Attached files
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
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For the quarterly period ended June 30, 2017
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☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
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For the transition period from
to
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Commission File number 000-00935
MEDITE CANCER DIAGNOSTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware
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36-4296006
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(State or other jurisdiction of
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(I.R.S. Employer
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incorporation or organization)
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Identification No.)
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4203 SW 34 th
Street, Orlando,
FL
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32811
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(Address of principal executive offices)
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(Zip Code)
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(407) 996-9630
(Registrant’s telephone number, including area code
)
Securities registered pursuant to Section 12(b) of the
Act:
Title of each class
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Name of each exchange on which registered
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None
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Not Applicable
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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 ☐ (not
required) ☐
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer or
a smaller reporting company. See the definitions of “large
accelerated filer,” “accelerated filer” and
“smaller reporting company” in Rue 12b-2 of the
Exchange Act. (Check one):
Large Accelerated Filer ☐
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Accelerated Filer ☐
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Non-Accelerated Filer ☐
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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 ☒
The number of shares outstanding of each of the issuer’s
classes of common equity, as of the latest practicable
date:
COMMON STOCK, $0.001 PAR VALUE, AT August 14, 2017: 27,658,820
shares
MEDITE Cancer Diagnostics,
Inc.
QUARTERLY REPORT ON FORM 10-Q
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PART I. — FINANCIAL
INFORMATION
ITEM 1. FINANCIAL STATEMENTS
MEDITE CANCER DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
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June
30, 2017
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December
31,
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(unaudited)
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2016
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Assets
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Current
Assets:
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Cash
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$410
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$108
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Accounts
receivable, net of allowance for doubtful accounts of $191 and
$123, respectively
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1,054
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1,346
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Inventories
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3,969
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3,811
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Prepaid
expenses and other current assets
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189
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79
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Total
current assets
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5,622
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5,344
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Property
and equipment, net
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1,576
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1,557
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In-process
research and development
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4,620
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4,620
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Trademarks,
trade names
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1,240
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1,240
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Goodwill
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4,658
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4,658
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Other
assets
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398
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351
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Total
assets
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$18,114
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$17,770
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Liabilities
and Stockholders’ Equity
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Current
Liabilities:
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Accounts
payable and accrued expenses
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$3,737
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$3,306
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Secured
lines of credit and current portion of long-term debt
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3,226
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3,214
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Notes
due to employees, current portion
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339
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681
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Advances
– related party
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154
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146
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Total
current liabilities
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7,456
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7,347
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Long-term
debt, net of current portion
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32
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60
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Notes
due to employees, net of current portion
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90
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135
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Deferred
tax liability
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2,205
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2,205
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Total
liabilities
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9,783
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9,747
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Commitments
and contingencies
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Stockholders’
equity :
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Preferred
stock, $0.001 par value; 10,000,000 shares authorized; 198,355
shares issued and outstanding (liquidation value of all classes of
preferred stock $2,579 and $2,533 as of June 30, 2017 and December
31, 2016, respectively)
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962
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962
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Common
stock, $0.001 par value; 50,000,000 and 35,000,000 shares
authorized, 27,658,820 and 22,421,987 shares issued and outstanding
as of June 30, 2017 and December 31, 2016,
respectively
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28
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23
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Additional
paid-in capital
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12,090
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9,366
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Stock
subscription
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25
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25
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Treasury
stock
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(327)
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(327)
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Accumulated
other comprehensive loss
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(483)
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(642)
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Accumulated
deficit
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(3,964)
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(1,384)
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Total
stockholders’ equity
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8,331
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8,023
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Total
liabilities and stockholders’ equity
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$18,114
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$17,770
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The accompanying notes are an integral part of these condensed
consolidated financial statements.
MEDITE CANCER DIAGNOSTICS, INC. AND
SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
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Three
Months Ended
June
30,
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2017
(unaudited)
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2016
(unaudited)
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Net
sales
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$1,277
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$2,816
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Cost
of revenues
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1,228
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1,546
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Gross
profit
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49
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1,270
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Operating
expenses
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Depreciation
and amortization expense
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54
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50
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Research
and development
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329
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421
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Selling,
general and administrative
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1,228
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918
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Total
operating expenses
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1,611
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1,389
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Operating
loss
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(1,562)
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(119)
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Other
expenses
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Interest
expense, net
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67
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139
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Other income,
net
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(8)
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(50)
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Total
other expense, net
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59
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89
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Loss
before income taxes
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(1,621)
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(208)
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Income
tax provision (benefit)
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4
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(6)
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Net
loss
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(1,625)
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(202)
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Preferred
dividend
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(23)
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(23)
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Net
loss available to common stockholders
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$(1,648)
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$(225)
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Loss per share
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Basic
and diluted loss per share
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$(0.06)
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$(0.01)
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Weighted
average basic and diluted shares outstanding
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25,866,163
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21,058,235
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Condensed consolidated statements of comprehensive
loss
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Net
loss
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$(1,625)
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$(202)
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Other
comprehensive income (loss)
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Foreign
currency translation adjustments
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212
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(136)
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Comprehensive
loss
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$(1,413)
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$(338)
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The accompanying notes are an integral part of these condensed
consolidated financial statements.
MEDITE CANCER DIAGNOSTICS,
INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
(Dollars in thousands, except shares and per share
amounts)
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Six
Months Ended June 30,
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2017
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2016
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(unaudited)
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(unaudited)
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Net
sales
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$3,168
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$4,947
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Cost of
revenues
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2,439
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2,759
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Gross
profit
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729
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2,188
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Operating
expenses
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Depreciation and
amortization expense
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103
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101
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Research and
development
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754
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781
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Selling, general
and administrative
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2,010
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1,775
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Total operating
expenses
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2,867
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2,657
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Operating
loss
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(2,138)
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(469)
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Other
expenses
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Interest
expense
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260
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400
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Loss
on extinguishment of notes due to employees
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158
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-
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Other (income)
expenses, net
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20
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(39)
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Total other
expenses, net
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438
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361
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Loss before income
taxes
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(2,576)
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(830)
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Income tax
provision (benefit)
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4
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(6)
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Net
loss
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(2,580)
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(824)
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Preferred
dividend
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(46)
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(46)
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Net loss to common
stockholders
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$(2,626)
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$(870)
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Loss per
share
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Basic and diluted
loss per share
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$(0.11)
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$(0.04)
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Weighted average
basic and diluted shares outstanding
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24,411,435
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21,058,235
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Condensed
consolidated statements of comprehensive loss
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Net
loss
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(2,580)
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(824)
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Other comprehensive
income (loss)
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Foreign currency
translation adjustments
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159
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55
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Comprehensive
loss
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$(2,421)
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$(769)
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The
accompanying notes are an integral part of these condensed
consolidated financial statements.
MEDITE CANCER DIAGNOSTICS, INC. AND
SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS
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Six
Months Ended ,
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2017
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2016
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Cash
flows from operating activities:
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Net
loss
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$(2,580)
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$(824)
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Adjustments
to reconcile net loss to cash used in operating
activities
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Depreciation
and amortization
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103
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101
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Provision
for doubtful accounts
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62
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-
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Stock-based
compensation
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63
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-
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Amortization
of debt discount and debt issuance costs
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-
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219
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Amortization
of shares issued for prepaid consulting services
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6
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-
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Estimated
fair value of warrants issued in connection with secured promissory
notes
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162
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51
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Loss
on extinguishment of notes due to employees
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158
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-
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Changes
in assets and liabilities:
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Accounts
receivable
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302
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42
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Inventories
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114
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(827)
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Prepaid
expenses and other assets
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(95)
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57
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Accounts
payable and accrued expenses
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313
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439
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Net
cash used in operating activities
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(1,392)
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(742)
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Cash
flows from investing activities:
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Purchases
of equipment
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(27)
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(3)
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Increase
in other assets
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-
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(104)
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Net
cash used in investing activities
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(27)
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(107)
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Cash
flows from financing activities:
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Net
(repayment) borrowings on lines of credit
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(24)
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406
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Repayment
of secured promissory notes
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(167)
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-
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Repayment
of notes due to employees
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(155)
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(50)
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Proceeds
from related party advances, net
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-
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13
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Proceeds
from sale of common stock, net of issuance costs
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2,000
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-
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Proceeds
from common stock subscribed
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25
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-
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Net
cash provided by financing activities
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1,679
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369
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Effect
of exchange rates on cash
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42
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38
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Net
change in cash
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302
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(442)
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Cash
at beginning of period
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108
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587
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Cash
at end of the period
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$410
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$145
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Supplemental
disclosure of cash flow information:
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Cash
paid for interest
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$97
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$89
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Cash
paid for income taxes
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$24
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$8
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Supplemental
schedule of non-cash investing and financing
activities:
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Reclassification
of warrant liability to additional paid in capital
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$-
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$90
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Settlement
of liabilities through issuance of common stock
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$-
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$275
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Issuance
of common stock for services
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$25
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$-
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Issuance
of warrants on secured promissory notes classified as additional
paid-in capital and debt discount
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$-
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$192
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Issuance
of common stock subscribed
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$25
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$-
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Conversion
of secured promissory note plus accrued interest into common
stock
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$58
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$-
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The accompanying notes are an integral part of these condensed
consolidated financial statements.
MEDITE CANCER
DIAGNOSTICS, INC. AND
SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(Tabular data in thousands, except share and per share
amounts)
Note
1.
Organization
The Company
MEDITE
Cancer Diagnostics, Inc. (“MDIT”, “MEDITE”,
“we”, “us” or the “Company”)
was incorporated in Delaware in December 1998.
These
statements include the accounts of MEDITE Cancer Diagnostics, Inc.
and its wholly owned subsidiaries, which consists of MEDITE
Enterprise, Inc., MEDITE GmbH, Burgdorf, Germany, MEDITE GmbH,
Salzburg, Austria, MEDITE Lab Solutions Inc., Orlando, USA, MEDITE
sp. z o.o., Zilona-Gora, Poland and CytoGlobe, GmbH, Burgdorf,
Germany.
MEDITE
is a medical technology company specialized in the development,
manufacturing, and marketing of molecular biomarkers, premium
medical devices and consumables for detection, risk assessment and
diagnosis of cancerous and precancerous conditions and related
diseases. The Company has 74 employees in four countries, a
distribution network to about 80 countries and a wide range of
products for anatomic pathology, histology and cytology
laboratories is available for sale.
Note
2.
Summary of
Significant Accounting Policies
Consolidation, Basis of Presentation and Significant
Estimates
The
accompanying condensed consolidated financial statements for the
periods ended June 30, 2017 and 2016 included herein are unaudited
and have been prepared in accordance with accounting principles
generally accepted in the United States of America
(“GAAP”) and include the accounts of the Company and
its wholly-owned subsidiaries. All intercompany balances and
transactions have been eliminated in consolidation. Such
consolidated financial statements reflect, in the opinion of
management, all adjustments necessary to present fairly the
financial position and results of operations as of and for the
periods indicated. All such adjustments are of a normal recurring
nature. These interim results are not necessarily indicative of the
results to be expected for the fiscal year ending December 31, 2017
or for any other period. Certain information and footnote
disclosures normally included in the consolidated financial
statements prepared in accordance with accounting principles
generally accepted in the United States have been condensed or
omitted pursuant to the rules and regulations of the Securities and
Exchange Commission. The Company believes that the disclosures are
adequate to make the interim information presented not misleading.
These condensed consolidated financial statements should be read in
conjunction with the Company’s audited consolidated financial
statements disclosed in the Report on Form 10-K for the year ended
December 31, 2016 filed on April 14, 2017 and other filings with
the Securities and Exchange Commission.
In
preparing the accompanying condensed consolidated financial
statements, management has made certain estimates and assumptions
that affect reported amounts in the condensed consolidated
financial statements and disclosures of contingencies. Changes in
facts and circumstances may result in revised estimates and actual
results may differ from these estimates.
Going Concern
The accompanying condensed consolidated financial
statements have been prepared in conformity with GAAP, which
contemplate continuation of the Company as a going
concern. This contemplates the realization of assets and
the liquidation of liabilities in the normal course of
business. Negative working capital at December 31, 2016
was $2,003 compared to June 30, 2017 of $1,834, an improvement of
$169. The Company has reported losses of $2,163 for the year
ended December 31, 2016 and $2,580 for the six months ended June
30, 2017. These factors raise substantial doubt about the
Company’s ability to continue as a going concern. The Company raised additional cash
of $2 million net of offering costs from the sale of 4,310,000
shares of common stock subsequent to December 31, 2016 through June
30, 2017.
The
Company has settled three of the five employee notes for $330,000
and warrants and paid the first installment of $94,000 in April
2017. The Company has extended the term of the secured promissory
notes and has paid $167,000 of the outstanding balance and one
noteholder converted a $50,000 note plus accrued interest into
116,833 shares of common stock at $0.50 per share. Management
believes that the remainder of the balance will be settled in some
combination of cash and stock.
Management is
actively seeking additional equity financing contemplated in the
$4.25 million stock purchase agreement. The Company has
negotiated with certain parties whose obligations are due in the
next twelve months to extend payment terms beyond one year. One
lender with an outstanding balance of $856,950 has stated that they
will not be able to refinance the debt however they have provided
an extension through September 2017. The rate of interest increased
three percent beginning in June 2017.
The
Company has accrued wages and vacation of approximately $1.1
million and a $50,000 note payable to the former CFO at June 30,
2017 and December 31, 2016. The Company believes that more than
half of the balance currently outstanding was to be converted into
common stock as a condition of the merger agreement at $2.00 a
share. See Note 8 for further discussion regarding the legal
proceedings with the Company’s former CFO.
The
Company owes Ms. Ott 91,136 Euros, ($97,351 as June 30, 2017). The
Company has made arrangements to repay this obligations evenly over
a 24 month period, starting on October 31, 2017. The Company also
settled obligations to Ms. Ott and Mr. Ott for past wages and
related expenses of $152,000 through an upfront payment each of
$6,750 and a payment plan which settled the amounts owed and
established a payment schedule for a period of 18 months starting
in October 2017. The upfront payment was not made as of the date of
this filing.
The
Company’s security agreement with its lender has provided
borrowings of 35% of our collateralized assets. The
Company continues to work on refinancing this debt to provide
additional liquidity.
Management
continues to expand its product offerings and has also expanded its
sales and distribution channels during 2017.
If
management is unsuccessful in completing its equity financing,
management will begin negotiating with some of the Company's major
vendors and lenders to extend the terms of their debt and also
evaluate certain expenses that have been implemented for the
Company’s growth strategy. However, there
can be no assurance that the Company will be successful in these
efforts. The condensed consolidated financial statements do not
include any adjustments that might result from the outcome of this
uncertainty.
Revenue Recognition
The
Company derives its revenue primarily from the sale of medical
products and supplies for the diagnosis and prevention of cancer.
Product revenue is recognized when all four of the following
criteria are met: (1) persuasive evidence that an arrangement
exists; (2) delivery of the products has occurred or risk of
loss transfers to the customer; (3) the selling price of the
product is fixed or determinable; and (4) collectability is
reasonably assured. The Company generates the majority of its
revenue from the sale of inventory. For certain sales, the Company
and its customers agree in the sales contract that risk of loss and
title transfer upon the Company packing the items for shipment,
segregating the items packaged and notifying the customer that
their items are ready for pickup. The Company records such sales at
time of completed packaging and segregation of the items from
general inventory and notification has been confirmed by the
customer.
Shipping
and handling costs are included in cost of goods sold and charged
to the customers based on the contractual terms.
Inventories
Inventories
are stated at the lower of cost or market. Cost is determined using
the first in first out method (FIFO) and market is based generally
on net realizable value.
Inventories
consists of parts inventory purchased from outside vendors, raw
materials used in the manufacturing of equipment; work in process
and finished goods. Management reviews inventory on a regular basis
and determines if inventory is still useable. A reserve is
established for the estimated decrease in carrying value for
obsolete or excess inventory. Once a reserve is established, it is
considered a permanent adjustment to the cost basis of the obsolete
or excess inventory.
Foreign Currency Translation
The
accounts of the US parent company are maintained in United States
Dollar (“USD”). The functional currency of the
Company’s German subsidiaries is the EURO
(“EURO”). The accounts of the German subsidiaries were
translated into USD in accordance with relevant accounting
guidance. All assets and liabilities are translated at the exchange
rate on the balance sheet dates, stockholders’ equity was
translated at the historical rates and statements of operations
transactions are translated at the average exchange rate for each
period. The resulting translation gains and losses are recorded in
accumulated other comprehensive loss as a component of
stockholders’ equity.
Research and Development
All
research and development costs are expensed as incurred. Research
and development costs consist of engineering, product development,
testing, developing and validating the manufacturing process, and
regulatory related costs.
Acquired In-Process Research and Development
Acquired
in-process research and development (“IPR&D”) that
the Company acquires through business combinations represents the
fair value assigned to incomplete research projects which, at the
time of acquisition, have not reached technological feasibility.
The amounts are capitalized and are accounted for as
indefinite-lived intangible assets, subject to impairment testing
until completion or abandonment of the projects. Upon successful
completion of each project, MEDITE will make a determination as to
the then useful life of the intangible asset, generally determined
by the period in which the substantial majority of the cash flows
are expected to be generated, and begin amortization. The Company
tests IPR&D for impairment at least annually, or more
frequently if impairment indicators exist, by first assessing
qualitative factors to determine whether it is more likely than not
that the fair value of the IPR&D intangible asset is less than
its carrying amount. If the Company concludes it is more likely
than not that the fair value is less than the carrying amount, a
quantitative test that compares the fair value of the IPR&D
intangible asset with its carrying value is performed. If the fair
value is less than the carrying amount, an impairment loss is
recognized in operating results.
Impairment of Indefinite Lived Intangible Assets Other Than
Goodwill
The
Company has the option first to assess qualitative factors to
determine whether the existence of events and circumstances
indicates that it is more likely than not that the indefinite-lived
intangible asset is impaired. If, after assessing the totality of
events and circumstances, the Company concludes that it is not more
likely than not that the indefinite-lived intangible asset is
impaired, then the entity is not required to take further action.
However, if the Company concludes otherwise, then it is required to
determine the fair value of the indefinite-lived intangible asset
and perform the quantitative impairment test by comparing the fair
value with the carrying amount in accordance with relevant
accounting guidance.
Goodwill
Goodwill
is recognized for the excess of cost of an acquired entity over the
amounts assigned to assets acquired and liabilities assumed in a
business combination. Goodwill is tested for impairment at
the reporting unit level (operating segment or one level below an
operating segment) on an annual basis (December 31 for us) and
between annual tests if an event occurs or circumstances change
that would more likely than not reduce the fair value of a
reporting unit below its carrying value. These events or
circumstances could include a significant change in the business
climate, legal factors, operating performance indicators,
competition, or sale or disposition of a significant portion of a
reporting unit.
Application
of the goodwill impairment test requires judgment, including the
identification of reporting units, assignment of assets and
liabilities to reporting units, assignment of goodwill to reporting
units, and determination of the fair value of each reporting unit
using a discounted cash flow methodology. This analysis requires
significant judgments, including estimation of future cash flows,
which is dependent on internal forecasts, estimation of the
long-term rate of growth for our business, estimation of the useful
life over which cash flows will occur, and determination of our
weighted average cost of capital.
The
estimates used to calculate the fair value of a reporting unit
change from year to year based on operating results, market
conditions, and other factors. Changes in these estimates and
assumptions could materially affect the determination of fair value
and goodwill impairment for each reporting unit.
Net Loss Per Share
Basic
loss per share is calculated based on the weighted-average number
of outstanding common shares. Diluted loss per share is calculated
based on the weighted-average number of outstanding common shares
plus the effect of dilutive potential common shares, using the
treasury stock method and the if-converted method. MEDITE’s
calculation of diluted net loss per share excludes potential common
shares as of June 30, 2017 and 2016 as the effect would be
anti-dilutive (i.e. would reduce the loss per share).
The
Company computes its loss applicable to common stock holders by
subtracting dividends on preferred stock, including undeclared or
unpaid dividends if cumulative, from its reported net loss and
reports the same on the face of the condensed consolidated
statement of operations.
Recent Accounting Pronouncements
In May
2014, the Financial Accounting Standards Board (“FASB”)
issued Accounting Standards Update (“ASU”) 2014-09,
“Revenue with Contracts from Customers.” ASU 2014-09
supersedes the current revenue recognition guidance, including
industry-specific guidance. The ASU introduces a five-step model to
achieve its core principal of the entity recognizing revenue to
depict the transfer of goods or services to customers at an amount
that reflects the consideration to which the entity expects to be
entitled in exchange for those goods and services. The updated
guidance is effective for public entities for interim and annual
periods beginning after December 15, 2017 with early adoption
permitted for annual reporting periods beginning after December 15,
2016. The Company has not yet selected a transition method and is
currently evaluating the impact of the updated guidance for the
Company’s consolidated financial statements.
In
February 2016, the FASB issued ASU No. 2016-02,
“Leases” (“ASU 2016-02”). The core
principle of ASU 2016-02 is that an entity should recognize on its
balance sheet assets and liabilities arising from a lease. In
accordance with that principle, ASU 2016-02 requires that a lessee
recognize a liability to make lease payments (the lease liability)
and a right-of-use asset representing its right to use the
underlying leased asset for the lease term. The recognition,
measurement, and presentation of expenses and cash flows arising
from a lease by a lessee will depend on the lease classification as
a finance or operating lease. This new accounting guidance is
effective for public companies for fiscal years beginning after
December 15, 2018 (i.e., calendar years beginning on January 1,
2019), including interim periods within those fiscal years. Early
adoption is permitted. The Company is currently evaluating the
impact the adoption of ASU 2016-02 will have on the Company’s
consolidated financial statements.
In
January 2017, the FASB issued ASU 2017-01, “Business
Combinations (Topic 805): Clarifying the definition of a
business”. The
amendments in this Update clarify the definition of a business with
the objective of adding guidance to assist entities with evaluating
whether transactions should be accounted for as acquisitions (or
disposals) of businesses. The guidance in this update is effective
for fiscal years beginning after December 15, 2017, and interim
periods within those years. Management does not anticipate the
implementation to have a material impact on the Company’s
consolidated financial statements.
In
January 2017, the FASB also issued ASU 2017-04, “Intangibles
- Goodwill and other (Topic 350): Simplifying the test for goodwill
impairment”. The amendments in this Update remove the second
step of the current goodwill impairment test. An entity will apply
a one-step quantitative test and record the amount of goodwill
impairment as the excess of a reporting unit's carrying amount over
its fair value, not to exceed the total amount of goodwill
allocated to the reporting unit. The new guidance does not amend
the optional qualitative assessment of goodwill impairment. This
guidance is effective for impairment tests in fiscal years
beginning after December 15, 2019. The Company is currently
evaluating the impact the adoption of ASU 2017-04 will have on the
Company’s consolidated financial statements.
In July
2017, the FASB issued a two-part ASU No. 2017-11, “(Part I)
Accounting for Certain Financial Instruments with Down Round
Features, (Part II) Replacement of the Indefinite Deferral for
Mandatorily Redeemable Financial Instruments of Certain Nonpublic
Entities and Certain Mandatorily Redeemable Noncontrolling
Interests with a Scope Exception.” The ASU will (1)
“change the classification analysis of certain equity-linked
financial instruments (or embedded features) with down round
features” and (2) improve the readability of ASC 480-10 by
replacing the indefinite deferral of certain pending content with
scope exceptions. The amendments in Part I of this Update change
the classification analysis of certain equity-linked financial
instruments (or embedded features) with down round features. When
determining whether certain financial instruments should be
classified as liabilities or equity instruments, a down round
feature no longer precludes equity classification when assessing
whether the instrument is indexed to an entity’s own stock.
The amendments also clarify existing disclosure requirements for
equity-classified instruments. As a result, a freestanding
equity-linked financial instrument (or embedded conversion option)
no longer would be accounted for as a derivative liability at fair
value as a result of the existence of a down round feature. For
freestanding equity classified financial instruments, the
amendments require entities that present earnings per share
(“EPS”) in accordance with Topic 260 to recognize the
effect of the down round feature when it is triggered. That effect
is treated as a dividend and as a reduction of income available to
common shareholders in basic EPS. Convertible instruments with
embedded conversion options that have down round features are now
subject to the specialized guidance for contingent beneficial
conversion features (in Subtopic 470-20, Debt—Debt with
Conversion and Other Options), including related EPS guidance (in
Topic 260). The amendments in Part II of this Update recharacterize
the indefinite deferral of certain provisions of Topic 480 that now
are presented as pending content in the Codification, to a scope
exception. Those amendments do not have an accounting effect. This
new accounting guidance is effective for public companies for
fiscal years beginning after December 15, 2018 (i.e., calendar
years beginning on January 1, 2019), including interim periods
within those fiscal years. Early adoption is permitted. The Company
is currently evaluating the impact the adoption of ASU 2017-11 will
have on the Company’s consolidated financial
statements.
Note
3.
Inventories
The
following is a summary of the components of inventories (in
thousands):
|
June
30,
2017
(Unaudited)
|
December
31,
2016
|
Raw
materials
|
$1,474
|
$1,309
|
Work
in process
|
142
|
203
|
Finished
goods
|
2,353
|
2,299
|
|
$3,969
|
$3,811
|
Note
4.
Secured Lines of
Credit, Long-term Debt, and Notes Due to
Employees
The
Company’s outstanding note payable indebtedness was as
follows as of (in thousands):
|
June
30,
2017
(Unaudited)
|
December
31,
2016
|
Hannoversche
Volksbank credit line #1
|
$1,447
|
$1,321
|
Hannoversche
Volksbank credit line #2
|
426
|
397
|
Hannoversche
Volksbank term loan #3
|
95
|
117
|
Secured
Promissory Note
|
433
|
650
|
DZ
Equity Partners Participation rights
|
857
|
789
|
Total
|
3,258
|
3,274
|
Less
current portion of long-term debt
|
(3,226)
|
(3,214)
|
Long-term
debt
|
$32
|
$60
|
In July
2006, MEDITE GmbH, Burgdorf, entered into a master credit line #1
with Hannoversche Volksbank. The line of credit was amended in
2012, 2015 and again in 2016, in which the credit line availability
is Euro 1.3 million ($1.485 million as of June 30, 2017).
Borrowings on the master line of credit agreement #1 bears interest
at a variable rate based on Euribor (Euro Interbank Offered Rate)
depending on the type of advance elected by the Company and defined
in the agreement. Interest rates depending on the type of advance
elected ranged from 3.75 – 8.00% during the period ended June
30, 2017. The line of credit has no stated maturity date. The line
of credit is collateralized by the accounts receivable and
inventory of MEDITE GmbH, Burgdorf, and a mortgage on the building
owned by the Company and is guaranteed by Michaela Ott and Michael
Ott, stockholders of the Company.
In June
2012, CytoGlobe, GmbH, Burgdorf, entered into a credit line #2 with
Hannoversche Volksbank. The line of credit granted a maximum
borrowing authority of Euro 400,000 ($457,040 as of June 30, 2017).
Borrowings on the master line of credit agreement #2 bears interest
at a variable rate based on Euribor (Euro Interbank Offered Rate)
depending on the type of advance elected by the Company and defined
in the agreement. Interest rates ranged from 3.90 – 8.00%
during the period ended June 30, 2017. The line of credit has no
stated maturity date. The line of credit is collateralized by the
accounts receivable and inventory of CytoGlobe GmbH, Burgdorf and
is guaranteed by Michaela Ott and Michael Ott, stockholders of the
Company, and the state of Lower Saxony (Germany) to support
high-tech companies in the area.
In
November 2008, MEDITE GmbH, Burgdorf, entered into a Euro 400,000
($457,040 as of June 30, 2017) term loan #3 with Hannoversche
Volksbank with an interest rate of 4.7% per annum. The term loan
has a maturity of December 31, 2018, and requires quarterly
principal repayments of Euro 13,890 ($15,871 as of June 30, 2017).
The term loan is guaranteed by Michaela Ott and Michael Ott,
stockholders of the Company, and is collateralized by a partial
subordinated pledge of the receivables and inventory of MEDITE
GmbH, Burgdorf.
In
March 2009, the Company entered into a participation rights
agreement with DZ Equity Partners (“DZ”) in the form of
a debenture with a mezzanine lender who advanced the Company up to
Euro 1.5 million, ($1.7 million as of June 30, 2017) in two
tranches of Euro 750,000 each ($856,950 as of June 30, 2017). The
first tranche was paid to the Company at closing with the second
tranche being conditioned on MEDITE GmbH, Burgdorf and its
subsidiaries hitting certain performance targets. Those targets
were not met and the second tranche was never called. The debenture
pays interest at the rate of 12.15% per annum and matured on
December 31, 2016, however the Notes were not considered in default
until June 1, 2017, when the German financial statements were due
to be filed. The Company has initiated discussions with DZ to
renegotiate the terms of the agreement or to convert any part of
the balance into stock. DZ has extended the maturity date to
September 1, 2017. The rate of interest increased three percent, to
15.15% on June 1, 2017.
On
December 31, 2015, the Company entered into a Securities Purchase
Agreement (the “2015 Purchase Agreement”) with seven
individual accredited investors (collectively the
“Purchasers”), pursuant to which the Company agreed to
issue to the Purchasers secured promissory notes in the aggregate
principal amount of $500,000 with interest accruing at an annual
rate of 15% (the “Note(s)”) and warrants to purchase up
to an aggregate amount of 250,000 shares of the common stock, par
value $0.001) per share, of the Company (the
“Warrant(s)”) with an initial exercise price of $1.60
per share, subject to adjustment and are exercisable for a period
of five years. On March 15, 2016, the Board of Directors
approved renegotiated terms to increase the warrants issued to the
Purchasers from a total of 250,000 warrants to 500,000 and fixed
the exercise price of the warrants to $0.80. The Notes mature on
the earlier of the third month anniversary date following the
Closing Date, as defined in the Note, or the third business day
following the Company’s receipt of funds exceeding one
million dollars from an equity or debt financing, not including the
financing contemplated under the 2015 Purchase Agreement. The Notes
are secured by the Company’s accounts receivable and
inventories held in the United States. If the Notes are not
redeemed by the Company on maturity, the Purchasers are entitled to
receive 10% of the principal balance of the Notes outstanding in
warrants for every month that the Notes are not
redeemed. On March 31, 2016, these Notes matured and
were not repaid. Therefore the Notes were in default on
April 1, 2016. The Company agreed to pay the Purchasers
10% of the principal balance of the Notes in warrants until the
Notes are repaid. During the six month period ended June
30, 2017, the Company issued 50,000 warrants in connection with the
default provision and 195,000 warrants in connection with the
January 2017 extension provision (see below), which were valued at
$11,443 and $59,199, respectively, and recorded it as interest
expense in the condensed consolidated statements of operations. The
Notes are secured by the Company’s accounts receivable and
inventories held in the United States. In January 2017, the Company
extended the term of the Notes in default on April 1, 2016 to June
30, 2017 and reduced the price on the warrants issued from $0.80 to
$0.50. The Company recorded $64,405 attributed to the repricing of
the warrants.
On June
30, 2017, one secured noteholder, an affiliate of a member of our
Board of Directors converted a $50,000 secured promissory note for
$50,000 plus $8,000 of accrued interest into 116,833 shares of
common stock. The Company issued 50,000 warrants to purchase shares
of common stock at a price of $0.50, with a term of five
years.
On
December 31, 2015, the Company recorded a discount related to the
issuance of warrants attributed to the Notes of approximately
$90,000. The discount was amortized to interest expense
during the six months ended June 30, 2016. We did not have any
discount amortization for the period ended June 30,
2017.
On May
25, 2016, the Company entered into a Securities Purchase Agreement
(the “May Purchase Agreement”) with two individual
accredited investors, one of which who serves on the
Company’s Board of Directors (collectively
the “May Purchasers”), pursuant to which the Company
agreed to issue to the May Purchasers secured promissory notes in
the aggregate principal amount of $150,000 (the “May
Note(s)”) with an interest rate of 15% and warrants to
purchase up to an aggregate amount of 150,000 shares of common
stock, of the Company (the “May Warrant(s)”). The
May Notes may be converted into Units issued pursuant to the
Company’s private financing of up to $5,000,000 (the
“Follow On Offering”) Units at a price of $0.80/Unit
(the “Units”) consisting of: (i) a 2 year
unsecured convertible note, which converts into shares of common
stock at an initial conversion price of $0.80 per share and (ii) a
warrant to purchase one half additional share of common stock, with
an initial exercise price equal to $0.80 per share (the
“Follow On Warrant”). The May Notes are secured by the
Company’s accounts receivable and inventories held in the
United States. The Company recorded a debt discount of $51,000
related to the relative fair value of the warrants on the date of
the May Purchase Agreement, which was amortized to interest expense
in the consolidated statement of operations during the year ended
December 31, 2016. If the May Notes are not redeemed by the Company
on maturity, the Purchasers are entitled to receive 10% of the
principal balance of the Notes outstanding in warrants for every
month that the Notes are not redeemed. On August 25, 2016, these
Notes matured and were not repaid. Therefore the Notes were
in default on August 26, 2016. The Company agreed to pay the
Purchasers 10% of the principal balance of the May Notes in
warrants until the May Notes are repaid. In January 2017, the
Company extended the term of the Notes in default to June 30, 2017
and reduced the price on the warrants issued from $0.80 to $0.50.
During the three and six month period ended June 30, 2017, the
Company issued 35,000 and 80,000 warrants in connection with the
January 2017 extension provision, which were valued at $9,948 and
$27,058 and recorded it as interest expense in the consolidated
statements of operations.
In
November 2015 and February 2016, the Company entered into
promissory notes totaling $927,000 with certain employees to repay
wages earned prior to December 31, 2014 not paid (“Notes Due
to Employees"). The Notes Due to Employees are to be
paid monthly through September 2019, with no interest due on the
outstanding balances. The monthly amounts increase over
the payment term. The amounts due become immediately due and
payable if payments are more than ten days late either one or two
consecutive months as defined in the agreement with the
employee.
On
March 30, 2017, the Company negotiated a settlement with three
current employees that hold notes, in the amount of $580,000 plus
accrued vacation. The agreement supersedes all prior agreements
with the group and was effective December 31, 2016. The Company is
to pay these employees approximately $330,000, the first payment of
$94,000 was paid in April 2017, the second payment of $94,000 was
due 30 days from signing the agreement and the final payment of
$142,000 was due 60 days from signing the agreement however the
remaining payments remained due at June 30, 2017. The employees are
working with the Company regarding the timing of the payments
discussed above. The Company issued 1,029,734 warrants to purchase
common stock at $0.50 a share with a term of 5 years. The fair
value of the warrants issued of $389,000 for the six months ended
June 30, 2017, was valued based on the Black Scholes model based on
a stock price of $0.70, an interest free rate of 1.33% and
volatility of 50%. The settlement was accounted for as an
extinguishment under the applicable accounting guidance. The
Company recorded a loss on extinguishment on notes due to employees
of $158,000.
Note
5.
Related Party
Transactions
Included in
advances – related parties are amounts owed to the
Company’s former CFO and Chairman of the Board of
$50,000 at June 30, 2017 and December 31, 2016. Also included
in advances – related parties are amounts owed to Ms. Ott of
20,000 Euros, ($22,852 as June 30, 2017) and 75,000 Euros ($85,695
as of June 30, 2017) related to two short term bridge loans. The
Company has made arrangements to settle these obligations to Ms.
Ott evenly over a 24 month period, starting on October 31, 2017. In
addition, the Company settled obligations related to accrued
salaries, vacation and related expenses totaling $152,000 owed to
Mr. and Ms. Ott. The Company will make an upfront payment to each
Mr. and Ms. Ott of $6,750 and will pay the remaining amount owed
over a period of 18 months starting in October 2017. The
loans noted above are interest-free loans. The Company plans to
continues to pay Mr. and Mrs. Ott the agreed upon severance
payments however the upfront payment was not paid as of June 30,
2017. Total severance payments totaled $118,810, of which $71,418
were accrued at June 30, 2017. Mr. Ott and Ms. Ott remain as
Directors of the Company and continue to work with the
Company.
On June
30, 2017, one secured noteholder, an affiliate of a member of our
Board of Directors, converted a $50,000 secured promissory note
plus accrued interest into 116,833 shares of common stock. The
Company issued 50,000 warrants to purchase shares of common stock
at a price of $0.50, with a term of five years. See further
discussion related to secured promissory notes in Note 4
above.
On
February 12, 2016, one of the Purchasers of a $100,000 secured
promissory note and holder of 50,000 (increased to 100,000 warrants
as of December 31, 2016) warrants to purchase shares of common
stock at the time of his election, was elected to the Board of
Directors to serve as Director and Chairman of the Company’s
audit committee. Total warrants due to this director related to the
above secured promissory notes for original issuance,
modifications, default period and the modification period at June
30, 2017 was 240,000 warrants to purchase common
stock.
At June
30, 2017 and December 31, 2016, the Company has accrued $65,000 and
$55,000, respectively to the above Director and Chairman of the
audit committee for services for 2016 as a member of the Board of
$35,000 and an additional $20,000 and $30,000 for audit committee
services for the year ended December 31, 2016 and for the six
months ended June 30, 2017, respectively.
Included in
accounts payable and accrued expense includes $35,408 due to its
CFO’s company for past services performed as a consultant to
the Company.
The
Company has accrued wages and vacation of approximately $1.1
million payable to the former CFO at June 30, 2017 and December 31,
2016. The Company believes that more than half of the balance
currently outstanding was to be converted into common stock as a
condition of the merger agreement at $2.00 a share. See Note 8 for
further discussion regarding the legal proceedings with the
Company’s former CFO.
Note
6.
Common
Stock
Effective April 28,
2017, the Company increased the authorized shares from 35,000,000
to 50,000,000.
During
the six months ended June 30, 2017, the Company issued 4,310,000
shares of common stock for $2,155,000, less $153,000 of issuance
costs. In connection with the issuance of common stock, the Company
issued 2,155,000 warrants to purchase shares of common stock at
$0.50, for a term of 5 years. We also issued 50,000 shares from
stock subscriptions of $25,000 at December 31, 2016 and issued
25,000 warrants on the same terms and conditions. At June 30, 2017,
the Company received $25,000 stock subscription for the purchase of
50,000 shares of common stock and 25,000 warrants. During the six
months ended June 30, 2016, the Company issued 292,167 shares to
settle certain liabilities totaling $274,870.
The
Board appointed two officers on May 4, 2017, who received 350,000
shares of restricted common stock with a three year vesting
schedule. In addition, on April 26, 2017, the Company appointed an
officer who received 200,000 shares of restricted common stock with
a three year vesting schedule. On June 9, 2017 the Company issued
160,000 shares of restricted common stock with a vesting schedule
through December 31, 2019. Amortization associated with restricted
stock to officers and management is $52,668 and $63,085 for the
three and six months ended June 30, 2017, respectively. In
addition, the Company issued 50,000 shares to an investor relations
firm in June 2017 at a value of $0.50 per share for services
through September 30, 2017. For the three and six months ended June
30, 2017, the Company recorded $6,250 included in selling, general
and administrative expenses for professional fees for investor
relations expense.
Note
7.
Options, Preferred Stock and
Warrants
A
summary of the Company’s preferred stock as of June 30, 2017
and December 31, 2016 is as follows.
|
June 30,
2017
(unaudited)
|
December 31,
2016
|
|
Shares
Issued &
|
Shares
Issued &
|
Offering
|
Outstanding
|
Outstanding
|
Series
A convertible
|
47,250
|
47,250
|
Series
B convertible, 10% cumulative dividend
|
93,750
|
93,750
|
Series
C convertible, 10% cumulative dividend
|
38,333
|
38,333
|
Series
E convertible, 10% cumulative dividend
|
19,022
|
19,022
|
Total
Preferred Stock
|
198,355
|
198,355
|
As
of June 30, 2017 and December 31, 2016, the Company had cumulative
preferred undeclared and unpaid dividends of $1,457,370 and
$1,411,946, respectively. In accordance with the relevant
accounting guidance, these dividends were added to the net loss in
the net loss per share calculation.
Options
The
Company’s 2017 Employee/Consultant Common Stock Compensation
Plan for the issuance of up to 3,000,000 options to grant common
stock to the Company’s employees, directors and consultants
was adopted pursuant to the written consent of holders of a
majority of The Company’s common stock obtained as on
March 7, 2017 and was considered approved on April 21,
2017. At June 30, 2017, no options have been issued from the
plan.
Warrants outstanding
|
Warrants
|
Weighted
Average Exercise Price
|
Aggregate
Intrinsic Value
|
Weighted
Average Remaining Contractual Life (Years)
|
Outstanding
at December 31, 2016
|
1,396,161
|
$1.08
|
—
|
4.11
|
Granted
|
4,256,150
|
0.50
|
—
|
5.00
|
Exercised
|
—
|
—
|
—
|
—
|
Expired
|
—
|
—
|
—
|
—
|
Outstanding
at June 30, 2017
|
5,652,311
|
$0.62
|
—
|
4.54
|
During
the three and six month period ended June 30, 2017, the Company
issued 130,000 and 325,000 warrants in connection with the default
provisions of the Notes and the May Notes, which were valued at
$40,980 and $97,700. The value of the warrants were
determined using the Black-Scholes model, at an interest free rate
of 1.33%, volatility of 50% and a remaining term of 5 years and a
market price of between $0.50 to $0.80 during the three and six
months ended June 30, 2017.
In
January 2017, the Company reached an agreement with all secured
promissory noteholders, to extend the maturity of the secured
promissory notes to June 30, 2017, whereby the warrants were
repriced from $0.80 a share to $0.50 a share. The notes continue to
bear interest at 15% and the secured promissory noteholders
continue to receive warrants amounting to 10% of the principal
balance, as long as the notes remain outstanding. The Company
repriced all warrants issued totaling 1.2 million warrants
amounting to a $64,405 incremental value using the Black-Scholes
model on January 16, 2017, the date of the amendments at a current
market price of $0.36 a share, at an interest free rate of 1.33%
and a remaining terms ranging from 4 years to 4 years and 11.5
months.
During
the six months ended June 30, 2017, the Company issued 4,310,000
shares of common stock for $2,155,000, less $153,000 of issuance
costs. In connection with the issuance of common stock, the Company
issued 2,155,000 warrants to purchase shares of common stock at
$0.50, for a term of 5 years. We also issued 50,000 shares from
stock subscriptions of $25,000 at December 31, 2016 and issued
25,000 warrants on the same terms and conditions. On January 16,
2017 the Company also amended the original equity raise closed on
December 7, 2016 and issued an additional 411,915 warrants to
purchase shares of common stock at an exercise price of $0.50, for
a term of 5 years. The Company issued 263,250 warrants to purchase
common stock to brokers related to the above transaction for
2017.
Note 8.
Commitments and Contingencies
Legal Proceedings
On
November 13, 2016, the Company’s former CFO filed a complaint
against the Company and certain officers and directors of the
Company in the United States District Court for the Northern
District of Illinois, Eastern Division, Case No. 1:16-cv-10554,
whereby he is alleging (i) breach of the Illinois Wage and
Protection Act, (ii) breach of employment contract and (iii) breach
of loan agreement. He is seeking monetary damages up to
approximately $1,665,972. The Company has denied the substantive
allegations in the complaint and is vigorously defending the suit.
Management believes that the claims set forth in the complaint
against the Company are without merit. The Company has accrued
wages and vacation of approximately $1.1 million and a $50,000 note
payable to the former CFO at June 30, 2017 and December 31, 2016.
The Company believes that more than half of the balance currently
outstanding was to be converted into common stock as a condition of
the merger agreement at $2.00 a share. The presiding Federal Judge
has referred the lawsuit to mediation. No settlement was reach
during the April 2017 meditation. The Company has proactively
initiated settlement offers with no progress from the former CFO.
The magistrate judge highly recommended that both parties work
towards a settlement and scheduled an update meeting in September
2017.
Note
9.
Segment
Information
The
Company operates in one operating segment. However, the Company has
assets and operations in the United States, Germany and Poland. The
following tables show the breakdown of the Company’s
operations and assets by region (in thousands):
|
United
States
|
Germany
|
Poland
|
Total
|
||||
|
June
30,
2017
|
December
31,
2016
|
June
30,
2017
|
December
31,
2016
|
June
30,
2017
|
December
31,
2016
|
June
30,
2017
|
December
31,
2016
|
Assets
|
$11,819
|
$11,268
|
$6,181
|
$6,264
|
$114
|
$238
|
$18,114
|
$17,770
|
Property
& equipment, net
|
60
|
68
|
1,516
|
1,487
|
-
|
2
|
1,576
|
1,557
|
Intangible
assets
|
10,518
|
10,518
|
-
|
-
|
-
|
-
|
10,518
|
10,518
|
|
United States
|
Germany
|
Poland
|
Total
|
||||
For the three months ended
|
June
30, 2017
|
June
30, 2016
|
June
30, 2017
|
June
30, 2016
|
June
30, 2017
|
June
30, 2016
|
June
30, 2017
|
June
30, 2016
|
Revenues:
|
|
|
|
|
|
|
|
|
Histology
Equipment
|
$38
|
$119
|
$220
|
$1,564
|
$5
|
$-
|
$263
|
$1,683
|
Histology
Consumables
|
136
|
24
|
667
|
644
|
-
|
3
|
803
|
671
|
Cytology
Consumables
|
-
|
136
|
211
|
326
|
-
|
-
|
211
|
462
|
Total
Revenues
|
$174
|
$279
|
$1,098
|
$2,534
|
$5
|
$3
|
$1,277
|
$2,816
|
Net
loss
|
$(667)
|
$(487)
|
$(921)
|
$333
|
$(37)
|
$(48)
|
$(1,625)
|
$(202)
|
|
United States
|
Germany
|
Poland
|
Total
|
||||
For
the six months ended
|
June
30, 2017
|
June
30, 2016
|
June
30, 2017
|
June
30, 2016
|
June
30, 2017
|
June
30, 2016
|
June
30, 2017
|
June
30, 2016
|
Revenues:
|
|
|
|
|
|
|
|
|
Histology
Equipment
|
$184
|
$215
|
$980
|
$2,564
|
$13
|
$8
|
$1,177
|
$2,787
|
Histology
Consumables
|
240
|
70
|
1,240
|
1,157
|
-
|
7
|
1,480
|
1,234
|
Cytology
Consumables
|
-
|
268
|
511
|
655
|
-
|
3
|
511
|
926
|
Total
Revenues
|
$424
|
$553
|
$2,731
|
$4,376
|
$13
|
$18
|
$3,168
|
$4,947
|
Net
loss
|
$(1,237)
|
$(977)
|
$(1,137)
|
$244
|
$(206)
|
$(91)
|
$(2,580)
|
(824)
|
Note
10.
Subsequent
Events
On July 10, 2017, all Note Holders, with
the exception of a single individual Note Holder who holds two
Notes and has elected not to waive default, agreed to further
extend the repayment of the Notes until July 31, 2017. The Company
issued 66,666 warrants to purchase shares of common stock at $0.50
a share for the default provision. No further warrants will be
issued on these defaulted Notes. No additional consideration is
being given by the Company for this extension by the consenting
Note Holders. On August 11, 2017, the above Note Holders agreed to
further extend the repayment of the Notes until August 31,
2017.
On
August 1, 2017 the Company received written consent of the holders
of the majority of the issued and outstanding shares of our Common
Stock, to amend the 2017 Employee/Consultant Common Stock
Compensation Plan and to file a Certificate of Amendment
to our Certificate of Incorporation (the “Certificate of
Incorporation”) to increase the Company’s authorized
common stock, par value $0.001 per share (the “Common
Stock”), from 50,000,000 shares to 100,000,000 shares, (the
“Amendment”) and keep the authorized shares of
preferred stock, par value $0.001 per share (the “Preferred
Stock”), unchanged.
On March 7, 2017
the Company filed a $4,250,000 Form D to issue up to 8.5 million
shares of common stock and approximately 2.2 million warrants to
issue common stock at $0.50 a share. The Company has extended this
offering through September 29, 2017.
Item
2.
Management’s Discussion and Analysis of
Financial Condition and Results of Operations
Caution Regarding Forward-Looking Statements
This
report contains “forward-looking statements” –
that is, statements related to future, not past, events. In this
context, forward-looking statements often address our expected
future business and financial performance and financial condition,
and often contain words such as “expect,”
“anticipate,” “intend,” “plan,”
“believe,” “seek,” “see,” or
“will.” These forward-looking statements are not
guarantees and are subject to known and unknown risks,
uncertainties and assumptions about us that may cause our actual
results, levels of activity, performance or achievements to be
materially different from any future results, levels of activity,
performance or achievements expressed or implied by such
forward-looking statements. For us, particular uncertainties that
could cause our actual results to be materially different than
those expressed in our forward-looking statements include: our
ability to raise capital; our ability to retain key employees; our
ability to engage third party distributors to sell our products;
economic conditions; technological advances in the medical field;
demand and market acceptance risks for new and existing products,
technologies, and healthcare services; the impact of competitive
products and pricing; US and international regulatory, trade, and
tax policies; product development risks, including technological
difficulties; ability to enforce patents; and foreseeable and
unforeseeable foreign regulatory and commercialization factors, our
ability to develop new products and respond to technological
changes in the markets in which we compete, our ability to obtain
government approvals of our products, our ability to market our
products, changes in third-party reimbursement procedures, and such
other factors that may be identified from time to time in our
Securities and Exchange Commission ("SEC") filings and other public
announcements including those set forth under the caption
“Risk Factors” in Part 1, Item 1A of our Annual Report
on Form 10-K for the year ended December 31, 2015. All subsequent
written and oral forward-looking statements attributable to us, or
persons acting on our behalf, are expressly qualified in their
entirety by the foregoing. Readers are cautioned not to place undue
reliance on our forward-looking statements, as they speak only as
of the date made. Except as required by law, we assume no duty to
update or revise our forward-looking statements.
Overview of MEDITE Cancer Diagnostics, Inc.
MEDITE
Cancer Diagnostics, Inc. (the “Company”,
“it”, “we”, or “us”), formerly
CytoCore, Inc., specializes
in the marketing and selling of MEDITE core products (instruments
and consumables), manufacturing, development of new solutions in
histology and cytology and marketing of molecular biomarkers. These
premium medical devices and consumables are for detection, risk
assessment and diagnosis of cancerous and precancerous conditions
and related diseases. Depending upon the type of cancer, segments
within the current target market of approximately $5.8 billion are
growing at annual rates between 10% and 30%. The well-established
brand of MEDITE Cancer Diagnostics is well received and remains a
professional description of the Company’s business. The
Company’s trading symbol is “MDIT”.
In 2016
and 2017 we focused on implementation of several growth
opportunities including enhanced distribution of core products
through focused sales and distribution channel(s), newly developed
and patent pending assays, new laboratory devices and several
marketing projects like the Chinese standardization projects for
histology and cytology. The Company is optimistic about
recent marketing efforts focusing on larger laboratory chains and
other important strategic relationships. The Company has
approximately 74 employees in four countries, a distribution
network to about 80 countries and a wide range of products for
anatomic pathology, histology and cytology laboratories available
for sale.
After
the successful market entrance into China in 2014, the
Company’s revenues (sales credits) in this market are
approximately $(35,390) and $29,610 for the three and six months
ended June 30, 2017 compared to $507,000 and $692,000 for the three
and six months ended June 30, 2016. Sales have been impacted by the
manufacturing issues addressed under Revenue and Results of
Operations discussed elsewhere within this filing. The Company has
addressed most of the product, service and training issues in
China. The Company sent a technician to China for approximately
four weeks to retrain and review the policies and procedures
relating to the products being serviced by UNIC in China. We also
addressed various issues, product related and warranty issues
related to prior deliveries. The Company has received $800,000 in
orders for China which they believe they can complete by the fourth
quarter. Total sales for the year ended December 31, 2016 were
approximately $1 million compared to $897,000 for the same period
in 2015. The Chinese market is growing quickly, and the
Company expects it will be one of two largest markets for its
products. By working with its Chinese distributor, UNIC Medical,
the Company has successfully received China Food and Drug
Administration (“CFDA”) approval for all MEDITE
histology laboratory devices at the end of 2014, and for the
Cytology device in 2015. The Company is working with UNIC and are
anticipating increased sales in China in the third and fourth
quarter of 2017. Also, together with UNIC, we are part
of a government supported project to standardize the histology
laboratory process in China. UNIC Medical is using MEDITE equipment
and consumables for processing, and launching new assays. UNIC has
taken an active role in branding MEDITE Cancer Diagnostics in
China. Medite is working through certain product rollout issues
which have impacted its anticipated increase in sales.
On May
31, 2016, UNIC received CFDA approval as a Class I in vitro
diagnostic reagent for MEDITE's "SureThin" cell preservation
solution. As China adopts Cytopathology standards across
the country, the Company expects 'Liquid Based Cytology Tests
(LBC)' will be used for the majority of Pap collections for
cervical cancer screening. We are prepared to sell the complete
SureThin product line, including the already approved Processor to
this potential market of 485 million women between the ages of 16
and 64 years of age. Management anticipates launching the product
in China by the third quarter of 2017 and in the US by the fourth
quarter of 2017.
The
Company’s cytology product line revenue remained at about the
same levels in Europe (non-Gyn and Gyn applications) during 2016
and 2017 related to a competitive threat that management believes
has been alleviated. The Company is in the process of moving
forward the submission of an application to the US Food and Drug
Administration (“FDA”) for SureThin Gyn applications.
Once approved we can compete with some of the dominant suppliers in
this $600 million market and target major strategic lab partners.
The impact of the gynecology segment SureThin solution in the US
and China market will drive significant new revenue and gross
margin improvement opportunities in the later part of
2017.
MEDITE
is clearing certain hurdles in obtaining FDA clearance of its
SureThin product offering for gyn use in the US. The product is
attracting the interest of larger labs that will use both the
SureThin non-gyn and gyn applications. The gyn clearance with the
sale of the SureThin processor will encourage market growth
Management believes will provide sources for improved sales
channels. MEDITE will launch SureThin in the US to independent labs
using the LDT (Laboratory Directed Tests) protocol in CLIA approved
sites as early as third quarter while continuing to work through
the FDA path.
The
developed and US patented self-collection device SoftKit is
targeting the growing POC & POP (point of care or point of
people care) market. Growth in this area is due to consumer driven
health care requirements and the necessity to support and address
incremental patient population needs for screening and on-going
diagnostic tests. SoftKit serves as just such a product, addressing
this market requirement. SoftKit is planned to be sold through
various marketing channels that serve the gynecology physician
consumer health and emerging post-acute care as the influence of
clinical labs are expanded. Initially the SoftKit is targeted at
the uterine cancer/HPV screening market. The next phase of testing
will include cervical screening. We are currently developing
a study plan with a major research center in the Midwest, with the
goal of submitting for FDA approval during 2018.
Management believes
that 2017 developments, allows us to more fully leverage the
products and biomarker solutions from CytoCore component of MEDITE.
The first entry will be the introduction of the SureCyte+ C1
(fluorogenic) instant stain, offering tremendous opportunities for
lab efficiencies and enhanced patient care, C1 is the first of many
new offering under the SureCyte brand. We are currently conducting
informal studies with several labs in the USA and preparing a
formal study with a hospital in China with our partner,
UNIC,
The
Company brought several other innovative products closer to
marketability during 2016, and continued during 2017 as listed
above. The above technologies, if successfully accepted
by the market, has the ability to change the competitive landscape
within the industry.
During
the first quarter of 2016, the Company opened a second German
manufacturing facility with approximately 4,000 square
feet in Nussloch. This facility is utilizing the local
workforce and their experience for the specialized skills required
for manufacturing of the newly developed and updated Microtome
product line and the newly developed Cryostat (instruments used for
sectioning tissue biopsies). The Company began manufacturing
the new Cryostat line during the first quarter of 2017 and
anticipates the first pre serial series to be available before the
end of the second quarter. This enhanced microtome and cryostat
production facility will allow MEDITE to meet the anticipated
demand for these instruments as well as enhance its worldwide
distribution channel through its suppliers including
China.
The
Company operates in one industry segment for cancer diagnostics
instruments and consumables for histology and cytology
laboratories.
Definition:
|
Histology - Cancer diagnostics based on the structures of cells in
tissues
|
|
Cytology - Cancer diagnostics based on the structures of individual
cells
|
Cancers
and precancerous conditions are defined in terms of structural
abnormalities in cells. For this reason cytology is widely used for
the detection of such conditions while histology is typically used
for the confirmation, identification and characterization of the
cellular abnormalities detected by cytology. Other diagnostics
methods such as marker-based assays provide additional information
that can supplement, but which cannot replace cytology and
histology. The trend towards more personalized treatment of cancer
increases the need for cytology, histology and assays for
identifying and testing the best treatment alternatives. We believe
that this segment will therefore be increasingly important for
future development of strategies to fight the “cancer
epidemic” (World Health Organization: World Cancer Report
2014) which expects about a 50 % increase in cancer cases worldwide
within the next 20 years.
This
segment sees a trend toward, and demand for, higher automation for
more throughput in bigger laboratories, process standardization,
digitalization of cell and tissue slides and computer aided
diagnostic systems, while also looking for cost effective
solutions. In the US the Patient Protection and Affordable Care Act
is a national example for the industry. More people have health
insurance and therefore can afford early cancer screening, while at
the same time the payers for health care continue looking for cost
reductions.
MEDITE
acts as a one-stop-shop for histology (also known as anatomic
pathology) laboratories either as part of a hospital, as part of a
chain of laboratories or individually. It is one out of only four
companies offering all equipment and consumables for these
laboratories worldwide. The MEDITE brand stands for innovative and
high quality products – most equipment made in Germany
– and competitive pricing.
For the
cytology market, MEDITE offers a wide range of consumable products
and equipment; in particular for liquid-based-cytology which is an
important tool in cancer screening and detection in the field of
cervical, bladder, breast, lung and other cancer types. It also
developed an innovative, easy to use standardized staining
solutions, and a very innovative and effective early cancer
detection marker-based assays. These new developments are cost
effective solutions able to replace more expensive competitive
products, and therefore are also becoming the first choice for the
growing demand in emerging countries.
All of
the Company’s operations during the reporting period were
conducted and managed within this segment, with management teams
reporting directly to our Chief Executive Office. For information
on revenues, profit or loss and total assets, among other financial
data, attributable to our operations, see the consolidated
financial statements included herein. Further during these 2016 and
2017 periods we added key personnel with excellent historical
performance in new product commercialization, sales development and
internal operations improvement.
Outlook
Due to
promising innovative new products for cancer risk assessment and an
increasing number of distributions contracts executed in the last
years, management believes the profitability and cash-flow of the
business will grow and improve. However, significant on-going
manufacturing issues have been identified and addressed and
additional operating expenditures may be necessary to manufacture
and market new and existing products to achieve the accelerated
sales growth targets outlined in the Company’s business plan.
To realize the planned growth potential, management will focus its
efforts on 1.) Finishing and gaining approval for the products
currently under development and 2.) Increase direct sales in the US
to optimize the excellent sales/distribution channels, invigorate
the distribution networks for the EU/ROW and continue to expand
Chinese market sales by broadening the Company’s
collaborations with the local distributor UNIC. We also will work
on continuously optimizing manufacturing capacity to increase our
gross margin. Implementation of our plans will be contingent upon
securing substantial additional debt and/or equity financing. If
the Company is unable to obtain additional capital or generate
profitable sales revenues, we may be required to curtail product
development and other activities. The condensed consolidated
financial statements presented herein do not include any
adjustments that might result from the outcome of this
uncertainty.
Currently, the
Company’s sales primarily are generated in Euro currency.
While in 2016 the average USD/Euro exchange rate was 1.10682 for
the six months ended June 30, 2016, compared to 1.0821 in and June
30, 2017 a decrease of 0.02472, however the conversion rate at
December 31, 2016 was 1.05204 and 1.1426 at June 30, 2017,
respectively. MEDITE’s sales in USD were lower on a year over
year basis as approximately 90% of our sales currently occurs in
Euros. The Company is working to lessen the impact of the
Euro’s decline versus the dollar by increasing the percentage
of overall product sales in the US and other countries such as
China whose currency is not pegged to the Euro.
The
Company believes the combination of MEDITE Enterprise, Inc. with
CytoCore, Inc. expedited the development and marketability of
CytoCore’s cytology products which include collection
devices, image analysis software, special stains and immuno-assays.
Currently, the recent launch of new products, the positive impact
from several new initiatives, and some recently executed
distribution contracts in the US, Europe and China are some primary
positive factors assisting growth.
A major
market movement for MEDITE is its recent acceptability into several
US key opinion leader clinical sites as well a strategic sales,
distribution and launch partners that will create immediate use and
purchasing sites, whitepapers and recognition required for MEDITE
to reach its next level of growth in its new product introductions.
Similar approaches are in place in China and scheduled for the
EU.
Results of Operations
The
following discussion and analysis should be read in conjunction
with the Company’s unaudited condensed consolidated financial
statements presented in Part I, Item 1 of this Quarterly Report and
the notes thereto, and our audited consolidated financial
statements and notes thereto, as well as our Management’s
Discussion and Analysis contained in our Annual Report on Form 10-K
for the year ended December 31, 2016 filed with the SEC on April
14, 2017.
Three months ended June 30, 2017 as compared to the three months
ended June 30, 2016 (in thousand USD)
Revenue
Revenue
for the three months ended June 30, 2017, was $1,277 as compared to
$2,816 for the three months ended June 30, 2016. Due to some
seasonality in the industry, usually the first half of the year is
weaker because many larger customers buy their lab equipment during
the last 4 to 5 months of the year. The Company
increased sales in the cytology product during 2016 period,
partially through the US sales doubling during the 2016 period
however due to cash constraints during the end of 2016 and into
2017, cytology products were not readily available for
sale. MEDITE manufactured lab equipment decreased during
2017, compared to the same period in 2016. The sales for the second
quarter were impacted by the identification by the new management
team of manufacturing, quality, installation and service issues
that were addressed during the period. The new management team
undertook a purposeful slowdown of production in order to fully
address these issues. Sales revenues included customer credits for
returns, allowances and adjustments associated with the
manufacturing quality and services issues discussed above. The
credits totaled $258 for the three month period ended June 30,
2017. New sales for the 2017 quarter were $1,535. The Company and
its new management team took a hard look at the product offering
and the endemic problems associated with certain products to make
the necessary changes in the manufactured products. During the
period, the Company slowed down its delivery of certain products to
ensure that issues identified were solved. Service staff attended
to equipment in various regions and reengineered certain equipment
as needed. Sales increased slowly but steadily from April through
June and the Company anticipates that the quality issues have been
identified and closely monitored to ensure that all quality
standards are in place and have been enforced. Our sales team has
communicated with our regional distribution channels the changes
that have been implemented and they are working with the Company to
create incremental sales. The Company had a backlog of sales at
June 30, 2017 was $335.
Costs of Revenue
Cost
of revenues were $1,228, or 96% of the revenues for the three
months ended June 30, 2017, as compared to $1,546, or 55% of the
revenues for the three months ended June 30, 2016. The cost of
revenue consisted of higher manufacturing and fixed costs during
2017 due delays in sourcing parts, quality and installation issues
discussed above. The Company has historically experienced cost of
revenue as a percentage of revenue of between 58% and 65%.
Manufacturing and service costs were not absorbed for the period in
2017, as the Company purposefully slowed down production for April
2017 and gradually increased production in May and June. The
service personnel were focused on reinstallation of equipment,
identifying solutions to prior installation, retraining our
distributors’ installers and evaluating what products went
back to the development department for reengineering.
Research and Development
Research
and development expenses are an important part of our business to
keep our existing products competitive, and to develop new
innovative solutions with interesting market potential that will
help us grow future revenues. These expenses include research work
for cancer marker consumables and developing work, including
engineering and industrial design, for histology and cytology
laboratories worldwide. The major components consist of
payroll-related costs for in-house scientific research, mechanical
and electrical engineering, instrument related software development
staff, prototype expenses and material purchased for
R&D.
For
the first quarter 2017, research and development expenses decreased
to $329 compared to $421 for the first quarter 2016. The
Company focused all its attention during the quarter as it related
to the manufacturing and service issue in Germany. The former
Cytocore research and development team continued to pursue its new
products anticipated to be rolled out in the third and fourth
quarter of 2017.
Selling, General and Administrative
For
the first quarter 2017, SG&A expenses were $1,228 as compared
to $918 for the first quarter 2016. Professional fees were lower
for the quarter ended June 30, 2017 specifically related to lower
audit fees for the 2016 audit and timing of the completion of the
audit through April 2017. Included in selling, general and
administrative expenses for the three months ended June 30, 2017
was the non-cash impact related to the issuance of common stock to
management and the amortization of the cost over the vesting period
of up to three years totaling $53 for the three months ended June
30, 2017. The Company increased its allowance for bad debt by $62
for the three months ended June 30, 2017 associated with the
related receivables identified above under revenues. Salary and
wages increased during the three months ended June 30, 2017, as the
Company completed its hiring of its management team in April and
May of 2017. Severance payments through September 30, 2017 were
$119 for the three months ended June 30, 2017 related to the
agreements signed with Michael and Michaela Ott on May 5,
2017.
Operating Loss
The
operating loss of $1,562 for the first quarter of 2017, compares to
$119 for the first quarter of 2016, and is directly related to
lower sales for the period, lower gross margins, higher selling,
general and administrative expenses offset by lower development
costs discussed above.
Interest Expense
Interest expenses decreased by 52% to $67 in the
three months ended June 30, 2017, compared to $139 for the three
months ended June 30, 2016, due to the amortization of the debt
issuance costs and the amortization of the debt discount attributed
to the secured promissory notes issued on May 25, 2016, which
matured on August 26, 2016. These notes bear interest at
15%, or $24 for the 2017 period compared to $19 for the 2016 period
and the amortization of the debt issuance costs and debt discount
totaled $54 for the three months ended June 30, 2016. The
2017 period did not have any amortization of the debt issuance
costs. During the three months ended June 30, 2017 the Company
recorded $31 and $10 to interest expense related to the fair value
of 130,000 warrants issued related to the extension feature in
secured promissory notes issued on December 31, 2015 and May 25,
2016, respectively. The effect of the interest, debt issuance
costs and debt discount, repricing and the penalty warrants on the
secured promissory notes was an effective yield of
49% and 68% for the three months ended June 30, 2017
and 2016, respectively.
Net Loss
The
net loss for the quarter ended June 30, 2017, totaled $1,625, as
compared to net loss of $202 for the quarter ended June 30, 2016.
The loss for 2017 directly related to lower sales and net margins
for the period and higher selling, general and administrative
expenses, offset by lower research and development costs discussed
above.
Six months ended June 30,
2017 as compared to the six months ended June 30, 2016 (in thousand
USD)
Revenue
Revenue
for the six months ended June 30, 2017, was $3,168 as compared to
$4,947 for the six months ended June 30, 2016. Due to some
seasonality in the industry, usually the first quarter of the year
is weaker because many larger customers buy their larger equipment
during the last 4 to 5 months of the year. The Company
increased sales in the cytology product during 2016 period ,
partially through the US sales doubling during the 2016 period
however due to cash constraints during the end of 2016 and into
2017, cytology products were not available for
sale. MEDITE manufactured lab equipment decreased during
2017, compared to the same period in 2016. The sales for the first
six months were impacted by the identification by the new
management team of manufacturing, quality, installation and service
issues that were addressed during the period. The new management
team undertook a purposeful slowdown of production in order to
fully address these issues. Sales revenues included customer
credits for returns, allowances and adjustments associated with the
manufacturing quality and services issues discussed above. The
credits totaled $286 for the six month period ended June 30, 2017.
New sales for the 2017 period were $3,454. The Company and its new
management team took a hard look at the product offering and the
endemic problems associated with certain products to make the
necessary changes in the manufactured products. During the period,
the Company slowed down its delivery of certain products to ensure
that issues identified were solved. Service staff attended to
equipment in various regions and reengineered certain equipment as
needed. Sales increased slowly but steadily from April through June
and the Company anticipates that the quality issues have been
identified and closely monitored to ensure that all quality
standards are in place and have been enforced. Our sales team has
communicated with our regional distribution channels the changes
that have been implemented and they are working with the Company to
create incremental sales. The Company had a backlog of sales at
June 30, 2017 was $335.
Costs of Revenue
Cost
of revenues were $2,439, or 77% of the revenues for the six months
ended June 30, 2017, as compared to $2,759, or 56% of the revenues
for the six months ended June 30, 2016. The cost of revenue
consisted of higher manufacturing and fixed costs during 2017 due
delays in sourcing parts, quality and installation issues discussed
above. The Company has historically experienced cost of revenue as
a percentage of revenue of between 58% and 65%. Manufacturing and
service costs were not absorbed for the period in 2017, as the
Company purposefully slowed down production for April 2017and
gradually increased production in May and June. The service
personnel were focused on reinstallation of equipment, identifying
solutions to prior installation, retraining their
distributors’ installers and evaluating what products went
back to the development department for reengineering.
Research and Development
Research
and development expenses are an important part of our business to
keep our existing products competitive, and to develop new
innovative solutions with interesting market potential that will
help us grow future revenues. These expenses include research work
for cancer marker consumables and developing work, including
engineering and industrial design, for histology and cytology
laboratories worldwide. The major components consist of
payroll-related costs for in-house scientific research, mechanical
and electrical engineering, instrument related software development
staff, prototype expenses and material purchased for
R&D.
For
the six month ended June 30, 2017, research and development
expenses decreased to $754 compared to $781 for the same
period in 2016. The Company expensed approximately $138 of
development expense for the six months ended June 30, 2017. The
Company focused all its attention for the period as it related to
the manufacturing and service issue in Germany. The former Cytocore
research and development team continued to pursue its new products
anticipated to be rolled out in the third and fourth quarter of
2017.
Selling, General and Administrative
For
the six months ended June 30, 2017, SG&A expenses were $2,010
as compared to $1,775 for the same period in 2016.
Professional fees were lower for the quarter ended June 30, 2017
specifically related to lower audit fees for the 2016 audit.
Included in selling, general and administrative expenses for the
six months ended June 30, 2017 was the non-cash impact related to
the issuance of common stock to management and the amortization of
the cost over the vesting period of up to three years totaling $63
for the six months ended June 30, 2017. The Company increased its
allowance for bad debt by $62 for the six months ended June 30,
2017 associated with the related receivables identified above under
revenues. Salary and wages increased during the six months ended
June 30, 2017, as the Company completed its hiring of its
management team in April and May of 2017. Severance payments
through September 30, 2017 were $119 for the six months ended June
30, 2017 related to the agreements signed with Michael and Michaela
Ott on My 5, 2017. The Company also incurred legal fees of $23
associated with the legal issues identified under Legal in Note
8.
Operating Loss
The
operating loss of $2,138 for the six months ended June 30, 2017,
compares to $469 for the same period in 2016, and is directly
related to lower sales and margin for the period and higher
selling, general and administrative expense discussed
above.
Interest Expense
Interest
expenses decreased by 35% to $260 in the six months ended June 30,
2017, compared to $400 for the six months ended June 30, 2016, due
to the amortization of the debt issuance costs and the amortization
of the debt discount attributed to the secured promissory notes
issued at December 31, 2015, which matured on June 30,
2016. These notes bear interest at 15%, or $42 for the
2017 period compared to $40 for the 2016 period and the
amortization of the debt issuance costs and debt discount totaled
$220 for the six months ended June 30, 2016. The 2017 period
had amortization of the debt issuance costs of $0. During the six
months ended June 30, 2017 the Company recorded $64 for interest
expense related to repricing of the warrants related to the secured
promissory notes. For the six months ended June 30, 2017 and 2016,
Company recorded $98 and $54, respectively, for the fair value of
warrants issued related to the penalty and refinancing feature in
secured promissory notes. The effect of the interest, debt
issuance costs and debt discount, repricing and the penalty
warrants on the secured promissory notes was an effective yield of
72% and 118% for the six months ended June 30, 2017 and 2016,
respectively.
Net Loss
The
net loss for the six months period ended June 30, 2017, totaled
$2,580, as compared to net loss of $824 for the six months ended
June 30, 2016. The loss for 2017 directly related to lower sales
and margin for the period and higher selling, general and
administrative expenses discussed above. Decreased interest costs,
resulted from the amortization of the debt issuance cost and debt
discount with the secured promissory notes of $220 in 2016 offset
by repricing and warrant issuances discussed above.
Liquidity and Capital Resources
Due
to promising new products and distributions contracts executed in
the last two years and management changes with increased focus on
the various sales channels and manufacturing and quality systems,
management anticipates the profitability and cash flow of the
business will improve. However, significant on-going manufacturing
issues have been identified and addressed and additional operating
expenditures may be necessary to manufacture and market new and
existing products to achieve the accelerated sales growth targets
outlined in the Company’s business plan. To realize the
planned growth potential management will focus its efforts on 1.)
finishing and gaining approval for the products currently under
development and 2.) increasing direct sales in the USA through
multiple focused sales distribution channels continue to increase
EU/ROW distribution and continue to expand Chinese market sales by
broadening the Company’s collaborations with the local
distributor UNIC. We also will work on continuously optimizing
manufacturing cost to increase our gross margin. Specific
forecasting is monitored continually by the Company to improve
purchasing and through put management.
For the
six months ended June 30, 2017, we used net cash in operations of
approximately $1,392 compared to $742 for the same period in 2016.
During 2017, cash used in operations consisted of loss from
operations, offset by non-cash transactions for warrants issued
related to secured promissory notes, loss on extinguishment of
notes due to employees, also net changes in accounts receivables,
inventories and accounts payables and accrued expenses. During
2016, cash used in operations consisted of loss from operations,
offset by non-cash transactions for warrants issued related to
secured promissory notes and also net changes in accounts
receivable, inventory and accounts payable and accrued
expense.
For the
six months ended June 30, 2017, net cash used in investing
activities were $27 compared to $107 for the same period in
2016. The improvement in this activity relates to lower
other asset purchases in 2017 compared to 2016.
For the
six months ended June 30, 2017, financing activities provided
$1,679 compared $369 for the same period in 2016. The Company sold
4.3 million shares of common stock for $2.0 million during the six
month period ended June 30, 2017, net of $153 of issuance costs.
The Company borrowed $406 for the six months ended June 30, 2016
compared to repayments of $24 for the same period in 2017. In
addition, during the 2017 period the Company repaid $155 of notes
due to employees and $167 of secured promissory notes.
The
Company must contemplate continuation as a going concern. This
contemplates the realization of assets and the liquidation of
liabilities in the normal course of business. At June
30, 2017, the Company’s cash balance was $410 and its
operating losses for the six months ended June 30, 2017 and the
year ended December 31, 2016, have used most of the Company’s
liquid assets. These factors raise substantial doubt about the
Company’s ability to continue as a going concern. However
working capital has improved by approximately $169 from December
31, 2016.
The
Company has settled three of the five employee notes for $330 and
warrants. In April 2017 the Company paid $94 for the first
installment and issued warrants to purchase 1,029,734 shares of
common stock at $0.50, for a period of 5 years. The balances owed
to these employees remains outstanding as of the date of this
filing however, these employees continue to work with the
Company.
During
the six months ended June 30, 2017, the Company paid $167 on
secured promissory notes and a noteholder converted a note and
accrued interest with a balance of $50 into 116,833 shares of
common stock, reducing the outstanding balance to $433. Management
believes that the remainder of the balance will be settled in some
combination of cash and stock.
Management is actively seeking additional equity financing
contemplated in the $4.25 million stock purchase
agreement. The Company has negotiated with certain parties
whose obligations are due in the next twelve months to extend
payment terms beyond one year. One lender with an outstanding
balance of $857 at June 30, 2017, has stated that they will not be
able to refinance the debt. The default rate of interest will
increase three percent.
The
Company has accrued wages and vacation of approximately $1.1
million and a $50 note payable to the former CFO at June 30, 2017
and December 31, 2016. The Company believes that more than half of
the balance currently outstanding was to be converted into common
stock as a condition of the merger agreement at $2.00 a share. See
further discussion regarding the legal proceedings with the
Company’s former Chief Financial Officer. Also included in
accrued salaries, vacation and related expenses are amounts owed to
both the Michaela and Michael Ott totaling approximately $152 at
June 30, 2017. The payments are to be made in 18 installments
starting on October 31, 2017.
The
Company owes Ms. Ott, 91 Euros, ($104 as June 30, 2017). The
Company has established a payment plan whereby the balances owed
will be repaid beginning on October 31, 2017, over a 24 months
period.
The
Company’s security agreement with its lender has provided
borrowings of 35% of our collateralized assets. The
Company continues to seek to refinance this debt to provide
additional liquidity.
Management
continues to expand its product offerings and has also expanded its
sales and distribution channels during 2017.
If
management is unsuccessful in completing its equity financing, they
will begin negotiating with some of their major vendors and lenders
to extend the terms of their debt and also evaluate certain
expenses that have been implemented for the Company’s growth
strategy. However, there can be no assurance that
the Company will be successful in these efforts. The condensed
consolidated financial statements do not include any adjustments
that might result from the outcome of this
uncertainty.
The
Company intends to continue growing, using current working capital,
however the growth of the Company could be slowed down if we are
unable to obtain debt and/or equity
financing. Consequently, there is substantial doubt
about our ability to continue as a going concern.
Off-Balance Sheet Arrangements
As
of June 30, 2017, we did not have any relationships with
unconsolidated entities or financial partners, such as entities
often referred to as structured finance or special purpose entities
established for the purpose of facilitating off-balance sheet
arrangements or other contractually narrow or limited purposes. As
such, we are not materially exposed to any financing, liquidity,
market or credit risk that could arise if we had engaged in such
relationships.
Item
4.
Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our
Chief Executive Officer and our Chief Financial Officer, evaluated
the effectiveness of our disclosure controls and procedures (as
defined in Rules 13a-15(e) and 15d-15(e) promulgated under the
Securities Exchange Act of 1934, as amended, the “Exchange
Act”) as of the end of the period covered by this report.
Based on that evaluation, our Chief Executive and Chief Financial
Officers have concluded that our disclosure controls and procedures
were not effective to provide reasonable assurance that the
information we are required to disclose in the reports filed or
submitted by us under the Exchange Act is recorded, processed,
summarized and reported within the time periods specified in the
SEC’s rules and forms, and accumulated and communicated to
our management, including our Chief Executive Officer and Chief
Financial Officer, as appropriate to allow timely decisions
regarding required disclosure.
Part II. Other
Information
Item
1.
Legal Proceedings.
On
November 13, 2016, the Company’s former CFO filed a complaint
against the Company and certain officers and directors of the
Company in the United States District Court for the Northern
District of Illinois, Eastern Division, Case No. 1:16-cv-10554,
whereby he is alleging (i) breach of the Illinois Wage and
Protection Act, (ii) breach of employment contract and (iii) breach
of loan agreement. He is seeking monetary damages up to
approximately $1,665,972. The Company has denied the substantive
allegations in the complaint and is vigorously defending the suit.
Management believes that the claims set forth in the complaint
against the Company are without merit. The Company has accrued
wages and vacation of approximately $1.1 million and a $50,000 note
payable to the former CFO at June 30, 2017. The Company believes
that more than half of the balance currently outstanding was to be
converted into common stock as a condition of the merger agreement
at $2.00 a share.
On
April 26, 2017 mediation with a court appointed Magistrate Judge
occurred. The mediation ended with detail of settlement parameters.
The Magistrate dismissed the meeting with specific instructions to
both sides to settle the lawsuit. The Company has proactively
offered settlement offers with no progress from the former CFO. If
needed a September 7, 2017 update meeting with the Magistrate Judge
is scheduled. Both sides will continue to work towards an equitable
settlement prior to September 7, 2017.
Item
2.
Unregistered Sales of Equity Securities and Use of
Proceeds.
On
March 7, 2017 the Company filed a $4,250,000 Form D to issue up to
8.5 million shares of common stock and approximately 2.2 million
warrants to issue common stock at $0.50 a share. From January
through June 30, 2017 the Company received $2.16 million proceeds
for the sale of 4.31 million shares of common stock at a purchase
price of $0.50, with 50% of the shares issued, and 2.16 million
warrants to purchase common shares at $0.50, with a term of 5
years. The Company incurred $153,000 of cash commissions and issued
263,250 warrants associated with the sale of these
securities.
Item
3.
Defaults upon Senior
Securities.
On
January 10, 2017, the Board of Directors agreed to renegotiate the
terms of the 2015 Notes and 2016 Notes (collectively the
“Notes”) with the consent of the 2015 Purchasers and
2016 Purchasers (collectively the “Note Holders”),
which was obtained on January 16, 2017, as follows:
●
The Note Holders agreed to waive the defaults and extend the Notes
for the earlier of six months or the receipt of a $3,000,000
investment into the Company pursuant to a future private equity
offering, whichever occurs first (the
“Extension”).
●
Upon the Company’s receipt of the first $1,000,000 invested
(including the capital raised to date in a prior private equity
offering), the Note Holders will be repaid one third of their
principal investment. On June 30, 2017, the Company paid
approximately $167,000 of the outstanding Notes.
●
Upon the Company’s receipt of the second and third
$1,000,000, respectively, the Note Holders will be repaid one third
of their principal investment on each $1,000,000
raised.
●
The exercise price on the Warrants were
adjusted from $0.80 to $0.50.
●
If the Notes are not paid back in full on the six month extension
date, the Note Holders will each receive additional warrants equal
to 50% of their respective investments, exercisable at $0.50, as a
penalty.
●
The interest payments on the Notes will continue to accrue on the
remaining balance of the unpaid Notes, and the additional warrants
of 10% of the amount of Notes outstanding, previously penalty
warrants, shall continue to accrue pursuant to the
Notes.
●
The Note Holders will have the option to convert their Notes to
equity either before or at the six month extension end date into
units offered in any future private equity offering of the
Company.
On August 25, 2016, the 2016 Notes matured and were not
repaid. Therefore the 2016 Notes were in default on
August 26, 2016.
On July 10, 2017, all Note Holders, with
the exception of a single individual Note Holder who holds two (2)
Notes and has elected not to waive default, agreed to further
extend the repayment of the Notes until July 31, 2017. No
additional consideration is being given by the Company for this
extension by the consenting Note Holders. On August 11, 2017, the
above Note Holders agreed to further extend the repayment of the
Notes until August 31, 2017.
On May 31, 2017, Medite GmbH
(“Medite”), a wholly-owned subsidiary of MEDITE Cancer
Diagnostics, Inc. (the “Company”) entered in an
agreement with VR Equity Partner GmbH (formerly DZ
Equity Partners) to extend the payment
date of a credit facility in the outstanding principal amount of
EUR 750,000 until September 1, 2017. In consideration for the
extension, Medite shall pay an interest increase on the outstanding
principal balance of three percent (3%).
Item 6. Exhibits
Exhibit
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Number
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Description
|
|
|
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10.1
|
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Form of
First Amendment to Amended and Restated Securities Purchase
Agreement
|
|
|
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31.1
|
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Section 302 certification by the principal executive officer
pursuant to Rules 13a-14(a) or 15d-14(a) of the Securities Exchange
Act of 1934, as adopted pursuant to Section 302 of the Sarbanes
Oxley Act of 2002.
|
|
|
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31.2
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Section 302 certification by the chief financial officer pursuant
to Rules 13a-14(a) or 15d-14(a) of the Securities Exchange Act of
1934, as adopted pursuant to Section 302 of the Sarbanes Oxley Act
of 2002.
|
|
|
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32.1
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Section 906 certification by the principal executive pursuant to 18
USC. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes Oxley Act of 2002.
|
|
|
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32.2
|
|
Section 906 certification by the chief financial officer pursuant
to 18 USC. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes Oxley Act of 2002.
|
|
|
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101.INS
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XBRL Instance
|
|
|
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101.SCH
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XBRL Taxonomy Extension Schema
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|
|
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101.CAL
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XBRL Taxonomy Extension Calculation
|
|
|
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101.DEF
|
|
XBRL Taxonomy Extension Definition
|
|
|
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101.LAB
|
|
XBRL Taxonomy Extension Labels
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation
|
SIGNATURES
Pursuant
to the requirements 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.
|
MEDITE Cancer Diagnostics, Inc.
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Date: August 14, 2017
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/s/ David Patterson
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David Patterson
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Chief Executive Officer
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Date: August 14, 2017
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/s/ Susan Weisman
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Susan Weisman
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Chief Financial Officer
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-23-