Emmaus Life Sciences, Inc. - Quarter Report: 2009 June (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
x
|
Quarterly
Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of
1934
|
For the
quarterly period ended June 30, 2009 or
¨
|
Transition
Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of
1934
|
For the
transition period from __________________ to
______________________.
Commission
file number 0-26285
CNS
RESPONSE, INC.
(Exact
name of registrant as specified in its charter)
Delaware
|
87-0419387
|
(State
or other jurisdiction of
|
(I.R.S.
Employer
|
incorporation
or organization)
|
Identification
No.)
|
2755
Bristol Street, Suite 285
Costa
Mesa, CA 92626
(Address
of principal executive offices)(Zip Code)
(714)
545-3288
(Registrant’s
telephone number, including area code)
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days.
Yes x No ¨
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Date 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 x
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 Rule 12b-2
of the Exchange Act.
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer¨
(Do not check if a smaller reporting company)
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange
Act).
Yes ¨
No x
As of
July 31, 2009, the issuer had 28,872,476 shares of common stock, par value $.001
per share, issued and outstanding.
CNS
RESPONSE, INC.
INDEX
TO FORM 10-Q
Page
|
||
PART
I
|
FINANCIAL
INFORMATION
|
3
|
Item
1.
|
Financial
Statements
|
3
|
Unaudited
Condensed Consolidated Statements of Operations for the three and nine
months ended June 30, 2009 and 2008
|
3
|
|
Condensed
Consolidated Balance Sheets as of June 30, 2009 (unaudited) and September
30, 2008
|
4
|
|
Unaudited
Condensed Consolidated Statements of Cash Flows for the nine months ended
June 30, 2009 and 2008
|
5
|
|
Unaudited
Condensed Consolidated Statements of Stockholders’ Equity
(Deficit) for the nine months ended June 30, 2009 and
2008
|
6
|
|
Notes
to Unaudited Condensed Consolidated Financial Statements
|
7
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
20
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
35
|
Item
4T.
|
Controls
and Procedures
|
35
|
PART
II
|
OTHER
INFORMATION
|
36
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Item
1
|
Legal
Proceedings
|
36
|
Item
1A.
|
Risk
Factors
|
36
|
Item
2
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
37
|
Item
3
|
Defaults
Upon Senior Securities
|
39
|
Item
6.
|
Exhibits
|
39
|
PART
I
FINANCIAL
INFORMATION
Item
1.
|
Financial
Statements
|
CNS
RESPONSE, INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For
the three months ended
June
30,
|
For
the nine months ended
June
30,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
REVENUES
|
||||||||||||||||
Laboratory
Information Services
|
$ | 26,700 | $ | 36,500 | $ | 86,300 | $ | 131,000 | ||||||||
Clinical
Services
|
133,700 | 196,400 | 441,900 | 377,000 | ||||||||||||
160,400 | 232,900 | 528,200 | 508,000 | |||||||||||||
OPERATING
EXPENSES
|
||||||||||||||||
Cost
of laboratory services revenues
|
30,700 | 34,200 | 99,800 | 131,600 | ||||||||||||
Research
and development
|
504,400 | 682,400 | 1,741,200 | 1,589,000 | ||||||||||||
Sales
and marketing
|
161,300 | 348,200 | 708,100 | 595,000 | ||||||||||||
General
and administrative
|
843,900 | 776,400 | 2,247,400 | 2,200,800 | ||||||||||||
Total
operating expenses
|
1,540,300 | 1,841,200 | 4,796,500 | 4,516,400 | ||||||||||||
OPERATING
LOSS
|
(1,379,900 | ) | (1,608,300 | ) | (4,268,300 | ) | (4,008,400 | ) | ||||||||
OTHER
INCOME (EXPENSE):
|
||||||||||||||||
Interest
income (expense), net
|
(126,300 | ) | 13,000 | (129,900 | ) | 97,200 | ||||||||||
Financing
premium (expense)
|
(90,000 | ) | - | (90,000 | ) | - | ||||||||||
Total
other income (expense)
|
(216,300 | ) | 13,000 | (219,900 | ) | 97,200 | ||||||||||
LOSS
BEFORE PROVISION FOR INCOME TAXES
|
(1,596,200 | ) | (1,595,300 | ) | (4,488,200 | ) | (3,911,200 | ) | ||||||||
Income
taxes
|
4,300 | 600 | 7,200 | 1,400 | ||||||||||||
|
||||||||||||||||
NET
LOSS
|
$ | (1,600,500 | ) | $ | (1,595,900 | ) | $ | (4,495,400 | ) | $ | (3,912,600 | ) | ||||
NET
LOSS PER SHARE:
|
||||||||||||||||
Basic
|
$ | (0.06 | ) | $ | (0.06 | ) | $ | (0.18 | ) | $ | (0.15 | ) | ||||
Diluted
|
$ | (0.06 | ) | $ | (0.06 | ) | $ | (0.18 | ) | $ | (0.15 | ) | ||||
WEIGHTED
AVERAGE SHARES OUTSTANDING:
|
||||||||||||||||
Basic
|
25,782,277 | 25,299,547 | 25,460,457 | 25,299,547 | ||||||||||||
Diluted
|
25,782,277 | 25,299,547 | 25,460,457 | 25,299,547 |
See
accompanying Notes to Unaudited Condensed Consolidated Financial
Statements.
3
CNS
RESPONSE, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
June 30,
2009
|
September 30,
2008
|
|||||||
|
(unaudited)
|
|||||||
ASSETS
|
||||||||
CURRENT
ASSETS
|
||||||||
Cash
|
$ | 748,300 | $ | 1,997,000 | ||||
Accounts
receivable (net of allowance for doubtful accounts of $11,600
(unaudited) as of June 30, 2009 and $17,200 as of September 30,
2008)
|
102,800 | 98,200 | ||||||
Prepaid
and other
|
201,400 | 189,400 | ||||||
Total
current assets
|
1,052,500 | 2,284,600 | ||||||
Other
assets
|
24,000 | 28,700 | ||||||
Goodwill
|
320,200 | 320,200 | ||||||
TOTAL
ASSETS
|
$ | 1,396,700 | $ | 2,633,500 | ||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||||||||
CURRENT
LIABILITIES
|
||||||||
Accounts
payable (including amounts due to related parties of $6,000
(unaudited) as of June 30, 2009 and $6,800 as of September 30,
2008)
|
$ | 772,900 | $ | 335,700 | ||||
Accrued
liabilities
|
261,400 | 207,500 | ||||||
Funds
pending exercise of options (related party)
|
280,500 | - | ||||||
Deferred
compensation (including $ 77,700 (unaudited) and $107,000 to
related parties as of June 30, 2009 and September
30, 2008 respectively)
|
216,100 | 264,900 | ||||||
Accrued
patient costs
|
524,200 | 397,500 | ||||||
Accrued
consulting fees
|
66,900 | 67,600 | ||||||
Accrued
interest
|
12,100 | 42,600 | ||||||
Convertible
promissory notes
|
- | 50,000 | ||||||
Secured
Convertible promissory notes net of discounts $950,500 ($700,000 is due to
related parties)
|
839,500 | - | ||||||
Current
portion of long-term debt
|
94,000 | 88,500 | ||||||
Total
current liabilities
|
3,067,600 | 1,454,300 | ||||||
LONG
–TERM LIABILITIES
|
||||||||
Note
payable to officer
|
48,900 | 118,600 | ||||||
Capital
lease
|
6,100 | 7,700 | ||||||
Total
long term liabilities
|
55,000 | 126,300 | ||||||
COMMITMENTS
AND CONTINGENCIES
|
- | - | ||||||
TOTAL
LIABILITIES
|
3,122,600 | 1,580,600 | ||||||
Stockholders’
equity (deficit):
|
||||||||
Common
stock, $0.001 par value; authorized, 750,000,000 shares, issued and
outstanding, 25,299,547 shares and 1,448,189 exercised warrants as of June
30, 2009 and 25,299,547 shares as of September 30, 2008
|
26,700 | 25,300 | ||||||
Additional
paid-in capital
|
19,416,500 | 17,701,300 | ||||||
Accumulated
deficit
|
(21,169,100 | ) | (16,673,700 | ) | ||||
Total
stockholders’ equity (deficit)
|
(1,725,900 | ) | 1,052,900 | |||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$ | 1,396,700 | $ | 2,633,500 |
See
accompanying Notes to Unaudited Condensed Consolidated Financial
Statements.
4
CNS
RESPONSE, INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For
the nine months ended
June
30,
|
||||||||
2009
|
2008
|
|||||||
CASH
FLOWS FROM OPERATING ACTIVITIES
|
||||||||
Net
loss
|
$ | (4,495,400 | ) | $ | (3,912,600 | ) | ||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Depreciation
|
6,700 | 90,600 | ||||||
Amortization
of note discount
|
107,500 | - | ||||||
Stock-based
compensation
|
644,200 | 837,500 | ||||||
Write-off
of doubtful accounts
|
22,700 | - | ||||||
Write-off
of deferred offering costs
|
- | 42,900 | ||||||
Changes
in operating assets and liabilities:
|
||||||||
Accounts
receivable
|
(27,300 | ) | 17,000 | |||||
Prepaids
and other current assets
|
(12,000 | ) | (137,400 | ) | ||||
Accounts
payable
|
437,200 | 20,800 | ||||||
Accrued
liabilities
|
113,400 | 4,900 | ||||||
Deferred
compensation
|
(48,800 | ) | 185,800 | |||||
Accrued
consulting fees
|
(700 | ) | (23,200 | ) | ||||
Accrued
patient costs
|
126,700 | 317,600 | ||||||
Net
cash used in operating activities
|
(3,125,800 | ) | (2,556,100 | ) | ||||
CASH
FLOWS FROM INVESTING ACTIVITIES
|
||||||||
Increase
in other assets
|
(2,000 | ) | (40,200 | ) | ||||
Cash
for acquisition, including transaction costs of $43,700
|
- | (11,600 | ) | |||||
Net
cash used in investing activities
|
(2,000 | ) | (51,800 | ) | ||||
CASH
FLOWS FROM FINANCING ACTIVITIES
|
||||||||
Cash
from Secured Convertible notes
|
1,700,000 | - | ||||||
Repayment
of notes
|
(114,400 | ) | (40,700 | ) | ||||
Repayment
of lease
|
(1,400 | ) | - | |||||
Funds
pending exercise of options
|
280,500 | - | ||||||
Cash
from exercise of warrants
|
14,400 | - | ||||||
Deferred
offering costs
|
- | (22,900 | ) | |||||
Net
cash from (used in ) financing activities
|
1,879,100 | (63,600 | ) | |||||
Net
decrease in cash
|
(1,248,700 | ) | (2,671,500 | ) | ||||
Cash,
beginning of period
|
1,997,000 | 5,790,100 | ||||||
Cash,
end of period
|
$ | 748,300 | $ | 3,118,600 | ||||
SUPPLEMENTAL
DISCLOSURE OF CASH FLOW
|
||||||||
INFORMATION
|
||||||||
Cash paid
during the period for:
|
||||||||
Interest
|
$ | 61,500 | $ | 10,300 | ||||
Income
taxes
|
$ | 7,200 | $ | 1,400 | ||||
Fair
value of note payable to officer for acquisition
|
- | $ | 265,900 | |||||
Fair
value of equipment acquired through a lease
|
- | $ | 10,500 |
See
accompanying Notes to Unaudited Condensed Consolidated Financial
Statements.
5
CNS
RESPONSE, INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
For
the nine months ended June 30, 2009
|
Common
Stock
|
Additional
Paid-in
|
Accumulated
|
|||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Total
|
||||||||||||||||
BALANCE
- September 30, 2008
|
25,299,547 | $ | 25,300 | $ | 17,701,300 | $ | (16,673,700 | ) | $ | 1,052,900 | ||||||||||
Exercise
of $0.01 warrants in June, 2009
|
1,448,189 | 1,400 | 13,000 | 14,400 | ||||||||||||||||
Issuance
of 3,433,333 warrants associated with bridge financings valued
at
|
- | - | 1,058,000 | - | 1,058,000 | |||||||||||||||
Stock-
based compensation
|
- | - | 644,200 | - | 644,200 | |||||||||||||||
Net
loss for the nine months ended June 30, 2009
|
- | - | - | (4,495,400 | ) | (4,495,400 | ) | |||||||||||||
Balance
at June 30, 2009
|
26,747,736 | $ | 26,700 | $ | 19,416,500 | $ | (21,169,100 | ) | $ | (1,725,900 | ) |
For
the nine months ended June 30, 2008
|
Common
Stock
|
Additional
Paid-in
|
Accumulated
|
|||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Total
|
||||||||||||||||
BALANCE
- September 30, 2007
|
25,299,547 | $ | 25,300 | $ | 16,630,000 | $ | (11,302,200 | ) | $ | 5,353,100 | ||||||||||
Stock-
based compensation
|
- | - | 837,500 | - | 837,500 | |||||||||||||||
Net
loss for the nine months ended June 30, 2008
|
- | - | - | (3,912,600 | ) | (3,912,600 | ) | |||||||||||||
Balance
at June 30, 2008
|
25,299,547 | $ | 25,300 | $ | 17,467,500 | $ | (15,214,800 | ) | $ | 2,278,000 |
See
accompanying Notes to Unaudited Condensed Consolidated Financial
Statements.
6
CNS RESPONSE, INC.
NOTES TO UNAUDITED CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
1. NATURE
OF OPERATIONS AND BASIS OF PRESENTATION
Organization
and Nature of Operations
CNS
Response, Inc. (the “Company”) was incorporated as Strativation, Inc. in
Delaware on July 10, 1984. In connection with the closing of a reverse merger
transaction on March 7, 2007, CNS Response, Inc., a California
corporation (“CNS California”), became a wholly-owned subsidiary of the
Company and the Company changed its name to its current name and commenced its
current operations. The Company utilizes a patented system that
guides psychiatrists and other physicians to determine a proper treatment for
patients with mental, behavioral and/or addictive disorders. The
Company also intends to guide pharmaceutical developers in the development of
new and approved pharmaceuticals.
In
addition, as a result of the acquisition of Neuro-Therapy Clinic, P.C., a
Colorado professional medical corporation (“NTC”) by Colorado CNS Response,
Inc., a Colorado corporation and a wholly-owned subsidiary of the Company, on
January 11, 2008, the Company provides behavioral health care
services. NTC is a center for highly-advanced testing and treatment
of neuropsychiatric problems, including learning, attentional and behavioral
challenges, mild head injuries, as well as depression, anxiety, bipolar and all
other common psychiatric disorders. Through this acquisition, the Company
expects to advance neurophysiology data collection, beta-test planned
technological advances in rEEG, advance physician training in rEEG and
investigate practice development strategies associated with rEEG.
Going
Concern Uncertainty
The
Company has a limited operating history and its operations are subject to
certain risks and uncertainties frequently encountered by companies operating in
rapidly evolving markets. These risks include the failure to timely develop or
supply technology or services, the ability to obtain financing in amounts and on
terms that are acceptable to the Company, competition within the Company’s
industry and technology trends.
To date,
the Company has financed its cash requirements primarily from debt and equity
financings. It will be necessary for the Company to raise additional
funds in order to continue to conduct its business. The Company’s
liquidity and capital requirements depend on several factors, including the rate
of market acceptance of its services, the ability to expand and retain its
customer base, its ability to execute its current business plan and other
factors. The Company is currently exploring additional sources of
capital but there can be no assurances that any financing arrangement will be
available in amounts and terms acceptable to the Company.
Basis
of Presentation
The
unaudited condensed consolidated financial statements of CNS Response, Inc.
(“CNS,” “we,” “us,” “our” or the “Company”) have been prepared pursuant to the
rules and regulations of the Securities and Exchange Commission and include all
the accounts of CNS and its wholly owned subsidiaries CNS Response, Inc., a
California corporation (“CNS California”), Colorado CNS Response, Inc., a
Colorado corporation, and NTC. Certain information and note
disclosures, normally included in financial statements prepared in accordance
with accounting principles generally accepted in the United States, have been
condensed or omitted pursuant to such rules and regulations. The unaudited
condensed consolidated financial statements reflect all adjustments, consisting
only of normal recurring adjustments, necessary for a fair statement of our
financial position as of June 30, 2009 and our operating results, cash flows,
and changes in stockholders’ equity for the interim periods presented. The
September 30, 2008 balance sheet was derived from our audited financial
statements but does not include all disclosures required by accounting
principles generally accepted in the United States of America. These condensed
consolidated financial statements and the related notes should be read in
conjunction with our financial statements and notes for the year ended September
30, 2008 which are included in our annual report on Form 10-K, filed with the
Securities and Exchange Commission on January 13, 2009.
7
CNS RESPONSE, INC.
NOTES TO UNAUDITED CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
The
preparation of financial statements in accordance with accounting principles
generally accepted in the United States requires management to make estimates
and assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities and revenues and expenses in the
financial statements. Examples of estimates subject to possible revision based
upon the outcome of future events include, among others, recoverability of
long-lived assets and goodwill, stock-based compensation, the allowance for
doubtful accounts, the valuation of equity instruments, use and other taxes.
Actual results could differ from those estimates.
The
results of operations for the nine months ended June 30, 2009 are not
necessarily indicative of the results that may be expected for future periods or
for the year ending September 30, 2009.
Fair
Value of Financial Instruments
SFAS 107,
“Disclosures about Fair Value of Financial Instruments” defines financial
instruments and requires disclosure of the fair value of financial instruments
held by the Company. The Company considers the carrying amount of cash, accounts
receivable, other receivables, accounts payable and accrued liabilities, to
approximate their fair values because of the short period of time between the
origination of such instruments and their expected realization.
The
Company also analyzes all financial instruments with features of both
liabilities and equity under SFAS 150, “Accounting for Certain Financial
Instruments with Characteristics of Both Liabilities and Equity,” SFAS No 133,
“Accounting for Derivative Instruments and Hedging Activities” and EITF 00-19,
“Accounting for Derivative Financial Instruments Indexed to, and Potentially
Settled in, a Company’s Own Stock.”
The
Company adopted SFAS 157, “Fair Value Measurements” on January 1, 2008. SFAS 157
defines fair value, establishes a three-level valuation hierarchy for
disclosures of fair value measurement and enhances disclosure requirements for
fair value measures. The three levels are defined as follow:
|
·
|
Level
1 inputs to the valuation methodology are quoted prices
(unadjusted) for identical assets or liabilities in active
markets.
|
|
·
|
Level
2 inputs to the valuation methodology include quoted
prices for similar assets and liabilities in active markets, and inputs
that are observable for the assets or liability, either directly or
indirectly, for substantially the full term of the financial
instruments.
|
|
·
|
Level
3 inputs to the valuation methodology are unobservable
and significant to the fair value.
|
During
the quarter ended June 30, 2009, the Company sold promissory notes in an
aggregate principal amount of $1,200,000 to certain investors as more fully
described in Note 2 below. In order to induce the investors to
purchase the notes, the Company issued to the investors an aggregate of
3,433,333 warrants to purchase its common stock. The fair value of
the 3,433,333 warrants issued in conjunction with the promissory notes were
determined using the Black-Scholes Model, defined as level 2 inputs, and
recorded as discount on notes on the balance sheet.
As of
June 30, 2009, the outstanding principal of the convertible promissory notes
amounted to $1,700,000, and the carrying value of the convertible notes amounted
to $749,500.
8
CNS RESPONSE, INC.
NOTES TO UNAUDITED CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
Carrying Value as of
June 30, 2009
|
Fair Value Measurements at June
30,
2009 Using Fair Value Hierarchy
|
|||||||||
Level 1
|
Level 2
|
Level 3
|
||||||||
Convertible
promissory notes
|
$ | 749,500 | $ | 1,080,000 |
Except
for promissory notes payable, the Company did not identify any other assets or
liabilities that are required to be presented on the balance sheet at fair value
in accordance with SFAS 157.
Recent
Accounting Pronouncements
In April
2009, the FASB issued FSP SFAS 107-1 and APB 28-1, "Interim
Disclosures about Fair Value of Financial Instruments", or FSP 107-1, which
requires that the fair value disclosures required for all financial instruments
within the scope of SFAS 107, "Disclosures about Fair Value of Financial
Instruments", be included in interim financial statements. This FSP also
requires entities to disclose the method and significant assumptions used to
estimate the fair value of financial instruments on an interim and annual basis
and to highlight any changes from prior periods. FSP 107-1 was effective for
interim periods ending after June 15, 2009, with early adoption permitted. The
adoption of FSP 107-1 did not have a material impact on the Company’s condensed
consolidated financial statements.
In May
2009, the FASB issued SFAS 165, Subsequent Event, which establishes general
standards of accounting for and disclosure of events that occur after the
balance sheet date but before financial statements are issued or are available
to be issued. In accordance with this Statement, entities should apply the
requirements to interim or annual financial periods ending after June 15,
2009. The adoption of this statement did not have a material impact
on the Company’s condensed consolidated financial statements.
In June
2009, the FASB approved its Accounting Standards Codification, or Codification,
as the single source of authoritative United States
accounting and reporting standards applicable for all
non-governmental entities, with the exception of the SEC and its staff. The
Codification, which changes the referencing of financial standards, is effective
for interim or annual financial periods ending after September 15, 2009.
Therefore, in the third quarter of fiscal year 2009, all references made to US
GAAP will use the new Codification numbering system prescribed by the FASB. As
the Codification is not intended to change or alter existing US GAAP, it is not
expected to have any impact on the Company’s financial statements.
2. CONVERTIBLE
PROMISSORY NOTES
Prior to
September 30, 2006, CNS California issued convertible promissory notes with
detachable warrants from time to time to fund its operations. The
notes bear interest at 8% per year, compounded annually, and are payable on
demand. The terms of the notes provide for the (i) conversion of
principal and accrued interest into the same type of securities issued by CNS
California upon a qualified institutional financing, the amount of which
financing varies between notes and ranges from $1 to $4 million, and (ii)
conversion price to be equal to the same price as the shares sold in the
financing. The notes provide for an aggregate of $2,196,000 in
principal to convert automatically and $920,700 to convert at the note holders’
options based upon certain financing requirements (as defined).
In
October 2006, CNS California and the note holders of certain convertible
promissory notes converted notes with an aggregate outstanding balance of
$3,061,700 and related accrued and unpaid interest of $1,005,300 at September
30, 2006 into 5,993,515 shares of CNS California Series A Preferred
Stock. In addition, the exercise price of warrants to purchase
1,062,116 shares of the CNS California common stock issued to such note holders
was changed to $0.59 per share. Upon completion of the reverse merger
pursuant to which CNS California became a subsidiary of the Company, the
preferred shares were converted into 5,993,515 shares of the Company’s common
stock and the warrants were converted into warrants to purchase 1,062,116 shares
of the Company’s common stock at an exercise price of $0.59 per
share. The consolidated financial statements of the Company presented
reflect the issuance of these shares as common stock.
9
CNS RESPONSE, INC.
NOTES TO UNAUDITED CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
As of
September 30, 2008, one note issued by CNS California with a principal
balance of $49,950 was outstanding. In May, 2009 the company entered into a
settlement and release agreement with this note holder and fully repaid the
promissory note and accrued interest on June 30, 2009.
On March
30, 2009, the Company executed two senior secured convertible promissory notes
each in the principal amount of $250,000 with Brandt Ventures, GP (“Brandt”) and
SAIL Venture Partners, LP (“SAIL”). Leonard Brandt, a member of the
Company’s board of directors and the Company’s former Chief Executive Officer,
is the general partner of Brandt and David Jones, also a member of the Company’s
board of directors, is a managing partner of SAIL.
These
notes accrue interest at the rate of 8% per annum and are due and payable upon a
declaration by the note holder(s) requesting repayment, unless sooner converted
into shares of the Company’s common stock (as described below), upon the earlier
to occur of: (i) June 30, 2009 or (ii) an Event of Default (as defined in the
notes), which includes the default that occurred as a result of Mr. Brandt no
longer serving as the Company’s Chief Executive Officer effective as of April
10, 2009. The notes are secured by a lien on substantially all of the
assets (including all intellectual property) of the Company. In the
event of a liquidation, dissolution or winding up of the Company, unless Brandt
and/or Sail informs the Company otherwise, the Company shall pay such investor
an amount equal to the product of 250% multiplied by the principal and all
accrued but unpaid interest outstanding on the note.
In
concert with an equity financing transaction of at least $1,500,000 (excluding
any and all other debt that is converted), the principal and all accrued, but
unpaid interest outstanding under the notes shall be automatically converted
into the securities issued in the equity financing by dividing such amount by
90% of the per share price paid by the investors in such financing.
On May
14, 2009, CNS Response Inc. entered into a Bridge Note and Warrant Purchase
Agreement with SAIL. David B. Jones, a member of the Company’s board
of directors, is a managing partner of SAIL.
Pursuant
to the Purchase Agreement, on May 14, 2009, SAIL purchased a Secured Promissory
Note in the principal amount of $200,000 from the Company. In order
to induce SAIL to purchase the note, the Company issued to SAIL a warrant to
purchase up to 100,000 shares of the Company’s common stock at a purchase price
equal to $0.25 per share. The warrant expires on the earlier to occur
of May 31, 2016 or a change of control of the Company.
The
Purchase Agreement also provides that, at any time on or after June 30, 2009,
and provided that certain conditions are satisfied by the Company, SAIL will
purchase from the Company a second Secured Convertible Promissory Note in the
principal sum of $200,000 and will be issued a second warrant identical in terms
to the warrant described above. The aforementioned conditions include
the Company entering into a term sheet in which investors commit to participate
in an equity financing by the Company of not less than $2,000,000 (excluding any
and all other debt that are to be converted).
The notes
issued or issuable pursuant to the Purchase Agreement accrue interest at the
rate of 8% per annum and are due and payable, unless sooner converted into
shares of the Company’s common stock (as described below), upon the earlier to
occur of: (i) a declaration by SAIL on or after June 30, 2009 or (ii) an Event
of Default as defined in the notes. The note(s) are secured by a lien
on substantially all of the assets (including all intellectual property) of the
Company. In the event of a liquidation, dissolution or winding up of
the Company, unless SAIL informs the Company otherwise, the Company shall pay
SAIL an amount equal to the product of 250% multiplied by the principal and all
accrued but unpaid interest outstanding on the note(s).
10
CNS RESPONSE, INC.
NOTES TO UNAUDITED CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
In the
event the Company consummates an equity financing transaction of at least
$1,500,000 (excluding any and all other debt that is converted), then the
principal and all accrued, but unpaid interest outstanding under the note(s)
shall be automatically converted into the securities issued in the equity
financing by dividing such amount by 85% of the per share price paid by the
investors in such financing.
In
addition, in the event the Company issues preferred stock that is not part of an
equity financing described above, SAIL may, at its option, convert the principal
and all accrued, but unpaid interest outstanding under the note(s) into
preferred stock by dividing such amount by 85% of the per share price paid by
the purchasers’ of the Company’s preferred stock.
On June
12, 2009, the Company entered into a Bridge Note and Warrant Purchase Agreement
with Mr. John Pappajohn (“Pappajohn”).
Pursuant
to the Purchase Agreement, on June 12, 2009, Pappajohn purchased a Secured
Convertible Promissory Note in the principal amount of $1,000,000 from the
Company. In order to induce Pappajohn to purchase the note, the
Company issued to Pappajohn a warrant to purchase up to 3,333,333 shares of the
Company’s common stock at a purchase price equal to $0.30 per
share. The warrant expires on June 30, 2016.
The note
issued pursuant to the Purchase Agreement provides that the principal amount of
$1,000,000 together with a single Premium Payment of $90,000 which is due and
payable, unless sooner converted into shares of the Company’s common stock (as
described below), upon the earlier to occur of: (i) a declaration by Pappajohn
on or after June 30, 2010 or (ii) an Event of Default as defined in the
note. The note is secured by a lien on substantially all of the
assets (including all intellectual property) of the Company. In the
event of a liquidation, dissolution or winding up of the Company, unless
Pappajohn informs the Company otherwise, the Company shall pay Pappajohn an
amount equal to the product of 250% multiplied by the then outstanding principal
amount of the note and the Premium Payment.
In the
event the Company consummates an equity financing transaction of at least
$1,500,000 (excluding any and all other debt that is converted), the then
outstanding principal amount of the note (but excluding the Premium Payment,
which will be repaid in cash at the time of such equity financing) shall be
automatically converted into the securities issued in the equity financing by
dividing such amount by the per share price paid by the investors in such
financing.
3. STOCKHOLDERS’
EQUITY
Common
and Preferred Stock
As of
June 30, 2009, the Company is authorized to issue 750,000,000 shares of common
stock of which 26,747,736 shares were issued and outstanding.
As of
June 30, 2009, CNS California is authorized to issue 100,000,000 shares of two
classes of stock, 80,000,000 of which are designated as common shares and
20,000,000 of which are designated as preferred shares.
As of
June 30, 2009, Colorado CNS Response, Inc. is authorized to issue 1,000,000
shares of common stock.
11
CNS RESPONSE, INC.
NOTES TO UNAUDITED CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
As of
June 30, 2009, Neuro-Therapy Clinic, P.C., a wholly-owned subsidiary of Colorado
CNS Response, Inc., is authorized to issue ten thousand (10,000) shares of
common stock, no par value per share.
Stock-Option
Plan
On August
3, 2006, CNS California adopted the CNS California 2006 Stock Incentive Plan
(the “2006 Plan”). The 2006 Plan provides for the issuance of awards in the form
of restricted shares, stock options (which may constitute incentive stock
options (ISO) or non-statutory stock options (NSO)), stock appreciation
rights and stock unit grants to eligible employees, directors and consultants
and is administered by the board of directors. A total of 10 million shares of
stock are reserved for issuance under the 2006 Plan. As of June 30,
2009, there were 8,786,754 options and 183,937 restricted shares outstanding
under the 2006 Plan and 1,029,309 shares available for issuance of
awards.
The 2006
Plan provides that in any calendar year, no eligible employee or director shall
be granted an award to purchase more than 3 million shares of stock. The option
price for each share of stock subject to an option shall be (i) no less than the
fair market value of a share of stock on the date the option is granted, if the
option is an ISO, or (ii) no less than 85% of the fair market value of the stock
on the date the option is granted, if the option is a NSO; provided, however, if
the option is an ISO granted to an eligible employee who is a 10% shareholder,
the option price for each share of stock subject to such ISO shall be no less
than 110% of the fair market value of a share of stock on the date such ISO is
granted. Stock options have a maximum term of ten years from the date of grant,
except for ISOs granted to an eligible employee who is a 10% shareholder, in
which case the maximum term is five years from the date of grant. ISOs may be
granted only to eligible employees. The Company has adopted SFAS No. 123R
(revised 2004), “Share-Based Payment”, and related interpretations. Under SFAS
No. 123R, share-based compensation cost is measured at the grant date based on
the calculated fair value of the award. The Company estimates the fair value of
each option on the grant date using the Black-Scholes model. No
options were granted during the 3 months ended June 30, 2009.
The
expense is recognized over the employees’ or service provider’s requisite
service period, generally the vesting period of the
award. Stock-based compensation expense included in the accompanying
statements of operations for the three and nine months ended June 30, 2009 and
2008 are as follows:
For
the three months ended June 30,
|
||||||||
2009
|
2008
|
|||||||
Operations
|
$ | 4,000 | $ | 4,000 | ||||
Research
and development
|
65,200 | 68,900 | ||||||
Sales
and marketing
|
27,000 | 46,300 | ||||||
General
and administrative
|
106,500 | 136,000 | ||||||
Total
|
$ | 202,700 | $ | 255,200 |
For
the nine months ended June 30,
|
||||||||
2009
|
2008
|
|||||||
Operations
|
$ | 12,100 | $ | 12,000 | ||||
Research
and development
|
195,600 | 255,500 | ||||||
Sales
and marketing
|
107,000 | 46,300 | ||||||
General
and administrative
|
329,500 | 523,700 | ||||||
Total
|
$ | 644,200 | $ | 837,500 |
12
CNS
RESPONSE, INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Total
unrecognized compensation expense as of June 30, 2009 amounted to
$1,295,900.
A summary
of stock option activity is as follows:
Number of
Shares
|
Weighted
Average Exercise
Price
|
|||||||
Outstanding
at September 30, 2008
|
8,964,567 | $ | 0.60 | |||||
Granted
|
24,000 | $ | 0.51 | |||||
Exercised
|
- | - | ||||||
Forfeited
|
(257,813 | ) | $ | 0.51 | ||||
Outstanding
at December 31, 2008
|
8,730,754 | $ | 0.61 | |||||
Granted
|
56,000 | $ | 0.40 | |||||
Exercised
|
- | - | ||||||
Forfeited
|
- | - | ||||||
Outstanding
at March 31, 2009
|
8,786,754 | $ | 0.60 | |||||
Granted
|
- | - | ||||||
Exercised
|
- | - | ||||||
Forfeited
|
- | |||||||
Outstanding
at June 30, 2009
|
8,786,754 | $ | 0.60 | |||||
Weighted
average of fair value of options granted during:
|
||||||||
9
months ended June 30, 2009
|
$ | 0.49 |
On June
19, 2009, Mr. Brandt, the former CEO and a current director of the Company,
paid the Company $280,500 to exercise 2,124,740 non-statutory qualified options
at $0.132 per share. When exercising non-statutory options it is
stipulated that ordinary income is recognized equal to the spread between the
fair market value of the purchased shares on the date of exercise and the
exercise price. Additionally, it is required that withholding taxes
on this recognized income are paid at the time of exercising non-statutory
options. Therefore, the exercise of these options cannot be completed
until the associated withholding taxes are paid; consequently the funds received
from Mr. Brandt are shown as a liability pending the perfected exercise of these
options. The withholding taxes were subsequently paid and on July 31,
2009 the aforementioned 2,124,740 shares were issued.
13
CNS RESPONSE, INC.
NOTES TO UNAUDITED CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
The
following is a summary of the status of options outstanding at June 30,
2009:
Exercise Price
|
Number of Shares
|
Weighted Average
Contractual Life
|
Weighted
Average
Exercise Price
|
|||||||
$
|
0.12
|
859,270 |
10
years
|
$ | 0.12 | |||||
$ |
0.132
|
3,112,545 |
7
years
|
$ | 0.132 | |||||
$ |
0.30
|
135,700 |
10
years
|
$ | 0.30 | |||||
$ |
0.59
|
28,588 |
10
years
|
$ | 0.59 | |||||
$ |
0.80
|
140,000 |
10
years
|
$ | 0.80 | |||||
$ |
0.89
|
968,875 |
10
years
|
$ | 0.89 | |||||
$ |
0.96
|
496,746 |
10
years
|
$ | 0.96 | |||||
$ |
1.09
|
2,614,232 |
10
years
|
$ | 1.09 | |||||
$ |
1.20
|
333,611 |
5
years
|
$ | 1.20 | |||||
$ |
0.51
|
41,187 |
10
Years
|
$ | 0.51 | |||||
$ |
0.40
|
56,000 |
10
Years
|
$ | 0.40 | |||||
Total
|
8,786,754 | $ | 0.60 |
Warrants
to Purchase Common Stock
At
September 30, 2008, there were warrants outstanding to purchase 6,899,353 shares
of the Company’s common stock at exercise prices ranging from $0.01 to $1.812
with a weighted average exercise price of $1.04. The warrants expire
at various times through 2017.
During
the quarter ended June 30, 2009, warrants to purchase 100,000 shares of common
stock were issued to SAIL Venture Partners LP at an exercise price of $0.25 and
expiration date of May 31, 2016. Additionally, warrants to purchase
3,333,333 shares of common stock were issued to Mr. Pappajohn at an exercise
price of $0.30 and an expiration date of June 30, 2016. Both sets of
warrants were issued in conjunction with the bridge financings described in Note
2. These warrants were valued using the Black-Scholes model at a
combined $1,058,000, which value will be amortized to interest expense over the
terms of their associated promissory notes. At June 30, $107,500 was
recognized as interest leaving a remaining balance of $950,500 which is shown as
a discount to the secured convertible debt.
During
the quarter ended June 30, 2009, warrants to purchases 1,448,189 shares of
common stock at an exercise price of $0.01 per share were
exercised.
At
June 30, 2009, warrants to purchase 8,884,497 shares of the Company’s common
stock were outstanding with exercise prices ranging from $0.01 to $1.812 with a
weighted average exercise price of $0.92. The warrants expire at
various times through 2017.
4. ACQUISITION OF NEURO THERAPY CLINIC,
PC
On
January 11, 2008, the Company, through its wholly owned subsidiary, Colorado CNS
Response, Inc., acquired all of the outstanding common stock of Neuro-Therapy
Clinic, PC (“NTC”) in exchange for a non-interest bearing note payable of
$300,000 payable in equal monthly installments over 36 months. Upon
the completion of the acquisition, the sole shareholder of NTC, Daniel Hoffman,
was appointed Chief Medical Officer of the Company. Prior to the
acquisition, NTC was the Company’s largest customer.
The
acquisition was accounted for under the purchase method of accounting, and
accordingly, the purchase price was allocated to NTC’s net tangible assets based
on their estimated fair values as of January 11, 2008. The excess purchase price
over the value of the net tangible assets was recorded as
goodwill. The purchase price and the allocation thereof are as
follows:
Fair
value of note payable issued
|
$ | 265,900 | ||
Direct
transaction costs
|
43,700 | |||
Purchase
price
|
309,600 | |||
Allocated
to net tangible liabilities, including
cash of $32,100
|
(10,600 | ) | ||
Allocated
to goodwill
|
$ | 320,200 |
14
CNS
RESPONSE, INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Upon the
occurrence of certain events, as defined in the purchase agreement, the prior
sole Shareholder of NTC has a repurchase option for a period of three years
subsequent to the closing, as well as certain rights of first refusal, in
relation to the assets and liabilities acquired by the Company.
The
acquisition was not material, and accordingly, no pro forma results are
presented.
5. LONG-TERM DEBT
During
the year ended September 30, 2008 the Company issued a note payable to an
officer in connection with the acquisition of NTC (see Note 4). The
note is non-interest bearing and the Company determined its fair value by
imputing interest at an annual rate of 8%. As of September 30, 2008
and June 30, 2009 the note had an outstanding principal balance in the
amount of $205,300 and $140,900, respectively.
6. REPORTABLE
SEGMENTS
The
Company operates in two business segments: Laboratory Information Services and
Clinic. Laboratory Information Services provide reports (“rEEG
Reports”) that assist physicians with treatment strategies for patients with
behavioral (psychiatric and/or addictive) disorders based on the patient’s own
physiology. Clinic operates NTC, a full service psychiatric
practice.
The
following tables show operating results for the Company’s reportable segments,
along with reconciliation from segment gross profit to (loss) from operations,
the most directly comparable measure in accordance with generally accepted
accounting principles in the United States, or GAAP:
Three
Months ended June 30, 2009
|
||||||||||||||||
Laboratory
Information
Services
|
Clinic
|
Eliminations
|
Total
|
|||||||||||||
Revenues
|
$ | 32,000 | $ | 133,700 | $ | (5,300 | ) | $ | 160,400 | |||||||
Operating
expenses:
|
||||||||||||||||
Cost
of revenues
|
30,700 | 5,300 | (5,300 | ) | 30,700 | |||||||||||
Research
and development
|
504,400 | - | - | 504,400 | ||||||||||||
Sales
and marketing
|
159,600 | 1,700 | - | 161,300 | ||||||||||||
General
and administrative
|
659,500 | 184,400 | - | 843,900 | ||||||||||||
Total
operating expenses
|
$ | 1,354,200 | $ | 191,400 | $ | (5,300 | ) | $ | 1,540,300 | |||||||
Loss
from operations
|
$ | (1,322,200 | ) | $ | (57,700 | ) | $ | - | $ | (1,379,900 | ) |
15
CNS
RESPONSE, INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Nine months ended June 30, 2009
|
||||||||||||||||
Laboratory
Information
Services
|
Clinic
|
Eliminations
|
Total
|
|||||||||||||
Revenues
|
$ | 98,800 | $ | 463,400 | $ | (34,000 | ) | $ | 528,200 | |||||||
Operating
expenses:
|
||||||||||||||||
Cost of
revenues
|
99,800 | 12,500 | (12,500 | ) | 99,800 | |||||||||||
Research and
development
|
1,741,200 | - | - | 1,741,200 | ||||||||||||
Sales and
marketing
|
702,500 | 5,600 | - | 708,100 | ||||||||||||
General and
administrative
|
1,767,100 | 501,800 | (21,500 | ) | 2,247,400 | |||||||||||
Total operating
expenses
|
$ | 4,310,600 | $ | 519,900 | $ | (34,000 | ) | $ | 4,796,500 | |||||||
Loss from
operations
|
$ | (4,211,800 | ) | $ | (56,500 | ) | $ | - | $ | (4,268,300 | ) |
The following table includes selected
segment financial
information as of June
30, 2009, related to goodwill and total
assets:
Laboratory
Information Services
|
Clinic
|
Total
|
||||||||||
Goodwill
|
$ | 320,200 | $ | - | $ | 320,200 | ||||||
Total
assets
|
$ | 1,354,300 | $ | 42,400 | $ | 1,396,700 |
7.
|
EARNINGS PER
SHARE
|
In accordance with SFAS 128,
“Computation of Earnings Per
Share,” basic net income (loss) per share is
computed by dividing the
net income (loss) to common stockholders for the period by the weighted average
number of common shares outstanding during the period. Diluted net income (loss)
per share is computed by dividing the net income (loss) for the period by
the weighted average number of common and
dilutive common equivalent shares outstanding during the period. For
the three and nine months ended June 30, 2009 and 2008, the Company has excluded all common
equivalent shares from the calculation of diluted net loss per share as such securities are
anti-dilutive.
A summary of the net income (loss) and
shares used to compute net income (loss) per share for the three months and nine months ended June 30, 2009 and 2008 are as follows:
For the three months
ended June 30,
|
2009
|
2008
|
||||||
Net loss for computation of basic
net loss per share
|
$ | (1,600,500 | ) | $ | (1,595,900 | ) | ||
Net loss for computation of
dilutive net loss per share
|
$ | (1,600,500 | ) | $ | (1,595,900 | ) | ||
Basic net loss per
share
|
$ | (0.06 | ) | $ | (0.06 | ) | ||
Diluted net loss per
share
|
$ | (0.06 | ) | $ | (0.06 | ) | ||
Basic weighted average shares
outstanding
|
25,782,277 | 25,299,547 | ||||||
Dilutive common equivalent
shares
|
- | - | ||||||
Diluted weighted average common
shares
|
25,782,277 | 25,299,547 |
16
CNS
RESPONSE, INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
For the nine months ended June 30,
|
2009
|
2008
|
||||||
Net loss for computation of basic
net loss per share
|
$ | (4,495,400 | ) | $ | (3,912,600 | ) | ||
Net loss for computation of
dilutive net loss per share
|
$ | (4,495,400 | ) | $ | (3,912,600 | ) | ||
Basic net loss per share
|
$ | (0.18 | ) | $ | (0.15 | ) | ||
Diluted net loss per
share
|
$ | (0.18 | ) | $ | (0.15 | ) | ||
Basic weighted average shares
outstanding
|
25,460,457 | 25,299,547 | ||||||
Dilutive common equivalent
shares
|
- | - | ||||||
Diluted weighted average
common
shares
|
25,460,457 | 25,299,547 | ||||||
Anti-dilutive common equivalent
shares not included in the computation of dilutive net loss per
share:
|
||||||||
For the three months ended
June 30,
|
2009
|
2008
|
||||||
Convertible
debt
|
- | 4,995,000 | ||||||
Warrants
|
7,594,401 | 6,899,353 | ||||||
Options
|
8,869,545 | 8,959,533 | ||||||
For the nine months ended June 30,
|
2009
|
2008
|
||||||
Convertible
debt
|
- | 4,995,000 | ||||||
Warrants
|
7,131,036 | 6,899,353 | ||||||
Options
|
8,885,551 | 8,510,578 |
As detailed in Note 2, convertible secured notes
totaling $1,700,000
and any accrued interest
may be automatically converted to common stock in concert with
a future equity financing transaction of at least $1,500,000. The
number of automatically converted shares issued will be determined by dividing
the amount of the secured notes and interest by the per share price paid by the
investors in such financing, less any stipulated discount on
conversion.
8.
|
COMMITMENTS AND CONTINGENT
LIABILITIES
|
Litigation
Background
Leonard Brandt, who currently serves as
one of five company directors, served as the Company’s Chairman and CEO over the
past three years until his dismissal by the Company’s board of directors on
April 10, 2009. Mr. Brandt is also a significant securityholder of
the Company, claiming beneficial ownership of 9,838,777 shares of common stock,
representing approximately 32.5% of the Company’s issued and outstanding common
stock. Mr. Brandt also holds a promissory note in the amount of
$250,000, which note is secured by all of the Company’s assets, making Mr.
Brandt and another note holder the co-holders of a first lien on all of the
Company’s assets, with collateral coverage equal to 250% of the principal amount
of the debt owed, as further described in Note 2 above.
17
CNS
RESPONSE, INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
On June 19, 2009, Mr. Brandt, his
children and EAC Investment, Inc. (“EAC”) (Mr. Brandt, his children and EAC are
collectively referred to herein as the “25% Stockholder Group”) sent notice to
the Company of their intention to call a special meeting of stockholders in lieu
of an annual meeting at which directors would be elected. (Under the
Company’s bylaws, holders of one-quarter of the outstanding stock may call a
special meeting; the Company contests whether this includes a special meeting in
lieu of an annual meeting). Subsequently, Mr. Brandt mailed to the
Company’s stockholders a notice of special meeting to be held on June 30, 2009,
and then made an additional mailing of a notice that changed the date of the
special meeting to July 3, 2009. Subsequently, Mr. Brandt send out another
mailing to Company Stockholders announcing his attempt to call another special
meeting on August 17, 2009. The Company is not aware of any other written
communications sent by Mr. Brandt or on his behalf to the Company’s stockholders
generally. Mr. Brandt then attempted to call the meeting on July 3,
July 12, July 21 and July 30, and in each instance, because there was no quorum
present for the conduct of business, he purportedly adjourned the meeting to a
later date. He now plans to attempt to reconvene the meeting on
August 17, 2009. The Company’s position is that those meetings have
not been properly noticed, called or adjourned and, therefore, any action taken
at any meeting or reconvened meeting relating to those notices, purported
meetings or purported adjournments would not be valid under the Company’s
certificate of incorporation, bylaws or the DGCL.
The board of directors has scheduled an
annual meeting of stockholders for September 29, 2009 and has set a record date
of August 27, 2009. The board believes that this will provide
sufficient time for the preparation and filing of proxy materials with the
Securities and Exchange Commission and the solicitation of proxies from
stockholders. The board of directors also has set a record date of August 27,
2009 for any special meeting of stockholders called by Mr. Brandt and for any
consent solicitation conducted by Mr. Brandt pursuant to definitive proxy
materials and/or consent solicitation materials filed by Mr. Brandt with the
Securities and Exchange Commission.
Related
Litigation
On June
26, 2009, the Company filed an action in the Delaware Court of Chancery against
Mr. Brandt seeking equitable relief to prevent Mr. Brandt from calling a special
meeting of stockholders. On June 30, attorneys for the Company and
Mr. Brandt appeared before the court for oral argument of the Company’s motion
and the Chancellor ruled in favor of Mr. Brandt, denying the Company’s motion to
restrain Mr. Brandt from calling that meeting.
On July
2, 2009, the Company filed an action in the United States District Court for the
Central District of California against Mr. Brandt and certain others. The
Company’s complaint alleges a variety of violations of federal securities laws,
including anti-fraud based claims under Rule 14a-9, solicitation of proxies in
violation of the filing and disclosure dissemination requirements of Regulation
14A, and material misstatements and omissions in and failures to promptly file
amendments to Schedule 13D. As part of the lawsuit, the Company is
seeking an injunction enjoining the use of proxies and written consents that Mr.
Brandt or the other defendants have obtained in violation of law, an injunction
or declaratory judgment declaring all of the proxies obtained by Mr. Brandt to
be invalid, an injunction against further unlawful proxy solicitation by the
defendants, an injunction enjoining any further violations of Section 13(d) and
14(a) under the Securities Exchange Act of 1934 and ordering that remedial
disclosures be filed, and damages in an amount to be determined. On
July 27, Mr. Brandt responded to the Company’s complaint by filing a motion to
dismiss, which is now pending.
On July
31, 2009, Mr. Brandt filed an action in the Delaware Court of Chancery against
the Company seeking access to the Company’s books and records under Section 220
of the Delaware General Corporation Law. In particular, Mr.
Brandt sought access to certain stockholder list materials which he needs in
order to comply with section 222 of the DGCL requiring notice of an adjourned
stockholder meeting currently scheduled for August 17, 2009, and in order to
solicit proxies for that meeting. In connection with the underlying
section 220 action, Mr. Brandt filed a motion to expedite proceedings and an
application for emergency injunctive relief, seeking a hearing on August 3 or
August 4 with respect to his request to immediately order the Company to provide
him access to the Company’s most recent stockholder list. On August
3, the Court of Chancery declined to expedite the proceedings and denied Mr.
Brandt’s application for emergency injunctive relief, and the section 220 action
will now proceed on a normal schedule.
18
CNS
RESPONSE, INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
As of
June 30, 2009 the Company has incurred legal fees in excess of $200,000 in
connection with the above matters.
Tax
Assessments
In March
2009, the Company was made aware of two tax assessments related to prior
periods. The first was a Delaware Franchise Tax assessment for
$74,400 pertaining to calendar years 2007 and 2008; this assessment has been
paid in full. The second was an IRS adjustment of $33,200 pertaining
to the Company’s 2006 payroll taxes; this assessment is still being investigated
and is fully accrued.
Lease Commitments
The Company leases its headquarters and
Laboratory Information Services space under an operating lease. In May
2009, the Company entered
into a new six-month lease for its headquarters at the same location expiring in
November 2009 and
requiring a monthly rent payment of $2,940.
The Company leases space for its
Clinical Services operations under an operating lease. The base rental as of
June 2009 through to the termination of the lease
on February 28, 2010 is
$6,021 per month.
The Company also sub-leases space for its Clinical
Services operations on a month-to-month basis for $1,075 per
month.
The Company leases a copier for $216 per
month which it accounts for as a capital lease with an interest rate of 9% per
year. The lease terminates in February 2013 at which time the copier
can be purchased at fair value.
Future Minimum Lease Payment and Debt
Maturities
At June
30, 2009, the estimated future minimum lease payment under non-cancelable
operating and capital leases and debt maturities were as follows:
Years ending June 30,
|
Operating
Leases
|
Bridge
Financings
|
Capital
Lease
|
Debt
Maturities
|
Total
|
|||||||||||||||
2010
|
$ | 62,900 | $ | 1,790,000 | $ | 2,600 | $ | 100,000 | $ | 1,955,500 | ||||||||||
2011
|
- | 2,600 | 50,000 | 52,600 | ||||||||||||||||
2012
|
- | 2,600 | - | 2,600 | ||||||||||||||||
2013
|
- | 1,700 | - | 1,700 | ||||||||||||||||
Total
|
$ | 62,900 | $ | 1,790,000 | $ | 9,500 | $ | 150,000 | $ | 2,012,400 | ||||||||||
Less
interest
|
(1,700 | ) | (80,000 | ) | (1,400 | ) | (9,100 | ) | (92,200 | ) | ||||||||||
Net present
value
|
61,200 | $ | 1,710,000 | 8,100 | 140,900 | 1,920,200 | ||||||||||||||
Less current
portion
|
(61,200 | ) | (1,710,000 | ) | (2,000 | ) | (92,000 | ) | (1,865,200 | ) | ||||||||||
Long-term debt and lease
obligation
|
$ | - | $ | - | $ | 6,100 | $ | 48,900 | $ | 55,000 |
19
Item
2. Management’s Discussion and Analysis of
Financial Condition and Results of Operations
The
information contained in this Form 10-Q is intended to update the information
contained in our Annual Report on Form 10-K for the year ended September 30,
2008 and presumes that readers have access to, and will have read, the
“Management's Discussion and Analysis of Financial Condition and Results of
Operations” and other information contained in such Form 10-K. The following
discussion and analysis also should be read together with our consolidated
financial statements and the notes to the consolidated financial statements
included elsewhere in this Form 10-Q.
This
discussion summarizes the significant factors affecting the condensed
consolidated operating results, financial condition and liquidity and cash flows
of CNS Response, Inc. for the three and nine months ended June 30, 2009 and
2008. Except for historical information, the matters discussed in this
management's discussion and analysis of financial condition and results of
operation are “forward-looking statements” that involve risks and uncertainties
and are based upon judgments concerning various factors that are beyond our
control. Actual results could differ materially from those projected in the
forward-looking statements as a result of, among other things, the factors
referred to under the caption “Risk Factors” contained in Item 1A of
each of our Annual Report on Form 10-K for the year ended September 30, 2008 and
this Quarterly Report on Form 10-Q.
Overview
We are a life sciences company with two
distinct business segments. Our Laboratory Information Services business, which we consider
our primary business, is focused on the commercialization of a patented system
that guides psychiatrists and other physicians to determine a proper treatment
for patients with behavioral (psychiatric and/or addictive) disorders. Our Clinical
Services business operated by Neuro-Therapy Clinic, P.C. (“NTC”) is a full service psychiatric
practice.
Laboratory Information
Services
In connection with our Laboratory
Information Services business, we have developed an extensive proprietary database (the
“CNS Database”) consisting of over 13,000 clinical
outcomes across over
2,000 patients who had
psychiatric or addictive problems. For each patient, we have compiled
electroencephalographic (“EEG”) scans, symptoms, course of
treatment and outcomes
often across multiple treatments from multiple psychiatrists and physicians.
Using the CNS
Database, our technology
compares a patient’s EEG scan to the outcomes in the
CNS Database and ranks treatment options
based on treatment success
of patients having similar neurophysiology. Trademarked as
Referenced-EEG® (“rEEG®”), this patented technology allows us to
create and provide simple reports (“rEEG Reports”) that specifically guide physicians to
treatment strategies based on the patient’s own physiology.
Our business is focused on increasing
the demand for our rEEG services. We believe the key factors that
will drive broader adoption of rEEG will be acceptance by healthcare providers
of its clinical benefits, demonstration of the cost-effectiveness of using our
technology, reimbursement by third-party payers,
expansion of our sales force and increased marketing
efforts.
Clinical Services
In January 2008, we acquired our largest
customer, the Neuro-Therapy Clinic, P.C. (“NTC”) located in Colorado. Upon the
completion of the transaction, NTC became a wholly-owned subsidiary of ours. NTC
operates one of the largest psychiatric medication management practices in the
state of Colorado, with nine full time and four part time employees
including psychiatrists and clinical nurse
specialists with prescribing privileges. Daniel A. Hoffman, M.D. is
the medical director at NTC, and, after the acquisition, became our Chief
Medical Officer.
NTC, having performed a significant
number of rEEG’s, serves an important resource in our
product development, the expansion of our CNS Database, production system
development and implementation, along with the integration of our rEEG services
into a medical practice. Through NTC, we also expect to
successfully develop marketing and patient
acquisition strategies for our Laboratory Information Services business.
Specifically, NTC is learning how to best communicate the advantages of rEEG to
patients and referring physicians in the local market. We will
share this knowledge and developed
communication programs learned through NTC with other physicians using our
services, which we believe will help drive market acceptance of our
services. In addition, we plan to use NTC to train practitioners
across the country in the uses of rEEG
technology.
20
We view our Clinical Services business
as secondary to our Laboratory Information Services business, and we have no
current plans to materially
expand this
business.
Recent Developments
On April
10, 2009, our board of directors elected George Carpenter, at the time the
President of the Company, to the position of Chief Executive Officer, and
elected Daniel Hoffman, MD, at the time the Chief Medical Officer of the
Company, to the additional position of President. Leonard
Brandt, the Company’s founder and original CEO, effective as of April 10, 2009
no longer serves as an officer of the Company, but remains on our
board.
On May
14, 2009, we entered into a Bridge Note and Warrant Purchase Agreement with
SAIL. David B. Jones, a member of our board of directors, is a
managing partner of SAIL.
Pursuant
to the Purchase Agreement, on May 14, 2009 SAIL purchased a Secured Promissory
Note in the principal amount of $200,000 from us. In order to induce
SAIL to purchase the note, we issued to SAIL a warrant to purchase up to 100,000
shares of our common stock at a purchase price equal to $0.25 per
share. The warrant expires on the earlier to occur of May 31, 2016 or
a change of control of the company. (for further details please see Note 2 to
the Financial Statements included elsewhere in this Current Report on Form
10-Q).
On June
12, 2009, we entered into a Bridge Note and Warrant Purchase Agreement with Mr.
John Pappajohn (“Pappajohn”).
Pursuant
to the Purchase Agreement, on June 12, 2009, Pappajohn purchased a Secured
Convertible Promissory Note in the principal amount of $1,000,000 from the
Company. In order to induce Pappajohn to purchase the note, the
Company issued to Pappajohn a warrant to purchase up to 3,333,333 shares of the
Company’s common stock at a purchase price equal to $0.30 per
share. The warrant expires on June 30, 2016 (for further details
please see Note 2 to the Financial Statements included elsewhere in this Current
Report on Form 10-Q).
Leonard
Brandt’s Attempt to Hold a Special Meeting of Stockholders
Leonard Brandt, who currently serves as
one of five company directors, served as our Chairman and CEO over the past
three years until his dismissal by our board of directors on April 10,
2009. Mr. Brandt is also a significant securityholder of the company,
claiming beneficial ownership of 9,838,777 shares of common stock, representing
approximately 32.5% of our issued and outstanding common stock. Mr.
Brandt also holds a promissory note in the amount of $250,000, which note is
secured by all of the company’s assets, making Mr. Brandt and another note
holder the co-holders of a first lien on all of our assets, with collateral
coverage equal to 250% of the principal amount of the debt owed, as further
described in Note 2 to the Financial Statements.
On June 19, 2009, Mr. Brandt, his
children and EAC Investment, Inc. (“EAC”) (Mr. Brandt, his children and EAC are
collectively referred to herein as the “25% Stockholder Group”) sent notice to
the company of their intention to call a special meeting of stockholders in lieu
of an annual meeting at which directors would be elected. (Under our
bylaws, holders of one-quarter of the outstanding stock may call a special
meeting; we contest whether this includes a special meeting in lieu of an annual
meeting). Subsequently, Mr. Brandt mailed to our stockholders a
notice of special meeting to be held on June 30, 2009, and then made an
additional mailing of a notice that changed the date of the special meeting to
July 3, 2009. Subsequently, Mr. Brandt send out another mailing to Company
Stockholders announcing his attempt to call another special meeting on August
17, 2009. We are not aware of any other written communications sent by Mr.
Brandt or on his behalf to our stockholders generally. Mr. Brandt
then attempted to call the meeting on July 3, July 12, July 21 and July 30, and
in each instance, because there was no quorum present for the conduct of
business, he purportedly adjourned the meeting to a later date. He
now plans to attempt to reconvene the meeting on August 17, 2009. The
company’s position is that those meetings have not been properly noticed, called
or adjourned and, therefore, any action taken at any meeting or reconvened
meeting relating to those notices, purported meetings or purported adjournments
would not be valid under the company’s certificate of incorporation, bylaws or
the DGCL.
21
The board of directors has scheduled an
annual meeting of stockholders for September 29, 2009 and has set a record date
of August 27, 2009. The board believes that this will provide
sufficient time for the preparation and filing of proxy materials with the
Securities and Exchange Commission and the solicitation of proxies from
stockholders. The board of directors also set a record date of August
27, 2009 for any special meeting of stockholders called by Mr. Brandt and for
any consent solicitation conducted by Mr. Brandt pursuant to definitive proxy
materials and/or consent solicitation materials filed by Mr. Brandt with the
Securities and Exchange Commission.
Related Litigation
On June
26, 2009, we filed an action in the Delaware Court of Chancery against Mr.
Brandt seeking equitable relief to prevent Mr. Brandt from calling a special
meeting of stockholders. On June 30, attorneys for the company and
Mr. Brandt appeared before the court for oral argument of the company’s motion
and the Chancellor ruled in favor of Mr. Brandt, denying our motion to restrain
Mr. Brandt from calling that meeting.
On July
2, 2009, we filed an action in the United States District Court for the Central
District of California against Mr. Brandt and certain others. Our complaint
alleges a variety of violations of federal securities laws, including anti-fraud
based claims under Rule 14a-9, solicitation of proxies in violation of the
filing and disclosure dissemination requirements of Regulation 14A, and material
misstatements and omissions in and failures to promptly file amendments to
Schedule 13D. As part of the lawsuit, we are seeking an
injunction enjoining the use of proxies and written consents that Mr. Brandt or
the other defendants have obtained in violation of law, an injunction or
declaratory judgment declaring all of the proxies obtained by Mr. Brandt to be
invalid, an injunction against further unlawful proxy solicitation by the
defendants, an injunction enjoining any further violations of Section 13(d) and
14(a) under the Securities Exchange Act of 1934 and ordering that remedial
disclosures be filed, and damages in an amount to be determined. On
July 17, Mr. Brandt responded to the Company’s complaint by filing a motion to
dismiss, which is now pending.
On July
31, 2009, Mr. Brandt filed an action in the Delaware Court of Chancery against
us seeking access to our books and records under Section 220 of the
DGCL. In particular, Mr. Brandt sought access to certain
stockholder list materials which he needs in order to comply with section 222 of
the DGCL requiring notice of an adjourned stockholder meeting currently
scheduled for August 17, 2009, and in order to solicit proxies for that
meeting. In connection with the underlying section 220 action, Mr.
Brandt filed a motion to expedite proceedings and an application for emergency
injunctive relief, seeking a hearing on August 3 or August 4 with respect to his
request to immediately order the company to provide Mr. Brandt access to its
most recent stockholder list. On August 3, the Court of Chancery
declined to expedite the proceedings and denied Mr. Brandt’s application for
emergency injunctive relief, and the section 220 action will now proceed on a
normal schedule.
As of
June 30, 2009 the Company has incurred legal fees in excess of $200,000 in
connection with the above matters.
Business operations
Since our inception, we have generated
significant net losses. As
of June 30, 2009, we had an accumulated deficit
of $21.2 million. We incurred operating losses
of $5.4 million for the fiscal year ended September 30, 2008. For the
nine months ended June 30, 2009 and 2008 we incurred losses of $4.5 million and $3.9 million respectively. We expect our net losses to
continue for at least the next several years. We anticipate that a
substantial portion of our
capital resources and efforts will be focused on research and development, scale
up of our commercial organization, and other general corporate
purposes. Research and development projects include the completion of
clinical trials which are essential to validate the
efficacy of our products and services relating to our rEEG technology across
different types of behavioral disorders, the
enhancement of the CNS Database and, to a lesser extent, the application of rEEG to pharmaceutical
development.
22
Financial Operations
Overview
Revenues
Our Laboratory Information Services
revenues are derived from the sale of rEEG Reports to physicians. Physicians are
generally billed upon delivery of a rEEG Report. The list prices of
our rEEG Reports to
physicians range from $200 to $800 with $400 being the most frequent
charge.
Patient service revenue is generated as
a result of providing services to patients on an outpatient basis. Patient
service revenue is recorded at our established billing rates less contractual adjustments.
Generally, collection in full is not expected on our established billing rates.
Contractual adjustments are recorded to state our patient service revenue at the
amount we expect to collect for the services provided based on amounts due from third-party payors at
contractually determined rates.
Cost of Revenues
Cost of revenues are for Laboratory
Information Services and represent the cost of direct labor and costs associated
with external processing, analysis and consulting review necessary to render an
individualized test result. Costs associated with performing our tests are
expensed as the tests are performed. We continually evaluate the
feasibility of hiring our own personnel to perform most of the processing and
analysis necessary to render a rEEG Report.
Cost of revenues for Clinical Services
are not broken out separately but are included in general and administrative
expenses.
Research and
Development
Research and development expenses are
associated with our Laboratory Information Services and primarily
represent costs incurred to design and conduct clinical studies, improve rEEG
processing, add data to the CNS Database, improve analytical techniques and
advance application of the methodology to additional clinical diagnosis. We charge all research and
development expenses to operations as they are incurred.
Sales and Marketing
For our Laboratory Information Services,
our selling and marketing expenses consist primarily of personnel costs and the
costs of educating physicians, laboratory personnel and other
healthcare professionals regarding our products and
services.
For our Clinical Services, selling and
marketing costs relate to advertising to attract patients to the
clinic.
General and
Administrative
Our general and administrative expenses consist primarily
of personnel, occupancy, legal, accounting and other professional and
administrative costs for both our Laboratory Information Services and Clinical
Services businesses.
23
Critical Accounting Policies and
Significant Judgments and
Estimates
This discussion and analysis of our
financial condition and results of operations is based on our financial
statements, which have been prepared in accordance with U.S. generally accepted
accounting principles. The preparation of these condensed consolidated financial statements
requires management to make estimates and judgments that affect the reported
amounts of assets, liabilities and expenses and the disclosure of contingent
assets and liabilities at the date of the financial statements, as well as revenues and
expenses during the reporting periods. We evaluate our estimates and judgments
on an ongoing basis. We base our estimates on historical experience and on
various other factors we believe are reasonable under the circumstances, the results of which form the
basis for making judgments about the carrying value of assets and liabilities
that are not readily apparent from other sources. Actual results could therefore
differ materially from those estimates under different assumptions or conditions.
We believe the following critical
accounting policies reflect our more significant estimates and assumptions used
in the preparation of our condensed consolidated financial
statements.
Revenue Recognition
We have generated limited
revenues since our
inception. Revenues for our Laboratory Service product are recognized when
a rEEG Report is delivered to a
Client-Physician. For our Clinical Services, revenues are recognized
when the services are performed.
Stock-based Compensation
Expense
Stock-based compensation expense, which
is a non-cash charge, results from stock option grants. Compensation
cost is measured at the grant date based on the calculated fair value of the
award. We recognize stock-based compensation expense on a
straight-line basis over
the vesting period of the underlying option. The amount of stock-based
compensation expense expected to be amortized in future periods may decrease if
unvested options are subsequently cancelled or may increase if future option
grants are made.
Results of Operations for the three months ended June 30, 2009 and 2008
As earlier described, we operate in two
business segments: Laboratory Information Services and Clinical
Services. Our Laboratory Information Services business focuses on the
delivery of reports
(“rEEG Reports”) that assist physicians with treatment
strategies for patients with behavioral (psychiatric and/or addictive) disorders
based on the patient's own physiology. Our Clinical Services business operated
through NTC provides full
service psychiatric services.
The following table presents
consolidated statement of operations data for each of the periods indicated as a
percentage of revenues.
Three Months
Ended
June 30, 2009
|
Three Months
Ended
June 30, 2008
|
|||||||
Revenues
|
100 | % | 100 | % | ||||
Cost of
revenues
|
19 | 15 | ||||||
Gross
profit
|
81 | 85 | ||||||
Research and
development
|
314 | 293 | ||||||
Sales and
marketing
|
101 | 150 | ||||||
General and administrative
expenses
|
526 | 333 | ||||||
Operating
loss
|
(860 | ) | (691 | ) | ||||
Other income (expense),
net
|
(138 | ) | 6 | |||||
Net income
(loss)
|
(998 | )% | (685 | )% |
24
Revenues
Three Months
Ended
June 30,
2009
|
Three Months
Ended
June 30,
2008
|
Percent
Change
|
||||||||||
Laboratory Service
Revenues
|
$ | 26,700 | $ | 36,500 | (27 | )% | ||||||
Clinical Service
Revenues
|
133,700 | 196,400 | (32 | )% | ||||||||
Total
Revenues
|
$ | 160,400 | $ | 232,900 | (31 | )% |
With respect to our Laboratory Information Services
business, the number of non-clinical study related rEEG Reports delivered for the period decreased from
103 in 2008 to 69 in 2009 while the average price per report increased from approximately $350 in 2008 to $387 (clinical study related rEEG reports are
provided free of charge). We do not expect to drive broader
adoption of reports based on our rEEG technology until the completion of our multi-site clinical study to
validate the efficacy of our products. Accordingly, we anticipate
that Laboratory Services
Revenues will not increase
substantially in the current fiscal year.
Our Clinical Services revenue is as a
result of patient billings
for psychiatric services rendered. Revenues declined by $62,700
in the third quarter of
2009 versus the same period in 2008 because
of a reduction in the
volume of patients treated
as a result of a reduction in the number of psychiatrists on staff. Currently, we do not plan
to materially expand our Clinical Services business, and therefore we do not
anticipate a significant increase in revenues generated by this business
segment.
Cost of Revenues
Three Months
Ended
June 30,
2009
|
Three Months
Ended
June 30,
2008
|
Percent
Change
|
||||||||||
Cost of Laboratory Information
Services revenues
|
$ | 30,700 | $ | 34,200 | (10 | )% |
Cost of Laboratory Information Services
revenues consists of payroll costs, consulting costs,
and other miscellaneous
charges. Consulting costs primarily represent external costs
associated with the processing and analysis of rEEG Reports and range between
$75 and $100 per rEEG Report. For the quarter ended June 30, 2009, cost of revenues consisted primarily of payroll costs (including stock-based compensation costs) of $24,600 and consulting fees of $5,900. For the quarter ended June 30, 2008, cost of revenues included payroll costs (including stock based compensation costs) of $22,400, and consulting fees of $11,600. Consulting fees decreased in
2009 due to the lower number of rEEG Reports
delivered and also due to our in-house capabilities which reduced the need for consulting services.
Since we do not expect to drive broader
adoption of reports based on our rEEG technology until the completion
of our multi-site clinical
study to validate the efficacy of our products, we anticipate that Cost of Laboratory Information Services
Revenues will not increase
substantially in the current fiscal year. However, we ultimately expect cost of revenues to increase as we deliver more rEEG
Reports, but decrease as a
percentage of revenues as operating efficiencies improve.
25
Research and
Development
Three Months
Ended
June 30,
2009
|
Three Months
Ended
June 30,
2008
|
Percent
Change
|
||||||||||
Laboratory Information Services
research and development
|
$ | 504,400 | $ | 682,400 | (26 | )% |
Research and development expenses
consist of clinical studies, projects for training doctors associated
with our research studies,
patent costs, consulting fees, payroll costs
(including stock-based compensation costs), expenses related to database
enhancements and maintenance, and other miscellaneous costs. Research
and development costs for
the quarter ended
June 30, 2009 primarily consisted of the following: patient costs of $204,400 associated with our studies to prove the efficacy of our
technology;
payroll and
benefit costs (including stock based
compensation) of $198,400; patent costs of $23,600; recruiting costs of $28,100; consultant costs of $33,100; database costs of $3,200; and conference and travel costs of $3,200. For the comparable period for 2008, research and development costs
included: patient costs
of $342,500, payroll costs of $201,900, patent costs of $26,800, recruiting costs of $25,300, consultant costs of $63,000, database costs of $6,100 and conference and travel
costs of $3,700.
Comparing the three month period ended
June 30, 2009 with the same period in 2008, patient costs decreased by $138,100 as the clinical study reached its recruitment goal during the quarter whereas in the comparable period in
2008, we incurred higher costs as we were initiating the study. Similarly, consulting costs
for the 2009 quarter declined by $29,900 as we neared completion of the
study.
Sales and marketing
Three Months
Ended
June 30,
2009
|
Three Months
Ended
June 30,
2008
|
Percent
Change
|
||||||||||
Sales and
Marketing
|
||||||||||||
Laboratory
Information Services
|
$ | 159,600 | $ | 330,500 | (52 | )% | ||||||
Clinical
Services
|
1,700 | 17,700 | (90 | )% | ||||||||
Total Sales and
Marketing
|
$ | 161,300 | $ | 348,200 | (54 | )% |
Sales and marketing expenses associated
with our Laboratory Information Services business consist primarily of
payroll and benefit
costs, including stock-based
compensation; advertising
and marketing; consulting fees and conference and travel expenses. These expenses for the quarter ended June 30, 2009 primarily consisted of the
following: payroll and benefit costs of $137,000, advertising and marketing costs of $8,400, consulting costs of $6,600 and conferences and travel expenses of $4,300. For the comparable period in 2008 sales and marketing costs consisted of the following: payroll and benefit costs of $137,700, advertising and marketing costs of $10,800, consulting costs of $106,900 and conferences and travel expenses of $58,100.
Comparing the three month period ended
June 30, 2009 with the same period in 2008, consulting fees decreased
by $100,300 due to costs associated with an economic impact study undertaken in
2008 that did not recur in 2009 and
conference and travel expenses decreased by $53,800 as a result of a reduced need to travel
and as a result of cost cutting efforts.
26
The Clinical Services sales and
marketing expenses consists
of advertising to
attract patients to the clinic. Sales and marketing costs in
2008 included the setup and design of the clinic’s website; these costs did not recur in
2009.
We anticipate a moderate increase in
marketing expenditure to
support our Clinical Services
business in the
future, which expenditures will be tailored
based on the knowledge we have acquired in attracting patients to our clinical
trials.
General and
administrative
Three Months
Ended June 30,
2009
|
Three Months
Ended June 30,
2008
|
Percent
Change
|
||||||||||
General and administrative
|
||||||||||||
Laboratory Information
Services
|
$ | 659,500 | $ | 528,800 | 25 | % | ||||||
Clinical Services
|
$ | 184,400 | 247,600 | (26 | )% | |||||||
Total General and
administrative
|
$ | 843,900 | $ | 776,400 | 9 | % |
General and administrative expenses for
our Laboratory Information
Services business are
largely comprised of payroll and benefit costs, including stock based compensation,
legal, other professional
and consulting fees, occupancy costs, insurance, conference and travel and miscellaneous costs. For the quarter ended June 30, 2009, General and Administrative costs consisted of salaries and benefit costs of
$171,400; legal fees of $258,600 and other professional and
consulting fees
of $122,000; occupancy costs of $13,400, insurance costs of $19,500 and conference and travel costs of $20,400. Miscellaneous costs were
$52,800 in the 2009
quarter. For the same period in 2008, General and Administrative
costs consisted of the following: salaries and
benefit costs of $300,700; legal fees of $59,100 and other professional and consulting fees
of $59,800; occupancy costs of $15,800, insurance costs of $17,300 and conference and travel
expenses of $10,000. Miscellaneous costs for the 2008 quarter were
$66,100.
With respect to our Laboratory
Information Services
business, in the quarter
ended June 30, 2009 in comparison to the same period in
2008, payroll and benefit expenses declined by $129,300 as a result of staff reductions. Consequently, professional and consulting fees
increased by a net $62,200 as greater reliance was placed on consulting resources in the 2009
quarter. Legal
fees in the 2009
quarter increased by
$199,500 largely in
response to the actions
discussed above taken by
Leonard Brandt, our former CEO and current director of the company and also as a result of the closing of two bridge financing transactions in the quarter. Conference and travel
expenses increased in the
2009 quarter by
$10,400 in association with our efforts to obtain bridge and additional
financing. Miscellaneous costs
in the 2009 quarter included a
write-off of
doubtful accounts of
$22,700 while the 2008
quarter included a write down of $42,900 related to offering costs of an unsuccessful effort to raise
capital.
General and administrative expenses for our Clinical Services business include all costs
associated with operating NTC. This includes payroll costs, medical
supply costs, occupancy costs and other general and
administrative costs. Costs fell in the quarter ended
June 30, 2009 as compared to the comparable
quarter in 2008 as select
NTC staff worked on our clinical study, and consequently their associated costs are included in
Laboratory Information Services expenses.
27
Interest income and financing expense
Three Months
Ended June 30,
2009
|
Three Months
Ended June 30,
2008
|
Percent
Change
|
||||||||||
Laboratory Information
Services (Expense),
net
|
$ | (216,300 | ) | $ | 13,000 |
*
|
||||||
Clinical
Services
|
- | - |
*
|
|||||||||
Total interest income
(expense)
|
$ | (216,300 | ) | $ | 13,000 |
*
|
||||||
* not
meaningful
|
With respect to our Laboratory
Information Services business, in the quarter ended June 30, 2009 we
incurred $19,200 of interest expense on outstanding promissory notes and incurred a warrant discount charge of
$107,500 associated
with the bridge financings completed in the
quarter. Additionally, a cost of $90,000 was incurred as a financing
premium in connection with
the promissory note issued to Pappajohn. In the quarter, we also earned interest income of $400 from interest bearing accounts. For the comparable period in 2008, interest income was $19,800 offset by interest expense of $6,800 due on promissory notes.
Net Loss
Three Months
Ended June 30,
2009
|
Three Months
Ended June 30,
2008
|
Percent
Change
|
||||||||||
Laboratory Information Services net loss
|
$ | (1,541,400 | ) | $ | (1,524,200 | ) | 1 | % | ||||
Clinical Services net
loss
|
(59,100 | ) | (71,700 | ) | (18 | )% | ||||||
Total Net
Loss
|
$ | (1,600,500 | ) | $ | (1,595,900 | ) | 0 | % |
Net loss remained at 2008 levels
for the three months ended
June 30, 2009. Although we experienced increases in legal fees within
general and administration costs and increases in interest and financing fees
for the Laboratory Information Services, these costs were offset by net
decreases in research and development and sales and marketing
costs. We expect
to incur net losses for the next few years as we continue to improve our rEEG
technology by expanding our
database, conducting additional clinical trials, and increasing marketing
expenditures to
commercialize our products.
28
Results of Operations for the
nine months ended June 30, 2009 and 2008
The following table presents
consolidated statement of operations data for each of the periods indicated as a
percentage of revenues.
Nine months
Ended
June 30, 2009
|
Nine months
Ended
June 30, 2008
|
|||||||
Revenues
|
100 | % | 100 | % | ||||
Cost of
revenues
|
19 | 26 | ||||||
Gross
profit
|
81 | 74 | ||||||
Research and
development
|
330 | 313 | ||||||
Sales and
marketing
|
134 | 117 | ||||||
General and administrative
expenses
|
425 | 433 | ||||||
Operating
loss
|
(808 | ) | (789 | ) | ||||
Other income (expense),
net
|
(43 | ) | 19 | |||||
Net income
(loss)
|
(851 | ) % | (770 | )% |
Revenues
Nine months
Ended
June 30,
2009
|
Nine months
Ended
June 30,
2008
|
Percent
Change
|
||||||||||
Laboratory Service
Revenues
|
$ | 86,300 | $ | 131,000 | (34 | )% | ||||||
Clinical Service
Revenues
|
441,900 | 377,000 | 17 | % | ||||||||
Total
Revenues
|
$ | 528,200 | $ | 508,000 | 4 | % |
With respect to our Laboratory
Information Services
business, the number of non-clinical study related rEEG Reports delivered
for the period decreased
from 396 in 2008 to 222 in
2009 while the average
price per report increased from approximately $350 in 2008 to $387 in 2009 (clinical study related rEEG reports are provided
free of charge). The reduction in the number of non-clinical study rEEG
Reports delivered during the period was
primarily due to the
acquisition of NTC on
January 11, 2008, which was
our largest customer in 2007. We do not expect to drive broader
adoption of reports based
on our rEEG technology until the completion of our multi-site clinical study to
validate the efficacy of our products. Accordingly, we anticipate
that Laboratory Services
Revenues will not increase
substantially in the current fiscal year.
Our Clinical Services revenue is as a result of
patient billings for psychiatric services rendered. For the nine months ended June 30 2008, these revenues are for the period beginning January 11, 2008 (the date of acquisition of NTC) through
June 30, 2008. Currently, we
do not plan to materially expand our Clinical Services business, and therefore
we do not anticipate a significant increase in revenues generated by this
business segment.
29
Cost
of Revenues
Nine months
Ended
June 30,
2009
|
Nine months
Ended
June 30,
2008
|
Percent
Change
|
||||||||||
Cost
of Laboratory Information Services revenues
|
$ | 99,800 | $ | 131,600 | (24 | )% |
Cost of
Laboratory Information Services revenues consists of payroll costs, consulting
costs, and other miscellaneous charges. Consulting costs primarily
represent external costs associated with the processing and analysis of rEEG
Reports and range between $75 and $100 per rEEG Report. For the nine
months ended June 30, 2009, cost of revenues consisted primarily of payroll
costs (including stock-based compensation costs) of $75,500 and consulting fees
of $22,300. For the nine months ended June 30, 2008, cost of
revenues consisted primarily of payroll costs (including stock based
compensation costs) of $86,300, and consulting fees of $39,300. Payroll
costs decreased in 2009 due to a bonus award that was made in 2008 which
did not recur in 2009. Consulting fees decreased in 2009 due to the
lower number of rEEG Reports delivered and also due to our in-house capabilities
which reduced the need for consulting services. Since we do not expect to
drive broader adoption of reports based on our rEEG technology until the
completion of our multi-site clinical study to validate the efficacy of our
products, we anticipate that Cost of Laboratory Information Services Revenues
will not increase substantially in the current fiscal year. However, we
ultimately expect cost of revenues to increase as we deliver more rEEG Reports,
but decrease as a percentage of revenues as operating efficiencies
improve.
Research
and Development
Nine months
Ended
June 30,
2009
|
Nine months
Ended
June 30,
2008
|
Percent
Change
|
||||||||||
Laboratory
Information Services research and development
|
$ | 1,741,200 | $ | 1,589,000 | 10 | % |
Research
and development expenses consist of clinical studies, projects for training
doctors associated with our research studies, patent costs, consulting fees,
payroll and benefit costs (including stock-based compensation costs),
expenses related to database enhancements and maintenance, and other
miscellaneous costs. Research and development costs for the nine
months ended June 30, 2009, primarily consisted of the following: patient costs
of $777,600 associated with our studies to prove the efficacy of our technology;
payroll and benefit costs of $594,600; patent costs of $112,700; recruiting
costs of $152,400; consultant costs of $46,700; database costs of $12,800; and
conference and travel costs of $9,000. For the comparable period in
2008, research and development costs included: patient costs of $417,100,
payroll costs of $656,900, patent costs of $93,500, recruiting costs of
$102,800, consultant costs of $211,200, database costs of $31,300 and conference
and travel costs of $41,700.
Comparing
the nine month period ended June 30, 2009 with the same period in 2008, patient
costs increased by $360,500 due to the full implementation of our
second, and larger, clinical trial in 2009. Patient recruiting costs
also increased by $49,600 in the 2009 period as efforts were increased to
attract additional patients into the clinical trial and patent costs increased
by $19,200 from the comparable period in 2008 due to increased legal fees
associated with patent prosecution. The aforementioned cost increases
were offset by a decline in payroll costs of $62,300 in the 2009 period, as
bonuses and stock-based compensation were reduced by $94,200 from their 2008
levels. Reliance on outside consultants also declined by $164,500 in the
2009 period as we completed the protocols for our clinical study and brought
resources in-house. In addition, the cost of database development
declined by $18,500 in the 2009 period as the company implemented cost cutting
measures. Similarly, travel and meeting expenses declined by $32,700
as there was a reduced need for travel and as we attempted to preserve working
capital.
30
Sales
and marketing
Nine months
Ended
June 30,
2009
|
Nine months
Ended
June 30,
2008
|
Percent
Change
|
||||||||||
Sales
and Marketing
|
||||||||||||
Laboratory
Information Services
|
$ | 702,500 | $ | 574,100 | 22 | % | ||||||
Clinical
Services
|
5,600 | 20,900 | (73 | )% | ||||||||
Total
Sales and Marketing
|
$ | 708,100 | $ | 595,000 | 19 | % |
Sales and
marketing expenses associated with our Laboratory Information Services business
consist primarily of payroll and benefit costs, including stock-based
compensation; advertising and marketing; consulting fees, computer services and
conference and travel expenses. Sales and marketing expenses for the
nine months ended June 30, 2009, primarily consisted of the following: payroll
and benefit costs of $457,900, advertising and marketing costs of $105,100,
consulting costs of $74,200, computer service costs of $29,900 and conferences
and travel costs of $25,500. For the comparable period in 2008 total sales and
marketing costs consisted of the following: payroll and benefit costs of
$228,900, advertising and marketing costs of $33,800, consulting costs of
$205,800, computer service costs of $7,700 and conferences and travel costs of
$73,100.
Comparing
the nine month period ended June 30, 2009 with the same period in
2008, payroll and benefit costs increased by $229,000 in the 2009
period as a result of the hiring additional marketing
personnel. The hires reduced our need for consulting services
relating to marketing, and consequently consulting fees for the period declined
by $131,600. Advertising and marketing expenses increased by $71,300 in the
period ended June 30, 2009 compared to the prior year period in an effort to
recruit more patients into the clinical trial and to promote general awareness
of the company in the marketplace. Computer service costs increased
$22,200 with the implementation of the Company’s CRM system and website
developments, while conference and travel expenses declined by $47,600 as there
was a reduced need to travel and as the company attempted to preserve working
capital.
Clinical
Services sales and marketing expenses consist of advertising in various media to
attract patients to the clinic. In 2008, these costs included the
setup and design of the clinic’s website; these costs did not recur in
2009. We anticipate a moderate increase in marketing expenditure to
expand our Clinical Services business in the future, which expenditures will be
tailored based on the knowledge we have acquired in attracting patients to our
clinical trials.
General
and administrative
Nine months
Ended
June 30,
2009
|
Nine months
Ended
June 30,
2008
|
Percent
Change
|
||||||||||
General
and administrative
|
||||||||||||
Laboratory
Information Services
|
$ | 1,745,600 | $ | 1,756,000 | (1 | )% | ||||||
Clinical
Services
|
$ | 501,800 | 444,800 | 13 | % | |||||||
Total
General and administrative
|
$ | 2,247,400 | $ | 2,200,800 | 2 | % |
31
General
and administrative expenses for our Laboratory Information Services business are
largely comprised of payroll and benefit costs, including stock based
compensation, legal costs, other professional and consulting fees, occupancy
costs, insurance costs, computer service costs, dues and fees, conference and
travel costs and other miscellaneous costs. For the nine months
ended June 30, 2009, general and administrative costs consisted of salaries
and benefit costs of $627,000; legal fees of $390,000 and other professional and
consulting fees of $368,300; occupancy costs of $40,000, insurance costs of
$59,300; computer service costs of $9,400; dues and fees of $41,700 and
conference and travel costs of $45,700. Miscellaneous costs were $181,700
for the 2009 period. For the same period in 2008, general and
administrative costs consisted of the following: salaries and benefit costs of
$1,128,600; legal fees of $117,400 and other professional and consulting fees of
$239,200; occupancy costs of $49,800, insurance costs of $58,800, computer
service costs of $7,200, dues and fees of $30,200 and conference and travel
expenses of $54,400. Miscellaneous costs for the 2008 period were
$69,700.
With
respect to our Laboratory Information Services business, in the nine months
ended June 30, 2009 in comparison to the same period in 2008, payroll and
benefit expenses declined by $501,600 as a result of staff attrition and as a
result of bonuses and option expenses incurred in the prior period
that did not recur in 2009. However, the decline in payroll and
benefit expenses was offset by a net increase in professional and consulting
fees of $129,100 in the period as greater reliance was placed on consulting
resources. Legal fees for the 2009 period increased by $272,600
compared to the same period in 2008 primarily as a result of the actions
discussed above taken by Leonard Brandt, our former CEO and a current director
of the company and also as a result of the closing of three bridge financing
transactions in the period. Miscellaneous expenses increased in the
2009 period by a net of $112,000 primarily as a result of a revised IRS
assessment on 2006 payroll taxes, Delaware Franchise Tax assessments for
calendar years 2007 and 2008 and a write down of doubtful debts in
2009.
General
and administrative expenses for our Clinical Services business include all costs
associated with operating NTC. This includes payroll costs, medical
supply costs, occupancy costs and other general and administrative
costs. Since NTC was acquired on January 11, 2008, the nine
month period ended June 30, 2008 only includes General and Administrative
expenses for NTC from the date of its acquisition, January 11, 2008 through June
30, 2008. In comparison, the nine month period ended June 30, 2009
includes general and administrative expenses for NTC for the entire nine month
period, as NTC was a wholly-owned subsidiary of the company throughout the
period.
Interest
income and financing expense
Nine months
Ended
June 30,
2009
|
Nine months
Ended
June 30,
2008
|
Percent
Change
|
||||||||||
Laboratory
Information Services (Expense), net
|
$ | (219,800 | ) | $ | 97,200 | * | ||||||
Clinical
Services (Expense)
|
(100 | ) | - | * | ||||||||
Total
interest income (expense)
|
$ | (219,900 | ) | $ | 97,200 | * |
* not meaningful
With
respect to our Laboratory Information Services business, in the nine month
period ended June 30, 2009 we incurred $30,900 of interest expense on
outstanding promissory notes and incurred a warrant discount charge of
$107,500 associated with our bridge financings completed in the
period. Additionally, a cost of $90,000 was incurred as a financing premium
in connection with the promissory note issued to Pappajohn. The
aforementioned interest expenses were offset by interest income of $8,600 from
interest bearing accounts earned during the period. For the
comparable period in 2008, interest income was $113,200 earned on the
remaining balance of the $7.8 million of cash raised in our private
placement completed in May 2007. This was offset by interest expense
of $16,000 due on promissory notes.
32
Net
Loss
Nine months
Ended
June 30,
2009
|
Nine months
Ended
June 30,
2008
|
Percent
Change
|
||||||||||
Laboratory
Information Services net loss
|
$ | (4,435,300 | ) | $ | (3,813,600 | ) | 16 | % | ||||
Clinical
Services net loss
|
(60,100 | ) | (99,000 | ) | (39 | )% | ||||||
Total
Net Loss
|
$ | (4,495,400 | ) | $ | (3,912,600 | ) | 15 | % |
The
increase in net loss of $582,800 in the nine months ended June 30,
2009 is due primarily to significant increases in our research and
development and sales and marketing operations as described above, as well as
interest costs associated with the promissory notes and the decline in interest
income. These expenses were partially offset by reductions in our
Cost of Revenues. We expect to incur net losses for the next few years as
we continue to improve our rEEG technology by expanding our database, conducting
additional clinical trials, and increasing marketing expenditures to
commercialize our products.
Liquidity
and Capital Resources
As of
June 30, 2009, we had approximately $0.75 million in cash and cash equivalents
and a working capital deficit balance of approximately $2.0
million compared to approximately $2.0 million in cash and cash equivalents
and a working capital balance of approximately $0.83 million at September 30,
2008. We expect that our existing cash will be used to fund working capital
and for other general corporate purposes.
Since our
inception, we have incurred significant losses and, as of June 30, 2009, we had
an accumulated deficit of approximately $21.2 million. We have not yet achieved
profitability and anticipate that we will continue to incur net losses for the
foreseeable future. We expect that our research and development and sales
and marketing expenses will continue to grow and, as a result, we will need to
generate significant product revenues to achieve profitability. There can be no
assurance of achieving profitability.
Operating
Capital and Capital Expenditure Requirements
Our
continued operating losses and limited capital raise substantial doubt about our
ability to continue as a going concern. We estimate that we will need
to raise $4 million to $5 million of additional funds in the next 12 months in
order to fund current and future clinical studies, market our rEEG technology
and to continue to conduct our business. Our liquidity and capital
requirements depend on several factors, including the rate of market acceptance
of our services, our ability to execute our current business plan, our rate of
investment in research and development and marketing and other
factors. Until we can generate a sufficient amount of revenues to
finance our cash requirements, which we may never do, we expect to finance
future cash needs primarily through public or private equity offerings, debt
financings, borrowings or strategic collaborations. We are currently exploring
additional sources of capital but there can be no assurances that any financing
arrangement will be available in amounts and terms acceptable to
us.
Sources
of Liquidity
To date,
substantially all of our operations have been financed with equity and debt
financings. Through June 30, 2009, we had received proceeds of $8.6
million from the sale of stock, $4,766,000 from the issuance of convertible
promissory notes and $220,000 from the issuance of common stock to employees in
connection with expenses paid by such employees on behalf of the
company.
33
Cash
Flows
Net cash
used in operating activities was $3.1 million for the nine months ended June 30,
2009 compared to $2.5 million for the nine months ended June 30,
2008. The increase in cash used of $569,700 was primarily
attributable to an increase in research and development and sales and marketing
expenses.
Investing
activities consisted of a $2,000 purchase of equipment during the nine
months ended June 30, 2009. In the comparable period in
2008, $51,800 of cash was used in connection with the purchase of NTC
and to purchase office furniture.
Net cash
of $1,879,100 was provided by financing activities during the nine
months ended June 30, 2009. During this period,
we closed three bridge financing in which we received an
aggregate of $1,700,000 in proceeds in exchange for secured convertible
promissory notes. During the period, we also received $14,400 in
connection with the exercise of warrants and $280,500 in connection with a
non-perfected exercise of options which option exercise was completed on
July 31, 2009. We also used $50,000 to pay off a convertible
promissory note and used $65,800 to pay down the promissory note issued in
connection with our acquisition of NTC and a capital lease.
Contractual
Obligations and Commercial Commitments
As of
June 30, 2009, our significant contractual obligations consisted of
$1,940,000 of Secured Convertible Promissory notes of which
$700,000, plus accrued interest, is payable on demand
and $1,090,000 is due on June 30, 2010. The
remaining balance of $150,000 relates to the promissory note issued in
connection with our acquisition of NTC. Additionally the company has
operating lease commitments totaling $62,900 for office
space.
As of
June 30, 2008, our only significant contractual obligations were the remaining
principal balance of $225,900 on the promissory issued in connection with our
acquisition of NTC and other obligations for operating leases on our office
space.
The
following summarizes our contractual obligations at June 30, 2009 and the
effects such obligations are expected to have on liquidity and cash flows in the
future periods:
Payment Due by Period
|
||||||||||||||||||||
Contractual Obligations
|
Total
|
Less Than
1 Year
|
1-3
Years
|
4-5
Years
|
After
5 Years
|
|||||||||||||||
Operating
Leases
|
$ | 62,900 | $ | 62,900 | - | - | - | |||||||||||||
Bridge
Financings
|
1,790,000 | 1,790,000 | - | - | - | |||||||||||||||
Capital
Lease
|
9,500 | 2,600 | 5,200 | 1,700 | - | |||||||||||||||
Debt
Maturities
|
150,000 | 100,000 | 50,000 | - | - | |||||||||||||||
Total
|
$ | 2,012,400 | 1,955,500 | 55,200 | 1,700 | - |
Income
Taxes
Since our
inception, we have incurred operating losses and, accordingly, have not recorded
a provision for federal income taxes for any periods presented. As of
September 30, 2008, we had net operating loss carryforwards for federal income
tax purposes of $12.4 million. If not utilized, the federal net operating loss
carryforwards will begin expiring in 2021. Utilization of net operating loss and
credit carryforwards may be subject to a substantial annual limitation due to
restrictions contained in the Internal Revenue Code that are applicable if we
experience an “ownership change”. The annual limitation may result in the
expiration of our net operating loss and tax credit carryforwards before they
can be used.
Off-Balance
Sheet Arrangements
We have
no off-balance sheet arrangements or financing activities with special purpose
entities.
34
Item 3. Quantitative
and Qualitative Disclosures about Market Risk.
Not applicable.
Item
4T. Controls and
Procedures.
Evaluation
of Disclosure Controls and Procedures
Members
of the company's management, including our Principal Executive and Financial
Officer, George Carpenter, have evaluated the effectiveness of our disclosure
controls and procedures, as defined by paragraph (e) of Exchange Act Rules
13a-15 or 15d-15, as of June 30, 2009, the end of the period covered by this
report. Based upon that evaluation, Mr. Carpenter has concluded that our
disclosure controls and procedures were effective.
In the
quarter ended December 31, 2008, the Company identified in its Current Report on
Form 10-Q, as filed with the Securities and Exchange Commission on February 17,
2009, that it had a material weakness in that it did not have proper oversight
and review by upper management of the accounting and finance function and two
significant deficiencies in that the Company (i) did not have proper segregation
of duties within the accounting and finance function and (ii) did not have a
comprehensive and formalized accounting and procedures manual. Since
the end of the quarter ended December 31, 2008, the Company has undertaken
remedial measures to address the aforementioned material weakness and
significant deficiencies and plans to continue to implement procedures to
address such weakness and deficiencies, so long as the perceived benefits of
such controls are deemed by management to outweigh their costs.
In order
to address the above material weakness, Mr. Carpenter has taken an active role
in the oversight and review of our accounting and finance functions by assuming
certain responsibilities typically performed by a Chief Financial Officer, while
we seek a long-term replacement for Brad Luce, our former Vice President Finance
and Control, who resigned effective December 19, 2008. In the coming
quarters, we intend to continue to improve our upper management’s oversight and
review of our accounting and finance functions by considering the addition of
controls, such as a formalized management checklist in connection with the
review of our financial statements and supporting documentation.
To
address the significant deficiencies identified at our quarter ended December
31, 2008, during the period ended June 30, 2009, we retained the services of
outside consultants to perform various accounting and finance functions for
us. As a result of the hiring of our consultants, we believe that we
have made significant improvements with regard to segregation of duties within
our accounting and finance functions. We will also develop a comprehensive and
formalized accounting and procedures manual that is tailored to the size of our
business. We plan to complete the design of the manual in the coming
quarter.
Changes
in Internal Control Over Financial Reporting
Other
than as stated above, there were no changes in our internal control over
financial reporting or in other factors identified in connection with the
evaluation required by paragraph (d) of exchange act rules 13a-15 or 15d-15 that
occurred during the three months ended June 30, 2009 that have materially
affected, or are reasonably likely to materially affect, our internal control
over financial reporting.
35
PART
II
OTHER
INFORMATION
Item
1. Legal
Proceedings.
Please
see the discussion under the heading “Leonard Brandt’s Attempt to Hold a
Special Meeting of Stockholders” on page 21, which discussion is
incorporated herein by reference.
Item
1A. Risk Factors
This
Quarterly Report on Form 10-Q contains forward-looking statements, which are
subject to a variety of risks and uncertainties. Other actual results could
differ materially from those anticipated in those forward-looking statements as
a result of various factors, including those set forth in our Annual Report on
Form 10-K for the year ended September 30, 2008. Other than as follows, there
have been no material changes to such risk factors during the nine months ended
June 30, 2009.
TO
CONTINUE AS A GOING CONCERN, WE WILL NEED ADDITIONAL FUNDING TO SUPPORT OUR
OPERATIONS AND CAPITAL EXPENDITURES, WHICH MAY NOT BE AVAILABLE TO
US.
As of
June 30, 2009, we had approximately $0.75 million in cash and cash equivalents
and a working capital deficit balance of approximately $2.0
million. We estimate that it will be necessary for us to
raise $4 million to $5 million in order to fund our current and future clinical
studies, market our rEEG technology and continue to conduct our
business. Our liquidity and capital requirements depend on several
factors, including the rate of market acceptance of our services, our ability to
execute our current business plan, our rate of investment in research and
development and marketing expenditures and other factors. Until we
can generate a sufficient amount of revenues to finance our cash requirements,
which we may never do, we expect to finance future cash needs primarily through
public or private equity offerings, debt financings, borrowings or strategic
collaborations. We are currently exploring additional sources of capital but
there can be no assurances that any financing arrangement will be available in
amounts and terms acceptable to us. If we are unable to secure
additional capital, there is substantial doubt about our ability to continue as
a going concern, and you may lose your entire investment in our
company.
THE
RECENT ATTEMPT BY LEONARD BRANDT, A MEMBER OF THE BOARD OF DIRECTORS AND FORMER
CEO TO REPLACE THE BOARD OF DIRECTORS WITH HIS OWN NOMINEES AND HIS EXPECTED
CONTINUING EFFORTS MAY RESULT IN A CHANGE IN COMPANY”S MANAGEMENT.
On April
10, 2009, the Board of Directors of the Company voted to remove Leonard Brandt
as the CEO of the Company, at which time he resigned as Chairman of the Board,
but retained his seat on the Board of Directors. On June 9, 2009 Mr.
Brandt exercised warrants to purchase 607,900 shares of common stock for $.01
per share and on June 19, 2009 Mr. Brandt exercised options to purchase an
additional 2,124,740 shares of common stock for $ .132 per share. The
Company provided notice to Mr. Brandt that he had not followed the proper
procedures for exercise on the June 19, 2009 exercise and therefore the shares
could not be issued until such time as the exercise was brought into
compliance. On July 31, 2009, the aforementioned 2,124,740
shares were issued.
On June
22, 2009, Mr. Brandt informed the Company of his intention to call a special
meeting of Company stockholders in lieu of an annual meeting, for the purpose of
unseating the other members of the Board and replacing them with his
nominees. Subsequently, Mr. Brandt made multiple mailings to
stockholders purporting to notice a meeting, scheduled multiple dates for the
meeting, attempted to call and adjourn meetings on June 30, July 3, July 12,
July 21 and July 30 and filed preliminary proxy materials with the SEC for
another meeting date or for action by written consent of stockholders to remove
the other Board members and replace them with his nominees.
36
The
Company believes that Mr. Brandt’s actions are inconsistent with its Bylaws,
Delaware law and federal securities law and is pursuing legal action against Mr.
Brandt. The Company has been made aware that to date Mr. Brandt has
contacted several significant shareholders and has been unsuccessful in securing
a quorum or a favorable proxy vote for the purported special meeting of
stockholders that he has called. However, the Company cannot assure
you that Mr. Brandt’s attempts to call a stockholder meeting will fail, either
as a result of lack of stockholder support or regulatory or court action, nor
can the Company assure you that if he is successful in replacing the current
Board that he will not take the actions he has stated he will take or additional
or other actions that may be inconsistent with the Company’s current business
strategy and focus. In addition, if Mr. Brandt is successful in identifying
other stockholders who are willing to take action by written consent without a
meeting of stockholders, he may be able to replace the current directors with
individuals whom the stockholders may not have an opportunity to
evaluate.
The
Company has scheduled its annual meeting of stockholders for September 29, 2009,
and at that meeting, directors will be elected. If Mr. Brandt is
unsuccessful in his other attempts to hold a stockholder meeting or remove the
current directors by written consent by that date, the Company expects that Mr.
Brandt will oppose the election of the Company’s director nominees and may
propose his own nominees. Although the Company’s stockholders will have an
opportunity to vote at the annual meeting, the Company cannot assure you that
Mr. Brandt will not be successful in blocking the election of the Company’s
nominees and/or electing an alternative slate of directors.
Item
2. Unregistered
Sales of Equity Securities and Use of Proceeds.
Issuance
of Secured Convertible Promissory Note and Warrant to Sail Venture Partners,
LP
On May
14, 2009, we entered into a Bridge Note and Warrant Purchase Agreement (the
“Purchase Agreement”) with SAIL Venture Partners, LP (“SAIL”). David
B. Jones, a member of our board of directors, is a managing partner of
SAIL.
Pursuant
to the Purchase Agreement, on May 14, 2009 SAIL purchased a Secured Promissory
Note in the principal amount of $200,000 from us. In order to induce
SAIL to purchase the note, we issued to SAIL a warrant to purchase up to 100,000
shares of our common stock at a purchase price equal to $0.25 per
share. The warrant expires on the earlier to occur of May 31, 2016 or
a change of control of the company.
The
Purchase Agreement also provides that, at any time on or after June 3, 2009, and
provided that certain conditions are satisfied by us, SAIL will purchase from us
a second Secured Convertible Promissory Note in the principal sum of $200,000
and will be issued a second warrant identical in terms to the warrant described
above. The aforementioned conditions include that we enter into a
term sheet in which investors commit to participate in an equity financing by us
of not less than $2,000,000 (excluding any and all other debt that are to be
converted).
The notes
issued or issuable pursuant to the Purchase Agreement accrue interest at the
rate of 8% per annum and are due and payable, unless sooner converted into
shares of our common stock (as described below), upon the earlier to occur of:
(i) a declaration by SAIL on or after June 30, 2009 or (ii) an Event of Default
(as defined in the notes). The note(s) are secured by a lien on
substantially all of the assets (including all intellectual property) of the
company. In the event of a liquidation, dissolution or winding up of
the company, unless SAIL informs us otherwise, we shall pay SAIL an amount equal
to the product of 250% multiplied by the principal and all accrued but unpaid
interest outstanding on the note(s).
In the
event we consummate an equity financing transaction of at least $1,500,000
(excluding any and all other debt that is converted), then the principal and all
accrued, but unpaid interest outstanding under the note(s) shall be
automatically converted into the securities issued in the equity financing by
dividing such amount by 85% of the per share price paid by the investors in such
financing.
In
addition, in the event we issue preferred stock that is not part of an equity
financing described above, SAIL may, at its option, convert the principal and
all accrued, but unpaid interest outstanding under the note(s) into preferred
stock by dividing such amount by 85% of the per share price paid by the
purchasers’ of our preferred stock.
37
In issuing the secured convertible
promissory note and warrant without registration under the Securities Act, as
amended (the “Securities Act”), we relied upon one or more of the exemptions
from registration contained in Sections 4(2) of the Securities Act, and in
Regulation D promulgated thereunder, as the note and the warrant were issued to
an accredited investor, without a view to distribution, and was not issued
through any general solicitation or advertisement. We made this determination
based on the representations of SAIL which included, in pertinent part, that
SAIL is an “accredited investor” within the meaning of Rule 501 of Regulation D
promulgated under the Securities Act, that the note and warrant issued pursuant
to the Purchase Agreement and the shares of stock to be issued upon conversion
or exercise of such note and warrant or upon conversion of the shares of stock
to be issued upon conversion or exercise of such note and warrant are being
acquired for its own account, for investment and not with a view to, or for
resale in connection with, any distribution or public offering thereof within
the meaning of the Securities Act and that SAIL understood that the note and
warrant and the securities issuable upon conversion or exercise thereof, as
applicable, may not be sold or otherwise disposed of without registration under
the Securities Act or an applicable exemption there from.
Issuance
of Secured Convertible Promissory Note and Warrant to John
Pappajohn
On June
12, 2009, we entered into a Bridge Note and Warrant Purchase Agreement (the
“Purchase Agreement”) with Mr. John Pappajohn (“Pappajohn”).
Pursuant
to the Purchase Agreement, on June 12, 2009, Pappajohn purchased a Secured
Convertible Promissory Note in the principal amount of $1,000,000 from
us. In order to induce Pappajohn to purchase the note, we issued to
Pappajohn a warrant to purchase up to 3,333,333 shares of our common stock at a
purchase price equal to $0.30 per share. The warrant expires on June
30, 2016.
The note
issued pursuant to the Purchase Agreement provides that the principal amount of
$1,000,000 together with a single payment of $90,000 (the “Premium Payment”) is
due and payable, unless sooner converted into shares of our common stock (as
described below), upon the earlier to occur of: (i) a declaration by Pappajohn
on or after June 30, 2010 or (ii) an Event of Default (as defined in the
note). The note is secured by a lien on substantially all of the
assets (including all intellectual property) of the company. In the
event of a liquidation, dissolution or winding up of the company, unless
Pappajohn informs us otherwise, we shall pay Pappajohn an amount equal to the
product of 250% multiplied by the then outstanding principal amount of the note
and the Premium Payment.
In the
event we consummate an equity financing transaction of at least $1,500,000
(excluding any and all other debt that is converted), the then outstanding
principal amount of the note (but excluding the Premium Payment, which will be
repaid in cash at the time of such equity financing) shall be automatically
converted into the securities issued in the equity financing by dividing such
amount by the per share price paid by the investors in such
financing.
In
issuing the warrant without registration under the Securities Act, we relied
upon one or more of the exemptions from registration contained in Sections 4(2)
of the Securities Act, and in Regulation D promulgated thereunder, as the
warrant was issued to an accredited investor, without a view to distribution,
and was not issued through any general solicitation or advertisement. We made
this determination based on the representations of Pappajohn which included, in
pertinent part, that Pappajohn is an “accredited investor” within the meaning of
Rule 501 of Regulation D promulgated under the Securities Act, that Pappajohn
was acquiring the warrant for investment purposes for its own account, and not
with a view to, or for resale in connection with, any distribution or public
offering thereof within the meaning of the Securities Act, and that Pappajohn
understood that the warrant and the securities issuable upon exercise thereof
may not be sold or otherwise disposed of without registration under the
Securities Act or an applicable exemption therefrom.
38
Item
3. Defaults Upon Senior Securities.
Event
of Default Under Notes Issued on March 30, 2009
On
March 30, 2009, we entered into two Senior Secured Convertible Promissory
Notes, each in the principal amount of $250,000 (each a “Note” and,
collectively, the “Notes”), with Brandt Ventures, GP (“Brandt Ventures”) and
SAIL. Leonard Brandt is the general partner of Brandt Ventures. The Notes accrue
interest at the rate of 8% per annum.
The Notes
are secured by a lien on substantially all of the assets (including all
intellectual property) of the company. The respective rights of each of Brandt
Ventures and SAIL in respect of the lien are to remain on parity with each other
without preference, priority or distinction during all times when both Notes are
outstanding.
The Notes
provide that any repayment made under either Note shall be made to each of
Brandt Ventures and SAIL in equal amounts. However, SAIL subsequently entered
into a loan agreement with us in which we agreed that, if SAIL demands us to do
so, we will repay Brandt Ventures without repaying SAIL.
On
June 30, 2009, each Note became due and payable if Brandt Ventures or SAIL,
respectively, declares its respective Note due and payable. Although nonpayment
on June 30, 2009 constituted an Event of Default as defined in the Notes,
an earlier Event of Default occurred under the Notes when Leonard Brandt’s
employment with us was terminated on April 10, 2009. As a result of the Events
of Default, the holders of the Notes can together declare both Notes due and
payable.
Event
of Default Under Note Issued on May 14, 2009
In connection with the note issued to
SAIL on May 14, 2009 (which is described above), on June 30, 2009, the note
became due and payable if SAIL declares its note due and payable. In addition,
an Event of Default as defined in the note occurred on July 31, 2009 when
Leonard Brandt filed a lawsuit against the company in the Delaware Court of
Chancery as further described on page 22. As a result of the aforementioned
events, SAIL can declare its note due and payable and can exercise any all
rights it has a secured creditor at any time, however the indebtedness evidenced
by the note is subordinate and junior in right of payment to the indebtedness of
the company evidenced by those certain notes, dated March 30, 2009, issued to
SAIL and Brandt Ventures (described above).
Item
6. Exhibits
The
following exhibits are filed as part of this report:
Exhibit
Number
|
Exhibit Title
|
|
3.1
|
Bylaws. Incorporated
by reference to Exhibit 3(ii) to the Registrant’s Form 10-SB (File No.
000-26285) filed with the Commission on June 7, 1999.
|
|
3.2
|
Amendment
No. 1 to Bylaws of CNS Reponse, Inc. Incorporated by reference
to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K (File No.
000-26285) filed with the Commission on July 2, 2009.
|
|
3.3
|
Amendment
No. 2 to Bylaws of CNS Reponse, Inc. Incorporated by reference
to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K (File No.
000-26285) filed with the Commission on July 23, 2009.
|
|
10.1
|
Purchase
Agreement, dated May 14, 2009, by and between the Company and SAIL Venture
Partners, LP. Incorporated by reference to the
Registrant’s Current Report on Form 8-K filed with the Securities and
Exchange Commission on May 20, 2009 (File Number
000-26285).
|
39
10.2
|
Form
of Convertible Promissory Note. Incorporated by
reference to the Registrant’s Current Report on Form 8-K filed with the
Securities and Exchange Commission on May 20, 2009 (File Number
000-26285).
|
|
10.3
|
Form of Warrant to Purchase
Shares. Incorporated by reference to the Registrant’s
Current Report on Form 8-K filed with the Securities and Exchange
Commission on May 20, 2009 (File Number 000-26285).
|
|
10.4
|
Bridge
Note and Warrant Purchase Agreement, dated June 12, 2009, by and between
the Company and Mr. John Pappajohn. Incorporated by
reference to the Registrant’s Current Report on Form 8-K filed with the
Securities and Exchange Commission on June 18, 2009 (File Number
000-26285).
|
|
10.5
|
Form
of Secured Convertible Promissory Note. Incorporated by reference
to the Registrant’s Current Report on Form 8-K filed with the Securities
and Exchange Commission on June 18, 2009 (File Number
000-26285).
|
|
10.6
|
Form
of Warrant to Purchase Shares Incorporated by reference to the
Registrant’s Current Report on Form 8-K filed with the Securities and
Exchange Commission on June 18, 2009 (File Number
000-26285).
|
|
31.1
|
Certification
of Principal Executive Officer pursuant to Securities Exchange Act Rules
13a-14(a) and 15d-14(a) as adopted pursuant to section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
31.2
|
Certification
of Principal Financial Officer pursuant to Securities Exchange Act Rules
13a-14(a) and 15d-14(a) as adopted pursuant to section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
32.1
|
Certification
of Principal Executive Officer and Principal Financial Officer pursuant to
18 U.S.C. Section 1350, as adopted pursuant to section 906 of the
Sarbanes-Oxley Act of 2002.
|
40
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, as amended, the Registrant caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
CNS
Response, Inc.
|
|||
Date:
August 10, 2009
|
/s/
George Carpenter
|
||
By:
|
George
Carpenter
|
||
Its:
|
Chief
Executive Officer
|
||
(Principal
Executive, Financial and
|
|||
Accounting
Officer)
|
|||
41