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 SEPTEMBER 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
November 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 September 30, 2008 (unaudited) and December
31,
2007
|
3
|
|
|
|
|
Unaudited
Condensed Statements of Operations for the three and nine months
ended
September 30, 2008 and September 30, 2007 and for the cumulative
period
from August 1, 2005 (inception) through September 30, 2008
|
4
|
|
|
|
|
Unaudited
Condensed Statement of Stockholders’ Equity (Deficiency) for the period
from August 1, 2005 (inception) through September 30, 2008
|
5
|
|
|
|
|
Unaudited
Condensed Statements of Cash Flows for the nine months ended September
30,
2008 and September 30, 2007 and for the cumulative period from August
1,
2005 (inception) through September 30, 2008
|
6
|
|
|
|
|
Notes
to Condensed Financial Statements (unaudited)
|
7
|
|
|
|
Item 2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
17
|
|
|
|
Item 3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
23
|
|
|
|
Item 4T.
|
Controls
and Procedures
|
23
|
|
|
|
PART II
|
OTHER
INFORMATION
|
24
|
|
|
|
Item 1.
|
Legal
Proceedings
|
24
|
|
|
|
Item 1A.
|
Risk
Factors
|
24
|
|
|
|
Item 2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
33
|
|
|
|
Item 3.
|
Defaults
Upon Senior Securities
|
33
|
|
|
|
Item 4.
|
Submission
of Matters to a Vote of Security Holders
|
33
|
|
|
|
Item 5.
|
Other
Information
|
33
|
|
|
|
Item 6.
|
Exhibits
|
33
|
|
|
|
|
Signatures
|
34
|
|
|
|
|
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 recurring losses, negative cash flows and an inability
to raise
additional capital could threaten our ability to continue as a going
concern;
|
|
·
|
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;
and
|
|
·
|
risks
relating to the transfer of our manufacturing technology to third-party
contract manufacturers.
|
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.
Condensed
Financial Statements.
ARNO
THERAPEUTICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
CONDENSED
BALANCE SHEETS
|
|
September 30, 2008
(unaudited)
|
|
December 31, 2007
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
13,225,890
|
|
$
|
1,646,243
|
|
Prepaid
expenses
|
|
|
229,271
|
|
|
74,092
|
|
Total
current assets
|
|
|
13,455,161
|
|
|
1,720,335
|
|
Deferred
financing fees, net
|
|
|
—
|
|
|
13,541
|
|
Property
and equipment, net
|
|
|
53,502
|
|
|
38,193
|
|
Security
deposit
|
|
|
12,165
|
|
|
12,165
|
|
TOTAL
ASSETS
|
|
$
|
13,520,828
|
|
$
|
1,784,234
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY (DEFICIENCY)
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
2,242,056
|
|
$
|
111,474
|
|
Accrued
expenses
|
|
|
383,002
|
|
|
1,120,179
|
|
Due
to related party
|
|
|
249,537
|
|
|
583
|
|
Total
current liabilities
|
|
|
2,874,595
|
|
|
1,232,236
|
|
Convertible
notes and accrued interest payable
|
|
|
—
|
|
|
4,179,588
|
|
TOTAL
LIABILITIES
|
|
|
2,874,595
|
|
|
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
|
|
|
—
|
|
|
—
|
|
Common
stock, $0.0001 par value: 80,000,000 shares authorized, 20,392,024
shares
issued and outstanding at September 30, 2008 and 9,968,797 shares
issued
and outstanding at December 31, 2007
|
|
|
2,039
|
|
|
997
|
|
Additional
paid-in capital
|
|
|
24,037,325
|
|
|
102,003
|
|
Deficit
accumulated during the development stage
|
|
|
(13,393,131
|
)
|
|
(3,730,590
|
)
|
TOTAL
STOCKHOLDERS’ EQUITY (DEFICIENCY)
|
|
|
10,646,233
|
|
|
(3,627,590
|
)
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIENCY)
|
|
$
|
13,520,828
|
|
$
|
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
September 30,
2008
|
|
For the Three
Months Ended
September 30,
2007
|
|
For the Nine
Months Ended
September 30,
2008
|
|
For the Nine
Months Ended
September 30,
2007
|
|
Cumulative
Period
from
August 1, 2005
(inception)
Through
September 30,
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
$
|
1,776,710
|
|
$
|
1,187,962
|
|
$
|
7,065,754
|
|
$
|
1,800,161
|
|
$
|
10,330,851
|
|
General
and administrative
|
|
|
520,647
|
|
|
92,586
|
|
|
1,694,024
|
|
|
226,126
|
|
|
2,059,433
|
|
Total
Operating Expenses
|
|
|
2,297,357
|
|
|
1,280,548
|
|
|
8,759,778
|
|
|
2,026,287
|
|
|
12,390,284
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS
FROM OPERATIONS
|
|
|
(2,297,357
|
)
|
|
(1,280,548
|
)
|
|
(8,759,778
|
)
|
|
(2,026,287
|
)
|
|
(12,390,284
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER
INCOME (EXPENSE)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
104,329
|
|
|
50,158
|
|
|
133,290
|
|
|
97,855
|
|
|
257,252
|
|
Interest
expense
|
|
|
-
|
|
|
(63,119
|
)
|
|
(1,036,053
|
)
|
|
(160,927
|
)
|
|
(1,260,099
|
)
|
Total
Other Income (Expense)
|
|
|
104,329
|
|
|
(12,961
|
)
|
|
(902,763
|
)
|
|
(63,072
|
)
|
|
(1,002,847
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
LOSS
|
|
$
|
(2,193,028
|
)
|
$
|
(1,293,509
|
)
|
$
|
(9,662,541
|
)
|
$
|
(2,089,359
|
)
|
$
|
(13,393,131
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
LOSS PER SHARE – BASIC AND DILUTED
|
|
$
|
(0.11
|
)
|
$
|
(0.13
|
)
|
$
|
(0.66
|
)
|
$
|
(0.21
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED
AVERAGE SHARES OUTSTANDING – BASIC AND DILUTED
|
|
|
20,392,024
|
|
|
9,968,797
|
|
|
14,533,714
|
|
|
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 SEPTEMBER 30, 2008
(unaudited)
|
|
|
|
|
|
Deficit
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
During the
|
|
|
|
|
|
|
|
Additional Paid-
|
|
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
|
|
|
-
|
|
|
-
|
|
|
582,618
|
|
|
-
|
|
|
582,618
|
|
Consultant
stock based compensation
|
|
|
-
|
|
|
-
|
|
|
81,400
|
|
|
-
|
|
|
81,400
|
|
Net
loss, nine months ended September 30, 2008
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
(9,662,541
|
)
|
|
(9,662,541
|
)
|
Balance
at September 30, 2008
|
|
|
20,392,024
|
|
$
|
2,039
|
|
$
|
24,037,325
|
|
$
|
(13,393,131
|
)
|
$
|
10,646,233
|
|
See
accompanying notes to condensed financial statements.
ARNO
THERAPEUTICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
CONDENSED
STATEMENTS OF CASH FLOWS
(unaudited)
|
|
For the Nine
Months Ended
September 30,
2008
|
|
For the Nine
Months Ended
September 30,
2007
|
|
Cumulative Period
from August 1, 2005
(inception) Through
September 30, 2008
|
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM OPERATING ACTIVITES:
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(9,662,541
|
)
|
$
|
(2,089,359
|
)
|
$
|
(13,393,131
|
)
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
41,658
|
|
|
16,140
|
|
|
54,767
|
|
Stock
based compensation to employees
|
|
|
582,618
|
|
|
47,300
|
|
|
680,618
|
|
Stock
based compensation to consultants
|
|
|
81,400
|
|
|
-
|
|
|
81,400
|
|
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
|
|
|
152,594
|
|
|
311,518
|
|
Changes
in operating assets and liabilities:
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Prepaid
expenses
|
|
|
(155,179
|
)
|
|
7,493
|
|
|
(229,271
|
)
|
Security
deposit
|
|
|
-
|
|
|
(12,165
|
)
|
|
(12,165
|
)
|
Accounts
payable
|
|
|
2,130,582
|
|
|
450,740
|
|
|
2,242,056
|
|
Accrued
expenses
|
|
|
(737,177
|
)
|
|
761,500
|
|
|
383,002
|
|
Due
to related parties
|
|
|
248,954
|
|
|
67,073
|
|
|
249,537
|
|
Net
cash used in operating activities
|
|
|
(6,066,964
|
)
|
|
(598,684
|
)
|
|
(8,242,753
|
)
|
|
|
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM INVESTING ACTIVITES:
|
|
|
|
|
|
|
|
|
|
|
Purchase
of equipment
|
|
|
(23,426
|
)
|
|
(11,105
|
)
|
|
(63,269
|
)
|
Cash
paid for intangible assets
|
|
|
-
|
|
|
(61,942
|
)
|
|
(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
|
|
|
(23,426
|
)
|
|
(423,047
|
)
|
|
(148,394
|
)
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
11,579,647
|
|
|
2,820,269
|
|
|
13,225,890
|
|
CASH
AND CASH EQUIVALENTS – BEGINNING OF PERIOD
|
|
|
1,646,243
|
|
|
18,201
|
|
|
|
|
CASH
AND CASH EQUIVALENTS – END OF PERIOD
|
|
$
|
13,225,890
|
|
$
|
2,838,470
|
|
$
|
13,225,890
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
Disclosure of Non-Cash and Financing Activities:
|
|
|
|
|
|
|
|
|
|
|
Conversion
of notes payable and interest to common stock
|
|
$
|
4,278,518
|
|
$
|
-
|
|
$
|
4,278,518
|
|
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
September
30, 2008
(unaudited)
1.
DESCRIPTION OF BUSINESS
Arno
Therapeutics, Inc. (“Arno” or “the Company”) develops innovative products for
the treatment of cancer. Arno’s lead clinical compound AR-67 has completed
patient enrollment of its Phase I 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 PI3K/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 September 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 September 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
condensed 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 current report on Form 8-K filed with the Securities and Exchange
Commission (“SEC”) on June 9, 2008.
In
accordance with the terms of the Merger, Old Arno’s outstanding common stock
automatically converted into shares of Laurier common stock at an exchange
ratio
of 1.99377. Accordingly, 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. All share and per share information in the interim condensed
financial statements has been restated to retroactively reflect the exchange
ratio of 1.99377.
ARNO
THERAPEUTICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONDENSED FINANCIAL STATEMENTS
September
30, 2008
(unaudited)
3.
LIQUIDITY AND CAPITAL RESOURCES
For
the
three and nine months ended September 30, 2008, the Company reported a net
loss
of $2,193,028, and $9,662,541, respectively, and the net loss
from August 1, 2005 (inception) through September 30, 2008 was
$13,393,131. The Company’s total cash balance as of September 30, 2008 was
$13,225,890 compared to $1,646,243 at December 31, 2007.
Through
September 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 September 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 fourth
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 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, particularly given the current economic conditions,
which
have made access to the capital markets more difficult. 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.
ARNO
THERAPEUTICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONDENSED FINANCIAL STATEMENTS
September
30, 2008
(unaudited)
(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.
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, accounts payable, accrued expenses and due to related parties.
The
carrying amounts of these instruments reasonably approximate their fair values
due to their short-term 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
September
30, 2008
(unaudited)
Potentially
dilutive securities include:
|
|
September 30, 2008
|
|
September 30, 2007
|
|
Warrants
to purchase common stock
|
|
|
495,252
|
|
|
—
|
|
Options
to purchase common stock
|
|
|
2,436,511
|
|
|
548,286
|
|
Total
potential dilutive securities
|
|
|
2,931,763
|
|
|
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 September 30, 2008, the
Company’s deferred tax assets are fully reserved for.
(l)
Recently Issued Accounting Standards
In
June
2008, the Financial Accounting Standards Board, (“FASB”), issued FASB Staff
Position, (“FSP”) Emerging Issuers Task Force (“EITF”) 03-6-1, “
Determining
Whether Instruments Granted in Share-Based Transactions Are Participating
Securities
.”
This
standard provides guidance in determining whether unvested instruments granted
under share-based payment transactions are participating securities and,
therefore, should be included in earnings per share calculations under the
two-class method provided under Statement of Financial Accounting Standards
(“SFAS”) No. 128, “
Earnings
per Share
.”
FSP
EITF 03-6-1 is effective for fiscal years beginning after December 15,
2008, and interim periods within those fiscal years. The Company does not expect
that the adoption of FSP EITF 03-6-1 will have a significant impact on its
condensed financial statements.
In
April
2008, the FASB issued FSP FAS 142-3,”
Determination
of the Useful Life of Intangible Assets
.”
FSP
FAS 142-3 amends the factors that should be considered in developing renewal
or
extension assumptions used to determine the useful life of a recognized
intangible asset under SFAS No. 142, “
Goodwill
and Other Intangible Assets
.”
FSP
FAS 142-3 aims to improve the consistency between the useful life of a
recognized intangible asset under SFAS No. 142 and the period of expected
cash flows used to measure the fair value of the asset under SFAS
No. 141(R) and other applicable accounting literature. FSP FAS 142-3 is
effective for financial statements issued for fiscal years beginning after
December 15, 2008 and must be applied prospectively to intangible assets
acquired after the effective date. The Company does not expect that the adoption
of FSP FAS 142-3 will have a significant impact on its condensed financial
statements.
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.
ARNO
THERAPEUTICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONDENSED FINANCIAL STATEMENTS
September
30, 2008
(unaudited)
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, Pitt granted the
Company 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. 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, Ohio State
granted the Company 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 each 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 to the extent the
Company fails to cure any such breach within 90 days after receiving notice
of
such breach or the Company files for bankruptcy. The Company may terminate
either license upon 90 days prior written notice.
ARNO
THERAPEUTICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONDENSED FINANCIAL STATEMENTS
September
30, 2008
(unaudited)
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. 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 9,968,797 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 were 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:
incentive stock options and non-statutory stock options; stock appreciation
rights stock awards; restricted stock; and 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.
ARNO
THERAPEUTICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONDENSED FINANCIAL STATEMENTS
September
30, 2008
(unaudited)
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
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
Term
|
|
|
5-10
years
|
|
|
10
years
|
|
|
5-10
years
|
|
|
10
years
|
|
Volatility
|
|
|
77-79
%
|
|
|
68
%
|
|
|
77-89%
|
|
|
65-68%
|
|
Dividend
yield
|
|
|
0.0%
|
|
|
0.0%
|
|
|
0.0%
|
|
|
0.0%
|
|
Risk-free
interest rate
|
|
|
3.0-3.2%
|
|
|
4.2-4.6%
|
|
|
2.5-3.2%
|
|
|
4.2-4.9%
|
|
Forfeiture
rate
|
|
|
0.0%
|
|
|
0.0%
|
|
|
0.0%
|
|
|
0.0%
|
|
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 September 30, 2008 totaled $762,018 of which $492,830 was
included in general and administrative expense and $269,188 was included in
research and development expense. For the nine months ended September 30, 2008
and 2007, the Company recorded stock-based compensation of $664,018 and $47,300,
respectively. For the three months ended September 30, 2008 and 2007, the
Company recorded stock-based compensation of $185,100 and $47,300, respectively.
At
September 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
|
|
|
2,436,511
|
|
$
|
1.71
|
|
|
8.99
years
|
|
$
|
4,430,834
|
|
Total
exercisable options
|
|
|
596,890
|
|
$
|
1.26
|
|
|
7.14
years
|
|
$
|
1,275,652
|
|
During
the nine months ended September 30, 2008, the Company granted to its Chief
Executive Officer stock options to purchase 430,000 shares of common stock
at an
exercise price of $3.00. The right to purchase 50% of such shares vest one
year
from the date of grant and the right to purchase the remaining 50% vest two
years from the date of grant in accordance with the Chief Executive Officer’s
employment agreement with the Company. A fair value of $896,500 was assigned
to
the options based on the Black-Scholes option-pricing model. The Company also
granted to this officer an additional stock option to purchase 430,000 shares
of
common stock at an exercise price of $3.00, which vest upon the successful
achievement of performance goals as determined by the Company’s Board of
Directors.
During
the nine months ended September 30, 2008, the Company granted to its Chief
Financial Officer a stock option to purchase 440,000 shares of common stock
at
an exercise price of $2.75. The right to purchase 25% of such shares vest one
year from the date of grant and the right to purchase the remaining 75% vest
in
equal monthly installments over the two years following the executive’s first
anniversary with the Company, as provided in the employment agreement between
the Company and the Chief Financial Officer. A fair value of $830,500 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
September
30, 2008
(unaudited)
During
the nine months ended September 30, 2008, the Company granted to a scientific
advisor a stock option to purchase 20,000 shares of common stock at an exercise
price of $3.00, which vest equally over two years from the date of grant. A
fair
value of $41,800 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 two members of its
Board of Directors stock 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 advisor
stock 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 stock
options to purchase 79,750 shares of common stock at an exercise price of $2.42.
The right to purchase 25% of such shares vests 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 stock options to purchase 199,377 shares of common stock
at an exercise price of $1.00, of which the right to purchase 50% of such shares
vested on June 1, 2008 and the right to purchase the remaining 50% will vest
on
June 1, 2009 in accordance with the executive’s employment agreement. The
Company also granted to this officer an additional stock option to purchase
199,377 shares, which vests upon the achievement of performance milestones.
As
of May 31, 2008, the right to purchase 50% of these shares had vested, and
the
remaining 50% will vest, subject to the achievement of the performance
milestones, on June 1, 2009, 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.
Activity
with respect to options granted under the Plan is summarized as follows:
|
|
For the Nine Months Ended
September 30, 2008
|
|
For the Nine Months Ended
September 30, 2007
|
|
|
|
Shares
|
|
Weighted
Average
Exercise
Price
|
|
Shares
|
|
Weighted
Average
Exercise
Price
|
|
Balance at January 1, 2008 and 2007,
respectively
|
|
|
687,849
|
|
$
|
0.81
|
|
|
149,532
|
|
$
|
0.67
|
|
Granted
under the Plan
|
|
|
1,748,662
|
|
|
|
|
|
538,319
|
|
$
|
1.00
|
|
Exercised
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Surrendered/cancelled
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Forfeited
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at September 30, 2008 and 2007, respectively
|
|
|
2,436,511
|
|
$
|
2.38
|
|
|
687,851
|
|
$
|
0.81
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable
at September 30, 2008 and 2007, respectively
|
|
|
596,890
|
|
$
|
1.26
|
|
|
395,846
|
|
$
|
0.67
|
|
As
of
September 30, 2008 and 2007, there was approximately $2,112,182 and $138,100
of
unrecognized compensation costs related to stock options, respectively. These
costs are expected to be recognized over a weighted average period of
approximately 2 years as of September 30, 2008 and 2007.
As
of
September 30, 2008, an aggregate of 58,892 shares remained available for future
grants and awards under the Plan, which covers stock options, warrants and
restricted awards. The Company issues unissued shares to satisfy stock options,
warrants exercises and restricted stock awards.
ARNO
THERAPEUTICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONDENSED FINANCIAL STATEMENTS
September
30, 2008
(unaudited)
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 certain of the Company’s
directors and founders. No interest is charged by Two River on any outstanding
balance owed by the Company. At September 30, 2008, reimbursable expenses
totaled $249,537, 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 general and administrative
costs
attributed to certain employees of Two River. The Company also granted fully
vested warrants to purchase 299,063 shares of its common stock at an exercise
price of $2.42 to the Two River employees who provided consultation and due
diligence efforts related to the in-licensing of AR-12 and AR-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”), a FINRA member broker dealer registered with the SEC, for
investment banking and other 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/or directors of the
Company. The Company paid a $100,000 non-accountable expense allowance to
Riverbank for 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
19, 2008, the Company entered into an employment agreement with Roger G. Berlin,
M.D., as its Chief Executive Officer, with an effective commencement date of
employment beginning on September 3, 2008. The agreement provides for a term
of
two years expiring on September 2, 2010, and an initial base salary of $375,000,
plus an annual target performance bonus of up to 50% of his base salary or
$187,500. Pursuant to the employment agreement, Dr. Berlin received a stock
option to purchase 430,000 employment shares of the Company’s common stock at an
exercise price of $3.00 per share. The right to purchase 215,000 shares of
the
Company’s common stock shall vest pro rata on each anniversary of his
employment. Additionally, pursuant to Dr. Berlin’s employment agreement, Dr.
Berlin received a stock option to purchase 430,000 performance options
contingent upon the successful achievement of performance goals established
by
the compensation committee of the Board of Directors. The employment stock
option grant had an approximate fair value of $896,500 at the date of grant
based on the Black-Scholes option-pricing model. The employment agreement
also entitles Dr. Berlin to certain severance benefits. In the event the Company
terminates Dr. Berlin’s employment without cause, then Dr. Berlin 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.
On
June
11, 2008, the Company entered into an employment agreement with Brian Lenz
pursuant to which Mr. Lenz agreed to serve as the Company’s Chief Financial
Officer. The agreement provides for a term of two years expiring on July 15,
2010, and an initial base salary of $200,000, plus an annual target performance
bonus of up to 30% of his base salary or $60,000. In addition, Mr. Lenz received
a one-time cash bonus in the amount of $25,000 and a stock option grant to
purchase 440,000 shares of the Company’s 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. The stock option grant had an approximate fair value of
$830,500 at the date of grant based on the Black-Scholes option-pricing model.
The employment agreement also entitles Mr. Lenz to certain severance benefits.
In the event the Company terminates Mr. Lenz’s employment without cause, then
Mr. Lenz 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.
On
June
1, 2007, the Company entered into an employment agreement with Scott 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 vests pro rata on the first two anniversaries of his
employment, and the right to purchase the remaining 199,377 shares vest upon
the
achievement of performance milestones, of which one-half, or 99,689 shares
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.
ARNO
THERAPEUTICS, INC.
(A
DEVELOPMENT STAGE COMPANY)
NOTES
TO CONDENSED FINANCIAL STATEMENTS
September
30, 2008
(unaudited)
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.
The
aggregate remaining minimum future payments under these leases at September
30,
2008 are approximately as follows:
Year
Ended December 31,
|
|
|
|
2008
|
|
$
|
17,000
|
|
2009
|
|
|
55,000
|
|
2010
|
|
|
52,000
|
|
Total
|
|
$
|
124,000
|
|
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 September 30, 2008
is
approximately $3,000,000.
10.
SUBSEQUENT EVENTS
On
October 17, 2008, the Company entered into a lease for new office space in
Parsippany, New Jersey. The lease commencement date is November 14, 2008, with
lease payments beginning on January 1, 2009. The lease expiration date is 5
years from the rent commencement date. The total five year lease obligation
is
approximately $670,000. The Company is obligated to provide a security deposit
of $44,018, or four months base rent, in the form of a letter of credit. The
letter of credit may be reduced by $11,005 on January 1, 2011 and by an
additional $11,005 on January 1, 2013, provided the Company maintains certain
conditions described in the lease agreement. The Company has an early
termination option, which provides the Company to terminate the lease on the
third anniversary, upon providing the landlord nine months written notice prior
to the third anniversary of the lease. If the Company exercises its termination
option, the Company would be obligated to pay a fee of $53,641 which consists
of
unamortized costs and expenses incurred by the landlord in connection with
the
lease. The Company also has an option to extend the term of the lease for a
period of five additional years, provided the Company gives notice to the
landlord no later than twelve months prior to the original expiration of the
term. The Company expects to abandon its current office lease for its Fairfield,
NJ facility and will record a liability on the date of abandonment less
estimated sublease income, in accordance with Financial Accounting Standard
No.
146, Accounting for Costs Associated with Exit or Disposal Activities. The
Company’s remaining estimated lease obligation on its current space is
approximately $111,000.
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 condensed 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 clinical product candidate is a novel, third-generation
campothecin analogue. We have completed patient enrollment of our
multi-center, ascending dose Phase I clinical trial of AR-67 in patients
with advanced solid tumors. Over the next 12 months, we anticipate
commencing a variety of Phase II clinical trials of AR-67 in patients
with
glioblastoma multiforme, or GBM, myelodysplastic syndrome or MDS,
or other
diseases. In light of current economic circumstances, we no longer
plan to
conduct these studies ourselves, but rather we plan to pursue
collaborations with oncology cooperative groups and/or identify other
researchers to conduct investigator - initiated studies. We believe
this
action will preserve our available cash resources, while continuing
to
advance the development of this product candidate.
|
|
·
|
AR-12
-
We are also developing AR-12, an orally available pre-clinical
compound for the treatment of cancer, is a novel inhibitor of
phosphoinositide dependent protein kinase-1, or PDK-1, that targets
the
PI3K/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. We anticipate commencing a Phase
I
clinical study of AR-12 in the United States during the first half
of
2009.
|
|
·
|
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. We also anticipate commencing a Phase I
clinical study in the United States during the first half of
2009.
|
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
an
equivalent foreign regulatory bodies to begin selling our pharmaceutical
candidates. There can be no assurance that we will ever receive 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 AR-67, which is completing
a Phase I clinical trial. 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 Old Arno common stock and borrowings.
Results
of Operations
Comparison
of the Three Months Ended September 30, 2008 and the Three Months Ended
September 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 September 30,
2008 and 2007 were $1,776,710 and $1,187,962, 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 September 30, 2008
compared to the three months ended September 30, 2007 of $588,748 is primarily
attributed to an increase in manufacturing and non-clinical costs for our drug
candidates AR-42 and AR-12. 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.
The
following table sets forth the research and development expenses per compound,
for the periods presented.
|
|
Three Months Ended September 30,
|
|
|
|
2008
|
|
2007
|
|
Cumulative amounts
during development
|
|
AR-67
|
|
$
|
16,984
|
|
$
|
1,016,627
|
|
$
|
5,006,011
|
|
AR-42
|
|
|
695,359
|
|
|
2,660
|
|
|
1,536,488
|
|
AR-12
|
|
|
644,768
|
|
|
23,330
|
|
|
2,003,208
|
|
General
R&D
|
|
|
419,599
|
|
|
145,345
|
|
|
1,785,144
|
|
Total
|
|
$
|
1,776,710
|
|
$
|
1,187,962
|
|
$
|
10,330,851
|
|
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
September 30, 2008 and 2007 were $520,647 and $92,586, respectively. G&A
expenses in the third quarter of 2008 increased by $428,061, which was primarily
attributed to increased professional fees of approximately $184,000, increased
stock compensation expense resulting in a non-cash charge of approximately
$133,000, in addition to having more employees during the third quarter of
2008
versus 2007, resulting in an increase in payroll and benefits expense of
approximately $50,000, 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 September 30, 2008 and 2007 was
$104,329 and $50,158, respectively. The increase of $54,171 was attributed
to
having a higher cash balance at the end of the third quarter 2008 versus 2007,
as a result of the June 2008 private placement of the Company’s common stock .
Interest
Expense
.
Interest expense for the three months ended September 30, 2008 and 2007 was
$0
and $63,119, respectively. The decrease of $63,119 interest expense is
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 September
30, 2008 was $2,193,028, or a net loss of $0.11 per share of common stock,
basic
and diluted, as compared to a net loss of $1,293,509 for the three months ended
September 30, 2007, or a net loss of $0.13 per common share, basic and diluted.
Comparison
of the Nine Months Ended September 30, 2008 and the Nine Months Ended September
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.
R&D
expenses for the nine months ended September 30, 2008 and 2007 were $7,065,754
and $1,800,161, 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 nine months ended September 30, 2008 of
$5,265,593, is primarily attributed to increased manufacturing costs of
approximately $2,229,000 for the development of our three drug candidates,
increased nonclinical development costs of approximately $1,112,000 and upfront
finders and licensing fees paid to acquire the worldwide rights to AR-12 and
AR-42 of approximately $1,562,000 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 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.
The
following table sets forth the research and development expenses per compound,
for the periods presented.
|
|
Nine Months Ended September 30,
|
|
|
|
2008
|
|
2007
|
|
Cumulative
amounts during
development
|
|
AR-67
|
|
$
|
2,255,802
|
|
$
|
1,582,371
|
|
$
|
5,006,011
|
|
AR-42
|
|
|
1,511,669
|
|
|
2,660
|
|
|
1,536,488
|
|
AR-12
|
|
|
1,999,835
|
|
|
28,330
|
|
|
2,003,208
|
|
General
R&D
|
|
|
1,298,448
|
|
|
186,800
|
|
|
1,785,144
|
|
Total
|
|
$
|
7,065,754
|
|
$
|
1,800,161
|
|
$
|
10,330,851
|
|
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 nine months ended September 30, 2008 and 2007 were
$1,694,024 and $226,126, respectively. G&A expenses for the nine months
ended 2008 increased by $1,467,898 primarily due a one-time charge of $500,000
for consulting fees related to the Merger, increased professional fees,
increased stock compensation expense resulting in a non-cash charge of
approximately $453,000, increased payroll and accrued bonus of approximately
$100,000 due to having more employees, 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 nine months ended September 30, 2008 and 2007 was
$133,290 and $97,855, respectively. The increase of $35,435 was attributed
to
having a higher cash balance earning interest during the third quarter of 2008
versus 2007, as a result of the June 2008 private placement of the Company’s
common stock.
Interest
Expense
.
Interest expense for the nine months ended September 30, 2008 and 2007 was
$1,036,053 and $160,927, respectively. The increase of $875,126 is primarily
attributable to the conversion of 6% convertible promissory notes that 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 nine months ended September
30, 2008 was $9,662,541, or a net loss of $0.66 per share of common stock,
basic
and diluted, as compared to a net loss of $2,089,359 for the nine months ended
September 30, 2007, or a net loss of $0.21 per common share, basic and diluted.
Off
Balance Sheet Arrangements
There
were no off-balance sheet arrangements as of September 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, Pitt granted us 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, Ohio State granted us
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 each 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 to 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 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
(“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 nine months ended September 30, 2008, we had a net loss of $2,193,028
and $9,662,541, respectively. From August 1, 2005 (inception) through September
30, 2008, we have incurred an aggregate net loss of $13,393,131, primarily
through a combination of research and development activities related to the
licensed technology under our control and expenses supporting those activities.
As of September 30, 2008, we had working capital of $10,580,566 and cash and
cash equivalents of $13,225,890.
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 nine months ended September 30, 2008
was $6,066,964. Our net cash used in operating activities primarily resulted
from a net loss of $9,662,541 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 $1,144,418,
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 of $2,130,582 offset by a decrease of accrued expenses
of
$737,177 attributed to clinical development costs and bonus accruals in addition
to an increase of $248,954 due to Two River Group Holdings, LLC, a related
party.
Our
net
cash used in investing activities for the nine months ended September 30, 2008
was $23,426, which resulted from capital expenditures attributable to the
purchases of computer and office equipment for the leased office space in
Fairfield, New Jersey.
Our
net
cash provided by financing activities for the nine months ended September 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 September 30, 2008 were $13,225,890, 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 before 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 September 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.
Based
upon the progress of our clinical development programs, we may hire several
additional full-time employees devoted to R&D activities and one or more
additional full-time employees for G&A. During the remainder of 2008, we
expect to spend approximately $3,500,000 on clinical R&D activities, and
approximately $500,000 on G&A expenses.
Based
on
our resources at September 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 into the fourth 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 of 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. 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
has completed enrollment. Multiple Phase II studies are being evaluated for
potential initiation during the next 12 months in a variety of tumor types.
In
light of current economic circumstances, we no longer plan to conduct these
studies ourselves, but rather we plan to pursue collaborations with oncology
cooperative groups and/or identify other researchers to conduct investigator
-
initiated studies. We believe this action will preserve our available cash
resources, while continuing to advance the development of this product
candidate.
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 PI3K/Akt pathway while also possessing activity in the endoplasmic reticulum
(ER) 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. We also
anticipate commencing a Phase I clinical study in the United States in the
first
half of 2009.
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.
We
also anticipate commencing a Phase I clinical study in the United States in
the
first half of 2009.
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. 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
June
2008, the Financial Accounting Standards Board, (“FASB”), issued FASB Staff
Position, (“FSP”) Emerging Issuers Task Force (“EITF”) 03-6-1, “
Determining
Whether Instruments Granted in Share-Based Transactions Are Participating
Securities
.”
This
standard provides guidance in determining whether unvested instruments granted
under share-based payment transactions are participating securities and,
therefore, should be included in earnings per share calculations under the
two-class method provided under Statement of Financial Accounting Standards
(“SFAS”) No. 128, “
Earnings
per Share
.”
FSP
EITF 03-6-1 is effective for fiscal years beginning after December 15,
2008, and interim periods within those fiscal years. The Company does not expect
that the adoption of FSP EITF 03-6-1 will have a significant impact on its
condensed financial statements.
In
April
2008, the FASB issued FSP FAS 142-3,”
Determination
of the Useful Life of Intangible Assets
.”
FSP
FAS 142-3 amends the factors that should be considered in developing renewal
or
extension assumptions used to determine the useful life of a recognized
intangible asset under SFAS No. 142, “
Goodwill
and Other Intangible Assets
.”
FSP
FAS 142-3 aims to improve the consistency between the useful life of a
recognized intangible asset under SFAS No. 142 and the period of expected
cash flows used to measure the fair value of the asset under SFAS
No. 141(R) and other applicable accounting literature. FSP FAS 142-3 is
effective for financial statements issued for fiscal years beginning after
December 15, 2008 and must be applied prospectively to intangible assets
acquired after the effective date. The Company does not expect that the adoption
of FSP FAS 142-3 will have a significant impact on its condensed financial
statements.
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’s rules and forms and that such information is
accumulated and communicated to the Company’s management, including its Chief
Executive Officer and Chief Financial Officer, 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 the 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 Chief Executive Officer and the Company’s Chief
Financial Officer, 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 Chief Executive
Officer and Chief Financial Officer 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.
PART
II — OTHER INFORMATION
Item 1.
Legal
Proceedings.
The
Company is not a party to any material pending legal proceedings.
Item 1A.
Risk
Factors.
Investment
in our common stock involves significant risk. You should carefully consider
the
information described in the following risk factors, together with the other
information appearing elsewhere in this report, before making an investment
decision regarding our common stock. If any of these risks actually occur,
our
business, financial conditions, results of operation and future growth prospects
would likely be materially and adversely affected. In these circumstances,
the
market price of our common stock could decline, and you may lose all or a part
of your investment in our common stock. Moreover, the risks described below
are
not the only ones that we face. Additional risks not presently known to us
or
that we currently deem immaterial may also affect our business, operating
results, prospects or financial condition.
Risks
Relating to Our Business
We
are a development stage
company.
We
have
not received any operating revenues to date and are in the development stage.
You should be aware of the problems, delays, expenses and difficulties
encountered by an enterprise in our stage of development, and particularly
for
companies engaged in the development of new biotechnology or biopharmaceutical
product candidates, many of which may be beyond our control. These include,
but
are not limited to, problems relating to product development, testing,
regulatory compliance, manufacturing, marketing, costs and expenses that may
exceed current estimates and competition. No assurance can be given that our
existing product candidates, or any technologies or products that we may acquire
in the future will be successfully developed, commercialized and accepted by
the
marketplace or that sufficient funds will be available to support operations
or
future research and development programs.
We
currently have no product revenues and will need to raise substantial additional
capital to operate our business.
To
date,
we have generated no product revenues, and do not expect to generate any
revenues until, and only if, we receive approval to sell our drugs from the
U.S.
Food and Drug Administration, or FDA, and other regulatory authorities for
our
product candidates. Therefore, for the foreseeable future, we will have to
fund
all of our operations and capital expenditures from cash on hand, licensing
fees
and grants.
The
use
of our existing cash will depend on many factors, including among other things,
the course of the clinical and regulatory development of our current product
candidates, the acquisition of new technologies and the hiring of new personnel.
Based on our current development plans, we expect that our current resources
will be sufficient to fund our operations into the fourth quarter 2009. We
will
need to seek substantial additional financing in order to continue developing
our current and any future product candidates. Such additional financing may
not
be available on favorable terms, if at all, particularly if the current
difficulty accessing the capital markets due to the general economic crisis
remains for a prolonged period.
If
we do
not succeed in raising additional funds on acceptable terms, we may be unable
to
complete planned pre-clinical testing and human clinical trials or obtain
approval of our product candidates from the FDA and other regulatory
authorities. In addition, we could be forced to discontinue product development
and/or reduce or forego attractive business opportunities. Any additional
sources of financing will likely involve the issuance of our common stock or
other securities convertible into our common stock, which will have a dilutive
effect on our stockholders.
We
are not currently profitable and may never become
profitable.
We
expect
to incur substantial losses and negative operating cash flow for the foreseeable
future, and we may never achieve or maintain profitability. For the year ended
December 31, 2007, we had a net loss of $3,359,697 and for the period from
our
inception on August 1, 2005 through September 30, 2008, we had a net loss of
$13,393,131. As of September 30, 2008, we have stockholders’ equity of
$10,646,233. Even if we succeed in developing and commercializing one or more
of
our product candidates, we expect to incur substantial losses for the
foreseeable future, as we:
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continue
to undertake pre-clinical development and clinical trials for our
product
candidates;
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seek
regulatory approvals for our product
candidates;
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in-license
or otherwise acquire additional products or product
candidates;
|
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|
implement
additional internal systems and infrastructure;
and
|
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hire
additional personnel.
|
Further,
for the nine months ended September 30, 2008, we had negative cash flows from
operating activities of $6,066,964 and since inception through September 30,
2008, we have had negative cash flows from operating activities of $8,242,753.
We expect to continue to experience negative cash flow for the foreseeable
future as we fund our operating losses and capital expenditures. As a result,
we
will need to generate significant revenues in order to achieve and maintain
profitability. We may not be able to generate these revenues or achieve
profitability in the future. Our failure to achieve or maintain profitability
could negatively impact the value of our common stock.
We
have a limited operating history upon which to base an investment
decision.
We
are a
development stage company and have not demonstrated our ability to perform
the
functions necessary for the successful commercialization of any of our product
candidates. The successful commercialization of our product candidates will
require us to perform a variety of functions, including:
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continuing
to undertake pre-clinical development and clinical trials for our
product
candidates;
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participating
in regulatory approval processes;
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formulating
and manufacturing products; and
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conducting
sales and marketing activities.
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Our
operations have been limited to organizing our company, acquiring, developing
and securing our proprietary technology and preparing for pre-clinical and
clinical trials of our product candidates. These operations provide a limited
basis for you to assess our ability to commercialize our product candidates
and
the advisability of investing in our securities.
We
may not successfully manage our growth.
Our
success will depend upon the expansion of our operations and the effective
management of our growth, which will place a significant strain on our
management and on our administrative, operational and financial resources.
To
manage this growth, we may need to expand our facilities, augment our
operational, financial and management systems and hire and train additional
qualified personnel. If we are unable to manage our growth effectively, our
business would be harmed.
We
may be exposed to liability claims associated with the use of hazardous
materials and chemicals.
Our
research and development activities may involve the controlled use of hazardous
materials and chemicals. Although we believe that our safety procedures for
using, storing, handling and disposing of these materials comply with federal,
state and local laws and regulations, we cannot completely eliminate the risk
of
accidental injury or contamination from these materials. In the event of such
an
accident, we could be held liable for any resulting damages and any liability
could materially adversely effect our business, financial condition and results
of operations. In addition, the federal, state and local laws and regulations
governing the use, manufacture, storage, handling and disposal of hazardous
or
radioactive materials and waste products may require us to incur substantial
compliance costs that could materially adversely affect our business, financial
condition and results of operations.
We
will rely on key
employees
and scientific and medical advisors, whose knowledge of our business and
technical expertise would be difficult to replace.
We
currently rely on certain key employees, the loss of any one or more of whom
could delay our development program. We are and will be highly dependent on
our
principal scientific, regulatory and medical advisors. We do not have “key
person” life insurance policies for any of our officers. The loss of the
technical knowledge and management and industry expertise of any of our key
personnel could result in delays in product development, loss of customers
and
sales and diversion of management resources, which could adversely affect our
operating results.
If
we are unable to hire additional qualified personnel, our ability to grow our
business may be harmed.
Attracting
and retaining qualified personnel will be critical to our success. Our success
is highly dependent on the hiring and retention of key personnel and scientific
staff. While we are actively recruiting additional experienced members for
the
management team, there is intense competition and demand for qualified personnel
in our area of business and no assurances can be made that we will be able
to
retain the personnel necessary for the development of our business on
commercially reasonable terms, if at all. Certain of our current officers,
directors, scientific advisors and/or consultants or certain of the officers,
directors, scientific advisors and/or consultants hereafter appointed may from
time to time serve as officers, directors, scientific advisors and/or
consultants of other biopharmaceutical or biotechnology companies. We rely,
in
substantial part, and for the foreseeable future will rely, on certain
independent organizations, advisors and consultants to provide certain services,
including substantially all aspects of regulatory approval, clinical management,
and manufacturing. There can be no assurance that the services of independent
organizations, advisors and consultants will continue to be available to us
on a
timely basis when needed, or that we can find qualified
replacements.
We
may incur substantial liabilities and may be required to limit commercialization
of our products in response to product liability
lawsuits.
The
testing and marketing of medical products entail an inherent risk of product
liability. If we cannot successfully defend ourselves against product liability
claims, we may incur substantial liabilities or be required to limit
commercialization of our products. Our inability to obtain sufficient product
liability insurance at an acceptable cost to protect against potential product
liability claims could prevent or inhibit the commercialization of
pharmaceutical products we develop, alone or with corporate collaborators.
We
currently do not have product liability insurance, but do maintain clinical
trial insurance coverage with respect to AR-67. Even if our agreements with
any
future corporate collaborators entitle us to indemnification against losses,
such indemnification may not be available or adequate should any claim
arise.
There
are certain interlocking relationships among us and certain affiliates of Two
River Group Holdings, LLC, which may present potential conflicts of
interest.
Dr.
Arie
S. Belldegrun, Peter M. Kash, Joshua A. Kazam and David M. Tanen, each a
director and stockholder of Arno, are the sole members of Two River Group
Management, LLC, which serves as the managing member of Two River Group
Holdings, LLC, or Two River, a venture capital firm specializing in the
formation of biotechnology companies. Messrs. Kash, Kazam and Tanen are officers
and directors of Riverbank Capital Securities, Inc., or Riverbank, a broker
dealer registered with the Financial Industry Regulatory Authority, or FINRA
(formerly NASD). Mr. Tanen also serves as our Secretary and Scott L. Navins,
the
Vice President of Finance for Two River and Financial and Operations Principal
for Riverbank, serves as our Treasurer. Additionally, certain employees of
Two
River, who are also our stockholders, perform substantial operational activity
for us, including without limitation financial, clinical and regulatory
activities. Generally, Delaware corporate law requires that any transactions
between us and any of our affiliates be on terms that, when taken as a whole,
are substantially as favorable to us as those then reasonably obtainable from
a
person who is not an affiliate in an arms-length transaction. Nevertheless,
none
of our affiliates or Two River is obligated pursuant to any agreement or
understanding with us to make any additional products or technologies available
to us, nor can there be any assurance, and the investors should not expect,
that
any biomedical or pharmaceutical product or technology identified by such
affiliates or Two River in the future will be made available to us. In addition,
certain of our current officers and directors or certain of any officers or
directors hereafter appointed may from time to time serve as officers or
directors of other biopharmaceutical or biotechnology companies. There can
be no
assurance that such other companies will not have interests in conflict with
our
own.
We
are controlled by current directors and principal
stockholders.
Our
executive officers, directors and principal stockholders beneficially own
approximately 44% of our outstanding voting securities. Accordingly, our
executive officers, directors, principal stockholders and certain of their
affiliates will have the ability to exert substantial influence over the
election of our board of directors and the outcome of issues submitted to our
stockholders.
We
will be required to implement additional finance and accounting systems,
procedures and controls in order to satisfy requirements under the securities
laws, including the Sarbanes-Oxley Act of 2002, which will increase our costs
and divert management’s time and attention.
We
are in
a continuing process of establishing controls and procedures that will allow
our
management to report on, and our independent registered public accounting firm
to attest to, our internal controls over financial reporting when required
to do
so under Section 404 of the Sarbanes-Oxley Act of 2002, or the
Sarbanes-Oxley Act. As a company with limited capital and human resources,
we
anticipate that more of management’s time and attention will be diverted from
our business to ensure compliance with these regulatory requirements than would
be the case with a company that has well established controls and procedures.
This diversion of management’s time and attention may have a material adverse
effect on our business, financial condition and results of
operations.
In
the
event we identify significant deficiencies or material weaknesses in our
internal controls over financial reporting that we cannot remediate in a timely
manner, or if we are unable to receive a positive attestation from our
independent registered public accounting firm with respect to our internal
controls over financial reporting when we are required to do so, investors
and
others may lose confidence in the reliability of our financial statements.
If
this occurs, the trading price of our common stock, if any, and our ability
to
obtain any necessary financing could suffer. In addition, in the event that
our
independent registered public accounting firm is unable to rely on our internal
controls over financial reporting in connection with its audit of our financial
statements, and in the further event that it is unable to devise alternative
procedures in order to satisfy itself as to the material accuracy of our
financial statements and related disclosures, we may be unable to file our
Annual Report on Form 10-K with the SEC. This would likely have an adverse
affect on the trading price of our common stock, if any, and our ability to
secure any necessary additional financing, and could result in the delisting
of
our common stock if we are listed on an exchange in the future. In such event,
the liquidity of our common stock would be severely limited and the market
price
of our common stock would likely decline significantly.
We
will experience increased costs as a result of becoming subject to the reporting
requirements of federal securities laws.
Since
our
merger with Laurier International, Inc. in June 2008, we are subject to the
reporting requirements of the Exchange Act, including the requirements of the
Sarbanes-Oxley Act of 2002. These requirements may place a strain on our systems
and resources. The Securities Exchange Act of 1934 requires that we file annual,
quarterly and current reports with respect to our business and financial
condition. The Sarbanes-Oxley Act requires that we maintain effective disclosure
controls and procedures and internal controls over financial reporting, which
is
discussed below. In order to maintain and improve the effectiveness of our
disclosure controls and procedures, significant resources and management
oversight will be required. We will be implementing additional procedures and
processes for the purpose of addressing the standards and requirements
applicable to public companies. In addition, sustaining our growth will also
require us to commit additional management, operational and financial resources
to identify new professionals to join our firm and to maintain appropriate
operational and financial systems to adequately support expansion. These
activities may divert management's attention from other business concerns,
which
could have a material adverse effect on our business, financial condition,
results of operations and cash flows. We expect to incur significant additional
annual expenses related to these steps and, among other things, additional
directors and officers liability insurance, director fees, reporting
requirements of the SEC, transfer agent fees, hiring additional accounting,
legal and administrative personnel, increased auditing and legal fees and
similar expenses.
Risks
Relating to the Clinical Testing, Regulatory Approval, Manufacturing
and
Commercialization of Our Product Candidates
We
may not obtain the necessary U.S. or worldwide regulatory approvals to
commercialize our product candidates.
We
will
need FDA approval to commercialize our product candidates in the U.S. and
approvals from the FDA equivalent regulatory authorities in foreign
jurisdictions to commercialize our product candidates in those jurisdictions.
In
order to obtain FDA approval of any of our product candidates, we must submit
to
the FDA a new drug application, or NDA, demonstrating that the product candidate
is safe for humans and effective for its intended use. This demonstration
requires significant research and animal tests, which are referred to as
pre-clinical studies, as well as human tests, which are referred to as clinical
trials. Satisfaction of the FDA’s regulatory requirements typically takes many
years, depends upon the type, complexity and novelty of the product candidate
and requires substantial resources for research, development and testing. We
cannot predict whether our research and clinical approaches will result in
drugs
that the FDA considers safe for humans and effective for indicated uses. The
FDA
has substantial discretion in the drug approval process and may require us
to
conduct additional pre-clinical and clinical testing or to perform
post-marketing studies. The approval process may also be delayed by changes
in
government regulation, future legislation or administrative action or changes
in
FDA policy that occur prior to or during our regulatory review. Delays in
obtaining regulatory approvals may:
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delay
commercialization of, and our ability to derive product revenues
from, our
product candidates;
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impose
costly procedures on us; or
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diminish
any competitive advantages that we may otherwise
enjoy.
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Even
if
we comply with all FDA requests, the FDA may ultimately reject one or more
of
our NDAs. We cannot be sure that we will ever obtain regulatory clearance for
our product candidates. Failure to obtain FDA approval of any of our product
candidates will severely undermine our business by reducing our number of
salable products and, therefore, corresponding product revenues.
In
foreign jurisdictions, we must receive approval from the appropriate regulatory
authorities before we can commercialize our drugs. Foreign regulatory approval
processes generally include all of the risks associated with the FDA approval
procedures described above. We cannot assure that we will receive the approvals
necessary to commercialize our product candidate for sale outside the
U.S.
All
of our product candidates are in early stages of clinical trials, which are
very
expensive and time-consuming. Any failure or delay in completing clinical trials
for our product candidates could harm our business.
All
three
of our current product candidates are in early stages of development and will
require extensive clinical and other testing and analysis before we will be
in a
position to consider seeking regulatory approval to sell such product
candidates. To date, we have only filed an investigational new drug application,
or IND, for AR-67, which is required in order to conduct clinical studies of
a
drug candidate. We do not intend to file INDs for AR-12 and AR-42 until early
2009.
Conducting
clinical trials is a lengthy, time consuming and very expensive process and
the
results are inherently uncertain. The duration of clinical trials can vary
substantially according to the type, complexity, novelty and intended use of
the
product candidate. We estimate that clinical trials of our product candidates
will take at least several years to complete. The completion of clinical trials
for our product candidates may be delayed or prevented by many factors,
including:
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delays
in patient enrollment, and variability in the number and types of
patients
available for clinical trials;
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difficulty
in maintaining contact with patients after treatment, resulting in
incomplete data;
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poor
effectiveness of product candidates during clinical
trials;
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safety
issues, side effects, or other adverse
events;
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results
that do not demonstrate the safety or effectiveness of the product
candidates;
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governmental
or regulatory delays and changes in regulatory requirements, policy
and
guidelines; and
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varying
interpretation of data by the FDA.
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In
conducting clinical trials, we may fail to establish the effectiveness of a
compound for the targeted indication or discover that it is unsafe due to
unforeseen side effects or other reasons. Even if our clinical trials are
commenced and completed as planned, their results may not support our product
candidate claims. Further, failure of product candidate development can occur
at
any stage of the clinical trials, or even thereafter, and we could encounter
problems that cause us to abandon or repeat clinical trials. These problems
could interrupt, delay or halt clinical trials for our product candidates and
could result in FDA, or other regulatory authorities, delaying approval of
our
product candidates for any or all indications. The results from pre-clinical
testing and prior clinical trials may not be predictive of results obtained
in
later or other larger clinical trials. A number of companies in the
pharmaceutical industry have suffered significant setbacks in clinical trials,
even in advanced clinical trials after showing promising results in earlier
clinical trials. Our failure to adequately demonstrate the safety and
effectiveness of any of our product candidates will prevent us from receiving
regulatory approval to market these product candidates and will negatively
impact our business. In addition, we or the FDA may suspend or curtail our
clinical trials at any time if it appears that we are exposing participants
to
unacceptable health risks or if the FDA finds deficiencies in the conduct of
these clinical trials or in the composition, manufacture or administration
of
the product candidates. Accordingly, we cannot predict with any certainty when
or if we will ever be in a position to submit a new drug application, or NDA,
for any of our product candidates, or whether any such NDA would ever be
approved.
Our
products use novel alternative technologies and therapeutic approaches, which
have not been widely studied.
Our
product development efforts focus on novel therapeutic approaches and
technologies that have not been widely studied. These approaches and
technologies may not be successful. We are applying these approaches and
technologies in our attempt to discover new treatments for conditions that
are
also the subject of research and development efforts of many other
companies.
Physicians
and patients may not accept and use our drugs.
Even
if
the FDA approves our product candidates, physicians and patients may not accept
and use them. Acceptance and use of our product will depend upon a number of
factors including:
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perceptions
by members of the health care community, including physicians, about
the
safety and effectiveness of our
drugs;
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cost-effectiveness
of our products relative to competing
products;
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availability
of reimbursement for our products from government or other healthcare
payers; and
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effectiveness
of marketing and distribution efforts by us and our licensees and
distributors, if any.
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Because
we expect sales of our current product candidates, if approved, to generate
substantially all of our product revenues for the foreseeable future, the
failure of any of these drugs to find market acceptance would harm our business
and could require us to seek additional financing.
Because
we are dependent on clinical research institutions and other contractors for
clinical testing and for research and development activities, the results of
our
clinical trials and such research activities are, to a certain extent, beyond
our control.
We
depend
upon independent investigators and collaborators, such as universities and
medical institutions, to conduct our pre-clinical and clinical trials under
agreements with us. These parties are not our employees and we cannot control
the amount or timing of resources that they devote to our programs. These
investigators may not assign as great a priority to our programs or pursue
them
as diligently as we would if we were undertaking such programs ourselves. If
outside collaborators fail to devote sufficient time and resources to our drug
development programs, or if their performance is substandard, the approval
of
our FDA applications, if any, and our introduction of new drugs, if any, will
be
delayed. These collaborators may also have relationships with other commercial
entities, some of whom may compete with us. If our collaborators assist our
competitors at our expense, our competitive position would be harmed.
Our
reliance on third parties to formulate and manufacture our product candidates
exposes us to a number of risks that may delay the development, regulatory
approval and commercialization of our products or result in higher product
costs.
We
have
no experience in drug formulation or manufacturing and do not intend to
establish our own manufacturing facilities. We lack the resources and expertise
to formulate or manufacture our own product candidates. Instead, we will
contract with one or more manufacturers to manufacture, supply, store and
distribute drug supplies for our clinical trials. If any of our product
candidates receive FDA approval, we will rely on one or more third-party
contractors to manufacture our drugs. Our anticipated future reliance on a
limited number of third-party manufacturers exposes us to the following risks:
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We
may be unable to identify manufacturers on acceptable terms or at
all
because the number of potential manufacturers is limited and the
FDA must
approve any replacement contractor. This approval would require new
testing and compliance inspections. In addition, a new manufacturer
would
have to be educated in, or develop substantially equivalent processes
for,
production of our products after receipt of FDA approval, if
any.
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Our
third-party manufacturers might be unable to formulate and manufacture
our
drugs in the volume and of the quality required to meet our clinical
and/or commercial needs, if any.
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Our
future contract manufacturers may not perform as agreed or may not
remain
in the contract manufacturing business for the time required to supply
our
clinical trials or to successfully produce, store and distribute
our
products.
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Drug
manufacturers are subject to ongoing periodic unannounced inspection
by
the FDA and corresponding state agencies to ensure strict compliance
with
good manufacturing practice and other government regulations and
corresponding foreign standards. We do not have control over third-party
manufacturers’ compliance with these regulations and standards, but we
will be ultimately responsible for any of their
failures.
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If
any third-party manufacturer makes improvements in the manufacturing
process for our products, we may not own, or may have to share, the
intellectual property rights to the innovation. This may prohibit
us from
seeking alternative or additional manufacturers for our
products.
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Each
of
these risks could delay our clinical trials, the approval, if any, of our
product candidates by the FDA, or the commercialization of our product
candidates or result in higher costs or deprive us of potential product
revenues.
We
have no experience selling, marketing or distributing products and no internal
capability to do so.
We
currently have no sales, marketing or distribution capabilities. We do not
anticipate having resources in the foreseeable future to allocate to the sales
and marketing of our proposed products. Our future success depends, in part,
on
our ability to enter into and maintain sales and marketing collaborative
relationships, the collaborator’s strategic interest in the products under
development and such collaborator’s ability to successfully market and sell any
such products. We intend to pursue collaborative arrangements regarding the
sales and marketing of our products, however, there can be no assurance that
we
will be able to establish or maintain such collaborative arrangements, or if
able to do so, that they will have effective sales forces. To the extent that
we
decide not to, or are unable to, enter into collaborative arrangements with
respect to the sales and marketing of our proposed products, significant capital
expenditures, management resources and time will be required to establish and
develop an in-house marketing and sales force with technical expertise. There
can also be no assurance that we will be able to establish or maintain
relationships with third-party collaborators or develop in-house sales and
distribution capabilities. To the extent that we depend on third parties for
marketing and distribution, any revenues we receive will depend upon the efforts
of such third parties, and there can be no assurance that such efforts will
be
successful. In addition, there can also be no assurance that we will be able
to
market and sell our product in the U.S. or overseas.
If
we cannot compete successfully for market share against other drug companies,
we
may not achieve sufficient product revenues and our business will
suffer.
The
market for our product candidates is characterized by intense competition and
rapid technological advances. If our product candidates receive FDA approval,
they will compete with a number of existing and future drugs and therapies
developed, manufactured and marketed by others. Existing or future competing
products may provide greater therapeutic convenience or clinical or other
benefits for a specific indication than our products, or may offer comparable
performance at a lower cost. If our products fail to capture and maintain market
share, we may not achieve sufficient product revenues and our business will
suffer.
We
will
compete against fully integrated pharmaceutical companies and smaller companies
that are collaborating with larger pharmaceutical companies, academic
institutions, government agencies and other public and private research
organizations. Many of these competitors have technologies already approved
or
in development. In addition, many of these competitors, either alone or together
with their collaborative partners, operate larger research and development
programs and have substantially greater financial resources than we do, as
well
as significantly greater experience in:
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undertaking
pre-clinical testing and human clinical
trials;
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obtaining
FDA and other regulatory approvals of
drugs;
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formulating
and manufacturing drugs; and
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launching,
marketing and selling drugs.
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Developments
by competitors may render our products or technologies obsolete or
non-competitive
.
The
biotechnology and pharmaceutical industries are intensely competitive and
subject to rapid and significant technological change. The drugs that we are
attempting to develop will have to compete with existing therapies. In addition,
a large number of companies are pursuing the development of pharmaceuticals
that
target the same diseases and conditions that we are targeting. We face
competition from pharmaceutical and biotechnology companies in the U.S. and
abroad. In addition, companies pursuing different but related fields represent
substantial competition. Many of these organizations competing with us have
substantially greater capital resources, larger research and development staffs
and facilities, longer drug development history in obtaining regulatory
approvals and greater manufacturing and marketing capabilities than we do.
These
organizations also compete with us to attract qualified personnel and parties
for acquisitions, joint ventures or other collaborations.
Our
ability to generate product revenues will be diminished if our drugs sell for
inadequate prices or patients are unable to obtain adequate levels of
reimbursement.
Our
ability to commercialize our drugs, alone or with collaborators, will depend
in
part on the extent to which reimbursement will be available from:
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government
and health administration
authorities;
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private
health maintenance organizations and health insurers;
and
|
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other
healthcare payers.
|
Significant
uncertainty exists as to the reimbursement status of newly approved healthcare
products. Healthcare payers, including Medicare, are challenging the prices
charged for medical products and services. Government and other healthcare
payers increasingly attempt to contain healthcare costs by limiting both
coverage and the level of reimbursement for drugs. Even if our product
candidates are approved by the FDA, insurance coverage may not be available,
and
reimbursement levels may be inadequate, to cover our drugs. If government and
other healthcare payers do not provide adequate coverage and reimbursement
levels for any of our products, once approved, market acceptance of our products
could be reduced.
Risks
Related to Our Intellectual Property
If
we fail to protect or enforce our intellectual property rights adequately or
secure rights to patents of others, the value of our intellectual property
rights would diminish.
Our
success, competitive position and future revenues will depend in part on our
ability and the abilities of our licensors to obtain and maintain patent
protection for our products, methods, processes and other technologies, to
preserve our trade secrets, to prevent third parties from infringing on our
proprietary rights and to operate without infringing upon the proprietary rights
of third parties. Additionally, if any third-party manufacturer makes
improvements in the manufacturing process for our products, we may not own,
or
may have to share, the intellectual property rights to the
innovation.
To
date,
we hold certain exclusive rights under U.S. patents and patent applications
as
well as rights under foreign patent applications. We anticipate filing
additional patent applications both in the U.S. and in other countries, as
appropriate. However, we cannot predict:
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the
degree and range of protection any patents will afford us against
competitors including whether third parties will find ways to invalidate
or otherwise circumvent our
patents;
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|
·
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if
and when patents will issue;
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|
·
|
whether
or not others will obtain patents claiming aspects similar to those
covered by our patents and patent applications;
or
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|
·
|
whether
we will need to initiate litigation or administrative proceedings
which
may be costly whether we win or
lose.
|
If
any of our trade secrets, know-how or other proprietary information is
disclosed, the value of our trade secrets, know-how and other proprietary rights
would be significantly impaired and our business and competitive position would
suffer.
Our
success also depends upon the skills, knowledge and experience of our scientific
and technical personnel, our consultants and advisors as well as our licensors
and contractors. To help protect our proprietary know-how and our inventions
for
which patents may be unobtainable or difficult to obtain, we rely on trade
secret protection and confidentiality agreements. To this end, we require all
of
our employees, consultants, advisors and contractors to enter into agreements
which prohibit the disclosure of confidential information and, where applicable,
require disclosure and assignment to us of the ideas, developments, discoveries
and inventions important to our business. These agreements may not provide
adequate protection for our trade secrets, know-how or other proprietary
information in the event of any unauthorized use or disclosure or the lawful
development by others of such information. If any of our trade secrets, know-how
or other proprietary information is disclosed, the value of our trade secrets,
know-how and other proprietary rights would be significantly impaired and our
business and competitive position would suffer.
If
we infringe upon the rights of third parties we could be prevented from selling
products, forced to pay damages, and defend against
litigation.
If
our
products, methods, processes and other technologies infringe upon the
proprietary rights of other parties, we could incur substantial costs and we
may
have to:
|
·
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obtain
licenses, which may not be available on commercially reasonable terms,
if
at all;
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|
·
|
redesign
our products or processes to avoid
infringement;
|
|
·
|
stop
using the subject matter claimed in the patents held by
others;
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|
·
|
defend
litigation or administrative proceedings which may be costly whether
we
win or lose, and which could result in a substantial diversion of
our
valuable management resources.
|
If
requirements under our license agreements are not met, we could suffer
significant harm, including losing rights to our
products.
We
depend
on licensing agreements with third parties to maintain the intellectual property
rights to our products under development. Presently, we have licensed rights
from the University of Pittsburgh and The Ohio State University Research
Foundation. These agreements require us and our licensors to perform certain
obligations that affect our rights under these licensing agreements. All of
these agreements last either throughout the life of the patents, or with respect
to other licensed technology, for a number of years after the first commercial
sale of the relevant product.
In
addition, we are responsible for the cost of filing and prosecuting certain
patent applications and maintaining certain issued patents licensed to us.
If we
do not meet our obligations under our license agreements in a timely manner,
we
could lose the rights to our proprietary technology.
Finally,
we may be required to obtain licenses to patents or other proprietary rights
of
third parties in connection with the development and use of our products and
technologies. Licenses required under any such patents or proprietary rights
might not be made available on terms acceptable to us, if at all.
Risks
Related to Our Securities
Because
we became public by means of a reverse merger, we may not be able to attract
the
attention of major brokerage firms.
Additional
risks may exist since we became public through a “reverse merger.” Security
analysts of major brokerage firms may not provide coverage of us since there
is
no incentive to brokerage firms to recommend the purchase of our common stock.
No assurance can be given that brokerage firms will want to conduct any
secondary offerings on behalf of our company in the future. The lack of such
analyst coverage may decrease the public demand for our common stock, making
it
more difficult for you to resell your shares when you deem
appropriate.
Our
common stock is considered “a penny stock.”
The
SEC
has adopted regulations which generally define “penny stock” to be an equity
security that has a market price of less than $5.00 per share, subject to
specific exemptions. Since trading of our common stock commenced on the OTC
Bulletin Board, the market price has been below $5.00 per share. Therefore,
our
common stock is deemed a “penny stock” according to SEC rules. This designation
requires any broker or dealer selling these securities to disclose certain
information concerning the transaction, obtain a written agreement from the
purchaser and determine that the purchaser is reasonably suitable to purchase
the securities. These rules may restrict the ability of brokers or dealers
to
sell shares of our common stock.
Because
we do not expect to pay dividends, you will not realize any income from an
investment in our common stock unless and until you sell your shares at
profit.
We
have
never paid dividends on our common stock and do not anticipate paying any
dividends for the foreseeable future. You should not rely on an investment
in
our common stock if you require dividend income. Further, you will only realize
income on an investment in our shares in the event you sell or otherwise dispose
of your shares at a price higher than the price you paid for your shares. Such
a
gain would result only from an increase in the market price of our common stock,
which is uncertain and unpredictable.
There
may be issuances of shares of blank check preferred stock in the
future.
Our
certificate of incorporation authorizes the issuance of up to 20,000,000 shares
of preferred stock, none of which are issued or currently outstanding. Our
board
of directors will have the authority to fix and determine the relative rights
and preferences of preferred shares, as well as the authority to issue such
shares, without further stockholder approval. As a result, our board of
directors could authorize the issuance of a series of preferred stock that
is
senior to our common stock and that would grant to holders preferred rights
to
our assets upon liquidation, the right to receive dividends, additional
registration rights, anti-dilution protection, the right to the redemption
to
such shares, together with other rights, none of which will be afforded holders
of our common stock.
If
our results do not meet analysts’ forecasts and expectations, our stock price
could decline.
In
the
future, analysts who cover our business and operations may provide valuations
regarding our stock price and make recommendations whether to buy, hold or
sell
our stock. Our stock price may be dependent upon such valuations and
recommendations. Analysts’ valuations and recommendations are based primarily on
our reported results and their forecasts and expectations concerning our future
results regarding, for example, expenses, revenues, clinical trials, regulatory
marketing approvals and competition. Our future results are subject to
substantial uncertainty, and we may fail to meet or exceed analysts’ forecasts
and expectations as a result of a number of factors, including those discussed
above under the sections “Risks Related to Our Business” and “Risks Related to
the Clinical Testing, Regulatory Approval, Manufacturing and Commercialization
of Our Product Candidates.” If our results do not meet analysts’ forecasts and
expectations, our stock price could decline as a result of analysts lowering
their valuations and recommendations or otherwise.
We
cannot assure you that our common stock will ever be listed on NASDAQ or any
other securities exchange.
Our
common stock trades on the OTC Bulletin Board. Stocks traded on the OTC Bulletin
Board and other electronic over-the-counter markets are often less liquid than
stocks traded on national securities exchanges. We plan to seek listing on
NASDAQ or the American Stock Exchange in the future, but we cannot assure you
that we will be able to meet the initial listing standards of either of those
or
any other stock exchange, or that we will be able to maintain a listing of
our
common stock on either of those or any other stock exchange. To the extent
that
our common stock is not traded on a national securities exchange, such as the
NASDAQ, the decreased liquidity of our common stock may make it more difficult
to sell your shares at desirable times and at prices.
We
are at risk of securities class action litigation.
In
the
past, securities class action litigation has often been brought against a
company following a decline in the market price of its securities. This risk
is
especially relevant for us because biotechnology companies have experienced
greater than average stock price volatility in recent years. If we faced such
litigation, it could result in substantial costs and a diversion of our
management’s attention and resources, which could harm our
business.
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.
None.
Item 6.
Exhibits
Exhibit Number
|
|
Description of Document
|
10.1
|
|
Employment
Agreement dated August 19, 2008 between Arno Therapeutics, Inc. and
Roger
G. Berlin (incorporated by reference to Exhibit 10.1 of the Registrant’s
Form 8-K filed September 3, 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: November
14, 2008
|
|
By:
|
/s/ Roger
G. Berlin
|
|
|
|
|
Roger
G. Berlin, M.D.
|
|
|
|
|
Chief
Executive Officer
|
|
|
|
|
(Principal
Executive Officer)
|
|
|
|
|
Date: November
14, 2008
|
|
By:
|
/s/ Brian
Lenz
|
|
|
|
|
Brian
Lenz
|
|
|
|
|
Chief
Financial Officer
|
|
|
|
|
(Principal
Financial and Accounting
Officer)
|
INDEX
OF EXHIBITS FILED WITH THIS REPORT
Exhibit No.
|
|
Exhibit Description
|
|
|
|
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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