EsoGuard® test volume increases 57
percent sequentially and 245 percent year-on-year
Conference call and webcast to be held
tomorrow, May 16th at
8:30 AM EST
NEW
YORK, May 15, 2023 /PRNewswire/ -- Lucid
Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the
"Company") a commercial-stage, cancer prevention medical
diagnostics company, and majority-owned 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 March 31,
2023.
Conference Call and Webcast
The webcast will take place on Tuesday, May 16, 2023, 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 877-870-4263 and international
listeners should dial 412-317-0790. All listeners should provide
the operator with the conference call name "Lucid Diagnostics
Business Update" to join.
Business Update Highlights
"Lucid had a strong start in the first quarter of 2023, with
robust sequential growth in EsoGuard testing volume," said
Lishan Aklog, M.D., Lucid's Chairman
and Chief Executive Officer. "We attribute this progress to our
relentless focus on EsoGuard commercial expansion, including the
growing popularity and utilization of our satellite Lucid Test
Center (sLTC) program, a broad expansion of #CheckYourFoodTube
Precancer Detection Events (#CYFT) and growing awareness of
EsoGuard as a much-needed widespread screening tool that is highly
effective in detecting esophageal precancer in a sizeable at-risk
patient population."
Highlights from the first quarter and recent weeks:
- Lucid's CLIA-certified clinical laboratory performed 1,841
commercial EsoGuard® Esophageal DNA Tests in the 1Q23,
which represents a 57 percent increase sequentially from 4Q22 and a
245 percent annual increase from 1Q22.
- Satellite Lucid Test Center (sLTC) activity, whereby Lucid
clinicians collect samples at physician offices or high-volume
testing events, continues to increase rapidly, representing 51
percent of all samples collected in 1Q23, up from 31 percent in
4Q22.
- In January, Lucid launched its #CheckYourFoodTube Precancer
Detection Event (#CYFT Event) program, bringing EsoGuard testing
directly to at-risk patients at high-volume testing day events.
Since the inaugural event, Lucid has held additional events across
the country during the first quarter and recent weeks. These events
have identified patients with suspected esophageal precancer based
on a positive EsoGuard result, including some less than 40 years of
age, who will undergo appropriate monitoring and treatment, as
indicated by clinical practice guidelines, to prevent progression
to esophageal cancer.
- Lucid and its collaborators presented compelling new data at
the Digestive Disease Week® (DDW) 2023 conference.
EsoGuard demonstrated excellent esophageal precancer and cancer
detection performance, including in the most prevalent and
challenging precancer subgroup—short segment non-dysplastic
Barrett's Esophagus. In addition, EsoCheck cell collection achieved
98 percent technical success and high DNA yields in real-world
study of 1,483 patients.
- In the first quarter and recent weeks, Medicare Administrative
Contractors Palmetto GBA MolDX and Noridian Healthcare Solutions
published foundational Future Effective Local Coverage
Determinations ("LCD"), both titled "Molecular Testing for
Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and
Neoplasia".
Financial Results
- For the three months ended March 31,
2023, EsoGuard related revenues were $0.4 million, compared to $0.2 million as of March
31, 2022. Operating expenses were approximately $14.8 million, including stock-based compensation
expenses of $3.2 million. GAAP net
loss attributable to common stockholders was approximately
$16.2 million, or $(0.40) 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 preliminary
non-GAAP adjusted loss for the three months ended March 31, 2023, was approximately $9.8 million or $(0.24) per common share.
- Lucid had cash and cash equivalents of $39.5 million as of March
31, 2023, compared to $22.5
million as of December 31,
2022.
- In March, the Company received $13.6
million from the sale of non-voting Series A Convertible
Preferred Stock, which may not be converted until September 2023 and not until March 2025 without surrendering the right to an
annual dividend.
- Also in March, the Company entered into a securities purchase
agreement for Series A Convertible Notes with an aggregated
principal amount of $11.1 million,
which may not be converted below the stated $5.00 conversion price until September 2023. The proceeds of these offerings
will extend the Company's cash runway into 2024, through near-term
commercial milestones, including expanded reimbursement.
- The unaudited financial results for the three months ended
March 31, 2023, were filed with the
SEC on Form 10-Q on May 15, 2023, and
are 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 months ended March 31,
2023, and 2022 are as follows:
|
|
For the three months
ended March 31,
|
|
|
2023
|
|
2022
|
(in thousands except
per-share amounts)
|
|
|
|
|
Revenue
|
|
$
446
|
|
$
189
|
|
|
|
|
|
Operating
expenses
|
|
14,763
|
|
12,460
|
Other (Income)
expense
|
|
1,930
|
|
(1)
|
Net
Loss
|
|
(16,247)
|
|
(12,270)
|
Net income (loss)
per common share, basic and diluted
|
|
$
(0.40)
|
|
$
(0.35)
|
Adjustments:
|
|
|
|
|
Depreciation and
amortization expense1
|
|
612
|
|
24
|
Interest expense,
net2
|
|
(45)
|
|
(1)
|
EBITDA
|
|
(15,680)
|
|
(12,247)
|
|
|
|
|
|
Other non-cash or
financing related expenses:
|
|
|
|
|
Stock-based
compensation expense3
|
|
3,208
|
|
3,835
|
ResearchDx acquisition
in stock1
|
|
713
|
|
—
|
Change in FV
convertible debt2
|
|
789
|
|
—
|
Offering costs
convertible debt2
|
|
1,186
|
|
—
|
Non-GAAP adjusted
(loss)
|
|
(9,784)
|
|
(8,412)
|
Basic and Diluted
shares outstanding
|
|
40,971
|
|
35,123
|
Non-GAAP adjusted
(loss) income per share
|
|
$(0.24)
|
|
$(0.24)
|
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:
|
|
|
For the three months
ended March 31,
|
(in thousands except
per-share amounts)
|
|
2023
|
|
2022
|
Cost of
revenues
|
|
1,338
|
|
369
|
Stock-based
compensation expense3
|
|
(19)
|
|
—
|
Net cost of
revenues
|
|
1,319
|
|
369
|
|
|
|
|
|
Amortization of
intangible assets
|
|
505
|
|
—
|
|
|
|
|
|
Sales and
marketing
|
|
4,127
|
|
3,318
|
Stock-based
compensation expense3
|
|
(356)
|
|
(440)
|
Net sales and
marketing
|
|
3,771
|
|
2,878
|
|
|
|
|
|
General and
administrative
|
|
6,511
|
|
5,892
|
Depreciation
expense
|
|
(107)
|
|
(24)
|
Stock-based
compensation expense3
|
|
(2,668)
|
|
(3,269)
|
Net general and
administrative
|
|
3,736
|
|
2,599
|
|
|
|
|
|
Research and
development
|
|
2,282
|
|
2,881
|
Stock-based
compensation expense3
|
|
(165)
|
|
(126)
|
Net research and
development
|
|
2,117
|
|
2,755
|
|
|
|
|
|
Total operating
expenses
|
|
14,763
|
|
12,460
|
Depreciation and
amortization expense
|
|
(612)
|
|
(24)
|
Stock-based
compensation expense3
|
|
(3,208)
|
|
(3,835)
|
Net operating
expenses
|
|
10,943
|
|
8,601
|
About EsoGuard and EsoCheck
Millions of patients with 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 in millions of GERD patients with
multiple risk factors, including age over 50 years, male gender,
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 likely death could have been prevented if the
at-risk GERD patient had been screened and then undergone
surveillance and curative treatment.
The only missing element for a viable esophageal cancer
prevention program has been the lack of a widespread screening tool
that can detect esophageal precancer. Lucid believes EsoGuard,
performed on samples collected 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 clinical practice guideline and an
American Gastroenterological Association 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 bisulfite-converted NGS DNA 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 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 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. 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
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 gastroesophageal reflux
disease (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, is the first and only commercially available
diagnostic test capable of serving as a widespread screening tool
to prevent cancer and cancer deaths through early detection of
esophageal precancer in at-risk GERD 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.
In addition, Lucid Diagnostics continues to monitor the COVID-19
pandemic and the pandemic's impact on Lucid Diagnostics'
businesses. 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.
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SOURCE Lucid Diagnostics