Item 9A. Controls and Procedures
ITEM
9A. CONTROLS AND PROCEDURES - continued
Remediation
- Material Weakness
As
of December 31, 2019, our management concluded our system of internal control over financial reporting was not effective, due
to the identification of a material weakness in our internal control over financial reporting, namely, we did
not maintain a properly designed control environment that identified key control risk areas with an appropriate level of precision,
in order to conclude on the operating effectiveness of our disclosure controls and procedures.
A
material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there
is a reasonable possibility a material misstatement of our annual or interim consolidated financial statements would not be prevented
or detected on a timely basis.
Management
implemented changes during 2020 to strengthen our internal control over financial reporting. These changes addressed the
identified material weakness and enhanced our overall internal control over financial reporting environment. The changes included
the hiring of a consulting firm to assist us in revising our internal control documentation so that it identifies key control
risk areas with sufficient precision for us to identify and test the operating effectiveness of our disclosure controls and procedures.
The consulting firm assisted us with the design, documentation, evaluation of design adequacy, and testing the operational
effectiveness of a revised system of internal control over financial reporting.
We
believe these actions remediated the material weakness, and we intend to continue to refine those internal controls over financial
reporting and monitor their effectiveness on an ongoing basis.
Changes
to Internal Controls Over Financial Reporting
Except
for the remediation and enhancements as described herein above, there has been no change in internal controls over financial reporting
(as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the year ended December 31, 2020 that
has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Item
9B. Other Information
None.
98
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 2020 Annual Meeting of Stockholders
to be filed with the Securities and Exchange Commission within 120 days of the fiscal year ended December 31, 2020.
Item
11. Executive Compensation
The
information required by this Item 11 is incorporated by reference to our Proxy Statement for the 2020 Annual Meeting of Stockholders
to be filed with the Securities and Exchange Commission within 120 days of the fiscal year ended December 31, 2020.
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 2020 Annual Meeting of Stockholders
to be filed with the Securities and Exchange Commission within 120 days of the fiscal year ended December 31, 2020.
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 2020 Annual Meeting of Stockholders
to be filed with the Securities and Exchange Commission within 120 days of the fiscal year ended December 31, 2020.
Item
14. Principal Accounting Fees and Services
The
information required by this Item 14 is incorporated by reference to our Proxy Statement for the 2020 Annual Meeting of Stockholders
to be filed with the Securities and Exchange Commission within 120 days of the fiscal year ended December 31, 2020.
99
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
Consolidated
Balance Sheets
Consolidated
Statements of Operations
Consolidated
Statements of Changes in Series A Convertible Preferred Stock and 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 W Warrant Certificate (1)
4.4
Series
W Warrant Agreement, dated April 28, 2016, between Continental Stock Transfer & Trust Company and the Registrant (3)
4.5
Form
of Unit Purchase Option (1)
4.6
Specimen
PAVmed Inc. Series Z Warrant Certificate (5)
4.7
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)
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)
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)
100
Item
15. Exhibits and Financial Statement Schedules - continued
Exhibit
No.
Description
10.8
PAVmed
Inc. Fourth Amended and Restated 2014 Long-Term Incentive Equity Plan (10)(12)
10.9
PAVmed
Inc. Employee Stock Purchase Plan (10)(12)
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
XBRL
Instance Document
101.SCH
XBRL
Taxonomy Extension Schema
101.CAL
XBRL
Taxonomy Extension Calculation Linkbase
101.DEF
XBRL
Taxonomy Extension Definition Linkbase
101.LAB
XBRL
Taxonomy Extension Label Linkbase
101.PRE
XBRL
Taxonomy Extension Presentation Linkbase
(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.
*
Management
contract or compensatory plan or arrangement.
†
Filed
herewith
Item
16. Form 10-K Summary
None
101
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.
March
15, 2021
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
March
15, 2021
Lishan
Aklog, M.D.
Chief
Executive Officer
( Principal
Executive Officer )
/s/
Dennis M. McGrath
President
March
15, 2021
Dennis
M. McGrath
Chief
Financial Officer
( Principal
Financial and Accounting Officer )
/s/
Michael J. Glennon
Vice
Chairman
March
15, 2021
Michael
J. Glennon
Director
/s/
David S. Battleman M.D.
Director
March
15, 2021
David
S. Battleman M.D.
/s/
James L. Cox, M.D.
Director
March
15, 2021
James
L. Cox, M.D.
/s/
Ronald M. Sparks
Director
March
15, 2021
Ronald
M. Sparks
/s/
David Weild IV
Director
March
15, 2021
David
Weild IV
102
PAVMED
INC.
and
SUBSIDIARIES
INDEX
TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Consolidated
Financial Statements
Report
of Independent Registered Public Accounting Firm
F-2
Consolidated
Balance Sheets as of December 31, 2020 and December 31, 2019
F-3
Consolidated
Statements of Operations for the years ended December 31, 2020 and 2019
F-4
Consolidated
Statements of Changes in Stockholders’ Equity (Deficit) for the year ended December 31, 2020
F-5
Consolidated
Statements of Changes in Stockholders’ Equity (Deficit) for the year ended December 31, 2019
F-6
Consolidated
Statements of Cash Flows for the year ended December 31, 2020 and 2019
F-7
Notes
to Consolidated Financial Statements
F-8
F- 1
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Shareholders and Board of Directors of
PAVmed
Inc. and Subsidiaries
Opinion
on the Financial Statements
We
have audited the accompanying consolidated balance sheets of PAVmed Inc. and Subsidiaries (the “Company”) as of December
31, 2020 and 2019, 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, 2020, 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, 2020 and 2019, and the results of its operations and its cash flows for each of the two years in the period ended
December 31, 2020, 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 provides a reasonable basis for our opinion.
/s/
Marcum llp
Marcum
llp
We
have served as the Company’s auditor since 2019.
New
York, NY
March
15, 2021
F- 2
PAVMED
INC.
and
SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
(amounts
in thousands except shares and per share data)
December
31, 2020
December
31, 2019
Assets:
Current assets:
Cash
$ 17,256
$ 6,219
Prepaid
expenses, deposits, and other current assets
1,685
328
Total current assets
18,941
6,547
Other assets
837
693
Total
assets
$ 19,778
$ 7,240
Liabilities, Preferred
Stock and Stockholders’ Deficit
Current liabilities:
Accounts payable
$ 2,966
$ 2,353
Accrued expenses
and other current liabilities
2,325
1,386
CARES
Act Paycheck Protection Program note payable
300
—
Senior Secured Convertible
Notes - at fair value
10,060
8,139
Senior
Convertible Note - at fair value
4,600
—
Total
liabilities
20,251
11,878
Commitments and contingencies (Note
7)
—
—
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
1,228,075 at December 31, 2020 and 1,158,209 shares at December 31, 2019
2,537
2,296
Common stock, $0.001 par value. Authorized,
150,000,000 shares; issued and outstanding, 63,819,935 shares at December 31, 2020 and 40,478,861 shares at December 31, 2019
64
41
Additional paid-in
capital
87,570
47,554
Accumulated
deficit
(88,275 )
(53,715 )
Total
PAVmed Inc. Stockholders’ Equity (Deficit)
1,896
(3,824 )
Noncontrolling
interests
(2,369 )
(814 )
Total
Stockholders’ Equity (Deficit)
(473 )
(4,638 )
Total
Liabilities and Stockholders’ Equity (Deficit)
$ 19,778
$ 7,240
See
accompanying notes to the consolidated financial statements.
F- 3
PAVMED
INC.
and
SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
(amounts
in thousands, except share and per share data)
Year
Ended December 31,
2020
2019
Revenue
$ —
$ —
Operating expenses:
General
and administrative
12,388
7,665
Research
and development
10,963
6,630
Total
operating expenses
23,351
14,295
Loss from operations
(23,351 )
(14,295 )
Other income (expense):
Interest expense
(53 )
(33 )
Change in fair value
- Senior Secured Convertible Notes and Senior Convertible Note
(5,327 )
(559 )
Offering costs -
Senior Secured Convertible Note and Senior Convertible Note
(660 )
(550 )
Debt
extinguishments loss - Senior Secured Convertible Notes
(6,497 )
(1,831 )
Other
income (expense), net
(12,537 )
(2,973 )
Loss before provision for income tax
(35,888 )
(17,268 )
Provision for
income taxes
—
—
Net loss before noncontrolling interests
(35,888 )
(17,268 )
Net loss attributable
to the noncontrolling interests
1,612
811
Net loss attributable to PAVmed Inc.
(34,276 )
(16,457 )
Less: Series
B Convertible Preferred Stock dividends earned
(287 )
(270 )
Net loss attributable
to PAVmed Inc. common stockholders
$ (34,563 )
$ (16,727 )
Per share information:
Net loss per
share attributable to PAVmed Inc. - basic and diluted
$ (0.72 )
$ (0.54 )
Net loss per
share attributable to PAVmed Inc. common stockholders – basic and diluted
$ (0.73 )
$ (0.55 )
Weighted average
common shares outstanding, basic and diluted
47,432,115
30,197,458
See
accompanying notes to the consolidated financial statements.
F- 4
PAVMED
INC.
and
SUBSIDIARIES
CONSOLIDATED
STATEMENT OF CHANGES IN EQUITY (DEFICIT)
for
the YEAR ENDED December 31, 2020
(in
thousands except 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
at December 31, 2019
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
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
—
—
—
Series
B Convertible Preferred Stock dividends declared
94,866
284
—
—
—
(284 )
—
—
Issue
common stock - 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
Loss
—
—
—
—
—
(34,276 )
(1,612 )
(35,888 )
Balance
at December 31, 2020
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- 5
PAVMED
INC.
and
SUBSIDIARIES
CONSOLIDATED
STATEMENT OF CHANGES IN EQUITY (DEFICIT)
for
the YEAR ENDED December 31, 2019
(in
thousands except 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
at December 31, 2018
1,069,941
$ 2,031
27,142,979
$ 28
$ 32,619
$ (36,993 )
$ (161 )
$ (2,476 )
Issue
common stock – registered offerings, net
—
—
5,480,000
5
5,374
—
—
5,379
Issue
common stock – upon partial conversions of Senior Secured Convertible Note
—
—
7,773,110
8
8,081
—
—
8,089
Series
B Convertible Preferred Stock dividends declared
88,268
265
—
—
—
(265 )
—
—
Issue
common stock – Employee Stock Purchase Plan
—
—
82,772
—
67
—
—
67
Stock-based
compensation - PAVmed Inc. 2014 Equity Plan
—
—
—
—
1,397
—
—
1,397
Stock-based
compensation - majority-owned subsidiary
—
—
—
—
16
—
158
174
Loss
—
—
—
—
—
(16,457 )
(811 )
(17,268 )
Balance
at December 31, 2019
1,158,209
$ 2,296
40,478,861
$ 41
$ 47,554
$ (53,715 )
$ (814 )
$ (4,638 )
See
accompanying notes to the consolidated financial statements.
F- 6
PAVMED
INC.
and
SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(in
thousands except shares and per share data)
Year
Ended December 31,
2020
2019
Cash flows from operating
activities
Net loss - before noncontrolling
interest (“NCI”)
$ (35,888 )
$ (17,268 )
Adjustments to reconcile net loss -
before NCI to net cash used in operating activities
Depreciation expense
23
14
Stock-based compensation
2,044
1,571
Change in fair value
- Senior Secured Convertible Notes and Senior Convertible Note
5,327
559
Debt extinguishment
loss - Senior Secured Convertible Notes
6,497
1,831
Changes in operating
assets and liabilities:
Prepaid expenses
and other current assets
(1,336 )
(90 )
Accounts payable
501
613
Accrued expenses
and other current liabilities
918
56
Deposits –
Long Term
—
(643 )
Net cash flows
used in operating activities
(21,914 )
(13,357 )
Cash flows from investing
activities
Purchase of equipment
(55 )
(27 )
Net cash flows
used in investing activities
(55 )
(27 )
Cash flows from financing
activities
Proceeds – issue of Senior Secured
Convertible Notes
13,300
—
Proceeds – issue of Senior Convertible
Note
3,700
6,300
Proceeds – Cares Act Paycheck
Protection Program Loan
300
—
Proceeds – issue of common stock
– registered offerings
16,032
5,413
Payment – offering costs –
registered offerings
(100 )
(34 )
Payment –Senior Secured Convertible
Note
—
(86 )
Payment – Senior Secured Convertible
Notes – non-installment payments
(600 )
(279 )
Proceeds – issue common stock
– Employee Stock Purchase Plan
357
67
Proceeds – exercise of Series
S Warrants
12
—
Proceeds –
exercise of stock options issued under equity incentive plan
of majority owned subsidiary
5
—
Net cash flows
provided by financing activities
33,006
11,381
Net increase (decrease) in cash
11,037
(2,003 )
Cash, beginning of period
6,219
8,222
Cash, end of period
$ 17,256
$ 6,219
See
accompanying notes to the consolidated financial statements.
F- 7
PAVMED
INC.
and
SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(All
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. (“PAVmed” or the “Company”) together with its majority owned subsidiaries, Lucid Diagnostics, Inc.
(“Lucid Diagnostics” or “LUCID”) and Solys Diagnostics, Inc. (“Solys Diagnostics” or “SOLYS”)
were organized to advance a broad pipeline of innovative medical technologies from concept to commercialization, employing a business
model focused on capital efficiency and speed to market. The Company’s activities have focused on advancing the lead products
towards regulatory approval and commercialization, protecting its intellectual property, and building its corporate infrastructure
and management team. The Company operates in one segment as a medical device company.
The
ability of the Company to generate revenue depends upon the Company’s ability to successfully advance the commercialization
of EsoGuard and CarpX while also completing the development and the necessary regulatory approvals of its other products and services.
In this regard:
●
The
EsoCheck device received 510(k) marketing clearance from the FDA as an esophageal cell collection device in June 2019;
●
EsoGuard
completed the certification required by the Clinical Laboratory Improvement Amendment (“CLIA”) and accreditation
of the College of American Pathologists (“CAP”) making it commercially available as a Laboratory Developed Test
(“LDT”) at LUCID’s contract diagnostic laboratory service provider in California in December 2019; and,
●
CarpX,
developed as a patented, single-use, disposable, minimally invasive device designed as a precision cutting tool to treat carpal
tunnel syndrome while reducing recovery times, received 510(k) marketing clearance from the FDA in April 2020.
Although
the Company’s current operational activities are principally focused on the commercialization of EsoGuard and CarpX its
development activities are focused on pursuing FDA approval and clearance of other lead products in our product portfolio pipeline,
including EsoGuard IVD, PortIO, DisappEAR, NextFlo, and EsoCure.
Financial
Condition
The
Company has financed its operations principally through the public and private issuances of its common stock, preferred stock,
common stock purchase warrants, and debt. The Company is subject to all of the risks and uncertainties typically faced
by medical device and diagnostic and medical device companies that devote substantially all of their efforts to the commercialization
of their initial product and services and ongoing R&D and clinical trials. The Company expects to continue to experience recurring
losses from operations, and will continue to fund its operations with debt and equity financing transactions. Notwithstanding,
however, together with the cash on-hand as of December 31, 2020, and the cash proceeds from the issue of shares of common stock
of the Company subsequent to December 31, 2020 in January and February 2021, the Company expects to be able to fund its future
operations for one year from the date of the issue of the Company’s consolidated financial statements, as included in the
Company’s Annual Report on Form 10-K for the year ended December 31, 2020. See Note 12, Stockholders’ Equity, Common
Stock Purchase Warrants, and Noncontrolling Interest , for a discussion of the issue of shares of common stock of the Company
subsequent to December 31, 2020, in each of January 2021 and February 2021; and Note 9, Outstanding Debt , for a discussion
of the principal repaid-in-full of each of the convertible notes subsequent to December 31, 2020, in each of January 2021 and
March 2021.
F- 8
Note
2 — Summary of Significant Accounting Policies and Recent Accounting Standards Updates
Significant
Accounting Policies
Basis
of Presentation
The
accompanying consolidated financial statements include the accounts of the Company and its majority-owned subsidiaries. All intercompany
transactions and balances have been eliminated in consolidation. The Company holds a majority ownership interest and has a controlling
financial interest in Lucid Diagnostics Inc. and Solys Diagnostics Inc., with the corresponding noncontrolling interest included
as a separate component of consolidated equity (deficit), including the recognition in the consolidated statement of operations
of the net loss attributable to the noncontrolling interest based on the respective minority interest ownership of each respective
entity. See Note 12, Stockholders’ Equity and Common Stock Purchase Warrants , for a discussion of the Company’s
majority-owned subsidiaries and the corresponding noncontrolling interest.
All
amounts in these accompanying notes to the accompanying consolidated financial statements are presented in thousands, if not otherwise
noted as being presented in millions, except for shares and per share amounts.
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles generally accepted in the United States of America
(“U.S. GAAP”) requires management to make accounting estimates and assumptions that affect the reported amounts of
assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported
amounts of expenses during the reporting period. Significant estimates in these consolidated financial statements include those
related to the fair value of debt obligations and common stock purchase warrants. Additional significant estimates include the
provision or benefit for income taxes and the corresponding valuation allowance on deferred tax assets. On an ongoing basis, the
Company evaluates its estimates, judgements, and methodologies. The Company bases its estimates on historical experience and on
various other assumptions believed to be reasonable. Due to the inherent uncertainty involved in making such judgements, assumptions,
and accounting estimates, the actual financial statement results could differ materially from such accounting estimates and assumptions.
Segment
Data
The
Company manages its operations as a single operating segment for the purposes of assessing performance and making operating decisions.
No revenue has been generated since inception, and all tangible assets are held in the United States.
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 and does not anticipate 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.
F- 9
Note
2 — Summary of Significant Accounting Policies and Recent Accounting Standards Updates - continued
Significant
Accounting Policies - continued
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.
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”).
In
the year ended December 31, 2020, stock-based compensation is recognized in accordance with the provisions of FASB ASC Topic 718,
Stock Compensation (“ASC 718”), as amended by FASB Accounting Standard Update (“ASU”) 2018-07 (“ASU
2018-07”). The provisions of ASU 2018-07 amended ASC 718 to align the accounting for stock-based awards granted to nonemployees
with the requirements for accounting for stock-based awards to employees; and to supersede the previous guidance of FASB ASC Topic
505-50, Equity-Based Payments to Non-Employees (“ASC 505-50”). The adoption as of January 1, 2020 of the updated
provisions of ASC 718, as amended by ASU 2018-07, had no effect on the Company’s consolidated financial statements.
In
the year ended December 31, 2020, with respect to stock-based awards granted to the board of directors, employees, and non-employees,
the Company recognizes stock-based compensation in accordance with the provisions of ASC 718, as amended by ASU 2018-07, wherein
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.
F- 10
Note
2 — Summary of Significant Accounting Policies and Recent Accounting Standards Updates - continued
Significant
Accounting Policies - continued
Stock-Based
Compensation - continued
In
the previous year ended December 31, 2019, with respect to stock-based awards granted to the board of directors and employees,
the Company recognized stock-based compensation in accordance with ASC 718, as described above; and with respect to non-employees,
the Company recognized stock-based compensation in accordance with previous provisions of ASC 505-50, wherein, the expense of
stock-based awards granted to non-employees was recognized on a vesting date basis by fixing the fair value of vested non-employee
stock options as of their respective vesting date. The fair value of vested non-employee stock options was not subject-to further
remeasurement at subsequent reporting dates. The estimated fair value of the unvested non-employee stock options was remeasured
to then current fair value at each subsequent reporting date, until such time when the stock options vest, at which time the fair
value is fixed, as noted above. The estimated fair value of stock-based awards granted to non-employees was recognized on a straight-line
basis over the requisite service period, which was generally the vesting period of the respective non-employee stock-based award,
with such straight-line recognition adjusted so the cumulative expense recognized was at-least equal-to-or-greater-than the estimated
fair value of the vested portion of the respective stock-based award.
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:
●
The expected
term of stock options represents the period of time stock options are expected to be outstanding, which is the expected term
derived using the simplified method and, through December 31, 2019 for non-employees was the remaining contractual term (under
the previous provisions of ASC 505-50);
●
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, 2020 and 2019; and for stock options granted to non-employees
in the year ended December 31, 2019, the period of volatility was commensurate with the remaining
contractual term of the respective stock option (under the previous provisions ASC 505-50).
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, 2019; and for
stock options granted to non-employees in the year ended December 31, 2019, the period of
volatility was commensurate with the remaining contractual term of the respective stock option
(under the previous provisions ASC 505-50). 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 granted under the
PAVmed Inc. 2014 Equity Plan is its quoted closing price per share. The price per share of Lucid Diagnostics Inc. common stock
used in the computation of estimated fair value of stock options granted under the Lucid Diagnostics Inc. 2018 Equity Plan was
estimated using a discounted cash flow method applied to a multi-year forecast of its future cash flows.
F- 11
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
Company evaluates its financial instruments to determine if those instruments or any embedded components of those instruments
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.
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, 2020, and December 31, 2019, 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, 2020
and 2019.
F- 12
Note
2 — Summary of Significant Accounting Policies and Recent Accounting Standards - 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, 2020 and 2019.
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, 2020, the
Company does not 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, 2020 and December 31, 2019 or recognized during the years
ended December 31, 2020 and 2019. 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- 13
Note
2 — Summary of Significant Accounting Policies and Recent Accounting Standards Updates - continued
Significant
Accounting Policies - continued
JOBS
Act EGC Accounting Election
The
Company is an “emerging growth company” or “EGC”, as defined in the Jumpstart Our Business Startups Act
of 2012 (the “JOBS Act”). Under the JOBS Act, an EGC can delay adopting new or revised accounting standards issued
after the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has irrevocably
elected to avail itself of this exemption from new or revised accounting standards, and, therefore, will not be subject to the
same new or revised accounting standards as public companies who are not an EGC.
Recent
Accounting Standards Updates
As
noted herein above, as of January 1, 2020, the Company adopted
the amended guidance of ASC 718 with respect to stock-based awards granted to non-employees, as amended by ASU 2018-07,
which aligned the accounting for stock-based payments to nonemployees for goods and services with the requirements
for accounting for stock-based awards to employees under ASC 718. In this regard, ASU 2018-07 provides for stock-based
payments to non-employees to be measured at the grant date fair value of the equity instruments to be provided to the
nonemployee when the goods or services have been delivered. Prior to the ASU 2018-07 amendment, nonemployee stock-based
payments were accounted for under the superseded provisions of ASC 505-50. The adoption of such amended guidance
did not have an effect on the Company’s consolidated financial statements.
As
of January 1, 2020, the Company adopted ASU 2018-13, Fair
Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement, which
modifies the disclosure requirements on fair value measurement. The adoption of ASU 2018-13 did not have an effect on the
Company’s consolidated financial statements.
As
of January 1, 2020, the Company adopted the guidance of ASU 2017-11, issued by the FASB in July 2017, Earnings Per Share (Topic
260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815) - Part I - Accounting for Certain
Financial Instruments with Down-Round Features, and Part II - Replacement of the Indefinite Deferral for Mandatorily Redeemable
Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception.
Principally, ASU 2017-11 amendments simplify the accounting for certain financial instruments with down-round features. The
amendments require companies to disregard the down-round feature when assessing whether the instrument is indexed to its own stock,
for purposes of determining liability or equity classification. Companies that provide earnings per share data will adjust their
basic earnings per share calculation for the effect of the down-round feature when triggered (i.e., when the exercise price of
the related equity-linked financial instrument is adjusted downward because of the down-round feature) and will also recognize
the effect of the trigger within equity. Additionally, ASU 2017-11 also addresses “navigational concerns” within the
FASB ASC related to an indefinite deferral available to private companies with mandatorily redeemable financial instruments and
certain noncontrolling interests, which has resulted in the existence of significant “pending content” in the ASC.
The FASB decided to reclassify the indefinite deferral as a scope exception, which does not have an accounting effect. The guidance
of ASU 2017-11 is effective for public business entities, as defined in the ASC Master Glossary, for fiscal years beginning after
December 15, 2018, including interim periods within those fiscal years. With respect to all other entities, including the Company
under its JOBS Act EGC Accounting Election, as discussed above, the guidance of ASU 2017-11 was effective for fiscal years beginning
after December 15, 2019, and interim periods within fiscal years beginning after December 15, 2020. The adoption of the ASU 2017-11
guidance as of January 1, 2020 did not have an effect on the Company’s consolidated financial statements.
F- 14
Note
2 — Summary of Significant Accounting Policies and Recent Accounting Standards Updates - continued
Significant
Accounting Policies - continued
Recent
Accounting Standards Updates - continued
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, including
convertible instruments and contracts on an entity’s own equity. 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 is not expected to 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 is not expected to have an effect on the Company’s
consolidated financial statements.
FASB
ASC Topic 842, Leases , (“ASC 842”) (ASU No. 2016-02, Leases , February-2016 - “ASU 2016-02” )
which established a right-of-use (“ROU”) model requiring a lessee to recognize a ROU asset and a lease liability
for all leases with terms greater-than 12 months. Leases are classified as either finance or operating, with classification affecting
the pattern of expense recognition in the income statement. The ASC 842 effective date for the Company is December 31, 2022 for
its annual consolidated financial statements, and for interim quarterly financial statements commencing March 31, 2023.
F- 15
Note
3 — Agreements Related to Acquired Intellectual Property Rights
Patent
License Agreement – Case Western Reserve University
On
May 12, 2018, Lucid Diagnostics Inc., a majority-owned subsidiary of the Company, entered into a patent license agreement with
Case Western Reserve University (“CWRU”), referred to as the “CWRU License Agreement”.
The
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 the “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 requires Lucid Diagnostics Inc. to achieve certain milestones with respect to regulatory filings and clearances
and commercialization of products and services. In this regard, in , 2019, the Company recognized a $75 research and development
expense in connection with a regulatory clearance milestone, which was paid in 2019. The CWRU License Agreement was amended 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 payment to CWRU in consideration for the aforementioned changes
to the commercialization milestone (“CWRU License Agreement Amendment”). In connection with such CWRU License Agreement
Amendment, the Company recognized $100 of general and administrative expense, with such expense included in accrued expenses as
of December 31, 2020. If the Company does not meet the remaining commercialization and regulatory clearance milestones listed
in the CWRU License Agreement, then CWRU has the right, in its sole discretion, to require PAVmed Inc. to transfer to CWRU 80%
of the shares of common stock of Lucid Diagnostics Inc. then held by PAVmed Inc. Such contingent milestone payments will be recognized
in the period in which such payment obligations are incurred.
Lucid
Diagnostics Inc. is required to pay a minimum annual royalty of a percentage of recognized net sales revenue resulting from the
commercialization of the products and /or services developed using the CWRU License Agreement intellectual property, with the
minimum amount of royalty payments based on net sales of such products and services, if any. Such contingent royalty payments
will be recognized in the period in which such payment obligations are incurred.
As
provided for under the CWRU License Agreement, reimbursement of CWRU billed patent fees of $250 and $200 were recognized as research
and development expense in the years ended December 31, 2020 and 2019, respectively.
The
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.
F- 16
Note
3 — Agreements Related to Acquired Intellectual Property Rights - continued
License
Agreement with Liquid Sensing Inc.
Upon
its formation in October 2019, Solys Diagnostics Inc., a majority-owned subsidiary of PAVmed Inc. entered into a licensing agreement
with Liquid Sensing, Inc., a subsidiary formed by Airware Inc., each an unrelated third-party, (“Liquid Sensing License
Agreement”). Under the Liquid Sensing License Agreement, Solys Diagnostics Inc. was
granted an exclusive worldwide license for six issued and one pending U.S. patents covering a proprietary nondispersive infrared
laser technology to develop and commercialize such proprietary technology to non-invasively monitor tissue concentrations of glucose
and other substances within the inpatient ( e.g. , hospital) field of use.
Solys
Diagnostics Inc. advanced the research and development plan and completed a milestone consistent with the parameters and by the
date under the Liquid Sensing License Agreement. Notwithstanding, PAVmed Inc. determined it would be in the best interests of
the shareholders of PAVmed Inc. to terminate the Liquid Sensing License Agreement. In this regard, subsequent to December 31,
2020, PAVmed Inc. on behalf of itself and Solys Diagnostics Inc., delivered to Airware Inc. and Liquid Sensing Inc. a written
notice of termination of the Liquid Sensing License Agreement, dated February 12, 2021 (“Liquid Sensing License Agreement
Termination Notice”). The Liquid Sensing License Agreement Termination Notice proposes the development of a negotiated mutually
agreeable final settlement between PAVmed Inc., Solys Diagnostics Inc., Airware Inc., and Liquid Sensing Inc.
A
discussion of each of the Company’s majority-owned subsidiaries and the corresponding noncontrolling interest is presented
in Note 12, Stockholders’ Equity and Common Stock Purchase Warrants .
Patent
License Agreement - Tufts University - Antimicrobial Resorbable Ear Tubes
The
Company previously executed a Patent License Agreement (the “Tufts Patent License Agreement”) with Tufts University
and its co-owners, the Massachusetts Eye and Ear Infirmary and Massachusetts General Hospital (the “Licensors”). Pursuant
to the Tufts Patent License Agreement, the Licensors granted the Company the exclusive right and license to certain patents in
connection with the development and commercialization of antimicrobial resorbable ear tubes based on a proprietary aqueous silk
technology conceived and developed by the Licensors.
The
Tufts Patent License Agreement also provides for potential payments from the Company to the Licensors upon the achievement of
certain product development and regulatory clearance milestones as well as royalty payments on net sales upon the commercialization
of products developed utilizing the licensed patents. The Company will recognize as a current period expense for contingent milestone
payments or royalties in the period in which such payment obligations are incurred, if any.
F- 17
Note
4 — Related Party Transactions
In
connection with the CWRU License Agreement, CWRU and each of the three physician inventors of the intellectual property licensed
under the CWRU License Agreement hold minority equity ownership interests in Lucid Diagnostics Inc., a majority-owned subsidiary
of PAVmed Inc. During the years ended December 31, 2020 and 2019 the Company incurred the following expenses with respect to the
minority shareholders of Lucid Diagnostics Inc.:
For
the year ended
December
31,
2020
2019
CWRU License Agreement –
reimbursement of patent legal fees
$ 250
$ 200
CWRU License Agreement Amendment
fee
100
75
EsoCheck devices provided to CWRU
15
—
Fees - Physician Inventors’ consulting
agreements
83
110
Stock-based compensation
expense - Physician Inventors’ stock option grants
23
57
Total
$ 471
$ 442
Lucid
Diagnostics Inc. entered into consulting agreements with each of the three physician inventors of the CWRU License Agreement intellectual
property, providing for compensation on a contractual rate per hour for consulting services provided. The consulting agreements
have a thirty-six month term ending May 12, 2021. Additionally, each of the three physician inventors were granted stock options
under the PAVmed Inc. 2014 Long-Term Incentive Equity Plan and the Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan.
See
Note 3, Agreements Related to Acquired Intellectual Property Rights - Patent License Agreement - CWRU, for a discussion
of the “CWRU License Agreement”; Note 10, Stock-Based Compensation , for information regarding each of the “PAVmed
Inc. 2014 Long-Term Incentive Equity Plan” and the separate “Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity
Plan”; and Note 12, Stockholders’ Equity, Common Stock Purchase Warrants, and Noncontrolling Interest , for
a discussion of each of the Company’s majority-owned subsidiaries and the corresponding noncontrolling interests.
Note
5 — Prepaid Expenses, Deposits and Other Current and Non-Current Assets
Prepaid
expenses and other current assets consisted of the following as of:
December
31, 2020
December
31, 2019
Advanced payments to service
providers and suppliers
$ 568
$ 294
Deposits
262
34
EsoCheck cell collection supplies
779
—
EsoGuard mailer supplies
55
—
CarpX devices
21
—
Total prepaid
expenses, deposits and other current assets
$ 1,685
$ 328
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, referred to as the EsoGuard CRO Agreement. Under the CRO agreement,
the Company incurred an on-account deposit of $755 and $643 as of December 31, 2020 and 2019, respectively, of which $643 has
been paid as of December 31, 2020, with the deposit classified as a non-current asset in the line item captioned “Other
assets” on the accompanying consolidated balance sheet as of December 31, 2020 and 2019. See Note 7, Commitments and
Contingencies , for a discussion of the EsoGuard CRO Agreement.
F- 18
Note
6 — Accrued Expenses and Other Current Liabilities
Accrued
expenses and Other Current Liabilities consist of the following items as of December 31, 2020 and 2019:
December
31, 2020
December
31, 2019
Compensation and Employee
Benefits
$ 1,777
$ 1,074
CWRU License Agreement fee
223
223
CWRU License Agreement Amendment
fee
100
—
Operating expenses
171
89
EsoGuard supplies
22
—
CarpX devices
32
—
Total
accrued expenses and other current liabilities
$ 2,325
$ 1,386
The
“Compensation and Employee Benefits” includes: the guaranteed bonus payment under the Company’s Chief Executive
Officer (“CEO”) Employment Agreement; discretionary bonus payments to other employees; unused employee vacation time;
and employee payroll deductions related to the PAVmed Inc. Employee Stock Purchase Plan (“PAVmed Inc. ESPP”). See
Note 11, Stock-Based Compensation , for additional information on the PAVmed Inc. ESPP.
The
CWRU License Agreement license fee was approximately $273, of which $50 was previously paid. The remaining balance of the license
fee is to be paid in quarterly installments of $50, until the license fee is paid-in-full, provided, however, the commencement
of the quarterly payments is subject to Lucid Diagnostics Inc. consummation of a bona fide financing with an unrelated third-party
in excess of $0.5 million. See Note 3, Agreements Related to Acquired Intellectual Property Rights - Patent License Agreement
- CWRU , for a discussion of the CWRU License Agreement.
The
amounts for operating expenses, EsoGuard supplies, and CarpX devices relate to respective amounts incurred by the Company but
not yet invoiced by the respective vendors.
F- 19
Note
7 — Commitment and Contingencies
Rental
Agreements - Office Space
The
Company’s corporate 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, and the lease agreement may be cancelled with two months written notice. Additionally,
the Company additionally has a short-term (one year or less) and a month-to-month office space rental agreements, which may be
cancelled with two months written notice. Total rent expense incurred under short-term and /or month-to-month rental agreements
for office space was $189 and $143, for the years ended December 31, 2020 and 2019, respectively. As of December 31, 2020, the
Company’s minimum lease payments for such office space rental agreements are estimated to be a total of approximately $157
for the period January 1, 2021 to December 31, 2021.
Clinical
Trials - Agreement with Clinical Research Organization
In
September 2019, 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
In
November 2020, a stockholder of the Company, on behalf of himself and other similarly situated stockholders, filed a complaint
in the Delaware Court of Chancery alleging broker non-votes were not properly counted in accordance with the Company’s bylaws
at the Company’s Annual Meeting of Stockholders on July 24, 2020, and, as a result, asserted certain matters deemed to have
been approved were not so approved (including matters relating to the increase in the size of the 2014 Equity Plan and the ESPP).
The relief sought under the complaint includes certain corrective actions by the Company, but does not seek any specific monetary
damages. The Company does not believe it is clear the prior approval of these matters is invalid or otherwise ineffective. However,
in order to avoid any uncertainty and to avoid 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 term sheet to settle the complaint, the terms of which do not contemplate payment of monetary damages to the putative
class in the proceeding. The settlement of the complaint is pending and is subject to court approval.
On
December 23, 2020, Benchmark Investments, Inc. filed a complaint against the Company in the U.S. District Court of the Southern
District of New York alleging the registered direct offerings of shares of common stock of the Company completed in December 2020
were in violation of provisions set forth in an engagement letter between the Company and the plaintiff. The plaintiff is seeking
monetary damages of up to $1.3 million. The Company disagrees with the allegations set forth in the complaint and intends to
vigorously contest the complaint.
In
the ordinary course of our business, particularly as it begins commercialization of its products, the Company may
be subject to certain other legal actions and claims, including product liability, consumer, commercial, tax and governmental
matters, which may arise from time to time. Except as otherwise noted herein, the Company does not believe it is currently a party
to any other pending legal proceedings. Notwithstanding, legal proceedings are subject-to inherent uncertainties, and an unfavorable
outcome could include monetary damages, and excessive verdicts can result from litigation, and as such, could result in a material
adverse impact on the Company’s business, financial position, results of operations, and /or cash flows. Additionally, although
the Company has specific insurance for certain potential risks, the Company may in the future incur judgments or enter into settlements
of claims which may have a material adverse impact on the Company’s business, financial position, results of operations,
and /or cash flows.
F- 20
Note
8 — Financial Instruments Fair Value Measurements
Recurring
Fair Value Measurements
The
fair value hierarchy table for the periods indicated is as follows:
Fair
Value Measurement on a Recurring Basis at
Reporting Date Using (1)
Level-1
Level-2
Level-3
Inputs
Inputs
Inputs
Total
December 31, 2020
Senior
Secured Convertible Note - November 2019
$ —
$ —
$ 1,270
$ 1,270
Senior Convertible
Note - April 2020
$ —
$ —
$ 4,600
$ 4,600
Senior
Secured Convertible Note – August 2020
$ —
$ —
$ 8,790
$ 8,790
Totals
$ —
$ —
$ 14,660
$ 14,660
December 31, 2019
Senior Secured Convertible
Note - December 2018
$ —
$ —
$ 1,700
$ 1,700
Senior
Secured Convertible Note - November 2019
$ —
$ —
$ 6,439
$ 6,439
Totals
$ —
$ —
$ 8,139
$ 8,139
(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 years ended December 31, 2020 and 2019.
The
August 2020 Senior Secured Convertible Note, the April 2020 Senior Convertible Note, the November 2019 Senior Secured Convertible
Note (Series-A and Series-B), and the December 2018 Senior Secured Convertible Note are each accounted for under the ASC 825-10-15-4
fair value option (“FVO”) election. Under the FVO election 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.
The
estimated fair value of financial instruments classified within the Level 3 category was determined using both observable inputs
and unobservable inputs. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in
fair value attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in unobservable
long- dated volatilities) inputs. Additional information with respect to the changes in Level 3 liabilities measured at fair value
for the years ended December 31, 2020 and 2019, is presented in Note 9 – “ Outstanding Debt .”
F- 21
Note
8 — Financial Instruments Fair Value Measurement s - continued
The
estimated fair value of each of the convertible notes as of December 31, 2020 and 2019, 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:
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 %
50.2 %
27.2 %
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 %
70 %
70 %
Risk free rate
0.09 %
0.11 %
0.12 %
Dividend yield
0 %
0 %
0 %
Senior
Secured Convertible Notes Fair Value and Fair
Value Assumptions – December 31, 2019:
December
2018
Senior Secured
Convertible Note
November
2019
Senior Secured
Convertible Note
Fair Value
$ 1,700
$ 6,439
Face value principal payable
$ 1,692
$ 7,000
Required rate of return
11.4 %
11.5 %
Conversion Price
$ 1.60
$ 1.60
Value of common stock
$ 1.20
$ 1.20
Expected term (years)
0.21
1.78
Volatility
49 %
55 %
Risk free rate
1.52 %
1.58 %
Dividend yield
0 %
0 %
The
estimated fair values reported utilize the Company’s common stock price along with certain Level 3 inputs, as discussed
below, 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- 22
Note
9 — Outstanding Debt
Convertible
Notes
The
fair value and face value principal of outstanding convertible notes as of December 31, 2020 and 2019 are as follows:
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
December 2018 Senior Secured Convertible
Note
December 31, 2020
7.875 %
$ 1.60
$ 1,692
$ 1,700
November 2019
Senior Secured Convertible Note
September 30,
2021
7.875 %
$ 1.60
$ 7,000
$ 6,439
Balance as of
December 31, 2019
$ 8,692
$ 8,139
Senior
Secured Convertible Note issued December 27, 2018 - (“December 2018 Senior Convertible Note”)
The
Company previously issued a Senior Secured Convertible Note dated December 27, 2018, with a $7.75 million face value principal,
a stated interest rate of 7.875% per annum, and, at the election of the holder, was convertible into shares of common stock of
the Company at a contractual conversion price of $1.60 per share - the “December 2018 Senior Convertible Note”.
In
the year ended December 31, 2020, with respect to the December 2018 Senior Convertible Notes, approximately $1,692 of installment
principal repayments and the payment of interest thereon of approximately $6, were settled through the issuance of 2,075,198 shares
of common stock of the Company, with a fair value of approximately $2,901 (with such fair value measured as the respective conversion
date quoted closing price of the common stock of the Company).
In
the previous year ended December 31, 2019, with respect to the December 2018 Senior Convertible Notes, approximately $6,058 of
installment principal repayments and the payment of interest thereon of approximately $200, were settled through the issuance
of 7,773,110 shares of common stock of the Company, with a fair value of approximately $8,089 (with such fair value measured as
the respective conversion date quoted closing price of the common stock of the Company). Additionally, approximately $279 of interest
non-installment payments were paid in cash during the year ended December 31, 2019.
The
December 2018 Senior Convertible Note was paid-in-full was paid in full as of June 4, 2020.
F- 23
Note
9 — Outstanding Debt - continued
Convertible
Notes - continued
Senior
Secured Convertible Note issued November 4, 2019 - Series A and Series B -
(“November
2019 Senior Convertible Notes”)
The
Company previously issued a Senior Secured Convertible Note dated November 4, 2019, with a $14.0 million aggregate face value
principal, a stated interest rate of 7.875% per annum (to the extent the investor has funded the cash proceeds), and, at the election
of the holder, is convertible into shares of common stock of the Company at a contractual conversion price of $1.60 per share
- the “November 2019 Senior Convertible Notes”. The November 2019 Senior Convertible Notes were comprised of a Series
A and Series B, each with a $7.0 million face value principal, and each having a $0.7 million lender fee deducted from the cash
proceeds when funded.
The
November 2019 Senior Convertible Note - Series A was issued on November 4, 2019, with a face value principal of approximately
$7,000 and a lender fee of approximately $700 (with such lender fee recognized as a current period other expense), resulting in
approximately $6,300 of cash proceeds received by the Company on the issue date. Additionally, the Company incurred a current
period expense of approximately $550, inclusive of a $410 placement agent advisory fee, along with legal fees.
The
November 2019 Senior Convertible Note - Series B was issued on March 30, 2020, with a face value principal of approximately $7,000
and a lender fee of approximately $700 (with such lender fee recognized as a current period other expense), resulting in approximately
$6,300 of cash proceeds received by the Company on the issue date. Additionally, the Company incurred a current period expense
of approximately $410 with respect to a placement agent advisory fee.
The
Company incurred interest expense of 3.0% per annum on the $7.0 million face value principal of the (unfunded) Series B during
the period from November 4, 2019 to March 29, 2020 when the Series B was not funded. The (cash) payment of such 3.0% interest
on the $7.0 million face value principal resulted in the recognition of approximately $53 and $33 of interest expense during the
year ended December 31, 2020 and 2019, respectively, with such interest expense included in other income (expense).
With
respect to the November 2019 Senior Convertible Notes, in the year ended December 31, 2020, approximately $13,044 of installment
principal repayments and the payment of interest thereon of approximately $465, were settled through the issuance of 8,854,004
shares of common stock of the Company, with a fair value of approximately $18,802 (with such fair value measured as the respective
conversion date quoted closing price of the common stock of the Company). As of December 31, 2020, the November 2019 Senior Convertible
Notes remaining unpaid outstanding face value principal was approximately $956.
Subsequent
to December 31, 2020, on January 5, 2021, the repayment of the remaining face value principal of the November 2019 Senior
Convertible Note of approximately $956, along with the payment of interest thereon of approximately $7, were 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), with such final conversion
resulting in the November 2019 Senior Convertible Note being paid-in-full as of January 5, 2021.
F- 24
Note
9 — Outstanding Debt - continued
Convertible
Notes - continued
Senior
Convertible Note issued April 30, 2020 - (“April 2020 Senior Convertible Note”)
The
Company issued a Senior Convertible Note dated April 30, 2020, with a face value principal of approximately $4,111, a stated interest
rate of 7.875% per annum, and, at the election of the holder, is convertible into shares of common stock of the Company at a contractual
conversion price of $5.00 per share - the “April 2020 Senior Convertible Note”.
The
April 2020 Senior Convertible Note resulted in approximately $3,700 of cash proceeds received by the Company on the issue date,
after a lender fee of approximately $411 (with such lender fee recognized as a current period other expense). Additionally, the
Company incurred a current period expense of approximately $200, inclusive of a $120 placement agent advisory fee, along with
legal fees.
The
Company was required to pay the holder in cash all
remaining outstanding unpaid face value principal at 115% of such principal amount plus unpaid interest thereon, on the April
30, 2022 maturity date.
In
the year ended December 31, 2020, approximately $215 of interest non-installment payments were paid in cash.
The
unpaid outstanding face value principal of the April 2020 Senior Convertible Note is approximately $4,111 as of December 31, 2020,
of which such principal was repaid-in-full subsequent to December 31, 2020, as discussed herein below.
Senior
Secured Convertible Note issued August 6, 2020 - (“August 2020 Senior Convertible Note”)
The
Company issued a Senior Secured Convertible Note dated August 6, 2020, with a face value principal of approximately $7,750,
a stated interest rate of 7.875% per annum, and, at the election of the holder, is convertible into shares of common stock of
the Company at a contractual conversion price of $5.00 per share - the “August 2020 Senior Convertible Note”.
The
August 2020 Senior Convertible Note resulted in approximately $7,000 of cash proceeds received by the Company on the issue date,
after a lender fee of approximately $750 (with such lender fee recognized as a current period other expense). Additionally, the
Company incurred a current period expense of approximately $50 with respect to legal fees.
The
Company was required to pay the holder in cash all
remaining outstanding unpaid face value principal at 115% of such principal amount plus unpaid interest thereon on the August
5, 2022 maturity date.
In
the year ended December 31, 2020, approximately $246 of interest non-installment payments were paid in cash.
The
unpaid outstanding face value principal of the April 2020 Senior Convertible Note is approximately $7,750 as of December 31, 2020,
of which such principal was repaid-in-full subsequent to December 31, 2020, as discussed herein below.
Principal
Repayments - April 2020 Senior Convertible Note and August 2020 Senior Convertible Note
Subsequent
to December 31, 2020: 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.
F- 25
Note
9 — Outstanding Debt - continued
Convertible
Notes - continued
Covenants
- Sr Secured Convertible Notes and Senior Convertible Note
As
of December 31, 2020, each of the November 2019 Senior Convertible
Note, April 2020 Senior Convertible Note, and the August 2020 Senior Convertible Note were each held by the same investor
and its affiliates.
Under
the November 2019 Senior Convertible Notes and the April 2020 Senior Convertible Note, as such convertible notes are discussed
above, the Company was subject to certain customary affirmative and negative covenants regarding the incurrence of
indebtedness, the existence of liens, the repayment of indebtedness, the payment of cash in respect of dividends, distributions
or redemptions, and the transfer of assets, among other matters. Additionally, the April 2020 Senior Convertible Note contained
a financial covenant requiring the Company to maintain available cash in the amount of approximately $1.8 million at the end
of each quarter, with such amount increased to $2.0 million under the August 2020 Senior Convertible Note. As of December 31,
2020, the Company was in compliance with this financial covenant.
The
August 2020 Senior Convertible Note contained substantively similar customary affirmative and negative covenants as those
described above, as well as the past transactions entered into with the investor, including the November 2019 Senior Convertible
Notes. The August 2020 Senior Secured Convertible Note contained security interest with a first priority in all of
our assets, including all of the Company’s current and future significant subsidiaries, similar to the November 2019 Senior
Secured Convertible Notes.
Notwithstanding,
as noted above, subsequent to December 31, 2020: the November 2019 Senior Convertible Note was repaid-in-full as of January 5,
2021; and both the April 2020 Senior Convertible Note and the August 2020 Senior Convertible Note were repaid-in-full as of March
2, 2021.
F- 26
Note
9 — Outstanding Debt - continued
Convertible
Notes - continued
A
reconciliation of the fair value of the convertible notes for the years ended December 31, 2020 and 2019 is as follows:
December
2018
Senior
Secured
Convertible
Note
November
2019
Senior
Secured
Convertible
Notes (1)(2)
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 )
Fair
Value - December 31, 2018
$ 7,903
$ —
$ —
$ —
$ 7,903
Face
value principal – issue date
—
7,000
—
—
7,000
Fair
value adjustment – issue date
—
(648 )
—
—
(648 )
$ 648
Installment
repayments – common stock
(6,059 )
—
—
—
(6,059 )
Non-installment
payments – common stock
(199 )
—
—
—
(199 )
Non-installment
payments – cash
(279 )
(86 )
—
—
(365 )
Change
in fair value
334
173
—
—
507
(507 )
Lender
Fees:
- November 2019 Senior Secured Convertible Note - Series A
—
—
—
—
—
(700 )
Fair
Value at December 31, 2019
$ 1,700
$ 6,439
$ —
$ —
$ 8,139
Other
Income (Expense) - Change in fair value – year ended December 31, 2019
$ (559 )
The
Senior Convertible Notes presented above are 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 8, Financial Instruments Fair Value Measurements , for a further discussion of fair
value assumptions.
F- 27
Note
9 — Outstanding 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”.
The
Paycheck Protection Program provides that (1) the use of PPP Loan amount shall be limited to certain qualifying expenses, (2)
100 per cent of the principal amount of the loan is guaranteed by the Small Business Administration and (3) an amount up to the
full principal amount may qualify for loan forgiveness in accordance with the terms of CARES Act. Under the CARES Act, loan forgiveness
is available for the sum of documented payroll costs, covered rent payments, covered mortgage interest and covered utilities during
either, at our discretion, the eight-week period or twenty-four week period beginning on the date of disbursement of proceeds
from the PPP loan. In the event the PPP loan, or any portion thereof, is forgiven pursuant to the PPP, the amount forgiven is
applied to outstanding principal with the Company being obligated to make equal monthly payments on the unforgiven principal and
interest balances to fully amortize the loan balance by the maturity date.
The
PPP Loan matures on April 8, 2022 and bears interest at a rate of approximately 1.0% per annum. Monthly amortized principle and
interest payments are deferred in accordance with The Paycheck Protection Flexibility Act of 2020 which extended the deferral
period for loan payments to either (1) the date that U.S. Small Business Administration remits the borrower’s loan forgiveness
amount to the lender or (2) if the borrower does not apply for loan forgiveness, 10 months after the end of the borrower’s
loan forgiveness covered period. As such, as of December 31, 2020, and to date, no principal or interest payments have been made.
F- 28
Note
10 — 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”), adopted by the Company’s
board of directors and stockholders in November 2014, is designed to enable the Company to offer employees, officers, directors,
and consultants, as defined, an opportunity to acquire a proprietary interest in the Company. 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 compensation committee of the Company’s
board of directors.
As
of December 31, 2020, the PAVmed Inc. 2014 Equity Plan has 2,003,406 shares available-for-grant of stock-based awards,
inclusive of the supplemental share reservation increase of an additional 2,000,000 shares, approved by the PAVmed Inc. board
of directors on March 12, 2020, and approved at the PAVmed Inc. 2020 annual meeting of stockholders on July 24, 2020, and re-approved
at a special meeting of stockholders of PAVmed Inc. on March 4, 2021. A discussion of the PAVmed Inc. special meeting of
stockholders is presented in Note 7, Commitments and Contingencies - Legal Proceedings . The shares
available-for-grant exclude a total of 500,854 PAVmed Inc. stock options previously granted outside the PAVmed Inc. 2014 Equity
Plan.
PAVmed
Inc. 2014 Equity Plan - Stock Options
Stock
options issued and outstanding under the PAVmed Inc. 2014 Equity Plan are as follows:
Number
Stock
Options
Weighted
Average
Exercise
Price
Remaining
Contractual
Term
(Years)
Intrinsic
Value (2)
Outstanding
stock options at December 31, 2018
3,327,140
$ 3.68
8.3
Granted (1)
1,925,000
$ 1.00
Exercised
—
$ —
Forfeited
(48,611 )
$ 5.00
Outstanding
stock options at December 31, 2019
5,203,529
2.58
8.1
$
394
Vested
and exercisable stock options at December 31, 2019
3,270,487
$ 3.45
7.5
$
126
Outstanding
stock options at December 31, 2019
5,203,529
$ 2.58
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
(1) Stock
options granted under the PAVmed Inc. 2014 Equity Plan vest ratably over twelve quarters
generally 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, 2020 and 2019 and the exercise price of the
underlying PAVmed Inc. stock options, to the extent such quoted price is greater than
the exercise price.
Subsequent
to December 31, 2020, as approved at the March 4, 2021 special meeting of stockholders, a total of 225,000 stock options were
granted with a weighted average exercise price of $2.03 per share of common stock of the Company. A discussion of the PAVmed Inc.
special meeting of stockholders is presented in Note 7, Commitments and Contingencies - Legal Proceedings.
F- 29
Note
10 — Stock-Based Compensation – continued
PAVmed
Inc. 2014 Equity Plan - Restricted Stock Awards
On
May 1, 2020, a total of 950,000 restricted stock awards were granted under the PAVmed Inc. 2014 Equity Plan, vesting as follows:
450,000 restricted stock awards vesting ratably on an annual basis over a three year period with an initial annual vesting date
of May 1, 2021; and 500,000 restricted stock awards vesting on May 1, 2023. The restricted stock awards are subject to forfeiture
if the requisite service period is not completed.
On
March 15, 2019, a total of 700,000 restricted stock awards were granted under the PAVmed Inc. 2014 Equity Plan, vesting as follows:
233,334 restricted stock awards vested on March 15, 2020; and 466,666 restricted awards vesting on March 15, 2022. The restricted
stock awards are subject to forfeiture if the requisite service period is not completed.
Lucid
Diagnostics Inc. 2018 Long-Term Incentive Equity Plan
The
Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan (“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 2,000,000 shares of common stock of Lucid Diagnostics Inc. are reserved for issuance under the Lucid Diagnostics Inc.
2018 Equity Plan, with 1,305,000 shares available for grant as of December 31, 2020, exclusive of 300,000 Lucid Diagnostics Inc.
stock options previously granted outside the Lucid Diagnostics Inc. 2018 Equity Plan.
Lucid
Diagnostics Inc. 2018 Equity Plan - Stock Options
Stock
options issued and outstanding under the Lucid Diagnostics Inc. 2018 Equity Plan for the period noted is as follows:
Number
Stock
Options
Weighted
Average
Exercise
Price
Remaining
Contractual
Term
(Years)
Outstanding stock options
at December 31, 2018
375,000
$ 0.60
9.4
Granted
620,000
$ 1.02
Exercised
—
$ —
Forfeited
—
$ —
Outstanding stock
options at December 31, 2019
995,000
$ 0.86
9.0
Granted
—
$ —
Exercised
(3,333 )
$ 1.50
Forfeited
—
$ —
Outstanding stock
options at December 31, 2020
991,667
$ 0.86
8.0
Vested and exercisable
stock options at December 31, 2020
772,491
$ 0.83
7.9
(1)
Stock options granted under the
Lucid Diagnostics Inc. 2018 Equity Plan, have a ten-year contractual term from date of grant, and vest ratably over twelve
successive calendar quarters, with first vesting date in the quarter of the date of grant.
During
the year ended December 31, 2020, 3,333 stock options issued under the Lucid Diagnostics Inc. 2018 Equity Plan were exercised
for cash proceeds of $5, resulting in the issue of a corresponding number of shares of common stock of Lucid Diagnostics Inc.
F- 30
Note
10 — Stock-Based Compensation – continued
Lucid
Diagnostics Inc. 2018 Equity Plan - Restricted Stock Awards
Subsequent
to December 31, 2020, on March 1, 2021, a total of 1,040,000 restricted stock awards were granted under the Lucid Diagnostics
Inc. 2018 Equity Plan, with a single vesting date of March 1, 2023. The restricted stock awards are subject to forfeiture if the
requisite service period is not completed.
Stock-Based
Compensation Expense
The
consolidated stock-based compensation expense recognized 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:
Year Ended
December
31,
2020
2019
General and administrative
expenses
$ 1,582
$ 1,163
Research and
development expenses
462
408
Total
$ 2,044
$ 1,571
The
consolidated stock-based compensation expense classified in research and development expenses, as presented above, includes $65
and $174 in the years ended December 31, 2020 and 2019, respectively, recognized by Lucid Diagnostics Inc., with stock-based compensation
expense recognized by Lucid Diagnostics Inc. inclusive of each of: stock options granted under the Lucid Diagnostics Inc. 2018
Equity Plan to employees of PAVmed Inc. and to non-employee consultants, with each providing services to Lucid Diagnostics Inc.;
and stock options granted under the PAVmed Inc. 2014 Equity Plan to non-employee consultants providing services to Lucid Diagnostics
Inc., summarized as follows for the periods noted:
Year Ended
December
31,
2020
2019
Lucid Diagnostics Inc 2018
Equity Plan – research and development expenses
$ 52
$ 158
PAVmed Inc 2014
Equity Plan - research and development expenses
13
16
Total stock-based
compensation expense – recognized by Lucid Diagnostics Inc
$ 65
$ 174
As
of December 31, 2020, 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:
Unrecognized
Expense
Weighted
Average
Remaining
Service
Period
PAVmed Inc. 2014 Equity Plan
Stock
Options
$ 1,866
0.9
years
Restricted Stock
Awards
$ 1,796
2.1
years
Lucid Diagnostics Inc. 2018 Equity Plan
Stock Options
$ 49
0.8
years
F- 31
Note
10 — Stock-Based Compensation - continued
Stock-Based
Compensation Expense - continued
The
stock options granted under the PAVmed Inc. 2014 Equity Plan during the years ended December 31, 2020 and 2019, had a weighted
average estimated fair value of $1.27 per share and $0.48 per share, respectively, calculated using the following weighted average
Black-Scholes valuation model assumptions:
Year
Ended December 31,
2020
2019
Expected
term of stock options (in years)
5.8
5.7
Expected stock price
volatility
73
%
50
%
Risk free interest
rate
0.5
%
2.4
%
Expected dividend
yield
0
%
0
%
Stock-based
compensation expense recognized with respect to stock options granted under the PAVmed Inc. 2014 Equity Plan to non-employees
in the prior year ended December 31, 2019, which was recognized under the previous provisions of ASC 505-50, was
based on a weighted average estimated fair value of such stock options of $1.97 per share, calculated using Black-Scholes valuation
model weighted-average assumptions of an 8.5 year contractual term, a 59% expected stock price volatility, a 2.3% risk free interest
rate, and a 0% expected dividend rate.
The
restricted stock awards granted to employees under the PAVmed Inc. 2014 Equity Plan are measured at their grant date estimated
fair value based on the date-of-grant quoted price per share of PAVmed Inc. common stock. The 700,000 restricted stock awards
granted on March 15, 2019 had an aggregate fair value of approximately $742 with such stock-based compensation expense recognized
ratably over the requisite service period, which is the three-year vesting period as discussed above. The 950,000 restricted stock
awards granted on May 1, 2020 had an aggregate fair value of approximately $1,938 with such stock-based compensation expense recognized
ratably over the requisite service period, which is the three-year vesting period as discussed above.
The
stock-based compensation expense recognized in general and administrative expense related to restricted stock awards was approximately
$576 and $206 in the years ended December 31, 2020 and 2019, respectively. The stock-based compensation expense recognized in
research and development expense related to restricted stock awards was $102 in the year ended December 31, 2020 (there was no
stock-based compensation expense recognized in research and development expense with respect to restricted stock awards in the
previous year ended December 31, 2019).
As
noted above, in the year ended December 31, 2020, there were no stock-based awards granted under the Lucid Diagnostics Inc 2018
Equity Plan. In the previous year ended December 31, 2019, 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 $0.32 per share, and was calculated using the following weighted average Black-Scholes valuation model assumptions:
Expected term of stock options
(in years)
5.8
Expected stock price volatility
63 %
Risk free interest rate
2.1 %
Expected dividend yield
0 %
Stock-based
compensation expense recognized with respect to stock options granted under the Lucid Diagnostics Inc. 2018 Equity Plan to non-employees
in the prior year ended December 31, 2019, which was recognized under the previous provisions of ASC 505-50, was
based on a weighted average estimated fair value of such stock options of $0.29 per share, calculated using Black-Scholes valuation
model weighted-average assumptions of a 8.8 year contractual term, a 57% expected stock price volatility, a 2.1% risk free interest
rate, and a 0% expected dividend rate.
F- 32
Note
10 — Stock-Based Compensation - continued
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. On each of the March 31, 2020 and September 30, 2020 ESPP
purchase dates, 154,266 and 152,289 shares of PAVmed Inc. common stock were issued for proceeds of approximately $126 and
$231, respectively; and in the previous year, on the initial September 30, 2019 ESPP purchase date, 82,772 shares of PAVmed Inc.
common stock were issued for proceeds of approximately $67.
As
of December 31, 2020, the PAVmed Inc. ESPP has a total reservation of 750,000 shares of common stock of PAVmed Inc., with 360,673
shares available-for-issue, inclusive of the supplemental share reservation increase of an additional 500,000 shares,
approved by the PAVmed Inc. board of directors on March 12, 2020, and approved at the PAVmed Inc. 2020 annual meeting of stockholders
on July 24, 2020, and re-approved at a PAVmed Inc. special meeting of stockholders on March 4, 2021. A discussion of the
PAVmed Inc. special meeting of stockholders is presented in Note 7, Commitments and Contingencies - Legal Proceedings .
F- 33
Note
11 - Preferred Stock
The
Company is authorized to issue 20 million shares of its preferred stock, par value of $0.001 per share, with such designation,
rights, and preferences as may be determined by the Company’s board of directors.
Series
B Convertible Preferred Stock
As
of December 31, 2020 and 2019, there were 1,228,075 and 1,158,209 shares of Series B Convertible Preferred Stock (classified in
permanent equity) issued and outstanding, respectively. During the year ended December 31, 2020 and 2019, a total of 94,866 and
88,268 shares, respectively, were issued in settlement of Series B Convertible Preferred Stock dividends declared in the respective
year ended December 31, 2020 and 2019, as such dividends are discussed below. Additionally, in March 2020, at the election of
the holder, 25,000 shares of Series B Convertible Preferred Stock were converted into a corresponding number of shares of common
stock of the Company.
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, 2020, the Company’s board-of-directors declared an aggregate of approximately $284 of Series
B Convertible Preferred Stock dividends, earned as of each 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.
During
the prior year ended December 31, 2019, the Company’s board-of-directors declared an aggregate of approximately $265 of
Series B Convertible Preferred Stock dividends, earned as of December 31, 2018, March 31, 2019, June 30, 2019, and September 30,
2019, which were settled by the issue of an additional aggregate 88,268 shares of Series B Convertible Preferred Stock.
Subsequent
to December 31, 2020, in January 2021, the Company’s board-of-directors declared a Series B Convertible Preferred Stock
dividend earned as of December 31, 2020 and payable as of January 1, 2021, of approximately $73 to be settled by the issue of
an additional 24,198 shares of Series B Convertible Preferred Stock (with such dividend not recognized as a dividend payable as
the Company’s board of directors had not declared such dividends payable as of December 31, 2020).
F- 34
Note
12 — Stockholders’ Equity, Common Stock Purchase Warrants, and Noncontrolling Interest
Common
Stock
The
Company is authorized to issue up to 150 million shares of its common stock, par value of $0.001 per share, inclusive of an increase
of 50 million shares approved by the Company’s stockholders at their July 24, 2020 annual meeting. There were 63,819,935
and 40,478,861 shares of common stock issued and outstanding as of December 31, 2020 and December 31, 2019, respectively.
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 9, Outstanding 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 10, Stock-Based Compensation .
Subsequent
to December 31, 2020, 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 9, Outstanding Debt .
Subsequent
to December 31, 2020, on January 5, 2021, a total of 6,000,000 shares of common stock of the Company were issued
for gross proceeds of approximately $13,440, before a placement agent fee and expenses of approximately $951, and offering
costs incurred by the Company of approximately $70. 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).
Subsequent
to December 31, 2020, on February 23, 2021, a total of 9,782,609 shares of common stock of the Company were issued for proceeds
of approximately $41,626, before underwriter expenses of approximately $50, and offering costs incurred by the Company of approximately
$360. 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).
Subsequent
to December 31, 2020, as of March 12, 2021, a total of 773,842 Series Z Warrants were exercised for cash at a $1.60 per share
of common stock of the Company, resulting in the issue of a corresponding number of shares of common stock of the Company. The
Series Z Warrants are discussed herein below.
Year
Ended December 31, 2019
●
During
2019, a total of 5,480,000 shares of common stock of the Company were issued for gross proceeds of approximately $5,480,
before placement agent fees and expenses of approximately $67, and total offering costs of $34. The shares of common stock
were issued in three registered direct offerings pursuant to respective Prospectus Supplement dated April 12, 2019, May 8,
2019, and June 25, 2019, each with respect to the Company’s effective shelf registration statement on Form S-3 (File
No. 333-220549).
●
In
2019, a total of 7,773,110 shares of common stock of the Company were issued upon conversions of the December 2018 Senior
Convertible Note, as discussed in Note 9, Outstanding Debt .
●
In
2019, 82,772 shares of common stock were purchase by employees through participation in the PAVmed Inc.
Employee Stock Purchase Plan, as discussed in Note 10, Stock-Based Compensation.
F- 35
Note
12 — Stockholders’ Equity, Common Stock Purchase Warrants, and Noncontrolling Interest
Common
Stock Purchase Warrants
The
common stock purchase warrants (classified in permanent equity) outstanding as of the dates indicated are as follows:
Common
Stock Purchase Warrants Issued and Outstanding at
Weighted
Weighted
December
31,
Average
Exercise
December
31,
Average
Exercise
Expiration
2020
Price
/Share
2019
Price/Share
Date
Series Z Warrants
16,814,939
$ 1.60
16,815,039
$ 1.60
April
2024
UPO - Series Z Warrants
53,000
$ 1.60
53,000
$ 1.60
January
2022
Series W Warrants
381,818
$ 5.00
381,818
$ 5.00
January
2022
Series S Warrants
—
$ —
1,199,383
$ 0.01
June
2032
Total
17,249,757
$ 1.68
18,449,240
$ 1.57
In
the year ended December 31, 2020, 1,199,383 Series S Warrants and 100 Series Z Warrants were exercised for cash at their respective
exercise price per share, resulting in the issue of a corresponding number of shares of common stock of the Company.
Additionally, subsequent to December 31, 2020, as of March 12, 2021, a total of 773,842 Series Z Warrants were exercised for
cash at their exercise price per share, resulting in the issue of a corresponding number of shares of common stock of the Company.
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.
Series
W Warrants
A
Series W Warrant is exercisable to purchase one share of common stock of the Company at an exercise price of $5.00 per share,
and expire after the close of business on January 29, 2022, if not earlier redeemed by the Company, as discussed below. The Series
W 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 W 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 W Warrant.
The
Company may redeem the Series W Warrants (other than those outstanding prior to the Company’s initial public offering (“IPO”)
held by the Company’s management, founders, and members thereof, but including the warrants held by the initial investors),
at the Company’s option, in whole or in part, at a price of $0.01 per warrant, at any time while the warrants are exercisable;
upon a minimum of 30 days’ prior written notice of redemption; if, and only if, the volume weighted average price of the
Company’s common stock equals or exceeds $10.00 (subject-to adjustment) for any 20 consecutive trading days ending three
business days before the Company issues its notice of redemption, and provided the average daily trading volume in the stock 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 of the Company underlying such warrants. The right to exercise will be forfeited unless the Series W Warrants
are exercised prior to the date specified in the notice of redemption. On and after the redemption date, a record holder of an
Series W Warrant will have no further rights except to receive the redemption price for such holder’s Series W Warrant upon
its surrender.
F- 36
Note
12 — Stockholders’ Equity, Common Stock Purchase Warrants, and Noncontrolling Interest - continued
Noncontrolling
Interest (“NCI”)
The
noncontrolling interest (“NCI”) included as a component of consolidated total stockholders’ equity is with respect
to the Company’s majority-owned subsidiaries Lucid Diagnostics Inc. and Solys Diagnostics Inc., summarized for the periods
indicated as follows:
Year
Ended
December 31, 2020
Year
Ended
December 31, 2019
NCI - equity (deficit) -
beginning of period
$ (814 )
$ (161 )
Minority Interest investment -Solys
Diagnostics Inc.
—
889
Minority Interest share subscription
receivable - Solys Diagnostics Inc.
—
(889 )
Lucid Diagnostics Inc. 2018 Equity Plan
stock option exercise
5
—
Net loss attributable to NCI - Lucid
Diagnostics Inc.
(1,503 )
(801 )
Net loss attributable to NCI - Solys
Diagnostics Inc.
(109 )
(10 )
Stock-based compensation
expense - Lucid Diagnostics Inc. 2018 Equity Plan
52
158
NCI - equity
(deficit) - end of period
$ (2,369 )
$ (814 )
Lucid
Diagnostics Inc.
As
of December 31, 2020 and 2019, there were 10,003,333 and 10,000,000 shares of common stock of Lucid Diagnostics Inc. issued and
outstanding, respectively. PAVmed Inc. holds 8,187,499 shares of the common stock of Lucid Diagnostics Inc., as of December 31,
2020 and 2019, representing a majority equity ownership interest of 81.85% and 81.875%, respectively, and has a controlling financial
interest. The minority equity ownership interest of the Lucid Diagnostics Inc. common stock includes: 943,464 shares held by CWRU,
289,679 shares held by each of the three individual physician inventors of the intellectual property underlying the CWRU
License Agreement (as such license agreement is discussed in Note 3, Agreements Related to Acquired Intellectual Property
Rights ), as of December 31, 2020 and 2019; and 3,333 shares held by an unrelated third-party consultant as of December 31,
2020, upon the exercise for cash at $1.50 per share of a corresponding number of stock options issued under the Lucid Diagnostics
Inc. 2018 Equity Plan in January 2020 (as such equity plan is discussed in Note 10, Stock-Based Compensation ).
As
of December 31, 2020 and 2019, Lucid Diagnostics Inc. is a consolidated majority-owned subsidiary of the Company, and a corresponding
noncontrolling interest (NCI) is included as a separate component of consolidated stockholders’ equity in the consolidated
balance sheet as of December 31, 2020 and 2019, along with the recognition of a net loss attributable to the NCI in the consolidated
statement of operations in the year ended December 31, 2020 and 2019.
Solys
Diagnostics Inc.
As
of December 31, 2020 and 2019, 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, 2020 and 2019, along with the recognition of a
net loss attributable to the NCI in the consolidated statement of operations in the years ended December 31, 2020 and 2019.
F- 37
Note
13 — Income Taxes
Income
tax (benefit) expense for respective periods noted is as follows:
Year
Ended December 31,
2020
2019
Current
Federal, State and Local
$ —
$ —
Deferred
Federal
(4,571 )
(3,342 )
State and Local
(4,147 )
(4,808 )
(8,718 )
(8,150 )
Less: Valuation
allowance reserve
8,718
8,150
$ —
$ —
The
reconciliation of the federal statutory income tax rate to the effective income tax rate for the respective period noted is as
follows:
Year
Ended December 31,
2020
2019
U.S. federal statutory rate
21.0 %
21.0 %
U.S. state and local income taxes, net
of federal benefit
9.9 %
14.2 %
Permanent differences
(5.8 )%
(3.5 )%
Other
(0.8 )%
15.5 %
Valuation
allowance
(24.3 )%
(47.2 )%
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:
Year
Ended December 31,
2020
2019
Deferred Tax Assets
Net operating loss
$ 21,836
$ 14,060
Non-deductible interest expense
517
357
Debt issue costs
205
285
Stock-based compensation expense
1,901
1,213
Patent licenses
14
14
Research and development tax credit
carryforwards
396
396
Accrued expenses
552
371
Section 195 deferred
start-up costs
24
28
Deferred tax
assets
$ 25,445
$ 16,724
Deferred Tax Liabilities
Depreciation
(19 )
(16 )
Deferred Tax
Liabilities
$ (19 )
$ (16 )
Deferred tax assets, net of deferred
tax liabilities
25,426
16,708
Less: valuation
allowance
(25,426 )
(16,708 )
Deferred tax
assets, net after valuation allowance
$ —
$ —
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.
F- 38
Note
13 — Income Taxes - continued
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, 2020 and 2019.
The
Company has total estimated federal and state net operating loss (“NOL”) carryforward of approximately $63 million
and $40.0 million as of December 31, 2020 and 2019, respectively, which is available to reduce future taxable income, of which
approximately $13.8 million have statutory expiration dates commencing in 2035, and approximately $49.2 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 $63.0 million have statutory expiration dates
commencing in 2035. The Company has total estimated research and development (“R&D”) tax credit carryforward of
approximately $0.4 million as of December 31, 2020 which are available to reduce future tax expense and have statutory expiration
dates commencing in 2035.
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. While the Company is currently evaluating
the impact of these CARES Act provisions, it is not expected, at this time, to 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- 39
Note
14 — Loss Per Share
The
“Net loss per share - attributable to PAVmed Inc. - basic and diluted” and “Net loss per share - attributable
to PAVmed Inc. common stockholders - basic and diluted” - for the respective periods indicated - is as follows:
Year
Ended December 31,
2020
2019
Numerator
Net loss - before noncontrolling
interest
$ (35,888 )
$ (17,268 )
Net loss attributable
to noncontrolling interest
1,612
811
Net loss - as
reported, attributable to PAVmed Inc.
$ (34,276 )
$ (16,457 )
Series
B Convertible Preferred Stock dividends – earned (1)
$ (287 )
$ (270 )
Net loss attributable
to PAVmed Inc. common stockholders
$ (34,563 )
$ (16,727 )
Denominator
Weighted average
common shares outstanding, basic and diluted (2)
47,432,115
30,197,458
Loss per share
Basic and diluted
Net
loss - as reported, attributable to PAVmed Inc.
$ (0.72 )
$ (0.54 )
Net
loss attributable to PAVmed Inc. common stockholders
$ (0.73 )
$ (0.55 )
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:
December
31,
2020
2019
PAVmed Inc. 2014 Equity
Plan stock options and restricted stock awards
8,215,195
5,903,529
Unit purchase options - as to shares
of common stock
53,000
53,000
Unit purchase options - as to shares
underlying Series Z Warrants
53,000
53,000
Series Z Warrants
16,814,939
16,815,039
Series W Warrants
381,818
381,818
Series
B Convertible Preferred Stock (3)
1,228,075
1,158,209
Total
26,746,027
24,364,595
(1)
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.
(2)
Basic
weighted-average number of shares of common stock outstanding for the years ended December 31, 2020 and 2019 include the shares
of the Company issued and outstanding during the years ended December 31, 2020 and December 31, 2019, each on a weighted average
basis. The basic weighted average number of shares 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.
(3)
If
converted, at the election of the holder, the shares of
Series B Convertible Preferred Stock issued and outstanding would result in a corresponding number of additional outstanding
shares of common stock of the Company.
F- 40
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.