UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
x
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
FOR
THE
QUARTERLY PERIOD ENDED JUNE 30, 2008
¨
|
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: 000-52153
ARNO
THERAPEUTICS, INC.
(Exact
Name Of Registrant As Specified In Its Charter)
Delaware
|
52-2286452
|
(State
of Incorporation)
|
(I.R.S.
Employer Identification
No.)
|
30
Two Bridges Rd., Suite #270
Fairfield,
NJ 07004
(Address
of principal executive offices)(Zip Code)
(862)
703-7170
(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 Exchange Act 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 is a large accelerated file, 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
August 14, 2008, there were 20,392,024 shares of the registrant’s common stock,
par value $0.0001 per share, issued and outstanding.
Index
|
|
|
Page
|
|
|
|
|
PART I
|
FINANCIAL
INFORMATION
|
|
3
|
|
|
|
|
Item 1.
|
Condensed
Financial Statements
|
|
3
|
|
|
|
|
|
Condensed
Balance Sheets as of June 30, 2008 (unaudited) and December 31,
2007
|
|
3
|
|
|
|
|
|
Condensed
Statements of Operations for the three and six months ended June
30, 2008
(unaudited) and June 30, 2007 (unaudited) and for the cumulative
period
from August 1, 2005 (inception) through June 30, 2008
(unaudited)
|
|
4
|
|
|
|
|
|
Condensed
Statement of Stockholders’ Equity (Deficiency) for the period from August
1, 2005 (inception) through June 30, 2008 (unaudited)
|
|
5
|
|
|
|
|
|
Condensed
Statements of Cash Flows for the six months ended June 30, 2008
(unaudited) and June 30, 2007 (unaudited) and for the cumulative
period
from August 1, 2005 (inception) through June 30, 2008
(unaudited)
|
|
6
|
|
|
|
|
|
Notes
to Condensed Financial Statements (unaudited)
|
|
7
|
|
|
|
|
Item 2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
|
16
|
|
|
|
|
Item 3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
|
22
|
|
|
|
|
Item 4T.
|
Controls
and Procedures
|
|
22
|
|
|
|
|
PART II
|
OTHER
INFORMATION
|
|
23
|
|
|
|
|
Item 1.
|
Legal
Proceedings
|
|
23
|
|
|
|
|
Item 1A.
|
Risk
Factors
|
|
23
|
|
|
|
|
Item 2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
|
23
|
|
|
|
|
Item 3.
|
Defaults
Upon Senior Securities
|
|
23
|
|
|
|
|
Item 4.
|
Submission
of Matters to a Vote of Security Holders
|
|
23
|
|
|
|
|
Item 5.
|
Other
Information
|
|
23
|
|
|
|
|
Item 6.
|
Exhibits
|
|
25
|
|
|
|
|
|
Signatures
|
|
25
|
|
|
|
|
|
Exhibit
Index
|
|
|
Note
Regarding Forward-Looking Statements
This
Quarterly Report on Form 10-Q contains “forward-looking statements.” The
forward-looking statements are only predictions and provide our current
expectations or forecasts of future events and financial performance and may
be
identified by the use of forward-looking terminology, including the terms
“believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,”
“will” or “should” or, in each case, their negative, or other variations or
comparable terminology, though the absence of these words does not necessarily
mean that a statement is not forward-looking. Forward-looking statements include
all matters that are not historical facts and include, without limitation,
statements concerning our business strategy, outlook, objectives, future
milestones, plans, intentions, goals, future financial conditions, our research
and development programs and planning for and timing of any clinical trials,
the
possibility, timing and outcome of submitting regulatory filings for our product
candidates under development, research and development of particular drug
products, the development of financial, clinical, manufacturing and marketing
plans related to the potential approval and commercialization of our drug
products, and the period of time for which our existing resources will enable
us
to fund our operations. Forward-looking statements are subject to many risks
and
uncertainties that could cause our actual results to differ materially from
any
future results expressed or implied by the forward-looking statements. Examples
of the risks and uncertainties include, but are not limited to:
|
·
|
the
risk that we may not successfully develop and market our product
candidates, and even if we do, we may not become
profitable;
|
|
·
|
risks
relating to the progress of our research and
development;
|
|
·
|
risks
relating to significant, time-consuming and costly research and
development efforts, including pre-clinical studies, clinical trials
and
testing, and the risk that clinical trials of our product candidates
may
be delayed, halted or fail;
|
|
·
|
risks
relating to the rigorous regulatory approval process required for
any
products that we may develop independently, with our development
partners
or in connection with any collaboration
arrangements;
|
|
·
|
the
risk that changes in the national or international political and
regulatory environment may make it more difficult to gain U.S. Food
and
Drug Administration, or FDA, or other regulatory approval of our
drug
product candidates;
|
|
·
|
risks
that the FDA or other regulatory authorities may not accept any
applications we file;
|
|
·
|
risks
that the FDA or other regulatory authorities may withhold or delay
consideration of any applications that we file or limit such applications
to particular indications or apply other label
limitations;
|
|
·
|
risks
that, after acceptance and review of applications that we file, the
FDA or
other regulatory authorities will not approve the marketing and sale
of
our drug product candidates;
|
|
·
|
risks
relating to our drug manufacturing operations, including those of
our
third-party suppliers and contract
manufacturers;
|
|
·
|
risks
relating to the ability of our development partners and third-party
suppliers of materials, drug substance and related components to
provide
us with adequate supplies and expertise to support manufacture of
drug
product for initiation and completion of our clinical
studies;
|
|
·
|
risks
relating to the transfer of our manufacturing technology to third-party
contract manufacturers; and
|
|
·
|
the
risk that recurring losses, negative cash flows and the inability
to raise
additional capital could threaten our ability to continue as a going
concern.
|
Other
risks that may affect forward-looking statements contained in this report are
described in our Current Report on Form 8-K filed on June 9, 2008 under the
caption “Risk Factors.” These risks, including those described above, could
cause our actual results to differ materially from those described in the
forward-looking statements. We undertake no obligation to publicly release
any
revisions to the forward-looking statements or reflect events or circumstances
after the date of this document. The risks discussed in the June 9, 2008 Form
8-K and elsewhere in this report should be considered in evaluating our
prospects and future performance.
PART
I — FINANCIAL INFORMATION
Item 1.
Financial
Statements.
ARNO
THERAPEUTICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
CONDENSED
BALANCE SHEETS
|
|
June 30, 2008
(unaudited)
|
|
December 31, 2007
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
14,412,517
|
|
$
|
1,646,243
|
|
Prepaid
expenses
|
|
|
122,999
|
|
|
74,092
|
|
Total
current assets
|
|
|
14,535,516
|
|
|
1,720,335
|
|
Deferred
financing fees, net
|
|
|
—
|
|
|
13,541
|
|
Property
and equipment, net
|
|
|
47,086
|
|
|
38,193
|
|
Security
deposit
|
|
|
12,165
|
|
|
12,165
|
|
TOTAL
ASSETS
|
|
$
|
14,594,767
|
|
$
|
1,784,234
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY (DEFICIENCY)
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
856,948
|
|
$
|
111,474
|
|
Accrued
expenses
|
|
|
880,232
|
|
|
1,120,179
|
|
Due
to related party
|
|
|
203,426
|
|
|
583
|
|
Convertible
notes and accrued interest payable
|
|
|
—
|
|
|
4,179,588
|
|
TOTAL
LIABILITIES
|
|
|
1,940,606
|
|
|
5,411,824
|
|
|
|
|
|
|
|
|
|
COMMITMENTS
AND CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS’
EQUITY (DEFICIENCY)
|
|
|
|
|
|
|
|
Preferred
stock, $0.0001 par value: 20,000,000 shares authorized, 0 shares
issued
and outstanding at June 30, 2008 and December 31, 2007
|
|
|
—
|
|
|
—
|
|
Common
stock, $0.0001 par value: 80,000,000 shares authorized, 20,392,024
shares
issued and outstanding at June 30, 2008 and 9,968,797 shares issued
and
outstanding at December 31, 2007
|
|
|
2,039
|
|
|
997
|
|
Additional
paid-in capital
|
|
|
23,852,225
|
|
|
102,003
|
|
Deficit
accumulated during the development stage
|
|
|
(11,200,103
|
)
|
|
(3,730,590
|
)
|
TOTAL
STOCKHOLDERS’ EQUITY (DEFICIENCY)
|
|
|
12,654,161
|
|
|
(3,627,590
|
)
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIENCY)
|
|
$
|
14,594,767
|
|
$
|
1,784,234
|
|
See
accompanying notes to condensed financial statements.
ARNO
THERAPEUTICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
CONDENSED
STATEMENTS OF OPERATIONS
(Unaudited)
|
|
For the Three
Months Ended
June 30, 2008
|
|
For the Three
Months Ended
June 30, 2007
|
|
For the Six
Months Ended
June 30, 2008
|
|
For the Six
Months Ended
June 30, 2007
|
|
Cumulative
Period from
August 1,
2005
(inception)
Through
June 30, 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
$
|
2,101,862
|
|
$
|
401,402
|
|
$
|
5,289,044
|
|
$
|
612,199
|
|
$
|
8,554,141
|
|
General
and administrative
|
|
|
741,112
|
|
|
75,512
|
|
|
1,173,377
|
|
|
133,540
|
|
|
1,538,786
|
|
Total
Operating Expenses
|
|
|
2,842,974
|
|
|
476,914
|
|
|
6,462,421
|
|
|
745,739
|
|
|
10,092,927
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS
FROM OPERATIONS
|
|
|
(2,842,974
|
)
|
|
(476,914
|
)
|
|
(6,462,421
|
)
|
|
(745,739
|
)
|
|
(10,092,927
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER
INCOME (EXPENSE)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
18,173
|
|
|
36,146
|
|
|
28,961
|
|
|
47,697
|
|
|
152,923
|
|
Interest
expense
|
|
|
(946,129
|
)
|
|
(64,550
|
)
|
|
(1,036,053
|
)
|
|
(97,808
|
)
|
|
(1,260,099
|
)
|
Total
Other Income (Expense)
|
|
|
(927,956
|
)
|
|
(28,404
|
)
|
|
(1,007,092
|
)
|
|
(50,111
|
)
|
|
(1,107,176
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
LOSS
|
|
$
|
(3,770,930
|
)
|
$
|
(505,318
|
)
|
$
|
(7,469,513
|
)
|
$
|
(795,850
|
)
|
$
|
(11,200,103
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
LOSS PER SHARE – BASIC AND DILUTED
|
|
$
|
(0.29
|
)
|
$
|
(0.05
|
)
|
$
|
(0.65
|
)
|
$
|
(0.08
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED
AVERAGE SHARES OUTSTANDING – BASIC AND
DILUTED
|
|
|
13,175,944
|
|
|
9,968,797
|
|
|
11,572,370
|
|
|
9,968,797
|
|
|
|
|
See
accompanying notes to condensed financial statements.
ARNO
THERAPEUTICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
STATEMENT
OF STOCKHOLDERS’ EQUITY (DEFICIENCY)
PERIOD
FROM AUGUST 1, 2005 INCEPTION THROUGH JUNE 30, 2008
(Unaudited)
|
|
Common
Stock
|
|
Additional Paid-
|
|
Deficit
Accumulated
During the
Development
|
|
Total Stockholders'
|
|
|
|
Shares
|
|
Amount
|
|
In Capital
|
|
Stage
|
|
Equity (Deficiency)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance
of common stock to founders at $0.0001 per share
|
|
|
9,968,797
|
|
$
|
997
|
|
$
|
4,003
|
|
$
|
-
|
|
$
|
5,000
|
|
Issuance
of stock options for services
|
|
|
-
|
|
|
-
|
|
|
98,000
|
|
|
-
|
|
|
98,000
|
|
Net
loss, period from August 1, 2005 (inception) through December 31,
2007
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(3,730,590
|
)
|
|
(3,730,590
|
)
|
Balance
at December 31, 2007
|
|
|
9,968,797
|
|
$
|
997
|
|
$
|
102,003
|
|
$
|
(3,730,590
|
)
|
$
|
(3,627,590
|
)
|
Common
stock sold in private placement, net of issuance costs of
$141,646
|
|
|
7,360,689
|
|
|
736
|
|
|
17,689,301
|
|
|
-
|
|
|
17,690,037
|
|
Conversion
of notes payable upon closing of private placement
|
|
|
1,962,338
|
|
|
196
|
|
|
4,278,322
|
|
|
-
|
|
|
4,278,518
|
|
Discount
arising from note conversion
|
|
|
-
|
|
|
-
|
|
|
475,391
|
|
|
-
|
|
|
475,391
|
|
Warrants
issued in connection with note conversion
|
|
|
-
|
|
|
-
|
|
|
348,000
|
|
|
-
|
|
|
348,000
|
|
Reverse
merger transaction-
Elimination
of accumulated deficit
|
|
|
-
|
|
|
-
|
|
|
(120,648
|
)
|
|
-
|
|
|
(120,648
|
)
|
Previously
issued Laurier common stock
|
|
|
1,100,200
|
|
|
110
|
|
|
120,538
|
|
|
-
|
|
|
120,648
|
|
Warrants
issued for services
|
|
|
-
|
|
|
-
|
|
|
480,400
|
|
|
-
|
|
|
480,400
|
|
Employee
stock based compensation
|
|
|
-
|
|
|
-
|
|
|
400,818
|
|
|
-
|
|
|
400,818
|
|
Consultant
stock based compensation
|
|
|
-
|
|
|
-
|
|
|
78,100
|
|
|
-
|
|
|
78,100
|
|
Net
loss, six months ended June 30, 2008
|
|
|
|
|
|
|
|
|
|
|
|
(7,469,513
|
)
|
|
(7,469,513
|
)
|
Balance
at June 30, 2008
|
|
|
20,392,024
|
|
$
|
2,039
|
|
$
|
23,852,225
|
|
$
|
(11,200,103
|
)
|
$
|
12,654,161
|
|
See
accompanying notes to condensed financial statements.
ARNO
THERAPEUTICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
CONDENSED
STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
For the Six
Months Ended
June 30, 2008
|
|
For the Six
Months Ended
June 30, 2007
|
|
Cumulative Period
from August 1, 2005
(inception) Through
June 30, 2008
|
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM OPERATING ACTIVITES:
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(7,469,513
|
)
|
$
|
(795,850
|
)
|
$
|
(11,200,103
|
)
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
38,598
|
|
|
5,269
|
|
|
51,707
|
|
Stock
based compensation to employees
|
|
|
400,818
|
|
|
10,000
|
|
|
498,818
|
|
Stock
based compensation to consultants
|
|
|
78,100
|
|
|
-
|
|
|
78,100
|
|
Write-off
of intangible assets
|
|
|
-
|
|
|
-
|
|
|
85,125
|
|
Warrants
issued for services
|
|
|
480,400
|
|
|
-
|
|
|
480,400
|
|
Warrants
issued in connection with note conversion
|
|
|
348,000
|
|
|
-
|
|
|
348,000
|
|
Note
discount arising from beneficial conversion feature
|
|
|
475,391
|
|
|
-
|
|
|
475,391
|
|
Non-cash
interest expense
|
|
|
98,930
|
|
|
92,599
|
|
|
311,518
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
Prepaid
expenses
|
|
|
(48,907
|
)
|
|
10,965
|
|
|
(122,999
|
)
|
Security
deposit
|
|
|
-
|
|
|
-
|
|
|
(12,165
|
)
|
Accounts
payable
|
|
|
745,474
|
|
|
(12,438
|
)
|
|
856,948
|
|
Accrued
expenses
|
|
|
(239,947
|
)
|
|
327,554
|
|
|
880,232
|
|
Due
to related parties
|
|
|
202,843
|
|
|
53,871
|
|
|
203,426
|
|
Net
cash used in operating activities
|
|
|
(4,889,813
|
)
|
|
(308,030
|
)
|
|
(7,065,602
|
)
|
|
|
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM INVESTING ACTIVITES:
|
|
|
|
|
|
|
|
|
|
|
Purchase
of equipment
|
|
|
(13,950
|
)
|
|
(2,098
|
)
|
|
(53,793
|
)
|
Cash
paid for intangible assets
|
|
|
-
|
|
|
(35,479
|
)
|
|
(85,125
|
)
|
Proceeds
from related party advance
|
|
|
-
|
|
|
175,000
|
|
|
525,000
|
|
Repayment
of related party advance
|
|
|
-
|
|
|
(525,000
|
)
|
|
(525,000
|
)
|
Net
cash used in investing activities
|
|
|
(13,950
|
)
|
|
(387,577
|
)
|
|
(138,918
|
)
|
|
|
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITES:
|
|
|
|
|
|
|
|
|
|
|
Deferred
financing fees paid
|
|
|
(20,000
|
)
|
|
(25,000
|
)
|
|
(45,000
|
)
|
Proceeds
from issuance of common stock in private placement, net
|
|
|
17,690,037
|
|
|
-
|
|
|
17,690,037
|
|
Proceeds
from
issuance
of common stock to founders
|
|
|
-
|
|
|
-
|
|
|
5,000
|
|
Proceeds
from issuance of notes payable
|
|
|
1,000,000
|
|
|
-
|
|
|
1,000,000
|
|
Repayment
of notes payable
|
|
|
(1,000,000
|
)
|
|
-
|
|
|
(1,000,000
|
)
|
Proceeds
from issuance of convertible notes payable
|
|
|
-
|
|
|
3,867,000
|
|
|
3,967,000
|
|
Net
cash provided by financing activities
|
|
|
17,670,037
|
|
|
3,842,000
|
|
|
21,617,037
|
|
NET
INCREASE IN CASH AND CASH EQUIVALENTS
|
|
|
12,766,274
|
|
|
3,146,393
|
|
|
14,412,517
|
|
CASH
AND CASH EQUIVALENTS – BEGINNING OF PERIOD
|
|
|
1,646,243
|
|
|
18,201
|
|
|
-
|
|
CASH
AND CASH EQUIVALENTS – END OF PERIOD
|
|
$
|
14,412,517
|
|
$
|
3,164,594
|
|
$
|
14,412,517
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
Disclosure of Non-Cash and Financing Activities:
|
|
|
|
|
|
|
|
|
|
|
Conversion
of notes payable and interest to common stock
|
|
$
|
4,277,729
|
|
$
|
-
|
|
$
|
4,277,729
|
|
Common
shares of Laurier issued in reverse merger transaction
|
|
$
|
110
|
|
|
-
|
|
$
|
110
|
|
See
accompanying notes to condensed financial statements.
ARNO
THERAPEUTICS, INC.
(a
development stage company)
NOTES
TO CONDENSED FINANCIAL STATEMENTS
June
30, 2008
(unaudited)
1.
DESCRIPTION OF BUSINESS
Arno
Therapeutics, Inc. (“Arno” or “the Company”) commercially develops innovative
products for the treatment of cancer. Arno’s lead compound, AR-67, is currently
in Phase I clinical studies for the treatment of solid tumors. AR-67 is a novel,
third-generation camptothecin analogue that has exhibited high potency and
improved pharmacokinetic properties compared with first-and second-generation
camptothecin analogues. The Company is also developing two novel pre-clinical
compounds, AR-12 and AR-42, for the treatment of cancer. AR-12 is an orally
available inhibitor of phosphoinositide dependent protein kinase-1, or
PDK-1, that targets the Akt pathway while also possessing activity in the
endoplasmic reticulum stress and other pathways targeting apoptosis. AR-42
is an
orally available, broad spectrum inhibitor of deacetylase targets, referred
to
as pan-DAC inhibition, as well as an inhibitor of Akt.
The
Company was incorporated in Delaware in March 2000, at which time its name
was
Laurier International, Inc. (“Laurier”). Pursuant to an Agreement and Plan of
Merger dated March 6, 2008 (as amended, the “Merger Agreement”), by and among
the Company, Arno Therapeutics, Inc., a Delaware corporation (“Old Arno”)” and
Laurier Acquisition, Inc., a Delaware corporation and wholly-owned subsidiary
of
the Company (“Laurier Acquisition”), on June 3, 2008, Laurier Acquisition merged
with and into Old Arno, with Old Arno remaining as the surviving corporation
and
a wholly-owned subsidiary of Laurier. Immediately following this merger, Old
Arno merged with and into Laurier and Laurier’s name was changed to Arno
Therapeutics, Inc. These two merger transactions are hereinafter collectively
referred to as the “Merger.” Immediately following the Merger, the former
stockholders of Old Arno collectively held 95% of the outstanding common stock
of Laurier, assuming the issuance of all shares issuable upon the exercise
of
outstanding options and warrants, and all of the officers and directors of
Old
Arno in office immediately prior to the Merger were appointed as the officers
and directors of Laurier immediately following the Merger. Further, Laurier,
which was a non-operating shell company prior to the Merger, adopted the
business plan of Old Arno. The merger of a private operating company into a
non-operating public shell corporation with nominal net assets is considered
to
be a capital transaction in substance, rather than a business combination,
for
accounting purposes. Accordingly, the Company treated this transaction as a
capital transaction without recording goodwill or adjusting any of its other
assets or liabilities. All costs incurred in connection with the Merger have
been expensed. On June 2, 2008, Old Arno completed a private placement of its
common stock resulting in gross proceeds of approximately $17,832,000. See
Note
6.
2.
BASIS OF PRESENTATION
The
Company is a development stage company since it has not yet generated any
revenue from the sale of its products. Through June 30, 2008, the Company’s
efforts have been principally devoted to developing its licensed technologies,
recruiting personnel, establishing office facilities, and raising capital.
Accordingly, the accompanying condensed financial statements have been prepared
in accordance with the provisions of Statement of Financial Accounting Standards
(SFAS) No. 7,
“Accounting
and Reporting by Development Stage Enterprises
.”
The
accompanying condensed financial statements have been prepared in accordance
with generally accepted accounting principles for interim financial information
and with the instructions to Form 10-Q adopted under the Securities Exchange
Act
of 1934, as amended. Accordingly, they do not include all of the information
and
footnotes required by accounting principles generally accepted in the United
States of America for complete financial statements. In the opinion of Arno’s
management, the accompanying condensed financial statements contain all
adjustments (consisting of normal recurring accruals and adjustments) necessary
to present fairly the financial position, results of operations and cash flows
of the Company at the dates and for the periods indicated. The interim results
for the period ended June 30, 2008 are not necessarily indicative of results
for
the full 2008 fiscal year or any other future interim periods. Because the
Merger was accounted for as a reverse acquisition under generally accepted
accounting principles, the financial statements for periods prior to June 3,
2008 reflect only the operations of Old Arno.
These
financial statements have been prepared by management and should be read in
conjunction with the audited financial statements for Arno Therapeutics, Inc.
and notes thereto for the year ended December 31, 2007, included in the
Company’s audited financial statements in our current report on Form 8-K filed
with the Securities and Exchange Commission (“SEC”) on June 9, 2008.
Following
the
Merger, the holders of Old Arno common stock immediately prior to the Merger
held 95% of the outstanding common stock of Laurier, assuming the issuance
of
all shares underlying outstanding options and warrants.
In
accordance with the terms of the Merger, Old Arno’s outstanding common stock
automatically converted into shares of Laurier common stock at a conversion
ratio of 1.99377.
All
share
and per share information in the interim condensed financial statements has
been
restated to retroactively reflect the conversion ratio of 1.99377.
ARNO
THERAPEUTICS, INC.
(a
development stage company)
NOTES
TO CONDENSED FINANCIAL STATEMENTS
June
30, 2008
(unaudited)
3.
LIQUIDITY AND CAPITAL RESOURCES
For
the
three and six months ended June 30, 2008, the Company reported a net loss of
$3,770,930, and $7,469,513, respectively, and the net loss from the date of
inception, August 1, 2005 through June 30, 2008 was $11,200,103. The
Company’s total cash balance as of June 30, 2008 was $14,412,517 compared to
$1,646,243 at December 31, 2007.
Through
June 30, 2008, all of the Company’s financing has been through private
placements of common stock and debt financing. During June 2008, the Company
completed a private placement of its common stock, raising approximately
$17,832,000 in gross proceeds. The Company expects to incur substantial and
increasing losses and have negative net cash flows from operating activities
as
it expands its technology portfolio and engages in further research and
development activities, particularly the conducting of pre-clinical and clinical
trials.
The
Company plans to continue to fund operations from its existing cash balances
and
additional funds raised through various sources, such as equity and debt
financing. Based on its current resources at June 30, 2008, and the current
plan
of expenditure on continuing development of current products, the Company
believes that it has sufficient capital to fund its operations into the third
quarter of 2009, and will need additional financing in the future until it
can
achieve profitability, if ever. The success of the Company depends on its
ability to discover and develop new products to the point of the Food and Drug
Administration (“FDA”) approval and subsequent revenue generation and,
accordingly, to raise enough capital to finance these developmental efforts.
The
Company plans to raise additional equity capital to finance the continued
operating and capital requirements of the Company. Amounts raised will be used
to further develop the Company’s products, acquire additional product licenses
and for other working capital purposes. However, there can be no assurance
that
the Company will be able to raise additional capital at times or on terms that
it desires, if at all. If the Company is unable to raise or otherwise secure
additional capital, it will likely be forced to curtail its operations, which
would delay the development of its product candidates.
4.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
(a)
Use of Estimates
The
preparation of financial statements in conformity with generally accepted
accounting principles requires that management make estimates and assumptions
that affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements and
the reported amounts of revenues and expenses during the reporting periods.
Estimates and assumptions principally relate to services performed by third
parties but not yet invoiced, estimates of the fair value and forfeiture rates
of stock options issued to employees and consultants, and estimates of the
probability and potential magnitude of contingent liabilities. Actual results
could differ from those estimates.
(b)
Cash and Cash Equivalents
The
Company considers all highly liquid investments with a remaining maturity of
three months or less at the time of acquisition to be cash equivalents. The
Company deposits cash and cash equivalents with high credit quality financial
institutions and is insured to the maximum limitations. Balances in these
accounts may exceed federally insured limits at times.
(c)
Deferred Financing Fees
Deferred
financing fees are associated with obtaining long and short-term debt financing
which have been deferred and were amortized to interest expense over the
expected term of the related debt, and have been fully
amortized
upon the repayment of the Notes concurrent with the Company’s June 2008
private placement. See Note 6.
(d)
Prepaid Expenses
Prepaid
expenses consist of payments made in advance to vendors relating to service
contracts for clinical trial development and insurance policies. These advanced
payments are amortized to expense either as services are performed or over
the
relevant service period using the straight line method.
(e)
Property and Equipment
Property
and equipment consist primarily of furnishings, fixtures, leasehold improvements
and computer equipment and are recorded at cost. Repairs and maintenance costs
are expensed in the period incurred.
ARNO
THERAPEUTICS, INC.
(a
development stage company)
NOTES
TO CONDENSED FINANCIAL STATEMENTS
June
30, 2008
(unaudited)
Depreciation
of property and equipment is provided for by the straight-line method over
the
estimated useful lives of the related assets. Leasehold improvements are
amortized using the straight-line method over the remaining lease term or the
life of the asset, whichever is shorter.
Description
|
|
Estimated Useful Life
|
Office
equipment and furniture
|
|
5
to 7 years
|
Leasehold
improvements
|
|
3
years
|
Computer
equipment
|
|
3
years
|
(f)
Fair Value of Financial Instruments
Financial
instruments included in the Company’s balance sheets consist of cash and cash
equivalents and accounts payable. The carrying amounts of these instruments
reasonably approximate their fair values due to their short maturities.
(g)
Research and Development
Research
and development costs are charged to expense as incurred. Research and
development includes fees associated with operational consultants, contract
clinical research organizations, contract manufacturing organizations, clinical
site fees, contract laboratory research organizations, contract central testing
laboratories, licensing activities, and allocated executive, human resources
and
facilities expenses. The Company accrues for costs incurred as the services
are
being provided by monitoring the status of the trial and the invoices received
from its external service providers. As actual costs become known, the Company
adjusts its accruals in the period when actual costs become known. Costs related
to the acquisition of technology rights and patents for which development work
is still in process are charged to operations as incurred and considered a
component of research and development expense.
(h)
Stock-Based Compensation
The
Company accounts for share based payments in accordance with SFAS
No. 123(R), “
Share-Based
Payment
,”
(“SFAS
123R”), which requires the Company to record as an expense in its financial
statements the fair value of all stock-based compensation awards. The Company
uses the Black-Scholes option-pricing model to calculate the fair value of
options and warrants granted under SFAS 123R. The key assumptions for this
valuation method include the expected term of the option, stock price
volatility, risk-free interest rate, dividend yield, and exercise price. The
terms and vesting schedules for stock-based awards vary by type of grant.
Generally, the awards vest based on time-based or performance-based conditions.
Performance-based vesting conditions generally include the attainment of goals
related to the Company’s development performance.
The
Company accounts for stock-based compensation arrangements for non-employees
under Emerging Issues Task Force No. 96-18, “
Accounting
for Equity Instruments that are Issued to Other Than Employees for Acquiring,
or
in Conjunction with Selling, Goods or Services
”
(“EITF
96-18”) and SFAS No. 123, “
Accounting
for Stock-Based Compensation
”
(“SFAS
123”). As such, we measure transactions on the grant date at either the fair
value of the equity instruments issued or the consideration received, whichever
is more reliably measurable.
(i)
Loss per Common Share
The
Company calculates loss per share in accordance with SFAS No. 128,
“
Earnings
per Share
.”
Basic
loss per share is computed by dividing the loss available to common shareholders
by the weighted-average number of common shares outstanding. Diluted loss per
share is computed similarly to basic loss per share except that the denominator
is increased to include the number of additional common shares that would have
been outstanding if the potential common shares had been issued and if the
additional common shares were dilutive.
For
all
periods presented, potentially dilutive securities are excluded from the
computation of fully diluted net loss per share as their effect is
anti-dilutive.
ARNO
THERAPEUTICS, INC.
(a
development stage company)
NOTES
TO CONDENSED FINANCIAL STATEMENTS
June
30, 2008
(unaudited)
Potentially
dilutive securities include:
|
|
June 30, 2008
|
|
June 30, 2007
|
|
Warrants
to purchase common stock
|
|
|
495,252
|
|
|
—
|
|
Options
to purchase common stock
|
|
|
1,116,508
|
|
|
548,286
|
|
Total
potential dilutive securities
|
|
|
1,611,760
|
|
|
548,286
|
|
(j)
Comprehensive Loss
We
have
no components of other comprehensive loss other than our net loss, and
accordingly, comprehensive loss is equal to net loss for all periods presented.
(k)
Income Taxes
The
Company accounts for income taxes in accordance with SFAS No. 109,
“
Accounting
for Income Taxes
,”
which
requires the recognition of deferred tax assets and liabilities for the expected
future tax consequences of events that have been included in the financial
statements or tax returns. Under this method, deferred income taxes are
recognized for the tax consequences in future years of differences between
the
tax basis of assets and liabilities and their financial reporting amounts based
on enacted tax laws and statutory tax rates applicable to the period in which
the differences are expected to affect taxable income. The Company provides
a
valuation allowance when it appears more likely than not that some or all of
the
net deferred tax assets will not be realized. As of June 30, 2008, the Company’s
deferred tax assets are fully reserved for.
(l)
Recently Issued Accounting Standards
In
December
2007, the Financial Accounting Standards Board (“FASB”) issued SFAS No. 141
(revised 2007), “Business Combinations” (“SFAS 141R”), which replaces SFAS 141.
SFAS 141R establishes principles and requirements for how an acquirer recognizes
and measures in its financial statements the identifiable assets acquired,
the
liabilities assumed, any non-controlling interest in the acquiree and the
goodwill acquired. SFAS 141R also establishes disclosure requirements which
will
enable users to evaluate the nature and financial effects of the business
combination. SFAS 141R is effective for business combinations for which the
acquisition date is on or after the beginning of the first annual reporting
period beginning on or after December 15, 2008. The Company does not anticipate
that the adoption of this new standard will have a material impact on its
financial statements
In
December 2007, the FASB issued SFAS No. 160, “
Noncontrolling
Interests in Consolidated Financial Statements—an Amendment of Accounting
Research Bulletin No. 51
”
(“SFAS
160”), which establishes accounting and reporting standards for ownership
interests in subsidiaries held by parties other than the parent, the amount
of
consolidated net income attributable to the parent and to the noncontrolling
interest, changes in a parent’s ownership interest and the valuation of retained
noncontrolling equity investments when a subsidiary is deconsolidated. SFAS
160
also establishes reporting requirements that provide sufficient disclosures
that
clearly identify and distinguish between the interests of the parent and the
interests of the noncontrolling owners. SFAS 160 is effective for fiscal years,
and interim periods within those fiscal years, beginning on or after
December 15, 2008. The Company does not anticipate that the adoption of
this new standard will have a material impact on its financial statements.
5.
INTANGIBLE ASSETS AND INTELLECTUAL PROPERTY
License
Agreements
AR-67
License Agreement
The
Company’s rights to AR-67 are governed by an October 2006 license agreement with
the University of Pittsburgh (“Pitt”). Under this agreement, the Company holds
an exclusive, worldwide, royalty-bearing license for the rights to commercialize
technologies embodied by certain issued patents, patent applications and
know-how relating to AR-67 for all therapeutic uses. The Company has expanded,
and intends to continue to expand, its patent portfolio by filing additional
patents covering expanded uses for this technology.
Under
the
terms of the license agreement with Pitt, the Company made a one-time cash
payment of $350,000 to Pitt and reimbursed it for past patent expenses of
approximately $60,000.
ARNO
THERAPEUTICS, INC.
(a
development stage company)
NOTES
TO CONDENSED FINANCIAL STATEMENTS
June
30, 2008
(unaudited)
Additionally,
Pitt will receive performance-based cash payments upon successful completion
of
clinical and regulatory milestones relating to AR-67. The Company will make
the
first milestone payment to Pitt upon the acceptance of the first New Drug
Application (“NDA”), by the FDA for AR-67. The Company is also required to
pay to Pitt an annual maintenance fee on each anniversary of the license
agreement, and to pay Pitt a royalty equal to a percentage of net sales of
AR-67. To the extent the Company enters into a sublicensing agreement relating
to AR-67, the Company will pay Pitt a portion of all non-royalty income received
from such sublicensee.
Under
the
license agreement with Pitt, the Company also agreed to indemnify and hold
Pitt
and its affiliates harmless from any and all claims, actions, demands,
judgments, losses, costs, expenses, damages and liabilities (including
reasonable attorneys’ fees) arising out of or in connection with (i) the
production, manufacture, sale, use, lease, consumption or advertisement of
AR-67, (ii) the practice by the Company or any affiliate or sublicensee of
the
licensed patent; or (iii) any obligation of the Company under the license
agreement unless any such claim is determined to have arisen out of the gross
negligence, recklessness or willful misconduct of Pitt. The license agreement
will terminate upon the expiration of the last patent relating to AR-67. Pitt
may generally terminate the agreement at any time upon a material breach by
the
Company to the extent it fails to cure any such breach within 60 days after
receiving notice of such breach or in the event the Company files for
bankruptcy. The Company may terminate the agreement for any reason upon 90
days
prior written notice.
AR-12
and AR-42 License Agreements
The
Company’s rights to both AR-12 and AR-42 are governed by separate license
agreements with The Ohio State University Research Foundation, (“Ohio State”),
entered into in January 2008. Pursuant to each of these agreements, the Company
has exclusive, worldwide, royalty-bearing licenses to commercialize certain
patent applications, know-how and improvements relating to AR-42 and AR-12
for
all therapeutic uses.
Pursuant
to the Company’s license agreements for AR-12 and AR-42, the Company made
one-time cash payments to Ohio State in the aggregate amount of $450,000 and
reimbursed it for past patent expenses in the aggregate amount of approximately
$134,000. Additionally, the Company will be required to make performance-based
cash payments upon successful completion of clinical and regulatory milestones
relating to AR-12 and AR-42 in the United States, Europe and Japan. The first
milestone payment for each of the licensed compounds will be due when the first
patient is dosed in the first Company sponsored Phase I clinical trial of each
of AR-12 and AR-42. To the extent the Company enters into a sublicensing
agreement relating to either or both of AR-12 or AR-42, it will be required
to
pay Ohio State a portion of all non-royalty income received from such
sublicensee.
The
license agreements with Ohio State further provide that the Company will
indemnify Ohio State from any and all claims arising out of the death of or
injury to any person or persons or out of any damage to property, or resulting
from the production, manufacture, sale, use, lease, consumption or advertisement
of either AR-12 or AR-42, except to the extent that any such claim arises out
of
the gross negligence or willful misconduct of Ohio State. The license agreements
for AR-12 and AR-42, respectively, expire on the later of (i) the expiration
of
the last valid claim contained in any licensed patent and (ii) 20 years after
the effective date of the license. Ohio State will generally be able to
terminate either license upon our breach of the terms of the license the extent
the Company fails to cure any such breach within 90 days after receiving notice
of such breach or our bankruptcy. The Company may terminate either license
upon
90 days prior written notice.
6.
STOCKHOLDERS’ EQUITY
(a)
Common Stock
As
a
condition to the closing of the Merger, on June 2, 2008, the Company completed
a
private placement of 7,360,689 shares of its common stock (as adjusted to give
effect to the Merger), resulting in gross proceeds of approximately $17,832,000.
Issuance costs related to the private placement were approximately $142,000,
which were capitalized and charged to stockholders’ equity upon completion.
Prior to the completion of this private placement, the Company had outstanding
a
series of 6% Convertible Promissory Notes (“Notes”) in the aggregate principal
amount of approximately $4,000,000.
ARNO
THERAPEUTICS, INC.
(a
development stage company)
NOTES
TO CONDENSED FINANCIAL STATEMENTS
June
30, 2008
(unaudited)
In
accordance with the terms of these Notes, contemporaneously with the completion
of the June 2, 2008 private placement, the outstanding principal and accrued
interest under the Notes converted into an aggregate of 1,962,338 shares
of common stock at an exercise price of $2.42 per share (as adjusted to
give effect to the Merger).
Additionally,
1,100,200 shares of common stock that were held by the original stockholders
of
Laurier prior to the Merger are reflected in the Company’s common stock
outstanding in the accompanying condensed financial statements.
In
August
2005, the Company issued an aggregate of 9,968,787 shares of common stock to
its
founders for $5,000.
(b)
Warrants
In
conjunction with the conversion of the Notes described above, the Company
issued
warrants to purchase 196,189 shares of common stock, with an exercise price
of
$2.42 per share. The fair value of the warrants based upon the Black-Scholes
option-pricing model was determined to be approximately $348,000. The
assumptions used under the Black-Scholes option-pricing model included a
risk
free interest rate of 3.41%, volatility of 94.30%, and a five year
life.
In
connection with the in-licensing of the Company’s compounds AR-12 and AR-42
product candidates, the Company issued 299,063 fully vested warrants to
employees of Two River Group Holdings, LLC (see Note 8) and a consultant for
their consultation and due diligence efforts as part of a finder’s fee
arrangement. The warrants have an exercise price of $2.42 and are valued at
$480,400 based upon the Black-Scholes option-pricing model. The assumptions
used
under the Black-Scholes option pricing model included a risk free interest
rate
of 3.27%, volatility of 80.80% and a five year life.
7.
STOCK OPTION PLAN
The
Company’s 2005 Stock Option Plan (the “Plan”) was originally adopted by the
Board of Directors of Old Arno in August 2005, and was assumed by the Company
on
June 3, 2008 in connection with the Merger. After giving effect to the Merger,
there are 2,990,655 shares of the Company’s common stock reserved for issuance
under the Plan. Under the Plan, common stock incentives may be granted to
officers, employees, directors, consultants, and advisors. Incentives under
the
Plan may be granted in any one or a combination of the following forms:
(a) incentive stock options and non-statutory stock options; (b) stock
appreciation rights (c) stock awards; (d) restricted stock and
(e) performance shares.
The
Plan
is administered by the Board of Directors, or a committee appointed by the
Board, which determines recipients and types of awards to be granted, including
the number of shares subject to the awards, the exercise price and the vesting
schedule. The term of stock options granted under the Plan cannot exceed ten
years. Options shall not have an exercise price less than the fair market value
of the Company’s common stock on the grant date, and generally vest over a
period of three to four years.
The
Company records compensation expense associated with stock options and other
forms of equity compensation in accordance with SFAS 123R
,
as
interpreted by Staff Accounting Bulletin No. 107 (“SAB 107”). Under the fair
value recognition provisions of this statement, stock-based compensation cost
is
measured at the grant date based on the value of the award and is recognized
as
expense over the required service period, which is generally equal to the
vesting period. The Company estimated the fair value of each option award using
the Black-Scholes option-pricing model and the following assumptions:
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
Term
|
|
|
5
years
|
|
|
10
years
|
|
|
5-10
years
|
|
|
10
years
|
|
Volatility
|
|
|
89
|
%
|
|
65
|
%
|
|
83-89
|
%
|
|
65
|
%
|
Dividend
yield
|
|
|
0.0
|
%
|
|
0.0
|
%
|
|
0.0
|
%
|
|
0.0
|
%
|
Risk-free
interest rate
|
|
|
2.5
|
%
|
|
4.9
|
%
|
|
2.5-2.8
|
%
|
|
4.9
|
%
|
Forfeiture
rate
|
|
|
0.0
|
%
|
|
0.0
|
%
|
|
0.0
|
%
|
|
0.0
|
%
|
ARNO
THERAPEUTICS, INC.
(a
development stage company)
NOTES
TO CONDENSED FINANCIAL STATEMENTS
June
30, 2008
(unaudited)
As
allowed by SFAS 123R for companies with a short period of publicly traded stock
history, management’s estimate of expected volatility is based on the average
expected volatilities of a sampling of five companies with similar attributes
to
the Company, including: industry, stage of life cycle, size and financial
leverage. The Company calculates the estimated life of stock options using
the
“simplified” method as permitted by SAB 107.
The
Company has no historical basis for determining expected forfeitures and, as
such, compensation expense for stock-based awards does not include an estimate
for forfeitures.
Total
stock compensation costs for the cumulative period from August 1, 2005
(inception) through June 30, 2008 totaled $576,918 of which $370,318 was
included in general and administrative expense and $206,600 was included in
research and development expense. For the six months ended June 30, 2008 and
2007, the Company recorded stock-based compensation of $478,918 and $10,000,
respectively. For the three months ended June 30, 2008 and 2007, the Company
recorded stock-based compensation of $78,100 and $0, respectively.
At
June
30, 2008, the total outstanding, and the total exercisable, options under the
Plan were as follows:
|
|
Number
Outstanding
|
|
Weighted-
Average
Exercise
Price
|
|
Weighted-
Average
Remaining
Contractual
Term
|
|
Aggregate
Intrinsic
Value
|
|
Total
outstanding options
|
|
|
1,116,508
|
|
$
|
1.43
|
|
|
8.29 years
|
|
$
|
2,031,306
|
|
Total
exercisable options
|
|
|
548,286
|
|
$
|
1.28
|
|
|
7.25 years
|
|
$
|
1,058,089
|
|
During
the six months ended June 30, 2008, the Company granted to two members of its
Board of Directors options to purchase an aggregate of 299,065 shares of common
stock at an exercise price of $2.42. The right to purchase 50% of such shares
vest immediately and the right to purchase the remaining amount vest over the
subsequent two years at a rate of 25% per year. A fair value of $540,700 was
assigned to the options based on the Black-Scholes option-pricing
model.
During
the six months ended June 30, 2008, the Company granted to a scientific advisory
board member options to purchase 49,844 shares of common stock at an exercise
price of $2.42, which vested immediately. A fair value of $78,100 was assigned
to the options based on the Black-Scholes option-pricing model.
During
the six months ended June 30, 2008, the Company granted to an employee options
to purchase 79,750 shares of common stock at an exercise price of $2.42. The
right to purchase 25% of such shares vest on the employee’s first anniversary of
employment, with the remaining shares vesting monthly for the following three
years. A fair value of $138,100 was assigned to the options based on the
Black-Scholes option-pricing model.
During
the six months ended June 30, 2007, the Company granted to its President and
Chief Medical Officer options to purchase 199,377 shares of common stock at
an
exercise price of $1.00, of which 50% have vested on the first anniversary
and
the remaining 50% will vest on the second anniversary in accordance with the
executive’s employment agreement. An additional 199,377 shares vest upon the
achievement of performance milestones, of which 50% have vested as of May 31,
2008, and the remaining 50% will vest on the second anniversary in accordance
with the executive’s employment agreement. A fair value of $252,768 was assigned
to the options based on the Black-Scholes option-pricing model.
ARNO
THERAPEUTICS, INC.
(a
development stage company)
NOTES
TO CONDENSED FINANCIAL STATEMENTS
June
30, 2008
(unaudited)
Activity
with respect to options granted under the Plan is summarized as follows:
|
|
For
the Six Months Ended
June
30, 2008
|
|
For the Six
Months Ended
June
30, 2007
|
|
|
|
Shares
|
|
Weighted
Average
Exercise
Price
|
|
Shares
|
|
Weighted
Average
Exercise
Price
|
|
Balance
at January 1, 2008
|
|
|
687,849
|
|
$
|
1.32
|
|
|
149,532
|
|
$
|
0.13
|
|
Granted
under the Plan
|
|
|
428,659
|
|
|
2.42
|
|
|
398,754
|
|
|
1.00
|
|
Exercised
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Surrendered/cancelled
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Forfeited
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Outstanding
at June 30, 2008 and 2007, respectively
|
|
|
1,116,508
|
|
$
|
1.43
|
|
|
548,286
|
|
$
|
0.76
|
|
Exercisable
at June 30, 2008 and 2007, respectively
|
|
|
548,286
|
|
$
|
1.28
|
|
|
149,532
|
|
$
|
0.13
|
|
As
of
June 30, 2008, there was approximately $434,000 of unrecognized compensation
costs related to stock options. These costs are expected to be recognized over
a
weighted average period of approximately 2 years.
As
of
June 30, 2008, an aggregate of 1,874,147 shares remained available for future
grants and awards under the Plan, which covers stock options and restricted
awards. The Company issues unissued shares to satisfy stock options exercises
and restricted stock awards.
8.
RELATED PARTIES
On
occasion, some of the Company’s expenses have been paid by Two River Group
Holdings, LLC (“Two River”), a company controlled by several partners who are
also directors and officers of the Company. No interest is charged by Two
River on any outstanding balance owed by the Company. At June 30, 2008,
reimbursable expenses totaled $203,426, which was primarily related to finder’s
fees paid to Two River employees for consulting and due diligence efforts
of
$150,000 related to the in-licensing of AR-12 and AR-42. In addition to the
cash
consideration, the Company also granted fully vested warrants to purchase
299,063 shares of its common stock at an exercise price of $2.42. The warrants
have a five year life and are valued at $480,400 based upon the Black-Scholes
option-pricing model.
The
Company utilized the services of Riverbank Capital Securities, Inc.
(“Riverbank”), for investment advisory services in connection with the June 2008
private placement and the Notes. Riverbank is an entity controlled by several
partners of Two River who are also officers and directors of the Company.
The
Company paid a $100,000 non-accountable expense allowance to Riverbank for
these
services related to the June 2008 private placement and is not obligated
to
Riverbank for any future payments.
The
financial condition and results of operations of the Company, as reported,
are
not necessarily indicative of results that would have been reported had the
Company operated completely independently.
9.
COMMITMENTS AND CONTINGENCIES
On
August
10, 2007, the Company entered into an operating lease for office space located
in Fairfield, New Jersey. The Company is obligated under non-cancelable
operating leases for the office space and related office equipment expiring
at
various dates through 2010.
ARNO
THERAPEUTICS, INC.
(a
development stage company)
NOTES
TO CONDENSED FINANCIAL STATEMENTS
June
30, 2008
(unaudited)
The
aggregate remaining minimum future payments under these leases at June 30,
2008
are approximately as follows:
Year Ended December 31,
|
|
|
|
2008
|
|
$
|
26,000
|
|
2009
|
|
|
55,000
|
|
2010
|
|
|
52,000
|
|
Total
|
|
$
|
133,000
|
|
The
Company has entered into various contracts with third parties in connection
with
the development of the licensed technology described in Note 5.
The
aggregate minimum commitment under these contracts as of June 30, 2008 is
approximately $1,700,000.
On
June
1, 2007, the Company entered into an employment agreement with Scott Z. Fields,
M.D., as its President and Chief Medical Officer. The agreement provides for
a
term of two years expiring on May 31, 2009, and an initial base salary of
$340,000, plus an annual target performance bonus of up to $150,000. Pursuant
to
the employment agreement, Dr. Fields received a stock option to purchase 398,754
shares of the Company’s common stock at an exercise price of $1.00. The right to
purchase 199,377 shares vest pro rata on the first two anniversaries of his
employment, of which one-half or 99,689 have vested as of May 31, 2008, and
the
right to purchase the remaining 199,377 shares vest upon the achievement of
performance milestones, of which one-half or 99,689 have vested as of May 31,
2008. The stock option grant had an approximate fair value of $252,800 at the
date of grant based on the Black-Scholes option-pricing model. The employment
agreement also entitles Dr. Fields to certain severance benefits. In the event
the Company terminates Dr. Fields’ employment without cause, then Dr. Fields
would be entitled to receive his then annualized base salary for a period of
one
year, in addition to any accrued obligations, and a pro rata performance bonus
based upon achievement for the year of his termination.
Item 2.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations.
The
following discussion of our financial condition and results of operations should
be read in conjunction with the financial statements and accompanying notes
included elsewhere in this Form 10-Q. This discussion includes forward-looking
statements that involve risks and uncertainties. See “Note Regarding Forward
Looking Statements.
”
Overview
We
are a
development stage company focused on acquiring, developing and eventually
commercializing innovative products for the treatment of cancer. We seek to
acquire rights to novel, pre-clinical or early stage clinical oncology product
candidates, primarily from academic and research institutions. We currently
have
the rights to and are developing three oncology product candidates:
|
·
|
AR-67
-
Our lead product candidate is a novel, third-generation campothecin
analogue. We are currently conducting a multi-center, ascending dose
Phase
I clinical trial of AR-67 in patients with advanced solid tumors.
Once the
maximum tolerated dose in the Phase I study is identified, we anticipate
commencing a Phase II clinical trial of AR-67 in patients with
glioblastoma multiforme, or GBM, an aggressive form of brain cancer.
We plan to initiate additional Phase II clinical trials in a
variety of other solid and hematological cancers. We are also evaluating
an oral formulation of AR-67.
|
|
·
|
AR-12
-
We are also developing AR-12, an orally available pre-clinical
compound for the treatment of cancer. AR-12 is a novel inhibitor
of phosphoinositide dependent protein kinase-1, or PDK-1, that targets
the
Akt pathway while also possessing activity in the endoplasmic reticulum
stress and other pathways targeting apoptosis. Pre-clinical studies
suggest that AR-12 may provide therapeutic benefit either alone or
in
combination with other therapeutic agents. We are currently conducting
pre-clinical toxicology and manufacturing studies that we anticipate
will
provide the basis for the filing of an investigational new drug
application, or IND, in early 2009, which will permit us to commence
a
Phase I clinical study in the United
States.
|
|
·
|
AR-42
–
We are also developing AR-42, an orally available pre-clinical compound
for the treatment of cancer. AR-42 is a broad spectrum inhibitor
of
deacetylase targets, or pan-DAC, as well as an inhibitor of Akt.
In
pre-clinical models, AR-42 has demonstrated greater potency and a
competitive profile in tumors when compared with vorinostat (also
known as
SAHA and marketed as Zolinza
®
by
Merck), the leading marketed histone deacetylase inhibitor. We are
currently conducting IND-enabling studies and anticipate filing
an IND in early 2009, which will permit us to commence a Phase I
clinical study in the United
States.
|
We
have
no product sales to date and we will not generate any product revenue unless
and
until we receive approval from the Food and Drug Administration, or FDA, or
equivalent foreign regulatory bodies to begin selling our pharmaceutical
candidates. There can be no assurance that we will ever received such regulatory
approval. Developing pharmaceutical products is a lengthy and very
expensive process. Assuming we do not encounter any unforeseen safety issues
during the course of developing our product candidates, we do not expect to
complete the development of a product candidate for several years, if ever.
Currently, the majority of our development expenses have related to our lead
product candidate, AR-67, which is in Phase I clinical development. As we
proceed with the clinical development of AR-12 and AR-42, our research and
development expenses will further increase. Research and development expenses
consist primarily of salaries and related personnel costs, fees paid to
consultants and outside service providers for clinical development, legal
expenses resulting from intellectual property protection, business development
and organizational affairs and other expenses relating to the acquiring, design,
development, testing, and enhancement of our product candidates, including
milestone payments for licensed technology. We expense our research and
development costs as they are incurred. To the extent we are successful in
acquiring additional product candidates for our development pipeline, our need
to finance further research and development will continue increasing.
Accordingly, our success depends not only on the safety and efficacy of our
product candidates, but also on our ability to finance the development of the
products. Our major sources of working capital have been proceeds from private
sales of common stock and borrowings.
Results
of Operations
Comparison
of the Three Months Ended June 30, 2008 and the Three Months Ended June 30,
2007
The
following analysis of our financial condition and results of operations should
be read in conjunction with our unaudited condensed financial statements and
notes contained elsewhere in this Form 10-Q.
Research
and Development Expenses.
Research
and development, or R&D, expenses for the three months ended June 30, 2008
and 2007 were $2,101,862 and $401,402, respectively. These expenses include
cash
and non-cash expenses relating to the development of our clinical and
pre-clinical programs.
The
increase in R&D expenses for the three months ended June 30, 2008 compared
to the three months ended June 30, 2007 of $1,700,460 is primarily attributed
to
approximately $933,000 of manufacturing expenses for our three drug candidates.
Increased
R&D is also a result of higher clinical development expenses in the second
quarter of 2008 of approximately $313,000 as compared to $172,000 for the second
quarter of 2007 due to an increase in sponsored clinical trial expenses, which
include increased patient enrollment, and the opening of additional clinical
sites for AR-67. The remainder of the increase was due to higher legal,
regulatory and non-clinical expenditures associated with the development of
our
three drug candidates. R&D consists primarily of salaries and related
personnel costs, fees paid to consultants and outside service providers for
pre-clinical, clinical, manufacturing development, legal fees resulting from
intellectual property protection and organizational affairs, and other expenses
relating to the design, development, testing, and enhancement of our product
candidates. We expense our R&D costs as they are incurred.
General
and Administrative Expenses.
General
and administrative, or G&A, expenses consist primarily of salaries and
related expenses for executive, and other administrative personnel, recruitment
expenses, professional fees and other corporate expenses, including accounting
and general legal activities. G&A expenses for the three months ended
June 30, 2008 and 2007 were $741,112 and $75,512, respectively. G&A
expenses in the second quarter of 2008 increased by $665,600 due to an increase
of employees, increased stock compensation expense resulting in a non-cash
charge of approximately $160,000, a one-time charge of $500,000 for consulting
fees related to the Merger, increased professional fees, and increased rent
as a
result of securing approximately 2,000 square feet of office space in Fairfield,
New Jersey effective August 10, 2007.
Interest
Income
.
Interest income for the three months ended June 30, 2008 and 2007 was $18,173
and $36,146, respectively. The decrease of $17,973 was attributed to having
a
lower cash balance earning interest and available at the end of June 2008 as
compared to June 2007.
Interest
Expense
.
Interest expense for the three months ended June 30, 2008 and 2007 was
$946,129 and $64,550, respectively. The increase of $881,579 is primarily
attributable to the conversion of the notes we issued in February 2007, which
had an aggregate principal amount of $3,967,000 and accrued interest equal
to
approximately $312,000. The notes included a 10% discount valued at
approximately $475,000 and conversion warrants valued at approximately $348,000
based upon the Black-Scholes option-pricing model. The notes’ principal and
accrued interest automatically converted upon the closing of
our
June
2008 private placement
into
1,962,338 shares of our common stock at a conversion price of $2.42.
Due
to
the factors mentioned above, the net loss for the three months ended June 30,
2008 was $3,770,930, or a net loss of $0.29 per share of common stock, basic
and
diluted, as compared to a net loss of $505,318 for the three months ended June
30, 2007, or a net loss of $0.05 per common share, basic and diluted.
Comparison
of the Six Months Ended June 30, 2008 and the Six Months Ended June 30,
2007
The
following analysis of our financial condition and results of operations should
be read in conjunction with our unaudited condensed financial statements and
notes contained elsewhere in this Form 10-Q.
Research
and Development Expenses.
R&D
expenses for the six months ended June 30, 2008 and 2007 were $5,289,044 and
$612,199, respectively. These expenses include cash and non-cash expenses
relating to the development of our clinical and pre-clinical programs. The
increase in R&D expenses for the six months ended June 30, 2008 of
$4,676,845, is primarily attributed to manufacturing costs of approximately
$2,120,000 for the development of our three drug candidates. Increased R&D
expenditures during the six months ended June 30, 2008 of approximately
$1,490,000 are also attributed to initial licensing fees paid to acquire the
worldwide rights to AR-12 and AR-42 and related fees paid to finders for
consultation and due diligence during the first quarter of 2008, in addition
to
legal fees related to the prosecution and filings for our drug candidates.
The
increased R&D expense is also attributable to higher clinical development
expenses during the six months ended 2008 of approximately $516,000 as compared
to approximately $262,000 for the second quarter of 2007 due to an increase
in
sponsored clinical trial expenses, which include increased patient enrollment,
and the opening of additional clinical sites for our lead drug candidate, AR-67.
The remainder of the increase was due to higher legal, regulatory and
non-clinical expenditures associated with the development of our three drug
candidates. R&D consists primarily of salaries and related personnel costs,
fees paid to consultants and outside service providers for pre-clinical,
clinical, manufacturing development, legal fees resulting from intellectual
property protection and organizational affairs, and other expenses relating
to
the design, development, testing, and enhancement of our product candidates.
We
expense our R&D costs as they are incurred.
General
and Administrative Expenses.
G&A
expenses consist primarily of salaries and related expenses for executive,
and
other administrative personnel, recruitment expenses, professional fees and
other corporate expenses, including accounting and general legal activities.
G&A expenses for the six months ended June 30, 2008 and 2007 were
$1,173,377 and $133,540, respectively. G&A expenses for the six months ended
2008 increased by $1,039,837 primarily due to increased payroll and accrued
bonus expenses due to having more employees, increased stock compensation
expense, a non-cash charge of approximately $331,000, a one-time charge of
$500,000 for consulting fees related to the Merger, increased professional
fees,
and increased rent as a result of securing approximately 2,000 square feet
of
office space in Fairfield, New Jersey effective August 10, 2007.
Interest
Income
.
Interest income for the six months ended June 30, 2008 and 2007 was $28,961
and
$47,697, respectively. The decrease of $18,736 was attributed to having a lower
cash balance earning interest and available at the end of June 2008 as compared
to June 2007.
Interest
Expense
.
Interest expense for the three months ended June 30, 2008 and 2007 was
$946,129 and $64,550, respectively. The increase of $881,579 is primarily
attributable to the conversion of the notes we issued in February 2007, which
had an aggregate principal amount of $3,967,000 and accrued interest equal
to
approximately $312,000. The notes included a 10% discount valued at
approximately $475,000 and conversion warrants valued at approximately $348,000
based upon the Black-Scholes option-pricing model. The notes’ principal and
accrued interest automatically converted upon the closing of our June 2008
private placement into 1,962,338 shares of our common stock at a conversion
price of $2.42.
Due
to
the factors mentioned above, the net loss for the six months ended June 30,
2008
was $7,469,513, or a net loss of $0.65 per share of common stock, basic and
diluted, as compared to a net loss of $795,850 for the six months ended June
30,
2007, or a net loss of $0.08 per common share, basic and diluted.
Off
Balance Sheet Arrangements
There
were no off-balance sheet arrangements as of June 30, 2008.
License
Agreement Commitments
AR-67
License Agreement
Our
rights to AR-67 are governed by an October 2006 license agreement with the
University of Pittsburgh, or Pitt. Under this agreement, we hold an
exclusive, worldwide, royalty-bearing license for the rights to commercialize
technologies embodied by certain issued patents, patent applications and
know-how relating to AR-67 for all therapeutic uses. We have expanded, and
intend to continue to expand, our patent portfolio by filing additional patents
covering expanded uses for this technology.
Under
the
terms of our license agreement with Pitt, we made a one-time cash payment of
$350,000 to Pitt and reimbursed it for past patent expenses of approximately
$60,000. Additionally, Pitt will receive performance-based cash payments upon
successful completion of clinical and regulatory milestones relating to AR-67.
We will make the first milestone payment to Pitt upon the acceptance of the
first New Drug Application, or NDA, by the FDA for AR-67. We are also
required to pay to Pitt an annual maintenance fee on each anniversary of the
license agreement, and to pay Pitt a royalty equal to a percentage of net sales
of AR-67. To the extent we enter into a sublicensing agreement relating to
AR-67, we will pay Pitt a portion of all non-royalty income received from such
sublicensee.
Under
the
license agreement with Pitt, we also agreed to indemnify and hold Pitt and
its
affiliates harmless from any and all claims, actions, demands, judgments,
losses, costs, expenses, damages and liabilities (including reasonable
attorneys’ fees) arising out of or in connection with (i) the production,
manufacture, sale, use, lease, consumption or advertisement of AR-67, (ii)
the
practice by us or any affiliate or sublicensee of the licensed patent; or (iii)
any obligation of us under the license agreement unless any such claim is
determined to have arisen out of the gross negligence, recklessness or willful
misconduct of Pitt. The license agreement will terminate upon the expiration
of
the last patent relating to AR-67. Pitt may generally terminate the agreement
at
any time upon a material breach by us to the extent we fail to cure any such
breach within 60 days after receiving notice of such breach or in the event
we
file for bankruptcy. We may terminate the agreement for any reason upon 90
days
prior written notice.
AR-12
and AR-42 License Agreements
Our
rights to both of AR-12 and AR-42 are governed by separate license agreements
with The Ohio State University Research Foundation, or Ohio State, entered
into
in January 2008. Pursuant to each of these agreements, we have exclusive,
worldwide, royalty-bearing licenses to commercialize certain patent
applications, know-how and improvements relating to AR-42 and AR-12 for all
therapeutic uses.
Pursuant
to our license agreements for AR-12 and AR-42, we made one-time cash payments
to
Ohio State in the aggregate amount of $450,000 and reimbursed it for past patent
expenses of approximately $134,000. Additionally, we are required to make
performance-based cash payments upon successful completion of clinical and
regulatory milestones relating to AR-12 and AR-42 in the U.S., Europe and Japan.
The first milestone payment for each of the licensed compounds will be due
when
the first patient is dosed in the first Company sponsored Phase I clinical
trial
of each of AR-42 and AR-12. To the extent we enter into a sublicensing agreement
relating to either or both of AR-12 or AR-42, we will be required to pay Ohio
State a portion of all non-royalty income received from such
sublicensee.
The
license agreements with Ohio State further provide that we will indemnify Ohio
State from any and all claims arising out of the death of or injury to any
person or persons or out of any damage to property, or resulting from the
production, manufacture, sale, use, lease, consumption or advertisement of
either AR-12 or AR-42, except to the extent that any such claim arises out
of
the gross negligence or willful misconduct of Ohio State. The license agreements
for AR-12 and AR-42, respectively, expire on the later of (i) the expiration
of
the last valid claim contained in any licensed patent and (ii) 20 years after
the effective date of the license.
Ohio
State will generally be able to terminate either license upon our breach of
the
terms of the license the extent we fail to cure any such breach within 90 days
after receiving notice of such breach or our bankruptcy. We may terminate either
license upon 90 days prior written notice.
Warrant
Grants
During
the first quarter of 2008, as consideration for the performance of consulting
and due diligence efforts related to the licensing of AR-12 and AR-42, we
granted and expensed for fully vested warrants to purchase 299,063 shares of
our
common stock at an exercise price of $2.42. Of the total amount of the warrants
granted, 239,250 were granted to employees of Two River Group Holdings, LLC,
or
Two River, a related party. The remaining 59,813 warrants were granted to
outside consultants.
During
the second quarter of 2008, we had outstanding a series of 6% convertible
promissory notes in the aggregate principal and accrued interest of
approximately $4,279,000. In accordance with the terms of these notes,
contemporaneously with the completion of our June 2, 2008 private placement,
the
outstanding principal and accrued interest under the notes converted into an
aggregate of 1,962,338 shares of our common stock and five-year warrants to
purchase an additional 196,189 shares at an exercise price of $2.42 per share,
all as adjusted to give effect to the Merger.
Liquidity
and Capital Resources
For
the
three and six months ended June 30, 2008, we had a net loss of $3,770,930 and
$7,469,513, respectively. From August 1, 2005 (inception) through June 30,
2008,
we have incurred an aggregate net loss of $11,200,103, primarily through a
combination of research and development activities related to the licensed
technology under our control and expenses supporting those activities. As of
June 30, 2008, we had working capital of $12,594,910 and cash and cash
equivalents of $14,412,517.
We
expect
to incur additional losses in the future as we increase our research and
clinical development activities. We have not generated any revenue from
operations to date, and we do not expect to generate revenue for several years,
if ever. We have financed our operations since inception primarily through
debt
and equity financings.
Our
net
cash used in operating activities for the six months ended June 30, 2008
was
$4,889,813. Our net cash used in operating activities primarily resulted
from a
net loss of $7,469,513 offset by non-cash items consisting of the impact
of
expensing stock based compensation relating to option and warrant grants
made to
employees, directors, consultants and finders for a total of $959,318, in
addition to non-cash charges related to warrants issued in connection with
the
Note conversion and the Note discount arising from the beneficial conversion
feature and non-cash interest expenses, of $348,000 and $475,391 and $98,930,
respectively. Other uses of cash from operating activities include an increase
of accounts payable and accrued expenses of $505,527 attributed to clinical
development costs and bonus accruals in addition to an increase of $202,843
due
to Two River, a related party.
Our
net
cash used in investing activities for the six months ended June 30, 2008 was
$13,950, which resulted from capital expenditures attributable to the purchases
of computer and office equipment for the recently leased office space in
Fairfield, New Jersey.
Our
net
cash provided by financing activities for the six months ended June 30, 2008
was
$17,670,037, which was attributed to the June 2, 2008 private placement of
7,360,689 shares of our common stock.
Total
cash resources as of June 30, 2008 were $14,412,517 compared to $1,646,243
at
December 31, 2007. Because our business does not generate any cash flow, we
will need to raise additional capital after we exhaust our current cash
resources in order to continue to fund our research and development, including
our long-term plans for clinical trials and new product development, as well
as
to fund operations generally. Our continued operations will depend on whether
we
are able to raise additional funds through various potential sources, such
as
equity and debt financing. Through June 30, 2008, all of our financing has
been
through private placements of common stock and debt financing.
We
will
continue to fund operations from cash on hand and through the similar sources
of
capital previously described, or through other sources that may be dilutive
to
existing stockholders. We can give no assurances that we will be able to secure
such additional financing, or if available, it will be sufficient to meet our
needs.
Our
actual cash requirements may vary materially from those now planned, however,
because of a number of factors including the changes in the focus and direction
of our research and development programs, including the acquisition and pursuit
of development of new product candidates; competitive and technical advances;
costs of commercializing any of the product candidates; and costs of filing,
prosecuting, defending and enforcing any patent claims and any other
intellectual property rights.
As
part
of our planned expansion, we anticipate hiring several additional full-time
employees devoted to R&D activities and one or more additional full-time
employees for G&A. During 2008, we expect to spend approximately $11,500,000
on clinical R&D activities, and approximately $2,200,000 on G&A
expenses.
Based
on
our resources at June 30, 2008, and our current plan of expenditure on
continuing development of our current products, we believe that we have
sufficient capital to fund our operations through the third quarter of 2009,
and
will need additional financing until we can achieve profitability, if ever.
If
we are unable to raise additional funds when needed, we may not be able to
market our products as planned or continue development and regulatory approval
of our products, or we could be required to delay, scale back or eliminate
some
or all our research and development programs. Each of these alternatives would
likely have a material adverse effect on the prospects of our business.
On
June
2, 2008 we completed a private placement of 7,360,689 shares of our common
stock, resulting in gross proceeds of approximately $17,832,000. In connection
with our June 2008 private placement, we engaged Riverbank Capital Securities,
Inc. (“Riverbank”), for investment banking and other investment advisory
services, as a placement agent. Riverbank is an entity controlled by several
partners of Two River who are also officers and directors of the Company.
We
paid Riverbank $100,000 in consideration for their services as placement
agent.
Prior
to
the completion of the June 2008 private placement, we had outstanding a series
of 6% convertible promissory notes in the aggregate principal amount of
approximately $4,000,000. In accordance with the terms of the notes,
contemporaneously with the completion of the June 2, 2008 private placement,
the
outstanding principal and accrued interest converted into an aggregate of
1,962,338 shares of common stock and five year warrants to purchase an
additional 196,189 warrants of common stock at an exercise price of $2.42 per
share.
Research
and Development Projects; Related Expenses
AR-67
AR-67
is
a novel, third-generation camptothecin analogue that has demonstrated high
potency in pre-clinical studies and improved pharmacokinetic properties in
humans as compared with first and second-generation products. We believe that
this unique profile may translate into superior efficacy. Additionally, AR-67’s
potential for oral administration may add a marketing advantage by increasing
patient convenience. We believe these advantages could allow AR-67 to become
a
leading product in the camptothecin market. A Phase I clinical study of AR-67
in
patients with advanced solid tumors is currently ongoing. Multiple Phase II
studies are planned for initiation in 2008 in a number of tumor types including,
without limitation, glioblastoma multiforme, or GBM, a highly aggressive form
of
brain cancer.
AR-12
We
are
also developing AR-12, an orally available pre-clinical compound that is a
novel
inhibitor of phosphoinositide dependent protein kinase-1, or PDK-1, that targets
the Akt pathway while also possessing activity in the endoplasmic
reticulum stress and other pathways targeting apoptosis. Pre-clinical
studies suggest that AR-12 may provide therapeutic benefit either alone or in
combination with other therapeutic agents. We are currently conducting
toxicology and manufacturing studies that we anticipate will provide the basis
for the filing of an investigational new drug application, or IND, in early
2009, which will permit us to commence a Phase I clinical study in the United
States.
AR-42
We
are
also developing AR-42, an orally available pre-clinical compound for the
treatment of cancer. AR-42 is a broad spectrum inhibitor of deacetylase targets,
referred to as pan-DAC inhibition, as well as an inhibitor of Akt. In
pre-clinical models, AR-42 has demonstrated greater potency and a competitive
profile in tumors when compared with vorinostat (also known as SAHA and marketed
as Zolinza
®
by
Merck), the leading marketed histone deacetylase inhibitor. We are currently
conducting IND-enabling studies and anticipate filing an IND in early 2009,
which will permit us to commence a Phase I clinical study in the United
States.
Critical
Accounting Policies
Our
condensed financial statements are prepared in accordance with generally
accepted accounting principles. The preparation of these condensed financial
statements requires us to make estimates and assumptions that affect the
reported amounts of assets, liabilities, revenues, expenses and related
disclosures. We evaluate our estimates and assumptions on an ongoing basis.
Our
estimates are based on historical experience and various other assumptions
that
we believe to be reasonable under the circumstances. Our actual results could
differ from these estimates.
We
believe that the assumptions and estimates associated with stock-based
compensation have the greatest potential impact on our condensed financial
statements. Therefore, we consider these to be our critical accounting policies
and estimates. For further information on all of our significant accounting
policies, please see Note 4 of the accompanying notes to our condensed
financial statements.
Stock-based
compensation
Our
results include non-cash compensation expense as a result of the issuance of
stock, stock options and warrants. The Company issued stock options to
employees, directors and consultants under the 2005 Stock Option Plan beginning
in 2006.
We
account for employee stock-based compensation in accordance with Statement
of
Financial Accounting Standards (“SFAS”) 123(R),
“Share-Based
Payment”
(SFAS
123R). SFAS 123R requires us to expense the fair value of stock options over
the
vesting period on a straight-line basis. We determine the fair value of stock
options using the Black-Scholes option-pricing model. This valuation model
requires us to make assumptions and judgments about the variables used in the
calculation. These variables and assumptions include the weighted average period
of time that the options granted are expected to be outstanding, the volatility
of our common stock, the risk-free interest rate and the estimated rate of
forfeitures of unvested stock options. Additional information on the variables
and assumptions used in our stock-based compensation are described in
Note 7 of the accompanying notes to our condensed financial statements.
Stock
options or other equity instruments to non-employees (including consultants
and
all members of the Company’s Scientific Advisory Board) issued as consideration
for goods or services received by the Company are accounted for, in accordance
with the provisions of Statement of Financial Accounting Standards 123, and
Emerging Issues Task Force No. 96-18, based on the fair value of the equity
instruments issued (unless the fair value of the consideration received can
be
more reliably measured). The fair value of stock options is determined using
the
Black-Scholes option-pricing model and is periodically remeasured as the
underlying options vest. The fair value of any options issued to non-employees
is recorded as expense over the applicable service periods.
The
terms
and vesting schedules for share-based awards vary by type of grant and the
employment status of the grantee. Generally, the awards vest based upon
time-based or performance-based conditions. Performance-based conditions
generally include the attainment of goals related to our financial and
development performance. Stock-based compensation expense is included in the
respective categories of expense in the statements of operations. We expect
to
record additional non-cash compensation expense in the future, which may be
significant.
Recently
Issued Accounting Standards
In
December 2007, the Financial Accounting Standards Board, or FASB, issued SFAS
No. 141 (revised 2007), “
Business
Combinations
,”
or
SFAS 141R, which replaces SFAS 141. SFAS 141R establishes principles and
requirements for how an acquirer recognizes and measures in its financial
statements the identifiable assets acquired, the liabilities assumed, any
non-controlling interest in the acquiree and the goodwill acquired. SFAS 141R
also establishes disclosure requirements which will enable users to evaluate
the
nature and financial effects of the business combination. SFAS 141R is effective
for business combinations for which the acquisition date is on or after the
beginning of the first annual reporting period beginning on or after
December 15, 2008. We do not anticipate that the adoption of this new
standard will have a material impact on our financial statements.
In
December 2007, the FASB issued SFAS No. 160, “
Noncontrolling
Interests in Consolidated Financial Statements – an Amendment of Accounting
Research Bulletin No. 51
,”
or
SFAS 160, which establishes accounting and reporting standards for ownership
interests in subsidiaries held by parties other than the parent, the amount
of
consolidated net income attributable to the parent and to the noncontrolling
interest, changes in a parent’s ownership interest and the valuation of retained
noncontrolling equity investments when a subsidiary is deconsolidated. SFAS
160
also establishes reporting requirements that provide sufficient disclosures
that
clearly identify and distinguish between the interests of the parent and the
interests of the noncontrolling owners. SFAS 160 is effective for fiscal years,
and interim periods within those fiscal years, beginning on or after
December 15, 2008. We do not anticipate that the adoption of this new
standard will have a material impact on our financial statements.
Item 3.
Quantitative
and Qualitative Disclosures About Market Risk.
As
a
smaller reporting company, the Company is not required to provide the
information required by this Item 3 of Part I.
Item 4T.
Controls
and Procedures.
The
Company maintains disclosure controls and procedures that are designed to ensure
that information required to be disclosed in the Company’s reports under the
Exchange Act is recorded, processed, summarized and reported within the time
periods specified in the SEC rules and forms and that such information is
accumulated and communicated to the Company’s management, including its
President and Treasurer, as appropriate, to allow for timely decisions regarding
required disclosure. In designing and evaluating the disclosure controls and
procedures, management recognizes that any controls and procedures, no matter
how well designed and operated, can provide only reasonable assurance of
achieving the desired control objectives, and management is required to apply
its judgment in evaluating the cost-benefit relationship of possible controls
and procedures.
As
required by SEC Rule 13a-15(b), the Company carried out an evaluation, under
the
supervision and with the participation of the Company’s management, including
the Company’s President and the Company’s Treasurer, of the effectiveness of the
design and operation of the Company’s disclosure controls and procedures as of
the end of the quarter covered by this report. Based on the foregoing, the
Company’s President and Treasurer concluded that the Company’s disclosure
controls and procedures were effective at the reasonable assurance level.
There
has
been no change in the Company’s internal controls over financial reporting
during the Company’s most recent fiscal quarter that has materially affected, or
is reasonably likely to materially affect, the Company’s internal controls over
financial reporting.
The
Company is currently deemed a “smaller reporting company” as that term is
defined under the SEC’s rules. Hence, under current law, the internal controls
certification and attestation requirements of Section 404 of the
Sarbanes-Oxley act will not apply to the Company until the fiscal year ended
December 31, 2008. Notwithstanding the fact that these internal control
requirements do not apply to the Company at this time, management has begun
reviewing the Company’s internal control procedures to facilitate compliance
with those requirements when they become applicable.
PART
II — OTHER INFORMATION
Item 1.
Legal
Proceedings.
The
Company is not a party to any material pending legal proceedings.
Item 1A.
Risk
Factors.
As
a
smaller reporting company, the Company is not required to provide the
information required by this Item 1A of Part II.
Item 2.
Unregistered
Sales of Securities and Use of Proceeds.
Not
applicable.
Item 3.
Defaults
Upon Senior Securities.
Not
applicable.
Item 4.
Submission
of Matters to a Vote of Security Holders.
Not
applicable.
Item 5.
Other
Information.
On
June
11, 2008, we entered into an employment agreement with Mr. Brian Lenz. Under
the
agreement, as amended on July 9, 2008, Mr. Lenz will be appointed as Chief
Financial Officer of the Company immediately following the filing of this
Quarterly Report on Form 10-Q, and will continue thereafter until July 15,
2010,
unless terminated earlier in accordance with the terms of the agreement. The
agreement provides that Mr. Lenz is entitled to an annualized base salary of
$200,000, and is eligible for an annual performance bonus in an amount up to
30%
of his base salary. In addition, upon the commencement of his employment, Mr.
Lenz received a one-time cash bonus in the amount of $25,000 and a stock option
grant pursuant to our 2005 Stock Option Plan to purchase 440,000 shares of
our
common stock at an exercise price equal to $2.75 per share. The right to
purchase 25% of the shares subject to the stock option vests in July 2009 and
thereafter the remaining shares vest in equal monthly installments over a 24
month period, subject to his continued employment with the Company.
If,
during the term of the employment agreement, we terminate Mr. Lenz’s employment
without “cause” (as defined in the agreement), then Mr. Lenz is entitled to
receive his then current base salary for a period of 9 months following such
termination, plus one-half of the performance bonus that Mr. Lenz would have
earned in the year of such termination. In addition, upon such termination,
the
unvested portion of the stock option described above will immediately vest
and
remain exercisable for a period of 12 months following the
termination.
The
employment agreement also provides that if Mr. Lenz’s employment is terminated
during the term as a result of a “change of control” (as defined in the
agreement), then Mr. Lenz is entitled to receive his then current base salary
for a period of 12 months following such termination, plus an amount equal
to
the performance bonus that Mr. Lenz would have earned in the year of such
termination. In addition, upon such termination, the unvested portion of the
stock option described above will immediately vest and remain exercisable for
a
period of 12 months following the termination.
The
term
“cause” is defined under the employment agreement to mean any of the following
acts or omissions committed by Mr. Lenz:
|
·
|
willful
failure to adequately perform material duties or obligations under
the
agreement, including without limitation, willful failure, disregard
or
refusal to abide by specific objective and lawful directions received
by
him in writing constituting an action of our Board of Directors;
|
|
·
|
any
willful, intentional or grossly negligent act having the reasonably
foreseeable effect of actually and substantially injuring, whether
financial or otherwise, our business reputation ;
|
|
·
|
indictment
of any felony or conviction of a misdemeanor involving moral
turpitude
that causes
or
could reasonably be expected to cause, substantial
harm to us or our reputation;
|
|
·
|
engagement
in some form of harassment prohibited by law (including, without
limitation, age, sex or race discrimination);
|
|
·
|
misappropriation
or embezzlement of Company property; and
|
|
·
|
material
breach of the agreement.
|
Under
the
agreement, the term “Change of Control” has the meaning set forth in our 2005
Stock Option Plan (a copy of which was filed as Exhibit 10.3 to our Current
Report on Form 8-K filed with the Commission on June 9, 2008), except that,
notwithstanding the terms of such plan, a Change of Control does not include
(i)
any private placement of our equity securities the purpose of which is to
finance our on-going operations, or (ii) a transaction that ascribes a valuation
of the Company of less than $100 million.
A
copy of
the employment agreement is filed with this Form 10-Q as Exhibit 10.1 and
incorporated herein by reference.
Prior
to
joining Arno, Mr. Lenz, age 36, was Chief Financial Officer and Treasurer of
VioQuest Pharmaceuticals, Inc. from April 2004, and prior to that served as
the
company’s controller from October 2003. At VioQuest, a publicly-held
biotechnology company based in Basking Ridge, NJ, Mr. Lenz was responsible
for
the financial and operational reporting, as well as capital raising and merger
and acquisition and other strategic transactions. Prior to VioQuest, Mr. Lenz
was a controller with Smiths Detection Group from 2000 to 2003. Before joining
Smiths, Mr. Lenz was a senior auditor with KPMG, LLP from 1998 to 2000. Mr.
Lenz
holds a BS in Accounting from Rider University and received his MBA from Saint
Joseph’s University,
and
is a
certified public accountant licensed in the State of New Jersey.
Item 6.
Exhibits
Exhibit Number
|
|
Description of Document
|
2.1
|
|
Amendment
No. 1 dated May 12, 2008 to Agreement and Plan of Merger by and among
Laurier International, Inc., Laurier Acquisition, Inc. and Arno
Therapeutics, Inc. (incorporated by reference to Exhibit 2.2 of the
Company’s Registration Statement on Form S-1 filed on July 31, 2008 (SEC
File 333-152660)).
|
2.2
|
|
Amendment
No. 2 dated May 30, 2008 to Agreement and Plan of Merger by and among
Laurier International, Inc., Laurier Acquisition, Inc. and Arno
Therapeutics, Inc. (incorporated by reference to Exhibit 2.2 of the
Company’s Registration Statement on Form S-1 filed on July 31, 2008 (SEC
File 333-152660)).
|
4.1
|
|
Form
of Common Stock Purchase Warrant issued to former note holders of
Arno
Therapeutics, Inc. (incorporated by reference to Exhibit 4.2 of the
Registrant’s Form 8-K filed June 9, 2008).
|
10.1
|
|
Employment
Agreement dated June 9, 2008 between Arno Therapeutics, Inc. and
Brian
Lenz, as amended on July 9, 2008.
|
10.2
|
|
Form
of Subscription Agreement between Arno Therapeutics, Inc. and the
investors in the June 2, 2008 private placement (incorporated by
reference
to Exhibit 10.8 of the Registrant’s Form 8-K filed June 9,
2008).
|
31.1
|
|
Certification
of Principal Executive Officer pursuant to Securities Exchange Act
Rule
13a-15(e)/15d-15(e) 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
Rule
13a-15(e)/15d-15(e) as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
32.1
|
|
Certification
of Principal Executive Officer pursuant to 18 U.S.C. Section 1350,
as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
32.2
|
|
Certification
of Principal Financial Officer pursuant to 18 U.S.C. Section 1350,
as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
caused this report to be signed on its behalf by the undersigned, thereunto
duly
authorized.
|
ARNO
THERAPEUTICS, INC.
|
|
|
|
Date: August
14, 2008
|
By:
|
/s/ Scott
Z. Fields
|
|
|
Scott
Z. Fields, M.D.
|
|
|
President
and Chief Medical Officer
|
|
|
(Principal
Executive Officer)
|
|
|
|
Date: August
14, 2008
|
By:
|
/s/ Scott
L. Navins
|
|
|
Scott
L. Navins
|
|
|
Treasurer
|
|
|
(Principal
Financial and Accounting
Officer)
|
INDEX
OF EXHIBITS FILED WITH THIS REPORT
Exhibit No.
|
|
Exhibit
Description
|
10.1
|
|
Employment
Agreement dated June 11, 2008 between Arno Therapeutics, Inc. and
Brian
Lenz, as amended on July 9, 2008.
|
|
|
|
31.1
|
|
Certification
of Principal Executive Officer pursuant to Securities Exchange
Act Rule
13a-15(e)/15d-15(e) 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 Rule
13a-15(e)/15d-15(e) as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
|
|
32.1
|
|
Certification
of Principal Executive Officer pursuant to 18 U.S.C. Section 1350,
as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
|
|
|
32.2
|
|
Certification
of Principal Financial Officer pursuant to 18 U.S.C. Section 1350,
as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
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