Management’s Discussion and Analysis of Financial Condition and Results of Operations
−Removed: The following discussion
−Removed: and analysis of our consolidated financial condition and results of operations should be read together with our consolidated financial
−Removed: statements and related notes appearing elsewhere in this Annual Report on Form 10-K.
−Removed: Some of the information contained in this discussion
−Removed: and analysis or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy
−Removed: for our business and related financing, includes forward-looking statements involving risks and uncertainties and should be read together
−Removed: with the “Forward-Looking Statements” and “Risk Factors” sections of this Annual Report on Form 10-K for a discussion
−Removed: of important factors which could cause actual results to differ materially from the results described in or implied by the forward-looking
−Removed: statements contained in the following discussion and analysis.
−Removed: Unless the context otherwise requires, references herein to “we”,
−Removed: “us”, and “our”, and to the “Company” or “Lucid” are to Lucid Diagnostics Inc.
−Removed: subsidiaries.
−Removed: are a commercial-stage medical diagnostics technology company focused on the millions of patients with long-standing GERD who are at
−Removed: risk of developing esophageal precancer and cancer, specifically highly lethal EAC, which is expected to lead to approximately 16,000
−Removed: deaths in 2021.
−Removed: believe that our lead products, the EsoGuard Esophageal DNA Test performed on samples collected with the EsoCheck Esophageal Cell Collection
−Removed: Device, constitute the first and only commercially available diagnostic test capable of serving as a widespread screening tool to prevent
−Removed: EAC deaths, through early detection of esophageal precancer in at-risk GERD patients.
−Removed: is a DNA test performed on surface esophageal cells collected with EsoCheck in a brief noninvasive office procedure which has been
−Removed: shown to be over 90% sensitive and specific at detecting Barrett’s Esophagus (“BE”), a precancerous condition of
−Removed: the esophagus and all conditions along the BE-EAC spectrum, including on samples collected with EsoCheck (Moinova, et al.
+Added: following discussion and analysis of our consolidated financial condition and results of operations should be read together with our
+Added: consolidated financial statements and related notes appearing elsewhere in this Annual Report on Form 10-K.
+Added: Some of the information contained
+Added: in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our
+Added: plans and strategy for our business and related financing, includes forward-looking statements involving risks and uncertainties and
+Added: should be read together with the “Forward-Looking Statements” and “Risk Factors” sections of this Annual Report
+Added: on Form 10-K for a discussion of important factors which could cause actual results to differ materially from the results described in
+Added: or implied by the forward-looking statements contained in the following discussion and analysis.
+Added: Unless the context otherwise requires,
+Added: references herein to “we”, “us”, and “our”, and to the “Company” or “Lucid”
+Added: are to Lucid Diagnostics Inc.
+Added: and its subsidiaries LucidDx Labs Inc.
+Added: (“LucidDx Labs”) and CapNostics, LLC (“CapNostics”).
+Added: Diagnostics Inc.
+Added: (“Lucid”) is a commercial-stage medical diagnostics technology company focused on the millions of patients
+Added: with gastroesophageal reflux disease (“GERD”), also known as chronic heartburn, acid reflux or simply reflux, who are at
+Added: risk of developing esophageal precancer and cancer, specifically highly lethal esophageal adenocarcinoma (“EAC”).
+Added: in this Form 10-K to “we,” “us” and “our” are to Lucid and, unless the context otherwise requires,
+Added: its subsidiaries.
+Added: believe that our flagship product, the EsoGuard Esophageal DNA Test, performed on samples collected with the EsoCheck Esophageal Cell
+Added: Collection Device, constitutes the first and only commercially available diagnostic test capable of serving as a widespread screening
+Added: tool to prevent esophageal adenocarcinoma (“EAC”) deaths, through early detection of esophageal precancer in at-risk gastroesophageal
+Added: reflux disease (“GERD,” also commonly known as chronic heartburn, acid reflux or simply reflux) patients.
+Added: is a bisulfite-converted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck.
+Added: quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1).
+Added: The assay was evaluated in a 408-patient multicenter
+Added: case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal
+Added: precancer and all conditions along the BE-EAC spectrum, including on samples collected with EsoCheck (Moinova, et al.
+Added: Sci Transl Med.
2018 Jan 17;10(424):
−Removed: is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter capable of sampling surface esophageal cells
−Removed: in a less than five-minute office procedure.
−Removed: We believe its proprietary Collect+Protect™ technology makes it the only noninvasive
−Removed: esophageal cell collection device capable of anatomically targeted and protected sampling to prevent dilution and contamination during
−Removed: device withdrawal.
−Removed: is commercialized in the U.S.
−Removed: as a laboratory developed test (“LDT”) previously performed previously at our
−Removed: unrelated third-party commercial clinical laboratory service partner ResearchDx Inc.
−Removed: (with a d/b/a “Pacific Dx”)
−Removed: (“RDx”), at their Clinical Laboratory Improvement Amendments (“CLIA”) certified commercial clinical laboratory,
−Removed: located in Irvine, CA.
−Removed: Starting March 2022, the EsoGuard LDT is performed at our CLIA-certified commercial clinical laboratory,
−Removed: located in Lake Forest, CA.
−Removed: Additionally, RDx also manufactures our EsoGuard Specimen Kits.
−Removed: EsoCheck is commercialized in the U.S.
−Removed: as a 510(k) cleared esophageal cell collection device currently manufactured for us by our contract manufacturing partner, Sage Product
−Removed: Development Inc., located in Foxborough, MA.
−Removed: We are in the process of transferring EsoCheck manufacturing to Coastline International
−Removed: Inc., a high-volume manufacturer headquartered in San Diego, CA with plants in Mexico.
−Removed: Both EsoGuard and EsoCheck recently completed
−Removed: the CE Mark certification process.
−Removed: EsoGuard, used with EsoCheck, was granted FDA Breakthrough Device designation and is the subject of
−Removed: two large, actively enrolling, international multicenter PMA clinical trials.
−Removed: EsoGuard PLA code 0114U secured final Medicare payment determination of $1,938.01, effective January 1, 2021.
−Removed: certified laboratory where the EsoGuard assay is performed has begun to submit claims and receive out-of-network private insurance
−Removed: We are awaiting Medicare local coverage determination.
−Removed: We are also aggressively pursuing EsoGuard U.S.
−Removed: private payor
−Removed: payment and coverage as well as payment in Europe.
−Removed: initial EsoGuard commercialization efforts have focused on gastroenterology (“GI”) physicians.
−Removed: EsoGuard testing has accelerated
−Removed: as pandemic-related healthcare facility limitations have eased.
−Removed: We have utilized a hybrid sales model of full-time sales management supervising
−Removed: senior independent sales representatives and supported by full-time clinical specialists.
−Removed: We are significantly expanding our full-time
−Removed: commercial team and currently employ a national director of sales, seven regional business managers, three clinical specialists and a
−Removed: sales operations manager.
−Removed: We are contracted with approximately fifty independent sales representatives and are actively recruiting full-time
−Removed: territory managers in each region to specifically call on either GI or primary care physicians.
−Removed: We are working to expand
−Removed: EsoGuard commercialization across multiple channels by targeting primary care physicians and consumers in addition to GI physicians.
−Removed: To assure sufficient testing capacity and geographic coverage, as part of this expansion, we are building our own network of Lucid Test
−Removed: Centers, staffed by Lucid-employed clinical personnel, where patients can undergo the EsoCheck procedure and have the sample sent for
−Removed: EsoGuard testing, starting with three test centers launched in the Phoenix metropolitan area and have recently announced we have expanded
−Removed: our test centers into Utah, Nevada, and Colorado.
−Removed: We also are establishing an EsoGuard Telemedicine Program, in partnership with UpScript,
−Removed: LLC, an independent third-party telemedicine provider, that can accommodate EsoGuard self-referrals from direct-to-consumer marketing.
−Removed: We are a majority owned subsidiary
−Removed: We are party to an amended and restated patent license agreement with CWRU, dated August 23, 2021 (“Amended CWRU License
−Removed: Agreement”), which provides for the exclusive worldwide license of the intellectual property rights for the proprietary technologies
−Removed: underlying EsoCheck and EsoGuard.
−Removed: of SARS-CoV-2 - COVID-19 Pandemic
−Removed: in December 2019, there was an outbreak of a novel strain of a coronavirus occurred, with such coronavirus designated by the United Nations
−Removed: (UN) World Health Organization (“WHO”) as the “Severe Acute Respiratory Syndrome Coronavirus 2” - or “SARS-CoV-2”.
−Removed: The SARS-CoV-2 spread on a global basis to other countries, including the United States of America (“USA” “U.S.”
−Removed: or “United States”).
−Removed: On March 11, 2020, the WHO declared a pandemic resulting from SARS-CoV-2, with such pandemic commonly
−Removed: referred to by its resulting illness of “COVID-19” (“coronavirus disease-2019”), and is referred to herein as
−Removed: the “COVID-19 pandemic”.
−Removed: The COVID-19 pandemic is ongoing, and we continue to monitor the ongoing impact of the COVID-19
−Removed: pandemic on the United States national economy, the global economy, and our business.
−Removed: COVID-19 pandemic may have an adverse impact on our operations, supply chains, and distribution systems and /or those of our contractors,
−Removed: and increase our expenses, including as a result of impacts associated with preventive and precautionary measures being taken, restrictions
−Removed: on travel, quarantine polices, and social distancing.
−Removed: Such adverse impact may include, for example, the inability of our employees and
−Removed: /or those of our contractors to perform their work or curtail their services provided to us.
−Removed: expect the significance of the COVID-19 pandemic, including the extent of its effect on our consolidated financial condition and consolidated
−Removed: operational results and cash flows, to be dictated by the success of United States and global efforts to mitigate the spread of and /or
−Removed: to contain the SARS-CoV-2 and the impact of such efforts.
−Removed: addition, the spread of the SARS-CoV-2 has disrupted the United States’ healthcare and healthcare regulatory systems which could
−Removed: divert healthcare resources away from, or materially delay United States Food and Drug Administration (“FDA”) approval with
−Removed: respect to our products.
−Removed: our clinical trials have been and may be further affected by the COVID-19 pandemic, as site initiation and patient enrollment may be
−Removed: delayed, for example, due to prioritization of hospital resources toward the virus and /or illness response, as well as travel restrictions
−Removed: imposed by governments, and the inability to access clinical test sites for initiation and monitoring.
−Removed: COVID-19 pandemic may have an adverse impact on the economies and financial markets of many countries, including the USA, resulting in
−Removed: an economic downturn that could adversely affect demand for our products and services and /or our product candidates.
−Removed: we are continuing to monitor and assess the effects of the COVID-19 pandemic on our business, the ultimate impact of the COVID-19 pandemic
−Removed: (or a similar health epidemic) is highly uncertain and subject to change, and therefore, its impact on our consolidated financial condition,
−Removed: consolidated results of operations, and /or consolidated cash flows, the adverse impact could be material.
+Added: EsoGuard is commercially available in the U.S.
+Added: as a Laboratory Developed Test (LDT) performed at our
+Added: CLIA-certified laboratory.
+Added: Cell samples, including those collected with EsoCheck, as discussed below, are sent to our laboratory, for
+Added: testing and analyses using our proprietary EsoGuard NGS DNA assay.
+Added: is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells
+Added: in a less than five-minute office.
+Added: It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from
+Added: which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells.
+Added: When vacuum suction is applied, the
+Added: balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted
+Added: region during device withdrawal.
+Added: We believe this proprietary Collect+Protect™ technology makes EsoCheck the only noninvasive esophageal
+Added: cell collection device capable of such anatomically targeted and protected sampling.
+Added: and EsoCheck are based on patented technology licensed by Lucid from Case Western Reserve University (“CWRU”).
+Added: EsoCheck have been developed to provide an accurate, non-invasive, patient-friendly screening test for the early detection of adenocarcinoma
+Added: of the esophagus (“EAC”) and Barrett’s Esophagus (“BE”), including dysplastic BE and related pre-cursors
+Added: to EAC in patients with chronic gastroesophageal reflux (“GERD”).
+Added: of Clinical Trials
+Added: are currently seeking to accelerate our collection of clinical utility data through a range of trials that can be efficiently executed.
+Added: These efforts include a planned investigator-initiated, retrospective analysis of prospectively collected data on the approximately 400
+Added: San Antonio fire fighters who underwent testing as part of a community-sponsored cancer awareness event (in
+Added: respect of which we expect to publish results in the first half of 2023) ;
+Added: an ongoing investigator-initiated, retrospective, single-center,
+Added: study with 500 patients (in respect of which we expect to publish results mid-2023), a virtual-patient randomized controlled trial with
+Added: intended recruitment of 100-200 physician participants (in respect of which we expect to publish
+Added: results this year) ;
+Added: a Lucid-sponsored multi-center, prospective, observational study with 500 patients;
+Added: and a Lucid-sponsored
+Added: registry at existing Lucid Test Centers, whereby all patients undergoing EsoCheck testing will be given the opportunity to provide informed
+Added: consent and contribute data about their risk factors, EsoGuard results, and subsequent diagnostic and/or therapeutic journey.
+Added: Both Lucid-sponsored
+Added: observational/registry studies expect to have preliminary results and/or interim analysis before the end of 2023.
+Added: previously disclosed, consequently, we have decided to delay for the time being the two previously commenced clinical trials, the “EsoGuard
+Added: screening study” (“BE-1”) and the “EsoGuard case-control study” (“BE-2”), as we are devoting
+Added: our clinical resources to the studies cited above, which we expect will more efficiently generate the clinical data we are currently
+Added: prioritzing to drive EsoGuard commercialization.
+Added: Labs Laboratory Operations Update
+Added: February 14, 2023, we and our subsidiary, LucidDx Labs Inc., entered into an agreement (the “MSA Termination Agreement ”)
+Added: with RDx, pursuant to which the parties mutually agreed to terminate the MSA-RDx without cause.
+Added: The termination was effective as February
+Added: Until the termination of the MSA-RDx, RDx had continued to provide certain testing and related services for the Laboratory
+Added: in accordance with the terms of the MSA-RDx.
+Added: Recently, however, we accelerated the development of internal resources necessary to operate
+Added: the Laboratory entirely on its own.
+Added: Accordingly, we believe that termination of the MSA-RDx will improve the efficiency of the performance
+Added: of the EsoGuard assay.
+Added: other things, the MSA Termination Agreement reduces the remaining amounts of the earnout payments and management fees due under the APA-RDx
+Added: and the MSA-RDx to $725,000 (from the $3,450,000 that would otherwise have been payable under the APA and MSA if the MSA had remained
+Added: in effect through the balance of its stated term), resulting in a net savings to us of $2,725,000.
+Added: The payment was satisfied through
+Added: the issuance of 553,436 shares of Lucid Diagnostics’ common stock on February 25, 2023.
+Added: we were not required to make any cash payments
+Added: in connection with the termination.
+Added: #CheckYourFoodTube
+Added: January 2023, we successfully completed our first #CheckYourFoodTube Precancer Testing Event, in partnership with Rachelle Hamblin, M.D.,
+Added: M.P.H., and the San Antonio Fire Department (SAFD), to detect esophageal precancer in at-risk members of the department.
+Added: The SAFD testing
+Added: event was held over two weekends in January, which has been designated as Firefighter Cancer Awareness Month by the International Association
+Added: of Fire Fighters (IAFF).
+Added: A total of 391 members, nearly one-quarter of the department, who were deemed by Dr.
+Added: Hamblin to be at-risk for
+Added: esophageal precancer, underwent a brief, on-site, noninvasive cell collection procedure, performed by our clinical personnel using EsoCheck.
+Added: Firefighters with suspected esophageal precancer based on a positive EsoGuard result were identified, including some less than forty
+Added: years of age, and will undergo appropriate monitoring and treatment, as indicated by clinical practice guidelines, to prevent progression
+Added: to esophageal cancer.
+Added: These events, which we look to expand across the country, are an extension of our expanding satellite Lucid Test
+Added: Center (sLTC) program, which brings our precancer testing directly to patients—at their physician’s office and now at large
+Added: testing day events.
+Added: We demonstrated that our nurse practitioners can each perform up to fifty EsoCheck procedures in a day, and our laboratory
+Added: team handled over two hundred incoming samples in a day, while maintaining turnaround times at target.
+Added: These successes provide an excellent
+Added: foundation for future testing events as we continue to drive EsoGuard commercialization using all the tools at our disposal.
+Added: and Benefit Expense Reimbursement Agreement
+Added: November 30, 2022, PAVmed and we entered into a payroll and benefit expense reimbursement agreement (the “PBERA”).
+Added: Historically,
+Added: PAVmed has paid for certain payroll and benefit-related expenses in respect of our personnel on our behalf, and we have reimbursed PAVmed
+Added: for the same.
+Added: Pursuant to the PBERA, PAVmed will continue to pay such expenses, and we will continue to reimburse PAVmed for the same.
+Added: The PBERA now provides that the expenses will be reimbursed on a quarterly basis or at such other frequency as the parties may determine,
+Added: in cash or, subject to approval by PAVmed’s and our boards of directors, in shares of our common stock, with such shares valued
+Added: at the volume weighted average price of such stock during the final ten trading days preceding the later of the two dates on which such
+Added: stock issuance is approved by PAVmed’s and our boards of directors (subject to a floor price of $0.40 per share), or in a combination
+Added: of cash and shares.
+Added: However, in no event shall we issue any shares of our common stock to PAVmed in satisfaction of all or any portion
+Added: of the expenses if the issuance of such shares of our common stock would exceed the maximum number of shares of common stock that we
+Added: may issue under the rules or regulations of The Nasdaq Stock Market LLC (“Nasdaq”), unless we obtain the approval of our
+Added: stockholders as required by the applicable rules of the Nasdaq for issuances of shares of our common stock in excess of such amount.
+Added: Series A Preferred Stock Offering
+Added: On March 7, 2023, we
+Added: entered into subscription agreements for the sale of 13,625 shares of Series A preferred stock (the “ Series A Preferred
+Added: Each share of the Series A Preferred Stock has a stated value of $1,000 and a conversion price of $1.394.
+Added: terms of the Series A Preferred Stock also include a one times preference on liquidation and a right to receive dividends equal to
+Added: 20% of the number of shares into which such Series A Preferred Stock is convertible, payable on the one-year and two-year
+Added: anniversary of the issuance date.
+Added: The Series A Preferred Stock is a non-voting security, other than with respect to limited matters
+Added: related to changes in terms of the Series A Preferred Stock.
+Added: The aggregate gross proceeds from the sale of shares in such offering
+Added: were $13.625 million.
+Added: Private Placement - Securities Purchase Agreement
+Added: Effective as of March 13, 2023,
+Added: we entered into a Securities Purchase Agreement (“SPA”) with an accredited institutional investor (“Investor”,
+Added: “Lender”, and /or “Holder”), pursuant to which we agreed to sell, and the Investor agreed to purchase a Senior
+Added: Secured Convertible Note with a face value principal of $11.1 million (the “March 2023 Senior Convertible Note”).
+Added: issuance of the March 2023 Senior Convertible Note is subject to customary closing conditions.
+Added: The March 2023 Senior Secured Convertible Note would have a 7.875% annual
+Added: stated interest rate, a contractual conversion price of $5.00 per share of the Company’s common stock (subject to standard adjustments
+Added: in the event of any stock split, stock dividend, stock combination, recapitalization or other similar transaction), and a contractual
+Added: maturity date of the two-year anniversary of the date of issuance.
+Added: The March 2023 Senior Convertible Note would be convertible into or
+Added: otherwise paid in shares of the Company’s common stock.
+Added: Under the March 2023
+Added: Senior Convertible Note, the Company would be subject to certain customary affirmative and negative covenants regarding the
+Added: incurrence of indebtedness, the existence of liens, the repayment of indebtedness and the making of investments, the payment of cash
+Added: in respect of dividends, distributions or redemptions, the transfer of assets, the maturity of other indebtedness, and transactions
+Added: with affiliates, among other customary matters.
+Added: Under the March 2023 Senior Convertible Note, the Company would also be subject to
+Added: financial covenants requiring that (i) the amount of our available cash equal or exceed $5.0 million at all times, (ii) the ratio of
+Added: (a) the outstanding principal amount of the notes issued under the SPA, accrued and unpaid interest thereon and accrued and unpaid
+Added: late charges to (b) the Company’s average market capitalization over the prior ten trading days, not exceed 30%, and (iii)
+Added: that the Company’s market capitalization shall at no time be less than an amount to be agreed upon.
+Added: Committed Equity Facility and ATM Facility
+Added: In March 2022, we entered into a
+Added: committed equity facility with an affiliate of Cantor Fitzgerald (“Cantor”).
+Added: Under the terms of the facility, Cantor has committed
+Added: to purchase up to $50 million of our common stock from time to time upon our request.
+Added: While there are distinct differences, the facility
+Added: is structured similarly to a traditional at-the-market equity facility, insofar as it allows us to raise primary capital on a periodic
+Added: basis at prices based on the existing market price.
+Added: Through December 31, 2022, 680,263 shares of our common stock were issued under this
+Added: facility for total proceeds of $1.8 million.
+Added: In November 2022, Lucid Diagnostics also entered into an “at-the-market
+Added: offering” for up to $6.5 million of its common stock that may be offered and sold under a Controlled Equity Offering Agreement between
+Added: Lucid Diagnostics and Cantor Fitzgerald & Co.
+Added: In the year ended December 31, 2022, there were no Lucid Diagnostics shares sold through
+Added: their at-the-market equity facility.
+Added: Subsequent to December 31, 2022, through March 9, 2023, Lucid Diagnostics sold 230,068 shares through
+Added: its at-the-market equity facility for approximately $0.3 million.
of Operations
−Removed: was recognized with respect to the EsoGuard Commercialization Agreement, dated August 1, 2021, between the Company’s majority-owned
−Removed: subsidiary, Lucid Diagnostics Inc., and ResearchDX Inc.
−Removed: (“RDx”), CLIA certified commercial laboratory service provider.
+Added: Company recognized revenue resulting from the delivery of patient EsoGuard test results when the Company considered the collection of
+Added: such consideration to be probable to the extent that it is unconstrained.
+Added: Additionally, revenue was recognized with respect to the EsoGuard
+Added: Commercialization Agreement, dated August 1, 2021, between the Company and RDx, a CLIA certified commercial laboratory service provider.
+Added: On February 25, 2022, the EsoGuard Commercialization Agreement was terminated upon the execution of an Asset Purchase Agreement between
+Added: the Company’s wholly-owned subsidiary of LucidDx Labs Inc.
+Added: of revenues recognized from the delivery of patient EsoGuard test results includes costs related to EsoCheck device usage, shipment of
+Added: test collection kits, royalties and the cost of services to process tests and provide results to physicians.
+Added: We incur expenses for tests
+Added: in the period in which the activities occur, therefore, gross margin as a percentage of revenue may vary from quarter to quarter due
+Added: to costs being incurred in one period that relate to revenues recognized in a later period.
+Added: expect that gross margin for our services will continue to fluctuate and be affected by EsoGuard test volume, our operating efficiencies,
+Added: patient compliance rates, payer mix, the levels of reimbursement, and payment patterns of payers and patients.
cost of revenue recognized with respect to the revenue recognized under the EsoGuard Commercialization Agreement is inclusive of:
8 unchanged sentences
and marketing expenses
−Removed: and marketing expenses consist primarily of the portion of the MSA Fee allocated to sales and marketing expenses, which are principally
−Removed: employee related costs of PAVmed employees, as well as advertising and promotion expenses.
−Removed: We anticipate our sales and marketing expenses
−Removed: will increase in the future, as we anticipate an increase in payroll and related expenses related to the roll-out of our commercial sales
−Removed: and marketing operations as we execute on our business strategy.
+Added: and marketing expenses consist primarily of salaries and related costs for employees engaged in sales and marketing activities, as well
+Added: as the portion of the MSA Fee allocated to sales and marketing expenses, which are principally employee related costs of PAVmed employees
+Added: who are performing services for the Company.
+Added: We anticipate our sales and marketing expenses will increase in the future, as we anticipate
+Added: an increase in payroll and related expenses related to our commercial sales and marketing operations as we execute on our business strategy.
and administrative expenses
2 unchanged sentences
general and administrative expenses.
−Removed: anticipate our general and administrative expenses will increase in the future, as we anticipate an increase in the MSA Fee allocated
−Removed: to general and administrative expense, related to continued expansion of our overall business operations.
−Removed: We also anticipate expenses
−Removed: related to being a public company, including professional services fees for legal, accounting, tax, audit, employees involved in third-party
−Removed: payor reimbursement contract negotiations and regulatory services associated with maintaining compliance as a public company, along with
−Removed: insurance premiums, investor relations, and other corporate expenses.
+Added: anticipate our general and administrative expenses will increase in the future related to continued expansion of our overall business
+Added: We also anticipate expenses related to being a public company, including professional services fees for legal, accounting,
+Added: tax, audit, employees involved in third-party payor reimbursement contract negotiations and regulatory services associated with maintaining
+Added: compliance as a public company, along with insurance premiums, investor relations, and other corporate expenses.
and development expenses
1 unchanged sentence
for the development of our technologies and conducting clinical trials, including:
−Removed: costs charged to us by various external contract research organizations we contract with to conduct preclinical studies and engineering
+Added: costs charged to us by various external contract research organizations we contract with
+Added: to conduct clinical and preclinical studies and engineering design and development;
associated with regulatory filings;
4 unchanged sentences
Fee allocated to research and development, as such MSA Fee are discussed below.
−Removed: plan to incur research and development expenses for the foreseeable future as we continue
−Removed: the development of our existing products as well as new innovations.
−Removed: Our research and development
−Removed: activities are focused principally on obtaining FDA approvals and developing product improvements
−Removed: or extending the utility of the lead products in our pipeline, including EsoCheck and EsoGuard.
−Removed: expense recognized is with respect to a Senior Unsecured Promissory Note, dated June 1, 2021, with a face value principal of $22.4 million,
−Removed: an annual interest rate of 7.875%, and a contractual maturity date of May 18, 2028, issued by us to PAVmed.
−Removed: The Senior Unsecured Promissory
−Removed: Note replaced the $22.4 million aggregate outstanding and payable balance of the Due To:
−Removed: PAVmed Inc., as of June 1, 2021.
−Removed: Unsecured Promissory Note provided for the partial or full repayment of the face value principal and accrued but unpaid interest thereon
−Removed: by the issue of shares of our common stock, at the election of PAVmed Inc., at a conversion price of $1.42 per share of Lucid Diagnostics
−Removed: common stock.
−Removed: October 13, 2021, we issued 15,803,200 shares of our common stock to PAVmed upon the election by PAVmed to convert the $22.4 million
−Removed: face value principal under the terms of a Senior Unsecured Promissory Note, dated June 1, 2021.
−Removed: our accompanying consolidated financial statements Note 6, Due To PAVmed Inc.
−Removed: , for a discussion of the Senior Unsecured Promissory
−Removed: Note dated June 1, 2021 issued by us to PAVmed.
−Removed: Shares Increase and Stock-Split - October 6, 2021
−Removed: October 6, 2021, our board of directors:
−Removed: increased the authorized shares of common stock to 100.0 million shares;
−Removed: and declared a 1.411-to-1.0
−Removed: common stock-split.
−Removed: The number of shares of our common stock and the stock options and restricted stock awards granted under the Lucid
−Removed: Diagnostics Inc.
−Removed: 2018 Equity Plan, and the corresponding stock option exercise price per share;
−Removed: the fair value per share of the stock
−Removed: options and restricted stock awards;
−Removed: and the Senior Unsecured Promissory Note conversion price per share, for all periods presented,
−Removed: as applicable, have been adjusted for such common stock split.
−Removed: Services Agreement (MSA)
−Removed: are a majority-owned subsidiary of PAVmed, which has a majority equity ownership interest and has financial control of Lucid Diagnostics.
−Removed: daily operations are managed by personnel employed by PAVmed, for which we incur the MSA Fee, according to the provisions of the
−Removed: MSA with PAVmed.
−Removed: The MSA Fee is charged on a quarterly basis and is subject-to periodic adjustment corresponding with changes in the
−Removed: number of PAVmed.
−Removed: employees providing services to us, with the change in the MSA Fee approved by each of the Lucid Diagnostics and PAVmed’s
−Removed: board of directors.
−Removed: The MSA does not have a termination date, but may be terminated by the Lucid Diagnostics board of directors.
−Removed: classification of the MSA Fee between cost-of-revenue, sales and marketing expense, general and administrative expense, and research
−Removed: and development expense is based on the PAVmed quarterly classification of employee salary expense.
−Removed: In this regard, PAVmed classifies
−Removed: employee salary expense as cost-of-revenue for employees engaged in service delivery under the EsoGuard Commercialization Agreement,
−Removed: and sales and marketing expenses for employees performing sales, marketing, and reimbursement activities and functions, general and administrative,
−Removed: and research and development except for those employees who are engaged in product and services engineering development and design and
−Removed: /or clinical trials activities, for which such employee salary is classified as research and development expense.
−Removed: our accompanying unaudited condensed financial statements Note 5 , Related Party Transactions - PAVmed Inc.
−Removed: - Management Services
−Removed: Agreement , for a discussion of the MSA between Lucid Diagnostics and PAVmed.
+Added: plan to incur research and development expenses for the foreseeable future as we continue the development of our existing products as
+Added: well as new innovations.
+Added: Our research and development activities, including our clinical trials, are focused principally on obtaining
+Added: FDA approvals, facilitating insurer reimbursement, encouraging physician adoption and developing product improvements or extending the
+Added: utility of the lead products in our pipeline, including EsoCheck and EsoGuard.
+Added: of Operations - continued
of Dollar Amounts
−Removed: dollar amounts in this Management’s Discussion and Analysis of Financial Condition and Results of Operations are presented in whole
−Removed: dollars, if not otherwise indicated as being presented as dollars in millions, except for the number of shares and per share amounts.
−Removed: ended December 31, 2021 versus December 31, 2020
−Removed: the year ended December 31, 2021, revenue was $0.5 million as compared to no revenue in the corresponding period in the prior year.
−Removed: $0.5 million increase principally relates to our EsoGuard Commercialization Agreement, dated August 1, 2021, which resulted in revenue
−Removed: recognition of $0.1 million per month beginning August 2021.
−Removed: the year ended December 31, 2021, cost of revenue was approximately $0.6 million, compared to no cost of revenue in the corresponding
−Removed: period in the prior year.
−Removed: The $0.6 million increase principally relates to costs associated with our commercialization agreement that
−Removed: started in August 2021.
+Added: dollar amounts in this Management’s Discussion and Analysis of Financial Condition and Results of Operations are presented as dollars
+Added: in millions, except for per share amounts.
+Added: year ended December 31, 2022 as compared to the year ended December 31, 2021
+Added: the year ended December 31, 2022, revenue was $0.4 million as compared to $0.5 million in the prior year.
+Added: The $0.1 million decrease principally
+Added: relates to the termination of the EsoGuard Commercialization Agreement with RDx, as the Company transitioned to its own laboratory operations
+Added: effective February 25, 2022.
+Added: The decrease was partially offset by revenue for our EsoGuard Esophageal DNA Test performed in our own CLIA
+Added: laboratory for the year ended December 31, 2022.
+Added: the year ended December 31, 2022, cost of revenue was approximately $3.6 million as compared to $0.6 million in the prior year.
+Added: million increase principally related to:
+Added: ● approximately
+Added: $0.6 million increase in compensation related costs as a result of an increase in headcount;
+Added: ● approximately
+Added: $0.7 million increase in EsoCheck and EsoGuard supplies usage costs;
+Added: ● approximately
+Added: $1.7 million increase in laboratory operations costs.
and marketing expenses
−Removed: the year ended December 31, 2021, sales and marketing costs were approximately $5.3 million, compared to $1.3 million for the corresponding
−Removed: period in the prior year.
+Added: the year ended December 31, 2022, sales and marketing costs were approximately $16.1 million, compared to $5.3 million in the prior year.
The net increase of $10.8 million was principally related to:
● approximately
−Removed: $1.9 million increase in compensation related costs principally related to an increase in headcount;
+Added: $8.1 million increase in compensation related costs principally as a result of an increase
+Added: in headcount;
● approximately
−Removed: $1.2 million increase in outside professional services related to EsoCheck, EsoGuard and consulting and professional services
+Added: $1.4 million increase in stock-based compensation from RSA grants to Lucid and PAVmed employees
+Added: and non-employees, and an increase in stock options granted corresponding with the increase
+Added: in headcount;
● approximately
−Removed: $0.9 million increase in the MSA fee allocation from PAVmed related to the growth and expansion of Lucid’s business and the
−Removed: services incurred through PAVmed.
+Added: $1.5 million increase in consulting and outside professional services fees and for EsoCheck
+Added: and EsoGuard;
+Added: ● approximately
+Added: $0.2 million increase general business expenses;
+Added: ● approximately
+Added: $0.4 million decrease in the MSA fee allocation from PAVmed due to less sales and marketing
+Added: related activities incurred through PAVmed.
and administrative expenses
−Removed: the year ended December 31, 2021, general and administrative costs were approximately $12.8 million, compared to $1.5 million for the
−Removed: corresponding period in the prior year.
+Added: the year ended December 31, 2022, general and administrative costs were approximately $23.7 million, compared to $12.8 million in the
The net increase of $10.9 million was principally related to:
● approximately
−Removed: $6.1 million increase in stock based compensation from RSA grants to Lucid and PAVmed employees and non-employees, and an increase
−Removed: in stock options granted corresponding with the increase in the number of employees;
+Added: $0.6 million increase in compensation related costs principally as a result of an increase
+Added: in headcount;
● approximately
−Removed: $4.5 million in consulting services related to patents, regulatory compliance, legal processes for contract review, transition
−Removed: of PR and IR firms, and public company expenses;
+Added: $2.0 million increase in stock-based compensation from RSA grants to Lucid and PAVmed employees
+Added: and non-employees, and an increase in stock options granted corresponding with the increase
+Added: in headcount;
● approximately
−Removed: $0.6 million increase in the MSA fees, after allocation, from PAVmed related to the growth
−Removed: and expansion of our business and the services incurred through PAVmed.
+Added: $5.0 million increase in consulting services related to patents, regulatory compliance, legal
+Added: processes for contract review, transition of public relations and investor relations firms,
+Added: and public company expenses;
+Added: ● approximately
+Added: $1.8 million increase in the MSA fee allocation from PAVmed related to the growth and expansion
+Added: of our business and the services incurred through PAVmed;
+Added: ● approximately
+Added: $1.5 million increase in general business expenses.
+Added: of Operations - continued
+Added: year ended December 31, 2022 as compared to the year ended December 31, 2021 - continued
and development expenses
−Removed: the year ended December 31, 2021, research and development costs were approximately $9.3 million, compared to $5.4 million for the corresponding
−Removed: period in the prior year.
+Added: the year ended December 31, 2022, research and development costs were approximately $11.5 million, compared to $9.3 million in the prior
The net increase of $2.2 million was principally related to:
● approximately
−Removed: $3.2 million increase in development costs, particularly in clinical trial activities and outside professional and consulting fees
−Removed: with respect to EsoCheck, EsoCure and EsoGuard;
+Added: $1.4 million increase in development costs, particularly in clinical trial activities and
+Added: outside professional and consulting fees with respect to EsoCheck, EsoCure and EsoGuard;
● approximately
−Removed: $0.3 million increase in compensation related costs and related to expanded clinical and engineering staff;
+Added: $0.2 million increase in compensation related costs and related to expanded clinical and
+Added: engineering staff;
● approximately
−Removed: $0.4 million increase in the MSA fee allocation from PAVmed related to the growth and expansion of Lucid’s business and the
−Removed: services incurred through PAVmed.
−Removed: our consolidated financial statements as of and for the years ended December 31, 2021 and 2020 for each of:
−Removed: Note 5, Related Party
−Removed: Transactions - PAVmed Inc., for a discussion of the consulting fee expense and stock based compensation expense recognized with respect
−Removed: to the Physician Inventors consulting agreements and stock options and restricted awards;
−Removed: and the MSA between Lucid Diagnostics and PAVmed;
−Removed: and Note 12, Stock-Based Compensation , for information regarding each of the Lucid Diagnostics 2018 Equity Plan and the
+Added: $0.6 million increase in the MSA fee allocation from PAVmed related to the growth and expansion
+Added: of our business and the services incurred through PAVmed.
+Added: our accompanying consolidated financial statements for each of:
+Added: Note 5 , Related Party Transactions, for a discussion of the consulting
+Added: fee expense and stock based compensation expense recognized with respect to the Physician Inventors consulting agreements and stock options
+Added: and restricted stock awards and for a discussion of the MSA between Lucid Diagnostics and PAVmed;
+Added: and Note 14 , Stock-Based Compensation ,
+Added: for information regarding each of the Lucid Diagnostics 2018 Equity Plan and the PAVmed Inc.
2014 Equity Plan.
+Added: of Acquired Intangible Assets
+Added: the year ended December 31, 2022, the amortization of acquired intangible assets was approximately $1.6 million as compared to no intangible
+Added: asset amortization in the prior year.
+Added: The increase was principally related to the purchase of laboratory licenses and certifications
+Added: and laboratory information management software in Q1 2022 and the amortization of a defensive asset.
and Capital Resources
−Removed: & Senior Unsecured Promissory Note Issued to PAVmed Inc.
−Removed: inception, prior to our IPO discussed below, our operations have been funded by PAVmed providing working capital cash advances
−Removed: and the payment by PAVmed of certain operating expenses on-our-behalf.
−Removed: Additionally, our daily operations are managed by personnel employed
−Removed: by PAVmed, for which we incur a MSA Fee expense according to the provisions of the MSA discussed above.
−Removed: of December 31, 2021, we had a Due To:
−Removed: payment obligation liability of an aggregate of approximately $1.6 million
−Removed: payable to reimburse for employee related costs and payments PAVmed Inc.
−Removed: made on behalf of Lucid Diagnostics.
−Removed: our accompanying consolidated financial statements Note 6, Due To PAVmed Inc .
−Removed: October 18, 2021, we completed an initial public offering (“IPO”) of our common stock under an effective registration statement
−Removed: on Form S-1 (SEC File No.
−Removed: 333-259721), wherein a total of 5.0 million shares of our common stock were issued, with such total shares
−Removed: inclusive of 571,428 shares issued to PAVmed, at an IPO price of $14.00 per share, resulting gross proceeds of $70.0 million, before
−Removed: underwriting fees of $4.9 million, and approximately $0.7 million of offering costs incurred by us.
+Added: current operational activities are principally focused on the commercialization of EsoGuard.
+Added: We are expanding commercialization across
+Added: multiple sales channels, including:
+Added: the communication to and education of medical practitioners and clinicians regarding EsoGuard;
+Added: the establishment of Lucid Diagnostics Test Centers for the collection of cell samples using EsoCheck.
+Added: Additionally, we are developing
+Added: expanded clinical evidence to support insurance reimbursement adoption by government and private insurers.
+Added: Further, as resources permit,
+Added: the Company also intends to pursue development of other products and services, including EsoCure, an Esophageal Ablation Device.
+Added: ability to generate revenue depends upon our ability to successfully advance the commercialization of EsoGuard, while also completing
+Added: the clinical studies, product and service development, and necessary regulatory approval thereof.
+Added: There are no assurances, however, we
+Added: will be able to obtain an adequate level of financial resources required for the long-term commercialization and development of our products
+Added: and services.
+Added: to our initial public offering (“IPO”) of our common stock in October 2021, our operations were funded by PAVmed, inclusive
+Added: of providing working capital cash advances and the payment of certain operating expenses on our behalf.
+Added: Additionally, certain of our
+Added: operations continue to be managed by PAVmed personnel, for which we incur expense according to the provisions of a MSA between us and
+Added: See Note 5 , Related Party Transactions, for a discussion of the MSA.
are subject to all of the risks and uncertainties typically faced by medical device and diagnostic companies that devote substantially
1 unchanged sentence
conducting clinical trials.
−Removed: We expect to continue to experience recurring losses from operations and we will continue to fund our operations
−Removed: with debt and/or equity financing transactions.
−Removed: Notwithstanding, however, with the cash on-hand as of the date hereof, of which is inclusive
−Removed: of the cash proceeds resulting from the as a result of our IPO, we expect to be able to fund its future operations for one year from
−Removed: the date of the issue of our consolidated financial statements, as included herein in this Annual Report on Form 10-K
−Removed: for the year ended December 31, 2021.
−Removed: Diagnostics Inc.
−Removed: Committed Equity Facility – Subsequent to December 31, 2021
−Removed: to December 31, 2021, in March 2022, we entered into a committed equity facility with an affiliate of Cantor.
−Removed: Under the terms of the
−Removed: facility, Cantor has committed to purchase up to $50 million in our shares of our common stock from time to time at our request.
−Removed: While there are distinct differences, the facility is structured similarly to a traditional at-the-market equity
−Removed: facility, insofar as it allows the Company to raise primary equity capital on a periodic basis at prices based on the existing market
−Removed: the initial satisfaction of the conditions to Cantor’s obligation to purchase shares under the facility, including that a registration
−Removed: statement registering the resale by Cantor of the Shares under the Securities Act is declared effective by the SEC and a final prospectus
−Removed: relating thereto is filed with the SEC, we will have the right, but not the obligation, from time to time at our sole discretion until
−Removed: the first day of the month next following the expiration of the 36-month period after the effective date of the registration statement,
−Removed: to direct Cantor to purchase shares in accordance with the terms of the facility, by delivering written notice to Cantor prior to the
−Removed: commencement of trading on any trading day, subject to certain maximum amounts.
−Removed: The purchase price of the shares will be 96% of the volume
−Removed: weighted average price of the shares of common stock during the trading date on which we have timely delivered written notice to Cantor
−Removed: directing it to purchase shares under the facility.
−Removed: will not sell, and Cantor will not purchase, any shares pursuant to the facility, if the aggregate number of shares of common stock issued
−Removed: pursuant to the facility would exceed 7,482,763 shares of common stock, unless we obtain approval of our stockholders for the sale of
−Removed: shares in excess of such amount.
−Removed: In addition, we will not sell, and Cantor will not purchase, any shares pursuant to the facility, which,
−Removed: when aggregated with all other shares of common stock then beneficially owned by Cantor and its affiliates, would result in the beneficial
−Removed: ownership by Cantor and its affiliates of more than 4.99% of our outstanding voting power or shares of common stock.
−Removed: connection with the execution of the agreement for the facility, we agreed to pay Cantor $1.0 million as consideration for its irrevocable commitment
−Removed: to purchase the shares upon the terms and subject to the satisfaction of the conditions set forth in such agreement.
−Removed: In addition, pursuant
−Removed: to the agreement, e agreed to reimburse Cantor for certain of its expenses.
−Removed: We also entered into a registration rights agreement with
−Removed: We have the right to terminate the agreement at any time after initial satisfaction of the conditions to Cantor’s obligation
−Removed: to purchase shares under the facility, at no cost or penalty, upon three trading days’ prior written notice.
+Added: We expect to continue to experience recurring losses from operations and will continue to fund our operations
+Added: with debt and equity financing transactions.
+Added: Notwithstanding, however, with our cash on-hand as of the date hereof and committed equity
+Added: sources of financing, the Company expects to be able to fund its operations and meet its financial obligations as they become due for
+Added: the one year period from the date of the issue of the Company’s consolidated financial statements, as included herein in this Form
+Added: Series A Preferred Stock Offering
+Added: On March 7, 2023, we
+Added: entered into subscription agreements for the sale of 13,625 shares of Series A preferred stock (the “ Series A Preferred
+Added: Each share of the Series A Preferred Stock has a stated value of $1,000 and a conversion price of $1.394.
+Added: terms of the Series A Preferred Stock also include a one times preference on liquidation and a right to receive dividends equal to
+Added: 20% of the number of shares into which such Series A Preferred Stock is convertible, payable on the one-year and two-year
+Added: anniversary of the issuance date.
+Added: The Series A Preferred Stock is a non-voting security, other than with respect to limited matters
+Added: related to changes in terms of the Series A Preferred Stock.
+Added: The aggregate gross proceeds from the sale of shares in such offering
+Added: were $13.625 million.
+Added: Private Placement - Securities Purchase Agreement
+Added: Effective as of March 13, 2023,
+Added: we entered into a Securities Purchase Agreement (“SPA”) with an accredited institutional investor (“Investor”,
+Added: “Lender”, and /or “Holder”), pursuant to which we agreed to sell, and the Investor agreed to purchase a Senior
+Added: Secured Convertible Note with a face value principal of $11.1 million (the “March 2023 Senior Convertible Note”).
+Added: issuance of the March 2023 Senior Convertible Note is subject to customary closing conditions.
+Added: The March 2023 Senior Secured
+Added: Convertible Note would have a 7.875% annual stated interest rate, a contractual conversion price of $5.00 per share of the Company’s
+Added: common stock (subject to standard adjustments in the event of any stock split, stock dividend, stock combination, recapitalization or
+Added: other similar transaction), and a contractual maturity date of the two-year anniversary of the date of issuance.
+Added: The March 2023 Senior
+Added: Convertible Note would be convertible into or otherwise paid in shares of the Company’s common stock.
+Added: Under the March 2023 Senior Convertible Note, the Company
+Added: would be subject to certain customary affirmative and negative covenants regarding the incurrence of indebtedness, the existence
+Added: of liens, the repayment of indebtedness and the making of investments, the payment of cash in respect of dividends, distributions or redemptions,
+Added: the transfer of assets, the maturity of other indebtedness, and transactions with affiliates, among other customary matters.
+Added: Under the March 2023 Senior Convertible Note, the Company
+Added: would also be subject to financial covenants requiring that (i) the amount of our available cash equal or exceed $5.0 million
+Added: at all times, (ii) the ratio of (a) the outstanding principal amount of the notes issued under the SPA, accrued and unpaid interest thereon
+Added: and accrued and unpaid late charges to (b) the Company’s average market capitalization over the prior ten trading days, not exceed
+Added: 30%, and (iii) that the Company’s market capitalization shall at no time be less than an amount to be agreed upon.
+Added: Committed Equity Facility and ATM Facility
+Added: In March 2022, we entered into
+Added: a committed equity facility with Cantor.
+Added: Under the terms of the committed equity facility, Cantor has committed to purchase up to $50
+Added: million of our common stock from time to time at our request.
+Added: While there are distinct differences, the committed equity facility is structured
+Added: similarly to a traditional at-the-market equity facility, insofar as it allows us to raise primary equity capital on a periodic basis
+Added: at prices based on the existing market price.
+Added: As of December 31, 2022, under the committed equity facility, a total of 680,263 shares
+Added: of common stock of the Company were issued for proceeds of approximately $1.8 million.
+Added: In November 2022, Lucid Diagnostics also entered into an “at-the-market
+Added: offering” for up to $6.5 million of its common stock that may be offered and sold under a Controlled Equity Offering Agreement between
+Added: Lucid Diagnostics and Cantor Fitzgerald & Co.
+Added: In the year ended December 31, 2022, there were no shares sold through their at-the-market
+Added: equity facility.
+Added: Subsequent to December 31, 2022, through March 9, 2023, Lucid Diagnostics sold 230,068 shares through its at-the-market
+Added: equity facility for approximately $0.3 million.
+Added: our inception in May 2018 through our IPO in October 2021, our operations were funded by PAVmed providing working capital cash advances
+Added: and the payment by PAVmed of certain operating expenses on our behalf.
+Added: Additionally, our daily operations have been and continue to be
+Added: principally managed by personnel employed by PAVmed, for which we incur a MSA Fee expense.
+Added: The MSA Fee is charged on a monthly basis
+Added: and is subject-to periodic adjustment corresponding with changes in the services provided by PAVmed Inc.
+Added: personnel to the Company, with
+Added: any such change in the MSA Fee being subject to approval of the Lucid Diagnostics Inc.
+Added: and PAVmed Inc.
+Added: boards of directors.
+Added: In this regard,
+Added: in August 2022, the boards of directors of Lucid Diagnostics Inc.
+Added: and PAVmed Inc.
+Added: approved a sixth amendment to the MSA to increase the
+Added: MSA Fee to $550 per month from $390 per month, with such increase effective on a prospective basis commencing July 1, 2022.
+Added: to the sixth amendment, the parties agreed PAVmed Inc.
+Added: may elect to receive payment of the monthly MSA Fee in cash or in shares of our
+Added: common stock, with such shares valued at the volume weighted average price (“VWAP”) during the final ten trading days of
+Added: the applicable month (subject to a floor price of $0.70 per share).
+Added: However, in no event will PAVmed Inc.
+Added: be entitled to receive under
+Added: the MSA, as amended, more than 7,709,836 shares of our common stock (representing 19.99% of our outstanding shares of common stock as
+Added: of immediately prior to the execution of the sixth amendment).
+Added: The shares that may be issued under the MSA, as amended, are being offered
+Added: and sold in transactions exempt from registration under the Securities Act of 1933, as amended, in reliance on the exemption afforded
+Added: under Section 4(a)(2) thereof.
+Added: accordance with the MSA, on November 30, 2022 PAVmed has elected to receive payment of $1.65 million in aggregated monthly fees under
+Added: the MSA through the issuance of 750,818 shares of Lucid Diagnostics Inc.
+Added: Common Stock.
+Added: November 30, 2022, the Company and PAVmed entered into a payroll and benefit expense reimbursement agreement (the “PBERA”).
+Added: Historically, PAVmed has paid for certain payroll and benefit-related expenses in respect of the Company’s personnel on behalf
+Added: of the Company, and the Company has reimbursed PAVmed for the same.
+Added: Pursuant to the PBERA, PAVmed will continue to pay such expenses,
+Added: and the Company will continue to reimburse PAVmed for the same.
+Added: The PBERA now provides that the expenses will be reimbursed on a quarterly
+Added: basis or at such other frequency as the parties may determine, in cash or, subject to approval by the board of directors of each of PAVmed
+Added: and the Company, in shares of the Company’s common stock, with such shares valued at the volume weighted average price of such
+Added: stock during the final ten trading days preceding the later of the two dates on which such stock issuance is approved by the board of
+Added: directors of each of PAVmed and the Company (subject to a floor price of $0.40 per share), or in a combination of cash and shares.
+Added: in no event shall the Company issue any shares of its common stock to PAVmed in satisfaction of all or any portion of the expenses if
+Added: the issuance of such shares of its common stock would exceed the maximum number of shares of common stock that the Issuer may issue under
+Added: the rules or regulations of The Nasdaq Stock Market LLC (“Nasdaq”), unless the Company obtains the approval of its stockholders
+Added: as required by the applicable rules of the Nasdaq for issuances of shares of its common stock in excess of such amount.
+Added: In accordance
+Added: with the PBERA, on November 30, 2022, PAVmed elected for the Company to reimburse PAVmed for $2.7 million in accrued and unreimbursed
+Added: payroll and benefit-related expenses paid by PAVmed on behalf of the Company through the third quarter of 2022 through the issuance of
+Added: 1,479,326 shares of the Company’s common stock.
+Added: previously disclosed, on October 5, 2021, PAVmed Subsidiary Corp., a wholly owned subsidiary of PAVmed (“PAVmed Sub”), acquired
+Added: 100% of the outstanding membership interest of CapNostics, LLC from a third party, for a purchase price of approximately $2.1 million.
+Added: Also as previously disclosed, effective as of April 1, 2022, pursuant to an assignment agreement (as amended and supplemented to date,
+Added: the “CapNostics Assignment Agreement”) between PAVmed Sub and the Company, PAVmed Sub assigned the interests to the Company
+Added: and, in consideration for the interests, the Company agreed to pay to PAVmed Sub an amount in cash equal to the purchase price paid by
+Added: PAVmed Sub to the third party.
+Added: On November 30, 2022, pursuant to a supplement to the CapNostics Assignment Agreement, the Company, PAVmed
+Added: Sub and PAVmed agreed that the Company would pay the price for the interests through the issuance to PAVmed of 1,145,086 shares of the
+Added: Company’s common stock.
+Added: of December 31, 2022, we had a Due To:
+Added: payment obligation liability of an aggregate of approximately $5.0 million payable
+Added: for the reimbursement of employee related costs and certain operating expenses paid by PAVmed on our behalf.
+Added: See our accompanying consolidated
+Added: financial statements Note 6 , Due To PAVmed Inc.
Accounting Policies and Significant Judgments and Estimates
13 unchanged sentences
financial statements.
−Removed: Company recognizes revenue under the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification
−Removed: (“ASC”) Topic 606, Revenue from Contracts with Customers , (“ASC 606”).
−Removed: At its inception, an arrangement
−Removed: is accounted for under the provisions of ASC 606 as a contract with a customer when there is:
−Removed: a legally enforceable contract between
−Removed: the rights of the parties are identified;
−Removed: the arrangement has commercial substance;
−Removed: and collectability of the contract consideration
−Removed: is deemed probable.
−Removed: To determine revenue recognition for arrangements determined to be within the scope of ASC 606, the Company performs
−Removed: the following five steps:
−Removed: (i) identify the contract(s) with a customer;
−Removed: (ii) identify the performance obligations in the contract;
−Removed: determine the transaction price;
−Removed: (iv) allocate the transaction price to the performance obligations in the contract;
−Removed: and (v) recognize
−Removed: revenue when (or as) the entity satisfies a performance obligation.
and Development Expenses
7 unchanged sentences
2014 Equity Plan.
−Removed: grant-date estimated fair value of the stock-based
−Removed: award is recognized on a straight-line basis over the requisite service period, which is generally the vesting period of the respective
−Removed: stock-based award, with such straight-line recognition adjusted, as applicable, so the cumulative expense recognized is at-least equal-to-or-greater-than
−Removed: the estimated fair value of the vested portion of the respective stock-based award as of the reporting date.
+Added: grant-date estimated fair value of the stock-based award is recognized on a straight-line basis over the requisite service period, which
+Added: is generally the vesting period of the respective stock-based award, with such straight-line recognition adjusted, as applicable, so
+Added: the cumulative expense recognized is at-least equal-to-or-greater-than the estimated fair value of the vested portion of the respective
+Added: stock-based award as of the reporting date.
Company uses the Black-Scholes valuation model to estimate the fair value of stock options granted under both the PAVmed Inc.
3 unchanged sentences
respect to the PAVmed Inc.
−Removed: 2014 Equity Plan, the expected stock price volatility is based on the historical stock price volatility
−Removed: of PAVmed Inc.
−Removed: common stock and the volatilities of similar entities within the medical device industry over the period commensurate
−Removed: with the expected term with respect to stock options granted to the board of directors and employees in the years ended December
−Removed: 31, 2021 and 2020;
+Added: 2014 Equity Plan, the expected stock price volatility is based
+Added: on the historical stock price volatility of PAVmed Inc.
+Added: common stock and the volatilities
+Added: of similar entities within the medical device industry over the period commensurate with
+Added: the expected term with respect to stock options granted to the board of directors and employees
+Added: in the years ended December 31, 2022 and 2021;
respect to stock options granted under the Lucid Diagnostics Inc.
−Removed: 2018 Equity Plan, the expected stock price volatility was based
−Removed: on the historical stock price volatility of similar entities within the medical device industry over the period commensurate with
−Removed: the expected term with respect to stock options granted to employees in the year ended December 31, 2021;
−Removed: There were no stock options
−Removed: granted under the Lucid Diagnostics Inc.
−Removed: 2018 Equity Plan in the year ended December 31, 2020;
+Added: 2018 Equity Plan, the expected
+Added: stock price volatility was based on the historical stock price volatility of similar entities
+Added: within the medical device industry over the period commensurate with the expected term with
+Added: respect to stock options granted to employees in the years ended December 31, 2022 and 2021;
risk-free interest rate is based on the interest rate payable on U.S.
−Removed: Treasury securities in effect at the time of grant for a period
−Removed: commensurate with either the expected term or the remaining contractual term, as applicable, of the stock option;
−Removed: expected dividend yield is based on annual dividends of $0.00 as there have not been dividends paid to-date, and there is no plan
−Removed: to pay dividends for the foreseeable future.
−Removed: price per share of PAVmed Inc.
−Removed: common stock used in the computation of estimated fair value of stock options and restricted stock
−Removed: awards granted under the PAVmed Inc.
−Removed: 2014 Equity Plan is its quoted closing price per share.
+Added: Treasury securities
+Added: in effect at the time of grant for a period commensurate with either the expected term or
+Added: the remaining contractual term, as applicable, of the stock option;
+Added: expected dividend yield is based on annual dividends of $0.00 as there have not been dividends
+Added: paid to-date, and there is no plan to pay dividends for the foreseeable future.
price per share of Lucid Diagnostics Inc.
7 unchanged sentences
various exit scenarios and an estimation of the return to the common stockholders under each scenario.
−Removed: and (iii) as of December 31, 2020,
−Removed: it was estimated using a discounted cash flow analysis applied to a multi-year forecast of its future cash flows.
−Removed: Company adopted FASB ASC Topic 842, Leases , (“ASC 842”) effective December 31, 2021, with such adoption not having
−Removed: an effect on the Company’s consolidated financial statements.
−Removed: All significant lease agreements and contractual agreements with
−Removed: embedded lease agreements are accounted for under the provisions of ASC 842, wherein, if the contractual arrangement:
−Removed: involves the use
−Removed: of a distinct identified asset;
−Removed: provides for the right to substantially all the economic benefits from the use of the asset throughout
−Removed: the contractual period;
−Removed: and, provides for the right to direct the use of the asset.
−Removed: A lease agreement is accounted for as either a finance
−Removed: lease (generally with respect real estate) or an operating lease (generally with respect to equipment).
−Removed: Under both a finance lease and
−Removed: an operating lease, the Company recognizes as of the lease commencement date a lease right-of-use (“ROU”) asset and a corresponding
−Removed: lease payment liability.
−Removed: lease ROU asset represents the Company’s right to use an underlying asset for the lease term, and the lease liability represents
−Removed: its contractual obligation to make lease payments.
−Removed: The lease ROU asset is measured at the lease commencement date as the present value
−Removed: of the future lease payments plus initial direct costs incurred.
−Removed: The Company recognizes lease expense of the amortization of the lease
−Removed: ROU asset for an operating lease on a straight-line basis over the lease term;
−Removed: and for financing leases on a straight-line basis unless
−Removed: another basis is more representative of the pattern of economic benefit.
−Removed: The lease liability is measured at the lease commencement date
−Removed: with the discount rate generally based on the Company’s incremental borrowing rate (to the extent the lease implicit rate is not
−Removed: known nor determinable), with interest expense recognized using the interest method for financing leases.
−Removed: Company accounts for income taxes using the asset and liability method, as required by FASB ASC Topic 740, Income Taxes, (ASC 740).
−Removed: tax liabilities or receivables are recognized for estimated income tax payable and/or refundable for the current year.
−Removed: Deferred tax assets
−Removed: and deferred tax liabilities are recognized for estimated future tax consequences attributable to differences between the financial statement
−Removed: carrying amounts of existing assets and liabilities and their respective tax basis, along with net operating loss and tax credit carryforwards.
−Removed: Deferred tax assets and deferred tax liabilities are measured using enacted tax rates expected to apply to taxable income in the years
−Removed: in which those temporary differences are expected to be recovered or settled.
−Removed: Changes in deferred tax assets and deferred tax liabilities
−Removed: are recorded in the provision for income taxes.
−Removed: ASC 740, a “more-likely-than-not” criterion is applied when assessing the estimated realization of deferred tax assets through
−Removed: their utilization to reduce future taxable income, or with respect to a deferred tax asset for tax credit carryforward, to reduce future
−Removed: A valuation allowance is established, when necessary, to reduce deferred tax assets, net of deferred tax liabilities, when
−Removed: the assessment indicates it is more-likely-than-not, the full or partial amount of the net deferred tax asset will not be realized.
−Removed: a result of the evaluation of the positive and negative evidence bearing upon the estimated realizability of net deferred tax assets,
−Removed: and based on a history of operating losses, it is more-likely-than-not the deferred tax assets will not be realized, and therefore a
−Removed: valuation allowance reserve equal to the full amount of the deferred tax assets, net of deferred tax liabilities, has been recognized
−Removed: as a charge to income tax expense as of December 31, 2021 and December 31, 2020.
−Removed: Company recognizes the benefit of an uncertain tax position it has taken or expects to take on its income tax return if such a position
−Removed: is more-likely-than-not to be sustained upon examination by the taxing authorities, with the tax benefit recognized being the largest
−Removed: amount having a greater than 50% likelihood of being realized upon ultimate settlement.
−Removed: As of December 31, 2021, the Company does not
−Removed: have any unrecognized tax benefits resulting from uncertain tax positions.
−Removed: Company’s policy is to record interest and penalties related to income taxes as part of its income tax provision.
−Removed: There were no
−Removed: amounts accrued for penalties or interest as of December 31, 2021 and December 31, 2020 or recognized during the year ended December
−Removed: 31, 2021 and December 31, 2020.
−Removed: The Company is not aware of any issues under review to potentially result in significant payments, accruals,
−Removed: or material deviations from its position.
−Removed: October 14, 2021, Lucid Diagnostics Inc.
−Removed: completed its initial public offering (“IPO”) of its common stock.
−Removed: holds a majority-interest equity ownership and has a controlling financial interest, its ownership interest was reduced from 81.8477%
−Removed: before the IPO to 79.9796% after the IPO.
−Removed: Accordingly, Lucid Diagnostics Inc.
−Removed: is included in the PAVmed Inc and Subsidiaries
−Removed: consolidated income tax returns through October 13, 2021, and effective October 14, 2021, Lucid Diagnostics Inc.
−Removed: its income tax returns on a stand-alone legal entity basis.
−Removed: The Lucid Diagnostics Inc.
−Removed: stand-alone legal entity estimated income
−Removed: tax provision was computed on an assumed separate income tax return for the periods presented through October 13, 2021, wherein,
−Removed: the estimated income tax provision of Lucid Diagnostics Inc.
−Removed: is computed as if its income tax returns were filed by Lucid Diagnostics
−Removed: on a stand-alone legal entity basis.
−Removed: Notwithstanding the absence of a formal tax sharing agreement between PAVmed Inc.
−Removed: Diagnostics Inc., the Lucid Diagnostics Inc.
−Removed: stand-alone legal entity current tax expense and /or tax refund, if any, would be settled
−Removed: with PAVmed Inc.
−Removed: (as opposed with the respective tax authority) through October 13, 2021.
−Removed: The deferred tax asset and /or deferred
−Removed: tax liability;
−Removed: a valuation allowance on the deferred tax asset, net;
−Removed: and /or an uncertain tax position, if any;
−Removed: each as discussed above,
−Removed: is determined based on Lucid Diagnostics Inc.
−Removed: stand-alone legal entity assumed filing of separate income tax returns.
+Added: price per share of PAVmed Inc.
+Added: common stock used in the computation of estimated fair value of stock options and restricted stock awards
+Added: granted under the PAVmed Inc.
+Added: 2014 Equity Plan is its quoted closing price per share.
Accounting Standards Updates Adopted
22 unchanged sentences
ASU 2019-12 guidance as of January 1, 2021 did not have an effect on the Company’s consolidated financial statements.
−Removed: Act EGC Accounting Election
−Removed: Company is an “emerging growth company” or “EGC”, as defined in the Jumpstart Our Business Startups Act of 2012
−Removed: (the “JOBS Act”).
−Removed: Under the JOBS Act, an EGC can delay adopting new or revised accounting standards issued after the enactment
−Removed: of the JOBS Act until such time as those standards apply to private companies.
−Removed: The Company has irrevocably elected to avail itself of
−Removed: this exemption from new or revised accounting standards, and, therefore, will not be subject to the same new or revised accounting standards
−Removed: as public companies who are not an EGC.
+Added: December 31, 2021, the Company adopted FASB ASC Topic 842, Leases, (“ASC 842”).
+Added: ASC 842 established a right-of-use (“ROU”)
+Added: model requiring a lessee to recognize a ROU asset and a lease liability for all leases with terms greater-than 12 months.
+Added: classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement.
+Added: The Company’s adoption of ASC 842 did not have an effect on the Company’s consolidated financial statements.
+Added: sheet arrangements
+Added: do not have any off-balance sheet arrangements.
Quantitative and Qualitative Disclosure About Market Risk
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.