Quarterly EsoGuard® test volume
increased 20 percent sequentially and 159 percent annually
Revenue cycle management upgrade completed
with immediate positive impact to claims processing and
payments
Unprecedented cancer and precancer detection
results from an NCI-funded EsoGuard study released
Conference call and webcast to be held
tomorrow, August 15th at
8:30 AM EDT
NEW
YORK, Aug. 14, 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 and six months ended June 30,
2023.
Conference Call and Webcast
The webcast will take place on Tuesday,
August 15, 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
1-833-816-1418 and international listeners should dial
412-317-0511. 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
"Lucid closed out a strong first half of 2023, with yet another
quarter of double-digit EsoGuard test volume growth and major
accomplishments on multiple strategic fronts, which we believe will
drive substantial value in the coming quarters" said Lishan Aklog, M.D., Lucid's Chairman and Chief
Executive Officer. "Commercial execution underpinning the sustained
test volume growth remained very strong, driven by steadily
increasing per-seller productivity as well as expanding utilization
of our satellite Lucid Test Center program and high-volume
#CheckYourFoodTube testing events. The launch of our first mobile
test unit and the execution of our first direct contract with an
employer to offer EsoGuard testing as an employee benefit, reflect
our relentless commitment to expanding EsoGuard access across all
available channels."
"Key accomplishments critical to translating this commercial
success into future revenue growth include: the recently completed
upgrade to our revenue cycle management infrastructure; reaching
target enrollment in our prospective clinical utility studies
which, together with the pending posting and submission of the
results of those studies, will support payor coverage; and the
release of unprecedented cancer and precancer detection results
from an NCI-funded EsoGuard study. I am particularly encouraged by
the immediate positive impact that the revenue cycle management
upgrade has had on EsoGuard claims processing and payments," Dr.
Aklog added.
Highlights from the second quarter and recent weeks:
- Lucid's CLIA-certified clinical laboratory performed 2,202
commercial EsoGuard® Esophageal DNA Tests in 2Q23, which
represents a 20 percent increase sequentially from 1Q23 and a 159
percent annual increase from 2Q22. Satellite Lucid Test Center
activity, including #CYFT high-volume testing events, increased 51
percent and now represents over half of all testing activity.
- Lucid upgraded its revenue cycle management provider to the
market leader, completing the transition to an upgraded claims
submission, adjudication, and payment collection process in late
June. Claims submission and adjudication was paused during the
transition starting in early May. An immediate positive impact on
claims processing, allowances and collections was noted for the
month of July.
- Lucid achieved its target end-of-quarter enrollment in its two
prospective clinical utility studies. The Lucid Registry and
multi-center CLUE studies have enrolled over 500 patients. Data on
these cohorts is being analyzed and results will be posted on a
preprint server later this month in advance of peer review.
Clinical utility data, along with claims history, remains the key
gating item in engaging payors on EsoGuard coverage.
- Lucid executed its first employer contract under its direct
contracting strategic initiative. A Texas-based automotive group will now offer
EsoGuard testing by Lucid as an employee benefit across twelve
locations. Further details will be forthcoming.
- The NCI-funded BETRNet consortium, consisting of the leading
academic medical centers in the field, released unprecedented
cancer and precancer detection results of its highly anticipated
case-control study of 242 patients comparing EsoGuard to upper
endoscopy. EsoGuard detected 100 percent of esophageal cancers and
over 80 percent of precancers, with an estimated negative
predictive value of 99 percent—unprecedented results for such a
molecular diagnostic test. Further details and analysis of these
results will be forthcoming.
Financial Results
- For the three months ended June 30,
2023, EsoGuard related revenues were $0.2 million. Operating expenses were
approximately $11.7 million,
including stock-based compensation expenses of $1.4 million. GAAP net loss was approximately
$11.4 million, or $(0.27) 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 June 30, 2023, was approximately $9.6 million or $(0.23) per common share.
- Lucid had cash and cash equivalents of $32.6 million as of June
30, 2023, compared to $39.5
million as of March 31,
2023.
- The unaudited financial results for the three months ended
June 30, 2023, were filed with the
SEC on Form 10-Q on August 14, 2023,
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 six months ended June 30,
2023, and 2022 are as follows:
Condensed
consolidated statements of operations (unaudited)
|
(in thousands except
per-share amounts)
|
|
For the three months
ended
June 30,
|
|
For the six months
ended
June 30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
159
|
|
$
—
|
|
$
605
|
|
$
189
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
11,743
|
|
14,628
|
|
26,505
|
|
27,088
|
Other (Income)
expense
|
|
(203)
|
|
(4)
|
|
1,728
|
|
(5)
|
Net
Loss
|
|
(11,381)
|
|
(14,624)
|
|
(27,628)
|
|
(26,894)
|
Net income (loss)
per common share, basic and diluted
|
|
$
(0.27)
|
|
$
(0.41)
|
|
$
(0.67)
|
|
$
(0.76)
|
Adjustments:
|
|
|
|
|
|
|
|
|
Depreciation and
amortization expense1
|
|
633
|
|
704
|
|
1,245
|
|
728
|
Interest expense,
net2
|
|
87
|
|
(4)
|
|
43
|
|
(5)
|
EBITDA
|
|
(10,661)
|
|
(13,924)
|
|
(26,340)
|
|
(26,171)
|
|
|
|
|
|
|
|
|
|
Other non-cash or
financing related expenses:
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense3
|
|
1,399
|
|
3,844
|
|
4,607
|
|
7,679
|
ResearchDx acquisition
paid in stock1
|
|
—
|
|
—
|
|
713
|
|
—
|
Change in FV
convertible debt2
|
|
(290)
|
|
—
|
|
499
|
|
—
|
Offering costs
convertible debt2
|
|
—
|
|
—
|
|
1,186
|
|
—
|
Non-GAAP adjusted
(loss)
|
|
(9,552)
|
|
(10,080)
|
|
(19,335)
|
|
(18,492)
|
Basic and Diluted
shares outstanding
|
|
41,834
|
|
35,760
|
|
41,405
|
|
35,444
|
Non-GAAP adjusted
(loss) income per share
|
|
$(0.23)
|
|
$(0.28)
|
|
$(0.47)
|
|
$(0.52)
|
|
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
June 30,
|
|
For the six months
ended
June 30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Cost of
revenues
|
|
1,549
|
|
—
|
|
2,887
|
|
369
|
Stock-based
compensation expense3
|
|
(25)
|
|
—
|
|
(44)
|
|
—
|
Net cost of
revenues
|
|
1,524
|
|
—
|
|
2,843
|
|
369
|
|
|
|
|
|
|
|
|
|
Amortization of
intangible assets
|
|
505
|
|
639
|
|
1,010
|
|
639
|
|
|
|
|
|
|
|
|
|
Sales and
marketing
|
|
4,032
|
|
3,873
|
|
8,159
|
|
7,191
|
Stock-based
compensation expense3
|
|
(367)
|
|
(376)
|
|
(723)
|
|
(816)
|
Net sales and
marketing
|
|
3,665
|
|
3,497
|
|
7,436
|
|
6,375
|
|
|
|
|
|
|
|
|
|
General and
administrative
|
|
3,830
|
|
6,676
|
|
10,340
|
|
12,568
|
Depreciation
expense
|
|
(128)
|
|
(65)
|
|
(235)
|
|
(89)
|
Stock-based
compensation expense3
|
|
(844)
|
|
(3,390)
|
|
(3,512)
|
|
(6,659)
|
Net general and
administrative
|
|
2,858
|
|
3,221
|
|
6,593
|
|
5,820
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
1,827
|
|
3,440
|
|
4,109
|
|
6,321
|
Stock-based
compensation expense3
|
|
(163)
|
|
(78)
|
|
(328)
|
|
(204)
|
Net research and
development
|
|
1,664
|
|
3,362
|
|
3,781
|
|
6,117
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
11,743
|
|
14,628
|
|
26,505
|
|
27,088
|
Depreciation and
amortization expense
|
|
(633)
|
|
(704)
|
|
(1,245)
|
|
(728)
|
Stock-based
compensation expense3
|
|
(1,399)
|
|
(3,844)
|
|
(4,607)
|
|
(7,679)
|
Net operating
expenses
|
|
9,711
|
|
10,080
|
|
20,653
|
|
18,681
|
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-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. EsoGuard is 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 - 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.
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. 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/lucid-diagnostics-provides-business-update-and-second-quarter-financial-results-301900272.html
SOURCE Lucid Diagnostics