Item 9A. Controls and Procedures
ITEM
9A. 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 December 31, 2021. Based on such evaluation, our principal executive officer and principal
financial officer concluded our disclosure controls and procedures (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act)
were effective as of such date to provide reasonable assurance the information required to be disclosed by us in the reports we file
or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s
rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure information
required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management,
including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required
disclosure.
Management’s
Report on Internal Control Over Financial Reporting
Our
management is responsible for establishing and maintaining an adequate system of internal control over financial reporting, as such term
is defined in Exchange Act Rules 13(a)-15(f). Our system of internal control over financial reporting is designed to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance
with accounting principles generally accepted in the U.S.
Our
internal control over financial reporting includes those policies and procedures that:
● pertain
to the maintenance of records, in reasonable detail, accurately and fairly reflect our transactions
and dispositions of our assets;
● provide
reasonable assurance our transactions are recorded as necessary to permit preparation of
our financial statements in accordance with accounting principles generally accepted in the
U.S., and our receipts and expenditures are being made only in accordance with authorizations
of our management and our directors; and;
● provide
reasonable assurance regarding prevention or timely detection of unauthorized acquisition,
use, or disposition of our assets could have a material effect on the financial statements.
Due
to its inherent limitations, a system of internal control over financial reporting can provide only reasonable assurance and may not
prevent or detect all misstatements. Further, because of changes in conditions, effectiveness of internal controls over financial reporting
may vary over time. Our system contains self-monitoring mechanisms, so actions will be taken to correct deficiencies as they are identified.
Our
management conducted an evaluation of the effectiveness of the system of internal control over financial reporting based on the framework
in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based
on this evaluation, our management concluded our system of internal control over financial reporting was effective as of December 31,
2021.
This
Form 10-K does not include an attestation report of our independent registered public accounting firm regarding internal control over
financial reporting. Management’s report was not subject to attestation by our registered public accounting firm pursuant to the
rules of the SEC to permit us to provide only management’s report in this Form 10-K.
Changes
to Internal Controls Over Financial Reporting
There have 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
the year ended December 31, 2021 that has materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
Item
9B. Other Information
None
Item
9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not
applicable.
82
PART
III
Item
10. Directors, Executive Officers and Corporate Governance
The
information required by this Item 10 is incorporated by reference to our Proxy Statement for the 2021 Annual Meeting of Stockholders
to be filed with the Securities and Exchange Commission within 120 days of the fiscal year ended December 31, 2021.
Item
11. Executive Compensation
The
information required by this Item 11 is incorporated by reference to our Proxy Statement for the 2021 Annual Meeting of Stockholders
to be filed with the Securities and Exchange Commission within 120 days of the fiscal year ended December 31, 2021.
Item
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The
information required by this Item 12 is incorporated by reference to our Proxy Statement for the 2021 Annual Meeting of Stockholders
to be filed with the Securities and Exchange Commission within 120 days of the fiscal year ended December 31, 2021.
Item
13. Certain Relationships and Related Transactions, and Director Independence
The
information required by this Item 13 is incorporated by reference to our Proxy Statement for the 2021 Annual Meeting of Stockholders
to be filed with the Securities and Exchange Commission within 120 days of the fiscal year ended December 31, 2021.
Item
14. Principal Accounting Fees and Services
The
information required by this Item 14 is incorporated by reference to our Proxy Statement for the 2021 Annual Meeting of Stockholders
to be filed with the Securities and Exchange Commission within 120 days of the fiscal year ended December 31, 2021.
83
PART
IV
Item
15. Exhibits and Financial Statement Schedules
(a)
The
following documents filed as a part of the report:
(1)
The
following financial statements:
Report
of Independent Registered Public Accounting Firm (PCAOB ID#688)
Consolidated Balance Sheets
Consolidated Statements of Operations
Consolidated Statements of Changes in Equity (Deficit)
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
(2)
The
financial statement schedules:
Schedules
other than those listed above are omitted for the reason they are not required or are not applicable, or the required information
is shown in the financial statements or notes thereto. Columns omitted from schedules filed have been omitted because the information
is not applicable.
(3)
The
following exhibits:
Exhibit
No.
Description
3.1
Certificate of Incorporation (1)
3.2
Certificate of Amendment to Certificate of Incorporation (1)
3.3
Certificate of Amendment to Certificate of Incorporation, dated October 1, 2018 (8)
3.4
Certificate of Amendment to Certificate of Incorporation, dated June 26, 2019 (10)
3.5
Certificate of Amendment to Certificate of Incorporation, dated July 24, 2020 (14)
3.6
Form of Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (11)
3.7
Certificate of Elimination - Series A Convertible Preferred Stock and Series A-1 Convertible Preferred Stock (6)
3.8
PAVmed Inc. Amended and Restated Bylaws (13)
4.1
Description of Registrant’s Securities †
4.2
Specimen PAVmed Inc. Common Stock Certificate (1)
4.3
Specimen PAVmed Inc. Series Z Warrant Certificate (5)
4.4
Amended and Restated Series Z Warrant Agreement, dated as of June 8, 2018, by and between PAVmed Inc. and Continental Stock Transfer & Trust Company, as Warrant Agent (7)
4.5
Form of Senior Secured Convertible Note (15)
10.1
Patent Option Agreement (1)
10.2.1
Form of Letter Agreement with HCFP Capital Partners III LLC (1)
10.2.2
Form of Letter Agreement with Pavilion Venture Partners LLC (1)
10.3.1
Letter agreement regarding corporate opportunities executed by Dr. Lishan Aklog, M.D. (1)
10.3.2
Letter agreement regarding corporate opportunities executed by Michael Glennon (1)
10.3.3
Letter agreement regarding corporate opportunities executed by Dr. Brian deGuzman, M.D. (1)
84
Exhibit
No.
Description
10.4.1
Securities Purchase Agreement between PAVmed Inc. and the purchasers of the Series A Preferred Stock Units (2)
10.4.2
Registration Rights Agreement between PAVmed Inc. and the purchasers of the Series A Preferred Stock Units (2)
10.5*
Amended and Restated Employment Agreement between PAVmed Inc. and Lishan Aklog, M.D. (9)
10.6*
Amended and Restated Employment Agreement between PAVmed Inc. and Dennis M. McGrath (9)
10.7*
Employment Agreement between PAVmed Inc. and Brian J. deGuzman, M.D. (4)
10.8
Employment Agreement between PAVmed Inc. and Shaun O’Neil (18)
10.9
PAVmed Inc. Fourth Amended and Restated 2014 Long-Term Incentive Equity Plan (10)(12)
10.10
PAVmed Inc. Employee Stock Purchase Plan (10)(12)
10.10.1
Common Stock Purchase Agreement, dated as of March 28, 2022, by and between CF Principal Investments LLC and Lucid Diagnostics Inc.(14)
10.10.2
Registration Rights Agreement, dated as of March 28, 2022, by and between CF Principal Investments LLC and Lucid Diagnostics Inc.(14)
10.11.1
Asset Purchase Agreement, dated as of February 25, 2022, by and among LucidDx Labs Inc., Lucid Diagnostics Inc. and ResearchDx, Inc. (17)
10.11.2
Management Services Agreement, dated as of February 25, 2022, by and among LucidDx Labs Inc. and ResearchDx, Inc. (17)
10.11.3
Form of Securities Purchase Agreement (15)
10.11.4
Form of Security Agreement (15)
10.11.5
Form of Voting Agreement (15)
14.1
Form of Code of Ethics (1)
21.1
List of Subsidiaries †
23.1
Consent of Marcum LLP †
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)
(1)
Incorporated
by reference to the Registrant’s Registration Statement on Form S-1 - SEC File No. 333-203569
(2)
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed February 1, 2017.
(3)
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed May 3, 2016.
(4)
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed July 19, 2016.
(5)
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed April 5, 2018.
(6)
Incorporated
by reference to the Registrant’s Current Report on Form 8-K/A filed April 20, 2018.
(7)
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed June 8, 2018.
(8)
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed October 2, 2018.
(9)
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed March 20, 2019.
(10)
Incorporated
by reference to the Registrant’s Definitive Proxy Statement on Schedule 14A filed June 11, 2020
(11)
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed June 27, 2019.
(12)
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed July 27, 2020.
(13)
Incorporated
by reference to the Registrant’s Current Report on Form 8-K filed January 15, 2021.
(14)
Incorporated by reference to Lucid Diagnostic Inc.’s
Current Report on Form 8-K filed on April 1, 2022.
(15)
Incorporated by reference to the Registrant’s
Current Report on Form 8-K filed April 4, 2022
(16)
Incorporated by reference to the Registrant’s
Definitive Proxy Statement on Schedule 14A filed April 30, 2021
(17)
Incorporated by reference to Lucid Diagnostic
Inc.’s Current Report on Form 8-K filed on March 3, 2022).
(18)
Incorporated by reference to the Registrant’s
Current Report on Form 8-K filed February 24, 2022.
*
Management
contract or compensatory plan or arrangement.
†
Filed
herewith
Item
16. Form 10-K Summary
None
85
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
PAVmed
Inc.
April
5, 2022
By:
/s/
Dennis M McGrath
Dennis
M McGrath
President
Chief
Financial Officer
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the report has been signed by the following persons on behalf
of the Registrant and in the capacities and on the dates indicated. Each person whose signature appears below hereby authorizes both
Lishan Aklog, M.D. and Dennis M. McGrath or either of them acting in the absence of the others, as his or her true and lawful attorney-in-fact
and agent, with full power of substitution and re-substitution for him or her and in his or her name, place and stead, in any and all
capacities to sign any and all amendments to this report, and to file the same, with all exhibits thereto and other documents in connection
therewith, with the United States Securities and Exchange Commission.
Signature
Title
Date
/s/
Lishan Aklog, M.D.
Chairman
of the Board of Directors
April
5, 2022
Lishan
Aklog, M.D.
Chief
Executive Officer
(Principal
Executive Officer)
/s/
Dennis M. McGrath
President
April
5, 2022
Dennis
M. McGrath
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
/s/
Michael J. Glennon
Vice
Chairman
April
5, 2022
Michael
J. Glennon
Director
/s/
Debra J. White
Director
April
5, 2022
Debra
J. White
/s/
James L. Cox, M.D.
Director
April
5, 2022
James
L. Cox, M.D.
/s/
Ronald M. Sparks
Director
April
5, 2022
Ronald
M. Sparks
/s/
Timothy Baxter
Director
April
5, 2022
Timothy
Baxter
/s/
Joan B. Harvey
Director
April
5, 2022
Joan
B. Harvey
86
PAVMED
INC.
and
SUBSIDIARIES
INDEX
TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Report
of Independent Registered Public Accounting Firm (PCAOB ID No. 688 )
F-2
Consolidated Balance Sheets as of December 31, 2021 and December 31, 2020
F-4
Consolidated Statements of Operations for the years ended December 31, 2021 and 2020
F-5
Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the year ended December 31, 2021
F-6
Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the year ended December 31, 2020
F-7
Consolidated Statements of Cash Flows for the year ended December 31, 2021 and 2020
F-8
Notes to Consolidated Financial Statements
F-9
F- 1
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Shareholders and Board of Directors of
PAVmed
Inc.
Opinion
on the Financial Statements
We
have audited the accompanying consolidated balance sheets of PAVmed Inc. and Subsidiaries (the “Company”) as of December
31, 2021 and 2020, the related consolidated statements of operations, changes in equity (deficit) and cash flows for each of the two
years in the period ended December 31, 2021, and the related notes (collectively referred to as the “financial statements”).
In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December
31, 2021 and 2020, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2021,
in conformity with accounting principles generally accepted in the United States of America.
Basis
for Opinion
These
financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s
financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board
(United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal
securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain
reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company
is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits
we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion
on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error
or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding
the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant
estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits
provide a reasonable basis for our opinion.
Critical
Audit Matters
The
critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated
or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial
statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters
does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit
matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
F- 2
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
(continued)
Valuation
of Lucid Diagnostics Inc. (LUCD) common stock prior to its IPO
Critical
Audit Matter Description
The
Company estimates the fair value of LUCD common stock for purpose of share based compensation utilizing valuation models with unobservable
inputs. Unlike Level 1 and 2 inputs, Level 3 inputs are unobservable, supported by little or no market activity and are significant to
the conclusion of fair value of LUCD common stock.
Subjective
and challenging judgment is required by management to determine the assumptions and valuation methodology to conclude on material Level
3 inputs that result in the conclusion of fair value of LUCD common stock. Auditing management’s models to determine the fair value
was complex and required judgment, particularly when evaluating inputs such as discount rates, probability of event occurring, estimated
IPO value, number of common equivalent shares, projections, guideline companies, weighting of the income approach and market approach,
public company multiples, and multiples of revenue. These assumptions are affected by potential future outcomes, market and industry
factors as well as estimates of the LUCD’s future growth.
How
the Critical Audit Matter Was Addressed in the Audit
Our
audit procedures to address this critical audit matter included the following:
●
We obtained an understanding
of the design of controls associated with the Company’s process to establish a valuation methodology and determine assumptions
used in valuation models to conclude on fair value. For example, we gained an understanding of management’s review controls
over the significant assumptions described above as well as over the data used in the valuation models.
●
With assistance from
our valuation specialists, we evaluated the reasonableness of the valuation methodology and significant assumptions; tested inputs
for reasonableness, including discount rates, guideline companies, weighting of the income approach and market approach, public company
multiples and multiples of revenue; and corroborated with audit evidence from external sources or comparisons to other companies
in the industry.
●
We gained an understanding
of the Company’s process used to develop projections and tested inputs including probability of event occurring, estimated
IPO value, and number of common equivalent shares for reasonableness. Further, we evaluated audit evidence from events or transactions
occurring after the measurement date for comparison to management’s estimate.
/s/
Marcum LLP
Marcum
llp
We
have served as the Company’s auditor since 2019.
New
York, NY
April
5, 2022
F- 3
PAVMED
INC.
and
SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
(in
thousands except number of shares and per share data)
December
31, 2021
December
31, 2020
Assets:
Current
assets:
Cash
$ 77,258
$ 17,256
Accounts
receivable
200
—
Prepaid
expenses, deposits, and other current assets
5,179
1,685
Total
current assets
82,637
18,941
Fixed
assets, net
1,585
82
Intangible
assets, net
2,029
—
Other
assets
725
755
Total
assets
$ 86,976
$ 19,778
Liabilities,
Preferred Stock and Stockholders’ Deficit
Current
liabilities:
Accounts
payable
$ 3,299
$ 2,966
Accrued
expenses and other current liabilities
4,259
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
7,558
20,251
Commitments
and contingencies (Note 11)
-
-
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
1,113,919 at December 31, 2021 and 1,228,075 shares at December 31, 2020
2,419
2,537
Common
stock, $ 0.001 par value. Authorized, 150,000,000 shares; 86,367,845 and 63,819,935 shares outstanding as of December 31, 2021 and
December 31, 2020, respectively
86
64
Additional
paid-in capital
198,071
87,570
Accumulated
deficit
( 138,910 )
( 88,275 )
Total
PAVmed Inc. Stockholders’ Equity
61,666
1,896
Noncontrolling
interests
17,752
( 2,369 )
Total
Stockholders’ Equity (Deficit)
79,418
( 473 )
Total
Liabilities and Stockholders’ Equity
$ 86,976
$ 19,778
See
accompanying notes to the consolidated financial statements.
F- 4
PAVMED
INC.
and
SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
(in
thousands except number of shares and per share amounts)
2021
2020
Year
Ended December 31,
2021
2020
Revenue
$ 500
$ —
Cost
of revenue
585
—
Gross
profit (loss)
( 85 )
—
Operating
expenses:
Sales
and marketing
8,895
2,789
General
and administrative
25,566
9,599
Research
and development
19,847
10,963
Total
operating expenses
54,308
23,351
Loss
from operations
( 54,393 )
( 23,351 )
Other
income (expense):
Interest
expense
—
( 53 )
Change
in fair value - Senior Secured Convertible Notes and Senior Convertible Note
1,682
( 5,327 )
Offering
costs - Senior Secured Convertible Note and Senior Convertible Note
—
( 660 )
Debt
extinguishments loss - Senior Secured Convertible Notes
( 3,715 )
( 6,497 )
Debt
forgiveness
300
—
Other
income (expense), net
( 1,733 )
( 12,537 )
Loss
before provision for income tax
( 56,126 )
( 35,888 )
Provision
for income taxes
—
—
Net
loss before noncontrolling interests
( 56,126 )
( 35,888 )
Net
loss attributable to the noncontrolling interests
5,779
1,612
Net
loss attributable to PAVmed Inc.
( 50,347 )
( 34,276 )
Less:
Series B Convertible Preferred Stock dividends earned
( 283 )
( 287 )
Net
loss attributable to PAVmed Inc. common stockholders
$ ( 50,630 )
$ ( 34,563 )
Per
share information:
Net
loss per share attributable to PAVmed Inc. - basic and diluted
$ ( 0.65 )
$ ( 0.72 )
Net
loss per share attributable to PAVmed Inc. common stockholders – basic and diluted
$ ( 0.65 )
$ ( 0.73 )
Weighted
average common shares outstanding, basic and diluted
77,515,767
47,432,115
See
accompanying notes to the consolidated financial statements.
F- 5
PAVMED
INC.
and
SUBSIDIARIES
CONSOLIDATED
STATEMENT OF CHANGES IN EQUITY (DEFICIT)
for
the YEAR ENDED December 31, 2021
(in
thousands except number of shares and per share data)
Shares
Amount
Shares
Amount
Capital
Deficit
Interest
Total
PAVmed
Inc. Stockholders’ Equity (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
96,292
288
—
—
—
( 288 )
—
—
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
Issue common stock – exercise Series S warrants
Issue common stock – exercise Series S warrants, shares
Vest
- restricted stock awards vests
—
—
150,000
—
—
—
—
—
Exercise
- Series Z warrants
—
—
4,877,484
5
7,799
—
—
7,804
Exercise
- Series W warrants
—
—
3,945
—
20
—
—
20
Conversions
- Senior Secured Convertible Note
—
—
667,668
1
1,722
—
—
1,723
Exercise
- stock options
—
—
621,164
—
979
—
—
979
Purchase
- Employee Stock Purchase Plan
—
—
234,592
—
436
—
—
436
Issue
common stock of majority-owned subsidiary
—
—
—
—
—
—
—
—
Impact
of subsidiary equity transactions (1)
—
—
—
—
39,576
—
16,760
56,336
Issue
of common stock of majority-owned subsidiary
—
—
—
—
—
—
6
6
Stock-based
compensation - PAVmed Inc.
—
—
—
—
5,410
—
—
5,410
Stock-based
compensation - majority-owned subsidiary
—
—
—
—
465
—
9,134
9,599
Issue
common stock of majority- owned subsidiary exercise of stock options
Net
loss
—
—
—
—
—
( 50,347 )
( 5,779 )
( 56,126 )
Balance
- December 31, 2021
1,113,919
$ 2,419
86,367,845
$ 86
$ 198,071
$ ( 138,910 )
$ 17,752
$ 79,418
(1) Primarily
represents the impact of the Lucid Diagnostics Inc. IPO. See Note 17, Noncontrolling
Interest for further information.
See
accompanying notes to the consolidated financial statements.
F- 6
PAVMED
INC.
and
SUBSIDIARIES
CONSOLIDATED
STATEMENT OF CHANGES IN EQUITY (DEFICIT)
for
the YEAR ENDED December 31, 2020
(in
thousands, except number of shares and per share data)
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 )
Balance
1,158,209
$ 2,296
40,478,861
$ 41
$ 47,554
$ ( 53,715 )
$ ( 814 )
$ ( 4,638 )
Issue
common stock – registered offerings, net
—
—
10,647,500
11
15,921
—
—
15,932
Issue
common stock upon partial conversions of Senior Secured Convertible Note
—
—
10,929,202
11
21,692
—
—
21,703
Conversions
- Senior Secured Convertible Note
—
—
10,929,202
11
21,692
—
—
21,703
Issue
common stock – exercise Series S warrants
—
—
1,199,383
1
11
—
—
12
Issue
common stock – exercise Series Z warrants
—
—
100
—
—
—
—
—
Issue
common stock – conversion Series B Convertible Preferred Stock
( 25,000 )
( 43 )
25,000
—
43
—
—
—
Conversions
- Series B Convertible Preferred Stock
( 25,000 )
( 43 )
25,000
—
43
—
—
—
Series
B Convertible Preferred Stock dividends declared
94,866
284
—
—
—
( 284 )
—
—
Dividends
declared - Series B Convertible Preferred Stock
94,866
284
—
—
—
( 284 )
—
—
Issue
common stock - Employee Stock Purchase Plan
—
—
306,555
—
357
—
—
357
Purchase
- Employee Stock Purchase Plan
—
—
306,555
—
357
—
—
357
Vesting
of restricted stock awards
—
—
233,334
—
—
—
—
—
Stock-based
compensation - PAVmed Inc. 2014 Equity Plan
—
—
—
—
1,979
—
—
1,979
Stock-based
compensation - majority-owned subsidiary
—
—
—
—
13
—
52
65
Issue
common stock of majority- owned subsidiary exercise of stock options
—
—
—
—
—
—
5
5
Net
Loss
—
—
—
—
—
( 34,276 )
( 1,612 )
( 35,888 )
Balance
- December 31, 2020
1,228,075
$ 2,537
63,819,935
$ 64
$ 87,570
$ ( 88,275 )
$ ( 2,369 )
$ ( 473 )
Balance
1,228,075
$ 2,537
63,819,935
$ 64
$ 87,570
$ ( 88,275 )
$ ( 2,369 )
$ ( 473 )
See
accompanying notes to the consolidated financial statements.
F- 7
PAVMED
INC.
and
SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(in
thousands, except number of shares and per share data)
2021
2020
Year
Ended December 31,
2021
2020
Cash
flows from operating activities
Net
loss - before noncontrolling interest (“NCI”)
$ ( 56,126 )
$ ( 35,888 )
Adjustments
to reconcile net loss - before NCI to net cash used in operating activities
Depreciation
expense
80
23
Amortization
expense
146
—
Stock-based
compensation
15,009
2,044
In-process
R&D charge
133
—
Change
in fair value - Senior Secured Convertible Notes and Senior Convertible Note
( 1,682 )
5,327
Debt
extinguishment loss - Senior Secured Convertible Notes and Senior Convertible Note
3,715
6,497
Debt
forgiveness
( 300 )
—
Changes
in operating assets and liabilities:
Accounts
receivable
( 200 )
—
Prepaid
expenses and other current assets
( 3,458 )
( 1,336 )
Accounts
payable
174
501
Accrued
expenses and other current liabilities
1,918
918
Net
cash flows used in operating activities
( 40,591 )
( 21,914 )
Cash
flows from investing activities
Purchase
of equipment
( 1,469 )
( 55 )
Acquisitions,
net of cash acquired
( 2,247 )
—
Net
cash flows used in investing activities
( 3,716 )
( 55 )
Cash
flows from financing activities
Proceeds
- issue of common stock - initial public offering - majority-owned subsidiary common stock
62,000
—
Payment
- offering costs - initial public offering - majority-owned subsidiary common stock
( 5,665 )
—
Proceeds
– issue of common stock – registered offerings
55,016
16,032
Payment
– offering costs – registered offerings
( 1,312 )
( 100 )
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 )
( 600 )
Proceeds
– exercise of Series Z warrants
7,804
—
Proceeds
– exercise of Series W warrants
20
—
Proceeds
– exercise of Series S warrants
—
12
Proceeds
– exercise of stock options
980
—
Proceeds
– issue common stock – Employee Stock Purchase Plan
436
357
Proceeds
– exercise of stock options issued under equity incentive plan of majority owned subsidiary
—
5
Net
cash flows provided by financing activities
104,309
33,006
Net
increase (decrease) in cash
60,002
11,037
Cash,
beginning of period
17,256
6,219
Cash,
end of period
$ 77,258
$ 17,256
See
accompanying notes to the consolidated financial statements.
F- 8
PAVMED
INC.
and
SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(amounts
in these accompanying notes are presented in thousands, except number of shares and per-share amounts.)
Note
1 — The Company
Description
of the Business
PAVmed
Inc and Subsidiaries, referred to herein as “PAVmed” or the “Company” is comprised of
PAVmed Inc. and its wholly-owned subsidiary and its majority-owned subsidiaries, inclusive of Lucid Diagnostics,
Inc. (“Lucid Diagnostics” or “LUCID”), Veris Health, Inc. (“Veris Health” or “VERIS”),
and Solys Diagnostics, Inc. (“Solys Diagnostics” or “SOLYS”).
The
Company is organized to advance a broad pipeline
of innovative medical technologies from concept to commercialization, employing a business model focused on capital efficiency and speed
to market. The Company’s activities have focused on advancing the lead products towards regulatory approval and commercialization,
protecting its intellectual property, and building its corporate infrastructure and management team.
The
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:
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, NextFlo, EsoCure and digital health technologies acquired by the Company’s majority-owned subsidiary Veris Health
Inc.
F- 9
Note
2 — Summary of Significant Accounting Policies and Recent Accounting Standards Updates
Significant
Accounting Policies
Basis
of Presentation
The
accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the
United States of America (“U.S. GAAP”), and applicable rules and regulations of the United States Securities and Exchange
Commission (“SEC”), and include the accounts of the Company and its wholly-owned and majority-owned subsidiaries. All significant
intercompany transactions and balances have been eliminated in consolidation. The Company holds a majority-ownership interest and has
controlling financial interest in each of: Lucid Diagnostics Inc., Veris Health Inc., and Solys Diagnostics Inc., with the corresponding
noncontrolling interest included as a separate component of consolidated stockholders’ equity (deficit), including the recognition
in the 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 17, Noncontrolling Interest , for a discussion of each of the majority-owned
subsidiaries noted above. The Company manages its operations as a single operating segment for the purposes of assessing performance
and making operating decisions.
All
amounts in the accompanying consolidated financial statements and these notes thereto are presented in thousands of
dollars, if not otherwise noted as being presented in millions of dollars, except for shares and per share amounts.
Use
of Estimates
In
preparing the consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates and assumptions
that affect the reported amounts of assets, inclusive of acquired intangible 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 consolidated financial
statements include those related to the estimated fair value of stock-based equity awards, financial instruments recognized as liabilities,
debt obligations, and common stock purchase warrants. Other significant estimates include the provision or benefit for income taxes and
the corresponding valuation allowance on deferred tax assets. Additionally, management’s assessment of the Company’s ability
to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. On an ongoing basis,
the Company evaluates its estimates and assumptions. The Company bases its estimates on historical experience and on various other assumptions
believed to be reasonable. Due to inherent uncertainty involved in making estimates, actual results reported in future periods may be
affected by changes in these estimates.
Financial
Condition
The
provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 205-40,
Presentation of Financial Statements - Going Concern (“ASC 205-40”) requires management to assess an entity’s
ability to continue as a going concern within one year of the date of the financial statements are issued. In each reporting period,
including interim periods, an entity is required to assess conditions known and reasonably knowable as of the financial statement issuance
date to determine whether it is probable an entity will not meet its financial obligations within one year from the financial statement
issuance date. Substantial doubt about an entity’s ability to continue as a going concern exists when conditions and events, considered
in the aggregate, indicate it is probable the entity will be unable to meet its financial obligations as they become due within one year
after the date the financial statements are issued.
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
for one year from the date of the issue of the Company’s consolidated financial statements included herein in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2021. See Note 20, Subsequent Events , for a discussion of the committed
sources of financing noted above.
F- 10
Note
2 — Summary of Significant Accounting Policies and Recent Accounting Standards Updates - continued
Significant
Accounting Policies - continued
Cash
The
Company maintains its cash at a major financial institution with high credit quality. At times, the balance of its cash deposits may
exceed federally insured limits. The Company has not experienced any losses on deposits with commercial banks and financial institutions
which exceed federally insured limits.
Offering
Costs
Offering
costs consist of certain legal, accounting, and other advisory fees incurred related to the Company’s efforts to raise debt and
equity capital. Offering costs in connection with equity financing are recognized as either an offset against the financing proceeds
to extent the underlying security is equity classified or a current period expense to extent the underlying security is liability classified
or for which the fair value option is elected. Offering costs, lender fees, and warrants issued in connection with debt financing, to
the extent the fair value option is not elected, are recognized as debt discount, which reduces the reported carrying value of the debt,
with the debt discount amortized as interest expense, generally over the contractual term of the debt agreement, to result in a constant
rate of interest. Offering costs associated with in-process capital financing are accounted for as deferred offering costs.
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. See Note 4, Revenue from Contracts with Customers , for further
information regarding revenue recognition.
F- 11
Note 2 — Summary of Significant Accounting Policies and Recent
Accounting Standards Updates - continued
Significant Accounting Policies - continued
Fixed
Assets
Fixed
assets are stated at cost and depreciated using the straight-line method over the assets’ estimated useful lives. Additions and
improvements are capitalized, including direct and indirect costs incurred to validate equipment and bring to working conditions. The
costs for maintenance and repairs are expensed as incurred.
Leases
The
Company adopted FASB ASC Topic 842, Leases , (“ASC 842”) effective December 31, 2021, with such adoption not having
an effect on the Company’s consolidated financial statements.
All
significant lease agreements and contractual agreements with embedded lease agreements are accounted for under the provisions of ASC
842, wherein, if the contractual arrangement: involves the use of a distinct identified asset; provides for the right to
substantially all the economic benefits from the use of the asset throughout the contractual period; and, provides for the right to
direct the use of the asset. A lease agreement is accounted for as either a finance lease (generally with respect real estate) or an
operating lease (generally with respect to equipment). Under both a finance lease and an operating lease, the Company recognizes as
of the lease commencement date a lease right-of-use (“ROU”) asset and a corresponding lease payment liability.
A
lease ROU asset represents the Company’s right to use an underlying asset for the lease term, and the lease liability represents its
contractual obligation to make lease payments. The lease ROU asset is measured at the lease commencement date as the present value of
the future lease payments plus initial direct costs incurred. The Company recognizes lease expense of the amortization of the lease ROU
asset for an operating lease on a straight-line basis over the lease term; and for financing leases on a straight-line basis unless another
basis is more representative of the pattern of economic benefit.
The
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. See Note 9, Leases .
Intangible
Assets
Purchased
intangible assets are recorded at cost and depreciated using the straight-line method over the assets’ estimated useful life. See Note 6, Acquisitions, for further information with respect to purchased intangible assets.
Impairment
- Long Lived Assets
The
Company reviews its long-lived assets, including intangible assets with finite lives, for recoverability whenever events or changes in
circumstances indicate the carrying amount of the assets may not be fully recoverable. The Company evaluates assets for potential impairment
by comparing estimated future undiscounted net cash flows to the carrying amount of the asset. If the carrying amount of the assets exceeds
the estimated future undiscounted cash flows, impairment is measured based on the difference between the carrying amount of the assets
and fair value which is generally an expected present value cash flow technique. The assessment and determination of the existence of
an impairment indicator comprises measurable operating performance criteria as well as qualitative factors deemed relevant and appropriate
to such evaluation.
F- 12
Note
2 — Summary of Significant Accounting Policies and Recent Accounting Standards Updates - continued
Significant
Accounting Policies - continued
Stock-Based
Compensation
Stock-based
awards are made to members of the board of directors of the Company, the Company’s employees and non-employees, under each of the
PAVmed Inc. 2014 Long-Term Incentive Equity Plan (“PAVmed Inc. 2014 Equity Plan”) and the Lucid Diagnostics Inc. 2018 Long-Term
Incentive Equity Plan (“Lucid Diagnostics Inc. 2018 Equity Plan”).
The
Company accounts for stock-based compensation
in accordance with the provisions of FASB ASC Topic 718, Stock Compensation (“ASC 718”).
The
grant-date estimated fair value of the stock-based
award is recognized on a straight-line basis over the requisite service period, which is generally the vesting period of the respective
stock-based award, with such straight-line recognition adjusted, as applicable, so the cumulative expense recognized is at-least equal-to-or-greater-than
the estimated fair value of the vested portion of the respective stock-based award as of the reporting date.
The
Company uses the Black-Scholes valuation model to estimate the fair value of stock options granted under both the PAVmed Inc. 2014 Equity
Plan and the Lucid Diagnostics Inc. 2018 Equity Plan, which requires the Company to make certain weighted-average valuation estimates
and assumptions for stock-based awards, principally as follows:
● With
respect to the PAVmed Inc. 2014 Equity Plan, the expected stock price volatility is based
on the historical stock price volatility of PAVmed Inc. common stock and the volatilities
of similar entities within the medical device industry over the period commensurate with
the expected term with respect to stock options granted to the board of directors and employees
in the years ended December 31, 2021 and 2020;
● With
respect to stock options granted under the Lucid Diagnostics Inc. 2018 Equity Plan, the expected
stock price volatility was based on the historical stock price volatility of similar entities
within the medical device industry over the period commensurate with the expected term with
respect to stock options granted to employees in the year ended December 31, 2021; There
were no stock options granted under the Lucid Diagnostics Inc. 2018 Equity Plan in the year
ended December 31, 2020;
● The
risk-free interest rate is based on the interest rate payable on U.S. Treasury securities
in effect at the time of grant for a period commensurate with either the expected term or
the remaining contractual term, as applicable, of the stock option; and,
● The
expected dividend yield is based on annual dividends of $ 0.00 as there have not been dividends
paid to-date, and there is no plan to pay dividends for the foreseeable future.
The
price per share of PAVmed Inc. common stock used in the computation of estimated fair value of stock options and restricted stock
awards granted under the PAVmed Inc. 2014 Equity Plan is its quoted closing price per share.
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 .
The price per share of Lucid Diagnostics Inc. common stock used in the computation of estimated fair value of stock options and restricted
stock awards granted under the Lucid Diagnostics Inc. 2018 Equity Plan is as follows: (i) for the period October 14, 2021 to December
31, 2021 it is its quoted closing price per share; and (ii) for the period January 1, 2021 to October 14, 2021, it was estimated 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; and (iii) as of December 31, 2020,
it was estimated using a discounted cash flow analysis applied to a multi-year forecast of its future cash flows.
F- 13
Note 2 — Summary of Significant Accounting Policies and Recent
Accounting Standards Updates - continued
Significant Accounting Policies - continued
Financial
Instruments Fair Value Measurements
FASB
ASC Topic 820, Fair Value Measurement, (ASC 820) defines fair value as the price which would be received to sell an asset or paid to
transfer a liability in an orderly transaction between market participants at a transaction measurement date. The ASC 820 three-tier
fair value hierarchy prioritizes the inputs used in the valuation methodologies, as follows:
Level
1
Valuations
based on quoted prices for identical assets and liabilities in active markets.
Level
2
Valuations
based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets or liabilities in
active markets, quoted prices for identical or similar assets and liabilities in markets which are not active, or other inputs observable
or can be corroborated by observable market data.
Level
3
Valuations
based on unobservable inputs reflecting the Company’s own assumptions, consistent with reasonably available assumptions made
by other market participants. These valuations require significant judgment.
The
recurring and non-recurring estimated fair value measurements are subjective and are affected by changes in inputs to the valuation models,
including the Company’s common stock price, and certain Level 3 inputs, including, the assumptions regarding the estimated volatility
in the value of the Company’s common stock price; the Company’s dividend yield; the likelihood and timing of future dilutive
transactions, as applicable, along with the risk-free rates based on U.S. Treasury security yields. Changes in these assumptions can
materially affect the estimated fair values.
As
of December 31, 2021 and December 31, 2020, the carrying values of cash, and accounts payable, approximate their respective fair value
due to the short-term nature of these financial instruments.
Fair
Value Option (“FVO”) Election
The
Senior Secured Convertible Notes and Senior Convertible Note are each a debt host financial instrument containing embedded features and
/or options which would otherwise be required to be bifurcated from the debt-host and recognized as separate derivative liabilities subject
to initial and subsequent periodic estimated fair value measurements under ASC 815. Notwithstanding, 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 its issue-date estimated fair value and then subsequently remeasured at estimated fair
value on a recurring basis at each reporting period date, with changes in the estimated fair value recognized as other income (expense)
in the accompanying consolidated statement of operations. In this regard, as provided for by ASC 825-10-50-30(b), the estimated fair
value adjustment is presented in a single line item within other income (expense) in the accompanying consolidated statement of operations.
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”). Notwithstanding, there
was no such portion of the fair value adjustment attributed to a change in the instrument-specific credit risk in the years ended December
31, 2021 and 2020.
F- 14
Note 2 — Summary of Significant Accounting Policies and Recent
Accounting Standards Updates - continued
Significant Accounting Policies - continued
Financial
Instruments - Derivatives
The
Company evaluates its financial instruments to determine if the financial instrument itself or if any embedded components of a financial
instrument potentially qualify as derivatives required to be separately accounted for in accordance with FASB ASC Topic 815, Derivatives
and Hedging (ASC 815). The accounting for warrants issued to purchase shares of common stock of the Company is based on the specific
terms of the respective warrant agreement, and are generally classified as equity, but may be classified as a derivative liability if
the warrant agreement provides required or potential full or partial cash settlement. A warrant classified as a derivative liability,
or a bifurcated embedded conversion or settlement option classified as a derivative liability, is initially measured at its issue-date
fair value, with such fair value subsequently adjusted at each reporting period, with the resulting fair value adjustment recognized
as other income or expense. If upon the occurrence of an event resulting in the warrant liability or the embedded derivative liability
being subsequently classified as equity, or the exercise of the warrant or the conversion option, the fair value of the derivative liability
will be adjusted on such date-of-occurrence, with such date-of-occurrence fair value adjustment recognized as other income or expense,
and then the derivative liability will be derecognized at such date-of-occurrence fair value.
Research
and Development Expenses
Research
and development expenses are recognized as incurred and include the salary and stock-based compensation of employees engaged in product
research and development activities, and the costs related to the Company’s various contract research service providers, suppliers,
engineering studies, supplies, and outsourced testing and consulting fees, as well as depreciation expense and rental costs for equipment
used in research and development activities, and fees incurred for access to certain facilities of contract research service providers.
Patent
Costs and Purchased Patent License Rights
Patent
related costs in connection with filing and prosecuting patent applications and patents filed by the Company are expensed as incurred
and are included in the line item captioned “general and administrative expenses” in the accompanying consolidated statements
of operations. Patent fee reimbursement expense incurred under the patent license agreement agreements are included in the line item
captioned “research and development expenses” in the accompanying consolidated statements of operations.
The
Company has entered into agreements with third parties to acquire technologies for potential commercial development. Such agreements
generally require an initial payment by the Company when the contract is executed. The purchase of patent license rights for use in research
and development activities, including product development, are expensed as incurred and are classified as research and development expense.
Additionally, the Company may be obligated to make future royalty payments in the event the Company commercializes the technology and
achieves a certain sales volume. In accordance with Financial Accounting Standards Board (“FASB”) Accounting Standard Codification
(“ASC”) Topic 730, “Research and Development”, (“ASC 730”), expenditures for research and development,
including upfront licensing fees and milestone payments associated with products not yet been approved by the United States Food and
Drug Administration (“FDA”), are charged to research and development expense as incurred. Future contract milestone and /or
royalty payments will be recognized as expense when achievement of the milestone is determined to be probable and the amount of the corresponding
milestone can be objectively estimated.
F- 15
Note
2 — Summary of Significant Accounting Policies and Recent Accounting Standards Updates - continued
Significant
Accounting Policies - continued
Income
Taxes
The
Company accounts for income taxes using the asset and liability method, as required by FASB ASC Topic 740, Income Taxes, (ASC 740). Current
tax liabilities or receivables are recognized for estimated income tax payable and/or refundable for the current year. Deferred tax assets
and deferred tax liabilities are recognized for estimated future tax consequences attributable to differences between the financial statement
carrying amounts of existing assets and liabilities and their respective tax basis, along with net operating loss and tax credit carryforwards.
Deferred tax assets and deferred tax liabilities are measured using enacted tax rates expected to apply to taxable income in the years
in which those temporary differences are expected to be recovered or settled. Changes in deferred tax assets and deferred tax liabilities
are recorded in the provision for income taxes.
Under
ASC 740, a “more-likely-than-not” criterion is applied when assessing the estimated realization of deferred tax assets through
their utilization to reduce future taxable income, or with respect to a deferred tax asset for tax credit carryforward, to reduce future
tax expense. A valuation allowance is established, when necessary, to reduce deferred tax assets, net of deferred tax liabilities, when
the assessment indicates it is more-likely-than-not, the full or partial amount of the net deferred tax asset will not be realized. As
a result of the evaluation of the positive and negative evidence bearing upon the estimated realizability of net deferred tax assets,
and based on a history of operating losses, it is more-likely-than-not the deferred tax assets will not be realized, and therefore a
valuation allowance reserve equal to the full amount of the deferred tax assets, net of deferred tax liabilities, has been recognized
as a charge to income tax expense as of December 31, 2021 and 2020.
The
Company recognizes the benefit of an uncertain tax position it has taken or expects to take on its income tax return if such a position
is more-likely-than-not to be sustained upon examination by the taxing authorities, with the tax benefit recognized being the largest
amount having a greater than 50% likelihood of being realized upon ultimate settlement. As of December 31, 2021, the Company does no t
have any unrecognized tax benefits resulting from uncertain tax positions.
The
Company’s policy is to record interest and penalties related to income taxes as part of its income tax provision. There were no
amounts accrued for penalties or interest as of December 31, 2021 and December 31, 2020 or recognized during the years ended December
31, 2021 and 2020. The Company is not aware of any issues under review to potentially result in significant payments, accruals, or material
deviations from its position.
Net
Loss Per Share
The
net loss per share is computed by dividing each of the respective net loss by the number of “basic weighted average common shares
outstanding” and diluted weighted average shares outstanding” for the reporting period indicated. The basic weighted-average
shares common shares outstanding are computed on a weighted average based on the number of days the shares of common stock of the Company
are issued and outstanding during the respective reporting period indicated. The diluted weighted average common shares outstanding are
the sum of the basic weighted-average common shares outstanding plus the number of common stock equivalents’ incremental shares
on an if-converted basis, computed using the treasury stock method, computed on a weighted average based on the number of days the incremental
shares would potentially be issued and outstanding during the periods indicated, if dilutive. The Company’s common stock equivalents
include convertible preferred stock, common stock purchase warrants, unit purchase options, and stock options.
Notwithstanding,
as the Company has a net loss for each reporting period presented, only the basic weighted average common shares outstanding are used
to compute the basic and diluted net loss per share attributable to PAVmed Inc. and the basic and diluted net loss per share attributable
to PAVmed Inc. common stockholders, for each reporting period presented.
The
Series B Convertible Preferred Stock dividends earned as of the each of the respective periods are included in the calculation of basic
and diluted net loss attributable to PAVmed Inc. common stockholders for each respective period presented. Further, the Series B Convertible
Preferred Stock has the right to receive common stock dividends. As such, the Series B Convertible Preferred Stock would potentially
be considered participating securities under the two-class method of calculating net loss per share. However, the Company has incurred
net losses to-date, and as such holders are not contractually obligated to share in the losses, there is no impact on the Company’s
net loss per share calculation for the periods presented.
F- 16
Note 2 — Summary of Significant Accounting
Policies and Recent Accounting Standards Updates - continued
Significant Accounting Policies - continued
JOBS
Act EGC Accounting Election
The
Company’s designation as an “emerging growth company” or “EGC” under the Jumpstart Our Business
Startups Act of 2012 (the “JOBS Act”), expired during 2021. As an EGC, the company had irrevocably elected to adopt new
or revised accounting standards using the effective date applicable to private companies. With the expiry of its EGC designation, effective
December 31, 2021, the Company adopted the previously deferred accounting standards in accordance with the effective date applicable
to non-EGC public companies, as such effective dates are applicable to SEC smaller reporting company requirements.
Recent
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 instrument 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 consolidated 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 consolidated financial statements.
Effective
December 31, 2021, the Company adopted FASB ASC
Topic 842, Leases, (“ASC 842”). ASC 842 established a right-of-use (“ROU”) model requiring a lessee to
recognize a ROU asset and a lease liability for all leases with terms greater-than 12 months. Leases are classified as either finance
or operating, with classification affecting the pattern of expense recognition in the income statement. The Company’s adoption
of ASC 842 did not have an effect on the Company’s consolidated financial statements. See Note 9, Leases .
F- 17
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 . 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 5, Related Party Transactions ,
for patent fee reimbursement payments paid to CWRU in the years ended December 31, 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.
F- 18
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 December 31, 2021 with respect to the revenue recognized under the
EsoGuard Commercialization Agreement, dated August 1, 2021, between Lucid Diagnostics Inc. and Research Dx Inc.
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 5, 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 14, 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”.
F- 19
Note
4 - Revenue from Contracts with Customers
Revenue
is recognized when the satisfaction of the performance obligation occurs, which is when the delivery of product and /or the provision
of service is rendered, and is measured as the amount of estimated consideration expected to be realized. In the year ended December
31, 2021, the Company recognized revenue under the EsoGuard Commercialization Agreement, dated August 1, 2021, as discussed below.
EsoGuard
Commercialization Agreement
The
Company, through its majority-owned subsidiary, Lucid Diagnostics Inc., entered into the EsoGuard Commercialization Agreement, dated
August 1, 2021, with its Commercial Laboratory Improvements Act (“CLIA”) certified commercial laboratory service provider,
ResearchDX Inc. (“RDx”), an unrelated third-party. The EsoGuard Commercialization Agreement is on a month-to-month
basis, and may be terminated by either party thereto, with or without cause, upon forty-five (45) days prior written notice.
On
February 25, 2022, the EsoGuard Commercialization Agreement was terminated in conjunction with the execution of an Asset Purchase Agreement
between Lucid Dx Labs Inc., a wholly-owned subsidiary of Lucid Diagnostics Inc. and RDx, as such agreement is further discussed in Note
20, Subsequent Events .
Revenue
Recognized
In
the year ended December 31, 2021, the Company recognized total revenue of $ 500 , which represents the minimum fixed monthly fee of $ 100
to be paid by RDx for the delivery of services under the EsoGuard Commercialization Agreement for the period from the agreement inception
date of August 1, 2021 to December 31, 2021. The monthly fee was deemed to be collectible for such period as RDx has timely paid the
applicable respective monthly fee.
Cost
of Revenue
The
cost of revenue recognized with respect to the revenue recognized under the EsoGuard Commercialization Agreement for the year ended
December 31, 2021 totaled $ 585 ,
inclusive of employee related costs of employees engaged in the delivery of the administration to patients of the EsoCheck
cell sample collection procedure; EsoCheck devices and EsoGuard mailers (cell sample shipping costs) distributed to medical
practitioners’ locations and the Lucid Test Centers; Lucid Test Centers operating expenses, including rent
expense and supplies; and royalty fees incurred under the Amended CWRU License Agreement.
F- 20
Note
5 — Related Party Transactions
Case
Western Reserve University and Physician Inventors - CWRU License Agreement
Case
Western Reserve University (“CWRU”) and each of the three physician inventors of the intellectual property licensed under
the CWRU License Agreement (“Physician Inventors”) each hold equity ownership minority interests in Lucid Diagnostics Inc.
The expenses incurred with respect to the CWRU License Agreement and the three Physician Inventors, as classified in the accompanying
consolidated statement of operations for the periods indicated are summarized as follows:
Schedule of Incurred Expenses of Minority Shareholders
2021
2020
For
the year ended December 31,
2021
2020
Cost
of Revenue
CWRU
– Royalty Fee
$ 25
$ —
General
and Administrative Expense
CWRU
– License Agreement - Amendment Fee - Milestone III
10
100
Stock-based
compensation expense – Physician Inventors’ restricted stock awards
910
—
Research
and Development Expense
CWRU
License Agreement - reimbursement of patent legal fees
195
250
EsoCheck
devices provided to CWRU
—
15
Fees
- Physician Inventors’ consulting agreements
29
83
Stock-based
compensation expense – Physician Inventors’ stock options
169
23
Total
Related Party Expenses
$ 1,338
$ 471
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. 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 14, 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 17, Noncontrolling
Interest , for a discussion of Lucid Diagnostics Inc. and the corresponding noncontrolling interests.
F- 21
Note
5 —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
of $ 21 and $ 7 in the years ended December 31, 2021 and 2020, respectively, in connection with the consulting agreement.
Veris
Health Inc. entered into a consulting agreement with Andrew Thoreson, M.D. effective June 2021 with such consulting agreement providing
for compensation on a contractual rate per hour for consulting services provided. Veris Health Inc. recognized general and administrative
expense of $ 54 in the year ended December 31, 2021 in connection with the consulting agreement.
F- 22
Note
6 — 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 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 . 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
Acquisition
- Oncodisc Inc.
Amount
Cash
Acquired
$ 108
Intangible
asset - in process R&D
133
Other
current assets
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 “Intangible assets, net” on the accompanying consolidated balance sheet, has an expected useful
life of one year, and is being recognized on a ratable basis over such period, which commenced in June 2021. See Note 17,
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 the membership interest of
CapNostics, LLC (“CapNostics”) for total (gross) purchase consideration of approximately $ 2.1
million of cash paid at the closing of the
transaction. The acquisition of CapNostics was accounted for as an asset acquisition. The intangible asset recognized for the defensive
technology of approximately $ 2.1
million, which is included in “Intangible
assets, net” on the accompanying consolidated balance sheet, has an expected useful life of five
years , and is being recognized on a ratable
basis over such period, which commenced in October 2021.
The Company 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
Acquisition
- CapNostics, LLC
Amount
Cash
Acquired
$ 5
Other
current assets
6
Intangible
asset - defensive technology
2,104
Liabilities
assumed
( 10 )
Total
net assets acquired
$ 2,105
Amortization
- Acquired Intangible Assets
Amortization
expense of the acquired intangible assets discussed above was $ 146 for the year ended December 31, 2021 (there was no such amortization
expense for the prior year ended December 31, 2020), and is included in general and administrative expenses in the accompanying consolidated
statements of operations. The scheduled future amortization expense of such acquired intangible assets is as follows: $ 449 for the year
2022; $ 420 for each of the years 2023, 2024, and 2025; and $ 319 for the year 2026.
F- 23
Note
7 — Prepaid Expenses, Deposits, and Other Current and Non-Current Assets
Current Assets
Prepaid
expenses and other current assets consisted of the following as of:
Schedule of Prepaid Expenses and Other Current Assets
December
31, 2021
December
31, 2020
Advanced
payments to service providers and suppliers
$ 2,084
$ 507
Prepaid insurance
1,856
61
Deposits
713
262
EsoCheck
cell collection supplies
434
779
EsoGuard
mailer supplies
59
55
CarpX devices
33
21
Total
prepaid expenses, deposits and other current assets
$ 5,179
$ 1,685
Non-Current
Assets
The
Company, through its majority-owned subsidiary Lucid Diagnostics Inc., entered into an agreement with a clinical research organization
(“CRO”) in connection with EsoGuard clinical trials (the “EsoGuard CRO Agreement”). The term of the EsoGuard
CRO Agreement is from the September 2019 effective date to the conclusion of the respective clinical trials, but not to exceed 60 months
from the effective date of the EsoGuard CRO Agreement. The CRO agreement may be cancelled with sixty days written notice, without an
early termination fee. The Company incurred an on-account deposit of $ 725
and $ 755
as of December 31, 2021 and 2020, respectively,
with the deposit classified as a non-current asset in the line item captioned “Other assets” on the accompanying consolidated
balance sheets as of December 31, 2021 and 2020. See Note 11, Commitment and Contingencies , for a discussion of the EsoGuard
CRO Agreement.
Note
8 — Fixed Assets
Fixed
assets, less accumulated depreciation, consisted of the following as of:
Schedule of Fixed Assets
Estimated
Useful Life
December
31, 2021
December
31, 2020
Computer
and office equipment
2 - 5
years
$ 426
$ 51
Laboratory
equipment
3 - 7
years
1,161
88
Furniture
and fixtures
3 - 5
years
96
—
Leasehold
improvements
- (1)
2
—
Assets
under construction
n/a
38
—
Total
Fixed Assets
1,723
139
Less
Accumulated Depreciation
( 138 )
( 57 )
Total
Fixed Assets, net
$ 1,585
$ 82
(1) Lesser of remaining lease term or estimated useful life.
The assets under
construction presented above are with respect to the establishment of a Company-owned CLIA-certified, CAP-accredited commercial
clinical laboratory. The total fixed assets is inclusive of $ 99 of accounts payable and $ 16 of accrued expenses and other current liabilities in the accompanying consolidated balance sheet as of December 31, 2021. Depreciation expense of $ 80 and $ 23 for the years ended December 31, 2021 and 2020, respectively, is included in general and administrative expenses in the accompanying consolidated statements of operations.
F- 24
Note
9 — Leases
As
of December 31, 2021, the Company only had short-term leases, inclusive of: an office rental agreement is on a month-to-month basis, with
a 5% per annum increase in the monthly lease payment effective February 1 of each year, with such rental agreement able to be cancelled
with two months written notice; and two other month-to-month office space rental agreements, each of which have an April 30, 2022 termination
date. The total rent expense incurred under month-to-month rental agreements was $ 191 and $ 189 , for the years ended December 31, 2021
and 2020, respectively.
In
addition to the short-term leases as of December 31, 2021 noted above, the Company entered into additional lease agreements, each
with commencement dates subsequent to December 31, 2021, classified as operating leases and short-term leases, including for each
of: a research and development facility; a commercial clinical laboratory; a light manufacturing facility; additional Lucid Test
Centers; and for office space.
As
of December 31, 2021, with respect to short-term leases: the total future lease payments of both the (existing) short-term leases effective
as of December 31, 2021 plus the (new) short-term leases (i.e. the new short-term leases with commencement dates subsequent to December
31, 2021), are $ 178 in 2022 and $ 9 in 2023.
As
of December 31, 2021, with respect to operating leases: the total future lease payments of the (new) operating leases (i.e. the new operating
leases with commencement dates subsequent to December 31, 2021), are as follows:
Schedule
of future minimum lease payments for capital leases
2022
$ 1,359
2023
1,592
2024
1,560
2025
696
2026
712
Thereafter
277
Total lease payments
6,196
Note
10 — Accrued Expenses and Other Current Liabilities
Accrued
expenses and other current liabilities consisted of the following items as of :
Schedule of Accrued Expenses and Other Current Liabilities
December
31, 2021
December
31, 2020
Compensation
and Employee Benefits
$ 3,151
$ 1,777
CWRU
License Agreement fee
—
223
CWRU
License Agreement Amendment fee
—
100
CWRU
Amended License Agreement - Royalty fee
25
—
Operating
expenses
1,083
171
EsoGuard
mailer supplies
—
22
CarpX
devices
—
32
Total
accrued expenses and other current liabilities
$ 4,259
$ 2,325
The
“Compensation and Employee Benefits” includes: discretionary bonus payments to employees; unused employee vacation time;
and employee payroll deductions related to the PAVmed Inc. Employee Stock Purchase Plan (“PAVmed Inc. ESPP”). See Note 14,
Stock-Based Compensation , for additional information on the PAVmed Inc. ESPP.
See
Note 3, Patent License Agreement - Case Western Reserve University , for a discussion of the CWRU License Agreement.
The
amounts for operating expenses and EsoGuard supplies presented above relate to respective amounts incurred by the Company but
not yet invoiced by the respective vendors.
F- 25
Note
11 — Commitment and Contingencies
Clinical
Trials - Agreement with Clinical Research Organization
The
Company, through its majority-owned subsidiary Lucid Diagnostics Inc., entered into an agreement with a clinical research organization
(“CRO”) in connection with EsoGuard clinical trials, referred to as the EsoGuard CRO Agreement. The CRO will assist the Company
with conducting two concurrent clinical trials referred to as the “EsoGuard screening study” and the “EsoGuard case
control study”. The term of the EsoGuard CRO Agreement is from the September 2019 effective date to the conclusion of the respective
clinical trials, but not to exceed 60 months from the effective date of the EsoGuard™ CRO Agreement. The CRO agreement may be cancelled
with sixty days written notice, without an early termination fee.
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 did not seek any specific monetary damages. The Company did
not believe it was clear the prior approval of these matters was invalid or otherwise ineffective. However, to avoid any uncertainty
and the expense of further litigation, on January 5, 2021, the Company’s Board of Directors determined it would be advisable and
in the best interests of the Company and its stockholders to re-submit these proposals to the Company’s stockholders for ratification
and/or approval. In this regard, the Company held a special meeting of stockholders on March 4, 2021, at which such matters were ratified
and approved. The parties have reached agreement on a proposed Settlement Term Sheet Agreement, dated January 28, 2021, to settle the
complaint, the terms of which do not contemplate payment of monetary damages to the putative class in the proceeding. The settlement
of the complaint is pending approval by the Court.
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 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 affiliated with 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.
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.
F- 26
Note
12 — 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
Inputs
Level-2
Inputs
Level-3
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. There were no transfers between the respective
Levels during the year ended December 31, 2020.
Convertible
notes are 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 consolidated statement
of operations.
There
were no fair value measurements as of December 31, 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 13, 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 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, using the following assumptions:
Senior
Secured Convertible Notes and Senior Convertible Note - Fair Value and Fair Value Assumptions – December 31, 2020:
Schedule
of Fair Value Assumption Used
November
2019 Senior Secured Convertible Notes
April
2020 Senior Convertible Note
August
2020
Senior
Secured Convertible Note
Fair
Value
$ 1,270
$ 4,600
$ 8,790
Face
value principal payable
$ 956
$ 4,111
$ 7,750
Required
rate of return
0.09 %
50.20 %
27.20 %
Conversion
Price
$ 1.60
$ 5.00
$ 5.00
Value
of common stock
$ 2.12
$ 2.12
$ 2.12
Expected
term (years)
0.25
1.33
1.59
Volatility
70.00 %
70.00 %
70.00 %
Risk
free rate
0.09 %
0.11 %
0.12 %
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 /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.
F- 27
Note
13 — 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
as of 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), resulting in the recognition of a loss from extinguishment
of debt of approximately $ 760 .
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 years ended December 31, 2021 and 2020, approximately $ 52 and $ 215 ,
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 years ended December 31, 2021 and 2020, approximately $ 102 and $ 246 ,
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 year ended December 31, 2021 in connection with the repayments of the April 2020 Senior Convertible Note
and the August 2020 Senior Convertible Note.
F- 28
Note
13 — Debt - continued
Convertible
Notes - continued
A
reconciliation of the fair value of the convertible notes for the year ended December 31, 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 December 31, 2021 (1)
$ —
$ —
$ —
$ —
-
Other
Income (Expense) - Change in fair value – year ended December 31, 2021 (1)
$ 1,682
(1) As discussed above,
all remaining convertible notes were previously repaid during the three months ended March 31, 2021.
A
reconciliation of the fair value of the convertible notes for the year ended December 31, 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
4,111
7,750
18,861
—
Fair
value adjustment – issue date
—
2,600
( 411 )
( 750 )
1,439
( 1,439 )
Installment
repayments – common stock
( 1,692 )
( 13,044 )
—
—
( 14,736 )
—
Non-installment
payments – common stock
( 6 )
( 464 )
—
—
( 470 )
—
Non-installment
payments – cash
—
( 138 )
( 216 )
( 246 )
( 600 )
—
Change
in fair value
( 2 )
( 1,123 )
1,116
2,036
2,027
( 2,027 )
Lender
Fees:
November
2019 Senior Secured Convertible Note - Series B;
—
—
—
—
—
( 700 )
April
2020 Senior Convertible Note; and
—
—
—
—
—
( 411 )
August
2020 Senior Secured Convertible Note
—
—
—
—
—
( 750 )
Fair
Value at December 31, 2020
$ —
$ 1,270
$ 4,600
$ 8,790
$ 14,660
-
Other
Income (Expense) - Change in fair value – year ended December 31, 2020
$ ( 5,327 )
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 12,
Financial Instruments Fair Value Measurements, for a further discussion of fair value assumptions.
F- 29
Note
13 — 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 consolidated statements of operations in the year ended December 31, 2021.
Note
14 — 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 11,951,081 shares of common stock of PAVmed Inc. are reserved for issuance under the PAVmed Inc. 2014 Equity Plan, with 1,160,573
shares available for grant as of December 31, 2021. 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 December 31, 2021.
PAVmed
Inc. 2014 Equity Plan - Stock Options
Stock
options issued and outstanding under the PAVmed Inc. 2014 Equity Plan and including PAVmed stock options granted outside the plan
is 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, 2019
5,203,529
$ 2.58
8.1
$ 394
Granted (1)
1,595,000
$ 2.13
Exercised
—
$ —
Forfeited
—
$ —
Outstanding
stock options at December 31, 2020
6,798,529
$ 2.55
7.3
$ 2,558
Vested
and exercisable stock options at December 31, 2020
4,861,433
$ 2.88
6.7
$ 1,707
Outstanding
stock options at December 31, 2020
6,798,529
$ 2.55
7.3
$ 2,558
Granted (1)
2,900,000
$ 4.90
Exercised
( 621,164 )
$ 1.58
Forfeited
( 357,167 )
$ 2.82
Outstanding
stock options at December 31, 2021
8,720,198
$ 3.39
6.8
$ 3,516
Vested
and exercisable stock options at December 31, 2021
6,228,106
$ 2.88
5.7
$ 3,245
(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 December 31, 2021 and 2020 and the exercise price of the underlying
PAVmed Inc. stock options, to the extent such quoted price is greater than the exercise price.
F- 30
Note
14 — Stock-Based Compensation - continued
PAVmed
Inc. 2014 Long-Term Incentive Equity Plan - continued
PAVmed
Inc. 2014 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
$ 1.5 million, which was measured using the grant date quoted closing price per share of PAVmed Inc. common stock, is 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.
On
December 15, 2021, a total of 100,000
restricted stock awards were granted to consultants
outside of the PAVmed Inc. 2014
Equity Plan, with such restricted stock awards having a single vesting date of December 15, 2023 .
The (December 15, 2021) restricted stock awards fair value of approximately $ 0.3
million, which was measured using the grant date
quoted closing price per share of PAVmed Inc. common stock, is 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 $ 2.7 million, which was measured using the respective grant date quoted closing
price per share of PAVmed Inc. common stock, with the 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 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.
Subsequent
to December 31, 2021, as of March 29, 2022, additional stock-based equity grants of 3.1 million stock options with a weighted average exercise price of $ 1.67
were granted under the PAVmed Inc 2014 Equity Plan.
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 5,644,000 shares
of common stock of Lucid Diagnostics Inc. are reserved for issuance under the Lucid Diagnostics Inc. 2018 Equity Plan, with 2,752,615 shares
available for grant as of December 31, 2021, with the share reservation not diminished by a total of 473,300 Lucid
Diagnostics Inc. stock options and restricted stock awards granted outside the Lucid Diagnostics Inc. 2018 Equity
Plan.
F- 31
Note
14 — Stock-Based Compensation - continued
Lucid
Diagnostics Inc. 2018 Equity Plan - Stock Options
Stock
options issued and outstanding under the Lucid Diagnostics Inc. 2018 Equity Plan and including Lucid Diagnostics options granted outside
the plan is as follows:
Schedule of Summarizes Information About Stock Options
Number
of Stock Options
Weighted
Average Exercise Price
Remaining
Contractual Term (Years)
Outstanding
stock options at December 31, 2019
1,403,945
$ 0.61
9.0
Granted (1)
—
$ —
Exercised
( 4,703 )
$ 1.06
Forfeited
—
$ —
Outstanding
stock options at December 31, 2020
1,399,242
$ 0.61
8.0
Vested
and exercisable stock options at December 31, 2020
1,085,288
$ 0.58
7.9
Outstanding
stock options at December 31, 2020
1,399,242
$ 0.61
8.0
Granted (1)
20,000
$ 9.08
Exercised
—
$ —
Forfeited
—
$ —
Outstanding
stock options at December 31, 2021
1,419,242
$ 0.60
7.0
Vested
and exercisable stock options at December 31, 2021
1,337,417
$ 0.61
7.0
(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.
Lucid
Diagnostics Inc. 2018 Equity Plan – Restricted Stock Awards
As
of December 31, 2021, a total of 1,897,795
restricted stock awards were granted under
the Lucid Diagnostics Inc. 2018 Equity Plan, summarized as follows:
On
March 1, 2021, a total of 1,467,440 restricted stock awards were granted under the Lucid Diagnostics Inc. 2018 Equity Plan 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, 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. The restricted stock awards are subject
to forfeiture if the requisite service period is not completed.
In
April 2021, a total of 91,715 restricted stock awards were granted under the Lucid Diagnostics Inc 2018 Equity Plan, inclusive of such
restricted stock awards granted to an employee of PAVmed Inc. and a consultant, 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. The restricted stock awards are subject to forfeiture if the requisite service period is not completed.
As of December 31, 2021, a total of 7,055 restricted stock awards have been forfeited.
In
July 2021, a total of 84,660 restricted stock awards were granted under the Lucid Diagnostics Inc 2018 Equity Plan, inclusive of such
restricted stock awards granted to member of the board of directors of Lucid Diagnostics Inc. with such restricted stock awards having
a single vesting date in July 2023, and an aggregate grant date fair value of approximately $ 1.1 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. The restricted stock awards are subject to forfeiture if the requisite service
period is not completed.
F- 32
Note
14 — Stock-Based Compensation - continued
Lucid
Diagnostics Inc. 2018 Equity Plan – Restricted Stock Awards - continued
In
September 2021, 169,320
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., with such restricted
stock award vesting ratably over a two year period with vesting dates of each of September 15, 2022 and 2023, and an
aggregate grant date fair value of approximately $ 2.3
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. The restricted stock awards are subject to forfeiture if the requisite service period
is not completed.
On October 14,
2021, 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., with such restricted stock awards having a single vesting date of October 14, 2023 , and
an aggregate grant date fair value of approximately $ 1.0
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.
On
December 15, 2021, 50,000
restricted stock awards were granted outside
of the Lucid Diagnostics Inc 2018 Equity Plan, with such restricted stock award having a single vesting date on December 15,
2023 , and an aggregate grant date fair value of approximately $ 0.3
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.
Subsequent to December 31, 2021, as of March 29, 2022, additional stock-based equity grants under the Lucid Diagnostics Inc. 2018 Equity Plan included each of: 1.8 million stock options with a weighted average exercise price of approximately $ 4.16 per share and the same vesting and contractual term as discussed above; and a total of 320,000 restricted stock awards with a weighted average grant date fair value of $ 4.52 per share of Lucid Diagnostics Inc. common stock, with single vesting date of three years from date of grant.
The
price per share of Lucid Diagnostics Inc. common stock used in the computation of estimated fair value of stock options and restricted
stock awards granted under the Lucid Diagnostics Inc. 2018 Equity Plan is as follows: (i) from October 14, 2021 to December 31, 2021
it is its quoted closing price per share on date of grant; and (ii) for the period January 1, 2021 to October 13, 2021, it
was estimated 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, wherein,
the 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.; and (iii) as of December 31, 2020, it was estimated
using a discounted cash flow analysis applied to a multi-year forecast of its future cash flows.
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 2.5%-25%
for the stay private scenario .
F- 33
Note
14 — 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
Year
Ended December 31,
2021
2020
Sales
and marketing expenses
$ 1,177
$ 278
General
and administrative expenses
12,799
1,304
Research
and development expenses
1,033
462
Total
stock-based compensation expense
$ 15,009
$ 2,044
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 5, 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
Year
Ended December 31,
2021
2020
Lucid
Diagnostics Inc 2018 Equity Plan – sales and marketing expenses
$ 8
$ —
Lucid
Diagnostics Inc 2018 Equity Plan – general and administrative expenses
9,073
—
Lucid
Diagnostics Inc 2018 Equity Plan – research and development expenses
66
52
PAVmed
Inc 2014 Equity Plan - sales and marketing expenses
202
—
PAVmed
Inc 2014 Equity Plan - general and administrative expenses
38
—
PAVmed
Inc 2014 Equity Plan - research and development expenses
212
13
Total
stock-based compensation expense – recognized by Lucid Diagnostics Inc
$ 9,599
$ 65
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
$ 7,559
1.8
Restricted
Stock Awards
$ 2,021
1.2
Lucid
Diagnostics Inc. 2018 Equity Plan
Stock
Options
$ 100
0.6
Restricted
Stock Awards
$ 16,000
1.3
F- 34
Note
14 — 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 $ 3.46 per share and $ 1.27 per share during the years ended December 31, 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
Year
Ended December 31,
2021
2020
Expected
term of stock options (in years)
5.6
5.8
Expected
stock price volatility
76.0 %
73.0 %
Risk
free interest rate
1.0 %
0.5 %
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 $ 5.13 per share during the year ended December 31, 2021. There were
no stock-based awards granted under the Lucid Diagnostics Inc. 2018 Equity Plan during the year ended December 31, 2020. 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
Year
Ended December 31,
2021
2020
Expected
term of stock options (in years)
5.7
0.0
Expected
stock price volatility
70.0 %
— %
Risk
free interest rate
1.3 %
— %
Expected
dividend yield
— %
— %
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 December 31, 2021.
Lucid
Diagnostics, Inc Employee Stock Purchase Plan (“ESPP”)
The
Lucid Diagnostics Inc. Employee Stock Purchase Plan (“Lucid Diagnostics Inc. ESPP”), adopted by the Company’s board
of directors effective November 9. 2021, provides eligible employees the opportunity to purchase shares of Lucid Diagnostics 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 Lucid Diagnostics Inc. common stock at the beginning or end of each six month share purchase period.
The Lucid Diagnostics Inc. ESPP share purchase dates are March 31 and September 30. The initial ESPP purchase date will be September
30, 2022.
The
Lucid Diagnostics Inc. ESPP has a total reservation of 500,000 shares of common stock of PAVmed Inc. of which 500,000 shares are available-for-issue
remaining as of December 31, 2021.
F- 35
Note
15 — Preferred Stock
The
Company is authorized to issue 20 million shares of its Series B Convertible 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.
Series
B Convertible Preferred Stock
As of December 31, 2021 and 2020,
there were 1,113,919 and 1,228,075 shares of Series B Convertible Preferred Stock (classified in permanent equity) issued and outstanding,
respectively.
The
Series B Convertible Preferred Stock is issued pursuant to the PAVmed Inc. Certificate of Designation of Preferences, Rights, and Limitations
of Series B Convertible Preferred Stock (“Series B Convertible Preferred Stock Certificate of Designation”), has a par value
of $ 0.001 per share, no voting rights, a stated value of $ 3.00 per share, and is immediately convertible upon its issuance. At the holders’
election, a share of Series B Convertible Preferred Stock is convertible into a share of common stock of the Company at a common stock
conversion exchange factor equal to a numerator and denominator of $ 3.00 , with each such numerator and denominator not subject to further
adjustment, except for the effect of stock dividends, stock splits or similar events affecting the Company’s common stock. The
Series B Convertible Preferred Stock shall not be redeemed for cash and under no circumstances shall the Company be required to net cash
settle the Series B Convertible Preferred Stock.
The
Series B Convertible Preferred Stock Certificate of Designation provides for dividends at a rate of 8 % 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. The dividends
may be settled after October 1, 2021, at the option of the Company, 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.
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 corresponding periods 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.
During
the year ended December 31, 2021, the Company’s board-of-directors declared an aggregate of approximately $ 288 of Series B Convertible
Preferred Stock dividends, earned as of December 31, 2020, March 31, 2021, June 30, 2021, and September 30, 2021, which have been settled
by the issue of an additional aggregate 96,292 shares of Series B Convertible Preferred Stock.
During
the year ended December 31, 2020, the Company’s board-of-directors declared an aggregate of approximately $ 284 of Series B Convertible
Preferred Stock dividends, earned as of December 31, 2019, March 31, 2020, June 30, 2020, and September 30, 2020, which have been settled
by the issue of an additional aggregate 94,866 shares of Series B Convertible Preferred Stock.
Subsequent
to December 31, 2021, in January 2022, the Company’s board-of-directors declared a Series B Convertible Preferred Stock dividend
earned as of December 31, 2021 and payable as of January 1, 2022, of approximately $ 67 , which will be settled by the issue of an additional
22,291 shares of Series B Convertible Preferred Stock (with such dividend not recognized as a dividend payable as of December 31, 2021,
as the Company’s board of directors had not declared such dividends payable as of such date).
In
the year ended December 31, 2021 and 2020, at the election of the holders, a total of 210,448 and 25,000 shares of Series B Convertible
Preferred Stock, respectively, were converted into the same number of shares of common stock of the Company.
F- 36
Note
16 — Common Stock and Common Stock Purchase Warrants
Common
Stock
The
Company is authorized to issue up to 150 million shares of its common stock, par value of $ 0.001 per share. There were 86,367,845 and
63,819,935 shares of common stock issued and outstanding as of December 31, 2021 and December 31, 2020, respectively.
Year
Ended December 31, 2021
● 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 13, Debt .
● During
the year ended December 31, 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 15, Preferred Stock , for a discussion
of the Series B Convertible Preferred Stock.
● During
the year ended December 31, 2021, an aggregate of 4,881,429 shares of common stock of the
Company were issued upon exercise of common stock purchase warrants, including 4,877,484
with respect to Series Z Warrants; and 3,945 with respect to Series W Warrants.
● During
the year ended December 31, 2021, 621,164
shares
of common stock of the Company were issued upon exercise of stock options for cash of approximately
$ 980 .
See Note 14, Stock-Based Compensation , for a discussion of the PAVmed Inc.
2014 Equity Plan.
● During
the year ended, the PAVmed Inc. Employee Stock Purchase Plan purchased 234,592
shares
of common stock of the Company. See Note 14, Stock-Based Compensation , for
a discussion of the PAVmed Inc. Employee Stock Purchase Plan.
Year
Ended December 31, 2020
● During
2020, a total of 10,647,500 shares of common stock of the Company were issued for gross proceeds
of approximately $ 17,036 , before a total placement agent fee and expenses of approximately
$ 1,004 , and total offering costs of approximately $ 100 . The shares of common stock were issued
in two registered direct offerings pursuant to a respective Prospectus Supplement dated December
11, 2020 and December 18, 2020, each with respect to the Company’s effective shelf
registration statement on Form S-3 (File No. 333-248709).
● In
2020, a total of 10,929,202 shares of common stock of the Company were issued upon partial
conversions of each of the December 2018 Senior Convertible Note and the November 2019 Senior
Convertible Notes, as discussed in Note 12, Debt .
● In
2020, 306,555
shares
of common stock were purchased by employees through participation in the PAVmed Inc. Employee
Stock Purchase Plan, as discussed in Note 14, Stock-Based Compensation .
F- 37
Note
16 — 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
December
31, 2021
Weighted
Average Exercise Price / Share
December
31, 2020
Weighted
Average Exercise Price / Share
Expiration
Date
Series
Z Warrants
11,937,455
$ 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
12,315,328
$ 1.70
17,249,757
$ 1.68
During
the year ended December 31, 2021, a total of 4,877,484
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.
During
the year ended December 31, 2021, a total of 3,945
Series W Warrants were exercised for cash at
$ 5.00
per share, resulting in the issue of the same
number of shares of common stock of the Company. Subsequent to December 31, 2021, the 377,873 Series W Warrants issued
and outstanding as of December 31, 2021, expired unexercised as of January 29, 2022.
The
Unit Purchase Options (UPO) expired unexercised as of January 29, 2021.
Series
Z Warrants
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
after the close of business on April 30, 2024, if not earlier redeemed by the Company , as discussed below. The Series Z Warrant exercise
price is not subject-to adjustment, unless by action of the PAVmed Inc. board of directors, or the effect of stock dividends, stock splits
or similar events affecting the common stock of the Company. Under no circumstances will the Company be required to net cash settle the
Series Z Warrants, nor to pay any liquidated damages in lieu of delivery of shares of common stock of the Company resulting from a failure
to satisfy any obligations under the Series Z Warrant.
The
Company may redeem the Series Z Warrants, at the Company’s option, in whole or in part, at a price of $0.01 per Series Z Warrant
at any time while the Series Z Warrants are exercisable, upon a minimum of 30 days’ prior written notice of redemption, if, and
only if, the volume weighted average closing price of the common stock of the Company equals or exceeds $9.00 (subject to adjustment)
for any 20 out of 30 consecutive trading days ending three business days before the Company issues its notice of redemption, and provided
the average daily trading volume in the common stock of the Company during such 30-day period is at least 20,000 shares per day; and
if, and only if, there is a current registration statement in effect with respect to the shares of Common Stock underlying such Series
Z Warrants.
F- 38
Note
17 — 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
2021
2020
Year
Ended December 31,
2021
2020
NCI
– equity (deficit) – beginning of period
$ ( 2,369 )
$ ( 814 )
Investment
in Veris Health Inc.
6
—
Net
loss attributable to NCI – Lucid Diagnostics Inc.
( 5,280 )
( 1,503 )
Net
loss attributable to NCI – Solys Diagnostics Inc.
( 34 )
( 109 )
Net
loss attributable to NCI – Veris Health Inc.
( 465 )
—
Impact
of subsidiary equity transactions
16,760
—
Lucid
Diagnostics Inc. 2018 Equity Plan stock option exercise
—
5
Stock-based
compensation expense - Lucid Diagnostics Inc. 2018 Equity Plan
9,134
52
NCI
– equity (deficit) – end of period
$ 17,752
$ ( 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 December 31, 2021
and December 31, 2020, and the recognition of a net loss attributable to the NCI in the consolidated statement of operations for the
years ended December 31, 2021 and 2020; and Veris Health Inc. as a component of consolidated total stockholders’ equity as of December
31, 2021, and the recognition of a net loss attributable to the NCI in the consolidated statement of operations for the period May 28,
2021 (inception date) to December 31, 2021.
Lucid
Diagnostics Inc.
As
of December 31, 2021 there were 34,917,907 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 a controlling financial interest in Lucid Diagnostics
Inc., and accordingly, Lucid Diagnostics Inc. is a consolidated majority-owned subsidiary of PAVmed Inc.
Effective
October 6, 2021, the Lucid Diagnostics Inc. board of directors declared a 1.411-to-1.0 common stock-split. The number of shares of common
stock of Lucid Diagnostics Inc. and the stock options and restricted stock awards granted under the Lucid Diagnostics Inc. 2018 Equity
Plan, and the respective exercise and /or conversion price per share, for all periods presented, as applicable, have been adjusted for
such common stock-split.
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 $ 22,400,000 , an annual interest
rate of 7.875 %, and a maturity date of May 18, 2028 . The Senior Unsecured Promissory Note replaced the $ 22.4 million aggregate outstanding
and payable balance of the intercompany Due To: PAVmed Inc. as of June 1, 2021. The Senior Unsecured Promissory Note 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 the election of PAVmed Inc., at a conversion price of $ 1.42 per share of Lucid Diagnostics Inc. common stock (with
such number of such shares and the conversion price adjusted for the Lucid Diagnostics Inc. 1.411-to-1.0 common stock split effective
October 6, 2021 as discussed above).
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 shares of common stock were issued, inclusive
of 571,428
issued to PAVmed Inc., at an IPO offering price
of $ 14.00
per share, resulting gross proceeds to Lucid
Diagnostics Inc. of $ 70.0
million, before underwriting fees of $ 4.9
million, and approximately $ 0.7
million of offering costs incurred by Lucid Diagnostics
Inc.
F- 39
Note
17 — Noncontrolling Interest - continued
Veris
Health Inc.
As
of December 31, 2021, 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 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
consolidated balance sheet as of December 31, 2021 along with the recognition of a net loss attributable to the NCI in the consolidated
statement of operations for the period of May 28, 2021 to December 31, 2021, upon its formation and contemporaneous acquisition of Oncodisc
Inc., as such the acquisition is discussed in Note 6, Acquisitions, subsection: Oncodisc Inc.
Solys
Diagnostics Inc.
As
of each of December 31, 2021 and December 31, 2020, 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 has a controlling financial interest, with the remaining
9.6765 % minority-interest ownership held by unrelated third parties. Accordingly, Solys Diagnostics 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 consolidated balance sheet as of December 31, 2021 and December 31, 2020, along with the recognition
of a net loss attributable to the NCI in the consolidated statement of operations for the years ended December 31, 2021 and 2020.
F- 40
Note
18 — Income Taxes
Income
tax (benefit) expense for respective periods noted is as follows:
Schedule of Income Tax (Benefit) Expense
2021
2020
Year
Ended December 31,
2021
2020
Current
Federal,
State and Local
$ —
$ —
Deferred
Federal
( 9,528 )
( 4,571 )
State
and Local
( 9,409 )
( 4,147 )
Deferred
Federal, State and Local
( 18,937 )
( 8,718 )
Less:
Valuation allowance reserve
18,937
8,718
Income
tax expense (Benefit)
$ —
$ —
The
reconciliation of the federal statutory income tax rate to the effective income tax rate for the respective period noted is as follows:
Schedule
of Effective Income Tax Rate Reconciliation
2021
2020
Year
Ended December 31,
2021
2020
U.S.
federal statutory rate
21.0 %
21.0 %
U.S.
state and local income taxes, net of federal benefit
13.2 %
9.9 %
Permanent
differences
( 0.6 ) %
( 5.8 )%
Other
0.1 %
( 0.8 )%
Valuation
allowance
( 33.7 ) %
( 24.3 )%
Effective
tax rate
— %
— %
The
tax effects of temporary differences which give rise to the net deferred tax assets for the respective period noted is as follows:
Schedule
of Deferred Tax Assets and Liabilities
2021
2020
Year
Ended December 31,
2021
2020
Deferred
Tax Assets
Net
operating loss
$ 35,989
$ 21,836
Non-deductible
interest expense
—
517
Debt
issue costs
—
205
Stock-based
compensation expense
7,091
1,901
Patent
licenses
—
14
Research
and development tax credit carryforwards
428
396
Accrued
expenses
897
552
Section
195 deferred start-up costs
16
24
Deferred
tax assets
$ 44,421
$ 25,445
Deferred
Tax Liabilities
Depreciation
( 22 )
( 19 )
Patent licenses
( 36 )
—
Deferred
Tax Liabilities
$ ( 58 )
$ ( 19 )
Deferred
tax assets, net of deferred tax liabilities
44,363
25,426
Less:
valuation allowance
( 44,363 )
( 25,426 )
Deferred
tax assets, net after valuation allowance
$ —
$ —
F- 41
Note
18 — Income Taxes - continued
Deferred
tax assets and deferred tax liabilities resulting from temporary differences are measured using enacted tax rates expected to apply to
taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect of the change in
the tax rate is recognized as income or expense in the period the change in tax rate is enacted.
As
required by FASB ASC Topic 740, Income Taxes, (“ASC 740), a “more-likely-than-not” criterion is applied when assessing
the estimated realization of deferred tax assets through their utilization to reduce future taxable income, or with respect to a deferred
tax asset for tax credit carryforward, to reduce future tax expense. A valuation allowance is established, when necessary, to reduce
deferred tax assets, net of deferred tax liabilities, when the assessment indicates it is more-likely-than-not, the full or partial amount
of the net deferred tax asset will not be realized. Accordingly, the Company evaluated the positive and negative evidence bearing upon
the estimated realizability of the net deferred tax assets, and based on the Company’s history of operating losses, concluded it
is more-likely-than-not the deferred tax assets will not be realized, and therefore recognized a valuation allowance reserve equal to
the full amount of the deferred tax assets, net of deferred tax liabilities, as of December 31, 2021 and 2020. As of December 31,
2021 and 2020, the deferred tax asset valuation allowance increased by $ 18,937 and $ 8,718 , respectively.
The
Company has total estimated federal net operating loss (“NOL”) carryforward of approximately $ 104.1 million and $ 63.0
million as of December 31, 2021 and 2020, respectively,
which is available to reduce future taxable income, of which approximately $ 13.8 million have statutory
expiration dates commencing in 2036 ,
and approximately $ 90.3 million which
do not have a statutory expiration date. The Company has not yet conducted a formal analysis and the NOL carryforward may be subject-to
limitation under U.S. Internal Revenue Code (“IRC”) Section 382 (provided there was a greater than 50% ownership change,
as computed under such IRC Section 382). The State and Local NOL carryforwards of approximately $ 103.9 million have statutory
expiration dates commencing in 2036. The Company has total estimated research and development (“R&D”) tax credit carryforward
of approximately $ 0.4 million as of December 31, 2021 which are available to reduce future tax expense and have statutory
expiration dates commencing in 2036.
On
March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) was enacted in response to the pandemic
resulting from the outbreak of a novel strain of a coronavirus designated as the “Severe Acute Respiratory Syndrome Coronavirus
2” - or “SARS-CoV-2”. The pandemic resulting from SARS-CoV-2 is commonly referred to by its resulting illness of “coronavirus
disease-2019” (“COVID-19”), and is referred to herein as the COVID-19 pandemic.
Among
other provisions, the CARES Act increases the limitation on the allowed business interest expense deduction from 30 percent to 50 percent
of adjusted taxable income for tax years beginning January 1, 2019 and 2020 and allows businesses to immediately expense the full cost
of Qualified Improvement Property, retroactive to tax years beginning on or after January 1, 2018. Additionally, the CARES Act permits
net operating loss carryovers (“NOLs”) and carrybacks to offset 100% of taxable income for taxable years beginning before
2021. In addition, the CARES Act allows NOLs incurred in 2018, 2019, and 2020 to be carried back to each of the five preceding taxable
years to generate a refund of previously paid income taxes. The Company evaluated the impact of these CARES Act provisions
and determined they did not have a material impact on the consolidated income tax provision.
The
Company files income tax returns in the United States in federal and applicable state and local jurisdictions. The Company’s tax
filings for the years 2017 and thereafter each remain subject to examination by taxing authorities. The Company’s policy is to
record interest and penalties related to income taxes as part of its income tax provision. The Company has not recognized any penalties
or interest related to its income tax provision.
F- 42
Note
19 — 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
Year
Ended December 31,
2021
2020
Numerator
Net
loss - before noncontrolling interest
$ ( 56,126 )
$ ( 35,888 )
Net
loss attributable to noncontrolling interest
5,779
1,612
Net
loss - as reported, attributable to PAVmed Inc.
$ ( 50,347 )
$ ( 34,276 )
Series
B Convertible Preferred Stock dividends – earned (1)
$ ( 283 )
$ ( 287 )
Net
loss attributable to PAVmed Inc. common stockholders
$ ( 50,630 )
$ ( 34,563 )
Denominator
Weighted
average common shares outstanding, basic and diluted (2)
77,515,767
47,432,115
Loss
per share
Basic
and diluted
Net
loss - as reported, attributable to PAVmed Inc.
$ ( 0.65 )
$ ( 0.72 )
Net
loss attributable to PAVmed Inc. common stockholders
$ ( 0.65 )
$ ( 0.73 )
The
common stock equivalents have been excluded from the computation of diluted weighted average shares outstanding as their inclusion would
be anti-dilutive, are as follows:
The
Series B Convertible Preferred Stock dividends earned as of the each of the respective periods noted, are included in the calculation
of basic and diluted net loss attributable to PAVmed Inc. common stockholders for each respective period presented. Notwithstanding,
the Series B Convertible Preferred Stock dividends are recognized as a dividend payable only upon the dividend being declared payable
by the Company’s board of directors.
Basic
weighted-average number of shares of common stock outstanding for the years ended December 31, 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
Year
Ended December 31,
2021
2020
PAVmed
Inc. 2014 Equity Plan stock options and restricted stock awards
10,386,864
8,215,195
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
11,937,455
16,814,939
Series
W Warrants
377,873
381,818
Series
B Convertible Preferred Stock
1,113,919
1,228,075
Total
23,816,111
26,746,027
Antidilutive securities excluded from computation of diluted weighted shares outstanding
23,816,111
26,746,027
F- 43
Note
20 - Subsequent Events
PAVmed
Inc - Private Placement - Securities Purchase Agreement
Subsequent
to December 31, 2021, on March 31, 2022, we entered into the March 2022 SPA with an accredited institutional investor , for the sale
of up to $ 50,000,000 in initial principal amount of March 2022 Notes, in a registered direct offering (which we refer to as the Offering),
for a purchase price equal to $1,000 for each $1,100 in principal amount of March 2022 Notes
Pursuant
to the SPA we executed the agreements for an initial closing for the sale of $ 27.5 million in principal amount of March 2022 Notes, of
which the Investor funded and the Company received cash proceeds of $ 24.9 million on April 5, 2022, after deduction of lender fees. Subject
to certain conditions being met or waived, from time to time after such time that stockholder approval for an increase in our authorized
shares from 150 million to 250 million is obtained, but before March 31, 2024, one or more additional closings for up to the remaining
principal amount of March 2022 Notes may occur, upon five trading days’ notice by us to the investor. The aggregate principal amount
of March 2022 Notes that may be offered in the additional closings may not be more than $22.5 million. The investor’s obligation
to purchase the notes at each additional closing is subject to certain conditions set forth in the March 2022 SPA (including minimum
price and volume thresholds, maximum ratio of debt to market capitalization, and minimum market capitalization), which may be waived
by the Required Holders (as defined in the March 2022 SPA). Under the March 2022 SPA, the investor will be required to purchase March
2022 Notes in the additional closings if such conditions are met or waived. In addition, from and after March 31, 2023, the investor
may by written notice to us elect to require us to issue up to $ 22.5 million in initial principal amount of March 2022 Notes, so long
as in doing so it would not cause the ratio of (a) the outstanding principal amount of the March 2022 Notes (including the additional
March 2022 Notes), 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 we fail to complete the sale of 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 we will be obligated to pay a break-up fee to the investor at such time in an aggregate amount equal to $ 1.35 million.
The
March 2022 Notes have a voluntary fixed conversion price of $ 5.00 per share, a stated interest rate of 7.875 % per annum, and a maturity
of 24 months (subject to extension in certain circumstances). The March 2022 Notes will be secured by all our existing and future assets
(including those of our significant subsidiaries, other than Lucid and its subsidiaries), but including only 9.99 % of Lucid’s outstanding
common stock held by us, pursuant to a security agreement by and between the Company and the Investor.
We
will be subject to certain customary affirmative and negative covenants regarding the rank of the March 2022 Notes, 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 will be 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 March 2022 Notes, 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 % , and (iii) that our market capitalization shall at no time be less than $ 75 million. The March 2022 Notes include certain customary
events of default.
F- 44
Note
20 - Subsequent Events - continued
Lucid
Diagnostics Inc - Committed Equity Facility
Subsequent
to December 31, 2021, 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 Lucid Diagnostics Inc. to raise primary equity capital on a periodic basis at prices based on the existing
market price.
In connection with the execution
of the agreement for the committed equity facility, Lucid Diagnostics Inc. agreed to pay Cantor $ 1.0 million as consideration for its
irrevocable commitment to purchase the shares upon the terms and subject to the satisfaction of the conditions set forth in such agreement.
In addition, pursuant to the agreement, e agreed to reimburse Cantor for certain of its expenses. Lucid Diagnostics Inc. also entered
into a registration rights agreement with Cantor. Lucid Diagnostics Inc. has the right to terminate the agreement at any time after initial
satisfaction of the conditions to Cantor’s obligation to purchase shares under the facility, at no cost or penalty, upon three
trading days’ prior written notice.
Asset
Purchase Agreement - ResearchDx Inc.
Subsequent
to December 31, 2021, on February 25, 2022, Lucid Diagnostics, Inc., through its wholly-owned subsidiary
LucidDx Labs, Inc., entered into an asset purchase agreement (“RDx APA”) with ResearchDx, Inc. (“RDx”),
an unrelated third-party. Under the RDx APA, LucidDx Labs Inc. acquired certain licenses and other related assets
necessary to operate a CLIA-certified, CAP-accredited commercial clinical laboratory. The RDx APA acquired assets, along
with other LucidDx Labs Inc. purchased and leased property and equipment, are being used to commence laboratory operations to perform
the EsoGuard® Esophageal DNA assay, inclusive of DNA extraction, next generation sequencing (“NGS”) and specimen
storage. Prior to consummation of the RDx APA, RDx provided such laboratory services at its owned CLIA-certified,
CAP-accredited laboratory. Under the RDx APA, LucidDx Labs Inc. will pay RDx an aggregate purchase price of up to $ 6.2
million for the acquired assets. Concurrent with
the RDx APA, LucidDx Labs Inc. and RDx also entered into a management services agreement (“RDx MSA”),
with a term of three
years , and a total of approximately $ 1.8
million of quarterly payments.
F- 45