Item 1. Financial Statements
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, 2021
December
31, 2020
Assets:
Current
assets:
Cash
$ 37,341
$ 17,256
Accounts
receivable
200
—
Inventory
50
—
Prepaid
expenses, deposits, and other current assets
4,141
1,685
Total
current assets
41,732
18,941
Fixed assets, net
451
82
Intangible assets, net
47
—
Other
assets
755
755
Total
assets
$ 42,985
$ 19,778
Liabilities,
Preferred Stock and Stockholders’ Deficit
Current
liabilities:
Accounts
payable
$ 6,080
$ 2,966
Accrued
expenses and other current liabilities
1,671
2,325
CARES
Act Paycheck Protection Program note payable
—
300
Senior
Secured Convertible Notes - at fair value
—
10,060
Senior
Convertible Note - at fair value
—
4,600
Total
liabilities
7,751
20,251
Commitments
and contingencies (Note 6)
—
—
Stockholders’
Equity (Deficit):
Preferred
stock, $ 0.001 par
value. Authorized, 20,000,000 shares;
Series B Convertible Preferred Stock, par value $ 0.001 ,
issued and outstanding 1,091,448
at
September 30, 2021 and 1,228,075
shares
at December 31, 2020
2,352
2,537
Common
stock, $ 0.001 par value. Authorized, 150,000,000 shares;
84,400,822 and 63,819,935 shares outstanding as of September 30, 2021
and December 31, 2020, respectively
84
64
Additional
paid-in capital
154,059
87,570
Accumulated
deficit
( 121,625 )
( 88,275 )
Total
PAVmed Inc. Stockholders’ Equity
34,870
1,896
Noncontrolling
interests
364
( 2,369 )
Total
Stockholders’ Equity (Deficit)
35,234
( 473 )
Total
Liabilities and Stockholders’ Equity
$ 42,985
$ 19,778
See
accompanying notes to the unaudited condensed consolidated financial statements.
1
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(in
thousands except number of shares and per share amounts)
(unaudited)
2021
2020
2021
2020
Three
Months Ended
September 30,
Nine
Months Ended
September 30,
2021
2020
2021
2020
Revenue
$ 200
$ —
$ 200
$ —
Cost
of revenue
144
—
144
—
Gross
profit
56
—
56
—
Operating
expenses:
Commercial
operations
2,432
687
5,792
1,532
General
and administrative
5,987
2,222
16,100
6,942
Research
and development
5,305
2,619
12,878
7,321
Total
operating expenses
13,724
5,528
34,770
15,795
Loss
from operations
( 13,668 )
( 5,528 )
( 34,714 )
( 15,795 )
Other
income (expense):
Interest
expense
—
—
—
( 53 )
Change
in fair value - Senior Secured Convertible Notes and Senior Convertible Note
—
367
1,682
( 5,521 )
Offering
costs - Senior Secured Convertible Note and Senior Convertible Note
—
( 50 )
—
( 660 )
Debt
extinguishments loss - Senior Secured Convertible Notes
—
( 663 )
( 3,715 )
( 4,600 )
Debt
forgiveness
—
—
300
—
Other
income (expense), net
—
( 346 )
( 1,733 )
( 10,834 )
Loss
before provision for income tax
( 13,668 )
( 5,874 )
( 36,447 )
( 26,629 )
Provision
for income taxes
—
—
—
—
Net
loss before noncontrolling interests
( 13,668 )
( 5,874 )
( 36,447 )
( 26,629 )
Net
loss attributable to the noncontrolling interests
1,441
391
3,318
1,093
Net
loss attributable to PAVmed Inc.
( 12,227 )
( 5,483 )
( 33,129 )
( 25,536 )
Less:
Series B Convertible Preferred Stock dividends earned
( 67 )
( 74 )
( 216 )
( 215 )
Net
loss attributable to PAVmed Inc. common stockholders
$ ( 12,294 )
$ ( 5,557 )
$ ( 33,345 )
$ ( 25,751 )
Per
share information:
Net
loss per share attributable to PAVmed Inc. - basic and diluted
$ ( 0.15 )
$ ( 0.11 )
$ ( 0.41 )
$ ( 0.56 )
Net
loss per share attributable to PAVmed Inc. common stockholders – basic and diluted
$ ( 0.15 )
$ ( 0.11 )
$ ( 0.42 )
$ ( 0.57 )
Weighted
average common shares outstanding,
basic and diluted
83,307,170
48,380,677
79,873,583
45,563,961
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, 2021
(in
thousands except number of shares and per share data)
(unaudited)
PAVmed
Inc. Stockholders’ Deficit
Series
B
Convertible
Additional
Non
Preferred
Stock
Common
Stock
Paid-In
Accumulated
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
Conversions
- Senior Secured Convertible Note
Conversions
- Senior Secured Convertible Note , shares
Registered
offerings, net
Registered
offerings, net , shares
Vest
- restricted stock awards vests
Vest
- restricted stock awards vests , shares
Issue
common stock of
majority-owned subsidiary
Exercise
- Series S warrants
Exercise
- Series S warrants , shares
Exercise
- stock options - majority-owned subsidiary
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.
3
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY (DEFICIT)
for
the THREE MONTHS ENDED September 30, 2020
(in
thousands except number of shares and per share data)
(unaudited)
PAVmed
Inc. Stockholders’ Deficit
Series
B
Convertible
Additional
Non
Preferred
Stock
Common
Stock
Paid-In
Accumulated
controlling
Shares
Amount
Shares
Amount
Capital
Deficit
Interest
Total
Balance
- June 30, 2020
1,179,872
$ 2,393
47,919,386
$ 48
$ 60,147
$ ( 73,908 )
$ ( 1,485 )
$ ( 12,805 )
Dividends
declared - Series B Convertible Preferred Stock
23,616
70
—
—
—
( 70 )
—
—
Conversions
- Senior Secured Convertible Note
—
—
1,584,140
2
3,100
—
—
3,102
Exercise
- Series Z warrants
—
—
100
—
—
—
—
—
Purchase
- Employee Stock Purchase Plan
—
—
152,289
—
230
—
—
230
Stock-based
compensation - PAVmed Inc.
—
—
—
—
570
—
—
570
Stock-based
compensation – majority-owned subsidiary
—
—
—
—
3
—
13
16
Net
loss
—
—
—
—
—
( 5,483 )
( 391 )
( 5,874 )
Balance
- September 30, 2020
1,203,488
$ 2,463
49,655,915
$ 50
$ 64,050
$ ( 79,461 )
$ ( 1,863 )
$ ( 14,761 )
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 NINE MONTHS ENDED September 30, 2021
(in
thousands except number of shares and per share data)
(unaudited)
PAVmed
Inc. Stockholders’ Deficit
Series
B
Convertible
Additional
Non
Preferred
Stock
Common
Stock
Paid-In
Accumulated
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 )
Dividends
declared - Series B Convertible Preferred Stock
73,821
221
—
—
—
( 221 )
—
—
Conversions
- Series B Convertible Preferred Stock
( 210,448 )
( 406 )
210,448
—
406
—
—
—
Registered
offerings, net
—
—
15,782,609
16
53,688
—
—
53,704
Vest
- restricted stock awards vests
—
—
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
Issue
common stock of
majority-owned subsidiary
—
—
—
—
—
—
6
6
Stock-based
compensation - PAVmed Inc.
—
—
—
—
4,473
—
—
4,473
Stock-based
compensation -
majority-owned subsidiary
—
—
—
—
111
—
6,045
6,156
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
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, 2020
(in
thousands except number of shares and per share data)
(unaudited)
PAVmed
Inc. Stockholders’ Deficit
Series
B
Convertible
Additional
Non
Preferred
Stock
Common
Stock
Paid-In
Accumulated
controlling
Shares
Amount
Shares
Amount
Capital
Deficit
Interest
Total
Balance
- December 31, 2019
1,158,209
$ 2,296
40,478,861
$ 41
$ 47,554
$ ( 53,715 )
$ ( 814 )
$ ( 4,638 )
Dividends
declared - Series B Convertible Preferred Stock
70,279
210
—
—
—
( 210 )
—
—
Conversion
- Series B Convertible Preferred Stock
( 25,000 )
( 43 )
25,000
—
43
—
—
—
Conversions
- Senior Secured Convertible Note
—
—
7,412,682
8
14,667
—
—
14,675
Exercise
- Series S warrants
—
—
1,199,383
1
11
—
—
12
Exercise
- Series Z warrants
—
—
100
—
—
—
—
—
Purchase
- Employee Stock Purchase Plan
—
—
306,555
—
356
—
—
356
Vest
- restricted stock awards
—
—
233,334
—
—
—
—
—
Vest
- restricted stock awards vests
—
—
233,334
—
—
—
—
—
Exercise
- stock options - majority-owned subsidiary
—
—
—
—
—
—
5
5
Stock-based
compensation - PAVmed Inc.
—
—
—
—
1,409
—
—
1,409
Stock-based
compensation - majority-owned subsidiary
—
—
—
—
10
—
39
49
Net
loss
—
—
—
—
—
( 25,536 )
( 1,093 )
( 26,629 )
Balance
at September 30, 2020
1,203,488
$ 2,463
49,655,915
$ 50
$ 64,050
$ ( 79,461 )
$ ( 1,863 )
$ ( 14,761 )
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)
2021
2020
Nine
Months Ended September 30,
2021
2020
Cash
flows from operating activities
Net
loss - before non controlling interest (“NCI”)
$ ( 36,447 )
$ ( 26,629 )
Adjustments
to reconcile net loss - before NCI to net cash used in operating activities
Depreciation
and amortization expense
60
17
Stock-based
compensation
10,629
1,458
In-process
R&D charge
133
—
Change
in fair value - Senior Secured Convertible Notes and Senior Convertible Note
( 1,682 )
5,521
Debt
extinguishment loss - Senior Secured Convertible Notes and Senior Convertible Note
3,715
4,600
Debt
forgiveness
( 300 )
—
Changes
in operating assets and liabilities:
Accounts
receivable
( 200 )
—
Prepaid
expenses and other current assets
( 1,918 )
( 1,159 )
Accounts
payable
2,911
854
Accrued
expenses and other current liabilities
( 715 )
152
Net
cash flows used in operating activities
( 23,814 )
( 15,186 )
Cash
flows from investing activities
Purchase
of equipment
( 192 )
( 47 )
Acquisition,
net of cash acquired
( 147 )
—
Net
cash flows used in investing activities
( 339 )
( 47 )
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 Notes
—
13,300
Proceeds
– issue of Senior Convertible Note
—
3,700
Proceeds
– Cares Act Paycheck Protection Program Loan
—
300
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 )
( 366 )
Proceeds
– exercise of Series Z warrants
4,115
—
Proceeds
– exercise of Series S warrants
—
12
Proceeds
– exercise of stock options
953
—
Proceeds
– issue common stock – Employee Stock Purchase Plan
436
356
Proceeds
– exercise of stock options issued under equity incentive plan of majority owned subsidiary
—
5
Net
cash flows provided by financing activities
44,238
17,307
Net
increase (decrease) in cash
20,085
2,074
Cash,
beginning of period
17,256
6,219
Cash,
end of period
$ 37,341
$ 8,293
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
PAVmed
Inc. (“PAVmed” or the “Company”) together with its majority owned subsidiaries, Lucid Diagnostics, Inc. (“Lucid
Diagnostics” or “LUCID”), Veris Health, Inc. (“Veris Health” or “VERIS”), and Solys Diagnostics,
Inc. (“Solys Diagnostics” or “SOLYS”), were 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 operates in one segment as a medical technology
company.
The
ability of the Company to generate revenue depends upon the Company’s ability to successfully advance the commercialization of
EsoGuard and CarpX while also completing the development and the necessary regulatory approvals of its other products and services. In
this regard:
●
EsoCheck
has received 510(k) marketing clearance from the FDA as an esophageal cell collection device in June 2019;
●
EsoGuard
completed the certification required by the Clinical Laboratory Improvement Amendment (“CLIA”) and accreditation of the
College of American Pathologists (“CAP”) making it commercially available as a Laboratory Developed Test (“LDT”)
at LUCID’s contract diagnostic laboratory service provider in California in December 2019; and,
●
CarpX,
developed as a patented, single-use, disposable, minimally invasive device designed as a precision cutting tool to treat carpal tunnel
syndrome while reducing recovery times, received 510(k) marketing clearance from the FDA in April 2020 with the first commercial
procedure successfully performed in December 2020.
Although
the Company’s current operational activities are principally focused on the commercialization of EsoGuard and CarpX its development
activities are focused on pursuing FDA approval and clearance of other lead products in our product portfolio pipeline, including EsoGuard
IVD, PortIO, DisappEAR, NextFlo, EsoCure and digital health technologies acquired by the Company’s majority-owned subsidiary Veris
Health Inc.
Lucid
Diagnostics Inc. Initial Public Offering - October 14, 2021
Subsequent
to September 30, 2021, on October 14, 2021, Lucid Diagnostics Inc. completed an initial public offering (“IPO”) of its common
stock under an effective registration statement on Form S-1 (SEC File No. 333-259721), wherein a total of 5.0
million IPO shares of common stock of Lucid Diagnostics
Inc. were issued, with such total IPO shares inclusive of 571,428
shares issued to PAVmed Inc., at an IPO offering
price of $ 14.00
per share, resulting gross proceeds of $70.0
million, before underwriting fees of $ 4.9
million, and approximately $ 0.7
million of offering costs incurred by Lucid Diagnostics
Inc. See Note 12, Noncontrolling Interest, with respect to Lucid Diagnostics Inc.
8
Note
2 — Summary of Significant Accounting Policies and Recent Accounting Standards Updates
Significant
Accounting Policies
The
Company’s significant accounting policies are as disclosed in the Company’s annual report on Form 10-K for the year ended
December 31, 2020 as filed with the SEC on March 15, 2021, except as otherwise noted herein below.
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements 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 the net loss attributable to the noncontrolling interest based on
the respective minority interest equity ownership of each majority-owned subsidiary. See Note 12, Noncontrolling Interest ,
for a discussion of each of the majority-owned subsidiaries noted above.
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally
accepted in the United States of America (“U.S. GAAP”), and applicable rules and regulations of the United States Securities
and Exchange Commission (“SEC”) regarding interim financial reporting. 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, 2020
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.
The
consolidated results of operations for the three and nine months ended September 30, 2021 are not necessarily indicative of the consolidated
results to be expected for the year ending December 31, 2021 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, 2020 included in the Company’s Annual Report on Form 10-K as filed with the SEC on March 15, 2021.
Subsequent
to September 30, 2021, effective October 6, 2021, the Lucid Diagnostics Inc. board of directors: increased the authorized shares of common
stock of Lucid Diagnostics Inc. to 100.0
million shares; and declared a 1.411-to-1.0 common stock-split
with respect to Lucid Diagnostics Inc. common stock (with no adjustment to the par value per share). All shares of Lucid
Diagnostics Inc. common stock, stock options, and restricted stock awards, and per share amounts, have been adjusted for the
common stock-split and are presented for all periods on a retrospective basis.
All
amounts in the accompanying unaudited notes to the unaudited condensed consolidated financial statements are presented in thousands,
if not otherwise noted as being presented in millions, except for the number of shares and per share amounts.
9
Note
2 — Summary of Significant Accounting Policies and Recent Accounting Standards Updates - continued
Significant
Accounting Policies - continued
Use
of Estimates
In
preparing unaudited condensed consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates
and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the
date of the unaudited condensed consolidated financial statements, as well as the reported amounts of expenses during the reporting period.
Due to inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these
estimates. On an ongoing basis, the Company evaluates its estimates and assumptions. These estimates and assumptions include the estimated
fair value of stock-based equity awards, and the estimated fair value of financial instruments recognized as liabilities. In addition,
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.
Revenue Recognition
The Company recognizes revenue
under the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”)
Topic 606, Revenue from Contracts with Customers , (“ASC 606”). At its inception, an arrangement is accounted for under
the provisions of ASC 606 as a contract with a customer when there is: a legally enforceable contract between the parties; the rights
of the parties are identified; the arrangement has commercial substance; and collectability of the contract consideration is deemed probable.
To determine revenue recognition for arrangements determined to be within the scope of ASC 606, the Company performs the following five
steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction
price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the
entity satisfies a performance obligation.
Statement
of Cash Flows - Supplemental Information
The
unaudited condensed consolidated statement of cash flows supplemental information as of September 30, 2021 is as follows: cash flows
used in investing activities with respect to the purchase of fixed assets of $ 192 is net of $ 153 included in accounts payable and $ 60
included in accrued expenses and other current liabilities in the accompanying unaudited condensed consolidated balance sheet as of September
30, 2021; and cash flows from financing activities with respect to proceeds from exercise of warrants of $ 4,115 is net of each of $ 568
of exercise proceeds from the exercise of 354,996 Series Z Warrants, and $ 20 from the exercise of 3,945 Series W Warrants, with such
exercise proceeds received from the Company’s transfer agent subsequent to September 30, 2021 on October 4, 2021, with such amounts
due from the transfer agent included prepaid expenses, deposits, and other current assets, in the accompanying unaudited condensed consolidated
balance sheet as of September 30, 2021.
Financial
Condition
The
Company has financed its operations principally through the 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 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. 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, the Company expects to be able to fund its future operations for one year from the date of the issue of
the Company’s unaudited condensed consolidated financial statements, as included herein in this Quarterly Report on Form 10-Q for
the period ended September 30, 2021.
10
Note
2 — Summary of Significant Accounting Policies and Recent Accounting Standards Updates - continued
Recent
Accounting Standards Updates
Accounting Standards Updates
Adopted
In
August 2020, the FASB issued ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and
Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40) , (“ASU 2020-06”). ASU 2020-06 simplifies
the accounting for certain financial instruments with characteristics of liabilities and equity, by eliminating the beneficial conversion
and cash conversion accounting models previously contained in ASC 470-20 that required separate accounting for embedded conversion features.
ASU 2020-06 also simplified the assessment of a financial instruments settlement to determine whether a contract is an entity’s
own equity qualifies for equity classification by removing certain conditions from ASC 815-4-25. The ASU 2020-06 amendments are effective
for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early
adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal
years. The Company’s adoption of the ASU 2020-06 guidance as of January 1, 2021 did not have an effect on the Company’s financial
statements.
In
December 2019, the FASB issued ASU No. 2019-12, “Income Taxes: Simplifying the Accounting for Income Taxes”, (“ASU
2019-12”). The guidance of ASU 2019-12 removes certain exceptions for recognizing deferred taxes for investments, performing intra-period
allocation, and calculating income taxes in interim periods, and adds revised guidance to reduce complexity in certain areas, including
recognizing deferred taxes for tax goodwill and allocating taxes to members of a consolidated group. Adoption of the guidance of ASU
2019-12 is required for annual and interim financial statements beginning after December 15, 2020. The Company’s adoption of the
ASU 2019-12 guidance as of January 1, 2021 did not have an effect on the Company’s financial statements.
Accounting Standards Updates
Not Yet Adopted
FASB
ASC Topic 842, Leases , (“ASC 842”) (ASU No. 2016-02, Leases , February-2016 - “ASU 2016-02” )
which established a right-of-use (“ROU”) model requiring a lessee to recognize a ROU asset and a lease liability for
all leases with terms greater-than 12 months. Leases are classified as either finance or operating, with classification affecting the
pattern of expense recognition in the income statement. The ASC 842 effective date for the Company is December 31, 2022 for its annual
financial statements, and for interim quarterly financial statements commencing March 31, 2023.
11
Note
3 — Patent License Agreement – Case Western Reserve University
Overview
The
Company, through its majority-owned subsidiary Lucid Diagnostics Inc., entered into a patent license agreement with Case Western Reserve
University (“CWRU”), captioned the Amended and Restated License Agreement and dated August 23, 2021 (“Amended CWRU
License Agreement”). The Amended CWRU License Agreement is a successor to and replaced in its entirety the previous CWRU License
Agreement, dated May 12, 2018, between Lucid Diagnostics Inc. and CWRU. The Amended CWRU License Agreement terminates upon the expiration
of certain related patents, or on May 12, 2038 in countries where no such patents exist, or upon expiration of any exclusive marketing
rights granted by the FDA or other U.S. government agency, whichever comes later.
The
Amended CWRU License Agreement (as did the predecessor CWRU License Agreement) provides for the exclusive worldwide license of the intellectual
property rights for the proprietary technologies of two distinct technology components - the “EsoCheck Cell Collection Device”
referred to as “EsoCheck®”; and a panel of proprietary methylated DNA biomarkers, a laboratory developed test (“LDT”),
referred to as “EsoGuard®”; and together are collectively referred to as the “EsoGuard Technology”.
The
CWRU License Agreement Fee was $ 273 ,
of which $ 50
was previously paid in 2018. On the August
23, 2021 effective date of the Amended CWRU License Agreement, the remaining balance of $ 223
became payable, and such amount was paid
in September 2021. Additionally, also in September 2021, the Company paid a $ 10
amendment fee in connection with the Amended
CWRU License Agreement. Additionally, the Amended CWRU License Agreement provides for each of patent fees reimbursement payments; milestone
payments; and royalty payments - each as discussed below.
Patent
Fees Reimbursement
Lucid
Diagnostics Inc. is responsible for reimbursement of certain CWRU billed patent fees. See Note 4, Related Party Transactions ,
for patent fee reimbursement payments paid to CWRU in the three and nine months ended September 30, 2021 and 2020.
Milestones
The (predecessor) CWRU License
Agreement contained milestones, including regulatory milestones with respect to the FDA 501(k) submission of EsoCheck and the FDA clearance
of EsoCheck, respectively regulatory submissions and clearances; which were achieved in accordance with the requisite contractual due
dates, for which a $ 75 research and development expense was recognized and paid with respect to the achievement of the regulatory milestone
related to FDA clearance of EsoCheck. The CWRU License Agreement was amended effective February 12, 2021, to: change the achievement
date of commercialization milestone from November 2020 to August 2021; to eliminate the payment with respect to the commercialization
milestone; and to add a non-refundable $ 100 payment to CWRU in consideration for such changes to the commercialization milestone (“CWRU
License Agreement Amendment Fee”), with such fee recognized as general and administrative expense as of December 31, 2020 and paid
in February 2021. The regulatory milestone related to FDA PMA submission of a licensed product (“PMA Milestone”) is included
in the Amended CWRU License Agreement, and is the sole remaining unachieved milestone, for which a $ 200 milestone payment would be payable
to CWRU upon its achievement.
12
Note
3 — Patent License Agreement – Case Western Reserve University - continued
Royalty
Fee
Under
the Amended CWRU License Agreement. the Company is required to pay a royalty fee to CWRU with respect to the “Licensed Products”
(as defined in the CWRU License Agreement) of a percentage of “Net Sales”, as defined in the Amended CWRU License Agreement,
as follows: 5.0 % of Net Sales up to $ 100.0 million per year; and 8.0 % of Net Sales of $ 100.0 million or greater per year, with such amounts
subject-to a minimum annual royalty fee.
The
base minimum annual royalty fee is $ 50
commencing January 1 following the first anniversary of the
“First Commercial Sale” of a “Licensed Product” (as such terms are defined in the Amended CWRU License Agreement).
The minimum annual royalty fee increases to each of: $ 150
if the annual “Net Sales” (as
defined in the Amended CWRU License Agreement) exceed $ 25.0
million up to $ 50.0
million; $ 300
if annual Net Sales exceed $ 50.0
million up to $ 100.0
million; and $ 600
if annual Net Sales exceed $ 100.0
million. The Company recognized a 5.0 %
royalty fee payment liability as of September 30, 2021 with respect to the revenue recognized under the EsoGuard Commercialization Agreement,
dated August 1, 2021, between Lucid Diagnostics Inc. and Research Dx Inc. Prior to September 30, 2021, no royalty fee has been incurred
under the CWRU license agreements.
Additionally,
the Company is required to pay a royalty fee on (sub-license) “Other Proceeds” (as defined in the Amended CWRU License Agreement)
of: 30 % of sub-license proceeds to extent the sub-license proceeds are realized prior to the first commercial Sale of a Licensed Product;
or 15 % of sub-license proceeds to extent the sub-license proceeds are realized after the first commercial Sale of a Licensed Product.
Consulting
Agreements with Physician Inventors - Intellectual Property - CWRU License Agreement
Lucid
Diagnostics Inc. entered into consulting agreements with each of the three physician inventors of the intellectual property licensed
under the Amended CWRU License Agreement (“Physician Inventors”), with each such consulting agreement providing for compensation
on a contractual rate per hour for consulting services provided, and an expiration date of May 12, 2024, upon each of the respective
the agreements’ renewal effective May 12, 2021. Additionally, each of the Physician Inventors have been granted stock options and
restricted stock awards under the Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan; and stock options under the PAVmed Inc.
2014 Long-Term Incentive Equity Plan. See Note 4, Related Party Transactions , with respect to the consulting fee expense
and stock based compensation expense recognized with respect to the Physician Inventors consulting agreements and stock options and restricted
awards discussed above; and Note 9, Stock-Based Compensation , for information regarding each of the “Lucid Diagnostics
Inc. 2018 Long-Term Incentive Equity Plan” and the separate “PAVmed Inc. 2014 Long-Term Incentive Equity Plan”.
13
Note
4 — Related Party Transactions
Case
Western Reserve University and Physician Inventors - CWRU License Agreement
Case
Western Reserve University (“CWRU”) and each of the three physician inventors of the intellectual property licensed under
the CWRU License Agreement (“Physician Inventors”) each hold equity ownership minority interests in Lucid Diagnostics Inc.
The expenses incurred with respect to the CWRU License Agreement and the three Physician Inventors, as classified in the accompanying
unaudited condensed consolidated statement of operations for the periods indicated are summarized as follows:
Schedule of Incurred Expenses of Minority Shareholders
2021
2020
2021
2020
For
the three months ended
September
30,
For
the nine months ended
September
30,
2021
2020
2021
2020
Cost
of Revenue
CWRU
– Royalty Fee
$ 10
$ —
$ 10
$ —
General
and Administrative Expense
CWRU
– License Agreement - Amendment Fee -
Milestone III
10
—
10
—
Stock-based
compensation expense – Physician Inventors’ restricted stock awards
273
—
637
—
Research
and Development Expense
CWRU
License Agreement - reimbursement of patent legal fees
82
80
195
138
EsoCheck
devices provided to CWRU
—
—
—
15
Fees
- Physician Inventors’ consulting agreements
8
20
22
74
Stock-based
compensation expense – Physician Inventors’ stock options
56
6
114
17
Total
Related Party Expenses
$ 439
$ 106
$ 988
$ 244
Lucid
Diagnostics Inc. entered into consulting agreements with each of the three Physician Inventors, with each such consulting agreement providing
for compensation on a contractual rate per hour for consulting services provided, and an expiration date of May 12, 2024, upon the agreements’
renewal effective May 12, 2021. Additionally, as discussed below, each of the Physician Inventors have been granted stock options under
the PAVmed Inc. 2014 Long-Term Incentive Equity Plan, and stock options and restricted stock awards under the Lucid Diagnostics Inc.
2018 Long-Term Incentive Equity Plan.
Under
each of their respective (initial) consulting agreements with Lucid Diagnostics Inc., the three Physician Inventors were each granted
25,000 stock options under the PAVmed Inc. 2014 Equity Plan, with a grant date of May 12, 2018, an exercise price of $ 1.59 per share
of common stock of PAVmed Inc., vesting ratably on a quarterly basis commencing June 30, 2018 and ending March 31, 2021, and a contractual
period of ten years from the date of grant. As of March 31, 2021, such stock options were fully vested and exercisable. Subsequent to
March 31, 2021, each of the Physician Inventors were granted 50,000 stock options under the PAVmed Inc. 2014 Equity Plan, with a grant
date of June 21, 2021, an exercise price of $ 6.41 per share of common stock of PAVmed Inc., vesting ratably on a quarterly basis commencing
June 30, 2021 and ending March 31, 2024, and a contractual period of ten years from the date of grant.
On
March 1, 2021, restricted stock awards were granted under the Lucid Diagnostics Inc. 2018 Equity Plan to each of the three Physician
Inventors, with such restricted stock awards having a single vesting date of March 1, 2023, with the fair value of such restricted stock
awards recognized as stock-based compensation expense ratably on a straight-line basis over the vesting period, which is commensurate
with the service period. The restricted stock awards are subject to forfeiture if the requisite service period is not completed.
See
Note 9, 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 12, Noncontrolling
Interest , for a discussion of Lucid Diagnostics Inc. and the corresponding noncontrolling interests.
14
Note
4 —Related Party Transactions - continued
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 as general and administrative
expense $ 8
and $ 21
in the three and nine months ended September
30, 2021, respectively, and $ 3 and $ 4 in the three and nine months ended September 30, 2020, respectively, in connection with
the consulting agreement.
Note
5 — Acquisitions
Oncodisc
Inc.
On
May 28, 2021, Veris Health Inc., a majority-owned subsidiary of PAVmed Inc., acquired all of the outstanding common stock of Oncodisc
Inc. (“Oncodisc”) for total (gross) purchase consideration of approximately $ 261 , consisting of: the issue of 1,564,514 shares
of common stock of Veris Health Inc., with such shares having an estimated fair value of approximately $ 6 ; and cash paid of approximately
$ 255 , inclusive of approximately $ 155 paid at the time of the transaction closing and the remaining balance paid in the three months
ended September 30, 2021. Additionally, the cash acquired was approximately $ 108 and liabilities assumed were approximately $ 50 . The
acquisition of Oncodisc was accounted for by Veris Health Inc as an asset acquisition. Veris Health Inc. has allocated the preliminary
purchase price based upon the respective fair values as of the date of acquisition as follows:
Schedule of Assets Acquired and Liabilities Assumed
Cash
acquired
$ 108
Intangible
asset - in-process research and development
133
Intangible
asset - assembled workforce
70
Liabilities
assumed
( 50 )
Total
net assets acquired
$ 261
The
intangible asset recognized for the in-process research and development (“IPRD”) of $ 133
was determined to have no alternative future
use and was recognized as a current period research and development expense. The intangible asset recognized for the assembled workforce
of approximately $ 70 ,
which is included in “Other assets” on the accompanying unaudited condensed consolidated balance sheet, has an expected useful
life of one year, and is being recognized as a research and development expense on a ratable basis over such period, commencing in June
2021. See Note 12, Noncontrolling Interest , for a discussion of Veris Health Inc. and the corresponding noncontrolling
interests.
CapNostics,
LLC.
On
October 5, 2021, PAVmed Subsidiary Corporation, a majority-owned subsidiary of PAVmed Inc., acquired all of the outstanding common stock
of CapNostics, LLC (“CapNostics”) for total (gross) purchase consideration of approximately $ 2,000 of cash, paid at the closing
of the transaction.
15
Note
6 — Commitment and Contingencies
Legal
Proceedings
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 2014 Equity Plan and the ESPP). The relief sought under the complaint includes certain corrective actions
by the Company, but does not seek any specific monetary damages. The Company does not believe it is clear the prior approval of these
matters is invalid or otherwise ineffective. However, to avoid any uncertainty and the expense of further litigation, on January 5, 2021,
the Company’s Board of Directors determined it would be advisable and in the best interests of the Company and its stockholders
to re-submit these proposals to the Company’s stockholders for ratification and/or approval. In this regard, the Company held a
special meeting of stockholders on March 4, 2021, at which such matters were ratified and approved. The parties have reached agreement
on a proposed Settlement Term Sheet Agreement, dated January 28, 2021, to settle the complaint, the terms of which do not contemplate
payment of monetary damages to the putative class in the proceeding. The settlement of the complaint is pending and is subject to court
approval.
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 the plaintiff. The plaintiff is seeking monetary damages of up
to $ 1.3 million. The Company disagrees with the allegations set forth in the complaint and intends to vigorously contest the complaint.
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.
16
Note
7 — Financial Instruments Fair Value Measurements
Recurring
Fair Value Measurements
The
fair value hierarchy table for the reporting dates 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
Level-2
Level-3
Inputs
Inputs
Inputs
Total
December
31, 2020
Senior
Secured Convertible Note - November 2019
$ —
$ —
$ 1,270
$ 1,270
Senior
Convertible Note - April 2020
$ —
$ —
$ 4,600
$ 4,600
Senior
Secured Convertible Note – August 2020
$ —
$ —
$ 8,790
$ 8,790
Totals
$ —
$ —
$ 14,660
$ 14,660
(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.
The
Senior Secured Convertible Note dated August 6, 2020, the Senior Convertible Note dated April 30, 2020, the Senior Secured Convertible
Note (Series-A and Series-B), dated November 19, 2019, and the Senior Secured Convertible Note dated December 27, 2018, were each accounted
for under the fair value option (“FVO”) election, wherein, each of the convertible notes were initially measured at their
respective issue-date estimated fair value and subsequently remeasured at estimated fair value on a recurring basis at each reporting
period date, with the resulting fair value adjustment recognized as other income (expense) in the unaudited condensed consolidated statement
of operations.
There
were no fair value measurements as of September 30, 2021 as each of the convertible notes were previously repaid-in-full in the three
months ended March 31, 2021, as discussed herein below in Note 8, Debt . The estimated fair value of each of the convertible
notes as of December 31, 2020, 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, and were therefore classified within the Level 3 category, as the fair value 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 values reported utilized the Company’s common stock price along with certain Level 3 inputs, as discussed above,
in the development of Monte Carlo simulation models, discounted cash flow analyses, and /or Black-Scholes valuation models. The estimated
fair values are subjective and are affected by changes in inputs to the valuation models /analyses, including the Company’s common
stock price, the Company’s dividend yield, the risk-free rates based on U.S. Treasury security yields, and certain other Level-3
inputs including, assumptions regarding the estimated volatility in the value of the Company’s common stock price. Changes in these
assumptions can materially affect the estimated fair values.
17
Note
8 — Debt
Convertible
Notes
All
of the convertible notes, as such convertible notes are discussed below, were repaid-in-full during the three months ended March 31,
2021. The fair value and face value principal of outstanding convertible notes at December 31, 2020 were as follows:
Summary of Outstanding Debt
Contractual
Maturity Date
Stated
Interest Rate
Conversion
Price per Share
Face
Value Principal Outstanding
Fair
Value
November
2019 Senior Secured Convertible Note
September
30, 2021
7.875 %
$ 1.60
$ 956
$ 1,270
April
2020 Senior Convertible Note
April
30,
2022
7.875 %
$ 5.00
$ 4,111
$ 4,600
August
2020 Senior Secured
Convertible Note
August
6,
2022
7.875 %
$ 5.00
$ 7,750
$ 8,790
Balance
- December 31, 2020
$ 12,817
$ 14,660
Senior
Secured Convertible Note issued November 4, 2019 - Series A and Series B -
(“November
2019 Senior Convertible Notes”)
The
“November 2019 Senior Convertible Notes” remaining unpaid outstanding face value principal of approximately $ 956 as of December
31, 2020 was repaid-in-full as of January 5, 2021, with the remaining principal balance, along with the payment of interest thereon of
approximately $ 7 , settled with the issuance of 667,668 shares common stock of the Company, with a fair value of approximately $ 1,723
(with such fair value measured as the respective conversion date quoted closing price of the common stock of the Company).
Senior
Convertible Note issued April 30, 2020 - (“April 2020 Senior Convertible Note”)
The
“April 2020 Senior Convertible Note” unpaid outstanding face value principal of approximately $ 4,111 as of December 31, 2020
was repaid-in-full in March 2021, as discussed herein below. In the three months ended September 30, 2020 approximately $ 81 of non-installment
payments were paid in cash. In the nine months ended September 30, 2021 and 2020, approximately $ 52 and $ 135 , respectively, of non-installment
payments were paid in cash.
Senior
Secured Convertible Note issued August 6, 2020 - (“August 2020 Senior Convertible Note”)
The
“August Senior Convertible Note” unpaid outstanding face value principal of approximately $ 7,750 as of December 31, 2020
was repaid-in-full in March 2021, as discussed herein below. In the nine months ended September 30, 2021 and 2020, approximately $ 102
and $ 93 , respectively, of non-installment payments were paid in cash.
Principal
Repayments - April 2020 Senior Convertible Note and August 2020 Senior Convertible Note
On
January 30, 2021, the Company paid in cash a $ 350 partial principal repayment of the April 2020 Senior Convertible Note; and on March
2, 2021, the Company paid in cash a total of $ 14,466 of principal repayments, resulting in both the April 2020 Senior Convertible Note
and the August 2020 Senior Convertible Note being repaid-in-full as of such date. The Company recognized a debt extinguishment loss of
approximately $ 2,955 in the nine months ended September 30, 2021 in connection with the repayments of the April 2020 Senior Convertible
Note and the August 2020 Senior Convertible Note.
18
Note
8 — Debt - continued
Convertible
Notes - continued
A
reconciliation in the fair value of debt during the nine months ended September 30, 2021 is as follows:
Schedule of Senior Convertible Note Estimated Fair Value
November
2019 Senior Secured Convertible Notes
April
2020 Senior Convertible Note
August
2020 Senior Secured Convertible Note
Sum
of Balance Sheet Fair Value Components
Other
Income (Expense)
Fair
Value - December 31, 2020
$ 1,270
$ 4,600
$ 8,790
$ 14,660
-
Installment
repayments – common stock
( 956 )
—
—
( 956 )
-
Non-installment
payments – common stock
( 7 )
—
—
( 7 )
-
Non-installment
payments – cash
—
( 52 )
( 102 )
( 154 )
-
Change
in fair value
( 307 )
( 437 )
( 938 )
( 1,682 )
1,682
Principal
repayments – cash
—
( 4,111 )
( 7,750 )
( 11,861 )
Fair
Value at September 30, 2021 (1)
$ —
—
$ —
$ —
-
Other
Income (Expense) - Change in fair value - nine months ended September 30, 2021 (1)
$ 1,682
(1)
As
discussed above, all remaining convertible notes were previously repaid during the three months ended March 31, 2021.
19
Note
8 — Debt - continued
A
reconciliation in the fair value of debt during the three and nine months ended September 30, 2020 is as follows:
December
2018 Senior Secured Convertible Note
November
2019 Senior Secured Convertible Notes
April
2020 Senior Convertible Note
August
2020 Senior Secured Convertible Note
Sum
of Balance Sheet Fair Value Components
Other
Income (Expense)
Fair
Value - December 31, 2019
$ 1,700
$ 6,439
$ —
$ —
$ 8,139
-
Face
value principal – issue date
—
7,000
—
—
7,000
Fair
value adjustment – issue date
—
2,600
—
—
2,600
$ ( 2,600 )
Installment
repayments – common stock
( 1,642 )
—
—
—
( 1,642 )
Non-installment
payments – common stock
( 4 )
—
—
—
( 4 )
Non-installment
payments – cash
—
( 138 )
—
—
( 138 )
Change
in fair value
9
4,699
—
—
4,708
( 4,708 )
Lender
Fee - November 2019 Senior Secured Convertible Notes
—
—
—
—
—
( 700 )
Fair
Value at March 31, 2020
$ 63
$ 20,600
—
$ —
$ 20,663
-
Other
Income (Expense) - Change in fair value - three months ended March 31, 2020
$ ( 8,008 )
Face
value principal – issue date
—
—
4,111
—
4,111
Fair
value adjustment – issue date
—
—
( 411 )
—
( 411 )
411
Installment
repayments – common stock
( 50 )
( 5,695 )
—
—
( 5,745 )
Non-installment
payments – common stock
( 2 )
( 242 )
—
—
( 244 )
Non-installment
payments – cash
—
—
( 54 )
—
( 54 )
Change
in fair value
( 11 )
( 2,363 )
254
—
( 2,120 )
2,120
Lender
Fee - April 2020 Senior Convertible Note
—
—
—
—
—
( 411 )
Fair
Value at June 30, 2020
$ —
$ 12,300
3,900
$ —
$ 16,200
-
Other
Income (Expense) - Change in fair value - three months ended June 30, 2020
$ 2,120
Other
Income (Expense) - Change in fair value - six months ended June 30, 2020
$ ( 5,888 )
Face
value principal – issue date
—
—
—
7,750
7,750
Fair
value adjustment – issue date
—
—
—
( 750 )
( 750 )
750
Installment
repayments – common stock
—
( 2,298 )
—
—
( 2,298 )
Non-installment
payments – common stock
—
( 141 )
—
—
( 141 )
Non-installment
payments – cash
—
—
( 81 )
( 93 )
( 174 )
Change
in fair value
—
( 2,961 )
781
1,813
( 367 )
367
Lender
Fee - August 2020 Senior Secured Convertible Note
—
—
—
—
—
( 750 )
Fair
Value at September 30, 2020
$ —
$ 6,900
$ 4,600
$ 8,720
$ 20,220
-
Other
Income (Expense) - Change in fair value - three months ended September 30, 2020
$ 367
Other
Income (Expense) - Change in fair value - nine months ended September 30, 2020
$ ( 5,521 )
The
Senior Convertible Notes presented above were each accounted for under the ASC 825-10-15-4 fair value option (“FVO”) election,
wherein, the financial instrument is initially measured at its issue-date estimated fair value and subsequently remeasured at estimated
fair value on a recurring basis at each reporting period date, with the resulting fair value adjustment recognized as other income (expense)
in the consolidated statement of operations. In this regard, as provided for by ASC 825-10-50-30(b), the estimated fair value adjustment
is presented as a single line item within other income (expense) in the accompanying consolidated statement of operations. See Note 7,
Financial Instruments Fair Value Measurements , for a further discussion of fair value assumptions.
20
Note
8 — Debt – continued
Cares
Act Paycheck Protection Program Loan
On
April 8, 2020 the Company entered into a loan agreement with JP Morgan Chase, N.A., and received approximately $ 300 of proceeds, pursuant
to the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”) Paycheck Protection Program (“PPP”)
- the “PPP Loan”. Through the life of the PPP Loan, the Company made no principal or interest payments. The Company submitted
its PPP Loan forgiveness application on April 21, 2021 and the forgiveness application was approved on June 9, 2021. Upon PPP Loan forgiveness,
the Company recognized a gain of $ 300 in its unaudited condensed consolidated results of operations in the nine months ended September
30, 2021.
21
Note
9 — 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”), provides for the granting, subject
to approval by the compensation committee of the PAVmed Inc. board of directors, of stock options, stock appreciation rights, restricted
stock, and other stock-based awards subject to limitations under applicable law. As of September 30, 2021, the PAVmed Inc. 2014 Equity
Plan has 1,249,653 shares available-for-grant of stock-based awards, with such shares available for grant, not diminished by 500,854
PAVmed Inc. stock options previously granted outside the PAVmed Inc. 2014 Equity Plan.
PAVmed
Inc. 2014 Long-Term Incentive Equity Plan - Stock Options
Stock
options issued and outstanding under the PAVmed Inc. 2014 Equity Plan is as follows:
Schedule of Summarizes Information About Stock Options
Number
Stock Options
Weighted
Average Exercise Price
Remaining
Contractual Term (Years)
Intrinsic
Value (2)
Outstanding
stock options - December 31, 2020
6,798,529
$ 2.55
7.3
Granted (1)
2,615,000
$ 4.86
Exercised
( 604,500 )
$ 1.58
Forfeited
( 161,247 )
$ 2.73
Outstanding
stock options - September 30, 2021
8,647,782
$ 3.32
6.9
$ 45,267
Vested
and exercisable stock options - September 30, 2021
5,919,023
$ 2.84
5.7
$ 33,031
(1)
Stock
options granted under the PAVmed Inc. 2014 Equity Plan generally vest ratably over twelve quarters, with the vesting commencing with
the grant date quarter, and have a ten-year contractual term from date-of-grant.
(2)
The
intrinsic value is computed as the difference between the quoted price of the PAVmed Inc. common stock on each of September 30, 2021
and December 31, 2020 and the exercise price of the underlying PAVmed Inc. stock options, to the extent such quoted price is greater
than the exercise price.
22
Note
9 — Stock-Based Compensation - continued
PAVmed
Inc. 2014 Long-Term Incentive Equity Plan - Restricted Stock Awards
On
April 1, 2021, a total of 300,000 restricted stock awards were granted to employees under the PAVmed Inc. 2014 Equity Plan, with such
restricted stock awards having a single vesting date of April 1, 2024. The (April 1, 2021) restricted stock awards fair value of approximately
$ 1,491 , which was measured using the grant date quoted closing price per share of PAVmed Inc. common stock, is being 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.
A
total of 1,650,000 restricted stock awards were previously granted under the PAVmed Inc. 2014 Equity Plan, with such restricted stock
awards having an aggregate fair value of approximately $ 2,680 , which was measured using the respective grant date quoted closing price
per share of PAVmed Inc. common stock, with the fair value being recognized as stock-based compensation expense ratably on a straight-line
basis over the vesting period, which is commensurate with the service period. The vesting of the previously granted restricted stock
awards is as follows: 233,334 vested on March 15, 2020; 466,666 vesting on March 15, 2022; 450,000 vesting ratably on an annual basis
over a three year period with the initial annual vesting date on May 1, 2021; and 500,000 restricted stock awards having a single vesting
date of May 1, 2023. The restricted stock awards are subject to forfeiture if the requisite service period is not completed.
Lucid
Diagnostics Inc. 2018 Long-Term Incentive Equity Plan
The
Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan (the “Lucid Diagnostics Inc. 2018 Equity Plan”), provides for
the granting, subject to approval by the Lucid Diagnostics Inc. board of directors, of stock options, stock appreciation rights, restricted
stock, and other stock-based awards subject to limitations under applicable law. As of September 30, 2021, the Lucid Diagnostics Inc.
2018 Equity Plan has 2,850,220
shares of common stock of Lucid Diagnostics Inc.
available-for-grant of stock-based awards.
Lucid
Diagnostics Inc. 2018 Long-Term Incentive Equity Plan - Stock Options
Stock
options issued and outstanding under the Lucid Diagnostics Inc. 2018 Equity Plan is as follows:
Schedule of Summarizes Information About Stock Options
Number
Stock
Options
Weighted
Average
Exercise
Price
Remaining
Contractual
Term
(Years)
Outstanding
stock options at December 31, 2020
1,399,242
$ 0.61
8.0
Granted (1)
—
$ —
Exercised
—
$ —
Forfeited
—
$ —
Outstanding
stock options at September 30, 2021
1,399,242
$ 0.61
7.2
Vested
and exercisable stock options at September 30, 2021
1,286,361
$ 0.59
7.2
(1)
Stock
options granted under the Lucid Diagnostics Inc. 2018 Equity Plan generally vest ratably over twelve quarters, with the vesting commencing
with the grant date quarter, and have a ten-year contractual term from date-of-grant.
23
Note
9 — Stock-Based Compensation - continued
Lucid
Diagnostics Inc. 2018 Long-Term Incentive Equity Plan – Restricted Stock Awards
As of September 30, 2021, a total of 1,813,135
restricted stock awards were granted under the Lucid Diagnostics Inc. 2018 Equity Plan, summarized as follows:
A total of 1,467,440 restricted stock
awards were granted under the Lucid Diagnostics Inc. 2018 Equity Plan in March 2021, inclusive of grants to employees of PAVmed Inc.,
a member of the board of directors of Lucid Diagnostics Inc. (who is also a member of the board of directors of PAVmed Inc.), and to
each of the three physician inventors of the intellectual property licensed under the CWRU License Agreement (“Physician Inventors”),
with such restricted stock awards having a single vesting date of March 1, 2023 , and an aggregate grant date fair value of approximately
$ 18.9 million, measured as discussed below, 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, and classified in general and administrative
expense in the accompanying unaudited condensed statement of operations. The restricted stock awards are subject to forfeiture if the
requisite service period is not completed. See Note 4, Related Party Transactions , for a summary of the stock based compensation
expense recognized with respect to the restricted stock awards granted under the Lucid Diagnostics Inc. 2018 Equity Plan to the Physician
Inventors.
A total of 91,715 restricted stock awards
were granted under the Lucid Diagnostics Inc. 2018 Equity Plan in April 2021, inclusive of grants to an employee of PAVmed Inc. and a
member of the board of directors of Lucid Diagnostics Inc., with such restricted stock awards having a single vesting date in April 2023 ,
and an aggregate grant date fair value of approximately $ 1.2 million, measured as discussed below, 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, with approximately $ 1.1 million classified in general and administrative expense and $ 0.1 million classified
in research and development expense in the accompanying unaudited condensed statement of operations. Subsequent to September 30, 2021,
as of October 1, 2021, 7,055 restricted stock awards granted in April 2021 were forfeited upon the employee’s termination of employment.
The restricted stock awards are subject to forfeiture if the requisite service period is not completed .
A total of 253,980 restricted stock awards
were granted under the Lucid Diagnostics Inc. 2018 Equity Plan in the three months ended September 30, 2021, to members of the board
of directors of Lucid Diagnostics Inc., with 169,320 restricted stock awards having annual vesting dates on the grant date anniversary
in each of September 2022 and 2023; and 84,660 restricted stock awards having a single vesting date in July 2023. The restricted stock
awards granted in the three months ended September 30, 2021, had an aggregate grant date fair value of approximately 3.4 million, measured
as discussed below, 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, classified in general and administrative expense in the
accompanying unaudited condensed statement of operations.
Subsequent to September 30, 2021, as of
October 14, 2021, an additional 84,660 restricted stock awards were granted under the Lucid Diagnostics Inc. 2018 Equity Plan to a member
of the board of directors of Lucid Diagnostics Inc.
The
estimated fair value of the restricted stock awards granted under the Lucid Diagnostics Inc. 2018 Equity Plan, as discussed above, was
determined using a probability-weighted average expected return methodology (“PWERM”),
which involves the determination of equity value under various exit scenarios and an estimation of the return to the common stockholders
under each scenario. In this regard, the Lucid Diagnostics Inc. common stock grant-date estimated fair value was based upon an analysis
of future values, assuming various outcomes, based upon the probability-weighted present value of expected future investment returns,
considering each of the possible future outcomes available to Lucid Diagnostics Inc.
The
PWERM principally involved (i) the identification of scenarios and related probabilities; (ii) determine the equity value under each
scenario; and (iii) determine the common stock shareholders’ return in each scenario. The two scenarios identified were an initial
public offering (“IPO”) of Lucid Diagnostics Inc. common stock (“IPO scenario”); and, to continue on as a private
company (“stay private scenario”). With respect to the IPO scenario, the valuation of the Lucid Diagnostics Inc. common stock
was computed using assumptions, including dates of the IPO, to calculate an estimated pre-money valuation; and, with respect to the stay
private scenario, an income approach was used, wherein a risk-adjusted discount rate is applied to projected future cash flows. For the
awards during 2021, a relative weighting ranged from 75%-97.5% for to the IPO scenario and the relative weighting ranged from 25% - 2.5%
for the stay private scenario.
24
Note
9 — Stock-Based Compensation - continued
Consolidated
Stock-Based Compensation Expense
The
consolidated stock-based compensation expense recognized by each of PAVmed Inc. and Lucid Diagnostics Inc. for both the PAVmed Inc. 2014
Equity Plan and the Lucid Diagnostics Inc. 2018 Equity Plan, with respect to stock options and restricted stock awards as discussed above,
for the periods indicated, was as follows:
Schedule of Stock-Based Compensation Awards Granted
Three
Months Ended
September 30,
Nine
Months Ended
September 30,
2021
2020
2021
2020
Commercial
operations expenses
$ 341
$ 85
$ 840
$ 183
General
and administrative expenses
3,339
363
9,062
948
Research
and development expenses
310
138
727
327
Total
stock-based compensation expenses
$ 3,990
$ 586
$ 10,629
$ 1,458
Stock-Based
Compensation Expense Recognized by Lucid Diagnostics Inc.
As
noted, the consolidated stock-based compensation expense presented above is inclusive of stock-based compensation expense recognized
by Lucid Diagnostics Inc., inclusive of each of: stock options granted under the PAVmed Inc. 2014 Equity Plan to the three physician
inventors of the intellectual property underlying the CWRU License Agreement (“Physician Inventors”) (as discussed above
in Note 4, Related Party Transactions ); and stock options and restricted stock awards granted to employees of PAVmed Inc.
and non-employee consultants under the Lucid Diagnostics Inc. 2018 Equity Plan.
The
stock-based compensation expense recognized by Lucid Diagnostics Inc. for both the PAVmed Inc. 2014 Equity Plan and the Lucid Diagnostics
Inc. 2018 Equity Plan, with respect to stock options and restricted stock awards as discussed above, for the periods indicated, was as
follows:
Schedule of Stock-Based Compensation Expense Classified in Research and Development Expenses
Three
Months Ended
September 30,
Nine
Months Ended
September 30,
2021
2020
2021
2020
Lucid
Diagnostics Inc 2018 Equity Plan – general and administrative expense
$ 2,695
$ —
$ 5,988
$ —
Lucid
Diagnostics Inc 2018 Equity Plan – research and development expenses
21
13
57
39
PAVmed
Inc 2014 Equity Plan - research and development expenses
56
3
111
10
Total
stock-based compensation expense –
recognized by Lucid Diagnostics Inc
$ 2,772
$ 16
$ 6,156
$ 49
25
Note
9 — Stock-Based Compensation - continued
Consolidated
Stock-Based Compensation Expense - continued
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
PAVmed
Inc. 2014 Equity Plan
Stock
Options
$ 7,641
1.4
years
Restricted
Stock Awards
$ 2,368
1.4
years
Lucid
Diagnostics Inc. 2018 Equity Plan
Stock
Options
$ 15
0.3
years
Restricted
Stock Awards
$ 17,491
1.5
years
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 $ 3.47 per share and $ 1.28 per share during the nine months ended September 30,
2021 and 2020, 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,
2021
2020
Expected
term of stock options (in years)
5.6
5.8
Expected
stock price volatility
76 %
73 %
Risk
free interest rate
0.9 %
0.5 %
Expected
dividend yield
0 %
0 %
PAVmed
Inc. Employee Stock Purchase Plan (“ESPP”)
The
PAVmed Inc. Employee Stock Purchase Plan (“PAVmed Inc. ESPP”), adopted by the Company’s board of directors effective
April 1, 2019, provides eligible employees the opportunity to purchase shares of PAVmed Inc. common stock through payroll deductions
during six month periods, wherein the purchase price per share of common stock is the lower of 85% of the quoted closing price per share
of PAVmed Inc. common stock at the beginning or end of each six month share purchase period. The PAVmed Inc. ESPP share purchase dates
are March 31 and September 30. A total of 203,480 shares and 154,266 shares of common stock of the Company were purchased for proceeds
of approximately $ 304 and $ 126 , on the ESPP purchase dates of March 31, 2021 and 2020, respectively. A total of 31,112 shares and 152,289
shares of common stock of the Company were purchased for proceeds of approximately $ 131 and $ 231 , on the ESPP purchase dates of September
30, 2021 and 2020, respectively. The PAVmed Inc. ESPP has a total reservation of 1,250,000 shares of common stock of PAVmed Inc. of which
626,081 shares are available-for-issue remaining as of September 30, 2021.
26
Note
10 — Preferred Stock
The
Company is authorized to issue 20 million shares of its preferred stock, par value of $ 0.001 per share, with such designation, rights,
and preferences as may be determined by the Company’s board of directors. There were 1,091,448 and 1,228,075 shares of Series B
Convertible Preferred Stock (classified in permanent equity) issued and outstanding as of September 30, 2021 and December 31, 2020, respectively.
In
the nine months ended September 30, 2021, at each of the respective holders’ election, a total of 210,448 shares of Series B Convertible
Preferred Stock were converted into the same number of shares of common stock of PAVmed Inc.
As
of September 30, 2021, the Company’s board-of-directors declared an aggregate of approximately $ 221 of Series B Convertible Preferred
Stock dividends, inclusive of approximately $ 73 earned as of December 31, 2020, $ 75 earned as of March 31, 2021, and $ 74 earned as of
June 30, 2021 which were settled by the issue of an additional aggregate 73,821 shares of Series B Convertible Preferred Stock. In the
corresponding period of the prior year, the board of directors declared an aggregate of approximately $ 211 of Series B Convertible Preferred
Stock dividends, inclusive of approximately $ 70 earned as of December 31, 2019, $ 70 earned as of March 31, 2020, and $ 71 earned as of
June 30, 2020 which were settled by the issue of an additional aggregate 70,279 shares of Series B Convertible Preferred Stock.
Subsequent
to September 30, 2021, in 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 , which will be settled by the issue of an additional
22,471 shares of Series B Convertible Preferred Stock (with such dividend not recognized as a dividend payable as of September 30, 2021,
as the Company’s board of directors had not declared such dividends payable as of such date).
27
Note
11 — Common Stock and Common Stock Purchase Warrants
The
Company is authorized to issue up to 150 million shares of its common stock, par value of $ 0.001 per share. There were 84,400,822 and
63,819,935 shares of common stock issued and outstanding as of September 30, 2021 and December 31, 2020, respectively.
●
On
January 5, 2021, a total of 6,000,000
shares of common stock of the Company were
issued for gross proceeds of approximately $ 13,434 ,
before a placement agent fee and expenses of approximately $ 951 ,
and offering costs incurred by the Company of approximately $ 71 .
The shares of common stock were issued in a registered direct offering pursuant to a Prospectus Supplement dated January 5, 2021
with respect to the Company’s effective shelf registration statement on Form S-3 (File No. 333-248709).
●
On
February 23, 2021, a total of 9,782,609
shares of common stock of the Company were
issued for proceeds of approximately $ 41,566 ,
before offering costs incurred by the Company of approximately $ 290 .
The shares of common stock were issued in an underwritten registered offering pursuant to a final Prospectus Supplement dated February
23, 2021, with respect to the Company’s effective shelf registration statement on Form S-3 (File No. 333-248709 and File No.
333-253384).
●
In
January 2021, 667,668
shares of the Company’s common stock
were issued upon conversion, at the election of the holder, of the November 2019 Senior Convertible Note remaining face value principal
of approximately $ 956
along with approximately $ 7
of interest thereon, as discussed in Note
8, Debt .
●
During
the nine months ended September 30, 2021, 210,448
shares of common stock of the Company were
issued upon conversion of the same number of shares of Series B Convertible Preferred Stock. See Note 10, Preferred Stock ,
for a discussion of the Series B Convertible Preferred Stock.
●
During
the nine months ended September 30, 2021, an aggregate of 2,931,070 shares of common stock
of the Company were issued upon exercise of common stock purchase warrants, including 2,927,125
with respect to Series Z Warrants; and 3,945 with respect to Series W Warrants. Subsequent
to September 30, 2021, as of November 18, 2021, 1,946,259 shares of common stock of the Company
were issued upon exercise of the same number of Series Z Warrants.
●
During
the nine months ended September 30, 2021, 604,500
shares of common stock of the Company were
issued upon exercise of stock options for cash of approximately $ 953 .
Subsequent to September 30, 2021, as of November 18, 2021, 16,664 shares of common stock of the Company were issued upon exercise
of the same number of stock options for cash of approximately $ 26 .
See Note 9, Stock-Based Compensation , for a discussion of the PAVmed Inc. 2014 Equity Plan.
●
On
March 31, 2021 and September 30, 2021, the PAVmed Inc. Employee Stock Purchase Plan purchased 203,480
shares and 31,112
shares, respectively, of common stock of
the Company. See in the Note 9, Stock-Based Compensation , for a discussion of the PAVmed Inc. Employee Stock Purchase
Plan.
28
Note
11 — Common Stock and Common Stock Purchase Warrants - continued
Common
Stock Purchase Warrants
The
common stock purchase warrants (classified in permanent equity) outstanding as of the dates indicated are as follows:
Schedule of Outstanding Warrants to Purchase Common Stock
Common
Stock Purchase Warrants Issued and Outstanding at
Weighted
Weighted
September
30,
Average
Exercise
December
31,
Average
Exercise
Expiration
2021
Price
/Share
2020
Price/Share
Date
Series
Z Warrants
13,887,814
$ 1.60
16,814,939
$ 1.60
April
2024
UPO
- Series Z Warrants
—
$ —
53,000
$ 1.60
January
2021
Series
W Warrants
377,873
$ 5.00
381,818
$ 5.00
January
2022
Total
14,265,687
$ 1.68
17,249,757
$ 1.57
During
the three and nine months ended September 30, 2021, a total of 1,186,467
and 2,927,125
shares of common stock of the Company were issued,
respectively, resulting from the exercise cash of $ 1.60
per share of the same number of Series Z Warrants.
Subsequent to September 30, 2021, as of November 18, 2021, a total of 1,946,259 Series Z Warrants were exercised for cash of $ 1.60
per share, resulting in the issue of the same
number of shares of common stock of the Company.
During
the three and nine months ended September 30, 2021, a total of 3,945 shares of common stock of the Company were issued resulting from
the exercise for cash of $ 5.00 per share of the same number of Series W Warrants.
The
Unit Purchase Options (UPO) expired unexercised as of January 29, 2021.
29
Note
12 — 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
Nine
Months Ended
September 30, 2021
Year
Ended
December 31, 2020
NCI
– equity (deficit) – beginning of period
$ ( 2,369 )
$ ( 814 )
Investment
in Veris Health Inc.
6
—
Net
loss attributable to NCI – Lucid Diagnostics Inc.
( 3,044 )
( 1,503 )
Net
loss attributable to NCI – Solys Diagnostics Inc.
( 29 )
( 109 )
Net
loss attributable to NCI – Veris Health Inc.
( 245 )
—
Lucid
Diagnostics Inc. 2018 Equity Plan stock option exercise
—
5
Stock-based
compensation expense - Lucid Diagnostics Inc. 2018 Equity Plan
6,045
52
NCI
– equity (deficit) – end of period
$ 364
$ ( 2,369 )
The
consolidated NCI presented above is with respect to the Company’s consolidated majority-owned subsidiaries, inclusive of: Lucid
Diagnostics Inc. and Solys Diagnostics Inc., as a component of consolidated total stockholders’ equity as of September 30, 2021
and December 31, 2020, and the recognition of a net loss attributable to the NCI in the unaudited condensed consolidated statement of
operations for the three and nine months ended September 30, 2021 and 2020; and Veris Health Inc. as a component of consolidated total
stockholders’ equity as of September 30, 2021, and the recognition of a net loss attributable to the NCI in the unaudited condensed
consolidated statement of operations for the three months ended September 30, 2021 and for the period May 28, 2021 (inception date) to
September 30, 2021.
Lucid
Diagnostics Inc.
As
of September 30, 2021 and December 31, 2020, PAVmed Inc. holds a 81.85 % majority -interest equity ownership and has a controlling
financial interest in Lucid Diagnostics Inc., with the remaining 18.15 % minority-interest equity ownership held by Case Western Reserve
University (“CWRU”); the individual physician inventors of the intellectual property underlying the Amended CWRU License
Agreement (the “Physician Inventors”); and a consultant upon the exercise of stock options issued under the Lucid Diagnostics
Inc. 2018 Equity Plan.
Subsequent
to September 30, 2021, on October 13, 2021, Lucid Diagnostics Inc. issued 15,803,200
shares of its common stock to PAVmed Inc. upon
the election by PAVmed Inc. to convert the $ 22.4
million face value principal under the terms
of a Senior Unsecured Promissory Note, dated June 1, 2021. The Senior Unsecured Promissory Note was issued by Lucid Diagnostics Inc.
to PAVmed Inc. with a face value principal of $ 22.4 million, which replaced the aggregate outstanding and payable balance of the intercompany
Due To: PAVmed Inc. as of June 1, 2021, had an annual interest rate of 7.875 %,
a contractual maturity date of May
18, 2028 , and, at the election of PAVmed Inc., provided for the partial or full repayment of the face value principal and accrued
but unpaid interest thereon by the issue of shares of Lucid Diagnostics Inc. common stock at a conversion price of $ 1.42 per share of
Lucid Diagnostics Inc. common stock.
Subsequent
to September 30, 2021, on October 14, 2021, Lucid Diagnostics Inc. completed an initial public offering (“IPO”) of its common
stock under an effective registration statement on Form S-1 (SEC File No. 333-259721), wherein a total of 5.0
million IPO shares of common stock of
Lucid Diagnostics Inc. were issued, with such total IPO shares inclusive of 571,428
shares issued to PAVmed Inc., at an IPO
offering price of $ 14.00
per share, resulting gross proceeds of
$ 70.0
million, before underwriting fees of $ 4.9
million, and approximately $ 0.7
million of offering costs incurred by
Lucid Diagnostics Inc.
30
Note
12 — Noncontrolling Interest - continued
Veris
Health Inc.
As
of September 30, 2021, PAVmed Inc. holds an 80.44 %
majority-interest ownership and has a controlling financial interest in Veris Health Inc., with the remaining 19.56 %
minority-interest ownership held by an unrelated third-party.
Solys
Diagnostics Inc.
As
of each of September 30, 2021 and December 31, 2020, PAVmed Inc. holds a 90.3235 %
majority-interest ownership and has a controlling financial interest in Solys Diagnostics Inc., with the remaining 9.6765 %
minority-interest ownership held by unrelated third parties.
31
Note
13 — Net Loss Per Share
The
respective “Net loss per share - attributable to PAVmed Inc. - basic and diluted” and “Net loss per share - attributable
to PAVmed Inc. common stockholders - basic and diluted” - for the periods indicated - is as follows:
Schedule of Comparison of Basic and Fully Diluted Net Loss Per Share
2021
2020
2021
2020
Three
Months Ended
Nine
Months Ended
September
30,
September
30,
2021
2020
2021
2020
Numerator
Net
loss - before noncontrolling interest
$ ( 13,668 )
$ ( 5,874 )
$ ( 36,447 )
$ ( 26,629 )
Net
loss attributable to noncontrolling interest
1,441
391
3,318
1,093
Net
loss - as reported, attributable to PAVmed Inc.
$ ( 12,227 )
$ ( 5,483 )
$ ( 33,129 )
$ ( 25,536 )
Series
B Convertible Preferred Stock dividends:
$ ( 67 )
$ ( 74 )
$ ( 216 )
$ ( 215 )
Net
loss attributable to PAVmed Inc. common stockholders
$ ( 12,294 )
$ ( 5,557 )
$ ( 33,345 )
$ ( 25,751 )
Denominator
Weighted
average common shares outstanding, basic and diluted
83,307,170
48,380,677
79,873,583
45,563,961
Net
Loss per share
Basic
and diluted
Net
loss - as reported, attributable to PAVmed Inc.
$ ( 0.15 )
$ ( 0.11 )
$ ( 0.41 )
$ ( 0.56 )
Net
loss attributable to PAVmed Inc. common stockholders
$ ( 0.15 )
$ ( 0.11 )
$ ( 0.42 )
$ ( 0.57 )
The
Series B Convertible Preferred Stock dividends earned as of the each of the respective periods noted, are included in the calculation
of basic and diluted net loss attributable to PAVmed Inc. common stockholders for each respective period presented. Notwithstanding,
the Series B Convertible Preferred Stock dividends are recognized as a dividend payable only upon the dividend being declared payable
by the Company’s board of directors.
Basic
weighted-average number of shares of common stock outstanding for the three and six months ended September 30, 2021 and 2020 include
the shares of the Company issued and outstanding during such periods, each on a weighted average basis. The basic weighted average number
of shares common stock outstanding excludes common stock equivalent incremental shares, while diluted weighted average number of shares
outstanding includes such incremental shares. However, as the Company was in a loss position for all periods presented, basic and diluted
weighted average shares outstanding are the same, as the inclusion of the incremental shares would be anti-dilutive. The common stock
equivalents excluded from the computation of diluted weighted average shares outstanding are as follows:
Schedule of Antidilutive Securities Excluded from Computation of Diluted Earnings Per Share
2021
2020
September
30,
2021
2020
PAVmed
Inc. 2014 Equity Plan stock options and
unvested restricted stock awards
10,213,615
8,090,195
Unit
purchase options - as to shares of common stock
—
53,000
Unit
purchase options - as to shares underlying Series Z Warrants
—
53,000
Series
Z Warrants
13,887,814
16,814,939
Series
W Warrants
377,873
381,818
Series
B Convertible Preferred Stock
1,091,448
1,203,488
Total
25,570,750
26,596,440
Antidilutive securities excluded from computation of diluted weighted shares outstanding
25,570,750
26,596,440
32
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, 2020 (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 each of
the PAVmed Inc. and its majority-owned subsidiaries, including: Lucid Diagnostics Inc. (“Lucid Diagnostics”
or “LUCID”), Veris Health Inc. (“Veris Health” or “VERIS”), and Solys Diagnostics, Inc. (“Solys
Diagnostics” or “SOLYS”).
Forward-Looking
Statements
This
Quarterly Report on Form 10-Q (this “Form 10-Q”), including the following discussion and analysis of our (unaudited) condensed
consolidated financial condition and results of operations, contains forward-looking statements that involve substantial risks and uncertainties.
All
statements, other than statements of historical facts, contained in this Form 10-Q, including without limitation statements regarding
our future consolidated results of operations and consolidated financial position, our estimates regarding expenses, future revenue,
capital and operating expenditure requirements and needs for additional financing, our business strategy and plans and the 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 our 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 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 sustain status as a going concern;
●
our
ability to protect our intellectual property;
●
our
ability to identify and complete strategic acquisitions and integrate the acquired operations;
●
our
ability to manage growth;
●
the
liquidity and trading of our securities;
●
our
regulatory or operational risks;
●
cybersecurity
risks;
●
risks
related to the COVID-19 pandemic;
●
our
estimates regarding expenses, future revenue, capital requirements, and needs for additional financing; and
●
our
status as an “emerging growth company” under the JOBS Act.
In
addition, our forward-looking statements do not incorporate 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
rely on our forward-looking statements. You should read this Form 10-Q, together with 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.
33
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
Overview
PAVmed is a highly differentiated, multi-product, commercial-stage
technology medical device 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 inception on June 26, 2014, the Company’s activities
have focused on advancing its lead products towards regulatory approval and commercialization, protecting its intellectual property,
and building its corporate infrastructure and management team.
The
Company operates in one segment as a medical technology company, with the following lines-of-business: “GI Health”, “Minimally
Invasive Interventions”, “Infusion Therapy”, “Digital Health”, and “Emerging Innovations”.
The Company has ongoing operations conducted through PAVmed Inc. and its majority-owned subsidiaries of Lucid Diagnostics, Veris
Health, and Solys Diagnostics.
PAVmed
Inc. and /or its subsidiaries have proprietary rights to the trademarks used herein, including, among others, PAVmed™, Lucid Diagnostics™,
LUCID™, Veris Health™, VERIS™, Oncodisc™, Solys Diagnostics™, SOLYS™, Caldus™, CarpX ® ,
DisappEAR™, EsoCheck ® , EsoGuard ® , EsoCheck Cell Collection Device ® , EsoCure Esophageal
Ablation Device™, NextCath™, NextFlo™, PortIO™, and “Innovating at the Speed of Life”™. Solely
as a matter of convenience, trademarks and trade names referred to herein may or may not be accompanied with the requisite marks of “™”
or “®”. However, the absence of such marks is not intended to indicate, in any way, PAVmed Inc. or its subsidiaries will
not assert, to the fullest extent possible under applicable law, their respective rights to such trademarks and trade names.
Our
multiple products and services are in various phases of development, regulatory clearances, approvals, and commercialization.
●
The
EsoCheck device received 510(k) marketing clearance from the U.S. Food and Drug Administration (“FDA”), in June 2019
and European CE Mark Certification in May 2021 as an esophageal cell collection device; and, EsoGuard has been established as a Laboratory
Developed Test (“LDT”), completed European CE Mark Certification in June 2021, and was launched commercially in December
2019 after Clinical Laboratory Improvement Amendment (“CLIA”) and College of American Pathologists accreditation of the
test at Lucid Diagnostics commercial diagnostic laboratory partner ResearchDx Inc. (“RDx”), headquartered in Irvine,
California. In August 2021, Lucid Diagnostics launched a strategic partnership with direct-to-consumer telemedicine company UpScriptHealth
to support our commercialization efforts. Also in August 2021, we tested our first patients referred by primary care physicians (“PCPs”)
in three Lucid Test Centers opened in the Phoenix metropolitan area.
●
Our
CarpX device is a patented, single-use, disposable, minimally-invasive surgical device designed
as a precision cutting tool to treat carpal tunnel syndrome while reducing recovery times
that was cleared by the FDA under section 510(k) in April 2020, with the first commercial
procedure successfully performed in December 2020. In May 2021 European CE Mark Certification
was received for CarpX.
●
In
May 2021, we formed Veris Health, which is our newest majority-owned subsidiary. In connection with it formation, Veris Health
acquired Oncodisc Inc (“Oncodisc”), a digital health company with ground breaking tools to improve personalized cancer
care through remote patient monitoring. Oncodisc’s core technologies include the first intelligent implantable vascular healthcare
platform that provides patients and physicians with new tools to improve outcomes and optimize the delivery of cost-effective care
through remote monitoring and data analytics. Its vascular access port contains biologic sensors capable of generating continuous
data on key physiologic parameters known to predict adverse outcomes in cancer patients undergoing treatment. Wireless communication
to the patient’s smartphone and its cloud-based digital healthcare platform efficiently and effectively delivers actionable
real time data to patients and physicians. The technologies are the subject of multiple patent applications and one allowed patent
awaiting final issuance.
34
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.