| Net Loss Per Share | Note
12 — Net Loss Per Share The
“Net loss per share basic and diluted” for the respective periods indicated - is as follows: Schedule
of Basic and Fully Diluted Net Loss Per Share
2022 2021 2022 2021
Three Months Ended June 30, Six Months Ended June 30,
2022 2021 2022 2021
Numerator
Net loss $ (14,624 ) $ (6,163 ) $ (26,894 ) $ (9,816 )
Denominator
Weighted average common shares outstanding, basic and diluted 35,760,492 14,114,707 35,443,526 14,114,707
Loss per share
Net loss per share - basic and diluted $ (0.41 ) $ (0.44 ) $ (0.76 ) $ (0.70 ) Basic
weighted-average number of shares of common stock outstanding for the periods ended June 30, 2022 and 2021 include the shares of the
Company issued and outstanding during such periods, each on a weighted average basis. The basic weighted average number of shares common
stock outstanding excludes common stock equivalent incremental shares, while diluted weighted average number of shares outstanding includes
such incremental shares. However, as the Company was in a loss position for all periods presented, basic and diluted weighted average
shares outstanding are the same, as the inclusion of the incremental shares would be anti-dilutive. The common stock equivalents excluded
from the computation of diluted weighted average shares outstanding are as follows: Schedule
of Anti-dilutive Securities Excluded from Computation of Diluted Earnings Per Share
June 30,
2022 2021
Stock options 2,459,666 1,399,242
Unvested restricted stock awards 2,260,740 1,552,100
Total 4,720,406 2,951,342 The
following discussion and analysis of our unaudited condensed consolidated financial condition and results of operations should be read
together with our Annual Report on Form 10-K for the year ended December 31, 2021 (the “Form 10-K”), as filed with the Securities
and Exchange Commission (the “SEC”). We are a majority-owned consolidated subsidiary of PAVmed Inc. (“PAVmed”). Unless
the context otherwise requires, references herein to “we”, “us”, and “our”, and to the “Company”
or “Lucid Diagnostics” are to Lucid Diagnostics Inc and its subsidiaries LucidDx Labs Inc. (“LucidDx Labs”) and
CapNostics, LLC. FORWARD-LOOKING
STATEMENTS This
Quarterly Report on Form 10-Q (this “Form 10-Q”), including the following discussion and analysis of our (unaudited) condensed
consolidated financial condition and results of operations, contains forward-looking statements that involve substantial risks and uncertainties.
All statements, other than statements of historical facts, contained in this Form 10-Q, including statements regarding our future results
of operations and financial position, business strategy and plans and objectives of management for future operations, are forward-looking
statements. The words “may,” “will,” “should,” “expects,” “plans,” “anticipates,”
“could,” “intends,” “target,” “projects,” “contemplates,” “believes,”
“estimates,” “predicts,” “potential” or “continue” or the negative of these terms or
other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these
identifying words. Forward-looking statements are not guarantees of future performance and the Company’s actual results may differ
significantly from the results discussed in the forward-looking statements. Factors that might cause such differences include, but are
not limited to, those discussed in Item 1A of Part I of the Form 10-K under the heading “Risk Factors.” Important
factors that may affect our actual results include:
● our limited operating history;
● our financial performance, including our ability to
generate revenue;
● our ability to obtain regulatory approval for the commercialization
of our products;
● our ability of our products to achieve market acceptance;
● our success in retaining or recruiting, or changes
required in, our officers, key employees or directors;
● our potential ability to obtain additional financing
when and if needed;
● our ability to protect our intellectual property;
● our ability to complete strategic acquisitions;
● our ability to manage growth and integrate acquired
operations;
● the potential liquidity and trading of our securities;
● regulatory and operational risks;
● cybersecurity risks;
● risks related to SARS-CoV-2 /COVID-19 pandemic;
● the impact of the material weakness identified by our
management; and
● our estimates regarding expenses, future revenue, capital
requirements and needs for additional financing. In
addition, our forward-looking statements do not reflect the potential impact of any future financings, acquisitions, mergers, dispositions,
joint ventures or investments we may make. We
may not actually achieve the plans, intentions, and /or expectations disclosed in our forward-looking statements, and you should not
place undue reliance on our forward-looking statements. You should read this Form 10-Q and the Form 10-K, and the documents we have filed
as exhibits to this Form 10-Q and the Form 10-K, completely and with the understanding our actual future results may be materially different
from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information,
future events or otherwise, except as required by applicable law. Overview We
are a commercial-stage, cancer prevention, medical diagnostics technology company focused on the millions of patients with long-standing
gastroesophageal reflux disease (“GERD”) who are at risk of developing esophageal precancer and cancer, specifically highly
lethal esophageal adenocarcinoma (“EAC”), which is expected to lead to approximately 16,000 U.S. deaths per year. We
believe that our lead products, the EsoGuard Esophageal DNA Test performed on samples collected with the EsoCheck Esophageal Cell Collection
Device, constitutes the first and only commercially available diagnostic test capable of serving as a widespread screening tool to prevent
EAC deaths, through early detection of esophageal precancer in at-risk GERD patients.
● EsoGuard is
a DNA test performed on surface esophageal cells collected with EsoCheck in a brief noninvasive office procedure which has been shown
to be over 90% sensitive and specific at detecting Barrett’s Esophagus (“BE”), a precancerous condition of the
esophagus and all conditions along the BE-EAC spectrum. (Moinova, et al. Sci Transl
Med. 2018 Jan 17;10(424): eaao5848).
● EsoCheck
is a United States Food and Drug Administration FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter
capable of sampling surface esophageal cells in a less than five-minute office procedure. We believe its proprietary
Collect+Protect™ technology makes it the only noninvasive esophageal cell collection device capable of anatomically targeted
and protected sampling to prevent dilution and contamination during device withdrawal. EsoGuard
is commercialized in the U.S. as a laboratory developed test (“LDT”). It was previously performed by our unrelated
third-party commercial clinical laboratory service partner ResearchDx Inc. (“RDx”), at their Clinical Laboratory
Improvement Amendments (“CLIA”) certified commercial clinical laboratory, located in Irvine, CA. Beginning in March
2022, the EsoGuard LDT has been performed at our own CLIA-certified commercial clinical laboratory, located in Lake Forest, CA. RDx
also manufactures our EsoGuard Specimen Kits. EsoCheck is commercialized in the U.S. as a 510(k) cleared esophageal cell collection
device currently manufactured for us by our contract manufacturing partner, Sage Product Development Inc., located in Foxborough,
MA. We are in the process of transferring EsoCheck manufacturing to Coastline International Inc., a high-volume manufacturer
headquartered in San Diego, CA with plants in Mexico. Both EsoGuard and EsoCheck have completed the CE Mark certification process.
EsoGuard, us ed with EsoCheck was granted FDA Breakthrough
Device designation and requires the completion of an international multicenter pre-market approval (“PMA”) clinical
trial to be able to submit EsoGuard to the FDA for approval as an in vitro diagnostic device (“IVD”). Presently, the
Company is focusing its clinical trial efforts and resources towards supporting insurance reimbursement adoption by government and
private insurers. Consequently, with the Company prioritizing shorter term clinical utility studies to facilitate widespread
insurance adoption, the completion of the BE-1 EsoGuard screening (as described below) study will be delayed indefinitely. The
Company expects to complete the EsoGuard BE-2 case control study (as described below) in due course. The
EsoGuard PLA code 0114U secured final Medicare payment determination of $1,938.01, effective January 1, 2021. We are awaiting Medicare
local coverage determination. We are also aggressively pursuing EsoGuard U.S. private payor payment and coverage as well as payment in
Europe. We
are working to expand EsoGuard commercialization across multiple channels by building a direct sales and marketing team targeting primary
care physicians, specialists, institutions and consumers. To assure sufficient testing capacity and geographic coverage, as part of this
expansion, we are building our own network of Lucid Test Centers, staffed by Lucid-employed clinical personnel, where patients can undergo
the EsoCheck procedure and have the sample sent for EsoGuard testing. We have also established an EsoGuard Telemedicine Program, in partnership
with UpScript, LLC, an independent third-party telemedicine provider, that can accommodate EsoGuard self-referrals from direct-to-consumer
marketing. Overview In connection
with our efforts to expand our presence in the diagnostic market, we are also developing EsoCure as an Esophageal Ablation Device, with
the intent to allow a clinician to treat dysplastic BE before it can progress to EAC, a highly lethal esophageal cancer, and to do so
without the need for complex and expensive capital equipment. As described below, we recently entered into a license agreement with our
parent company, PAVmed Inc., pursuant to which we were granted the rights to commercialize EsoCure. A successful pre-clinical feasibility
animal study of EsoCure has been completed, demonstrating excellent, controlled circumferential ablation of the esophageal mucosal lining.
An acute and survival animal study of EsoCure™ Esophageal Ablation Device has also been completed, demonstrating successful direct
thermal balloon catheter ablation of esophageal lining through the working channel of a standard endoscope. We plan to conduct additional
development work and animal testing of EsoCure to support a future FDA 510(k) submission. We
are a majority owned subsidiary of PAVmed. We are party to an amended and restated patent license agreement with CWRU, dated August 23,
2021 (“Amended CWRU License Agreement”), which provides for the exclusive worldwide license of the intellectual property
rights for the proprietary technologies underlying EsoCheck and EsoGuard. Recent
Developments Business Clinical
Guideline Update - ACG and AGA In April 2022, the American College
of Gastroenterology (“ACG”) updated its clinical guideline to support esophageal precancer (“Barrett’s Esophagus”-
or “BE”) screening to prevent highly lethal EAC utilizing our EsoGuard® DNA Test on samples collected with our EsoCheck®
Cell Collection Device. The clinical guideline reiterates the ACG’s long-standing recommendation for esophageal precancer screening
in at-risk patients with GERD, commonly known as chronic heartburn, acid reflux or simply reflux. In its Recommendation 5, the ACG suggests
a single screening endoscopy in patients with chronic GERD symptoms and 3 or more additional risk factors for BE, including male sex,
age greater than 50 years, White race, tobacco smoking, obesity, and family history of BE or EAC in a first-degree relative. Furthermore,
and importantly for the first time, the clinical guideline also endorses nonendoscopic biomarker screening as an acceptable alternative
to costly and invasive endoscopy by stating in its Recommendation 6 that the ACG suggests that a swallowable, nonendoscopic capsule device
combined with a biomarker is an acceptable alternative to endoscopy for screening for BE. The clinical guideline specifically mentions
EsoCheck, along with the Company’s EsophaCap® device, as such swallowable, nonendoscopic esophageal cell collection devices,
as well as methylated DNA biomarkers such as EsoGuard. The summary of evidence for this recommendation cites the seminal NIH-funded multicenter,
case-control study published in 2018 in Science Translational Medicine, which demonstrated that EsoGuard is highly accurate at detecting
esophageal precancer and cancer, including on samples collected with EsoCheck. In July 2022, the American Gastroenterology
Association (“AGA”) published updated clinical guidance that mirrors the same furnished by the ACG as described above ,
without Recent Developments Business - continued Local
Coverage Determination Update - CMS In April 2022, a proposed Local
Coverage Determination (“LCD”) DL39256, entitled “Molecular Testing for Detection of Upper Gastrointestinal Metaplasia,
Dysplasia, and Neoplasia” was published on the Center for Medicare and Medicaid Services (“CMS”) website by MAC Palmetto
GBA. The proposed LCD is a further step in our efforts to secure Medicare coverage and payment for EsoGuard. The
proposed LCD, which the CMS website explicitly characterizes as a “work in progress” for “public review,” outlines
criteria that MolDX expects upper gastrointestinal precancer and cancer molecular diagnostic tests to meet. These criteria include active
GERD with at least two risk factors, as well as evidence of analytic validity, clinical validity, and clinical utility. Although it found
that no currently existing test has fulfilled all these criteria, it indicated that it will “monitor the evidence and will provide
coverage based on the pertinent literature and society recommendations.” Notably, the proposed LCD pre-dated, and therefore does
not include consideration of, the most recent ACG clinical guideline update endorsing swallowable, nonendoscopic capsule devices combined
with a biomarker, such as EsoCheck and EsoGuard. The publication of the proposed LCD included a written comment period that extended
through May 14, 2022. MolDX held an open meeting on May 10, 2022, during which stakeholders and other interested parties had the opportunity
to address the proposed LCD. We
have used the written comment process and the open meeting to bring to MolDX essential information that was not incorporated into the
proposed LCD. These include: the updated ACG clinical guideline; the fact that EsoGuard’s published performance is at or above
accepted performance criteria for detection of lower gastrointestinal cancers in approved and currently effective Medicare coverage determinations;
and data from ongoing clinical utility studies Lucid and clinical investigators are performing. A final LCD will not be issued until
the MAC has had the opportunity to assess and consider the comments and input from the written comment period and the open meeting. Following
the MAC Palmetto GBA release of a proposed LCD, Noridian Healthcare Solutions published a proposed LCD entitled Molecular Testing for
Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia DL39262. The proposed LCD mirrors the MAC Palmetto GBA proposed
LCD. We have used the Noridian Healthcare Solutions open meeting held on May 26, 2022, and the written comment period that ended on June
11, 2022 to bring the same essential information that we provided to the MAC Palmetto GBA to maintain consistency in our approach and
advocate appropriately. EsoGuard
BE-1 and BE-2 Clinical Trials In 2021 Lucid Diagnostics Inc. began conducting two concurrent clinical
trials, including each of: the “EsoGuard screening study” (“BE-1”); and the “EsoGuard case-control study”
(“BE-2”), to expand the clinical evidence for the technologies and to support a United States Food and Drug Administration
(“FDA”) pre-market approval (“PMA”) of the use of EsoGuard and EsoCheck as an in-vitro diagnostic medical device
(“IVD”). However, in light of the recently published proposed Local Coverage Determination (“LCD”) DL39256, the
recently updated AGA guidance, and the ACG update to its clinical guideline that supports screening to prevent highly lethal esophageal
cancer (“EAC”) utilizing our EsoGuard® DNA Test on samples collected with our EsoCheck® Cell Collection Device, the
Company has determined to prioritize its clinical trial efforts and resources towards supporting studies that will help secure insurance
reimbursement adoption by government and private insurers. Consequently, we have decided to delay for the time being the BE-1 trial while
continuing to enroll GERD patients with a previous diagnosis of nondysplastic BE, low-grade dysplasia, high-grade dysplasia, or EAC in
the BE-2 case-control study through Q2 2023. Recent Developments Business - continued MediNcrease
Health Plans In May 2022 LucidDx Labs, Inc.
entered into a participating provider agreement with MediNcrease Health Plans, LLC (“MediNcrease”). A national directly-contracted,
multi-specialty PPO provider network with over 8 million lives covered through its clients and payers, which include regional and national
health plans, insurance companies, third party administrators, self-insured employer groups, municipalities, unions and other entities
involved in the management of medical claims. Pursuant to the agreement, persons covered by MediNcrease clients and payers will have in-network
access to our EsoGuard® DNA test. The agreement provides rates of reimbursement as a percent of charges for services rendered to such
covered persons by LucidDx Labs, including the performance of the EsoGuard® DNA test. In
June and July 2022, LucidDx Labs Inc. continued to expand its in-network base by entering into participating provider agreements
with Galaxy Health Network, Three Rivers Provider Network, and Prime Health Services (collectively, “the PPOs”), as well
as Alivio Health. The PPOs cover millions of lives through the provider networks they have compiled for their clients, including
third-party administrators, insurance companies, self-insured companies, corporations, and government entities to access, while
Alivio provides its clients access to its specialized diagnostic laboratory network. Pursuant to the agreement, persons covered by
the PPOs will have in-network access to our EsoGuard® DNA test. The agreements provides rates of reimbursement as a percentage
of charges for services rendered to such covered persons by LucidDx Labs, including the performance of the EsoGuard test. Company-Owned
Commercial Clinical Laboratory Through
our wholly-owned subsidiary, LucidDx Labs Inc., we entered into an asset purchase agreement (“APA”) dated February 25,
2022, with ResearchDx, Inc. (“RDx”), an unrelated third-party - “APA-RDx”. Under the APA-RDx, LucidDx Labs
Inc. acquired certain assets from RDx which were combined with LucidDx Labs purchased and leased property and equipment to establish
a Company-owned CLIA certified, CAP accredited commercial clinical laboratory capable of performing the EsoGuard® Esophageal DNA
assay, inclusive of DNA extraction, next generation sequencing (“NGS”) and specimen storage. Prior to consummation of
the APA-RDx, RDx provided such laboratory services to us at its owned CLIA-certified, CAP-accredited clinical laboratory. Recent Developments Business - continued Third-Party
Payor Billing and Revenue Cycle Management As part of the transition to
our own Company-owned commercial clinical laboratory, we also contracted with a revenue cycle management (“RCM”) service provider
to submit third-party reimbursement claims on our behalf. The RCM service provider will have complete oversight of payer claims, appeals
processes, patient billing, online payment collection, and claims tracking. With the appropriate licenses and certifications for billing
and credentialing secured, and our recently having put in place the necessary back office systems, claims for approximately 1,000 tests
performed since the establishment of our own lab are now being processed, including 850 tests in the three months ended June 30, 2022
(although not having yet secured reimbursed rates from Medicare and Medicaid, the Company does not know the amount per claim it will receive
from payors). Refer to Note 3 of our Condensed Consolidated Financial Statements for more information on Revenue from Contracts
with Customers. Presently, recognized revenue for GAAP purposes is subject to actual amounts collected during the period.
Accordingly, since the RCM began submitting claims processed from our own lab subsequent to June 30, 2022, there were no collections during
the three months ended June 30, 2022. EsoCure License Agreement with PAVmed Inc. EsoCure has been in development
as an esophageal ablation device by PAVmed. In April 2022, following the approval from both ours and the PAVmed Inc. boards of directors,
we and PAVmed Inc. entered into an intercompany license agreement (“EsoCure License Agreement”), pursuant to which we were
granted the rights to commercialize EsoCure. The EsoCure License Agreement, includes a royalty arrangement whereby we will pay PAVmed
Inc. a 5% royalty on all EsoCure sales up to $100 million per calendar year, and an 8.0% royalty on annual sales in excess of $100 million
per calendar year. We are obligated to reimburse PAVmed Inc. for any ongoing development costs and cumulative patent expenses associated
with the licensed technology. CapNostics,
LLC On October 5, 2021, PAVmed Subsidiary Corp, a wholly-owned
subsidiary of PAVmed Inc., acquired 100% of the outstanding membership interest of CapNostics, LLC (“CapNostics”), an unrelated
third-party, for total (gross) purchase consideration of approximately $2.1 million in cash, paid at the closing of the transaction. Subsequently,
Lucid Diagnostics Inc. and PAVmed Subsidiary Corp entered into an agreement, effective April 1, 2022, pursuant to which PAVmed Subsidiary
Corp assigned to Lucid Diagnostics Inc. 100% of the membership interest in CapNostics, LLC, inclusive of an acquired defensive technology
intangible asset, and a $2.1 million payment obligation Due To: PAVmed Inc. Additionally, Lucid Diagnostics Inc. was also assigned on a prospective basis effective April 1, 2022, the consulting
agreement with the previous principal owner of CapNostics, LLC. Results
of Operations Overview Revenue Revenue was recognized with respect to the EsoGuard
Commercialization Agreement, dated August 1, 2021, between the Company and ResearchDx Inc. (“RDx”), a CLIA certified commercial
laboratory service provider. On February 25, 2022, the EsoGuard Commercialization Agreement was terminated upon the execution of an Asset
Purchase Agreement between the Company’s wholly-owned subsidiary LucidDx Labs Inc. and RDx. Cost
of revenue The
cost of revenue recognized with respect to the revenue recognized under the EsoGuard Commercialization Agreement is inclusive of: a royalty
fee incurred under the Amended CWRU License Agreement; the MSA Fee (as defined and discussed herein below) allocated to cost of revenue,
which is principally employee related costs of PAVmed employees engaged in the administration to patients of the EsoCheck cell sample
collection procedure (principally at the LUCID Test Centers); the EsoCheck devices and EsoGuard mailers (cell sample shipping costs)
distributed to medical practitioners locations and the LUCID Test Centers; and LUCID Test Centers operating expenses, including rent
expense and supplies. Sales
and marketing expenses Sales
and marketing expenses consist primarily of the portion of the MSA Fee allocated to sales and marketing expenses, which are principally
employee related costs of PAVmed employees, as well as advertising and promotion expenses. We anticipate our sales and marketing expenses
will increase in the future, as we anticipate an increase in payroll and related expenses related to the roll-out of our commercial sales
and marketing operations as we execute on our business strategy. General
and administrative expenses General
and administrative expenses consist primarily of professional fees, accounting and legal services, consultants and expenses associated
with obtaining and maintaining patents within our intellectual property portfolio, along with the portion of the MSA Fee allocated to
general and administrative expenses. We
anticipate our general and administrative expenses will increase in the future, as we anticipate an increase in the MSA Fee allocated
to general and administrative expense, related to continued expansion of our overall business operations. We also anticipate expenses
related to being a public company, including professional services fees for legal, accounting, tax, audit, employees involved in third-party
payor reimbursement contract negotiations and regulatory services associated with maintaining compliance as a public company, along with
insurance premiums, investor relations, and other corporate expenses. Results of Operations Overview - continued Research
and Development Expenses Research
and development expenses are recognized in the period they are incurred and consist principally of internal and external expenses incurred
for the development of our technologies and conducting clinical trials, including:
● consulting
costs charged to us by various external contract research organizations we contract with to conduct preclinical studies and engineering
studies;
● costs associated with regulatory filings;
● patent license fees;
● cost of laboratory supplies and acquiring, developing,
and manufacturing preclinical prototypes;
● product design engineering studies;
● fees associated with conducting clinical trials for
our EsoGuard diagnostic assay; and
● MSA Fee allocated to research and development, as such
MSA Fee are discussed below. We
plan to incur research and development expenses for the foreseeable future as we continue the development of our existing products as
well as new innovations. Our research and development activities are focused principally on obtaining FDA approvals and developing product
improvements or extending the utility of the lead products in our pipeline, including EsoCheck and EsoGuard. Presentation
of Dollar Amounts All
dollar amounts in this Management’s Discussion and Analysis of Financial Condition and Results of Operations are presented in thousands
of dollars, if not otherwise indicated as being presented as dollars in millions, except for the number of shares and per share amounts. Results
of Operations Three
months ended June 30, 2022 as compared to three months ended June 30, 2021 The
Company did not recognize revenue nor cost of revenue during the three months ended June 30, 2022 and June 30, 2021. Sales
and marketing expenses In
the three months ended June 30, 2022, sales and marketing costs were approximately $3.9 million, compared to $1.0 million for the corresponding
period in the prior year. The net increase of $2.9 million was principally related to:
● approximately
$2.5 million increase in compensation related costs, including stock-based compensation of approximately $0.4 million in stock based
compensation with respect to restricted stock awards (“RSA”) grants under the Lucid Diagnostics Inc. 2018 Equity Plan to Lucid Diagnostics and PAVmed employees and non-employees,
and an increase in stock options granted corresponding with the increase in the number of employees principally related to an increase
in headcount;
● approximately
$0.5 million increase in outside professional services related to EsoCheck, EsoGuard and consulting and professional services fees;
and
● approximately $0.1 million
decrease in the MSA fee allocation from PAVmed related to the growth and expansion of our business and the services incurred
through PAVmed. General
and administrative expenses In
the three months ended June 30, 2022, general and administrative costs were approximately $7.3 million, compared to $3.1 million for
the corresponding period in the prior year. The net increase of $4.2 million was principally related to:
● approximately
$0.5 million increase in compensation related costs, including stock-based compensation of approximately $0.2 million with respect to restricted stock awards (“RSA”) grants under the Lucid Diagnostics Inc. 2018 Equity Plan to
Lucid Diagnostics and PAVmed employees and non-employees, and an increase in stock options granted corresponding with the increase
in the number of employees principally related to an increase in headcount;
● approximately
$2.1 million increase in consulting services related to patents, regulatory compliance, legal processes for contract review,
transition of public relations and investor relations firms, and public company expenses;
● approximately $0.6 million of amortization expense related to our intangible
assets;
● approximately $0.3 million
increase in the MSA fees, after allocation, from PAVmed related to the growth and expansion of our business and the services incurred
through PAVmed; and
● approximately $0.7 million
increase in general business expenses. Research
and development expenses In
the three months ended June 30, 2022, research and development costs were approximately $3.4 million, compared to $1.9 million for the
corresponding period in the prior year. The net increase of $1.5 million was principally related to:
● approximately
$1.4 million increase in development costs, particularly in clinical trial activities and outside professional and consulting fees
with respect to EsoCheck, EsoCure and EsoGuard; and
● approximately $0.1 million
increase in the MSA fee allocation from PAVmed related to the growth and expansion of our business and the services incurred
through PAVmed. See
our accompanying unaudited condensed consolidated financial statements for each of: Note 4 , Related Party Transactions, , Stock-Based
Compensation Results
of Operations Six
months ended June 30, 2022 as compared to six months ended June 30, 2021 Revenue In the six months ended June
30, 2022, revenue was $0.2 million as compared to no revenue in the corresponding period in the prior year. The $0.2 million increase
relates to our EsoGuard Commercialization Agreement, dated August 1, 2021, which resulted in revenue recognition of $0.1 million per month
commencing August 2021 and ending February 2022 upon the February 25, 2022 termination date of such agreement. Cost
of revenue In
the six months ended June 30, 2022, cost of revenue was approximately $0.4 million, compared to no cost of revenue in the corresponding
period in the prior year. The $0.4 million increase principally relates to costs associated with the EsoGuard Commercialization Agreement
noted above. Sales
and marketing expenses In
the six months ended June 30, 2022, sales and marketing costs were approximately $7.2 million, compared to $1.7 million for the corresponding
period in the prior year. The net increase of $5.5 million was principally related to:
● approximately
$4.8 million increase in compensation related costs, including stock-based compensation of approximately $0.8 million in stock based
compensation with respect to restricted stock awards (“RSA”) grants under the Lucid Diagnostics Inc. 2018 Equity Plan to Lucid Diagnostics and PAVmed employees and non-employees,
and an increase in stock options granted corresponding with the increase in the number of employees principally related to an increase
in headcount;
● approximately $0.9 million
increase in outside professional services related to EsoCheck, EsoGuard and consulting and professional services fees; and
● approximately $0.2 million
decrease in the MSA fee allocation from PAVmed related to the growth and expansion of our business and the services incurred
through PAVmed. General
and administrative expenses In
the six months ended June 30, 2022, general and administrative costs were approximately $13.2 million, compared to $4.3 million for the
corresponding period in the prior year. The net increase of $8.9 million was principally related to:
● approximately
$2.0 million increase in compensation related costs, including stock-based compensation of approximately $1.6 million in stock based
compensation with respect to restricted stock awards (“RSA”) grants under the Lucid Diagnostics Inc. 2018 Equity Plan to Lucid Diagnostics and PAVmed employees and non-employees,
and an increase in stock options |
