EsoGuard test volume increased 28%
sequentially and 436% annually
Conference call and webcast to be held today
at 4:30 PM EDT
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 and
nine months ended September 30, 2022.
Conference Call and Webcast
A conference call and webcast for today’s business update and
third quarter 2022 financial results will take place at 4:30 PM
EDT. To access the conference call, listeners should dial
877-407-0789 toll-free in the U.S., and international listeners
should dial 201-689-8562 and ask to join the “Lucid Diagnostics
Business Update Conference Call”. The webcast presentation and
conference call will be available live and for replay at the
investor relations section of the Company’s website at
https://ir.luciddx.com. Following the conclusion of the conference
call, a replay will be available for one week and can be accessed
by dialing 844-512-2921 toll-free in the U.S. or 412-317-6671,
followed by the PIN number: 13732743.
Business Update Highlights
“With recent transformational milestones behind us, the Lucid
team is now intensely focused on executing on our long-term growth
strategy and delivered solid results for the past quarter,” said
Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer.
“I am particularly proud that the team is delivering these results
well under budget for the quarter and year, as we continue to keep
a close eye on cash preservation to protect our long-term position.
Testing volume continues to grow at a steady clip, consistent with
the ‘mid-throttle’ strategy we have implemented until reimbursement
becomes more predictable. I am also gratified that the claims
submission process, which we launched mid-quarter, is starting to
bear fruit in terms of payments and recognized revenue.”
Highlights from the third quarter and recent weeks include:
- LucidDx Labs Inc. (“LucidDx Labs”), Lucid’s wholly owned
CLIA-certified, CAP-accredited clinical laboratory, performed 1,088
commercial EsoGuard® Esophageal DNA Tests in the third quarter of
2022, which represents a 28% increase sequentially from the second
quarter of 2022 and a 436% annual increase from the third quarter
of 2021.
- Lucid continued the steady expansion of its sales team to 37
professionals, particularly sales representatives who call on
primary care physicians, and is progressing well towards its
near-term target of 58 sales professionals early in the new
year.
- Lucid now operates 13 Lucid Test Centers (LTC) in 11 states,
including one recently opened in the Chicago metropolitan area.
Test centers in three new cities are targeted to launch by the end
of the year. Satellite LTC activity is rapidly increasing,
representing 22% of patients tested in the third quarter.
- LucidDx Labs’ is now operating independently and has rapidly
enhanced key quality and efficiency metrics, including reducing
average EsoGuard test turn-around time to less than one week.
- In August, LucidDx Labs began submitting claims for tests
performed since the February transfer of the CLIA laboratory
operations, which were held until its new revenue cycle management
partner was in place. LucidDx Labs began receiving some payments
for claims during the quarter.
- Lucid commenced production of its EsoCheck® Esophageal Cell
Collection Devices (“EsoCheck”) at Coastline International, Inc., a
high-volume manufacturer headquartered in San Diego, CA with plants
in Mexico, which is expected to decrease per-unit manufacturing
costs by 60% and provide scalable manufacturing capacity to
accommodate accelerating growth in EsoGuard testing volume.
Financial Results
- For the three months ended September 30, 2022, EsoGuard related
revenues were $0.1 million. Operating expenses were approximately
$14.4 million, including stock-based compensation expenses of $3.6
million. GAAP net loss attributable to common stockholders was
approximately $14.3 million, or $(0.39) 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 September 30,
2022, was approximately $10.2 million or $(0.28) per common
share.
- Lucid had cash and cash equivalents of $26.9 million as of
September 30, 2022, compared to $53.7 million as of December 31,
2021.
- In March 2022, Lucid entered into a committed equity facility
with an affiliate of Cantor Fitzgerald (“Cantor”). Under the terms
of the facility, Cantor has committed to purchase up to $50 million
of Lucid common stock from time to time upon the request of Lucid.
Through September 30, 2022, 680,263 Lucid shares were issued under
this facility for total proceeds of $1.8 million.
- The unaudited financial results for the three months ended
September 30, 2022, were filed with the SEC on Form 10-Q on
November 14, 2022, and will be 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 and nine months ended September 30, 2022, and
2021 are as follows:
For the three months endedSeptember 30, For the nine months
endedSeptember 30,
2022
2021
2022
2021
Revenue
$
76
$
200
$
265
$
200
Operating expenses
14,425
6,710
41,508
16,378
Other (Income) expense
-
447
-
594
Net loss
(14,349
)
(6,957
)
(41,243
)
(16,772
)
Net income (loss) per common share, basic and diluted $
(0.39
)
$
(0.49
)
$
(1.15
)
(1.19
)
Adjustments: Depreciation and amortization expense
1
593
-
1,321
3
Interest expense, net
-
447
-
147
EBITDA
(13,756
)
(6,510
)
(39,922
)
(16,622
)
Other non-cash or financing related expenses:
Stock-based compensation expense
2
3,572
2,772
11,251
6,156
Non-GAAP adjusted (loss)
$
(10,184
)
$
(3,738
)
$
(28,671
)
$
(10,466
)
Basic and Diluted shares outstanding
36,406
14,115
35,768
14,115
Non-GAAP adjusted (loss) income per share
($0.28
)
($0.26
)
($0.80
)
($0.74
)
Non-GAAP Operating Expenses For the three months
endedSeptember 30, For the nine months endedSeptember 30,
2022
2021
2022
2021
Cost of revenue
1,626
144
1,996
144
2
Stock-based compensation expense (SBC)
(9
)
-
(9
)
-
Net cost of revenue
$
1,617
$
144
$
1,987
$
144
1
Amortization of acquired intangible assets
505
-
1,144
-
Sales and marketing expense total
3,930
918
11,121
2,627
2
Stock-based compensation expense
(414
)
-
(1,230
)
-
Net sales and marketing expense
$
3,516
$
918
$
9,891
$
2,627
General and administrative expense total
5,660
3,458
18,223
7,793
1
Depreciation and amortization expense
(88
)
-
(177
)
(3
)
2
Stock-based compensation expense
(3,069
)
(2,695
)
(9,728
)
(5,988
)
Net general and administrative expense
$
2,503
$
763
$
8,318
$
1,802
Research and development expense total
2,704
2,190
9,024
5,814
2
Stock-based compensation expense
(80
)
(77
)
(284
)
(168
)
Net research and development expense
$
2,624
$
2,113
$
8,740
$
5,646
Total operating expenses
14,425
6,710
41,508
16,378
1
Depreciation and amortization
(593
)
-
(1,321
)
(3
)
2
Stock-based compensation expense
(3,572
)
(2,772
)
(11,251
)
(6,156
)
Net Non-GAAP operating expenses
$
10,260
$
3,938
$
28,936
$
10,219
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% 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% 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% to 15% 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% 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 nonendoscopic 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% 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. (Nasdaq: LUCD) is a commercial-stage,
cancer prevention medical diagnostics company, and majority-owned
subsidiary of PAVmed Inc. (Nasdaq: PAVM). Lucid is focused on the
millions of patients with gastroesophageal 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. EsoGuard is commercialized in the U.S. as a
Laboratory Developed Test (LDT). EsoCheck is commercialized in the
U.S. as a 510(k)-cleared esophageal cell collection device.
EsoGuard, used with EsoCheck, was granted FDA Breakthrough Device
designation and is the subject of multiple ongoing clinical trials.
Lucid is building nationwide direct sales and marketing teams
targeting primary care physicians, specialists, and institutions,
as well as a network of Lucid Test Centers, where at-risk GERD
patients can undergo the EsoCheck procedure for EsoGuard testing.
For more information, please visit www.luciddx.com, follow Lucid on
Twitter, and connect with Lucid on LinkedIn. For detailed
information on EsoGuard, please visit www.EsoGuard.com and follow
us on Twitter, Facebook and Instagram.
Forward-Looking Statements
This press release includes forward-looking statements that
involve risks 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’s 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’s common stock; general economic and market
conditions; the uncertainties inherent in research and development,
including the cost and time required to advance Lucid’s products to
regulatory submission; whether regulatory authorities will be
satisfied with the design of and results from Lucid’s clinical and
preclinical studies; whether and when Lucid’s products are cleared
by regulatory authorities; market acceptance of Lucid’s products
once cleared and commercialized; Lucid’s ability to raise
additional funding as needed; and other competitive developments.
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’s future operations, see Part I, Item 1A,
“Risk Factors,” in Lucid’s 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 after its most recent Annual
Report and Lucid’s Registration Statement No. 333-259721 filed with
the Securities and Exchange Commission. Lucid 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221114006065/en/
Investors and Media Adrian K.
Miller PAVmed Inc. AKM@PAVmed.com
PAVmed (NASDAQ:PAVMZ)
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