Forward-Looking Statements
As used in this Quarterly Report on Form 10-Q (this "Form 10-Q"), unless the
context otherwise requires, the terms "we," "us," "our," "ENDRA" and the
"Company" refer to ENDRA Life Sciences Inc., a Delaware corporation, and its
direct and indirect subsidiaries. The following discussion and analysis of our
financial condition and results of operations should be read in conjunction with
our historical financial statements and related notes thereto in this Form 10-Q.
This Form 10-Q contains forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended, that are intended to be covered by the "safe
harbor" created by those sections. Forward-looking statements, which are based
on certain assumptions and describe our future plans, strategies and
expectations, can generally be identified by the use of forward-looking terms
such as "believe," "expect," "may," "will," "should," "could," "seek," "intend,"
"plan," "estimate," "anticipate" or other comparable terms. All statements other
than statements of historical facts included in this Form 10-Q regarding our
strategies, prospects, financial condition, operations, costs, plans and
objectives are forward-looking statements. Examples of forward-looking
statements include, among others, statements we make regarding expectations for
revenues, cash flows and financial performance, the anticipated results of our
development efforts and the timing for receipt of required regulatory approvals
and product launches. Forward-looking statements are neither historical facts
nor assurances of future performance. Instead, they are based only on our
current beliefs, expectations and assumptions regarding the future of our
business, future plans and strategies, projections, anticipated events and
trends, the economy and other future conditions. Because forward-looking
statements relate to the future, they are subject to inherent uncertainties,
risks and changes in circumstances that are difficult to predict and many of
which are outside of our control. Our actual results and financial condition may
differ materially from those indicated in the forward-looking statements.
Therefore, you should not rely on any of these forward-looking statements.
Important factors that could cause our actual results and financial condition to
differ materially from those indicated in the forward-looking statements
include, among others, the following: our limited commercial experience, limited
cash and history of losses; our ability to obtain adequate financing to fund our
business operations in the future; our ability to achieve profitability; our
ability to develop a commercially feasible application based on our
Thermo-Acoustic Enhanced Ultrasound ("TAEUS") technology; market acceptance of
our technology; uncertainties associated with COVID-19 or coronavirus, including
its possible effects on our operations; results of our human studies, which may
be negative or inconclusive; our ability to find and maintain development
partners; our reliance on collaborations and strategic alliances and licensing
arrangements; the amount and nature of competition in our industry; our ability
to protect our intellectual property; potential changes in the healthcare
industry or third-party reimbursement practices; delays and changes in
regulatory requirements, policy and guidelines including potential delays in
submitting required regulatory applications for Food and Drug Administration
("FDA") approval; our ability to obtain and maintain CE mark certification and
secure required FDA and other governmental approvals for our TAEUS applications;
our ability to comply with regulation by various federal, state, local and
foreign governmental agencies and to maintain necessary regulatory clearances or
approvals; and the other risks and uncertainties described in the Risk Factors
section of our Annual Report on Form 10-K for the period ended December 31,
2020, as filed with the SEC on March 25, 2021, and in the Management's
Discussion and Analysis of Financial Condition and Results of Operations section
of this Form 10-Q. We undertake no obligation to publicly update any
forward-looking statement, whether written or oral, that may be made from time
to time, whether as a result of new information, future developments or
otherwise.
Available Information
From time to time, we use press releases, Twitter (@endralifesci) and LinkedIn
(www.linkedin.com/company/endra-inc) to distribute material information. Our
press releases and financial and other material information are routinely posted
to and accessible on the Investors section of our website, www.endrainc.com.
Accordingly, investors should monitor these channels, in addition to our SEC
filings and public conference calls and webcasts. In addition, investors may
automatically receive e-mail alerts and other information about the Company by
enrolling their e-mail addresses by visiting the "Email Alerts" section of our
website at investors.endrainc.com. Information that is contained in and can be
accessed through our website, Twitter posts and LinkedIn are not incorporated
into, and do not form a part of, this Quarterly Report or any other report or
document we file with the SEC.
Overview
We are leveraging experience with pre-clinical enhanced ultrasound devices to
develop technology for increasing the capabilities of clinical diagnostic
ultrasound, to broaden patient access to the safe diagnosis and treatment of a
number of significant medical conditions in circumstances where expensive X-ray
computed tomography ("CT") and magnetic resonance imaging ("MRI") technology, or
other diagnostic technologies such as surgical biopsy, are unavailable or
impractical.
In 2010, we began marketing and selling our Nexus 128 system, which combined
light-based thermoacoustics and ultrasound to address the imaging needs of
researchers studying disease models in pre-clinical applications. Building on
this expertise in thermoacoustics, we have developed a next-generation
technology platform - Thermo Acoustic Enhanced Ultrasound, or TAEUS - which is
intended to enhance the capability of clinical ultrasound technology and support
the diagnosis and treatment of a number of significant medical conditions that
currently require the use of expensive CT or MRI imaging or where imaging is not
practical using existing technology. We ceased production, service support and
parts for our Nexus 128 system in 2019 in order to focus our resources on the
development of our TAEUS technology.
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Unlike the near-infrared light pulses used in our legacy Nexus 128 system, our
TAEUS technology uses radio frequency ("RF") pulses to stimulate tissues, using
a small fraction (less than 1%) of the energy that would be transmitted into the
body during an MRI scan. The use of RF energy allows our TAEUS technology to
penetrate deep into tissue, enabling the imaging of human anatomy at depths
equivalent to those of conventional ultrasound. The RF pulses are absorbed by
tissue and converted into ultrasound signals, which are detected by an external
ultrasound receiver and a digital acquisition system that is part of the TAEUS
system. The detected ultrasound is processed into images and other forms of data
using our proprietary algorithms and displayed to complement conventional
gray-scale ultrasound images.
We expect that the first-generation TAEUS application will be a standalone
ultrasound accessory designed to cost-effectively quantify fat in the liver and
stage progression of nonalcoholic fatty liver disease ("NAFLD"), which can only
be achieved today with impractical surgical biopsies or MRI scans. Subsequent
TAEUS offerings are expected to be implemented via a second generation hardware
platform that can run multiple clinical software applications that we will offer
TAEUS users for a one-time licensing fee - adding ongoing customer value to the
TAEUS platform and a growing software revenue stream for our Company.
In April 2016, we entered into a Collaborative Research Agreement with General
Electric Company, acting through its GE Healthcare business unit and the GE
Global Research Center (collectively, "GE Healthcare"). Under the terms of the
agreement, GE Healthcare has agreed to assist us in our efforts to commercialize
our TAEUS technology for use in a fatty liver application by, among other
things, providing equipment and technical advice, and facilitating introductions
to GE Healthcare clinical ultrasound customers. In return for this assistance,
we have agreed to afford GE Healthcare certain rights of first offer with
respect to manufacturing and licensing rights for the target application. On
December 16, 2020, we and GE Healthcare entered into an amendment to our
agreement, extending its term to December 16, 2022.
Each of our TAEUS platform applications will require regulatory approvals before
we are able to sell or license the application. Based on certain factors, such
as the installed base of ultrasound systems, availability of other imaging
technologies, such as CT and MRI, economic strength and applicable regulatory
requirements, we intend to seek initial approval of our applications for sale in
the European Union and the United States, followed by China.
In March 2020, we received CE mark approval for our TAEUS FLIP (Fatty Liver
Imaging Probe) System. The CE marking indicates that TAEUS FLIP System complies
with all applicable European Directives and Regulations in the European Union
and other CE mark geographies, including the 27 EU member states.
In June 2020, we submitted a 510(k) Application to the FDA for our TAEUS FLIP
System. FDA review of a 510(k) submission requires careful review of indication
for intended use, effectiveness and safety, of both the predicate device and the
submitted device. We continue to work with the FDA on the submission. However,
TAEUS represents an advancement in medical ultrasound technology and this
process has been taking longer than expected and may continue to do so. There
can be no assurance regarding the timing for the FDA to complete its regulatory
review or with regard to the ultimate outcome of that review.
In March 2021, we announced an agreement with a clinical-stage biopharmaceutical
company to incorporate TAEUS as an add-on technology to support the company's
patient screening and biomarker measurement during an upcoming clinical trial.
We are also party to clinical evaluation agreements with several research
institutions to provide additional data on our TAEUS FLIP system.
Financial Operations Overview
Revenue
No revenue has been generated by our TAEUS technology, which we have not
commercially sold as of September 30, 2021.
Cost of Goods Sold
No cost of goods sold has been generated by our TAEUS technology, which we have
not commercially sold as of September 30, 2021.
Research and Development Expenses
Our research and development expenses primarily include wages, fees and
equipment for the development of our TAEUS technology platform and the proposed
applications. Additionally, we incur certain costs associated with the
protection of our products and inventions through a combination of patents,
licenses, applications and disclosures.
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Sales and Marketing Expenses
Sales and marketing expenses consist primarily of headcount and consulting
costs, and marketing and tradeshow expenses. Currently, our marketing efforts
are through our website and attendance of key industry meetings and conferences.
In connection with the commercialization of our TAEUS applications, we are
building a small sales and marketing team to train and support global ultrasound
distributors, and expect to execute traditional marketing activities such as
promotional materials, electronic media and participation in industry events and
conferences. In September 2020, we hired our first full-time sales
representative in the United Kingdom, and during 2021 we added two additional
representatives in France and one in Germany. We expect to continue actively
adding to our sales representation and support headcount for operations in the
EU in the coming quarters, as well begin staffing our sales efforts in the
United States once we have obtained FDA approval for the sale of the TAEUS
product in that region.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and related
expenses for our management and personnel, and professional fees, such as for
accounting, consulting and legal services.
Critical Accounting Policies and Estimates
Use of Estimates
The preparation of the financial statements in conformity with accounting
principles generally accepted in the United States requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities, and disclosure of contingent liabilities at the date of the
financial statements and the reported amounts of expenses during the reporting
period. Actual results could differ from those estimates.
Management makes estimates that affect certain accounts including deferred
income tax assets, accrued expenses, fair value of equity instruments and
reserves for any other commitments or contingencies. Any adjustments applied to
estimates are recognized in the period in which such adjustments are determined.
Share-based Compensation
Our 2016 Omnibus Incentive Plan (the "Omnibus Plan") permits the grant of stock
options and other stock awards to our employees, consultants and non-employee
members of our board of directors. Each January 1 the pool of shares available
for issuance under the Omnibus Plan automatically increases by an amount equal
to the lesser of (i) the number of shares necessary such that the aggregate
number of shares available under the Omnibus Plan equals 25% of the number of
fully-diluted outstanding shares on the increase date (assuming the conversion
of all outstanding shares of preferred stock and other outstanding convertible
securities and exercise of all outstanding options and warrants to purchase
shares) and (ii) if the board of directors takes action to set a lower amount,
the amount determined by the board. On January 1, 2021, the pool of shares
issuable under the Omnibus Plan automatically increased by 1,599,570 shares from
5,861,658 shares to 7,461,228. As of September 30, 2021, there were 2,365,018
shares of common stock remaining available for issuance under the Omnibus Plan.
We record share-based compensation in accordance with the provisions of the
Share-based Compensation Topic of the FASB Codification. The guidance requires
the use of option-pricing models that require the input of highly subjective
assumptions, including the option's expected life and the price volatility of
the underlying stock. The fair value of each option grant is estimated on the
date of grant using the Black-Scholes option valuation model which uses certain
assumptions related to risk-free interest rates, expected volatility, expected
life of the common stock options, and future dividends, and the resulting charge
is expensed using the straight-line attribution method over the vesting period.
Stock compensation expense recognized during the period is based on the value of
share-based awards that were expected to vest during the period adjusted for
estimated forfeitures. The estimated fair value of grants of stock options and
warrants to non-employees is charged to expense, if applicable, in the financial
statements.
Debt Discount and Detachable Debt-Related Warrants
The Company accounts for debt discounts originating in connection with
conversion features that are embedded in the notes related warrants in
accordance with ASC Subtopic 470-20, Debt with Conversion and Other Options.
These costs are classified on the consolidated balance sheet as a direct
deduction from the debt liability. The Company amortizes these costs over the
term of the securities as interest expense-debt discount in the consolidated
statement of operations. Debt discounts relate to the relative fair value of
warrants issued in conjunction with the debt and are also recorded as a
reduction to the debt balance and accreted over the expected term of the
securities to interest expense.
Recent Accounting Pronouncements
See Note 2 of the accompanying financial statements for a discussion of recently
issued accounting standards.
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Results of Operations
Three months ended September 30, 2021 and 2020
Revenue
We had no revenue during the three months ended September 30, 2021 and 2020.
Cost of Goods Sold
We had no cost of goods sold during the three months ended September 30, 2021
and 2020.
Research and Development
Research and development expenses were $1,173,319 for the three months ended
September 30, 2021, as compared to $1,769,339 for the three months ended
December 31, 2020, a decrease of $596,020, or 34%. The costs include primarily
wages, fees and equipment for the development of our TAEUS product line.
Research and development expenses decreased from the same period for the prior
year as we completed development of our initial TAEUS product and began focusing
our spending on commercialization of the product that has been developed.
Sales and Marketing
Sales and marketing expenses were $275,565 for the three months ended September
30, 2021, as compared to $139,751 for the three months ended September 30, 2020,
an increase of $135,814, or 97%. The increase was primarily due to additional
headcount and pre-selling activities for our TAEUS product line. Currently, our
marketing efforts are through our website and attendance of key industry
meetings. During the period ending September 30, 2021 we continued hiring and
training additional staff to support our sales efforts.
General and Administrative
Our general and administrative expenses for the three months ended September 30,
2021 were $1,201,851, compared to $1,346,360 for the three months ended
September 30, 2020, a decrease of $144,509, or 11%. Our wage and related
expenses for the three months ended September 30, 2021 were $517,829, compared
to $443,913 for the three months ended September 30, 2020. Wage and related
expenses in the three months ended September 30, 2021 included $44,652 for
bonuses and $136,008 of stock compensation expense related to the issuance and
vesting of options, compared to $53,751 for bonuses, $151,947 of stock
compensation expense related to the issuance and vesting of options, for the
three months ended September 30, 2020. Our professional fees, which include
legal, audit, and investor relations, for the three months ended September 30,
2021 were $448,728, compared to $718,397 for the three months ended September
30, 2020.
Net Loss
As a result of the foregoing, for the three months ended September 30, 2021, we
recorded a net loss of $2,658,242, compared to a net loss of $3,258,071 for the
three months ended September 30, 2020.
Nine months ended September 30, 2021 and 2020
Revenue
We had no revenue during the nine months ended September 30, 2021 and 2020.
Cost of Goods Sold
We had no cost of goods sold during the nine months ended September 30, 2021 and
2020.
Research and Development
Research and development expenses were $4,059,730 for the nine months ended
September 30, 2021, as compared to $4,774,534 for the nine months ended December
31, 2020, a decrease of $714,804, or 15%. The costs include primarily wages,
fees and equipment for the development of our TAEUS product line. Research and
development expenses decreased from the same period for the prior year as we
completed development of our initial TAEUS product and began focusing our
spending on commercialization of the product that has been developed.
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Sales and Marketing
Sales and marketing expenses were $693,263 for the nine months ended September
30, 2021, as compared to $389,469 for the nine months ended September 30, 2020,
an increase of $303,794, or 78%. The increase was primarily due to additional
headcount and pre-selling activities for our TAEUS product line. Currently, our
marketing efforts are through our website and attendance of key industry
meetings. During the period ending September 30, 2021 we began hiring and
training additional staff to support our sales efforts.
General and Administrative
Our general and administrative expenses for the nine months ended September 30,
2021 were $3,673,771, compared to $4,083,572 for the nine months ended September
30, 2020, a decrease of $409,801, or 10%. Our wage and related expenses for the
nine months ended September 30, 2021 were $1,518,718, compared to $1,647,780 for
the nine months ended September 30, 2020. Wage and related expenses in the nine
months ended September 30, 2021 included $149,112 for bonuses and $366,799 of
stock compensation expense related to the issuance and vesting of options,
compared to $173,695 for bonuses, $627,365 of stock compensation expense related
to the issuance and vesting of options, for the nine months ended September 30,
2020. Our professional fees, which include legal, audit, and investor relations,
for the nine months ended September 30, 2021 were $1,526,874, compared to
$1,980,201 for the nine months ended September 30, 2020.
Gain on Extinguishment of Debt
During the nine months ending September 30, 2021, we received notice that the
SBA Loan had been forgiven in full in accordance with the terms and provisions
of the PPP, and recorded a gain on extinguishment of debt of $308,600.
Amortization of Debt Discount
During the nine months ended September 30, 2020, we incurred non-cash expenses
of $232,426 related to the amortization of debt discount incurred as result of
our issuance of our convertible notes and warrants issued in July 2019. During
the nine months ended September 30, 2021, we had no such expense.
Net Loss
As a result of the foregoing, for the nine months ended September 30, 2021, we
recorded a net loss of $8,126,622, compared to a net loss of $9,474,740 for the
nine months ended September 30, 2020.
Liquidity and Capital Resources
To date we have funded our operations primarily through private and public sales
of our securities. As of September 30, 2021, we had $11,793,189 in cash.
As of the date of this Report, we believe that our cash on hand at September 30,
2021 will be sufficient to fund our current operations into the second half of
2022. We will need additional capital by such time to allow us to continue to
execute our commercialization plans. We continue to evaluate and manage our
capital needs to support our clinical, regulatory and operational activities and
prepare for EU commercialization, and US commercialization upon FDA approval of
our TAEUS product. We are considering potential financing options that may be
available to us, including additional sales of our common stock through our
At-The-Market Issuance Sales Agreement with Ascendiant Capital Markets, LLC,
dated June 21, 2021 (the "June 2021 ATM Agreement"). However, except for the
June 2021 ATM Agreement, we have no commitments to obtain any additional funds,
and there can be no assurance funds will be available in sufficient amounts or
on acceptable terms. If we are unable to obtain sufficient additional financing
in a timely fashion and on terms acceptable to us, our financial condition and
results of operations may be materially adversely affected and we may not be
able to continue operations or execute our stated commercialization plan.
The consolidated financial statements included in this Form 10-Q have been
prepared assuming we will continue as a going concern, which contemplates the
realization of assets and the settlement of liabilities and commitments in the
normal course of business. As reflected in the accompanying consolidated
financial statements, during the nine months ended September 30, 2021, we
incurred net losses of $8,126,622 and used cash in operations of $8,469,653.
While we maintain cash balances in excess of our anticipated needs for cash for
the next twelve months, it is likely that we will need to raise additional
capital prior to any ability to fund operations from revenue generated from the
sale of our products. The financial statements do not include any adjustments
that might be necessary should we be unable to continue as a going concern.
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Operating Activities
During the nine months ended September 30, 2021, we used $8,469,653 of cash in
operating activities primarily as a result of our net loss of $8,126,622, offset
by share-based compensation of $1,032,840, gain on extinguishment of debt of
$308,600, depreciation expense of $94,977, amortization of right of use assets
of $75,768, and net changes in operating assets and liabilities of $(1,238,016).
During the nine months ended September 30, 2020, we used $8,673,489 of cash in
operating activities primarily as a result of our net loss of $9,474,740, offset
by share-based compensation of $1,559,232, amortization of debt discount of
$232,426, depreciation expense of $45,114, amortization of right of use assets
of $48,859, and net changes in operating assets and liabilities of $(1,114,380).
Investing Activities
During the nine months ended September 30, 2021, we used $45,000 in investing
activities related to purchases of equipment.
During the nine months ended September 30, 2020, we used $10,483 in investing
activities related to purchases of equipment.
Financing Activities
During the nine months ended September 30, 2021, our financing activities
provided $13,080,526, including $10,294,899 in proceeds from issuance of common
stock, and $2,785,627 in proceeds from warrant exercises.
During the nine months ended September 30, 2020, financing activities provided
$6,303,058, including $4,644,084 in proceeds from warrant exercises, $337,084 in
proceeds from loans, and $1,321,890 in proceeds from issuance of common stock.
Funding Requirements
We have not completed the commercialization of any of our TAEUS technology
platform applications. We expect to continue to incur significant expenses for
the foreseeable future. We anticipate that our expenses will increase
substantially as we:
? advance the engineering design and development of our NAFLD TAEUS
application;
? acquire parts and build finished goods inventory of the TAEUS FLIP system;
? complete regulatory filings required for marketing approval of our NAFLD
TAEUS application in the United States;
? seek to hire a small internal marketing team to engage and support channel
partners and clinical customers for our NAFLD TAEUS application;
? expand marketing of our NAFLD TAEUS application;
? advance development of our other TAEUS applications; and
? add operational, financial and management information systems and
personnel, including personnel to support our product development, planned
commercialization efforts and our operation as a public company.
It is possible that we will not achieve the progress that we expect because the
actual costs and timing of completing the development and regulatory approvals
for a new medical device are difficult to predict and are subject to substantial
risks and delays. We have no committed external sources of funds. We do not
expect that our existing cash will be sufficient for us to complete the
commercialization of our NAFLD TAEUS application or to complete the development
of any other TAEUS application and we will need to raise substantial additional
capital for those purposes. As a result, we will need to finance our future cash
needs through public or private equity offerings, debt financings, corporate
collaboration and licensing arrangements or other financing alternatives. Our
forecast of the period of time through which our financial resources will be
adequate to support our operations is a forward-looking statement and involves
risks and uncertainties, and actual results could vary as a result of a number
of factors, including the factors discussed in the section of our Annual Report
on Form 10-K for the year ended December 31, 2020, filed with the SEC on March
25, 2021 entitled "Risk Factors". We have based this estimate on assumptions
that may prove to be wrong, and we could utilize our available capital resources
sooner than we currently expect.
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Until we can generate a sufficient amount of revenue from our TAEUS platform
applications, if ever, we expect to finance future cash needs through public or
private equity offerings, debt financings or corporate collaborations and
licensing arrangements. Additional funds may not be available when we need them
on terms that are acceptable to us, or at all. As described below, the COVID-19
pandemic has impacted our business operations to some extent and is expected to
continue to do so and, in light of the effect of such pandemic on financial
markets, these impacts may include reduced access to capital. If adequate funds
are not available, we may be required to delay, reduce the scope of or eliminate
one or more of our research or development programs or our commercialization
efforts or perhaps even cease the operation of our business. To the extent that
we raise additional funds by issuing equity securities, our stockholders may
experience additional dilution, and debt financing, if available, may involve
restrictive covenants. To the extent that we raise additional funds through
collaborations and licensing arrangements, it may be necessary to relinquish
some rights to our technologies or applications or grant licenses on terms that
may not be favorable to us. We may seek to access the public or private capital
markets whenever conditions are favorable, even if we do not have an immediate
need for additional capital at that time.
Coronavirus ("COVID-19") Pandemic
The COVID-19 pandemic has prompted governments and regulatory bodies throughout
the world to issue "stay-at-home" or similar orders, and enact restrictions on
the performance of "non-essential" services, public gatherings and travel.
Beginning in March 2020, we undertook precautionary measures intended to help
minimize the risk of the virus to our employees, including requiring most
employees to work remotely, pausing all non-essential travel worldwide for our
employees, and limiting employee attendance at industry events and in-person
work-related meetings, to the extent those events and meetings are continuing.
As a cash-conserving measure taken in light of the adverse economic conditions
caused by the COVID-19 pandemic, in April 2020 we reduced the cash salaries of
members of management by 33% for the remainder of 2020, including the salaries
of our executive officers. In lieu of cash, the Company paid this portion of
management salaries in the form of restricted stock units that vested over the
remainder of the year. Additionally, we amended our Non-Employee Director
Compensation Policy to provide that our non-employee directors' annual retainers
for the second, third and fourth fiscal quarters of 2020 would be paid in in the
form of restricted stock units rather than cash. To date we do not believe these
actions have had a significant negative impact on our operations. However, these
actions or additional measures we may undertake may ultimately delay progress on
our developmental goals or otherwise negatively affect our business. In
addition, third-party actions taken to contain its spread and mitigate its
public health effects of COVID-19 may negatively affect our business.
The COVID-19 pandemic has impacted our clinical trial activities. Patient visits
in ongoing clinical trials have been delayed, for example, due to prioritization
of hospital resources toward the COVID-19 outbreak, travel restrictions imposed
by governments, and the inability to access sites for initiation and monitoring.
COVID-19 has also had an effect on the business at the FDA and other health
authorities by causing them to reallocate resources to addressing the pandemic,
which has resulted in delays of reviews and approvals, including with respect to
our NAFLD TAEUS application.
Off-Balance Sheet Transactions
At September 30, 2021, the Company did not have any transactions, obligations or
relationships that could be considered off-balance sheet arrangements.
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