UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2023
OR
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from _____ to _____
Commission
File Number: 001-37685
PAVMED
INC.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
47-1214177
(State
or Other Jurisdiction of
(IRS
Employer
Incorporation
or Organization)
Identification
No.)
360
Madison Avenue
25th
Floor
New
York , NY
10017
(Address
of Principal Executive Offices)
(Zip
Code)
(212)
949-4319
(Registrant’s
Telephone Number, Including Area Code)
Securities
registered under Section 12(b) of the Exchange Act:
Title
of each Class
Trading
Symbol(s)
Name
of each Exchange on which Registered
Common
Stock, $0.001 par value per share
PAVM
The
NASDAQ Stock Market LLC
Series
Z Warrants, each to purchase one share of Common Stock
PAVMZ
The
NASDAQ Stock Market LLC
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically Interactive Data File required to be submitted pursuant to Rule 405
of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was
required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”
, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
Accelerated filer
☐
Accelerated
filed
☐
Non-accelerated
filer
☒
Smaller
reporting company
☒
Emerging
growth company
☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to section 13(c) of the Exchange Act ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of August 10, 2023, there were 111,418,679 shares of the registrant’s Common Stock, par value $0.001 per share, issued and
outstanding (with such number of shares inclusive of shares of common stock underlying unvested restricted stock awards granted under
the PAVmed Inc. 2014 Long-Term Incentive Equity Plan as of such date).
TABLE
OF CONTENTS
Page
Part I - Financial Information
Item 1.
Financial Statements
Condensed Consolidated Balance Sheets (unaudited) as of June 30 2023 and December 31, 2022
1
Condensed Consolidated Statements of Operations (unaudited) for the three and six months ended June 30, 2023 and 2022
2
Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) (unaudited) for the three and six months ended June 30, 2023 and 2022
3
Condensed Consolidated Statements of Cash Flows (unaudited) for the six months ended June 30, 2023 and 2022
7
Notes to Unaudited Condensed Consolidated Financial Statements
8
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
28
Item 4.
Controls and Procedures
37
Part II - Other Information
Item 1.
Legal Proceedings
38
Item 5.
Other Information
38
Item 6.
Exhibits
38
Signature
39
Exhibit Index
40
i
Part
I - Financial Information
Item
1. Financial Statements
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands except number of shares and per share data - unaudited)
June 30, 2023
December 31, 2022
Assets:
Current assets:
Cash
$ 37,163
$ 39,744
Accounts receivable
41
17
Prepaid expenses, deposits, and other current assets
5,923
4,165
Total current assets
43,127
43,926
Fixed assets, net
2,028
2,451
Operating lease right-of-use assets
5,014
3,037
Intangible assets, net
2,435
3,445
Other assets
1,079
1,121
Total assets
$ 53,683
$ 53,980
Liabilities, Preferred Stock and Stockholders’ Equity
Current liabilities:
Accounts payable
$ 1,162
$ 2,704
Accrued expenses and other current liabilities
4,946
3,705
Operating lease liabilities, current portion
1,427
1,141
Senior Secured Convertible Notes - at fair value
42,990
33,650
Derivative liability - at fair value
260
—
Total current liabilities
50,785
41,200
Operating lease liabilities, less current portion
3,728
1,846
Total liabilities
54,513
43,046
Commitments and contingencies (Note 9)
-
-
Stockholders’ Equity:
Preferred stock, $ 0.001 par value. Authorized, 20,000,000 shares; Series B Convertible Preferred Stock, par value $ 0.001 , issued and outstanding 1,254,497 at June 30, 2023 and 1,205,759 shares at December 31, 2022
2,841
2,695
Common stock, $ 0.001 par value. Authorized, 250,000,000 shares; 108,537,994 and 94,510,537 shares outstanding as of June 30, 2023 and December 31, 2022, respectively
109
95
Additional paid-in capital
226,321
216,106
Accumulated deficit
( 260,783 )
( 228,169 )
Treasury stock
—
( 408 )
Total PAVmed Inc. Stockholders’ Equity
( 31,512 )
( 9,681 )
Noncontrolling interests
30,682
20,615
Total Stockholders’ Equity
( 830 )
10,934
Total Liabilities and Stockholders’ Equity
$ 53,683
$ 53,980
See
accompanying notes to the unaudited condensed consolidated financial statements.
1
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(in
thousands except number of shares and per share data - unaudited)
2023
2022
2023
2022
Three Months Ended
June 30,
Six Months Ended
June 30,
2023
2022
2023
2022
Revenue
$ 166
$ —
$ 612
$ 189
Operating expenses:
Cost of revenue
1,685
—
3,030
369
Sales and marketing
4,339
4,898
8,877
8,823
General and administrative
6,652
11,196
16,670
20,672
Amortization of acquired intangible assets
505
650
1,010
773
Research and development
3,469
6,740
7,909
12,671
Total operating expenses
16,650
23,484
37,496
43,308
Operating loss
( 16,484 )
( 23,484 )
( 36,884 )
( 43,119 )
Other income (expense):
Interest income
163
7
283
9
Interest expense
( 228 )
( 523 )
( 411 )
( 523 )
Change in fair value - Senior Secured Convertible Notes
( 340 )
( 2,000 )
( 1,380 )
( 2,000 )
Loss on issue and offering costs - Senior Secured Convertible Note
—
( 3,101 )
( 1,186 )
( 3,101 )
Debt extinguishments loss - Senior Secured Convertible Notes
( 743 )
—
( 1,268 )
—
Change in fair value - derivative liability
( 260 )
—
( 260 )
—
Gain on sale of intellectual property
—
—
1,000
—
Other income (expense), net
( 1,408 )
( 5,617 )
( 3,222 )
( 5,615 )
Loss before provision for income tax
( 17,892 )
( 29,101 )
( 40,106 )
( 48,734 )
Provision for income taxes
—
—
—
—
Net loss before noncontrolling interests
( 17,892 )
( 29,101 )
( 40,106 )
( 48,734 )
Net loss attributable to the noncontrolling interests
3,355
3,576
7,638
6,337
Net loss attributable to PAVmed Inc.
( 14,537 )
( 25,525 )
( 32,468 )
( 42,397 )
Less: Series B Convertible Preferred Stock dividends earned
( 75 )
( 70 )
( 149 )
( 138 )
Net loss attributable to PAVmed Inc. common stockholders
$ ( 14,612 )
$ ( 25,595 )
$ ( 32,617 )
$ ( 42,535 )
Per share information:
Net loss per share attributable to PAVmed Inc. - basic and diluted
$ ( 0.14 )
$ ( 0.29 )
$ ( 0.32 )
$ ( 0.49 )
Net loss per share attributable to PAVmed Inc. common stockholders – basic and diluted
$ ( 0.14 )
$ ( 0.29 )
$ ( 0.32 )
$ ( 0.49 )
Weighted average common shares outstanding, basic and diluted
104,349,822
86,957,352
100,742,530
86,689,857
See
accompanying notes to the unaudited condensed consolidated financial statements.
2
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED CONSOLIDATED
STATEMENT OF CHANGES IN EQUITY (DEFICIT)
for
the THREE MONTHS ENDED June 30, 2023
(in
thousands except number of shares and per share data)
Shares
Amount
Shares
Amount
Capital
Deficit
Stock
Interest
Total
PAVmed Inc. Stockholders’ Equity (Deficit)
Series B Convertible
Preferred Stock
Common Stock
Additional Paid-In
Accumulated
Treasury
Non controlling
Shares
Amount
Shares
Amount
Capital
Deficit
Stock
Interest
Total
Balance - March 31, 2023
1,229,887
$ 2,767
100,596,406
$ 101
$ 221,247
$ ( 246,172 )
$ —
$ 32,861
$ 10,804
Dividends declared - Series B Convertible Preferred Stock
24,610
74
—
—
—
( 74 )
—
—
—
Issue common stock - PAVM ATM Facility
—
—
1,248,750
1
608
—
—
—
609
Conversions - Senior Secured Convertible Note
—
—
5,192,838
5
2,388
—
—
—
2,393
Impact of subsidiary equity transactions
—
—
—
—
143
—
—
( 143 )
—
Issuance - vendor service agreement
—
—
1,500,000
2
600
—
—
147
749
Stock-based compensation - PAVmed Inc.
—
—
—
—
1,090
—
—
—
1,090
Stock-based compensation - majority-owned subsidiary
—
—
—
—
245
—
—
1,172
1,417
Net loss
—
—
—
—
—
( 14,537 )
—
( 3,355 )
( 17,892 )
Balance - June 30, 2023
1,254,497
$ 2,841
108,537,994
$ 109
$ 226,321
$ ( 260,783 )
$ —
$ 30,682
$ ( 830 )
See
accompanying notes to the unaudited condensed consolidated financial statements.
3
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY (DEFICIT)
for
the SIX MONTHS ENDED June 30, 2023
(in
thousands, except number of shares and per share data - unaudited)
PAVmed Inc. Stockholders’ Equity (Deficit)
Series B Convertible
Preferred Stock
Common Stock
Additional Paid-In
Accumulated
Treasury
Non controlling
Shares
Amount
Shares
Amount
Capital
Deficit
Stock
Interest
Total
Balance - December 31, 2022
1,205,759
$ 2,695
94,510,537
$ 95
$ 216,106
$ ( 228,169 )
$ ( 408 )
$ 20,615
$ 10,934
Dividends declared - Series B Convertible Preferred Stock
48,738
146
—
—
—
( 146 )
—
—
—
Issue common stock - PAVM ATM Facility
—
—
2,330,747
2
1,164
—
—
—
1,166
Vest - restricted stock awards
—
—
100,000
—
—
—
—
—
—
Conversions - Senior Secured Convertible Note
—
—
9,523,481
10
4,411
—
—
—
4,421
Purchase - Employee Stock Purchase Plan
—
—
384,383
—
122
—
60
—
182
Purchase - majority-owned subsidiary common stock - Employee Stock Purchase Plan
—
—
—
—
—
—
—
276
276
Issuance - majority-owned subsidiary common stock - At-The-Market Facility, net of financing charges
—
—
—
—
—
—
—
284
284
Impact of subsidiary equity transactions
—
—
—
—
1,332
—
—
( 1,332 )
—
Issuance - majority-owned subsidiary common stock - Settlement APA-RDx - Termination Payment
—
—
—
—
—
—
—
713
713
Issuance - vendor service agreement
—
—
1,500,000
2
600
—
—
147
749
Issuance - majority-owned subsidiary preferred stock
—
—
—
—
—
—
—
13,625
13,625
Stock-based compensation - PAVmed Inc.
—
—
—
—
2,288
—
—
—
2,288
Stock-based compensation - majority-owned subsidiaries
—
—
—
—
646
—
—
3,992
4,638
Treasury stock
—
—
188,846
—
( 348 )
—
348
—
—
Net loss
—
—
—
—
—
( 32,468 )
—
( 7,638 )
( 40,106 )
Balance - June 30, 2023
1,254,497
$ 2,841
108,537,994
$ 109
$ 226,321
$ ( 260,783 )
$ —
$ 30,682
$ ( 830 )
See
accompanying notes to the unaudited condensed consolidated financial statements.
4
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY (DEFICIT)
for
the THREE MONTHS ENDED June 30, 2022
(in
thousands, except number of shares and per share data- unaudited)
PAVmed Inc. Stockholders’ Equity (Deficit)
Series B Convertible
Preferred Stock
Common Stock
Additional Paid-In
Accumulated
Treasury
Non controlling
Shares
Amount
Shares
Amount
Capital
Deficit
Stock
Interest
Total
Balance - March 31, 2022
1,136,210
$ 2,486
86,911,646
$ 87
$ 199,719
$ ( 155,849 )
$ ( 512 )
$ 18,802
$ 64,733
Dividends declared - Series B Convertible Preferred Stock
22,740
68
—
—
—
( 68 )
—
—
—
Vest - restricted stock awards
—
—
75,000
—
( 1 )
—
—
—
( 1 )
Exercise - stock options
—
—
62,500
—
61
—
—
—
61
Exercise - stock options of majority-owned subsidiary
—
—
—
—
—
—
—
501
501
Impact of subsidiary equity transactions
—
—
—
—
99
—
—
142
241
Stock-based compensation - PAVmed Inc.
—
—
—
—
1,449
—
—
—
1,449
Stock-based compensation - majority-owned subsidiary
—
—
—
—
—
—
—
3,557
3,557
Treasury stock
—
—
( 25,935 )
—
—
—
( 36 )
—
( 36 )
Net loss
—
—
—
—
—
( 25,525 )
—
( 3,576 )
( 29,101 )
Balance - June 30, 2022
1,158,950
$ 2,554
87,023,211
$ 87
$ 201,327
$ ( 181,442 )
$ ( 548 )
$ 19,426
$ 41,404
See
accompanying notes to the unaudited condensed consolidated financial statements.
5
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY (DEFICIT)
for
the SIX MONTHS ENDED June 30, 2022
(in
thousands, except number of shares and per share data - unaudited)
PAVmed Inc. Stockholders’ Equity (Deficit)
Series B Convertible
Preferred Stock
Common Stock
Additional Paid-In
Accumulated
Treasury
Non controlling
Shares
Amount
Shares
Amount
Capital
Deficit
Stock
Interest
Total
Balance - December 31, 2021
1,113,919
$ 2,419
86,367,845
$ 86
$ 198,071
$ ( 138,910 )
$ —
$ 17,752
$ 79,418
Beginning balance
1,113,919
$ 2,419
86,367,845
$ 86
$ 198,071
$ ( 138,910 )
$ —
$ 17,752
$ 79,418
Dividends declared - Series B Convertible Preferred Stock
45,031
135
—
—
—
( 135 )
—
—
—
Vest - restricted stock awards
—
—
541,666
—
( 1 )
—
—
—
( 1 )
Exercise - Series Z warrants
—
—
5
—
—
—
—
—
—
Exercise - stock options
—
—
299,999
1
302
—
—
—
303
Exercise - stock options of majority-owned subsidiary
—
—
—
—
—
—
—
688
688
Purchase - Employee Stock Purchase Plan
—
—
194,240
—
217
—
—
—
217
Impact of subsidiary equity transactions
—
—
—
—
12
—
—
229
241
Stock-based compensation - PAVmed Inc.
—
—
—
—
2,726
—
—
—
2,726
Stock-based compensation - majority-owned subsidiaries
—
—
—
—
—
—
—
7,094
7,094
Treasury stock
—
—
( 380,544 )
—
—
—
( 548 )
—
( 548 )
Net Loss
—
—
—
—
—
( 42,397 )
—
( 6,337 )
( 48,734 )
Balance - June 30, 2022
1,158,950
$ 2,554
87,023,211
$ 87
$ 201,327
$ ( 181,442 )
$ ( 548 )
$ 19,426
$ 41,404
Ending balance
1,158,950
$ 2,554
87,023,211
$ 87
$ 201,327
$ ( 181,442 )
$ ( 548 )
$ 19,426
$ 41,404
See
accompanying notes to the unaudited condensed consolidated financial statements.
6
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in
thousands, except number of shares and per share data - unaudited)
2023
2022
Six Months Ended June 30,
2023
2022
Cash flows from operating activities
Net loss - before noncontrolling interest (“NCI”)
$ ( 40,106 )
$ ( 48,734 )
Adjustments to reconcile net loss - before NCI to net cash used in operating activities
Depreciation and amortization expense
1,474
1,031
Stock-based compensation
6,926
9,820
Gain on sale of intellectual property
( 1,000 )
—
APA-RDx: Issue common stock of majority-owned subsidiary - settle termination payment
713
239
Issue common stock - vendor service agreement
625
—
Change in fair value - Senior Secured Convertible Notes
1,380
2,000
Loss on issue - Senior Secured Convertible Note
1,111
2,500
Debt extinguishment loss - Senior Secured Convertible Note
1,268
—
Change in fair value - derivative liability
260
—
Non-cash lease expense
192
57
Changes in operating assets and liabilities:
Accounts receivable
( 24 )
200
Prepaid expenses, deposits and current and other assets
( 1,592 )
( 1,665 )
Accounts payable
( 1,541 )
1,057
Accrued expenses and other current liabilities
1,241
( 1,326 )
Net cash flows used in operating activities
( 29,073 )
( 34,821 )
Cash flows from investing activities
Purchase of equipment
( 41 )
( 926 )
Proceeds from sale of intellectual property
1,000
—
Asset acquisitions
—
( 2,200 )
Net cash flows used in investing activities
959
( 3,126 )
Cash flows from financing activities
Proceeds – issue of preferred stock - majority-owned subsidiary
13,625
—
Proceeds – issue of Senior Secured Convertible Note
10,000
25,000
Proceeds – issue of common stock - At-The-Market Facility
1,166
—
Proceeds – majority-owned subsidiary common stock - At-The-Market Facility
284
—
Proceeds – exercise of stock options
—
303
Proceeds – issue common stock – Employee Stock Purchase Plan
182
217
Proceeds – majority-owned subsidiary common stock – Employee Stock Purchase Plan
276
—
Proceeds – exercise of stock options issued under equity plan of majority owned subsidiary
—
688
Purchase Treasury Stock – payment of employee payroll tax obligation in connection with stock-based compensation
—
( 366 )
Net cash flows provided by financing activities
25,533
25,842
Net increase (decrease) in cash
( 2,581 )
( 12,105 )
Cash, beginning of period
39,744
77,258
Cash, end of period
$ 37,163
$ 65,153
See
accompanying notes to the unaudited condensed consolidated financial statements.
7
PAVMED
INC.
and
SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(amounts
in these accompanying notes are presented in thousands, except number of shares and per-share amounts.)
Note
1 — The Company
Description
of the Business
PAVmed
Inc. and Subsidiaries, referred to herein as “PAVmed” or the “Company,” is comprised of PAVmed Inc. and its wholly-owned
subsidiary and its majority-owned subsidiaries, inclusive of Lucid Diagnostics Inc. (“Lucid Diagnostics” or “Lucid”)
and Veris Health Inc. (“Veris Health” or “Veris”).
PAVmed
is a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors,
including through Lucid Diagnostics, a commercial-stage cancer prevention diagnostics company, and Veris
Health, a private digital health company focused on enhanced personalized cancer care through remote patient monitoring using implantable biologic sensors with wireless communication along with a custom
suite of connected external devices. The Company’s current central focus is on
the commercialization of Lucid’s EsoGuard assay and Veris Health’s Veris Cancer Care Platform. As resources permit, we will
continue to explore internal and external innovations that fulfill our project selection criteria without limiting ourselves to any target
specialty or condition.
The
Company has financed its operations principally through public and private issuances of its common stock, preferred stock, common stock
purchase warrants, and debt. The Company is subject to all of the risks and uncertainties typically faced by medical device and diagnostic
companies that devote substantially all of their efforts to the commercialization of their initial product and services and ongoing research
and development activities and conducting clinical trials. The Company expects to continue to experience recurring losses from operations
and will continue to fund its operations with debt and equity financing transactions. Notwithstanding, however, with the cash on-hand
as of the date hereof and other debt and equity committed sources of financing, the Company expects to be able to fund its operations
for one year from the date of the issue of the Company’s consolidated financial statements included herein in the Company’s
Quarterly Report on Form 10-Q for the period ended June 30, 2023.
Note
2 — Summary of Significant Accounting Policies
Significant
Accounting Policies
The
Company’s significant accounting policies are as disclosed in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2022 as filed with the SEC on March 14, 2023, except as otherwise noted herein below.
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements of PAVmed and its subsidiaries have been prepared in accordance with
accounting principles generally accepted in the United States of America (“U.S. GAAP”), and applicable rules and regulations
of the United States Securities and Exchange Commission (“SEC”), and include the accounts of the Company and its wholly-owned
and majority-owned subsidiaries. All intercompany transactions and balances have been eliminated in consolidation. The Company holds
a majority-ownership interest and has controlling financial interest in each of: Lucid Diagnostics and Veris Health, with the corresponding
noncontrolling interest included as a separate component of consolidated stockholders’ equity (deficit), including the recognition
in the unaudited condensed consolidated statement of operations of a net loss attributable to the noncontrolling interest based on the
respective minority-interest equity ownership of each majority-owned subsidiary. See Note 15, Noncontrolling Interest , for a discussion
of each of the majority-owned subsidiaries noted above. The Company manages its operations as a single operating segment for the purposes
of assessing performance and making operating decisions.
As
permitted under SEC rules, certain footnotes or other financial information normally required by U.S. GAAP have been condensed or omitted.
The balance sheet as of December 31, 2022 has been derived from audited consolidated financial statements at such date. The accompanying
unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated
financial statements, and in the opinion of management, include all adjustments, consisting only of routine recurring adjustments, necessary
for a fair statement of the Company’s unaudited condensed consolidated financial information.
8
Note
2 — Summary of Significant Accounting Policies - continued
The
consolidated results of operations for the three and six months ended June 30, 2023 are not necessarily indicative of the consolidated
results to be expected for the year ending December 31, 2023 or for any other interim period or for any other future periods. The accompanying
unaudited condensed consolidated financial statements and related unaudited condensed consolidated financial information should be read
in conjunction with the Company’s audited consolidated financial statements and related notes thereto as of and for the year ended
December 31, 2022 included in the Company’s Annual Report on Form 10-K as filed with the SEC on March 14, 2023.
All
amounts in the accompanying unaudited condensed consolidated financial statements and the notes thereto are presented in thousands
of dollars, if not otherwise noted as being presented in millions of dollars, except for shares and per share amounts.
Use
of Estimates
In
preparing the unaudited condensed consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates
and assumptions that affect the reported amounts of assets and the determination of corresponding carrying value reserve, if any, and
liabilities and the disclosure of contingent losses, as of the date of the consolidated financial statements, as well as the reported
amounts of revenue and expenses during the reporting period. Significant estimates in these unaudited condensed consolidated financial
statements include those related to the estimated fair value of debt obligations, stock-based equity awards, intangible assets and common
stock purchase warrants. Other significant estimates include the estimated incremental borrowing rate, the provision or benefit for income
taxes and the corresponding valuation allowance on deferred tax assets. Additionally, management’s assessment of the Company’s
ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. On an ongoing
basis, the Company evaluates its estimates and assumptions. The Company bases its estimates on historical experience and on various other
assumptions believed to be reasonable. Due to inherent uncertainty involved in making estimates, actual results reported in future periods
may be affected by changes in these estimates.
Revenue
Recognition
Revenues
are recognized when the satisfaction of the performance obligation occurs, in an amount that reflects the consideration the Company expects
to collect in exchange for those services. The Company’s revenue is primarily generated by its laboratory testing services utilizing
its EsoGuard Esophageal DNA tests. The services are completed upon release of a patient’s test result to the ordering healthcare
provider. Revenue recognized is inclusive of both variable consideration in connection with an individual patient’s third-party
insurance coverage policy and fixed consideration in connection with a contracted services arrangement with an unrelated third party
legal entity. To determine revenue recognition for the arrangements that the Company determines are within the scope of ASC 606, Revenue
from Contracts with Customers, the Company performs the following five steps: (1) identify the contract(s) with a customer, (2) identify
the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance
obligations in the contract and (5) recognize revenue when (or as) the entity satisfies a performance obligation.
The
key aspects considered by the Company include the following:
Contracts —The
Company’s customer is primarily the patient, but the Company does not enter into a formal reimbursement contract with a patient.
The Company establishes a contract with a patient in accordance with other customary business practices, which is the point in time an
order is received from a provider and a patient specimen has been returned to the laboratory for testing. Payment terms are a function
of a patient’s existing insurance benefits, including the impact of coverage decisions with Center for Medicare & Medicaid
Services (“CMS”) and applicable reimbursement contracts established between the Company and payers. However, when a patient
is considered self-pay, the Company requires payment from the patient prior to the commencement of the Company’s performance obligations.
The Company’s consideration can be deemed variable or fixed depending on the structure of specific payer contracts, and the Company
considers collection of such consideration to be probable to the extent that it is unconstrained.
Performance
obligations —A performance obligation is a promise in a contract to transfer a distinct good or service (or a bundle of goods
or services) to the customer. The Company’s contracts have a single performance obligation, which is satisfied upon rendering of
services, which culminates in the release of a patient’s test result to the ordering healthcare provider. The Company elects the
practical expedient related to the disclosure of unsatisfied performance obligations, as the duration of time between providing testing
supplies, the receipt of a sample, and the release of a test result to the ordering healthcare provider is far less than one year.
9
Note
2 — Summary of Significant Accounting Policies - continued
Transaction
price —The transaction price is the amount of consideration that the Company expects to collect in exchange for transferring
promised goods or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes). The
consideration expected to be collected from a contract with a customer may include fixed amounts, variable amounts, or both.
If
the consideration derived from the contracts is deemed to be variable, the Company estimates the amount of consideration to which it
will be entitled in exchange for the promised goods or services. The Company limits the amount of variable consideration included in
the transaction price to the unconstrained portion of such consideration. In other words, the Company recognizes revenue up to the amount
of variable consideration that is not subject to a significant reversal until additional information is obtained or the uncertainty associated
with the additional payments or refunds is subsequently resolved.
When
the Company does not have significant historical experience or that experience has limited predictive value, the constraint over estimates
of variable consideration may result in no revenue being recognized upon delivery of patient EsoGuard test results to the ordering healthcare
provider. As such, the Company recognizes revenue up to the amount of variable consideration not subject to a significant reversal until
additional information is obtained or the uncertainty associated with additional payments or refunds, if any, is subsequently resolved.
Differences between original estimates and subsequent revisions, including final settlements, represent changes in estimated expected
variable consideration, with the change in estimate recognized in the period of such revised estimate. With respect to a contracted service
arrangement, the fixed consideration revenue is recognized on an as-billed basis upon delivery of the laboratory test report with realization
of such fixed consideration deemed probable based upon actual historical experience.
Allocate
transaction price —The transaction price is allocated entirely to the performance obligation contained within the contract with
a customer on the basis of the relative standalone selling prices of each distinct good or service.
Practical
Expedients —The Company does not adjust the transaction price for the effects of a significant financing component, as at contract
inception, the Company expects the collection cycle to be one year or less.
Fair
Value Option (“FVO”) Election
Under
a Securities Purchase Agreement dated March 31, 2022, the Company issued a Senior Secured Convertible Note dated April 4, 2022, referred
to herein as the “April 2022 Senior Convertible Note”, and a Senior Secured Convertible Note dated September 8, 2022, referred
to herein as the “September 2022 Senior Convertible Note”, which are accounted under the “fair value option election”
as discussed below.
Under
a Securities Purchase Agreement dated March 13, 2023, Lucid Diagnostics issued a Senior Secured Convertible Note dated March 21, 2023,
referred to herein as the “Lucid March 2023 Senior Convertible Note”, which is accounted under the “fair value option
election” as discussed below.
Under
Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 815, Derivative
and Hedging , (“ASC 815”), a financial instrument containing embedded features and/or options may be required to be bifurcated
from the financial instrument host and recognized as separate derivative asset or liability, with the bifurcated derivative asset or
liability initially measured at estimated fair value as of the transaction issue date and then subsequently remeasured at estimated fair
value as of each reporting period balance sheet date.
Alternatively,
FASB ASC Topic 825, Financial Instruments , (“ASC 825”) provides for the “fair value option” (“FVO”)
election. In this regard, ASC 825-10-15-4 provides for the FVO election (to the extent not otherwise prohibited by ASC 825-10-15-5) to
be afforded to financial instruments, wherein the financial instrument is initially measured at estimated fair value as of the transaction
issue date and then subsequently remeasured at estimated fair value as of each reporting period balance sheet date, with changes in the
estimated fair value recognized as other income (expense) in the statement of operations. The estimated fair value adjustment of the
April 2022 Senior Convertible Note, the September 2022 Senior Convertible Note and the Lucid March 2023 Senior Convertible Note are presented
in a single line item within other income (expense) in the accompanying unaudited condensed consolidated statement of operations (as
provided for by ASC 825-10-50-30(b)). Further, as required by ASC 825-10-45-5, to the extent a portion of the fair value adjustment is
attributed to a change in the instrument-specific credit risk, such portion would be recognized as a component of other comprehensive
income (“OCI”) (for which there was no such adjustment with respect to the April 2022 Senior Convertible Note, the September
2022 Senior Convertible Note or the Lucid March 2023 Senior Convertible Note).
See
Note 10, Financial Instruments Fair Value Measurements , with respect to the FVO election; and Note 11, Debt , for a discussion
of the April 2022 Senior Convertible Note, the September 2022 Senior Convertible Note and the Lucid March 2023 Senior Convertible Note.
Reclassifications
Certain
prior-year amounts have been reclassified to conform to the current year presentation, which includes presenting costs of revenue within
operating expenses on the statements of operations, in the unaudited condensed consolidated financial statements and accompanying notes
to the unaudited condensed consolidated financial statements. The impact of the reclassifications made to prior year amounts is not material
and did not affect net loss.
10
Note
2 — Summary of Significant Accounting Policies - continued
Recently
Adopted Accounting Pronouncements
In
June 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments-Credit Losses (Topic In
June 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments-Credit Losses (Topic 326):
Measurement of Credit Losses on Financial Instruments. The updated guidance requires companies to measure all expected credit losses
for financial instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable forecasts.
This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets, including trade
receivables. The guidance was adopted by the Company on January 1, 2023. The adoption of the ASU did not have an impact on the Company’s
unaudited condensed consolidated financial statements.
Note
3 — Revenue from Contracts with Customers
EsoGuard
Commercialization Agreement
The
Company, through its majority-owned subsidiary, Lucid Diagnostics, entered into the EsoGuard Commercialization Agreement, dated August
1, 2021, with its former commercial laboratory service provider, ResearchDx Inc. (“RDx”), an unrelated third-party. The EsoGuard
Commercialization Agreement was on a month-to-month basis, and was terminated on February 25, 2022 upon the execution of an asset purchase
agreement (“APA”) dated February 25, 2022, between LucidDx Labs Inc. (a wholly-owned subsidiary of Lucid Diagnostics) and
RDx, with such agreement further discussed in Note 5 , Asset Purchase Agreement and Management Services Agreement.
Revenue
Recognized
In
the three and six months ended June 30, 2023, the Company recognized total revenue of $ 166
and $ 612 ,
respectively, primarily resulting from the delivery of patient EsoGuard test results. Revenue recognized from customer contracts
deemed to include a variable consideration transaction price is limited to the unconstrained portion of the variable consideration.
The Company’s revenue for the three and six months ended June 30, 2022 was $ 0 and $ 189 ,
which solely reflects the revenue recognized under the EsoGuard Commercialization Agreement, which represented the minimum fixed
monthly fee of $ 100 for
the period January 1, 2022 to the February 25, 2022 termination date as discussed above. The monthly fee was deemed to be
collectible for such period as RDx has timely paid the applicable respective monthly fee.
Cost
of Revenue
The
cost of revenues principally includes the costs related to the Company’s laboratory operations (excluding estimated costs associated
with research activities), the costs related to the EsoCheck cell collection device, cell sample mailing kits and license royalties.
In
the three and six months ended June 30, 2023, the cost of revenue was $ 1,685
and $ 3,030 ,
respectively, and was primarily related to costs for our laboratory operations and EsoCheck device supplies. The Company’s
cost of revenue for the three and six months ended June 30, 2022 was $ 0 and $ 369 ,
which solely reflects the costs attributable to delivering the services under the EsoGuard Commercialization Agreement for the
period January 1, 2022 thru its termination on February 25, 2022. In the three months ended June 30, 2022, laboratory operations costs are included in operating expenses as general
and administrative expenses in the accompanying unaudited condensed consolidated statements of operations.
11
Note
4 — Related Party Transactions
Case
Western Reserve University and Physician Inventors - Amended CWRU License Agreement
Case
Western Reserve University (“CWRU”) and each of the three physician inventors (“Physician Inventors”) of the
intellectual property licensed under the amended and restated patent license agreement with CWRU, dated August 23, 2021 (the “Amended
CWRU License Agreement”), each hold a minority equity ownership interest in Lucid Diagnostics Inc. The expenses incurred with respect
to the Amended CWRU License Agreement and the three Physician Inventors, as classified in the accompanying unaudited condensed consolidated
statement of operations for the periods indicated are summarized as follows:
Schedule
of Incurred Expenses of Minority Shareholders
Three Months Ended June 30,
Six Months Ended June 30,
2023
2022
2023
2022
Cost of Revenue
CWRU – Royalty Fees
$ 10
$ —
$ 34
$ 9
General and Administrative Expense
Stock-based compensation expense – Physician Inventors’ restricted stock awards
—
272
180
544
Research and Development Expense
Amended CWRU – License Agreement - reimbursement of patent legal fees
—
209
389
209
Fees - Physician Inventors’ consulting agreements
9
10
10
18
Sponsored research agreement
—
—
—
3
Stock-based compensation expense – Physician Inventors’ stock options
52
52
105
99
Total Related Party Expenses
$ 71
$ 543
$ 718
$ 882
See
Note 12, Stock-Based Compensation , for information regarding each of the “PAVmed Inc. 2014 Long-Term Incentive Equity Plan”
and the separate “Lucid Diagnostics Inc 2018 Long-Term Incentive Equity Plan”; and Note 15, Noncontrolling Interest ,
for a discussion of Lucid Diagnostics Inc. and the corresponding noncontrolling interests.
Other
Related Party Transactions
Effective
June 2021, Veris Health entered into a consulting agreement with Andrew Thoreson, M.D. which provides for compensation on a contractual
rate per hour for consulting services provided. Dr. Thoreson holds a partial ownership interest in the legal entity which holds a minority
interest in Veris Health. Veris Health recognized general and administrative expense of $ 13 and $ 18 in the three and six months ended
June 30, 2023, respectively, and $ 13 and $ 37 in the three and six months ended June 30, 2022, respectively, in connection with the consulting
agreement.
12
Note
5 — Asset Purchase Agreement and Management Services Agreement
Asset
Purchase Agreement and Management Services Agreement - ResearchDx Inc.
LucidDx
Labs, a wholly-owned subsidiary of Lucid Diagnostics, entered into an asset purchase agreement (“APA”) dated February 25,
2022, with ResearchDx, Inc. (“RDx”), an unrelated third-party (“APA-RDx”). Under the APA-RDx, LucidDx Labs acquired
certain assets from RDx which were combined with LucidDx Labs purchased and leased property and equipment to establish a Company-owned
Commercial Lab Improvements Act (“CLIA”) certified, College of American Pathologists (“CAP”) accredited commercial
clinical laboratory capable of performing the EsoGuard® Esophageal DNA assay, inclusive of DNA extraction, next generation sequencing
(“NGS”) and specimen storage. Prior to February 25, 2022, RDx provided such laboratory services at its owned CLIA-certified,
CAP-accredited clinical laboratory. In connection with the execution and delivery of the APA-RDx, LucidDx Labs and RDx entered into a
separate management services agreement (“MSA-RDx”), dated and effective February 25, 2022, pursuant to which RDx provided
certain testing and related services for the Laboratory.
The
total purchase price consideration payable under the APA-RDx is a face value of $ 3,200 comprised of three contractually specified periodic
payments. The APA-RDx is being accounted for as an asset acquisition, with the recognition of an intangible asset of approximately $ 3,200 ,
which is included in “Intangible assets, net” on the accompanying unaudited condensed consolidated balance sheet, as further
discussed in Note 8, Intangible Assets, net.
Termination
of Management Services Agreement and Modification of Other Payment Obligations - ResearchDx Inc
On
February 14, 2023, Lucid Diagnostics and LucidDx Labs entered into an agreement (the “MSA Termination Agreement”) with RDx,
pursuant to which the parties mutually agreed to terminate the MSA-RDx without cause. The termination was effective as February 10, 2023.
Until the termination of the management service agreement with RDx, RDx had continued to provide certain testing and related services
for the Laboratory in accordance with the terms of the MSA-RDx.
The
MSA Termination Agreement reduces the remaining amounts of the earnout payments and management fees due under the APA-RDx and the MSA-RDx
to $ 713 . The payment was satisfied through the issuance of 553,436 shares of Lucid Diagnostics’ common stock in February 2023.
Lucid Diagnostics was not required to make any cash payments in connection with the termination.
Note
6 — Prepaid Expenses, Deposits, and Other Current Assets
Prepaid
expenses and other current assets consisted of the following as of:
Schedule
of Prepaid Expenses and Other Current Assets
June 30, 2023
December 31, 2022
Advanced payments to service providers and suppliers
$ 567
$ 599
Prepaid insurance
799
300
Deposits
4,314
3,005
EsoCheck cell collection supplies
39
59
EsoGuard mailer supplies
3
52
Veris Box supplies
201
150
Total prepaid expenses, deposits and other current assets
$ 5,923
$ 4,165
13
Note
7 — Leases
During
the six months ended June 30, 2023, the Company entered into additional lease agreements that have commenced and are classified as operating
leases and short-term leases, including for each of: principal corporate offices and additional Lucid Test Centers.
The
Company’s future lease payments as of June 30, 2023, which are presented as operating lease liabilities, current portion and operating
lease liabilities, less current portion on the Company’s unaudited condensed consolidated balance sheets are as follows:
Schedule
of Future Lease Payments
2023 (remainder of year)
$ 844
2024
1,825
2025
835
2026
787
2027
617
Thereafter
1,319
Total lease payments
$ 6,227
Less: imputed interest
( 1,072 )
Present value of lease liabilities
$ 5,155
Supplemental
disclosure of cash flow information related to the Company’s cash and non-cash activities with its leases are as follows:
Schedule
of Supplemental Cash Flow Information Related to Cash and Non-cash Activities with Leases
Six Months Ended June 30,
2023
2022
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows from operating leases
$ 705
$ 483
Non-cash investing and financing activities
Right-of-use assets obtained in exchange for new operating lease liabilities
$ 2,689
$ 3,633
Weighted-average remaining lease term - operating leases (in years)
4.75
3.31
Weighted-average discount rate - operating leases
7.875 %
7.875 %
As
of June 30, 2023 and December 31, 2022, the Company’s right-of-use assets from operating leases were $ 5,014 and $ 3,037 , respectively,
which are reported in operating lease right-of-use assets in the unaudited condensed consolidated balance sheets. As of June 30, 2023
and December 31, 2022, the Company had outstanding operating lease obligations of $ 5,155 and $ 2,987 , respectively, of which $ 1,427 and
$ 1,141 , respectively, are reported in operating lease liabilities, current portion and $ 3,728 and $ 1,846 , respectively, are reported
in operating lease liabilities less current portion in the Company’s unaudited condensed consolidated balance sheets. The Company
calculates its incremental borrowing rates for specific lease terms, used to discount future lease payments, as a function of the financing
terms the Company would likely receive on the open market.
In
September 2022, the Company entered into a lease agreement for its principal corporate offices, in New York, New York. The lease agreement
term is from the September 15, 2022 execution date to the date which is seven years and eight months from the lease commencement date,
with the rent abated for the first eight months of the lease term . The lease commenced on February 1, 2023. The aggregate (undiscounted)
rent payments are approximately $ 3.2 million over the lease term.
14
Note
8 — Intangible Assets, net
Intangible
assets, less accumulated amortization, consisted of the following as of:
Schedule
of Intangible Assets, Less Accumulated Amortization
Estimated Useful Life
June 30, 2023
December 31, 2022
Defensive asset
60 months
$ 2,105
$ 2,105
Laboratory licenses and certifications and laboratory information management software
24 months
3,200
3,200
Other
1 year
70
70
Total Intangible assets
5,375
5,375
Less Accumulated Amortization
( 2,940 )
( 1,930 )
Intangible Assets, net
$ 2,435
$ 3,445
The
defensive technology intangible asset was recognized upon its acquisition of CapNostics, an unrelated third-party, for total purchase
consideration paid on the October 5, 2021 acquisition date of approximately $ 2.1 million in cash. The CapNostics transaction was accounted
for as an asset acquisition, resulting in the recognition of the defensive technology intangible asset. The defensive technology intangible
asset is being amortized on a straight-line basis over an expected useful life 60 months commencing on the acquisition date.
The
intangible assets recognized under the APA-RDx are the laboratory licenses and certifications, inclusive of a CLIA certification, CAP
accreditation, and clinical laboratory licenses for five (5) U.S. States transfer to the Company from RDx, and a laboratory information
management software perpetual-use royalty-free license granted under the APA-RDx, with such intangible asset having a useful life of
twenty-four months commencing on the APA-RDx February 25, 2022 transaction date.
Amortization
expense of the intangible assets discussed above was $ 505 and $ 650 for the three month periods ended June 30, 2023 and 2022, respectively,
and $ 1,010 and $ 773 for the six month periods ended June 30, 2023 and 2022, respectively, and is included in amortization of acquired
intangible assets in the accompanying unaudited condensed consolidated statements of operations. As of June 30, 2023, the estimated future
amortization expense associated with the Company’s finite-lived intangible assets for each of the five succeeding fiscal years
is as follows:
Schedule of Estimated Amortization Expense for Intangible Assets
2023 (remainder of year)
$ 1,011
2024
688
2025
421
2026
315
Total
$ 2,435
Note
9 — Commitment and Contingencies
Other
Matters
In the ordinary course of PAVmed 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. The Company is not aware of any such pending legal or other proceedings
that are reasonably likely to have a material impact on the Company. 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.
15
Note
10 — Financial Instruments Fair Value Measurements
Recurring
Fair Value Measurements
The
fair value hierarchy table for the periods indicated is as follows:
Schedule of Financial Liabilities Measured at Fair Value on Recurring Basis
Fair Value Measurement on a Recurring Basis at Reporting Date Using 1
Level-1 Inputs
Level-2 Inputs
Level-3 Inputs
Total
June 30, 2023
Senior Secured Convertible Note - April 2022
$ —
$ —
$ 19,530
$ 19,530
Senior Secured Convertible Note - September 2022
—
—
11,850
11,850
Lucid Senior Secured Convertible Note - March 2023
—
—
11,610
11,610
Derivative liability
—
—
260
260
Totals
$ —
$ —
$ 43,250
$ 43,250
Level-1 Inputs
Level-2 Inputs
Level-3 Inputs
Total
December 31, 2022
Senior Secured Convertible Note - April 2022
$ —
$ —
$ 22,000
$ 22,000
Senior Secured Convertible Note - September 2022
—
—
11,650
11,650
Totals
$ —
$ —
$ 33,650
$ 33,650
1
There
were no transfers between the respective Levels during the period ended June 30, 2023.
As
discussed in Note 11, Debt , the Company issued Senior Secured Convertible Notes dated April 4, 2022 and September 8, 2022, with
an initial $ 27.5 million face value principal (“April 2022 Senior Convertible Note”) and an initial $ 11.25 million face value
principal (“September 2022 Senior Convertible Note”), respectively. Both convertible notes are accounted for under the ASC
825-10-15-4 fair value option (“FVO”) election, wherein, the financial instrument is initially measured at its issue-date
estimated fair value and subsequently remeasured at estimated fair value on a recurring basis at each reporting period date.
As
discussed in Note 11, Debt, Lucid Diagnostics issued a Senior Secured Convertible Note dated March 21, 2023, with an initial $ 11.1
million face value principal (“Lucid March 2023 Senior Convertible Note”). This convertible note is also accounted for under
the ASC 825-10-15-4 fair value option (“FVO”) election, wherein, the financial instrument is initially measured at its issue-date
estimated fair value and subsequently remeasured at estimated fair value on a recurring basis at each reporting period date.
The
estimated fair value of the financial instruments classified within the Level 3 category was determined using both observable inputs
and unobservable inputs. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in fair
value attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in unobservable long-
dated volatilities) inputs.
The
estimated fair value of the Lucid March 2023 Senior Convertible Note as of each of March 21, 2023 and June 30, 2023, and the estimated
fair value of the April 2022 Senior Convertible Note and the September 2022 Senior Convertible Note as of June 30, 2023, were computed
using a Monte Carlo simulation of the present value of its cash flows using a synthetic credit rating analysis and a required rate-of-return,
using the following assumptions:
Schedule
of Fair Value Assumption Used
April 2022 Senior Convertible Note:
June 30, 2023
September 2022 Senior Convertible Note:
June 30, 2023
Lucid March 2023 Senior Convertible Note:
March 21, 2023
Lucid March 2023 Senior Convertible Note:
June 30, 2023
Fair Value
$ 19,530
$ 11,850
$ 11,900
$ 11,610
Face value principal payable
$ 18,554
$ 11,250
$ 11,111
$ 11,111
Required rate of return
11.400 %
11.300 %
11.00 %
11.00 %
Conversion Price
$ 5.00
$ 5.00
$ 5.00
$ 5.00
Value of common stock
$ 0.41
$ 0.41
$ 1.54
$ 1.39
Expected term (years)
0.29
1.19
2.00
1.73
Volatility
200.00 %
200.00 %
75.00 %
70.00 %
Risk free rate
5.29 %
5.21 %
4.09 %
4.89 %
Dividend yield
— %
— %
— %
— %
16
Note
10 — Financial Instruments Fair Value Measurements - continued
Derivative
Liability - Written Protective Put
The
Company, through its majority-owned subsidiary Veris Health, entered into a Research and Development Agreement, with an effective
date of May 31, 2023, with an unrelated third-party technical services provider (the “May 31, 2023 R&D Agreement”). The
principal service to be provided by the service provider under the May 31, 2023 R&D Agreement was the continued development of the
electronics and firmware for the Veris Health implantable physiologic monitor.
As
discussed in Note 14, Common Stock and Common Stock Purchase Warrants , 1.5
million shares of PAVmed common stock were issued to the service provider as the consideration for a $ 750 portion of the services to
be rendered under the May 31, 2023 R&D Agreement. The issued shares of common stock are (contingently) settlement-in-full of the
consideration obligations of the Company under the May 31, 2023 R&D Agreement, subject-to a contractual “minimum fair
market value” as such amount is discussed below.
The
resolution of the contingent settlement-in-full with respect to the issued shares of common stock of the Company is predicated on and
subject-to such issued shares having a $ 750 minimum “fair market value” (as defined), with such derived fair market value
computed using a contractual formula based on the PAVmed Inc. common stock volume weighted average price per share (“VWAP”)
during the last ten days of the six month anniversary of the May 31, 2023 R&D Agreement.
If
the fair market value, as such amount is computed as described above, is equal-to or greater than $750, then no further contractual consideration
is required. However, if such fair market value is less than $ 750 , then, the Company will incur an additional contractual consideration
obligation in amount equal to the difference between the required minimum fair market value of $ 750 and the contractual formula based
computed fair market value . At the election of the Company, the additional contractual consideration obligation, if any, may be paid
in cash or settled with the issue of additional shares of PAVmed common stock.
The
contingent additional contractual consideration obligation is deemed to be a separate unit-of-account, in the form of a written protective
put, and recognized as a derivative liability measured at estimated fair value. The derivative liability had an initial May 31, 2023
estimated fair value of approximately $ 262 which was recognized as a current period charge classified in other income (expense) in the
accompanying (unaudited) condensed consolidated statement of operations. Further, such recognized derivative liability is further remeasured
at estimated fair value as of each quarterly reporting period date, with changes in the estimated fair value recognized as current period
other income (expense), with such remeasurement recognized through the date of the final determination and settlement or extinguishment
of the contingent additional contractual consideration obligation, if any. In this regard, as of June 30, 2023, the remeasured estimated
fair value was approximately $ 260 , with the change in the estimated fair value recognized as other income (expense).
The
estimated fair value of the written protective put derivative liability, as such is discussed above, were computed using a Monte Carlo
simulation to generate stock price paths (assuming geometric-Brownian motion) of the PAVmed Inc. common stock to compute the respective
written protective put expected fair value, with the principal assumptions of such estimated fair value computation, for the respective
measurement dates noted, as follows:
Schedule
of Fair Value Assumption Used
As of:
May 31, 2023
As of:
June 30, 2023
Fair Value
$ 262
$ 260
Contractual minimum effective conversion price
$ 0.50
$ 0.50
Price per share
$ 0.40
$ 0.41
Remaining expected term (years)
0.50
0.42
Volatility
160.00 %
200.00 %
Risk free rate
5.30 %
5.30 %
Dividend yield
— %
— %
The
estimated fair values recognized with respect to the senior secured convertible debt and the written protective put derivative liability,
as each is discussed above, utilized PAVmed and Lucid Diagnostics common stock prices, along with certain Level 3 inputs (as
presented in the respective tables above), in the development of Monte Carlo simulation models, discounted cash flow analyses, and /or
Black-Scholes valuation models. The estimated fair values are subjective and are affected by changes in inputs to the valuation models
and analyses, including the respective common stock prices, the dividend yields, 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 respective common
stock prices. Changes in these assumptions can materially affect the recognized estimated fair values.
17
Note
11 — Debt
The
fair value and face value principal outstanding of the Senior Convertible Notes as of the dates indicated are as follows:
Summary of Outstanding Debt
Contractual
Maturity Date
Stated
Interest Rate
Conversion
Price per Share
Face Value Principal
Outstanding
Fair Value
April 2022 Senior Convertible Note
April 4, 2024
7.875 %
$ 5.00
$ 18,554
$ 19,530
September 2022 Senior Convertible Note
September 6, 2024
7.875 %
$ 5.00
$ 11,250
$ 11,850
Lucid March 2023 Senior Convertible Note
March 21, 2025
7.875 %
$ 5.00
$ 11,111
$ 11,610
Balance as of June 30, 2023
$ 40,915
$ 42,990
Contractual
Maturity Date
Stated
Interest Rate
Conversion
Price per Share
Face Value Principal
Outstanding
Fair Value
April 2022 Senior Convertible Note
April 4, 2024
7.875 %
$ 5.00
$ 21,497
$ 22,000
September 2022 Senior Convertible Note
September 6, 2024
7.875 %
$ 5.00
$ 11,250
$ 11,650
Balance as of December 31, 2022
$ 32,747
$ 33,650
The
changes in the fair value of debt during the three and six months ended June 30, 2023 is as follows:
Schedule of Changes in Fair Value of Debt
April 2022 Senior Convertible Note
September 2022 Senior Convertible Note
Lucid March 2023 Senior Convertible Note
Sum of Balance Sheet Fair Value Components
Other Income (expense)
Fair Value - December 31, 2022
$ 22,000
$ 11,650
$ —
$ 33,650
$ —
Face value principal – issue date
—
—
11,111
11,111
—
Fair value adjustment – issue date
—
—
789
789
( 789 )
Installment repayments – common stock
( 1,335 )
—
—
( 1,335 )
—
Non-installment payments – common stock
( 166 )
—
—
( 166 )
—
Change in fair value
251
—
—
251
( 251 )
Fair Value at March 31, 2023
$ 20,750
$ 11,650
$ 11,900
$ 44,300
—
Fair Value, Beginning
$ 20,750
$ 11,650
$ 11,900
$ 44,300
—
Other Income (Expense) - Change in fair value – three months ended March 31, 2023
$ ( 1,040 )
Installment repayments – common stock
( 1,608 )
—
—
( 1,608 )
—
Non-installment payments – common stock
( 42 )
—
—
( 42 )
—
Change in fair value
430
200
( 290 )
340
( 340 )
Fair Value at June 30, 2023
$ 19,530
$ 11,850
$ 11,610
$ 42,990
—
Fair Value, Ending
$ 19,530
$ 11,850
$ 11,610
$ 42,990
—
Other Income (Expense) - Change in fair value – three months ended June 30, 2023
$ ( 340 )
Other Income (Expense) - Change in fair value – six months ended June 30, 2023
$ ( 1,380 )
18
Note
11 — Debt - continued
PAVmed
- Senior Secured Convertible Notes
The
Company entered into a Securities Purchase Agreement (“SPA”) dated March 31, 2022, with an accredited institutional investor
(“Investor”, “Lender”, and /or “Holder”), wherein, the Company agreed to sell, and the Investor agreed
to purchase an aggregate of $ 50.0 million face value principal of debt - comprised of: an initial issuance of $ 27.5 million face value
principal; and up to an additional $ 22.5 million of face value principal (upon the satisfaction of certain conditions). The debt was
issued in a registered direct offering under the Company’s effective shelf registration statement.
Under
the SPA, the Company issued a Senior Secured Convertible Note dated April 4, 2022, referred to herein as the “April 2022 Senior
Convertible Note”, with such note having a $ 27.5 million face value principal, a 7.875 % annual stated interest rate, a contractual
conversion price of $ 5.00 per share of the Company’s common stock (subject to standard adjustments in the event of any stock split,
stock dividend, stock combination, recapitalization or other similar transaction), and a contractual maturity date of April 4, 2024 .
The April 2022 Senior Convertible Note may be converted into shares of common stock of the Company at the Holder’s election.
Under
the same SPA, the Company issued an additional Senior Secured Convertible Note dated September 8, 2022, referred to herein as the “September
2022 Senior Convertible Note”, with such note having a $ 11.25 million face value principal, a 7.875 % annual stated interest rate,
a contractual conversion price of $ 5.00 per share of the Company’s common stock (subject to standard adjustments in the event of
any stock split, stock dividend, stock combination, recapitalization or other similar transaction), and a contractual maturity date of
September 6, 2024 . The September 2022 Senior Convertible Note may be converted into shares of common stock of the Company at the Holder’s
election.
The
Company is subject to financial covenants requiring: (i) a minimum of $8.0 million of available cash at all times; (ii) the ratio of
(a) the outstanding principal amount of the total senior convertible notes outstanding, accrued and unpaid interest thereon and accrued
and unpaid late charges to (b) the Company’s average market capitalization over the prior ten trading days, to not exceed 30% (except
that such maximum percentage was 50% for the period from September 8, 2022 through March 5, 2023) (the “Debt to Market Cap Ratio
Test”); and (iii) the Company’s market capitalization to at no time be less than $75 million . (the “Market Cap Test”
and, together with the Debt to Market Cap Ratio Test, the “Financial Tests”). From time to time from and after June 1, 2023 through August 14, 2023,
the Company was not in compliance with the Financial Tests. As of August 14, 2023, the Investor agreed to waive any such non-compliance
during such time period and thereafter through November 30, 2023.
In
the six months ended June 30, 2023, approximately $ 3,151 of principal repayments along with approximately $ 57 of interest expense thereon,
were settled through the issuance of 9,523,481 shares of common stock of the Company, with such shares having a fair value of approximately
$ 4,419 (with such fair value measured as the respective conversion date quoted closing price of the common stock of the Company). The
conversions resulted in a debt extinguishment loss of $ 743 and $ 1,268 in the three and six months ended June 30, 2023. Subsequent to
June 30, 2023, as of August 10, 2023, approximately $ 601 of principal repayments along with approximately $ 25 of interest
expense thereon, were settled through the issuance of 2,005,685 shares of common stock of the Company, with such shares having a fair
value of approximately $ 771 (with such fair value measured as the respective conversion date quoted closing price of the common
stock of the Company).
Lucid
Diagnostics - Senior Secured Convertible Notes
Lucid
Diagnostics entered into a Securities Purchase Agreement (“Lucid SPA”) dated March 13, 2023, with an accredited institutional
investor (“Investor”, “Lender”, and /or “Holder”), wherein, Lucid agreed to sell, and the Investor
agreed to purchase an aggregate of $ 11.1 million face value principal of debt. The debt was issued in a registered direct offering under
the Lucid’s effective shelf registration statement.
Under
the SPA dated March 13, 2023, Lucid issued a Senior Secured Convertible Note dated March 21, 2023, referred to herein as the “Lucid
March 2023 Senior Convertible Note”, with such note having a $ 11.1 million face value principal, a 7.875 % annual stated interest
rate, a contractual conversion price of $ 5.00 per share of Lucid’s common stock (subject to standard adjustments in the event of
any stock split, stock dividend, stock combination, recapitalization or other similar transaction), and a contractual maturity date of
March 21, 2025 . The Lucid March 2023 Senior Convertible Note may be converted into shares of common stock of Lucid at the Holder’s
election.
The
Lucid March 2023 Senior Convertible Note proceeds were $ 9.925 million after deducting a $ 1.186 million lender fee and offering costs.
The lender fee and offering costs were recognized as of the March 21, 2023 issue date as a current period expense in other income (expense)
in the Company’s unaudited condensed consolidated statement of operations.
During
the period from March 21, 2023 to September 20, 2023, Lucid is required to pay interest expense only (on the $ 11.1 million face value
principal), at 7.875 % per annum, computed on a 360 day year. Lucid paid in cash interest expense of $ 219 and $ 243 for the three and six
months ended June 30, 2023.
Commencing
September 21, 2023, and then on each of the successive first and tenth trading day of each month thereafter through to and including
March 14, 2025 (each referred to as an “Installment Date”); and on the March 21, 2025 maturity date, Lucid will be required
to make a principal repayment of $ 292 together with accrued interest thereon, with such 38 payments referred to herein as the “Installment
Amount”, settled in shares of common stock of Lucid, subject to customary equity conditions, including minimum share price and
volume thresholds, or at the election of Lucid, in cash, in whole or in part.
19
Note
11 — Debt - continued
In
addition to the Installment Amount repayments, the Holder may elect to accelerate the conversion of future Installment Amount repayments,
and interest thereon, subject to certain restrictions, as defined, utilizing the then current conversion price of the most recent Installment
Date conversion price.
The
payment of all amounts due and payable under this senior convertible note is guaranteed by Lucid’s subsidiaries; and the obligations
under this senior convertible note are secured by all of the assets of Lucid and its subsidiaries.
Lucid
is subject to certain customary affirmative and negative covenants regarding the rank of the note, along with the incurrence of further
indebtedness, the existence of liens, the repayment of indebtedness and the making of investments, the payment of cash in respect of
dividends, distributions or redemptions, the transfer of assets, the maturity of other indebtedness, and transactions with affiliates,
among other customary matters.
Lucid
is subject to financial covenants requiring: (i) a minimum of $5.0 million of available cash at all times; (ii) the ratio of (a) the
outstanding principal amount of the total senior convertible notes outstanding, accrued and unpaid interest thereon and accrued and unpaid
late charges to (b) Lucid’s average market capitalization over the prior ten trading days, as of the last day of any fiscal quarter
commencing with September 30, 2023, to not exceed 30%; and (iii) Lucid’s market capitalization to at no time be less than $30 million .
During
the three and six months ended June 30, 2023, the Company recognized debt extinguishment losses of approximately $ 743 and $ 1,268 , in
connection with issuing common stock for principal repayments on convertible debt mentioned above. During the three and six months ended
June 30, 2022, the Company did not recognize debt extinguishment losses.
See
Note 10, Financial Instruments Fair Value Measurements , for a further discussion of fair value assumptions.
Note
12 — Stock-Based Compensation
PAVmed
Inc. 2014 Long-Term Incentive Equity Plan
The
PAVmed Inc. 2014 Long-Term Incentive Equity Plan (the “PAVmed 2014 Equity Plan”) is designed to enable PAVmed to offer employees,
officers, directors, and consultants, as defined, an opportunity to acquire shares of common stock of PAVmed. The types of awards that
may be granted under the PAVmed 2014 Equity Plan include stock options, stock appreciation rights, restricted stock, and other stock-based
awards subject to limitations under applicable law. All awards are subject to approval by the PAVmed compensation committee.
A
total of 21,052,807 shares of common stock of PAVmed are reserved for issuance under the PAVmed 2014 Equity Plan, with 1,310,092 shares
available for grant as of June 30, 2023. The share reservation is not diminished by a total of 600,854 PAVmed Inc. stock options and
restricted stock awards granted outside the PAVmed 2014 Equity Plan as of June 30, 2023. In January 2023, the number of shares available
for grant was increased by 4,700,000 in accordance with the evergreen provisions of the plan.
PAVmed
Stock Options
PAVmed
stock options granted under the PAVmed 2014 Equity Plan and stock options granted outside such plan are summarized as follows:
Schedule of Summarizes Information About Stock Options
Number of
Stock Options
Weighted Average
Exercise Price
Remaining Contractual Term (Years)
Intrinsic Value (2)
Outstanding stock options at December 31, 2022
11,568,655
$ 2.71
7.4
$ —
Granted (1)
7,280,000
$ 0.48
-
Exercised
—
$ —
Forfeited
( 1,326,249 )
$ 1.87
Outstanding stock options at June 30, 2023 (3)
17,522,406
$ 1.85
7.9
$ 7
Vested and exercisable stock options at June 30, 2023
7,998,032
$ 2.92
6.2
$ —
(1)
Stock
options granted under the PAVmed 2014 Equity Plan and those granted outside such plan generally vest one-third in one year then ratably
over the next eight quarters, 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 common stock on each of June 30, 2023 and December
31, 2022 and the exercise price of the underlying PAVmed stock options, to the extent such quoted price is greater than the exercise
price.
(3)
The
outstanding stock options presented in the table above, are inclusive of 500,854 stock options granted outside the PAVmed 2014 Equity
Plan, as of June 30, 2023 and December 31, 2022.
20
Note
12 — Stock-Based Compensation - continued
PAVmed
Restricted Stock Awards
PAVmed
restricted stock awards granted under the PAVmed 2014 Equity Plan and restricted stock awards granted outside such plan are summarized
as follows:
Schedule of Restricted Stock Award Activity
Number of Restricted
Stock Awards
Weighted Average
Grant Date Fair Value
Unvested restricted stock awards as of December 31, 2022 (1)
975,000
$ 3.05
Granted
—
—
Vested
( 100,000 )
3.10
Forfeited
—
—
Unvested restricted stock awards as of June 30, 2023
875,000
$ 3.04
(1)
The
unvested restricted stock awards presented in the table above, are inclusive of 100,000 restricted stock awards granted outside the
PAVmed 2014 Equity Plan as of December 31, 2022. These 100,000 restricted stock awards were fully vested during the period ended
June 30, 2023.
Lucid
Diagnostics Inc. 2018 Long-Term Incentive Equity Plan
The
Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan (“Lucid Diagnostics 2018 Equity Plan”) is separate and apart
from the PAVmed 2014 Equity Plan discussed above. The Lucid Diagnostics 2018 Equity Plan is designed to enable Lucid Diagnostics to offer
employees, officers, directors, and consultants, an opportunity to acquire shares of common stock of Lucid Diagnostics. The types of
awards that may be granted under the Lucid Diagnostics 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
compensation committee.
A
total of 11,644,000 shares of common stock of Lucid Diagnostics are reserved for issuance under the Lucid Diagnostics 2018 Equity Plan,
with 3,936,554 shares available for grant as of June 30, 2023. The share reservation is not diminished by a total of 423,300 stock options
and 50,000 restricted stock awards granted outside the Lucid Diagnostics 2018 Equity Plan, as of June 30, 2023. In January 2023, the
number of shares available for grant was increased by 2,500,000 in accordance with the evergreen provisions of the plan.
Lucid
Diagnostics Stock Options
Lucid
Diagnostics stock options granted under the Lucid Diagnostics 2018 Equity Plan and stock options granted outside such plan are summarized
as follows:
Schedule of Summarizes Information About Stock Options
Number of
Stock Options
Weighted Average
Exercise Price
Remaining Contractual
Term (Years)
Intrinsic
Value (2)
Outstanding stock options at December 31, 2022
2,565,377
$ 3.14
8.3
$ 428
Granted (1)
2,732,500
$ 1.31
Exercised
—
$ —
Forfeited
( 347,915 )
$ 2.57
Outstanding stock options at June 30, 2023 (3)
4,949,962
$ 2.17
8.7
$ 641
Vested and exercisable stock options at June 30, 2023
1,374,179
$ 2.76
6.9
$ 440
(1)
Stock
options granted under the Lucid Diagnostics 2018 Equity Plan and those granted outside such plan generally vest one-third in one
year then ratably over the next eight quarters, and have a ten-year contractual term from date-of-grant.
(2)
The
intrinsic value is computed as the difference between the quoted price of the Lucid Diagnostics common stock on each of June 30,
2023 and December 31, 2022 and the exercise price of the underlying Lucid Diagnostics stock options, to the extent such quoted price
is greater than the exercise price.
(3)
The
outstanding stock options presented in the table above, are inclusive of 423,300 stock options granted outside the Lucid Diagnostics
2018 Equity Plan, as of June 30, 2023 and December 31, 2022.
21
Note
12 — Stock-Based Compensation - continued
Lucid
Diagnostics Restricted Stock Awards
Lucid
Diagnostics restricted stock awards granted under the Lucid Diagnostics 2018 Equity Plan and restricted stock awards granted outside
such plan are summarized as follows:
Schedule of Restricted Stock Award Activity
Number of Restricted
Stock Awards
Weighted Average
Grant Date Fair Value
Unvested restricted stock awards as of December 31, 2022 (1)
2,091,420
$ 11.44
Granted
—
—
Vested
( 219,320 )
11.27
Forfeited
—
—
Unvested restricted stock awards as of June 30, 2023
1,872,100
$ 11.46
(1)
The
unvested restricted stock awards presented in the table above, are inclusive of 50,000 restricted stock awards granted outside the
Lucid Diagnostics 2018 Equity Plan as of December 31, 2022. These 50,000 restricted stock awards were fully vested during the period
ended June 30, 2023.
Consolidated
Stock-Based Compensation Expense
The
consolidated stock-based compensation expense recognized by each of PAVmed and Lucid Diagnostics for both the PAVmed 2014 Equity Plan
and the Lucid Diagnostics 2018 Equity Plan, with respect to stock options and restricted stock awards as discussed above, for the periods
indicated, was as follows:
Schedule
of Stock-Based Compensation Expense
Three Months Ended
June 30,
Six Months Ended
June 30,
2023
2022
2023
2022
Cost of revenue
$ 31
$ —
$ 54
$ —
Sales and marketing expenses
455
591
899
1,216
General and administrative expenses
1,674
4,162
5,262
8,164
Research and development expenses
347
254
711
440
Total stock-based compensation expense
$ 2,507
$ 5,007
$ 6,926
$ 9,820
Stock-Based
Compensation Expense Recognized by Lucid Diagnostics
As
noted, the consolidated stock-based compensation expense presented above is inclusive of stock-based compensation expense recognized
by Lucid Diagnostics, inclusive of each of: stock options granted under the PAVmed 2014 Equity Plan to the three physician inventors
of the intellectual property underlying the CWRU License Agreement (“Physician Inventors”) (as discussed above in Note 4,
Related Party Transactions ); and stock options and restricted stock awards granted to employees of PAVmed and non-employee consultants
under the Lucid Diagnostics 2018 Equity Plan. The stock-based compensation expense recognized by Lucid Diagnostics for both the PAVmed
2014 Equity Plan and the Lucid Diagnostics 2018 Equity Plan, with respect to stock options and restricted stock awards as discussed above,
for the periods indicated, was as follows:
Schedule
of Stock-Based Compensation Expense Recognized by Lucid Diagnostics
Three Months Ended June 30,
Six Months Ended June 30,
2023
2022
2023
2022
Lucid Diagnostics 2018 Equity Plan – cost of revenue
$ 16
$ —
$ 28
$ —
Lucid Diagnostics 2018 Equity Plan – sales and marketing
247
215
470
480
Lucid Diagnostics 2018 Equity Plan – general and administrative
836
3,313
3,348
6,514
Lucid Diagnostics 2018 Equity Plan – research and development
66
26
136
97
PAVmed 2014 Equity Plan - cost of revenue
9
—
16
—
PAVmed 2014 Equity Plan - sales and marketing
120
161
253
336
PAVmed 2014 Equity Plan - general and administrative
8
77
164
145
PAVmed 2014 Equity Plan - research and development
97
52
192
107
Total stock-based compensation expense – recognized by Lucid Diagnostics
$ 1,399
$ 3,844
$ 4,607
$ 7,679
Total stock-based compensation expense
$ 1,399
$ 3,844
$ 4,607
$ 7,679
22
Note
12 — Stock-Based Compensation - continued
The
consolidated unrecognized stock-based compensation expense and weighted average remaining requisite service period with respect to stock
options and restricted stock awards issued under each of the PAVmed 2014 Equity Plan and the Lucid Diagnostics 2018 Equity Plan, as discussed
above, is as follows:
Schedule of Unrecognized Compensation Expense
Unrecognized
Expense
Weighted Average
Remaining
Service Period
(Years)
PAVmed 2014 Equity Plan
Stock Options
$ 6,192
2.2
Restricted Stock Awards
$ 375
0.8
Lucid Diagnostics 2018 Equity Plan
Stock Options
$ 4,129
2.3
Restricted Stock Awards
$ 1,141
1.1
Stock-based
compensation expense recognized with respect to stock options granted under the PAVmed 2014 Equity Plan was based on a weighted average
estimated fair value of such stock options of $ 0.35 per share and $ 0.74 per share during the periods ended June 30, 2023 and 2022, respectively,
calculated using the following weighted average Black-Scholes valuation model assumptions:
Schedule
of Fair Values of Stock Options Granted Using Black-scholes Valuation Model Assumptions
Six Months Ended June 30,
2023
2022
Expected term of stock options (in years)
5.7
5.8
Expected stock price volatility
88 %
84 %
Risk free interest rate
3.7 %
3.0 %
Expected dividend yield
— %
— %
Stock-based
compensation expense recognized with respect to stock options granted under the Lucid Diagnostics 2018 Equity Plan was based on a weighted
average estimated fair value of such stock options of $0.87 per share and $1.48 per share during the periods ended June 30, 2023 and
2022, respectively, calculated using the following weighted average Black-Scholes valuation model assumptions:
Schedule
of Fair Values of Stock Options Granted Using Black-scholes Valuation Model Assumptions
Six Months Ended June 30,
2023
2022
Expected term of stock options (in years)
5.6
5.7
Expected stock price volatility
75 %
71 %
Risk free interest rate
3.7 %
3.0 %
Expected dividend yield
— %
— %
PAVmed
Inc. Employee Stock Purchase Plan (“PAVmed ESPP”)
A
total of 573,229 shares and 194,240 shares of common stock of the Company were purchased for proceeds of approximately $ 182 and $ 218 ,
on March 31, 2023 and 2022, respectively under the PAVmed ESPP. The March 31, 2023 purchase was partially settled through the redeployment
of 188,846 shares of treasury stock. The PAVmed ESPP has a total reserve of 2,000,000 shares of common stock of PAVmed of which 416,914
shares are available for issue as of June 30, 2023. In January 2023, the number of shares available-for-issue was increased by 250,000
in accordance with the evergreen provisions of the plan.
Lucid
Diagnostics Inc. Employee Stock Purchase Plan (“Lucid ESPP”)
A
total of 231,987 shares of common stock of Lucid Diagnostics were purchased for proceeds of approximately $ 276 on March 31, 2023 under
the Lucid ESPP. The Lucid ESPP has a total reserve of 1,000,000 shares of common stock of Lucid Diagnostics of which 683,983 shares are
available-for-issue as of June 30, 2023. In January 2023, the number of shares available for issue was increased by 500,000 in accordance
with the evergreen provisions of the plan.
23
Note
13 — Preferred Stock
As
of June 30, 2023 and December 31, 2022, there were 1,254,497 and 1,205,759 shares of PAVmed Series B Convertible Preferred Stock, classified
in permanent equity, issued and outstanding, respectively.
Series
B Convertible Preferred Stock Dividends
The
PAVmed Inc. Series B Convertible Preferred Stock dividends are 8.0 % per annum based on the $ 3.00 per share stated value of the Series
B Convertible Preferred Stock, with such dividends compounded quarterly, accumulate, and are payable in
arrears upon being declared by the Company’s board of directors. Such dividends may be settled, at the discretion of the board of
directors, through any combination of the issue of additional shares of Series B Convertible Preferred Stock, the issue shares of common
stock of the Company, and /or cash payment.
Series
B Convertible Preferred Stock Dividends Earned
The
Series B Convertible Preferred Stock dividends earned are included in the calculation of basic and diluted net loss attributable to PAVmed
common stockholders for each of the respective corresponding periods presented in the accompanying unaudited condensed consolidated statement
of operations, inclusive of $ 75 and $ 149 of such dividends earned in the three and six months ended June 30, 2023, respectively; and
$ 70 and $ 138 of such dividends earned in the three and six months ended June 30, 2022, respectively.
Series
B Convertible Preferred Stock Dividends Declared
In
the six months ended June 30, 2023, the Company’s board-of-directors declared Series B Convertible Preferred Stock dividends of
an aggregate of $ 146 , inclusive of $ 72 earned as of December 31, 2022; and $ 74 earned as of March 31, 2023; with such dividends settled
by the issue of an aggregate 48,738 additional shares of Series B Convertible Preferred Stock, inclusive of 24,128 shares issued with
respect to the dividends earned as of December 31, 2022; and 24,610 shares issued with respect to the dividends earned as of March 31,
2023.
In
the six months ended June 30, 2022, the Company’s board-of-directors declared Series B Convertible Preferred Stock dividends of
an aggregate of $ 135 , inclusive of: $ 67 earned as of December 31, 2021; and $ 68 earned as of March 31, 2022; with such dividends settled
by the issue of an aggregate 45,031 additional shares of Series B Convertible Preferred Stock, inclusive of 22,291 shares issued with
respect to the dividends earned as of December 31, 2021; and 22,740 shares issued with respect to the dividends earned as of March 31,
2022.
Subsequent
to June 30, 2023, in August 2023, the Company’s board of directors declared a Series B Convertible Preferred Stock dividend, earned
as of June 30, 2023, of $ 75 , to be settled by the issue of 25,104 additional shares of Series B Convertible Preferred Stock.
The
Series B Convertible Preferred Stock dividends are recognized as a dividend payable liability only upon the dividend being declared payable
by the Company’s board of directors. Accordingly, the dividends declared payable subsequent to the date of the accompanying condensed
consolidated balance sheet were not recognized as a dividend payable liability as the Company’s board of directors had not declared
the dividends payable as of each such date.
24
Note
14 — Common Stock and Common Stock Purchase Warrants
Common
Stock
On
December 29, 2022, the
Company received a notice from the Listing Qualifications Department of Nasdaq stating that, for the prior 30 consecutive business
days (through December 28, 2022), the closing bid price of the Company’s common stock had been below the minimum of $1 per
share required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). The notification letter
stated that the Company would be afforded 180 calendar days (until June 27, 2023) to regain compliance. On June 28, 2023, the
Company received a second notice from the Listing Qualifications Department of Nasdaq granting the Company a 180-day extension (or
until December 26, 2023) to regain compliance with the minimum bid price requirement. In order to regain compliance, the closing bid
price of the Company’s common stock must be at least $1 for a minimum of ten consecutive business days . During the
special meeting (“Special Meeting”) of shareholders held on March 31, 2023, the shareholders approved a proposal to
amend the
Company’s Certificate of Incorporation, to effect, at any time prior to the one-year anniversary date of the Special Meeting,
(i) a reverse split of the Company’s outstanding shares of common stock at a specific ratio, ranging from 1-for-5 to 1-for-15,
to be determined by the board of directors of the Company in its sole discretion, and (ii) an associated reduction in the number of
shares of common stock the Company is authorized to issue, from 250,000,000 shares to 50,000,000 shares. If the Company’s
board of directors authorizes the Company to consummate the reverse stock split, the Company anticipates it will regain compliance
with the Nasdaq requirements for continued listing through such transaction .
As
discussed above in Note 10, Financial Instruments Fair Value Measurements , a total of 1,500,000 shares of PAVmed common stock
was issued to a service provider as the consideration for the services rendered under the May 31, 2023 R&D Agreement. The
issued shares of common stock had a fair value of approximately $ 602 (with such fair value measured using the quoted closing price of
the common stock of the Company on the effective date of the respective underlying agreement). The issued shares of common stock are
nonrefundable. As the service provider has substantially rendered the services under the May 31, 2023 R&D Agreement as of June 30,
2023, the estimated fair value of the issued shares was recognized as a research and development expense in the accompanying (unaudited)
condensed consolidated statement of operations for the three and six months ended June 30, 2023. See Note 10, Financial Instruments
Fair Value Measurements , for a further discussion of the May 31, 2023 R&D Agreement, including the contingent additional contractual
consideration obligation.
During
the six months ended June 30, 2023 a total of 573,229 shares of common stock of the Company were issued under the PAVmed ESPP. See Note
12, Stock-Based Compensation , for a discussion of each of the PAVmed 2014 Equity Plan and the PAVmed ESPP.
In
the six months ended June 30, 2023, 9,523,481 shares of the Company’s common stock were issued upon conversion, at the election
of the holder, of the April 2022 Senior Convertible Note, for 3,151 face value principal repayments, as discussed in Note 11, Debt .
In
the six months ended June 30, 2023, the Company sold 2,330,747
shares through their at-the-market
equity facility for net proceeds of approximately 1,165 ,
after payment of 3 %
commissions.
Common
Stock Purchase Warrants
As
of June 30, 2023 and December 31, 2022, Series Z Warrants outstanding totaled 11,937,450 .
The Series Z Warrants are exercisable to purchase one share of common stock of the Company at an exercise price of $ 1.60
per share, and expire April
30, 2024 . There were no
Series Z Warrants exercised during
the six months ended June 30, 2023.
25
Note
15 — Noncontrolling Interest
The
noncontrolling interest (“NCI”) included as a component of consolidated total stockholders’ equity is summarized for
the periods indicated as follows:
Schedule of Noncontrolling Interest of Stockholders' Equity
June 30, 2023
NCI – equity – December 31, 2022
$ 20,615
Net loss attributable to NCI
( 7,638 )
Impact of subsidiary equity transactions
( 1,332 )
Lucid Diagnostics Inc. proceeds from issuance of preferred stock
13,625
Lucid Diagnostics Inc. proceeds from At-The-Market Facilities, net of deferred financing charges
284
Lucid Diagnostics Inc. issuance of common stock for settlement of APA-RDx installment and termination payment
713
Lucid Diagnostics Inc. issuance of common stock for settlement of vendor service agreement
147
Lucid Diagnostics Inc. Employee Stock Purchase Plan Purchase
276
Stock-based compensation expense - Lucid Diagnostics Inc. 2018 Equity Plan
3,982
Stock-based compensation expense - Veris Health Inc. 2021 Equity Plan
10
NCI – equity – June 30, 2023
$ 30,682
The
consolidated NCI presented above is with respect to the Company’s consolidated majority-owned subsidiaries as a component of consolidated
total stockholders’ equity as of June 30, 2023 and December 31, 2022; and the recognition of a net loss attributable to the NCI
in the unaudited condensed consolidated statement of operations for the periods beginning on the acquisition date of the respective majority-owned
subsidiaries.
Lucid
Diagnostics
As
of June 30, 2023, there were 41,853,603 shares of common stock of Lucid Diagnostics issued and outstanding, of which, PAVmed holds 31,302,420
shares, representing a majority ownership equity interest and PAVmed has a controlling financial interest in Lucid Diagnostics, and accordingly,
Lucid Diagnostics is a consolidated majority-owned subsidiary of PAVmed.
On
March 7, 2023, Lucid issued 13,625 shares of newly designated Lucid Series A Convertible Preferred Stock (the “Lucid Series A Preferred
Stock”). Each share of the Lucid Series A Preferred Stock has a stated value of $ 1,000 and a conversion price of $ 1.394 . The Lucid
Series A Preferred Stock is convertible into shares of Lucid Diagnostics’ common stock at any time at the option of the holder from and after the six-month
anniversary of its issuance, and automatically converts into shares of Lucid Diagnostics’ common stock on the second anniversary of its issuance. The
terms of the Lucid Series A Preferred Stock also include a one times preference on liquidation and a right to receive dividends equal
to 20 % of the number of shares of Lucid common stock into which such Lucid Series A Preferred Stock is convertible, payable on the one-year
and two-year anniversary of the issuance date. The Lucid Series A Preferred Stock is a non-voting security, other than with respect to
limited matters related to changes in terms of the Lucid Series A Preferred Stock. The aggregate gross proceeds from the sale of shares
in such offering were $ 13.625 million.
In
November 2022, Lucid Diagnostics entered into an “at-the-market offering” for up to $ 6.5
million of its common stock that may be offered and sold under a Controlled Equity Offering Agreement between Lucid Diagnostics and
Cantor Fitzgerald & Co. In the six months ended June 30, 2023, Lucid Diagnostics sold 230,068
shares through their at-the-market equity facility for net proceeds of approximately 0.3
million, after payment of 3 %
commissions. No shares were sold through Lucid’s at-the-market equity facility during the three months ended June 30, 2023.
Veris
Health
As
of June 30, 2023, there were 8,000,000 shares of common stock of Veris Health issued and outstanding, of which PAVmed holds an 80.44 %
majority-interest ownership and PAVmed has a controlling financial interest, with the remaining 19.56 % minority-interest ownership held
by an unrelated third-party. Accordingly, Veris Health 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 accompanying
unaudited condensed consolidated balance sheets.
26
Note
16 — Net Loss Per Share
The
Net loss per share - attributable to PAVmed Inc. - basic and diluted and Net loss per share - attributable to PAVmed Inc. common stockholders
- basic and diluted - for the respective periods indicated - is as follows:
Schedule of Comparison of Basic and Fully Diluted Net Loss Per Share
Three Months Ended
June 30,
Six Months Ended
June 30,
2023
2022
2023
2022
Numerator
Net loss - before noncontrolling interest
$ ( 17,892 )
$ ( 29,101 )
$ ( 40,106 )
$ ( 48,734 )
Net loss attributable to noncontrolling interest
3,355
3,576
7,638
6,337
Net loss - as reported, attributable to PAVmed Inc.
$ ( 14,537 )
$ ( 25,525 )
$ ( 32,468 )
$ ( 42,397 )
Series B Convertible Preferred Stock dividends – earned
$ ( 75 )
$ ( 70 )
$ ( 149 )
$ ( 138 )
Net loss attributable to PAVmed Inc. common stockholders
$ ( 14,612 )
$ ( 25,595 )
$ ( 32,617 )
$ ( 42,535 )
Denominator
Weighted average common shares outstanding, basic and diluted
104,349,822
86,957,352
100,742,530
86,689,857
Weighted average common shares outstanding, basic
104,349,822
86,957,352
100,742,530
86,689,857
Net loss per share
Basic and diluted
Net loss - as reported, attributable to PAVmed Inc.
$ ( 0.14 )
$ ( 0.29 )
$ ( 0.32 )
$ ( 0.49 )
Net loss - as reported, attributable to PAVmed
Inc, basic
$ ( 0.14 )
$ ( 0.29 )
$ ( 0.32 )
$ ( 0.49 )
Net loss attributable to PAVmed Inc. common stockholders
$ ( 0.14 )
$ ( 0.29 )
$ ( 0.32 )
$ ( 0.49 )
Net loss attributable to PAVmed Inc. common
stockholders, basic
$ ( 0.14 )
$ ( 0.29 )
$ ( 0.32 )
$ ( 0.49 )
The
common stock equivalents have been excluded from the computation of diluted weighted average shares outstanding as their inclusion would
be anti-dilutive, are as follows:
The
Series B Convertible Preferred Stock dividends earned as of each of the respective periods noted, are included in the calculation of
basic and diluted net loss attributable to PAVmed common stockholders for each respective period presented. Notwithstanding, the Series
B Convertible Preferred Stock dividends are recognized as a dividend payable only upon the dividend being declared payable by the Company’s
board of directors.
Basic
weighted-average number of shares of common stock outstanding for the periods ended June 30, 2023 and 2022 include the shares of the
Company issued and outstanding during such periods, each on a weighted average basis. The basic weighted average number of shares of
common stock outstanding excludes common stock equivalent incremental shares, while diluted weighted average number of shares outstanding
includes such incremental shares. However, as the Company was in a loss position for all periods presented, basic and diluted weighted
average shares outstanding are the same, as the inclusion of the incremental shares would be anti-dilutive. The common stock equivalents
excluded from the computation of diluted weighted average shares outstanding are as follows:
Schedule of Antidilutive Securities Excluded from Computation of Diluted Earnings Per Share
2023
2022
June 30,
2023
2022
Stock options and restricted stock awards
18,397,406
12,177,406
Series Z Warrants
11,937,450
11,937,450
Series B Convertible Preferred Stock
1,254,497
1,158,950
Total
31,589,353
25,273,806
The
total stock options and restricted stock awards are inclusive of 500,854 stock options as of June 30, 2023 and 2022; and 100,000 restricted
stock awards as of June 30, 2022 granted outside the PAVmed 2014 Equity Plan. These 100,000 restricted stock awards were fully vested
during the period ended June 30, 2023.
27
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The
following discussion and analysis of our unaudited condensed consolidated financial condition and results of operations should be read
together with our Annual Report on Form 10-K for the year ended December 31, 2022 (the “Form 10-K”), as filed with the Securities
and Exchange Commission (the “SEC”).
Unless
the context otherwise requires, references herein to “we”, “us”, and “our”, and to the
“Company” or “PAVmed” are to PAVmed Inc. and its subsidiaries, including its majority-owned subsidiary Lucid
Diagnostics Inc. (“Lucid Diagnostics” or “Lucid”) and its majority-owned subsidiary Veris Health Inc.
(“Veris Health” or “Veris”).
FORWARD-LOOKING
STATEMENTS
This
Quarterly Report on Form 10-Q (this “Form 10-Q”) including the following discussion and analysis of our unaudited condensed
consolidated financial condition and results of operations, contains forward-looking statements that involve substantial risks and uncertainties.
All statements, other than statements of historical facts, contained in this Form 10-Q, including statements regarding our future results
of operations and financial position, business strategy and plans and objectives of management for future operations, are forward-looking
statements. The words “may,” “will,” “should,” “expects,” “plans,” “anticipates,”
“could,” “intends,” “target,” “projects,” “contemplates,” “believes,”
“estimates,” “predicts,” “potential” or “continue” or the negative of these terms or
other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these
identifying words. Forward-looking statements are not guarantees of future performance and the Company’s actual results may differ
significantly from those expressed or implied in the forward-looking statements. Factors that might cause such differences include, but are
not limited to, those discussed in Item 1A of Part I of the Form 10-K under the heading “Risk Factors.”
Important
factors that may affect our actual results include:
●
our
limited operating history;
●
our
financial performance, including our ability to generate revenue;
●
our
ability to obtain regulatory approval for the commercialization of our products;
●
the
ability of our products to achieve market acceptance;
●
our
success in retaining or recruiting, or changes required in, our officers, key employees or directors;
●
our
potential ability to obtain additional financing when and if needed;
●
our
ability to protect our intellectual property;
●
our
ability to complete strategic acquisitions;
●
our
ability to manage growth and integrate acquired operations;
●
the
potential liquidity and trading of our securities;
●
our
regulatory and operational risks;
●
cybersecurity
risks;
●
risks
related to the COVID-19 pandemic and other health-related emergencies; and
●
our
estimates regarding expenses, future revenue, capital requirements and needs for additional financing.
In
addition, our forward-looking statements do not reflect the potential impact of any future financings, acquisitions, mergers, dispositions,
joint ventures or investments we may make.
We
may not actually achieve the plans, intentions, and/or expectations disclosed in our forward-looking statements, and you should not place
undue reliance on our forward-looking statements. You should read this Form 10-Q and the documents we have filed as exhibits to this
Form 10-Q and the Form 10-K completely and with the understanding our actual future results may be materially different from what we
expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events
or otherwise, except as required by applicable law.
Overview
PAVmed
is a diversified commercial-stage medical technology operating in the medical device, diagnostics, and digital health sectors, including
through its majority-owned subsidiaries Lucid Diagnostics, a publicly-traded commercial-stage cancer prevention diagnostics company,
and Veris Health, a private digital health company focused on enhanced personalized cancer care through remote patient monitoring using
implantable biologic sensors with wireless communication along with a custom suite of connected external devices. Our current central
focus is on the commercialization of Lucid Diagnostics’s EsoGuard and Veris Health’s Veris Cancer Care Platform. As resources
permit, we will continue to explore internal and external innovations that fulfill our project selection criteria without limiting ourselves
to any target specialty or condition. More broadly, we strive to maintain balance within our pipeline with shorter-term, lower-risk projects
with the prospect for rapid commercialization and revenue generation supporting development of longer-term projects. At the same time,
we are continuously re-assessing each project’s long-term commercial potential relative to other projects in our pipeline, accelerating
or decelerating the project and reallocating resources.
See Part I, Item 1,
“Business,” in the Form 10-K for a more detailed summary of the medical device, diagnostics, and digital health sectors
and our key products, including in particular EsoGuard and the Veris Cancer Care Platform, which are currently our two leading
products.
28
Recent
Developments
Business
PAVmed
Strategic Business Update
In
January 2023, PAVmed launched a strategic initiative designed to maximize cash runway and protect long-term shareholder interests through
adjustments in near-term strategic priorities and associated resource allocation. The Company is currently focusing substantially all
of its resources and near-term efforts on the commercialization of Lucid’s and Veris’ products.
Status
of Lucid Clinical Trials
Lucid
is currently seeking to accelerate its collection of clinical utility data through a range of trials that can be efficiently
executed. These efforts include a planned investigator-initiated, retrospective analysis of prospectively collected data on the 391
San Antonio fire fighters who underwent testing as part of a community-sponsored cancer awareness event described below (in respect
of which we expect to publish results in the second half of 2023); a virtual-patient randomized controlled trial with intended
recruitment of at least 100 physician participants (in respect of which we expect to publish results this year); a Lucid-sponsored
multi-center, prospective, observational study with 500 patients; and a Lucid-sponsored registry at existing Lucid Test Centers,
whereby all patients undergoing EsoCheck testing will be given the opportunity to provide informed consent and contribute data about
their risk factors, EsoGuard results, and subsequent diagnostic and/or therapeutic journey. Both Lucid-sponsored
observational/registry studies expect to have preliminary results and/or interim analysis submitted for peer review before the end
of 2023.
LucidDx
Labs Laboratory Operations Update
On February 14, 2023, Lucid and its subsidiary, LucidDx Labs, entered into
an agreement (the “MSA Termination Agreement”) with RDx, pursuant to which the parties mutually agreed to terminate the management
service agreement between them (the “MSA-RDx”) without cause. The termination was effective as of February 10, 2023. Until
the termination of the MSA-RDx, RDx had provided certain testing and related services for our laboratory in accordance with the terms
of the MSA-RDx. In anticipation of the termination of the MSA-RDx, however, Lucid accelerated the development of internal resources necessary
to operate its laboratory entirely on its own. The termination of the MSA-RDx and our operating the laboratory on our own has improved
the performance of the EsoGuard assay.
Among
other things, the MSA Termination Agreement reduces the remaining amounts of the earnout payments and management fees due under the MSA-RDx
and the related asset purchase agreement (the “APA-RDx”) to $0.7 million (from the $3.4 million that would otherwise have
been payable under the MSA-RDx and APA-RDX, if the MSA-RDx had remained in effect through the balance of its stated term), resulting
in a net savings to Lucid of $2.7 million. The payment was satisfied through the issuance of 553,436 shares of Lucid’s common stock
on February 25, 2023. Lucid was not required to make any cash payments in connection with the termination.
#CheckYourFoodTube
Events
In
January 2023, Lucid completed its first #CheckYourFoodTube Precancer Testing Event, with the San Antonio Fire Department (the “SAFD”)
during Firefighter Cancer Awareness Month as designated by the International Association of Fire Fighters (IAFF). A total of 391 members
who were deemed to be at-risk for esophageal precancer, underwent a brief, on-site, noninvasive cell collection procedure, performed
by our clinical personnel using EsoCheck. Firefighters with suspected esophageal precancer based on a positive EsoGuard result were identified,
including some less than 40 years of age, and will undergo appropriate monitoring and treatment, as indicated by clinical practice guidelines,
to prevent progression to esophageal cancer.
Since
then, additional testing events have been hosted with the SAFD, and similar events have been held with fire departments throughout the
country. These events are ongoing and are an extension of Lucid’s satellite Lucid Test Center (“sLTC”) program, which
brings Lucid precancer testing directly to patients—at their physician’s office and now at large testing day events.
Launch
of EsoGuard® #CheckYourFoodTube Mobile Testing Unit
In
June 2023, Lucid launched its first EsoGuard #CheckYourFoodTube Mobile Test Unit (“mobile testing unit”), with the inaugural
mobile testing unit event being held in Sarasota, Florida. The mobile testing unit is another channel by which the Company is bringing
EsoGuard testing to at-risk patients.
Launch
of Direct Contracting Strategic Initiative
In
March 2023, Lucid launched a Direct Contracting Strategic Initiative (DCSI) to engage directly with large Administrative Services Only
(ASO) self-insured employers, unions and other entities, seeking to replicate the successes of other diagnostic companies that have deployed
similar strategies. In August 2023, the company announced it had contracted with the Ancira Automotive Group as a result of this initiative,
providing access to esophageal precancer testing for its employees at all 12 San Antonio locations.
New
Revenue Cycle Management Provider
In
May 2023, Lucid began to transition claims submission responsibility to a new revenue cycle management provider that offered more robust
capabilities for, among other things, claims processing and appeals. The provider upgrade has been completed and claim submissions resumed
in June 2023. Since completing the transition, the upgrade has demonstrated an improvement in speed of collections, turnaround time to
claim submission, percentage of claims paid, and actionable data for appeals.
Veris
Health Commercialization Update
In
December 2022 Veris Health, PAVmed’s digital health subsidiary, commercially launched its Veris Cancer Care Platform™ by
executing its first commercial contract with New Jersey Cancer Care, PA (“NJCC”), an oncology practice and member of the
prestigious Quality Cancer Care Alliance. In February 2023, the Veris Cancer Care Platform went live following successful onboarding
of the first cohort of cancer patients and their clinicians at NJCC. Enrolled patients received a VerisBox™ and began connecting
their Bluetooth-enabled health care devices to transmit real-time physiologic data to the cloud-based Veris Cancer Care Platform clinician
portal. The patients also began reporting symptoms and quality-of-life parameters through the Veris Cancer Care Platform patient smartphone
app, which is now available for patients on the Apple App Store and Google Play. The cloud-based clinician portal was concurrently integrated
into the oncology practice and the cancer care team began using it to review physiologic and clinical data and other remote patient monitoring
(“RPM”) services. Since the Veris Cancer Care Platform went “live” in February, Veris added two additional accounts,
expanding utilization of the product to a total of six locations across three oncology practices while continuing to seek to build a
pipeline of prospective customers.
Veris continues to make progress
toward regulatory submission of its implantable monitor which is targeted for commercial launch next year. The device, which is designed
to be implanted in conjunction with a chemotherapy vascular access port, will further the power of the Veris Cancer Care Platform by better
assuring patient compliance with RPM data reporting requirements. It recently completed an animal study which demonstrated intended device
performance, consistent with its design and clinical specifications, over an extended implant period.
In April 2023, Gary Manning joined PAVmed to become the President of Veris
Health. Mr. Manning has a track record spanning three decades, including leading companies in the medical device, wearable, and digital
health sectors and commercializing products in the global market.
29
NASDAQ
Notice
On
December 29, 2022, the Company received a notice from the Listing Qualifications Department of Nasdaq stating that, for the prior 30
consecutive business days (through December 28, 2022), the closing bid price of the Company’s common stock had been below the
minimum of $1 per share required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). The
notification letter stated that the Company would be afforded 180 calendar days (until June 27, 2023) to regain compliance, and that
the Company could be eligible for additional time. Although the Company did not regain compliance within the initial 180 calendar
day period, Nasdaq determined that the Company was eligible for an additional 180 calendar day period to regain compliance (until
December 26, 2023). In order to regain compliance, the closing bid price of the Company’s common stock must be at least $1 for
a minimum of ten consecutive business days during the additional 180 calendar day period. The Company intends to consider all
available options to regain compliance with the Nasdaq listing standards. On March 31, 2023, the Company’s stockholders
approved an amendment to its certificate of incorporation, authorizing the Company to effect, at any time prior to March 31, 2024,
(i) a reverse split of the Company’s outstanding shares of common stock at a specific ratio, ranging from 1-for-5 to 1-for-15,
to be determined by the board of directors of the Company in its sole discretion, and (ii) an associated reduction in the number of
shares of common stock the Company is authorized to issue, from 250,000,000 shares to 50,000,000 shares. The Company has not yet
determined the specific ratio of the reverse split or the timing of the reverse split and authorized capital reduction, or whether
the Company will effect the reverse split and authorized capital reduction at all. However, the Company may effectuate the reverse
split, if necessary, as part of its effort to regain compliance with the Nasdaq minimum bid price requirement.
Financing
Lucid
Diagnostics Inc. - ATM Facility
In
November 2022, Lucid Diagnostics commenced an “at-the-market offering” of up to $6.5 million of its common stock pursuant to a Controlled Equity Offering Agreement between Lucid Diagnostics and Cantor Fitzgerald & Co. (“Cantor”).
In the six months ended June 30, 2023, Lucid Diagnostics sold 230,068 shares in this “at-the-market” offering for net proceeds
of approximately $0.3 million, after payment of 3% commissions. No shares were sold in this “at-the-market” offering during the
three months ended June 30, 2023.
Lucid
Diagnostics - Series A Preferred Stock Offering
On
March 7, 2023, Lucid issued 13,625 shares of newly designated Lucid Series A Convertible Preferred Stock (the “Lucid Series A
Preferred Stock”). Each share of the Lucid Series A Preferred Stock has a stated value of $1,000 and a conversion price of
$1.394. The Lucid Series A Preferred Stock is convertible into shares of Lucid’s common stock at any time at the option of the
holder from and after the six-month anniversary of its issuance (or, if later, the effective date of an increase in Lucid
Diagnostics’ authorized share capital or the effective date of a registration statement covering the resale of the underlying
shares), and automatically converts into shares of Lucid’s common stock on the second anniversary of its issuance. The terms
of the Lucid Series A Preferred Stock also include a preference on liquidation and a right to receive dividends equal to 20% of the
number of shares of Lucid common stock into which such Lucid Series A Preferred Stock is convertible, payable on each of the
one-year and two-year anniversary of the issuance date. The Lucid Series A Preferred Stock is a non-voting security, other than with
respect to limited matters related to changes in terms of the Lucid Series A Preferred Stock. The sale of the Lucid Series A
Preferred Stock generated $13.625 million in aggregate gross proceeds.
Lucid
Diagnostics - Securities Purchase Agreement - March 13, 2023 - Senior Secured Convertible Note - March 21, 2023
Effective
as of March 13, 2023, Lucid Diagnostics entered into a Securities Purchase Agreement (“Lucid SPA”) with an accredited
institutional investor, pursuant to which Lucid Diagnostics agreed to sell, and the investor agreed to purchase a Senior Secured
Convertible Note with a face value principal of $11.1 million (the “Lucid March 2023 Senior Convertible Note”). Lucid
Diagnostics issued the Lucid March 2023 Senior Convertible Note on March 21, 2023 pursuant to the Lucid
SPA. The sale of the Lucid March 2023 Senior Convertible Note generated $9.925 million in proceeds, after deducting a $1.186 million
lender fee and offering costs.
The
Lucid March 2023 Senior Secured Convertible Note has a 7.875% annual stated interest rate, a contractual conversion price of $5.00
per share of Lucid Diagnostics’ common stock (subject to standard adjustments in the event of any stock split, stock dividend,
stock combination, recapitalization or other similar transaction), and a contractual maturity date of the two-year anniversary of
the date of issuance. The principal of the Lucid March 2023 Senior Convertible Note and the interest thereon is convertible into or
otherwise payable in shares of Lucid Diagnostics’ common stock (subject to the satisfaction of certain customary equity
conditions and except for interest payable prior to September 21, 2023).
Under
the Lucid March 2023 Senior Convertible Note, Lucid Diagnostics is subject to certain customary affirmative and negative covenants
regarding the incurrence of indebtedness, the existence of liens, the repayment of indebtedness and the making of investments, the
payment of cash in respect of dividends, distributions or redemptions, the transfer of assets, the maturity of other indebtedness,
and transactions with affiliates, among other customary matters. Under the Lucid March 2023 Senior Convertible Note, Lucid
Diagnostics is also subject to financial covenants requiring that (i) the amount of its available cash shall equal or exceed
$5.0 million at all times, (ii) the ratio of (a) the outstanding principal amount of the notes issued under the Lucid SPA,
accrued and unpaid interest thereon and accrued and unpaid late charges as of the last day of any fiscal quarter commencing with
September 30, 2023 to (b) Lucid Diagnostics’ average market capitalization over the prior ten trading days, shall not exceed
30%, and (iii) that Lucid Diagnostics’ market capitalization shall at no time be less than $30 million.
30
Results
of Operations
Overview
Revenue
The
Company recognized revenue resulting from the delivery of patient EsoGuard test results when the Company considered the collection of
such consideration to be probable to the extent that it is unconstrained. Additionally, in the three months ended March 31, 2022, revenue
was recognized with respect to the EsoGuard Commercialization Agreement, dated August 1, 2021, between the Lucid Diagnostics Inc. and
ResearchDx Inc. (“RDx”), a CLIA certified commercial laboratory service provider. On February 25, 2022, the EsoGuard Commercialization
Agreement was terminated upon the execution of the APA-RDx.
Cost
of revenue
Cost
of revenues recognized from the delivery of patient EsoGuard test results includes costs related to EsoCheck device usage, shipment of
test collection kits, royalties and the cost of services to process tests and provide results to physicians. We incur expenses for tests
in the period in which the activities occur, therefore, gross margin as a percentage of revenue may vary from quarter to quarter due
to costs being incurred in one period that relate to revenues recognized in a later period.
We
expect that gross margin for our services will continue to fluctuate and be affected by EsoGuard test volume, our operating efficiencies,
patient compliance rates, payor mix, the levels of reimbursement, and payment patterns of payors and patients.
The
cost of revenue recognized with respect to the revenue recognized under the EsoGuard Commercialization Agreement is inclusive of: a royalty
fee incurred under the Amended CWRU License Agreement (as defined in Note 4, Related Party Transactions , to our accompanying unaudited
condensed consolidated financial statements); the cost of EsoCheck devices and EsoGuard mailers (cell sample shipping costs) distributed
to medical practitioners locations and the Lucid Test Centers; and Lucid Test Centers operating expenses, including rent expense and
supplies.
Sales
and marketing expenses
Sales
and marketing expenses consist primarily of salaries and related costs for employees engaged in sales and marketing activities, as well
as advertising and promotion expenses. We anticipate our sales and marketing expenses will increase in the future, to the extent we expand
our commercial sales and marketing operations as resources permit.
General
and administrative expenses
General and administrative expenses consist primarily of salaries and related
costs for personnel, travel expenses, facility-related costs, professional fees for accounting and legal services, salaries and related
costs for employees involved in third-party payor reimbursement contract negotiations and consulting and other expenses associated
with obtaining and maintaining patents within our intellectual property portfolio.
We
anticipate our general and administrative expenses will increase in the future as and to the extent our business operations grow. We
also anticipate continued expenses related to being a public company, including fees and expenses for audit, legal, regulatory, and
tax-related services associated with maintaining compliance as a public company, insurance premiums and investor relations
costs.
Research
and development expenses
Research
and development expenses are recognized in the period they are incurred and consist principally of internal and external expenses incurred
for the research and development of our products, including:
●
consulting costs for engineering design and development;
●
salary
and benefit costs associated with our chief medical officer and engineering personnel;
●
costs
associated with regulatory filings;
●
patent
license fees;
●
cost
of laboratory supplies and acquiring, developing, and manufacturing preclinical prototypes;
●
product
design engineering studies; and
●
rental
expense for facilities maintained solely for research and development purposes.
Our
current research and development activities, including our clinical trials, are focused principally on the acceleration of EsoGuard and
Veris Cancer Care Platform commercialization. We will resume research and development activities with respect to other products in our
pipeline as well as applicable new technologies, as resources permit.
Other
Income and Expense, net
Other
income and expense, net, consists principally of changes in fair value of our convertible notes and losses on extinguishment of debt
upon repayment of such convertible notes.
31
Results
of Operations - continued
Presentation
of Dollar Amounts
All
dollar amounts in this Management’s Discussion and Analysis of Financial Condition and Results of Operations are presented as dollars
in millions, except for share and per share amounts.
Three
months ended June 30, 2023 as compared to three months ended June 30, 2022
Revenue
In
the three months ended June 30, 2023, revenue was $0.2 million as compared to $0.0 million for the corresponding period in the prior
year. The $0.2 million increase principally relates to the revenue for our EsoGuard Esophageal DNA Test performed in our own CLIA laboratory,
as compared to revenue from the EsoGuard Commercialization Agreement with RDx, in the prior year period, which was terminated on February
25, 2022 when Lucid Diagnostics transitioned to its own laboratory operations.
Cost
of revenue
In
the three months ended June 30, 2023, cost of revenue was approximately $1.7 million as compared to $0.0 million for the corresponding
period in the prior year. The $1.7 million increase principally related to:
●
approximately
$0.6 million increase in laboratory facility and operations costs;
●
approximately
$0.6 million increase in EsoCheck and EsoGuard supplies costs; and
●
approximately
$0.5 million increase in compensation related costs.
Sales
and marketing expenses
In
the three months ended June 30, 2023, sales and marketing costs were approximately $4.3 million as compared to $4.9 million for the corresponding
period in the prior year. The net decrease of $0.6 million was principally related to:
●
approximately
$0.7 million decrease related to a reduction of third party marketing expenses; and
●
approximately
$0.1 million increase in facility related costs.
General
and administrative expenses
In
the three months ended June 30, 2023, general and administrative costs were approximately $6.7 million as compared to $11.2 million for
the corresponding period in the prior year. The net decrease of $4.5 million was principally related to:
●
approximately
$2.5 million decrease in stock based compensation from RSA and stock option grants to Lucid and PAVmed employees and non-employees;
●
approximately $1.6 million decrease in third-party professional fees
and expenses related to legal services, accounting and audit services, consulting fees and professional recruiting services; and
●
approximately $0.4 million decrease related to the termination of the
MSA-RDx and lower general business expenses primarily related to reduced insurance premiums.
Research
and development expenses
In
the three months ended June 30, 2023, research and development costs were approximately $3.5 million as compared to $6.7 million for
the corresponding period in the prior year. The net decrease of $3.2 million was principally related to:
●
approximately
$3.5 million decrease in development costs, particularly in clinical trial activities and outside professional and consulting fees
primarily with respect to CarpX, EsoCure, and NextFlo; and
●
approximately
$0.3 million increase in compensation related costs, including stock based compensation.
As
mentioned above, above we have paused research and development with respect to CarpX, EsoCure, NextFlo and PortIO. Until such time as
resources permit, we expect to devote substantially all of our research and development efforts to EsoGuard, EsoCheck and the Veris Cancer
Care Platform.
Amortization
of Acquired Intangible Assets
The
amortization of acquired intangible assets remained relatively level in the three months ended June 30, 2023, as compared to the corresponding
period in the prior year.
32
Results
of Operations - continued
The
three months ended June 30, 2023 as compared to the three months ended June 30, 2022 - continued
Other
Income and Expense
Change
in fair value of convertible debt
In the three months ended June 30, 2023, the change in the fair value
of our convertible notes was approximately $0.3 million of expense, related to the April 2022 Senior Convertible Note (as defined in “ Liquidity
and Capital Resources ” below), the September 2022 Senior Convertible Note (as defined in “ Liquidity and Capital Resources ”
below), and the Lucid March 2023 Senior Convertible Note. The April 2022 Senior Convertible Note, the September 2022 Senior Convertible
Note, and the Lucid March 2023 Senior Convertible Note were initially measured at their issue-date estimated fair value and subsequently
remeasured at estimated fair value as of the reporting period date. The Company initially recognized an aggregate of $4.3 million of fair
value non-cash expense on the issue dates.
Loss
on Debt Extinguishment
In
the three months ended June 30, 2023, a debt extinguishment loss in the aggregate of approximately $0.7 million was recognized in connection
with our April 2022 Senior Convertible Note as discussed below.
●
In
the three months ended June 30, 2023, approximately $1.7 million of principal repayments, along with less than $0.1 million of interest
expense thereon, were settled through the issuance of 5,192,838 shares of common stock of the Company, with such shares having a
fair value of approximately $2.4 million (with such fair value measured as the respective conversion date quoted closing price of
the common stock of the Company). The conversions resulted in a debt extinguishment loss of $0.7 million in the three months ended
June 30, 2023.
There
were no similar debt extinguishment losses in the three months ended June 30, 2022.
See
Note 11 , Debt , to the Financial Statements, for additional information with respect to the April 2022 Senior Convertible Note,
the September 2022 Senior Convertible Note, and the Lucid March 2023 Senior Convertible Note.
33
Results
of Operations - continued
Six
months ended June 30, 2023 as compared to six months ended June 30, 2022
Revenue
In
the six months ended June 30, 2023, revenue was $0.6 million as compared to $0.2 million for the corresponding period in the prior year.
The $0.4 million increase principally relates to the revenue for our EsoGuard Esophageal DNA Test performed in our own CLIA laboratory,
as compared to revenue from the EsoGuard Commercialization Agreement with RDx, in the prior year period, which was terminated on February
25, 2022 when Lucid Diagnostics transitioned to its own laboratory operations.
Cost
of revenue
In
the six months ended June 30, 2023, cost of revenue was approximately $3.0 million as compared to $0.4 million for the corresponding
period in the prior year. The $2.6 million increase principally related to:
●
approximately
$1.0 million increase in laboratory facility and operations costs;
●
approximately
$0.9 million increase in EsoCheck and EsoGuard supplies costs; and
●
approximately
$0.7 million increase in compensation related costs.
Sales
and marketing expenses
In
the six months ended June 30, 2023, sales and marketing costs were approximately $8.9 million as compared to $8.8 million for the corresponding
period in the prior year. The net increase of $0.1 million was principally related to:
●
approximately
$1.3 million increase in compensation related costs principally as a result of an increase in headcount;
●
approximately $0.2 million increase in facility related costs;
●
approximately
$1.1 million decrease in third party marketing expenses; and
●
approximately
$0.3 million decrease in stock based compensation from RSA and stock option grants to Lucid and PAVmed employees.
General
and administrative expenses
In
the six months ended June 30, 2023, general and administrative costs were approximately $16.7 million as compared to $20.7 million for
the corresponding period in the prior year. The net decrease of $4.0 million was principally related to:
●
approximately
$2.9 million decrease in stock based compensation from RSA and stock option grants to Lucid and PAVmed employees and non-employees;
●
approximately $2.0 million decrease in third-party professional fees and
expenses related to legal services, consulting fees and professional recruiting services; and
●
approximately
$0.9 million increase in compensation related costs.
Research
and development expenses
In
the six months ended June 30, 2023, research and development costs were approximately $7.9 million as compared to $12.7 million for the
corresponding period in the prior year. The net decrease of $4.8 million was principally related to:
●
approximately
$5.5 million decrease in development costs, particularly in clinical trial activities and outside professional and consulting fees
primarily with respect to CarpX, EsoCure, and NextFlo;
●
approximately
$0.4 million decrease in third-party professional consulting services related to regulatory and development activities; and
●
approximately
$1.1 million increase in compensation related costs, including stock based compensation.
As
mentioned above, we have paused research and development with respect to CarpX, EsoCure, NextFlo and PortIO. Until such time as resources
permit, we expect to devote substantially all of our research and development efforts to EsoGuard, EsoCheck and the Veris Cancer Care
Platform.
Amortization
of Acquired Intangible Assets
The
amortization of acquired intangible assets remained relatively level in the six months ended June 30, 2023, as compared to the corresponding
period in the prior year.
34
Results
of Operations - continued
The
six months ended June 30, 2023 as compared to the six months ended June 30, 2022 - continued
Other
Income and Expense
Change
in fair value of convertible debt
In
the six months ended June 30, 2023, the change in the fair value of our convertible notes was approximately $1.4 million of expense,
related to the April 2022 Senior Convertible Note, the September 2022 Senior Convertible Note, and the Lucid March 2023 Senior Convertible
Note. The April 2022 Senior Convertible Note, the September 2022 Senior Convertible Note, and the Lucid March 2023 Senior Convertible
Note were initially measured at their issue-date estimated fair value and subsequently remeasured at estimated fair value as of the reporting
period date. The Company initially recognized an aggregate of $4.3 million of fair value non-cash expense on the issue dates.
Loss
on Issue and Offering Costs - Senior Secured Convertible Note
In
the six months ended June 30, 2023, in connection with the issue of the Lucid March 2023 Senior Convertible Notes, we recognized a total
of approximately $1.2 million of lender fees and offering costs paid by us. In the six months ended June 30, 2022, in connection with
the issue of the April 2022 Senior Convertible Notes, we recognized a total of approximately $3.1 million of lender fees and offering
costs.
Loss
on Debt Extinguishment
In
the six months ended June 30, 2023, a debt extinguishment loss in the aggregate of approximately $1.3 million was recognized in connection
with our April 2022 Senior Convertible Note as discussed below.
●
In
the six months ended June 30, 2023, approximately $3.2 million of principal repayments along with less than $0.1 million of interest
expense thereon, were settled through the issuance of 9,523,481 shares of common stock of the Company, with such shares having a
fair value of approximately $4.4 million (with such fair value measured as the respective conversion date quoted closing price of
the common stock of the Company). The conversions resulted in a debt extinguishment loss of $1.3 million in the six months ended
June 30, 2023.
There
were no similar debt extinguishment losses in the six months ended June 30, 2022.
See
Note 11 , Debt , to the Financial Statements, for additional information with respect to the April 2022 Senior Convertible Note,
the September 2022 Senior Convertible Note, and the Lucid March 2023 Senior Convertible Note.
Liquidity
and Capital Resources
Our
current operational activities are principally focused on the commercialization of EsoGuard and the Veris Cancer Care Platform, and,
as resources permit, our development activities would be focused on pursuing FDA approval and clearance of other lead products in our
product portfolio pipeline. Our ability to generate revenue depends upon successfully advancing the commercialization of EsoGuard and
the Veris Cancer Care Platform while, as resources permit, also completing the development and the necessary regulatory approvals of
our other products and services. There are no assurances, however, we will be able to obtain an adequate level of financial resources
required for the short-term or long-term commercialization and development of our products and services.
We
have financed our operations principally through the public and private issuances of our common stock, preferred stock, common stock
purchase warrants, and debt. We are subject to all of the risks and uncertainties typically faced by medical device and diagnostic and
medical device companies that devote substantially all of their efforts to the commercialization of their initial product and services
and ongoing R&D and clinical trials. We experienced a net loss before noncontrolling interests of approximately $40.1 million and
used approximately $29.1 million of cash in operations for the six months ended June 30, 2023. Financing activities provided $25.5 million
of cash during the six months ended June 30, 2023. We ended the quarter with cash on-hand of $37.2 million as of June 30, 2023. We expect
to continue to experience recurring losses and negative cash flows from operations, and will continue to fund our operations with debt
and/or equity financing transactions. Notwithstanding, however, with the cash on-hand as of the date hereof and the other debt and equity
committed sources of financing described below, we expect to be able to fund our future operations for the one year period from the date
of the issue of the our unaudited condensed consolidated Financial Statements, as included herein this Form 10-Q.
Issue
of Shares of Our Common Stock
During
the six months ended June 30, 2023
●
We
issued 573,229 shares of our common stock for proceeds of approximately $0.2 million under the PAVmed Employee Stock Purchase Plan
(“ESPP”), as such plan is discussed in Note 12, Stock-Based Compensation, to the Financial Statements.
●
We
issued 2,330,747 shares of our common stock for net proceeds of approximately $1.2 million, after payment of 3% commissions, from
the sale of shares through PAVmed’s at-the-market equity facility through Cantor. See below for more information.
●
We
issued 1,500,000 shares of our common stock to a service provider as the consideration for services rendered. The issued shares
of common stock had a fair value of approximately $0.6 million. See Note 14, Common Stock and Common Stock Purchase Warrants for additional
discussion. On the six-month anniversary of the issuance of the shares, the then-current market value of the shares will be determined
based on the volume weighted average price per share of the common stock during the last ten trading days of such six-month period. If
the aggregate market value of the shares as so determined is less than $750,000, the Company shall, at its election, either pay to the service
provider an amount in cash equal to the shortfall or issue to the service provider a number of additional shares equal to the shortfall
divided by the greater of the market value and $0.10. In no event will the number of shares issued exceed 9.99% of the Company’s
outstanding common stock as of May 31, 2023.
Securities
Purchase Agreement - March 31, 2022 - Senior Secured Convertible Notes - April 4, 2022 and September 8, 2022
Effective
as of March 31, 2022, we entered into the SPA with an accredited investor, pursuant to which we agreed to sell, and the investor agreed to purchase
an aggregate of $50.0 million face value principal of Senior Secured Convertible Notes. The SPA provided for the sale of the initial
Senior Secured Convertible Note with a face value principal of $27.5 million, which closed on April 4, 2022 (referred to as the “April
2022 Senior Convertible Note”). The SPA also provided for sales of additional Senior Secured Convertible Notes in one or more additional
closings (upon the satisfaction of certain conditions), with an aggregate face value principal of up to an additional $22.5 million.
The April 2022 Senior Secured Convertible Note has a 7.875% annual stated interest rate, a contractual conversion price of $5.00 per
share of the Company’s common stock (subject to standard adjustments in the event of any stock split, stock dividend, stock combination,
recapitalization or other similar transaction), and a contractual maturity date of April 4, 2024. The April 2022 Senior Convertible Note
may be converted into or otherwise paid in shares of our common stock as described in Note 11, Debt. The April 2022 Senior Convertible
Note proceeds were $24.4 million after deducting a $2.5 million lender fee and the Company’s offering costs of approximately $0.6
million, inclusive primarily of $0.5 million placement agent fees.
On
September 8, 2022, we completed an additional closing under the SPA, in which we sold to the investor an additional Senior Secured Convertible
Note with a face value principal of $11.25 million (referred to as the “September 2022 Senior Convertible Note”). The September
2022 Senior Secured Convertible Note has a 7.875% annual stated interest rate, a contractual conversion price of $5.00 per share of the
Company’s common stock (subject to standard adjustments in the event of any stock split, stock dividend, stock combination, recapitalization
or other similar transaction), and a contractual maturity date of September 6, 2024. The September 2022 Senior Convertible Note may be
converted into or otherwise paid in shares of our common stock as described in Note 11, Debt. The September 2022 Senior Convertible Note
proceeds were $10.0 million after deducting a $1.0 million lender fee and the Company’s total offering costs of approximately $0.2
million, inclusive primarily of placement agent fees.
35
Liquidity
and Capital Resources - continued
Under the April 2022 Senior Convertible Note, the September 2022 Senior
Convertible Note and the SPA, we are subject to certain customary affirmative and negative covenants regarding the incurrence of indebtedness,
the existence of liens, the repayment of indebtedness and the making of investments, the payment of cash in respect of dividends, distributions
or redemptions, the transfer of assets, the maturity of other indebtedness, and transactions with affiliates, among other customary matters.
We also are subject to financial covenants requiring that (i) the amount of our available cash equal or exceed $8.0 million at all times,
(ii) the ratio of (a) the outstanding principal amount of the notes issued under the SPA, accrued and unpaid interest thereon and accrued
and unpaid late charges to (b) our average market capitalization over the prior ten trading days, not exceed 30% (except that such maximum
percentage was 50% for the period from September 8, 2022 through March 5, 2023) (the “Debt to Market Cap Ratio Test”), and
(iii) that our market capitalization shall at no time be less than $75 million (the “Market Cap Test” and, together with the
Debt to Market Cap Ratio Test, the “Financial Tests”). From time to time from and after June 1, 2023 through August 14,
2023, the Company was not in compliance with the Financial Tests. As of August 14, 2023, the investor agreed to waive any such non-compliance
during such time period and thereafter through November 30, 2023.
See
Note 11 , Debt , to the Financial Statements for additional information about the SPA, the April 2022 Senior Convertible Note, and
the September 2022 Senior Convertible Note.
Lucid
Diagnostics - Series A Preferred Stock Offering
On March 7, 2023, Lucid Diagnostics entered into subscription agreements
for the sale of 13,625 shares of the Lucid Series A Preferred Stock. Each share of the Lucid Series A Preferred Stock has a stated value
of $1,000 and a conversion price of $1.394. The Lucid Series A Preferred Stock is convertible into shares of Lucid Diagnostics’
common stock at any time at the option of the holder from and after the six-month anniversary of its issuance (or, if later, the effective
date of an increase in Lucid Diagnostics’ authorized share capital or the effective date of a registration statement covering the
resale of the underlying shares), and automatically converts into shares of Lucid Diagnostics’ common stock on the second anniversary
of its issuance. The terms of the Lucid Series A Preferred Stock also include a preference on liquidation and a right to receive dividends
equal to 20% of the number of shares of Lucid common stock into which such Lucid Series A Preferred Stock is convertible, payable on each
of the one-year and two-year anniversary of the issuance date. The Lucid Series A Preferred Stock is a non-voting security, other than
with respect to limited matters related to changes in terms of the Lucid Series A Preferred Stock. The aggregate gross proceeds from the
sale of shares in such offering were $13.625 million.
Lucid
Diagnostics - Securities Purchase Agreement - March 13, 2023 - Senior Secured Convertible Note - March 21, 2023
Effective as of March 13, 2023, Lucid Diagnostics entered into the Lucid
SPA with an accredited institutional investor, pursuant to which Lucid Diagnostics agreed to sell, and the investor agreed to purchase
the Lucid March 2023 Senior Convertible Note with a face value principal of $11.1 million. Lucid Diagnostics issued the Lucid March 2023
Senior Convertible Note on March 21, 2023 pursuant to the Lucid SPA. The Lucid March 2023 Senior Convertible Note proceeds were $9.925
million after deducting a $1.186 million lender fee and offering costs.
The
Lucid March 2023 Senior Convertible Note has a 7.875% annual stated interest rate, a contractual conversion price of $5.00 per share
of the Company’s common stock (subject to standard adjustments in the event of any stock split, stock dividend, stock combination,
recapitalization or other similar transaction), and a contractual maturity date of the two-year anniversary of the date of issuance.
The principal and interest on the Lucid March 2023 Senior Convertible Note is convertible into or otherwise payable in shares of Lucid
Diagnostics’ common stock (subject to the satisfaction of certain customary equity conditions and except for interest payable prior
to September 21, 2023).
Under
the Lucid March 2023 Senior Convertible Note, Lucid Diagnostics is subject to certain customary affirmative and negative covenants regarding
the incurrence of indebtedness, the existence of liens, the repayment of indebtedness and the making of investments, the payment of cash
in respect of dividends, distributions or redemptions, the transfer of assets, the maturity of other indebtedness, and transactions with
affiliates, among other customary matters. Under the Lucid March 2023 Senior Convertible Note, Lucid Diagnostics is also subject to financial
covenants requiring that (i) the amount of its available cash equal or exceed $5.0 million at all times, (ii) the ratio of (a) the outstanding
principal amount of the notes issued under the Lucid SPA, accrued and unpaid interest thereon and accrued and unpaid late charges, as
of the last day of any fiscal quarter commencing with September 30, 2023, to (b) Lucid Diagnostics’ average market capitalization
over the prior ten trading days, not exceed 30%, and (iii) that Lucid Diagnostics’ market capitalization shall at no time be less
than $30 million (the “Lucid Financial Tests”). As of June 30, 2023, Lucid Diagnostics was in compliance with the Lucid Financial
Tests. In addition, Lucid Diagnostics presently is in compliance with the Lucid Financial Tests.
36
Liquidity
and Capital Resources - continued
PAVmed
Inc. ATM Facility
In
December 2021, we entered into an “at-the-market offering” for up to $50 million of our common stock that may be offered
and sold under a Controlled Equity Offering Agreement between us and Cantor. In March 2023, the “at-the-market offering”
became subject to General Instruction I.B.6 of Form S-3, which limits sales of our securities under this instruction in any 12-month
period to one-third of the aggregate market value of our public float (unless our public float rises to $75 million or more, in which
case the instruction will cease to apply). As a result of this limitation and our then-current public float, in May 2023, we amended
our “at-the-market offering” to cover up to an additional $18 million of our common stock. In the six months ended June 30,
2023, the Company sold 2,330,747 shares through its at-the-market equity facility for net proceeds of approximately $1.2 million, after
payment of 3% commissions.
Lucid
Diagnostics Inc. - Committed Equity Facility and ATM Facility
In
March 2022, Lucid Diagnostics entered into a committed equity facility with a Cantor affiliate. Under the terms of the committed equity
facility, the Cantor affiliate has committed to purchase up to $50 million of Lucid Diagnostics’ common stock from time to time
at Lucid Diagnostics’ request. While there are distinct differences, the committed equity facility is structured similarly to a
traditional at-the-market equity facility, insofar as it allows Lucid Diagnostics to raise primary equity capital on a periodic basis
at prices based on the existing market price. Cumulatively a total of 680,263 shares of Lucid Diagnostics’ common stock were issued
for net proceeds of approximately $1.8 million, after a 4% discount, as of June 30, 2023.
In
November 2022, Lucid Diagnostics also entered into an “at-the-market offering” for up to $6.5 million of its common stock
that may be offered and sold under a Controlled Equity Offering Agreement between Lucid Diagnostics and Cantor. In the six months ended
June 30, 2023, Lucid Diagnostics sold 230,068 shares through its at-the-market equity facility for net proceeds of approximately $0.3
million, after payment of 3% commissions. No shares were sold through Lucid’s at-the-market equity facility during the three months ended June 30, 2023.
Critical
Accounting Policies and Significant Judgments and Estimates
The
discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial
statements, which have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S.
GAAP”). The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions
that affect the amounts reporting in our unaudited condensed consolidated financial statements and accompanying notes. On an ongoing
basis, we evaluate our estimates and judgements. In accordance with U.S. GAAP, we base our estimates on historical experience and on
various other factors that are believed to be appropriate under the circumstances. Actual results may differ from these estimates under
different assumptions or conditions. Our critical accounting policies are as disclosed in the Company’s Annual Report on Form 10-K
for the year ended December 31, 2022 as filed with the SEC on March 14, 2023. There have been no material changes to our critical accounting
policies and estimates in the six months ended June 30, 2023.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our principal executive officer and our principal financial officer, evaluated the effectiveness
of our disclosure controls and procedures as of June 30, 2023. Based on such evaluation, our principal executive officer and principal
financial officer concluded our disclosure controls and procedures (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act)
were effective as of such date to provide reasonable assurance the information required to be disclosed by us in the reports we file
or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s
rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure information
required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management,
including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required
disclosure.
Changes
to Internal Controls Over Financial Reporting
There
has been no change in internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act)
that occurred during our fiscal quarter ended June 30, 2023 that has materially affected, or is reasonably likely to materially affect,
our internal control over financial reporting.
37
Part
II - Other Information
Item
1. Legal Proceedings
See
Note 9, Commitment and Contingencies - Legal Proceedings , of the unaudited condensed consolidated financial statements included
in this Quarterly Report, for a description of certain material legal proceedings involving the Company, which description is incorporated
herein by reference.
In the ordinary course of PAVmed business, particularly as it begins commercialization
of its products, the Company may be subject to legal actions and claims, including product liability, consumer, commercial, tax and governmental
matters, which may arise from time to time. The Company is not aware of any such pending legal or other proceedings that are reasonably
likely to have a material impact on the Company. Notwithstanding, legal proceedings are subject-to inherent uncertainties, and an unfavorable
outcome could include monetary damages, and excessive verdicts can result from litigation, and as such, could result in a material adverse
impact on the Company’s business, financial position, results of operations, and /or cash flows. Additionally, although the Company
has specific insurance for certain potential risks, the Company may in the future incur judgments or enter into settlements of claims
which may have a material adverse impact on the Company’s business, financial position, results of operations, and /or cash flows.
Item 3. Defaults Upon Senior Securities
The information set forth in Part I, Item 2 under the caption “ Liquidity and Capital Resources — Securities
Purchase Agreement - March 31, 2022 - Senior Secured Convertible Notes - April 4, 2022 and September 8, 2022 ” is incorporated
herein by reference.
Item
5. Other Information
None.
Item
6. Exhibits
The
exhibits filed as part of this Quarterly Report on Form 10-Q are set forth in the “ Exhibit Index ” below.
38
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized.
PAVmed
Inc.
August
14, 2023
By:
/s/
Dennis M McGrath
Dennis
M McGrath
President
and Chief Financial Officer
(Principal
Financial and Accounting Officer)
39
EXHIBIT
INDEX
Incorporation
by Reference
Exhibit
No.
Description
Form
Exhibit
No.
Date
31.1
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
*
31.2
Certification of Principal Financial and Accounting Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
*
32.1
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
*
32.2
Certification of Principal Financial and Accounting Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
*
101.INS
Inline
XBRL Instance Document
*
101.CAL
Inline
XBRL Taxonomy Extension Schema
*
101.DEF
Inline
XBRL Taxonomy Extension Calculation Linkbase
*
101.LAB
Inline
XBRL Taxonomy Extension Label Linkbase
*
101.PRE
Inline
XBRL Taxonomy Extension Presentation Linkbase
*
104
Cover
Page Interactive Data File (embedded within the Inline XBRL document)
*
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.