ENDRA Life Sciences Inc. - Quarter Report: 2018 June (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☑ QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
FOR
THE QUARTERLY PERIOD ENDED JUNE 30, 2018
OR
☐ TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
COMMISSION FILE NUMBER 001-37969
ENDRA LIFE SCIENCES INC.
(Exact
name of registrant as specified in its charter)
Delaware
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26-0579295
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(State of incorporation)
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(I.R.S. Employer Identification No.)
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3600 Green Court, Suite 350, Ann Arbor, MI 48105-1570
(Address of principal executive
office) ( Zip code )
(734) 335-0468
(Registrant’s telephone number, including area
code)
Indicate by check
mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such
shorter period that the registrant was required to file such
reports), and (2) has been subject to such filing requirements
for the past 90
days. Yes ☑
No ☐
Indicate by check
mark whether the registrant has submitted electronically and posted
on its corporate Web site, if any, every Interactive Data File
required to be submitted and posted pursuant to Rule 405 of
Regulation S-T (§232.405 of this chapter) during the preceding
12 months (or for such shorter period that the registrant was
required to submit and post such files).
Yes ☑
No ☐
Indicate by check
mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, smaller reporting
company or an emerging growth company. See the definitions of
“large accelerated filer,” “accelerated
filer,” “smaller reporting company” and
“emerging growth company” in Rule 12b-2 of the
Exchange Act:
Large
accelerated filer
|
☐
|
Accelerated
filer
|
☐
|
Non-accelerated
filer
|
☐ (Do not check if a smaller reporting
company)
|
Smaller
reporting company
|
☑
|
|
|
Emerging
growth company
|
☑
|
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange
Act. ☐
Indicate by check mark whether the registrant is a
shell company (as defined in Rule 12b-2 of the Exchange
Act). Yes ☐ No ☑
As of August 10, 2018, there were 3,923,027 shares of our Common
Stock, par value $0.0001 per share,
outstanding.
ENDRA LIFE SCIENCES INC.
FORM 10-Q
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2018
INDEX
PAGE
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Item 1. Financial
Statements
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3
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|
|
Item 2. Management’s Discussion and Analysis of Financial
Condition and Results of Operations
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14
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Item 3. Quantitative and Qualitative Disclosure About Market
Risk
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20
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Item 4. Controls and Procedures
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20
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PART II – OTHER INFORMATION
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Item 1. Legal
Proceedings
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21
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Item 1A. Risk Factors
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21
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Item 2. Recent Sales of Unregistered Securities; Use of Proceeds
from Registered Securities
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21
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Item 3. Defaults Upon Senior Securities
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21
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Item 4. Mine Safety Disclosures
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22
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Item 5. Other
Information
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22
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Item 6.
Exhibits
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22
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SIGNATURES
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23
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EXHIBIT
INDEX
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xx
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2
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
ENDRA Life Sciences Inc.
Condensed Consolidated Balance Sheets
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June
30
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December
31,
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Assets
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2018
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2017
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Assets
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(Unaudited)
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|
Cash
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$2,205,858
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$5,601,878
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Accounts
receivable
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11,770
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6,850
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Prepaid
expenses
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318,924
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67,497
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Inventory
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279,210
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191,680
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Other current
assets
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18,553
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14,249
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Total Current
Assets
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2,834,315
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5,882,154
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Other
Assets
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Fixed assets,
net
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211,345
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241,549
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Total
Assets
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$3,045,660
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$6,123,702
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Liabilities
and Stockholders’ Equity
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Current
Liabilities:
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Accounts payable
and accrued liabilities
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$751,376
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$848,214
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Senior secured
convertible promissory notes payable, net of discount
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353,581
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-
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Total
Liabilities
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1,104,957
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848,214
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Stockholders’
Equity
|
|
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Preferred stock,
$0.0001 par value; 10,000,000 shares authorized; no shares issued
or outstanding
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-
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-
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Common stock,
$0.0001 par value; 50,000,000 shares authorized; 3,923,027 and
3,923,027 shares issued and outstanding
|
392
|
392
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Additional paid in
capital
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24,507,821
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23,170,531
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Accumulated
deficit
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(22,567,510)
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(17,895,435)
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Total
Stockholders’ Equity
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1,940,703
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5,275,488
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Total
Liabilities and Stockholders’ Equity
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$3,045,660
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$6,123,702
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The
accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
3
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
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Three Months Ended
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Three Months Ended
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Six Months Ended
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Six Months Ended
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June 30
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June 30
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June 30
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June 30
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2018
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2017
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2018
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2017
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Revenue
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$-
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$57,772
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$6,174
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$57,772
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Cost
of Goods Sold
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-
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51,427
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-
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51,427
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Gross Profit
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$-
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$6,345
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$6,174
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$6,345
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Operating Expenses
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Research
and development
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839,756
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174,725
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2,508,579
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270,539
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Sales
and marketing
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41,357
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6,904
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148,534
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8,028
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General
and administrative
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941,956
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881,570
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2,009,747
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1,145,329
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Total
operating expenses
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1,823,068
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1,063,199
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4,666,860
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1,423,897
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|
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Operating
loss
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(1,823,068)
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(1,056,855)
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(4,660,686)
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(1,417,552)
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Other Expenses
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Other
income (expense)
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(23,704)
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(374,937)
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(11,389)
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(755,862)
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Total
other expenses
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(23,704)
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(374,937)
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(11,389)
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(755,862)
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Loss
from operations before income taxes
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(1,846,772)
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(1,431,791)
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(4,672,075)
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(2,173,414)
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Provision
for income taxes
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-
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-
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-
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-
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Net Loss
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$(1,846,772)
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$(1,431,791)
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$(4,672,075)
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$(2,173,414)
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Net
loss per share – basic and diluted
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$(0.47)
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$(0.59)
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$(1.19)
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$(1.37)
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Weighted average common shares – basic and
diluted
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3,923,027
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2,437,010
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3,923,027
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1,584,906
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The
accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
4
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
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Six Months Ended
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Six Months Ended
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June 30
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June 30
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2018
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2017
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Cash
Flows from Operating Activities
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Net
loss
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$(4,672,075)
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$(2,173,414)
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Adjustments to
reconcile net loss to net cash used in operating
activities:
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Depreciation and
amortization
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30,204
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30,964
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Common stock,
options and warrants issued for services
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749,749
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306,184
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Interest on
discount of convertible debt
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-
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711,472
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Imputed interest on
promissory notes
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-
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1,480
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Amortization of
debt discount
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5,822
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-
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Changes in
operating assets and liabilities:
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Increase in
accounts receivable
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(4,920)
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-
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Increase in prepaid
expenses
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(251,428)
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(4,200)
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Increase in
inventory
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(87,530)
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(93,316)
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Increase in other
asset
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(4,304)
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(272)
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Decrease in
accounts payable and accrued liabilities
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(96,838)
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(157,618)
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Net cash used in
operating activities
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(4,331,320)
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(1,378,720)
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Cash
Flows from Investing Activities:
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Purchases of fixed
assets
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-
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(7,862)
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Net cash used in
investing activities
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-
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(7,862)
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Cash
Flows from Financing Activities
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Proceeds from
issuance of common stock, net of fees
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-
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8,590,700
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Repayment of notes
payable
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-
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(50,000)
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Proceeds from
senior secured convertible promissory notes, net of
fees
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935,300
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225,000
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Net cash provided
by financing activities
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935,300
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8,765,700
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Net
Increase/(Decrease) in cash
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(3,396,020)
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7,379,118
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Cash, beginning of
period
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5,601,878
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144,953
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Cash,
end of period
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$2,205,858
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$7,524,071
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Supplemental
disclosures:
|
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Interest
paid
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$-
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$-
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Income
tax paid
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$-
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$-
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Supplemental
disclosures of non-cash Items:
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|
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Discount on
convertible notes
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$587,541
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$225,000
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The
accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
5
ENDRA Life Sciences Inc.
Notes to Condensed Consolidated Financial Statements
For the three and six months ended June 30, 2018 and
2017
(Unaudited)
Note 1 – Nature of the Business
ENDRA Life Sciences Inc. (“ENDRA” or the
“Company”) is developing a medical imaging technology
based on the thermoacoustic effect that improves the sensitivity
and specificity of clinical ultrasound.
On May 8, 2017, the Company effected a 1-for-3.5 reverse stock
split (the “Reverse Split”) of the Company’s
common stock, with no reduction in authorized capital stock. In the
Reverse Split, every 3.5 outstanding shares of common stock became
one (1) share of common stock. All common stock and stock incentive
plan information in these financial statements reflect the Reverse
Split.
ENDRA was incorporated on July 18, 2007 as a Delaware
corporation.
ENDRA Life Sciences Canada Inc. was organized under the laws of
Ontario, Canada on July 6, 2017, and is wholly owned by the
Company.
Note 2 – Summary of Significant Accounting
Policies
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.
Principles of Consolidation
The Company’s unaudited consolidated financial statements
include all accounts of the Company and its consolidated subsidiary
and/or entities as of reporting period ending date(s) and for the
reporting period(s) then ended. All inter-company balances and
transactions have been eliminated.
Basis of Presentation
The accompanying unaudited financial statements and related notes
have been prepared pursuant to the rules and regulations of the
Securities and Exchange Commission (the “SEC”).
Accordingly, certain information and footnote disclosures normally
included in financial statements prepared in accordance with
generally accepted accounting principles have been omitted pursuant
to such rules and regulations. In the opinion of management, all
adjustments (consisting of normal recurring accruals) considered
necessary for a fair presentation have been included. Operating
results for the three and six months ended June 30, 2018 are not
necessarily indicative of the results that may be expected for the
year ended December 31, 2018. The balance sheet at December 31,
2017 has been derived from the audited financial statements at such
date. For further information, refer to the financial statements
and footnotes thereto included in ENDRA Life Sciences Inc. annual
financial statements for the year ended December 31, 2017 included
in the Company’s Annual Report on Form 10-K filed with the
SEC on March 20, 2018.
Cash and Cash Equivalents
The Company considers all cash on hand and in banks, including
accounts in book overdraft positions, certificates of deposit and
other highly-liquid investments with maturities of one year or
less, when purchased, to be cash. As of June 30, 2018 and December
31, 2017, the Company had no cash equivalents. The Company
maintains its cash in bank deposit accounts which, at times, may
exceed federally insured limits. The Company has not experienced
any losses in such accounts and periodically evaluates the credit
worthiness of the financial institutions and has determined the
credit exposure to be negligible.
6
Inventory
The Company’s inventory is stated at the lower of cost or
estimated net realizable value, with cost primarily determined on a
weighted-average cost basis on the first-in, first-out
(“FIFO”) method. The Company periodically determines
whether a reserve should be taken for devaluation or obsolescence
of inventory. As of June 30, 2018 and December 31, 2017, no such
reserve was taken.
Capitalization of Fixed Assets
The Company capitalizes expenditures related to property and
equipment, subject to a minimum rule, that have a useful life
greater than one year for: (1) assets purchased; (2) existing
assets that are replaced, improved or the useful lives have been
extended; or (3) all land, regardless of cost. Acquisitions of new
assets, additions, replacements and improvements (other than land)
costing less than the minimum rule in addition to maintenance and
repair costs, including any planned major maintenance activities,
are expensed as incurred.
Capitalization of Intangible Assets
The Company records the purchase of intangible assets not purchased
in a business combination in accordance with the ASC Topic
350.
Revenue Recognition
In May 2014, the FASB issued ASU No. 2014-09, Revenue from
Contracts with Customers (Topic 606). This standard provides a
single set of guidelines for revenue recognition to be used across
all industries and requires additional disclosures. The updated
guidance introduces a five-step model to achieve its core principal
of the entity recognizing revenue to depict the transfer of goods
or services to customers at an amount that reflects the
consideration to which the entity expects to be entitled in
exchange for those goods or services. The Company adopted the
updated guidance effective January 1, 2018 using the full
retrospective method. The new standard did not have a material
impact on its financial position and results of operations, as it
did not change the manner or timing of recognizing
revenue.
Under ASC 606, in order to recognize revenue, the Company is
required to identify an approved contract with commitments to
preform respective obligations, identify rights of each party in
the transaction regarding goods to be transferred, identify the
payment terms for the goods transferred, verify that the contract
has commercial substance and verify that collection of
substantially all consideration is probable. The adoption of ASC
606 did not have an impact on the Company’s operations or
cash flows.
Research and Development Costs
The Company follows ASC 730-10, “Research and
Development”. Research and development costs are charged to
the statement of operations as incurred. During the six months
ended June 30, 2018 and June 30, 2017, the Company incurred
$2,508,579 and $270,539 of expenses related to research and
development costs, respectively.
Net Earnings (Loss) Per Common Share
The Company computes earnings per share under ASC Subtopic 260-10,
Earnings Per Share (“ASC 260-10”). Basic earnings
(loss) per share is computed by dividing the net income (loss)
attributable to the common stockholders (the numerator) by the
weighted average number of shares of common stock outstanding (the
denominator) during the reporting periods. Diluted loss per
share is computed by increasing the denominator by the weighted
average number of additional shares that could have been
outstanding from securities convertible into common stock (using
the “treasury stock” method), unless their effect on
net loss per share is anti-dilutive. There were 3,267,052 and
3,208,262 potentially dilutive shares, which include outstanding
common stock options, warrants, and convertible notes, as of June
30, 2018 and December 31, 2017, respectively.
The potential shares, which are excluded from the determination of
basic and diluted net loss per share as their effect is
anti-dilutive, are as follows:
|
June 30,
2018
|
December 31,
2017
|
Options
to purchase common stock
|
978,911
|
940,121
|
Warrants
to purchase common stock
|
2,288,141
|
2,268,141
|
Potential
equivalent shares excluded
|
3,267,052
|
3,208,262
|
7
Fair Value Measurements
Disclosures about fair value of financial instruments require
disclosure of the fair value information, whether or not recognized
in its balance sheet, where it is practicable to estimate that
value. As of June 30, 2018 and December 31, 2017, the amounts
reported for cash, accrued liabilities and accrued interest
approximated fair value because of their short
maturities.
In accordance with ASC Topic 820, “Fair Value Measurements
and Disclosures,” the Company measures certain financial
instruments at fair value on a recurring basis. ASC Topic 820
defines fair value, established a framework for measuring fair
value in accordance with accounting principles generally accepted
in the United States, and expands disclosures about fair value
measurements.
Fair value is defined as the price that would be received to sell
an asset or paid to transfer a liability in an orderly transaction
between market participants at the measurement date. ASC Topic 820
established a three-tier fair value hierarchy, which prioritizes
the inputs used in measuring fair value. The hierarchy gives the
highest priority to unadjusted quoted prices in active markets for
identical assets or liabilities (Level 1 measurements) and the
lowest priority to unobservable inputs (Level 3 measurements).
These tiers include:
● Level 1, defined as
observable inputs such as quoted prices for identical instruments
in active markets;
● Level 2, defined as
inputs other than quoted prices in active markets that are either
directly or indirectly observable such as quoted prices for similar
instruments in active markets or quoted prices for identical or
similar instruments in markets that are not active;
and
● Level 3, defined as
unobservable inputs in which little or no market data exists,
therefore requiring an entity to develop its own assumptions, such
as valuations derived from valuation techniques in which one or
more significant inputs or significant value drivers are
unobservable.
Financial assets are considered Level 3 when their fair values are
determined using pricing models, discounted cash flow methodologies
or similar techniques and at least one significant model assumption
or input is unobservable.
The carrying amounts of the Company’s financial assets and
liabilities, including cash, prepaid expenses, accounts payable,
accrued expenses, and other current liabilities, approximate their
fair values because of the short maturity of these instruments. The
fair value of notes payable and convertible notes approximates
their fair values since the current interest rates and terms on
these obligations are the same as prevailing market
rates.
Share-based Compensation
The Company’s 2016 Omnibus Incentive Plan (the “Omnibus
Plan”) permits the grant of stock options and other
share-based awards to its employees, consultants and non-employee
members of the board of directors covering up to 1,345,074 shares
of common stock, of which approximately 350,000 remain available to be granted. Each January 1 the
pool of shares available for issuance under the Omnibus Plan will
automatically increase 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.
The Company records 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, and the resulting charge is expensed using the
straight-line attribution method over the vesting period. The
Company has elected to use the calculated value method to account
for the options it issued in 2017 (prior to commencement on June
28, 2017 of public trading in the Company’s common stock).
Under the Share-based Compensation Topic of the FASB Codification,
a nonpublic entity that is unable to estimate the expected
volatility of the price of its underlying shares may measure awards
based on a “calculated value,” which substitutes the
volatility of appropriate public companies (representative of the
company’s size and industry) as a benchmark for the
volatility of the entity’s own share price. The Company has
used the historical closing values of these companies to estimate
volatility, which was calculated to be 90%, for periods prior to
June 28, 2017, when there was no active market for the
Company’s common stock.
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 of
the Company is charged to expense, if applicable, in the financial
statements. These options vest in the same manner as the employee
options granted under the stock incentive plan as described
above.
8
Beneficial Conversion Feature
If the conversion feature of conventional convertible debt provides
for a rate of conversion that is below market value, this feature
is characterized as a beneficial conversion feature
(“BCF”). A BCF is recorded by the Company as a debt
discount pursuant to ASC Topic 470-20 “Debt with Conversion
and Other Options.” In those circumstances, the convertible
debt is recorded net of the discount related to the BCF and the
Company amortizes the discount to interest expense over the life of
the debt using the effective interest method.
Debt Discount
The Company determines if the convertible promissory notes should
be accounted for as liability or equity under ASC 480, Liabilities
— Distinguishing Liabilities from Equity. ASC 480 applies to
certain contracts involving a company’s own equity, and
requires that issuers classify the following freestanding financial
instruments as liabilities: mandatorily redeemable financial
instruments, obligations that require or may require repurchase of
the issuer’s equity shares by transferring assets (e.g.,
written put options and forward purchase contracts), and certain
obligations where at inception the monetary value of the obligation
is based solely or predominantly on:
●
A fixed monetary amount known at inception (for example, a payable
settleable with a variable number of the issuer’s equity
shares with an issuance date fair value equal to a fixed dollar
amount);
●
Variations in something other than the fair value of the
issuer’s equity shares (for example, a financial instrument
indexed to the S&P 500 and settleable with a variable number of
the issuer’s equity shares); or
●
Variations inversely related to changes in the fair value of the
issuer’s equity shares (for example, a written put that could
be net share settled).
If the Company determines the instrument meets the guidance under
ASC 480, the instrument is accounted for as a liability with a
respective debt discount. The Company has previously recorded debt
discounts in connection with raising funds through the issuance of
promissory notes. These costs are amortized to noncash interest
expense over the life of the debt. If a conversion of the
underlying debt occurs, a proportionate share of the unamortized
amounts is immediately expensed. See Note 6, Convertible Notes, for
further discussion on the Company’s accounting treatment for
the outstanding notes.
Going Concern
The Company’s financial statements are prepared using
accounting principles generally accepted in the United States
(“U.S. GAAP”) applicable to a going concern, which
contemplates the realization of assets and liquidation of
liabilities in the normal course of business. The Company has
limited commercial experience and had a cumulative net loss from
inception to June 30, 2018 of $22,567,510. The Company had working
capital of $1,729,359 as of June 30, 2018. The Company has not
established an ongoing source of revenue sufficient to cover its
operating costs and to allow it to continue as a going concern. The
accompanying financial statements for the period ended June 30,
2018 have been prepared assuming the Company will continue as a
going concern. The Company’s cash resources will likely be
insufficient to meet its anticipated needs during the next twelve
months. The Company will require additional financing to fund its
future planned operations, including research and development and
commercialization of its products.
The ability of the Company to continue as a going concern is
dependent on the Company obtaining adequate capital to fund
operating losses until it establishes a revenue stream and becomes
profitable. Management’s plans to continue as a going concern
include raising additional capital through sales of equity
securities and borrowing. However, management cannot provide any
assurances that the Company will be successful in accomplishing any
of its plans. If the Company is not able to obtain the necessary
additional financing on a timely basis, the Company will be
required to delay, reduce the scope of or eliminate one or more of
the Company’s research and development activities or
commercialization efforts or perhaps even cease the operation of
its business. The ability of the Company to continue as a
going concern is dependent upon its ability to successfully secure
other sources of financing and attain profitable operations. There
is substantial doubt about the ability of the Company to continue
as a going concern for one year from the issuance of the
accompanying financial statements. The accompanying financial
statements do not include any adjustments that might be necessary
if the Company is unable to continue as a going
concern.
Recent Accounting Pronouncements
In May 2014, the Financial Accounting Standards Board
(“FASB”) issued Accounting Standards Update
(“ASU”) No. 2014-09, Revenue from Contracts with
Customers. ASU 2014-09 is a comprehensive revenue recognition
standard that supersedes nearly all existing revenue recognition
guidance under current U.S. GAAP and replace it with a principle
based approach for determining revenue recognition. Under ASU
2014-09, revenue is recognized when a customer obtains control of
promised goods or services and is recognized in an amount that
reflects the consideration which the entity expects to receive in
exchange for those goods or services. In addition, the standard
requires disclosure of the nature, amount, timing, and uncertainty
of revenue and cash flows arising from contracts with customers.
The FASB has recently issued ASU 2016-08, ASU 2016-10, ASU 2016-11,
ASU 2016-12,and ASU 2016-20, all of which clarify certain
implementation guidance within ASU 2014-09. ASU 2014-09 is
effective for interim and annual periods beginning after December
15, 2017. The standard can be adopted either retrospectively to
each prior reporting period presented (full retrospective method),
or retrospectively with the cumulative effect of initially applying
the guidance recognized at the date of initial application (the
cumulative catch-up transition method). The Company has reviewed
ASU 2014-09 and using the full retrospective method has determined
that its adoption has had no impact on its financial position,
results of operations or cash flows. The Company has adopted the
provisions of this statement in the first quarter of fiscal
2018.
9
In February 2016, the FASB issued ASU No. 2016-02, Leases. ASU
2016-02 requires a lessee to record a right of use asset and a
corresponding lease liability on the balance sheet for all leases
with terms longer than 12 months. ASU 2016-02 is effective for all
interim and annual reporting periods beginning after December 15,
2018. Early adoption is permitted. A modified retrospective
transition approach is required for lessees for capital and
operating leases existing at, or entered into after, the beginning
of the earliest period presented in the financial statements. The
Company is currently evaluating the expected impact that the
standard could have on its financial statements and related
disclosures.
In May 2017, the FASB issued ASU No. 2017-09, Compensation –
Stock Compensation (Topic 718) Scope of Modification Accounting
(“ASU 2017-09”). The amendments in ASU 2017-09 provide
guidance about which changes to the terms or conditions of a
share-based payment award require an entity to apply modification
accounting in Topic 718. The adoption of ASU 2017-09, which will
become effective for annual periods beginning after December 15,
2017 and for interim periods within those annual periods, has not
and is not expected to have any impact on the Company’s
financial statement presentation or disclosures.
Other recent accounting pronouncements issued by the FASB,
including its Emerging Issues Task Force, the American Institute of
Certified Public Accountants, and the SEC did not or in
management’s opinion will not have a material impact on the
Company’s present or future financial
statements.
Note 3 – Inventory
As
of June 30, 2018 and December 31, 2017, inventory consisted of raw
materials to be used in the assembly of a Nexus 128 system. As of
June 30, 2018 and December 31, 2017 the Company had no orders
pending for the sale of a Nexus 128 system. On June 15, 2018, the
Company reported that it would explore strategic alternatives with
respect to its pre-clinical business, including a potential
sale.
Note 4 – Fixed Assets
As of
June 30, 2018 and December 31, 2017, fixed assets consisted of the
following:
|
June
30,
2018
|
December
31,
2017
|
Computer equipment
and fixtures
|
$579,179
|
$579,179
|
Accumulated
depreciation
|
(367,834)
|
(337,630)
|
Fixed assets,
net
|
$211,345
|
$241,549
|
Depreciation expense for the six months ended June 30, 2018 and
2017 was $30,204 and $30,964, respectively.
Note 5 – Accounts Payable and Accrued
Liabilities
As of
June 30, 2018 and December 31, 2017, current liabilities consisted
of the following:
|
June
30,
2018
|
December
31,
2017
|
Accounts
payable
|
$462,589
|
$780,262
|
Accrued
payroll
|
34,839
|
40,578
|
Accrued
bonuses
|
131,749
|
-
|
Accrued employee
benefits
|
52,229
|
27,375
|
Insurance premium
financing
|
69,675
|
-
|
Accrued interest on
senior secured convertible promissory notes
|
295
|
-
|
Total
|
$751,376
|
$848,215
|
10
Note 6 – Convertible Notes
On June 28, 2018, the Company conducted a private placement
offering in which the Company sold $1,077,000 aggregate principal
amount of senior secured convertible promissory notes (the
“Notes”) to accredited investors and National
Securities Corporation, which served as placement agent in the
offering. Certain of the Company’s officers and directors
participated in the offering.
The Notes are convertible into common stock at a conversion price
equal to the lesser of (a) the lowest per share price at which
commons stock is sold in a Qualified Financing (as defined below),
as applicable, less a discount of 20%, or (b) $2.016, but in any
event no less than a conversion price floor of $1.40.
Each Note bears interest at a rate of 10% per annum until maturity
on December 31, 2018 (the “Maturity Date”). Interest
will be paid in arrears on the outstanding principal amount on the
three month anniversary of the issuance of the Notes and each three
month period thereafter and on the Maturity Date or on the date of
conversion in full of each such Note. The principal amount of the
Notes will automatically convert into shares of common stock (i)
upon the consummation of a sale by the Company of common stock
resulting in aggregate gross cash proceeds of at least $7.0 million
(a “Qualified Financing”) or (ii) if the holders of a
majority of the aggregate principal amount of outstanding Notes
elect to convert the Notes at any time until three days prior to a
Qualified Financing. Additionally, noteholders are entitled to
convert the principal amount of Notes into common stock (i) at any
time until three days prior to the consummation of a Qualified
Financing or (ii) if a material Event of Default (as defined in the
Notes) shall have occurred and be continuing. In each case,
conversion is subject to the terms and provisions of the
Notes.
The Notes provide for customary events of default. In the case of
an event of default with respect to the Notes, each Noteholder may
declare its Note to be due and payable immediately without further
action or notice. If such an event of default occurs and be
continuing, interest on the Notes will automatically be increased
to 15% until the default is cured.
In
addition, the Company issued warrants
exercisable for 267,113 shares of the Company’s common stock
to accredited investors and issued to National Securities
Corporation, which served as placement agent in the offering, and
its designees warrants exercisable for 53,423 shares of common
stock. Each warrant will entitle the holder to purchase shares of
Common Stock for an exercise price per share equal to $2.52, which
was the closing bid price of shares of Common Stock on the NASDAQ
Capital Market on June 27, 2018. The warrants are exercisable
commencing six months after the date of issuance and expire June
28, 2021. The fair value of these warrants was determined to be
$587,541 using the Black-Scholes-Merton option-pricing model based
on the following assumptions: (i) volatility rate of 99%, (ii)
discount rate of 0%, (iii) zero expected dividend yield, and (iv)
expected life of 3 years. The value of the warrants of
$587,541 was considered as debt discount upon issuance and was
being amortized as interest over the term of the notes or in full
upon the conversion of the corresponding notes. During three and
six months ended June 30, 2016, the Company amortized $5,822 of
such discount to interest expense, and the unamortized discount as
of June 30, 2018 was $581,719.
Note 7 – Capital Stock
At June 30, 2018, the authorized capital of the Company consisted
of 60,000,000 shares of capital stock, consisting of 50,000,000
shares of common stock with a par value of $0.0001 per share, and
10,000,000 shares of preferred stock with a par value of
$0.0001 per share. As of June 30, 2018, there were 3,923,027
shares of common stock issued and outstanding and no preferred
stock outstanding.
Common Stock Issued for Services
During the year ended December 31, 2017, the Company issued 16,000
shares of common stock for services valued at $57,440, $47,865 of
which was expensed during the six months ended June 30, 2018, based
on the duration of the contract. The certificates
for these shares were issued in January 2018.
Note 8 – Stock Options and Warrants
Stock options are awarded to the Company’s employees,
consultants and non-employee members of the board of directors
under the 2016 Omnibus Incentive Plan and are generally granted
with an exercise price equal to the market price of the
Company’s common stock at the date of grant. The fair value
of these stock options granted by the Company during the three and
six months ended June 30, 2018 was determined to be $0 and
$206,096, respectively, using the Black-Scholes-Merton
option-pricing model based on the following assumptions: (i)
volatility rate of 120% to 127%%, (ii) discount rate of 0%, (iii)
zero expected dividend yield, and (iv) expected life of 8 years. A
summary of option activity under the Company’s stock options
as of June 30, 2018, and changes during the six months then ended
is presented below:
11
|
Number of Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual Term
(Years)
|
Balance outstanding
at December 31, 2017
|
940,121
|
$5.65
|
6.46
|
Granted
|
49,790
|
4.44
|
8
|
Exercised
|
-
|
-
|
-
|
Forfeited
|
-
|
-
|
-
|
Cancelled or
expired
|
(2,000)
|
2.50
|
-
|
Balance outstanding
at June 30, 2018
|
987,911
|
$5.60
|
6.29
|
Exercisable at June
30, 2018
|
438,664
|
$6.37
|
5.14
|
On January 16, 2018, the Company granted warrants to purchase
20,000 shares of common stock with an exercise price of $5.50 per
share for services. The warrants vest in six monthly installments
beginning on February 16, 2018. The fair value of these warrants
was determined to be $40,384 using the Black-Scholes-Merton
option-pricing model based on the following assumptions: (i)
volatility rate of 126%, (ii) discount rate of 0%, (iii) zero
expected dividend yield, and (iv) expected life of 3 years. During
the three and six months ended June 30, 2018, $20,192 and $37,019,
respectively, was expensed.
On June 28, 2018, the Company conducted a private placement
offering (see note 6) in which the Company issued warrants
exercisable for 267,113 shares of the Company’s common stock
to accredited investors and issued to National Securities
Corporation, which served as placement agent in the offering, and
its designees warrants exercisable for 53,423 shares of common
stock. Each warrant will entitle the holder to purchase shares of
Common Stock for an exercise price per share equal to $2.52, which
was the closing bid price of shares of Common Stock on the NASDAQ
Capital Market on June 27, 2018. The warrants are exercisable
commencing six months after the date of issuance and expire June
28, 2021. The fair value of these warrants was determined to be
$587,541 using the Black-Scholes-Merton option-pricing model based
on the following assumptions: (i) volatility rate of 99%, (ii)
discount rate of 0%, (iii) zero expected dividend yield, and (iv)
expected life of 3 years.
The following table summarizes all stock warrant activity of the
Company for the six months ended June 30, 2018:
|
Number of
Warrants
|
Weighted Average
Exercise Price
|
Weighted Average
Remaining Contractual Term (Years)
|
Balance outstanding
at December 31, 2017
|
2,268,141
|
$7.09
|
4.21
|
Granted
|
340,536
|
$2.70
|
2.97
|
Exercised
|
-
|
-
|
-
|
Forfeited
|
-
|
-
|
-
|
Expired
|
-
|
-
|
-
|
Balance outstanding
at June 30, 2018
|
2,608,677
|
$6.51
|
3.61
|
Exercisable at June
30, 2018
|
2,284,808
|
$7.08
|
3.68
|
Note 9 – Commitments & Contingencies
Office Lease
Effective January 1, 2015, the Company entered into an office lease
agreement with Green Court, LLC, a Michigan limited liability
company, for approximately 3,657 rentable square feet of space, for
the initial monthly rent of $5,986, which commenced on January 1,
2015 for an initial term of 60 months and was amended on October
10, 2017 to increase the space to 3,950 square feet and the monthly
rent to $7,798. Under the terms of the lease the Company has an
option on the same space for an additional 60-month term. Future
minimum payments under this lease are as follows:
2018
|
31,867
|
2019
|
79,269
|
Total
|
$111,136
|
12
For the six months ended June 30, 2018 and 2017, the Company
incurred rent expenses of $52,248 and $31,699,
respectively.
Employment and Consulting Agreements
Francois Michelon. Effective May 12, 2017, the Company
entered into an amended and restated employment agreement with
Francois Michelon, the Company’s Chief Executive Officer and
Chairman of the board of directors. The term of the employment
agreement runs through December 31, 2019. The employment agreement
provides for an annual base salary that is subject to adjustment at
the board of directors’ discretion. The annual base salary in
effect during the period covered by this Form 10-Q was $345,000.
Under the employment agreement, Mr. Michelon is eligible for an
annual cash bonus based upon achievement of performance-based
objectives established by the board of directors. Pursuant to Mr.
Michelon’s employment agreement, in connection with the
closing of the Company’s initial public offering he was
granted options to purchase an aggregate 339,270 shares of common
stock. The options have a weighted average exercise price of $4.96
per share of common stock and vest in three equal annual
installments beginning on May 12, 2018. Upon termination without
cause, any portion of Mr. Michelon’s options scheduled to
vest within 12 months will automatically vest, and upon termination
without cause within 12 months following a change of control, the
entire unvested portion of the options will automatically vest.
Upon termination for any other reason, the entire unvested portion
of the options will terminate.
If Mr. Michelon’s employment is terminated by the Company
without cause, Mr. Michelon will be entitled to receive 12
months’ continuation of his current base salary and a lump
sum payment equal to 12 months of continued healthcare coverage (or
24 months’ continuation of his current base salary and a lump
sum payment equal to 24 months of continued healthcare coverage if
such termination occurs within one year following a change in
control).
Under his employment agreement, Mr. Michelon is eligible to receive
benefits that are substantially similar to those of the
Company’s other senior executive officers.
Michael Thornton. Effective May 12, 2017, the Company
entered into an amended and restated employment agreement with
Michael Thornton, the Company’s Chief Technology Officer. The
term of the employment agreement runs through December 31, 2019.
The employment agreement provides for an annual base salary that is
subject to adjustment at the board of directors’ discretion.
The annual base salary in effect during the period covered by this
Form 10-Q was $260,000. Under the employment agreement, Mr.
Thornton is eligible for an annual cash bonus based upon
achievement of performance-based objectives established by the
board of directors. Pursuant to Mr. Thornton’s employment
agreement, in connection with the closing of the Company’s
initial public offering he was granted options to purchase an
aggregate 345,298 shares of common stock. The options have a
weighted average exercise price of $4.96 per share of common stock
and vest in three equal annual installments beginning on May 12,
2018. Upon termination without cause, any portion of Mr.
Thornton’s option scheduled to vest within 12 months will
automatically vest, and upon termination without cause within 12
months following a change of control, the entire unvested portion
of the options will automatically vest. Upon termination for any
other reason, the entire unvested portion of the options will
terminate.
If Mr. Thornton’s employment is terminated by the Company
without cause, Mr. Thornton will be entitled to receive 12
months’ continuation of his current base salary and a lump
sum payment equal to 12 months of continued healthcare coverage (or
24 months’ continuation of his current base salary and a lump
sum payment equal to 24 months of continued healthcare coverage if
such termination occurs within one year following a change in
control).
Under his employment agreement, Mr. Thornton is eligible to receive
benefits that are substantially similar to those of the
Company’s other senior executive officers.
David R. Wells. On May 12,
2017, the Company entered into a consulting agreement with
StoryCorp Consulting (“StoryCorp”), pursuant to which
David Wells provides services to the Company as its Chief Financial
Officer. Pursuant to the consulting agreement, the Company pays to
StoryCorp a monthly fee of $9,000. Additionally, pursuant to the
consulting agreement, the Company granted to Mr. Wells a stock
option to purchase 15,000 shares of common stock in connection with
the closing of the Company’s initial public offering, having
an exercise price per share equal to $5.00 and vesting in twelve
equal quarterly installments, and, for so long as the consulting
agreement is in place, will grant to Mr. Wells a stock option to
purchase the same number of shares of common stock with the same
terms on each annual anniversary of the date of the consulting
agreement.
Litigation
From time to time the Company may become a party to litigation in
the normal course of business. There are currently no legal matters
that Management believes would have a material effect on the
Company’s financial position or results of
operations.
13
Item 2. Management’s Discussion and Analysis of Financial
Condition and Results of Operations
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 wholly-owned
subsidiary. 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; 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 CE mark certification or Food and Drug
Administration (“FDA”) approval; our ability to obtain
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, 2017, as filed with the SEC
on March 20, 2018, 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.
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 is 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.
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 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 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 non-alcoholic
fatty liver disease, or (“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.
14
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, followed by the United States and
China.
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. More
specifically, we have agreed that, prior to commercially releasing
our NAFLD TAEUS application, we will offer to negotiate an
exclusive ultrasound manufacturer relationship with GE Healthcare
for a period of at least one year of commercial sales. The
commercial sales would involve, within our sole discretion, either
our Company commercially selling GE Healthcare ultrasound systems
as the exclusive ultrasound system with our TAEUS fatty liver
application embedded, or GE Healthcare being the exclusive
ultrasound manufacturer to sell ultrasound systems with our TAEUS
fatty liver application embedded. The agreement is subject to
termination by either party upon not less than 60 days’
notice. On January 30, 2018, we and GE Healthcare entered into
an amendment to our agreement, extending its term by 21 months
to January 22, 2020.
In November 2017 we engaged two firms that specialize in medical
device software development to commence productization of our TAEUS
device targeting NAFLD. The agreements call for these vendors to
provide us with the specialized engineering resources necessary to
translate our current prototype TAEUS device into a clinical
product meeting CE regulatory requirements required for commercial
launch in the European Union followed by FDA submission for the
U.S. market.
In November 2017, we also contracted the Centre for Imaging
Technology Commercialization (CIMTEC) to initiate human studies
with our TAEUS device, and anticipate results from these studies to
be announced during the third quarter of 2018.
In June
2018, we reported that, in order to focus our resources on
developing our TAEUS technology for clinical use, we are exploring
strategic alternatives with respect to our pre-clinical business,
including a potential sale.
Financial Operations Overview
Revenue
To date our revenue has been generated by the placement and sale of
our discontinued Nexus 128 thermoacoustic imaging systems for use
in pre-clinical applications, and related service revenue. No
revenue has been generated by our TAEUS technology, which is in
development.
Cost of Goods Sold
Our cost of goods sold is related to our direct costs associated
with the development and shipment of our discontinued Nexus 128
systems placed in pre-clinical settings.
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.
Sales and Marketing Expenses
Sales and marketing expenses consist primarily of advertising,
marketing and consulting expenses and headcount. Currently, our
marketing efforts are through our website and attendance of key
industry meetings. In connection with the commercialization of our
TAEUS applications, we expect to build a small sales and marketing
team to train and support global ultrasound distributors, as well
as execute traditional marketing activities such as promotional
materials, electronic media and participation in industry
conferences.
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 accounting, consulting and
legal.
15
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 permits the grant of share options
and shares to our employees, consultants and non-employee members
of our board of directors for up to 1,345,074 shares of common
stock. Each January 1 the pool of shares available for issuance
under the Omnibus Plan will automatically increase 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.
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.
Recent Accounting Pronouncements
See Note 2 of the accompanying financial statements for a
discussion of recently issued accounting standards.
Results of Operations
Three Months Ended June 30, 2018 and 2017
Revenues
We had revenue of $0 for the three months ended June 30, 2018, as
compared to $57,772 for the three months ended June 30, 2017. The
revenue in 2017 was a result of service activity on our existing
installed base of Nexus 128 pre-clinical systems. On June 15, 2018,
we reported that would explore
strategic alternatives with respect to our pre-clinical business,
comprised of the assembly and sale of our Nexus 128 system,
including a potential sale. We will continue to honor our
commitments under current contracts relating to Nexus 128 systems,
but we do not expect to generate substantial revenue from this
business in the future.
Cost of Goods Sold
There
was no cost of goods sold for the three months ended June 30, 2018.
Cost of goods sold for the three months ended June 30, 2017 was
$51,427. The cost of goods sold was a result of product service
materials required for the service of a Nexus 128 system. Gross
margin was approximately 11% for the three months ended June 30,
2017.
Research and Development
Research
and development expenses were $839,756 for the three months ended
June 30, 2018, as compared to $174,725 for the three months ended
June 30, 2017, an increase of $665,031, or 381%. The costs include
primarily wages, fees and equipment for the development of our
TAEUS product line. Research and development expenses increased
from the same period for the prior year due primarily to increased
efforts to develop TAEUS applications with proceeds from our May
2017 initial public offering (the “IPO”), including by
our contracted development vendors.
16
Sales and Marketing
Sales
and marketing expenses were $41,357 for the three months ended June
30, 2018, as compared to $6,904 for the three months ended June 30,
2017, an increase of $34,453, or 499%. The increase was primarily
due to the hiring of a full-time sales representative for our Nexus
128 product line, which has since been discontinued. Currently our
marketing efforts are through our website and attendance of key
industry meetings. Our future clinical business will involve hiring
and training additional staff to support our sales efforts. As we
seek to complete the development and commercialization of our TAEUS
applications, we intend to build a small sales and marketing team
to train and support global ultrasound distributors, as well as
execute traditional marketing activities such as promotional
materials, electronic media and participation in industry
conferences.
General and Administrative
Our
general and administrative expenses for the three months ended June
30, 2018 were $941,956, an increase of $60,386, or 7%, compared to
$881,570 for the three months ended June 30, 2017. General and
administrative expenses increased due to an increase in headcount
and as a result of being a public company. Our wage and
related expenses for the three months ended June 30, 2018 were
$440,449, compared to $372,440 for the three months ended June 30,
2017. Wage and related expenses in the three months ended June 30,
2018, included $40,800 for bonuses, $163,371 of stock compensation
expense related to the issuance and vesting of options, compared to
$218,528 of stock compensation expense for the same period in 2017.
Our professional fees for the three months ended June 30, 2018 were
$438,402, compared to $441,592 for the three months ended June 30,
2017.
Net Loss
As a
result of the foregoing, for the three months ended June 30, 2018,
we recorded a net loss of $1,846,772 compared to a net loss of
$1,431,791 for the three months ended June 30, 2017.
Six Months Ended June 30, 2018 and 2017
Revenue
We had revenue of $6,174 for the six months ended June 30, 2018, as
compared to $57,772 for the six months ended June 30, 2017. The
revenue was a result of service activity on our existing installed
base of Nexus 128 pre-clinical systems. On June 15, 2018,
we reported that would explore
strategic alternatives with respect to our pre-clinical business,
comprised of the assembly and sale of its Nexus 128 system,
including a potential sale. We will continue to honor our
commitments under current contracts relating to Nexus 128 systems
but we do not expect to generate substantial revenue from this
business in the future.
Cost of Goods Sold
There
was no cost of goods sold for the six months ended June 30, 2018.
Cost of
goods sold was $51,427 for the six months ended June 30, 2017. The
cost of goods sold was a result of product service materials
required for the service of a Nexus 128 system. Gross margin was
approximately 11% for the six months ended June 30,
2017.
Research and Development
Research
and development expenses were $2,508,579 for the six months ended
June 30, 2018, as compared to $270,539 for the six months ended
June 30, 2017, an increase of $2,238,040, or 827%. The costs
include primarily wages, fees and equipment for the development of
our TAEUS product line. Research and development expenses increased
from the same period for the prior year due primarily to increased
efforts to develop TAEUS applications with proceeds from the IPO,
including by our contracted development vendors.
Sales and Marketing
Sales
and marketing expenses were $148,534 for the six months ended June
30, 2018, as compared to $8,028 for the six months ended June 30,
2017, an increase of $140,506, or 1,750%. The increase was
primarily due to the hiring of a full-time sales representative for
our discontinued Nexus 128 product line. Currently our marketing
efforts are through our website and attendance of key industry
meetings. Our future clinical business will involve hiring and
training additional staff to support our sales efforts. As we seek
to complete the development and commercialization of our TAEUS
applications, we intend to build a small sales and marketing team
to train and support global ultrasound distributors, as well as
execute traditional marketing activities such as promotional
materials, electronic media and participation in industry
conferences.
17
General and Administrative
Our
general and administrative expenses for the six months ended June
30, 2018 were $2,009,747, an increase of $864,418, or 75%, compared
to $1,145,329 for the six months ended June 30, 2017. General and
administrative expenses increased due to an increase in headcount
and as a result of being a public company. Our wage and
related expenses for the six months ended June 30, 2018 were
$916,703, compared to $499,206 for the six months ended June 30,
2017. Wage and related expenses in the six months ended June 30,
2018, included $177,950 for bonuses, $327,042 of stock compensation
expense related to the issuance and vesting of options, compared to
$239,225 of stock compensation expense for the same period in 2017.
Our professional fees for the six months ended June 30, 2018 were
$853,139, compared to $514,064 for the six months ended June 30,
2017.
Net Loss
As a
result of the foregoing, for the six months ended June 30, 2018, we
recorded a net loss of $4,672,075 compared to a net loss of
$2,173,414 for the six months ended June 30, 2017.
Liquidity and Capital Resources
To date
we have funded our operations through private and public sales of
our securities. As of June 30, 2018, we had approximately $2.2
million in cash. In May 2017, we completed the IPO, raising net
proceeds of approximately $8.6 million after deducting offering
expenses of approximately $0.8 million in underwriting discounts,
commissions and expenses and approximately $0.3 million in offering
expenses payable by us. In June 2018, we completed the placement of
senior secured convertible promissory notes and warrants, raising
net proceeds of approximately $935,000 after deducting offering
expenses of approximately $142,000 payable by us. The promissory
notes bear interest at a rate of 10% per annum until maturity on
December 31, 2018.
We
believe that cash on hand at June 30, 2018 will be sufficient to
fund our current operations into the fourth quarter of 2018. If we
do not raise additional capital in the next several months we will
need to significantly slow or pause our business activities until
such time as we are able to raise additional capital. We continue
to evaluate and manage our capital needs to support our clinical,
regulatory and operational activities and prepare for the results
of our human studies data and EU commercialization. We are
currently exploring potential financing options that may be
available to us, including additional sales of our common stock.
However, we have no commitments to obtain any additional funds, and
there can be no assurance such funds will be available on
acceptable terms or at all. If we are unable to obtain 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
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 financial statements, during the six months ended June
30, 2018, we incurred net losses of approximately $4.7 million, and
used cash in operations of approximately $4.3 million. These and
other factors raise substantial doubt about our ability to continue
as a going concern for one year from the issuance of the
accompanying financial statements. The financial statements do not
include any adjustments that might be necessary should we be unable
to continue as a going concern.
Operating Activities
During
the six months ended June 30, 2018, we used $4,331,230 of cash in
operating activities primarily as a result of our net loss of
$4,672,075, offset by share-based compensation of $749,749, $30,204
in depreciation and amortization expenses, $5,822 in amortization
of debt discount, and net changes in operating assets and
liabilities of $(445,020).
During
the six months ended June 30, 2017, we used $1,378,720 of cash in
operating activities primarily as a result of our net loss of
$2,173,414, offset in part by $711,472 for the amortization of
discount of convertible debt, $306,184 in non-cash stock
compensation expense, $30,964 in depreciation and amortization
expense, imputed interest of $1,480, and net changes in operating
assets and liabilities of $(225,406).
Investing Activities
There
were no investing activities for the six months ended June 30,
2018. During the six months ended June 30, 2017, the Company used
$7,862 in investing activities related to purchase of
equipment.
18
Financing Activities
During
the six months ended June 30, 2018, financing activities provided
$935,300 in proceeds from the placement of senior secured
convertible promissory notes.
During
the six months ended June 30, 2017, financing activities provided
$8,590,700 in proceeds from the IPO and $225,000 in proceeds from
convertible notes. The Company used $50,000 in repayments of notes
payable.
Funding Requirements
We have
not completed development 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;
●
prepare regulatory
filings required for marketing approval of our NAFLD TAEUS
application in the European Union and 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;
●
commence 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, 2017, entitled
“Risk Factors” and elsewhere in this Form 10-Q. 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.
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. 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.
Off-Balance Sheet Transactions
At June
30, 2018, the Company did not have any transactions, obligations or
relationships that could be considered off-balance sheet
arrangements.
19
Item 3. Quantitative and Qualitative Disclosure About Market
Risk
As a
smaller reporting company, we are not required to provide the
information required by this Item 3.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
As of the end of the period covered by this Form 10-Q, management
performed, with the participation of our principal executive
officer and principal financial officer, an evaluation of the
effectiveness of our disclosure controls and procedures as defined
in Rules 13a-15(e) and 15d-15(e) of the Securities and Exchange Act
of 1934, as amended (the “Exchange Act”). Our
disclosure controls and procedures are designed to ensure that
information required to be disclosed in the reports we file or
submit under the Exchange Act is recorded, processed, summarized,
and reported within the time periods specified in the SEC’s
forms, and that such information is accumulated and communicated to
our management, including our principal executive officer and
principal financial officer, to allow timely decisions regarding
required disclosures. Based on the evaluation, our principal
executive officer and principal financial officer concluded that,
as of June 30, 2018, our disclosure controls and procedures were
not effective.
A material weakness is a deficiency, or a combination of
deficiencies, in internal control over financial reporting, such
that there is a reasonable possibility that a material misstatement
of our annual or interim financial statements will not be prevented
or detected on a timely basis. We identified the following material
weakness as of June 30, 2018: insufficient personnel resources
within the accounting function to segregate the duties over
financial transaction processing and reporting.
To remediate our internal control weaknesses, management intends to
implement the following measures, as finances allow:
●
Adding sufficient accounting personnel or outside consultants to
properly segregate duties and to effect a timely, accurate
preparation of the financial statements.
● Developing and maintaining adequate written
accounting policies and procedures, once we hire additional
accounting personnel or outside consultants.
The
additional hiring is contingent upon our efforts to obtain
additional funding and the results of our operations. Management
expects to secure funds in the coming fiscal year but provides no
assurances that it will be able to do so.
Changes in Internal Control over Financial Reporting
There
was no change to our internal controls or in other factors that
could affect these controls during the three month period ended
June 30, 2018 that has materially affected, or is reasonably likely
to materially affect, our internal control over financial
reporting. However, our management is currently seeking to improve
our controls and procedures in an effort to remediate the
deficiency described above.
20
PART II – OTHER INFORMATION
Item 1. Legal Proceedings
We are
not currently a party to any pending legal proceedings that we
believe will have a material adverse effect on our business or
financial conditions. We may, however, be subject to various claims
and legal actions arising in the ordinary course of business from
time to time.
Item 1A. Risk Factors
In addition to the risk factor and uncertainties described below
and the other information set forth in this report, you should
carefully consider the factors discussed under “Risk
Factors” in our Annual Report on Form 10-K for the period
ended December 31, 2017, as filed with the Securities and Exchange
Commission on March 20, 2018. These factors could materially
adversely affect our business, financial condition, liquidity,
results of operations and capital position, and could cause our
actual results to differ materially from our historical results or
the results contemplated by any forward-looking statements
contained in this report.
We will need to raise additional capital to meet our business
requirements in the future, including obligations relating to
outstanding indebtedness, and such capital raising may be costly or
difficult to obtain and could dilute current stockholders’
ownership interests.
We have
a history of losses from operations and expect to continue to incur
losses until we are able to significantly grow our revenues.
In our June 2018 private placement
transaction (the “June 2018 Private Placement”), we
issued senior secured convertible promissory notes in the aggregate
principal amount of $1,077,000 with a maturity date of December 31,
2018. Accordingly, we will need additional financing to
maintain and expand our business and to repay the promissory notes
at maturity. Such financing may not be available on favorable
terms, if at all.
If we
are unable to obtain such additional financing on a timely basis,
we may have to curtail our development activities and growth plans
and/or be forced to sell assets, perhaps on unfavorable terms,
which would have a material adverse effect on our business,
financial condition and results of operations, and ultimately could
be forced to discontinue our operations and liquidate, in which
event it is unlikely that stockholders would receive any
distribution on their shares. See “Item 2. Management’s
Discussion and Analysis of Financial Condition and Results of
Operations—Liquidity and Capital Resources” above.
Further, we may not be able to continue operating if we do not
generate sufficient revenues from operations needed to stay in
business.
Any
additional capital raised through the sale of equity or
equity-linked securities may dilute current stockholders’
ownership percentages and could also result in a decrease in the
market value of our equity securities. Additionally, the terms of
any securities issued by us in future capital transactions may be
more favorable to new investors, and may include preferences,
superior voting rights and the issuance of warrants or other
derivative securities, which may have a further dilutive effect on
the holders of any of our securities then outstanding.
In
addition, we may incur substantial costs in pursuing future capital
financing, including investment banking fees, legal fees,
accounting fees, securities law compliance fees, printing and
distribution expenses and other costs. We may also be required to
recognize non-cash expenses in connection with certain securities
we issue, such as convertible promissory notes and warrants, which
may adversely impact our financial results.
Item 2. Recent Sales of Unregistered Securities; Use of Proceeds
from Registered Securities
Use of Proceeds from Registered Securities
On May
8, 2017, our Registration Statement on Form S-1, as amended (File
No. 333-193522), was declared effective by the SEC and, on May 8,
2017, our Registration Statement on Form S-1 (File No. 333-217788)
became effective upon filing with the SEC. Each such Registration
Statement was filed in connection with our initial public offering,
as a result of which we raised net proceeds of approximately $8.6
million.
There
has been no material change in the planned use of proceeds from our
initial public offering as described in the final prospectus filed
with the SEC pursuant to Rule 424(b) under the Securities Act on
May 10, 2017.
Item 3. Defaults Upon Senior Securities
Not
applicable.
21
Item 4. Mine Safety Disclosures
Not
applicable.
Item 5. Other Information
On
August 13, 2018, we issued an earnings release reporting our
results of operations for the three and six months ended June 30,
2018. A copy of that earnings release is furnished herewith as
Exhibit 99.1 pursuant to Item 2.02 of Form 8-K. This information
shall not be deemed filed for purposes of Section 18 of the
Securities Exchange Act of 1934, nor shall it be deemed
incorporated by reference in any filing under the Securities Act of
1933.
Item 6. Exhibits
Exhibit Number
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|
Description
|
|
Fourth
Amended and Restated Certificate of Incorporation of the Company
(incorporated by reference to Exhibit 3.2 to the Company’s
Current Report on Form 8-K filed on May 12, 2017)
|
|
|
Amended
and Restated Bylaws of the Company (incorporated by reference to
Exhibit 3.4 to the Company’s Registration Statement on Form
S-1 (File No. 333-214724), as amended, originally filed on November
21, 2016)
|
|
|
Specimen
Certificate representing shares of common stock of the Company
(incorporated by reference to Exhibit 4.1 to the Company’s
Registration Statement on Form S-1 (File No. 333-214724), as
amended, originally filed on November 21, 2016)
|
|
|
Form of
Warrant Agreement and Warrant comprising a part of the
Company’s units issued in its initial public offering
(incorporated by reference to Exhibit 4.2 to the Company’s
Registration Statement on Form S-1 (File No. 333-214724), as
amended, originally filed on November 21, 2016)
|
|
|
Form of
Underwriters’ Warrant issued to certain designees of the
underwriters in the Company’s 2017 initial public offering
(incorporated by reference to Exhibit 4.3 to the Company’s
Registration Statement on Form S-1 (File No. 333-214724), as
amended, originally filed on November 21, 2016)
|
|
|
Form of
Convertible Promissory Note issued in June 2018 Private Placement
(incorporated by reference to Exhibit 4.1 to the Company’s
Current Report on Form 8-K filed on July 2, 2018)
|
|
|
Form of
Warrant issued in June 2018 Private Placement (incorporated by
reference to Exhibit 4.2 to the Company’s Current Report on
Form 8-K filed on July 2, 2018)
|
|
|
Form of
Securities Purchase Agreement from June 2018 Private Placement,
dated June 28, 2018. (incorporated by reference to Exhibit 10.1 to
the Company’s Current Report on Form 8-K filed on July 2,
2018)
|
|
|
Form of
Registration Rights Agreement from June 2018 Private Placement,
dated June 28, 2018 (incorporated by reference to Exhibit 10.2 to
the Company’s Current Report on Form 8-K filed on July 2,
2018)
|
|
|
Form of
Security Agreement from June 2018 Private Placement, dated June 28,
2018 (incorporated by reference to Exhibit 10.3 to the
Company’s Current Report on Form 8-K filed on July 2,
2018)
|
|
|
Certification
of Periodic Report by Chief Executive Officer pursuant to Rule
13a-14(a)/15d-14a and pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002 (filed herewith)
|
|
|
Certification
of Periodic Report by Chief Financial Officer pursuant to Rule
13a-14(a)/15d-14a and pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002 (filed herewith)
|
|
|
Certification
of Periodic Report by Chief Executive Officer and Chief Financial
Officer pursuant to U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 (filed
herewith)
|
|
|
Earnings release issued August 13, 2018 (furnished
herewith)
|
|
101.INS
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XBRL
Instance Document (filed herewith)
|
101.SCH
|
|
XBRL
Taxonomy Schema (filed herewith)
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101.CAL
|
|
XBRL
Taxonomy Extension Calculation Linkbase (filed
herewith)
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101.DEF
|
|
XBRL
Taxonomy Extension Definition Linkbase (filed
herewith)
|
101.LAB
|
|
XBRL
Taxonomy Extension Label Linkbase (filed herewith)
|
101.PRE
|
|
XBRL
Taxonomy Extension Presentation Linkbase (filed
herewith)
|
22
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned, thereunto duly
authorized.
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ENDRA LIFE SCIENCES INC.
|
|
|
(Registrant)
|
|
|
|
|
|
|
|
Date:
August 13, 2018
|
By:
|
/s/ Francois
Michelon
|
|
|
Name:
Francois Michelon
|
|
|
Title:
Chief Executive Officer and Chairman
(Principal
Executive Officer)
|
Date:
August 13, 2018
|
By:
|
/s/ David
Wells
|
|
|
Name:
David Wells
|
|
|
Title:
Chief Financial Officer
(Principal
Financial and Accounting Officer)
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23