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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported): November
13, 2024
LUCID
DIAGNOSTICS INC. |
(Exact
Name of Registrant as Specified in Charter) |
Delaware |
|
001-40901 |
|
82-5488042 |
(State
or Other Jurisdiction
of
Incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
360
Madison Avenue, 25th
Floor, New
York, New
York |
|
10017 |
(Address
of Principal Executive Offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (917)
813-1828
N/A |
(Former
Name or Former Address, if Changed Since Last Report) |
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425). |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12). |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)). |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)). |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, Par Value $0.001 Per Share |
|
LUCD |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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(a) of the Exchange Act.
Item
2.02 Results of Operations and Financial Condition.
On
November 13, 2024, the Company issued a press release announcing financial results for its fiscal quarter ended September 30, 2024 and
providing a business update. A copy of the press release is attached to this report as Exhibit 99.1 and is incorporated herein by reference.
Item
7.01. Regulation FD Disclosure.
The
disclosure set forth under Item 2.02 is incorporated herein by reference.
The
information furnished under Items 2.02 and 7.01, including the exhibit related thereto, shall not be deemed “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any disclosure document of
the Company, except as shall be expressly set forth by specific reference in such document.
Item
9.01. Financial Statements and Exhibits.
(d)
Exhibits:
Exhibit
No. |
|
Description |
99.1 |
|
Press release. |
104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
Dated:
November 13, 2024 |
LUCID
DIAGNOSTICS INC. |
|
|
|
|
By:
|
/s/
Dennis McGrath |
|
|
Dennis
McGrath |
|
|
Chief
Financial Officer |
Exhibit
99.1
Lucid
Diagnostics Provides Business Update and Third Quarter 2024 Financial Results
EsoGuard®
revenue up 20 percent sequentially
Clinical
evidence package for Medicare coverage submission complete
Direct
contracting initiative expanded to multiple programs to drive near-term revenue growth
Conference
call and webcast to be held today, November 13th at 8:30 AM EST
NEW
YORK, November 13, 2024 - Lucid Diagnostics Inc. (Nasdaq: LUCD) (“Lucid” or the “Company”) a commercial-stage,
cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (“PAVmed”), today provided
a business update for the Company and presented financial results for the three months ended September 30, 2024.
Conference
Call and Webcast
The
webcast will take place on Wednesday, November 13, 2024, at 8:30 AM and will be accessible in the investor relations section of the Company’s
website at luciddx.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184
and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name “Lucid
Diagnostics Business Update” to join.
Following
the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company’s
website at luciddx.com.
Business
Update Highlights
“The
third quarter and recent weeks have been a transformational period for Lucid, including two key milestones announced last week,”
said Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer. “We are now fully armed with a complete body
of outstanding clinical data to go along with a renewed commercial focus on programs designed to drive near-term revenue. Our team is
ready to make our final push towards broad reimbursement, including our upcoming submission formally seeking Medicare coverage of EsoGuard.
We are energized by the vast clinical and market opportunity before us as we seek to expand patient access to our groundbreaking technologies
to detect esophageal precancer, and drive shareholder value.”
Highlights
from the third quarter and recent weeks:
| ● | For
the quarter, EsoGuard® Esophageal DNA Test revenue was $1.2M, which
represents a 20 percent increase sequentially from 2Q24 and a 50 percent annual increase
from 3Q23. |
| ● | Lucid’s
CLIA-certified clinical laboratory performed 2,787 commercial EsoGuard tests in 3Q24. Additionally,
for the month of October, the lab performed a single-month record of more than 1,400 tests,
contributing to the largest three-month total in the Company’s history. |
| ● | ESOGUARD
BE-1 clinical validation study accepted for peer-reviewed publication in the American
Journal of Gastroenterology. This publication completes Lucid’s clinical evidence package
for submission to formally seek Medicare coverage. |
| ● | Company
leveraging complete clinical evidence package to expand direct contracting initiative
with multiple programs focused on driving near-term revenue growth, including a shift
to fully-contracted #CYFT Precancer Testing Events, broadening employer markets activity,
and a new foray into the concierge medicine sector. |
| ● | Met
with CMS Medicare Administrative Contractor (MAC) Palmetto GBA’s Molecular Diagnostics
Program (MolDX) to discuss EsoGuard clinical evidence package for upcoming submission for
Medicare coverage. |
| ● | Peer-reviewed
publication of EsoGuard analytical validation study, demonstrating excellent analytical
accuracy, repeatability, and reproducibility of the assay. |
| ● | Received
Notice of Allowance for key patent underlying EsoGuard. |
Financial
Results
| ● | For
the three months ended September 30, 2024, EsoGuard related revenues were $1.2 million. Operating
expenses were approximately $12.9 million, which included stock-based compensation expenses
of $1.2 million. GAAP net loss attributable to common stockholders was approximately $12.4
million or $(0.25) per common share. |
| ● | As
shown below and for the purpose of illustrating the effect of stock-based compensation and
other non-cash income and expenses on the Company’s financial results, the Company’s
non-GAAP adjusted loss for the three months ended September 30, 2024 was approximately $10.1
million or $(0.20) per common share. |
| ● | Lucid
had cash and cash equivalents of $14.5 million as of September 30, 2024, compared to $18.9
million as of December 31, 2023. As of November 12, the Company has entered into subscription
agreements with long-term accredited investors to purchase $21.75 million of five-year Senior
Secured Convertible Notes. The Company gave notice to the existing convertible note holder
that it is exercising its right to redeem the existing notes. Upon closing of the subscription
agreements and completing the redemption of the existing notes, the company expects to
increase its cash runway by approximately $13.2 million. |
| ● | The
unaudited financial results for the three and nine months ended September 30, 2024, were
filed with the SEC on Form 10-Q on November 12, 2024, and available at www.luciddx.com or
www.sec.gov. |
Lucid
Non-GAAP Measures
| ● | To
supplement our unaudited financial results presented in accordance with U.S. generally accepted
accounting principles (GAAP), management provides certain non-GAAP financial measures of
the Company’s financial results. These non-GAAP financial measures include net loss
before interest, taxes, depreciation, and amortization (EBITDA), and non-GAAP adjusted loss,
which further adjusts EBITDA for stock-based compensation expense and other non-cash income
and expenses, if any. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted
loss are not recognized terms under U.S. GAAP. |
| ● | Non-GAAP
financial measures are presented with the intent of providing greater transparency to the
information used by us in our financial performance analysis and operational decision-making.
We believe these non-GAAP financial measures provide meaningful information to assist investors,
shareholders, and other readers of our unaudited financial statements in making comparisons
to our historical financial results and analyzing the underlying performance of our results
of operations. These non-GAAP financial measures are not intended to be, and should not be,
a substitute for, considered superior to, considered separately from, or as an alternative
to, the most directly comparable GAAP financial measures. |
| ● | Non-GAAP
financial measures are provided to enhance readers’ overall understanding of our current
financial results and to provide further information for comparative purposes. Management
believes the non-GAAP financial measures provide useful information to management and investors
by isolating certain expenses, gains, and losses that may not be indicative of our core operating
results and business outlook. Specifically, the non-GAAP financial measures include non-GAAP
adjusted loss, and its presentation is intended to help the reader understand the effect
of the loss on the issuance or modification of convertible securities, the periodic change
in fair value of convertible securities, the loss on debt extinguishment, and the corresponding
accounting for non-cash charges on financial performance. In addition, management believes
non-GAAP financial measures enhance the comparability of results against prior periods. |
| ● | A
reconciliation to the most directly comparable GAAP measure of all non-GAAP financial measures
included in this press release for the three and nine months ended September 30, 2024, and
2023 are as follows: |
Condensed
consolidated statements of operations (unaudited)
(in thousands except per-share amounts) | |
For the three months ended September 30, | | |
For the nine months ended September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Revenue | |
$ | 1,172 | | |
$ | 783 | | |
$ | 3,149 | | |
$ | 1,388 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses | |
| 12,866 | | |
| 11,911 | | |
| 36,826 | | |
| 38,417 | |
Other (Income) expense | |
| 677 | | |
| 3,080 | | |
| 311 | | |
| 4,807 | |
Net Loss | |
| (12,371 | ) | |
| (14,208 | ) | |
| (33,988 | ) | |
| (41,836 | ) |
Net income (loss) per common share, basic and diluted | |
$ | (0.25 | ) | |
$ | (0.34 | ) | |
$ | (0.87 | ) | |
$ | (1.01 | ) |
Net loss attributable to common stockholders | |
| (12,371 | ) | |
| (14,208 | ) | |
| (41,484 | ) | |
| (41,836 | ) |
Preferred Stock dividends and deemed dividends | |
| — | | |
| — | | |
| 7,496 | | |
| — | |
Net income (loss) as reported | |
| (12,371 | ) | |
| (14,208 | ) | |
| (33,988 | ) | |
| (41,836 | ) |
Adjustments: | |
| | | |
| | | |
| | | |
| | |
Depreciation and amortization expense1 | |
| 215 | | |
| 625 | | |
| 945 | | |
| 1,870 | |
Interest expense, net2 | |
| (80 | ) | |
| 33 | | |
| (237 | ) | |
| 75 | |
EBITDA | |
| (12,236 | ) | |
| (13,550 | ) | |
| (33,280 | ) | |
| (39,891 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other non-cash or financing related expenses: | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation expense3 | |
| 1,228 | | |
| 1,252 | | |
| 3,363 | | |
| 5,859 | |
ResearchDx acquisition paid in stock1 | |
| — | | |
| — | | |
| — | | |
| 713 | |
Operating expenses issued in stock1 | |
| 135 | | |
| — | | |
| 248 | | |
| 23 | |
Change in FV convertible debt2 | |
| 322 | | |
| 3,021 | | |
| (568 | ) | |
| 3,520 | |
Offering costs convertible debt2 | |
| — | | |
| — | | |
| — | | |
| 1,186 | |
Debt extinguishments loss - Senior Secured Convertible Note2 | |
| 435 | | |
| 26 | | |
| 1,116 | | |
| 26 | |
Non-GAAP adjusted (loss) | |
$ | (10,116 | ) | |
$ | (9,251 | ) | |
$ | (29,121 | ) | |
$ | (28,564 | ) |
Basic and Diluted shares outstanding | |
| 50,374 | | |
| 41,863 | | |
| 47,876 | | |
| 41,559 | |
Non-GAAP adjusted (loss) income per share | |
$ | (0.20 | ) | |
$ | (0.22 | ) | |
$ | (0.61 | ) | |
$ | (0.69 | ) |
1
Included in general and administrative expenses in the financial statements.
2
Included in other income and expenses.
3
Stock-based compensation (“SBC”) expense included in operating expenses is detailed as follows in the table below by
category within operating expenses for the non-GAAP Net operating expenses:
Reconciliation
of GAAP Operating Expenses to Non-GAAP Net Operating Expenses
(in thousands except per-share amounts) | |
For the three months ended
September 30, | | |
For the nine months ended
September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Cost of revenues | |
$ | 1,684 | | |
$ | 1,634 | | |
$ | 4,954 | | |
$ | 4,522 | |
Stock-based compensation expense3 | |
| (41 | ) | |
| (26 | ) | |
| (121 | ) | |
| (70 | ) |
Net cost of revenues | |
| 1,643 | | |
| 1,608 | | |
| 4,833 | | |
| 4,452 | |
| |
| | | |
| | | |
| | | |
| | |
Amortization of intangible assets | |
| 105 | | |
| 505 | | |
| 582 | | |
| 1,516 | |
| |
| | | |
| | | |
| | | |
| | |
Sales and marketing | |
| 4,056 | | |
| 3,837 | | |
| 12,459 | | |
| 11,996 | |
Stock-based compensation expense3 | |
| (351 | ) | |
| (334 | ) | |
| (1,066 | ) | |
| (1,056 | ) |
Net sales and marketing | |
| 3,705 | | |
| 3,503 | | |
| 11,393 | | |
| 10,940 | |
| |
| | | |
| | | |
| | | |
| | |
General and administrative | |
| 5,355 | | |
| 4,320 | | |
| 14,292 | | |
| 15,049 | |
Depreciation expense | |
| (110 | ) | |
| (120 | ) | |
| (363 | ) | |
| (354 | ) |
RDx Settlement in Stock | |
| — | | |
| — | | |
| — | | |
| (713 | ) |
Operating expenses issued in stock | |
| (135 | ) | |
| — | | |
| (248 | ) | |
| (23 | ) |
Stock-based compensation expense3 | |
| (700 | ) | |
| (728 | ) | |
| (1,640 | ) | |
| (4,239 | ) |
Net general and administrative | |
| 4,410 | | |
| 3,472 | | |
| 12,041 | | |
| 9,720 | |
| |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 1,666 | | |
| 1,615 | | |
| 4,539 | | |
| 5,334 | |
Stock-based compensation expense3 | |
| (136 | ) | |
| (164 | ) | |
| (536 | ) | |
| (494 | ) |
Net research and development | |
| 1,530 | | |
| 1,451 | | |
| 4,003 | | |
| 4,840 | |
| |
| | | |
| | | |
| | | |
| | |
Total operating expenses | |
| 12,866 | | |
| 11,911 | | |
| 36,826 | | |
| 38,417 | |
Depreciation and amortization expense | |
| (215 | ) | |
| (625 | ) | |
| (945 | ) | |
| (1,870 | ) |
RDx Settlement in Stock | |
| — | | |
| — | | |
| — | | |
| (713 | ) |
Operating expenses issued in stock | |
| (135 | ) | |
| — | | |
| (248 | ) | |
| (23 | ) |
Stock-based compensation expense3 | |
| (1,228 | ) | |
| (1,252 | ) | |
| (3,363 | ) | |
| (5,859 | ) |
Net operating expenses | |
$ | 11,288 | | |
$ | 10,034 | | |
$ | 32,270 | | |
$ | 29,952 | |
About
EsoGuard and EsoCheck
Millions
of patients with gastroesophageal reflux disease (GERD) are at risk of developing esophageal precancer and a highly lethal form of esophageal
cancer (“EAC”). Over 80 percent of EAC patients die within five years of diagnosis, making it the second most lethal cancer
in the U.S. The mortality rate is high even in those diagnosed with early stage EAC. The U.S. incidence of EAC has increased 500 percent
over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently
progresses until it manifests itself with new symptoms of advanced disease. All EAC is believed to arise from esophageal precancer, which
occurs in approximately 5 percent to 15 percent of at-risk GERD patients. Early esophageal precancer can be monitored for progression
to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer.
Esophageal
precancer screening is already recommended by clinical practice guidelines for the millions of GERD patients with multiple risk factors,
including age over 50 years, male sex, White race, obesity, smoking history, and a family history of esophageal precancer or cancer.
Unfortunately, fewer than 10 percent of those recommended for screening undergo traditional invasive endoscopic screening. The profound
tragedy of an EAC diagnosis is that death could likely have been prevented if the at-risk GERD patient had been screened and then undergone
surveillance and curative treatment at the precancer stage.
The
only missing element for a viable esophageal cancer prevention program has been the lack of an easily accessible, in-office screening
tool that can detect esophageal precancer. Lucid believes EsoGuard, performed on samples collected non-endoscopically with EsoCheck,
is the missing element – the first and only commercially available test capable of serving as a widespread screening tool to prevent
esophageal cancer deaths through the early detection of esophageal precancer in at-risk GERD patients. An updated American College of
Gastroenterology (ACG) clinical practice guideline and an American Gastroenterological Association (AGA) clinical practice update both
endorse non-endoscopic biomarker tests as an acceptable alternative to costly and invasive endoscopy for esophageal precancer screening.
EsoGuard is the only such test currently available in the United States.
EsoGuard
is a Next Generation Sequencing (NGS) based DNA methylation assay performed on surface esophageal cells collected with EsoCheck, which
quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was initially evaluated in a 408-patient,
multicenter, case-control study published in Science Translational Medicine and showed greater than 90 percent sensitivity and specificity
at detecting esophageal precancer and cancer.
EsoCheck
is a CE Marked and FDA 510(k) cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal
cells in a less than three-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. Lucid believes this proprietary Collect+Protect™ technology makes EsoCheck the
only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling. The sample is sent by
overnight express mail to Lucid’s CLIA-certified, CAP-accredited, NYS CLEP approved laboratory, LucidDx Labs, for EsoGuard testing.
About
Lucid Diagnostics
Lucid
Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. Lucid is focused
on the millions of patients with GERD, also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer.
Lucid’s EsoGuard® Esophageal DNA Test, performed on samples collected in a brief, noninvasive office procedure with
its EsoCheck® Esophageal Cell Collection Device - the first and only commercially available tools designed with the goal
of preventing esophageal cancer and cancer deaths through widespread, early detection of esophageal precancer in at-risk patients.
For
more information, please visit luciddx.com and for more information about its parent company PAVmed, please visit pavmed.com.
Forward-Looking
Statements
This
press release includes forward-looking statements that involve risk and uncertainties. Forward-looking statements are any statements
that are not historical facts. Such forward-looking statements, which are based upon the current beliefs and expectations of Lucid Diagnostics’
management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks
and uncertainties that may cause such differences include, among other things, volatility in the price of Lucid Diagnostics’ common
stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required
to advance Lucid Diagnostics’ products to regulatory submission; whether regulatory authorities will be satisfied with the design
of and results from Lucid Diagnostics’ clinical and preclinical studies; whether and when Lucid Diagnostics’ products are
cleared by regulatory authorities; market acceptance of Lucid Diagnostics’ products once cleared and commercialized; Lucid Diagnostics’
ability to raise additional funding as needed; and other competitive developments. These factors are difficult or impossible to predict
accurately and many of them are beyond Lucid Diagnostics’ control. In addition, new risks and uncertainties may arise from time
to time and are difficult to predict. For a further list and description of these and other important risks and uncertainties that may
affect Lucid Diagnostics’ future operations, see Part I, Item 1A, “Risk Factors,” in Lucid Diagnostics’ most
recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A,
“Risk Factors” in any Quarterly Report on Form 10-Q filed by Lucid Diagnostics after its most recent Annual Report. Lucid
Diagnostics disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in
its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood
that actual results will differ from those contained in the forward-looking statements.
Investor
and Media Contact
Matt
Riley
PAVmed
and Lucid Diagnostics
mjr@pavmed.com
v3.24.3
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Grafico Azioni Lucid Diagnostics (NASDAQ:LUCD)
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Da Nov 2024 a Dic 2024
Grafico Azioni Lucid Diagnostics (NASDAQ:LUCD)
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Da Dic 2023 a Dic 2024