Full Press Release Details
Diagnostics Provides Business Update and Third Quarter 2024 Financial Results
revenue up 20 percent sequentially
evidence package for Medicare coverage submission complete
contracting initiative expanded to multiple programs to drive near-term revenue growth
call and webcast to be held today, November 13th at 8:30 AM EST
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.
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.
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.
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."
from the third quarter and recent weeks:
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 expense 1 | 215 | 625 | 945 | 1,870 | ||||||||||||
| Interest expense, net 2 | (80 | ) | 33 | (237 | ) | 75 | ||||||||||
| EBITDA | (12,236 | ) | (13,550 | ) | (33,280 | ) | (39,891 | ) | ||||||||
| Other non-cash or financing related expenses: | ||||||||||||||||
| Stock-based compensation expense 3 | 1,228 | 1,252 | 3,363 | 5,859 | ||||||||||||
| ResearchDx acquisition paid in stock 1 | - | - | - | 713 | ||||||||||||
| Operating expenses issued in stock 1 | 135 | - | 248 | 23 | ||||||||||||
| Change in FV convertible debt 2 | 322 | 3,021 | (568 | ) | 3,520 | |||||||||||
| Offering costs convertible debt 2 | - | - | - | 1,186 | ||||||||||||
| Debt extinguishments loss - Senior Secured Convertible Note 2 | 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 | ) |
Included in general and administrative expenses in the financial statements.
Included in other income and expenses.
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:
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 expense 3 | (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 expense 3 | (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 expense 3 | (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 expense 3 | (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 expense 3 | (1,228 | ) | (1,252 | ) | (3,363 | ) | (5,859 | ) | ||||||||
| Net operating expenses | $ | 11,288 | $ | 10,034 | $ | 32,270 | $ | 29,952 |
EsoGuard and EsoCheck
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.
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.
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.
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.
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.
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.
more information, please visit luciddx.com and for more information about its parent company PAVmed, please visit pavmed.com.
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.
and Lucid Diagnostics