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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
(Mark
One)
☒ |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended June 30, 2023
OR
☐ |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the transition period from _____ to _____
Commission
File Number: 001-40901
LUCID
DIAGNOSTICS INC.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware |
|
82-5488042 |
(State
or Other Jurisdiction of |
|
(IRS
Employer |
Incorporation
or Organization) |
|
Identification
No.) |
|
|
|
360
Madison Avenue |
|
|
25th
Floor |
|
|
New
York, NY |
|
10017 |
(Address
of Principal Executive Offices) |
|
(Zip
Code) |
(212)
949-4319
(Registrant’s
Telephone Number, Including Area Code)
Securities
registered under Section 12(b) of the Exchange Act:
Title
of each Class |
|
Trading
Symbol(s) |
|
Name
of each Exchange on which Registered |
Common
Stock, $0.001 par value per share |
|
LUCD |
|
The
NASDAQ Stock Market LLC |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically Interactive Data File required to be submitted pursuant to Rule 405
of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was
required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”
, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
Accelerated filer |
☐ |
Accelerated
filed |
☐ |
Non-accelerated
filer |
☒ |
Smaller
reporting company |
☒ |
|
|
Emerging
growth company |
☒ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to section 13(c) of the Exchange Act
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of August 10, 2023 there were 43,725,703 shares of the registrant’s Common Stock, par value $0.001 per share, issued and
outstanding (with such number of shares inclusive of shares of common stock underlying unvested restricted stock awards granted under
the Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan as of such date).
TABLE
OF CONTENTS
Part
I - Financial Information
Item
1. Financial Statements
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
(a
majority-owned subsidiary of PAVmed Inc.)
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands except number of shares and per share data - unaudited)
| |
June 30, 2023 | | |
December 31, 2022 | |
Assets: | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash | |
$ | 32,570 | | |
$ | 22,474 | |
Accounts receivable | |
| 35 | | |
| 17 | |
Prepaid expenses, deposits, and other current assets | |
| 3,144 | | |
| 1,865 | |
Total current assets | |
| 35,749 | | |
| 24,356 | |
Fixed assets, net | |
| 1,389 | | |
| 1,592 | |
Operating lease right-of-use assets | |
| 1,835 | | |
| 2,008 | |
Intangible assets, net | |
| 2,435 | | |
| 3,445 | |
Other assets | |
| 1,078 | | |
| 1,108 | |
Total assets | |
$ | 42,486 | | |
$ | 32,509 | |
Liabilities, Preferred Stock and Stockholders’ Equity | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 637 | | |
$ | 1,056 | |
Accrued expenses and other current liabilities | |
| 2,640 | | |
| 1,447 | |
Operating lease liabilities, current portion | |
| 1,099 | | |
| 962 | |
Senior Secured Convertible Note - at fair value | |
| 11,610 | | |
| — | |
Due To: PAVmed Inc. - MSA Fee and operating expenses | |
| 10,697 | | |
| 4,960 | |
Total current liabilities | |
| 26,683 | | |
| 8,425 | |
Operating lease liabilities, less current portion | |
| 732 | | |
| 1,037 | |
Total liabilities | |
| 27,415 | | |
| 9,462 | |
Commitments and contingencies | |
| - | | |
| - | |
Stockholders’ Equity: | |
| | | |
| | |
Preferred stock, $0.001 par value, 20,000,000 shares authorized; Series A Convertible Preferred Stock, issued and outstanding 13,625 at June 30, 2023 and no shares issued and outstanding at December 31, 2022 | |
| 13,625 | | |
| — | |
Common stock, $0.001 par value, 200,000,000 shares authorized; 41,853,603 and 40,518,792 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively | |
| 42 | | |
| 41 | |
Additional paid-in capital | |
| 127,107 | | |
| 121,081 | |
Accumulated deficit | |
| (125,703 | ) | |
| (98,075 | ) |
Total Stockholders’ Equity | |
| 15,071 | | |
| 23,047 | |
Total Liabilities and Stockholders’ Equity | |
$ | 42,486 | | |
$ | 32,509 | |
See
accompanying notes to the unaudited condensed consolidated financial statements.
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
(a
majority-owned subsidiary of PAVmed Inc.)
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(in
thousands except number of shares and per share data - unaudited)
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenue | |
$ | 159 | | |
$ | — | | |
$ | 605 | | |
$ | 189 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Cost of revenue | |
| 1,549 | | |
| — | | |
| 2,887 | | |
| 369 | |
Sales and marketing | |
| 4,032 | | |
| 3,873 | | |
| 8,159 | | |
| 7,191 | |
General and administrative | |
| 3,830 | | |
| 6,676 | | |
| 10,340 | | |
| 12,568 | |
Amortization of acquired intangible assets | |
| 505 | | |
| 639 | | |
| 1,010 | | |
| 639 | |
Research and development | |
| 1,827 | | |
| 3,440 | | |
| 4,109 | | |
| 6,321 | |
Total operating expenses | |
| 11,743 | | |
| 14,628 | | |
| 26,505 | | |
| 27,088 | |
Operating loss | |
| (11,584 | ) | |
| (14,628 | ) | |
| (25,900 | ) | |
| (26,899 | ) |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 136 | | |
| 4 | | |
| 214 | | |
| 5 | |
Interest expense | |
| (223 | ) | |
| — | | |
| (257 | ) | |
| — | |
Change in fair value - Senior Secured Convertible Note | |
| 290 | | |
| — | | |
| (499 | ) | |
| — | |
Loss on issue and offering costs - Senior Secured Convertible Note | |
| — | | |
| — | | |
| (1,186 | ) | |
| — | |
Other income (expense), net | |
| 203 | | |
| 4 | | |
| (1,728 | ) | |
| 5 | |
Provision for income taxes | |
| — | | |
| — | | |
| — | | |
| — | |
Net loss | |
$ | (11,381 | ) | |
$ | (14,624 | ) | |
$ | (27,628 | ) | |
$ | (26,894 | ) |
Net loss per share - basic and diluted | |
$ | (0.27 | ) | |
$ | (0.41 | ) | |
$ | (0.67 | ) | |
$ | (0.76 | ) |
Weighted average common shares outstanding, basic and diluted | |
| 41,833,823 | | |
| 35,760,492 | | |
| 41,404,547 | | |
| 35,443,526 | |
See
accompanying notes to the unaudited condensed consolidated financial statements.
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
(a
majority-owned subsidiary of PAVmed Inc.)
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
for
the THREE AND SIX MONTHS ENDED June 30, 2023
(in
thousands except number of shares and per share data - unaudited)
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Total | |
| |
Preferred Stock | | |
Common Stock | | |
Additional
Paid-In | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Total | |
Balance as of March 31, 2023 | |
| 13,625 | | |
| 13,625 | | |
| 41,753,603 | | |
$ | 42 | | |
$ | 125,561 | | |
$ | (114,322 | ) | |
$ | 24,906 | |
Stock-based compensation - Lucid Diagnostics Inc. | |
| — | | |
| — | | |
| — | | |
| — | | |
| 1,165 | | |
| — | | |
| 1,165 | |
Stock-based compensation - PAVmed Inc. | |
| — | | |
| — | | |
| — | | |
| — | | |
| 234 | | |
| — | | |
| 234 | |
Issue common stock - vendor service agreement | |
| — | | |
| — | | |
| 100,000 | | |
| — | | |
| 147 | | |
| — | | |
| 147 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (11,381 | ) | |
| (11,381 | ) |
Balance as of June 30, 2023 | |
| 13,625 | | |
$ | 13,625 | | |
| 41,853,603 | | |
$ | 42 | | |
$ | 127,107 | | |
$ | (125,703 | ) | |
$ | 15,071 | |
Balance | |
| 13,625 | | |
$ | 13,625 | | |
| 41,853,603 | | |
$ | 42 | | |
$ | 127,107 | | |
$ | (125,703 | ) | |
$ | 15,071 | |
| |
Preferred Stock | | |
Common Stock | | |
Additional
Paid-In | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Total | |
Balance as of December 31, 2022 | |
| — | | |
$ | — | | |
| 40,518,792 | | |
$ | 41 | | |
$ | 121,081 | | |
$ | (98,075 | ) | |
$ | 23,047 | |
Balance | |
| — | | |
$ | — | | |
| 40,518,792 | | |
$ | 41 | | |
$ | 121,081 | | |
$ | (98,075 | ) | |
$ | 23,047 | |
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan | |
| — | | |
| — | | |
| — | | |
| — | | |
| 3,982 | | |
| — | | |
| 3,982 | |
Stock-based compensation - PAVmed Inc. 2014 Equity Plan | |
| — | | |
| — | | |
| — | | |
| — | | |
| 625 | | |
| — | | |
| 625 | |
Vest - restricted stock awards | |
| — | | |
| — | | |
| 219,320 | | |
| — | | |
| — | | |
| — | | |
| — | |
APA-RDx - Termination payment | |
| — | | |
| — | | |
| 553,436 | | |
| — | | |
| 713 | | |
| — | | |
| 713 | |
Issuance - At-The-Market Facility, net of deferred financing charges | |
| — | | |
| — | | |
| 230,068 | | |
| 1 | | |
| 283 | | |
| — | | |
| 284 | |
Purchase - Employee Stock Purchase Plan | |
| — | | |
| — | | |
| 231,987 | | |
| — | | |
| 276 | | |
| — | | |
| 276 | |
Issuance - Series A Preferred Stock | |
| 13,625 | | |
| 13,625 | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 13,625 | |
Issue common stock - vendor service agreement | |
| — | | |
| — | | |
| 100,000 | | |
| | | |
| 147 | | |
| — | | |
| 147 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (27,628 | ) | |
| (27,628 | ) |
Balance as of June 30, 2023 | |
| 13,625 | | |
$ | 13,625 | | |
| 41,853,603 | | |
$ | 42 | | |
$ | 127,107 | | |
$ | (125,703 | ) | |
$ | 15,071 | |
Balance | |
| 13,625 | | |
$ | 13,625 | | |
| 41,853,603 | | |
$ | 42 | | |
$ | 127,107 | | |
$ | (125,703 | ) | |
$ | 15,071 | |
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
(a
majority-owned subsidiary of PAVmed Inc.)
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
for
the THREE AND SIX MONTHS ENDED June 30, 2022
(in
thousands except number of shares and per share data - unaudited)
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Total | |
| |
Common Stock | | |
Additional
Paid-In | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Total | |
Balance as of March 31, 2022 | |
| 35,171,796 | | |
$ | 35 | | |
$ | 100,630 | | |
$ | (54,174 | ) | |
$ | 46,491 | |
Balance | |
| 35,171,796 | | |
$ | 35 | | |
$ | 100,630 | | |
$ | (54,174 | ) | |
$ | 46,491 | |
Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan | |
| 705,500 | | |
| 1 | | |
| 501 | | |
| — | | |
| 502 | |
Stock-based compensation - Lucid Diagnostics Inc. | |
| — | | |
| — | | |
| 3,553 | | |
| — | | |
| 3,553 | |
Stock-based compensation - PAVmed Inc. | |
| — | | |
| — | | |
| 290 | | |
| — | | |
| 290 | |
CapNostics, LLC | |
| — | | |
| — | | |
| (210 | ) | |
| — | | |
| (210 | ) |
APA-RDx - Installment Payment | |
| 117,371 | | |
| — | | |
| 239 | | |
| — | | |
| 239 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| (14,624 | ) | |
| (14,624 | ) |
Balance as of June 30, 2022 | |
| 35,994,667 | | |
$ | 36 | | |
$ | 105,003 | | |
$ | (68,798 | ) | |
$ | 36,241 | |
Balance | |
| 35,994,667 | | |
$ | 36 | | |
$ | 105,003 | | |
$ | (68,798 | ) | |
$ | 36,241 | |
| |
Common Stock | | |
Additional Paid-In | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Total | |
Balance as of December 31, 2021 | |
| 34,917,907 | | |
$ | 35 | | |
$ | 96,608 | | |
$ | (41,904 | ) | |
$ | 54,739 | |
Balance | |
| 34,917,907 | | |
$ | 35 | | |
$ | 96,608 | | |
$ | (41,904 | ) | |
$ | 54,739 | |
Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan | |
| 959,389 | | |
| 1 | | |
| 687 | | |
| — | | |
| 688 | |
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan | |
| — | | |
| — | | |
| 7,091 | | |
| — | | |
| 7,091 | |
Stock-based compensation - PAVmed Inc. 2014 Equity Plan | |
| — | | |
| — | | |
| 588 | | |
| — | | |
| 588 | |
CapNostics, LLC | |
| — | | |
| — | | |
| (210 | ) | |
| — | | |
| (210 | ) |
APA-RDx - Installment Payment | |
| 117,371 | | |
| — | | |
| 239 | | |
| — | | |
| 239 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| (26,894 | ) | |
| (26,894 | ) |
Balance as of June 30, 2022 | |
| 35,994,667 | | |
$ | 36 | | |
$ | 105,003 | | |
$ | (68,798 | ) | |
$ | 36,241 | |
Balance | |
| 35,994,667 | | |
$ | 36 | | |
$ | 105,003 | | |
$ | (68,798 | ) | |
$ | 36,241 | |
See
accompanying notes to the unaudited condensed consolidated financial statements.
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
(a
majority-owned subsidiary of PAVmed Inc.)
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in
thousands except number of shares and per share data - unaudited)
| |
2023 | | |
2022 | |
| |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
Cash flows from operating activities | |
| | | |
| | |
Net loss | |
$ | (27,628 | ) | |
$ | (26,894 | ) |
| |
| | | |
| | |
Adjustments to reconcile net loss to net cash used in operating activities | |
| | | |
| | |
Depreciation and amortization expense | |
| 1,245 | | |
| 728 | |
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan | |
| 3,982 | | |
| 7,091 | |
Stock-based compensation - PAVmed Inc. 2014 Equity Plan | |
| 625 | | |
| 588 | |
Change in fair value - Senior Secured Convertible Note | |
| 499 | | |
| — | |
Loss on issue - Senior Secured Convertible Note | |
| 1,111 | | |
| — | |
APA-RDx: Issue common stock - settle termination payment | |
| 713 | | |
| 239 | |
Issue common stock - vendor service agreement | |
| 23 | | |
| — | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| (18 | ) | |
| 200 | |
Prepaid expenses and other current assets | |
| (1,120 | ) | |
| (748 | ) |
Accounts payable | |
| (419 | ) | |
| 916 | |
Accrued expenses and other current liabilities | |
| 1,193 | | |
| 132 | |
Due To: PAVmed Inc. - operating expenses, employee related costs, MSA Fee | |
| 5,737 | | |
| (1,333 | ) |
Net cash flows used in operating activities | |
| (14,057 | ) | |
| (19,081 | ) |
| |
| | | |
| | |
Cash flows from investing activities | |
| | | |
| | |
Purchase of equipment | |
| (32 | ) | |
| (384 | ) |
Asset acquisition | |
| — | | |
| (2,200 | ) |
Net cash flows used in investing activities | |
| (32 | ) | |
| (2,584 | ) |
| |
| | | |
| | |
Cash flows from financing activities | |
| | | |
| | |
Proceeds – issue of preferred stock | |
| 13,625 | | |
| — | |
Proceeds – issue of Senior Convertible Note | |
| 10,000 | | |
| — | |
Proceeds – issue of common stock – Committed Equity Facility | |
| 284 | | |
| — | |
Proceeds – exercise of stock options | |
| — | | |
| 688 | |
Proceeds – issue common stock – Employee Stock Purchase Plan | |
| 276 | | |
| — | |
Net cash flows provided by financing activities | |
| 24,185 | | |
| 688 | |
| |
| | | |
| | |
Net increase (decrease) in cash | |
| 10,096 | | |
| (20,977 | ) |
Cash, beginning of period | |
| 22,474 | | |
| 53,656 | |
Cash, end of period | |
$ | 32,570 | | |
$ | 32,679 | |
See
accompanying notes to the unaudited condensed consolidated financial statements.
LUCID
DIAGNOSTICS INC.
and
SUBSIDIARIES
(a
majority-owned subsidiary of PAVmed Inc.)
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 — Summary Description of the Company
Lucid
Diagnostics Inc. (“Lucid”, “Lucid Diagnostics” or the “Company”) is a commercial-stage medical diagnostics
technology company focused on the millions of patients with gastroesophageal reflux disease (“GERD”), also known as chronic
heartburn, acid reflux or simply reflux, who are at risk of developing esophageal precancer and cancer, specifically highly lethal esophageal
adenocarcinoma (“EAC”). Lucid is a majority-owned subsidiary of PAVmed Inc. (“PAVmed”).
The
Company believes that its flagship product, the EsoGuard Esophageal DNA Test, performed on samples collected with the EsoCheck
Esophageal Cell Collection Device, constitutes the first and only commercially available diagnostic test capable of serving as a
widespread tool for the early detection of esophageal precancer in at-risk gastroesophageal reflux disease (“GERD,” also
commonly known as chronic heartburn, acid reflux or simply reflux) patients. Early detection of esophageal precancer allows patients
to undergo appropriate monitoring and treatment, as indicated by clinical practice guidelines, in an effort to prevent progression
to esophageal cancer.
EsoGuard
is a bisulfite-converted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck. Cell samples, including those collected with EsoCheck, as discussed below, are sent to our laboratory, for
testing and analyses using our proprietary EsoGuard NGS DNA assay.
EsoCheck
is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal
cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin
silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When
vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and
dilution by cells outside of the targeted region during device withdrawal. The Company believes that this proprietary
Collect+Protect™ technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically
targeted and protected sampling.
EsoGuard
and EsoCheck are based on patented technology licensed by Lucid from Case Western Reserve University (“CWRU”). EsoGuard and
EsoCheck have been developed to provide an accurate, non-invasive, patient-friendly test for the early detection of EAC and Barrett’s
Esophagus (“BE”), including dysplastic BE and related pre-cursors to EAC in patients with chronic GERD.
The
Company is subject to all of the risks and uncertainties typically faced by medical device and diagnostic companies that devote substantially
all of their efforts to the commercialization of their initial product and services and ongoing research and development activities and
conducting clinical trials. The Company expects to continue to experience recurring losses from operations and will continue to fund
its operations with debt and equity financing transactions. Notwithstanding, however, with the cash on-hand as of the date hereof and
committed equity sources of financing, the Company expects to be able to fund its operations and meet its financial obligations as they
become due for the one year period from the date of the issue of the Company’s unaudited condensed consolidated financial statements,
as included herein in this Quarterly Report on Form 10-Q for the period ended June 30, 2023.
Note
2 — Summary of Significant Accounting Policies
Significant
Accounting Policies
The
Company’s significant accounting policies are as disclosed in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2022 as filed with the SEC on March 14, 2023, except as otherwise noted herein below.
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements of the Company 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. All intercompany transactions and balances have been eliminated in consolidation. The Company is a majority-owned consolidated
subsidiary of PAVmed, which has a majority equity ownership interest and has financial control of the Company. The Company manages its
operations as a single operating segment for the purposes of assessing performance and making operating decisions.
As
permitted under SEC rules, certain footnotes or other financial information normally required by U.S. GAAP have been condensed or omitted.
The balance sheet as of December 31, 2022 has been derived from audited consolidated financial statements at such date. The accompanying
unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated
financial statements, and in the opinion of management, include all adjustments, consisting only of routine recurring adjustments, necessary
for a fair statement of the Company’s unaudited condensed consolidated financial information.
The
consolidated results of operations for the three and six months ended June 30, 2023 are not necessarily indicative of the consolidated
results to be expected for the year ending December 31, 2023 or for any other interim period or for any other future periods. The accompanying
unaudited condensed consolidated financial statements and related unaudited condensed consolidated financial information should be read
in conjunction with the Company’s audited consolidated financial statements and related notes thereto as of and for the year ended
December 31, 2022 included in the Company’s Annual Report on Form 10-K as filed with the SEC on March 14, 2023.
All
amounts in the accompanying unaudited condensed consolidated financial statements and the notes thereto are presented in thousands
of dollars, if not otherwise noted as being presented in millions of dollars, except for shares and per share amounts.
Use
of Estimates
In
preparing the unaudited condensed consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates
and assumptions that affect the reported amounts of assets and the determination of corresponding carrying value reserves, if any, and
liabilities and the disclosure of contingent losses, as of the date of the consolidated financial statements, as well as the reported
amounts of revenue and expenses during the reporting period. Significant estimates in these unaudited condensed consolidated financial
statements include those related to the estimated fair value of debt obligations, stock-based equity awards and intangible assets. Other
significant estimates include the estimated incremental borrowing rate, the provision or benefit for income taxes and the corresponding
valuation allowance on deferred tax assets. Additionally, management’s assessment of the Company’s ability to continue as
a going concern involves the estimation of the amount and timing of future cash inflows and outflows. On an ongoing basis, the Company
evaluates its estimates and assumptions. The Company bases its estimates on historical experience and on various other assumptions believed
to be reasonable. Due to inherent uncertainty involved in making estimates, actual results reported in future periods may be affected
by changes in these estimates.
Revenue
Recognition
Revenues
are recognized when the satisfaction of the performance obligation occurs, in an amount that reflects the consideration the Company expects
to collect in exchange for those services. The Company’s revenue is primarily generated by its laboratory testing services utilizing
its EsoGuard Esophageal DNA tests. The services are completed upon release of a patient’s test result to the ordering healthcare
provider. Revenue recognized is inclusive of both variable consideration in connection with an individual patient’s third-party
insurance coverage policy and fixed consideration in connection with a contracted services arrangement with an unrelated third party
legal entity. To determine revenue recognition for the arrangements that the Company determines are within the scope of ASC 606, Revenue
from Contracts with Customers, the Company performs the following five steps: (1) identify the contract(s) with a customer, (2) identify
the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance
obligations in the contract and (5) recognize revenue when (or as) the entity satisfies a performance obligation.
Note
2 — Summary of Significant Accounting Policies - continued
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.
Financial
Instruments Fair Value Measurements
FASB
ASC Topic 820, Fair Value Measurement, (ASC 820) defines fair value as the price which would be received to sell an asset or paid to
transfer a liability in an orderly transaction between market participants at a transaction measurement date. The ASC 820 three-tier
fair value hierarchy prioritizes the inputs used in the valuation methodologies, as follows:
|
Level
1 | Valuations
based on quoted prices for identical assets and liabilities in active markets. |
|
| |
|
Level 2 | Valuations
based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets or liabilities in active
markets, quoted prices for identical or similar assets and liabilities in markets which are not active, or other inputs observable or
can be corroborated by observable market data. |
|
| |
|
Level 3 | Valuations
based on unobservable inputs reflecting the Company’s own assumptions, consistent with reasonably available assumptions made by
other market participants. These valuations require significant judgment. |
The
Company evaluates its financial instruments to determine if those instruments or any embedded components of those instruments potentially
qualify as derivatives required to be separately accounted for in accordance with FASB ASC Topic 815, Derivatives and Hedging (ASC 815).
Note
2 — Summary of Significant Accounting Policies - continued
The
recurring and non-recurring estimated fair value measurements are subjective and are affected by changes in inputs to the valuation models,
including the Company’s common stock price, and certain Level 3 inputs, including, the assumptions regarding the estimated volatility
in the value of the Company’s common stock price; the Company’s dividend yield; the likelihood and timing of future dilutive
transactions, as applicable, along with the risk-free rates based on U.S. Treasury security yields. Changes in these assumptions can
materially affect the estimated fair values.
As
of June 30, 2023 and December 31, 2022, the carrying values of cash, and accounts payable, approximate their respective fair
value due to the short-term nature of these financial instruments.
Fair
Value Option (“FVO”) Election
Under
a Securities Purchase Agreement dated March 13, 2023, the Company issued a Senior Secured Convertible Note dated March 21, 2023, referred
to herein as the “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
March 2023 Senior Convertible Note is presented in a single line item within other income (expense) in the accompanying 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 March 2023 Senior Convertible
Note).
See
Note 10, Financial Instruments Fair Value Measurements, with respect to the FVO election; and Note 11, Debt, for a discussion of the
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.
Recently
Adopted Accounting Pronouncements
In
June 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments-Credit Losses (Topic 326):
Measurement of Credit Losses on Financial Instruments. The updated guidance requires companies to measure all expected credit losses
for financial instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable forecasts.
This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets, including trade
receivables. The guidance was adopted by the Company on January 1, 2023. The adoption of the ASU did not have an impact on the Company’s
unaudited condensed consolidated financial statements.
Note
3 — Revenue from Contracts with Customers
EsoGuard
Commercialization Agreement
The
Company entered into the EsoGuard Commercialization Agreement, dated August 1, 2021, with its former commercial laboratory service provider,
ResearchDx Inc. (“RDx”), an unrelated third-party. The EsoGuard Commercialization Agreement was on a month-to-month basis
and was terminated on February 25, 2022 upon the execution of an asset purchase agreement (“APA”) dated February 25, 2022,
between LucidDx Labs Inc., a wholly-owned subsidiary of the Company, and RDx, with such agreement further discussed in Note 6, Asset
Purchase Agreement and Management Services Agreement.
Revenue
Recognized
In
the three and six months ended June 30, 2023, the Company recognized revenue of $159
and $605,
respectively, resulting from the delivery of patient EsoGuard test results. Revenue recognized from customer contracts deemed to
include a variable consideration transaction price is limited to the unconstrained portion of the variable consideration. The
Company’s revenue for the three and six months ended June 30, 2022 was $0 and $189,
which solely reflects the revenue recognized under the EsoGuard Commercialization Agreement, which represented the minimum fixed
monthly fee of $100
for the period January 1, 2022 to the February 25, 2022 termination date as discussed above. The monthly fee was deemed to be
collectible for such period as RDx has timely paid the applicable respective monthly fee.
Cost
of Revenue
The
cost of revenues principally includes the costs related to the Company’s laboratory operations (excluding estimated costs associated
with research activities), the costs related to the EsoCheck cell collection device, cell sample mailing kits and license royalties.
In
the three and six months ended June 30, 2023, the cost of revenue was $1,549
and $2,887,
respectively, and was primarily related to costs for our laboratory operations and EsoCheck device supplies. The Company’s
cost of revenue for the three and six months ended June 30, 2022 was $0 and $369,
which solely reflects the costs attributable to delivering the services under the EsoGuard Commercialization Agreement for the
period January 1, 2022 to February 25, 2022. In the three months ended June 30, 2022, laboratory operations costs are included in operating expenses as general
and administrative expenses in the accompanying unaudited condensed consolidated statements of operations.
Note
4 — Related Party Transactions
Case
Western Reserve University and Physician Inventors - Amended CWRU License Agreement
Case
Western Reserve University (“CWRU”) and each of the three physician inventors (“Physician Inventors”) of the
intellectual property licensed under the amended and restated patent license agreement with CWRU, dated August 23, 2021 (the “Amended
CWRU License Agreement”), each hold a minority equity ownership interest in Lucid Diagnostics Inc. The expenses incurred with respect
to the Amended CWRU License Agreement and the three Physician Inventors, as classified in the accompanying unaudited condensed consolidated
statement of operations for the periods indicated are summarized as follows:
Schedule of Incurred Expenses of Minority Shareholders
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Cost of Revenue | |
| | | |
| | | |
| | | |
| | |
CWRU – Royalty Fees | |
$ | 10 | | |
$ | — | | |
$ | 34 | | |
$ | 9 | |
| |
| | | |
| | | |
| | | |
| | |
General and Administrative Expense | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation expense – Physician Inventors’ restricted stock awards | |
| — | | |
| 272 | | |
| 180 | | |
| 544 | |
| |
| | | |
| | | |
| | | |
| | |
Research and Development Expense | |
| | | |
| | | |
| | | |
| | |
Amended CWRU – License Agreement - reimbursement of patent legal fees | |
| — | | |
| 209 | | |
| 389 | | |
| 209 | |
Fees - Physician Inventors’ consulting agreements | |
| 9 | | |
| 10 | | |
| 10 | | |
| 18 | |
Sponsored research agreement | |
| — | | |
| — | | |
| — | | |
| 3 | |
Stock-based compensation expense – Physician Inventors’ stock options | |
| 52 | | |
| 52 | | |
| 105 | | |
| 99 | |
Total Related Party Expenses | |
$ | 71 | | |
$ | 543 | | |
$ | 718 | | |
$ | 882 | |
PAVmed
Inc. - Management Services Agreement
The
Company’s daily operations are also managed in part by personnel employed by PAVmed, for which the Company incurs a service fee,
referred to as the “MSA Fee”, according to the provisions of a Management Services Agreement (“MSA”) with PAVmed.
The MSA does not have a termination date, but may be terminated by the Company’s board of directors. The MSA Fee is charged on
a monthly basis and is subject-to periodic adjustment corresponding with changes in the services provided by PAVmed personnel to the
Company, with any such change in the MSA Fee being subject to approval of the boards of directors of each of the Company and PAVmed.
The respective companies’ boards of directors approved a seventh amendment to the MSA to increase the MSA Fee to $750 per month,
effective January 1, 2023, which was entered into by PAVmed and the Company on May 9, 2023. During the three and six months ended June
30, 2022, MSA Fees were $390 per month.
Note
4 — Related Party Transactions - continued
The
MSA Fee expense classification in the unaudited condensed consolidated statement of operations for the periods noted is as follows:
Schedule of MSA Fee Expense Classification in Statements of Operations
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Sales & Marketing | |
| 109 | | |
| 183 | | |
| 218 | | |
| 383 | |
General & Administrative | |
| 1,554 | | |
| 640 | | |
| 3,108 | | |
| 1,284 | |
Research & Development | |
| 587 | | |
| 347 | | |
| 1,174 | | |
| 673 | |
Total MSA Fee | |
$ | 2,250 | | |
$ | 1,170 | | |
$ | 4,500 | | |
$ | 2,340 | |
The
classification of the MSA Fee as presented above is based on the PAVmed classification of employee salary expense and other operating
expenses. In this regard, PAVmed classifies employee salary expense as sales and marketing expenses for employees performing sales, marketing,
and reimbursement activities and functions, general and administrative, and research and development except for those employees who are
engaged in product and services engineering development and design and /or clinical trials activities, for which such employee salary
is classified as research and development expense.
Note
5 — Due To PAVmed Inc.
The
aggregate Due To: PAVmed Inc. for the periods indicated is summarized as follows:
Schedule of Senior Unsecured Promissory Note
| |
MSA Fees | | |
Employee-Related Costs | | |
PAVmed Inc. OBO Payments | | |
Total | |
Balance - December 31, 2022 | |
$ |
1,650 | | |
$ |
3,026 | | |
$ |
284 | | |
$ |
4,960 | |
MSA fees | |
| 4,500 | | |
| — | | |
| — | | |
| 4,500 | |
ERC - Payroll & Benefits | |
| — | | |
| 922 | | |
| — | | |
| 922 | |
On Behalf Of (OBO) activities | |
| — | | |
| — | | |
| 601 | | |
| 601 | |
Cash payments to PAVmed Inc. | |
| — | | |
| — | | |
| (286 | ) | |
| (286 | ) |
Balance - June 30, 2023 | |
$ | 6,150 | | |
$ | 3,948 | | |
$ | 599 | | |
$ | 10,697 | |
Note
6 — Asset Purchase Agreement and Management Services Agreement
Asset
Purchase Agreement and Management Services Agreement - ResearchDx Inc.
Through
its wholly-owned subsidiary, LucidDx Labs Inc. (“LucidDx Labs”), the Company entered into an asset purchase agreement (“APA”)
dated February 25, 2022, with ResearchDx, Inc. (“RDx”), an unrelated third-party - “APA-RDx”. Under the APA-RDx,
LucidDx Labs Inc. acquired certain assets from RDx which were combined with other property and equipment to establish a Company-owned
CLIA certified, CAP accredited commercial clinical laboratory capable of performing the EsoGuard® Esophageal DNA assay, inclusive
of DNA extraction, next generation sequencing (“NGS”) and specimen storage. Prior to February 25, 2022, RDx provided such
laboratory services at its owned CLIA-certified, CAP-accredited clinical laboratory. In connection with the execution and delivery of
the APA-RDx, LucidDx Labs Inc. and RDx entered into a separate management services agreement (“MSA-RDx”), dated and effective
February 25, 2022, pursuant to which RDx provided certain testing and related services for the Laboratory.
The
total purchase price consideration payable under the APA-RDx is a face value of $3,200 comprised of three contractually specified periodic
payments. The APA-RDx is being accounted for as an asset acquisition, with the recognition of an intangible asset of approximately $3,200,
which is included in “Intangible assets, net” on the accompanying unaudited condensed consolidated balance sheet, as further
discussed in Note 9, Intangible Assets, net.
Termination
of Management Services Agreement and Modification of Other Payment Obligations - ResearchDx Inc.
On
February 14, 2023, through LucidDx Labs Inc, the Company entered into an agreement (the “MSA Termination Agreement”) with
RDx, pursuant to which the parties mutually agreed to terminate the MSA-RDx without cause. The termination was effective as February
10, 2023. Until the termination of the management service agreement with RDx, RDx had continued to provide certain testing and related
services for the Laboratory in accordance with the terms of the MSA-RDx.
The
MSA Termination Agreement reduces the remaining amounts of the earnout payments and management fees due under the APA-RDx and the MSA-RDx
to $713. The payment was satisfied through the issuance of 553,436 shares of the Company’s common stock in February 2023. The Company
was not required to make any cash payments in connection with the termination.
Note
7 — Prepaid Expenses, Deposits, and Other Current Assets
Prepaid
expenses and other current assets consisted of the following as of:
Schedule of Prepaid Expenses and Other Current Assets
| |
June 30, 2023 | | |
December 31, 2022 | |
Advanced payments to service providers and suppliers | |
$ | 344 | | |
$ | 371 | |
Prepaid insurance | |
| 171 | | |
| 52 | |
Deposits | |
| 2,587 | | |
| 1,331 | |
EsoCheck cell collection supplies | |
| 39 | | |
| 59 | |
EsoGuard mailer supplies | |
| 3 | | |
| 52 | |
Total prepaid expenses, deposits and other current assets | |
$ | 3,144 | | |
$ | 1,865 | |
Note
8 — Leases
During
the six months ended June 30, 2023, the Company entered into additional lease agreements that have commenced and are classified
as operating leases and short-term leases for additional Lucid Test Centers.
The
Company’s future lease payments as of June 30, 2023, which are presented as operating lease liabilities, current portion and
operating lease liabilities, less current portion on the Company’s unaudited condensed consolidated balance sheets are as follows:
Schedule Of Future Lease Payments Of Operating Lease Liabilities
| |
| | |
2023 (remainder of year) | |
$ | 611 | |
2024 | |
| 1,133 | |
2025 | |
| 127 | |
2026 | |
| 63 | |
2027 | |
| 24 | |
Total lease payments | |
$ | 1,958 | |
Less: imputed interest | |
| (127 | ) |
Present value of lease liabilities | |
$ | 1,831 | |
Supplemental
disclosure of cash flow information related to the Company’s cash and non-cash activities with its leases are as follows:
Schedule Of Cash Flow Supplemental Information
| |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
Cash paid for amounts included in the measurement of lease liabilities | |
| | | |
| | |
Operating cash flows from operating leases | |
$ | 583 | | |
$ | 453 | |
Non-cash investing and financing activities | |
| | | |
| | |
Right-of-use assets obtained in exchange for new operating lease liabilities | |
$ | 341 | | |
$ | 2,448 | |
Weighted-average remaining lease term - operating leases (in years) | |
| 1.80 | | |
| 2.48 | |
Weighted-average discount rate - operating leases | |
| 7.875 | % | |
| 7.875 | % |
As
of June 30, 2023 and December 31, 2022, the Company’s right-of-use assets from operating leases were $1,835 and $2,008, respectively,
which are reported in operating lease right-of-use assets in the unaudited condensed consolidated balance sheets. As of June 30,
2023 and December 31, 2022, the Company had outstanding operating lease obligations of $1,831 and $1,999, respectively, of which $1,099
and $962, respectively, are reported in operating lease liabilities, current portion and $732 and $1,037, 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
9 — Intangible Assets, net
Intangible
assets, less accumulated amortization, consisted of the following as of:
Schedule of Intangible Assets Accumulated Amortization
| |
Estimated Useful Life | |
June 30, 2023 | | |
December 31, 2022 | |
Defensive technology | |
60 months | |
$ | 2,105 | | |
$ | 2,105 | |
Laboratory licenses and certifications and laboratory information management software | |
24 months | |
| 3,200 | | |
$ | 3,200 | |
Total Intangible assets | |
| |
| 5,305 | | |
| 5,305 | |
Less Accumulated Amortization | |
| |
| (2,870 | ) | |
| (1,860 | ) |
Intangible Assets, net | |
| |
$ | 2,435 | | |
$ | 3,445 | |
The
defensive technology intangible asset of $2.1 million (and approximately $0.2 million of accumulated amortization) was recognized by
the Company as of the April 1, 2022 effective date of the transfer of CapNostics, LLC (“CapNostics”) to the Company from
PAVmed Subsidiary Corp (a wholly-owned subsidiary of PAVmed). The transfer was accounted for as entities under common control. The defensive
technology intangible asset was recognized by PAVmed Subsidiary Corp upon its acquisition of CapNostics, an unrelated third-party, for
total purchase consideration paid on the October 5, 2021 acquisition date of approximately $2.1 million in cash. The CapNostics transaction
was accounted for as an asset acquisition, resulting in the recognition of the defensive technology intangible asset. The defensive technology
intangible asset is being amortized on a straight-line basis over an expected useful life 60 months commencing on the acquisition date.
As
noted in Note 6, Asset Purchase Agreement and Management Services Agreement, the asset purchase agreement between the Company
and ResearchDx Inc. (“APA-RDx”), is being accounted for as an asset acquisition. The intangible assets recognized under the
APA-RDx are the laboratory licenses and certifications (inclusive of a CLIA certification, CAP accreditation, and clinical laboratory
licenses for five (5) U.S. States transferred to the Company from RDx), and a laboratory information management software perpetual-use
royalty-free license granted under the APA-RDx, with such intangible asset having a useful life of twenty-four months commencing on the
APA-RDx February 25, 2022 transaction date.
Amortization
expense of the intangible assets discussed above was $505 and $639 for the three month periods ended June 30, 2023 and 2022, respectively,
and $1,010 and $639 for the six month periods ended June 30, 2023 and 2022, respectively, and is included in amortization of acquired
intangible assets in the accompanying unaudited condensed consolidated statements of operations. As of June 30, 2023, the estimated
future amortization expense associated with the Company’s finite-lived intangible assets for each of the five succeeding fiscal
years is as follows:
Schedule of Future Amortization Expense
| |
| | |
2023 (remainder of year) | |
$ | 1,011 | |
2024 | |
| 688 | |
2025 | |
| 421 | |
2026 | |
| 315 | |
Total | |
$ | 2,435 | |
Note
10 — Financial Instruments Fair Value Measurements
Recurring
Fair Value Measurements
The
fair value hierarchy table for the reporting date noted is as follows:
Schedule of Financial Liabilities Measured at Fair Value on Recurring Basis
| |
Fair Value Measurement on a Recurring Basis at Reporting Date Using1 | |
| |
Level-1 Inputs | | |
Level-2 Inputs | | |
Level-3 Inputs | | |
Total | |
June 30, 2023 | |
| | | |
| | | |
| | | |
| | |
March 2023 Senior Convertible Note | |
$ | — | | |
$ | — | | |
$ | 11,610 | | |
$ | 11,610 | |
Totals | |
$ | — | | |
$ | — | | |
$ | 11,610 | | |
$ | 11,610 | |
As
discussed in Note 11, Debt, the Company issued a Senior Secured Convertible Note dated March 21, 2023 with a $11.1 million face
value principal (“March 2023 Senior Convertible Note”.) The convertible note is accounted for under the ASC 825-10-15-4 fair
value option (“FVO”) election, wherein, the financial instrument is initially measured at its issue date estimated fair value
and subsequently remeasured at estimated fair value on a recurring basis at each reporting period date.
The
estimated fair value of the financial instruments classified within the Level 3 category was determined using both observable inputs
and unobservable inputs. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in fair
value attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in unobservable long-
dated volatilities) inputs.
The
estimated fair value of the March 2023 Senior Convertible Note as of each of March 21, 2023 and June 30, 2023 were computed using
a Monte Carlo simulation of the present value of its cash flows using a synthetic credit rating analysis and a required rate-of-return,
using the following assumptions:
Schedule of Fair Value Assumption Used
| |
March 2023 Senior Convertible Note: March 21, 2023 | | |
March 2023 Senior Convertible Note: June 30, 2023 | |
Fair Value | |
$ | 11,900 | | |
$ | 11,610 | |
Face value principal payable | |
$ | 11,111 | | |
$ | 11,111 | |
Required rate of return | |
| 11.00 | % | |
| 11.00 | % |
Conversion Price | |
$ | 5.00 | | |
$ | 5.00 | |
Value of common stock | |
$ | 1.54 | | |
$ | 1.39 | |
Expected term (years) | |
| 2.00 | | |
| 1.73 | |
Volatility | |
| 75.00 | % | |
| 70.00 | % |
Risk free rate | |
| 4.09 | % | |
| 4.89 | % |
Dividend yield | |
| — | % | |
| — | % |
The
estimated fair values reported utilized the Company’s common stock price along with certain Level 3 inputs (as discussed in the
table 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 Company’s
common stock price, the Company’s dividend yield, the risk-free rates based on U.S. Treasury security yields, and certain other
Level-3 inputs including, assumptions regarding the estimated volatility in the value of the Company’s common stock price. Changes
in these assumptions can materially affect the estimated fair values.
Note
11 — Debt
The
fair value and face value principal outstanding of the March 2023 Senior Convertible Note 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 | |
March 2023 Senior Convertible Note | |
March 21, 2025 | |
| 7.875 | % | |
$ | 5.00 | | |
$ | 11,111 | | |
$ | 11,610 | |
Balance as of June 30, 2023 | |
| |
| | | |
| | | |
$ | 11,111 | | |
$ | 11,610 | |
The
changes in the fair value of debt during the three and six months ended June 30, 2023 is as follows:
Schedule
of Changes in Fair Value of Debt
| |
March 2023 Senior Convertible Note | | |
Other Income (expense) | |
Fair Value - December 31, 2022 | |
$ | — | | |
$ | — | |
Face value principal – issue date | |
| 11,111 | | |
| — | |
Fair value adjustment – issue date | |
| 789 | | |
| (789 | ) |
Change in fair value | |
| — | | |
| — | |
Fair Value at March 31, 2023 | |
$ | 11,900 | | |
| - | |
Other Income (Expense) - Change in fair value – three months ended March 31, 2023 | |
| | | |
$ | (789 | ) |
| |
| | | |
| | |
Change in fair value | |
| (290 | ) | |
| 290 | |
Fair Value at June 30, 2023 | |
$ | 11,610 | | |
| - | |
Other Income (Expense) - Change in fair value – three months ended June 30, 2023 | |
| | | |
$ | 290 | |
Other Income (Expense) - Change in fair value – six months ended June 30, 2023 | |
| | | |
$ | (499 | ) |
March
2023 Senior Secured Convertible Note
Lucid
Diagnostics entered into a Securities Purchase Agreement (“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.
Under
the SPA, Lucid issued in a registered direct offering under its effective shelf registration statement a Senior Secured Convertible Note
dated March 21, 2023, referred to herein as the “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 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 March 21, 2025. The March 2023 Senior Convertible Note may be converted
into shares of common stock of the Company at the Holder’s election.
The
March 2023 Senior Convertible Note proceeds were $9.925 million after deducting a $1.186 million lender fee and offering costs. The lender
fee and offering costs were recognized as of the March 21, 2023 issue date as a current period expense in other income (expense) in the
Company’s unaudited condensed consolidated statement of operations.
During
the period from March 21, 2023 to September 20, 2023, Lucid is required to pay interest expense only (on the $11.1 million face value
principal), at 7.875% per annum, computed on a 360 day year. The Company paid in cash interest expense of $219 and $243 for the three
and six months ended June 30, 2023, respectively.
Note
11 — Debt - continued
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, the Company will be
required to make a principal repayment of $292 together with accrued interest thereon, with such 38 payments referred to herein as the
“Installment Amount”, settled in shares of common stock of the Company, subject to customary equity conditions, including
minimum share price and volume thresholds, or at the election of the Company, in cash, in whole or in part.
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 all of Lucid Diagnostics’ subsidiaries;
and the obligations under this senior convertible note are secured by all of the assets of Lucid Diagnostics 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) the Company’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) the Company’s market capitalization to at no time be less
than $30 million.
Note
12 — Stock-Based Compensation
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 below. The Lucid Diagnostics 2018 Equity Plan is designed to enable Lucid Diagnostics to offer
employees, officers, directors, and consultants, an opportunity to acquire shares of common stock of Lucid Diagnostics. The types of
awards that may be granted under the Lucid Diagnostics 2018 Equity Plan include stock options, stock appreciation rights, restricted
stock, and other stock-based awards subject to limitations under applicable law. All awards are subject to approval by the Lucid Diagnostics
compensation committee.
A
total of 11,644,000 shares of common stock of Lucid Diagnostics are reserved for issuance under the Lucid Diagnostics 2018 Equity Plan,
with 3,936,554 shares available for grant as of June 30, 2023. The share reservation is not diminished by a total of 423,300 stock
options and 50,000 restricted stock awards granted outside the Lucid Diagnostics 2018 Equity Plan, as of June 30, 2023.
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 Stock Options Issued and Outstanding Activities
| |
Number of Stock Options | | |
Weighted Average Exercise Price | | |
Remaining Contractual Term (Years) | | |
Intrinsic
Value(2) | |
Outstanding stock options at December 31, 2022 | |
| 2,565,377 | | |
$ | 3.14 | | |
| 8.3 | | |
$ | 428 | |
Granted(1) | |
| 2,732,500 | | |
$ | 1.31 | | |
| | | |
| | |
Exercised | |
| — | | |
$ | — | | |
| | | |
| | |
Forfeited | |
| (347,915 | ) | |
$ | 2.57 | | |
| | | |
| | |
Outstanding stock options at June 30, 2023(3) | |
| 4,949,962 | | |
$ | 2.17 | | |
| 8.7 | | |
$ | 641 | |
Vested and exercisable stock options at June 30, 2023 | |
| 1,374,179 | | |
$ | 2.76 | | |
| 6.9 | | |
$ | 440 | |
Note
12 — Stock-Based Compensation - continued
See
Note 4, Related Party Transactions, for a summary of the stock-based compensation expense recognized with respect to the stock
options granted under the Lucid Diagnostics 2018 Equity Plan to the Physician Inventors.
Lucid
Diagnostics Restricted Stock Awards
Lucid
Diagnostics restricted stock awards granted under the Lucid Diagnostics 2018 Equity Plan and restricted stock awards granted outside
such plan are summarized as follows:
Schedule
of Restricted Stock Award Activity
| |
Number of Restricted Stock Awards | | |
Weighted Average Grant Date Fair Value | |
Unvested restricted stock awards as of December 31, 2022(1) | |
| 2,091,420 | | |
$ | 11.44 | |
Granted | |
| — | | |
| — | |
Vested | |
| (219,320 | ) | |
| 11.27 | |
Forfeited | |
| — | | |
| — | |
Unvested restricted stock awards as of June 30, 2023 | |
| 1,872,100 | | |
$ | 11.46 | |
PAVmed
Inc. 2014 Equity Plan
The
PAVmed Inc. 2014 Long-Term Incentive Equity Plan (the “PAVmed 2014 Equity Plan”), is separate and apart from the Lucid Diagnostics
2018 Equity Plan (as such equity plan is discussed above).
Stock-Based
Compensation Expense
The
stock-based compensation expense recognized by the Company for both the Lucid Diagnostics 2018 Equity Plan and the PAVmed 2014 Equity
Plan, for the periods indicated, was as follows:
Schedule
of Stock-Based Compensation Expense
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Lucid Diagnostics 2018 Equity Plan – cost of revenue | |
$ | 16 | | |
$ | — | | |
$ | 28 | | |
$ | — | |
Lucid Diagnostics 2018 Equity Plan – sales and marketing | |
| 247 | | |
| 215 | | |
| 470 | | |
| 480 | |
Lucid Diagnostics 2018 Equity Plan - general and administrative | |
| 836 | | |
| 3,313 | | |
| 3,348 | | |
| 6,514 | |
Lucid Diagnostics 2018 Equity Plan - research and development | |
| 66 | | |
| 26 | | |
| 136 | | |
| 97 | |
PAVmed 2014 Equity Plan - cost of revenue | |
| 9 | | |
| — | | |
| 16 | | |
| — | |
PAVmed 2014 Equity Plan - sales and marketing | |
| 120 | | |
| 161 | | |
| 253 | | |
| 336 | |
PAVmed 2014 Equity Plan - general and administrative | |
| 8 | | |
| 77 | | |
| 164 | | |
| 145 | |
PAVmed 2014 Equity Plan - research and development | |
| 97 | | |
| 52 | | |
| 192 | | |
| 107 | |
Total stock-based compensation expense | |
$ | 1,399 | | |
$ | 3,844 | | |
$ | 4,607 | | |
$ | 7,679 | |
The
stock-based compensation expense, as presented above, is inclusive of: stock options and restricted stock awards granted under the Lucid
Diagnostics 2018 Equity Plan to employees of PAVmed, the Physician Inventors, and members of the board of directors of Lucid Diagnostics,
as well as the stock options granted under the PAVmed 2014 Equity Plan to the Physician Inventors.
Note
12 — Stock-Based Compensation - continued
As
of June 30, 2023, 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 Lucid Diagnostics 2018 Equity Plan and the PAVmed 2014 Equity Plan,
as discussed above, is as follows:
Schedule
of Unrecognized Compensation Expense and Weighted Average Remaining Service Period
| |
Unrecognized Expense | | |
Weighted Average Remaining Service Period (Years) | |
Lucid Diagnostics 2018 Equity Plan | |
| | | |
| | |
Stock Options | |
$ | 4,129 | | |
| 2.3 | |
Restricted Stock Awards | |
$ | 1,141 | | |
| 1.1 | |
PAVmed 2014 Equity Plan | |
| | | |
| | |
Stock Options | |
$ | 861 | | |
| 2.0 | |
Stock-based
compensation expense recognized with respect to stock options granted under the Lucid Diagnostics 2018 Equity Plan was based on a weighted
average estimated fair value of such stock options of $0.87 per share and $1.48 per share during the periods ended June 30, 2023
and 2022, respectively, calculated using the following weighted average Black-Scholes valuation model assumptions:
Schedule
of Stock-based Compensation Valuation Assumptions
| |
2023 | | |
2022 | |
| |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
Expected term of stock options (in years) | |
| 5.6 | | |
| 5.7 | |
Expected stock price volatility | |
| 75 | % | |
| 71 | % |
Risk free interest rate | |
| 3.7 | % | |
| 3.0 | % |
Expected dividend yield | |
| — | % | |
| — | % |
Lucid
Diagnostics Inc Employee Stock Purchase Plan (“Lucid ESPP”)
A
total of 231,987 shares of common stock of Lucid Diagnostics were purchased for proceeds of approximately $276 on March 31, 2023 under
the Lucid ESPP. The Lucid ESPP has a total reservation of 1,000,000 shares of common stock of which 683,983 shares are available-for-issue
as of June 30, 2023. In January 2023, the number of shares available-for-issue was increased by 500,000 in accordance with the evergreen
provisions of the plan.
Note
13 — Stockholders’ Equity
Series
A Preferred Stock Offering
On
March 7, 2023, the Company issued 13,625 shares of newly designated Series A Convertible Preferred Stock, par value $0.001 per share
(the “Series A Preferred Stock”), to accredited investors at a purchase price of $1,000 per share, for aggregate gross proceeds
to the Company of $13.625 million. In connection with the issuance the Company filed a Certificate of Designation of Preferences, Rights
and Limitations of the Series A Preferred Stock with the Secretary of State of the State of Delaware (the “Certificate of Designation”).
The key terms of the Series A Preferred Stock are as follows:
Each
share of Series A Preferred Stock is convertible at the option of the holder, subject to certain beneficial ownership limitations into
such number of shares of the Company’s common stock, equal to the number of Series A Preferred Shares to be converted, multiplied
by the stated value of $1,000 (the “Stated Value”), divided by the conversion price in effect at the time of the conversion.
The initial conversion price is $1.394, subject to adjustment in the event of stock splits, stock dividends, and similar transactions.
The Series A Preferred Stock is convertible into shares of our 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 our common stock on March 7, 2025, the second anniversary
of its issuance.
The
Series A Preferred Stock will be senior to the Common Stock and any other class of the Company’s capital stock that is not by its
terms senior to or pari passu with the Series A Preferred Stock.
Note
13 — Stockholders’ Equity - continued
The
holders of Series A Preferred Stock will be entitled to dividends payable as follows: (i) a number of shares of Common Stock equal to
20% of the number of shares of Common Stock issuable upon conversion of the Series A Preferred Stock then held by such Holder on March
7, 2024, and (ii) a number of shares of Common Stock equal to 20% of the number of shares of Common Stock issuable upon conversion of
the Series A Preferred Stock then held by such Holder on March 7, 2025. A holder that converts its Series A Preferred Stock prior to
March 7, 2024 or March 7, 2025, as the case may be, will not receive the dividend that accrues on such date with respect to such converted
Series A Preferred Stock. The holders of the Series A Preferred Stock also will be entitled to dividends equal, on an as-if-converted
to shares of Common Stock basis, to and in the same form as dividends actually paid on shares of the Common Stock when, as, and if such
dividends are paid on shares of the Common Stock.
In
the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company (or any Deemed Liquidation Event as defined
in the Certificate of Designation), the holders of shares of Series A Preferred Stock then outstanding will be entitled to be paid out
of the assets of the Company available for distribution to its stockholders, before any payment shall be made to the holders of Common
Stock by reason of their ownership thereof, an amount per share equal to the greater of (i) the Stated Value, plus any dividends accrued
but unpaid thereon, or (ii) such amount per share as would have been payable had all shares of Series A Preferred Stock been converted
into Common Stock immediately prior to such event.
The
Series A Preferred Stock is a non-voting security, other than with respect to limited matters related to changes in terms of the Series
A Preferred Stock.
The
Company will not effect any conversion of the Series A Preferred Stock, and a holder will not have the right to receive dividends or
convert any portion of the Series A Preferred Stock, to the extent that, after giving effect to the receipt of dividends or the conversion,
the holder (together with such holder’s affiliates, and any persons acting as a group together with such holder or any of the holder’s
affiliates) would beneficially own in excess of 4.99% of the Company’s outstanding common stock (or, upon election of the holder,
9.99% of the Company’s outstanding common stock).
The
Company and the investors in the offering also executed a registration rights agreement (the “Registration Rights Agreement”),
pursuant to which the Company agreed to file a registration statement covering the resale of the shares of Common Stock issuable pursuant
to the Series A Preferred Stock.
Lucid
Diagnostics Common Stock
In
June 2023, the Company received shareholder approval to issue up to 200 million shares of its common stock, an increase of 100 million
shares.
As
of June 30, 2023 and December 31, 2022 there were 41,853,603 and 40,518,792 shares of common stock issued and outstanding,
respectively. As of June 30, 2023, PAVmed holds 31,302,420 shares, representing a majority-interest equity ownership and PAVmed
has a controlling financial interest in the Company.
Committed
Equity Facility and ATM Facility
On
March 28, 2022, the Company entered into a committed equity facility with an affiliate of Cantor Fitzgerald (“Cantor”). Under
the terms of the committed equity facility, Cantor has committed to purchase up to $50 million of the Company’s common stock from
time to time at the request of the Company. While there are distinct differences, the facility is structured similarly to a traditional
at-the-market equity facility, insofar as it allows the Company to raise primary equity capital on a periodic basis at prices based on
the existing market price. Cumulatively a total of 680,263 shares of Lucid Diagnostics’ common stock were issued for net proceeds
of approximately $1.8 million, after a 4% discount, as of June 30, 2023.
In
November 2022, the Company entered into an “at-the-market offering” (“ATM”) for up to $6.5
million of its common stock that may be offered and sold under a Controlled Equity Offering Agreement between the Company and Cantor
Fitzgerald & Co. In the six months ended June 30, 2023, the Company sold 230,068
shares through the at-the-market equity facility for net proceeds of approximately $0.3
million, after payments of 3%
commissions. No shares were sold under the at-the-market equity facility during the three months ended June 30, 2023.
Note
14 — Net Loss Per Share
The
Net loss per share basic and diluted for the respective periods indicated is as follows:
Schedule
of Basic and Fully Diluted Net Loss Per Share
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Numerator | |
| | |
| | |
| | |
| |
Net loss | |
$ | (11,381 | ) | |
$ | (14,624 | ) | |
$ | (27,628 | ) | |
$ | (26,894 | ) |
| |
| | | |
| | | |
| | | |
| | |
Denominator | |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding, basic and diluted | |
| 41,833,823 | | |
| 35,760,492 | | |
| 41,404,547 | | |
| 35,443,526 | |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share | |
| | | |
| | | |
| | | |
| | |
Net loss per share - basic and diluted | |
$ | (0.27 | ) | |
$ | (0.41 | ) | |
$ | (0.67 | ) | |
$ | (0.76 | ) |
Basic
weighted-average number of shares of common stock outstanding for the periods ended June 30, 2023 and 2022 include the shares of
the Company issued and outstanding during such periods, each on a weighted average basis. The basic weighted average number of shares
common stock outstanding excludes common stock equivalent incremental shares, while diluted weighted average number of shares outstanding
includes such incremental shares. However, as the Company was in a loss position for all periods presented, basic and diluted weighted
average shares outstanding are the same, as the inclusion of the incremental shares would be anti-dilutive. The common stock equivalents
excluded from the computation of diluted weighted average shares outstanding are as follows:
Schedule
of Anti-dilutive Securities Excluded from Computation of Diluted Earnings Per Share
| |
2023 | | |
2022 | |
| |
June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Stock options | |
| 4,949,962 | | |
| 2,459,666 | |
Unvested restricted stock awards | |
| 1,872,100 | | |
| 2,260,740 | |
Preferred stock | |
| 13,695,850 | | |
| — | |
Total | |
| 20,517,912 | | |
| 4,720,406 | |
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The
following discussion and analysis of our unaudited condensed consolidated financial condition and results of operations should be read
together with our Annual Report on Form 10-K for the year ended December 31, 2022 (the “Form 10-K”), as filed with the
Securities and Exchange Commission (the “SEC”).
Unless
the context otherwise requires, references herein to (i) “we”, “us”, and “our”, and to the “Company”,
“Lucid” or “Lucid Diagnostics” are to the Company and its subsidiaries LucidDx Labs Inc. (“LucidDx Labs”)
and CapNostics, LLC (“CapNostics”), (ii) “FDA” are to the Food and Drug Administration, (iii) “510(k)”
are 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” are to the Clinical Laboratory Improvement Amendments of 1988 and associated
regulations set forth in 42 CFR § 493, and (v) “CE Mark” are to a “Conformité Européenne”
Mark, a mark indicating that a product such as a medical device conforms to the essential requirements of the relevant European directive.
FORWARD-LOOKING
STATEMENTS
This
Quarterly Report on Form 10-Q (this “Form 10-Q”) including the following discussion and analysis of our unaudited condensed
consolidated financial condition and results of operations, contains forward-looking statements that involve substantial risks and uncertainties.
All statements, other than statements of historical facts, contained in this Form 10-Q, including statements regarding our future results
of operations and financial position, business strategy and plans and objectives of management for future operations, are forward-looking
statements. The words “may,” “will,” “should,” “expects,” “plans,” “anticipates,”
“could,” “intends,” “target,” “projects,” “contemplates,” “believes,”
“estimates,” “predicts,” “potential” or “continue” or the negative of these terms or
other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these
identifying words. Forward-looking statements are not guarantees of future performance and the Company’s actual results may differ
significantly from those expressed or implied in the forward-looking statements. Factors that might cause such differences include, but are
not limited to, those discussed in Item 1A of Part I of the Form 10-K under the heading “Risk Factors.”
Important
factors that may affect our actual results include:
| ● | our
limited operating history; |
| ● | our
financial performance, including our ability to generate revenue; |
| ● | our
ability to obtain regulatory approval for the commercialization of our products; |
| ● | the
ability of our products to achieve market acceptance; |
| ● | our
success in retaining or recruiting, or changes required in, our officers, key employees or
directors; |
| ● | our
potential ability to obtain additional financing when and if needed; |
| ● | our
ability to protect our intellectual property; |
| ● | our
ability to complete strategic acquisitions; |
| ● | our
ability to manage growth and integrate acquired operations; |
| ● | the
potential liquidity and trading of our securities; |
| ● | our
regulatory and operational risks; |
| ● | cybersecurity
risks; |
| ● | risks
related to the COVID-19 pandemic and other health-related emergencies; |
| ● | risks
related to our relationship with PAVmed; and |
| ● | our
estimates regarding expenses, future revenue, capital requirements and needs for additional
financing. |
In
addition, our forward-looking statements do not reflect the potential impact of any future financings, acquisitions, mergers, dispositions,
joint ventures or investments we may make.
We
may not actually achieve the plans, intentions, and/or expectations disclosed in our forward-looking statements, and you should not place
undue reliance on our forward-looking statements. You should read this Form 10-Q, the documents we have filed as exhibits to this Form
10-Q, and the Form 10-K completely and with the understanding our actual future results may be materially different from what we expect.
We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise,
except as required by applicable law.
Overview
We
are a commercial-stage medical diagnostics technology company focused on the millions of patients with gastroesophageal reflux disease
(“GERD”), also known as chronic heartburn, acid reflux or simply reflux, who are at risk of developing esophageal precancer
and cancer, specifically highly lethal esophageal adenocarcinoma (“EAC”).
We
believe that our flagship product, the EsoGuard Esophageal DNA Test, performed on samples collected with the EsoCheck Esophageal Cell
Collection Device, constitutes the first and only commercially available diagnostic test capable of serving as a widespread tool for
the early detection of esophageal precancer, including Barrett’s Esophagus (“BE”), in at-risk GERD patients. Early detection of esophageal precancer allows patients to undergo
appropriate monitoring and treatment, as indicated by clinical practice guidelines, in an effort to prevent progression to esophageal
cancer.
EsoGuard
is a bisulfite-converted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck. It
quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient multicenter
case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal
precancer and all conditions along the BE-EAC spectrum, including on samples collected with EsoCheck (Moinova, et al. Sci Transl Med.
2018 Jan 17;10(424): eaao5848). EsoGuard is commercially available in the U.S. as a Laboratory Developed Test (LDT) performed at our
CLIA-certified laboratory. Cell samples, including those collected with EsoCheck, as discussed below, are sent to our laboratory, for
testing and analyses using EsoGuard.
Overview
- continued
EsoCheck
is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells
in a less than five-minute office. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from
which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the
balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted
region during device withdrawal. We believe this proprietary Collect+Protect™ technology makes EsoCheck the only noninvasive esophageal
cell collection device capable of such anatomically targeted and protected sampling.
EsoGuard
and EsoCheck are based on patented technology licensed by Lucid from Case Western Reserve University (“CWRU”). EsoGuard and
EsoCheck have been developed to provide an accurate, non-invasive, patient-friendly test for the early detection of EAC and BE,
including dysplastic BE and related precursors to EAC in patients with chronic GERD.
Recent
Developments
Business
Status
of Clinical Trials
Lucid
is currently seeking to accelerate its collection of clinical utility data through a range of trials that can be efficiently
executed. These efforts include a planned investigator-initiated, retrospective analysis of prospectively collected data on the 391
San Antonio fire fighters who underwent testing as part of a community-sponsored cancer awareness event described below (in respect
of which we expect to publish results in the second half of 2023); a virtual-patient randomized controlled trial with intended
recruitment of at least 100 physician participants (in respect of which we expect to publish results this year); a Lucid-sponsored
multi-center, prospective, observational study with 500 patients; and a Lucid-sponsored registry at existing Lucid Test Centers,
whereby all patients undergoing EsoCheck testing will be given the opportunity to provide informed consent and contribute data about
their risk factors, EsoGuard results, and subsequent diagnostic and/or therapeutic journey. Both Lucid-sponsored
observational/registry studies expect to have preliminary results and/or interim analysis submitted for peer review before the end
of 2023.
#CheckYourFoodTube
Events
In
January 2023, Lucid completed its first #CheckYourFoodTube Precancer Testing Event, with the San Antonio Fire Department (the “SAFD”)
during Firefighter Cancer Awareness Month as designated by the International Association of Fire Fighters (IAFF). A total of 391 members
who were deemed to be at-risk for esophageal precancer, underwent a brief, on-site, noninvasive cell collection procedure, performed
by our clinical personnel using EsoCheck. Firefighters with suspected esophageal precancer based on a positive EsoGuard result were identified,
including some less than 40 years of age, and will undergo appropriate monitoring and treatment, as indicated by clinical practice guidelines,
to prevent progression to esophageal cancer.
Since
then, additional testing events have been hosted with the SAFD, and similar events have been held with fire departments throughout the
country. These events are ongoing and are an extension of Lucid’s satellite Lucid Test Center (“sLTC”) program,
which brings Lucid precancer testing directly to patients—at their physician’s office and now at testing day events.
Launch
of EsoGuard #CheckYourFoodTube Mobile Testing Unit
In
June 2023, Lucid launched its first EsoGuard #CheckYourFoodTube Mobile Test Unit (“mobile testing unit”),
with the inaugural mobile testing unit event being held in Sarasota, Florida. The mobile testing unit is another channel
by which we are bringing EsoGuard testing to at-risk patients.
Launch
of Direct Contracting Strategic Initiative
In
March 2023, we launched a Direct Contracting Strategic Initiative (“DCSI”) to engage directly with large Administrative Services Only (“ASO”)
self-insured employers, unions and other entities, seeking to replicate the successes of other cancer screening diagnostic companies
that have deployed similar strategies. In August 2023, the company announced it had contracted with the Ancira Automotive Group as a result of
this initiative, providing access to esophageal precancer testing for its employees at all 12 San Antonio locations.
New Revenue Cycle Management Provider
In May 2023, Lucid began to transition claims submission responsibility to a new revenue cycle management provider
that offered more robust capabilities for, among other things, claims processing and appeals. The provider upgrade has been completed
and claim submissions resumed in June 2023. Since completing the transition, the upgrade has demonstrated an improvement in speed of collections,
turnaround time to claim submission, percentage of claims paid, and actionable data for appeals.
Financing
Series
A Preferred Stock Offering
On
March 7, 2023, we entered into subscription agreements for the sale of 13,625 shares of Series A convertible preferred stock, par value
$0.001 per share (the “Series A Preferred Stock”). Each share of the Series A Preferred Stock has a stated value of $1,000
and a conversion price of $1.394. The Series A Preferred Stock is convertible into shares of our common stock at any time at the option
of the holder from and after the six-month anniversary of its issuance (or, if later, the effective date of an increase in our authorized share capital or the effective date of a registration
statement covering the resale of the underlying shares), and automatically converts into shares of our common stock on
the second anniversary of its issuance. The terms of the Series A Preferred Stock also include a preference on liquidation and a right
to receive dividends equal to 20% of the number of shares into which such Series A Preferred Stock is convertible, payable on each of
the one-year and two-year anniversary of the issuance date. The Series A Preferred Stock is a non-voting security, other than with respect
to limited matters related to changes in terms of the Series A Preferred Stock. The aggregate gross proceeds from the sale of shares
in such offering were $13.625 million.
Private
Placement - Securities Purchase Agreement
Effective
as of March 13, 2023, we entered into a Securities Purchase Agreement (“SPA”) with an accredited institutional investor, pursuant to which we agreed to sell, and the investor agreed to purchase, a Senior
Secured Convertible Note with a face value principal of $11.1 million (the “March 2023 Senior Convertible Note”). We issued
the March 2023 Senior Convertible Note on March 21, 2023 pursuant to the SPA. The March 2023 Senior Convertible Note proceeds were $9.925
million after deducting a $1.186 million lender fee and offering costs.
The
March 2023 Senior Secured Convertible Note has a 7.875% annual stated interest rate, a contractual conversion price of $5.00 per share
of the Company’s common stock (subject to standard adjustments in the event of any stock split, stock dividend, stock combination,
recapitalization or other similar transaction), and a contractual maturity date of the two-year anniversary of the date of issuance.
The principal and interest on the March 2023 Senior Convertible Note is convertible into or otherwise payable in shares of the Company’s
common stock (subject to the satisfaction of certain customary equity conditions and except for interest payable prior to September 21,
2023).
Under
the March 2023 Senior Convertible Note, the Company 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 March 2023 Senior Convertible Note, the Company is also subject to financial covenants
requiring that (i) the amount of our 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 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) the Company’s average market capitalization over the prior
ten trading days, not exceed 30%, and (iii) that the Company’s market capitalization shall at no time be less than $30 million.
ATM
Facility
In
November 2022, Lucid Diagnostics entered into an “at-the-market offering” for up to $6.5 million of its common stock
that may be offered and sold under a Controlled Equity Offering Agreement between Lucid Diagnostics and Cantor Fitzgerald & Co. (“Cantor”).
In the six months ended June 30, 2023, we sold 230,068 shares through our at-the-market equity facility for net proceeds of approximately
$0.3 million, after payment of 3% commissions. No shares were sold through our at-the-market equity facility during the three months ended June 30, 2023.
Results
of Operations
Overview
Revenue
The
Company recognized revenue resulting from the delivery of patient EsoGuard test results when the Company considered the collection of
such consideration to be probable to the extent that it is unconstrained. Additionally, in the three months ended March 31, 2022, revenue
was recognized with respect to the EsoGuard Commercialization Agreement, dated August 1, 2021, between the Company and RDx, a CLIA certified
commercial laboratory service provider. On February 25, 2022, the EsoGuard Commercialization Agreement was terminated upon the execution
of the APA-RDx.
Cost
of revenue
Cost
of revenues recognized from the delivery of patient EsoGuard test results includes costs related to EsoCheck device usage, shipment of
test collection kits, royalties and the cost of services to process tests and provide results to physicians. We incur expenses for tests
in the period in which the activities occur, therefore, gross margin as a percentage of revenue may vary from quarter to quarter due
to costs being incurred in one period that relate to revenues recognized in a later period.
We
expect that gross margin for our services will continue to fluctuate and be affected by EsoGuard test volume, our operating efficiencies,
patient compliance rates, payer mix, the levels of reimbursement, and payment patterns of payers and patients.
For
the previously terminated EsoGuard Commercialization Agreement in February 2022, the cost of revenue recognized is inclusive of: a
royalty fee incurred under the Amended CWRU License Agreement (as defined in Note 4, Related Party Transactions, to our
accompanying unaudited condensed consolidated financial statements); the cost of EsoCheck devices and EsoGuard mailers (cell sample
shipping costs); and Lucid Test Centers operating expenses, including rent expense and supplies.
Sales
and marketing expenses
Sales
and marketing expenses consist primarily of salaries and related costs for employees engaged in sales and marketing activities, as well
as the portion of the MSA Fee allocated to sales and marketing expenses, which are principally costs related to PAVmed employees who
are performing services for the Company. 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 professional fees for accounting, tax, audit and legal services (including those fees
incurred as a result of our being a public company), consulting fees, expenses associated with obtaining and maintaining patents within
our intellectual property portfolio, and certain employee costs, along with the portion of the MSA Fee (as defined in Note 4, Related
Party Transactions, to our accompanying unaudited condensed consolidated financial statements) allocated to general and administrative
expenses.
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 technologies and conducting clinical trials, including:
| ● | costs
associated with regulatory filings; |
| ● | patent
license fees; |
| ● | cost
of laboratory supplies and acquiring, developing, and manufacturing preclinical prototypes;
and |
| ● | MSA
Fee allocated to research and development. |
We
plan to incur research and development expenses for the foreseeable future as we continue the development of our existing products as
well as new innovations. Our research and development activities, including our clinical trials, are focused principally on facilitating insurer reimbursement, encouraging physician adoption and developing product improvements or extending the
utility of the lead products in our pipeline, including EsoCheck and EsoGuard.
Results
of Operations - continued
Overview
- continued
Presentation
of Dollar Amounts
All
dollar amounts in this Management’s Discussion and Analysis of Financial Condition and Results of Operations are presented as dollars
in millions, except for share and per share amounts.
Three
months ended June 30, 2023 as compared to three months ended June 30, 2022
Revenue
In
the three months ended June 30, 2023, revenue was $0.2 million as compared to $0.0 million for the corresponding period in the prior
year. The $0.2 million increase principally relates to the revenue for our EsoGuard Esophageal DNA Test performed in our own CLIA laboratory,
as compared to revenue from the EsoGuard Commercialization Agreement with RDx, in the prior year period, which was terminated on February
25, 2022 when the Company transitioned to its own laboratory operations.
Cost
of revenue
In
the three months ended June 30, 2023, cost of revenue was approximately $1.5 million as compared to $0.0 million for the corresponding
period in the prior year. The $1.5 million increase was principally related to:
| ● | approximately
$0.6 million increase in laboratory facility and operations costs; |
| ● | approximately
$0.5 million increase in EsoCheck and EsoGuard supplies costs; and |
| ● | approximately
$0.4 million increase in compensation related costs. |
Sales
and marketing expenses
In
the three months ended June 30, 2023, sales and marketing costs were approximately $4.0 million as compared to $3.9 million for
the corresponding period in the prior year. The net increase of $0.1 million was principally related to:
| ● | approximately
$0.6 million increase in compensation related costs principally as a result of an increase
in headcount; |
| ● | approximately
$0.1 million increase in facility costs; and |
| ● | approximately
$0.6 million decrease in third party marketing expenses. |
General
and administrative expenses
In
the three months ended June 30, 2023, general and administrative costs were approximately $3.8 million as compared to $6.7 million
for the corresponding period in the prior year. The net decrease of $2.8 million was principally related to:
| ● | approximately
$0.9 million increase related to the amended MSA with PAVmed due to the growth
and expansion of our business and the services incurred through PAVmed; |
| ● | approximately
$2.5 million decrease in stock-based compensation from RSA and stock option grants to Lucid
employees and non-employees; and |
| ● | approximately
$1.2 million decrease related to the termination of the MSA-RDx and lower general business expenses
primarily related to reduced insurance premiums and reduced third-party consulting fees and
professional recruiting services. |
Results
of Operations - continued
Three
months ended June 30, 2023 as compared to three months ended June 30, 2022 - continued
Research
and development expenses
In
the three months ended June 30, 2023, research and development costs were approximately $1.8 million, compared to $3.4 million for
the corresponding period in the prior year. The net decrease of $1.6 million was principally related to:
| ● | approximately
$1.8 million decrease in development costs, particularly in clinical trial activities and
outside professional and consulting fees with respect to EsoCure; and |
| ● | approximately
$0.2 million increase in compensation related costs. |
Amortization
of Acquired Intangible Assets
The
amortization of acquired intangible assets remained relatively level in the three months ended June 30, 2023, as compared to the
corresponding period in the prior year.
Other
Income and Expense
Change
in fair value of convertible debt
In
the three months ended June 30, 2023, the change in the fair value of our convertible note was approximately $0.3 million of income,
related to the March 2023 Senior Convertible Note. The March 2023 Convertible Note was initially measured at its issue-date estimated
fair value and subsequently remeasured at estimated fair value as of the reporting period date. The Company initially recognized a $0.8
million fair value non-cash expense on the issue date.
See
Note 11, Debt, to our accompanying unaudited condensed consolidated financial statements, for additional information with respect
to the March 2023 Senior Convertible Note.
Results
of Operations - continued
Six
months ended June 30, 2023 as compared to six months ended June 30, 2022
Revenue
In
the six months ended June 30, 2023, revenue was $0.6 million as compared to $0.2 million for the corresponding period in the prior
year. The $0.4 million increase principally relates to the revenue for our EsoGuard Esophageal DNA Test performed in our own CLIA laboratory,
as compared to revenue from the EsoGuard Commercialization Agreement with RDx, in the prior year period, which was terminated on February
25, 2022 when the Company transitioned to its own laboratory operations.
Cost
of revenue
In
the six months ended June 30, 2023, cost of revenue was approximately $2.9 million as compared to $0.4 million for the corresponding
period in the prior year. The $2.5 million increase was principally related to:
| ● | approximately
$1.1 million increase in laboratory facility and operations costs; |
| ● | approximately
$0.9 million increase in EsoCheck and EsoGuard supplies costs; and |
| ● | approximately
$0.5 million increase in compensation related costs. |
Sales
and marketing expenses
In
the six months ended June 30, 2023, sales and marketing costs were approximately $8.2 million as compared to $7.2 million for the
corresponding period in the prior year. The net increase of $1.0 million was principally related to:
| ● | approximately
$1.9 million increase in compensation related costs principally as a result of an increase
in headcount; and |
| ● | approximately
$0.9 million decrease in third party marketing expenses. |
General
and administrative expenses
In
the six months ended June 30, 2023, general and administrative costs were approximately $10.3 million as compared to $12.6 million
for the corresponding period in the prior year. The net decrease of $2.3 million was principally related to:
| ● | approximately
$1.8 million increase related to the amended MSA with PAVmed due to the growth
and expansion of our business and the services incurred through PAVmed; |
| ● | approximately
$3.1 million decrease in stock-based compensation from RSA and stock option grants to Lucid
employees and non-employees; and |
| ● | approximately
$1.0 million decrease related to the termination of the MSA-RDx and lower general business expenses primarily related to reduced
insurance premiums and reduced third-party consulting fees and professional recruiting services. |
Results
of Operations - continued
Six
months ended June 30, 2023 as compared to six months ended June 30, 2022 - continued
Research
and development expenses
In
the six months ended June 30, 2023, research and development costs were approximately $4.1 million, compared to $6.3 million for
the corresponding period in the prior year. The net decrease of $2.2 million was principally related to:
| ● | approximately
$2.9 million decrease in development costs, particularly in clinical trial activities and
outside professional and consulting fees with respect to EsoCure; |
| ● | approximately
$0.5 million increase related to the amended MSA with PAVmed due to the
growth and expansion of our business and the services incurred through PAVmed; and |
| ● | approximately
$0.2 million increase in compensation related costs. |
Amortization
of Acquired Intangible Assets
The
amortization of acquired intangible assets remained relatively level in the six months ended June 30, 2023, as compared to the
corresponding period in the prior year.
Other
Income and Expense
Change
in fair value of convertible debt
In
the six months ended June 30, 2023, the change in the fair value of our convertible note was approximately $0.5 million of
expense, related to the March 2023 Senior Convertible Note. The March 2023 Convertible Note was initially measured at its issue date
estimated fair value and subsequently remeasured at estimated fair value as of the reporting period date. The Company initially
recognized a $0.8 million fair value non-cash expense on the issue date.
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 March 2023 Senior Convertible Note, we recognized a total
of approximately $1.2 million of lender fee and offering costs paid by us.
See
Note 11, Debt, to our accompanying unaudited condensed consolidated financial statements, for additional information with respect
to the March 2023 Senior Convertible Note.
Liquidity
and Capital Resources
Our
current operational activities are principally focused on the commercialization of EsoGuard. We are pursuing commercialization across
multiple sales channels, including: the communication to and education of medical practitioners and clinicians regarding EsoGuard; the
establishment of Lucid Diagnostics Test Centers for the collection of cell samples using EsoCheck; the launch of the mobile testing unit;
ongoing #CheckYourFoodTube testing days; and our direct contracting strategic initiative. Additionally, we are developing expanded clinical
evidence to support insurance reimbursement adoption by government and private insurers. Further, as resources permit, the Company also
intends to pursue development of other products and services, including EsoCure, an Esophageal Ablation Device.
Our
ability to generate revenue depends upon our ability to successfully advance the commercialization of EsoGuard, including
significantly expanding insurance reimbursement coverage, while also completing the clinical studies, product and service
development, and necessary regulatory approval thereof. There are no assurances, however, we will be able to obtain an adequate
level of financial resources required for the long-term commercialization and development of our products and services.
We
are 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. We experienced a net loss of approximately $27.6 million and used approximately $14.1 million of cash in
operations for the six months ended June 30, 2023. Financing activities provided $24.2 million of cash during the six months ended
June 30, 2023. We ended the quarter with cash on-hand of $32.6 million as of June 30, 2023. We expect to continue to experience
recurring losses and negative cash flow from operations and will continue to fund our operations with debt and equity financing transactions.
Notwithstanding, however, with our cash on-hand as of the date hereof and the committed equity sources of financing described below,
the Company expects to be able to fund its operations and meet its financial obligations as they become due for the one year period from
the date of the issue of the Company’s unaudited condensed consolidated financial statements, as included herein in this Form 10-Q.
Series
A Preferred Stock Offering
On
March 7, 2023, we entered into subscription agreements for the sale of 13,625 shares of Series A Preferred Stock. Each share of the Series
A Preferred Stock has a stated value of $1,000 and a conversion price of $1.394. The Series A Preferred Stock is convertible into shares
of our common stock at any time at the option of the holder from and after the six-month anniversary of its issuance (or, if later, the effective date of an increase in our authorized share capital or the effective date of a registration
statement covering the resale of the underlying shares), and automatically
converts into shares of our common stock on the second anniversary of its issuance. The terms of the Series A Preferred Stock also include
a preference on liquidation and a right to receive dividends equal to 20% of the number of shares into which such Series A Preferred
Stock is convertible, payable on each of the one-year and two-year anniversary of the issuance date. The Series A Preferred Stock is
a non-voting security, other than with respect to limited matters related to changes in terms of the Series A Preferred Stock. The aggregate
gross proceeds from the sale of shares in such offering were $13.625 million.
Private
Placement - Securities Purchase Agreement
Effective
as of March 13, 2023, we entered into the SPA with an accredited institutional investor, pursuant to which we agreed to sell, and the investor agreed to purchase the March 2023 Senior
Secured Convertible Note with a face value principal of $11.1 million. We issued
the March 2023 Senior Convertible Note on March 21, 2023 pursuant to the SPA. The March 2023 Senior Convertible Note proceeds were
$9.925 million after deducting a $1.186 million lender fee and offering costs.
The
March 2023 Senior Secured Convertible Note has a 7.875% annual stated interest rate, a contractual conversion price of $5.00 per share
of the Company’s common stock (subject to standard adjustments in the event of any stock split, stock dividend, stock combination,
recapitalization or other similar transaction), and a contractual maturity date of the two-year anniversary of the date of issuance.
The principal and interest on the March 2023 Senior Convertible Note is convertible into or otherwise payable in shares of the Company’s
common stock (subject to the satisfaction of certain customary equity conditions and except for interest payable prior to September 21,
2023).
Under
the March 2023 Senior Convertible Note, the Company 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 March 2023 Senior Convertible Note, the Company is also subject to financial covenants
requiring that (i) the amount of our 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 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) the Company’s average market capitalization over the prior
ten trading days, not exceed 30%, and (iii) that the Company’s market capitalization shall at no time be less than $30 million
(the “Financial Tests”). As of June 30, 2023, the Company was in compliance, and as of the date hereof, the
Company is in compliance, with the Financial Tests.
Committed
Equity Facility and ATM Facility
In
March 2022, we 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 our common stock from time to time at our 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
us 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 common stock of the Company were issued for net proceeds of approximately $1.8 million, after a 4% discount, as
of June 30, 2023. No shares were sold through this facility during the three months ended June 30, 2023.
In
November 2022, Lucid Diagnostics also entered into an “at-the-market offering” for up to $6.5 million of its common
stock that may be offered and sold under a Controlled Equity Offering Agreement between Lucid Diagnostics and Cantor. In the six
months ended June 30, 2023, we sold 230,068 shares through our at-the-market equity facility for net proceeds of approximately
$0.3 million, after payment of 3% commissions. No shares were sold through our at-the-market equity facility during the three months
ended June 30, 2023.
Due
To: PAVmed Inc.
Since
our inception in May 2018 through our IPO in October 2021, our operations were funded by PAVmed providing working capital cash advances
and by PAVmed paying certain operating expenses on our behalf. Additionally, our daily operations have been and continue to be
conducted in part by personnel employed by PAVmed, for which we incur an MSA Fee expense. The MSA Fee is charged on a monthly basis and
is subject-to periodic adjustment corresponding with changes in the services provided by PAVmed personnel to the Company, with any such
change in the MSA Fee being subject to approval of the Company and PAVmed boards of directors. In this regard, in May 2023, the respective
companies’ boards of directors approved a seventh amendment to the MSA to increase the MSA Fee to $750 per month, effective January
1, 2023. Pursuant to the MSA, as amended by the seventh amendment, the parties agreed PAVmed may elect to receive payment of the monthly
MSA Fee in cash or in shares of our common stock, with such shares valued at the volume weighted average price (“VWAP”) during
the final ten trading days of the applicable month (subject to a floor price of $0.70 per share). However, in no event will PAVmed be
entitled to receive under the MSA, as amended, more than 7,709,836 shares of our common stock (representing 19.99% of our outstanding
shares of common stock as of immediately prior to the execution of the sixth amendment).
In
addition, on November 30, 2022, PAVmed and we entered into a payroll and benefit expense reimbursement agreement (the “PBERA”).
Historically, PAVmed has paid for certain payroll and benefit-related expenses in respect of our personnel on our behalf, and we have
reimbursed PAVmed for the same. Pursuant to the PBERA, PAVmed will continue to pay such expenses, and we will continue to reimburse PAVmed
for the same. The PBERA provides that the expenses will be reimbursed on a quarterly basis or at such other frequency as the parties
may determine, in cash or, subject to approval by PAVmed’s and our boards of directors, in shares of our common stock, with such
shares valued at the volume weighted average price of such stock during the final ten trading days preceding the later of the two dates
on which such stock issuance is approved by PAVmed’s and our boards of directors (subject to a floor price of $0.40 per share),
or in a combination of cash and shares. However, in no event will we issue any shares of our common stock to PAVmed in satisfaction of
all or any portion of the expenses if the issuance of such shares of our common stock would exceed the maximum number of shares of common
stock that we may issue under the rules or regulations of Nasdaq, unless we obtain the approval of our stockholders as required by the
applicable rules of the Nasdaq for issuances of shares of our common stock in excess of such amount.
As
of June 30, 2023, we had a Due To: PAVmed Inc. payment obligation liability of approximately $10.7 million, which liability is
primarily comprised of our obligations under the PBERA and the MSA, as well other operating expenses paid by PAVmed on our
behalf. See our accompanying unaudited condensed consolidated financial statements Note 5, Due To PAVmed Inc.
Critical
Accounting Policies and Significant Judgments and Estimates
The
discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial
statements, which have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S.
GAAP”). The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions
that affect the amounts reporting in our unaudited condensed consolidated financial statements and accompanying notes. On an ongoing
basis, we evaluate our estimates and judgements. In accordance with U.S. GAAP, we base our estimates on historical experience and on
various other factors that are believed to be appropriate under the circumstances. Actual results may differ from these estimates under
different assumptions or conditions. Our critical accounting policies are as disclosed in the Company’s Annual Report on Form 10-K
for the year ended December 31, 2022 as filed with the SEC on March 14, 2023, except as otherwise noted in “Fair Value Option (“FVO”)
Election” subsection of Note 2, Summary of Significant Accounting Policies, to our unaudited condensed consolidated financial
statements included herein in this Form 10-Q with respect to the March 2023 Senior Convertible Note. We determined upon the issuance
of our March 2023 Senior Convertible Note to elect the fair value option. At issuance, the carrying value of the March 2023 Senior Convertible
Note was recorded at estimated fair value. The estimated fair values reported utilized Lucid’s common stock price along with certain
Level 3 inputs, 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 Company’s
common stock price, the Company’s dividend yield, the risk-free rates based on U.S. Treasury security yields, and certain other
Level-3 inputs including, assumptions regarding the estimated volatility in the value of the Company’s common stock price. We remeasure
the March 2023 Senior Convertible Note to its estimated fair value at each reporting period using valuation techniques similar to those
applied at issuance. The change in the fair value is recognized as other income (expense) in the statement of operations. A significant
change in the volatility could have a material impact to the carrying value of the March 2023 Senior Convertible Note as well as the
amount of change recognized during the period.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our principal executive officer and our principal financial officer, evaluated the effectiveness
of our disclosure controls and procedures as of June 30, 2023. Based on such evaluation, our principal executive officer and principal
financial officer concluded our disclosure controls and procedures (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act)
were effective as of such date to provide reasonable assurance the information required to be disclosed by us in the reports we file
or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s
rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure information
required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management,
including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required
disclosure.
Changes
to Internal Controls Over Financial Reporting
There
has been no change in internal controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act)
that occurred during our fiscal quarter ended June 30, 2023 that has materially affected, or is reasonably likely to materially
affect, our internals control over financial reporting.
Part
II - Other Information
Item
1. Legal Proceedings
In
the ordinary course of our business, particularly as it begins commercialization of its products, the Company may be subject to
certain other legal actions and claims, including product liability, consumer, commercial, tax and governmental matters, which may
arise from time to time. 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, we did not sell any unregistered securities or repurchase any of our securities
during the three months ended June 30, 2023.
On
October 14, 2021, we completed our initial public offering (“IPO”) of our common stock under an effective registration statement
on Form S-1 (SEC File No. 333-259721). As of June 30, 2023, of the net proceeds of $64.4 million, approximately $57.5 million has been
used, in a manner consistent with the use of proceeds set forth in the prospectus for our IPO, as follows: approximately $5.3 million
of net repayments of Due To: PAVmed Inc.; approximately $5.0 million for the purchase of our laboratory equipment, software, and its
operating expenses; and $47.2 million of working capital expenditures. None of the proceeds have been paid to any of our directors, officers,
10% stockholders, or affiliates, other than as described above.
Item
5. Other Information
None.
Item
6. Exhibits
The
exhibits filed as part of this Quarterly Report on Form 10-Q are set forth in the “Exhibit Index” below.
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.
|
Lucid
Diagnostics Inc. |
|
|
|
August
14, 2023 |
By: |
/s/
Dennis M McGrath |
|
|
Dennis
M McGrath |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial and Accounting Officer) |
EXHIBIT
INDEX
*
Filed herewith.
‡
Certain exhibits and schedules have been omitted pursuant to Item 601(b)(10) of Regulation S-K. The registrant hereby undertakes to furnish
supplementally a copy of any omitted exhibit or schedule upon request by the Securities and Exchange Commission.
Exhibit
31.1
CERTIFICATION
BY PRINCIPAL EXECUTIVE OFFICER
I,
Lishan Aklog, M.D., certify that:
1 |
I
have reviewed this Quarterly Report on Form 10-Q of Lucid Diagnostics Inc. and Subsidiaries; |
|
|
2 |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3 |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4 |
The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a) |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b) |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
d) |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5 |
The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions): |
|
a) |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b) |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
August 14, 2023 |
By: |
/s/
Lishan Aklog, M.D. |
|
|
Lishan
Aklog, M.D., Chief Executive Officer
(Principal
Executive Officer) |
Exhibit
31.2
CERTIFICATION
BY PRINCIPAL FINANCIAL OFFICER
I,
Dennis M. McGrath, certify that:
1 |
I
have reviewed this Quarterly Report on Form 10-Q of Lucid Diagnostics Inc. and Subsidiaries; |
|
|
2 |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3 |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4 |
The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a) |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b) |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
d) |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5 |
The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions): |
|
a) |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b) |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
August 14, 2023 |
By: |
/s/
Dennis M. McGrath |
|
|
Dennis
M. McGrath
Chief
Financial Officer
(Principal
Financial and Accounting Officer) |
Exhibit
32.1
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report on Form 10-Q of Lucid Diagnostics Inc. and Subsidiaries (the “Company”) for the quarter
ended June 30, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the
undersigned, Lishan Aklog, M.D., Chief Executive Officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, that to
his knowledge:
(1) |
the
Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
(2) |
the
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company. |
Date:
August 14, 2023 |
By: |
/s/
Lishan Aklog, M.D. |
|
|
Lishan
Aklog, M.D.
Chief
Executive Officer
(Principal
Executive Officer) |
Exhibit
32.2
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report on Form 10-Q of Lucid Diagnostics Inc. and Subsidiaries (the “Company”) for the quarter
ended June 30, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the
undersigned, Dennis M. McGrath, President and Chief Financial Officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section
1350, that to his knowledge:
(1) |
the
Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
(2) |
the
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company. |
Date:
August 14, 2023 |
By: |
/s/
Dennis M. McGrath |
|
|
Dennis
M. McGrath
Chief
Financial Officer
(Principal
Financial and Accounting Officer) |
v3.23.2
Cover - shares
|
6 Months Ended |
|
Jun. 30, 2023 |
Aug. 10, 2023 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
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|
|
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false
|
|
Document Period End Date |
Jun. 30, 2023
|
|
Document Fiscal Period Focus |
Q2
|
|
Document Fiscal Year Focus |
2023
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-40901
|
|
Entity Registrant Name |
LUCID
DIAGNOSTICS INC.
|
|
Entity Central Index Key |
0001799011
|
|
Entity Tax Identification Number |
82-5488042
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
360
Madison Avenue
|
|
Entity Address, Address Line Two |
25th
Floor
|
|
Entity Address, City or Town |
New
York
|
|
Entity Address, State or Province |
NY
|
|
Entity Address, Postal Zip Code |
10017
|
|
City Area Code |
(212)
|
|
Local Phone Number |
949-4319
|
|
Title of 12(b) Security |
Common
Stock, $0.001 par value per share
|
|
Trading Symbol |
LUCD
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
|
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|
|
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|
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v3.23.2
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Current assets: |
|
|
Cash |
$ 32,570
|
$ 22,474
|
Accounts receivable |
35
|
17
|
Prepaid expenses, deposits, and other current assets |
3,144
|
1,865
|
Total current assets |
35,749
|
24,356
|
Fixed assets, net |
1,389
|
1,592
|
Operating lease right-of-use assets |
1,835
|
2,008
|
Intangible assets, net |
2,435
|
3,445
|
Other assets |
1,078
|
1,108
|
Total assets |
42,486
|
32,509
|
Current liabilities: |
|
|
Accounts payable |
637
|
1,056
|
Accrued expenses and other current liabilities |
2,640
|
1,447
|
Operating lease liabilities, current portion |
1,099
|
962
|
Senior Secured Convertible Note - at fair value |
11,610
|
|
Due To: PAVmed Inc. - MSA Fee and operating expenses |
10,697
|
4,960
|
Total current liabilities |
26,683
|
8,425
|
Operating lease liabilities, less current portion |
732
|
1,037
|
Total liabilities |
27,415
|
9,462
|
Commitments and contingencies |
|
|
Stockholders’ Equity: |
|
|
Preferred stock, $0.001 par value, 20,000,000 shares authorized; Series A Convertible Preferred Stock, issued and outstanding 13,625 at June 30, 2023 and no shares issued and outstanding at December 31, 2022 |
13,625
|
|
Common stock, $0.001 par value, 200,000,000 shares authorized; 41,853,603 and 40,518,792 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively |
42
|
41
|
Additional paid-in capital |
127,107
|
121,081
|
Accumulated deficit |
(125,703)
|
(98,075)
|
Total Stockholders’ Equity |
15,071
|
23,047
|
Total Liabilities and Stockholders’ Equity |
$ 42,486
|
$ 32,509
|
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v3.23.2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Preferred stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, shares authorized |
20,000,000
|
20,000,000
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
200,000,000
|
200,000,000
|
Common stock, shares issued |
41,853,603
|
40,518,792
|
Common stock, shares outstanding |
41,853,603
|
40,518,792
|
Series A Preferred Stock [Member] |
|
|
Preferred stock, shares issued |
13,625
|
0
|
Preferred stock, shares outstanding |
13,625
|
0
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.2
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
Revenue |
$ 159
|
|
$ 605
|
$ 189
|
Operating expenses: |
|
|
|
|
Cost of revenue |
1,549
|
|
2,887
|
369
|
Sales and marketing |
4,032
|
3,873
|
8,159
|
7,191
|
General and administrative |
3,830
|
6,676
|
10,340
|
12,568
|
Amortization of acquired intangible assets |
505
|
639
|
1,010
|
639
|
Research and development |
1,827
|
3,440
|
4,109
|
6,321
|
Total operating expenses |
11,743
|
14,628
|
26,505
|
27,088
|
Operating loss |
(11,584)
|
(14,628)
|
(25,900)
|
(26,899)
|
Other income (expense): |
|
|
|
|
Interest income |
136
|
4
|
214
|
5
|
Interest expense |
(223)
|
|
(257)
|
|
Change in fair value - Senior Secured Convertible Note |
290
|
|
(499)
|
|
Loss on issue and offering costs - Senior Secured Convertible Note |
|
|
(1,186)
|
|
Other income (expense), net |
203
|
4
|
(1,728)
|
5
|
Loss before provision for income tax |
(11,381)
|
(14,624)
|
(27,628)
|
(26,894)
|
Provision for income taxes |
|
|
|
|
Net loss |
$ (11,381)
|
$ (14,624)
|
$ (27,628)
|
$ (26,894)
|
Net loss per share - basic |
$ (0.27)
|
$ (0.41)
|
$ (0.67)
|
$ (0.76)
|
Net loss per share - diluted |
$ (0.27)
|
$ (0.41)
|
$ (0.67)
|
$ (0.76)
|
Weighted average common shares outstanding, basic |
41,833,823
|
35,760,492
|
41,404,547
|
35,443,526
|
Weighted average common shares outstanding, diluted |
41,833,823
|
35,760,492
|
41,404,547
|
35,443,526
|
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v3.23.2
Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit) (Unaudited) - USD ($) $ in Thousands |
Preferred Stock [Member] |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2021 |
|
$ 35
|
$ 96,608
|
$ (41,904)
|
$ 54,739
|
Balance, shares at Dec. 31, 2021 |
|
34,917,907
|
|
|
|
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan |
|
|
7,091
|
|
7,091
|
Stock-based compensation - PAVmed Inc. 2014 Equity Plan |
|
|
588
|
|
588
|
Net loss |
|
|
|
(26,894)
|
(26,894)
|
Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan |
|
$ 1
|
687
|
|
688
|
Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan, shares |
|
959,389
|
|
|
|
CapNostics, LLC |
|
|
(210)
|
|
(210)
|
APA-RDx - Installment Payment |
|
|
239
|
|
239
|
APA-RDx - Installment Payment, shares |
|
117,371
|
|
|
|
Balance at Jun. 30, 2022 |
|
$ 36
|
105,003
|
(68,798)
|
36,241
|
Balance, shares at Jun. 30, 2022 |
|
35,994,667
|
|
|
|
Balance at Mar. 31, 2022 |
|
$ 35
|
100,630
|
(54,174)
|
46,491
|
Balance, shares at Mar. 31, 2022 |
|
35,171,796
|
|
|
|
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan |
|
|
3,553
|
|
3,553
|
Stock-based compensation - PAVmed Inc. 2014 Equity Plan |
|
|
290
|
|
290
|
Net loss |
|
|
|
(14,624)
|
(14,624)
|
Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan |
|
$ 1
|
501
|
|
502
|
Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan, shares |
|
705,500
|
|
|
|
CapNostics, LLC |
|
|
(210)
|
|
(210)
|
APA-RDx - Installment Payment |
|
|
239
|
|
239
|
APA-RDx - Installment Payment, shares |
|
117,371
|
|
|
|
Balance at Jun. 30, 2022 |
|
$ 36
|
105,003
|
(68,798)
|
36,241
|
Balance, shares at Jun. 30, 2022 |
|
35,994,667
|
|
|
|
Balance at Dec. 31, 2022 |
|
$ 41
|
121,081
|
(98,075)
|
23,047
|
Balance, shares at Dec. 31, 2022 |
|
40,518,792
|
|
|
|
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan |
|
|
3,982
|
|
3,982
|
Stock-based compensation - PAVmed Inc. 2014 Equity Plan |
|
|
625
|
|
625
|
Issue common stock - vendor service agreement |
|
|
147
|
|
147
|
Issuance - Operating expenses, shares |
|
100,000
|
|
|
|
Net loss |
|
|
|
(27,628)
|
(27,628)
|
Vest - restricted stock awards |
|
|
|
|
|
Vest restricted stock awards, shares |
|
219,320
|
|
|
|
APA-RDx - Termination payment |
|
|
713
|
|
713
|
APA-RDx - Termination payment, shares |
|
553,436
|
|
|
|
Issuance - At-The-Market Facility, net of deferred financing charges |
|
$ 1
|
283
|
|
284
|
Issuance - At-The-Market Facility, net of deferred financing charges, shares |
|
230,068
|
|
|
|
Purchase - Employee Stock Purchase Plan |
|
|
276
|
|
276
|
Purchase - Employee Stock Purchase Plan, shares |
|
231,987
|
|
|
|
Issuance - Series A Preferred Stock |
$ 13,625
|
|
|
|
13,625
|
Issuance - Series A Preferred Stock, shares |
13,625
|
|
|
|
|
Balance at Jun. 30, 2023 |
$ 13,625
|
$ 42
|
127,107
|
(125,703)
|
15,071
|
Balance, shares at Jun. 30, 2023 |
13,625
|
41,853,603
|
|
|
|
Balance at Mar. 31, 2023 |
$ 13,625
|
$ 42
|
125,561
|
(114,322)
|
24,906
|
Balance, shares at Mar. 31, 2023 |
13,625
|
41,753,603
|
|
|
|
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan |
|
|
1,165
|
|
1,165
|
Stock-based compensation - PAVmed Inc. 2014 Equity Plan |
|
|
234
|
|
234
|
Issue common stock - vendor service agreement |
|
|
147
|
|
147
|
Issuance - Operating expenses, shares |
|
100,000
|
|
|
|
Net loss |
|
|
|
(11,381)
|
(11,381)
|
Balance at Jun. 30, 2023 |
$ 13,625
|
$ 42
|
$ 127,107
|
$ (125,703)
|
$ 15,071
|
Balance, shares at Jun. 30, 2023 |
13,625
|
41,853,603
|
|
|
|
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v3.23.2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Cash flows from operating activities |
|
|
Net loss |
$ (27,628)
|
$ (26,894)
|
Adjustments to reconcile net loss to net cash used in operating activities |
|
|
Depreciation and amortization expense |
1,245
|
728
|
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan |
3,982
|
7,091
|
Stock-based compensation - PAVmed Inc. 2014 Equity Plan |
625
|
588
|
Change in fair value - Senior Secured Convertible Note |
499
|
|
Loss on issue - Senior Secured Convertible Note |
1,111
|
|
APA-RDx: Issue common stock - settle termination payment |
713
|
239
|
Issue common stock - vendor service agreement |
23
|
|
Changes in operating assets and liabilities: |
|
|
Accounts receivable |
(18)
|
200
|
Prepaid expenses and other current assets |
(1,120)
|
(748)
|
Accounts payable |
(419)
|
916
|
Accrued expenses and other current liabilities |
1,193
|
132
|
Due To: PAVmed Inc. - operating expenses, employee related costs, MSA Fee |
5,737
|
(1,333)
|
Net cash flows used in operating activities |
(14,057)
|
(19,081)
|
Cash flows from investing activities |
|
|
Purchase of equipment |
(32)
|
(384)
|
Asset acquisition |
|
(2,200)
|
Net cash flows used in investing activities |
(32)
|
(2,584)
|
Cash flows from financing activities |
|
|
Proceeds – issue of preferred stock |
13,625
|
|
Proceeds – issue of Senior Convertible Note |
10,000
|
|
Proceeds – issue of common stock – Committed Equity Facility |
284
|
|
Proceeds – exercise of stock options |
|
688
|
Proceeds – issue common stock – Employee Stock Purchase Plan |
276
|
|
Net cash flows provided by financing activities |
24,185
|
688
|
Net increase (decrease) in cash |
10,096
|
(20,977)
|
Cash, beginning of period |
22,474
|
53,656
|
Cash, end of period |
$ 32,570
|
$ 32,679
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v3.23.2
Summary Description of the Company
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Summary Description of the Company |
Note
1 — Summary Description of the Company
Lucid
Diagnostics Inc. (“Lucid”, “Lucid Diagnostics” or the “Company”) is a commercial-stage medical diagnostics
technology company focused on the millions of patients with gastroesophageal reflux disease (“GERD”), also known as chronic
heartburn, acid reflux or simply reflux, who are at risk of developing esophageal precancer and cancer, specifically highly lethal esophageal
adenocarcinoma (“EAC”). Lucid is a majority-owned subsidiary of PAVmed Inc. (“PAVmed”).
The
Company believes that its flagship product, the EsoGuard Esophageal DNA Test, performed on samples collected with the EsoCheck
Esophageal Cell Collection Device, constitutes the first and only commercially available diagnostic test capable of serving as a
widespread tool for the early detection of esophageal precancer in at-risk gastroesophageal reflux disease (“GERD,” also
commonly known as chronic heartburn, acid reflux or simply reflux) patients. Early detection of esophageal precancer allows patients
to undergo appropriate monitoring and treatment, as indicated by clinical practice guidelines, in an effort to prevent progression
to esophageal cancer.
EsoGuard
is a bisulfite-converted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck. Cell samples, including those collected with EsoCheck, as discussed below, are sent to our laboratory, for
testing and analyses using our proprietary EsoGuard NGS DNA assay.
EsoCheck
is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal
cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin
silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When
vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and
dilution by cells outside of the targeted region during device withdrawal. The Company believes that this proprietary
Collect+Protect™ technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically
targeted and protected sampling.
EsoGuard
and EsoCheck are based on patented technology licensed by Lucid from Case Western Reserve University (“CWRU”). EsoGuard and
EsoCheck have been developed to provide an accurate, non-invasive, patient-friendly test for the early detection of EAC and Barrett’s
Esophagus (“BE”), including dysplastic BE and related pre-cursors to EAC in patients with chronic GERD.
The
Company is subject to all of the risks and uncertainties typically faced by medical device and diagnostic companies that devote substantially
all of their efforts to the commercialization of their initial product and services and ongoing research and development activities and
conducting clinical trials. The Company expects to continue to experience recurring losses from operations and will continue to fund
its operations with debt and equity financing transactions. Notwithstanding, however, with the cash on-hand as of the date hereof and
committed equity sources of financing, the Company expects to be able to fund its operations and meet its financial obligations as they
become due for the one year period from the date of the issue of the Company’s unaudited condensed consolidated financial statements,
as included herein in this Quarterly Report on Form 10-Q for the period ended June 30, 2023.
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- DefinitionThe entire disclosure for the business description and basis of presentation concepts. Business description describes the nature and type of organization including but not limited to organizational structure as may be applicable to holding companies, parent and subsidiary relationships, business divisions, business units, business segments, affiliates and information about significant ownership of the reporting entity. Basis of presentation describes the underlying basis used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS).
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v3.23.2
Summary of Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
Note
2 — Summary of Significant Accounting Policies
Significant
Accounting Policies
The
Company’s significant accounting policies are as disclosed in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2022 as filed with the SEC on March 14, 2023, except as otherwise noted herein below.
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements of the Company 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. All intercompany transactions and balances have been eliminated in consolidation. The Company is a majority-owned consolidated
subsidiary of PAVmed, which has a majority equity ownership interest and has financial control of the Company. The Company manages its
operations as a single operating segment for the purposes of assessing performance and making operating decisions.
As
permitted under SEC rules, certain footnotes or other financial information normally required by U.S. GAAP have been condensed or omitted.
The balance sheet as of December 31, 2022 has been derived from audited consolidated financial statements at such date. The accompanying
unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated
financial statements, and in the opinion of management, include all adjustments, consisting only of routine recurring adjustments, necessary
for a fair statement of the Company’s unaudited condensed consolidated financial information.
The
consolidated results of operations for the three and six months ended June 30, 2023 are not necessarily indicative of the consolidated
results to be expected for the year ending December 31, 2023 or for any other interim period or for any other future periods. The accompanying
unaudited condensed consolidated financial statements and related unaudited condensed consolidated financial information should be read
in conjunction with the Company’s audited consolidated financial statements and related notes thereto as of and for the year ended
December 31, 2022 included in the Company’s Annual Report on Form 10-K as filed with the SEC on March 14, 2023.
All
amounts in the accompanying unaudited condensed consolidated financial statements and the notes thereto are presented in thousands
of dollars, if not otherwise noted as being presented in millions of dollars, except for shares and per share amounts.
Use
of Estimates
In
preparing the unaudited condensed consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates
and assumptions that affect the reported amounts of assets and the determination of corresponding carrying value reserves, if any, and
liabilities and the disclosure of contingent losses, as of the date of the consolidated financial statements, as well as the reported
amounts of revenue and expenses during the reporting period. Significant estimates in these unaudited condensed consolidated financial
statements include those related to the estimated fair value of debt obligations, stock-based equity awards and intangible assets. Other
significant estimates include the estimated incremental borrowing rate, the provision or benefit for income taxes and the corresponding
valuation allowance on deferred tax assets. Additionally, management’s assessment of the Company’s ability to continue as
a going concern involves the estimation of the amount and timing of future cash inflows and outflows. On an ongoing basis, the Company
evaluates its estimates and assumptions. The Company bases its estimates on historical experience and on various other assumptions believed
to be reasonable. Due to inherent uncertainty involved in making estimates, actual results reported in future periods may be affected
by changes in these estimates.
Revenue
Recognition
Revenues
are recognized when the satisfaction of the performance obligation occurs, in an amount that reflects the consideration the Company expects
to collect in exchange for those services. The Company’s revenue is primarily generated by its laboratory testing services utilizing
its EsoGuard Esophageal DNA tests. The services are completed upon release of a patient’s test result to the ordering healthcare
provider. Revenue recognized is inclusive of both variable consideration in connection with an individual patient’s third-party
insurance coverage policy and fixed consideration in connection with a contracted services arrangement with an unrelated third party
legal entity. To determine revenue recognition for the arrangements that the Company determines are within the scope of ASC 606, Revenue
from Contracts with Customers, the Company performs the following five steps: (1) identify the contract(s) with a customer, (2) identify
the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance
obligations in the contract and (5) recognize revenue when (or as) the entity satisfies a performance obligation.
Note
2 — Summary of Significant Accounting Policies - continued
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.
Financial
Instruments Fair Value Measurements
FASB
ASC Topic 820, Fair Value Measurement, (ASC 820) defines fair value as the price which would be received to sell an asset or paid to
transfer a liability in an orderly transaction between market participants at a transaction measurement date. The ASC 820 three-tier
fair value hierarchy prioritizes the inputs used in the valuation methodologies, as follows:
|
Level
1 | Valuations
based on quoted prices for identical assets and liabilities in active markets. |
|
| |
|
Level 2 | Valuations
based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets or liabilities in active
markets, quoted prices for identical or similar assets and liabilities in markets which are not active, or other inputs observable or
can be corroborated by observable market data. |
|
| |
|
Level 3 | Valuations
based on unobservable inputs reflecting the Company’s own assumptions, consistent with reasonably available assumptions made by
other market participants. These valuations require significant judgment. |
The
Company evaluates its financial instruments to determine if those instruments or any embedded components of those instruments potentially
qualify as derivatives required to be separately accounted for in accordance with FASB ASC Topic 815, Derivatives and Hedging (ASC 815).
Note
2 — Summary of Significant Accounting Policies - continued
The
recurring and non-recurring estimated fair value measurements are subjective and are affected by changes in inputs to the valuation models,
including the Company’s common stock price, and certain Level 3 inputs, including, the assumptions regarding the estimated volatility
in the value of the Company’s common stock price; the Company’s dividend yield; the likelihood and timing of future dilutive
transactions, as applicable, along with the risk-free rates based on U.S. Treasury security yields. Changes in these assumptions can
materially affect the estimated fair values.
As
of June 30, 2023 and December 31, 2022, the carrying values of cash, and accounts payable, approximate their respective fair
value due to the short-term nature of these financial instruments.
Fair
Value Option (“FVO”) Election
Under
a Securities Purchase Agreement dated March 13, 2023, the Company issued a Senior Secured Convertible Note dated March 21, 2023, referred
to herein as the “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
March 2023 Senior Convertible Note is presented in a single line item within other income (expense) in the accompanying 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 March 2023 Senior Convertible
Note).
See
Note 10, Financial Instruments Fair Value Measurements, with respect to the FVO election; and Note 11, Debt, for a discussion of the
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.
Recently
Adopted Accounting Pronouncements
In
June 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments-Credit Losses (Topic 326):
Measurement of Credit Losses on Financial Instruments. The updated guidance requires companies to measure all expected credit losses
for financial instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable forecasts.
This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets, including trade
receivables. The guidance was adopted by the Company on January 1, 2023. The adoption of the ASU did not have an impact on the Company’s
unaudited condensed consolidated financial statements.
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v3.23.2
Revenue from Contracts with Customers
|
6 Months Ended |
Jun. 30, 2023 |
Revenue from Contract with Customer [Abstract] |
|
Revenue from Contracts with Customers |
Note
3 — Revenue from Contracts with Customers
EsoGuard
Commercialization Agreement
The
Company entered into the EsoGuard Commercialization Agreement, dated August 1, 2021, with its former commercial laboratory service provider,
ResearchDx Inc. (“RDx”), an unrelated third-party. The EsoGuard Commercialization Agreement was on a month-to-month basis
and was terminated on February 25, 2022 upon the execution of an asset purchase agreement (“APA”) dated February 25, 2022,
between LucidDx Labs Inc., a wholly-owned subsidiary of the Company, and RDx, with such agreement further discussed in Note 6, Asset
Purchase Agreement and Management Services Agreement.
Revenue
Recognized
In
the three and six months ended June 30, 2023, the Company recognized revenue of $159
and $605,
respectively, resulting from the delivery of patient EsoGuard test results. Revenue recognized from customer contracts deemed to
include a variable consideration transaction price is limited to the unconstrained portion of the variable consideration. The
Company’s revenue for the three and six months ended June 30, 2022 was $0 and $189,
which solely reflects the revenue recognized under the EsoGuard Commercialization Agreement, which represented the minimum fixed
monthly fee of $100
for the period January 1, 2022 to the February 25, 2022 termination date as discussed above. The monthly fee was deemed to be
collectible for such period as RDx has timely paid the applicable respective monthly fee.
Cost
of Revenue
The
cost of revenues principally includes the costs related to the Company’s laboratory operations (excluding estimated costs associated
with research activities), the costs related to the EsoCheck cell collection device, cell sample mailing kits and license royalties.
In
the three and six months ended June 30, 2023, the cost of revenue was $1,549
and $2,887,
respectively, and was primarily related to costs for our laboratory operations and EsoCheck device supplies. The Company’s
cost of revenue for the three and six months ended June 30, 2022 was $0 and $369,
which solely reflects the costs attributable to delivering the services under the EsoGuard Commercialization Agreement for the
period January 1, 2022 to February 25, 2022. In the three months ended June 30, 2022, laboratory operations costs are included in operating expenses as general
and administrative expenses in the accompanying unaudited condensed consolidated statements of operations.
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v3.23.2
Related Party Transactions
|
6 Months Ended |
Jun. 30, 2023 |
Related Party Transactions [Abstract] |
|
Related Party Transactions |
Note
4 — Related Party Transactions
Case
Western Reserve University and Physician Inventors - Amended CWRU License Agreement
Case
Western Reserve University (“CWRU”) and each of the three physician inventors (“Physician Inventors”) of the
intellectual property licensed under the amended and restated patent license agreement with CWRU, dated August 23, 2021 (the “Amended
CWRU License Agreement”), each hold a minority equity ownership interest in Lucid Diagnostics Inc. The expenses incurred with respect
to the Amended CWRU License Agreement and the three Physician Inventors, as classified in the accompanying unaudited condensed consolidated
statement of operations for the periods indicated are summarized as follows:
Schedule of Incurred Expenses of Minority Shareholders
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Cost of Revenue | |
| | | |
| | | |
| | | |
| | |
CWRU – Royalty Fees | |
$ | 10 | | |
$ | — | | |
$ | 34 | | |
$ | 9 | |
| |
| | | |
| | | |
| | | |
| | |
General and Administrative Expense | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation expense – Physician Inventors’ restricted stock awards | |
| — | | |
| 272 | | |
| 180 | | |
| 544 | |
| |
| | | |
| | | |
| | | |
| | |
Research and Development Expense | |
| | | |
| | | |
| | | |
| | |
Amended CWRU – License Agreement - reimbursement of patent legal fees | |
| — | | |
| 209 | | |
| 389 | | |
| 209 | |
Fees - Physician Inventors’ consulting agreements | |
| 9 | | |
| 10 | | |
| 10 | | |
| 18 | |
Sponsored research agreement | |
| — | | |
| — | | |
| — | | |
| 3 | |
Stock-based compensation expense – Physician Inventors’ stock options | |
| 52 | | |
| 52 | | |
| 105 | | |
| 99 | |
Total Related Party Expenses | |
$ | 71 | | |
$ | 543 | | |
$ | 718 | | |
$ | 882 | |
PAVmed
Inc. - Management Services Agreement
The
Company’s daily operations are also managed in part by personnel employed by PAVmed, for which the Company incurs a service fee,
referred to as the “MSA Fee”, according to the provisions of a Management Services Agreement (“MSA”) with PAVmed.
The MSA does not have a termination date, but may be terminated by the Company’s board of directors. The MSA Fee is charged on
a monthly basis and is subject-to periodic adjustment corresponding with changes in the services provided by PAVmed personnel to the
Company, with any such change in the MSA Fee being subject to approval of the boards of directors of each of the Company and PAVmed.
The respective companies’ boards of directors approved a seventh amendment to the MSA to increase the MSA Fee to $750 per month,
effective January 1, 2023, which was entered into by PAVmed and the Company on May 9, 2023. During the three and six months ended June
30, 2022, MSA Fees were $390 per month.
Note
4 — Related Party Transactions - continued
The
MSA Fee expense classification in the unaudited condensed consolidated statement of operations for the periods noted is as follows:
Schedule of MSA Fee Expense Classification in Statements of Operations
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Sales & Marketing | |
| 109 | | |
| 183 | | |
| 218 | | |
| 383 | |
General & Administrative | |
| 1,554 | | |
| 640 | | |
| 3,108 | | |
| 1,284 | |
Research & Development | |
| 587 | | |
| 347 | | |
| 1,174 | | |
| 673 | |
Total MSA Fee | |
$ | 2,250 | | |
$ | 1,170 | | |
$ | 4,500 | | |
$ | 2,340 | |
The
classification of the MSA Fee as presented above is based on the PAVmed classification of employee salary expense and other operating
expenses. In this regard, PAVmed classifies employee salary expense as sales and marketing expenses for employees performing sales, marketing,
and reimbursement activities and functions, general and administrative, and research and development except for those employees who are
engaged in product and services engineering development and design and /or clinical trials activities, for which such employee salary
is classified as research and development expense.
|
X |
- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.23.2
Due To PAVmed Inc.
|
6 Months Ended |
Jun. 30, 2023 |
Debt Disclosure [Abstract] |
|
Due To PAVmed Inc. |
Note
5 — Due To PAVmed Inc.
The
aggregate Due To: PAVmed Inc. for the periods indicated is summarized as follows:
Schedule of Senior Unsecured Promissory Note
| |
MSA Fees | | |
Employee-Related Costs | | |
PAVmed Inc. OBO Payments | | |
Total | |
Balance - December 31, 2022 | |
$ |
1,650 | | |
$ |
3,026 | | |
$ |
284 | | |
$ |
4,960 | |
MSA fees | |
| 4,500 | | |
| — | | |
| — | | |
| 4,500 | |
ERC - Payroll & Benefits | |
| — | | |
| 922 | | |
| — | | |
| 922 | |
On Behalf Of (OBO) activities | |
| — | | |
| — | | |
| 601 | | |
| 601 | |
Cash payments to PAVmed Inc. | |
| — | | |
| — | | |
| (286 | ) | |
| (286 | ) |
Balance - June 30, 2023 | |
$ | 6,150 | | |
$ | 3,948 | | |
$ | 599 | | |
$ | 10,697 | |
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v3.23.2
Asset Purchase Agreement and Management Services Agreement
|
6 Months Ended |
Jun. 30, 2023 |
Asset Purchase Agreement And Management Services Agreement |
|
Asset Purchase Agreement and Management Services Agreement |
Note
6 — Asset Purchase Agreement and Management Services Agreement
Asset
Purchase Agreement and Management Services Agreement - ResearchDx Inc.
Through
its wholly-owned subsidiary, LucidDx Labs Inc. (“LucidDx Labs”), the Company entered into an asset purchase agreement (“APA”)
dated February 25, 2022, with ResearchDx, Inc. (“RDx”), an unrelated third-party - “APA-RDx”. Under the APA-RDx,
LucidDx Labs Inc. acquired certain assets from RDx which were combined with other property and equipment to establish a Company-owned
CLIA certified, CAP accredited commercial clinical laboratory capable of performing the EsoGuard® Esophageal DNA assay, inclusive
of DNA extraction, next generation sequencing (“NGS”) and specimen storage. Prior to February 25, 2022, RDx provided such
laboratory services at its owned CLIA-certified, CAP-accredited clinical laboratory. In connection with the execution and delivery of
the APA-RDx, LucidDx Labs Inc. and RDx entered into a separate management services agreement (“MSA-RDx”), dated and effective
February 25, 2022, pursuant to which RDx provided certain testing and related services for the Laboratory.
The
total purchase price consideration payable under the APA-RDx is a face value of $3,200 comprised of three contractually specified periodic
payments. The APA-RDx is being accounted for as an asset acquisition, with the recognition of an intangible asset of approximately $3,200,
which is included in “Intangible assets, net” on the accompanying unaudited condensed consolidated balance sheet, as further
discussed in Note 9, Intangible Assets, net.
Termination
of Management Services Agreement and Modification of Other Payment Obligations - ResearchDx Inc.
On
February 14, 2023, through LucidDx Labs Inc, the Company entered into an agreement (the “MSA Termination Agreement”) with
RDx, pursuant to which the parties mutually agreed to terminate the MSA-RDx without cause. The termination was effective as February
10, 2023. Until the termination of the management service agreement with RDx, RDx had continued to provide certain testing and related
services for the Laboratory in accordance with the terms of the MSA-RDx.
The
MSA Termination Agreement reduces the remaining amounts of the earnout payments and management fees due under the APA-RDx and the MSA-RDx
to $713. The payment was satisfied through the issuance of 553,436 shares of the Company’s common stock in February 2023. The Company
was not required to make any cash payments in connection with the termination.
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v3.23.2
Prepaid Expenses, Deposits, and Other Current Assets
|
6 Months Ended |
Jun. 30, 2023 |
Prepaid Expenses Deposits And Other Current Assets |
|
Prepaid Expenses, Deposits, and Other Current Assets |
Note
7 — Prepaid Expenses, Deposits, and Other Current Assets
Prepaid
expenses and other current assets consisted of the following as of:
Schedule of Prepaid Expenses and Other Current Assets
| |
June 30, 2023 | | |
December 31, 2022 | |
Advanced payments to service providers and suppliers | |
$ | 344 | | |
$ | 371 | |
Prepaid insurance | |
| 171 | | |
| 52 | |
Deposits | |
| 2,587 | | |
| 1,331 | |
EsoCheck cell collection supplies | |
| 39 | | |
| 59 | |
EsoGuard mailer supplies | |
| 3 | | |
| 52 | |
Total prepaid expenses, deposits and other current assets | |
$ | 3,144 | | |
$ | 1,865 | |
|
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v3.23.2
Leases
|
6 Months Ended |
Jun. 30, 2023 |
Leases |
|
Leases |
Note
8 — Leases
During
the six months ended June 30, 2023, the Company entered into additional lease agreements that have commenced and are classified
as operating leases and short-term leases for additional Lucid Test Centers.
The
Company’s future lease payments as of June 30, 2023, which are presented as operating lease liabilities, current portion and
operating lease liabilities, less current portion on the Company’s unaudited condensed consolidated balance sheets are as follows:
Schedule Of Future Lease Payments Of Operating Lease Liabilities
| |
| | |
2023 (remainder of year) | |
$ | 611 | |
2024 | |
| 1,133 | |
2025 | |
| 127 | |
2026 | |
| 63 | |
2027 | |
| 24 | |
Total lease payments | |
$ | 1,958 | |
Less: imputed interest | |
| (127 | ) |
Present value of lease liabilities | |
$ | 1,831 | |
Supplemental
disclosure of cash flow information related to the Company’s cash and non-cash activities with its leases are as follows:
Schedule Of Cash Flow Supplemental Information
| |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
Cash paid for amounts included in the measurement of lease liabilities | |
| | | |
| | |
Operating cash flows from operating leases | |
$ | 583 | | |
$ | 453 | |
Non-cash investing and financing activities | |
| | | |
| | |
Right-of-use assets obtained in exchange for new operating lease liabilities | |
$ | 341 | | |
$ | 2,448 | |
Weighted-average remaining lease term - operating leases (in years) | |
| 1.80 | | |
| 2.48 | |
Weighted-average discount rate - operating leases | |
| 7.875 | % | |
| 7.875 | % |
As
of June 30, 2023 and December 31, 2022, the Company’s right-of-use assets from operating leases were $1,835 and $2,008, respectively,
which are reported in operating lease right-of-use assets in the unaudited condensed consolidated balance sheets. As of June 30,
2023 and December 31, 2022, the Company had outstanding operating lease obligations of $1,831 and $1,999, respectively, of which $1,099
and $962, respectively, are reported in operating lease liabilities, current portion and $732 and $1,037, 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.
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v3.23.2
Intangible Assets, net
|
6 Months Ended |
Jun. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Intangible Assets, net |
Note
9 — Intangible Assets, net
Intangible
assets, less accumulated amortization, consisted of the following as of:
Schedule of Intangible Assets Accumulated Amortization
| |
Estimated Useful Life | |
June 30, 2023 | | |
December 31, 2022 | |
Defensive technology | |
60 months | |
$ | 2,105 | | |
$ | 2,105 | |
Laboratory licenses and certifications and laboratory information management software | |
24 months | |
| 3,200 | | |
$ | 3,200 | |
Total Intangible assets | |
| |
| 5,305 | | |
| 5,305 | |
Less Accumulated Amortization | |
| |
| (2,870 | ) | |
| (1,860 | ) |
Intangible Assets, net | |
| |
$ | 2,435 | | |
$ | 3,445 | |
The
defensive technology intangible asset of $2.1 million (and approximately $0.2 million of accumulated amortization) was recognized by
the Company as of the April 1, 2022 effective date of the transfer of CapNostics, LLC (“CapNostics”) to the Company from
PAVmed Subsidiary Corp (a wholly-owned subsidiary of PAVmed). The transfer was accounted for as entities under common control. The defensive
technology intangible asset was recognized by PAVmed Subsidiary Corp upon its acquisition of CapNostics, an unrelated third-party, for
total purchase consideration paid on the October 5, 2021 acquisition date of approximately $2.1 million in cash. The CapNostics transaction
was accounted for as an asset acquisition, resulting in the recognition of the defensive technology intangible asset. The defensive technology
intangible asset is being amortized on a straight-line basis over an expected useful life 60 months commencing on the acquisition date.
As
noted in Note 6, Asset Purchase Agreement and Management Services Agreement, the asset purchase agreement between the Company
and ResearchDx Inc. (“APA-RDx”), is being accounted for as an asset acquisition. The intangible assets recognized under the
APA-RDx are the laboratory licenses and certifications (inclusive of a CLIA certification, CAP accreditation, and clinical laboratory
licenses for five (5) U.S. States transferred to the Company from RDx), and a laboratory information management software perpetual-use
royalty-free license granted under the APA-RDx, with such intangible asset having a useful life of twenty-four months commencing on the
APA-RDx February 25, 2022 transaction date.
Amortization
expense of the intangible assets discussed above was $505 and $639 for the three month periods ended June 30, 2023 and 2022, respectively,
and $1,010 and $639 for the six month periods ended June 30, 2023 and 2022, respectively, and is included in amortization of acquired
intangible assets in the accompanying unaudited condensed consolidated statements of operations. As of June 30, 2023, the estimated
future amortization expense associated with the Company’s finite-lived intangible assets for each of the five succeeding fiscal
years is as follows:
Schedule of Future Amortization Expense
| |
| | |
2023 (remainder of year) | |
$ | 1,011 | |
2024 | |
| 688 | |
2025 | |
| 421 | |
2026 | |
| 315 | |
Total | |
$ | 2,435 | |
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v3.23.2
Financial Instruments Fair Value Measurements
|
6 Months Ended |
Jun. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Financial Instruments Fair Value Measurements |
Note
10 — Financial Instruments Fair Value Measurements
Recurring
Fair Value Measurements
The
fair value hierarchy table for the reporting date noted is as follows:
Schedule of Financial Liabilities Measured at Fair Value on Recurring Basis
| |
Fair Value Measurement on a Recurring Basis at Reporting Date Using1 | |
| |
Level-1 Inputs | | |
Level-2 Inputs | | |
Level-3 Inputs | | |
Total | |
June 30, 2023 | |
| | | |
| | | |
| | | |
| | |
March 2023 Senior Convertible Note | |
$ | — | | |
$ | — | | |
$ | 11,610 | | |
$ | 11,610 | |
Totals | |
$ | — | | |
$ | — | | |
$ | 11,610 | | |
$ | 11,610 | |
1 | | There were no transfers
between the respective Levels during the period ended June 30, 2023. |
As
discussed in Note 11, Debt, the Company issued a Senior Secured Convertible Note dated March 21, 2023 with a $11.1 million face
value principal (“March 2023 Senior Convertible Note”.) The convertible note is accounted for under the ASC 825-10-15-4 fair
value option (“FVO”) election, wherein, the financial instrument is initially measured at its issue date estimated fair value
and subsequently remeasured at estimated fair value on a recurring basis at each reporting period date.
The
estimated fair value of the financial instruments classified within the Level 3 category was determined using both observable inputs
and unobservable inputs. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in fair
value attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in unobservable long-
dated volatilities) inputs.
The
estimated fair value of the March 2023 Senior Convertible Note as of each of March 21, 2023 and June 30, 2023 were computed using
a Monte Carlo simulation of the present value of its cash flows using a synthetic credit rating analysis and a required rate-of-return,
using the following assumptions:
Schedule of Fair Value Assumption Used
| |
March 2023 Senior Convertible Note: March 21, 2023 | | |
March 2023 Senior Convertible Note: June 30, 2023 | |
Fair Value | |
$ | 11,900 | | |
$ | 11,610 | |
Face value principal payable | |
$ | 11,111 | | |
$ | 11,111 | |
Required rate of return | |
| 11.00 | % | |
| 11.00 | % |
Conversion Price | |
$ | 5.00 | | |
$ | 5.00 | |
Value of common stock | |
$ | 1.54 | | |
$ | 1.39 | |
Expected term (years) | |
| 2.00 | | |
| 1.73 | |
Volatility | |
| 75.00 | % | |
| 70.00 | % |
Risk free rate | |
| 4.09 | % | |
| 4.89 | % |
Dividend yield | |
| — | % | |
| — | % |
The
estimated fair values reported utilized the Company’s common stock price along with certain Level 3 inputs (as discussed in the
table 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 Company’s
common stock price, the Company’s dividend yield, the risk-free rates based on U.S. Treasury security yields, and certain other
Level-3 inputs including, assumptions regarding the estimated volatility in the value of the Company’s common stock price. Changes
in these assumptions can materially affect the estimated fair values.
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v3.23.2
Debt
|
6 Months Ended |
Jun. 30, 2023 |
Debt Disclosure [Abstract] |
|
Debt |
Note
11 — Debt
The
fair value and face value principal outstanding of the March 2023 Senior Convertible Note 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 | |
March 2023 Senior Convertible Note | |
March 21, 2025 | |
| 7.875 | % | |
$ | 5.00 | | |
$ | 11,111 | | |
$ | 11,610 | |
Balance as of June 30, 2023 | |
| |
| | | |
| | | |
$ | 11,111 | | |
$ | 11,610 | |
The
changes in the fair value of debt during the three and six months ended June 30, 2023 is as follows:
Schedule
of Changes in Fair Value of Debt
| |
March 2023 Senior Convertible Note | | |
Other Income (expense) | |
Fair Value - December 31, 2022 | |
$ | — | | |
$ | — | |
Face value principal – issue date | |
| 11,111 | | |
| — | |
Fair value adjustment – issue date | |
| 789 | | |
| (789 | ) |
Change in fair value | |
| — | | |
| — | |
Fair Value at March 31, 2023 | |
$ | 11,900 | | |
| - | |
Other Income (Expense) - Change in fair value – three months ended March 31, 2023 | |
| | | |
$ | (789 | ) |
| |
| | | |
| | |
Change in fair value | |
| (290 | ) | |
| 290 | |
Fair Value at June 30, 2023 | |
$ | 11,610 | | |
| - | |
Other Income (Expense) - Change in fair value – three months ended June 30, 2023 | |
| | | |
$ | 290 | |
Other Income (Expense) - Change in fair value – six months ended June 30, 2023 | |
| | | |
$ | (499 | ) |
March
2023 Senior Secured Convertible Note
Lucid
Diagnostics entered into a Securities Purchase Agreement (“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.
Under
the SPA, Lucid issued in a registered direct offering under its effective shelf registration statement a Senior Secured Convertible Note
dated March 21, 2023, referred to herein as the “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 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 March 21, 2025. The March 2023 Senior Convertible Note may be converted
into shares of common stock of the Company at the Holder’s election.
The
March 2023 Senior Convertible Note proceeds were $9.925 million after deducting a $1.186 million lender fee and offering costs. The lender
fee and offering costs were recognized as of the March 21, 2023 issue date as a current period expense in other income (expense) in the
Company’s unaudited condensed consolidated statement of operations.
During
the period from March 21, 2023 to September 20, 2023, Lucid is required to pay interest expense only (on the $11.1 million face value
principal), at 7.875% per annum, computed on a 360 day year. The Company paid in cash interest expense of $219 and $243 for the three
and six months ended June 30, 2023, respectively.
Note
11 — Debt - continued
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, the Company will be
required to make a principal repayment of $292 together with accrued interest thereon, with such 38 payments referred to herein as the
“Installment Amount”, settled in shares of common stock of the Company, subject to customary equity conditions, including
minimum share price and volume thresholds, or at the election of the Company, in cash, in whole or in part.
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 all of Lucid Diagnostics’ subsidiaries;
and the obligations under this senior convertible note are secured by all of the assets of Lucid Diagnostics 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) the Company’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) the Company’s market capitalization to at no time be less
than $30 million.
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v3.23.2
Stock-Based Compensation
|
6 Months Ended |
Jun. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Stock-Based Compensation |
Note
12 — Stock-Based Compensation
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 below. The Lucid Diagnostics 2018 Equity Plan is designed to enable Lucid Diagnostics to offer
employees, officers, directors, and consultants, an opportunity to acquire shares of common stock of Lucid Diagnostics. The types of
awards that may be granted under the Lucid Diagnostics 2018 Equity Plan include stock options, stock appreciation rights, restricted
stock, and other stock-based awards subject to limitations under applicable law. All awards are subject to approval by the Lucid Diagnostics
compensation committee.
A
total of 11,644,000 shares of common stock of Lucid Diagnostics are reserved for issuance under the Lucid Diagnostics 2018 Equity Plan,
with 3,936,554 shares available for grant as of June 30, 2023. The share reservation is not diminished by a total of 423,300 stock
options and 50,000 restricted stock awards granted outside the Lucid Diagnostics 2018 Equity Plan, as of June 30, 2023.
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 Stock Options Issued and Outstanding Activities
| |
Number of Stock Options | | |
Weighted Average Exercise Price | | |
Remaining Contractual Term (Years) | | |
Intrinsic
Value(2) | |
Outstanding stock options at December 31, 2022 | |
| 2,565,377 | | |
$ | 3.14 | | |
| 8.3 | | |
$ | 428 | |
Granted(1) | |
| 2,732,500 | | |
$ | 1.31 | | |
| | | |
| | |
Exercised | |
| — | | |
$ | — | | |
| | | |
| | |
Forfeited | |
| (347,915 | ) | |
$ | 2.57 | | |
| | | |
| | |
Outstanding stock options at June 30, 2023(3) | |
| 4,949,962 | | |
$ | 2.17 | | |
| 8.7 | | |
$ | 641 | |
Vested and exercisable stock options at June 30, 2023 | |
| 1,374,179 | | |
$ | 2.76 | | |
| 6.9 | | |
$ | 440 | |
(1) | Stock
options granted under the Lucid Diagnostics 2018 Equity Plan and those granted outside such
plan generally vest one-third in one year then ratably over the next eight quarters, and
have a ten-year contractual term from date-of-grant. |
(2) | The
intrinsic value is computed as the difference between the quoted price of the Lucid Diagnostics
common stock on each of June 30, 2023 and December 31, 2022 and the exercise price of
the underlying Lucid Diagnostics stock options, to the extent such quoted price is greater
than the exercise price. |
(3) | The
outstanding stock options presented in the table above, are inclusive of 423,300 stock options
granted outside the Lucid Diagnostics 2018 Equity Plan, as of June 30, 2023 and December
31, 2022. |
Note
12 — Stock-Based Compensation - continued
See
Note 4, Related Party Transactions, for a summary of the stock-based compensation expense recognized with respect to the stock
options granted under the Lucid Diagnostics 2018 Equity Plan to the Physician Inventors.
Lucid
Diagnostics Restricted Stock Awards
Lucid
Diagnostics restricted stock awards granted under the Lucid Diagnostics 2018 Equity Plan and restricted stock awards granted outside
such plan are summarized as follows:
Schedule
of Restricted Stock Award Activity
| |
Number of Restricted Stock Awards | | |
Weighted Average Grant Date Fair Value | |
Unvested restricted stock awards as of December 31, 2022(1) | |
| 2,091,420 | | |
$ | 11.44 | |
Granted | |
| — | | |
| — | |
Vested | |
| (219,320 | ) | |
| 11.27 | |
Forfeited | |
| — | | |
| — | |
Unvested restricted stock awards as of June 30, 2023 | |
| 1,872,100 | | |
$ | 11.46 | |
(1) | The
unvested restricted stock awards presented in the table above, are inclusive of 50,000 restricted
stock awards granted outside the Lucid Diagnostics 2018 Equity Plan as of December 31, 2022.
These 50,000 restricted stock awards were fully vested during the period ended June 30,
2023. |
PAVmed
Inc. 2014 Equity Plan
The
PAVmed Inc. 2014 Long-Term Incentive Equity Plan (the “PAVmed 2014 Equity Plan”), is separate and apart from the Lucid Diagnostics
2018 Equity Plan (as such equity plan is discussed above).
Stock-Based
Compensation Expense
The
stock-based compensation expense recognized by the Company for both the Lucid Diagnostics 2018 Equity Plan and the PAVmed 2014 Equity
Plan, for the periods indicated, was as follows:
Schedule
of Stock-Based Compensation Expense
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Lucid Diagnostics 2018 Equity Plan – cost of revenue | |
$ | 16 | | |
$ | — | | |
$ | 28 | | |
$ | — | |
Lucid Diagnostics 2018 Equity Plan – sales and marketing | |
| 247 | | |
| 215 | | |
| 470 | | |
| 480 | |
Lucid Diagnostics 2018 Equity Plan - general and administrative | |
| 836 | | |
| 3,313 | | |
| 3,348 | | |
| 6,514 | |
Lucid Diagnostics 2018 Equity Plan - research and development | |
| 66 | | |
| 26 | | |
| 136 | | |
| 97 | |
PAVmed 2014 Equity Plan - cost of revenue | |
| 9 | | |
| — | | |
| 16 | | |
| — | |
PAVmed 2014 Equity Plan - sales and marketing | |
| 120 | | |
| 161 | | |
| 253 | | |
| 336 | |
PAVmed 2014 Equity Plan - general and administrative | |
| 8 | | |
| 77 | | |
| 164 | | |
| 145 | |
PAVmed 2014 Equity Plan - research and development | |
| 97 | | |
| 52 | | |
| 192 | | |
| 107 | |
Total stock-based compensation expense | |
$ | 1,399 | | |
$ | 3,844 | | |
$ | 4,607 | | |
$ | 7,679 | |
The
stock-based compensation expense, as presented above, is inclusive of: stock options and restricted stock awards granted under the Lucid
Diagnostics 2018 Equity Plan to employees of PAVmed, the Physician Inventors, and members of the board of directors of Lucid Diagnostics,
as well as the stock options granted under the PAVmed 2014 Equity Plan to the Physician Inventors.
Note
12 — Stock-Based Compensation - continued
As
of June 30, 2023, 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 Lucid Diagnostics 2018 Equity Plan and the PAVmed 2014 Equity Plan,
as discussed above, is as follows:
Schedule
of Unrecognized Compensation Expense and Weighted Average Remaining Service Period
| |
Unrecognized Expense | | |
Weighted Average Remaining Service Period (Years) | |
Lucid Diagnostics 2018 Equity Plan | |
| | | |
| | |
Stock Options | |
$ | 4,129 | | |
| 2.3 | |
Restricted Stock Awards | |
$ | 1,141 | | |
| 1.1 | |
PAVmed 2014 Equity Plan | |
| | | |
| | |
Stock Options | |
$ | 861 | | |
| 2.0 | |
Stock-based
compensation expense recognized with respect to stock options granted under the Lucid Diagnostics 2018 Equity Plan was based on a weighted
average estimated fair value of such stock options of $0.87 per share and $1.48 per share during the periods ended June 30, 2023
and 2022, respectively, calculated using the following weighted average Black-Scholes valuation model assumptions:
Schedule
of Stock-based Compensation Valuation Assumptions
| |
2023 | | |
2022 | |
| |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
Expected term of stock options (in years) | |
| 5.6 | | |
| 5.7 | |
Expected stock price volatility | |
| 75 | % | |
| 71 | % |
Risk free interest rate | |
| 3.7 | % | |
| 3.0 | % |
Expected dividend yield | |
| — | % | |
| — | % |
Lucid
Diagnostics Inc Employee Stock Purchase Plan (“Lucid ESPP”)
A
total of 231,987 shares of common stock of Lucid Diagnostics were purchased for proceeds of approximately $276 on March 31, 2023 under
the Lucid ESPP. The Lucid ESPP has a total reservation of 1,000,000 shares of common stock of which 683,983 shares are available-for-issue
as of June 30, 2023. In January 2023, the number of shares available-for-issue was increased by 500,000 in accordance with the evergreen
provisions of the plan.
|
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v3.23.2
Stockholders’ Equity
|
6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
Stockholders’ Equity |
Note
13 — Stockholders’ Equity
Series
A Preferred Stock Offering
On
March 7, 2023, the Company issued 13,625 shares of newly designated Series A Convertible Preferred Stock, par value $0.001 per share
(the “Series A Preferred Stock”), to accredited investors at a purchase price of $1,000 per share, for aggregate gross proceeds
to the Company of $13.625 million. In connection with the issuance the Company filed a Certificate of Designation of Preferences, Rights
and Limitations of the Series A Preferred Stock with the Secretary of State of the State of Delaware (the “Certificate of Designation”).
The key terms of the Series A Preferred Stock are as follows:
Each
share of Series A Preferred Stock is convertible at the option of the holder, subject to certain beneficial ownership limitations into
such number of shares of the Company’s common stock, equal to the number of Series A Preferred Shares to be converted, multiplied
by the stated value of $1,000 (the “Stated Value”), divided by the conversion price in effect at the time of the conversion.
The initial conversion price is $1.394, subject to adjustment in the event of stock splits, stock dividends, and similar transactions.
The Series A Preferred Stock is convertible into shares of our 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 our common stock on March 7, 2025, the second anniversary
of its issuance.
The
Series A Preferred Stock will be senior to the Common Stock and any other class of the Company’s capital stock that is not by its
terms senior to or pari passu with the Series A Preferred Stock.
Note
13 — Stockholders’ Equity - continued
The
holders of Series A Preferred Stock will be entitled to dividends payable as follows: (i) a number of shares of Common Stock equal to
20% of the number of shares of Common Stock issuable upon conversion of the Series A Preferred Stock then held by such Holder on March
7, 2024, and (ii) a number of shares of Common Stock equal to 20% of the number of shares of Common Stock issuable upon conversion of
the Series A Preferred Stock then held by such Holder on March 7, 2025. A holder that converts its Series A Preferred Stock prior to
March 7, 2024 or March 7, 2025, as the case may be, will not receive the dividend that accrues on such date with respect to such converted
Series A Preferred Stock. The holders of the Series A Preferred Stock also will be entitled to dividends equal, on an as-if-converted
to shares of Common Stock basis, to and in the same form as dividends actually paid on shares of the Common Stock when, as, and if such
dividends are paid on shares of the Common Stock.
In
the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company (or any Deemed Liquidation Event as defined
in the Certificate of Designation), the holders of shares of Series A Preferred Stock then outstanding will be entitled to be paid out
of the assets of the Company available for distribution to its stockholders, before any payment shall be made to the holders of Common
Stock by reason of their ownership thereof, an amount per share equal to the greater of (i) the Stated Value, plus any dividends accrued
but unpaid thereon, or (ii) such amount per share as would have been payable had all shares of Series A Preferred Stock been converted
into Common Stock immediately prior to such event.
The
Series A Preferred Stock is a non-voting security, other than with respect to limited matters related to changes in terms of the Series
A Preferred Stock.
The
Company will not effect any conversion of the Series A Preferred Stock, and a holder will not have the right to receive dividends or
convert any portion of the Series A Preferred Stock, to the extent that, after giving effect to the receipt of dividends or the conversion,
the holder (together with such holder’s affiliates, and any persons acting as a group together with such holder or any of the holder’s
affiliates) would beneficially own in excess of 4.99% of the Company’s outstanding common stock (or, upon election of the holder,
9.99% of the Company’s outstanding common stock).
The
Company and the investors in the offering also executed a registration rights agreement (the “Registration Rights Agreement”),
pursuant to which the Company agreed to file a registration statement covering the resale of the shares of Common Stock issuable pursuant
to the Series A Preferred Stock.
Lucid
Diagnostics Common Stock
In
June 2023, the Company received shareholder approval to issue up to 200 million shares of its common stock, an increase of 100 million
shares.
As
of June 30, 2023 and December 31, 2022 there were 41,853,603 and 40,518,792 shares of common stock issued and outstanding,
respectively. As of June 30, 2023, PAVmed holds 31,302,420 shares, representing a majority-interest equity ownership and PAVmed
has a controlling financial interest in the Company.
Committed
Equity Facility and ATM Facility
On
March 28, 2022, the Company entered into a committed equity facility with an affiliate of Cantor Fitzgerald (“Cantor”). Under
the terms of the committed equity facility, Cantor has committed to purchase up to $50 million of the Company’s common stock from
time to time at the request of the Company. While there are distinct differences, the facility is structured similarly to a traditional
at-the-market equity facility, insofar as it allows the Company to raise primary equity capital on a periodic basis at prices based on
the existing market price. Cumulatively a total of 680,263 shares of Lucid Diagnostics’ common stock were issued for net proceeds
of approximately $1.8 million, after a 4% discount, as of June 30, 2023.
In
November 2022, the Company entered into an “at-the-market offering” (“ATM”) for up to $6.5
million of its common stock that may be offered and sold under a Controlled Equity Offering Agreement between the Company and Cantor
Fitzgerald & Co. In the six months ended June 30, 2023, the Company sold 230,068
shares through the at-the-market equity facility for net proceeds of approximately $0.3
million, after payments of 3%
commissions. No shares were sold under the at-the-market equity facility during the three months ended June 30, 2023.
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v3.23.2
Net Loss Per Share
|
6 Months Ended |
Jun. 30, 2023 |
Earnings Per Share [Abstract] |
|
Net Loss Per Share |
Note
14 — Net Loss Per Share
The
Net loss per share basic and diluted for the respective periods indicated is as follows:
Schedule
of Basic and Fully Diluted Net Loss Per Share
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Numerator | |
| | |
| | |
| | |
| |
Net loss | |
$ | (11,381 | ) | |
$ | (14,624 | ) | |
$ | (27,628 | ) | |
$ | (26,894 | ) |
| |
| | | |
| | | |
| | | |
| | |
Denominator | |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding, basic and diluted | |
| 41,833,823 | | |
| 35,760,492 | | |
| 41,404,547 | | |
| 35,443,526 | |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share | |
| | | |
| | | |
| | | |
| | |
Net loss per share - basic and diluted | |
$ | (0.27 | ) | |
$ | (0.41 | ) | |
$ | (0.67 | ) | |
$ | (0.76 | ) |
Basic
weighted-average number of shares of common stock outstanding for the periods ended June 30, 2023 and 2022 include the shares of
the Company issued and outstanding during such periods, each on a weighted average basis. The basic weighted average number of shares
common stock outstanding excludes common stock equivalent incremental shares, while diluted weighted average number of shares outstanding
includes such incremental shares. However, as the Company was in a loss position for all periods presented, basic and diluted weighted
average shares outstanding are the same, as the inclusion of the incremental shares would be anti-dilutive. The common stock equivalents
excluded from the computation of diluted weighted average shares outstanding are as follows:
Schedule
of Anti-dilutive Securities Excluded from Computation of Diluted Earnings Per Share
| |
2023 | | |
2022 | |
| |
June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Stock options | |
| 4,949,962 | | |
| 2,459,666 | |
Unvested restricted stock awards | |
| 1,872,100 | | |
| 2,260,740 | |
Preferred stock | |
| 13,695,850 | | |
| — | |
Total | |
| 20,517,912 | | |
| 4,720,406 | |
|
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v3.23.2
Summary of Significant Accounting Policies (Policies)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements of the Company 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. All intercompany transactions and balances have been eliminated in consolidation. The Company is a majority-owned consolidated
subsidiary of PAVmed, which has a majority equity ownership interest and has financial control of the Company. The Company manages its
operations as a single operating segment for the purposes of assessing performance and making operating decisions.
As
permitted under SEC rules, certain footnotes or other financial information normally required by U.S. GAAP have been condensed or omitted.
The balance sheet as of December 31, 2022 has been derived from audited consolidated financial statements at such date. The accompanying
unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated
financial statements, and in the opinion of management, include all adjustments, consisting only of routine recurring adjustments, necessary
for a fair statement of the Company’s unaudited condensed consolidated financial information.
The
consolidated results of operations for the three and six months ended June 30, 2023 are not necessarily indicative of the consolidated
results to be expected for the year ending December 31, 2023 or for any other interim period or for any other future periods. The accompanying
unaudited condensed consolidated financial statements and related unaudited condensed consolidated financial information should be read
in conjunction with the Company’s audited consolidated financial statements and related notes thereto as of and for the year ended
December 31, 2022 included in the Company’s Annual Report on Form 10-K as filed with the SEC on March 14, 2023.
All
amounts in the accompanying unaudited condensed consolidated financial statements and the notes thereto are presented in thousands
of dollars, if not otherwise noted as being presented in millions of dollars, except for shares and per share amounts.
|
Use of Estimates |
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 reserves, if any, and
liabilities and the disclosure of contingent losses, as of the date of the consolidated financial statements, as well as the reported
amounts of revenue and expenses during the reporting period. Significant estimates in these unaudited condensed consolidated financial
statements include those related to the estimated fair value of debt obligations, stock-based equity awards and intangible assets. Other
significant estimates include the estimated incremental borrowing rate, the provision or benefit for income taxes and the corresponding
valuation allowance on deferred tax assets. Additionally, management’s assessment of the Company’s ability to continue as
a going concern involves the estimation of the amount and timing of future cash inflows and outflows. On an ongoing basis, the Company
evaluates its estimates and assumptions. The Company bases its estimates on historical experience and on various other assumptions believed
to be reasonable. Due to inherent uncertainty involved in making estimates, actual results reported in future periods may be affected
by changes in these estimates.
|
Revenue Recognition |
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.
Note
2 — Summary of Significant Accounting Policies - continued
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.
|
Financial Instruments Fair Value Measurements |
Financial
Instruments Fair Value Measurements
FASB
ASC Topic 820, Fair Value Measurement, (ASC 820) defines fair value as the price which would be received to sell an asset or paid to
transfer a liability in an orderly transaction between market participants at a transaction measurement date. The ASC 820 three-tier
fair value hierarchy prioritizes the inputs used in the valuation methodologies, as follows:
|
Level
1 | Valuations
based on quoted prices for identical assets and liabilities in active markets. |
|
| |
|
Level 2 | Valuations
based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets or liabilities in active
markets, quoted prices for identical or similar assets and liabilities in markets which are not active, or other inputs observable or
can be corroborated by observable market data. |
|
| |
|
Level 3 | Valuations
based on unobservable inputs reflecting the Company’s own assumptions, consistent with reasonably available assumptions made by
other market participants. These valuations require significant judgment. |
The
Company evaluates its financial instruments to determine if those instruments or any embedded components of those instruments potentially
qualify as derivatives required to be separately accounted for in accordance with FASB ASC Topic 815, Derivatives and Hedging (ASC 815).
Note
2 — Summary of Significant Accounting Policies - continued
The
recurring and non-recurring estimated fair value measurements are subjective and are affected by changes in inputs to the valuation models,
including the Company’s common stock price, and certain Level 3 inputs, including, the assumptions regarding the estimated volatility
in the value of the Company’s common stock price; the Company’s dividend yield; the likelihood and timing of future dilutive
transactions, as applicable, along with the risk-free rates based on U.S. Treasury security yields. Changes in these assumptions can
materially affect the estimated fair values.
As
of June 30, 2023 and December 31, 2022, the carrying values of cash, and accounts payable, approximate their respective fair
value due to the short-term nature of these financial instruments.
|
Fair Value Option (“FVO”) Election |
Fair
Value Option (“FVO”) Election
Under
a Securities Purchase Agreement dated March 13, 2023, the Company issued a Senior Secured Convertible Note dated March 21, 2023, referred
to herein as the “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
March 2023 Senior Convertible Note is presented in a single line item within other income (expense) in the accompanying 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 March 2023 Senior Convertible
Note).
See
Note 10, Financial Instruments Fair Value Measurements, with respect to the FVO election; and Note 11, Debt, for a discussion of the
March 2023 Senior Convertible Note.
|
Reclassifications |
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.
|
Recently Adopted Accounting Pronouncements |
Recently
Adopted Accounting Pronouncements
In
June 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments-Credit Losses (Topic 326):
Measurement of Credit Losses on Financial Instruments. The updated guidance requires companies to measure all expected credit losses
for financial instruments held at the reporting date based on historical experience, current conditions, and reasonable supportable forecasts.
This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets, including trade
receivables. The guidance was adopted by the Company on January 1, 2023. The adoption of the ASU did not have an impact on the Company’s
unaudited condensed consolidated financial statements.
|
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v3.23.2
Related Party Transactions (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Related Party Transactions [Abstract] |
|
Schedule of Incurred Expenses of Minority Shareholders |
Schedule of Incurred Expenses of Minority Shareholders
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Cost of Revenue | |
| | | |
| | | |
| | | |
| | |
CWRU – Royalty Fees | |
$ | 10 | | |
$ | — | | |
$ | 34 | | |
$ | 9 | |
| |
| | | |
| | | |
| | | |
| | |
General and Administrative Expense | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation expense – Physician Inventors’ restricted stock awards | |
| — | | |
| 272 | | |
| 180 | | |
| 544 | |
| |
| | | |
| | | |
| | | |
| | |
Research and Development Expense | |
| | | |
| | | |
| | | |
| | |
Amended CWRU – License Agreement - reimbursement of patent legal fees | |
| — | | |
| 209 | | |
| 389 | | |
| 209 | |
Fees - Physician Inventors’ consulting agreements | |
| 9 | | |
| 10 | | |
| 10 | | |
| 18 | |
Sponsored research agreement | |
| — | | |
| — | | |
| — | | |
| 3 | |
Stock-based compensation expense – Physician Inventors’ stock options | |
| 52 | | |
| 52 | | |
| 105 | | |
| 99 | |
Total Related Party Expenses | |
$ | 71 | | |
$ | 543 | | |
$ | 718 | | |
$ | 882 | |
|
Schedule of MSA Fee Expense Classification in Statements of Operations |
Schedule of MSA Fee Expense Classification in Statements of Operations
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Sales & Marketing | |
| 109 | | |
| 183 | | |
| 218 | | |
| 383 | |
General & Administrative | |
| 1,554 | | |
| 640 | | |
| 3,108 | | |
| 1,284 | |
Research & Development | |
| 587 | | |
| 347 | | |
| 1,174 | | |
| 673 | |
Total MSA Fee | |
$ | 2,250 | | |
$ | 1,170 | | |
$ | 4,500 | | |
$ | 2,340 | |
|
X |
- DefinitionTabular disclosure of condensed income statement, including, but not limited to, income statements of consolidated entities and consolidation eliminations.
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v3.23.2
Due To PAVmed Inc. (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Debt Disclosure [Abstract] |
|
Schedule of Senior Unsecured Promissory Note |
The
aggregate Due To: PAVmed Inc. for the periods indicated is summarized as follows:
Schedule of Senior Unsecured Promissory Note
| |
MSA Fees | | |
Employee-Related Costs | | |
PAVmed Inc. OBO Payments | | |
Total | |
Balance - December 31, 2022 | |
$ |
1,650 | | |
$ |
3,026 | | |
$ |
284 | | |
$ |
4,960 | |
MSA fees | |
| 4,500 | | |
| — | | |
| — | | |
| 4,500 | |
ERC - Payroll & Benefits | |
| — | | |
| 922 | | |
| — | | |
| 922 | |
On Behalf Of (OBO) activities | |
| — | | |
| — | | |
| 601 | | |
| 601 | |
Cash payments to PAVmed Inc. | |
| — | | |
| — | | |
| (286 | ) | |
| (286 | ) |
Balance - June 30, 2023 | |
$ | 6,150 | | |
$ | 3,948 | | |
$ | 599 | | |
$ | 10,697 | |
|
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v3.23.2
Prepaid Expenses, Deposits, and Other Current Assets (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Prepaid Expenses Deposits And Other Current Assets |
|
Schedule of Prepaid Expenses and Other Current Assets |
Prepaid
expenses and other current assets consisted of the following as of:
Schedule of Prepaid Expenses and Other Current Assets
| |
June 30, 2023 | | |
December 31, 2022 | |
Advanced payments to service providers and suppliers | |
$ | 344 | | |
$ | 371 | |
Prepaid insurance | |
| 171 | | |
| 52 | |
Deposits | |
| 2,587 | | |
| 1,331 | |
EsoCheck cell collection supplies | |
| 39 | | |
| 59 | |
EsoGuard mailer supplies | |
| 3 | | |
| 52 | |
Total prepaid expenses, deposits and other current assets | |
$ | 3,144 | | |
$ | 1,865 | |
|
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v3.23.2
Leases (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Leases |
|
Schedule Of Future Lease Payments Of Operating Lease Liabilities |
The
Company’s future lease payments as of June 30, 2023, which are presented as operating lease liabilities, current portion and
operating lease liabilities, less current portion on the Company’s unaudited condensed consolidated balance sheets are as follows:
Schedule Of Future Lease Payments Of Operating Lease Liabilities
| |
| | |
2023 (remainder of year) | |
$ | 611 | |
2024 | |
| 1,133 | |
2025 | |
| 127 | |
2026 | |
| 63 | |
2027 | |
| 24 | |
Total lease payments | |
$ | 1,958 | |
Less: imputed interest | |
| (127 | ) |
Present value of lease liabilities | |
$ | 1,831 | |
|
Schedule Of Cash Flow Supplemental Information |
Supplemental
disclosure of cash flow information related to the Company’s cash and non-cash activities with its leases are as follows:
Schedule Of Cash Flow Supplemental Information
| |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
Cash paid for amounts included in the measurement of lease liabilities | |
| | | |
| | |
Operating cash flows from operating leases | |
$ | 583 | | |
$ | 453 | |
Non-cash investing and financing activities | |
| | | |
| | |
Right-of-use assets obtained in exchange for new operating lease liabilities | |
$ | 341 | | |
$ | 2,448 | |
Weighted-average remaining lease term - operating leases (in years) | |
| 1.80 | | |
| 2.48 | |
Weighted-average discount rate - operating leases | |
| 7.875 | % | |
| 7.875 | % |
|
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v3.23.2
Intangible Assets, net (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Schedule of Intangible Assets Accumulated Amortization |
Intangible
assets, less accumulated amortization, consisted of the following as of:
Schedule of Intangible Assets Accumulated Amortization
| |
Estimated Useful Life | |
June 30, 2023 | | |
December 31, 2022 | |
Defensive technology | |
60 months | |
$ | 2,105 | | |
$ | 2,105 | |
Laboratory licenses and certifications and laboratory information management software | |
24 months | |
| 3,200 | | |
$ | 3,200 | |
Total Intangible assets | |
| |
| 5,305 | | |
| 5,305 | |
Less Accumulated Amortization | |
| |
| (2,870 | ) | |
| (1,860 | ) |
Intangible Assets, net | |
| |
$ | 2,435 | | |
$ | 3,445 | |
|
Schedule of Future Amortization Expense |
Schedule of Future Amortization Expense
| |
| | |
2023 (remainder of year) | |
$ | 1,011 | |
2024 | |
| 688 | |
2025 | |
| 421 | |
2026 | |
| 315 | |
Total | |
$ | 2,435 | |
|
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v3.23.2
Financial Instruments Fair Value Measurements (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Schedule of Financial Liabilities Measured at Fair Value on Recurring Basis |
The
fair value hierarchy table for the reporting date noted is as follows:
Schedule of Financial Liabilities Measured at Fair Value on Recurring Basis
| |
Fair Value Measurement on a Recurring Basis at Reporting Date Using1 | |
| |
Level-1 Inputs | | |
Level-2 Inputs | | |
Level-3 Inputs | | |
Total | |
June 30, 2023 | |
| | | |
| | | |
| | | |
| | |
March 2023 Senior Convertible Note | |
$ | — | | |
$ | — | | |
$ | 11,610 | | |
$ | 11,610 | |
Totals | |
$ | — | | |
$ | — | | |
$ | 11,610 | | |
$ | 11,610 | |
1 | | There were no transfers
between the respective Levels during the period ended June 30, 2023. |
|
Schedule of Fair Value Assumption Used |
The
estimated fair value of the March 2023 Senior Convertible Note as of each of March 21, 2023 and June 30, 2023 were computed using
a Monte Carlo simulation of the present value of its cash flows using a synthetic credit rating analysis and a required rate-of-return,
using the following assumptions:
Schedule of Fair Value Assumption Used
| |
March 2023 Senior Convertible Note: March 21, 2023 | | |
March 2023 Senior Convertible Note: June 30, 2023 | |
Fair Value | |
$ | 11,900 | | |
$ | 11,610 | |
Face value principal payable | |
$ | 11,111 | | |
$ | 11,111 | |
Required rate of return | |
| 11.00 | % | |
| 11.00 | % |
Conversion Price | |
$ | 5.00 | | |
$ | 5.00 | |
Value of common stock | |
$ | 1.54 | | |
$ | 1.39 | |
Expected term (years) | |
| 2.00 | | |
| 1.73 | |
Volatility | |
| 75.00 | % | |
| 70.00 | % |
Risk free rate | |
| 4.09 | % | |
| 4.89 | % |
Dividend yield | |
| — | % | |
| — | % |
|
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v3.23.2
Debt (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Debt Disclosure [Abstract] |
|
Summary of Outstanding Debt |
The
fair value and face value principal outstanding of the March 2023 Senior Convertible Note 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 | |
March 2023 Senior Convertible Note | |
March 21, 2025 | |
| 7.875 | % | |
$ | 5.00 | | |
$ | 11,111 | | |
$ | 11,610 | |
Balance as of June 30, 2023 | |
| |
| | | |
| | | |
$ | 11,111 | | |
$ | 11,610 | |
|
Schedule of Changes in Fair Value of Debt |
The
changes in the fair value of debt during the three and six months ended June 30, 2023 is as follows:
Schedule
of Changes in Fair Value of Debt
| |
March 2023 Senior Convertible Note | | |
Other Income (expense) | |
Fair Value - December 31, 2022 | |
$ | — | | |
$ | — | |
Face value principal – issue date | |
| 11,111 | | |
| — | |
Fair value adjustment – issue date | |
| 789 | | |
| (789 | ) |
Change in fair value | |
| — | | |
| — | |
Fair Value at March 31, 2023 | |
$ | 11,900 | | |
| - | |
Other Income (Expense) - Change in fair value – three months ended March 31, 2023 | |
| | | |
$ | (789 | ) |
| |
| | | |
| | |
Change in fair value | |
| (290 | ) | |
| 290 | |
Fair Value at June 30, 2023 | |
$ | 11,610 | | |
| - | |
Other Income (Expense) - Change in fair value – three months ended June 30, 2023 | |
| | | |
$ | 290 | |
Other Income (Expense) - Change in fair value – six months ended June 30, 2023 | |
| | | |
$ | (499 | ) |
|
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v3.23.2
Stock-Based Compensation (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Stock Options Issued and Outstanding Activities |
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 Stock Options Issued and Outstanding Activities
| |
Number of Stock Options | | |
Weighted Average Exercise Price | | |
Remaining Contractual Term (Years) | | |
Intrinsic
Value(2) | |
Outstanding stock options at December 31, 2022 | |
| 2,565,377 | | |
$ | 3.14 | | |
| 8.3 | | |
$ | 428 | |
Granted(1) | |
| 2,732,500 | | |
$ | 1.31 | | |
| | | |
| | |
Exercised | |
| — | | |
$ | — | | |
| | | |
| | |
Forfeited | |
| (347,915 | ) | |
$ | 2.57 | | |
| | | |
| | |
Outstanding stock options at June 30, 2023(3) | |
| 4,949,962 | | |
$ | 2.17 | | |
| 8.7 | | |
$ | 641 | |
Vested and exercisable stock options at June 30, 2023 | |
| 1,374,179 | | |
$ | 2.76 | | |
| 6.9 | | |
$ | 440 | |
(1) | Stock
options granted under the Lucid Diagnostics 2018 Equity Plan and those granted outside such
plan generally vest one-third in one year then ratably over the next eight quarters, and
have a ten-year contractual term from date-of-grant. |
(2) | The
intrinsic value is computed as the difference between the quoted price of the Lucid Diagnostics
common stock on each of June 30, 2023 and December 31, 2022 and the exercise price of
the underlying Lucid Diagnostics stock options, to the extent such quoted price is greater
than the exercise price. |
(3) | The
outstanding stock options presented in the table above, are inclusive of 423,300 stock options
granted outside the Lucid Diagnostics 2018 Equity Plan, as of June 30, 2023 and December
31, 2022. |
|
Schedule of Restricted Stock Award Activity |
Schedule
of Restricted Stock Award Activity
| |
Number of Restricted Stock Awards | | |
Weighted Average Grant Date Fair Value | |
Unvested restricted stock awards as of December 31, 2022(1) | |
| 2,091,420 | | |
$ | 11.44 | |
Granted | |
| — | | |
| — | |
Vested | |
| (219,320 | ) | |
| 11.27 | |
Forfeited | |
| — | | |
| — | |
Unvested restricted stock awards as of June 30, 2023 | |
| 1,872,100 | | |
$ | 11.46 | |
(1) | The
unvested restricted stock awards presented in the table above, are inclusive of 50,000 restricted
stock awards granted outside the Lucid Diagnostics 2018 Equity Plan as of December 31, 2022.
These 50,000 restricted stock awards were fully vested during the period ended June 30,
2023. |
|
Schedule of Stock-Based Compensation Expense |
The
stock-based compensation expense recognized by the Company for both the Lucid Diagnostics 2018 Equity Plan and the PAVmed 2014 Equity
Plan, for the periods indicated, was as follows:
Schedule
of Stock-Based Compensation Expense
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Lucid Diagnostics 2018 Equity Plan – cost of revenue | |
$ | 16 | | |
$ | — | | |
$ | 28 | | |
$ | — | |
Lucid Diagnostics 2018 Equity Plan – sales and marketing | |
| 247 | | |
| 215 | | |
| 470 | | |
| 480 | |
Lucid Diagnostics 2018 Equity Plan - general and administrative | |
| 836 | | |
| 3,313 | | |
| 3,348 | | |
| 6,514 | |
Lucid Diagnostics 2018 Equity Plan - research and development | |
| 66 | | |
| 26 | | |
| 136 | | |
| 97 | |
PAVmed 2014 Equity Plan - cost of revenue | |
| 9 | | |
| — | | |
| 16 | | |
| — | |
PAVmed 2014 Equity Plan - sales and marketing | |
| 120 | | |
| 161 | | |
| 253 | | |
| 336 | |
PAVmed 2014 Equity Plan - general and administrative | |
| 8 | | |
| 77 | | |
| 164 | | |
| 145 | |
PAVmed 2014 Equity Plan - research and development | |
| 97 | | |
| 52 | | |
| 192 | | |
| 107 | |
Total stock-based compensation expense | |
$ | 1,399 | | |
$ | 3,844 | | |
$ | 4,607 | | |
$ | 7,679 | |
|
Schedule of Unrecognized Compensation Expense and Weighted Average Remaining Service Period |
As
of June 30, 2023, 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 Lucid Diagnostics 2018 Equity Plan and the PAVmed 2014 Equity Plan,
as discussed above, is as follows:
Schedule
of Unrecognized Compensation Expense and Weighted Average Remaining Service Period
| |
Unrecognized Expense | | |
Weighted Average Remaining Service Period (Years) | |
Lucid Diagnostics 2018 Equity Plan | |
| | | |
| | |
Stock Options | |
$ | 4,129 | | |
| 2.3 | |
Restricted Stock Awards | |
$ | 1,141 | | |
| 1.1 | |
PAVmed 2014 Equity Plan | |
| | | |
| | |
Stock Options | |
$ | 861 | | |
| 2.0 | |
|
Schedule of Stock-based Compensation Valuation Assumptions |
Schedule
of Stock-based Compensation Valuation Assumptions
| |
2023 | | |
2022 | |
| |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
Expected term of stock options (in years) | |
| 5.6 | | |
| 5.7 | |
Expected stock price volatility | |
| 75 | % | |
| 71 | % |
Risk free interest rate | |
| 3.7 | % | |
| 3.0 | % |
Expected dividend yield | |
| — | % | |
| — | % |
|
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v3.23.2
Net Loss Per Share (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Earnings Per Share [Abstract] |
|
Schedule of Basic and Fully Diluted Net Loss Per Share |
The
Net loss per share basic and diluted for the respective periods indicated is as follows:
Schedule
of Basic and Fully Diluted Net Loss Per Share
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Numerator | |
| | |
| | |
| | |
| |
Net loss | |
$ | (11,381 | ) | |
$ | (14,624 | ) | |
$ | (27,628 | ) | |
$ | (26,894 | ) |
| |
| | | |
| | | |
| | | |
| | |
Denominator | |
| | | |
| | | |
| | | |
| | |
Weighted average common shares outstanding, basic and diluted | |
| 41,833,823 | | |
| 35,760,492 | | |
| 41,404,547 | | |
| 35,443,526 | |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share | |
| | | |
| | | |
| | | |
| | |
Net loss per share - basic and diluted | |
$ | (0.27 | ) | |
$ | (0.41 | ) | |
$ | (0.67 | ) | |
$ | (0.76 | ) |
|
Schedule of Anti-dilutive Securities Excluded from Computation of Diluted Earnings Per Share |
Schedule
of Anti-dilutive Securities Excluded from Computation of Diluted Earnings Per Share
| |
2023 | | |
2022 | |
| |
June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Stock options | |
| 4,949,962 | | |
| 2,459,666 | |
Unvested restricted stock awards | |
| 1,872,100 | | |
| 2,260,740 | |
Preferred stock | |
| 13,695,850 | | |
| — | |
Total | |
| 20,517,912 | | |
| 4,720,406 | |
|
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v3.23.2
Schedule of MSA Fee Expense Classification in Statements of Operations (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Related Party Transaction [Line Items] |
|
|
|
|
Sales & Marketing |
$ 4,032
|
$ 3,873
|
$ 8,159
|
$ 7,191
|
General & Administrative |
3,830
|
6,676
|
10,340
|
12,568
|
Research & Development |
1,827
|
3,440
|
4,109
|
6,321
|
Pavmed Inc [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Total MSA Fee |
|
390
|
750
|
390
|
Pavmed Inc [Member] | Management Services Agreement [Member] |
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
Sales & Marketing |
109
|
183
|
218
|
383
|
General & Administrative |
1,554
|
640
|
3,108
|
1,284
|
Research & Development |
587
|
347
|
1,174
|
673
|
Total MSA Fee |
$ 2,250
|
$ 1,170
|
$ 4,500
|
$ 2,340
|
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v3.23.2
Schedule of Senior Unsecured Promissory Note (Details) $ in Thousands |
6 Months Ended |
Jun. 30, 2023
USD ($)
|
Short-Term Debt [Line Items] |
|
Balance - December 31, 2022 |
$ 4,960
|
MSA fees |
4,500
|
ERC - Payroll & Benefits |
922
|
On Behalf Of (OBO) activities |
601
|
Cash payments to PAVmed Inc. |
(286)
|
Balance - June 30, 2023 |
10,697
|
MSA Fees [Member] |
|
Short-Term Debt [Line Items] |
|
Balance - December 31, 2022 |
1,650
|
MSA fees |
4,500
|
ERC - Payroll & Benefits |
|
On Behalf Of (OBO) activities |
|
Cash payments to PAVmed Inc. |
|
Balance - June 30, 2023 |
6,150
|
ERC Payroll Benefits [Member] |
|
Short-Term Debt [Line Items] |
|
Balance - December 31, 2022 |
3,026
|
MSA fees |
|
ERC - Payroll & Benefits |
922
|
On Behalf Of (OBO) activities |
|
Cash payments to PAVmed Inc. |
|
Balance - June 30, 2023 |
3,948
|
OBO Payments [Member] |
|
Short-Term Debt [Line Items] |
|
Balance - December 31, 2022 |
284
|
MSA fees |
|
ERC - Payroll & Benefits |
|
On Behalf Of (OBO) activities |
601
|
Cash payments to PAVmed Inc. |
(286)
|
Balance - June 30, 2023 |
$ 599
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Leases (Details Narrative) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Leases |
|
|
Operating lease right of use asset |
$ 1,835
|
$ 2,008
|
Operating lease obligations |
1,831
|
1,999
|
Operating lease liabilities, current |
1,099
|
962
|
Operating lease liabilities, non-current |
$ 732
|
$ 1,037
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v3.23.2
Schedule of Intangible Assets Accumulated Amortization (Details) - USD ($) $ in Thousands |
Jun. 30, 2023 |
Dec. 31, 2022 |
Finite-Lived Intangible Assets [Line Items] |
|
|
Total Intangible assets |
$ 5,305
|
$ 5,305
|
Less Accumulated Amortization |
(2,870)
|
(1,860)
|
Total Intangible Assets, net |
$ 2,435
|
$ 3,445
|
Defensive Technology [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Estimated useful life |
60 months
|
60 months
|
Total Intangible assets |
$ 2,105
|
$ 2,105
|
Laboratory Information Management Software [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Estimated useful life |
24 months
|
24 months
|
Total Intangible assets |
$ 3,200
|
$ 3,200
|
X |
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v3.23.2
Intangible Assets, net (Details Narrative) - USD ($) $ in Thousands |
|
3 Months Ended |
6 Months Ended |
|
|
Oct. 05, 2021 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Apr. 02, 2022 |
Impairment Effects on Earnings Per Share [Line Items] |
|
|
|
|
|
|
|
Intangible assets |
|
$ 5,305
|
|
$ 5,305
|
|
$ 5,305
|
|
Accumulated amortization |
|
(2,870)
|
|
(2,870)
|
|
$ (1,860)
|
|
Amortization expense of intangible assets |
|
$ 505
|
$ 639
|
$ 1,010
|
$ 639
|
|
|
Defensive Technology [Member] | Pavmed Inc [Member] |
|
|
|
|
|
|
|
Impairment Effects on Earnings Per Share [Line Items] |
|
|
|
|
|
|
|
Intangible assets |
|
|
|
|
|
|
$ 2,100
|
Accumulated amortization |
|
|
|
|
|
|
$ 200
|
Purchase consideration paid |
$ 2,100
|
|
|
|
|
|
|
Finite lived intangible asset useful life |
|
60 months
|
|
60 months
|
|
|
|
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v3.23.2
Schedule of Financial Liabilities Measured at Fair Value on Recurring Basis (Details) $ in Thousands |
Jun. 30, 2023
USD ($)
|
[1] |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value of liability |
$ 11,610
|
Fair Value, Inputs, Level 1 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value of liability |
|
Fair Value, Inputs, Level 2 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value of liability |
|
Fair Value, Inputs, Level 3 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value of liability |
11,610
|
March 2023 Senior Convertible Note [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value of liability |
11,610
|
March 2023 Senior Convertible Note [Member] | Fair Value, Inputs, Level 1 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value of liability |
|
March 2023 Senior Convertible Note [Member] | Fair Value, Inputs, Level 2 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value of liability |
|
March 2023 Senior Convertible Note [Member] | Fair Value, Inputs, Level 3 [Member] |
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
Fair value of liability |
$ 11,610
|
|
|
X |
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Schedule of Fair Value Assumption Used (Details) $ in Thousands |
|
6 Months Ended |
|
|
Mar. 21, 2023
USD ($)
|
Jun. 30, 2023
USD ($)
|
Mar. 31, 2023
USD ($)
|
Dec. 31, 2022
USD ($)
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
Fair value |
|
$ 11,610
|
|
|
Face value principal payable |
$ 11,100
|
11,111
|
|
|
March 2023 Senior Convertible Note [Member] |
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
Fair value |
11,900
|
11,610
|
$ 11,900
|
|
Face value principal payable |
$ 11,111
|
$ 11,111
|
|
|
March 2023 Senior Convertible Note [Member] | Measurement Input Required Rate of Return [Member] |
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
Fair value assumption measurement input |
11.00
|
11.00
|
|
|
March 2023 Senior Convertible Note [Member] | Measurement Input, Conversion Price [Member] |
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
Fair value assumption measurement input |
5.00
|
5.00
|
|
|
March 2023 Senior Convertible Note [Member] | Measurement Input, Share Price [Member] |
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
Fair value assumption measurement input |
1.54
|
1.39
|
|
|
March 2023 Senior Convertible Note [Member] | Measurement Input, Expected Term [Member] |
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
Expected term years |
2 years
|
1 year 8 months 23 days
|
|
|
March 2023 Senior Convertible Note [Member] | Measurement Input, Price Volatility [Member] |
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
Fair value assumption measurement input |
75.00
|
70.00
|
|
|
March 2023 Senior Convertible Note [Member] | Measurement Input, Risk Free Interest Rate [Member] |
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
Fair value assumption measurement input |
4.09
|
4.89
|
|
|
March 2023 Senior Convertible Note [Member] | Measurement Input, Expected Dividend Rate [Member] |
|
|
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
|
|
Fair value assumption measurement input |
|
|
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v3.23.2
Summary of Outstanding Debt (Details) - USD ($) $ / shares in Units, $ in Thousands |
6 Months Ended |
|
|
|
Jun. 30, 2023 |
Mar. 31, 2023 |
Mar. 21, 2023 |
Dec. 31, 2022 |
Short-Term Debt [Line Items] |
|
|
|
|
Face Value Principal Outstanding |
$ 11,111
|
|
$ 11,100
|
|
Fair Value |
$ 11,610
|
|
|
|
March 2023 Senior Convertible Note [Member] |
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
Maturity Date |
Mar. 21, 2025
|
|
|
|
Stated Interest Rate |
7.875%
|
|
7.875%
|
|
Conversion Price |
$ 5.00
|
|
$ 5.00
|
|
Face Value Principal Outstanding |
$ 11,111
|
|
$ 11,111
|
|
Fair Value |
$ 11,610
|
$ 11,900
|
$ 11,900
|
|
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3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Short-Term Debt [Line Items] |
|
|
|
|
|
Fair value adjustment – issue date |
$ (290)
|
|
|
$ 499
|
|
Fair Value at June 30, 2023 |
11,610
|
|
|
11,610
|
|
Other Operating Income (Expense) [Member] |
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
Fair Value at March 31, 2023 |
|
|
|
|
|
Face value principal – issue date |
|
|
|
|
|
Fair value adjustment – issue date |
|
(789)
|
|
|
|
Change in fair value |
290
|
|
|
|
|
Other Income (Expense) - Change in fair value |
290
|
(789)
|
|
(499)
|
|
Fair Value at June 30, 2023 |
|
|
|
|
|
March 2023 Senior Convertible Note [Member] |
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
Fair Value at March 31, 2023 |
11,900
|
|
|
|
|
Face value principal – issue date |
|
11,111
|
|
|
|
Fair value adjustment – issue date |
|
789
|
|
|
|
Change in fair value |
(290)
|
|
|
|
|
Fair Value at June 30, 2023 |
$ 11,610
|
$ 11,900
|
|
$ 11,610
|
|
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v3.23.2
Debt (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands |
|
|
3 Months Ended |
6 Months Ended |
|
Sep. 21, 2023 |
Mar. 21, 2023 |
Jun. 30, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Sep. 20, 2023 |
Short-Term Debt [Line Items] |
|
|
|
|
|
|
Face value principal payable |
|
$ 11,100
|
$ 11,111
|
$ 11,111
|
|
|
Proceeds from convertible debt |
|
|
|
$ 10,000
|
|
|
Covenant description |
|
|
|
(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) the Company’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) the Company’s market capitalization to at no time be less
than $30 million
|
|
|
March 2023 Senior Convertible Note [Member] |
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
Face value principal payable |
|
$ 11,111
|
$ 11,111
|
$ 11,111
|
|
|
Stated interest rate |
|
7.875%
|
7.875%
|
7.875%
|
|
|
Conversion price |
|
$ 5.00
|
$ 5.00
|
$ 5.00
|
|
|
Proceeds from convertible debt |
|
$ 9,925
|
|
|
|
|
Debt fees amount |
|
$ 1,186
|
|
|
|
|
Interest expense |
|
|
$ 219
|
$ 243
|
|
|
Debt instrument maturity date |
|
|
|
Mar. 21, 2025
|
|
|
March 2023 Senior Convertible Note [Member] | Forecast [Member] |
|
|
|
|
|
|
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|
|
|
|
|
|
Stated interest rate |
|
|
|
|
|
7.875%
|
Debt fees amount |
|
|
|
|
|
$ 11,100
|
Debt instrument maturity date |
Mar. 21, 2025
|
|
|
|
|
|
Principal repayment |
$ 292
|
|
|
|
|
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v3.23.2
Schedule of Stock Options Issued and Outstanding Activities (Details) - 2018 Equity Plan [Member] - USD ($) $ / shares in Units, $ in Thousands |
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Number of Stock Options, Outstanding Stock Options Beginning |
|
2,565,377
|
|
|
Weighted Average Exercise Price, Weighted Average Grant Date Fair Value, Outstanding Stock Options Beginning |
|
$ 3.14
|
|
|
Remaining Contractual Term (Years), Outstanding Stock Options Ending |
|
8 years 8 months 12 days
|
[1] |
8 years 3 months 18 days
|
Outstanding Stock Options, Intrinsic Value Beginning |
[2] |
$ 428
|
|
|
Number of Stock Options, Granted |
[3] |
2,732,500
|
|
|
Weighted Average Exercise Price, Granted |
[3] |
$ 1.31
|
|
|
Number of Stock Options, Exercised |
|
|
|
|
Weighted Average Exercise Price, Exercised |
|
|
|
|
Number of Stock Options, Forfeited |
|
(347,915)
|
|
|
Weighted Average Exercise Price, Forfeited |
|
$ 2.57
|
|
|
Number of Stock Options, Outstanding Stock Options Ending |
|
4,949,962
|
[1] |
2,565,377
|
Weighted Average Exercise Price, Weighted Average Grant Date Fair Value, Outstanding Stock Options Ending |
|
$ 2.17
|
[1] |
$ 3.14
|
Outstanding Stock Options, Intrinsic Value Ending |
[2] |
$ 641
|
[1] |
$ 428
|
Number of Stock Options, Vested and exercisable stock options |
|
1,374,179
|
|
|
Weighted Average Exercise Price, Vested and exercisable stock options |
|
$ 2.76
|
|
|
Remaining Contractual Term (Years), Vested and Exercisable |
|
6 years 10 months 24 days
|
|
|
Vested and Exercisable Stock Options, intrinsic value |
[2] |
$ 440
|
|
|
|
|
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Schedule of Restricted Stock Award Activity (Details) - Restricted Stock [Member]
|
6 Months Ended |
Jun. 30, 2023
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Number of Restricted Stock Awards, Outstanding Beginning | shares |
2,091,420
|
[1] |
Weighted Average Grant Date Fair Value, Outstanding Beginning | $ / shares |
$ 11.44
|
[1] |
Number of Restricted Stock Awards, Granted | shares |
|
|
Weighted Average Grant Date Fair Value, Granted | $ / shares |
|
|
Number of Restricted Stock Awards, Vested | shares |
(219,320)
|
|
Weighted Average Grant Date Fair Value, Vested | $ / shares |
$ 11.27
|
|
Number of Restricted Stock Awards, Forfeited | shares |
|
|
Weighted Average Grant Date Fair Value, Forfeited | $ / shares |
|
|
Number of Restricted Stock Awards, Outstanding Ending | shares |
1,872,100
|
|
Weighted Average Grant Date Fair Value, Outstanding Ending | $ / shares |
$ 11.46
|
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v3.23.2
Schedule of Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Total stock-based compensation expense |
$ 1,399
|
$ 3,844
|
$ 4,607
|
$ 7,679
|
2018 Equity Plan [Member] | Cost of Revenue [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Total stock-based compensation expense |
16
|
|
28
|
|
2018 Equity Plan [Member] | Selling and Marketing Expense [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Total stock-based compensation expense |
247
|
215
|
470
|
480
|
2018 Equity Plan [Member] | General and Administrative Expense [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Total stock-based compensation expense |
836
|
3,313
|
3,348
|
6,514
|
2018 Equity Plan [Member] | Research and Development Expense [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Total stock-based compensation expense |
66
|
26
|
136
|
97
|
PAVmed Inc 2014 Equity Plan [Member] | Selling and Marketing Expense [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Total stock-based compensation expense |
120
|
161
|
253
|
336
|
PAVmed Inc 2014 Equity Plan [Member] | General and Administrative Expense [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Total stock-based compensation expense |
8
|
77
|
164
|
145
|
PAVmed Inc 2014 Equity Plan [Member] | Research and Development Expense [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Total stock-based compensation expense |
97
|
52
|
192
|
107
|
PAVmed Inc 2014 Equity Plan [Member] | Cost of Revenue Expense [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Total stock-based compensation expense |
$ 9
|
|
$ 16
|
|
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v3.23.2
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- DefinitionThe estimated dividend rate (a percentage of the share price) to be paid (expected dividends) to holders of the underlying shares over the option's term.
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v3.23.2
Stock-Based Compensation (Details Narrative) - USD ($) $ in Thousands |
6 Months Ended |
12 Months Ended |
9606 Months Ended |
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Jun. 30, 2823 |
Jan. 31, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Proceeds for issuance |
$ 276
|
|
|
|
Restricted Stock [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Restricted stock awards granted |
|
|
|
|
2018 Equity Plan [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Number of shares reserved |
11,644,000
|
|
|
|
Shares available for issue |
3,936,554
|
|
|
|
Stock option grants |
423,300
|
423,300
|
|
|
2018 Equity Plan [Member] | Restricted Stock [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Restricted stock awards granted |
50,000
|
|
|
|
Employee Stock Purchase Plan [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Number of shares reserved |
1,000,000
|
|
|
|
Shares available for issue |
683,983
|
|
|
500,000
|
Number of common stock purchased |
231,987
|
|
|
|
Proceeds for issuance |
|
|
$ 276
|
|
X |
- DefinitionAggregate number of common shares reserved for future issuance.
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v3.23.2
Stockholders’ Equity (Details Narrative) - USD ($)
|
|
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
|
|
|
|
|
Mar. 07, 2023 |
Mar. 28, 2022 |
Jun. 30, 2023 |
Jun. 30, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Mar. 31, 2023 |
Dec. 31, 2022 |
Nov. 30, 2022 |
Mar. 31, 2022 |
Dec. 31, 2021 |
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Designated preferred stock, shares |
|
|
20,000,000
|
20,000,000
|
20,000,000
|
|
|
20,000,000
|
|
|
|
Preferred stock, per share |
|
|
$ 0.001
|
$ 0.001
|
$ 0.001
|
|
|
$ 0.001
|
|
|
|
Preferred stock, stated value |
|
|
$ 13,625,000
|
$ 13,625,000
|
$ 13,625,000
|
|
|
|
|
|
|
Number of shares authorized |
|
|
200,000,000
|
200,000,000
|
200,000,000
|
|
|
200,000,000
|
|
|
|
Common stock, shares issued |
|
|
41,853,603
|
41,853,603
|
41,853,603
|
|
|
40,518,792
|
|
|
|
Common stock, shares outstanding |
|
|
41,853,603
|
41,853,603
|
41,853,603
|
|
|
40,518,792
|
|
|
|
Proceeds from issuance of common stock |
|
|
|
|
$ 284,000
|
|
|
|
|
|
|
Common Stock, Value, Issued |
|
|
$ 42,000
|
$ 42,000
|
$ 42,000
|
|
|
$ 41,000
|
|
|
|
Controlled Equity Offering Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Common Stock, Value, Issued |
|
|
|
|
|
|
|
|
$ 6,500,000
|
|
|
Sale of Stock, Number of Shares Issued in Transaction |
|
|
|
|
230,068
|
|
|
|
|
|
|
Sale of Stock, Consideration Received Per Transaction |
|
|
|
|
$ 300,000
|
|
|
|
|
|
|
Percentage of commission paid to broker |
|
|
|
3.00%
|
3.00%
|
|
|
|
|
|
|
Cantor Fitzgerald [Member] | Commited Equity Facility [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Sale of Stock, Consideration Received on Transaction |
|
$ 50,000,000
|
|
|
|
|
|
|
|
|
|
Issuance of common stock |
|
|
|
|
680,263
|
|
|
|
|
|
|
Proceeds from issuance of common stock |
|
|
|
|
$ 1,800,000
|
|
|
|
|
|
|
Percentage of discount on sale of stock |
|
|
|
|
4.00%
|
|
|
|
|
|
|
Lucid Diagnostics Inc [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Majority-interest equity ownership shares |
|
|
31,302,420
|
31,302,420
|
31,302,420
|
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Number of shares authorized |
|
|
200,000,000
|
200,000,000
|
200,000,000
|
|
|
|
|
|
|
Increase in common stock |
|
|
$ 100,000,000
|
|
|
|
|
|
|
|
|
Majority-interest equity ownership shares |
|
|
41,853,603
|
41,853,603
|
41,853,603
|
35,994,667
|
41,753,603
|
40,518,792
|
|
35,171,796
|
34,917,907
|
Series A Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Designated preferred stock, shares |
13,625
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, per share |
$ 0.001
|
|
|
|
|
|
|
|
|
|
|
Share price, per share |
$ 1,000
|
|
|
|
|
|
|
|
|
|
|
Proceeds from convertible preferred stock |
$ 13,625,000
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, stated value |
$ 1,000
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, conversion price per share |
$ 1.394
|
|
|
|
|
|
|
|
|
|
|
Preferred stock dividend payment terms |
The
holders of Series A Preferred Stock will be entitled to dividends payable as follows: (i) a number of shares of Common Stock equal to
20% of the number of shares of Common Stock issuable upon conversion of the Series A Preferred Stock then held by such Holder on March
7, 2024, and (ii) a number of shares of Common Stock equal to 20% of the number of shares of Common Stock issuable upon conversion of
the Series A Preferred Stock then held by such Holder on March 7, 2025. A holder that converts its Series A Preferred Stock prior to
March 7, 2024 or March 7, 2025, as the case may be, will not receive the dividend that accrues on such date with respect to such converted
Series A Preferred Stock. The holders of the Series A Preferred Stock also will be entitled to dividends equal, on an as-if-converted
to shares of Common Stock basis, to and in the same form as dividends actually paid on shares of the Common Stock when, as, and if such
dividends are paid on shares of the Common Stock
|
|
|
|
|
|
|
|
|
|
|
Conversion of stock, description |
The
Company will not effect any conversion of the Series A Preferred Stock, and a holder will not have the right to receive dividends or
convert any portion of the Series A Preferred Stock, to the extent that, after giving effect to the receipt of dividends or the conversion,
the holder (together with such holder’s affiliates, and any persons acting as a group together with such holder or any of the holder’s
affiliates) would beneficially own in excess of 4.99% of the Company’s outstanding common stock (or, upon election of the holder,
9.99% of the Company’s outstanding common stock)
|
|
|
|
|
|
|
|
|
|
|
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v3.23.2
Schedule of Basic and Fully Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Earnings Per Share [Abstract] |
|
|
|
|
Net loss |
$ (11,381)
|
$ (14,624)
|
$ (27,628)
|
$ (26,894)
|
Weighted average common shares outstanding, basic |
41,833,823
|
35,760,492
|
41,404,547
|
35,443,526
|
Weighted average common shares outstanding, diluted |
41,833,823
|
35,760,492
|
41,404,547
|
35,443,526
|
Net loss per common share - basic |
$ (0.27)
|
$ (0.41)
|
$ (0.67)
|
$ (0.76)
|
Net loss per common share - diluted |
$ (0.27)
|
$ (0.41)
|
$ (0.67)
|
$ (0.76)
|
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v3.23.2
Schedule of Anti-dilutive Securities Excluded from Computation of Diluted Earnings Per Share (Details) - shares
|
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
20,517,912
|
4,720,406
|
Lucid Diagnostics in 2018 Equity Plan Stock Options [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
4,949,962
|
2,459,666
|
Lucid Diagnostics in 2018 Equity Plan Unvested Restricted Stock Awards [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
1,872,100
|
2,260,740
|
Convertible Preferred Stock [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total |
13,695,850
|
|
X |
- DefinitionSecurities (including those issuable pursuant to contingent stock agreements) that could potentially dilute basic earnings per share (EPS) or earnings per unit (EPU) in the future that were not included in the computation of diluted EPS or EPU because to do so would increase EPS or EPU amounts or decrease loss per share or unit amounts for the period presented.
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