Item 2. Management’s Discussion and Analysis
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
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”).
Unless the context otherwise requires, references herein to “we”, “us”,
and “our”, and to the “Company” or “PAVmed” are to PAVmed Inc. and Subsidiaries, including each of
the PAVmed Inc. and its majority-owned subsidiaries, including: Lucid Diagnostics Inc. (“Lucid Diagnostics” or “LUCID”),
Veris Health Inc. (“Veris Health” or “VERIS”), and Solys Diagnostics, Inc. (“Solys Diagnostics” or
“SOLYS”).
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;
●
the
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;
●
our
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.
25
Overview
The
Company is a highly differentiated, multi-product, commercial-stage medical technology company organized to advance a broad pipeline
of innovative medical technologies from concept to commercialization, employing a business model focused on capital efficiency and speed
to market. Since the Company’s inception of PAVmed Inc. on June 26, 2014, its activities have focused on advancing
its lead products towards regulatory approval and commercialization, protecting its intellectual property, and building its corporate
infrastructure and management team. The Company has ongoing operations conducted through PAVmed Inc. and its majority-owned subsidiaries.
The
Company operates in one segment as a medical technology company, with the following lines-of-business: “Medical Devices”,
“Diagnostics”, “Digital Health”, and “Emerging Innovations”.
Our products, services, and
opportunities, as discussed herein and in Item 1 of Part I of the Form 10-K under the heading Business Background and Overview, are as
follows:
●
Diagnostics - EsoGuard Esophageal DNA Laboratory Developed Test,
EsoCheck Esophageal Cell Collection Device, and EsoCure Esophageal Ablation Device with Caldus Technology;
●
Medical Devices - CarpX Minimally Invasive Surgical Device for Carpal
Tunnel Syndrome; Infusion Therapy - PortIO Implantable Intraosseous Vascular Access Device and NextFlo Highly Accurate Disposable
Intravenous Infusion Platform Technology;
●
Digital Health - Veris cancer healthcare platform and implantable
intelligent vascular port combining remote monitoring and data analytics;
●
Emerging Innovations -Include a diversified and expanding portfolio
of innovative products designed to address unmet clinical needs across a broad range of clinical conditions. We are evaluating a
number of these product opportunities and intellectual property covering a wide spectrum of clinical conditions, which have either
been developed internally or have been presented to us by clinician innovators and academic medical institutions for consideration
of a partnership to develop and commercialize these products.
Our
multiple products and services are in various phases of development, regulatory clearances, approvals, and commercialization.
●
The
EsoCheck device received 510(k) marketing clearance from the U.S. Food and Drug Administration (“FDA”), in June 2019 and
European CE Mark Certification in May 2021 as an esophageal cell collection device; and, EsoGuard has been established as a
Laboratory Developed Test (“LDT”), completed European CE Mark Certification in June 2021, and was launched commercially
in December 2019 after Clinical Laboratory Improvement Amendment (“CLIA”) and College of American Pathologists
(“CAP”) accreditation of the test at Lucid Diagnostics commercial diagnostic laboratory partner ResearchDx Inc.
(“RDx”), headquartered in Irvine, California. On February 25, 2022, Lucid Diagnostics’ wholly owned subsidiary,
LucidDx Labs Inc. (“LucidDx Labs”) acquired from RDx certain licenses and other related assets necessary for LucidDx
Labs to operate its own new CLIA-certified, CAP-accredited clinical laboratory located in Lake Forest, CA. In August 2021, Lucid
Diagnostics launched a strategic partnership with direct-to-consumer telemedicine company UpScriptHealth to support our
commercialization efforts. Also in August 2021, we tested our first patients referred by primary care physicians
(“PCPs”) in our initial Lucid Test Centers opened in the Phoenix metropolitan area. We have since expanded our Lucid
Test Centers into six additional cities expanding from its origin in the Southwest United States and stretching to the
Northwest.
26
Overview - continued
●
In
connection with our efforts to expand our presence in the diagnostic market, we are 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. We have successfully completed a pre-clinical feasibility
animal study of EsoCure demonstrating excellent, controlled circumferential ablation of the esophageal mucosal lining. We have also
completed an acute and survival animal study of EsoCure™ Esophageal Ablation Device, 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.
●
CarpX is a minimally invasive surgical device for use
in the treatment of carpal tunnel syndrome which received FDA 510(k) marketing clearance in April 2020, with the first commercial
procedure successfully performed in December 2020. After an initial slowdown in commercialization related to COVID, more recently
we have recruited new sales leadership and have recently trained eight new surgeons to perform the CarpX procedure with four more
scheduled to undergo training in the coming months. Our limited-release commercialization efforts thru 2022 are focused on engaging
key opinion hand surgeons designed to solicit input for ergonomic improvements to the device, procedure development and surgical-time
optimization, and ease of use. Concurrently, we are presently working on improvements to the device that will be released in stages
over the next several quarters
●
We believe CarpX is designed to allow the physician
to relieve the compression on the median nerve without an open incision or the need for endoscopic or other imaging equipment. To
use CarpX, the operator first advances a guidewire through the carpal tunnel under the ligament, and then advanced over the wire
and positioned in the carpal tunnel under ultrasonic and/or fluoroscopic guidance. When the CarpX balloon is inflated it creates
tension in the ligament positioning the cutting electrodes underneath it and creates space within the tunnel, providing anatomic
separation between the target ligament and critical structures such as the median nerve. Radiofrequency energy is briefly delivered
to the electrodes, rapidly cutting the ligament, and relieving the pressure on the nerve. We believe CarpX will be significantly
less invasive than existing treatments .
●
In
May 2021, we formed Veris Health, and concurrently, acquired Oncodisc Inc (“Oncodisc”), a digital health company
with ground breaking tools to improve personalized cancer care through remote patient monitoring. Oncodisc’s core technologies
include the first intelligent implantable vascular healthcare platform that provides patients and physicians with new tools to improve
outcomes and optimize the delivery of cost-effective care through remote monitoring and data analytics. Its vascular access port
contains biologic sensors capable of generating continuous data on key physiologic parameters known to predict adverse outcomes in
cancer patients undergoing treatment. Wireless communication to the patient’s smartphone and its cloud-based digital healthcare
platform efficiently and effectively delivers actionable real time data to patients and physicians. The technologies are the subject
of multiple patent applications and one allowed patent awaiting final issuance.
●
Our other products in development have not yet received
clearance or approval to be marketed or sold in the U.S. or elsewhere
27
Overview
- continued
Financing
Subsequent
to March 31, 2022, on April 4, 2022, the Company
entered into a Senior Secured Convertible Note in the amount of $27.5 million, pursuant to a Securities Purchase Agreement
(“SPA”) executed in March 2022 with an accredited institutional investor (“investor”). Under the SPA,
the Company agreed to sell, and the investor agreed to purchase, up to an additional $22.5 million initial principal amount of
Senior Secured Convertible Notes (for an aggregate of $50.0 million in initial principal) upon the satisfaction of certain
conditions. The purchase price of the Secured Promissory Notes is $1,000 for each $1,100 in principal amount of the notes, representing
an original issue discount of $100 per $1,100 in principal amount of the notes. A further discussion of the SPA dated, March 31,
2022, can be found herein below under Liquidity and Capital Resources - PAVmed Inc - Private Placement - Securities Purchase
Agreement .
In March 2022, Lucid Diagnostics,
Inc. entered into a committed equity facility with an affiliate of Cantor Fitzgerald (“Cantor”). Under the terms of
the facility, Cantor has committed to purchase up to $50 million of Lucid Diagnostics Inc. common stock from time to time at the request
of Lucid Diagnostics Inc. While there are distinct differences, the facility is structured similarly to a traditional at-the-market equity
facility, insofar as it allows Lucid Diagnostics Inc. to raise primary capital on a periodic basis at prices based on the existing market
price.
Impact
of SARS-CoV-2 - COVID-19 Pandemic
Previously,
in December 2019, there was an outbreak of a novel strain of a coronavirus occurred, with such coronavirus designated by the United
Nations (UN) World Health Organization (“WHO”) as the “Severe Acute Respiratory Syndrome Coronavirus 2” - or
“SARS-CoV-2”. The SARS-CoV-2 spread on a global basis to other countries, including the United States. On March 11,
2020, the WHO declared a pandemic resulting from SARS-CoV-2, with such pandemic commonly referred to by its resulting illness of coronavirus
disease 2019, or “COVID-19”. The COVID-19 pandemic is ongoing, and we continue to monitor the ongoing impact of the COVID-19
pandemic on the United States national economy, the global economy, and our business.
The
COVID-19 pandemic may have an adverse impact on our operations, supply chains, and distribution systems and /or those of our contractors
of our laboratory partner, and increase our expenses, including as a result of impacts associated with preventive and precautionary measures
being taken, restrictions on travel, quarantine polices, and social distancing. Such adverse impact may include, for example, the inability
of our employees and /or those of our contractors or laboratory partner to perform their work or curtail their services provided to us.
We
expect the significance of the COVID-19 pandemic, including the extent of its effect on our consolidated financial condition and consolidated
operational results and cash flows, to be dictated by the success of United States and global efforts to mitigate the spread of and /or
to contain the SARS-CoV-2 and the impact of such efforts.
In
addition, the spread of the SARS-CoV-2 has disrupted the United States’ healthcare and healthcare regulatory systems which could
divert healthcare resources away from, or materially delay United States Food and Drug Administration (“FDA”) approval with
respect to our products.
Furthermore,
our clinical trials have been and may be further affected by the COVID-19 pandemic, as site initiation and patient enrollment may be
delayed, for example, due to prioritization of hospital resources toward the virus and /or illness response, as well as travel restrictions
imposed by governments, and the inability to access clinical test sites for initiation and monitoring.
The
COVID-19 pandemic may have an adverse impact on the economies and financial markets of many countries, including the United States, resulting
in an economic downturn that could adversely affect demand for our products and services and /or our product candidates.
Although
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
(or a similar health epidemic) is highly uncertain and subject to change, and therefore, its impact on our consolidated financial condition,
consolidated results of operations, and /or consolidated cash flows, the adverse impact could be material.
28
Results
of Operations
Overview
Revenue
Revenue
was recognized with respect to the EsoGuard Commercialization Agreement, dated August 1, 2021, between the Company’s majority-owned
subsidiary, Lucid Diagnostics Inc., 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 LucidDx Labs Inc., a wholly-owned subsidiary of Lucid Diagnostics 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; employee related costs of 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 salaries and related costs for employees engaged in sales and marketing activities, 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 salaries and related costs for personnel, travel expenses, facility-related costs, professional
fees, accounting and legal services, employees involved in third-party payor reimbursement contract negotiations and consultants and
expenses associated with obtaining and maintaining patents within our intellectual property portfolio.
We
anticipate our general and administrative expenses will increase in the future, as we anticipate an increase in payroll and related expenses
related with the growth and expansion of our business operations objectives. We also anticipate continued expenses related to being a
public company, including audit, legal, regulatory, and tax-related services associated with maintaining compliance as a public company,
insurance premiums and investor relations costs.
29
Results of Operations - continued
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 research and development of our products, including:
●
consulting
costs charged to us by various external contract research organizations we contract with to conduct preclinical studies and engineering
studies;
●
salary
and benefit costs associated with our chief medical officer and engineering personnel;
●
costs
associated with regulatory filings;
●
patent
license fees;
●
cost
of laboratory supplies and acquiring, developing, and manufacturing preclinical prototypes;
●
product
design engineering studies; and
●
rental
expense for facilities maintained solely for research and development purposes.
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 CarpX, EsoCheck and EsoGuard, along with advancing
our PortIO and NextFlo products, our Digital Health product, and two of our Emerging Innovation product candidates through
their respective development phase, including our DisappEAR reabsorable ear tubes product and a non-invasive glucose monitoring product.
Other
Income and Expense, net
Other
income and expense, net, consists principally of changes in fair value of our contingent consideration and our convertible notes
and losses on extinguishment of debt upon repayment of such convertible notes.
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.
30
Three
months ended March 31, 2022 as
compared to three months ended March 31, 2021
Revenue
In
the three months ended March 31, 2022, revenue was $0.2 million as compared to no revenue in the corresponding period in the prior year.
The $0.2 million relates to our EsoGuard Commercialization Agreement, dated August 1, 2021, which resulted in revenue recognition of
$0.1 million per month beginning August 2021 - through the February 25, 2022 termination date of such agreement.
Cost
of revenue
In
the three months ended March 31, 2022, cost of revenue was approximately $0.4 million as 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 three months ended March 31, 2022, sales and marketing costs were approximately $3.9 million, compared to $1.4 million for the corresponding
period in the prior year. The net increase of $2.5 million was principally related to:
●
approximately
$1.6 million increase in compensation related costs principally related to an increase in headcount and severance expense incurred
for 2 former employees;
●
approximately
$0.4 million increase in stock based compensation from RSA grants to Lucid and PAVmed employees and non-employees, and an increase
in stock options granted corresponding with the increase in the number of employees; and
●
approximately
$0.5 million increase in outside professional services related to EsoCheck, EsoGuard and consulting and professional services fees.
General
and administrative expenses
In
the three months ended March 31, 2022, general and administrative costs were approximately $9.4 million, compared to $3.4 million for
the corresponding period in the prior year. The net increase of $6.0 million was principally related to:
●
approximately
$1.1 million increase in compensation related costs principally related to an increase in headcount;
●
approximately
$1.8 million increase in stock based compensation from RSA grants to Lucid and PAVmed employees and non-employees, and an increase
in stock options granted corresponding with the increase in the number of employees; and
●
approximately
$2.3 million 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; and
●
approximately
$0.8 million in general business expenses.
Research
and development expenses
In
the three months ended March 31, 2022, research and development costs were approximately $5.9 million as compared to $3.3 million for
the corresponding period in the prior year. The net increase $2.6 million was principally related to:
●
approximately
$2.1 million increase in development costs, particularly in clinical trial activities and outside professional and consulting fees
with respect to EsoCheck, EsoCure, CarpX, NextFlo, Port IO, our Digital Health product, and one of our Emerging Innovation product
candidates (the non-invasive glucose monitoring product); and
●
approximately
$0.5 million increase in compensation related costs and related to expanded clinical and engineering staff.
31
Three months ended March 31, 2022 as compared
to three months ended March 31, 2021 - continued
Other
Income and Expense
Change
in fair value of convertible debt
In
the three months ended March 31, 2021, the non-cash income (expense) recognized for the change in the fair value of our convertible notes
was approximately $1.7 million. The change in the fair value adjustment of the convertible notes is principally related to each of the
convertible notes being repaid-in-full during the three months ended March 31, 2021, as discussed herein below under “Other Income
and Expense - Loss from Extinguishment of Debt”.
Loss
from Extinguishment of Debt
In
the three months ended March 31, 2021, a debt extinguishment loss in the aggregate of approximately $3.7 million was recognized in connection
with the convertible notes, as discussed below.
●
On
January 5, 2021, the repayment of the remaining face value principal of the November 2019 Senior Convertible Note, along with
the payment of interest thereon, of approximately $1.0 million, were settled with the issuance of 667,668 shares of
our common stock, with a fair value of approximately $1,7 million (with such fair value measured as the respective conversion
date quoted closing price of our common stock), resulting in the recognition of a loss from extinguishment of debt of approximately
$0.8 million in the six months ended June 30, 2021; and,
●
On
January 30, 2021, we paid in cash a $350 partial principal repayment of the Senior Convertible Note dated April 30, 2020 (“April
2020 Senior Convertible Note”); and on March 2, 2021, we made a cash payment of approximately $14,466, resulting in the repayment-in-full
on such date of both the April 2020 Senior Convertible Note and the Senior Secured Convertible Note dated August 6, 2021, resulting
in the recognition of a loss from extinguishment of debt of approximately $2,955 in the six months ended June 30, 2021.
See
our unaudited condensed consolidated financial statements Note 12 , Debt , for additional information with respect
to the convertible notes.
32
Liquidity
and Capital Resources
We
have financed our operations principally through the public and private issuances of our common stock, preferred stock, common stock
purchase warrants, and debt. We are subject to all of the risks and uncertainties typically faced by medical device and diagnostic and
medical device companies that devote substantially all of their efforts to the commercialization of their initial product and services
and ongoing R&D and clinical trials. We expect to continue to experience recurring losses from operations, and will continue to fund
our operations with debt and/or equity financing transactions. Notwithstanding, however, with the cash on-hand as of March 31, 2022,
we expect to be able to fund our future operations for one year from the date of the issue of our unaudited condensed consolidated financial
statements, as included in this Quarterly Report on Form 10-Q for the period ended March 31, 2022.
Common
Stock Transactions
During
the three months ended March 31, 2022:
●
We
issued 237,499 shares of our common stock
for cash proceeds of approximately $241 upon exercise of stock options granted under the PAVmed Inc 2014 Equity Plan,
as such equity plan is discussed in Note 13, Stock-Based Compensation , of our unaudited condensed consolidated
financial statements.
●
We
issued 194,240 shares of our common stock under the
PAVmed Inc. Employee Stock Purchase Plan (“ESPP”), as such ESPP is discussed in Note 13, Stock-Based Compensation ,
of our unaudited condensed consolidated financial statements.
Debt
Transactions
Subsequent
to March 31, 2022, on April 4, 2022, the Company entered into a Senior Secured Convertible Note in the amount of
$27.5 million, pursuant to the SPA with an accredited institutional investor. Under the SPA, the Company agreed to sell, and the
investor agreed to purchase, up to an additional $22.5 in additional initial principal amount of Senior Secured Convertible Notes
(for an aggregate of $50.0 million in initial principal amount of Secured Promissory Notes) upon the satisfaction of certain
conditions (as more fully described below). The notes are being offered and sold in a registered direct offering under the
Company’s effective shelf registration statement (the “Offering”). The purchase price of the Secured Promissory
Notes is $1,000 for each $1,100 in principal amount of the notes, representing an original issue discount of $100 per $1,100 in
principal amount of the notes. We herein refer to the Senior Secured Convertible Notes issued or issuable under the SPA as March
2022 Notes.
Pursuant
to the SPA we completed an initial closing for the sale of $27.5 million in principal amount of March 2022 Notes, of which the
investor funded and the Company received cash proceeds of $24.9 million on April 5, 2022, after deduction of lender fees. Subject
to certain conditions being met or waived, from time to time after such time stockholder approval for an increase in our authorized shares
from 150 million to 250 million is obtained, but before March 31, 2024, one or more additional closings for up to the remaining principal
amount of March 2022 Notes may occur, upon five trading days’ notice by us to the investor. The aggregate principal amount of March
2022 Notes that may be offered in the additional closings may not be more than $22.5 million. The investor’s obligation to purchase
the notes at each additional closing is subject to certain conditions set forth in the March 2022 SPA (including minimum price and volume
thresholds, maximum ratio of debt to market capitalization, and minimum market capitalization), which may be waived by the Required Holders
(as defined in the March 2022 SPA). Under the March 2022 SPA, the investor will be required to purchase March 2022 Notes in the additional
closings if such conditions are met or waived. In addition, from and after March 31, 2023, the investor may by written notice to us elect
to require us to issue up to $22.5 million in initial principal amount of March 2022 Notes, so long as in doing so it would not cause
the ratio of (a) the outstanding principal amount of the March 2022 Notes (including the additional March 2022 Notes), accrued and unpaid
interest thereon and accrued and unpaid late charges to (b) our average market capitalization over the prior ten trading days, to exceed
25%. If we fail to complete the sale of the additional March 2022 Notes contemplated by any such written notice, or if the investor
is unable to deliver any such notice prior to March 31, 2024 as a result of the limitation described in the preceding sentence, then
we will be obligated to pay a break-up fee to the investor at such time in an aggregate amount equal to $1.35 million.
33
Liquidity and Capital Resources - continued
We will not pay any selling
commission to any party in connection with the Offering, although we will pay a financial advisory fee equal to 1.8% of the gross proceeds
from the Offering to an independent financial advisor. We estimate that the net cash proceeds will be approximately $20.4 million from
the additional closings of the Offering, after deducting the estimated expenses of the Offering, assuming the sale of all of the March
2022 Notes.
The March 2022 Notes have a
voluntary fixed conversion price of $5.00 per share, a stated interest rate of 7.875% per annum, and a maturity of 24 months (subject
to extension in certain circumstances). The March 2022 Notes will be secured by all our existing and future assets (including those of
our significant subsidiaries, other than Lucid and its subsidiaries), but including only 9.99% of Lucid’s outstanding common stock
held by us, pursuant to a security agreement by and between the Company and the investor.
On
the date six months after the issuance of a March 2022 Note, on the 1st and 10th trading day of each calendar month thereafter, and on
the maturity date (each an “Installment Date”), the Company will make an amortization payment on the March 2022 Note in an
amount equal to the initial principal balance of the note divided by the total number of such amortization payments (such that the entire
initial principal balance will be repaid by the maturity date), plus any amounts that have been deferred or accelerated to the applicable
installment date, plus all accrued and unpaid interest and any late charges (the “Installment Amount”). Each Installment
Amount will be satisfied in shares of the Company’s common stock, subject to certain customary equity conditions (including
minimum price and volume thresholds) at 100% of the Installment Amount or otherwise (or at our election, in whole or in part) in cash
at 115% of the Installment Amount. The conversion price for any Installment Amount so converted will be based on the then current market
price, but not more than the fixed conversion price then in effect and not less than a floor price. The March 2022 Notes also may required
to be repaid in shares of our common stock, at a price per share of our common stock based on the then current market price,
but not more than the fixed conversion price then in effect and not less than a floor price, upon the occurrence of certain events of
default. We may be required to repay the March 2022 Notes, in cash, at a premium to the outstanding principal balance, upon the
occurrence of an event of default or upon a Change of Control (as defined in the March 2022 Notes).
We
will be subject to certain customary affirmative and negative covenants regarding the rank of the March 2022 Notes, the incurrence of
indebtedness, the existence of liens, the repayment of indebtedness and the making of investments, the payment of cash in respect of
dividends, distributions or redemptions, the transfer of assets, the maturity of other indebtedness, and transactions with affiliates,
among other customary matters. We also will be subject to financial covenants requiring that (i) the amount of our available cash equal
or exceed $8.0 million at all times, (ii) the ratio of (a) the outstanding principal amount of the March 2022 Notes, accrued and unpaid
interest thereon and accrued and unpaid late charges to (b) our average market capitalization over the prior ten trading days, not exceed
30%, and (iii) that our market capitalization shall at no time be less than $75 million. The March 2022 Notes include certain customary
events of default.
Lucid
Diagnostics Inc - Committed Equity Facility
In March 2022, Lucid Diagnostics
Inc. entered into a committed equity facility with an affiliate of Cantor Fitzgerald (“Cantor”). Under the terms of
the facility, Cantor has committed to purchase up to $50 million of Lucid Diagnostics Inc. common stock from time to time at the request
of Lucid Diagnostics Inc. While there are distinct differences, the facility is structured similarly to a traditional at-the-market equity
facility, insofar as it allows Lucid Diagnostics Inc. to raise primary equity capital on a periodic basis at prices based on the existing
market price.
Critical
Accounting Policies and Significant Judgments and Estimates
The
discussion and analysis of our (unaudited) financial condition and consolidated results of operations is based on our unaudited condensed
consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United
States of America (“U.S. GAAP”). The preparation of these unaudited condensed consolidated financial statements requires
us to make estimates and assumptions affecting the reported amounts of assets, liabilities, and equity, along with the disclosure of
contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts of
expenses during the corresponding periods. In accordance with U.S. GAAP, we base our estimates on historical experience and on various
other assumptions we believe are reasonable under the circumstances. Actual results may differ from these estimates under different assumptions
or conditions. Please see Note 2, Summary of Significant Accounting Policies and Recent Accounting Standards Updates , of our unaudited
condensed consolidated financial statements included herein in this Form 10-Q, for a summary of significant accounting policies.
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