Conference call to be held today at 4:30 PM
EDT
Lucid Diagnostics Inc. (Nasdaq: LUCD) (“Lucid”, 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 preliminary financial
results for the three months ended March 31, 2022.
Conference Call and Webcast
A conference call and webcast for today’s business update and
first 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 conference call will be
available live via a webcast 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: 13729511.
Business Update Highlights
“I am delighted to report that Lucid Diagnostics is making
excellent progress on all fronts and that we continue to lay a
solid foundation for our long-term growth strategy,” said Lishan
Aklog, M.D., Lucid’s Chairman and Chief Executive Officer. “Our
team continues to drive EsoGuard® commercialization, expand our
sales infrastructure, execute the second stage of our Lucid Test
Center rollout, transition to our own fully staffed laboratory, and
work tirelessly to secure EsoGuard reimbursement. Our balance sheet
remains strong, providing us with the necessary resources to
execute this strategy.”
Highlights from the first quarter and recent weeks include:
- On April 4th, the American College of Gastroenterology (“ACG”)
updated its clinical guideline for the diagnosis and management of
esophageal precancer, endorsing, for the first time, nonendoscopic
biomarker screening as an acceptable alternative to costly and
invasive endoscopy to detect precancer and prevent highly lethal
esophageal cancer. The updated guideline supports esophageal
precancer screening utilizing Lucid’s EsoGuard® DNA Test on samples
collected with its EsoCheck® Cell Collection Device, the only such
nonendoscopic biomarker screening test available.
- Lucid processed 533 commercial EsoGuard tests in the first
quarter of 2022, which represents a 76% increase sequentially from
the fourth quarter of 2021 and a nearly 500% increase annually from
the first quarter of 2021. The Company continued to expand its
sales infrastructure consistent with its year-end goals.
- Lucid completed its first stage of its Lucid Test Center
program covering metropolitan areas in seven states. The Company
subsequently launched the second stage of the program and plans to
open test centers in nine additional states this year. The Company
hired an experienced Director of Clinical Services to oversee the
expansion.
- LucidDx Labs Inc. (“LucidDx Labs”), a wholly owned subsidiary
of Lucid, acquired the assets necessary to operate its own
CLIA-certified, CAP-accredited clinical laboratory effective
February 25, 2022. The Company hired an experienced VP of
Laboratory Operations who will oversee an accelerated transition
from the current management service agreement to the lab being
fully staffed by Lucid employees. It also upgraded its revenue
cycle management provider which for the first time will begin
billing and processing claims directly on behalf of Lucid.
- LucidDx Labs entered into Lucid’s first commercial payer
agreement—a participating provider agreement with MediNcrease
Health Plans, LLC, a national, directly-contracted, multi-specialty
PPO provider network with over 8 million lives covered through its
clients and payers. The agreement provides for reimbursement rates
at a percent of charges for services rendered, including the
performance of the EsoGuard test.
- Medicare Administrative Contractor Palmetto GBA’s MolDX Program
published a proposed foundational Local Coverage Determination
(“LCD”) for tests designed to detect upper gastrointestinal
precancer and cancer, an important step in Lucid’s efforts to
secure Medicare coverage for EsoGuard. As part of the public review
process which extends to May 14, 2022, Lucid, along with multiple
other stakeholders, will be submitting comments suggesting
important modifications to the proposed LCD. The Company, along
with other stakeholders, also participated in a substantive Open
Meeting held by the MolDx Program on May 10, 2022.
Preliminary Financial Results
- For the three months ended March 31, 2022, EsoGuard related
revenues were $0.2 million. Operating expenses were approximately
$11.9 million, which include stock-based compensation expenses of
$3.8 million. GAAP net loss attributable to common stockholders was
approximately $12.3 million, or $(0.35) per common share.
- As shown below and for the purpose of illustrating the effect
of stock-based compensation and other non-cash expenses on the
Company’s financial results, the Company’s preliminary non-GAAP
adjusted loss for the three months ended March 31, 2022, was
approximately $8.2 million or $(0.23) per common share.
- Lucid had cash and cash equivalents of $47.9 million as of
March 31, 2022, compared to $53.7 as of December 31, 2021.
- On March 28, 2022, the Company entered into a Common Stock
Purchase Agreement (the “Purchase Agreement”) with CF Principal
Investments LLC (“Cantor”), an affiliate of Cantor Fitzgerald,
relating to a committed equity facility (the “Facility”). Pursuant
to the Purchase Agreement, the Company has the right to sell to
Cantor up to $50.0 million of its common shares (the “Shares”),
subject to certain conditions and limitations set forth in the
Purchase Agreement. While there are distinct differences, the
Facility is structured similarly to a traditional at-the-market
equity facility, insofar as it allows the Company to raise primary
equity capital on a periodic basis at a price related to the
current market price.
- Sales of the Shares to Cantor under the Purchase Agreement and
the timing of any sales, will be determined by the Company from
time to time at its sole discretion and will depend on a variety of
factors, including, among other things, market conditions, the
trading price of the Shares, and determinations by the Company
regarding the use of proceeds of such Shares. Upon the satisfaction
of the conditions to Cantor’s obligation to purchase Shares, the
Company will have the right, from time to time during the 36-month
period after the commencement of the Facility, to direct Cantor to
purchase up to a maximum number of Shares on any trading day. The
purchase price of the Shares will be 96% of the volume-weighted
average price of the Shares on such trading day.
- The unaudited financial results for the three months ended
March 31, 2022, are expected to be filed with the SEC on Form 10-Q
on May 16, 2022 and will then 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 ended March 31, 2022, and 2021 is as
follows:
For the three months ended
March 31,
2022
2021
Revenue
$
189
$
-
Gross profit
(180
)
-
Operating expenses
11,917
3,653
Other expense
173
-
Net loss
(12,270
)
(3,653
)
Net income (loss) per common share, basic and diluted
$
(0.35
)
$
(0.26
)
Adjustments: Depreciation and amortization expense1
24
3
Interest expense, net3
-
-
EBITDA
(12,246
)
(3,650
)
Other non-cash or financing related expenses:
Stock-based compensation expense3
3,835
805
Fair value adjustments2
173
-
Non-GAAP adjusted (loss)
(8,238
)
(2,845
)
Basic and Diluted shares outstanding
35,123
14,114
Non-GAAP adjusted (loss) income per share
($0.23
)
($0.20
)
1
Included in general and administrative expenses in the financial
statements
2
Included in other income and expenses
For the three months ended
March 31,
2022
2021
3
Stock-based compensation ("SBC") expenses: Sales and
Marketing expense total
3,318
689
Stock-based compensation expense
(440
)
-
Net commercial operations expense
excluding SBC
2,878
689
General and administrative expense total
5,718
1,212
Stock-based compensation expense
(3,269
)
(789
)
Net general and administrative
expense excluding SBC
2,449
423
Research and development expense total
2,881
1,752
Stock-based compensation expense
(126
)
(16
)
Net research and development
expense excluding SBC
2,755
1,736
Total operating expenses
11,917
3,653
Stock-based compensation expense
(3,835
)
(805
)
Net operating expenses excluding
SBC
8,082
2,848
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. A recently updated American College of
Gastroenterology clinical practice guideline endorses 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 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 a nationwide direct sales and marketing team
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.
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, Lucid has been monitoring
the COVID-19 pandemic and the pandemic’s impact on Lucid’s
businesses. Lucid expects the significance of the COVID-19
pandemic, including the extent of its effect on its financial and
operational results, to be dictated by, among other things, the
success of efforts to contain the pandemic and the impact of such
efforts on Lucid’s businesses. These factors are difficult or
impossible to predict accurately and many of them are beyond
Lucid’s 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’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 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/20220511006012/en/
Investors Adrian K. Miller PAVmed
Inc. AKM@PAVmed.com
Media Shani Lewis
LaVoieHealthScience (609) 516-5761
PAVmed@lavoiehealthscience.com
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