) of the Exchange Act ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of August 10, 2022 there were 90,999,078 shares of the registrant’s Common Stock, par value $0.001 per share, issued (with such
number of shares inclusive of shares of common stock underlying granted but unvested restricted stock awards granted under the PAVmed
Inc. 2014 Long-Term Incentive Equity Plan as of such date).
TABLE
OF CONTENTS
Part I - Financial Information
Page
Item
1.
Financial Statements
Condensed Consolidated Balance Sheets (unaudited) as of June 30, 2022 and December 31, 2021
1
Condensed Consolidated Statements of Operations (unaudited) for the three and six months ended June 30, 2022 and 2021
2
Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) (unaudited) for the three and six months ended June 30, 2022 and 2021
3
Condensed Consolidated Statements of Cash Flows (unaudited) for the six months ended June 30, 2022 and 2021
7
Notes to Unaudited Condensed Consolidated Financial Statements
8
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
28
Item
4.
Controls and Procedures
40
PART II - Other Information
Item
1.
Legal Proceedings
41
Item
5.
Other Information
41
Item
6.
Exhibits
41
Signature
42
Exhibit Index
43
i
PART
I. Financial Information
Item
1. Financial Statements
PAVMED
INC.
and
SUBSIDIARIES
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
$ 65,153
$ 77,258
Accounts receivable
—
200
Prepaid expenses, deposits, and other current assets
5,662
5,179
Total current assets
70,815
82,637
Fixed assets, net
2,253
1,585
Operating lease right-of-use assets
3,205
—
Intangible assets, net
4,456
2,029
Other assets
1,725
725
Total assets
$ 82,454
$ 86,976
Liabilities, Preferred Stock and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 4,492
$ 3,299
Accrued expenses and other current liabilities
2,932
4,259
Operating lease liabilities, current portion
943
—
Senior Secured Convertible Notes - at fair value
29,500
—
Purchase consideration payable
1,000
—
Total current liabilities
38,867
7,558
Long-term liabilities
Operating lease liabilities, less current portion
2,183
—
Total long-term liabilities
2,183
—
Total liabilities
41,050
7,558
Commitments and contingencies (Note 9)
-
Stockholders’ Equity:
Preferred stock, $ 0.001 par value. Authorized, 20,000,000 shares; Series B Convertible Preferred Stock, par value $ 0.001 , issued and outstanding 1,158,950 at June 30, 2022 and 1,113,919 shares at December 31, 2021
2,554
2,419
Common stock, $ 0.001 par value. Authorized, 250,000,000 shares; 87,023,211 and 86,367,845 shares outstanding as of June 30, 2022 and December 31, 2021, respectively
87
86
Additional paid-in capital
201,327
198,071
Accumulated deficit
( 181,442 )
( 138,910 )
Treasury stock
( 548 )
—
Total PAVmed Inc. Stockholders’ Equity
21,978
61,666
Noncontrolling interests
19,426
17,752
Total Stockholders’ Equity
41,404
79,418
Total Liabilities and Stockholders’ Equity
$ 82,454
$ 86,976
See
accompanying notes to the unaudited condensed consolidated financial statements.
1
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(in
thousands except number of shares and per share amounts - 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
4,898
1,875
8,823
3,262
General and administrative
11,839
6,837
21,436
10,211
Research and development
6,740
4,258
12,671
7,573
Total operating expenses
23,477
12,970
42,930
21,046
Loss from operations
( 23,477 )
( 12,970 )
( 43,110 )
( 21,046 )
Other income (expense):
Interest expense
( 523 )
—
( 523 )
—
Change in fair value - Senior Secured Convertible Note
( 2,000 )
—
( 2,000 )
1,682
Loss on issue and offering costs - Senior Secured Convertible Note
( 3,101 )
—
( 3,101 )
—
Debt extinguishments loss - Senior Secured Convertible Notes
—
—
—
( 3,715 )
Debt forgiveness
—
300
—
300
Other income (expense), net
( 5,624 )
300
( 5,624 )
( 1,733 )
Loss before provision for income tax
( 29,101 )
( 12,670 )
( 48,734 )
( 22,779 )
Provision for income taxes
—
—
—
—
Net loss before noncontrolling interests
( 29,101 )
( 12,670 )
( 48,734 )
( 22,779 )
Net loss attributable to the noncontrolling interests
3,576
1,199
6,337
1,877
Net loss attributable to PAVmed Inc.
( 25,525 )
( 11,471 )
( 42,397 )
( 20,902 )
Less: Series B Convertible Preferred Stock dividends earned
( 70 )
( 74 )
( 138 )
( 149 )
Net loss attributable to PAVmed Inc. common stockholders
$ ( 25,595 )
$ ( 11,545 )
$ ( 42,535 )
$ ( 21,051 )
Per share information:
Net loss per share attributable to PAVmed Inc. - basic and diluted
$ ( 0.29 )
$ ( 0.14 )
$ ( 0.49 )
$ ( 0.27 )
Net loss per share attributable to PAVmed Inc. common stockholders – basic and diluted
$ ( 0.29 )
$ ( 0.14 )
$ ( 0.49 )
$ ( 0.27 )
Weighted average common shares outstanding, basic and diluted
86,957,352
82,235,397
86,689,857
78,117,637
See
accompanying notes to the unaudited condensed consolidated financial statements.
2
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY (DEFICIT)
for
the THREE MONTHS ENDED June 30, 2022
(in
thousands except number of shares and per share data - unaudited)
Shares
Amount
Shares
Amount
Capital
Deficit
Stock
Interest
Total
PAVmed Inc. Stockholders’ Equity (Deficit)
Series B Convertible Preferred Stock
Common Stock
Additional Paid-In
Accumulated
Treasury
Non controlling
Shares
Amount
Shares
Amount
Capital
Deficit
Stock
Interest
Total
Balance - March 31, 2022
1,136,210
$ 2,486
86,911,646
$ 87
$ 199,719
$ ( 155,849 )
$ ( 512 )
$ 18,802
$ 64,733
Dividends declared - Series B Convertible Preferred Stock
22,740
68
—
—
—
( 68 )
—
—
—
Vest - restricted stock awards
—
—
75,000
—
( 1 )
—
—
—
( 1 )
Exercise - stock options
—
—
62,500
—
61
—
—
—
61
Exercise - stock options of majority-owned subsidiary
—
—
—
—
—
—
—
501
501
Impact of subsidiary equity transactions
—
—
—
—
99
—
—
142
241
Stock-based compensation - PAVmed Inc.
—
—
—
—
1,449
—
—
—
1,449
Stock-based compensation - majority-owned subsidiary
—
—
—
—
—
—
—
3,557
3,557
Treasury stock
—
—
( 25,935 )
—
—
—
( 36 )
—
( 36 )
Net loss
—
—
—
—
—
( 25,525 )
—
( 3,576
)
( 29,101
)
Balance - June 30, 2022
1,158,950
$ 2,554
87,023,211
$ 87
$ 201,327
$ ( 181,442
)
$ ( 548 )
$ 19,426
$ 41,404
See
accompanying notes to the unaudited condensed consolidated financial statements.
3
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY (DEFICIT)
for
the SIX MONTHS ENDED June 30, 2022
(in
thousands except number of shares and per share data - unaudited)
PAVmed Inc. Stockholders’ Equity (Deficit)
Series B Convertible Preferred Stock
Common Stock
Additional Paid-In
Accumulated
Treasury
Non controlling
Shares
Amount
Shares
Amount
Capital
Deficit
Stock
Interest
Total
Balance - December 31, 2021
1,113,919
$ 2,419
86,367,845
$ 86
$ 198,071
$ ( 138,910 )
$ —
$ 17,752
$ 79,418
Dividends declared - Series B Convertible Preferred Stock
45,031
135
—
—
—
( 135 )
—
—
—
Exercise - Series Z Warrants
—
—
5
—
—
—
—
—
—
Vest - restricted stock awards
—
—
541,666
—
( 1 )
—
—
—
( 1 )
Exercise - stock options
—
—
299,999
1
302
—
—
—
303
Exercise - stock options of majority-owned subsidiary
—
—
—
—
—
—
—
688
688
Purchase - Employee Stock Purchase Plan
—
—
194,240
—
217
—
—
—
217
Impact of subsidiary equity transactions
—
—
—
—
12
—
—
229
241
Stock-based compensation - PAVmed Inc.
—
—
—
—
2,726
—
—
—
2,726
Stock-based compensation - majority-owned subsidiary
—
—
—
—
—
—
—
7,094
7,094
Treasury stock
—
—
( 380,544 )
—
—
—
( 548 )
—
( 548 )
Net loss
—
—
—
—
—
( 42,397 )
—
( 6,337 )
( 48,734 )
Balance - June 30, 2022
1,158,950
$ 2,554
87,023,211
$ 87
$ 201,327
$ ( 181,442 )
$ ( 548 )
$ 19,426
$ 41,404
See
accompanying notes to the unaudited condensed consolidated financial statements.
4
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY (DEFICIT)
for
the THREE MONTHS ENDED June 30, 2021
(in
thousands, except number of shares and per share data - unaudited)
PAVmed Inc. Stockholders’ Equity (Deficit)
Series B Convertible Preferred Stock
Common Stock
Additional Paid-In
Accumulated
Non controlling
Shares
Amount
Shares
Amount
Capital
Deficit
Interest
Total
Balance - March 31, 2021
1,241,438
$ 2,587
81,424,744
$ 81
$ 145,396
$ ( 97,778 ) -
$ ( 2,246 )
$ 48,040
Dividends declared - Series B Convertible Preferred Stock
25,046
76
—
—
—
( 76 )
—
—
Conversions - Series B Convertible Preferred Stock
( 80,799 )
( 164 )
80,799
—
164
—
—
—
Vest - restricted stock awards
—
—
150,000
—
—
— -
—
—
Exercise - Series Z warrants
—
—
880,441
2
1,409
—
—
1,411
Exercise - stock options
—
—
40,832
—
51
—
—
51
Stock-based compensation - PAVmed Inc.
—
—
—
—
2,622
—
—
2,622
Stock-based compensation - majority-owned subsidiary
—
—
—
—
52
—
2,528
2,580
Investment in Veris Health Inc. subsidiary
—
—
—
—
—
—
6
6
Net loss
—
—
—
—
—
( 11,471 ) -
( 1,199 )
( 12,670 )
Balance - June 30, 2021
1,185,685
$ 2,499
82,576,816
$ 83
$ 149,694
$ ( 109,325 ) -
$ ( 911 )
$ 42,040
See
accompanying notes to the unaudited condensed consolidated financial statements.
5
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY (DEFICIT)
for
the SIX MONTHS ENDED June 30, 2021
(in
thousands, except number of shares and per share data - unaudited)
Shares
Amount
Shares
Amount
Capital
Deficit
Interest
Total
PAVmed Inc. Stockholders’ Equity (Deficit)
Series B Convertible Preferred Stock
Common Stock
Additional Paid-In
Accumulated
Non controlling
Shares
Amount
Shares
Amount
Capital
Deficit
Interest
Total
Balance - December 31, 2020
1,228,075
$ 2,537
63,819,935
$ 64
$ 87,570
$ ( 88,275 ) -
$ ( 2,369 )
$ ( 473 )
Issue common stock – registered offerings, net
—
—
15,782,609
16
53,688
—
—
53,704
Issue common stock upon partial conversions of Senior Secured Convertible Note
—
—
667,668
1
1,722
—
—
1,723
Issue common stock – exercise Series Z warrants
—
—
1,740,658
2
2,783
—
—
2,785
Issue common stock – conversion Series B Convertible Preferred Stock
( 91,634 )
( 186 )
91,634
—
186
—
—
—
Series B Convertible Preferred Stock dividends declared
49,244
148
—
—
—
( 148 ) -
—
—
Issue common stock - Employee Stock Purchase Plan
—
—
203,480
—
304
—
—
304
Exercise - stock options
—
—
120,832
—
131
—
—
131
Vest - restricted stock awards
—
—
150,000
—
—
—
—
—
Stock-based compensation - PAVmed Inc.
—
—
—
—
3,254
—
—
3,254
Stock-based compensation - majority-owned subsidiary
—
—
—
—
56
—
3,329
3,385
Investment in Veris Health Inc. subsidiary
—
—
—
—
—
—
6
6
Net Loss
—
—
—
—
—
( 20,902 ) -
( 1,877 )
( 22,779 )
Balance - June 30, 2021
1,185,685
$ 2,499
82,576,816
$ 83
$ 149,694
$ ( 109,325 ) -
$ ( 911 )
$ 42,040
See
accompanying notes to the unaudited condensed consolidated financial statements.
6
PAVMED
INC.
and
SUBSIDIARIES
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 - before noncontrolling interest (“NCI”)
$ ( 48,734 )
$ ( 22,779 )
Adjustments to reconcile net loss - before NCI to net cash used in operating activities
Depreciation and amortization expense
1,031
28
Stock-based compensation
9,820
6,639
In-process R&D charge
—
133
APA-RDx: Issue common stock of majority-owned subsidiary - settle installment payment
239
—
Change in fair value - Senior Secured Convertible Note
2,000
( 1,682 )
Loss upon Issuance - Senior Secured Convertible Note
2,500
—
Debt extinguishment loss - Senior Secured Convertible Notes and Senior Convertible Note
—
3,715
Debt forgiveness
—
( 300 )
Non-cash lease expense
57
—
Changes in operating assets and liabilities:
Accounts receivable
200
—
Prepaid expenses and other current and non-current assets
( 1,665 )
( 1,441 )
Accounts payable
1,057
650
Accrued expenses and other current liabilities
( 1,326 )
( 759 )
Net cash flows used in operating activities
( 34,821 )
( 15,796 )
Cash flows from investing activities
Purchase of equipment
( 926 )
( 157 )
Payments - Acquisitions, net of cash
( 2,200 )
( 47 )
Net cash flows used in investing activities
( 3,126 )
( 204 )
Cash flows from financing activities
Proceeds – issue of common stock – registered offerings
—
55,016
Payment – offering costs – registered offerings
—
( 1,312 )
Proceeds – issue of Senior Secured Convertible Note
25,000
—
Payment – repayment of Senior Convertible Note and Senior Secured Convertible Note
—
( 14,816 )
Payment – Senior Convertible Note and Senior Secured Convertible Note – non-installment payments
—
( 154 )
Proceeds – exercise of Series Z warrants
—
2,785
Proceeds – exercise of stock options
303
131
Proceeds – issue common stock – Employee Stock Purchase Plan
217
304
Proceeds – exercise of stock options issued under equity plan of majority owned subsidiary
688
—
Purchase Treasury Stock – payment of employee payroll tax obligation in connection with stock-based compensation
( 366 )
—
Net cash flows provided by financing activities
25,842
41,954
Net increase (decrease) in cash
( 12,105 )
25,954
Cash, beginning of period
77,258
17,256
Cash, end of period
$ 65,153
$ 43,210
See
accompanying notes to the unaudited condensed consolidated financial statements.
7
PAVMED
INC.
and
SUBSIDIARIES
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 — The Company
Description
of the Business
PAVmed
Inc and Subsidiaries, referred to herein as “PAVmed” or the “Company” is comprised of PAVmed Inc. and its wholly-owned
subsidiary and its majority-owned subsidiaries, inclusive of Lucid Diagnostics Inc. (“Lucid Diagnostics” or “LUCID”),
Veris Health Inc. (“Veris Health” or “VERIS”), and Solys Diagnostics Inc. (“Solys Diagnostics” or
“SOLYS”).
The
Company is organized to advance a broad pipeline of innovative medical technologies from concept to commercialization, employing a business
model focused on capital efficiency and speed to market. The Company’s activities have focused on advancing the lead products towards
regulatory approval and commercialization, protecting its intellectual property, and building its corporate infrastructure and management
team.
The
Company’s current operational activities are principally focused on the commercialization of EsoGuard and CarpX, while its development
activities are focused on pursuing FDA approval and clearance of other lead products in our product portfolio pipeline, including EsoGuard
IVD, PortIO, EsoCure and digital health technologies acquired by the Company’s majority-owned subsidiary Veris Health
Inc.
The
ability of the Company to generate revenue depends upon the Company’s ability to successfully advance the commercialization of
EsoGuard and CarpX while also completing the development and the necessary regulatory approvals of its other products and services. 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.
The
Company has financed its operations principally through public and private issuances of its common stock, preferred stock, common stock
purchase warrants, and debt. The Company is subject to all of the risks and uncertainties typically faced by medical device and diagnostic
companies that devote substantially all of their efforts to the commercialization of their initial product and services and ongoing research
and development activities and conducting clinical trials. The Company 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 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.
8
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 PAVmed 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
and majority-owned subsidiaries. All significant intercompany transactions and balances have been eliminated in consolidation. The Company
holds a majority-ownership interest and has controlling financial interest in each of: Lucid Diagnostics Inc., Veris Health Inc., and
Solys Diagnostics Inc., with the corresponding noncontrolling interest included as a separate component of consolidated stockholders’
equity (deficit), including the recognition in the unaudited condensed consolidated statement of operations of a net loss attributable
to the noncontrolling interest based on the respective minority-interest equity ownership of each majority-owned subsidiary. See Note
15, Noncontrolling Interest , for a discussion of each of the majority-owned subsidiaries noted above. 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 the determination of corresponding
carrying value reserve, if any, 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 debt obligations, stock-based equity
awards, intangible assets, and common stock purchase warrants. 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.
9
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. 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.
10
Note
2 — Summary of Significant Accounting Policies and Recent Accounting Standards Updates - continued
Significant
Accounting Policies - Continued
Fair
Value Option (“FVO”) Election
Under
a Securities Purchase Agreement dated March 31, 2022, the Company issued a Senior Secured Convertible Note dated April 4, 2022 - referred
to herein as the “April 2022 Senior Convertible Note” - which is accounted under the “fair value option election”
as discussed below.
Under
Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 815, Derivative
and Hedging , (“ASC 815”), a financial instrument containing embedded features and /or options may be required to be bifurcated
from the financial instrument host and recognized as separate derivative asset or liability, with the bifurcated derivative asset or
liability initially measured at estimated fair value as of the transaction issue date and then subsequently remeasured at estimated fair
value as of each reporting period balance sheet date.
Alternatively,
FASB ASC Topic 825, Financial Instruments , (“ASC 825”) provides for the “fair value option” (“FVO”)
election. In this regard, ASC 825-10-15-4 provides for the FVO election (to the extent not otherwise prohibited by ASC 825-10-15-5) to
be afforded to financial instruments, wherein the financial instrument is initially measured at estimated fair value as of the transaction
issue date and then subsequently remeasured at estimated fair value as of each reporting period balance sheet date, with changes in the
estimated fair value recognized as other income (expense) in the statement of operations. The estimated fair value adjustment of the
April 2022 Senior Convertible Note is presented in a single line item within other income (expense) in the accompanying unaudited condensed
consolidated statement of operations (as provided for by ASC 825-10-50-30(b)). Further, as required by ASC 825-10-45-5, to the extent
a portion of the fair value adjustment is attributed to a change in the instrument-specific credit risk, such portion would be recognized
as a component of other comprehensive income (“OCI”) (for which there was no such adjustment with respect to the April 2022
Senior Convertible Note).
See
Note 10, Financial Instruments Fair Value Measurements , with respect to the FVO election; and Note 11, Debt , for a discussion
of the April 2022 Senior Convertible Note.
11
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, through its majority-owned
subsidiary, Lucid Diagnostics Inc., entered into the EsoGuard Commercialization Agreement, dated August 1, 2021, with its Commercial Laboratory
Improvements Act (“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 5, 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.
12
Note
4 — Related Party Transactions
Case
Western Reserve University and Physician Inventors - Amended CWRU License Agreement
Case
Western Reserve University (“CWRU”) and each of the three physician inventors (“Physician Inventors”) of the
intellectual property licensed under the amended and restated patent license agreement with CWRU, dated August 23, 2021 (the
“Amended CWRU License Agreement”), 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
$ —
General and Administrative Expense
Stock-based compensation expense – Physician Inventors’ restricted stock awards
272
273
544
364
Research and Development Expense
Amended 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
Total Related Party Expenses
$ 543
$ 439
$ 882
$ 549
See
Note 12, Stock-Based Compensation , for information regarding each of the “PAVmed Inc. 2014 Long-Term Incentive Equity Plan”
and the separate “Lucid Diagnostics Inc 2018 Long-Term Incentive Equity Plan”; and Note 15, Noncontrolling Interest ,
for a discussion of Lucid Diagnostics Inc. and the corresponding noncontrolling interests.
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.
Effective
June 2021, Veris Health Inc. entered into a consulting agreement with Andrew Thoreson, M.D. which provides for compensation on a contractual rate per hour for consulting services provided. Dr. Thoreson holds a partial ownership interest in the legal entity which holds a minority interest in Veris Health
Inc. Veris Health Inc. recognized
general and administrative expense of $ 13
and $ 37
in the three and six months ended June 30, 2022 in connection with the consulting agreement.
13
Note
5 — Asset Purchase Agreement and Management Services Agreement
Asset
Purchase Agreement - ResearchDx Inc.
LucidDx
Labs Inc., a wholly-owned subsidiary of Lucid Diagnostics Inc., 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 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. 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 8, 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 unpaid 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 LucidDx Labs Inc. 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.
14
Note
6 — Prepaid Expenses, Deposits, and Other Current Assets
Prepaid
expenses and other current assets consisted of the following as of:
Schedule of Prepaid Expenses and Other Current Assets
June 30, 2022
December 31, 2021
Advanced payments to service providers and suppliers
$ 834
$ 808
Prepaid insurance
1,156
1,856
Deposits
3,317
1,989
EsoCheck cell collection supplies
215
434
EsoGuard mailer supplies
65
59
CarpX devices
75
33
Total prepaid expenses, deposits and other current assets
$ 5,662
$ 5,179
Note
7 — 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 research and development facility; a commercial clinical laboratory; additional
Lucid Test Centers; and for office space.
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 minimum lease payments for capital leases
2022 (remainder of year)
$ 562
2023
1,175
2024
1,139
2025
272
2026
272
Thereafter
132
Total lease payments
$ 3,552
Less: imputed interest
( 426 )
Present value of lease liabilities
$ 3,126
Supplemental disclosure of cash flow information related to the Company’s cash and non-cash activities with
its leases are as follows:
Schedule
of Supplemental Balance Sheet Information Related to Cash and Non-cash Activities with Leases
2022
2021
Six Months Ended June 30,
2022
2021
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows from operating leases
$ 483
$ —
Non-cash investing and financing activities
Right-of-use assets obtained in exchange for new operating lease liabilities
$ 3,633
$ —
Weighted-average remaining lease term - operating leases (in years)
3.31
—
Weighted-average discount rate - operating leases
7.875 %
— %
As
of June 30, 2022, the Company’s right-of-use assets from operating leases are $ 3,205 , 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 $ 3,126 , of which $ 943 is reported in operating lease liabilities, current portion and $ 2,183 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.
15
Note
8 — Intangible 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
December 31, 2021
Defensive asset
60 months
$ 2,105
$ 2,105
Laboratory licenses and certifications and laboratory information management software
(“LIMSDx”)
24 months
3,200
---
Other
1 year
70
70
Total Intangible assets
5,375
2,175
Less Accumulated Amortization
( 919 )
( 146 )
Intangible Assets, net
$ 4,456
$ 2,029
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.
As noted in Note 5, Asset
Purchase Agreement and Management Services Agreement , the asset purchase agreement between the Company and ResearchDx Inc. (“APA-RDx”),
is being accounted as asset acquisition. The intangible assets recognized under the APA-RDx are the laboratory licenses and certifications,
inclusive of 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 $ 650 and $ 6 for the three month periods ended June 30, 2022 and 2021,
respectively, and $ 773
and $ 6
for the 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 identified finite-lived intangible assets for each of the five succeeding fiscal years is as
follows:
Schedule
of Estimated Amortization Expense for Intangible Assets
2022 (remainder of year)
$ 1,010
2023
2,021
2024
688
2025
421
2026
316
Total
$ 4,456
16
Note
9 — Commitment and Contingencies
Legal
Proceedings
Delaware
Court of Chancery Complaint
On
November 2, 2020, a stockholder of the Company, on behalf of himself and other similarly situated stockholders, filed a complaint in
the Delaware Court of Chancery alleging broker non-votes were not properly counted in accordance with the Company’s bylaws at the
Company’s Annual Meeting of Stockholders on July 24, 2020, and, as a result, asserted certain matters deemed to have been approved
were not so approved (including matters relating to the increase in the size of the PAVmed Inc. 2014 Long-Term Incentive Equity Plan
and the PAVmed Inc. Employee Stock Purchase Plan). The relief sought under the complaint includes certain corrective actions by the Company,
but did not seek any specific monetary damages. The Company did not believe it was clear the prior approval of these matters was invalid
or otherwise ineffective. However, to avoid any uncertainty and the expense of further litigation, on January 5, 2021, the Company’s
board of directors determined it would be advisable and in the best interests of the Company and its stockholders to re-submit these
proposals to the Company’s stockholders for ratification and/or approval. In this regard, the Company held a special meeting of
stockholders on March 4, 2021, at which such matters were ratified and approved. The parties have reached agreement on a proposed Settlement
Term Sheet Agreement, dated January 28, 2021, to settle the complaint, the terms of which do not contemplate payment of monetary damages
to the putative class in the proceeding. In connection with the foregoing, on August 3, 2022, the parties agreed that plaintiff’s
counsel would not seek an award from the Court in excess of $ 450 , to be paid by the Company, upon Court approval, as compensation for
the benefits conferred by the settlement, and the Company would not object to an award of up to such maximum amount. Such agreement was
approved by the Company’s board of directors as of August 5, 2022.The settlement of the complaint and plaintiff’s counsel’s
fee award is subject-to the approval of the Court. The settlement hearing before the Court is scheduled for November 3, 2022.
Benchmark
Investments, Inc. / Benchmark Investments LLC
On December 23, 2020, Benchmark
Investments, Inc. filed a complaint against the Company in the U.S. District Court of the Southern District of New York alleging the registered
direct offerings of shares of common stock of the Company completed in December 2020 were in violation of provisions set forth in an engagement
letter between the Company and Kingswood Capital Markets, a “division” of Benchmark Investments, Inc. On December 16, 2021,
the court granted PAVmed’s motion to dismiss the case for lack of subject matter jurisdiction. On February 7, 2022, Benchmark Investments
LLC, which claimed to be a successor to Benchmark Investments, Inc., filed a new complaint in the Supreme Court of the State of New York,
New York County, asserting claims similar to those in the federal action, and adding to its allegations that financings conducted by the
Company in January 2021 and February 2021 also violated the Company’s engagement letter with Kingswood Capital Markets. The Company
has made a motion to dismiss this complaint for Benchmark Investments LLC’s lack of standing, which motion is pending. In any event,
the Company disagrees with the allegations set forth in the complaint and intends to vigorously contest the complaint.
Other
Matters
In
the ordinary course of our business, particularly as it begins commercialization of its products, the Company may be subject to certain
other legal actions and claims, including product liability, consumer, commercial, tax and governmental matters, which may arise from
time to time. Except as otherwise noted herein, the Company does not believe it is currently a party to any other pending legal proceedings.
Notwithstanding, legal proceedings are subject-to inherent uncertainties, and an unfavorable outcome could include monetary damages,
and excessive verdicts can result from litigation, and as such, could result in a material adverse impact on the Company’s business,
financial position, results of operations, and /or cash flows. Additionally, although the Company has specific insurance for certain
potential risks, the Company may in the future incur judgments or enter into settlements of claims which may have a material adverse
impact on the Company’s business, financial position, results of operations, and /or cash flows.
17
Note
10 — Financial Instruments Fair Value Measurements
Recurring
Fair Value Measurements
The
fair value hierarchy table for the reporting date noted is as follows:
Schedule of Financial Liabilities Measured at Fair Value on Recurring Basis
Fair
Value Measurement on a Recurring Basis at Reporting Date Using (1)
Level-1
Inputs
Level-2
Inputs
Level-3
Inputs
Total
June
30, 2022
Senior
Secured Convertible Note - April 2022
$
—
$
—
$
29,500
$
29,500
Totals
$
—
$
—
$
29,500
$
29,500
(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 June 30, 2022.
As
discussed in Note 11, Debt , the Company issued a Senior Secured Convertible Note dated April 4, 2022, with an initial $ 27.5 million
face value principal (“April 2022 Senior Convertible Note”). The April 2022 Senior Convertible Note is accounted for under
the ASC 825-10-15-4 fair value option (“FVO”) election, wherein, the financial instrument is initially measured at its issue-date
estimated fair value and subsequently remeasured at estimated fair value on a recurring basis at each reporting period date.
The
estimated fair value of the financial instruments classified within the Level 3 category was determined using both observable inputs
and unobservable inputs. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in fair
value attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in unobservable long-
dated volatilities) inputs.
The
estimated fair value of the April 2022 Senior Convertible Note as of each of April 4, 2022 and June 30, 2022, were computed using a Monte
Carlo simulation of the present value of its cash flows using a synthetic credit rating analysis and a required rate-of-return, using
the following assumptions:
Schedule
of Fair Value Assumption Used
April 2022
Senior
Convertible Note:
April 4, 2022
April 2022
Senior
Convertible Note:
June 30, 2022
Fair Value
$ 30,100
$ 29,500
Face value principal payable
$ 27,500
$ 27,500
Required rate of return
7.875 %
11.20 %
Conversion Price
$ 5.00
$ 5.00
Value of common stock
$ 1.26
$ 0.94
Expected term (years)
2.00
1.76
Volatility
115.00 %
130.00 %
Risk free rate
2.40 %
2.85 %
Dividend yield
— %
— %
The
estimated fair values reported utilized the Company’s common stock price along with certain Level 3 inputs (as discussed above),
in the development of Monte Carlo simulation models, discounted cash flow analyses, and /or Black-Scholes valuation models. The estimated
fair values are subjective and are affected by changes in inputs to the valuation models /analyses, including the Company’s common
stock price, the Company’s dividend yield, the risk-free rates based on U.S. Treasury security yields, and certain other Level-3
inputs including, assumptions regarding the estimated volatility in the value of the Company’s common stock price. Changes in these
assumptions can materially affect the estimated fair values.
18
Note
11 — Debt
The Company entered into a Securities Purchase Agreement (“SPA”) dated March 31, 2022, with an accredited institutional
investor (“Investor”, “Lender”, and /or “Holder”), wherein, the Company agreed to sell, and the Investor
agreed to purchase an aggregate of $ 50.0 million face value principal of debt - comprised of: an initial issuance of $ 27.5 million face
value principal; and up to an additional $ 22.5 million of face value principal (upon the satisfaction of certain conditions). The debt
is being issued in a registered direct offering under the Company’s effective shelf registration statement.
Under
the SPA dated March 31, 2022, the Company issued a Senior Secured Convertible Note dated April 4, 2022, referred to herein as the “April
2022 Senior Convertible Note”, with such note having a $ 27.5 million face value principal, a 7.875 % annual stated interest rate,
a contractual conversion price of $ 5.00 per share of the Company’s common stock (subject to standard adjustments in the event of
any stock split, stock dividend, stock combination, recapitalization or other similar transaction), and a contractual maturity date of
April 4, 2024. The April 2022 Senior Convertible Note may be converted into shares of common stock of the Company at the Holder’s
election, as discussed below.
The
April 2022 Senior Convertible Note proceeds were $ 25.0 million after deducting a $ 2.5 million lender fee; and additionally, the Company
incurred total offering costs of approximately $ 601 , inclusive of the payment of a total of $ 450 placement agent fees. The lender fee
and offering costs were recognized as of the April 4, 2022 issue date as a current period expense in other income (expense) in the consolidated
statement of operations.
During
the period from April 4, 2022 to October 3, 2022, the Company is required to pay interest expense only (on the $ 27.5 million face value
principal), at 7.875 % per annum, computed on a 360 day year. The Company paid in cash interest expense of approximately $ 523 for the
period April 4, 2022 to June 30, 2022; and approximately $ 181 subsequent to June 30, 2022 as of August 10, 2022.
Commencing
October 4, 2022, and then on each of the successive first and tenth trading day of each month thereafter through to and including
April 1, 2024 (each referred to as an “Installment Date”); and on the April 4, 2024 maturity date, the Company will be
required to make a principal repayment of $ 724
together with accrued interest thereon, with such 38 payments referred to herein as the “Installment Amount”, settled in
shares of common stock of the Company, subject to customary equity conditions, including minimum share price and volume thresholds,
or at the election of the Company, in cash, in whole or in part.
In
addition to the Installment Amount repayments, the Holder may elect to accelerate the conversion of future Installment Amount repayments,
and interest thereon, subject to certain restrictions, as defined, utilizing the then current conversion price of the most recent Installment
Date conversion price.
Subject
to certain conditions being met or waived, from time to time, one or more additional closings may occur, for up to the remaining $ 22.5
million face value principal, upon five trading days’ notice given by the Company to the Investor. The Investor’s obligation
to purchase the additional notes at each additional closing is subject to certain conditions set forth in the SPA dated March 31, 2022,
including, among others, contractual closing requirements: minimum price and trading volume thresholds of the Company’s common
stock; the maximum ratio of debt to market capitalization (as defined); and minimum market capitalization (as defined), with such requirements
being waived by the Investor in its sole discretion.
Additionally,
effective March 31, 2023, the Investor may by written notice elect to require the Company to issue additional notes of up to $ 22.5 million
in face value principal, so long as in doing so it would not cause the ratio of (a) the outstanding principal amount of the April 2022 Senior Convertible Note (and any additional notes issued under the SPA dated March 31, 2022), accrued and unpaid interest thereon and accrued and unpaid late charges to (b) our
average market capitalization over the prior ten trading days, to exceed 25%. If the Company does not issue the additional notes contemplated
by any such written notice, or if the Investor is unable to deliver any such notice prior to March 31, 2024 as a result of the limitation
described in the preceding sentence, then the Company will be obligated to pay up to a maximum of a $1.35 million a break-up fee .
19
Note
11 — Debt - continued
The payment of all amounts due
and payable under the April 2022 Senior Convertible Note is guaranteed by the Company and its wholly-owned and majority-owned subsidiaries,
except for Lucid Diagnostics Inc and its wholly-owned subsidiaries; and the obligations under the April 2022 Senior Convertible Note are
secured by all of the assets of the Company and each guarantor, except only up to 9.99% of the shares of common stock of Lucid Diagnostics
Inc. held by PAVmed Inc. are pledged to secure the indebtedness under the April 2022 Senior Convertible Note.
The Company
is subject to certain customary affirmative and negative covenants regarding the rank of the notes, along with the incurrence of further
indebtedness, the existence of liens, the repayment of indebtedness and the making of investments, the payment of cash in respect of dividends,
distributions or redemptions, the transfer of assets, the maturity of other indebtedness, and transactions with affiliates, among other
customary matters.
The Company is subject to financial covenants requiring: (i) a minimum of $8.0 million of available cash at all times;
(ii) the ratio of (a) the outstanding principal amount of the April 2022 Senior Convertible Note, (and any additional notes issued under
the SPA dated March 31, 2022), accrued and unpaid interest thereon and accrued and unpaid late charges to (b) the Company’s average
market capitalization over the prior ten trading days, to not exceed 30% (the “Debt to Market Cap Ratio Test”); and (iii)
the Company’s market capitalization to at no time be less than $75 million. (the “Market Cap Test” and, together with
the Debt to Market Cap Ratio Test, the “Financial Tests”). The Company is currently in compliance with these financial covenants,
although from time to time since the date of issuance of the April 2022 Senior Convertible Note through August 10, 2022 (including, in
the case of the Debt to Market Cap Ratio Test, as of June 30, 2022), the Company was not in compliance with the Financial Tests. As of
August 9, 2022, the Investor agreed to waive any such non-compliance during such aforementioned time periods, under each of the SPA dated
March 31, 2022 and the April 2022 Senior Convertible Note.
In
connection with the waiver dated August 9, 2022, the Company and the Investor also amended the April 2022 Senior Convertible Note to
permit the Investor to convert up to $ 5.0
million of the face value principal of the April 2022 Senior Convertible Note at the then current conversion price as if the date of
conversion were an Installment Date, i.e. a price per share of common stock equal to the lower of (i) the fixed conversion price
then in effect (currently $ 5.00 )
and (ii) 82.5 %
of the average VWAP of the Company’s common stock for each of the two trading days with the lowest VWAP of the Company’s
common stock during the ten consecutive trading day period ending and including the trading day immediately prior to the applicable
conversion date, but in the case of clause (ii), not less than $ 0.18
per share. As contemplated by such amendment, subsequent
to June 30, 2022, on August 10, 2022, approximately $ 2,882
of principal repayments along with approximately $ 6
of interest expense thereon, were settled through the issuance of 3,000,867
shares of common stock of the Company, with such shares having a fair value of approximately $ 5,462
(with such fair value measured as the respective conversion date quoted closing price of the common stock of the
Company).
The
fair value and face value principal of outstanding of the April 2022 Senior Convertible Note as of June 30, 2022 is as follows:
Summary of Outstanding Debt
Contractual Maturity Date
Stated Interest Rate
Conversion Price per Share
Face Value Principal Outstanding
Fair Value
April 2022 Senior Convertible Note
April 4, 2024
7.875 %
$ 5.00
$ 27,500
$ 29,500
Balance as of June 30, 2022
$ 27,500
$ 29,500
The
Company did not have convertible debt outstanding at December 31, 2021. During the six month period ended June 30, 2021, the Company
recognized debt extinguishment losses of approximately $ 3,715 , in connection with repaying-in-full all remaining convertible notes outstanding
at the time.
The
April 2022 Senior Convertible Note is accounted for under the ASC 825-10-15-4 fair value option (“FVO”) election, wherein,
the financial instrument is initially measured at its issue-date estimated fair value and subsequently remeasured at estimated fair value
on a recurring basis at each reporting period date with the resulting fair value adjustment recognized as other income (expense) in the
(unaudited) condensed consolidated statement of operations. In this regard, as provided for by ASC 825-10-50-30(b), the estimated fair
value adjustment is presented as a single line item within other income (expense) in the accompanying consolidated statement of operations.
See Note 10, Financial Instruments Fair Value Measurements , for a further discussion of fair value assumptions.
20
Note
12 — Stock-Based Compensation
PAVmed
Inc. 2014 Long-Term Incentive Equity Plan
The
PAVmed Inc. 2014 Long-Term Incentive Equity Plan (the “PAVmed Inc. 2014 Equity Plan”) is designed to enable PAVmed Inc. to
offer employees, officers, directors, and consultants, as defined, an opportunity to acquire shares of common stock of PAVmed Inc. The
types of awards that may be granted under the PAVmed Inc. 2014 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 PAVmed Inc.
board of directors.
A
total of 16,352,807 shares of common stock of PAVmed Inc. are reserved for issuance under the PAVmed Inc. 2014 Equity Plan, with 2,830,092
shares available for grant as of June 30, 2022. The share reservation is not diminished by a total of 600,854 PAVmed Inc. stock options
and restricted stock awards granted outside the PAVmed Inc. 2014 Equity Plan as of June 30, 2022.
PAVmed
Inc. Stock Options
PAVmed
Inc. stock options granted under the PAVmed Inc. Inc. 2014 Equity Plan and stock options granted outside such plan are summarized as follows:
Schedule of Summarizes Information About Stock Options
Number of Stock Options
Weighted Average Exercise Price
Remaining Contractual Term (Years)
Intrinsic Value (2)
Outstanding stock options at December 31, 2021
8,720,198
$ 3.39
6.8
$ 3,516
Granted (1)
4,219,350
$ 1.49
Exercised
( 299,999 )
$ 1.01
Forfeited
( 1,437,143 )
$ 3.04
Outstanding stock options at June 30, 2022 (3)
11,202,406
$ 2.79
7.9
$ 8
Vested and exercisable stock options at June 30, 2022
5,994,046
$ 3.07
6.5
$ 1
(1)
Stock
options granted under the PAVmed Inc. 2014 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
intrinsic value is computed as the difference between the quoted price of the PAVmed Inc. common stock on each of June 30, 2022 and
December 31, 2021 and the exercise price of the underlying PAVmed Inc. stock options, to the extent such quoted price is greater
than the exercise price.
(3)
The
outstanding stock options presented in the table above, are inclusive of 500,854 stock options granted outside the PAVmed Inc. 2014
Equity Plan. as of June 30, 2022 and December 31, 2021.
PAVmed
Inc. Restricted Stock Awards
PAVmed
Inc. restricted stock awards granted under the PAVmed Inc. 2014 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
1,666,666
$ 2.36
Granted
—
—
Vested
( 541,666 )
1.20
Forfeited
( 150,000 )
2.04
Unvested restricted stock awards as of June 30, 2022 (1)
975,000
$ 3.05
(1)
The
unvested restricted stock awards presented in the table above, are inclusive of 100,000 restricted stock awards granted outside the
PAVmed Inc. 2014 Equity Plan. as of June 30, 2022 and December 31, 2021.
21
Note
12 — Stock-Based Compensation - continued
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 above. 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, with the share reservation 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.
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 Summarizes Information About Stock Options
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, 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.
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.
22
Note
12 — Stock-Based Compensation - continued
Consolidated
Stock-Based Compensation Expense
The
consolidated stock-based compensation expense recognized by each of PAVmed Inc. and Lucid Diagnostics Inc. for both the PAVmed Inc. 2014
Equity Plan and the Lucid Diagnostics Inc. 2018 Equity Plan, with respect to stock options and restricted stock awards as discussed above,
for the periods indicated, was as follows:
Schedule of Stock-Based Compensation Awards Granted
Three Months Ended
June 30,
Six Months Ended
June 30,
2022
2021
2022
2021
Sales and marketing expenses
$ 591
$ 298
$ 1,216
$ 500
General and administrative expenses
4,162
4,599
8,164
5,722
Research and development expenses
254
306
440
417
Total stock-based compensation expense
$ 5,007
$ 5,203
$ 9,820
$ 6,639
Stock-Based
Compensation Expense Recognized by Lucid Diagnostics Inc.
As
noted, the consolidated stock-based compensation expense presented above is inclusive of stock-based compensation expense recognized
by Lucid Diagnostics Inc., inclusive of each of: stock options granted under the PAVmed Inc. 2014 Equity Plan to the three physician
inventors of the intellectual property underlying the CWRU License Agreement (“Physician Inventors”) (as discussed above
in Note 4, Related Party Transactions ); and stock options and restricted stock awards granted to employees of PAVmed Inc. and
non-employee consultants under the Lucid Diagnostics Inc. 2018 Equity Plan. The stock-based compensation expense recognized
by Lucid Diagnostics Inc. for both the PAVmed Inc. 2014 Equity Plan and the Lucid Diagnostics Inc. 2018 Equity Plan, with respect to
stock options and restricted stock awards as discussed above, for the periods indicated, was as follows:
Schedule of Stock-Based Compensation Expense Classified in Research and Development Expenses
Three Months Ended
June 30,
Six Months Ended
June 30,
2022
2021
2022
2021
Lucid Diagnostics Inc 2018 Equity Plan – sales and marketing expenses
$ 215
$ —
$ 480
$ —
Lucid Diagnostics Inc 2018 Equity Plan – general and administrative expenses
3,313
2,505
6,514
3,295
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 – recognized by Lucid Diagnostics Inc
$ 3,844
$ 2,580
$ 7,679
$ 3,385
The
consolidated 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 PAVmed Inc. 2014 Equity Plan and the Lucid Diagnostics Inc. 2018 Equity
Plan, as discussed above, is as follows:
Schedule of Unrecognized Compensation Expense
Unrecognized Expense
Weighted Average Remaining Service Period (Years)
PAVmed Inc. 2014 Equity Plan
Stock Options
$ 9,127
2.3
Restricted Stock Awards
$ 1,510
1.2
Lucid Diagnostics Inc. 2018 Equity Plan
Stock Options
$ 4,030
2.6
Restricted Stock Awards
$ 10,873
1.0
23
Note
12 — Stock-Based Compensation - continued
Stock-based
compensation expense recognized with respect to stock options granted under the PAVmed Inc. 2014 Equity Plan was based on a weighted
average estimated fair value of such stock options of $0.74 per share and $3.32 per share during the periods ended June 30, 2022 and
2021, respectively, calculated using the following weighted average Black-Scholes valuation model assumptions:
Schedule of Fair Values of Stock Options Granted Using Black-scholes Valuation Model Assumptions
Six Months Ended
June 30,
2022
2021
Expected term of stock options (in years)
5.8
5.6
Expected stock price volatility
84.0 %
75.0 %
Risk free interest rate
3.0 %
1.0 %
Expected dividend yield
— %
— %
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 year ended June 30, 2022. There were no stock-based
awards granted under the Lucid Diagnostics Inc. 2018 Equity Plan during the period ended June 30, 2021. The stock-based compensation
was calculated using the following weighted average Black-Scholes valuation model assumptions:
Schedule
of Fair Values of Stock Options Granted Using Black-scholes Valuation Model Assumptions
Six Months Ended
June 30,
2022
Expected term of stock options (in years)
5.7
Expected stock price volatility
71.0 %
Risk free interest rate
3.0 %
Expected dividend yield
— %
PAVmed
Inc. Employee Stock Purchase Plan (“ESPP”)
A
total of 194,240 shares and 203,480 shares of common stock of the Company were purchased for proceeds of approximately $ 217 and $ 304 ,
on March 31, 2022 and 2021, respectively under the PAVmed Inc Employee Stock Purchase Plan (“PAVmed Inc ESPP”). The PAVmed
Inc. ESPP has a total reservation of 1,750,000 shares of common stock of PAVmed Inc. of which 931,841 shares are available-for-issue
as of June 30, 2022.
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 share purchase dates are March 31 and September 30. The Lucid
Diagnostics Inc. ESPP has a total reservation of 500,000 shares of common stock of Lucid Diagnostics Inc. for which all shares are available-for-issue
as of June 30, 2022.
24
Note
13 — Preferred Stock
The
Series B Convertible Preferred Stock dividends are 8.0 % per annum based on the $ 3.00 per share stated value of the Series B Convertible
Preferred Stock, with such dividends compounded quarterly, accumulate, and are payable in arrears upon being declared by the Company’s
board of directors. The Series B Convertible Preferred Stock dividends earned are included in the calculation of basic and diluted net
loss attributable to PAVmed Inc. common stockholders for each of the respective corresponding periods presented in the accompanying unaudited
condensed consolidated statement of operations, inclusive of dividends earned of $ 68 as of the three months ended March 31, 2022 and
$ 70 as of the three months ended June 30, 2022; and dividends earned of $ 75 as of the three months ended March 31, 2021 and $ 74 as of
the three months ended June 30, 2021.
The
Series B Convertible Preferred Stock dividends are recognized as a dividend payable only upon the dividend being declared payable by
the Company’s board of directors. In this regard, in the six months ended June 30, 2022, the Company’s board-of-directors
declared Series B Convertible Preferred Stock dividends of an aggregate of approximately $ 135 , inclusive of approximately $ 67 earned
as of December 31, 2021, and approximately $ 68 earned as of March 31, 2022, with each such dividends settled by the issue of an aggregate
45,031 additional shares of Series B Convertible Preferred Stock, inclusive of 22,291 shares issued with respect to the dividends earned
as of December 31, 2021, and 22,740 shares issued with respect to the dividends earned as of March 31, 2022. In the six months ended
June 30, 2021, the Company’s board-of-directors declared Series B Convertible Preferred Stock dividends of an aggregate of approximately
$ 148 , inclusive of approximately $ 73 earned as of December 31, 2020, and approximately $ 75 earned as of March 31, 2021, with each such
dividends settled by the issue of an aggregate 49,244 additional shares of Series B Convertible Preferred Stock, inclusive of 24,198
shares issued with respect to the dividends earned as of December 31, 2020, and 25,046 shares issued with respect to the dividends earned
as of March 31, 2021.
Subsequent
to June 30, 2022, in July 2022, the Company’s board-of-directors declared a Series B Convertible Preferred Stock dividend earned
as of June 30, 2022 and payable as of July 1, 2022, of approximately $ 70 , to be settled by the issue of an additional 23,196 shares of
Series B Convertible Preferred Stock (with such dividend not recognized as a dividend payable as of June 30, 2022, as the Company’s
board of directors had not declared such dividends payable as of such date).
Note
14 — Common Stock and Common Stock Purchase Warrants
Common
Stock
In
June 2022, the Company received shareholder approval to issue up to 250 million shares of its common stock, an increase of 100
million shares.
During
the six months ended June 30, 2022, 299,999 shares of common stock of the
Company were issued upon exercise of stock options for cash of approximately $ 302 ; and . during the six months ended June 30, 2022, a
total of 194,240 shares of common stock of the Company were issued under the PAVmed Inc. Employee Stock Purchase Plan (“ESPP”).
See Note 12, Stock-Based Compensation , for a discussion of each of the PAVmed Inc. 2014 Equity Plan and the PAVmed Inc ESPP.
Common
Stock Purchase Warrants
As
of June 30, 2022 and December 31, 2021, Series Z Warrants outstanding totaled 11,937,450 and 11,937,455 , respectively. A Series Z Warrant
is exercisable to purchase one share of common stock of the Company at an exercise price of $ 1.60 per share, and expire April 30, 2024 .
During the six months ended June 30, 2022, a total of 5 Series Z Warrants were exercised for cash at $ 1.60 per share, resulting in the
issue of the same number of shares of common stock of the Company.
As
of December 31, 2021, Series W Warrants outstanding totaled 377,873 . The remaining 377,873 Series W Warrants expired unexercised as of
January 29, 2022 .
25
Note
15 — Noncontrolling Interest
The
noncontrolling interest (“NCI”) included as a component of consolidated total stockholders’ equity is summarized for
the periods indicated as follows:
Schedule of Noncontrolling Interest of Stockholders' Equity
June 30, 2022
December 31, 2021
NCI – equity (deficit) – beginning of period
$ 17,752
$ ( 2,369 )
Investment in Veris Health Inc.
—
6
Net loss attributable to NCI - Lucid Diagnostics Inc.
( 5,711 )
( 5,779 )
Net loss attributable to NCI – Solys Diagnostics Inc.
( 6 )
—
Net loss attributable to NCI – Veris Health Inc.
( 620 )
—
Impact of subsidiary equity transactions
229
16,760
Lucid Diagnostics Inc. 2018 Equity Plan stock option exercise
688
—
Stock-based compensation expense - Lucid Diagnostics Inc. 2018 Equity Plan
7,091
9,134
Stock-based compensation expense - Veris Health Inc. 2021 Equity Plan
3
—
NCI – equity (deficit) – end of period
$ 19,426
$ 17,752
The
consolidated NCI presented above is with respect to the Company’s consolidated majority-owned subsidiaries, inclusive of: Lucid
Diagnostics Inc., Veris Health Inc. and Solys Diagnostics Inc., as a component of consolidated total stockholders’ equity as of
June 30, 2022 and December 31, 2021; and the recognition of a net loss attributable to the NCI in the unaudited condensed consolidated
statement of operations with respect to Lucid Diagnostics Inc. and Solys Diagnostics Inc. for the three and six months ended June 30,
2022 and 2021; and with respect to Veris Health Inc. for the three and six months ended June 30, 2022 and from the period of May 28,
2021 to June 30, 2021 (as the Veris Health Inc. inception date was May 28, 2021).
Lucid
Diagnostics Inc.
As
of June 30, 2022, there were 35,171,796 shares of common stock of Lucid Diagnostics Inc. issued and outstanding, of which, PAVmed Inc.
holds 27,927,190 shares, representing a majority ownership equity interest and PAVmed Inc. has a controlling financial interest in Lucid
Diagnostics Inc., and accordingly, Lucid Diagnostics Inc. is a consolidated majority-owned subsidiary of PAVmed Inc.
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 Lucid Diagnostics Inc. 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 Lucid Diagnostics Inc. were issued for proceeds of approximately $ 927 .
Veris
Health Inc.
As
of June 30, 2022, there were 8,000,000 shares of common stock of Veris Health Inc. issued and outstanding, of which PAVmed Inc. holds
an 80.44 % majority-interest ownership and PAVmed Inc. has a controlling financial interest, with the remaining 19.56 % minority-interest
ownership held by an unrelated third-party. Accordingly, Veris Health Inc. is a consolidated majority-owned subsidiary of the Company,
for which a provision of a noncontrolling interest (NCI) is included as a separate component of consolidated stockholders’ equity
in the unaudited condensed consolidated balance sheet as of June 30, 2022 along with the recognition of a net loss attributable to the
NCI in the unaudited condensed consolidated statement of operations for the period of May 28, 2021 to December 31, 2021, upon its formation
and contemporaneous acquisition of Oncodisc Inc.
Solys
Diagnostics Inc.
As
of each of June30, 2022 and December 31, 2021, there were 9,189,190 shares of common stock of Solys Diagnostics Inc. issued and outstanding,
of which PAVmed Inc. holds a 90.3235 % majority-interest ownership and PAVmed Inc. has a controlling financial interest, with the remaining
9.6765 % minority-interest ownership held by unrelated third parties.
26
Note
16 — Net Loss Per Share
The
respective “Net loss per share - attributable to PAVmed Inc. - basic and diluted” and “Net loss per share - attributable
to PAVmed Inc. common stockholders - basic and diluted” - for the periods indicated - is as follows:
Schedule of Comparison of Basic and Fully Diluted Net Loss Per Share
Three Months Ended
June 30,
Six Months Ended
June 30,
2022
2021
2022
2021
Numerator
Net loss - before noncontrolling interest
$ ( 29,101 )
$ ( 12,670 )
$ ( 48,734 )
$ ( 22,779 )
Net loss attributable to noncontrolling interest
3,576
1,199
6,337
1,877
Net loss - as reported, attributable to PAVmed Inc.
$ ( 25,525 )
$ ( 11,471 )
$ ( 42,397 )
$ ( 20,902 )
Series B Convertible Preferred Stock dividends – earned
$ ( 70 )
$ ( 74 )
$ ( 138 )
$ ( 149 )
Net loss attributable to PAVmed Inc. common stockholders
$ ( 25,595 )
$ ( 11,545 )
$ ( 42,535 )
$ ( 21,051 )
Denominator
Weighted average common shares outstanding, basic and diluted
86,957,352
82,235,397
86,689,857
78,117,637
Loss per share
Basic and diluted
Net loss - as reported, attributable to PAVmed Inc.
$ ( 0.29 )
$ ( 0.14 )
$ ( 0.49 )
$ ( 0.27 )
Net loss attributable to PAVmed Inc. common stockholders
$ ( 0.29 )
$ ( 0.14 )
$ ( 0.49 )
$ ( 0.27 )
The
common stock equivalents have been excluded from the computation of diluted weighted average shares outstanding as their inclusion would
be anti-dilutive, are as follows:
The
Series B Convertible Preferred Stock dividends earned as of the each of the respective periods noted, are included in the calculation
of basic and diluted net loss attributable to PAVmed Inc. common stockholders for each respective period presented. Notwithstanding,
the Series B Convertible Preferred Stock dividends are recognized as a dividend payable only upon the dividend being declared payable
by the Company’s board of directors.
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 of
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 Antidilutive Securities Excluded from Computation of Diluted Earnings Per Share
2022
2021
June 30,
2022
2021
Stock options and restricted stock awards
12,177,406
10,573,530
Series Z Warrants
11,937,450
15,074,281
Series W Warrants
—
381,818
Series B Convertible Preferred Stock
1,158,950
1,185,685
Total
25,273,806
27,215,314
The
total stock options and restricted stock awards are inclusive of 500,854 stock options as of June 30, 2022 and 2021; and 100,000 restricted
stock awards as of June 30, 2022, granted outside the PAVmed Inc. 2014 Equity Plan.
27
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The
following discussion and analysis of our unaudited condensed consolidated financial condition and results of operations should be read
together with our Annual Report on Form 10-K for the year ended December 31, 2021 (the “Form 10-K”) as filed with the Securities
and Exchange Commission (the “SEC”).
Unless
the context otherwise requires, references herein to “we”, “us”, and “our”, and to the
“Company” or “PAVmed” are to PAVmed Inc. and Subsidiaries, including PAVmed Inc. and its
wholly-owned subsidiary PAVmed Subsidiary Corp; and its majority-owned subsidiaries, including: Lucid Diagnostics Inc. (“Lucid
Diagnostics” or “LUCID”), Veris Health Inc. (“Veris Health” or “VERIS”), and Solys
Diagnostics, Inc. (“Solys Diagnostics” or “SOLYS”).
FORWARD-LOOKING
STATEMENTS
This
Quarterly Report on Form 10-Q (this “Form 10-Q”), including the following discussion and analysis of our (unaudited) condensed
consolidated financial condition and results of operations, contains forward-looking statements that involve substantial risks and uncertainties.
All statements, other than statements of historical facts, contained in this Form 10-Q, including statements regarding our future results
of operations and financial position, business strategy and plans and objectives of management for future operations, are forward-looking
statements. The words “may,” “will,” “should,” “expects,” “plans,” “anticipates,”
“could,” “intends,” “target,” “projects,” “contemplates,” “believes,”
“estimates,” “predicts,” “potential” or “continue” or the negative of these terms or
other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these
identifying words. Forward-looking statements are not guarantees of future performance and the Company’s actual results may differ
significantly from the results discussed in the forward-looking statements. Factors that might cause such differences include, but are
not limited to, those discussed in Item 1A of Part I of the Form 10-K under the heading “Risk Factors.”
Important
factors that may affect our actual results include:
●
our
limited operating history;
●
our
financial performance, including our ability to generate revenue;
●
our
ability to obtain regulatory approval for the commercialization of our products;
●
the
ability of our products to achieve market acceptance;
●
our
success in retaining or recruiting, or changes required in, our officers, key employees or directors;
●
our
potential ability to obtain additional financing when and if needed;
●
our
ability to protect our intellectual property;
●
our
ability to complete strategic acquisitions;
●
our
ability to manage growth and integrate acquired operations;
●
the
potential liquidity and trading of our securities;
●
our
regulatory and operational risks;
●
cybersecurity
risks;
●
risks
related to SARS-CoV-2 /COVID-19 pandemic;
●
the
impact of the material weakness identified by our management; and
●
our
estimates regarding expenses, future revenue, capital requirements and needs for additional financing.
In
addition, our forward-looking statements do not reflect the potential impact of any future financings, acquisitions, mergers, dispositions,
joint ventures or investments we may make.
We
may not actually achieve the plans, intentions, and /or expectations disclosed in our forward-looking statements, and you should not
place undue reliance on our forward-looking statements. You should read this Form 10-Q and the Form 10-K, and the documents we have filed
as exhibits to this Form 10-Q and the Form 10-K, completely and with the understanding our actual future results may be materially different
from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information,
future events or otherwise, except as required by applicable law.
28
Overview
The
Company is a highly differentiated, multi-product, commercial-stage medical technology company organized to advance a broad pipeline
of innovative medical technologies from concept to commercialization, employing a business model focused on capital efficiency and speed
to market. Since the Company’s inception on June 26, 2014, its activities have focused on advancing its lead products
through regulatory approval, expanding commercial operations, and protecting its intellectual property, while building its corporate
infrastructure and management team. The Company has ongoing operations conducted both through PAVmed Inc. and its majority-owned subsidiaries.
The
Company operates in one segment as a medical technology company, with the following lines-of-business: “Diagnostics”, “Medical
Devices”, and “Digital Health”.
Our
products, services, and opportunities, as discussed herein and in Item 1 of Part I of the Form 10-K under the heading Business Background
and Overview, are as follows:
●
Diagnostics - EsoGuard Esophageal DNA Laboratory Developed Test- and EsoCheck
Esophageal Cell Collection Device;
●
Medical Devices – CarpX Minimally Invasive Surgical Device for Carpal Tunnel Syndrome, – EsoCure Esophageal
Ablation Device with Caldus Technology, and PortIO Implantable Intraosseous Vascular Access Device.
●
Digital Health – Veris Cancer Care Platform with implantable smart device, remote monitoring and data analytics.
We are also
pursuing a number of research and development project and product opportunities across these three segments, which have either been developed
internally or have been presented to us by clinician innovators and academic medical institutions for consideration.
Our
multiple products and services are in various phases of development, regulatory clearances, approvals, and commercialization.
●
We believe that the EsoGuard Esophageal DNA Test, performed on samples collected with the EsoCheck Esophageal Cell
Collection Device, constitutes the first and only commercially available diagnostic test capable of serving as a widespread screening
tool to prevent esophageal adenocarcinoma (“EAC”)
deaths, through early detection of esophageal precancer in at-risk gastroesophageal reflux disease (“GERD”) patients. 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 EsoGuard; and establishing
“Lucid Diagnostics Test Centers” for the collection of cell samples using EsoCheck. Previously the collected cell samples
were sent to ResearchDx Inc. (“RDx”), an unrelated third-party CLIA-certified commercial laboratory service provider, for
the performance of the EsoGuard LDT. On February 25, 2022, Lucid Diagnostics’ wholly owned subsidiary, LucidDx Labs Inc. (“LucidDx
Labs”) acquired from RDx certain licenses and other related assets necessary for LucidDx Labs to operate its own new Clinical Laboratory
Improvement Amendments (“CLIA”) certified, College of American Pathologists (“CAP”) accredited clinical laboratory
located in Lake Forest, CA. RDx was previously responsible for submitting claims for EsoGuard tests performed and was receiving out-of-network
private insurance payments. As part of the transition to our own lab, we also contracted with a revenue cycle management (“RCM”)
provider to submit claims on our behalf. The RCM provider will have complete oversight of payer claims, appeals processes, patient billing,
online payment collection, and claims tracking. With the appropriate licenses and certifications for billing and credentialing secured,
and our recently having put in place the necessary back office systems, claims for more than 1,000 tests performed since the establishment
of our own lab are now being processed, including 850 tests in the three months ended June 30, 2022 (although not having yet secured reimbursed
rates from Medicare and Medicaid, the Company does not know the amount per claim it will receive from payors). Refer to Note 3 of
our Condensed Consolidated Financial Statements for more information on Revenue from Contracts with Customers. Presently, recognized
revenue for GAAP purposes is subject to actual amounts collected during the period. Accordingly, since the RCM began submitting
claims processed from our own lab subsequent to June 30, 2022, there were no collections during the three months ended June 30, 2022.
29
Overview
- continued
●
In
connection with our efforts to expand our presence in the diagnostic market, we are developing EsoCure as an Esophageal
Ablation Device, with the intent to allow a clinician to treat dysplastic Barrett’s Esophagus (“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. We have successfully completed a pre-clinical feasibility
animal study of EsoCure demonstrating excellent, controlled circumferential ablation of the esophageal mucosal lining. We have also completed
an acute and survival animal study of EsoCure, demonstrating successful direct thermal balloon catheter
ablation of esophageal lining through the working channel of a standard endoscope. We plan to conduct additional development work and
animal testing of EsoCure to support a future FDA 510(k) submission.
●
CarpX is a minimally invasive surgical device for use in the treatment of carpal tunnel syndrome which received FDA 510(k) marketing clearance
in April 2020, with the first commercial procedure successfully performed in December 2020. Our limited-release commercialization efforts
through 2022 are focused on engaging key opinion hand surgeons designed to solicit input for ergonomic improvements to the device, procedure
development and surgical-time optimization, and ease of use.
●
In May 2021, we formed Veris Health, and concurrently,
acquired Oncodisc Inc (“Oncodisc”), a digital health company with ground breaking tools to improve personalized cancer
care through remote patient monitoring which we now refer to as our Veris Cancer Care Platform. These core technologies
include the first intelligent implantable vascular healthcare platform that provides patients and physicians with new tools to
improve outcomes and optimize the delivery of cost-effective care through remote monitoring and data analytics. Its vascular access
port contains biologic sensors capable of generating continuous data on key physiologic parameters known to predict adverse outcomes
in cancer patients undergoing treatment. Wireless communication to the patient’s smartphone and its cloud-based digital
healthcare platform efficiently and effectively delivers actionable real time data to patients and physicians. The technologies are
the subject of multiple patent applications and one allowed patent awaiting final issuance. We plan to seek commercialization
through a de novo process, and, as such, we’ll commercialize the digital health offering in three phases. The three phases are
called Veris Solar, Veris Mercury, and Veris Venus which include software, device, and data. Recently, we had a favorable meeting
with the FDA surrounding the Mercury phase.
●
PortIO is an implantable intraosseous vascular access device that is being developed as a means for infusing fluids,
medications, and other substances directly into the bone marrow cavity and from there into the central venous circulation. We are pursuing
an FDA clearance for use in patients with a need for longer-term vascular access under de novo classification of section 513(f)2 of the
FDCA. The broader clearance is being pursued in discussion with FDA following our previous initial submission to the FDA for a 510(k)
premarket notification for use in patients only requiring 24-hour emergency type vascular access. PortIO completed its first-in-human
clinical study in Colombia, South America, and has recently successfully implanted seven additional patients. We are currently working
with our partners to first pursue a European study to support EU CE Mark clearance followed by providing additional human data for U.S.
approval.
30
Recent Developments
Business
Clinical
Guideline Update – ACG and AGA
In
April 2022, the American College of Gastroenterology (“ACG”) updated its clinical guideline to support esophageal precancer
(“Barrett’s Esophagus”, “BE”) screening to prevent highly lethal esophageal cancer (“EAC”)
utilizing Lucid Diagnostics’ EsoGuard® DNA Test on samples collected with our EsoCheck® Cell Collection Device. The clinical
guideline reiterates the ACG’s long-standing recommendation for esophageal precancer screening in at-risk patients with gastroesophageal
reflux disease (“GERD”), commonly known as chronic heartburn, acid reflux or simply reflux. In its Recommendation 5, the
ACG suggests a single screening endoscopy in patients with chronic GERD symptoms and 3 or more additional risk factors for BE, including
male sex, age >50 yr, White race, tobacco smoking, obesity, and family history of BE or EAC in a first-degree relative. Furthermore,
and importantly for the first time, the clinical guideline also endorses nonendoscopic biomarker screening as an acceptable alternative
to costly and invasive endoscopy by stating in its Recommendation 6 that the ACG suggests that a swallowable, nonendoscopic capsule device
combined with a biomarker is an acceptable alternative to endoscopy for screening for BE. The clinical guideline specifically mentions
EsoCheck, along with Lucid Diagnostics’ EsophaCap® device, as such swallowable, nonendoscopic esophageal cell collection devices,
as well as methylated DNA biomarkers such as EsoGuard. The summary of evidence for this recommendation cites the seminal NIH-funded multicenter,
case-control study published in 2018 in Science Translational Medicine, which demonstrated that EsoGuard is highly accurate at detecting
esophageal precancer and cancer, including on samples collected with EsoCheck.
In
July 2022, the American Gastroenterology Association (“AGA”) published updated clinical guidance that mirrors the same furnished
by the ACG as described above , endorsing the use of non-invasive screening tools like
our EsoCheck® Cell Collection Device, which is cited in its guideline, as an acceptable alternative to endoscopy to directly address
the need for noninvasive screening tools that are easy to administer, patient friendly, and cost-effective for the detection of
BE. The clinical practice update by the AGA also significantly expands the target population for esophageal precancer screening, including
for EsoGuard and EsoCheck, by recommending, for the first time, screening in at-risk patients without symptoms of reflux.
The AGA does so by adding a history of chronic GERD as merely an additional, seventh, risk factor to the six risk factors for BE and
EAC that have traditionally identified at-risk symptomatic patients recommended for screening. As a result, chronic symptomatic GERD
is no longer a mandatory prerequisite and asymptomatic patients with three of the other six risk factors (e.g., male sex, age >50
yr, White race, tobacco smoking, obesity, and family history of BE) are now considered appropriate for screening.
EsoGuard
BE-1 and BE-2 Clinical Trials
In 2021 the Lucid Diagnostics
Inc. began conducting two concurrent clinical trials, including each of: the “EsoGuard screening study” (“BE-1”);
and the “EsoGuard case-control study” (“BE-2”), to expand the clinical evidence for the technologies and to support
a United States Food and Drug Administration (“FDA”) pre-market approval (“PMA”) of the use of EsoGuard and EsoCheck
as an in-vitro diagnostic medical device (“IVD”). However, in light of the recently published proposed Local Coverage Determination
(“LCD”) DL39256, the recently updated AGA guidance, and the ACG update to its clinical guideline that supports screening to
prevent highly lethal esophageal cancer (“EAC”) utilizing our EsoGuard® DNA Test on samples collected with our EsoCheck®
Cell Collection Device, the Company has determined to prioritize its clinical trial efforts and resources towards supporting studies that
will help secure insurance reimbursement adoption by government and private insurers. Consequently, we have decided to delay for the time
being the BE-1 trial while continuing to enroll GERD patients with a previous diagnosis of nondysplastic BE, low grade dysplasia, high
grade dysplasia,, or EAC in the BE-2 case-control study through Q2 2023.
31
Recent Developments - continued
Financing
Securities
Purchase Agreement - March 31, 2022
-
Senior Secured Convertible Note - April 4, 2022
We
entered into a Securities Purchase Agreement (“SPA”) dated March 31, 2022, with an accredited institutional investor
(“Investor”, “Lender”, and /or “Holder”), wherein, we agreed to sell, and the Investor agreed to
purchase an aggregate of $50.0 million face value principal of debt - comprised of: an initial issuance of $27.5 million face value
principal; and up to an additional $22.5 million of face value principal (upon the satisfaction of certain conditions). The debt is
being issued in a registered direct offering under our effective shelf registration statement.
See our accompanying unaudited
condensed consolidated financial statements Note 11, Debt , for further discussion of the SPA dated March 31, 2022 and the
April 2022 Senior Convertible Note, including a description of a recent waiver and amendment.
Lucid
Diagnostics Inc. - Committed Equity Facility
In
March 2022, our majority-owned subsidiary 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 Lucid Diagnostics Inc. While there are distinct differences,
the facility is structured similarly to a traditional at-the-market equity facility, insofar as it allows Lucid Diagnostics Inc. to raise
primary 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 of Lucid Diagnostics Inc. 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 Lucid Diagnostics Inc. were issued for proceeds of approximately $927.
32
Results
of Operations
Overview
Revenue
Revenue
was recognized with respect to the EsoGuard Commercialization Agreement, dated August 1, 2021, between the Company’s majority-owned
subsidiary, Lucid Diagnostics Inc., and ResearchDx Inc. (“RDx”), a CLIA certified commercial laboratory service provider.
On February 25, 2022, the EsoGuard Commercialization Agreement was terminated upon the execution of an Asset Purchase Agreement between
LucidDx Labs Inc., a wholly-owned subsidiary of Lucid Diagnostics Inc. and RDx.
Cost
of revenue
The
cost of revenue recognized with respect to the revenue recognized under the EsoGuard Commercialization Agreement is inclusive of: a royalty
fee incurred under the Amended CWRU License Agreement; employee related costs of employees engaged in the administration to patients
of the EsoCheck cell sample collection procedure (principally at the LUCID Test Centers); the EsoCheck devices and EsoGuard mailers (cell
sample shipping costs) distributed to medical practitioners locations and the LUCID Test Centers; and LUCID Test Centers operating expenses,
including rent expense and supplies.
Sales
and marketing expenses
Sales
and marketing expenses consist primarily of salaries and related costs for employees engaged in sales and marketing activities, as well
as advertising and promotion expenses. We anticipate our sales and marketing expenses will increase in the future, as we anticipate an
increase in payroll and related expenses related to the roll-out of our commercial sales and marketing operations as we execute on our
business strategy.
General
and administrative expenses
General
and administrative expenses consist primarily of salaries and related costs for personnel, travel expenses, facility-related costs, professional
fees, accounting and legal services, employees involved in third-party payor reimbursement contract negotiations and consultants and
expenses associated with obtaining and maintaining patents within our intellectual property portfolio.
We
anticipate our general and administrative expenses will increase in the future, as we anticipate an increase in payroll and related expenses
related with the growth and expansion of our business operations objectives. We also anticipate continued expenses related to being a
public company, including audit, legal, regulatory, and tax-related services associated with maintaining compliance as a public company,
insurance premiums and investor relations costs.
Research
and development expenses
Research
and development expenses are recognized in the period they are incurred and consist principally of internal and external expenses incurred
for the research and development of our products, including:
●
consulting
costs charged to us by various external contract research organizations we contract with to conduct preclinical studies and engineering
studies;
●
salary
and benefit costs associated with our chief medical officer and engineering personnel;
●
costs
associated with regulatory filings;
●
patent
license fees;
●
cost
of laboratory supplies and acquiring, developing, and manufacturing preclinical prototypes;
●
product
design engineering studies; and
●
rental
expense for facilities maintained solely for research and development purposes.
We
plan to incur research and development expenses for the foreseeable future as we continue the development of our existing products as
well as new innovations. Our research and development activities are focused principally on obtaining FDA approvals and developing product
improvements or extending the utility of the lead products in our pipeline, including EsoCheck and EsoGuard and CarpX, along with
advancing our Veris Cancer Care Platform and EsoCure and PortIO products.
33
Results
of Operations - continued
Overview
- continued
Other
Income and Expense, net
Other
income and expense, net, consists principally of changes in fair value of our contingent consideration and our convertible notes and
losses on extinguishment of debt upon repayment of such convertible notes.
Presentation
of Dollar Amounts
All
dollar amounts in this Management’s Discussion and Analysis of Financial Condition and Results of Operations are presented in thousands
of dollars, if not otherwise indicated as being presented as dollars in millions, except for the number of shares and per share amounts.
34
Results
of Operations - continued
Three
months ended June 30, 2022 as compared to three months ended June 30, 2021
The
Company did not recognize revenue nor cost of revenue during the three months ended June 30, 2022 and June 30, 2021.
Sales
and marketing expenses
In
the three months ended June 30, 2022, sales and marketing costs were approximately $4.9 million, compared to $1.9 million for the corresponding
period in the prior year. The net increase of $3.0 million was principally related to:
●
approximately
$2.2 million increase in compensation related costs principally related to an increase in headcount;
●
approximately
$0.3 million increase in stock based compensation from RSA grants to Lucid and PAVmed employees and non-employees, and an increase
in stock options granted corresponding with the increase in the number of employees; and
●
approximately
$0.5 million increase in outside professional services related to EsoCheck, EsoGuard and consulting and professional services fees.
General
and administrative expenses
In
the three months ended June 30, 2022, general and administrative costs were approximately $11.8 million, compared to $6.8 million for
the corresponding period in the prior year. The net increase of $5.0 million was principally related to:
●
approximately
$1.3 million increase in compensation related costs principally related to an increase in headcount;
●
approximately $1.1 million decrease stock based compensation primarily
due to the absence in the current year of stock-based compensation expense incurred in the prior year period resulting from the acceleration
of vesting of stock options granted to former members of the Company’s board of directors in June 2021, partially offset by an increase
in stock options granted corresponding with the increase in the number of employees;
●
approximately
$3.4 million increase in consulting services related to patents, regulatory compliance, legal processes for contract review, transition
of public relations and investor relations firms, and public company expenses; and
●
approximately $0.6 million of amortization expense related to our intangible assets;
●
approximately
$0.8 million increase in general business expenses.
Research
and development expenses
In
the three months ended June 30, 2022, research and development costs were approximately $6.7 million as compared to $4.3 million for
the corresponding period in the prior year. The net increase $2.5 million was principally related to:
●
approximately $2.1 million increase in development costs, particularly
in clinical trial activities and outside professional and consulting fees with respect to EsoCheck, EsoCure, CarpX, our Veris Cancer Care
Platform and PortIO, and
●
approximately
$0.4 million increase in compensation related costs and related to expanded clinical and engineering staff.
Other Income and Expense
Change
in fair value of convertible debt
In
the three months ended June 30, 2022, the non-cash expense recognized for the change in the fair value of our convertible notes was approximately
$2.0 million, related to the April 2022 Senior Convertible Note. The April 2022 Senior Convertible Note was initially measured
at its issue-date estimated fair value and subsequently remeasured at estimated fair value as of the reporting period
date. The Company initially recognized a $2.6 million fair value non-cash expense on the issue-date. This initial recognition was partially
offset by a $0.6 million decrease in estimated fair value upon remeasurement as of June 30, 2022.
Loss on Issue and Offering Costs - Senior Secured
Convertible Note
In the three months ended June 30, 2022, in connection with the issue of the April 2022 Senior Convertible Note,
we recognized a total of approximately $3.1 million of other expense, inclusive of approximately $2.5 million of lender fee non-cash expense,
and approximately $0.6 million of offering costs paid by us.
See
our unaudited condensed consolidated financial statements Note 11 , Debt , for additional information with respect to the April 2022 Senior Convertible Note.
35
Results
of Operations - continued
Six
months ended June 30, 2022 as compared to six months ended June 30, 2021
Revenue
In
the six months ended June 30, 2022, revenue was $0.2 million as compared to no revenue in the corresponding period in the prior year.
The $0.2 million relates to our EsoGuard Commercialization Agreement, dated August 1, 2021, which resulted in revenue recognition of
$0.1 million per month commencing August 2021 and ending February 2022 upon the February 25, 2022 termination date of such agreement.
Cost
of revenue
In
the six months ended June 30, 2022, cost of revenue was approximately $0.4 million as compared to no cost of revenue in the corresponding
period in the prior year. The $0.4 million increase principally relates to costs associated with the EsoGuard Commercialization Agreement
noted above.
Sales
and marketing expenses
In
the six months ended June 30, 2022, sales and marketing costs were approximately $8.8 million, compared to $3.3 million for the corresponding
period in the prior year. The net increase of $5.6 million was principally related to:
●
approximately
$3.8 million increase in compensation related costs principally related to an increase in headcount;
●
approximately
$0.7 million increase in stock based compensation from RSA grants to Lucid and PAVmed employees and non-employees, and an increase
in stock options granted corresponding with the increase in the number of employees; and
●
approximately
$1.1 million increase in outside professional services related to EsoCheck, EsoGuard and consulting and professional services fees.
General
and administrative expenses
In
the six months ended June 30, 2022, general and administrative costs were approximately $21.4 million, compared to $10.2 million for
the corresponding period in the prior year. The net increase of 11.2 million was principally related to:
●
approximately
$2.5 million increase in compensation related costs principally related to an increase in headcount;
●
approximately
$0.7 million increase in stock based compensation from RSA grants to Lucid and PAVmed employees and non-employees, and an increase
in stock options granted corresponding with the increase in the number of employees;
●
approximately
$5.7 million increase in consulting services related to patents, regulatory compliance, legal processes for contract review, transition
of public relations and investor relations firms, and public company expenses; and
●
approximately $0.7 million of amortization expense related to our intangible assets;
●
approximately
$1.6 million increase in general business expenses.
Research
and development expenses
In
the six months ended June 30, 2022, research and development costs were approximately $12.7 million as compared to $7.6 million for the
corresponding period in the prior year. The net increase $5.1 million was principally related to:
●
approximately $4.1 million increase in development costs, particularly
in clinical trial activities and outside professional and consulting fees with respect to EsoCheck, EsoCure, CarpX, our Veris Cancer Care
Platform and PortIO, and
●
approximately
$1.0 million increase in compensation related costs and related to expanded clinical and engineering staff.
36
Results
of Operations - continued
Six
months ended June 30, 2022 as compared to six months ended June 30, 2021 - continued
Other
Income and Expense
Change
in fair value of convertible debt
In
the six months ended June 30, 2022, the non-cash expense recognized for
the change in the fair value of our convertible notes was approximately $2.0 million, related to the April 2022 Senior Convertible Note.
The April 2022 Senior Convertible Note was initially measured at its issue-date estimated fair value and subsequently remeasured at estimated
fair value as of the reporting period date. The Company initially recognized a $2.6 million fair value non-cash expense
on the issue-date. This initial recognition was partially offset by a $0.6 million decrease in fair value upon remeasurement June 30,
2022.
Loss
on Issue and Offering Costs - Senior Secured Convertible Note
In the six months ended June 30, 2022, in connection with the issue of the April 2022 Senior Convertible Note, we
recognized a total of approximately $3.1 million of other expense, inclusive of approximately $2.5 million of lender fee non-cash expense,
and approximately $0.6 million of offering costs paid by us.
Loss
from Extinguishment of Debt
In
the prior year six months ended June 30, 2021, a debt extinguishment loss
in the aggregate of approximately $3.7 million was recognized in connection with the (previous) convertible notes, as discussed below.
●
On
January 5, 2021, the repayment of the remaining face value principal of the November 2019 Senior Convertible Note, along with the
payment of interest thereon of approximately $1.0 million, were settled with the issuance of 667,668 shares of our common stock,
with a fair value of approximately $1.7 million (with such fair value measured as the respective conversion date quoted closing price
of our common stock), resulting in the recognition of a loss from extinguishment of debt of approximately $0.8 million in the six
months ended June 30, 2021; and,
●
On
January 30, 2021, we paid in cash a $350 partial principal repayment of the Senior Convertible Note dated April 30, 2020 (“April
2020 Senior Convertible Note”); and on March 2, 2021, we made a cash payment of approximately $14,466, resulting in the repayment-in-full
on such date of both the April 2020 Senior Convertible Note and the Senior Secured Convertible Note dated August 6, 2021, resulting
in the recognition of a loss from extinguishment of debt of approximately $2,955 in the six months ended June 30, 2021.
See
our unaudited condensed consolidated financial statements Note 11 , Debt , for additional information with respect to the April 2022 Senior Convertible Note.
37
Liquidity
and Capital Resources
Our current operational activities are principally focused
on the commercialization of EsoGuard and CarpX, and our development activities are focused on pursuing FDA approval and clearance of other
lead products in our product portfolio pipeline. Our ability to generate revenue depends upon successfully advancing the commercialization
of EsoGuard and CarpX while also completing the development and the necessary regulatory approvals of its other products and services.
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.
We
have financed our operations principally through the public and private issuances of our common stock, preferred stock, common stock
purchase warrants, and debt. We are 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 R&D and clinical trials. We expect to continue to experience recurring losses from operations, and will continue to fund
our operations with debt and/or equity financing transactions. Notwithstanding, however, with the cash on-hand as of the date hereof and other debt and equity committed sources of financing, we
expect to be able to fund our future operations for one year from the date of the issue of our unaudited condensed consolidated financial
statements, as included in this Quarterly Report on Form 10-Q for the period ended June 30, 2022.
Issue
of Shares of Our Common Stock
During
the six months ended June 30, 2022
●
We
issued 299,999 shares of our common stock for cash proceeds of approximately $0.3 million upon exercise of stock options granted under the
PAVmed Inc 2014 Equity Plan, as such plan is discussed in Note 12, Stock-Based Compensation , of our unaudited condensed
consolidated financial statements.
●
We
issued 194,240 shares of our common stock for proceeds of approximately $0.2 million under the PAVmed Inc. Employee Stock Purchase
Plan (“ESPP”), as such plan is discussed in Note 12, Stock-Based Compensation of our unaudited condensed
consolidated financial statements.
Securities
Purchase Agreement - March 31, 2022
-
Senior Secured Convertible Note - April 4, 2022
We
entered into a Securities Purchase Agreement (“SPA”) dated March 31, 2022, with an accredited institutional investor (“Investor”,
“Lender”, and /or “Holder”), pursuant to which we agreed to sell, and the Investor agreed to purchase an aggregate of
$50.0 million face value principal of debt - comprised of: an initial issuance of $27.5 million face value principal; and up to an additional
$22.5 million of face value principal (upon the satisfaction of certain conditions).
Under
the SPA dated March 31, 2022, we issued a Senior Secured Convertible Note dated April 4, 2022, referred to herein as the “April
2022 Senior Convertible Note”, with such note having a $27.5 million face value principal, a 7.875% annual stated interest rate,
a contractual conversion price of $5.00 per share of the Company’s common stock (subject to standard adjustments in the event of
any stock split, stock dividend, stock combination, recapitalization or other similar transaction), and a contractual maturity date of
April 4, 2024. The April 2022 Senior Convertible Note may be converted into shares of our common stock at the Holder’s election.
During the period from April 4, 2022 to October 3, 2022, we are required to pay interest expense only (on the $27.5 million face value
principal), at 7.875% per annum, computed on a 360 day year.
The
April 2022 Senior Convertible Note proceeds were $25.0 million after deducting a $2.5 million lender fee; and additionally, we incurred
total offering costs of approximately $601, inclusive of the payment of a total of $450 placement agent fees.
Subject
to certain conditions being met or waived, from time to time, one or more additional closings may occur, for up to the remaining $22.5
million face value principal, upon five trading days’ notice given by us to the Investor. The Investor’s obligation to purchase
the additional notes at each additional closing is subject to certain conditions set forth in the SPA dated March 31, 2022, including,
among others, contractual closing requirements: minimum price and trading volume thresholds of our common stock; the maximum ratio of
debt to market capitalization (as defined); and minimum market capitalization (as defined), with such requirements being waived by the
Investor in its sole discretion.
38
Liquidity
and Capital Resources - continued
Securities Purchase Agreement
- March 31, 2022
- Senior Secured Convertible
Note - April 4, 2022 - continued
Under the April 2022 Senior Convertible Note and the SPA, we are subject to certain customary affirmative and negative
covenants regarding the incurrence of indebtedness, the existence of liens, the repayment of indebtedness and the making of investments,
the payment of cash in respect of dividends, distributions or redemptions, the transfer of assets, the maturity of other indebtedness,
and transactions with affiliates, among other customary matters. We also are subject to financial covenants requiring that (i) the amount
of our available cash equal or exceed $8,000,000 at all times, (ii) the ratio of (a) the outstanding principal amount of the notes issued
under the SPA, accrued and unpaid interest thereon and accrued and unpaid late charges to (b) our average market capitalization over the
prior ten trading days, not exceed 30% (the “Debt to Market Cap Ratio Test”), and (iii) that our market capitalization shall
at no time be less than $75 million (the “Market Cap Test” and, together with the Debt to Market Cap Ratio Test, the “Financial
Tests”). The Company is currently in compliance with these financial covenants, although from time to time since the date of issuance
of the April 2022 Senior Convertible Note through August 10, 2022 (including, in the case of the Debt to Market Cap Ratio Test, as of
June 30, 2022), the Company was not in compliance with the Financial Tests. As of August 9, 2022, the Investor agreed to waive any such
non-compliance during such aforementioned time periods, under each of the SPA dated March 31, 2022 and the April 2022 Senior Convertible
Note.
In connection with such waiver, the Company and the Investor also amended the April 2022 Senior Convertible to permit
the Investor to convert up to $5,000,000 of the principal amount of the April 2022 Senior Convertible Note at the then current conversion
price as if the date of conversion were an Installment Date, i.e. a price per share of common stock equal to the lower of (i) the fixed
conversion price then in effect (currently $5.00) and (ii) 82.5% of the average VWAP of the Company’s common stock for each of the
two trading days with the lowest VWAP of the Company’s common stock during the ten consecutive trading day period ending and including
the trading day immediately prior to the applicable conversion date, but in the case of clause (ii), not less than $0.18 per share. As
contemplated by such amendment, subsequent to June 30, 2022,
on August 10, 2022, approximately $2,882 of principal repayments along with approximately $6 of interest expense thereon, were settled
through the issuance of 3,000,867 shares of our common stock, with such shares having a fair value of approximately $5,462 (with such
fair value measured as the respective conversion date quoted closing price of our common stock).
Lucid
Diagnostics Inc. - Committed Equity Facility
In
March 2022, our majority-owned subsidiary Lucid Diagnostics, Inc. entered into a committed equity facility with 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 Lucid Diagnostics Inc. While there are distinct differences,
the facility is structured similarly to a traditional at-the-market equity facility, insofar as it allows Lucid Diagnostics Inc. to raise
primary 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 of Lucid Diagnostics Inc. 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 Lucid Diagnostics Inc. were issued for proceeds of approximately $927.
Critical
Accounting Policies and Significant Judgments and Estimates
The
discussion and analysis of our (unaudited) financial condition and consolidated results of operations is based on our unaudited condensed
consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United
States of America (“U.S. GAAP”). The preparation of these unaudited condensed consolidated financial statements requires
us to make estimates and assumptions affecting the reported amounts of assets, liabilities, and equity, along with the disclosure of
contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts of
expenses during the corresponding periods. In accordance with U.S. GAAP, we base our estimates on historical experience and on various
other assumptions we believe are reasonable under the circumstances. Actual results may differ from these estimates under different assumptions
or conditions. Our critical accounting policies are as disclosed in the Company’s annual report on Form 10-K for the year
ended December 31, 2021 as filed with the SEC on April 6, 2022, except as otherwise noted in Note 2, Summary of Significant Accounting Policies and Recent Accounting Standards Updates , of our unaudited
condensed consolidated financial statements included herein in this Form 10-Q.
39
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our principal executive officer and our principal financial officer, evaluated the effectiveness
of our disclosure controls and procedures as of June 30, 2022. Based on such evaluation, our principal executive officer and principal
financial officer concluded our disclosure controls and procedures (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act)
were effective as of such date to provide reasonable assurance the information required to be disclosed by us in the reports we file
or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s
rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure information
required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management,
including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required
disclosure.
Changes
to Internal Controls Over Financial Reporting
There
has been no change in internal controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act)
that occurred during our fiscal quarter ended June 30, 2022 that has materially affected, or is reasonably likely to materially affect,
our internal controls over financial reporting.
40
Part
II - Other Information
Item
1. Legal Proceedings
See
Note 9, Commitment and Contingencies - Legal Proceedings , of the unaudited condensed consolidated financial statements included
in this Quarterly Report, for a description of certain material legal proceedings involving the Company, which description is incorporated
herein by reference.
In
the ordinary course of our business, particularly as it begins commercialization of its products, the Company may be subject to certain
other legal actions and claims, including product liability, consumer, commercial, tax and governmental matters, which may arise from
time to time. Except as otherwise noted herein, the Company does not believe it is currently a party to any other pending legal proceedings.
Notwithstanding, legal proceedings are subject-to inherent uncertainties, and an unfavorable outcome could include monetary damages,
and excessive verdicts can result from litigation, and as such, could result in a material adverse impact on the Company’s business,
financial position, results of operations, and /or cash flows. Additionally, although the Company has specific insurance for certain
potential risks, the Company may in the future incur judgments or enter into settlements of claims which may have a material adverse
impact on the Company’s business, financial position, results of operations, and /or cash flows.
Item
5. Other Information
Under the April 2022 Senior Convertible Note and the
SPA, we are subject to certain customary affirmative and negative covenants regarding the incurrence of indebtedness, the existence of
liens, the repayment of indebtedness and the making of investments, the payment of cash in respect of dividends, distributions or redemptions,
the transfer of assets, the maturity of other indebtedness, and transactions with affiliates, among other customary matters. We also are
subject to financial covenants requiring that (i) the amount of our available cash equal or exceed $8,000,000 at all times, (ii) the ratio
of (a) the outstanding principal amount of the notes issued under the SPA, accrued and unpaid interest thereon and accrued and unpaid
late charges to (b) our average market capitalization over the prior ten trading days, not exceed 30% (the “Debt to Market Cap Ratio
Test”), and (iii) that our market capitalization shall at no time be less than $75 million (the “Market Cap Test” and,
together with the Debt to Market Cap Ratio Test, the “Financial Tests”). The Company is currently in compliance with these
financial covenants, although from time to time since the date of issuance of the April 2022 Senior Convertible Note through August 10,
2022 (including, in the case of the Debt to Market Cap Ratio Test, as of June 30, 2022), the Company was not in compliance with the Financial
Tests. As of August 9, 2022, the Investor agreed to waive any such non-compliance during such aforementioned time periods, under each
of the SPA dated March 31, 2022 and the April 2022 Senior Convertible Note. In connection with such waiver, the Company and the Investor
also amended the April 2022 Senior Convertible to permit the Investor to convert up to $5,000,000 of the principal amount of the April
2022 Senior Convertible Note at the then current conversion price as if the date of conversion were an Installment Date, i.e. a price
per share of common stock equal to the lower of (i) the fixed conversion price then in effect (currently $5.00) and (ii) 82.5% of the
average VWAP of the Company’s common stock for each of the two trading days with the lowest VWAP of the Company’s common stock
during the ten consecutive trading day period ending and including the trading day immediately prior to the applicable conversion date,
but in the case of clause (ii), not less than $0.18. As contemplated by the amendment discussed above, on August 10, 2022, the Investor
converted $2,882,000 of the principal amount of the April 2022 Senior Convertible Note (plus interest accrued thereon), resulting in an
issuance to the Investor of 3,000,867 shares of the Company’s common stock.
Item
6. Exhibits
The
exhibits filed as part of this Quarterly Report on Form 10-Q are set forth in the “ Exhibit Index ” below.
41
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized.
PAVmed
Inc.
August
15, 2022
By:
/s/
Dennis M McGrath
Dennis
M McGrath
President
and Chief Financial Officer
(Principal
Financial and Accounting Officer)
42
EXHIBIT INDEX
Exhibit
No.
Description
2.1
Asset Purchase Agreement, dated as of February 25, 2022, by and among LucidDx Labs Inc., Lucid Diagnostics Inc. and ResearchDx, Inc. (incorporated by reference to Exhibit 2.1 to the Current Report on Form 8-K filed by Lucid on March 3, 2022).
3.1
Certificate of Amendment to Certificate of Incorporation dated June 21, 2022 (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed by the Company on June 22, 2022).
4.1
Form of Senior Secured Convertible Note (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed by the Company on April 4, 2022).
10.1
Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed by the Company on April 4, 2022).
10.2
Form of Security Agreement (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed by the Company on April 4, 2022).
10.3
Form of Voting Agreement (incorporated by reference to Exhibit 10.3 to the Current Report on Form 8-K filed by the Company on April 4, 2022).
31.1
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.†
31.2
Certification of Principal Financial and Accounting Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. †
32.1
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. †
32.2
Certification of Principal Financial and Accounting Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. †
101.INS
Inline XBRL
Instance Document
101.SCH
Inline XBRL
Taxonomy Extension Schema
101.CAL
Inline
XBRL Taxonomy Extension Calculation Linkbase
101.DEF
Inline XBRL
Taxonomy Extension Definition Linkbase
101.LAB
Inline XBRL
Taxonomy Extension Label Linkbase
101.PRE
Inline XBRL
Taxonomy Extension Presentation Linkbase
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
†
Filed
herewith
43
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.