ENDRA Life Sciences Inc. - Quarter Report: 2017 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, 2017
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 ☐
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Accelerated filer ☐
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Non-accelerated filer ☐ (Do not check if smaller reporting
company)
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Smaller
reporting company ☑
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Emerging
growth company ☑
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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 3, 2017, there were 3,907,027 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, 2017
INDEX
PART I - FINANCIAL INFORMATION
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PAGE
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Item 1. Financial Statements
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1
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Item 2. Management’s Discussion and Analysis of Financial
Condition and Results of Operations
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12
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Item 3. Quantitative and Qualitative Disclosure About Market
Risk
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17
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Item 4. Controls and Procedures
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17
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PART II – OTHER INFORMATION
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Item 1. Legal Proceedings
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18
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Item 1A. Risk Factors
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18
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Item 2. Recent Sales of Unregistered Securities; Use of Proceeds
from Registered Securities
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18
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Item 3. Defaults Upon Senior Securities
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19
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Item 4. Mine Safety Disclosures
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19
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Item 5. Other Information
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19
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Item 6. Exhibits
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19
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SIGNATURES
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19
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EXHIBIT INDEX
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21
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PART I - FINANCIAL INFORMATION
ENDRA Life Sciences
Inc.
Condensed Balance Sheets
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June
30,
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December
31,
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Assets
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2017
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2016
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Assets
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(Unaudited)
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Cash
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$7,524,071
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$144,953
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Prepaid
expenses
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4,200
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-
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Inventory
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133,422
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40,105
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Other current
assets
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10,806
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10,535
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Total Current
Assets
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7,672,500
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195,594
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Other
Assets
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Fixed assets,
net
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272,066
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295,168
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Total
Assets
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$7,944,565
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$490,761
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Liabilities and Stockholders’ Equity
(Deficit)
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Current
Liabilities
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Accounts payable
and accrued liabilities
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$162,302
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$434,552
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Notes
payable
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-
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50,000
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Convertible notes
payable, related party, net of discount
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-
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99,804
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Convertible notes
payable, net of discount
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-
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800,172
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Total Current
Liabilities
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162,302
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1,384,528
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Total
Liabilities
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162,302
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1,384,528
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Stockholders’
Equity (Deficit)
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Preferred stock,
$0.0001 par value; 10,000,000 shares authorized; no shares issued
or outstanding at June 30, 2017 and December 31, 2016
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-
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-
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Common stock,
$0.0001 par value; 50,000,000 shares authorized; 3,907,027 and
723,335 shares issued and outstanding at June 30, 2017 and December
31, 2016
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390
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72
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Stock
payable
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-
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81,000
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Additional paid in
capital
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22,473,759
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11,543,634
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Accumulated
deficit
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(14,691,886)
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(12,518,473)
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Total
Stockholders’ Equity (Deficit)
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7,782,263
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(893,767)
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Total
Liabilities and Stockholders’ Equity (Deficit)
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$7,944,565
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$490,761
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The
accompanying notes are an integral part of these unaudited
condensed financial
statements.
1
ENDRA Life Sciences
Inc.
Condensed 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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2017
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2016
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2017
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2016
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Revenue
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$57,772
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$-
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$57,772
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$-
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Cost
of Goods Sold
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51,427
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-
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51,427
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-
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Gross Profit
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$6,345
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$-
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$6,345
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$-
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Operating Expenses
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Research
and development
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174,726
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103,640
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270,540
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198,877
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Sales
and marketing
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6,904
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5,724
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8,028
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10,157
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General
and administrative
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882,570
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384,948
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1,146,330
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658,734
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Total
operating expenses
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1,064,200
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494,312
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1,424,898
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867,768
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Operating
loss
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(1,057,855)
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(494,312)
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(1,418,553)
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(867,768)
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Other Expenses
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Loss
on warrant exercise
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-
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(5,823)
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Interest
expense
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(373,936)
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(234,802)
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(754,860)
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(235,000)
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Total
other expenses
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(373,936)
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(234,802)
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(754,860)
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(240,823)
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Loss
from operations before income taxes
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(1,431,791)
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(729,114)
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(2,173,413)
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(1,108,591)
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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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$(1,431,791)
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$(729,114)
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$(2,173,413)
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$(1,108,591)
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Net loss per share – basic and diluted
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$(0.59)
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$(1.01)
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$(1.37)
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$(1.53)
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Weighted average common shares – basic and
diluted
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2,437,010
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723,335
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1,584,906
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723,233
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The
accompanying notes are an integral part of these unaudited
condensed financial
statements.
2
ENDRA Life Sciences
Inc.
Condensed 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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2017
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2016
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Cash
Flows from Operating Activities
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Net
loss
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$(2,173,413)
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$(1,108,591)
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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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30,964
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32,272
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Common stock,
options and warrants issued for services
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306,184
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87,240
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Additional warrants
issued during exchange
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-
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5,823
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Amortization of
discount of convertible debt
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711,472
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215,693
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Imputed interest on
promissory notes
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1,480
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-
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Changes in
operating assets and liabilities:
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Increase in prepaid
expenses
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(4,200)
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-
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Increase in
inventory
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(93,317)
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(21,375)
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Increase in other
assets
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(271)
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(439)
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Increase (decrease)
in accounts payable and accrued liabilities
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(157,619)
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19,918
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Net cash used in
operating activities
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(1,378,720)
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(769,459)
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Cash
Flows from Investing Activities:
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Purchases of fixed
assets
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(7,862)
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-
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Net cash used in
investing activities
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(7,862)
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-
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Cash
Flows from Financing Activities
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Proceeds from
issuance of common stock
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8,590,700
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5,000
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Proceeds from notes
payable
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-
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50,000
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Repayment of notes
payable
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(50,000)
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-
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Proceeds from
convertible notes
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225,000
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1,199,448
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Net cash provided
by financing activities
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8,765,700
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1,254,448
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Net increase in
cash
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7,379,118
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484,989
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Cash, beginning of
period
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144,953
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19,128
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Cash,
end of period
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$7,524,071
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$504,117
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Supplemental
disclosures:
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Interest
paid
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$-
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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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Discount on
convertible notes
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$225,000
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$-
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Common shares to be
issued for accrued salaries - related parties
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$-
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$60,910
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Conversion of
convertible notes
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$1,951,200
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$-
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The
accompanying notes are an integral part of these unaudited
condensed financial
statements.
3
ENDRA Life Sciences Inc.
Notes to Condensed Financial Statements
For the three and six months ended June 30, 2017 and
2016
(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 one-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 share of common stock. See Note 6 below.
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.
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-month periods ended June 30, 2017
are not necessarily indicative of the results that may be expected
for the year ended December 31, 2017. The balance sheet at December
31, 2016 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,
2016 included in Amendment No. 10 to the Company’s
Registration Statement on Form S-1 filed with the SEC on May 1,
2017.
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 three months or
less, when purchased, to be cash and cash equivalents. As of June
30, 2017 and December 31, 2016, the Company had no cash
equivalents. The Company maintains its cash in bank deposit
accounts which, at times, may exceed federally insured
limits.
Inventory
The
Company’s inventory is stated at the lower of cost or
estimated 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, 2017 and December 31, 2016, 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.
4
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
The
Company recognizes revenue in accordance with the requirements of
ASC 605-10-599, which directs that it should recognize revenue when
(1) persuasive evidence of an arrangement exists (contracts); (2)
delivery has occurred; (3) the seller’s price is fixed or
determinable (per the customer’s contract); and (4)
collectability is reasonably assured (based upon our credit
policy). For products sold to end users revenue is recognized when
title has passed to the customer and collectability is reasonably
assured; and no further efforts are required. Future revenue from
anticipated new products will follow this same policy.
Income Taxes
The
Company utilizes ASC 740, “Income Taxes,” which
requires the recognition of deferred tax assets and liabilities for
the expected future tax consequences of events that have been
included in the financial statements or tax returns. Under this
method, deferred tax assets and liabilities are determined based on
the difference between the tax basis of assets and liabilities and
their financial reporting amounts based on enacted tax laws and
statutory tax rates applicable to the periods in which the
differences are expected to affect taxable income. A valuation
allowance is recorded when it is “more likely-than-not”
that a deferred tax asset will not be realized.
The
Company generated a deferred tax asset through net operating loss
carry-forwards. However, a valuation allowance of 100% has been
established due to the uncertainty of the Company’s
realization of the net operating loss carry forward prior to its
expiration.
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 three and six months ended June
30, 2017, the Company incurred $174,726 and $270,540 of expenses
related to research and development costs, respectively. During the
three and six months ended June 30, 2016, the Company incurred
$103,640 and $198,877 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 3,176,262 and
1,346,441 potentially dilutive shares, which include outstanding
common stock options, warrants, and convertible notes, as of June
30, 2017 and December 31, 2016, 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:
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June 30,
2017
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December 31,
2016
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Options
to purchase common stock
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928,121
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151,881
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Warrants
to purchase common stock
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2,248,141
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152,812
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Convertible
notes
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-
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1,041,748
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Potential
equivalent shares excluded
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3,176,262
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1,346,441
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Fair Value Measurements
Disclosures about fair value of financial instruments require
disclosure of the fair value information, whether or not recognized
in our balance sheet, where it is practicable to estimate that
value. As of June 30, 2017 and December 31, 2016, the amounts
reported for cash, accrued liabilities and accrued interest
approximated fair value because of their short
maturities.
5
In accordance with ASC Topic 820, “Fair Value Measurements
and Disclosures,” the Company measure 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:
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●
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Level
1, defined as observable inputs such as quoted prices for identical
instruments in active markets;
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●
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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
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●
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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.
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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, which has been
approved by its board of directors, permits the grant of share
options and shares to its employees, consultants and non-employee
members of the board of directors for up to 1,345,074 shares of
common stock, of which approximately 500,000 remain available to be
granted. 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) and
in 2016. A nonpublic entity that is unable to estimate the expected
volatility of the price of its underlying share 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 bench mark for the
volatility of the entity’s own share price. Prior to June 28,
2017, there was no active market for the Company’s common
shares. The Company has used the historical closing values of these
companies to estimate volatility, which was calculated to be
90%.
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.
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 debenture 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:
6
●
|
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 entity
determined the instrument meets the guidance under ASC 480 the
instrument is accounted for as a liability with a respective debt
discount. The Company records debt discounts in connection with
raising funds through the issuance of promissory notes (see Note
5). 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.
|
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 a limited operating history and
had a cumulative net loss from inception to June 30, 2017 of
$14,691,886. The Company had working capital of $7,510,198 as of
June 30, 2017. The Company has not yet 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, 2017 have been prepared
assuming the Company will continue as a going concern. The
Company’s cash resources could 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 forced to delay or
scale down some or all of its development activities 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 within one
year after the date that the financial statements are issued. 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 will supersede
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. Early adoption is permitted only
in annual reporting periods beginning after December 15, 2016,
including interim periods therein. 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 is currently in the process of analyzing the
information necessary to determine the impact of adopting this new
guidance on its financial position, results of operations, and cash
flows. The Company plans to adopt the provisions of this statement
in the first quarter of fiscal 2018.
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.
7
Other
recent accounting pronouncements issued by the FASB, including its
Emerging Issues Task Force, the American Institute of Certified
Public Accountants, and the Securities and Exchange Commission did
not or are not believed by management to have a material impact on
the Company’s present or future financial
statements.
Note 3 – Inventory
As of
June 30, 2017 and 2016, inventory consisted of raw materials to be
used in the assembly of a Nexus 128 system. As of June 30, 2017 the
Company had one order pending for the sale of a Nexus 128 system,
and as of June 30, 2016 there were no orders pending for such
units.
Note 4 – Fixed Assets
As of
June 30, 2017 and December 31, 2016, fixed assets consisted of the
following:
|
June
30,
2017
|
December
31,
2016
|
Computer equipment
and fixtures
|
$579,179
|
$571,318
|
Accumulated
depreciation
|
(307,113)
|
(276,150)
|
Fixed assets,
net
|
$272,066
|
$295,168
|
Depreciation
expense for the three months ended June 30, 2017 and 2016 was
$15,274 and $16,091, respectively. Depreciation expense for the six
months ended June 30, 2017 and 2016 was $30,964 and $32,272,
respectively.
Note 5 – Current Liabilities
As of
June 30, 2017 and December 31, 2016, current liabilities consisted
of the following:
|
June 30,
2017
|
December 31,
2016
|
Accounts
payable
|
$132,646
|
$227,744
|
Accrued
payroll
|
-
|
105,258
|
Accrued
employee benefits
|
29,656
|
29,552
|
Accrued
interest
|
-
|
71,998
|
Notes
payable
|
-
|
50,000
|
Convertible
notes, related party, net of discount
|
-
|
99,804
|
Convertible
notes, net of discount
|
-
|
800,172
|
Total
|
$162,302
|
$1,384,528
|
On
January 28, 2016, the Company entered into promissory notes with
three investors for a total amount of $50,000. The notes
matured one year from the issue date, accrued no interest and were
payable at maturity. Prior to the maturity date, the Company and
the promissory note holders agreed to extend the maturity date of
all three notes to July 31, 2017, on the same terms as previously
agreed. The Company accounted for imputed interest of $493
and $1,480 for the three and
six months ended June 30, 2017, respectively, which was calculated
at a rate of 8% per annum, consistent with other notes issued by
the Company. During the three-month period ended June 30, 2017, the
promissory notes were repaid in full to all holders.
During
2016, the Company entered into convertible promissory notes with
approximately 60 investors for a total principal amount of
$1,386,448, $132,000 of which were purchased by related parties
(the “2016 Notes”). On March 15, 2017, the Company
extended the 2016 Notes offering by $250,000. The extension was
made available only to existing noteholders and obtained
subscriptions for $225,000. Pursuant to the terms of the 2016
Notes, noteholders holding a majority of the outstanding principal
amount of the 2016 Notes elected to convert the principal and
accrued interest on all outstanding 2016 Notes into shares of the
Company’s common stock at a conversion price of $1.40 per
share immediately prior to the Company’s initial public
offering. 1,232,859 shares of the Company’s common stock were
issued upon such conversion (see Note 6). In connection with the
issuance of the 2016 Notes, the Company recorded a debt discount at
an initial aggregate value of $1,611,448, of which $359,745 and
$711,472 was amortized during the three and six months ended June
30, 2017, respectively, resulting in a debt discount balance of $0
as of June 30, 2017. The Company accrued interest expenses of
$14,495 and $42,633 for the three- and six-month periods ended June
30, 2017, respectively.
In
connection with the funding of the IPO, on May 12, 2017, the
principal and interest due under the Company’s convertible
notes, in an aggregate amount of $1,726,079, was converted into
1,232,859 shares of the Company’s common stock. The
purchasers of the convertible notes are subject to lock-up
requirements with respect to the conversion shares for periods that
expire on May 9, 2018.
8
Note 6 – Capital Stock
At June
30, 2017, 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.
Reverse Stock Split
On May
8, 2017, the Company filed a certificate of amendment (the
“Certificate of Amendment”) to its certificate of
incorporation with the Secretary of State of the State of Delaware
to effect the Reverse Split of the Company’s common stock,
with no reduction in authorized capital stock. Pursuant to the
terms of the Certificate of Amendment, the Reverse Split became
effective at 11:59 p.m. Eastern Time on May 8, 2017. In the Reverse
Split, every 3.5 outstanding shares of common stock became one
share of common stock. No fractional shares were issued in
connection with the Reverse Split. Subject to the terms of the
Certificate of Amendment, stockholders who were otherwise entitled
to receive a fractional share of common stock received one whole
share of common stock.
The
Reverse Split was previously approved by holders of a majority of
the Company’s issued and outstanding common stock. All common
stock and stock incentive plan information in these financial
statements has been restated to reflect this split.
Initial Public Offering of Units
The
Company’s Registration Statement on Form S-1, as amended
(Reg. No. 333-214724), was declared effective by the Securities and
Exchange Commission (the “SEC”) on May 8, 2017, and the
Company’s Registration Statement on Form S-1 (Reg. No.
333-217788), which was filed on May 8, 2017 with the SEC pursuant
to Rule 462(b) of the Securities Act of 1933, as amended (the
“Securities Act”), became effective upon filing. These
registration statements registered the securities offered in the
Company’s initial public offering (the “IPO”). In
the IPO, the Company sold 1,932,000 units at a price to the public
of $5.00 per unit, including the full exercise of the
underwriters’ option to purchase additional units. Each unit
consisted of one share of the Company’s common stock and a
warrant to purchase a share of the Company’s common stock at
an exercise price of $6.25 per share. The warrants terminate on May
12, 2022.
The IPO
closed on May 12, 2017 and the underwriters exercised their
overallotment option as of May 22, 2017, as a result of which the
Company raised net proceeds of approximately $8.6 million after
deducting approximately $773,000 in underwriting discounts,
commissions and expenses and approximately $297,000 in offering
expenses payable by the Company. National Securities Corporation
and Dougherty & Company LLC were the underwriters of the IPO.
No payments were made by the Company to its directors or officers
or persons owning ten percent or more of its common stock or to
their associates, or to the Company’s affiliates, other than
payments in the ordinary course of business to officers for
salaries and to non-employee directors as compensation for board or
board committee service.
The
shares of common stock and warrants initially traded together on
the Nasdaq Capital Market as units under the symbol
“NDRAU”.
Effective
at 12:01 a.m. on June 28, 2017, each of the Company’s units
issued in the IPO separated into one share of the Company’s
common stock and a warrant to purchase a share of the
Company’s common stock. Following separation, the common
stock and warrants included in the units commenced trading on The
Nasdaq Capital Market separately under the symbols
“NDRA” and “NDRAW,” respectively, and
trading of the units under the symbol “NDRAU” was
suspended.
Conversion of Convertible Notes
In
connection with the funding of the IPO, on May 12, 2017, the
principal and interest due under the Company’s convertible
notes, in an aggregate amount of $1,726,079, was converted into
1,232,859 shares of the Company’s common stock. The
purchasers of the convertible notes are subject to lock-up
requirements with respect to the conversion shares for periods that
expire on May 9, 2018.
During
the six months ended June 30, 2017, the Company issued 18,833
shares of common stock for services valued at $94,165 to a firm
owned by David Wells, the Company’s Chief Financial
Officer.
As of
June 30, 2017, there were 3,907,027 shares of common stock issued
and outstanding and no preferred stock outstanding.
Note 7 – 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 months ended June 30, 2017 was
determined to be $3,198,853 using the Black-Scholes-Merton
option-pricing model based on the following assumptions: (i)
volatility rate of 90%, (ii) discount rate of 0%, (iii) zero
expected dividend yield, and (iv) expected life of 4 to 8 years. A
summary of option activity under the Company’s stock options
as of June 30, 2017, and changes during the six-month period then
ended is presented below:
9
|
Number of
Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
|
Balance outstanding
at December 31, 2016
|
151,890
|
$9.99
|
2.47
|
Granted
|
791,216
|
4.94
|
7.77
|
Exercised
|
-
|
-
|
-
|
Forfeited
|
-
|
-
|
-
|
Cancelled or
expired
|
(14,985)
|
10.02
|
-
|
Balance outstanding
at June 30, 2017
|
928,121
|
$5.69
|
6.95
|
Exercisable at June
30, 2017
|
144,110
|
$8.92
|
3.14
|
During
the six months ended June 30, 2017, in connection with the closing
of the IPO, the Company issued to the underwriters and their
designees warrants to purchase an aggregate of 154,560 shares of
the Company’s common stock (the “Underwriters’
Warrants”) at an exercise price of $6.25 per share with an
expiration date of May 8, 2022. The Underwriters’ Warrants
become exercisable on November 8, 2017.
During
the six months ended June 30, 2017, the Company granted warrants to
purchase 10,000 shares of common stock with an exercise price of
$5.50 per share for services. The warrants vest in six monthly
installments beginning on June 12, 2017. The fair value of these
warrants was determined to be $27,779 using the
Black-Scholes-Merton option-pricing model based on the following
assumptions: (i) volatility rate of 90%, (ii) discount rate of 0%,
(iii) zero expected dividend yield, and (iv) expected life of 3
years. During the six months ended June 30, 2017, $5,823 was
expensed.
The
following table summarizes all stock warrant activity of the
Company for the six months ended June 30, 2017:
|
Number of
Warrants
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
|
Balance outstanding
at December 31, 2016
|
152,828
|
$5.41
|
3.30
|
Granted
|
2,096,563
|
6.25
|
4.86
|
Exercised
|
-
|
-
|
-
|
Forfeited
|
-
|
-
|
-
|
Expired
|
(1,250)
|
10.02
|
-
|
Balance outstanding
at June 30, 2017
|
2,248,141
|
$7.11
|
4.72
|
Exercisable at June
30, 2017
|
2,085,245
|
$7.18
|
4.72
|
Note 8 –
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. 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:
2017
|
$37,657
|
2018
|
77,348
|
2019
|
79,269
|
Total
|
$194,274
|
For the
three- and six-month periods ended June 30, 2017, the Company
incurred rent expenses of $12,732 and $31,700, respectively. For
the three- and six-month periods ended June 30, 2016, the Company
incurred rent expenses of $18,959 and $37,124,
respectively.
10
Employment and Consulting Agreements
On
November 11, 2007, the Company entered into an at-will employment
agreement with Michael Thornton, its Chief Operating Officer (now
its Chief Technology Officer). The employment agreement required
annual base salary payments of $200,000 per year, with a bonus
potential of 20% of the then current base salary. In addition, the
executive was granted an option to purchase 29,429 shares of
Company's common stock exercisable at $10.01 per share, vesting in
3 equal annual installments on each anniversary of its three year
term. The agreement also provided for severance compensation if
terminated other than for cause (as defined therein) of 6 months of
the then applicable base salary if he had been employed at least 6
months, and compensation equal to 12 months of the then applicable
base salary if employed over 12 months. Effective May 12, 2017, the
Company and Mr. Thornton entered into a new employment agreement,
as described below.
On
August 28, 2014, the Company entered into a services agreement with
StoryCorp Consulting dba Wells Compliance Group
(“StoryCorp”) for financial reporting and compliance
services. David R. Wells is the owner of this firm and is the
Company’s Chief Financial Officer. The services agreement
called for monthly payments of $5,000, and accrued an additional
$3,000 per month in fees to be paid by common stock at the time of
a public offering. The accrued balance due under the cash portion
as of June 30, 2017 and December 31, 2016 was $0 and $25,000,
respectively, and the accrued balance due under the stock portion
was $0 and $81,000, respectively. Effective May 12, 2017, the
Company entered into a consulting agreement with StoryCorp that
superseded the services agreement, as described below.
On
April 16, 2015, the Company entered into an at-will employment
agreement with Francois Michelon, its Chief Executive Officer. The
employment agreement required annual base salary payments of
$250,000 per year with a bonus potential of 50% of the then current
base salary. In addition, the executive was granted an option to
purchase 35,499 shares of Company’s common stock exercisable
at $10.01 per share, vesting in 3 equal annual installments on each
anniversary of its three year term. The agreement also provided for
severance compensation if terminated other than for cause (as
defined therein) of 6 months of the then applicable base salary if
he has been employed at least 6 months, and compensation equal to
12 months of the then applicable base salary if employed over 12
months. Effective May 12, 2017, the Company and Mr. Michelon
entered into a new employment agreement, as described
below.
Effective
as of May 12, 2017, upon the closing of the IPO, the Company
entered into amended and restated employment agreements with Mr.
Michelon and Mr. Thornton. Mr. Michelon’s employment
agreement provides for an annual base salary of $325,000 and
eligibility for an annual cash bonus up to a percentage of such
base salary (in 2016, up to 35% of his base salary then in effect).
Mr. Thornton’s employment agreement provides for an annual
base salary of $245,000 and eligibility for an annual cash bonus up
to a percentage of such base salary (in 2016, up to 22% of his base
salary then in effect). The employment agreements also provide for
eligibility to receive benefits substantially similar to those of
the Company’s other senior executive officers.
Pursuant to the employment agreements, in connection with the
closing of the IPO, Mr. Michelon and Mr. Thornton were granted
stock options to purchase 339,270 and 345,298 shares of the
Company’s common stock, respectively, which, taken together
with the number of shares such officer already held, equaled 5.0%
of the Company’s total issued and outstanding shares of
common stock on a fully diluted basis following the IPO and
underwriters’ exercise of their overallotment option. The
stock options have a weighted average exercise price of
approximately $4.96, and vest in three equal annual installments
beginning on May 12, 2018.
Effective as of May 12, 2017, the Company entered into a consulting
agreement with StoryCorp, pursuant to which Mr. Wells will continue
to provide services to the Company as its Chief Financial Officer.
Pursuant to the consulting agreement, the Company will pay 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 IPO, having an exercise price per share equal to
$5.00 (the price per unit to the public in the IPO) and vesting in
twelve equal quarterly installments, and 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. The consulting agreement supersedes the
services agreement previously in effect between the Company and
StoryCorp.
Litigation
From time to time the Company may become a party to litigation in
the normal course of business. Management believes that there are
no current legal matters that would have a material effect on the
Company’s financial position or results of
operations.
Note 9 – Subsequent Events
ENDRA
Life Sciences Canada Inc. was organized under the laws of Ontario,
Canada on July 6, 2017, and is wholly owned by the
Company.
11
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. 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 ability to develop a commercially feasible
technology; receipt of necessary regulatory approvals; our ability
to find and maintain development partners, market acceptance of our
technology, the amount and nature of competition in our industry;
our ability to protect our intellectual property; and the other
risks and uncertainties described in the Risk Factors section of
our Quarterly Report on Form 10-Q for the period ended March 31,
2017, as filed with the SEC on June 21, 2017, 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 have
commercialized an enhanced ultrasound technology for the
pre-clinical research market and are leveraging that expertise 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.
Since
2010, we have marketed and sold our Nexus 128 system, which
combines light-based thermoacoustics and ultrasound, to address the
imaging needs of researchers studying disease models in
pre-clinical applications. Sales of the Nexus 128 system were
approximately $1.4 million in 2015 and $515,000 in 2016. Our Nexus
128 system is used in a number of leading global academic research
centers, including Stanford University, The University of Michigan,
Shanghai Jiao Tong University, and Purdue University. We expect to
continue to sell our Nexus 128 system to maintain a base level of
revenue, but believe the market potential for our clinical systems
is much higher.
Building
on our expertise in thermoacoustics, we 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 Nexus 128 system, our
TAEUS technology uses radio frequency (“RF”) pulses to
stimulate tissues, using a small fraction of the energy 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 overlaid in real
time onto 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.
12
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
April 21, 2017, we and GE Healthcare entered into an amendment to
our agreement, extending its term by one year to April 22,
2018.
Financial Operations Overview
Revenue
To date
our revenue has been generated by the placement and sale of our
Nexus 128 system for use in pre-clinical applications.
Cost of Goods Sold
Our
cost of goods sold is related to our direct costs associated with
the development and shipment of our thermoacoustic imaging 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
our 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 for our pre-clinical business are through distributors in
China, the European Union, Australia, Korea and the United Kingdom,
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.
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.
13
Share-based Compensation
Our
2016 Omnibus Incentive Plan, which has been approved by our board
of directors, 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. 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 financial statements for a discussion of recently
issued accounting standards.
Results of Operations
Three Months Ended June 30, 2017 and 2016
Revenues
We had
revenue of $57,772 for the three months ended June 30, 2017, as
compared to $0 for the three months ended June 30, 2016. The
revenue was a result of product service fees generated from our
installed base of Nexus 128 laboratory imaging systems in the three
months ended June 30, 2017.
Cost of Goods Sold
Cost of
goods sold was $51,427 and $0 for the three months ended June 30,
2017 and 2016, respectively. The cost of goods sold was a result of
product service materials required for the service of a unit in our
installed base of Nexus 128 laboratory imaging systems. Gross
margin was approximately 11% for the three months ended June 30,
2017.
Research and Development
Research
and development expenses were $174,726 for the three months ended
June 30, 2017, as compared to $103,640 for the three months ended
June 30, 2016, an increase of $71,086, or 69%. 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
wages and employment related expenses.
Sales and Marketing
Sales
and marketing expenses were $6,904 for the three months ended June
30, 2017, as compared to $5,724 for the three months ended June 30,
2016, an increase of $1,180, or 21%. Currently our marketing
efforts for our pre-clinical business are through distributors in
China, the European Union, Australia and the United Kingdom, 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, 2017 were $882,570, an increase of $497,622, or 129%, compared
to $384,948 for the three months ended June 30, 2016. General and
administrative expenses increased due to an increase in headcount
and one-time expenses related to the IPO. Our wage and related expenses for the
three months ended June 30, 2017 were $372,440, compared to
$158,112 for the three months ended June 30, 2016. Wage and related
expenses in the three month period ended June 30, 2017 included
$218,528 of stock compensation expense related to the issuance and
vesting of options, compared to $0 of stock compensation expense
for the same period in 2016. Our professional fees for the three
months ended June 30, 2017 were $414,444, compared to $178,520 for
the three months ended June 30, 2016.
14
Net loss
As a
result of the foregoing, for the three months ended June 30, 2017,
we recorded a net loss of $1,431,791 compared to a net loss of
$729,114 for the three months ended June 30, 2016.
Six Months Ended June 30, 2017 and 2016
Revenues
We had
revenue of $57,772 for the six months ended June 30, 2017, as
compared to $0 for the six months ended June 30, 2016. The revenue
was a result of product service fees generated from our installed
base of Nexus 128 laboratory imaging systems for the six months
ended June 30, 2017.
Cost of Goods Sold
Cost of
goods sold was $51,427 and $0 for the six months ended June 30,
2017 and 2016, respectively. The cost of goods sold was a result of
product service materials required for the service of a unit in our
installed base of Nexus 128 laboratory imaging systems. Gross
margin was approximately 11% for the six months ended June 30,
2017.
Research and Development
Research
and development expenses were $270,540 for the six months ended
June 30, 2017, as compared to $198,877 for the six months ended
June 30, 2016, an increase of $71,663, or 36%. 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 due to
increased wages and employment related expenses.
Sales and Marketing
Sales
and marketing expenses were $8,028 for the six months ended June
30, 2017, as compared to $10,157 for the six months ended June 30,
2016, a decrease of $2,129, or 21%. The decrease was primarily due
to reduced commissions paid on the sale of our Nexus 128 system.
Currently our marketing efforts for our pre-clinical business are
through distributors in China, the European Union, Australia and
the United Kingdom, 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 six months ended June
30, 2017 were $1,146,330, an increase of $487,597, or 74%, compared
to $658,734 for the six months ended June 30, 2016. General and
administrative expenses increased due to an increase in headcount
and one-time expenses related to the IPO. Our wage and related expenses for the
six months ended June 30, 2017 were $499,206, compared to $317,512
for the six months ended June 30, 2016. Wage and related expenses
in the six month period ended June 30, 2017 included $239,225 of
stock compensation expense related to the issuance and vesting of
options, compared to $69,240 of stock compensation expense for the
same period in 2016. Our professional fees for the six months ended
June 30, 2017 were $486,916, compared to $234,945 for the six
months ended June 30, 2016.
Net loss
As a
result of the foregoing, for the six months ended June 30, 2017, we
recorded a net loss of $2,173,413 compared to a net loss of
$1,108,591 for the six months ended June 30, 2016.
Liquidity and Capital Resources
To
date, we have generated only limited revenues from sales of our
Nexus 128 system. We have funded our operations to date through
private and public sales of our securities. As of June 30, 2017, we
had $7,524,071 in cash. In May 2017, we completed the IPO, raising
net proceeds of approximately $8.6 million after deducting offering
expenses of approximately $773,000 in underwriting discounts,
commissions and expenses and approximately $297,000 in offering
expenses payable by the Company.
The
financial statements included in this Form 10-Q have been prepared
assuming the Company 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, 2017, the Company incurred net losses of
$2,173,413, and used cash in operations of $1,378,720. These and
other factors raise substantial doubt about the Company’s
ability to continue as a going concern for one year from the
issuance of the financial statements. The financial statements do
not include any adjustments that might be necessary should the
Company be unable to continue as a going concern.
15
Operating Activities
During
the six months ended June 30, 2017, the Company used $1,378,720 of
cash in operating activities primarily as a result of its net loss
of $2,173,413, offset by amortization of discount of convertible
debt of $711,472, share-based compensation of $306,184, $30,964 in
depreciation and amortization expenses, and net changes in
operating assets and liabilities of $(255,407).
During
the six months ended June 30, 2016, the Company used $769,459 of
cash in operating activities primarily as a result of its net loss
of $1,108,591, offset in part by net changes in operating assets
and liabilities of $(1,896), $32,272 in depreciation and
amortization expense, $87,240 in non-cash stock compensation
expense, amortization of discount of convertible debt of $215,693,
and additional warrants of $5,823 issued during the warrant
exchange program, pursuant to which the Company issued warrants to
participating warrant holders in exchange for such
participants’ exercising their then-held
warrants.
Investing Activities
During
the six months ended June 30, 2017, the Company used $7,862 in
investing activities related to purchase of equipment. There were
no investing activities for the six months ended June 30,
2016.
Financing Activities
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.
During
the six months ended June 30, 2016, financing activities provided
$1,254,448, including $5,000 from common stock issued for cash,
$50,000 in proceeds from notes payable, and $1,199,448 in proceeds
from convertible notes.
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
applications 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.
We
believe that our existing cash, taking into account the net
proceeds of our IPO, will be sufficient for us to fund the
development and regulatory approval and to prepare for the
commercialization of our NAFLD TAEUS application in the European
Union. 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 Quarterly
Report on Form 10-Q for the period ended March 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.
16
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. 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
We do
not have any off balance sheet transactions.
Item 3. Quantitative and Qualitative Disclosure About Market
Risk
The
information required by Item 3 is not required to be provided by
issuers that satisfy the definition of “smaller reporting
company” under Securities and Exchange Commission
rules.
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 Securities
and Exchange Commission’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, 2017, 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, 2017: 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:
●
We
will add sufficient accounting personnel or outside consultants to
properly segregate duties and to effect a timely, accurate
preparation of the financial statements.
●
Upon
the hiring of additional accounting personnel or outside
consultants, we will develop and maintain adequate written
accounting policies and procedures.
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, 2017 that has materially affected, or is reasonably likely
to materially affect, our internal control over financial
reporting. However, our management is currently seeking resolutions
to improve our controls and procedures in an effort to remediate
the deficiency described above.
17
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 other information set forth in this report, you
should carefully consider the factors discussed under “Risk
Factors” in our Quarterly Report on Form 10-Q for the period
ended March 31, 2017, as filed with the Securities and Exchange
Commission on June 21, 2017. 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.
Item 2. Recent Sales of Unregistered Securities; Use of Proceeds
from Registered Securities
Stock Options and Warrants
On May
12, 2017, we granted to Francois Michelon, Chief Executive Officer
and Chairman, and Michael Thornton, Chief Technology Officer, stock
options to purchase 307,310 and 313,338 shares of our common stock,
respectively. The stock options have an exercise price of $5.00 per
share, a term of eight years, and vest in three equal annual
installments beginning on May 12, 2018.
On May
12, 2017, we granted to David Wells, Chief Financial Officer, two
tranches of stock options to purchase an aggregate of 22,000 shares
of our common stock with an exercise price of $5.00 per share. The
first tranche, a stock option with respect to 7,000 shares of
common stock, has a term of five years and was fully vested upon
grant. The second tranche, a stock option with respect to 15,000
shares of common stock, has a term of four years and vests in
twelve equal quarterly installments beginning on August 12, 2017.
On the same date, we issued 18,833 shares of our common stock for
services to a firm owned by Mr. Wells.
On May
12, 2017, we granted to each of Michael Harsh, Alexander Tokman,
Anthony DiGiandomenico and Sanjiv Gambhir, non-employee directors,
a stock option to purchase 12,000 shares of our common stock. Each
stock option has an exercise price of $5.00 per share, has a term
of five years, and was fully vested upon grant.
On May
12, 2017, the Company granted to MZHCI, LLC warrants to purchase
10,000 shares of common stock for services. The warrants have an
exercise price of $5.50 per share, have a term of three years, and
vest in six equal monthly installments.
On June
9, 2017, we granted to each of Mr. Michelon and Mr. Thornton a
stock option to purchase 31,960 shares of common stock. Each stock
option has an exercise price of $4.55 per share, has a term of
eight years, and vests in three equal annual installments beginning
on May 12, 2018.
On June
9, 2017, we granted to each of the two members of its Scientific
Advisory Board a stock option to purchase 15,824 shares of common
stock. Each stock option has an exercise price of $4.55 per share,
has a term of eight years, and vests as follows: one-fourth of the
option immediately, one-half of the option on December 31, 2017,
and one-fourth of the option on December 31, 2018.
All of
the stock options described above were granted in reliance upon an
available exemption from the registration requirements of the
Securities Act of 1933, as amended (the “Securities
Act”), including those contained in Section 4(a)(2) thereof
or in Regulation D promulgated thereunder.
All of
the stock options described above were granted pursuant to our 2016
Omnibus Incentive Plan. On June 21, 2017, we filed with the SEC a
Registration Statement on Form S-8 to register 1,345,074 shares of
our common stock issuable pursuant to our 2016 Omnibus Incentive
Plan, including the shares issuable pursuant to the above described
stock options.
18
Use of Proceeds from Offering of Registered Securities
On May
8, 2017, our Registration Statement on Form S-1, as amended (Reg.
No. 333-193522), was declared effective by the SEC and, on May 8,
2017, our Registration Statement on Form S-1 (Reg. No. 333-217788)
became effective upon filing with the SEC. Each such Registration
Statement was filed in connection with our initial public offering,
pursuant to which we sold 1,932,000 units, each consisting of one
share of our common stock and a warrant to purchase one share of
our common stock, at a price to the public of $5.00 per unit, which
amount includes the full exercise of the underwriters’ option
to purchase additional units. Each warrant is exercisable for a
share of our common stock at a price of $6.25 per share. The
offering closed on May 12, 2017 and the underwriters exercised
their overallotment option as of May 22, 2017, as a result of which
we raised net proceeds of approximately $8.6 million after
deducting approximately $773,000 in underwriting discounts,
commissions and expenses and approximately $297,000 in offering
expenses payable by us. National Securities Corporation and
Dougherty & Company LLC were the underwriters for the offering.
No payments were made by us to directors, officers or persons
owning ten percent or more of our common stock or to their
associates, or to our affiliates, other than payments in the
ordinary course of business to officers for salaries and to
non-employee directors as compensation for board or board committee
service.
The
common stock and warrants comprising each unit separated and began
trading separately on June 28, 2017. At such time, our units were
cancelled and ceased to be listed on the Nasdaq Capital
Market.
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.
Item 4. Mine Safety Disclosures
Not
applicable.
Item 5. Other Information
Not
applicable.
Item 6. Exhibits
The
exhibits required to be filed as a part of this report are listed
in the Exhibit Index.
19
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.
|
ENDRA LIFE SCIENCES INC.
|
|
|
(Registrant)
|
|
|
|
|
|
|
|
Date:
August 7, 2017
|
By:
|
/s/
Francois Michelon
|
|
|
Name:
Francois Michelon
|
|
|
Title:
Chief Executive Officer and Chairman
(Principal
Executive Officer)
|
20
EXHIBIT INDEX
Exhibit Number
|
Description
|
3.1
|
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)
|
3.2
|
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)
|
4.1
|
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)
|
4.2
|
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)
|
4.3
|
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)
|
4.4
|
Form of
Unit Certificate (incorporated by reference to Exhibit 4.10 to the
Company’s Registration Statement on Form S-1 (File No.
333-214724), as amended, originally filed on November 21,
2016)
|
4.5
|
Form of
Convertible Promissory Note (incorporated by reference to Exhibit
4.8 to the Company’s Registration Statement on Form S-1 (File
No. 333-214724), as amended, originally filed on November 21,
2016)
|
10.1
|
Amendment
to Collaborative Research Agreement, dated April 21, 2017, by and
between the Company and General Electric Company (incorporated by
reference to Exhibit 10.21 to the Company’s Registration
Statement on Form S-1 (File No. 333-214724), as amended, originally
filed on November 21, 2016)
|
10.2†
|
Amended
and Restated Employment Agreement, dated May 12, 2017, by and
between the Company and Francois Michelon (incorporated by
reference to Exhibit 10.1 to the Company’s Current Report on
Form 8-K filed on May 12, 2017)
|
10.3†
|
Amended
and Restated Employment Agreement, dated May 12, 2017, by and
between the Company and Michael Thornton (incorporated by reference
to Exhibit 10.2 to the Company’s Current Report on Form 8-K
filed on May 12, 2017)
|
10.4†
|
Consulting
Agreement, dated May 12, 2017, by and between the Company and
StoryCorp Consulting (incorporated by reference to Exhibit 10.3 to
the Company’s Current Report on Form 8-K filed on May 12,
2017)
|
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)
|
101.INS
|
XBRL
Instance Document (filed herewith)
|
101.SCH
|
XBRL
Taxonomy Schema (filed herewith)
|
101.CAL
|
XBRL
Taxonomy Extension Calculation Linkbase (filed
herewith)
|
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)
|
_____________
†
Indicates management compensatory plan, contract or
arrangement
21