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, 2024
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)
(917)
813-1828
(Registrant’s
Telephone Number, Including Area Code)
Securities
registered pursuant to 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 1/15th of 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 June 30, 2024 and August 8, 2024, there were 10,010,844 and 10,406,433 shares, respectively, 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, 2024 and December 31, 2023
1
Condensed
Consolidated Statements of Operations (unaudited) for the three and six months ended June 30, 2024 and 2023
2
Condensed
Consolidated Statements of Changes in Stockholders’ Equity (Deficit) (unaudited) for the three and six months ended June 30,
2024 and 2023
3
Condensed
Consolidated Statements of Cash Flows (unaudited) for the six months ended June 30, 2024 and 2023
7
Notes
to Unaudited Condensed Consolidated Financial Statements
8
Item
2.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
29
Item
4.
Controls
and Procedures
40
Part
II - Other Information
Item
1.
Legal
Proceedings
41
Item
5.
Other
Information
41
Item
6.
Exhibits
41
Signature
42
Exhibit
Index
43
i
Part
I - Financial Information
Item
1. Financial Statements
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands except number of shares and per share data - unaudited)
June
30,
2024
December
31,
2023
Assets:
Current
assets:
Cash
$ 25,499
$ 19,639
Accounts
receivable
219
61
Inventory
687
278
Prepaid
expenses, deposits, and other current assets
3,802
4,520
Total
current assets
30,207
24,498
Fixed
assets, net
1,331
1,783
Operating
lease right-of-use assets
5,771
4,267
Intangible
assets, net
947
1,424
Other
assets
1,157
1,147
Total
assets
$ 39,413
$ 33,119
Liabilities,
Preferred Stock and Stockholders’ Equity
Current
liabilities:
Accounts
payable
$ 1,232
$ 1,786
Accrued
expenses and other current liabilities
6,789
6,626
Operating
lease liabilities, current portion
1,369
1,565
Senior
Secured Convertible Notes - at fair value
44,000
44,200
Total
current liabilities
53,390
54,177
Operating
lease liabilities, less current portion
4,665
2,960
Total
liabilities
58,055
57,137
Commitments
and contingencies (Note 8)
-
-
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
1,357,976 at June 30, 2024 and 1,305,213 shares at December 31, 2023
3,151
2,993
Common
stock, $ 0.001 par value. Authorized, 50,000,000 shares; 9,554,381 and 8,578,505 shares outstanding as of June 30, 2024 and December
31, 2023, respectively
10
9
Additional
paid-in capital
243,524
237,600
Accumulated
deficit
( 320,630 )
( 294,433 )
Total
PAVmed Inc. Stockholders’ Equity (Deficit)
( 73,945 )
( 53,831 )
Noncontrolling
interests
55,303
29,813
Total
Stockholders’ Equity (Deficit)
( 18,642 )
( 24,018 )
Total
Liabilities and Stockholders’ Equity (Deficit)
$ 39,413
$ 33,119
See
accompanying notes to the unaudited condensed consolidated financial statements.
1
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(in
thousands except number of shares and per share data - unaudited)
Three
Months Ended
June
30,
Six
Months Ended
June
30,
2024
2023
2024
2023
Revenue
$ 979
$ 166
$ 1,989
$ 612
Operating
expenses:
Cost
of revenue
1,666
1,685
3,411
3,030
Sales
and marketing
4,242
4,339
8,552
8,877
General
and administrative
7,009
6,652
13,688
17,060
Amortization
of acquired intangible assets
105
505
477
1,010
Research
and development
1,641
3,469
3,583
7,519
Total
operating expenses
14,663
16,650
29,711
37,496
Operating
loss
( 13,684 )
( 16,484 )
( 27,722 )
( 36,884 )
Other
income (expense):
Interest
income
110
163
182
283
Interest
expense
( 11 )
( 228 )
( 26 )
( 411 )
Change
in fair value - Senior Secured Convertible Notes
( 566 )
( 340 )
( 2,728 )
( 1,380 )
Loss
on issue and offering costs - Senior Secured Convertible Note
—
—
—
( 1,186 )
Debt
extinguishments loss - Senior Secured Convertible Notes
( 763 )
( 743 )
( 1,132 )
( 1,268 )
Debt
modification expense
—
—
( 2,000 )
—
Change
in fair value - derivative liability
—
( 260 )
—
( 260 )
Gain
on sale of intellectual property
—
—
—
1,000
Other
income (expense), net
( 1,230 )
( 1,408 )
( 5,704 )
( 3,222 )
Loss
before provision for income tax
( 14,914 )
( 17,892 )
( 33,426 )
( 40,106 )
Provision
for income taxes
—
—
—
—
Net
loss before noncontrolling interests
( 14,914 )
( 17,892 )
( 33,426 )
( 40,106 )
Net
loss attributable to the noncontrolling interests
4,087
3,355
7,387
7,638
Net
loss attributable to PAVmed Inc.
( 10,827 )
( 14,537 )
( 26,039 )
( 32,468 )
Less:
Series B Convertible Preferred Stock dividends earned
( 81 )
( 75 )
( 161 )
( 149 )
Less:
Deemed dividend on Subsidiary Preferred Stock attributable to the noncontrolling interests
—
—
( 7,496 )
—
Net
loss attributable to PAVmed Inc. common stockholders
$ ( 10,908 )
$ ( 14,612 )
$ ( 33,696 )
$ ( 32,617 )
Per
share information:
Net
loss per share attributable to PAVmed Inc. common stockholders – basic and diluted
$ ( 1.19 )
$ ( 2.10 )
$ ( 3.78 )
$ ( 4.86 )
Weighted
average common shares outstanding, basic and diluted
9,152,819
6,956,655
8,923,862
6,716,169
See
accompanying notes to the unaudited condensed consolidated financial statements.
2
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
for
the THREE MONTHS ENDED June 30, 2024
(in
thousands except number of shares and per share data)
PAVmed
Inc. Stockholders’ Equity (Deficit)
Series
B Convertible Preferred Stock
Common
Stock
Additional
Paid-In
Accumulated
Non
controlling
Shares
Amount
Shares
Amount
Capital
Deficit
Interest
Total
Balance
- March 31, 2024
1,331,336
$ 3,071
8,858,597
$ 9
$ 237,863
$ ( 309,723 ) -
$ 48,205
$ ( 20,575 )
Dividends
declared - Series B Convertible Preferred Stock
26,640
80
—
—
—
( 80 ) -
—
—
Issue
common stock - PAVM ATM Facility
—
—
200,000
—
198
— -
—
198
Vest
- restricted stock awards
—
—
4,064
—
—
— -
—
—
Conversions
- Senior Secured Convertible Note
—
—
461,963
1
805
— -
—
806
Conversions
- subsidiary common stock - Senior Secured Convertible Note
—
—
—
—
—
— -
1,854
1,854
Impact
of subsidiary equity transactions
—
—
—
—
3,903
— -
( 3,903 )
—
Issuance
- vendor service agreement
—
—
29,757
—
50
— -
401
451
Issuance
- subsidiary preferred stock (Series B-1)
—
—
—
—
—
— -
11,634
11,634
Stock-based
compensation - PAVmed Inc.
—
—
—
—
598
— -
—
598
Stock-based
compensation - subsidiary
—
—
—
—
107
— -
1,199
1,306
Net
loss
—
—
—
—
—
( 10,827 ) -
( 4,087 )
( 14,914 )
Balance
- June 30, 2024
1,357,976
$ 3,151
9,554,381
$ 10
$ 243,524
$ ( 320,630 ) -
$ 55,303
$ ( 18,642 )
See
accompanying notes to the unaudited condensed consolidated financial statements.
3
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
for
the SIX MONTHS ENDED June 30, 2024
(in
thousands, except number of shares and per share data - unaudited)
PAVmed
Inc. Stockholders’ Equity (Deficit)
Series
B Convertible Preferred Stock
Common
Stock
Additional
Paid-In
Accumulated
Non
controlling
Shares
Amount
Shares
Amount
Capital
Deficit
Interest
Total
Balance
- December 31, 2023
1,305,213
$ 2,993
8,578,505
$ 9
$ 237,600
$ ( 294,433 ) -
$ 29,813
$ ( 24,018 )
Dividends
declared - Series B Convertible Preferred Stock
52,763
158
—
—
—
( 158 ) -
—
—
Issue
common stock - PAVM ATM Facility
—
—
333,299
—
693
— -
—
693
Vest
- restricted stock awards
—
—
4,064
—
—
— -
—
—
Conversions
- Senior Secured Convertible Note
—
—
574,424
1
1,112
— -
—
1,113
Conversions
- subsidiary common stock - Senior Secured Convertible Note
—
—
—
—
—
— -
2,541
2,541
Exercise
- stock options of subsidiary
—
—
—
—
—
— -
4
4
Purchase
- Employee Stock Purchase Plan
—
—
34,332
—
62
— -
—
62
Purchase
- subsidiary common stock - Employee Stock Purchase Plan
—
—
—
—
—
— -
353
353
Impact
of subsidiary equity transactions
—
—
—
—
2,169
— -
( 2,169 )
—
Issuance
- vendor service agreement
—
—
29,757
—
50
— -
401
451
Issuance
- subsidiary preferred stock (Series A-1)
—
—
—
—
—
— -
5,670
5,670
Exchange
- subsidiary preferred stock (Series A and Series A-1)
—
—
—
—
—
— -
( 24,294 )
( 24,294 )
Issuance
- subsidiary preferred stock (Series B and Series B-1)
—
—
—
—
—
— -
55,919
55,919
Subsidiary
deemed dividends on preferred stock attributable to noncontrolling interests
—
—
—
—
—
— -
( 7,496 )
( 7,496 )
Stock-based
compensation - PAVmed Inc.
—
—
—
—
1,532
— -
—
1,532
Stock-based
compensation - subsidiaries
—
—
—
—
306
— -
1,948
2,254
Net
loss
—
—
—
—
—
( 26,039 ) -
( 7,387 )
( 33,426 )
Balance
- June 30, 2024
1,357,976
$ 3,151
9,554,381
$ 10
$ 243,524
$ ( 320,630 ) -
$ 55,303
$ ( 18,642 )
See
accompanying notes to the unaudited condensed consolidated financial statements.
4
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED CONSOLIDATED
STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
for
the THREE 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
- March 31, 2023
1,229,887
$ 2,767
6,706,427
$ 7
$ 221,341
$ ( 246,172 )
$ —
$ 32,861
$ 10,804
Dividends
declared - Series B Convertible Preferred Stock
24,610
74
—
—
—
( 74 )
—
—
—
Issue
common stock - PAVM ATM Facility
—
—
83,250
—
609
—
—
—
609
Conversions
- Senior Secured Convertible Note
—
—
346,190
—
2,395
—
—
—
2,395
Impact
of subsidiary equity transactions
—
—
—
—
143
—
—
( 143 )
—
Issuance
- vendor service agreement
—
—
100,000
—
600
—
—
147
747
Stock-based
compensation - PAVmed Inc.
—
—
—
—
1,090
—
—
—
1,090
Stock-based
compensation - subsidiary
—
—
—
—
245
—
—
1,172
1,417
Net
loss
—
—
—
—
—
( 14,537 )
—
( 3,355 )
( 17,892 )
Balance
- June 30, 2023
1,254,497
$ 2,841
7,235,867
$ 7
$ 226,423
$ ( 260,783 )
$ —
$ 30,682
$ ( 830 )
See
accompanying notes to the condensed consolidated financial statements.
5
PAVMED
INC.
and
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ 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
6,300,703
$ 6
$ 216,195
$ ( 228,169 )
$ ( 408 )
$ 20,615
$ 10,934
Balance
1,205,759
$ 2,695
6,300,703
$ 6
$ 216,195
$ ( 228,169 )
$ ( 408 )
$ 20,615
$ 10,934
Dividends
declared - Series B Convertible Preferred Stock
48,738
146
—
—
—
( 146 )
—
—
—
Issue
common stock - PAVM ATM Facility
—
—
155,384
—
1,166
—
—
—
1,166
Vest
- restricted stock awards
—
—
6,666
—
—
—
—
—
—
Conversions
- Senior Secured Convertible Note
—
—
634,899
1
4,422
—
—
—
4,423
Purchase
- Employee Stock Purchase Plan
—
—
25,626
—
122
—
60
—
182
Purchase
- subsidiary common stock - Employee Stock Purchase Plan
—
—
—
—
—
—
—
276
276
Issuance
- subsidiary common stock - Committed Equity Facility, net of financing charges
—
—
—
—
—
—
—
284
284
Impact
of subsidiary equity transactions
—
—
—
—
1,332
—
—
( 1,332 )
—
Issuance
- subsidiary common stock - Settlement APA-RDx - Installment Payment
—
—
—
—
—
—
—
713
713
Issuance
- vendor service agreement
—
—
100,000
—
600
—
—
147
747
Issuance
- subsidiary preferred stock (Series A)
—
—
—
—
—
—
—
13,625
13,625
Stock-based
compensation - PAVmed Inc.
—
—
—
—
2,288
—
—
—
2,288
Stock-based
compensation - subsidiaries
—
—
—
—
646
—
—
3,992
4,638
Treasury
stock
—
—
12,589
—
( 348 )
—
348
—
—
Net
Loss
—
—
—
—
—
( 32,468 )
—
( 7,638 )
( 40,106 )
Balance
- June 30, 2023
1,254,497
$ 2,841
7,235,867
$ 7
$ 226,423
$ ( 260,783 )
$ —
$ 30,682
$ ( 830 )
Balance
1,254,497
$ 2,841
7,235,867
$ 7
$ 226,423
$ ( 260,783 )
$ —
$ 30,682
$ ( 830 )
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)
Six
Months Ended June 30,
2024
2023
Cash
flows from operating activities
Net
loss - before noncontrolling interest (“NCI”)
$ ( 33,426 )
$ ( 40,106 )
Adjustments
to reconcile net loss - before NCI to net cash used in operating activities
Depreciation
and amortization expense
891
1,474
Stock-based
compensation
3,786
6,926
Gain
on sale of intellectual property
—
( 1,000 )
APA-RDx:
Issue common stock of subsidiary - termination payment
—
713
Amortization
of common stock payment for vendor service agreement
163
625
Change
in fair value - Senior Secured Convertible Notes
2,728
1,380
Loss
on issue - Senior Secured Convertible Note
—
1,111
Debt
extinguishment loss - Senior Secured Convertible Note
1,132
1,268
Change
in fair value - derivative liability
—
260
Non-cash
lease expense
5
192
Changes
in operating assets and liabilities:
Accounts
receivable
( 158 )
( 24 )
Prepaid
expenses, deposits and current and other assets
380
( 1,592 )
Accounts
payable
( 553 )
( 1,541 )
Accrued
expenses and other current liabilities
287
1,241
Net
cash flows used in operating activities
( 24,765 )
( 29,073 )
Cash
flows from investing activities
Purchase
of equipment
( 45 )
( 41 )
Proceeds
from sale of intellectual property
—
1,000
Net
cash flows provided by (used in) investing activities
( 45 )
959
Cash
flows from financing activities
Proceeds
– issue of preferred stock - subsidiary
29,798
13,625
Proceeds
– issue of Senior Secured Convertible Note
—
10,000
Payment
– Senior Secured Convertible Note – acceleration floor payments
( 531 )
—
Proceeds
– issue of common stock - At-The-Market Facility
984
1,166
Proceeds
– subsidiary common stock - Committed Equity Facility and At-The-Market Facility
—
284
Proceeds
– issue common stock – Employee Stock Purchase Plan
62
182
Proceeds
– subsidiary common stock – Employee Stock Purchase Plan
353
276
Proceeds
– exercise of stock options issued under equity plan of subsidiary
4
—
Net
cash flows provided by financing activities
30,670
25,533
Net
increase (decrease) in cash
5,860
( 2,581 )
Cash,
beginning of period
19,639
39,744
Cash,
end of period
$ 25,499
$ 37,163
See
accompanying notes to the unaudited condensed consolidated financial statements.
7
PAVMED
INC.
and
SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(amounts
in these accompanying notes are presented in thousands, except number of shares and per-share amounts.)
Note
1 — The Company
Description
of the Business
PAVmed
is structured to be a multi-product life sciences company organized to advance a pipeline of innovative healthcare technologies. Led
by a team of highly skilled personnel with a track record of bringing innovative products to market, PAVmed is focused on innovating,
developing, acquiring, and commercializing novel products that target unmet medical needs with large addressable market opportunities.
Leveraging our corporate structure—a parent company that will establish distinct subsidiaries for each financed asset—we
have the flexibility to raise capital at the PAVmed level to fund product development, or to structure financing directly into each subsidiary
in a manner tailored to the applicable product, the latter of which is our current strategy given prevailing market conditions.
Our
current focus is multi-fold. We continue to pursue commercial expansion and execution of EsoGuard, which is the flagship product of our
subsidiary Lucid Diagnostics Inc. (Nasdaq: LUCD) (“Lucid”). In addition, through a separate majority-owned subsidiary, Veris
Health (“Veris”), we are focused on entering into strategic partnership opportunities with leading academic oncology systems
to expand access to the Veris Platform. In terms of other existing products and technologies, we have adopted an incubator-type platform
where we are looking to obtain financing on a product-by-product basis as necessary to advance each asset to a meaningful inflection
point along its path to commercialization. Finally, as resources permit, we will continue to explore external innovations that fulfill
our project selection criteria without limiting ourselves to any target sector, specialty or condition.
Note
2 — Liquidity and Going Concern
The
Company’s management is required to assess the Company’s ability to continue as a going concern for the one year period following
the date of the financial statements being issued. In each reporting period, including interim periods, an entity is required to assess
conditions known and reasonably knowable as of the financial statement issuance date to determine whether it is probable an entity will
not meet its financial obligations within one year from the financial statement issuance date. Substantial doubt about an entity’s
ability to continue as a going concern exists when conditions and events, considered in the aggregate, indicate it is probable the entity
will be unable to meet its financial obligations as they become due within one year after the date the financial statements are issued.
The
Company has financed its operations principally through public and private issuances of its common stock, preferred stock, common stock
purchase warrants, and debt. The Company is subject to all of the risks and uncertainties typically faced by medical device and diagnostic
companies that devote substantially all of their efforts to the commercialization of their initial product and services and ongoing research
and development activities and conducting clinical trials. The Company generated $ 1.0 million and $ 2.0 million of revenues for the three
and six month periods ended June 30, 2024, respectively, however the Company does not expect to generate positive cash flows from operating
activities in the near future.
The
Company incurred a net loss attributable to PAVmed Inc. common stockholders of approximately $ 33.7 million and had net cash flows used
in operating activities of approximately $ 24.8 million for the six month period ended June 30, 2024. As of June 30, 2024, the Company
had negative working capital of approximately $ 23.2 million, with such working capital inclusive of the Senior Secured Convertible Notes
classified as a current liability of an aggregate of approximately $ 44.0 million and approximately $ 25.5 million of cash.
The
Company’s ability to continue operations 12 months beyond the issuance of the financial statements, will depend upon generating
substantial revenue that is conditioned upon obtaining positive third-party reimbursement coverage for its EsoGuard Esophageal DNA Test
from both government and private health insurance providers, increasing revenue through contracting directly with self-insured employers,
and on its ability to raise additional capital through various potential sources including equity and/or debt financings or refinancing
existing debt obligations. These factors raise substantial doubt about the Company’s ability to continue as a going concern within
one year after the date the accompanying unaudited condensed consolidated financial statements are issued.
8
Note
3 — 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, 2023 as filed with the SEC on March 25, 2024, 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
subsidiaries, majority-owned subsidiaries and Lucid Diagnostics. All intercompany transactions and balances have been eliminated in consolidation.
The Company has a 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 subsidiary. See Note 14, Noncontrolling Interest , for a discussion of each of the 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, 2023 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.
The
unaudited condensed consolidated results of operations for the three and six months ended June 30, 2024 are not necessarily indicative
of the consolidated results to be expected for the year ending December 31, 2024 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, 2023 included in the Company’s Annual Report on Form 10-K as filed with the SEC on March
25, 2024.
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 unaudited condensed 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.
9
Note
3 — Summary of Significant Accounting Policies - continued
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.
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.
10
Note
3 — Summary of Significant Accounting Policies - continued
Fair
Value Option (“FVO”) Election
Under
a Securities Purchase Agreement dated March 31, 2022, the Company issued a Senior Secured Convertible Note dated April 4, 2022, referred
to herein as the “April 2022 Senior Convertible Note”, and a Senior Secured Convertible Note dated September 8, 2022, referred
to herein as the “September 2022 Senior Convertible Note”, which are accounted under the “fair value option election”
as discussed below.
Under
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, including the component related to accrued interest, is presented
in a single line item within other income (expense) in the accompanying unaudited condensed consolidated statement of operations (as
provided for by ASC 825-10-50-30(b)). Further, as required by ASC 825-10-45-5, to the extent a portion of the fair value adjustment is
attributed to a change in the instrument-specific credit risk, such portion would be recognized as a component of other comprehensive
income (“OCI”) (for which there was no such adjustment with respect to the April 2022 Senior Convertible Note, the September
2022 Senior Convertible Note or the Lucid March 2023 Senior Convertible Note).
See
Note 9, Financial Instruments Fair Value Measurements , with respect to the FVO election; and Note 10, 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.
Recent
Accounting Standards Updates Not Yet Adopted
In
December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740)—Improvements to Income Tax Disclosures (“ASU 2023-09”),
which is intended to enhance the transparency and decision usefulness of income tax disclosures. The amendments in ASU 2023-09 provide
for enhanced income tax information primarily through changes to the rate reconciliation and income taxes paid information. ASU 2023-09
is effective for the Company prospectively to all annual periods beginning after December 15, 2024. Early adoption is permitted. The
Company does not expect the standard to have a significant impact on its unaudited condensed consolidated financial statements.
In
November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280)—Improvements to Reportable Segment Disclosures (“ASU
2023-07”), which require public companies disclose significant segment expenses and other segment items on an annual and interim
basis and to provide in interim periods all disclosures about a reportable segment’s profit or loss and assets that are currently
required annually. The guidance is effective for public entities for fiscal years beginning after December 15, 2023, and interim periods
within fiscal years beginning after December 15, 2024. Early adoption is permitted. The guidance is applied retrospectively to all periods
presented in the financial statements, unless it is impracticable. The Company does not expect the standard to have a significant impact
on its unaudited condensed consolidated financial statements.
In
October 2023, the FASB issued ASU No. 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure
Update and Simplification Initiative. This update modifies the disclosure or presentation requirements of a variety of topics in the
Accounting Standards Codification to conform with certain SEC amendments in Release No. 33-10532, Disclosure Update and Simplification.
The amendments in this update should be applied prospectively, and the effective date for each amendment will be the date on which the
SEC’s removal of that related disclosure from Regulation S-X or S-K becomes effective. However, if the SEC has not removed the
related disclosure from its regulations by June 30, 2027, the amendments will be removed from the Codification and not become effective.
Early adoption is prohibited. The Company is currently evaluating the impact this update will have on its unaudited condensed consolidated
financial statements and disclosures.
11
Note
4 — Revenue from Contracts with Customers
Revenue
Recognized
In
the three and six month periods ended June 30, 2024, the Company recognized total revenue of $ 979 and $ 1,989 , 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 month periods ended June 30, 2023 was $ 166 and $ 612 , respectively, primarily resulting from the delivery of patient
EsoGuard test results.
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 month periods ended June 30, 2024, the cost of revenue was $ 1,666 and $ 3,411 , respectively, primarily related to costs
for our laboratory operations and EsoCheck device supplies. The Company’s cost of revenue for the three and six month periods ended
June 30, 2023 was $ 1,685 and $ 3,030 , respectively, primarily related to costs for our laboratory operations and EsoCheck device supplies.
Note
5 — 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, 2024
December
31, 2023
Advanced
payments to service providers and suppliers
$ 738
$ 739
Prepaid
insurance
872
848
Deposits
1,896
2,672
Veris
Box supplies
296
261
Total
prepaid expenses, deposits and other current assets
$ 3,802
$ 4,520
Note
6 — Leases
During
the six months ended June 30, 2024, the Company entered into additional lease agreements that have commenced and are classified as operating
leases, including in June 2024, Lucid exercised a renewal option to extend the lease term on its central laboratory in California for
an additional three years through December 31, 2027. The aggregate (undiscounted) rent payments are approximately $ 2.6 million over the
extended lease term .
The
Company’s future lease payments as of June 30, 2024, which are presented as operating lease liabilities, current portion and operating
lease liabilities, less current portion on the Company’s unaudited condensed consolidated balance sheets are as follows:
Schedule
of Future Minimum Lease Payments for Operating Leases
2024
(remainder of year)
$ 909
2025
1,724
2026
1,677
2027
1,507
2028
472
Thereafter
848
Total
lease payments
$ 7,137
Less:
imputed interest
( 1,103 )
Present
value of lease liabilities
$ 6,034
12
Note
6 — Leases - continued
Supplemental
disclosure of cash flow information related to the Company’s cash and non-cash activities with its leases are as follows:
Schedule
of Supplemental Balance Sheet Information Related to Cash and Non-cash Activities with Leases
2024
2023
Six
Months Ended June 30,
2024
2023
Cash
paid for amounts included in the measurement of lease liabilities
Operating
cash flows from operating leases
$ 942
$ 705
Non-cash
investing and financing activities
Right-of-use
assets obtained in exchange for new operating lease liabilities
$ 2,285
$ 2,689
Weighted-average
remaining lease term - operating leases (in years)
4.40
4.75
Weighted-average
discount rate - operating leases
7.875 %
7.875 %
As
of June 30, 2024 and December 31, 2023, the Company’s right-of-use assets from operating leases were $ 5,771 and $ 4,267 , respectively,
which are reported in operating lease right-of-use assets in the unaudited condensed consolidated balance sheets. As of June 30, 2024
and December 31, 2023, the Company had outstanding operating lease obligations of $ 6,034 and $ 4,525 , respectively, of which $ 1,369 and
$ 1,565 , respectively, are reported in operating lease liabilities, current portion and $ 4,665 and $ 2,960 , 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.
Note
7 — 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, 2024
December
31, 2023
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
( 4,428 )
( 3,951 )
Intangible
Assets, net
$ 947
$ 1,424
Amortization
expense of the intangible assets discussed above was $ 105 and $ 505 for the three month periods ended June 30, 2024 and 2023, respectively,
and $ 477 and $ 1,010 for the six month periods ended June 30, 2024 and 2023, respectively, and is included in amortization of acquired
intangible assets in the accompanying unaudited condensed consolidated statements of operations. As of June 30, 2024, 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
2024
(remainder of year)
$ 210
2025
421
2026
316
Total
$ 947
Note
8 — 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.
13
Note
9 — 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, 2024
Senior
Secured Convertible Note - April 2022
$ —
$ —
$ 19,200
$ 19,200
Senior
Secured Convertible Note - September 2022
—
—
13,600
13,600
Lucid
Senior Secured Convertible Note - March 2023
—
—
11,200
11,200
Totals
$ —
$ —
$ 44,000
$ 44,000
Level-1
Inputs
Level-2
Inputs
Level-3
Inputs
Total
December
31, 2023
Senior
Secured Convertible Note - April 2022
$ —
$ —
$ 19,000
$ 19,000
Senior
Secured Convertible Note - September 2022
—
—
11,250
11,250
Lucid
Senior Secured Convertible Note - March 2023
—
—
13,950
13,950
Totals
$ —
$ —
$ 44,200
$ 44,200
1 There were no transfers
between the respective Levels during the six months ended June 30, 2024.
As
discussed in Note 10, 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 10, 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.
14
Note
9 — Financial Instruments Fair Value Measurements - continued
The
estimated fair value of the April 2022 Senior Convertible Note, the September 2022 Senior Convertible Note and the Lucid March 2023 Senior
Convertible Note as of each of June 30, 2024 and December 31, 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, 2024
September
2022 Senior
Convertible Note:
June 30, 2024
Lucid
March 2023 Senior
Convertible Note:
June 30, 2024
Fair
Value
$ 19,200
$ 13,600
$ 11,200
Face
value principal payable
$ 17,602
$ 8,082
$ 9,811
Required
rate of return
10.000 %
9.700 %
10.00 %
Conversion
Price
$ 75.00
$ 75.00
$ 5.00
Value
of common stock
$ 0.82
$ 0.82
$ 0.82
Expected
term (years)
0.76
1.19
0.72
Volatility
160.00 %
160.00 %
60.00 %
Risk
free rate
5.07 %
4.90 %
5.09 %
Dividend
yield
— %
— %
— %
April
2022 Senior
Convertible Note:
December 31, 2023
September
2022 Senior
Convertible Note:
December 31, 2023
Lucid
March 2023 Senior
Convertible Note:
December 31, 2023
Fair
Value
$ 19,000
$ 11,250
$ 13,950
Face
value principal payable
$ 17,602
$ 9,062
$ 11,019
Required
rate of return
10.00 %
- 10.50 %
10.00 %
- 10.20 %
10.00 %
Conversion
Price
$ 75.00
$ 75.00
$ 5.00
Value
of common stock
$ 4.12
$ 4.12
$ 1.41
Expected
term (years)
0.26
- 1.26
0.69
- 1.69
1.22
Volatility
85.00 %
85.00 %
60.00 %
Risk
free rate
4.54 %
- 5.25 %
4.31 %
- 4.96 %
4.56 %
Dividend
yield
— %
— %
— %
The
estimated fair values recognized utilized PAVmed’s and Lucid’s 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, as compared to the floor price on conversions, 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.
15
Note
10 — 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, 2025
7.875 %
$ 75.00
$ 17,602
$ 19,200
September
2022 Senior Convertible Note
September
8, 2025
7.875 %
$ 75.00
8,082
13,600
Lucid
March 2023 Senior Convertible Note
March
21, 2025
7.875 %
$ 5.00
9,811
11,200
Balance
as of June 30, 2024
$ 35,495
$ 44,000
Contractual
Maturity Date
Stated
Interest Rate
Conversion
Price per Share
Face
Value Principal Outstanding
Fair
Value
April
2022 Senior Convertible Note
April
4, 2025
7.875 %
$ 75.00
$ 17,602
$ 19,000
September
2022 Senior Convertible Note
September
8, 2025
7.875 %
$ 75.00
9,062
11,250
Lucid
March 2023 Senior Convertible Note
March
21, 2025
7.875 %
$ 5.00
11,019
13,950
Balance
as of December 31, 2023
$ 37,683
$ 44,200
The
changes in the fair value of debt during the three and six month periods ended June 30, 2024 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 - March 31, 2024
$ 18,800
$ 13,600
$ 13,140
$ 45,540
$ —
Installment
repayments – common stock
—
( 700 )
( 1,125 )
( 1,825 )
—
Non-installment
payments – common stock
—
( 65 )
( 216 )
( 281 )
—
Change
in fair value
400
765
( 599 )
566
( 566 )
Fair
Value at June 30, 2024
$ 19,200
$ 13,600
$ 11,200
$ 44,000
-
Other
Income (Expense) - Change in fair value – three month period ended June 30, 2024
$ ( 566 )
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, 2023
$ 19,000
$ 11,250
$ 13,950
$ 44,200
$ —
Installment
repayments – common stock
—
( 980 )
( 1,208 )
( 2,188 )
—
Non-installment
payments – common stock
—
( 88 )
( 652 )
( 740 )
—
Change
in fair value
200
3,418
( 890 )
2,728
( 2,728 )
Fair
Value at June 30, 2024
$ 19,200
$ 13,600
$ 11,200
$ 44,000
-
Other
Income (Expense) - Change in fair value – six month period ended June 30, 2024
$ ( 2,728 )
16
Note
10 — Debt - continued
The
changes in the fair value of debt during the three and six month periods ended June 30, 2023 is as follows:
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 - March 31, 2023
$ 20,750
$ 11,650
$ 11,900
$ 44,300
$ —
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
-
Other
Income (Expense) - Change in fair value – three month period ended June 30, 2023
$ ( 340 )
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
$ —
Fair Value - Beginning of Period
$ 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
( 2,943 )
—
—
( 2,943 )
—
Non-installment
payments – common stock
( 208 )
—
—
( 208 )
—
Change
in fair value
681
200
( 290 )
591
( 591 )
Fair
Value at June 30, 2023
$ 19,530
$ 11,850
$ 11,610
$ 42,990
-
Fair Value - Ending of Period
$ 19,530
$ 11,850
$ 11,610
$ 42,990
-
Other
Income (Expense) - Change in fair value – six month period ended June 30, 2023
$ ( 1,380 )
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 $ 75.00 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 ,
which maturity date the investor agreed to extend by one year, to April 4, 2025 . 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 $ 75.00 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 , which maturity date the investor agreed to extend by one year, to September 8, 2025. The September 2022 Senior
Convertible Note may be converted into shares of common stock of the Company at the Holder’s election.
17
Note
10 — Debt - continued
The
Company has agreed to reduce temporarily, and the Investor has consented to reducing temporarily, the contractual conversion price under
the April 2022 Senior Convertible Note and the September 2022 Senior Convertible Note to equal to 82.5 % of the two lowest VWAPs during
the last 10 trading days preceding the date of conversion, subject to a conversion floor price of $ 0.40 , during the period from June
30, 2024 through September 3, 2024; provided that the aggregate amount of conversions under the April 2022 Senior Convertible Note and
the September 2022 Senior Convertible Note during such period may not exceed 1 million shares.
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% (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 December 1, 2023 through March 12, 2024, the Company was not in compliance with the Financial Tests. As of March
12, 2024, the Investor agreed to waive any such non-compliance during such time period and thereafter through August 31, 2024.
In
consideration of the covenant waiver and maturity extensions discussed above, the Company agreed to pay the holder of the notes $ 2,000
in cash (or in such other form as may be mutually agreed in writing). The covenant waiver and maturity extension fee was recognized as
debt modification expense on the Company’s unaudited condensed consolidated statement of operations, and currently included in
accrued expenses and other current liabilities on the Company’s unaudited condensed consolidated balance sheets as of June 30,
2024.
The
April 2022 Senior Convertible Note and September 2022 Senior Convertible Note installment payments may be made in shares of PAVmed common
stock at a conversion price that is the lower of the contractual conversion price and 82.5 % of the two lowest VWAPs during the last 10
trading days preceding the date of conversion, subject to a conversion price floor of $ 2.70 . The notes are also subject to certain provisions
that may require redemption upon the occurrence of certain events, including an event of default, a change of control, or certain equity
issuances.
In
the three and six month periods ended June 30, 2024, approximately $ 700
and $ 980 ,
respectively, of principal repayments along with approximately $ 65
and $ 88 ,
respectively, of interest expense thereon, were settled through the issuance of 461,963
and 574,424 ,
respectively, shares of common stock of the Company, with such shares having a fair value of approximately $ 805
and $ 1,113 ,
respectively, (with such fair value measured as the respective conversion date quoted closing price of the common stock of the Company).
In addition, during the three and six month periods ended June 30, 2024, the Company paid $ 209
and $ 407 ,
respectively, in cash related to acceleration floor payments on these notes related to the conversion price being below the floor price,
which is included in debt extinguishment loss on the Company’s unaudited condensed consolidated statements of operations. The conversions
and cash paid resulted in debt extinguishment losses of $ 249
and $ 452
in the three and six month periods ended June
30, 2024, respectively.
Lucid
Diagnostics - Senior Secured Convertible Note
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
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 was 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
month periods ended June 30, 2023, respectively.
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 is 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.
18
Note
10 — 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.
As of June 30, 2024, the Company was in compliance, and as of the date hereof, the Company is in compliance, with these financial covenants.
The
Lucid March 2023 Senior Convertible Note installment payments may be made in shares of Lucid Diagnostics common stock at a conversion
price that is the lower of the contractual conversion price and 82.5 % of the two lowest VWAPs during the last 10 trading days preceding
the date of conversion, subject to a conversion price floor of $ 0.30 . The notes are also subject to certain provisions that may require
redemption upon the occurrence of an event of default, a change of control, or certain equity issuances.
In
the three and six month periods ended June 30, 2024, approximately $ 1,125
and $ 1,208 ,
respectively, of principal repayments along with approximately $ 215
and $ 652 ,
respectively, of interest expense thereon, were settled through the issuance of 2,117,833
and 2,661,181 ,
respectively, shares of common stock of Lucid, with such shares having a fair value of approximately $ 1,854
and $ 2,541 ,
respectively, (with such fair value measured as the respective conversion date quoted closing price of the common stock of Lucid). The
conversions resulted in debt extinguishment losses of $ 512
and $ 681
in the three and six month periods ended June
30, 2024, respectively. Subsequent to June 30, 2024, as of August 8, 2024, approximately $ 375
of principal repayments along with approximately
$ 80
of interest expense thereon, was settled through
the issuance of 747,909
shares of common stock of Lucid, with such shares
having a fair value of approximately $ 619
(with such fair value measured as the respective
conversion date quoted closing price of the common stock of Lucid).
During
the three and six month periods ended June 30, 2024, the Company recognized debt extinguishment losses in total of approximately $ 763
and $ 1,132 , respectively, in connection with issuing common stock for principal repayments on convertible debt mentioned above. During
the three and six month periods ended June 30, 2023, the Company recognized debt extinguishment losses in total of approximately $ 743
and $ 1,268 , respectively.
See
Note 9, Financial Instruments Fair Value Measurements , for a further discussion of fair value assumptions.
Note
11 — 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 1,835,970 shares of common stock of PAVmed are reserved for issuance under the PAVmed 2014 Equity Plan, with 77,379 shares available
for grant as of June 30, 2024. The share reservation is not diminished by a total of 66,720 PAVmed Inc. stock options and restricted
stock awards granted outside the PAVmed 2014 Equity Plan as of June 30, 2024. In January 2024, the number of shares available for grant
was increased by 432,452 in accordance with the evergreen provisions of the plan.
19
Note
11 — Stock-Based Compensation - continued
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, 2023
1,192,458
$ 26.18
7.3
$ —
Granted (1)
79,500
$ 2.28
Exercised
—
$ —
Forfeited
( 36,909 )
$ 12.25
Outstanding
stock options at June 30, 2024 (3)
1,235,049
$ 25.06
6.8
$ —
Vested
and exercisable stock options at June 30, 2024
850,180
$ 32.88
5.9
$ —
(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, 2024 and December
31, 2023 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 60,054 stock options granted outside the PAVmed 2014 Equity
Plan, as of June 30, 2024 and December 31, 2023.
On
February 22, 2024, the Company granted 59,500 stock options under the PAVmed Inc 2014 Equity Plan with a weighted average exercise price
of $ 1.85 . Each such option will vest one-third after one year then ratably over the next eight quarters. In addition, on February 22,
2024, a total of 390,000 restricted stock awards were granted to the Board of Directors under the PAVmed 2014 Equity Plan, with such
restricted stock awards having an aggregate fair value of approximately $ 0.7 million, which was measured using the respective grant date
quoted closing price per share of PAVmed Inc. common stock, with the fair value recognized as stock-based compensation expense ratably
on a straight-line basis over the vesting period, which is commensurate with the service period. The vesting of the restricted stock
awards vest ratably on an annual basis over a three year period with the initial annual vesting date of November 30, 2024. The restricted
stock awards are subject to forfeiture if the requisite service period is not completed.
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, 2023
70,527
$ 38.77
Granted
390,000
1.85
Vested
( 4,064 )
5.79
Forfeited
—
—
Unvested
restricted stock awards as of June 30, 2024
456,463
$ 7.45
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 14,324,038 shares of common stock of Lucid Diagnostics are reserved for issuance under the Lucid Diagnostics 2018 Equity Plan,
with 768,595 shares available for grant as of June 30, 2024. The share reservation is not diminished by a total of 523,300 stock options
and 50,000 restricted stock awards granted outside the Lucid Diagnostics 2018 Equity Plan, as of June 30, 2024. In January 2024, the
number of shares available for grant was increased by 2,680,038 in accordance with the evergreen provisions of the plan.
20
Note
11 — Stock-Based Compensation - continued
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, 2023
5,504,383
$ 2.00
8.5
$ 765
Granted (1)
3,519,000
$ 1.23
Exercised
( 3,333 )
$ 1.31
Forfeited
( 275,424 )
$ 1.63
Outstanding
stock options at June 30, 2024 (3)
8,744,626
$ 1.70
8.6
$ 199
Vested
and exercisable stock options at June 30, 2024
3,082,590
$ 2.26
7.3
$ 199
(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,
2024 and December 31, 2023 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 523,300 stock options granted outside the Lucid Diagnostics
2018 Equity Plan, as of June 30, 2024 and December 31, 2023.
On
February 22, 2024 ,
Lucid granted 2,895,000 stock options under the Lucid Diagnostics Inc 2018 Equity
Plan with a weighted average exercise price of $ 1.25 . Each option will vest
one-third after one year then ratably over the next eight quarters.
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, 2023
2,337,440
$ 8.99
Granted
1,600,000
1.03
Vested
( 26,912 )
4.56
Forfeited
( 13,088 )
4.56
Unvested
restricted stock awards as of June 30, 2024
3,897,440
$ 5.77
In
May 2024, a total of 1,600,000 restricted stock awards were granted to management under the Lucid Diagnostics 2018 Equity Plan, with
such restricted stock awards having an aggregate fair value of approximately $ 1.5 million, which was measured using the respective grant
date quoted closing price per share of Lucid Diagnostics Inc. common stock, with the fair value recognized as stock-based compensation
expense ratably on a straight-line basis over the vesting period, which is commensurate with the service period. The vesting of the restricted
stock awards vest on a single vest date of May 20, 2026. The restricted stock awards are subject to forfeiture if the requisite service
period is not completed.
Consolidated
Stock-Based Compensation Expense
The
consolidated stock-based compensation expense recognized by each of PAVmed 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
2024
2023
2024
2023
Three
Months Ended
June
30,
Six
Months Ended
June
30,
2024
2023
2024
2023
Cost
of revenue
$ 44
$ 31
$ 80
$ 54
Sales
and marketing expenses
387
455
790
899
General
and administrative expenses
1,214
1,674
2,292
5,262
Research
and development expenses
259
347
624
711
Total
stock-based compensation expense
$ 1,904
$ 2,507
$ 3,786
$ 6,926
21
Note
11 — Stock-Based Compensation - continued
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 Amended CWRU License Agreement; 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
2024
2023
2024
2023
Three
Months Ended
June
30,
Six
Months Ended
June
30,
2024
2023
2024
2023
Lucid
Diagnostics 2018 Equity Plan – cost of revenue
$ 33
$ 16
$ 58
$ 28
Lucid
Diagnostics 2018 Equity Plan – sales and marketing
326
247
597
470
Lucid
Diagnostics 2018 Equity Plan – general and administrative
609
836
937
3,348
Lucid
Diagnostics 2018 Equity Plan – research and development
138
66
258
136
PAVmed
2014 Equity Plan - cost of revenue
11
9
22
16
PAVmed
2014 Equity Plan - sales and marketing
39
120
118
253
PAVmed
2014 Equity Plan - general and administrative
1
8
4
164
PAVmed
2014 Equity Plan - research and development
44
97
141
192
Total
stock-based compensation expense – recognized by Lucid Diagnostics
$ 1,201
$ 1,399
$ 2,135
$ 4,607
Total
stock-based compensation expense
$ 1,201
$ 1,399
$ 2,135
$ 4,607
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
$ 2,103
1.7
Restricted
Stock Awards
$ 660
2.4
Lucid
Diagnostics 2018 Equity Plan
Stock
Options
$ 4,665
2.1
Restricted
Stock Awards
$ 2,305
1.8
22
Note
11 — Stock-Based Compensation - continued
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 $ 1.47 per share and $ 5.25 per share during the six month periods ended June 30, 2024 and
2023, 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,
2024
2023
Expected
term of stock options (in years)
5.8
5.7
Expected
stock price volatility
90 %
88 %
Risk
free interest rate
4.3 %
3.7 %
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 $ 0.80 per share and $ 0.87 per share during the six month periods ended June 30,
2024 and 2023, 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,
2024
2023
Expected
term of stock options (in years)
5.7
5.6
Expected
stock price volatility
74 %
75 %
Risk
free interest rate
4.4 %
3.7 %
Expected
dividend yield
— %
— %
PAVmed
Inc. Employee Stock Purchase Plan (“PAVmed ESPP”)
A
total of 34,332 shares and 38,216 shares of common stock of the Company were purchased for proceeds of approximately $ 62 and $ 182 , on
March 31, 2024 and 2023, respectively, under the PAVmed ESPP. The March 31, 2023 purchase was partially settled through the redeployment
of 12,590 shares of treasury stock. The PAVmed ESPP has a total reserve of 300,001 shares of common stock of PAVmed of which 139,863
shares are available for issue as of June 30, 2024. In January 2024, the number of shares available-for-issue was increased by 166,667
in accordance with the evergreen provisions of the plan.
Lucid
Diagnostics Inc. Employee Stock Purchase Plan (“Lucid ESPP”)
A
total of 511,884 shares and 231,987 shares of common stock of Lucid Diagnostics were purchased for proceeds of approximately $ 353 and
$ 276 on March 31, 2024 and 2023, respectively, under the Lucid ESPP. The Lucid ESPP has a total reserve of 1,500,000 shares of common
stock of Lucid Diagnostics of which 395,886 shares are available for issue as of June 30, 2024. In January 2024, the Lucid board authorized
an increase in the number of shares available for issue by 500,000 .
23
Note
12 — Preferred Stock
As
of June 30, 2024 and December 31, 2023, there were 1,357,976 and 1,305,213 shares of PAVmed Series B Convertible Preferred Stock, classified
in permanent equity, issued and outstanding, respectively.
PAVmed
Series B Convertible Preferred Stock Dividends
The
Series B Convertible Preferred Stock is issued pursuant to the PAVmed Inc. Certificate of Designation of Preferences, Rights, and Limitations
of Series B Convertible Preferred Stock (“Series B Convertible Preferred Stock Certificate of Designation”), has a par value
of $ 0.001 per share, no voting rights, a stated value of $ 3.00 per share, and was immediately convertible upon its issuance. At the holders’
election, fifteen shares of Series B Convertible Preferred Stock are currently convertible into one share of common stock of the Company,
subject to further adjustment for the effect of future stock dividends, stock splits or similar events affecting the Company’s
common stock. The Series B Convertible Preferred Stock shall not be redeemed for cash and under no circumstances shall the Company be
required to net cash settle the Series B Convertible Preferred Stock.
The
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.
PAVmed
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 $ 81 and $ 161 of such dividends earned in the three and six month periods ended June 30, 2024, respectively;
and $ 75 and $ 149 of such dividends earned in the three and six month periods ended June 30, 2023, respectively.
PAVmed
Series B Convertible Preferred Stock Dividends Declared
During
the six months ended June 30, 2024, the Company’s board of directors declared an aggregate of approximately $ 158 of Series B Convertible
Preferred Stock dividends, inclusive of $ 78 earned as of December 31, 2023; and $ 80 earned as of March 31, 2024, with such dividends
settled by the issue of an aggregate 52,763 additional shares of Series B Convertible Preferred Stock, inclusive of 26,123 shares issued
with respect to the dividends earned as of December 31, 2023; and 26,640 shares issued with respect to the dividends earned as of March
31, 2024.
During
the six months ended June 30, 2023, the Company’s board of directors declared an aggregate of approximately $ 146 of Series B Convertible
Preferred Stock dividends, 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.
Subsequent
to June 30, 2024, in August 2024, the Company’s board of directors declared a PAVmed Series B Convertible Preferred Stock dividend,
earned as of June 30, 2024, of $ 81 , to be settled by the issue of 27,173 additional shares of Series B Convertible Preferred Stock.
The
PAVmed 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
unaudited 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
13 — Common Stock and Common Stock Purchase Warrants
Common
Stock
In
February 2023, the Company distributed a proxy statement for a special meeting of shareholders that was held on March 31, 2023 (the “Special
Meeting”), at which the Company sought approval of an amendment to the Company’s Certificate of Incorporation, to effect,
(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. On March 31, 2023, the shareholders
approved the above 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. On November 28, 2023 the Company’s board of directors, unanimously authorized management to effect
the reverse split at the ratio of 1-for-15 . The reverse stock split became effective on December 7, 2023. At the effective date, every
15 shares of the Company’s common stock that were issued and outstanding were automatically combined into one issued and outstanding
share, without any change in par value of such shares. No fractional shares were issued in connection with the reverse stock split. Instead,
each fractional share remaining after completion of the reverse stock split that was less than a whole share was rounded up to one whole
share. The reverse stock split also correspondingly affected all outstanding PAVmed equity awards and outstanding convertible securities.
On March 7, 2024, the Company
received a notice from the Nasdaq Listing Qualifications Department stating that, for the preceding 30 consecutive business days (through
March 6, 2024), the market value of the Company’s listed securities (“MVLS”) had been below the minimum of $35 million
required for continued inclusion on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(2). The notification letter stated that
the Company would be afforded 180 calendar days (until September 3, 2024) to regain compliance. In order to regain compliance, the Company’s
MVLS must close at $35 million or more for a minimum of ten consecutive business days. The notification letter also states that in the
event the Company does not regain compliance prior to the expiration of the 180-day period, the Company will receive written notification
that its securities are subject to delisting. The Nasdaq notification has no effect at this time on the listing of the Company’s
common stock or Series Z warrants, and the stock and warrants will continue to trade uninterrupted under the symbol “PAVM”
and “PAVMZ”, respectively. Moreover, the Company is actively pursuing strategies that it believes will allow it to regain
compliance with the listing requirements, although there can be no assurance that those strategies will be successful.
During
the six months ended June 30, 2024 a total of 34,332 shares of common stock of the Company were issued under the PAVmed ESPP. See Note
11, 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, 2024, 574,424 shares of the Company’s common stock were issued upon conversion, at the election of
the holder, of the April 2022 Senior Convertible Note and the September 2022 Senior Convertible Note, for $ 980 face value principal repayments,
as discussed in Note 10, Debt .
In
the six months ended June 30, 2024, the Company sold 333,299
shares through their at-the-market equity facility
for net proceeds of approximately $ 693 ,
after payment of 3 %
commissions. Subsequent to June 30, 2024, as of August 8, 2024, the Company sold 288,067
shares through their at-market equity facility
for net proceeds of approximately $ 277
after payment of 3 %
commissions.
PAVmed
Distribution of Lucid Diagnostics Common Stock to Shareholders
On
February 15, 2024, the Company distributed by special dividend to the Company stockholders 3,331,747 shares of Lucid Diagnostics common
stock held by the Company. On such date, each PAVmed shareholder as of the January 15, 2024 record date received a stock dividend of
approximately 38 shares of Lucid common stock for every 100 shares of PAVmed common stock they held as of such date. The shares distributed
were approximately equal to the number of shares of common stock that Lucid issued to PAVmed on or about January 26, 2024 in satisfaction
of certain intercompany obligations due to Lucid from PAVmed.
The
Company’s distribution of Lucid common stock to PAVmed stockholders, constituted an “Extraordinary Dividend” as defined
in the Warrant Agreement. Accordingly, as a result of the distribution, pursuant to Section 4.3 of the Warrant Agreement, the Warrant
Price has been decreased by $ 0.52 (the fair market value of 0.37709668 of a share of Lucid Diagnostics’ common stock on the distribution
date) to $ 23.48 per share.
Common
Stock Purchase Warrants
As
of June 30, 2024 and December 31, 2023, Series Z Warrants outstanding totaled 11,937,450 representing the right to purchase 795,830 shares
of the Company’s common stock. The Series Z Warrants are now exercisable to purchase one whole share of common stock of the Company
at an exercise price of $ 23.48 ($ 24.00 post reverse-split, decreased by $ 0.52 due to distribution of Lucid common stock to PAVmed stockholders,
discussed further above). There were no Series Z Warrants exercised during the six months ended June 30, 2024.
25
Note
14 — 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, 2024
NCI
– equity - December 31, 2023
$ 29,813
Net
loss attributable to NCI
( 7,387 )
Impact
of subsidiary equity transactions
( 2,169 )
Lucid
Diagnostics proceeds from issuance of preferred stock Series A-1
5,670
Lucid
Diagnostics exchange of preferred stock Series A and Series A-1
( 24,294 )
Lucid
Diagnostics proceeds from issuance of preferred stock Series B and Series B-1
55,919
Lucid
Diagnostics deemed dividend on preferred stock
( 7,496 )
Lucid Diagnostics issuance of common stock for settlement of vendor service agreement
401
Lucid
Diagnostics 2018 Equity Plan stock option exercise
4
Lucid
Diagnostics Employee Stock Purchase Plan Purchase
353
Conversion
of Lucid Diagnostics common stock for Senior Secured Convertible Debt
2,541
Stock-based
compensation expense - Lucid Diagnostics 2018 Equity Plan
1,850
Stock-based
compensation expense - Veris Health 2021 Equity Plan
98
NCI
– equity - June 30, 2024
$ 55,303
The
consolidated NCI presented above is with respect to the Company’s consolidated subsidiaries as a component of consolidated total
stockholders’ equity as of June 30, 2024 and December 31, 2023; 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 subsidiaries.
Lucid
Diagnostics
As
of June 30, 2024, there were 49,344,945 shares of common stock of Lucid Diagnostics issued and outstanding, of which, PAVmed held 31,302,444
shares. PAVmed has a controlling financial interest through its majority voting interest by means of ownership and an irrevocable proxy
in Lucid Diagnostics, and accordingly, Lucid Diagnostics is a consolidated subsidiary of PAVmed.
On
January 26, 2024 PAVmed elected to receive payment of $ 4,675 of fees and reimbursements due from Lucid, through the issuance of 3,331,771
shares of Lucid Diagnostics common stock. On February 15, 2024, the Company distributed by special dividend to the Company stockholders,
as of the record date noted above, 3,331,747 shares of Lucid Diagnostics common stock held by the Company.
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.
On
March 13, 2024, Lucid issued an additional 5,670 shares of Lucid Series A-1 Preferred Stock, for aggregate gross proceeds of $ 5.67 million.
On
March 13, 2024, Lucid issued 44,285 shares of newly designated Lucid Series B Convertible Preferred Stock (the “Lucid Series B
Preferred Stock”). The terms of the Lucid Series B Preferred Stock are substantially identical to the terms of the Lucid Series
A Preferred Stock and the Lucid Series A-1 Preferred Stock, except that the Lucid Series B Preferred Stock has a conversion price of
$ 1.2444 , and the holders of the Lucid Series B Preferred Stock vote with the common stock on an as-converted basis (subject to any applicable
ownership limitations). On the same day, Lucid issued an additional 5,670 shares of Lucid Series A-1 Preferred Stock, for aggregate gross
proceeds of $ 5.67 million (all of which shares were immediately exchanged for shares of Lucid Series B Preferred Stock). The aggregate
gross proceeds from the sale of shares in such offering were $ 18.1 million.
As
a result of 100 % of the then-outstanding shares of Lucid Series A Preferred Stock and Lucid Series A-1 Preferred Stock being exchanged
for shares of Lucid Series B Preferred Stock in the Lucid Series B Offering and Exchange, no shares of Lucid Series A Preferred Stock
or Lucid Series A-1 Preferred Stock remain outstanding.
26
Note
14 — Noncontrolling Interest - continued
On
May 6, 2024, Lucid issued approximately 11,634 shares of newly designated Lucid Series B-1 Convertible Preferred Stock (the “Lucid
Series B-1 Preferred Stock”). The terms of the Lucid Series B-1 Preferred Stock are substantially identical to the terms of the
Lucid Series B Preferred Stock, except that the Lucid Series B-1 Preferred Stock has a conversion price of $ 0.7228 . The aggregate gross
proceeds from the sale of shares in such offering were $ 11.6 million.
Deemed
Dividend on Series A and Series A-1 Convertible Preferred Stock Exchange Offer
The
fair value of the consideration given in the form of the issue of 44,285 shares of Series B Convertible Preferred Stock, with such fair
value recognized as the carrying value of such issued shares of Series B Convertible Preferred Stock, as compared to both the newly issued
Series B Convertible Preferred Stock (fair value of $ 12,495 ) and the carrying value of the extinguished Series A and Series A-1 Convertible
Preferred Stock (carrying value of $ 24,294 ), resulting in an excess of fair value of $ 7.5 million recognized as a deemed dividend charged
to accumulated deficit in the unaudited condensed consolidated balance sheet on March 13, 2024, with such deemed dividend included as
a component of net loss attributable to common stockholders, summarized as follows:
Schedule
of Net Loss Attributable to Common Stockholders
Series
B Convertible Preferred Stock Issuance and Series A/A-1 Exchange Offer
March
13, 2024
Fair
Value - 44,285 shares of Series B Preferred Stock issued
$ 44,285
Less:
Fair value related to newly issued Series B Preferred Stock (of 12,495 shares)
( 12,495 )
Less:
Carrying value related to Series A and Series A-1 Preferred Stock Exchanged for Series B Preferred Stock (of 24,295 shares)
( 24,294 )
Deemed
Dividend Charged to Accumulated Deficit
$ 7,496
Note
15 — 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
2024
2023
2024
2023
Three Months Ended
June 30,
Six Months Ended
June 30,
2024
2023
2024
2023
Numerator
Net loss - before noncontrolling interest
$ ( 14,914 )
$ ( 17,892 )
$ ( 33,426 )
$ ( 40,106 )
Net loss attributable to noncontrolling interest
4,087
3,355
7,387
7,638
Net loss - as reported, attributable to PAVmed Inc.
$ ( 10,827 )
$ ( 14,537 )
$ ( 26,039 )
$ ( 32,468 )
Series B Convertible Preferred Stock dividends – earned
$ ( 81 )
$ ( 75 )
$ ( 161 )
$ ( 149 )
Deemed dividend on Subsidiary Preferred Stock attributable to the noncontrolling interests
$ —
$ —
$ ( 7,496 )
$ —
Net loss attributable to PAVmed Inc. common stockholders
$ ( 10,908 )
$ ( 14,612 )
$ ( 33,696 )
$ ( 32,617 )
Denominator
Weighted average common shares outstanding, basic and diluted
9,152,819
6,956,655
8,923,862
6,716,169
Net loss per share (1)
Basic and diluted
Net loss attributable to PAVmed Inc. common stockholders
$ ( 1.19 )
$ ( 2.10 )
$ ( 3.78 )
$ ( 4.86 )
(1) - Convertible Preferred
Stock would potentially be considered a participating security under the two-class method of calculating net loss per share. However,
the Company has incurred net losses to-date, and as such holders are not contractually obligated to share in the losses, there is no
impact on the Company’s net loss per share calculation for the periods indicated.
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 years 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.
27
Note
15 — Net Loss Per Share - continued
Basic
weighted-average number of shares of common stock outstanding for the six month periods ended June 30, 2024 and 2023 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 years 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
2024
2023
June
30,
2024
2023
Stock
options and restricted stock awards
1,691,512
1,263,715
Series
Z Warrants
795,830
795,830
Series
B Convertible Preferred Stock
90,532
83,634
Total
2,577,874
2,143,179
The
total stock options and restricted stock awards are inclusive of 60,054 and 33,391 stock options as of June 30, 2024 and 2023, respectively,
granted outside the PAVmed 2014 Equity Plan.
28
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The
following discussion and analysis of our unaudited condensed consolidated financial condition and results of operations should be read
together with our Annual Report on Form 10-K for the year ended December 31, 2023 (the “Form 10-K”), as filed with the Securities
and Exchange Commission (the “SEC”).
Unless
the context otherwise requires, (i) “we”, “us”, and “our”, and the “Company” and “PAVmed”
refer to PAVmed Inc. and its subsidiaries, including its subsidiary Lucid Diagnostics Inc. (“Lucid Diagnostics” or “Lucid”)
and its majority-owned subsidiary Veris Health Inc. (“Veris Health” or “Veris”), (ii) “FDA” refers
to the Food and Drug Administration, (iii) “510(k)” refers to a premarket notification, submitted to the FDA by a manufacturer
pursuant to § 510(k) of the Food, Drug and Cosmetic Act and 21 CFR § 807 subpart E, (iv) “CLIA” refers to the Clinical
Laboratory Improvement Amendments of 1988 and associated regulations set forth in 42 CFR § 493, and (v) “LDT” refers
to a diagnostic test, defined by the FDA as “an IVD that is intended for clinical use and designed, manufactured and used within
a single laboratory,” which is generally subject only to self-certification of analytical validity under the CMS CLIA program.
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
risk that the FDA will cease to exercise enforcement discretion with respect to LDTs, like EsoGuard;
●
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 results, plans, and/or objectives disclosed in our forward-looking statements, and the intended or expected
developments and/or other events disclosed in our forward-looking statements may not actually occur, and accordingly 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.
29
Overview
PAVmed
is structured to be a multi-product life sciences company organized to advance a pipeline of innovative healthcare technologies. Led
by a team of highly skilled personnel with a track record of bringing innovative products to market, PAVmed is focused on innovating,
developing, acquiring, and commercializing novel products that target unmet needs with large addressable market opportunities. Leveraging
our corporate structure—a parent company that will establish distinct subsidiaries for each financed asset—we have the flexibility
to raise capital at the PAVmed level to fund product development, or to structure financing directly into each subsidiary in a manner
tailored to the applicable product, the latter of which is our current strategy given prevailing market conditions.
Our
current focus is multi-fold. We continue to pursue commercial expansion and execution of EsoGuard, which is the flagship product of our
subsidiary, Lucid Diagnostics (Nasdaq: LUCD). In addition, through a separate
majority-owned subsidiary, Veris Health, we are focused on entering into strategic
partnership opportunities with leading academic oncology systems to expand access to the Veris Platform. In terms of other existing products
and technologies, we have created an incubator-type platform where we are looking to obtain financing on a product-by-product basis as
necessary to advance each asset to a meaningful inflection point along its path to commercialization. Finally, as resources permit, we
will continue to explore external innovations that fulfill our project selection criteria without limiting ourselves to any target sector,
specialty or condition.
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 Platform, which are currently our two leading products.
Recent
Developments
Business
PAVmed
Distribution of Lucid Diagnostics Common Stock to Shareholders
On
February 15, 2024, the Company distributed by special dividend to the Company stockholders 3,331,747 shares of Lucid Diagnostics common
stock held by the Company. On such date, each PAVmed shareholder as of the January 15, 2024 record date received a stock dividend of
approximately 38 shares of Lucid common stock for every 100 shares of PAVmed common stock they held as of such date. The shares distributed
were approximately equal to the number of shares of common stock that Lucid issued to PAVmed on or about January 26, 2024 in satisfaction
of certain intercompany obligations due to Lucid from PAVmed, as discussed above.
This
distribution constituted an “Extraordinary Dividend” as defined in the warrant agreement that governs the Company’s
Series Z Warrants. As a result, pursuant to the warrant agreement, the exercise price under the Series Z Warrants per full share of PAVmed
common stock was automatically decreased by $0.52 (the fair market value of 0.37709668 of a share of Lucid Diagnostics’ common
stock as of the date of the distribution) to $23.48 per share.
Management
Services Agreement/Payroll Benefits and Expense Reimbursement Agreement with Lucid Diagnostics
On
August 6, 2024, Lucid and the Company entered into a ninth amendment to the management services agreement between Lucid and PAVmed
(“MSA”) to increase the monthly fee thereunder from $0.83 million per month to $1.05 million per month, effective as of July
1, 2024.
On
March 22, 2024, PAVmed and Lucid entered into an eighth amendment to MSA to increase the monthly fee thereunder from $0.75 million per
month to $0.83 million per month, effective as of January 1, 2024. The amendment also reset the maximum number of shares issuable under
the agreement to 19.99% of the shares outstanding as of the date of the amendment.
On
January 26, 2024, in accordance with the MSA and the payroll, benefits and expense reimbursement agreement between PAVmed and Lucid (“PBERA”),
PAVmed elected to receive payment of approximately $4.7 million of fees and reimbursements accrued under the MSA and the PBERA through
the issuance of 3,331,771 shares of Lucid’s common stock.
Nasdaq
Notice
On
March 7, 2024, the Company received a notice from the Nasdaq Listing Qualifications Department stating that, for the preceding 30 consecutive
business days (through March 6, 2024), the market value of the Company’s listed securities (“MVLS”) had been below
the minimum of $35 million required for continued inclusion on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(2). The notification
letter stated that the Company would be afforded 180 calendar days (until September 3, 2024) to regain compliance. In order to regain
compliance, the Company’s MVLS must close at $35 million or more for a minimum of ten consecutive business days. The notification
letter also states that in the event the Company does not regain compliance prior to the expiration of the 180-day period, the Company
will receive written notification that its securities are subject to delisting. The Nasdaq notification has no effect at this time on
the listing of the Company’s common stock or Series Z warrants, and the stock and warrants will continue to trade uninterrupted
under the symbol “PAVM” and “PAVMZ”, respectively. Moreover, the Company is actively pursuing strategies that
it believes will allow it to regain compliance with the listing requirements, although there can be no assurance that those strategies
will be successful.
30
Business
- continued
Incubator
Program
On
March 21, 2024, the Company announced that it has launched a wholly owned incubator, PMX, to complete development and commercialization
of existing portfolio technologies, including PortIO, EsoCure and CarpX. PMX and Hatch Medical, L.L.C. (“Hatch Medical”),
a medical device incubator and technology brokerage firm, have executed a joint venture agreement to advance the technologies.
Pursuant
to the joint venture agreement, PAVmed will assign PortIO, EsoCure and CarpX to its wholly owned incubator, PMX. Starting with PortIO,
the Company will seek to independently finance a separate subsidiary of the incubator to develop and commercialize each technology. Hatch
Medical will provide strategic advisory and brokerage services to the subsidiary to advance the technology through key milestones and,
subsequently, seek to engage a strategic partner to acquire, license or distribute the commercial product.
Veris
Cancer Care Platform
On
June 13, 2024, we announced that Veris and a National Cancer Institute-Designated Comprehensive Cancer Center launched a pilot program
and has enrolled the first patients from such center in such program on the Veris Cancer Care Platform.
FDA
Enforcement Discretion
In
April 2024, FDA published the final rule under which FDA intends to phase out its general enforcement discretion approach for LDTs so
that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs (the proposed rule was
published in October 2023). In the final rule, FDA has expanded the categories of LDTs that will be eligible for continued enforcement
discretion, which include LDTs first marketed prior to May 6, 2024 and LDTs approved by New York State’s Clinical Laboratory Evaluation
Program (NYS CLEP). As EsoGuard was marketed prior to the May 6, 2024, and is also NYS CLEP-approved, EsoGuard remains under continued
enforcement discretion from FDA’s premarket review requirements and quality systems requirements (except for record-keeping). As
such, there is no immediate impact from the final rule on EsoGuard’s regulatory strategy.
Financing
Extension
of Senior Convertible Notes
Effective
as of March 12, 2024, the Company entered into an amendment and waiver (the “Note Amendment and Waiver”) with the holder
of the April 2022 Senior Convertible Note and the September 2022 Senior Convertible Note (each as defined in “ Liquidity and
Capital Resources ” below). Pursuant to the Note Amendment and Waiver, the maturity date of the April 2022 Senior
Convertible Note was extended to April 4, 2025 and the maturity date of the September 2022 Senior Convertible Note was extended to
September 8, 2025, in each case subject to further extension in certain circumstances. The holder of the such note also waived, for
the period commencing on December 1, 2023 and ending on August 31, 2024, the financial covenant contained in such notes requiring
that the ratio of (a) the outstanding principal amount of the notes, 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, not exceed 30%, and that the
Company’s market capitalization not be less than $75 million. In consideration of the Note Amendment and Waiver, the Company
agreed to pay the holder of the notes $2.0 million in cash (or in such other form as may be mutually agreed in writing), which
currently is included in accrued expenses and other current liabilities on the Company’s unaudited condensed consolidated
balance sheets as of June 30, 2024.
See
our accompanying unaudited condensed consolidated financial statements Note 10, Debt , for further discussion of the senior convertible
notes.
31
Financing
- continued
Lucid
Diagnostics - Preferred Stock Offerings
On
March 13, 2024, Lucid entered into subscription agreements (each, a “Lucid Series B Subscription Agreement”) and
exchange agreements (each, a “Lucid Series B Exchange Agreement”) with certain accredited investors (collectively, the
“Lucid Series B Investors”), which agreements provided for (i) the sale to the Lucid Series B Investors of 12,495 shares
of Lucid’s newly designated Series B Convertible Preferred Stock, par value $0.001 per share (the “Lucid Series B
Preferred Stock”), at a purchase price of $1,000 per share, and (ii) the exchange by the Lucid Series B Investors of 13,625
shares of Lucid’s Series A Convertible Preferred Stock, par value $0.001 per share (the “Lucid Series A Preferred
Stock”), and 10,670 shares of Lucid’s Series A-1 Convertible Preferred Stock, par value $0.001 per share (the
“Lucid Series A-1 Preferred Stock”), held by them for 31,790 shares of Lucid Series B Preferred Stock (collectively, the
“Lucid Series B Offering and Exchange”). Prior to the execution of the Lucid Series B Subscription Agreements and the
Lucid Series B Exchange Agreements, Lucid entered into subscription agreements with certain of the Lucid Series B Investors
providing for the sale to such investors of 5,670 shares of Lucid Series A-1 Preferred Stock, at a purchase price of $1,000 per
share, which shares the investors immediately agreed to exchange for shares of Lucid Series B Preferred Stock pursuant to the Lucid
Series B Exchange Agreements (and are included in the 10,670 shares of Lucid Series A-1 Preferred Stock set forth above). Each share
of the Lucid Series B Preferred Stock has a stated value of $1,000 and a conversion price of $1.2444. The terms of the Lucid Series
B 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 B Preferred Stock is convertible, payable on the one-year and two-year
anniversary of the issuance date. The holders of the Lucid Series B Preferred Stock also will be entitled to dividends equal, on an
as-if-converted to shares of Lucid common stock basis, to and in the same form as dividends actually paid on shares of Lucid common
stock when, as, and if such dividends are paid on shares of Lucid common stock. The Lucid Series B Preferred Stock is a voting
security. The aggregate gross proceeds to Lucid of these transactions was $18.16 million (inclusive of $5.67 million of aggregate
gross proceeds from the sale of the Lucid Series A-1 Preferred Stock that was immediately exchanged for Lucid Series B Preferred
Stock in the transactions).
As
a result of 100% of the then-outstanding shares of Lucid Series A Preferred Stock and Lucid Series A-1 Preferred Stock being exchanged
for shares of Lucid Series B Preferred Stock in the Lucid Series B Offering and Exchange, no shares of Lucid Series A Preferred Stock
or Lucid Series A-1 Preferred Stock remain outstanding.
On
May 6, 2024, Lucid issued approximately 11,634 shares of newly designated Lucid Series B-1 Convertible Preferred Stock (the “Lucid
Series B-1 Preferred Stock”). The terms of the Lucid Series B-1 Preferred Stock are substantially identical to the terms of the
Lucid Series B Preferred Stock, except that the Lucid Series B-1 Preferred Stock has a conversion price of $0.7228. The aggregate gross
proceeds from the sale of shares in such offering were $11.6 million.
PAVmed
- 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 Fitzgerald & Co. (“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 $18 million of our common stock. In the
six month period ended June 30, 2024, the Company sold 333,299 shares through its at-the-market equity facility for net proceeds of approximately
$0.7 million, after payment of 3% commissions. As of June 30, 2024, the Company had approximately $15.3 million remaining under the PAVmed
ATM Facility. Subsequent to June 30, 2024, as of August 8, 2024, the Company sold 288,067 shares through their at-market equity
facility for net proceeds of approximately $0.3 million after payment of 3% commissions.
Lucid
Diagnostics - 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, 2024.
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. Cumulatively, a total
of 230,068 shares of Lucid Diagnostics’ common stock were issued through its at-the-market equity facility for net proceeds of
approximately $0.3 million, after payment of 3% commissions, as of June 30, 2024.
32
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.
Cost
of revenue
Cost
of revenues recognized from the delivery of patient EsoGuard test results includes costs related to EsoCheck device usage, shipment of
test collection kits, royalties and the cost of services to process tests and provide results to physicians. We incur expenses for tests
in the period in which the activities occur, therefore, gross margin as a percentage of revenue may vary from quarter to quarter due
to costs being incurred in one period that relate to revenues recognized in a later period.
We
expect that gross margin for our services will continue to fluctuate and be affected by EsoGuard test volume, our operating efficiencies,
patient compliance rates, payer mix, the levels of reimbursement, and payment patterns of payers and patients.
Sales
and marketing expenses
Sales
and marketing expenses consist primarily of salaries and related costs for employees engaged in sales, sales support 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 and insurance reimbursement coverage for our EsoGuard test
expands.
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, tax, audit and legal services, salaries and related costs for employees involved in third-party payor reimbursement
contract negotiations and consulting fees 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 to the extent our business operations grow. Furthermore,
we anticipate continued expenses related to being a public company, including fees and expenses for audit, legal, regulatory, tax-related
services, insurance premiums and investor relations costs associated with maintaining compliance as a public company.
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 development of our products, including:
●
consulting
costs for engineering design and development;
●
salary
and benefit costs associated with our medical research personnel 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
●
expenses
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.
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.
33
The
three months ended June 30, 2024 as compared to three months ended June 30, 2023
Revenue
In
the three months ended June 30, 2024, revenue was $1.0 million as compared to $0.2 million for the corresponding period in the prior
year. The $0.8 million increase principally relates to the increase in volume of our EsoGuard Esophageal DNA Tests performed in our own
CLIA laboratory for the period and the consideration received for the performance of the EsoGuard Esophageal DNA Tests.
Cost
of revenue
In
the three months ended June 30, 2024, cost of revenue remained relatively level, at approximately $1.7 million, as compared to the corresponding
period in the prior year.
Sales
and marketing expenses
In
the three months ended June 30, 2024, sales and marketing costs were approximately $4.2 million as compared to $4.3 million for the corresponding
period in the prior year. The net decrease of $0.1 million was principally related to:
●
approximately
$0.1 million decrease in third-party consulting services at Lucid.
General
and administrative expenses
In
the three months ended June 30, 2024, general and administrative costs were approximately $7.0 million as compared to $6.7 million for
the corresponding period in the prior year. The net increase of $0.3 million was principally related to:
●
approximately
$0.8 million increase in third-party professional fees and expenses related to investor relations and legal services; and
●
approximately
$0.5 million decrease in stock based compensation from RSA and stock option grants to Lucid and PAVmed employees.
Research
and development expenses
In
the three months ended June 30, 2024, research and development costs were approximately $1.6 million as compared to $3.5 million for
the corresponding period in the prior year. The net decrease of $1.9 million was principally related to:
●
approximately
$1.5 million decrease in development costs, particularly in clinical trial activities and outside professional and consulting fees;
and
●
approximately
$0.4 million decrease in compensation and stock based compensation from RSA and stock option grants to Lucid and PAVmed employees and
non-employees.
Amortization
of Acquired Intangible Assets
The
amortization of acquired intangible assets was approximately $0.1 million in the three months ended June 30, 2024, as compared to $0.5
million for the corresponding period in the prior year. The decrease of $0.4 million in the current period was due to certain acquired
intangible assets being fully amortized in February 2024.
34
Results
of Operations - continued
The
three months ended June 30, 2024 as compared to the three months ended June 30, 2023 - continued
Other
Income and Expense
Change
in fair value of convertible debt
In
the three months ended June 30, 2024, the change in the fair value of our convertible notes was approximately $0.6 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 (as defined in “ Liquidity and Capital Resources ” below). 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 each 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, 2024, a debt extinguishment loss in the aggregate of approximately $0.8 million was recognized in connection
with our April 2022 Senior Convertible Note, September 2022 Senior Convertible Note and the Lucid March 2023 Senior Convertible Note
as discussed below.
●
In
the three months ended June 30, 2024, approximately $0.7 million of principal repayments, along with less than $0.1 million of interest
expense thereon, were settled through the issuance of 461,963 shares of common stock of the Company, with such shares having a fair
value of approximately $0.8 million (with such fair value measured as the respective conversion date quoted closing price of the common
stock of the Company). In addition, the Company paid $0.2 million in cash related to acceleration floor payments on these notes related
to the conversion price being below the floor, recorded as debt extinguishment loss. The conversions and cash paid resulted in a debt
extinguishment loss of $0.3 million in the three months ended June 30, 2024.
●
In
the three months ended June 30, 2024, approximately $1.1 million of principal repayments along with approximately $0.2 million of interest
expense thereon, were settled through the issuance of 2,117,883 shares of Lucid common stock, with such shares having a fair value
of approximately $1.9 million (with such fair value measured as the quoted closing price of the common stock of Lucid on the respective
conversion date). The conversions resulted in a debt extinguishment loss of $0.5 million in the three months ended June 30, 2024.
In
comparison, 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 346,190 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.
See
Note 10 , 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.
35
Results
of Operations - continued
The
six months ended June 30, 2024 as compared to six months ended June 30, 2023
Revenue
In
the six months ended June 30, 2024, revenue was $2.0 million as compared to $0.6 million for the corresponding period in the prior year.
The $1.4 million increase principally relates to the revenue for our EsoGuard Esophageal DNA Test performed in our own CLIA laboratory
for the period and the consideration received for the performance of the EsoGuard Esophageal DNA Tests.
Cost
of revenue
In
the six months ended June 30, 2024, cost of revenue was approximately $3.4 million as compared to $3.0 million for the corresponding
period in the prior year. The $0.4 million increase was principally related to:
●
approximately
$0.2 million increase in the CLIA laboratory supplies required to perform the EsoGuard Esophageal DNA tests and royalty costs; and
●
approximately
$0.2 million increase in compensation related costs, including stock-based compensation.
Sales
and marketing expenses
In
the six months ended June 30, 2024, sales and marketing costs were approximately $8.6 million as compared to $8.9 million for the corresponding
period in the prior year. The net decrease of $0.3 million was principally related to:
●
approximately
$0.2 million decrease in compensation related costs, including stock-based compensation; and
●
approximately
$0.1 million decrease in third party sales and marketing costs.
General
and administrative expenses
In
the six months ended June 30, 2024, general and administrative costs were approximately $13.7 million as compared to $17.1 million for
the corresponding period in the prior year. The net decrease of $3.4 million was principally related to:
●
approximately
$3.0 million decrease in stock-based compensation, related to decreases at both PAVmed and Lucid;
●
approximately
$0.5 million decrease in third-party professional fees and expenses related to related to the termination of the MSA-RDx, finance and
legal services; and
●
approximately
$0.1 million increase in compensation related costs.
Research
and development expenses
In
the six months ended June 30, 2024, research and development costs were approximately $3.6 million as compared to $7.5 million for the
corresponding period in the prior year. The net decrease of $3.9 million was principally related to:
●
approximately
$3.0 million decrease in development costs, particularly in clinical trials activities and outside professional and consulting fees;
and
●
approximately
$0.9 million decrease in compensation related costs and stock-based compensation, related to employees at PAVmed and Lucid.
Amortization
of Acquired Intangible Assets
The
amortization of acquired intangible assets was approximately $0.5 million in the six months ended June 30, 2024, as compared to $1.0
million for the corresponding period in the prior year. The decrease of $0.5 million in the current period was due to certain acquired
intangible assets being fully amortized in February 2024.
36
Results
of Operations - continued
The
six months ended June 30, 2024 as compared to six months ended June 30, 2023 - continued
Other
Income and Expense
Change
in fair value of convertible debt
In
the six months ended June 30, 2024 and June 30, 2023, the change in the fair value of our convertible notes was approximately $2.7 million
and $1.4 million of expense, respectively, 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 each 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 Note, we recognized a total
of approximately $1.2 million of lender fees and offering costs. The Company did not incur lender fees and offering costs in the six
months ended June 30, 2024.
Loss
on Debt Extinguishment
In
the six months ended June 30, 2024, a debt extinguishment loss in the aggregate of approximately $1.1 million was recognized in connection
with our April 2022 Senior Convertible Note and September 2022 Senior Convertible Note as discussed below.
●
In
the six months ended June 30, 2024, approximately $1.0 million of principal repayments along with less than $0.1 million of interest
expense thereon, were settled through the issuance of 574,424 shares of common stock of the Company, with such shares having a fair
value of approximately $1.1 million (with such fair value measured as the quoted closing price of the common stock of the Company on
the respective conversion date). In addition, the Company paid $0.4 million in cash related to acceleration floor payments on these
notes related to the conversion price being below the floor, recorded as debt extinguishment loss. The conversions and cash paid resulted
in a debt extinguishment loss of $0.5 million in the six months ended June 30, 2024.
●
In
the six months ended June 30, 2024, approximately $1.2 million of principal repayments along with approximately $0.7 million of interest
expense thereon, were settled through the issuance of 2,661,181 shares of Lucid common stock, with such shares having a fair value
of approximately $2.5 million (with such fair value measured as the quoted closing price of the common stock of Lucid on the respective
conversion date). The conversions resulted in a debt extinguishment loss of $0.7 million in the six months ended June 30, 2024.
In
comparison, 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 634,899 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 quoted closing price of the common stock of the Company on
the respective conversion date). The conversions resulted in a debt extinguishment loss of $1.3 million in the six months ended June
30, 2023.
See
Note 10 , 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.
Deemed
Dividend on Series A and Series A-1 Convertible Preferred Stock Exchange Offer
The
fair value of the consideration given in the form of the issue of 44,285 shares of Lucid Series B Preferred Stock, with such fair value
recognized as the carrying value of such issued shares of Lucid Series B Preferred Stock, as compared to both the newly issued Lucid
Series B Preferred Stock (fair value of $12.5 million) and the carrying value of the extinguished Lucid Series A and Series A-1 Preferred
Stock (carrying value of $24.3 million), resulting in an excess of fair value of $7.5 million recognized as a deemed dividend charged
to accumulated deficit in the unaudited condensed consolidated balance sheet on March 13, 2024, with such deemed dividend included as
a component of net loss attributable to common stockholders, summarized as follows:
Series
B Convertible Preferred Stock Issuance and Series A/A-1 Exchange Offer
March
13, 2024
Fair
Value - 44,285 shares of Series B Preferred Stock issued
$ 44,285
Less:
Fair value related to newly issued Series B Preferred Stock (of 12,495 shares)
(12,495 )
Less:
Carrying value related to Series A and Series A-1 Preferred Stock Exchanged for Series B Preferred Stock (of 24,295 shares)
(24,294 )
Deemed
Dividend Charged to Accumulated Deficit
$ 7,496
37
Liquidity
and Capital Resources
Our
current financing strategy is to obtain capital directly into Lucid, Veris and other subsidiaries to fund any product development or
other related activities. 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 $33.4 million and
used approximately $24.8 million of cash in operations for the six months ended June 30, 2024. Financing activities provided $30.7 million
of cash during the six months ended June 30, 2024. We ended the quarter with cash on-hand of $25.5 million as of June 30, 2024. 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, including current obligations on the Company’s existing convertible debt which in accordance
with management’s plans may include conversions to equity and refinancing our existing debt obligations to extend the maturity
date. The Company’s ability to continue operations 12 months beyond the issuance of the financial statements will depend upon generating
substantial revenue that is conditioned on obtaining positive third-party reimbursement coverage for its EsoGuard Esophageal DNA Test
from both government and private health insurance providers, increasing revenue through contracting directly with self-insured employers,
and on its ability to raise additional capital through various potential sources including equity and/or debt financings or refinancing
existing debt obligations. These factors raise substantial doubt about the Company’s ability to continue as a going concern within
one year after the date the accompanying unaudited condensed consolidated financial statements are issued.
Issue
of Shares of Our Common Stock
During
the six months ended June 30, 2024
●
We
issued 34,332 shares of our common stock for proceeds of approximately $0.1 million under the PAVmed Employee Stock Purchase Plan (“ESPP”),
as such plan is discussed in Note 11, Stock-Based Compensation, to the Financial Statements.
●
We
issued 333,299 shares of our common stock for net proceeds of approximately $0.7 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 574,424 shares of our common stock in satisfaction of approximately $1.0 million of principal repayments along with less than
$0.1 million of interest expense thereon under the April 2022 Senior Convertible Note and September 2022 Senior Convertible Note.
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 a Securities Purchase Agreement (referred to as 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 April 2022 Senior Secured Convertible Note had an initial contractual maturity
date of April 4, 2024, which maturity date the investor agreed to extend by one year, to April 4, 2025. The April 2022 Senior Convertible
Note may be converted into or otherwise paid in shares of our common stock as described in Note 10, Debt .
On
September 8, 2022, we completed an additional closing under the SPA, in which we sold to the investor an additional Senior Secured Convertible
Note with a face value principal of $11.25 million (referred to as the “September 2022 Senior Convertible Note”). The September
2022 Senior Secured Convertible Note had an initial contractual maturity date of September 6, 2024, which maturity date the investor
agreed to extend by one year, to September 8, 2025. The September 2022 Senior Convertible Note may be converted into or otherwise paid
in shares of our common stock as described in Note 10, Debt .
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% (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 December 1, 2023 through March 12, 2024, the Company
was not in compliance with the Financial Tests. As of March 12, 2024, the investor agreed to waive any such non-compliance during such
time period and thereafter through August 31, 2024. Based on the waiver, as of June 30, 2024, the Company was in compliance with the
Financial Tests. In addition, based on the waiver, the Company presently is in compliance with the Financial Tests.
38
Liquidity
and Capital Resources - continued
In
consideration of the covenant waiver and maturity extensions discussed above, the Company agreed to pay the holder of the notes $2.0
million in cash (or in such other form as may be mutually agreed in writing).
See
Note 10 , 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 - Preferred Stock Offerings
On
March 13, 2024, Lucid entered into Lucid Series B Subscription Agreements and Lucid Series B Exchange Agreements with the Lucid Series
B Investors, which agreements provided for (i) the sale to the Lucid Series B Investors of 12,495 shares of newly designated Lucid Series
B Preferred Stock, at a purchase price of $1,000 per share, and (ii) the exchange by the Lucid Series B Investors of 13,625 shares of
Lucid Series A Preferred Stock, and 10,670 shares of Lucid Series A-1 Preferred Stock held by them for 31,790 shares of Lucid Series
B Preferred Stock. Prior to the execution of the Lucid Series B Subscription Agreements and the Lucid Series B Exchange Agreements, Lucid
entered into subscription agreements with certain of the Lucid Series B Investors providing for the sale to such investors of 5,670 shares
of Lucid Series A-1 Preferred Stock, at a purchase price of $1,000 per share, which shares the investors immediately agreed to exchange
for shares of Lucid Series B Preferred Stock pursuant to the Lucid Series B Exchange Agreements (and are included in the 10,670 shares
of Lucid Series A-1 Preferred Stock set forth above). Each share of the Lucid Series B Preferred Stock has a stated value of $1,000 and
a conversion price of $1.2444. The terms of the Lucid Series B 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 B Preferred Stock
is convertible, payable on the one-year and two-year anniversary of the issuance date. The holders of the Lucid Series B Preferred Stock
also will be entitled to dividends equal, on an as-if-converted to shares of Lucid common stock basis, to and in the same form as dividends
actually paid on shares of the Lucid common stock when, as, and if such dividends are paid on shares of the Lucid common stock. The Lucid
Series B Preferred Stock is a voting security. The aggregate gross proceeds to Lucid of these transactions was $18.16 million (inclusive
of $5.67 million of aggregate gross proceeds from the sale of the Lucid Series A-1 Preferred Stock that was immediately exchanged for
Lucid Series B Preferred Stock in the transactions).
As
a result of 100% of the then-outstanding shares of Lucid Series A Preferred Stock and Lucid Series A-1 Preferred Stock being exchanged
for shares of Lucid Series B Preferred Stock in the Lucid Series B Offering and Exchange, no shares of Lucid Series A Preferred Stock
or Lucid Series A-1 Preferred Stock remain outstanding.
On
May 6, 2024, Lucid issued approximately 11,634 shares of newly designated Lucid Series B-1 Preferred Stock. The terms of the Lucid Series
B-1 Preferred Stock are substantially identical to the terms of the Lucid Series B Preferred Stock, except that the Lucid Series B-1
Preferred Stock has a conversion price of $0.7228. The aggregate gross proceeds from the sale of shares in such offering were $11.6 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 a Securities Purchase Agreement (referred to as the “Lucid SPA”)
with an accredited institutional investor, pursuant to which Lucid Diagnostics agreed to sell, and the investor agreed to purchase a
Senior Convertible Note (referred to as 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.
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, 2024, Lucid Diagnostics was in compliance with the Lucid Financial
Tests. In addition, Lucid Diagnostics presently is in compliance with the Lucid Financial Tests.
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 the six months ended June 30, 2024, the Company sold
333,299 shares through its at-the-market equity facility for net proceeds of approximately $0.7 million, after payment of 3% commissions.
Subsequent to June 30, 2024, as of August 8, 2024, the Company sold 288,067 shares through their at-market equity facility
for net proceeds of approximately $0.3 million after payment of 3% commissions.
39
Liquidity
and Capital Resources - continued
Lucid
Diagnostics Inc. - Committed Equity Facility and ATM Facility
In
March 2022, Lucid Diagnostics entered into a committed equity facility with a Cantor affiliate. 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, 2024.
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. Cumulatively, a total
of 230,068 shares of Lucid Diagnostics’ common stock were issued through its at-the-market equity facility for net proceeds of
approximately $0.3 million, after payment of 3% commissions, as of June 30, 2024.
Critical
Accounting 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, 2023 as filed with the SEC on March 25, 2024. There have been no material changes to our critical accounting
policies and estimates in the six months ended June 30, 2024.
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, 2024. 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, 2024 that has materially affected, or is reasonably likely to materially affect,
our internal control over financial reporting.
40
Part
II - Other Information
Item
1. Legal Proceedings
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
2. Unregistered Sales of Equity Securities and Use of Proceeds
Except
as previously disclosed in our current reports on Form 8-K filed prior to the date of this Form 10-Q and in Note 12, Preferred Stock ,
to our accompanying unaudited condensed consolidated financial statements, we did not sell any unregistered securities or repurchase
any of our securities during the three months ended March 31, 2024. The offers and sales disclosed in Note 12, Preferred Stock , to our accompanying unaudited condensed consolidated financial statements were exempt from the registration
requirements of the Securities Act of 1933, as amended (the “Securities Act”), pursuant to Section 4(a)(2) of the Securities
Act, as transactions not involving public offerings.
See
Part I, Item 2 under the caption “ Liquidity and Capital Resources ” for a description of limitations on the payment
of dividends.
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
During
the fiscal quarter ended June 30, 2024, none of our directors or officers (as defined in Rule 16a-1 under the Exchange Act) adopted or
terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement” (as those terms are defined
in Item 408 of Regulation S-K).
Item
6. Exhibits
The
exhibits filed as part of this Quarterly Report on Form 10-Q are set forth in the “ Exhibit Index ” below.
41
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized.
PAVmed
Inc.
August
12, 2024
By:
/s/
Dennis M McGrath
Dennis
M McGrath
President
and Chief Financial Officer
(Principal
Financial and Accounting Officer)
42
EXHIBIT
INDEX
Incorporation
by Reference
Exhibit
No.
Description
Form
Exhibit
No.
Date
10.2
Form
of Registration Rights Agreement (Lucid Series B-1)
8-K
(Lucid)
10.1
5/7/2024
10.4
Form
of Amendment and Waiver
10-Q
10.4
5/13/2024
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)
*
43
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.