UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-QSB/A
(Amendment
No. 1)
(Mark
One)
x
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For
the
quarterly period ended
October
31, 2007
¨
TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT
For
the
transition period from ________ to ________
Commission
file number
000-13176
NON-INVASIVE
MONITORING SYSTEMS, INC.
(Exact
name of small business issuer as specified in its charter)
FLORIDA
|
59-2007840
|
(State
or other jurisdiction of incorporation or organization)
|
(IRS
Employer Identification No.)
|
4400
Biscayne Blvd., Suite 680, Miami, Florida 33137
(Address
of principal executive offices)
(Issuer
'
s
telephone number)
(Former
name, former address and former fiscal year, if changed since last
report)
Check
whether the issuer (1) filed all reports required to be filed by Section 13
or
15(d) of the Exchange Act during the past 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
x
No
¨
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes
¨
No
x
APPLICABLE
ONLY TO ISSUERS INVOLVED IN BANKRUPTCY
PROCEEDINGS
DURING THE PRECEDING FIVE YEARS
Check
whether the registrant filed all documents and reports required to be filed
by
Section 12, 13 or 15(d) of the Exchange Act after the distribution of securities
under a plan confirmed by a court.
Yes
¨
No
¨
APPLICABLE
ONLY TO CORPORATE ISSUERS
State
the
number of shares outstanding of each of the issuer's classes of common equity,
as of the latest practicable date:
The
number of shares outstanding of the registrant’s Common Stock, par value $.01
per share (the “Common Stock”), as of October 31, 2007 was
67,455,399
Indicate
if the registrant is a shell company (as defined in Rule 12b-2 of the Exchange
Act). Yes
¨
No
x
Transitional
Small Business Disclosure Format (Check one):
Yes
¨
No
x
NON-INVASIVE
MONITORING SYSTEMS, INC
.
Report
on
Form 10-QSB/A
For
the
Fiscal Quarter Ended October 31, 2007
TABLE
OF CONTENTS
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Item 1.
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Condensed
Financial Statements and Notes to Financial Statements
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(a)
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Condensed
Balance Sheet as of October 31, 2007 (unaudited)
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4
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(b)
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Condensed
Statements of Operations for the Three Months Ended October 31, 2007
and
2006 (unaudited)
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5
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(c)
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Condensed
Statements of Cash Flows for the Three Months Ended October 31, 2007
and
2006 (unaudited)
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6
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(d)
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Notes
to Unaudited Condensed Financial Statements
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7
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Item 2.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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14
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Item 3.
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Controls
and Procedures
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18
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Part
II. OTHER INFORMATION
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Item 2.
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Unregistered
Sales of Equity Securities and Use of Proceeds
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19
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Item 6.
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Exhibits
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19
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Signatures
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20
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NON-INVASIVE
MONITORING SYSTEMS, INC.
Report
on
Form 10-QSB/A
For
the
Fiscal Quarter Ended October 31, 2007
Forward-Looking
Statements
This
Report contains, in addition to historical information, forward-looking
statements regarding Non-Invasive Monitoring Systems, Inc. (the “Company” or
“NIMS”), which represent the Company’s expectations or beliefs including, but
not limited to, statements concerning the Company’s operations, performance,
financial condition, business strategies, and other information and that involve
substantial risks and uncertainties. The company’s actual results of operations,
some of which are beyond the Company’s control, could differ materially. For
this purpose, any statements contained in this Report that are not statements
of
historical fact may be deemed to be forward-looking statements. Without limiting
the generality of the forgoing, words such as “may,” “expect,” “believe,”
“anticipate,” ”intend,” “could,” “estimate,” or “continue” or the negative or
other variations thereof or comparable terminology are intended to identify
forward-looking statements. Factors that could cause or contribute to such
difference include, but are not limited to, history of operating losses and
accumulated deficit; need for additional financing; dependence on future sales
of the “Exer-Rest,” motion platform; competition; dependence on management;
risks related to proprietary rights; government regulation; and other factors
discussed herein and in the Company’s other filings with the Securities and
Exchange Commission.
Explanatory
Note
This
Amendment No. 1 to the Quarterly Report on Form10-QSB for the fiscal quarter
ended October 31, 2007 of the Company is being filed to restate in their
entirety Part I, Items 1, 2, and 3 and Part II, Items 2 and 6 as set forth
on
the Form 10-QSB filed on December 17, 2007 (the “Original Filing”). The changes
to Part I, Item 1 and Item 2 relate to a change in previously reported
compensation for options granted in October 2007. The net effect of this change
was to increase stock-based compensation and operating expenses for the three
months ended October 31, 2007 by $108,257, thus increasing the net loss for
the
period to $329,813. In addition, the number of options outstanding as of October
31, 2007 has been corrected in Footnote 3 of the Notes to Condensed Financial
Statements in Part I, Item 1. Furthermore, we corrected certain information
relating to our relationship with VivoMetrics in Footnote 6 of the Notes to
Condensed Financial Statements in Part I, Item 1. In light of the errors cited
above we have reconsidered the effectiveness of our controls and procedures
at
October 31, 2007 and as a result we have amended Part I, Item 3. In Part II,
Item 2, we have added the issuances of options previously reported on Form
8-K
filed October 23, 2007 under Item 8.01, as a recent sale of unregistered
securities. We have also added a product development and supply agreement
previously described in a Form 8-K filed September 11, 2007 to our list of
Exhibits and are thus amending Part II, Item 6.
Pursuant
to Rule 12b-15 under the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), this Amendment No. 1 amends the foregoing items in their
entirety and contains new certifications pursuant to Rules 13a-14 and 15d-14
under the Exchange Act and Section 302 of the Sarbanes-Oxley Act of 2002. Other
than as set forth above and the inclusion of new certifications pursuant to
Rules 13a-14 and 15d-14 under the Exchange Act and Section 302 of the
Sarbanes-Oxley Act of 2002, no other changes or amendments to the Original
Filing are being made.
This
Amendment No. 1 contains only the sections and exhibits to the Original Filing
that are being amended, and those unaffected parts or exhibits are not included
herein. This Amendment No. 1 contains adjustments as of the date of the Original
Filing and the Company has not updated the disclosure contained herein to
reflect events that have occurred since the date of the Original Filling.
Accordingly, this Amendment No. 1 should be read in conjunction with the
Company’s other filings made with the Securities and Exchange Commission, and is
subject to updating and supplementing as provided in the periodic reports that
the Company has filed and will file after the date of the Original Filing with
the Securities and Exchange Commission.
NON-INVASIVE
MONITORING SYSTEMS, INC.
CONDENSED
BALANCE SHEET
(Unaudited)
|
|
October
31,
2007
(Restated - Note 9)
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ASSETS
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Current
assets
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Cash
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$
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771,164
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Restricted
cash
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400,000
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Royalties
receivable
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44,643
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Inventory
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99,333
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Prepaid
expenses, deposits, and other current assets
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18,185
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Total
current assets
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1,333,325
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|
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|
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Furniture,
equipment, website and tooling, net
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193,778
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Total
assets
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$
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1,527,103
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LIABILITIES
AND SHAREHOLDERS' EQUITY
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Current
liabilities
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Note
payable - bank
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$
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500,000
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Notes
payable - other
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7,305
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Accounts
payable and accrued expenses
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221,147
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Deferred
warranty income
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3,900
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|
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Total
current liabilities
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732,352
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Deferred
warranty income
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1,500
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Total
liabilities
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733,852
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Commitments
(Note 7)
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Shareholders'
equity
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Series
B Preferred Stock, par value $1.00 per share;
100
shares authorized, issued and outstanding
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100
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Series
C Preferred Stock, par value $1.00 per share;
62,048
shares authorized, issued and outstanding
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62,048
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Common
Stock, $ .01 par value; 100,000,000 shares authorized; 67,455,399
shares
issued and outstanding
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674,554
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Additional
paid in capital
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16,585,358
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Accumulated
deficit
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(16,528,809
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)
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Total
shareholders' equity
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793,251
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Total
liabilities and shareholders' equity
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$
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1,527,103
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The
accompanying notes are an integral part of these unaudited condensed financial
statements.
NON-INVASIVE
MONITORING SYSTEMS, INC.
CONDENSED
STATEMENTS OF OPERATIONS
(Unaudited)
For
the Three months ended October 31, 2007 and 2006
:
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2007
(Restated
–
Note
9)
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2006
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Revenues
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Product
sales, net
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$
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14,000
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$
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22,710
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Royalties
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71,640
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52,970
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Research,
consulting and warranty
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1,442
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1,360
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Total
revenues
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87,082
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77,040
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Operating
expenses
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Cost
of revenues
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10,839
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10,490
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Selling,
general and administrative
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364,148
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435,352
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Research
and development
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48,613
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96,239
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Total
operating expenses
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423,600
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542,081
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Operating
loss
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(336,518
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)
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(465,041
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)
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Interest
income (expense), net
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6,705
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(29,748
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)
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Net
loss
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$
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(329,813
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)
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$
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(494,789
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)
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Weighted
average number of common shares outstanding - basic and
diluted
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67,336,016
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54,744,733
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Basic
and diluted loss per common share
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$
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(0.00
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)
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$
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(0.01
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)
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The
accompanying notes are an integral part of the unaudited condensed financial
statements.
NON-INVASIVE
MONITORING SYSTEMS, INC.
CONDENSED
STATEMENTS OF CASH FLOWS
(Unaudited)
For
the Three months ended October 31, 2007 and 2006
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2007
(Restated-Note
9)
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2006
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Operating
Activities
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Net
loss
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$
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(329,813
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)
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$
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(494,789
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)
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Adjustments
to reconcile net loss to net cash from operating
activities
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Deferred
warranty Income
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(975
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)
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(975
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)
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Depreciation
and amortization
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1,612
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3,246
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Stock
based compensation expense
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131,963
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23,006
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Fair
value of bonus shares issued to directors and debt
guarantors
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296,451
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Changes
in operating assets and liabilities
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Royalties
receivable
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4,113
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(10,846
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)
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Inventories
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(99,333
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)
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10,490
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Prepaid
expenses and other assets
|
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11,618
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(61,872
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)
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Accounts
payable and accrued expenses
|
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3,470
|
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(11,356
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)
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Net
cash used in operating activities
|
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(277,345
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)
|
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(246,645
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)
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Investing
Activities.
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Fixed
asset purchases - Net cash used in investing activities
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(175,365
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)
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-
|
|
|
|
|
|
|
|
|
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Financing
activities
|
|
|
|
|
|
|
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Net
proceeds from issuance of common stock and exercise of options and
warrants
|
|
|
80,832
|
|
|
2,192,584
|
|
Repayments
of note payable
|
|
|
(13,295
|
)
|
|
(22,029
|
)
|
Net
cash provided by financing activities
|
|
|
67,537
|
|
|
2,170,555
|
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Net
(decrease) increase in cash
|
|
|
(385,173
|
)
|
|
1,923,910
|
|
Cash,
beginning of period
|
|
|
1,156,337
|
|
|
404,376
|
|
Cash,
end of period
|
|
$
|
771,164
|
|
$
|
2,328,286
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure
|
|
|
|
|
|
|
|
Cash
paid for interest
|
|
$
|
9,736
|
|
$
|
8,606
|
|
|
|
|
|
|
|
|
|
Supplemental
schedule of non-cash financing activities
|
|
|
|
|
|
|
|
Notes
converted to common stock or used in option exercise
|
|
|
|
|
$
|
165,000
|
|
Insurance
premiums financed by notes payable
|
|
$
|
38,758
|
|
|
|
|
The
accompanying notes are an integral part of these unaudited condensed financial
statements.
NON-INVASIVE
MONITORING SYSTEMS, INC
.
NOTES
TO CONDENSED FINANCIAL STATEMENTS (Unaudited)
October
31, 2007
The
unaudited interim financial statements included herein have been prepared by
Non-Invasive Monitoring Systems, Inc. (the “Company” or “NIMS”). These
statements reflect adjustments, all of which are of a normal, recurring nature,
and which are, in the opinion of management, necessary to present fairly the
Company’s financial position as of October 31, 2007, and results of
operations and cash flows for the three months ended October 31, 2007 and
2006. The results of operations for the three months ended October 31, 2007
are not necessarily indicative of the results for a full year. Certain
information and footnote disclosure normally included in financial statements
prepared in accordance with accounting principles generally accepted in the
United States have been condensed or omitted. Preparing financial statements
requires the Company’s management to make estimates and assumptions that affect
the reported amounts of assets, liabilities, revenues and expenses. Actual
results could differ from those estimates. The Company’s accounting policies
continue unchanged from July 31, 2007. These financial statements should be
read in conjunction with the financial statements and notes thereto included
in
the Company’s annual report on form 10-KSB for the year ended July 31,
2007.
1.
|
ORGANIZATION
AND BUSINESS
|
Organization.
Non-Invasive Monitoring Systems, Inc. (the “Company” or “NIMS”), a Florida
corporation, has licensed its rights to its computer-aided continuous monitoring
devices to detect abnormal respiratory and cardiac events using sensors placed
on the body’s surface to the SensorMedics Division of ViaSys Health Care Inc.
(“SensorMedics”) and to VivoMetrics, Inc. (“VivoMetrics”). The Company is
concentrating on the marketing and selling of the Exer-Rest™ therapeutic motion
platform, a more efficient, cost effective, home and clinic version of its
patented AT-101 motion platform technology. In addition, the Company performs
consultative research of diagnostic monitoring devices. The Company is seeking
FDA approval to market the Exer-Rest™ for sales in the United
States.
Business.
During
the calendar years 2002 through January 2005, the Company restructured its
operations and revised its business strategy to transform the Company from
a
research and development company into a company that marketed and distributed
the AT-101 powered exercise device on a worldwide basis. During the calendar
years 2005 to 2007, the Company reorganized its operations and designed,
developed and manufactured the Exer-Rest™ motorized platform, to replace the
Company’s flagship AT- 101 and promote its use for the improved circulation and
joint mobility.
The
Company had originally registered the AT-101 with the Food and Drug
Administration (“FDA”) as a Class 1 (exempt) powered exercise device and was
selling it to physicians and patients on prescriptions but in January 2005,
FDA
disagreed with the Company’s device classification. FDA instructed the Company
that it submit a 510(k) application for the AT-101 as a therapeutic vibrator
and
cease marketing the AT-101 until receiving approval on the 510(k) submission
to
FDA. Accordingly, the Company ceased its sales and marketing efforts thereafter.
Revenue has continued to be received from royalties on sales of diagnostic
monitoring hardware and software by SensorMedics and VivoMetrics (a related
party). Additionally, the Company has received revenues from sales of parts
and
units sold for research purposes.
Basis
of Presentation.
The
Company’s financial statements have been prepared and presented on a basis
assuming it will continue as a going concern. As reflected in the accompanying
financial statements the Company had a net loss in the amount of $329,813 and
$494,789 for the three months ended October 31, 2007 and 2006 respectively,
and has an accumulated deficit of $16,528,809 as of October 31, 2007, and
has substantial purchase commitments at October 31, 2007 (see Note 7).
These matters raise substantial doubt about the Company’s ability to continue as
a going concern.
The
Company will need to raise additional capital during fiscal year 2008.
Additional debt or equity financing will be required for the Company to continue
its business activities, which are currently focused on the development,
marketing and production of the Exer-Rest. It is management’s intention to
obtain the required additional capital needed to continue its business
activities through new debt or equity financing, but there can be no assurance
that it will be successful in this regard. The accompanying financial statements
do not include any adjustments that might be necessary from the outcome of
this
uncertainty.
2.
|
SUMMARY
OF SIGNIFICANT ACCOUNTING
POLICIES
|
Use
of Estimates.
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date
of
the financial statements and reported amounts of revenues and expenses during
the reporting period. Such items include input variables for stock based
compensation. Actual results could differ from these estimates.
NON-INVASIVE
MONITORING SYSTEMS, INC
.
NOTES
TO CONDENSED FINANCIAL STATEMENTS (Unaudited)
October
31, 2007
Inventories.
Inventories are stated at lower of cost or market using the first-in, first-out
method. Inventories at October 31, 2007, consist of purchased
sub-assemblies to be used by the Company’s contract manufacturer in production
of the Exer-Rest™.
Furniture
and Equipment, Website and Tooling.
These
assets are stated at cost and depreciated or amortized using the straight-line
method, over their estimated useful lives.
Long-lived
Assets.
The
Company reviews its long-lived assets for impairment whenever events or changes
in circumstances indicate that the carrying amount may not be recoverable.
In
performing the review for recoverability, the Company estimates the future
cash
flows expected to result from the use of the asset and its eventual disposition.
If the sum of the expected future cash flows is less than the carrying amount
of
the assets, an impairment loss is recognized as the difference between the
fair
value and the carrying amount of the asset.
Income
Taxes.
The
Company provides for income taxes in accordance with Statements of Financial
Accounting Standard, No. 109, Accounting for Income Taxes (“SFAS
No. 109”) using an asset and liability based approach. Deferred income tax
assets and liabilities are recorded to reflect the tax consequences in future
years of temporary differences between the carrying amounts of assets and
liabilities for financial statement and income tax purposes
As
of
October 31, 2007, the Company had a net operating loss carryforward of
approximately $15,100,000 available to offset future taxable income for federal
and state income tax purposes. The net operating loss carryforward is subject
to
limitation if there have been significant changes of ownership as defined in
provisions under Section 382 of the Internal Revenue Code and similar state
provisions.
SFAS
No. 109 provides that the Company recognize income tax benefits for loss
carryforwards. The tax benefits recognized must be reduced by a valuation
allowance if it is more likely than not that loss carryforwards will expire
before the Company is able to realize their benefit, or if future deductibility
is uncertain. For financial statement purposes, the deferred tax asset for
loss
carryforwards has been fully offset by a valuation allowance since it is
uncertain whether any future benefit will be realized.
Effective
August 1, 2007, we adopted the provisions of the Financial Accounting
Standards Board (“FASB”) Interpretation No. 48, “Accounting for Uncertainty
in Income Taxes, an interpretation of FASB Statement No.109” (“FIN 48”). FIN 48
clarifies the accounting for uncertainties in income taxes recognized in a
company’s financial statements in accordance with SFAS No. 109 and
prescribes a recognition threshold and measurement attribute for financial
disclosure of tax positions taken or expected to be taken on a tax return.
In
addition, FIN 48 provides guidance on derecognition, classification, interest
and penalties, accounting in interim periods, disclosure and transition. The
adoption of FIN 48 did not impact our financial position, results of operations
or cash flows for the three months ended October 31, 2007.
We
file
our tax returns as prescribed by the laws of the jurisdictions in which we
operate. Our tax years ranging from 2004 to 2007 remain open to examination
by
various taxing jurisdictions as the statute of limitations has not expired.
It
is the Company’s policy to include income tax interest and penalties expense in
its tax provision.
Revenue
Recognition.
Revenue
from product sales is recognized when persuasive evidence of an arrangement
exists, the goods are shipped and title has transferred, the price is fixed
or
determinable, and the collection of the sales proceeds is reasonably assured.
The Company recognizes royalties as they are earned, based on reports from
licensees. Research and consulting revenue and warranty income on extended
AT-101 warranties outstanding are recognized over the term of the respective
agreements.
Advertising
Costs.
The
Company expenses all costs of advertising as incurred. There were no advertising
costs included in general and administrative expenses for the three months
ended
October 31, 2007 and October 31, 2006.
Research
and Development Costs.
Research
and development costs primarily consist of expenditures by the Company for
research and development of the “Exer-Rest™” device to third parties and are
expensed as incurred.
Warranties.
The
Company’s warranties are one-year on all products sold and are accrued based on
management’s estimates and the history of warranty costs incurred. There were no
warranty costs during the three months ended October 31, 2007 and
October 31, 2006.
Earnings
(Loss) Per Share.
Basic
net loss per common share is computed using the weighted average number of
common shares outstanding during the period. Diluted net loss per share is
computed using the weighted average number of common and dilutive common
equivalent shares outstanding during the period. In computing diluted net loss
per share, no effect has been given to the 3,251,663 options, 1, 551,200 common
shares issuable upon conversion of the Class C preferred stock, and 325,000
warrants outstanding at October 31, 2007, due to the net loss reported for
the three months then ended. For the three months ended October 31, 2006 no
effect has been given to the 4,398,655 options, 1,551,200 common shares issuable
upon conversion of the Class C preferred stock, and 325,000 warrants
outstanding, due to the net loss reported.
NON-INVASIVE
MONITORING SYSTEMS, INC
.
NOTES
TO CONDENSED FINANCIAL STATEMENTS (Unaudited)
October
31, 2007
Fair
Value of Financial Instruments.
Fair
value estimates discussed herein are based upon certain market assumptions
and
pertinent information available to management as of October 31, 2007. The
respective carrying value of certain on-balance-sheet financial instruments
such
as royalties receivable, accounts payable, accrued expenses and notes payable
approximate fair values because they are short term in nature or they bear
current market interest rates.
Stock-Based
Compensation
.
In
December 2004, the FASB issued a revision of SFAS 123 (“SFAS 123(R)”) that
requires employee compensation costs related to share-based payment transactions
to be recognized in the statement of operations. With limited exceptions, the
amount of compensation cost is measured based on the grant-date fair value
of
the equity or liability instruments issued. In addition, liability awards are
remeasured each reporting period. Compensation cost is recognized over the
period that an employee provides service in exchange for the award. SFAS 123(R)
replaces SFAS 123 and was effective for the Company August 1,
2006.
3.
|
STOCK
BASED COMPENSATION
|
Effective
August 1, 2006, the Company adopted Statement of Financial Accounting
Standard No. 123 (Revised 2004), Share Based Payment (SFAS No. 123R), which
requires a public entity to measure the cost of employee, officer and director
services received in exchange for an award of equity instruments based on the
grant-date fair value of the award. SFAS No. 123R supersedes the Company’s
previous accounting under FAS No. 123, accounting for Stock-Based
Compensation (SFAS No. 123), which permitted the Company to account for such
compensation under Accounting Principles Board Opinion No. 25, Accounting
for Stock Issued to Employees (APB No. 25). Pursuant to APB No. 25,
and related interpretations, no compensation cost had been recognized in
connection with the issuance of stock options, as all options granted under
the
Company’s stock option plan had an exercise price equal to or greater than the
market value of the underlying common stock on the date of the
grant.
The
Company adopted SFAS No. 123(R) using the modified prospective transition
method, which requires that compensation cost be recorded as earned for all
unvested stock options outstanding at August 1, 2006 based upon the grant
date fair value estimated in accordance with the original provisions of SFAS
No. 123 and for compensation cost for all share-based payments granted or
modified subsequent to the adoption, based on fair value estimated in accordance
with the provisions of SFAS No. 123(R). The Company’s financial statements
for the three months ended October 31, 2007 reflect the current impact of
the adoption of SFAS No. 123R. The Company recorded share-based
compensation of $131,963 and $23,006 which is included in the Company’s selling,
general and administrative expenses for the three months ended October 31,
2007 and 2006 respectively.
The
Company’s 2000 Stock Option Plan (the “Plan”), as amended, provides for a total
of 2,000,000 shares of Common Stock. The Plan allows the issuance of incentive
stock options, stock appreciation rights and restricted stock awards. The
exercise price of the options is determined by the compensation committee of
the
Company’s Board of Directors, but incentive stock options must be granted at an
exercise price not less than the fair market value of the Company’s Common Stock
as of the grant date or an exercise price of not less than 110% of the fair
value for a 10% shareholder. Options expire ten years from the date of the
grant
and are exercisable according to the terms of the individual options
agreement.
A
summary
of the Company’s stock options activity for the three months ended
October 31, 2007 is as follows:
|
|
Shares
|
|
Weighted
Average
Exercise
Price
|
|
Weighted
average
remaining
contractual
term
(years)
|
|
Aggregate
intrinsic
Value
|
|
Options
outstanding, July 31, 2007 *
|
|
|
2,886,161
|
|
$
|
0.388
|
|
|
|
|
|
|
|
Options
granted
|
|
|
547,500
|
|
$
|
0.880
|
|
|
|
|
|
|
|
Options
exercised
|
|
|
(161,665
|
)
|
$
|
0.500
|
|
|
|
|
|
|
|
Options
outstanding and expected to vest, October 31, 2007
|
|
|
3,271,996
|
|
$
|
0.465
|
|
|
3.42
|
|
$
|
1,817,607
|
|
Exercisable,
October 31, 2007
|
|
|
2,505,746
|
|
$
|
0.432
|
|
|
3.32
|
|
$
|
1,620,294
|
|
*
Number
of options as restated in July 31, 2007 Amended Form 10-KSB/A.
NON-INVASIVE
MONITORING SYSTEMS, INC
.
NOTES
TO CONDENSED FINANCIAL STATEMENTS (Unaudited)
October
31, 2007
The
Company estimates the fair value of stock options using a Black-Scholes
valuation model, consistent with provisions of SFAS No.123(R), Securities and
Exchange Commission (SEC) Staff Accounting Bulletin No. 107 and the
Company’s prior period pro forma disclosures of net loss, including the fair
value of stock-based compensation. Key input assumptions used to estimate the
fair value of stock options include the expected term until exercise of the
option, expected volatility of the Company’s stock, the risk free interest rate,
option forfeiture rates, and dividends, if any. The expected term of the option
is based on a historical weighted average of exercised options. The expected
volatility is derived from historical volatility of the Company’s stock on the
U.S. Over the Counter market for a period that matches the expected term of
the
option. The risk-free interest rate is the yield from a treasury bond or note
corresponding to the expected term of the option. The Company has not paid
dividends and does not expect to pay dividends in the future.
Compensation
costs for stock options with graded vesting are recognized over the vesting
period. As of October 31, 2007, there was $308,890 of unrecognized costs
related to granted stock options. These costs are expected to be recognized
over
a weighted average period of 1.37 years.
There
were 547,500 options granted during the three months ended October 31, 2007
to directors and officers of the Company and no options were granted for the
three months ended October 31, 2006. There were 161,665 options exercised
during the three months ended October 31, 2007. There were 3,105,004
options exercised during the three months ended October 31, 2006. The total
intrinsic value of stock options exercised for the three months ended
October 31, 2007 and 2006 were $53,350 and $1,285,319
respectively.
As
of
July 31, 2006 notes payable to the Company’s Chairman of the Board and
shareholder of the Company totaled $165,000. There were two notes outstanding;
$100,000 and $65,000. The notes were payable upon demand in cash or common
or
preferred stock of the Company and in the event of default the notes would
become immediately due and payable in cash with interest accruing at
1.5% per month on any unpaid balance. The $100,000 note bore interest at
the prime rate plus 2% and the $65,000 note was non-interest bearing. The
Chairman of the Board waived the interest on the $100,000 note.
The
notes
totaling $165,000 plus cash of $10,000 were used by the Chairman in exercising
his options to purchase 562,500 common shares plus 112,500 bonus common shares
in the October, 2006 private placement. (See Note 5.)
The
Company refinanced its existing bank debt in February, 2007 at another bank
by
securing a $500,000 line of credit, which expires in March, 2008. The debt
is
collateralized by certificates of deposit in the amount of $400,000, and bears
interest at one percent per annum below prime rate.
Notes
payable
–
other were issued to finance insurance premiums and are payable in ten monthly
installments through December, 2007, with interest at 12.73 % per
annum.
Effective
October 16, 2006, the Company accepted $2.193 million for the exercise of
outstanding options and warrants held by Board members and private investors.
In
addition, the Chairman of the Board utilized outstanding notes totaling $165,000
plus cash of $10,000 to purchase common stock. As a result of the exercise,
14,616,005 shares of the Company’s common stock, $0.01 par value (“Common
Stock”) were issued to the exercising optionholders and
warrantholders.
The
options and warrants were exercised pursuant to an offer (the “Offer”) by the
Company to certain optionholders and warrantholders to grant exercising
optionholders and warrantholders upon exercise an additional number of shares
of
Common Stock equal to 20% of the shares received upon exercise (“Bonus
Shares”).
Options
to purchase 3,105,004 shares of common stock were exercised at exercise prices
ranging from $0.145 to $0.50 and warrants to purchase 9,175,000 shares of common
stock were exercised at an exercise price of $0.15. An additional 601,001 Bonus
Shares were issued to exercising optionholders and an additional 1,835,000
Bonus
Shares were issued to exercising
warrantholders.
The
exercised warrants were issued pursuant to Stock Purchase Agreements dated
August 1, 2005 between the Company and various private investors. The
exercised options were issued to directors and others in connection with, among
other things, a private placement in 2002, options to Directors in lieu of
salary and certain guarantees of the Company’s debt. The Company recorded
$296,451 of compensation and interest expense for the three months ended
October 31, 2006 for the fair value of bonus shares issued to directors and
guarantors of the Company’s indebtedness.
NON-INVASIVE
MONITORING SYSTEMS, INC
.
NOTES
TO CONDENSED FINANCIAL STATEMENTS (Unaudited)
October
31, 2007
Directors
(including a director holding more than 10% of the outstanding Common Stock
(a
“10% Holder”)) exercised in the aggregate, options to purchase 2,189,164 shares
of Common Stock and received 437,833 Bonus Shares for payment of $592,084.
A 10%
Holder exercised warrants to purchase 3,250,000 shares of Common Stock and
received 650,000 Bonus Shares for payment of $487,500. Warrants to purchase
125,000 shares that may be deemed to be beneficially owned by an officer of
the
Company were exercised for payment of $18,750 and 25,000 Bonus Shares were
issued on account of such exercise.
Pursuant
to the Offer, the Company also accepted an additional $25,000 from an exercising
optionholder for the exercise of options to purchase 62,500 shares of Common
Stock, and the issuance of 12,500 Bonus Shares.
During
fiscal 2007, the Company accepted an additional $25,000 from an exercising
optionholder, for the exercise of options to purchase 62,500 shares of Common
Stock. In addition, a former employee of the Company exercised 50,000 options
in
a cashless transaction and received 44,057 shares of the Company’s common stock
during 2007. During the three months ended October 31, 2007 the Company
accepted $80,833, from existing optionholders for the exercise of options to
purchase 161,665 shares of Common Stock.
6.
|
RELATED
PARTY TRANSACTIONS
|
Dr. Marvin
A. Sackner, the Company’s Chairman of the Board, also personally leases office
space used by the Company for business on a month-to-month basis in North Bay
Village, Florida. Under an arrangement with the Company, the Company reimburses
Dr. Sackner for the cost of the space monthly. The amounts reimbursed to
Dr. Sackner by the Company for the three months ended October 31, 2007
and 2006 were $5,227 and $5,025, respectively.
The
Company has an approximately 2% interest in VivoMetrics. The Company’s interest
in VivoMetrics is carried at a zero valuation.
For
several years, until November 2007, Dr. Sackner’s son-in-law was the Chief
Operating Officer for VivoMetrics.
Dr. Sackner
served as a member of the Scientific Advisory Board of VivoMetrics until 2004,
and is currently a less than 1% shareholder of VivoMetrics. Pursuant to an
Agreement Regarding Assignment of Patents and Related Intellectual Property
dated August 14, 2000, the Company assigned all of its rights, title and
interest in certain patents and intellectual property as well as a
non-exclusive, worldwide license under these items to VivoMetrics in
consideration for a royalty of 3% of VivoMetrics’ gross revenues from sales of
certain products for so long as VivoMetrics sells such products. Royalty income
under the agreement with VivoMetrics was $23,143 and $19,277 for the three
months ended October 31, 2007 and 2006, respectively. Pursuant to a related
license agreement with VivoMetrics, VivoMetrics granted to the Company the
non-exclusive, worldwide right and license to use certain patents and
software.
7.
|
COMMITMENTS
AND CONTINGENCIES
|
Leases.
The
Company leases office space in Sarasota, Florida. The lease expires in November
2008. The minimum future rental payments are $2,712 per month through November
2008. Additionally, the Company leases office space in Miami, Florida on a
month
to month basis and is in the process of negotiating a long-term lease for new
office space.
Product
Development and Supply Agreement.
On
September 4, 2007, the Company executed a Product Development and Supply
Agreement with Sing Lin Technologies Co. Ltd., a company based in Taichung,
Taiwan (“Sing Lin”).
Pursuant
to the Agreement, the Company consigned to Sing Lin the development and design
of the second generation “Exer-Rest™” and “Somno-Ease” devices. Sing Lin will
manufacture the Company’s’ patented “Exer-Rest™” motorized platform. This motion
platform has the appearance and functionality of either a cot or twin bed in
standard and extra-long dimensions.
The
Company paid Sing Lin $150,000 upon execution of the Agreement and must pay
$150,000 upon final approval by the Company of the product prototypes and
$100,000 upon delivery of the product sample. These amounts are to be applied
toward tooling development and other tooling costs.
Under
the
Agreement, the Company grants Sing Lin for the term of the agreement, the
exclusive distribution rights, for the products in certain countries in the
Far
East, including Taiwan, China, Japan, South Korea, Malaysia, Indonesia and
certain other countries. Sing Lin has agreed not to sell the Products outside
its geographic areas in the Far East.
NON-INVASIVE
MONITORING SYSTEMS, INC
.
NOTES
TO CONDENSED FINANCIAL STATEMENTS (Unaudited)
October
31, 2007
The
Agreement commenced as of September 3, 2007 and has a term that extends
three years from the acceptance of the first-run of production units by NIMS.
Thereafter, the Agreement automatically renews for successive one year terms
unless either party sends the other a notice of non-renewal.
The
Company has committed to purchase approximately $2.2 million of
“Exer-Rest
TM
”
and
“Somno-Ease” units, within one year of acceptance of the final product. The
Company expects final approval of the products in the third quarter of fiscal
2008. Additionally, the Company has agreed to purchase $3.5 million and $7.5
million of “Exer-Rest
TM
”
and
“Somno-Ease” products respectively, in 2009 and 2010.
8.
|
RECENT
ACCOUNTING PRONOUCEMENTS
|
In
September 2006, the FASB issued Statement of Financial Accounting Standard
(SFAS) No. 157, “
Fair
Value Measurements
”.
SFAS
No. 157 defines fair value, establishes a framework for measuring fair
value and expands disclosures about fair value. SFAS No. 157 is effective
for the Company’s fiscal year beginning August 1, 2008. The company is
currently evaluating the impact of this standard on the financial
statements.
In
February 2007, the FASB issued Statement of Financial Accounting Standards
(SFAS) No. 159, “
The
Fair Value Option for Financial Assets and Financial
Liabilities
”.
SFAS
No. 159 provides an option to report selected financial assets and
financial liabilities using fair value. The standard establishes required
presentation and disclosures to facilitate comparisons with companies that
use
different measurements for similar assets and liabilities. SFAS No. 159 is
effective for the Company’s fiscal year beginning August 1, 2008, with
early adoption allowed only if SFAS No. 157 is also adopted. The Company is
currently evaluating the impact of this standard on the financial
statements.
In
December 2007, the FASB issued Statement of Financial Accounting Standard (SFAS)
No. 141 (revised 2007), “Business Combinations”. SFAS No. 141 R will
replace SFAS 141, and establishes principles and requirements for how the
acquirer in a business combination reorganizes and measures in its financial
statements the identifiable assets acquired, the liabilities assumed and any
non-controlling interest in the acquiree; recognizes and measures the goodwill
acquired in the business combination or gain from a bargain purchase; and
determines what information to disclose to enable users of the financial
statements to evaluate the nature and financial effects of the business
combination. SFAS No. 141R applies prospectively to business combinations
for which the acquisition date is on or after the beginning of the first annual
reporting period beginning on or after December 15, 2008. Currently the
Company does not anticipate that this Statement will have an impact on its
financial statements.
In
December 2007, the FASB issued Statement No. 160, “Non-Controlling
Interests in Consolidated Financial Statements - an Amendment of ARB
No. 51.” This statement requires that Non-Controlling or minority interests
in subsidiaries be presented in the consolidated statement of financial position
within equity, but separate from the parents’ equity, and that the amount of the
consolidated net income attributable to the parent and to the non-controlling
interest be clearly identified and presented on the face of the consolidated
statement of income. SFAS No. 160 is effective for the fiscal years, and
interim periods within those fiscal years, beginning on or after
December 15, 2008. Currently the Company does not anticipate that this
statement will have an impact on its financial statements.
9.
|
REVISIONS
TO PREVIOUSLY ISSUED FINANCIAL STATEMENTS AS OF AND FOR THE THREE
MONTHS
ENDED OCTOBER 31, 2007
|
In
connection with the Company’s review
of
the
financial statements for the quarter ended January 31, 2008, Management
uncovered an error relating to the number of outstanding options as of July
31,
2006 and July 31, 2007 as reported in reports on Form 10-KSB for the periods
ended as of such dates. Also, options previously reported as having been
forfeited during the quarter ended October 31, 2007 were found to have been
forfeited in prior years. In addition, Management discovered an error in the
amortization of stock based compensation expense related to options granted
in
October 2007. The following tables summarize the adjustments to the Company’s
financial statements for the quarter ended October 31, 2007.
NON-INVASIVE
MONITORING SYSTEMS, INC
.
NOTES
TO CONDENSED FINANCIAL STATEMENTS (Unaudited)
October
31, 2007
Summary
of adjustments to the Company’s reported stock option activity for the three
months ended October 31, 2007:
|
|
As
Previously Reported
|
|
Adjustment
|
|
As
Restated
|
|
Options
outstanding, July 31, 2007
|
|
|
2,639,160
|
|
|
247,001
|
|
|
2,886,161
|
|
Options
granted
|
|
|
547,500
|
|
|
-
|
|
|
547,500
|
|
Options
exercised
|
|
|
(161,665
|
)
|
|
-
|
|
|
(161,665
|
)
|
Options
forfeited
|
|
|
(276,665
|
)
|
|
276,665
|
|
|
-
|
|
Options
outstanding and expected to vest, October 31, 2007
|
|
|
2,748,330
|
|
|
523,666
|
|
|
3,271,996
|
|
Aggregate
Intrinsic Value of Outstanding Options, October 31, 2007
|
|
$
|
1,113,814
|
|
$
|
703,793
|
|
$
|
1,817,607
|
|
Options
Exercisable, October 31, 2007
|
|
|
1,982,080
|
|
|
523,666
|
|
|
2,505,746
|
|
Aggregate
Intrinsic Value of Exercisable Options, October 31, 2007
|
|
$
|
916,501
|
|
$
|
703,793
|
|
$
|
1,620,294
|
|
Summary
of adjustments to the Company’s Balance Sheet as of October 31,
2007:
|
|
As
Previously Reported
|
|
Adjustment
|
|
As
Restated
|
|
Total
assets
|
|
$
|
1,527,103
|
|
$
|
-
|
|
$
|
1,527,103
|
|
Total
liabilities
|
|
|
733,852
|
|
|
-
|
|
|
733,852
|
|
Preferred
Stock
|
|
|
62,148
|
|
|
-
|
|
|
62,148
|
|
Common
Stock
|
|
|
674,554
|
|
|
-
|
|
|
674,554
|
|
Additional
paid in capital
|
|
|
16,477,101
|
|
|
108,527
|
|
|
16,585,358
|
|
Accumulated
deficit
|
|
|
(16,420,552
|
)
|
|
(108,257
|
)
|
|
(16,528,809
|
)
|
Total
shareholders’ equity
|
|
|
793,251
|
|
|
-
|
|
|
793,251
|
|
Total
liabilities and shareholders’ equity
|
|
$
|
1,527,103
|
|
$
|
-
|
|
$
|
1,527,103
|
|
Summary
of adjustments to the Company’s Statement of Operations for the three months
ended October 31, 2007:
|
|
As
Previously Reported
|
|
Adjustment
|
|
As
Restated
|
|
Total
revenues
|
|
$
|
87,082
|
|
$
|
-
|
|
$
|
87,082
|
|
Selling,
general and administrative expense
|
|
|
255,891
|
|
|
108,257
|
|
|
364,148
|
|
Cost
of revenues and other operating expenses
|
|
|
59,452
|
|
|
-
|
|
|
59,452
|
|
Operating
loss
|
|
|
(228,261
|
)
|
|
(108,257
|
)
|
|
(336,518
|
)
|
Interest
income
|
|
|
6,705
|
|
|
-
|
|
|
6,705
|
|
Net
loss
|
|
$
|
(221,556
|
)
|
$
|
(108,257
|
)
|
$
|
(329,813
|
)
|
Basic
and diluted loss per common share
|
|
$
|
(0.00
|
)
|
$
|
(0.00
|
)
|
$
|
(0.00
|
)
|
Summary
of adjustments to the Company’s Statement of Cash Flows for the three months
ended October 31, 2007:
|
|
As
Previously Reported
|
|
Adjustment
|
|
As
Restated
|
|
Net
loss
|
|
$
|
(221,556
|
)
|
$
|
(108,257
|
)
|
$
|
(329,813
|
)
|
Adjustments
to reconcile net loss to net cash from operating
activities
|
|
|
|
|
|
|
|
|
|
|
Stock
based compensation
|
|
|
23,706
|
|
|
108,257
|
|
|
131,963
|
|
All
other adjustments
|
|
|
(79,495
|
)
|
|
-
|
|
|
(79,495
|
)
|
Net
cash used in operating activities
|
|
|
(277,345
|
)
|
|
-
|
|
|
(277,345
|
)
|
Net
cash used in investing activities
|
|
|
(175,365
|
)
|
|
-
|
|
|
(175,365
|
)
|
Net
cash provided by financing activities
|
|
|
67,537
|
|
|
-
|
|
|
67,537
|
|
Net
decrease in cash
|
|
$
|
(385,173
|
)
|
$
|
-
|
|
$
|
(385,173
|
)
|
|
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OOPERATIONS.
|
Cautionary
Statement Regarding Forward-looking Statements
This
Report contains, in addition to historical information, forward-looking
statements regarding Non-Invasive Monitoring Systems, Inc. (the “Company” or
“NIMS”), which represent the Company’s expectations or beliefs including, but
not limited to, statements concerning the Company’s operations, performance,
financial condition, business strategies, and other information and that involve
substantial risks and uncertainties. The Company’s actual results of operations,
some of which are beyond the Company’s control, could differ materially. For
this purpose, any statements contained in this Report that are not statements
of
historical fact may be deemed to be forward-looking statements. Without limiting
the generality of the foregoing, words such as “may,” “will,” “expect,”
“believe,” “anticipate,” “intend,” “could,” “estimate,” or “continue” or the
negative or other variations thereof or comparable terminology are intended
to
identify forward-looking statements. Factors that could cause or contribute
to
such difference include, but are not limited to, history of operating losses
and
accumulated deficit; need for additional financing; dependence on future sales
of the Exer-Rest™ motion platform; competition; dependence on management; risks
related to proprietary rights; government regulation; and other factors
discussed herein and in the Company’s other filings with the Securities and
Exchange Commission.
Non-Invasive
Monitoring Systems, Inc. (the “Company” or “NIMS”) primary business is the
research, development, manufacturing and marketing of a non-invasive, whole
body, periodic acceleration, motorized platform, which has been designated
as
the “Exer-Rest™,” the home, wellness center and clinic version of the previously
fabricated AT-101. In addition, the Company has developed computer assisted,
non-invasive diagnostic monitoring devices and related software designed to
detect abnormal respiratory, cardiac, and other medical conditions from sensors
placed externally on the body’s surface. These diagnostic devices were sold
SensorMedics Division of ViaSys (NYSE) for cash and royalties on sales and
to
privately held VivoMetrics, Inc., (a related party) in Ventura CA, for royalties
on sales and an equity position.
Business
Strategy
During
the calendar years 2002 through January 2005, the Company restructured its
operations and revised its business strategy to transform the Company from
a
research and development company into a company that marketed and distributed
the AT-101 powered exercise device on a worldwide basis. During the calendar
years 2005 to 2007, the Company reorganized its operations and designed,
developed and manufactured the Exer-Rest™ motorized platform, to replace the
Company’s flagship AT-101 and promote its use for the improved circulation and
joint mobility.
The
Company had originally registered the AT-101 with the Food and Drug
Administration (“FDA”) as a Class 1 (exempt) powered exercise device and was
selling it to physicians and patients on prescriptions but in January 2005,
FDA
disagreed with the Company’s device classification. FDA instructed the Company
that it submit a 510(k) application for the AT-101 as a therapeutic vibrator
and
cease marketing the AT-101 until receiving approval on the 510(k) submission
to
FDA. Accordingly, the Company ceased its sales and marketing efforts thereafter.
Revenue has continued to be received from royalties on sales of diagnostic
monitoring hardware and software by the SensorMedics and
VivoMetrics.
Additionally,
the Company has received revenues from sales of parts and units sold for
research purposes.
NIMS
assigned its patents for an ambulatory monitoring shirt to VivoMetrics, Inc.,
a
health care information company based in Ventura, California. In return for
these patent rights, NIMS was given equity ownership now carried at zero value
for financial reporting purposes in VivoMetrics, Inc. and paid royalties on
sales and leasing of LifeShirt
TM
systems.
In April, 2002, VivoMetrics, Inc. received FDA clearance allowing VivoMetrics,
Inc. to market the LifeShirt
TM
System.
There can be no assurance as to the amount of revenues that will be derived
from
sales of the LifeShirt system. Commercial sales of the AT 101 were halted in
January 2005. In 2006, design, marketing research and fabrication of a less
costly and more efficient version of the AT-101 for home, wellness centers,
home
fitness and clinic use called the “Exer-Rest™” was achieved. This revolutionary,
non invasive, drug-free device developed by NIMS is powering a new dimension
in
fitness and wellness for all ages, lifestyles and physical abilities. It
accomplishes such solutions through our patented technology called whole body,
periodic acceleration. The Exer-Rest™ serves as an aid to improve circulation,
increase joint mobility, and to provide relief of minor aches and pains. The
development of the Exer-Rest™ has necessitated an additional capital commitment.
The Company anticipates experiencing losses through the next two fiscal quarters
as it awaits sales to commence in the UK, Europe, India and Latin America.
It is
anticipated that the Exer-Rest™ will be marketed and sold during the third
quarter of fiscal 2008.
Revenue
is expected to be derived from sales of the “Exer-Rest™” device overseas
commencing in the third quarter of fiscal 2008 and in the U.S if FDA approval
for marketing is obtained, and from existing royalties.
NON-INVASIVE
MONITORING SYSTEMS, INC
.
The
Company recently entered into a Product and Development and Supply Agreement
with Sing Lin Technology Co., Ltd. (“Sing Lin”) of Taichung, Taiwan. Sing Lin
will manufacture NIMS patented “Exer-Rest II” and “Somno-Ease” motorized
platforms.
Management
of the Company has determined that it is in the best interest of the Company
and
its shareholders to focus the Company’s time and resources on developing and
marketing the “Exer-Rest™”, “Exer-Rest (II)” and the new “Somno-Ease” motorized
platforms. These devices will be marketed and sold by NIMS under the
Acceleration Therapeutics brand name in the UK, Europe, India and Latin America.
They will be sold by Sing Lin in the Far East. The “Somno-Ease” which will not
require FDA approval will be marketed and sold by NIMS in the United States
and
by the Acceleration Therapeutics division of NIMS in the UK, Europe, India
and
Latin America.
The
“Exer-Rest™” is currently being tested in a controlled pilot study in the U.S.
for temporary relief of musculoskeletal pain associated with osteoarthritis
of
the hip prior to the pivotal trial to be submitted to the FDA for approval
to
market in the United States.
Current
Products
AT-101
Therapeutic Motion Platform and the “Exer-Rest™.”
Sales
of
the AT-101 commenced in October 2002 in Japan and in February 2003 in USA.
QTM
Incorporated, an FDA registered manufacturer (Oldsmar, FL) manufactured the
device. The AT-101 is built in accordance with ISO and FDA Good Manufacturing
Practices. Several recent animal and human research studies have revealed that
application of the AT-101 technology caused release of beneficial substances
from the inner lining of blood vessels. These data are not being claimed as
an
intended use of the device for marketing the “Exer-Rest™” but demonstrate a
potential mechanism for benefits.
The
AT-101 and “Exer-Rest™” therapeutic motion platforms are inventions by Marvin A.
Sackner, M.D., Professor of Medicine at the University of Miami at Mt. Sinai
and
Emeritus Director of Medical Services at Mt. Sinai Medical Center.
Dr. Sackner (Chairman of the Board of Directors) is a past President of the
American Thoracic Society, past Chairman of the Pulmonary Disease Subspecialty
Board and a past Member of the American Board of Internal Medicine. He holds
30
United States patents.
The
“Exer-Rest™” therapeutic vibrator is based upon the design and concept of the
AT-101 therapeutic vibrator which is a comfortable gurney styled device that
moves repetitively in a head-to-foot motion similar to the movement used to
comfort a child in a baby carriage but at a much more rapid pace. The
“Exer-Rest™” has a much less costly drive mechanism than the AT-101, has the
dimensions and appearance of a commercial extra long twin bed with weight about
one half the AT-101, and is designed such that the user can utilize and operate
it without assistance, and has a much lower selling price than the
AT-101.
The
Company had obtained additional capital in 2006 to permit it to continue
operations and perform a clinical trial needed to obtain FDA approval to market
the “Exer-Rest™” therapeutic vibrator for physician offices and home use. No
such approval can be assured.
LifeShirt:
The
LifeShirt is a Wearable Physiological Computer (U.S. Patents 6,551,252 issued
[October 22, 2003], 6,413,225 [issued October 2, 2002], 6,047,203 [issued
October 4, 2000]
)
that
incorporates four inductive plethysmographic transducers, electrocardiographic
electrodes, and a two posture sensor into a low turtle neck sleeveless garment.
Pulse oximetry is an optional add-on. These transducers are connected to a
miniaturized, battery powered, electronic module that has been fabricated.
This
in turn interfaces with a Personal Digital Assistant (“PDA”) with compact flash
memory for collection of raw waveforms and digital data from the electronic
module. Such data are transmitted from flash memory to a Data Collection Center
that checks for quality control and transforms data into minute-by-minute median
trends of over 31 physical and emotional signs of health and disease. In
addition, the monitored patient can enter symptoms with intensity, mood, and
medication diary into the PDA for integration with the physiologic information
collected with the LifeShirt garment. Data from flash memory can be mailed
to
VivoMetrics, Inc.’s Data Collection Center for quality control, generation of
reports, and database storage. Vital and physiological signs can be obtained
non-invasively, continuously, cheaply, and reliably with the comfortably worn
LifeShirt garment system while at rest, during exercise, at work, and during
sleep.
RECENT
ACCOUNTING PRONOUNCEMENTS.
In
September 2006, the FASB issued Statement of Financial Accounting Standards
(SFAS) No. 157, “
Fair
Value Measurements”
,
SFAS
No. 157 defines fair value, establishes a framework for measuring fair
value and expands disclosures about fair value. SFAS No. 157 is effective
for the Company’s fiscal year beginning August 1, 2008. The Company is
currently evaluating the impact of this standard on the financial
statements.
NON-INVASIVE
MONITORING SYSTEMS, INC
.
In
February 2007, the FASB issued Statement of Financial Accounting Standards
(SFAS) No. 159, “
The
Fair Value Option for Financial Assets and Financial
Liabilities
”.
SFAS
No. 159 provides an option to report selected financial assets and
financial liabilities using fair value. The standard establishes required
presentation and disclosures to facilitate comparisons with companies that
use
different measurements for similar assets and liabilities. SFAS No. 159 is
effective for the Company’s fiscal year beginning August 1, 2008, with
early adoption allowed only if SFAS No. 157 is also adopted. The Company is
currently evaluating the impact of this standard on the financial
statements.
In
December 2007, the FASB issued Statement of Statement of Financial Accounting
Standards (SFAS) No. 141 (revised 2007), “Business Combinations”. SFAS
No. 141 R will replace SFAS 141, and establishes principles and
requirements for how the acquirer in a business combination reorganizes and
measures in its financial statements the identifiable assets acquired, the
liabilities assumed and any noncontrolling interest in the acquiree; recognizes
and measures the goodwill acquired in the business combination or gain from
a
bargain purchase; and determines what information to disclose to enable users
of
the financial statements to evaluate the nature and financial effects of the
business combination. SFAS No. 141R applies prospectively to business
combinations for which the acquisition date is on or after the beginning of
the
first annual reporting period beginning on or after December 15, 2008.
Currently the Company does not anticipate that this Statement will have an
impact on its financial statements.
In
December 2007, the Company issued Statement No. 160, “Non-Controlling
Interests in consolidated Financial Statements - an Amendment of ARB
No. 51.” This statement requires that noncontrolling or minority interests
in subsidiaries be presented in the consolidated statement of financial position
within equity, but separate from the parents’ equity, and that the amount of the
consolidated net income attributable to the parent and to the noncontrolling
interest be clearly identified and presented on the face of the consolidated
statement of income. SFAS No. 160 is effective for the fiscal years, and
interim periods within those fiscal years, beginning on or after
December 15, 2008. Currently the Company does not anticipate that this
statement will have an impact on its financial statements.
Total
Revenues and Costs of Operations
Total
revenues
.
Total
revenues increased from $77,040 for the three months ended October 31, 2006,
to
$87,082 for the three months ended October 31 , 2007, a increase of $10,042
primarily as a result of an increase in royalty income of $18,670 and a
reduction in products sales of $8,710.
As
indicated under “Business Strategy” above, the Company has stopped selling the
AT-101, except for medical research. The “Exer-Rest™” will commence sales
internationally in the first calendar quarter of 2008. The Company will begin
sales of the “Exer-Rest™” commercially in the United States when it receives FDA
approval. Royalties increased this period due to the increase in sales by the
Company’s licensees.
Cost
of revenues.
There
was one sale of the AT-101 for medical research purposes in each of the three
months ended October 31, 2007 and 2006 respectively.
Selling,
general and administrative expenses.
Selling,
general and administrative expenses decreased from $435,352 to $364,148 for
the
three months ended October 31, 2007, a decrease of $ 71,204 primarily as a
result decreased professional service fees and stock based compensation expense
due to bonus shares given to directors and bank debt guarantors who exercised
options during the October 2006 equity funding, offset by an increase in
insurance, marketing and sales expense, payroll and travel.
Research
and development costs.
Research
and development costs decreased from $96,239 for the three months ended
October 31, 2006 to $48,613 for the three months ended October 31,
2007, a decrease of $47,626, primarily as a result of product development costs
for the AT 101 home version being completed in fiscal year ended July 31,
2007. Current research and development costs have been incurred for regulatory
testing required for FDA approval.
Total
operating expenses.
Total
operating expenses decreased from $542,081 for the three months ended October
31, 2006 to $423,600 for the three months ended October 31, 2007, a
decrease of $118,481. The decrease is primarily attributed to decreased selling,
general and administrative expenses and research and development
costs.
Interest
income (expense), net
.
Interest income (expense), net reflects income in the 2007 period compared
to
expense in the 2006 period as a result of the interest earned on the proceeds
of
the private placement completed in October 2006.
Net
loss.
Net loss
decreased from $494,789 for the three months ended October 31, 2006 to
$329,813 for the three months ended October 31, 2007, a decrease of
$164,976. The decrease is mainly attributed to decreased operating
expenses.
NON-INVASIVE
MONITORING SYSTEMS, INC
.
Liquidity
and Capital Resources
Our
operations have been primarily financed through private sales of our equity
securities. At October 31, 2007 we had unrestricted cash of $771,164 and
working capital of $600,973. While these funds could be sufficient for our
immediate operating needs, the Company will need to obtain additional debt
or
equity financing to continue its business activities during fiscal 2008. To
fulfill the Company’s “Exer-Rest II” and “Somno-Ease” product purchase
commitments to a Taiwanese manufacture, the Company is required to raise
additional debt or equity financing.
Net
cash
used in operating activities was $277,345 for the three months ended
October 31, 2007, up from $246,645 for the three months ended
October 31, 2006, an increase of $30,700. The larger net loss in 2006 was
offset by non-cash expense of the fair value of bonus shares issued to directors
and debt guarantors, in the amount of $296,451.
Net
cash
used in investing activities increased to $175,365 for the three months ended
October 31, 2007 from $0 for the three months ended October 31, 2006.
The increase was primarily due to the purchase of fixed assets, as the company
entered into a product, design and supply agreement with a Taiwanese
manufacturer for the development of the “Exer-Rest II” and “Somno-Ease” motion
platforms, and the creation of new website.
Net
cash
provided by financing activities decreased to $67,537 for the three months
ended
October 31, 2007 from $2,170,555, for the three months ended
October 31, 2006, a decrease of $2,103,018. The decrease was principally
due to the equity funds received during the October 2006 financing, offset
by
options exercised during the three months ended October 31,
2007.
Effective
October 16, 2006, the Company accepted $2,193 million for the exercise of
outstanding options and warrants held by Board members and private investors.
As
a result of the exercise, 14,616,005 shares of the Company’s common stock, $0.01
par value (“Common Stock”) were issued to the exercising optionholders and
warrantholders.
The
options and warrants were exercised pursuant to an offer (the “Offer”) by the
Company to certain optionholders and warrantholders to grant exercising
optionholders and warrantholders upon exercise an additional number of shares
of
Common Stock equal to 20% of the shares received upon exercise (“Bonus
Shares”).
Options
to purchase 3,005,004 shares of common stock were exercised at exercise prices
ranging from $0.145 to $0.50 and warrants to purchase 9,175,000 shares of common
stock were exercised at an exercise price of $0.15. An additional 601,001 Bonus
Shares were issued to exercising optionholders and an additional 1,835,000
Bonus
Shares were issued to exercising warrantholders.
Royalties
from VivoMetrics and SensorMedics were $71,640 and $52,970 for the three months
ended October 31, 2007 and 2006 respectively. There can be no assurances
that the Company will continue to receive similar royalties.
At
October 31, 2007, we had available net operating loss carry forwards of
approximately $15,100,000 which expires in various years through 2027. The
net
operating loss carryfowards may be subject to limitation due to change of
ownership provisions under Section 382 of the Internal Revenue Code and
similar state provisions.
The
Company’s financial statements have been prepared and presented on a basis
assuming it will continue as a going concern. As reflected in the accompanying
financial statements the Company had a net loss in the amount of $329,813 and
$494,789 for the three months ended October 31, 2007 and 2006 respectively,
and has an accumulated deficit of $16,528,809 as of October 31, 2007, and
has substantial purchase commitments at October 31, 2007 (see Note 7). These
matters raise substantial doubt about the Company’s ability to continue as a
going concern.
The
Company will need to raise additional capital during fiscal year 2008.
Additional debt or equity financing will be required for the Company to continue
its business activities, which are currently focused on the development,
marketing and production of the Exer-Rest. It is management’s intention to
obtain the required additional capital needed to continue its business
activities through new debt or equity financing, but there can be no assurance
that it will be successful in this regard. The accompanying financial statements
do not include any adjustments that might be necessary from the outcome of
this
uncertainty.
ITEM
3.
|
CONTROLS
AND PROCEDURES.
|
We
carried out an evaluation, under the supervision and with the participation
of
our management, including our Chief Executive Officer and Chief Financial
Officer, of the effectiveness of our disclosure controls and procedures, as
defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of
1934
as of the end of the period covered by this report. Based on that evaluation,
our Chief Executive Officer and Chief Financial Officer have concluded that
our
disclosure controls and procedures as of October 31, 2007 were not effective
to
ensure that information required to be disclosed by us in reports that we file
or submit under the Securities Exchange Act of 1934 is recorded, processed,
summarized and reported within the time periods specified in the Securities
and
Exchange Commission’s rules and forms. This was based on the following;
In
reviewing the financial statements for the quarter ended January 31, 2008,
we
uncovered an error relating to the number of outstanding options as of July
31,
2006 and July 31, 2007 as reported in our reports on Form 10-KSB for the periods
ended as of such dates. The net effect of the error was that there were 247,001
additional options outstanding as of July 31, 2006 and July 31, 2007, than
were
disclosed in Footnote 10 of the Annual Report on Form 10-KSB for the periods
ended July 31, 2006 and July 31, 2007, respectively. These options, which had
become fully vested in prior years, had been reported in earlier SEC filings
but
erroneously had been left off current lists of outstanding options. This error
had no impact on the financial position, results of operations or cash flows
for
the years ended July 31 2007 and 2006.
We
also
discovered an error in the Form 10-QSB for the quarter ended October 31, 2007
relating to the calculation of the amount of stock based compensation expense
for options granted in October 2007. The effect of this was to increase the
operating expenses and net loss by $108,257, increasing
the net
loss for the period to $329,813.
As
of the
date of this filing, we have adopted more stringent procedures and controls
to
assure outstanding options will be properly reported in the future. These
include instituting and maintaining a subsidiary ledger that will be balanced
at
each month end and referenced to the minutes of the Board giving authorization
for the options. In addition we have implemented certain more stringent review
of our quarterly and annual reports to assure compliance with disclosure
requirements, including the use of outside professionals to assist us with
compliance.
As
a
result of the foregoing, we are concurrently filing a Form 10-KSB/A (Amendment
No. 2) for the fiscal year ended July 31, 2007 in which we discuss management’s
reconsideration of the effectiveness of our disclosure controls and procedures
as of the end of such year. Other than as described above, there have been
no
material changes in our internal controls over financial reporting or in other
factors that could materially affect, or are reasonably likely to affect, our
internal controls over financial reporting during the quarter ended October
31, 2007.
NON-INVASIVE
MONITORING SYSTEMS, INC
.
PART
II OTHER INFORMATION
Issuance
of Common Stock. On October 5, 2007 and October 9, 2007, the Company issued
161,665 shares of its Common Stock, upon exercise of options by two investors
at
an exercise price of $ 0.50 per share for total consideration of $80,833. The
proceeds will be used for general working capital purposes.
On
October 17, 2007 the Company issued options to purchase 547,500 shares of Common
Stock. 517,500 options were issued to directors and officers and 30,000 options
were issued to employees. Options vested and were exercisable immediately with
respect to 187,500 underlying shares; options with respect to the 360,000
underlying shares vest and are exercisable at the rate of 40,000 options as
of
the first day of the calendar quarter until fully vested.
Exemption
from Registration.
The
Company issued the above-described Common Stock and 547,500 options in reliance
upon the exemption from registration provided by Section 4(2) of the
Securities Act of 1933, as amended
and/or
Regulation D promulgated
under
the Securities Act of 1933. The securities described above were issued to
accredited investors, except for options to purchase 30,000 shares, which were
issued to two employees. The issued options and exercised options restrict
transfer of Common Stock acquired upon exercise thereof unless an applicable
exemption exists under the securities laws. In the case of the issued stock,
a
legend was placed on the stock certificates representing the Common Stock issued
upon exercise to the effect that the shares were not registered and absent
registration could only be transferred with an appropriate exemption.
10.1
|
|
Product
Development and Supply Agreement executed September 4, 2007 between
Sing
Lin Technologies and the Company (Confidential Treatment has been
Requested for Portions of this Exhibit)
|
|
|
|
31.1
|
|
Certification
of Periodic Report by Chief Executive Officer pursuant to Rule 13a-14
and
15d-14 of the Securities Exchange Act of 1934.
|
|
|
|
31.2
|
|
Certification
of Periodic Report by Chief Financial Officer pursuant to Rule 13a-14
and
15d-14 of the Securities Exchange Act of 1934.
|
|
|
|
32.1
|
|
Certification
of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as
adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
|
|
|
32.2
|
|
Certification
of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as
adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
|
NON-INVASIVE
MONITORING SYSTEMS, INC.
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act
of 1934 the Company has duly caused this report to be signed on its behalf
by
the undersigned, thereunto duly authorized.
Dated:
April 22, 2008
|
By:
|
/s/
Dr. Marvin A, Sackner
|
|
|
Dr.
Marvin A. Sackner
|
|
|
Chief
Executive Officer
|
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has
been
signed below by the following person on behalf of the registrant and in the
capacities and on the dates indicated.
Dated
April 22, 2008
|
By:
|
/s/
Gary M. Wetstein
|
|
|
Gary
M. Wetstein
|
|
|
Chief
Financial Officer
|
NON-INVASIVE
MONITORING SYSTEMS, INC.
EXHIBIT
INDEX
|
|
Description
of Exhibits
|
|
|
|
10.1
|
|
Product
Development and Supply Agreement executed September 4, 2007 between
Sing
Lin Technologies and the Company (Confidential Treatment has been
Requested for Portions of this Exhibit)
|
|
|
|
31.1
|
|
Certification
of Chief Executive Officer Pursuant to Rules 13a-14 and 15d-14 under
the
Securities Exchange Act of 1934.
|
|
|
|
31.2
|
|
Certification
of Chief Financial Officer Pursuant to Rules 13a-14 and 15d-14 under
the
Securities Exchange Act of 1934.
|
|
|
|
32.1
|
|
Certification
of Chief Executive Officer Pursuant to 18 U.S.C. 1350 as enacted
Pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.2
|
|
Certification
of Chief Financial Officer Pursuant to 18 U.S.C. 1350 as enacted
Pursuant
to Section 906 of the Sarbanes-Oxley Act of
2002.
|