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 September 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
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 November 10, 2022, there were 93,704,719 shares of the registrant’s Common Stock, par value $0.001 per share, issued and outstanding
(with such number of shares inclusive of shares of common stock underlying unvested restricted stock awards granted under the PAVmed
Inc. 2014 Long-Term Incentive Equity Plan as of such date).
TABLE
OF CONTENTS
Page
Part I - Financial Information
Item
1.
Financial Statements
Condensed Consolidated Balance Sheets (unaudited) as of September 30, 2022 and December 31, 2021
1
Condensed Consolidated Statements of Operations (unaudited) for the three and nine months ended September 30, 2022 and 2021
2
Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) (unaudited) for the three and nine months ended September 30, 2022 and 2021
3
Condensed Consolidated Statements of Cash Flows (unaudited) for the nine months ended September 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
29
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)
September 30, 2022
December 31, 2021
Assets:
Current assets:
Cash
$ 56,785
$ 77,258
Accounts receivable
31
200
Prepaid expenses, deposits, and other current assets
5,163
5,179
Total current assets
61,979
82,637
Fixed assets, net
2,374
1,585
Operating lease right-of-use assets
3,079
—
Intangible assets, net
3,950
2,029
Other assets
1,083
725
Total assets
$ 72,465
$ 86,976
Liabilities, Preferred Stock and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 2,454
$ 3,299
Accrued expenses and other current liabilities
2,930
4,259
Operating lease liabilities, current portion
1,027
—
Senior Secured Convertible Notes - at fair value
35,500
—
Total current liabilities
41,911
7,558
Operating lease liabilities, less current portion
1,998
—
Total liabilities
43,909
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 1,182,101 at September 30, 2022 and 1,113,919 shares at December 31, 2021
2,624
2,419
Common stock, $ 0.001 par value. Authorized, 250,000,000 shares; 92,228,862 and 86,367,845 shares outstanding as of September 30, 2022 and December 31, 2021, respectively
92
86
Additional paid-in capital
214,278
198,071
Accumulated deficit
( 207,638 )
( 138,910 )
Treasury stock
( 408 )
—
Total PAVmed Inc. Stockholders’ Equity
8,948
61,666
Noncontrolling interests
19,608
17,752
Total Stockholders’ Equity
28,556
79,418
Total Liabilities and Stockholders’ Equity
$ 72,465
$ 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 data - unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2022
2021
2022
2021
Revenue
$ 76
$ 200
$ 265
$ 200
Operating expenses:
Cost of revenue
1,626
144
1,996
144
Sales and marketing
4,736
2,293
13,559
5,555
General and administrative
10,320
6,109
30,982
16,314
Amortization of acquired intangible assets
505
17
1,278
23
Research and development
6,202
5,305
18,873
12,878
Total operating expenses
23,389
13,868
66,688
34,914
Net loss from operations
( 23,313 )
( 13,668 )
( 66,423 )
( 34,714 )
Other income (expense):
Interest expense
( 525 )
—
( 1,049 )
—
Change in fair value - Senior Secured Convertible Notes and Senior Convertible Note
261
—
( 1,739 )
1,682
Loss on issue and offering costs - Senior Secured Convertible Note
( 1,232 )
—
( 4,332 )
—
Debt extinguishments loss - Senior Secured Convertible Notes
( 5,123 )
—
( 5,123 )
( 3,715 )
Debt forgiveness
—
—
—
300
Other income (expense), net
( 6,619 )
—
( 12,243 )
( 1,733 )
Loss before provision for income tax
( 29,932 )
( 13,668 )
( 78,666 )
( 36,447 )
Provision for income taxes
—
—
—
—
Net loss before noncontrolling interests
( 29,932 )
( 13,668 )
( 78,666 )
( 36,447 )
Net loss attributable to the noncontrolling interests
3,806
1,441
10,143
3,318
Net loss attributable to PAVmed Inc.
( 26,126 )
( 12,227 )
( 68,523 )
( 33,129 )
Less: Series B Convertible Preferred Stock dividends earned
( 71 )
( 67 )
( 209 )
( 216 )
Net loss attributable to PAVmed Inc. common stockholders
$ ( 26,197 )
$ ( 12,294 )
$ ( 68,732 )
$ ( 33,345 )
Per share information:
Net loss per share attributable to PAVmed Inc. - basic and diluted
$ ( 0.29 )
$ ( 0.15 )
$ ( 0.78 )
$ ( 0.41 )
Net loss per share attributable to PAVmed Inc. common stockholders – basic and diluted
$ ( 0.29 )
$ ( 0.15 )
$ ( 0.78 )
$ ( 0.42 )
Weighted average common shares outstanding, basic and diluted
89,758,927
83,307,170
87,724,124
79,873,583
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 September 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 - June 30, 2022
1,158,950
$ 2,554
87,023,211
$ 87
$ 201,327
$ ( 181,442 )
$ ( 548 )
$ 19,426
$ 41,404
Dividends declared - Series
B Convertible Preferred Stock
23,196
70
—
—
—
( 70 )
—
—
—
Conversions - Series B Convertible
Preferred Stock
( 45 )
—
45
—
—
—
—
—
—
Conversions - Senior Secured
Convertible Note
—
—
5,013,908
5
10,107
—
—
—
10,112
Exercise - stock options of
majority-owned subsidiary
—
—
—
—
—
—
—
6
6
Purchase - Employee Stock
Purchase Plan
—
—
—
—
—
—
140
—
140
Purchase - majority-owned
subsidiary common stock - Employee Stock Purchase Plan
—
—
—
—
—
—
—
109
109
Issuance - majority-owned
subsidiary common stock - Committed Equity Facility, net of deferred financing charges
—
—
—
—
—
—
—
1,767
1,767
Impact of subsidiary equity
transactions
—
—
—
—
1,363
—
—
( 1,363 )
—
Issuance - majority-owned
subsidiary common stock - Settlement APA-RDx - Installment Payment
—
—
—
—
—
—
—
186
186
Stock-based compensation -
PAVmed Inc.
—
—
—
—
1,481
—
—
—
1,481
Stock-based compensation -
majority-owned subsidiary
—
—
—
—
—
—
—
3,283
3,283
Treasury stock
—
—
191,698
—
—
—
—
—
—
Net loss
—
—
—
—
—
( 26,126 )
—
( 3,806 )
( 29,932 )
Balance - September 30,
2022
1,182,101
$ 2,624
92,228,862
$ 92
$ 214,278
$ ( 207,638 )
$ ( 408 )
$ 19,608
$ 28,556
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 NINE MONTHS ENDED September 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
68,227
205
—
—
—
( 205 )
—
—
—
Conversions - Series B Convertible
Preferred Stock
( 45 )
—
45
—
—
—
—
—
—
Vest - restricted stock awards
—
—
541,666
1
( 1 )
—
—
—
—
Exercise - Series Z warrants
—
—
5
—
—
—
—
—
—
Conversions - Senior Secured
Convertible Note
—
—
5,013,908
5
10,107
—
—
—
10,112
Exercise - stock options
—
—
299,999
—
302
—
—
—
302
Exercise - stock options of
majority-owned subsidiary
—
—
—
—
—
—
—
694
694
Purchase - Employee Stock
Purchase Plan
—
—
194,240
—
218
—
140
—
358
Purchase - majority-owned
subsidiary common stock - Employee Stock Purchase Plan
—
—
—
—
—
—
—
109
109
Issuance - majority-owned
subsidiary common stock - Committed Equity Facility, net of deferred financing charges
—
—
—
—
—
—
—
1,767
1,767
Impact of subsidiary equity
transactions
—
—
—
—
1,375
—
—
( 1,375 )
—
Issuance - majority-owned
subsidiary common stock - Settlement APA-RDx - Installment Payment
—
—
—
—
—
—
—
427
427
Stock-based compensation -
PAVmed Inc.
—
—
—
—
4,206
—
—
—
4,206
Stock-based compensation -
majority-owned subsidiary
—
—
—
—
—
—
—
10,377
10,377
Treasury stock
—
—
( 188,846 )
—
—
—
( 548 )
—
( 548 )
Net loss
—
—
—
—
—
( 68,523 )
—
( 10,143 )
( 78,666 )
Balance - September 30,
2022
1,182,101
$ 2,624
92,228,862
$ 92
$ 214,278
$ ( 207,638 )
$ ( 408 )
$ 19,608
$ 28,556
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 September 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 - June 30, 2021
1,185,685
$ 2,499
82,576,816
$ 83
$ 149,694
$ ( 109,325 )
$ ( 911 )
$ 42,040
Dividends declared - Series
B Convertible Preferred Stock
24,577
73
—
—
—
( 73 )
—
—
Conversions - Series B Convertible
Preferred Stock
( 118,814 )
( 220 )
118,814
—
220
—
—
—
Exercise - Series Z warrants
—
—
1,186,467
1
1,897
—
—
1,898
Exercise - Series W warrants
—
—
3,945
—
20
—
—
20
Exercise - stock options
—
—
483,668
—
823
—
—
823
Purchase - Employee Stock
Purchase Plan
—
—
31,112
—
131
—
—
131
Stock-based compensation -
PAVmed Inc.
—
—
—
—
1,218
—
—
1,218
Stock-based compensation -
majority-owned subsidiary
—
—
—
—
56
—
2,716
2,772
Net loss
—
—
—
—
—
( 12,227 )
( 1,441 )
( 13,668 )
Balance - September 30,
2021
1,091,448
$ 2,352
84,400,822
$ 84
$ 154,059
$ ( 121,625 )
$ 364
$ 35,234
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 NINE MONTHS ENDED September 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 - December 31, 2020
1,228,075
$ 2,537
63,819,935
$ 64
$ 87,570
$ ( 88,275 )
$ ( 2,369 )
$ ( 473 )
Beginning
balance
1,228,075
$ 2,537
63,819,935
$ 64
$ 87,570
$ ( 88,275 )
$ ( 2,369 )
$ ( 473 )
Dividends declared - Series
B Convertible Preferred Stock
73,821
221
—
—
—
( 221 )
—
—
Conversions - Series B Convertible
Preferred Stock
( 210,448 )
( 406 )
210,448
—
406
—
—
—
Issue common stock –
registered offerings, net
—
—
15,782,609
16
53,688
—
—
53,704
Vest - restricted stock awards
—
—
150,000
—
—
—
—
—
Exercise - Series Z warrants
—
—
2,927,125
3
4,680
—
—
4,683
Exercise - Series W warrants
—
—
3,945
—
20
—
—
20
Conversions - Senior Secured
Convertible Note
—
—
667,668
1
1,722
—
—
1,723
Exercise - stock options
—
—
604,500
—
953
—
—
953
Purchase - Employee Stock
Purchase Plan
—
—
234,592
—
436
—
—
436
Stock-based compensation -
PAVmed Inc.
—
—
—
—
4,473
—
—
4,473
Stock-based compensation -
majority-owned subsidiary
—
—
—
—
111
—
6,045
6,156
Investment in Veris Health
Inc. subsidiary
—
—
—
—
—
—
6
6
Net Loss
—
—
—
—
—
( 33,129 )
( 3,318 )
( 36,447 )
Balance - September 30,
2021
1,091,448
$ 2,352
84,400,822
$ 84
$ 154,059
$ ( 121,625 )
$ 364
$ 35,234
Ending
balance
1,091,448
$ 2,352
84,400,822
$ 84
$ 154,059
$ ( 121,625 )
$ 364
$ 35,234
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)
Nine Months Ended September 30,
2022
2021
Cash flows from operating activities
Net loss - before noncontrolling interest (“NCI”)
$ ( 78,666 )
$ ( 36,447 )
Adjustments to reconcile net loss - before NCI to net cash used in operating activities
Depreciation and amortization expense
1,731
60
Stock-based compensation
14,583
10,629
In-process R&D charge
—
133
APA-RDx: Issue common stock of majority-owned subsidiary - settle installment payment
427
—
Change in fair value - Senior Secured Convertible Note
1,739
( 1,682 )
Loss upon Issuance - Senior Secured Convertible Note
3,523
—
Debt extinguishment loss - Senior Secured Convertible Notes and Senior Convertible Note
5,123
3,715
Debt forgiveness
—
( 300 )
Non-cash lease expense
82
—
Changes in operating assets and liabilities:
Accounts receivable
169
( 200 )
Prepaid expenses and other current and non-current assets
( 563 )
( 1,918 )
Accounts payable
( 981 )
2,911
Accrued expenses and other current liabilities
( 1,329 )
( 715 )
Net cash flows used in operating activities
( 54,162 )
( 23,814 )
Cash flows from investing activities
Purchase of equipment
( 1,242 )
( 192 )
Payments – Acquisitions, net of cash
( 3,200 )
( 147 )
Net cash flows used in investing activities
( 4,442 )
( 339 )
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, net of offering costs
35,227
—
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 – majority-owned subsidiary common stock - Committed Equity Facility
1,807
—
Proceeds – exercise of Series Z warrants
—
4,115
Proceeds – exercise of stock options
302
953
Proceeds – issue common stock – Employee Stock Purchase Plan
358
436
Proceeds – majority-owned subsidiary common stock – Employee Stock Purchase Plan
109
—
Proceeds – exercise of stock options issued under equity plan of majority owned subsidiary
694
—
Purchase Treasury Stock – payment of employee payroll tax obligation in connection with stock-based compensation
( 366 )
—
Net cash flows provided by financing activities
38,131
44,238
Net increase (decrease) in cash
( 20,473 )
20,085
Cash, beginning of period
77,258
17,256
Cash, end of period
$ 56,785
$ 37,341
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”)
and Veris Health Inc. (“Veris Health” or “VERIS”).
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, CarpX and Veris Solar, 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, CarpX, and Veris Solar 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 September
30, 2022.
Note
2 — Summary of Significant Accounting Policies
Significant
Accounting Policies
The
Company’s significant accounting policies are as disclosed in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2021 as filed with the SEC on April 6, 2022, except as otherwise noted herein below.
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements of 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 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.
As permitted under SEC rules, certain
footnotes or other financial information normally required by U.S. GAAP have been condensed or omitted. The balance sheet as of December
31, 2021 has been derived from audited consolidated financial statements at such date. The accompanying unaudited condensed consolidated
financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements, and in the
opinion of management, include all adjustments, consisting only of routine recurring adjustments, necessary for a fair presentation of
the Company’s unaudited condensed consolidated financial information.
8
Note
2 — Summary of Significant Accounting Policies - continued
The
consolidated results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the consolidated
results to be expected for the year ending December 31, 2022 or for any other interim period or for any other future periods. The accompanying
unaudited condensed consolidated financial statements and related unaudited condensed consolidated financial information should be read
in conjunction with the PAVmed Inc and Subsidiaries audited consolidated financial statements and related notes thereto as of and for
the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K as filed with the SEC on April 6, 2022.
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.
Reclassifications
Certain prior-year amounts
have been reclassified to conform to the current year presentation, which includes presenting costs of revenue within operating
expenses on the statements of operations, in the unaudited condensed consolidated financial statements and accompanying notes to the
unaudited condensed consolidated financial statements. The impact of the reclassifications made to prior year amounts is not
material and did not affect net loss.
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.
Leases
The
Company adopted FASB ASC Topic 842, Leases , (“ASC 842”) effective December 31, 2021.
All
significant lease agreements and contractual agreements with embedded lease agreements are accounted for under the provisions of ASC
842, wherein, if the contractual arrangement: involves the use of a distinct identified asset; provides for the right to substantially
all the economic benefits from the use of the asset throughout the contractual period; and provides for the right to direct the use of
the asset. A lease agreement is accounted for as either a finance lease (generally with respect real estate) or an operating lease (generally
with respect to equipment). Under both a finance lease and an operating lease, the Company recognizes as of the lease commencement date
a lease right-of-use (“ROU”) asset and a corresponding lease payment liability.
A
lease ROU asset represents the Company’s right to use an underlying asset for the lease term, and the lease liability represents
its contractual obligation to make lease payments. The lease ROU asset is measured at the lease commencement date as the present value
of the future lease payments plus initial direct costs incurred. The Company recognizes lease expense of the amortization of the lease
ROU asset for an operating lease on a straight-line basis over the lease term; and for financing leases on a straight-line basis unless
another basis is more representative of the pattern of economic benefit. The operating ROU asset also includes any lease incentives received
for improvements to leased property, when the improvements are lessee-owned. For improvements to leased property that are lessor-owned,
the Company includes amounts the Company incurred for the improvements as ROU assets which are amortized on a straight-line basis over
the life of the lease.
The
lease liability is measured at the lease commencement date with the discount rate generally based on the Company’s incremental
borrowing rate (to the extent the lease implicit rate is not known nor determinable), with interest expense recognized using the interest
method for financing leases.
Certain
leases may include options to extend or terminate the agreement. The Company does not assume renewals in determination of the lease term
unless the renewals are deemed to be reasonably certain at lease commencement. As well, an option to terminate is considered unless it
is reasonably certain the Company will not exercise the option. The Company elected the practical expedient to not recognize a lease
ROU asset and lease payment liability for leases with a term of twelve months or less (“short-term leases”), resulting in
the aggregate lease payments being recognized on a straight line basis over the lease term. The Company’s leases with a commencement
date prior to January 1, 2022 were short-term leases and therefore did not require recording a ROU asset or lease liability at December
31, 2021. Additionally, the Company elected the practical expedient to not separate lease and non-lease components.
9
Note
2 — Summary of 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”, and a Senior Secured Convertible Note dated September 8, 2022, referred
to herein as the “September 2022 Senior Convertible Note”, which are 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 or the September 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 and the September 2022 Senior Convertible Note.
Revenue
Recognition
Revenues
are recognized when the satisfaction of the performance obligation occurs, in an amount that reflects the consideration the Company expects
to collect in exchange for those services. The Company’s revenue is primarily generated by its laboratory testing services utilizing
its EsoGuard Esophageal DNA tests. The services are completed upon release of a patient’s test result to the ordering healthcare
provider. Revenue recognized is inclusive of both variable consideration in connection with an individual patient’s third-party
insurance coverage policy and fixed consideration in connection with a contracted services arrangement with an unrelated third party legal
entity. To determine revenue recognition for the arrangements that the Company determines are within the scope of ASC 606, Revenue
from Contracts with Customers, the Company performs the following five steps: (1) identify the contract(s) with a customer, (2) identify
the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance
obligations in the contract and (5) recognize revenue when (or as) the entity satisfies a performance obligation.
The
key aspects considered by the Company include the following:
Contracts —The
Company’s customer is primarily the patient, but the Company does not enter into a formal reimbursement contract with a patient.
The Company establishes a contract with a patient in accordance with other customary business practices, which is the point in time an
order is received from a provider and a patient specimen has been returned to the laboratory for testing. Payment terms are a function
of a patient’s existing insurance benefits, including the impact of coverage decisions with Center for Medicare & Medicaid
Services (“CMS”) and applicable reimbursement contracts established between the Company and payers. However, when a patient
is considered self-pay, the Company requires payment from the patient prior to the commencement of the Company’s performance obligations.
The Company’s consideration can be deemed variable or fixed depending on the structure of specific payer contracts, and the Company
considers collection of such consideration to be probable to the extent that it is unconstrained.
Performance
obligations —A performance obligation is a promise in a contract to transfer a distinct good or service (or a bundle of goods
or services) to the customer. The Company’s contracts have a single performance obligation, which is satisfied upon rendering of
services, which culminates in the release of a patient’s test result to the ordering healthcare provider. The Company elects the
practical expedient related to the disclosure of unsatisfied performance obligations, as the duration of time between providing testing
supplies, the receipt of a sample, and the release of a test result to the ordering healthcare provider is far less than one year.
10
Note 2 — Summary of Significant Accounting
Policies - continued
Transaction
price —The transaction price is the amount of consideration that the Company expects to collect in exchange for transferring
promised goods or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes). The
consideration expected to be collected from a contract with a customer may include fixed amounts, variable amounts, or both.
If the
consideration derived from the contracts is deemed to be variable, the Company estimates the amount of consideration to which it will be entitled
in exchange for the promised goods or services. The Company limits the amount of variable consideration included in the transaction price to the unconstrained
portion of such consideration. In other words, the Company recognizes revenue up to the amount of variable consideration that is not
subject to a significant reversal until additional information is obtained or the uncertainty associated with the additional
payments or refunds is subsequently resolved.
When
the Company does not have significant historical experience or that experience has limited predictive value, the constraint over estimates
of variable consideration may result in no revenue being recognized upon delivery of patient EsoGuard test results to the ordering healthcare provider. As such, the Company recognizes revenue up to the amount of variable consideration not subject to a significant
reversal until additional information is obtained or the uncertainty associated with additional payments or refunds, if any, is subsequently
resolved. Differences between original estimates and subsequent revisions, including final settlements, represent changes in estimated
expected variable consideration, with the change in estimate recognized in the period of such revised estimate. With respect to a contracted
service arrangement, the fixed consideration revenue is recognized on an as-billed basis upon delivery of the laboratory test report with
realization of such fixed consideration deemed probable based upon actual historical experience.
Allocate
transaction price —The transaction price is allocated entirely to the performance obligation contained within the contract with
a customer on the basis of the relative standalone selling prices of each distinct good or service.
Practical
Expedients —The Company does not adjust the transaction price for the effects of a significant financing component, as at contract
inception, the Company expects the collection cycle to be one year or less.
Note
3 — Revenue from Contracts with Customers
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 former 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 three months and nine months ended September 30, 2022, the Company recognized total revenue of $ 76 and $ 265 , respectively. For the
three month period ended September 30, 2022, the Company recognized revenue resulting from the delivery of patient EsoGuard test results
. Revenue recognized from customer contracts deemed to include a variable consideration transaction price is limited
to the unconstrained portion of the variable consideration as the Company did not estimate expected variable consideration given the lack
of historical experience and objective reliable actual reimbursement data. In addition to the revenue recognized during the three month
period ended September 30, 2022, the Company’s revenue for the nine month period ended September 30, 2022 includes $ 189 of revenue
recognized under the EsoGuard Commercialization Agreement, which represented 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. In the three and nine months ended September 30, 2021, the Company recognized
total revenue of $ 200 and $ 200 , respectively, under the EsoGuard Commercialization Agreement.
Cost
of Revenue
The
cost of revenues principally includes the costs related to the Company’s laboratory operations (excluding estimated costs associated with research activities), the costs
related to the EsoCheck cell collection device, cell sample mailing kits and license royalties.
In
the three months ended September 30, 2022, the cost of revenue was $ 1,626
and was primarily related to costs for our laboratory operations and EsoCheck device supplies. For the nine months ended September
30, 2022, the cost of revenue was $ 1,996 ,
including $ 369
reflecting costs attributable to delivering the services under the EsoGuard Commercialization Agreement for the period January 1,
2022 to February 25, 2022 . In the three and nine months ended September 30, 2021, the cost of revenue was $ 144 and $ 144 , respectively, which
solely related to the EsoGuard Commercialization Agreement.
11
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
Three Months Ended
September 30,
Nine Months Ended
September 30,
2022
2021
2022
2021
Cost of Revenue
CWRU – Royalty Fee
$ 4
$ 10
$ 13
$ 10
Cost of Revenue
$ 4
$ 10
$ 13
$ 10
General and Administrative Expense
CWRU – License Agreement - Amendment Fee - Milestone III
—
10
—
10
Stock-based compensation expense – Physician Inventors’ restricted stock awards
275
273
819
637
Research and Development Expense
Amended CWRU License Agreement - reimbursement of patent legal fees
—
82
209
195
Fees - Physician Inventors’ consulting agreements
15
8
32
22
Sponsored research agreement
4
—
6
—
Stock-based compensation expense – Physician Inventors’ stock options
52
56
151
114
Total Related Party Expenses
$ 350
$ 439
$ 1,230
$ 988
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 $ 21 in the three and nine months ended September 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 $ 8 and $ 45 in the three and nine months
ended September 30, 2022 in connection with the consulting agreement.
12
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 nine months ended September 30, 2022, a total of $ 1,000 and $ 3,200 ,
respectively, of cash was paid with respect to 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 nine months ended September 30, 2022, as provided for in
the APA-RDx, installment payments were settled with the issuances of 82,618 and 199,989 shares of common stock of Lucid Diagnostics Inc.,
with such shares having fair values of $ 188 and $ 427 , respectively, (with the fair value measured as the quoted closing price on the
dates 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. without cause 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.
13
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
September 30, 2022
December 31, 2021
Advanced payments to service providers and suppliers
$ 581
$ 808
Prepaid insurance
453
1,856
Deposits
3,980
1,989
EsoCheck cell collection supplies
55
434
EsoGuard mailer supplies
49
59
CarpX devices
45
33
Total prepaid expenses, deposits and other current assets
$ 5,163
$ 5,179
Note
7 — Leases
During
the nine months ended September 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 September 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)
$ 299
2023
1,229
2024
1,184
2025
288
2026
272
Thereafter
132
Total lease payments
$ 3,404
Less: imputed interest
( 379 )
Present value of lease liabilities
$ 3,025
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
Nine Months Ended September 30,
2022
2021
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows from operating leases
$ 763
$ —
Non-cash investing and financing activities
Right-of-use assets obtained in exchange for new operating lease liabilities
$ 3,753
$ —
Weighted-average remaining lease term - operating leases (in years)
3.08
—
Weighted-average discount rate - operating leases
7.875 %
— %
As
of September 30, 2022, the Company’s right-of-use assets from operating leases are $ 3,079 , which are reporting in right-of-use
assets - operating leases in the unaudited condensed consolidated balance sheets. As of September 30, 2022, the Company has outstanding
operating lease obligations of $ 3,025 , of which $ 1,027 is reported in operating lease liabilities, current portion and $ 1,998 is reporting
in operating lease liabilities less current portion in the Company’s unaudited condensed consolidated balance sheets. The Company
did not have operating leases as of December 31, 2021. The Company calculates its incremental borrowing rates for specific lease terms,
used to discount future lease payments, as a function of the financing terms the Company would likely receive on the open market.
14
Note 7 — Leases - continued
In September 2022,
the Company entered into a lease agreement for its principal
corporate offices, in New York, New York. The lease agreement term is from the September 15, 2022 execution date to the date which is
seven years and eight months from the lease commencement date, with the rent abated for the first eight months of the lease term . The
anticipated lease commencement date is dependent upon the completion of leasehold improvements, which, as of September 30, 2022, is currently
expected to be no later than March 31, 2023. The aggregate (undiscounted) rent payments are approximately $ 3.2
million over the lease term.
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
September 30, 2022
December 31, 2021
Defensive asset
60 months
$ 2,105
$ 2,105
Laboratory licenses and certifications and laboratory information management software
24 months
3,200
—
Other
1 year
70
70
Total Intangible assets
5,375
2,175
Less Accumulated Amortization
( 1,425 )
( 146 )
Intangible Assets, net
$ 3,950
$ 2,029
The
defensive technology intangible asset was recognized 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.
The
intangible assets recognized under the APA-RDx are the laboratory licenses and certifications, inclusive of a CLIA certification, CAP
accreditation, and clinical laboratory licenses for five (5) U.S. States transfer to the Company from RDx, and a laboratory information
management software 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 $ 505 and $ 17 for the three month periods ended September 30, 2022 and 2021, respectively,
and $ 1,278 and $ 23 for the nine month periods ended September 30, 2022 and 2021, respectively, and is included in general and administrative
expenses in the accompanying unaudited condensed consolidated statements of operations. As of September 30, 2022, the estimated future
amortization expense associated with the Company’s finite-lived intangible assets for each of the five succeeding fiscal years
is as follows:
Schedule of Estimated Amortization Expense for Intangible Assets
2022 (remainder of year)
$ 504
2023
2,021
2024
688
2025
421
2026
316
Total
$ 3,950
15
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 included 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 reached agreement on a Settlement Term Sheet Agreement, dated January 28, 2021, to settle the complaint, the
terms of which did 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. The settlement and a plaintiff’s fee award of $ 450
were approved by the Court on November 3, 2022. Such award shall become payable within 10 days of December 2, 2022, assuming no
appeal is filed prior to such date. As of September 30, 2022, the Company has fully accrued for this settlement, which is included
in accrued expenses and other current liabilities on the Company’s unaudited condensed consolidated balance sheets.
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 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.
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
September 30, 2022
Senior Secured Convertible Note - April 2022
$ —
$ —
$ 23,500
$ 23,500
Senior Secured Convertible Note - September 2022
$ —
$ —
$ 12,000
$ 12,000
Totals
$ —
$ —
$ 35,500
$ 35,500
(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 September 30, 2022.
16
Note
10 — Financial Instruments Fair Value Measurements - continued
As
discussed in Note 11, Debt , the Company issued Senior Secured Convertible Notes dated April 4, 2022 and September 8, 2022, with
an initial $27.5 million face value principal (“April 2022 Senior Convertible Note”) and an initial $11.25 million face value
principal (“September 2022 Senior Convertible Note”), respectively. Both convertible notes are 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 September 30, 2022, and the estimated
fair value of the September 2022 Senior Convertible Note as of each of September 8, 2022 and September 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
September 2022 Senior Convertible Note:
September 8, 2022
April 2022 Senior Convertible Note:
September 30, 2022
September 2022 Senior Convertible Note:
September 30, 2022
Fair Value
$ 30,100
$ 12,200
$ 23,500
$ 12,000
Face value principal payable
$ 27,500
$ 11,250
$ 22,511
$ 11,250
Required rate of return
7.875 %
7.875 %
11.50 %
11.60 %
Conversion Price
$ 5.00
$ 5.00
$ 5.00
$ 5.00
Value of common stock
$ 1.26
$ 1.21
$ 0.86
$ 0.86
Expected term (years)
2.00
2.00
1.30
1.94
Volatility
115.00 %
120.00 %
135.00 %
135.00 %
Risk free rate
2.40 %
3.42 %
4.02 %
4.12 %
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 and analyses, including the Company’s
common stock price, the Company’s dividend yield, the risk-free rates based on U.S. Treasury security yields, and certain other
Level-3 inputs including, assumptions regarding the estimated volatility in the value of the Company’s common stock price. Changes
in these assumptions can materially affect the estimated fair values.
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 was
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.
Under
the same SPA, the Company issued an additional Senior Secured Convertible Note dated September 8, 2022, referred to herein as the “September
2022 Senior Convertible Note”, with such note having a $ 11.25 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
September 6, 2024. The September 2022 Senior Convertible Note may be converted into shares of common stock of the Company at the Holder’s
election.
17
Note
11 — Debt - continued
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.
The
September 2022 Senior Convertible Note proceeds were $ 10.2 million after deducting a $ 1.0 million lender fee; and additionally, the Company
incurred total offering costs of approximately $ 209 , inclusive of the payment of a total of $ 184 placement agent fees. The lender fee
and offering costs were recognized as of the September 8, 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 $ 481 and $ 1,005
for the three and nine month periods ended September 30, 2022, respectively; and approximately $ 153 subsequent to September 30, 2022
as of November 10, 2022 .
During
the period from September 8, 2022 to March 6, 2023, the Company is required to pay interest expense only (on the $11.25
million face value principal), at 7.875 %
per annum, computed on a 360 day year. The Company paid in cash interest expense of approximately $ 54
for both the three and nine month periods ended September 30, 2022; and approximately $ 76
subsequent to September 30, 2022 as of November 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.
Commencing
March 6, 2023, and then on each of the successive first and tenth trading day of each month thereafter through to and including September
1, 2024 (each referred to as an “Installment Date”); and on the September 6, 2024 maturity date, the Company will be required
to make a principal repayment of $ 296 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 $ 11.25
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 $ 11.25
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 the September 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 .
The
payment of all amounts due and payable under both senior convertible notes are guaranteed by the Company and its subsidiaries,
except for Lucid Diagnostics Inc and its subsidiaries; and the obligations under both senior convertible notes are secured by all of
the assets of the Company and each guarantor, except in the case of the Lucid Diagnostics Inc. common stock held by PAVmed Inc. only
9.99% of Lucid Diagnostics Inc.’s issued and outstanding common stock is pledged to secure the indebtedness of the convertible
notes.
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.
18
Note
11 — Debt - continued
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 total senior convertible notes outstanding, accrued and unpaid interest thereon and accrued
and unpaid late charges to (b) the Company’s average market capitalization over the prior ten trading days, to not exceed 30% (except
that such maximum percentage is 50% for the period from September 8, 2022 through March 5, 2023) (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 in compliance with the above
covenants .
The
Company and the investor entered into a waiver dated August 9, 2022 whereby the April 2022 Senior Convertible Note was amended 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, in August 2022, approximately $ 4,989 of principal repayments along with approximately
$ 11 of interest expense thereon, were settled through the issuance of 5,013,908 shares of common stock of the Company, with such shares
having a fair value of approximately $ 10,112 (with such fair value measured as the respective conversion date quoted closing price of
the common stock of the Company). The conversions resulted in a debt extinguishment loss of $ 5.1 million in the three months ended September
30, 2022. Subsequent to September 30, 2022, as of November 10, 2022, approximately $ 424 of principal repayments along with approximately $ 4 of interest
expense thereon, were settled through the issuance of 500,857 shares of common stock of the Company, with such shares having a fair value
of approximately $536 (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 outstanding of the Senior Convertible Notes as of September 30, 2022 are 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
$ 22,511
$ 23,500
September 2022 Senior Convertible Note
September 6, 2024
7.875 %
$ 5.00
$ 11,250
$ 12,000
Balance as of September 30, 2022
$ 33,761
$ 35,500
The
Company did not have convertible debt outstanding at December 31, 2021. During the nine month period ended September 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.
See
Note 10, Financial Instruments Fair Value Measurements , for a further discussion of fair value assumptions.
19
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 2,520,927
shares available for grant as of September 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 September 30, 2022.
PAVmed
Inc. Stock Options
PAVmed
Inc. stock options granted under the PAVmed 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)
4,734,350
$ 1.54
Exercised
( 299,999 )
$ 1.01
Forfeited
( 1,542,978 )
$ 3.13
Outstanding stock options at September 30, 2022 (3)
11,611,571
$ 2.73
7.7
$ —
Vested and exercisable stock options at September 30, 2022
6,623,157
$ 3.01
6.5
$ —
(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 September 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 September 30, 2022 and December 31, 2021.
20
Note
12 — Stock-Based Compensation - continued
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 September 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 September 30, 2022 and December 31, 2021.
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 3,754,051 shares available for grant as of September 30, 2022. The share reservation is not diminished by a total of 423,300
stock options and 50,000 restricted stock awards granted outside the Lucid Diagnostics Inc. 2018 Equity Plan, as of September 30, 2022.
Lucid
Diagnostics Inc. Stock Options
Lucid
Diagnostics Inc. stock options granted under the Lucid Diagnostics Inc. 2018 Equity Plan and stock options granted outside such plan
are summarized as follows:
Schedule of 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
1,419,242
$ 0.73
7.0
$ 6,665
Granted (1)
2,320,000
$ 3.71
Exercised
( 964,717 )
$ 0.72
Forfeited
( 141,436 )
$ 4.33
Outstanding stock options at September 30, 2022 (3)
2,633,089
$ 3.17
8.6
$ 499
Vested and exercisable stock options at September 30, 2022
960,364
$ 2.33
7.2
$ 499
(1)
Stock
options granted under the Lucid Diagnostics Inc. 2018 Equity Plan and those granted outside such plan generally vest ratably over
twelve quarters, with the vesting commencing with the grant date quarter-end, and have a ten-year contractual term from date-of-grant.
(2)
The
intrinsic value is computed as the difference between the quoted price of the Lucid Diagnostics Inc. common stock on each of September
30, 2022 and December 31, 2021 and the exercise price of the underlying Lucid Diagnostics 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 423,300 stock options granted outside the Lucid Diagnostics
Inc. 2018 Equity Plan, as of September 30, 2022 and December 31, 2021.
21
Note
12 — Stock-Based Compensation - continued
Lucid
Diagnostics Inc. Restricted Stock Awards
Lucid
Diagnostics Inc. restricted stock awards granted under the Lucid Diagnostics Inc. 2018 Equity Plan and restricted stock awards granted
outside such plan are summarized as follows:
Schedule of Restricted Stock Award Activity
Number of Restricted Stock Awards
Weighted Average Grant Date Fair Value
Unvested restricted stock awards as of December 31, 2021
1,940,740
$ 12.76
Granted
320,000
4.53
Vested
( 169,320 )
13.48
Forfeited
—
—
Unvested restricted stock awards as of September 30, 2022 (1)
2,091,420
$ 11.44
(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 September
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.
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
September 30,
Nine Months Ended
September 30,
2022
2021
2022
2021
Cost of revenue
$ 9
$ —
$ 9
$ —
Sales and marketing expenses
643
327
1,859
814
General and administrative expenses
3,854
3,353
12,016
9,088
Research and development expenses
258
310
699
727
Total stock-based compensation expense
$ 4,764
$ 3,990
$ 14,583
$ 10,629
22
Note
12 — Stock-Based Compensation - continued
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
2022
2021
2022
2021
Three Months Ended
September 30,
Nine Months Ended
September 30,
2022
2021
2022
2021
Lucid Diagnostics Inc 2018 Equity Plan – cost of revenue
$ 9
$ —
$ 9
$ —
Lucid Diagnostics Inc 2018 Equity Plan – sales and marketing expenses
253
—
733
—
Lucid Diagnostics Inc 2018 Equity Plan – general and administrative expenses
2,990
2,695
9,504
5,988
Lucid Diagnostics Inc 2018 Equity Plan – research and development expenses
28
21
125
57
PAVmed Inc 2014 Equity Plan - sales and marketing expenses
161
—
497
—
PAVmed Inc 2014 Equity Plan - general and administrative expenses
78
—
224
—
PAVmed Inc 2014 Equity Plan - research and development expenses
52
56
159
111
Total stock-based compensation expense – recognized by Lucid Diagnostics Inc
$ 3,571
$ 2,772
$ 11,251
$ 6,156
Total stock-based compensation expense
$ 3,571
$ 2,772
$ 11,251
$ 6,156
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
$ 8,424
2.1
Restricted Stock Awards
$ 1,222
0.9
Lucid Diagnostics Inc. 2018 Equity Plan
Stock Options
$ 3,791
2.4
Restricted Stock Awards
$ 7,165
0.8
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 $ 1.08 per share and $ 3.47 per share during the periods ended September 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
Nine Months Ended
September 30,
2022
2021
Expected term of stock options (in years)
5.8
5.6
Expected stock price volatility
86.0 %
76.0 %
Risk free interest rate
2.9 %
0.9 %
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 $ 1.61 per share during the period ended September 30, 2022. 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
Nine Months Ended
September 30,
2022
Expected term of stock options (in years)
5.8
Expected stock price volatility
72.0 %
Risk free interest rate
3.2 %
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 $ 218 and $ 304 ,
on March 31, 2022 and 2021, respectively under the PAVmed Inc Employee Stock Purchase Plan (“PAVmed Inc ESPP”). A total of
191,698 shares and 31,112 shares of common stock of the Company were purchased for proceeds of approximately $ 140 and $ 131 , on September
30, 2022 and 2021, respectively under the PAVmed Inc ESPP. The September 30, 2022 purchase was settled through the redeployment of treasury
stock, and did not reduce the number of shares available-for-issue under the 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 September 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
was April 1, 2022 to September 30, 2022. A total of 84,030 shares of common stock of Lucid Diagnostics Inc were purchased for proceeds
of approximately $ 109 on September 30, 2022 under the Lucid Diagnostics Inc. ESPP. The Lucid Diagnostics Inc. ESPP has a total reservation
of 500,000 shares of common stock of Lucid Diagnostics Inc. of which 415,970 shares are available-for-issue as of September 30, 2022.
24
Note
13 — Preferred Stock
As
of September 30, 2022 and December 31, 2021, there were 1,182,101 and 1,113,919 shares of Series B Convertible Preferred Stock (classified
in permanent equity) issued and outstanding, respectively.
Series
B Convertible Preferred Stock Dividends
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, with the dividends earned from April 1, 2018 through October 1, 2021 payable-in-kind (“PIK”) by the issue
of additional shares of Series B Convertible Preferred Stock; and after October 1, 2021, dividends may be settled, at the election of
the discretion of the board of directors, through any combination of the issue of shares of Series B Convertible Preferred Stock, the
issue shares of common stock of the Company, and /or cash payment.
Series
B Convertible Preferred Stock Dividends Earned
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 as of each of March 31, 2022, June 30, 2022, and September 30, 2022, of approximately
$ 71 and $ 209 in the three and nine months ended September 30, 2022, respectively. The prior year unaudited condensed consolidated statement
of operations, inclusive of dividends earned as of each of March 31, 2021, June 30, 2021, and September 30, 2021 of approximately $ 67
and $ 216 in the three and nine months ended September 30, 2021, respectively.
Series
B Convertible Preferred Stock Dividends Declared
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 nine months ended September 30, 2022, the Company’s board-of-directors
declared Series B Convertible Preferred Stock dividends of an aggregate of approximately $ 204 , inclusive of approximately $ 67 earned
as of December 31, 2021, and approximately $ 68 earned as of March 31, 2022, and approximately $ 69 earned as of June 30, 2022; with each
such dividends settled by the issue of an aggregate 68,227 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; 22,740 shares issued with respect to the dividends earned
as of March 31, 2022; and 23,196 shares issued with respect to the dividends earned as of June 30, 2022.
In
the nine months ended September 30, 2021, the Company’s board-of-directors declared Series B Convertible Preferred Stock dividends
of an aggregate of approximately $ 221 , inclusive of approximately $ 73 earned as of December 31, 2020; approximately $ 75 earned as of
March 31, 2021; and approximately $ 74 earned as of June 30, 2021; with each such dividends settled by the issue of an aggregate 73,821
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; 25,046 shares issued with respect to the dividends earned as of March 31, 2021; and 24,577 shares issued with respect
to the dividends earned as of June 30, 2021.
Subsequent
to September 30, 2022, in October 2022, the Company’s board-of-directors declared a Series B Convertible Preferred Stock dividend
earned as of September 30, 2022 and payable as of October 1, 2022, of approximately $ 71 , to be settled by the issue of an additional
23,658 shares of Series B Convertible Preferred Stock (with such dividend not recognized as a dividend payable as of September 30, 2022,
as the Company’s board of directors had not declared such dividends payable as of such date). In the prior year October 2021, the
Company’s board-of-directors declared a Series B Convertible Preferred Stock dividend earned as of September 30, 2021 and payable
as of October 1, 2021, of approximately $ 67 , settled by the issue of an additional 22,471 shares of Series B Convertible Preferred Stock.
25
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 nine months ended September 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 nine months ended September 30, 2022 a total of 385,938 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.
In
August 2022, 5,103,908 shares of the Company’s common stock were issued upon conversion, at the election of the holder, of the
April 2022 Senior Convertible Note for $ 4,989 face value principal repayments, along with approximately $ 11 of interest thereon, as discussed
in Note 11, Debt .
Common
Stock Purchase Warrants
As
of September 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 nine months ended September 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 .
26
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
September 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.
( 9,032 )
( 5,779 )
Net loss attributable to NCI – Solys Diagnostics Inc.
( 6 )
—
Net loss attributable to NCI – Veris Health Inc.
( 1,105 )
—
Impact of subsidiary equity transactions
( 1,375 )
16,760
Lucid Diagnostics Inc. proceeds from Committed Equity Facility, net of deferred financing charges
1,767
—
Lucid Diagnostics Inc. issuance of common stock for settlement of APA-RDx installment payment
427
—
Lucid Diagnostics Inc. 2018 Equity Plan stock option exercise
694
—
Lucid Diagnostics Inc. Employee Stock Purchase Plan Purchase
109
—
Stock-based compensation expense - Lucid Diagnostics Inc. 2018 Equity Plan
10,371
9,134
Stock-based compensation expense - Veris Health Inc. 2021 Equity Plan
6
—
NCI – equity (deficit) – end of period
$ 19,608
$ 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
September 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 nine months ended September
30, 2022 and 2021; and with respect to Veris Health Inc. for the three and nine months ended September 30, 2022 and from the period of
May 28, 2021 to September 30, 2021 (as the Veris Health Inc. inception date was May 28, 2021).
Lucid
Diagnostics Inc.
As
of September 30, 2022, there were 37,016,225 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 September 30, 2022, under the committed equity facility, a total of 680,263 shares
of common stock of Lucid Diagnostics Inc. were issued for proceeds of approximately $ 1,807 .
Veris
Health Inc.
As
of September 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 September 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 September 30, 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.
27
Note
16 — Net Loss Per Share
The
“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 respective periods indicated - is as follows:
Schedule of Comparison of Basic and Fully Diluted Net Loss Per Share
2022
2021
2022
2021
Three Months Ended
September 30,
Nine Months Ended
September 30,
2022
2021
2022
2021
Numerator
Net loss - before noncontrolling interest
$ ( 29,932 )
$ ( 13,668 )
$ ( 78,666 )
$ ( 36,447 )
Net loss attributable to noncontrolling interest
3,806
1,441
10,143
3,318
Net loss - as reported, attributable to PAVmed Inc.
$ ( 26,126 )
$ ( 12,227 )
$ ( 68,523 )
$ ( 33,129 )
Series B Convertible Preferred Stock dividends – earned
$ ( 71 )
$ ( 67 )
$ ( 209 )
$ ( 216 )
Net loss attributable to PAVmed Inc. common stockholders
$ ( 26,197 )
$ ( 12,294 )
$ ( 68,732 )
$ ( 33,345 )
Denominator
Weighted average common shares outstanding, basic and diluted
89,758,927
83,307,170
87,724,124
79,873,583
Net loss per share
Basic and diluted
Net loss - as reported, attributable to PAVmed Inc.
$ ( 0.29 )
$ ( 0.15 )
$ ( 0.78 )
$ ( 0.41 )
Net loss attributable to PAVmed Inc. common stockholders
$ ( 0.29 )
$ ( 0.15 )
$ ( 0.78 )
$ ( 0.42 )
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 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 September 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
September 30,
2022
2021
Stock options and restricted stock awards
12,586,571
10,214,448
Series Z Warrants
11,937,450
13,887,814
Series W Warrants
—
377,873
Series B Convertible Preferred Stock
1,182,101
1,091,448
Total
25,706,122
25,571,583
The
total stock options and restricted stock awards are inclusive of 500,854 stock options as of September 30, 2022 and 2021; and 100,000
restricted stock awards as of September 30, 2022, granted outside the PAVmed Inc. 2014 Equity Plan.
28
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 its majority-owned subsidiaries, including Lucid Diagnostics Inc. (“Lucid Diagnostics” or “LUCID”)
and Veris Health Inc. (“Veris Health” or “VERIS”).
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 the COVID-19 pandemic; 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.
29
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 and services in each line of business, as discussed below
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 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 lines of business, which
have either been developed internally or have been presented to us by clinician innovators and academic medical institutions for consideration.
Our
products and services are in various phases of development, regulatory approval and commercialization, as follows:
EsoGuard
and EsoCheck
● 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,”
also commonly known as chronic heartburn, acid reflux or simply reflux) 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 the establishment of “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 Clinical Laboratory Improvement Amendments (“CLIA”) certified commercial laboratory service provider,
for the performance of EsoGuard. 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 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 has joint oversight of payer claims, appeals processes, patient billing, online payment collection, and claims tracking. At
the point when submission by the RCM began in August 2022, more than 2,000 claims had accumulated since the commencement of our CLIA
laboratory operations (LucidDX Labs, on February 25, 2022). These claims and other claims that were subsequently generated are now being
processed, including 1,088 tests in the three months ended September 30, 2022. Refer to Note 3 of our Condensed Consolidated Financial
Statements for more information on Revenue from Contracts with Customers.
● 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 Esophageal DNA Test on samples collected with our EsoCheck Cell
Collection Device. The clinical guideline reiterates the ACG’s long-standing recommendation for esophageal precancer screening
in at-risk patients with GERD. In its Recommendation 5, the ACG suggests a single screening endoscopy in patients with chronic GERD
symptoms and 3 or more additional risk factors for BE, including male sex, age greater than 50 years, White race, tobacco smoking,
obesity, and family history of BE or EAC in a first-degree relative. Furthermore, and importantly for the first time, the clinical
guideline also endorses nonendoscopic biomarker screening as an acceptable alternative to costly and invasive endoscopy by stating
in its Recommendation 6 that the ACG suggests that a swallowable, nonendoscopic capsule device combined with a biomarker is an
acceptable alternative to endoscopy for screening for BE. The clinical guideline specifically mentions EsoCheck, along with our
EsophaCap device, as such swallowable, nonendoscopic esophageal cell collection devices. The clinical guideline also mentions
methylated DNA markers (like those detected by the EsoGuard test) as such a biomarker .
The summary of evidence for this recommendation includes a reference to 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.
30
Overview
- continued
● In
July 2022, the American Gastroenterology Association (“AGA”) published updated clinical guidance that mirrors the same
furnished by the ACG as described above , endorsing the use of non-invasive screening
tools like our EsoCheck Cell Collection Device, which is cited in its guideline, as an acceptable alternative to endoscopy to
directly address the need for noninvasive screening tools that are easy to administer, patient friendly, and cost-effective for the
detection of BE. The clinical practice update by the AGA also significantly expands the target population for esophageal precancer
screening, including for EsoGuard and EsoCheck, by recommending, for the first time, screening in at-risk patients without symptoms
of reflux. The AGA does so by adding a history of chronic GERD as merely an additional, seventh, risk factor to the six risk factors
for BE and EAC that have traditionally identified at-risk symptomatic patients recommended for screening. As a result, chronic
symptomatic GERD is no longer a mandatory prerequisite and asymptomatic patients with three of the other six risk factors (e.g.,
male sex, age greater than 50 years, White race, tobacco smoking, obesity, and family history of BE) are now considered at-risk
patients recommended for screening.
● In
2021 the Lucid Diagnostics Inc. began conducting two concurrent clinical trials, 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”) application 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 a biomarker test like EsoGuard on samples collected
with a swallowable, nonendoscopic capsule device like EsoCheck, the Company has determined to prioritize its
clinical trial efforts and resources towards supporting studies that will help secure insurance
reimbursement adoption for EsoGuard and EsoCheck 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.
CarpX
● 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. 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. As a result of this clinical input, we have initiated a product development
project to incorporate intraluminal ultrasound into the device to include real time imaging
of the ligament to be cut together with critical anatomic structures. The design and development
work, including cadaver testing is expected to culminate in a FDA submission and clearance
in 2023.
Veris
Health
● 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. The core technologies incorporated in the Veris Cancer Care Platform 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
will deliver 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 of the implantable device through a FDA 510(k)
process, and, as such, we will begin to commercialize the digital health offering in three phases which include software, device,
and data. The initial launch will be in conjunction with a package we are calling Veris Solar, with Veris branded OEM Bluetooth
enabled connected health care devices. The next product, which we call Veris Mercury, is an implantable physiologic monitor designed
to be implanted in conjunction with a traditional vascular access port for chemotherapy or other treatments. We have recently
completed a successful pre-submission meeting with the FDA, which provided us with an outline for a clear path to 510(k) clearance of Veris Mercury with a submission in 2023 (although there can be no assurance as to product clearance). Veris Venus
will be the third product in the development process which will include full integration of the implantable monitor with the
vascular access port. We are working with the FDA to finalize the regulatory path for Veris Venus to determine if it
will be a 510(k) submission or a de novo pathway.
31
Overview - continued
EsoCure
● In
connection with our efforts to expand our presence in the EAC diagnostic market, we are also
developing the EsoCure Esophageal Ablation Device, with the intent to allow a clinician
to treat dysplastic BE before it can progress to EAC, a highly lethal esophageal cancer,
and to do so without the need for complex and expensive capital equipment. We have successfully
completed a pre-clinical feasibility animal study of EsoCure demonstrating excellent, controlled
circumferential ablation of the esophageal mucosal lining. An acute and survival animal study
of EsoCure Esophageal Ablation Device has also been completed, demonstrating successful
direct thermal balloon catheter ablation of esophageal lining through the working channel
of a standard endoscope. We plan to conduct additional development work and animal testing
of EsoCure to support a future FDA 510(k) submission.
PortIO
● 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 earlier this year successfully
implanted seven additional patients for a series of infusions over seven days and a successful
explant of the device. The next set of patients will have device implanted for 60 days which
will influence the regulatory path of pursuing a CE Mark in Europe or to proceed with a US
IDE trial. Recruitment of these patients is underway.
Recent
Developments
Business
EsoCheck
Manufacturing Update
On
October 4, 2022, Lucid completed its first full day of manufacturing of EsoCheck at Coastline International, a high-volume
manufacturing company. Through mid-2023, we expect to transition from our current manufacturer, Sage Product Development, to
Coastline International as the manufacturing process is further optimized.
EsoCheck
Cell Collection Device Update
In
October 2022, the FDA announced they completed their review of the EsoCheck 510(k) (#K222366) premarket notification of intent to market
the device and granted the use of the EsoCheck Cell Collection Device for the collection and retrieval of surface cells of the esophagus
in the general population of adults and adolescents, 12 years of age and older. This action by the FDA now expands the targeted US patient
population to include adolescents not previously covered by the Company’s initial EsoCheck 510(k) clearance.
Veris
Health Update
At
the end of August, we moved our software platform from a development environment to a production environment. At the same time, we initiated
our HIPAA and SOC2 audits which were completed in October. During the quarter we completed a presubmission meeting with the FDA, outlining
a clear regulatory pathway for our first intelligent implantable device.
New
Opportunities - Novosound Agreement
In
October 2022, PAVmed entered into an option agreement with Novosound Ltd, a Scottish company specializing in the design and manufacturing
of ultrasound sensors using a proprietary thin-film technique. Pursuant to the terms of the agreement, PAVmed and Novosound will collaborate
on an research and development project leveraging Novosound’s ultrasound platform technology for development of novel intravascular
ultrasound (“IVUS”) imaging devices, with PAVmed having the option to license the technology on an exclusive basis for use
in intravascular imaging.
32
Recent
Developments
- continued
Financing
Securities
Purchase Agreement - March 31, 2022 - Senior Secured Convertible Note - April 4, 2022 and Senior Secured Convertible Note - September
8, 2022
Effective as of March 31, 2022, we
entered into a Securities Purchase Agreement (“SPA”) 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 Senior Secured Convertible Notes. The SPA provided for the sale to the Investor
of an initial Senior Secured Convertible Note with a face value principal of $27.5 million, which closed on April 4, 2022 (the
“April 2022 Senior Convertible Note”). The SPA also provided for sales of additional Senior Secured Convertible Notes in
one or more additional closings (upon the satisfaction of certain conditions), with an aggregate face value principal of up to an
additional $22.5 million. The April 2022 Senior Convertible Note proceeds were $24.4 million after deducting a $2.5 million lender
fee and the Company’s offering costs of approximately $0.6 million, inclusive primarily of $0.5 million placement agent
fees.
On September 8, 2022, we completed an additional closing under the SPA, in which we sold to the Investor an additional Senior
Secured Convertible Note with a face value principal of $11.25 million (the “September 2022 Senior Convertible Note”).
The September 2022 Senior Convertible Note proceeds were $10.0 million after deducting a $1.0 million lender fee and the
Company’s offering costs of approximately $0.2 million, inclusive primarily of placement agent
fees.
See
our accompanying unaudited condensed consolidated financial statements Note 11, Debt , for further discussion of the SPA dated
March 31, 2022 and the senior convertible notes.
Lucid
Diagnostics Inc. - Committed Equity Facility
In
March 2022, our majority-owned subsidiary, Lucid Diagnostics, entered into a committed equity facility with an affiliate of Cantor
Fitzgerald (“Cantor”). Under the terms of the facility, Cantor committed to purchase up to $50 million of Lucid Diagnostics common stock from time to time upon the request of Lucid Diagnostics. While there are distinct differences, the facility is
structured similarly to a traditional at-the-market equity facility, insofar as it allows Lucid Diagnostics to raise primary capital
on a periodic basis at prices based on the existing market price. Through September 30, 2022, 680,263 shares of common stock of Lucid
Diagnostics were issued under this facility for total proceeds of approximately $1.8 million.
33
Results
of Operations
Overview
Revenue
The
Company recognized revenue resulting from the delivery of patient EsoGuard test results for which cash collections have occurred or payment
was reasonably assured. Additionally, revenue was recognized with respect to the EsoGuard Commercialization Agreement, dated August 1,
2021, between the 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
the Company’s wholly-owned subsidiary of LucidDx Labs Inc. and RDx.
Cost
of revenue
Cost
of revenues recognized from the delivery of patient EsoGuard test results includes costs related to EsoCheck device usage, shipment
of test collection kits, royalties and the cost of services to process tests and provide results to physicians. We incur expenses
for tests in the period in which the activities occur, therefore, gross margin as a percentage of revenue may vary from quarter to
quarter due to costs being incurred in one period that relate to revenues recognized in a later period.
We
expect that gross margin for our services will continue to fluctuate and be affected by EsoGuard test volume, our operating efficiencies,
patient compliance rates, payer mix, the levels of reimbursement, and payment patterns of payers and patients.
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 clinical and preclinical studies and engineering design and development;
● 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, including our clinical trials, are focused principally on obtaining FDA approvals, facilitating insurer reimbursement, encouraging physician adoption 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.
Other
Income and Expense, net
Other
income and expense, net, consists principally of changes in fair value of our convertible notes and losses on extinguishment of debt
upon repayment of such convertible notes.
34
Results
of Operations - continued
Presentation
of Dollar Amounts
All
dollar amounts in this Management’s Discussion and Analysis of Financial Condition and Results of Operations are presented as dollars in millions, except for per share amounts.
Three
months ended September 30, 2022 as compared to three months ended September 30, 2021
Revenue
In
the three months ended September 30, 2022, revenue was $0.1 million as compared to $0.2 million in the corresponding period in the prior
year. The $0.1 million decrease principally relates to the termination of the EsoGuard Commercialization Agreement with RDx, as the Company
transitioned to its own laboratory operations effective February 25, 2022. The decrease was offset by revenue for our EsoGuard Esophageal
DNA Test performed in our own CLIA laboratory for the three months ended September 30, 2022.
Cost
of revenue
In
the three months ended September 30, 2022, cost of revenue was approximately $1.6 million as compared to $0.1 million for the corresponding
period in the prior year. The $1.5 million increase principally related to:
● approximately
$0.2 million increase in compensation related costs as a result of an increase in headcount;
● approximately
$0.4 million increase in EsoCheck and EsoGuard supplies usage costs; and
● approximately
$0.9 million increase in laboratory operations costs.
Sales
and marketing expenses
In
the three months ended September 30, 2022, sales and marketing costs were approximately $4.7 million, compared to $2.3 million for the
corresponding period in the prior year. The net increase of $2.4 million was principally related to:
● approximately
$2.1 million increase in compensation related costs, including stock based compensation of approximately $0.3 million with respect to restricted
stock awards to Lucid Diagnostics and PAVmed employees and non-employees, and an increase in stock options granted
corresponding with the increase in headcount; and
● approximately
$0.3 million increase in consulting and outside professional services.
General
and administrative expenses
In
the three months ended September 30, 2022, general and administrative costs were approximately $10.3 million, compared to $6.1 million
for the corresponding period in the prior year. The net increase of $4.2 million was principally related to:
● approximately
$1.8 million increase in compensation related costs principally as a result of an increase
in headcount;
● approximately
$0.4 million increase in stock based compensation primarily due to the absence in the current
year of stock based compensation expense incurred in the prior year resulting from the
acceleration of vesting of stock options granted to former members of the Company’s
board of directors, partially offset by an increase in stock options granted
corresponding with the increase in the number of employees;
● approximately
$1.5 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
$0.5 million increase in general business expenses.
Research
and development expenses
In
the three months ended September 30, 2022, research and development costs were approximately $6.2 million as compared to $5.3 million
for the corresponding period in the prior year. The net increase $0.9 million was principally related to:
● approximately
$0.2 million increase in development costs, particularly in clinical trial activities and
outside professional and consulting fees with respect to EsoCheck, CarpX, Veris Cancer
Care Platform, EsoCure and PortIO; and
● approximately
$0.7 million increase in compensation related costs and related to expanded clinical and
engineering staff.
Change
in fair value of convertible debt
In
the three months ended September 30, 2022, the non-cash expense recognized for the change in the fair value of our convertible notes
was approximately $0.3 million of income, related to both the April 2022 and September 2022 Senior Convertible Notes. The April 2022
and September 2022 Senior Convertible Notes were initially measured at their issue-date estimated fair value and subsequently remeasured
at estimated fair value as of the reporting period date. The Company initially recognized a $0.9 million fair value non-cash expense on the September 2022 Senior Convertible
Note issue-date. This initial recognition was more than offset by $1.2 million of decreases in fair value upon remeasurements through
September 30, 2022.
35
Results
of Operations - continued
Three months ended September 30, 2022 as
compared to three months ended September 30, 2021 - continued
Loss
on Issue and Offering Costs - Senior Secured Convertible Note
In
the three months ended September 30, 2022, in connection with the issue of the September 2022 Senior Convertible Note, we recognized
a total of approximately $1.2 million of other expense, inclusive of approximately $1.0 million of lender fee non-cash expense, and approximately
$0.2 million of offering costs paid by us.
See
our unaudited condensed consolidated financial statements Note 11 , Debt , for additional information with respect to the September
2022 Senior Convertible Note.
Loss
on Debt Extinguishment
In
the three months ended September 30, 2022, a debt extinguishment loss in the aggregate of approximately $5.1 million was recognized in
connection with our April 2022 Senior Convertible Note as discussed below.
● In
August 2022, approximately $5.0 million of principal repayments along with less than $0.1 million of
interest expense thereon, were settled through the issuance of 5,013,908 shares of common
stock of the Company, with such shares having a fair value of approximately $10.1 million (with
such fair value measured as the respective conversion date quoted closing price of the common
stock of the Company). The conversions resulted in a debt extinguishment loss of $5.1 million
in the three months ended September 30, 2022.
Nine
months ended September 30, 2022 as compared to nine months ended September 30, 2021
Revenue
In
the nine months ended September 30, 2022, revenue was $0.3 million as compared to $0.2 million in the corresponding period in the prior
year. The $0.1 million increase principally relates to revenue for laboratory services rendered for our EsoGuard Esophageal DNA Test
performed in our own CLIA laboratory. The increase was partially offset by the termination of the EsoGuard Commercialization Agreement,
with RDx as the Company transitioned to its own laboratory operations effective February 25, 2022.
Cost
of revenue
In
the nine months ended September 30, 2022, cost of revenue was approximately $2.0 million as compared to $0.1 million for the corresponding
period in the prior year. The $1.9 million increase principally related to:
● approximately
$0.4 million increase in compensation related costs as a result of an increase in headcount;
● approximately
$0.6 million increase in EsoCheck and EsoGuard supplies usage costs; and
● approximately
$0.9 million increase in laboratory operations costs.
Sales
and marketing expenses
In
the nine months ended September 30, 2022, sales and marketing costs were approximately $13.6 million, compared to $5.6 million for the
corresponding period in the prior year. The net increase of $8.0 million was principally related to:
● approximately
$5.5 million increase in compensation related costs principally as a result of an increase
in headcount;
● approximately
$1.0 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
$1.5 million increase in consulting and outside professional services, and for EsoCheck and EsoGuard marketing supplies.
General
and administrative expenses
In
the nine months ended September 30, 2022, general and administrative costs were approximately $31.0 million, compared to $16.3 million
for the corresponding period in the prior year. The net increase of $14.7 million was principally related to:
● approximately
$4.3 million increase in compensation related costs principally as a result of an increase
in headcount;
● approximately
$1.0 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
$7.7 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
$1.7 million increase in general business expenses.
36
Results of Operations - continued
Nine months ended September 30, 2022 as
compared to nine months ended September 30, 2021 - continued
Research
and development expenses
In
the nine months ended September 30, 2022, research and development costs were approximately $18.9 million as compared to $12.9 million
for the corresponding period in the prior year. The net increase $6.0 million was principally related to:
● approximately
$4.3 million increase in development costs, particularly in clinical trial activities and
outside professional and consulting fees with respect to EsoCheck, CarpX, Veris Cancer
Care Platform, EsoCure and PortIO; and
● approximately
$1.7 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 nine months ended September 30, 2022, the non-cash expense recognized for the change in the fair value of our convertible notes was
approximately $1.7 million, related to both the April 2022 and September 2022 Senior Convertible Notes. The April 2022 and September 2022
Senior Convertible Notes were 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 $3.5 million fair value non-cash expense on the issue-dates.
This initial recognition was partially offset by $1.8 million of decreases in fair value upon remeasurements through September 30, 2022.
In
the nine months ended September 30, 2021, the non-cash income (expense) recognized for the change in the fair value of our convertible
notes was approximately $1.7 million of other income. The change in the fair value adjustment of the convertible notes is principally
related to each of the convertible notes being repaid-in-full during the nine months ended September 30, 2021, as discussed herein below
under “Loss from Extinguishment of Debt.”
Loss
on Issue and Offering Costs - Senior Secured Convertible Note
In
the nine months ended September 30, 2022, in connection with the issue of both the April 2022 and September 2022 Senior Convertible
Notes, we recognized a total of approximately $4.3 million of other expense, inclusive of approximately $3.5 million of lender fee
non-cash expense, and approximately $0.8 million of offering costs paid by us.
Loss
from Extinguishment of Debt
In
the nine months ended September 30, 2022, a debt extinguishment loss in the aggregate of approximately $5.1 million was recognized in
connection with our April 2022 Senior Convertible Note as discussed below.
● In
August 2022, approximately $5.0 million of principal repayments along with less than $0.1 million of
interest expense thereon, were settled through the issuance of 5,013,908 shares of common
stock of the Company, with such shares having a fair value of approximately $10.1 million (with
such fair value measured as the respective conversion date quoted closing price of the common
stock of the Company). The conversions resulted in a debt extinguishment loss of $5.1 million
in the nine months ended September 30, 2022.
In
the prior year nine months ended September 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 nine months ended September 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 $14.5 million, 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 $3.0 million in the nine months ended September 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, we 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 Form 10-Q.
Issue
of Shares of Our Common Stock
During
the nine months ended September 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 2014 Equity Plan, as such equity
plan is discussed in Note 12, Stock-Based Compensation , of our unaudited condensed
consolidated financial statements.
● We
issued 385,938 shares of our common stock for proceeds of approximately $0.4 million under
the PAVmed 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 Notes - April 4, 2022 and September 8, 2022
Effective as of March 31, 2022,
we entered into the SPA with the Investor, pursuant to which we agreed to sell, and the Investor agreed to purchase an aggregate of $50.0
million face value principal of Senior Secured Convertible Notes. The SPA provided for the sale of the initial Senior Secured Convertible Note with a face value principal of $27.5 million, which closed on April 4, 2022 (referred
to as the “April 2022 Senior Convertible Note”). The SPA also provided for sales of additional Senior Secured Convertible
Notes in one or more additional closings (upon the satisfaction of certain conditions), with an aggregate face value principal of up
to an additional $22.5 million.
The April 2022 Senior Secured
Convertible Note has 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 or otherwise
paid in shares of our common stock as described in Note 11, Debt .
On September 8, 2022, we completed
an additional closing under the SPA, in which we sold to the Investor an additional Senior Secured Convertible Note with a face value
principal of $11.25 million (referred to as the “September 2022 Senior Convertible Note”). The September 2022 Senior Secured
Convertible Note has 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 September 6, 2024. The September 2022 Senior Convertible Note may be converted
into or otherwise paid in shares of our common stock as described in Note 11, Debt .
The April 2022 Senior Convertible
Note proceeds were $24.4 million after deducting a $2.5 million lender fee and the Company’s offering costs of approximately $0.6
million, inclusive primarily of $0.5 million placement agent fees.
The September 2022 Senior Convertible Note proceeds were $10.0 million
after deducting a $1.0 million lender fee and the Company’s total offering costs of approximately $0.2 million, inclusive primarily
of placement agent fees.
38
Liquidity
and Capital Resources - continued
Under
the Senior Convertible Notes 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 $8.0 million 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% (except that such maximum percentage is 50% for the period from September 8, 2022 through
March 5, 2023) (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”). As of September 30, 2022, the Company was in compliance with the Financial Tests. In addition, the Company presently
is in compliance with the Financial Tests.
On
August 9, 2022, the Company and the Investor also agreed, in connection with the waiver described in Note 11 above, that the Investor
may convert up to $5.0 million 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, in August 2022, approximately $5.0 million of principal repayments along with less than $0.1 million of interest expense
thereon, were settled through the issuance of 5,103,908 shares of our common stock.
See Note 11 , Debt ,
for additional information about the SPA and the Senior Secured Convertible Notes.
Lucid
Diagnostics Inc. - Committed Equity Facility
In
March 2022, our majority-owned subsidiary, Lucid Diagnostics, 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 common stock from time
to time at the request of Lucid Diagnostics. While there are distinct differences, the facility is structured similarly to a traditional
at-the-market equity facility, insofar as it allows Lucid Diagnostics to raise primary equity capital on a periodic basis at prices
based on the existing market price. As of September 30, 2022, under the committed equity facility, a total of 680,263 shares of common
stock of Lucid Diagnostics were issued for proceeds of approximately $1.8 million.
39
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.
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 September 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 (i) recorded, processed, summarized and reported within
the time periods specified in the SEC’s rules and forms and (ii) 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 September 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
None.
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.
November 14, 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).
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.