Item 1. Financial
Statements.
ARNO THERAPUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONDENSED BALANCE SHEETS
|
|
June 30, 2013
|
|
|
December 31, 2012
|
|
|
|
(unaudited)
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
Current assets
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
4,554,390
|
|
|
$
|
10,943,437
|
|
Prepaid expenses and other current assets
|
|
|
168,296
|
|
|
|
203,516
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
4,722,686
|
|
|
|
11,146,953
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
18,158
|
|
|
|
24,837
|
|
Deferred financing fees
|
|
|
1,416,468
|
|
|
|
1,709,530
|
|
Security deposit
|
|
|
10,455
|
|
|
|
10,455
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
6,167,767
|
|
|
$
|
12,891,775
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
2,180,766
|
|
|
$
|
1,553,154
|
|
Accrued expenses and other current liabilities
|
|
|
647,980
|
|
|
|
1,652,159
|
|
Due to related party
|
|
|
27,874
|
|
|
|
28,268
|
|
Deferred rent
|
|
|
10,378
|
|
|
|
12,711
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
2,866,998
|
|
|
|
3,246,292
|
|
|
|
|
|
|
|
|
|
|
Convertible debentures, net
|
|
|
3,288,960
|
|
|
|
491,039
|
|
Accrued interest
|
|
|
489,200
|
|
|
|
-
|
|
Derivative liabilities
|
|
|
22,401,235
|
|
|
|
21,420,276
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
29,046,393
|
|
|
|
25,157,607
|
|
|
|
|
|
|
|
|
|
|
COMMITMENTS AND CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS' (DEFICIT) EQUITY
|
|
|
|
|
|
|
|
|
Preferred stock, $0.0001 par value, 35,000,000 shares authorized, none issued and outstanding
|
|
|
-
|
|
|
|
-
|
|
Common stock, $0.0001 par value, 500,000,000 shares authorized, 39,453,675 and 36,364,942 shares issued and outstanding
|
|
|
3,920
|
|
|
|
3,611
|
|
Additional paid-in capital
|
|
|
39,256,954
|
|
|
|
37,631,339
|
|
Deficit accumulated during the development stage
|
|
|
(62,139,500
|
)
|
|
|
(49,900,782
|
)
|
|
|
|
|
|
|
|
|
|
Total stockholders' (deficit) equity
|
|
|
(22,878,626
|
)
|
|
|
(12,265,832
|
)
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders' (deficit) equity
|
|
$
|
6,167,767
|
|
|
$
|
12,891,775
|
|
See accompanying notes to the unaudited
condensed financial statements.
ARNO THERAPUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONDENSED STATEMENTS OF OPERATIONS
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from
|
|
|
|
Three months ended June 30,
|
|
|
Six months ended June 30,
|
|
|
August 1, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(inception) to
|
|
|
|
2013
|
|
|
2012
|
|
|
2013
|
|
|
2012
|
|
|
June 30, 2013
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
2,741,756
|
|
|
$
|
2,341,092
|
|
|
$
|
5,734,787
|
|
|
$
|
4,218,685
|
|
|
$
|
42,579,995
|
|
General and administrative
|
|
|
668,011
|
|
|
|
536,713
|
|
|
|
1,519,848
|
|
|
|
1,154,181
|
|
|
|
10,862,460
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
3,409,767
|
|
|
|
2,877,805
|
|
|
|
7,254,635
|
|
|
|
5,372,866
|
|
|
|
53,442,455
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(3,409,767
|
)
|
|
|
(2,877,805
|
)
|
|
|
(7,254,635
|
)
|
|
|
(5,372,866
|
)
|
|
|
(53,442,455
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (expense) income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
2,932
|
|
|
|
1,852
|
|
|
|
6,992
|
|
|
|
5,240
|
|
|
|
421,112
|
|
Interest expense
|
|
|
(1,858,887
|
)
|
|
|
-
|
|
|
|
(4,017,608
|
)
|
|
|
|
|
|
|
(11,638,736
|
)
|
Other (expense) income
|
|
|
(6,039,108
|
)
|
|
|
2,600,647
|
|
|
|
(973,467
|
)
|
|
|
2,523,689
|
|
|
|
2,520,579
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other (expense) income
|
|
|
(7,895,063
|
)
|
|
|
2,602,499
|
|
|
|
(4,984,083
|
)
|
|
|
2,528,929
|
|
|
|
(8,697,045
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(11,304,830
|
)
|
|
$
|
(275,306
|
)
|
|
$
|
(12,238,718
|
)
|
|
$
|
(2,843,937
|
)
|
|
$
|
(62,139,500
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and diluted
|
|
$
|
(0.29
|
)
|
|
$
|
(0.01
|
)
|
|
$
|
(0.33
|
)
|
|
$
|
(0.08
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares outstanding-basic and diluted
|
|
|
38,518,577
|
|
|
|
36,306,261
|
|
|
|
37,475,070
|
|
|
|
36,305,601
|
|
|
|
|
|
See accompanying notes to the unaudited
condensed financial statements.
ARNO THERAPEUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONDENSED STATEMENT OF STOCKHOLDERS’
(DEFICIT) EQUITY
PERIOD FROM AUGUST 1, 2005 (INCEPTION) TO
JUNE 30, 2013
(unaudited)
|
|
PREFERRED
STOCK
|
|
|
COMMON
STOCK
|
|
|
|
|
|
|
|
|
|
|
|
|
SHARES
|
|
|
AMOUNT
|
|
|
SHARES
|
|
|
AMOUNT
|
|
|
ADDITIONAL
PAID-IN
CAPITAL
|
|
|
DEFICIT
ACCUMULATED
DURING THE
DEVELOPMENT
STAGE
|
|
|
TOTAL
STOCKHOLDERS'
EQUITY (DEFICIT)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common shares to
founders at $0.0001 per share
|
|
|
-
|
|
|
$
|
-
|
|
|
|
9,968,797
|
|
|
$
|
997
|
|
|
$
|
4,003
|
|
|
$
|
-
|
|
|
$
|
5,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation for services
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
9,700
|
|
|
|
-
|
|
|
|
9,700
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss, period from
August 1, 2005 (inception) through December 31, 2006
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(370,893
|
)
|
|
|
(370,893
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006
|
|
|
-
|
|
|
|
-
|
|
|
|
9,968,797
|
|
|
|
997
|
|
|
|
13,703
|
|
|
|
(370,893
|
)
|
|
|
(356,193
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation for services
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
88,300
|
|
|
|
-
|
|
|
|
88,300
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss, year ended December 31, 2007
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(3,359,697
|
)
|
|
|
(3,359,697
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation for services
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,131,218
|
|
|
|
-
|
|
|
|
1,131,218
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss, year ended December 31, 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(12,913,566
|
)
|
|
|
(12,913,566
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008
|
|
|
-
|
|
|
|
-
|
|
|
|
20,392,024
|
|
|
|
2,039
|
|
|
|
24,504,525
|
|
|
|
(16,644,156
|
)
|
|
|
7,862,408
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation for services
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
647,448
|
|
|
|
-
|
|
|
|
647,448
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock option exercise
|
|
|
-
|
|
|
|
-
|
|
|
|
20,000
|
|
|
|
2
|
|
|
|
2,598
|
|
|
|
-
|
|
|
|
2,600
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss, year ended December 31, 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,936,705
|
)
|
|
|
(6,936,705
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009
|
|
|
-
|
|
|
|
-
|
|
|
|
20,412,024
|
|
|
|
2,041
|
|
|
|
25,154,571
|
|
|
|
(23,580,861
|
)
|
|
|
1,575,751
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation for services
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
249,286
|
|
|
|
-
|
|
|
|
249,286
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible preferred
units issued in private placement, net of issuance costs of $1,299,770
|
|
|
15,274,000
|
|
|
|
1,527
|
|
|
|
-
|
|
|
|
-
|
|
|
|
13,507,983
|
|
|
|
-
|
|
|
|
13,509,510
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants issued in connection
with convertible preferred units issued in private placement
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(3,340,421
|
)
|
|
|
-
|
|
|
|
(3,340,421
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants issues to placement
agents in connection with private placement
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
464,720
|
|
|
|
-
|
|
|
|
464,720
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss, year ended December 31, 2010
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(4,023,026
|
)
|
|
|
(4,023,026
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2010
|
|
|
15,274,000
|
|
|
|
1,527
|
|
|
|
20,412,024
|
|
|
|
2,041
|
|
|
|
36,036,139
|
|
|
|
(27,603,887
|
)
|
|
|
8,435,820
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation for services
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
707,284
|
|
|
|
-
|
|
|
|
707,284
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock conversion
|
|
|
(15,274,000
|
)
|
|
|
(1,527
|
)
|
|
|
15,274,000
|
|
|
|
1,527
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of stock dividend
in connection with conversion of preferred stock
|
|
|
-
|
|
|
|
-
|
|
|
|
319,074
|
|
|
|
32
|
|
|
|
(32
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant of restricted shares
|
|
|
-
|
|
|
|
-
|
|
|
|
250,000
|
|
|
|
-
|
|
|
|
115,168
|
|
|
|
-
|
|
|
|
115,168
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock option exercise
|
|
|
-
|
|
|
|
-
|
|
|
|
49,844
|
|
|
|
5
|
|
|
|
6,475
|
|
|
|
-
|
|
|
|
6,480
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss, year ended December 31, 2011
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(7,909,113
|
)
|
|
|
(7,909,113
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2011
|
|
|
-
|
|
|
|
-
|
|
|
|
36,304,942
|
|
|
|
3,605
|
|
|
|
36,865,034
|
|
|
|
(35,513,000
|
)
|
|
|
1,355,639
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation for services
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
722,811
|
|
|
|
-
|
|
|
|
722,811
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common shares
pursuant to placement agent agreement
|
|
|
-
|
|
|
|
-
|
|
|
|
60,000
|
|
|
|
6
|
|
|
|
43,494
|
|
|
|
-
|
|
|
|
43,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss, year ended December 31, 2012
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(14,387,782
|
)
|
|
|
(14,387,782
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2012
|
|
|
-
|
|
|
|
-
|
|
|
|
36,364,942
|
|
|
|
3,611
|
|
|
|
37,631,339
|
|
|
|
(49,900,782
|
)
|
|
|
(12,265,832
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation for services
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
699,298
|
|
|
|
-
|
|
|
|
699,298
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common shares
in lieu of liquidated damages
|
|
|
-
|
|
|
|
-
|
|
|
|
3,045,013
|
|
|
|
305
|
|
|
|
913,205
|
|
|
|
-
|
|
|
|
913,510
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common shares upon debenture conversion
|
|
|
-
|
|
|
|
-
|
|
|
|
43,720
|
|
|
|
4
|
|
|
|
13,112
|
|
|
|
-
|
|
|
|
13,116
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss, six months ended June, 2013
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(12,238,718
|
)
|
|
|
(12,238,718
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2013
|
|
|
-
|
|
|
$
|
-
|
|
|
|
39,453,675
|
|
|
$
|
3,920
|
|
|
$
|
39,256,954
|
|
|
$
|
(62,139,500
|
)
|
|
$
|
(22,878,626
|
)
|
See accompanying notes to the unaudited
condensed financial statements.
ARNO THERAPEUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONDENSED STATEMENTS OF CASH FLOWS
(unaudited)
|
|
|
|
|
|
|
|
Period from
|
|
|
|
Six months ended June 30,
|
|
|
August 1, 2005
|
|
|
|
|
|
|
|
|
|
(inception) to
|
|
|
|
2013
|
|
|
2012
|
|
|
June 30, 2013
|
|
Cash flows from operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(12,238,718
|
)
|
|
$
|
(2,843,937
|
)
|
|
$
|
(62,139,500
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustment to reconcile net loss to net cash used in operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
6,679
|
|
|
|
6,916
|
|
|
|
121,659
|
|
Stock-based compensation
|
|
|
699,298
|
|
|
|
361,598
|
|
|
|
4,370,513
|
|
Change in fair value of derivative liability
|
|
|
980,959
|
|
|
|
(2,522,042
|
)
|
|
|
(1,460,740
|
)
|
Write-off of intangible assets
|
|
|
-
|
|
|
|
-
|
|
|
|
85,125
|
|
Warrants issued for services
|
|
|
-
|
|
|
|
-
|
|
|
|
480,400
|
|
Warrants issued in connection with note conversion
|
|
|
-
|
|
|
|
-
|
|
|
|
348,000
|
|
Note discount arising from beneficial conversion feature
|
|
|
-
|
|
|
|
-
|
|
|
|
475,391
|
|
Deferred rent
|
|
|
(2,333
|
)
|
|
|
6,896
|
|
|
|
10,378
|
|
Loss on disposal of assets
|
|
|
-
|
|
|
|
-
|
|
|
|
5,357
|
|
Noncash interest expense
|
|
|
4,497,357
|
|
|
|
-
|
|
|
|
11,064,871
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in operating assets and liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets
|
|
|
35,220
|
|
|
|
198,645
|
|
|
|
(168,296
|
)
|
Security deposit
|
|
|
-
|
|
|
|
-
|
|
|
|
(10,455
|
)
|
Accounts payable
|
|
|
627,612
|
|
|
|
59,177
|
|
|
|
2,180,766
|
|
Accrued expenses
|
|
|
(994,727
|
)
|
|
|
175,149
|
|
|
|
63,144
|
|
Due to related party
|
|
|
(394
|
)
|
|
|
(64,844
|
)
|
|
|
27,874
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(6,389,047
|
)
|
|
|
(4,622,442
|
)
|
|
|
(44,545,513
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment
|
|
|
-
|
|
|
|
-
|
|
|
|
(100,174
|
)
|
Cash paid for intangible assets
|
|
|
-
|
|
|
|
-
|
|
|
|
(85,125
|
)
|
Proceeds from related party advance
|
|
|
-
|
|
|
|
-
|
|
|
|
525,000
|
|
Repayment of related party advance
|
|
|
-
|
|
|
|
-
|
|
|
|
(525,000
|
)
|
Net cash used in investing activities
|
|
|
-
|
|
|
|
-
|
|
|
|
(185,299
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock to founders
|
|
|
-
|
|
|
|
-
|
|
|
|
5,000
|
|
Proceeds from issuance of preferred stock in private placement, net
|
|
|
-
|
|
|
|
-
|
|
|
|
13,974,230
|
|
Proceeds from issuance of common stock in private placement, net
|
|
|
-
|
|
|
|
-
|
|
|
|
17,690,037
|
|
Deferred financing fees paid
|
|
|
-
|
|
|
|
-
|
|
|
|
(1,217,345
|
)
|
Proceeds from issuance of notes payable
|
|
|
-
|
|
|
|
-
|
|
|
|
1,000,000
|
|
Repayment of notes payable
|
|
|
-
|
|
|
|
-
|
|
|
|
(1,000,000
|
)
|
Proceeds from issuance of convertible notes payable
|
|
|
-
|
|
|
|
-
|
|
|
|
3,967,000
|
|
Proceeds from issuance of convertible debentures payable
|
|
|
-
|
|
|
|
-
|
|
|
|
14,857,200
|
|
Proceeds from exercise of stock options
|
|
|
-
|
|
|
|
-
|
|
|
|
9,080
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
-
|
|
|
|
-
|
|
|
|
49,285,202
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
(6,389,047
|
)
|
|
|
(4,622,442
|
)
|
|
|
4,554,390
|
|
Cash and cash equivalents at beginning of period
|
|
|
10,943,437
|
|
|
|
6,678,344
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
4,554,390
|
|
|
$
|
2,055,902
|
|
|
$
|
4,554,390
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental schedule of cash flows information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
$
|
63,088
|
|
|
$
|
-
|
|
|
$
|
248,122
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental schedule of non-cash investing and financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of debentures into common stock
|
|
$
|
13,116
|
|
|
$
|
-
|
|
|
$
|
13,116
|
|
Conversion of notes payable and interest to common stock
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
4,278,518
|
|
Common shares of Laurier issued in reverse merger transaction
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
110
|
|
Issuance of common shares in lieu of liquidated damages
|
|
$
|
913,510
|
|
|
$
|
-
|
|
|
$
|
913,510
|
|
Issuance of warrants in connection with private placement of convertible preferred units
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
3,340,421
|
|
Issuance of warrants in connection with private placement of convertible debentures
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
12,973,055
|
|
Issuance of common stock pursuant to placement agent agreement
|
|
$
|
-
|
|
|
$
|
28,500
|
|
|
$
|
43,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock dividends settled in common stock
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
319,074
|
|
See accompanying notes to the unaudited
condensed financial statements.
ARNO THERAPEUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
June 30, 2013
(unaudited)
1. DESCRIPTION OF BUSINESS
Arno Therapeutics, Inc. (“Arno”
or the “Company”) develops innovative drug candidates for the treatment of patients with cancer. The following is a
summary of the Company’s product development pipeline:
|
·
|
Onapristone
–
Onapristone is an anti-progestin
hormone blocker that has been shown to have anti-tumor activity in patients with breast cancer. In prior clinical studies, onapristone
has demonstrated a 56% objective response rate as a first line “hormone” treatment of breast cancer. In connection
with the development of onapristone, the Company has engaged Clarient Diagnostic Services, Inc. to develop a diagnostic product
to selectively identify patients who express the activated form of the progesterone receptor and therefore may be more likely to
benefit from treatment with onapristone. The Company completed initial pre-clinical toxicology studies enabling the submission
of an Investigational Medicinal Product Dossier (“IMPD”), the foreign equivalent of an investigational new drug application
(“IND”) in the second quarter of 2013. The IMPD was accepted on July 31, 2013. The Company has completed
manufacturing activities of onapristone Phase I study supplies and plans on initiating a Phase I study in patients with progesterone
receptor positive carcinomas during the second half of 2013.
|
|
·
|
AR-42
– AR-42 is an orally available, broad spectrum
inhibitor of both histone and non-histone deacetylation proteins, or Pan-DAC, which play an important role in the regulation of
gene expression, cell growth and survival. AR-42 is currently being studied in an investigator-initiated Phase I/II clinical
study in adult subjects with relapsed or refractory multiple myeloma, chronic lymphocytic leukemia, or CLL, or lymphoma. The protocol
has been amended to include a solid tumor dose escalation cohort which is currently closed to accrual and is being amended to include
additional patients with solid tumors at the recommended phase 2 dose. The Company plans on supporting an investigator initiated
Phase I study of AR-42 in combination with decitabine in patients with hematological malignancies during the second half of 2013.
|
|
·
|
AR-12
– AR-12 is an orally available, targeted
anti-cancer agent that has been shown in pre-clinical studies to inhibit phosphoinositide dependent protein kinase-1, or PDK-1,
a protein in the PI3K/Akt pathway that is involved in the growth and proliferation of cells, including cancer cells. AR-12 has
also been reported to cause cell death through the induction of endoplasmic reticulum stress and work is ongoing to further understand
the mechanism of action. The Company has completed a multi-centered Phase I clinical study of AR-12 in adult subjects
with advanced or recurrent solid tumors or lymphoma. During the first quarter of 2013, the last study subject completed the planned
dose-escalation phase of the study.
|
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 formed on August 1, 2005 (“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
was a non-operating shell company prior to the Merger. 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. Upon
completion of the Merger, the Company adopted Old Arno’s business plan.
ARNO THERAPEUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
June 30, 2013
(unaudited)
2. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
The Company is a development stage enterprise
since it has not yet generated any revenue from the sale of products and, through June 30, 2013, its 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 Accounting Standards Codification
(“ASC”) 915, “Development Stage Entities.” The Company has experienced net losses since its inception and
has an accumulated deficit of approximately $62.1 million at June 30, 2013. The Company expects to incur substantial and increasing
losses and to have negative net cash flows from operating activities as it expands its technology portfolio and engages in further
research and development activities, particularly from conducting manufacturing activities, pre-clinical studies and clinical trials.
The accompanying unaudited Condensed Financial
Statements have been prepared in accordance with generally accepted accounting principles for interim financial information and
with the instructions to Form 10-Q adopted under the Securities Exchange Act of 1934, as amended. Accordingly, they do not include
all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete
financial statements. In the opinion of Arno’s management, the accompanying Condensed Financial Statements contain all adjustments
(consisting of normal recurring accruals and adjustments) necessary to present fairly the financial position, results of operations
and cash flows of the Company at the dates and for the periods indicated. The interim results for the period ended June 30, 2013
are not necessarily indicative of results for the full 2013 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 unaudited Condensed Financial Statements
have been prepared by management and should be read in conjunction with the financial statements and notes thereto included in
the Company’s Annual Report on Form 10-K for the year ended December 31, 2012, as filed with the Securities and Exchange
Commission.
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.
Research and Development
Research and development costs are charged
to expense as incurred. Research and development includes employee costs, 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 office, insurance, depreciation, 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. The Company adjusts its accruals when actual costs become known. Costs related to
the acquisition of technology rights for which development work is still in process are charged to operations as incurred and considered
a component of research and development expense.
ARNO THERAPEUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
June 30, 2013
(unaudited)
2. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
(Continued)
Convertible Debentures and Warrant Liability
The Company accounts for the convertible
debentures and warrants issued in connection with the 2012 Purchase Agreement (see Note 6) and for the warrants issued in connection
with the 2010 Purchase Agreement (see Note 8) in accordance with the guidance on Accounting for Certain Financial Instruments with
Characteristics of both Liabilities and Equity, which provides that the Company classify the warrant instrument as a liability
at its fair value and adjusts the instrument to fair value at each reporting period. This liability is subject to re-measurement
at each balance sheet date until exercised, and any change in fair value is recognized as a component of other income or expense.
The fair value of warrants issued by the Company, in connection with private placements of securities, has been estimated using
a Monte Carlo simulation model and, in doing so, the Company’s management utilized a third-party valuation report. The Monte
Carlo simulation is a generally accepted statistical method used to generate a defined number of stock price paths in order to
develop a reasonable estimate of the range of the Company’s future expected stock prices and minimizes standard error.
3. LIQUIDITY AND CAPITAL RESOURCES
Cash resources as of June 30, 2013 were
approximately $4.6 million, compared to approximately $10.9 million as of December 31, 2012. Based on its resources at June 30,
2013 and the current plan of expenditure on continuing development of the Company’s current product candidates, the Company
believes that it has sufficient capital to fund its operations through approximately the third quarter of 2013. However, the Company
will need substantial additional financing in order to fund its operations beyond such period and thereafter until it can achieve
profitability, if ever. The Company’s continued operations will depend on its ability to raise additional funds through various
potential sources, such as equity and debt financing, or to license its product candidates to another pharmaceutical company. The
Company will continue to fund operations from cash on hand and through sources of capital similar to those previously described.
The Company cannot assure that it will be able to secure such additional financing, or if available, that it will be sufficient
to meet its needs.
The success of the Company depends on its
ability to develop new products to the point of regulatory approval and subsequent revenue generation and, accordingly, to raise
enough capital to finance these developmental efforts. Management plans to raise additional capital either by selling shares of
its stock or other securities, issuing additional indebtedness or by licensing one or more of its products to finance the continued
operating and capital requirements of the Company. Amounts raised will be used to further develop the Company’s product candidates,
acquire rights to additional product candidates and for other working capital purposes. While the Company will extend its best
efforts to raise additional capital to fund all operations beyond the third quarter of 2013, management can provide no assurances
that the Company will be successful in raising sufficient funds.
In addition, to the extent that the Company
raises additional funds by issuing shares of its common stock or other securities convertible or exchangeable for shares of common
stock, stockholders may experience significant dilution. In the event the Company raises additional capital through debt financings,
the Company may incur significant interest expense and become subject to covenants in the related transaction documentation that
may affect the manner in which the Company conducts its business. To the extent that the Company raises additional funds through
collaboration and licensing arrangements, it may be necessary to relinquish some rights to its technologies or product candidates,
or grant licenses on terms that may not be favorable to the Company. Any or all of the foregoing may have a material adverse effect
on the Company’s business and financial performance.
These factors raise substantial doubt about
the Company's ability to continue as a going concern. The Company’s financial statements have been prepared on a going concern
basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business.
The financial statements do not include any adjustments that might result from the inability of the Company to continue as a going
concern.
ARNO THERAPEUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
June 30, 2013
(unaudited)
4. BASIC AND DILUTED LOSS 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 the Three Months Ended June 30,
|
|
|
|
|
|
|
|
|
For the Six Months Ended June 30,
|
|
|
|
|
|
|
|
|
|
2013
|
|
|
|
|
|
|
|
|
2012
|
|
|
|
|
|
|
|
|
2013
|
|
|
|
|
|
|
|
|
2012
|
|
|
|
|
|
|
Loss
|
|
|
Shares
|
|
|
Per Share
|
|
|
Loss
|
|
|
Shares
|
|
|
Per Share
|
|
|
Loss
|
|
|
Shares
|
|
|
Per Share
|
|
|
Loss
|
|
|
Shares
|
|
|
Per Share
|
|
|
|
(Numerator)
|
|
|
(Denominator)
|
|
|
Amount
|
|
|
(Numerator)
|
|
|
(Denominator)
|
|
|
Amount
|
|
|
(Numerator)
|
|
|
(Denominator)
|
|
|
Amount
|
|
|
(Numerator)
|
|
|
(Denominator)
|
|
|
Amount
|
|
Net loss
|
|
$
|
(11,304,830
|
)
|
|
|
|
|
|
|
|
|
|
$
|
(275,306
|
)
|
|
|
|
|
|
|
|
|
|
$
|
(12,238,718
|
)
|
|
|
|
|
|
|
|
|
|
$
|
(2,843,937
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted EPS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss available to common stockholders
|
|
$
|
(11,304,830
|
)
|
|
|
38,518,577
|
|
|
$
|
(0.29
|
)
|
|
$
|
(275,306
|
)
|
|
|
36,306,261
|
|
|
$
|
(0.01
|
)
|
|
$
|
(12,238,718
|
)
|
|
|
37,475,070
|
|
|
$
|
(0.33
|
)
|
|
$
|
(2,843,937
|
)
|
|
|
36,305,601
|
|
|
$
|
(0.08
|
)
|
For all periods presented, potentially
dilutive securities are excluded from the computation of fully diluted loss per share as their effect is anti-dilutive.
As of June 30, 2013, potentially dilutive
securities include:
Warrants to purchase common stock
|
|
|
51,794,003
|
|
Options to purchase common stock
|
|
|
5,907,879
|
|
Total potentially dilutive securities
|
|
|
57,701,882
|
|
There were no potentially dilutive securities
as of June 30, 2012.
For the three months ended June 30, 2013
and 2012, 58,330,500 and 14,968,048 options, warrants and convertible debentures have been excluded from the computation of potentially
dilutive securities, respectively, as their exercise prices are greater than the fair market price per common share as of June
30, 2013 and 2012, respectively.
5. INTANGIBLE ASSETS AND INTELLECTUAL PROPERTY
License Agreements
Onapristone License Agreement
The Company’s rights to onapristone
are governed by a license agreement with Invivis Pharmaceuticals, Inc. (“Invivis”), dated February 13, 2012. Under
this agreement, the Company holds an exclusive, royalty-bearing license for the rights to commercialize onapristone for all therapeutic
uses. The license agreement provides the Company with worldwide rights to onapristone with the exception of France; provided, however,
that the Company has an option to acquire French commercial rights from Invivis upon notice to Invivis together with additional
consideration.
The onapristone license agreement provides
the Company with exclusive, worldwide rights to a United States provisional patent application that relates to assays for predictive
biomarkers for anti-progestin efficacy. The Company intends to expand its patent portfolio by filing additional patent applications
covering the use of onapristone and/or a companion diagnostic product. If the pending patent application issues, the issued patent
would be scheduled to expire in 2031.
ARNO THERAPEUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
June 30, 2013
(unaudited)
5. INTANGIBLE ASSETS AND INTELLECTUAL PROPERTY
(Continued)
The Company made a one-time cash payment
of $500,000 to Invivis upon execution of the license agreement on February 13, 2012. Additionally, Invivis will receive performance-based
cash payments of up to an aggregate of $15.1 million upon successful completion of clinical and regulatory milestones relating
to onapristone, which milestones include the marketing approval of onapristone in multiple indications in the United States or
the European Union as well as Japan. The Company will make the first milestone payment to Invivis upon the dosing of the first
subject in the first Company-sponsored Phase I clinical trial of onapristone, which is anticipated in the fourth quarter 2013.
In addition, the Company will pay Invivis low single digit sales royalties based on net sales of onapristone by the Company or
any of its sublicensees. Pursuant to a separate services agreement, Invivis will provide the Company with certain clinical development
support services, which includes the assignment of up to two full-time employees to perform such services, in exchange for a monthly
cash payment.
Under the license agreement with Invivis,
the Company also agreed to indemnify and hold Invivis and its affiliates harmless from any and all claims arising out of or in
connection with the production, manufacture, sale, use, lease, consumption or advertisement of onapristone, provided, however,
that the Company shall have no obligation to indemnify Invivis for claims that (a) any patent rights infringe third party intellectual
property, (b) arise out of the gross negligence or willful misconduct of Invivis, or (c) result from a breach of any representation,
warranty confidentiality obligation of Invivis under the license agreement. The license agreement will terminate upon the later
of (i) the last to expire valid claim contained in the patent rights, and (ii) February 13, 2032. In general, Invivis may terminate
the license agreement at any time upon a material breach by the Company to the extent the Company fails to cure any such breach
within 90 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-12 and AR-42 for all therapeutic
uses.
In 2008, 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. Additionally, the Company is 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 license agreements for AR-12 and AR-42 provide for aggregate potential milestone payments of up to $6.1 million for AR-12,
of which $5.0 million is due only after marketing approval in the United States, Europe and Japan, and $5.1 million for AR-42,
of which $4.0 million is due only after marketing approval in the United States, Europe and Japan. In September 2009,
the Company paid Ohio State a milestone payment upon the commencement of the first Company-sponsored Phase I clinical study
of AR-12. The first milestone payment for AR-42 will be due when the first patient is dosed in the first Company-sponsored
clinical trial, which is not expected to occur in 2013 . Pursuant to the license agreements for AR-12 and AR-42, the Company
must pay Ohio State royalties on net sales of licensed products at rates in the low-single digits. To the extent the
Company enters into a sublicensing agreement relating to either or both of AR-12 or AR-42, the Company will be required to pay
Ohio State a portion of all non-royalty income received from such sublicensee. The Company does not expect to be required to make
any milestone payments under these license agreements during 2013.
ARNO THERAPEUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
June 30, 2013
(unaudited)
5. INTANGIBLE ASSETS AND INTELLECTUAL PROPERTY
(Continued)
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 the Company’s 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.
AR-67 License Agreement
In January 2012, the Company received a
notice from the University of Pittsburgh, (“Pitt”) claiming that the Company was in default under its license agreement
relating to AR-67 for failure to pay a $250,000 annual license fee under the terms of that agreement and providing the Company
with 60 days’ notice to remedy the default. On March 29, 2012, following the Company’s determination not to proceed
with further development of AR-67, the Company agreed with Pitt to terminate the license agreement. In February 2013, Pitt commenced
an action in the Court of Common Pleas of Allegheny County, Pennsylvania, seeking damages of $250,000, plus interest and costs,
based on its claim that the Company breached the license agreement by failing to pay the annual license fee. On March 28, 2013,
the Company entered into a settlement agreement with Pitt pursuant to which the Company agreed to pay $235,000 in full satisfaction
of all remaining obligations under the license agreement, which payment was made on April 2, 2013.
6. CONVERTIBLE DEBENTURES AND NOTES PAYABLE
On November 26, 2012, the Company entered
into a Securities Purchase Agreement, or the 2012 Purchase Agreement, with a number of institutional and accredited investors pursuant
to which the Company sold in a private placement an aggregate principal amount of $14,857,200 of three-year 8% Senior Convertible
Debentures, or the Debentures. In accordance with the 2012 Purchase Agreement, as amended on December 13, 2012, the Company also
issued five-year Series A warrants to purchase an aggregate of 49,524,003 shares of common stock at an initial exercise price of
$0.50 per share and 18-month Series B warrants to purchase an aggregate of 49,524,003 shares of common stock at an initial exercise
price of $0.30 per share. The sale of the Debentures and 2012 Warrants, which occurred in two closings on November 26, 2012 and
December 18, 2012, resulted in aggregate gross proceeds of approximately $14.9 million, before deducting placement agent fees and
other transaction-related expenses of approximately $1.2 million. The 2012 Warrants were valued at $12,430,524 on issuance and
recorded as a debt discount (see Note 7).
The conversion price of the Debentures is
subject to a “full-ratchet” anti-dilution provision, such that in the event the Company makes an issuance of common
stock (subject to customary exceptions) at a price per share less than the applicable exercise price of the Debentures, the applicable
conversion price will be reduced to the price per share applicable to such new issuance. However, after such time as the Company
has raised at least $12 million in subsequent equity financings, the conversion price of the Debentures will be subject to a customary
weighted-average price adjustment with respect to new issuances. This conversion feature of the Debentures is considered an embedded
derivative and was accounted for separately from the Debentures and was valued at $7,548,500 on issuance and recorded as a debt
discount (see Note 7).
ARNO THERAPEUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
June 30, 2013
(unaudited)
6. CONVERTIBLE DEBENTURES AND NOTES PAYABLE
(Continued)
The following table reflects the debt discount
for the 2012 Warrants and the embedded conversion feature of the Debentures at their fair values on issuance:
|
|
Issuance
|
|
Debentures, principal
|
|
|
14,857,200
|
|
2012 Warrant liability
|
|
|
(12,430,524
|
)
|
Debenture conversion feature
|
|
|
(7,548,500
|
)
|
|
|
|
(5,121,824
|
)
|
The excess fair value over proceeds on the
date of issuance of approximately $5.1 million was recorded in interest expense on the statement of operations on the issuance.
As of June 30, 2013 and December 31, 2012, the Company recorded amortization on the debt discount of $1.9 million and $0.5 million,
respectively, to interest expense.
Pursuant to the terms of a Registration
Rights Agreement entered into on November 26, 2012 in connection with the Company’s entry into the 2012 Purchase Agreement,
the Company agreed to file a registration statement under the Securities Act of 1933, as amended, covering the resale of: (i) 100%
of the shares of common stock issuable as payment of accrued interest under the Debentures and upon exercise of the Series A Warrants;
and (ii) 150% of the shares of common stock issuable upon conversion of the Debentures and upon exercise of the Series B Warrants
(collectively, the “Registrable Securities”). The Company further agreed to cause such registration statement to be
filed within 30 days following the date of the Registration Rights Agreement, or by December 26, 2012, and to cause such registration
statement to be declared effective within 60 days following the date of the Registration Rights Agreement, or by January 25, 2013,
or, if the registration statement was subject to review by the SEC, to cause such registration statement to be declared effective
within 120 days following the date of the Registration Rights Agreement, or by March 26, 2013. If such registration statement,
covering 100% of the Registrable Securities, was not declared effective by the SEC by the applicable date, the Company agreed to
pay liquidated damages to the investors in the amount of 2% of each investor’s aggregate investment amount per month until
the registration statement is declared effective or until such earlier time as the Registrable Securities may be traded pursuant
to Rule 144.
On December 26, 2012, the Company filed
a registration statement seeking to register 100% of the Registrable Securities. However, the SEC determined that the number of
shares the Company was seeking to register exceeded the limitations imposed by the SEC under Rule 415, and the Company was thus
unable to register a significant amount of the Registrable Securities. As a result of the SEC’s determination, the Company
amended the registration statement to reduce the number of Registrable Securities covered thereby by including only the shares
issuable upon exercise of the Series B Warrants. As amended, the registration statement was declared effective by the SEC on April
18, 2013. Accordingly, because a registration statement covering 100% of the Registrable Securities was not declared effective
by March 26, 2013, the investors each became entitled to liquidated damages in the amount of 2% of their investment amount per
month, payable on March 27, 2013 and on each monthly anniversary thereafter until the Registrable Securities may be traded pursuant
to Rule 144. Because Rule 144 became available to the investors six months after the applicable closing date, the Company was required
to pay the investors approximately three months’ of liquidated damages, or approximately $0.9 million in the aggregate.
ARNO THERAPEUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
June 30, 2013
(unaudited)
6. CONVERTIBLE DEBENTURES AND NOTES PAYABLE
(Continued)
On March 25, 2013, the Company and holders
of approximately 80% of the principal amount of Debentures entered into an amendment to the Registration Rights Agreement, permitting
the Company, in its sole discretion, to elect to pay liquidated damages resulting from the Company’s failure to successfully
cause the registration statement covering the resale of 100% of the Registrable Securities to be declared effective by the SEC
by March 26, 2013, by issuing shares of common stock in lieu of cash. If electing to issue shares in lieu of paying cash, the Company
shall issue to each investor a number of shares of common stock equal to (a) the aggregate amount of liquidated damages that the
Company is electing to pay to such investor in the form of shares, divided by (b) $0.30. Pursuant to the terms of the Registration
Rights Agreement, because holders of over two-thirds of the Debentures consented in writing to the March 25, 2013 amendment, such
amendment is binding on all holders of Registrable Securities. On March 27, 2013, in accordance with the amendment to the Registration
Rights Agreement, the Company issued an aggregate of 990,477 shares of common stock to the investors in lieu of an aggregate cash
payment of $297,144, representing the first installment of liquidated damages under the Registration Rights Agreement, as amended.
On April 29, 2013, in accordance with the amendment to the Registration Rights Agreement, the Company issued an aggregate of 1,092,291
shares of common stock to the investors in lieu of an aggregate cash payment of $327,688, representing the second installment of
liquidated damages under the Registration Rights Agreement, as amended.
In May 2013, the Company determined that
investors were entitled to additional liquidated damages arising from the issuance of convertible debt in 2012 in the amount of
$288,674. The Company has assessed that this amount should have been accrued in 2012 as part of the debt issuance. The Company
determined that the impact of not reflecting this in 2012 is not material to the 2012 financial statements and has reflected this
as interest expense in the first quarter of 2013. This expense resulted in the issuance of additional shares to the
investors and will thus be a non-cash charge. On May 27, 2013, the Company issued an aggregate of 962,245 shares of common stock
to the investors in lieu of an aggregate cash payment of $288,674, representing the third and final installment of liquidated damages
under the Registration Rights Agreement, as amended.
In late March 2013, the Company sought the
agreement of the Debenture holders to amend their respective Debentures to provide for the accrual of all interest payments under
such Debentures until the applicable maturity date in November or December of 2015, with such interest accruing at the rate of
8% per annum, compounding quarterly. As of June 30, 2013, the Company had entered into such amendments with the holders of Debentures
in the aggregate principal amount of $12,230,000. Assuming no additional Debenture holders elect to enter into such amendments,
the Company will continue to make quarterly interest payments in cash of approximately $52,544 to the holders of Debentures in
the aggregate principal amount of $2,627,200, less any conversions. The unpaid accrued interest of $244,600 per quarter will not
be payable until the fourth quarter of 2015.
7. FAIR VALUE OF FINANCIAL INSTRUMENTS
The Company defines fair value as the amount
at which an asset (or liability) could be bought (or incurred) or sold (or settled) in a current transaction between willing parties,
that is, other than in a forced or liquidation sale. The fair value estimates presented in the table below are based on information
available to the Company as of June 30, 2013.
ARNO THERAPEUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
June 30, 2013
(unaudited)
7. FAIR VALUE OF FINANCIAL INSTRUMENTS
(Continued)
The accounting standard regarding fair value
measurements discusses valuation techniques, such as the market approach (comparable market prices), the income approach (present
value of future income or cash flow), and the cost approach (cost to replace the service capacity of an asset or replacement cost).
The standard utilizes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into
three broad levels. The following is a brief description of those three levels:
|
•
|
Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities.
|
|
•
|
Level 2: Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These
include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or
liabilities in markets that are not active.
|
|
•
|
Level 3: Unobservable inputs that reflect the reporting entity’s own assumptions.
|
The Company has determined the fair value
of certain liabilities using the market approach: the following table presents the Company’s fair value hierarchy for these
assets measured at fair value on a recurring basis as of June 30, 2013:
|
|
|
|
|
Quoted Market
|
|
|
|
|
|
|
|
|
|
|
|
|
Prices in Active
|
|
|
Significant Other
|
|
|
Significant
|
|
|
|
Fair Value
|
|
|
Markets
|
|
|
Observable Inputs
|
|
|
Unobservable Inputs
|
|
|
|
June 30, 2013
|
|
|
(Level 1)
|
|
|
(Level 2)
|
|
|
(Level 3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant liability - 2010 Series A&B
|
|
$
|
853,206
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
853,206
|
|
Debenture conversion feature -2012
|
|
|
8,212,000
|
|
|
|
-
|
|
|
|
-
|
|
|
|
8,212,000
|
|
Warrant liability - 2012 placement agent
|
|
|
608,360
|
|
|
|
-
|
|
|
|
-
|
|
|
|
608,360
|
|
Warrant liability - 2012 Series A&B
|
|
|
12,727,669
|
|
|
|
-
|
|
|
|
-
|
|
|
|
12,727,669
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
22,401,235
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
22,401,235
|
|
The following table provides a summary of
changes in fair value of the Company’s liabilities, as well as the portion of losses included in income attributable to unrealized
appreciation that relate to those liabilities held at June 30, 2013:
Fair Value Measurements Using
|
|
Significant Unobservable Inputs (Level 3)
|
|
|
|
Warrant Liability
|
|
Balance at January 1, 2012
|
|
$
|
(3,705,472
|
)
|
Purchases, sales and settlements:
|
|
|
|
|
Warrants and other derivatives issued
|
|
|
(20,521,554
|
)
|
Total gains or losses:
|
|
|
|
|
Unrealized depreciation
|
|
|
2,806,750
|
|
Balance at January 1, 2013
|
|
|
(21,420,276
|
)
|
Total gains or losses:
|
|
|
|
|
Unrealized appreciation
|
|
|
(980,959
|
)
|
Balance at June 30, 2013
|
|
$
|
(22,401,235
|
)
|
ARNO THERAPEUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
June 30, 2013
(unaudited)
8. STOCKHOLDERS’ EQUITY
Common Stock
On November 21, 2012, the Company amended
its Amended & Restated Certificate of Incorporation to increase the number of shares of common stock that the Company is authorized
to issue from 80,000,000 shares to 500,000,000 shares.
On March 27, 2013, in accordance with the
amendment to the Registration Rights Agreement, the Company issued an aggregate of 990,477 shares of common stock to the investors
in lieu of an aggregate cash payment of $297,144, representing the first installment of liquidated damages under the Registration
Rights Agreement, as amended.
On April 29, 2013, in accordance with the
amendment to the Registration Rights Agreement, the Company issued an aggregate of 1,092,291 shares of common stock to the investors
in lieu of an aggregate cash payment of $327,688, representing the second installment of liquidated damages under the Registration
Rights Agreement, as amended.
On May 27, 2013, in accordance with the
amendment to the Registration Rights Agreement, the Company issued an aggregate of 962,245 shares of common stock to the investors
in lieu of an aggregate cash payment of $288,674, representing the third and final installment of liquidated damages under the
Registration Rights Agreement, as amended.
As of June 30, 2013, the Company had 39,453,675
shares of common stock issued and outstanding and an additional 165,512,665 shares of common stock reserved for issuance upon the
exercise of outstanding options, warrants and convertible debentures.
Warrants
In accordance with the 2010 issuance of
preferred stock, the Company issued two-and-one-half-year Class A warrants to purchase an aggregate of 1,221,920 shares of Series
A Preferred Stock at an initial exercise price of $1.00 per share and five-year Class B warrants to purchase an aggregate of 6,415,080
shares of Series A Preferred Stock at an initial exercise price of $1.15 per share. The terms of the warrants contain an anti-dilutive
price adjustment provision, such that, in the event the Company issues common shares at a price below the current exercise price
of the warrants, the exercise price will be adjusted based on the lower issuance price. Because of this anti-dilution provision
and the inherent uncertainty as to the probability of future common share issuances, the Black-Scholes option pricing model the
Company uses for valuing stock options could not be used. Management used a Monte Carlo simulation model and, in doing
so, utilized a third-party valuation report to determine the warrant liability to be approximately $0.9 million and approximately
$0.9 million at June 30, 2013 and December 31, 2012, respectively. The Monte Carlo simulation is a generally accepted statistical
method used to generate a defined number of stock price paths in order to develop a reasonable estimate of the range of the Company’s
future expected stock prices and minimizes standard error. This valuation is revised on a quarterly basis until the warrants are
exercised or they expire with the changes in fair value recorded in other income (expense) on the statement of operations. The
1,221,920 Class A warrants expired during the six months ended June 30, 2013.
ARNO THERAPEUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
June 30, 2013
(unaudited)
8. STOCKHOLDERS’ EQUITY
(Continued)
Pursuant to the 2012 Purchase Agreement,
the Company issued five-year Series A warrants to purchase an aggregate of 49,524,003 shares of common stock at an initial exercise
price of $0.50 per share and 18-month Series B warrants to purchase an aggregate of 49,524,003 shares of common stock at an initial
exercise price of $0.30 per share. The terms of the warrants contain an anti-dilutive price adjustment provision, such that, in
the event the Company issues common shares at a price below the current exercise price of the warrants, the exercise price will
be adjusted based on the lower issuance price and the number of shares purchasable thereunder increased such that the aggregate
exercise price of the warrants (exercise price per share multiplied by total number of shares underlying the warrants) remained
unchanged. Because of this anti-dilution provision and the inherent uncertainty as to the probability of future common share issuances,
the Black-Scholes option pricing model the Company uses for valuing stock options could not be used. Management used
a Monte Carlo simulation model and, in doing so, utilized a third-party valuation report to determine the warrant liability to
be approximately $12.7 million and $12.4 million at June 30, 2013 and December 31, 2012, respectively.
In connection with the 2012 offering of
Debentures and Warrants, the Company engaged Maxim Group LLC, or Maxim Group, to serve as placement agent. In consideration for
its services, the Company paid Maxim Group a placement fee of $1,035,000. In addition, the Company issued to Maxim Partners LLC,
or Maxim Partners, an affiliate of Maxim Group, 60,000 shares of common stock and five-year warrants to purchase an additional
2,270,000 shares of common stock at an initial exercise price of $0.33 per share. The warrants issued to Maxim Partners are in
substantially the same form as the Warrants issued to the investors, except that they do not include certain anti-dilution provisions
contained in the Warrants. However, the placement warrants do contain a provision that could require the Company to repurchase
the warrants from the holder under certain conditions. Management used a Monte Carlo simulation model and, in doing so, utilized
a third-party valuation report to determine the warrant liability to be approximately $0.6 million and $0.5 million at June 30,
2013 and December 31, 2012, respectively.
Below is a table that
summarizes all outstanding warrants to purchase shares of the Company’s common stock as of June 30, 2013.
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise
|
|
|
Exercise
|
|
|
Expiration
|
|
|
|
|
Warrants
|
|
Grant Date
|
|
Warrants Issued
|
|
|
Price
|
|
|
Price
|
|
|
Date
|
|
Exercised
|
|
|
Outstanding
|
|
09/03/2010
|
|
|
6,415,080
|
|
|
$
|
0.56
|
|
|
$
|
0.56
|
|
|
09/03/2015
|
|
|
-
|
|
|
|
6,415,080
|
|
09/03/2010
|
|
|
1,056,930
|
|
|
$
|
1.10
|
|
|
$
|
1.10
|
|
|
09/03/2015
|
|
|
-
|
|
|
|
1,056,930
|
|
11/26/2012
|
|
|
42,350,002
|
|
|
$
|
0.30
|
|
|
$
|
0.30
|
|
|
05/26/2014
|
|
|
-
|
|
|
|
42,350,002
|
|
12/18/2012
|
|
|
7,174,001
|
|
|
$
|
0.30
|
|
|
$
|
0.30
|
|
|
06/18/2014
|
|
|
-
|
|
|
|
7,174,001
|
|
11/26/2012
|
|
|
42,350,002
|
|
|
$
|
0.50
|
|
|
$
|
0.50
|
|
|
11/26/2017
|
|
|
-
|
|
|
|
42,350,002
|
|
11/26/2012
|
|
|
2,090,000
|
|
|
$
|
0.33
|
|
|
$
|
0.33
|
|
|
11/26/2017
|
|
|
-
|
|
|
|
2,090,000
|
|
12/18/2012
|
|
|
7,174,001
|
|
|
$
|
0.50
|
|
|
$
|
0.50
|
|
|
12/18/2017
|
|
|
-
|
|
|
|
7,174,001
|
|
12/18/2012
|
|
|
180,000
|
|
|
$
|
0.33
|
|
|
$
|
0.33
|
|
|
12/18/2017
|
|
|
-
|
|
|
|
180,000
|
|
|
|
|
108,790,016
|
|
|
|
|
|
|
$
|
0.41
|
|
|
|
|
|
-
|
|
|
|
108,790,016
|
|
ARNO THERAPEUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
June 30, 2013
(unaudited)
9. 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 were initially 2,990,655 shares of the
Company’s common stock reserved for issuance under the Plan. On April 25, 2011, the Company’s Board of Directors approved
an amendment to the Plan to increase the number of shares of common stock issuable under the Plan to 7,000,000 shares. On January
14, 2013, the Company’s Board of Directors approved an amendment to the Plan to increase the number of shares of common stock
issuable under the Plan to 7,562,210 shares. Under the Plan, incentives may be granted to officers, employees, directors, consultants,
and advisors. Incentives under the Plan may be granted in any one or a combination of the following forms: (a) incentive stock
options and non-statutory stock options, (b) stock appreciation rights, (c) stock awards, (d) restricted stock and (e) performance
shares.
The Plan is administered by the Board of
Directors, or a committee appointed by the Board, which determines recipients and types of awards to be granted, including the
number of shares subject to the awards, the exercise price and the vesting schedule. The term of stock options granted under the
Plan cannot exceed 10 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.
As of June 30, 2013, there are no remaining
shares 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.
During the three and six months ended June
30, 2013, the Company issued 1,413,500 and 50,000 stock options, respectively. The Company did not issue any stock options during
the three and six months ended June 30, 2012. The Company estimated the fair value of each option award granted using the Black-Scholes
option-pricing model. The following assumptions were used for the three and six months ended June 30, 2013:
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30, 2013
|
|
|
June 30, 2013
|
|
Expected volatility
|
|
|
96.0
|
%
|
|
|
89
- 96
|
%
|
Expected term
|
|
|
5 years
|
|
|
|
4 - 6 years
|
|
Dividend yield
|
|
|
0
|
%
|
|
|
0
|
%
|
Risk-free interest rate
|
|
|
0.77
|
%
|
|
|
.0.77%
- 0.89
|
%
|
Stock price
|
|
$
|
0.30
|
|
|
$
|
0.30
|
|
Forfeiture rate
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
ARNO THERAPEUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
June 30, 2013
(unaudited)
9. STOCK OPTION PLAN
(Continued)
A summary of the status of the options issued
under the Plan at June 30, 2013, and information with respect to the changes in options outstanding is as follows:
|
|
|
|
|
Options Outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
|
|
|
Outstanding
|
|
|
Weighted-
|
|
|
Aggregate
|
|
|
|
Available for
|
|
|
Stock
|
|
|
Average
|
|
|
Intrinsic
|
|
|
|
Grant
|
|
|
Options
|
|
|
Exercise Price
|
|
|
Value
|
|
Balance at January 1, 2013
|
|
|
901,290
|
|
|
|
5,778,866
|
|
|
$
|
1.11
|
|
|
|
|
|
Shares authorized for issuance
|
|
|
562,210
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
Options granted under the Plan
|
|
|
(1,463,500
|
)
|
|
|
1,463,500
|
|
|
$
|
0.30
|
|
|
|
|
|
Options exercised
|
|
|
-
|
|
|
|
-
|
|
|
$
|
-
|
|
|
|
|
|
Options forfeited
|
|
|
-
|
|
|
|
-
|
|
|
$
|
-
|
|
|
|
|
|
Balance at June 30, 2013
|
|
|
-
|
|
|
|
7,242,366
|
|
|
$
|
0.51
|
|
|
$
|
292,894
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at June 30, 2013
|
|
|
|
|
|
|
4,659,667
|
|
|
$
|
0.63
|
|
|
$
|
105,759
|
|
The following table summarizes information about stock options
outstanding at June 30, 2013:
|
|
|
Outstanding
|
|
|
Exercisable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise
Price
|
|
|
Shares
|
|
|
Weighted-
Average
Remaining
Contractual Life
(Years)
|
|
|
Weighted-
Average
Exercise Price
|
|
|
Shares
|
|
|
Weighted-
Average
Exercise Price
|
|
$
|
0.30
|
|
|
|
5,907,879
|
|
|
|
6.06
|
|
|
$
|
0.30
|
|
|
|
3,365,182
|
|
|
$
|
0.30
|
|
$
|
1.00
|
|
|
|
943,754
|
|
|
|
0.05
|
|
|
$
|
1.00
|
|
|
|
903,752
|
|
|
$
|
1.00
|
|
$
|
2.42
|
|
|
|
299,066
|
|
|
|
0.01
|
|
|
$
|
2.42
|
|
|
|
299,066
|
|
|
$
|
2.42
|
|
$
|
3.00
|
|
|
|
91,667
|
|
|
|
0.00
|
|
|
$
|
3.00
|
|
|
|
91,667
|
|
|
$
|
3.00
|
|
|
Total
|
|
|
|
7,242,366
|
|
|
|
6.11
|
|
|
$
|
0.51
|
|
|
|
4,659,667
|
|
|
$
|
0.63
|
|
Stock-based compensation costs under the Plan for
the three and six months ended June 30, 2013 and 2012 and for the cumulative period from August 1, 2005 (inception) through
June 30, 2013 are as follows:
|
|
Three months ended June 30,
|
|
|
Six months ended June 30,
|
|
|
Period from
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
August 1, 2005 (inception)
|
|
|
|
2013
|
|
|
2012
|
|
|
2013
|
|
|
2012
|
|
|
through June 30, 2013
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
106,416
|
|
|
$
|
84,057
|
|
|
$
|
324,682
|
|
|
$
|
112,814
|
|
|
$
|
2,311,292
|
|
General and administrative
|
|
|
128,855
|
|
|
|
109,996
|
|
|
|
374,616
|
|
|
|
248,784
|
|
|
|
2,059,221
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
235,271
|
|
|
$
|
194,053
|
|
|
$
|
699,298
|
|
|
$
|
361,598
|
|
|
$
|
4,370,513
|
|
ARNO THERAPEUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
June 30, 2013
(unaudited)
9. STOCK OPTION PLAN
(Continued)
The fair value of options vested under the
Plan was approximately $156,999 and $322,688 for the three months ended June 30, 2013 and 2012, respectively, approximately $544,804
and $329,669 for the six months ended June 30, 2013 and 2012, respectively and approximately $3,760,368 for the period from August
1, 2005 (inception) through June 30, 2013.
At June 30, 2013, total unrecognized estimated
compensation cost related to stock options granted prior to that date was approximately $912,176, which is expected to be recognized
over a weighted-average vesting period of 1.6 years. This unrecognized estimated employee compensation cost does not include any
estimate for forfeitures of performance-based stock options.
Common stock, stock options or other equity
instruments issued to non-employees (including consultants and all members of the Company’s Scientific Advisory Board) as
consideration for goods or services received by the Company are accounted for based on the fair value of the equity instruments
issued (unless the fair value of the consideration received can be more reliably measured). The fair value of stock options is
determined using the Black-Scholes option-pricing model and is expensed as the underlying options vest. The fair value of any options
issued to non-employees is recorded as expense over the applicable service periods.
10. RELATED PARTIES
On June 1, 2009, the Company entered into
a services agreement with Two River Consulting, LLC (“TRC”) to provide various clinical development, operational, managerial,
accounting and financial, and administrative services to the Company for a period of one year. David M. Tanen, a director of the
Company and at the time also its President, Arie S. Belldegrun, the Chairman of the Board of Directors, and Joshua A. Kazam, a
director until September 2010, are each partners of TRC. The terms of the Services Agreement were reviewed and approved by a special
committee of the Company’s Board of Directors consisting of independent directors. None of the members of the special committee
has any interest in TRC or the services agreement. As compensation for the services contemplated by the services agreement, the
Company paid TRC a monthly cash fee of $55,000. The services agreement with TRC expired on April 1, 2011 and until
a new agreement is in place, TRC is billing the Company for actual hours worked on a monthly basis. For the three and
six months ended June 30, 2013, TRC billed the Company $67,974 and $144,126, respectively. For the three and six months ended June
30, 2012, TRC has billed the Company $63,210 and $132,825, respectively. For the period from inception to June 30, 2013, TRC has
billed the Company a total of $1,887,366.
On occasion, some of the Company’s
expenses are paid by TRC. No interest is charged by TRC on any outstanding balance owed by the Company. For the three and six months
ended June 30, 2013 and 2012 and for the period from August 1, 2005 (inception) through June 30, 2013 services and reimbursed expenses
totaled $74,595, $160,203, $70,522, $171,129, and $2,291,420, respectively. As of June 30, 2013, the Company had a payable to TRC
of $27,874, which was paid in full during July 2013.
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.
|
Item 2.
|
Management’s Discussion and Analysis of Financial
Condition and Results of Operations.
|
Overview
We are a development stage company focused
on developing innovative products for the treatment of cancer. The following is a summary of our product development pipeline:
|
·
|
Onapristone
– On February 13, 2012, we entered
into a license agreement granting us rights to commercially develop onapristone, an anti-progestin hormone blocker that has been
shown to have considerable anti-tumor activity in breast cancer. Onapristone appears to have a unique ability to block the activated
progesterone receptor and inhibit tumor growth. Onapristone was originally developed by Schering AG for potential use as a contraceptive
and an anti-endocrine treatment of breast cancer. In clinical studies, onapristone has demonstrated a 56% objective response rate
as a first line “hormone” treatment of patients with breast cancer. In connection with the development of onapristone,
we have engaged Clarient Diagnostic Services, Inc. to develop a diagnostic product to selectively identify patients who express
the activated form of the progesterone receptor and therefore may be more likely to benefit from treatment with onapristone. We
have completed initial pre-clinical toxicology studies enabling the submission of an Investigational Medicinal Product Dossier
(“IMPD”), the foreign equivalent of an investigational new drug application (“IND”) in the second quarter
of 2013. The IMPD was accepted on July 31, 2013. We have completed manufacturing activities of onapristone Phase I
study supplies and plans on initiating a Phase I study in patients with progesterone receptor positive carcinomas during the second
half of 2013.
|
|
·
|
AR-42 –
AR-42 is being developed as an orally
available, broad spectrum inhibitor of both histone and non-histone deacetylation proteins, or Pan-DAC, which play an important
role in the regulation of gene expression, cell growth and survival. In preclinical studies, AR-42 has demonstrated greater
potency and activity in solid tumors and hematological malignancies when compared to vorinostat (also known as SAHA and marketed
as Zolinza® by Merck). These data demonstrate the potent and potential differentiating activity of AR-42. Additionally, pre-clinical
findings presented at the 2009 American Society of Hematology Annual Meeting showed that AR-42 potently and selectively inhibits
leukemic stem cells in acute myeloid leukemia, or AML. AR-42 is currently being studied in an investigator-initiated Phase
I/II clinical study in adult subjects with relapsed or refractory hematological malignancies: multiple myeloma, chronic lymphocytic
leukemia (CLL), or lymphoma. The recommended Phase II dose, or RP2D, in patients with hematological malignancies has been
determined and the expansion phase of the program has been initiated. We expect that the expansion phase of the hematological
malignancy cohort will take at least 12 months to complete. The protocol has been amended to include a separate solid tumor dose
escalation cohort and patients are being actively screened to enter into this cohort. We plan on supporting an investigator initiated
Phase I study of AR-42 in combination with decitabine in patients with hematological malignancies during the second half of 2013.
In preclinical studies, AR-42 has demonstrated anti-tumor activity in both meningioma and schwannoma. Meningioma and schwannoma
are rare, benign tumors that can present in different locations within the brain and the spinal cord and may cause substantial
morbidity for those affected individuals. The primary treatment option for patients with these tumors is surgical excision. In
February 2012, the FDA granted two orphan drug designations for AR-42 for the treatment of meningioma and the treatment of schwannoma
of the central nervous system. Additionally, AR-42 has been granted three orphan-drug designations by the European Medicines, or
EMA, for the treatment of neurofibromatosis type 2 (NF2), the treatment of meningioma and the treatment of schwannoma. NF2
is a rare genetic disorder characterized by the growth of noncancerous tumors in the brain and spinal cord, juvenile cataracts,
and neurofibromas of the skin.
|
|
·
|
AR-12
– We are also developing AR-12 as an orally
available, targeted anti-cancer agent that has been shown in early pre-clinical studies to inhibit phosphoinositide dependent protein
kinase-1, or PDK-1, a protein in the PI3K/Akt pathway that is involved in the growth and proliferation of cells, including cancer
cells. We believe AR-12 may also cause cell death through the induction of stress in the endoplasmic reticulum and work is ongoing
to further understand the mechanism of action. Preliminary data demonstrates that AR-12 may inhibit multiple different kinase targets.
In May 2009, the FDA accepted our IND for AR-12. We are currently conducting a multi-centered Phase I clinical study of AR-12 in
adult patients with advanced or recurrent solid tumors or lymphoma. The Phase I study of AR-12 was originally designed to be conducted
in two parts. The first part is a dose-escalating study, which we refer to as the Escalation Phase, primarily designed to evaluate
the safety of AR-12 in order to identify the MTD and RP2D for future studies of the compound. We have completed the dose escalation
phase of the Phase I trial, and have determined the RP2D and MTD of the current formulation. Following the Escalation Phase, we
planned to initiate the second part of the study, which we refer to as the Expansion Phase, which would have involved enrolling
an expanded cohort of additional patients at the RP2D in multiple tumor types. We will not be moving forward with the Expansion
Phase of this study as an improved formulation that has been shown to substantially increase bioavailability in preclinical models
has been developed. During the first quarter of 2013, the last study subject completed the planned dose-escalation phase of the
study.
|
We have no product sales to date and we
will not generate any product revenue until we receive approval from the FDA or equivalent foreign regulatory bodies to begin selling
our pharmaceutical product candidates. Developing pharmaceutical products is a lengthy and very expensive process. Assuming we
do not encounter any unforeseen safety or other 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. To date, almost all of our development expenses
have been incurred on each of our product candidates: Onapristone, AR-42, AR-12 and AR-67. As we proceed with the clinical development
of our product candidates, primarily focusing our resources on onapristone and AR-42, our research and development expenses
will further increase. 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. To date, our
major sources of working capital have been proceeds from private and public sales of our common and preferred stock and debt financings.
Research and development, or R&D, expenses
consist primarily of salaries and related personnel costs, fees paid to consultants and outside service providers for pre-clinical,
clinical, and manufacturing development, legal expenses resulting from intellectual property prosecution, costs related to obtaining
and maintaining our product license agreements, contractual review, and other expenses relating to the design, development, testing,
and enhancement of our product candidates. We expense our R&D costs as they are incurred.
General and administrative, or G&A, expenses
consist primarily of salaries and related expenses for executive, finance and other administrative personnel, accounting, legal
and other professional fees, business development expenses, rent, business insurance and other corporate expenses.
Our results include non-cash compensation
expense as a result of the issuance of stock options and warrants. We expense the fair value of stock options and warrants over
the vesting period. When more precise pricing data is unavailable, we determine the fair value of stock options using the Black-Scholes
option-pricing model. 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 performance and product development. 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.
Results of Operations
General and Administrative Expenses
.
G&A expenses for the three months ended June 30, 2013 and 2012 were approximately $0.7 million and $0.5 million, respectively.
This increase of approximately $0.2 million over the same period in 2012 is primarily attributable to increased compensations costs,
including stock-based compensation, of approximately $0.1 million to our CEO as result of a contractual increase in the CEO’s
salary and additional expenses recognized from a new stock option grant and a re-pricing of his previous grants made during the
first quarter of 2013. Additionally, there was an increase of approximately $0.1 million over the same period in 2012 as a result
of increased legal and consulting fees associated with the Company’s active registration statement and amendments, including
amendments with the Company’s convertible debenture holders being negotiated during the second quarter of 2013.
G&A expenses for the six months ended
June 30, 2013 and 2012 were approximately $1.5 million and $1.2 million, respectively. This increase of approximately $0.3 million
over the same period in 2012 is primarily attributable to increased compensation costs, including stock compensation expenses,
of approximately $0.2 million to our CEO as result of a contractual increase in the CEO’s salary and additional expenses
recognized from a new stock option grant and a re-pricing of his previous grants made during the first quarter of 2013. There were
no new grants or re-pricings during the first six months of 2012. Additionally, there was an increase of approximately $0.1 million
over the same period in 2012 as a result of increased legal and consulting fees associated with the Company’s active registration
statement and amendments, including amendments with the Company’s convertible debenture holders being negotiated during the
first and second quarters of 2013, with no such transactions during the same period of 2012.
Research and Development Expenses
.
R&D expenses for the three months ended June 30, 2013 and 2012 were approximately $2.7 million and $2.3 million, respectively.
The increase of approximately $0.4 million compared to the same period in 2012 is primarily due to expenses incurred developing
onapristone, the rights to which we in-licensed during the first quarter of 2012. Onapristone-related costs for the three months
ended June 30, 2013 were approximately $1.9 million, consisting of approximately $1.0 million on manufacturing activities, approximately
$0.3 million on pre-clinical development activities and approximately $0.6 million on clinical development support services. For
the three months ended June 30, 2012, we had only recently acquired the rights to onapristone and had spent approximately $0.5
million on initial preclinical development efforts and an approximately $0.5 million one-time initial license fee.
These increases of approximately $0.9
million related to onapristone development were partially offset by an approximately $0.3 million and approximately $0.2
million decreases in costs relating to our AR-42 and AR-12 programs, respectively. The AR-42 program cost decreases were
driven primarily by the fact that during the three months ended June 30, 2012, AR-42 was still undergoing various
preclinical studies and manufacturing activities that were completed by the end of 2012 and, therefore, no such development
costs were incurred during the six months ended June 30, 2013. The decrease in AR-12 costs over the three months ended
June 30, 2012 was primarily due to the timing of Phase I clinical study which was actively enrolling during the second
quarter 2012 and the last patient was enrolled during the first quarter of 2013.
R&D expenses for the six months ended
June 30, 2013 and 2012 were approximately $5.7 million and $4.2 million, respectively. The increase of approximately $1.5 million
compared to the same period in 2012 was primarily due to expenses incurred developing onapristone, the rights to which we in-licensed
during the first quarter of 2012. There were significant increases in manufacturing and pre-clinical development activities of
approximately $1.3 million and $0.7 million, respectively, compared to the six months ended June 30, 2012. These increases are
primarily driven by the fact that we had only recently acquired the rights to onapristone during the first quarter of 2012 and
we were just beginning our development efforts versus the same period in 2013 where there were significant development efforts
ongoing as we prepare for clinical trial activities planned in the second half of 2013.
Additionally, we had an increase of approximately
$0.2 million during the six months ended June 30, 2013, compared to the same period of 2012, in stock compensation costs relating
to our R&D employees. During the first quarter of 2013, we granted new stock options and re-priced previously granted stock
options, with no new grants or re-repricings during the same period of 2012.
These increases related to onapristone and
stock compensation costs were partially offset by an approximately $0.2 million decrease in costs in each of our AR-67 and AR-42
programs. The decrease in AR-67 program costs was due to lower costs resulting from the termination of our AR-67 license agreement
in late March of 2012. The AR-42 program cost decreases were driven primarily by the fact that during the six months ended June
30, 2012, AR-42 was still undergoing various preclinical studies that were completed by the end of 2012 and, therefore, no such
development costs were incurred during the six months ended June 30, 2013.
The following table summarizes our R&D
expenses incurred for preclinical support, contract manufacturing of clinical supplies, clinical trial services provided by third
parties and milestone payments for in-licensed technology for each of our product candidates for the three and six months ended
June 30, 2013 and 2012, as well as the cumulative amounts since we began development of each product candidate through June 30,
2013. The table also summarizes unallocated costs, which consist of personnel, facilities and other costs not directly allocable
to development programs:
|
|
|
|
|
|
|
|
Cumulative
|
|
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
amounts during
|
|
|
|
2013
|
|
|
2012
|
|
|
2013
|
|
|
2012
|
|
|
development
|
|
Onapristone
|
|
$
|
1,910,914
|
|
|
$
|
1,039,428
|
|
|
$
|
3,814,704
|
|
|
$
|
1,867,784
|
|
|
$
|
8,317,515
|
|
AR-42
|
|
|
38,231
|
|
|
|
386,413
|
|
|
|
256,860
|
|
|
|
593,042
|
|
|
|
5,240,069
|
|
AR-12
|
|
|
201,683
|
|
|
|
373,307
|
|
|
|
403,657
|
|
|
|
505,610
|
|
|
|
10,077,394
|
|
Former R&D Programs
|
|
|
13,627
|
|
|
|
28,816
|
|
|
|
24,660
|
|
|
|
287,827
|
|
|
|
8,107,295
|
|
Unallocated R&D
|
|
|
577,301
|
|
|
|
513,128
|
|
|
|
1,234,906
|
|
|
|
964,422
|
|
|
|
10,837,722
|
|
Total
|
|
$
|
2,741,756
|
|
|
$
|
2,341,092
|
|
|
$
|
5,734,787
|
|
|
$
|
4,218,685
|
|
|
$
|
42,579,995
|
|
Onapristone.
We are currently developing
onapristone, an anti-progestin hormone blocker that has been shown to have considerable anti-tumor activity in breast and endometrial
cancer. Onapristone appears to have a unique ability to block the activated progesterone receptor and inhibit tumor growth. Onapristone
was originally being developed by Schering AG for potential use as both a contraceptive and an anti-endocrine treatment of breast
cancer. In clinical studies, onapristone has demonstrated a 56% objective response rate as a first line “hormone”
treatment of breast cancer. In connection with the development of onapristone, we intend to develop a companion diagnostic product
to identify patients who express activated progesterone and therefore may benefit from treatment with onapristone. We have completed
initial pre-clinical toxicology studies enabling the submission of an Investigational Medicinal Product Dossier (“IMPD”),
the foreign equivalent of an investigational new drug application (“IND”) in the second quarter of 2013. The
IMPD was accepted on July 31, 2013. We have completed manufacturing activities of onapristone Phase I study supplies and
plans on initiating a Phase I study in patients with progesterone receptor positive carcinomas during the second half of 2013.
Based on our current development plans for onapristone, we anticipate spending approximately $9.0 million on external development
costs during the fiscal year 2013.
AR-42.
We are also developing
AR-42, an orally available, broad spectrum inhibitor of both histone and non-histone deacetylation proteins. AR-42 is currently
being studied in an investigator sponsored Phase I/IIa clinical study in adult patients with relapsed or refractory multiple myeloma,
chronic lymphocytic leukemia or lymphoma and a separate cohort of patients with solid tumors. In preclinical studies, AR-42 has
demonstrated greater potency and activity in solid and liquid tumors when compared to vorinostat (also known as SAHA and marketed
as Zolinza
®
by Merck). These data demonstrate the potent and differentiating activity of AR-42. Additionally, pre-clinical
findings presented at the 2009 American Society of Hematology Annual Meeting and Exposition showed that AR-42 potently and selectively
inhibits leukemic stem cells in acute myeloid leukemia. We plan on supporting an investigator initiated Phase I study of AR-42
in combination with decitabine in patients with hematological malignancies during the second half of 2013. In addition, preclinical
models have demonstrated anti-tumor activity in tumor types (schwannoma and meningioma) that are associated with the genetic illness,
neurofibromatosis type 2 (NF2). During the first quarter of 2013, the last study subject completed the planned dose-escalation
phase of the study. Based on our current development plans for AR-42, we anticipate spending approximately $0.5 million on external
development costs during the fiscal year 2013.
AR-12.
We are also developing AR-12
as a potentially first-in-class, orally available, targeted anti-cancer agent that has been shown in pre-clinical studies to inhibit
phosphoinositide dependent protein kinase-1, or PDK-1, a protein in the PI3K/Akt pathway, and may also cause cell death through
the induction of endoplasmic reticulum stress. In May 2009, the FDA accepted our investigational new drug application, or IND,
for AR-12. We are currently conducting a multi-centered Phase I clinical study of AR-12 in adult patients with advanced or
recurrent solid tumors or lymphoma. The Phase I study of AR-12 was originally designed to be conducted in two parts.
The first part is a dose-escalating study, which we refer to as the Escalation Phase, primarily designed to evaluate the compound’s
safety in order to identify the maximum tolerated dose, or MTD, or a recommended Phase II dose, or RP2D, for future studies of
AR-12. We have completed the dose escalation phase of the Phase I trial, and have determined the RP2D and MTD of the current
AR-12 formulation. Following the Escalation Phase, we planned to initiate the second part of the study, which we refer to
as the Expansion Phase, which would have involved enrolling an expanded cohort of additional patients at the RP2D in multiple tumor
types in order to further evaluate and confirm the pharmacodynamics, or PD, effects, potential anti-tumor activity, and safety
of AR-12 at the MTD or RP2D in specific patient populations. We will not be moving forward with the Expansion Phase of this
study as a novel and improved formulation that has shown to increase the bioavailability in preclinical models has been developed.
During the first quarter 2013, the last study subject completed the planned dose-escalation phase of the study. Based on our current
development plans for AR-12, we anticipate spending approximately $0.7 million on external development costs during the fiscal
year 2013.
Our expenditures on current and future clinical
development programs are expected to be substantial, particularly in relation to our available capital resources, and to increase.
However, these planned expenditures are subject to many uncertainties, including the results of clinical trials and whether we
develop any of our drug candidates with a partner or independently. As a result of such uncertainties, it is very difficult to
accurately predict the duration and completion costs of our research and development projects or whether, when and to what extent
we will generate revenues from the commercialization and sale of any of our product candidates. The duration and cost of clinical
trials may vary significantly over the life of a project as a result of unanticipated events arising during clinical development
and a variety of factors, including:
|
·
|
the
number of trials and studies in a clinical program;
|
|
·
|
the
number of patients who participate in the trials;
|
|
·
|
the
number of sites included in the trials;
|
|
·
|
the
rates of patient recruitment and enrollment;
|
|
·
|
the
duration of patient treatment and follow-up;
|
|
·
|
the
costs of manufacturing our drug candidates; and
|
|
·
|
the
costs, requirements, timing of, and ability to secure regulatory approvals.
|
Interest Income
. Interest income for
the three months ended June 30, 2013 and 2012 was $2,932 and $1,852 respectively. The increase in interest income compared to the
same period in 2012 is primarily due to higher average cash balances held during 2013 compared to the same period of 2012, as a
result of our fourth quarter 2012 convertible debenture financing proceeds.
Interest income for the six months
ended June 30, 2013 and 2012 was $6,992 and $5,240 respectively. The increase in interest income compared to the same period in
2012 is primarily due to higher average cash balances held during 2013 compared to the same period of 2012, as a result of our
fourth quarter 2012 convertible debenture financing proceeds.
Interest Expense
. Interest expense
for the three months ended June 30, 2013 and 2012 was approximately $1.9 million and $0, respectively. The increase in interest
expense compared to the same period in 2012 is a result of interest charged on our approximately $14.9 million fourth quarter 2012
convertible debenture financing and the related fees incurred completing the transaction, which are charged to interest expense
over the expected term of the debentures.
Interest expense for the six months
ended June 30, 2013 and 2012 was approximately $4.0 million and $0, respectively. The increase in interest expense compared to
the same period in 2012 is a result of interest charged on our approximately $14.9 million fourth quarter 2012 convertible debenture
financing and the related fees incurred completing the transaction, which are charged to interest expense over the expected term
of the debentures.
In May 2013, we became aware that the investors
in our 2012 offering of convertible debentures and warrants were entitled to additional liquidated damages in the amount of $288,674,
which amount should have been accrued in 2012 as part of the debt issuance. We determined that the impact of not reflecting this
in 2012 was not material to the 2012 financial statements and instead reflected this as interest expense in the first quarter of
2013. This expense resulted in the issuance on May 27, 2013, of 962,245 additional shares to the investors in lieu of an aggregate
cash payment of $288,674, representing the third and final installment of liquidated damages under the Registration Rights Agreement
dated November 26, 2012, as amended, between us and the investors. As such, the amount of the expense was a non-cash charge.
Other Income (Expense).
Other expense
for the three months ended June 30, 2013 was approximately $6.0 million compared to other income of approximately $2.6 million
for the three months ended June 30, 2012. During the three months ended June 30, 2013, there was an increase of approximately $6.0
million to Company’s derivative liabilities driven by an increased stock price assumption in the warrant valuation model.
During the three months ended June 30, 2012, there was a decrease to the Company’s derivative liabilities of approximately
$2.6 million driven by a decrease in the Company’s stock price during the second quarter of 2012.
Other expense for the six months ended June
30, 2013 was approximately $1.0 million compared to other income of approximately $2.5 million for the six months ended June 30,
2012. During the six months ended June 30, 2013, there was an increase of approximately $1.0 million to Company’s derivative
liabilities driven by an increased stock price assumption in the warrant valuation model. During the six months ended June 30,
2012, there was a decrease to the Company’s derivative liabilities of approximately $2.5 million driven by a decrease in
the Company’s stock price during the second quarter of 2012.
Liquidity and Capital Resources
The following table summarizes
our liquidity and capital resources as of June 30, 2013 and December 31, 2012 and our net changes in cash and cash equivalents
for the six months ended June 30, 2013 and 2012 (the amounts stated are expressed in thousands):
Liquidity and capital resources
|
|
June 30, 2013
|
|
|
December 31, 2012
|
|
Cash and cash equivalents
|
|
$
|
4,554
|
|
|
$
|
10,943
|
|
Working Capital
|
|
$
|
1,856
|
|
|
$
|
7,901
|
|
Stockholders' (deficit) equity
|
|
$
|
(22,879
|
)
|
|
$
|
(12,266
|
)
|
|
|
Six Months Ended June 30,
|
|
Cash flow data
|
|
2013
|
|
|
2012
|
|
Cash used in:
|
|
|
|
|
|
|
|
|
Operating activities
|
|
$
|
(6,389
|
)
|
|
$
|
(4,622
|
)
|
Investing activities
|
|
|
-
|
|
|
|
-
|
|
Financing activities
|
|
|
-
|
|
|
|
-
|
|
Net decrease in cash and cash equivalents
|
|
$
|
(6,389
|
)
|
|
$
|
(4,622
|
)
|
Our total cash resources as of June 30, 2013
were approximately $4.6 million compared to approximately $10.9 million as of December 31, 2012. As of June 30, 2013, we had approximately
$29.0 million in liabilities (of which approximately $25.7 million represented convertible debentures and non-cash derivative
liabilities), and approximately $1.9 million in net working capital. We incurred a net loss of approximately $12.2 million
and had negative cash flow from operating activities of $6.4 million for the six months ended June 30, 2013. Since August 1, 2005
(inception) through June 30, 2013, we have incurred an aggregate net loss of approximately $62.1 million, while negative cash flow
from operating activities has amounted to $44.5 million. As we continue to develop our product candidates, we expect to continue
to incur substantial and increasing losses, which will continue to generate negative net cash flows from operating activities as
we expand our technology portfolio and engage in further research and development activities, particularly the conducting of pre-clinical
studies and clinical trials.
From inception through June 30, 2013, we
have financed our operations through private sales of our equity and debt securities. As we have not generated any revenue
from operations to date, and we do not expect to generate revenue for several years, if ever, we will need to raise substantial
additional capital 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. We may seek to raise additional funds through various
potential sources, such as equity and debt financings, or through strategic collaborations and license agreements. We can
give no assurances that we will be able to secure such additional sources of funds to support our operations, or if such funds
are available to us, that such additional financing will be sufficient to meet our needs.
Based on our current development plans, we
believe our existing cash resources are sufficient to fund our operations through approximately the third quarter of
2013. However, based on the various options for future clinical studies of onapristone, AR-42 and AR-12, our projected cash needs
are difficult to predict. In addition, there are other factors which may also cause our actual cash requirements to vary materially,
including changes in the focus and direction of our research and development programs; 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. If we are unable
to raise additional funds when needed, we may not be able to continue development and regulatory approval of our products, and
we could be required to delay, scale back or eliminate some or all our research and development programs and we may need to wind
down our operations altogether. Each of these alternatives would likely have a material adverse effect on our business and
may result in a loss of your entire investment in our common stock.
The actual amount of funds we will need to
operate is subject to many factors, some of which are beyond our control. These factors include the following:
|
·
|
the progress of our research activities;
|
|
·
|
the costs of hiring additional full-time personnel;
|
|
·
|
the number and scope of our research programs;
|
|
·
|
the progress of our pre-clinical and clinical development activities;
|
|
·
|
the costs and timing of manufacturing our drug candidates;
|
|
·
|
the progress of the development efforts of parties with whom we have
entered into research and development agreements;
|
|
·
|
our ability to maintain current research and development programs
and to establish new research and development and licensing arrangements; and
|
|
·
|
the cost involved in prosecuting and enforcing patent claims and other
intellectual property rights; and the cost and timing of regulatory approvals.
|
We have based our estimates on assumptions
that may prove to be wrong. We may need to obtain additional funds sooner than planned or in greater amounts than we currently
anticipate.
License Agreement Commitments
Onapristone License Agreement
Our rights to onapristone are governed
by a license agreement with Invivis dated February 13, 2012. Under this agreement, we hold an exclusive, royalty-bearing license
for the rights to commercialize onapristone for all therapeutic uses. The license agreement provides us with worldwide commercial
rights to onapristone with the exception of France, although under the license agreement we have an option to acquire French commercial
rights from Invivis by providing notice to Invivis and making a cash payment.
The onapristone license agreement provides
us with exclusive, worldwide rights to a U.S. provisional patent application that relates to assays for predictive biomarkers for
anti-progestin efficacy. We intend to expand our patent portfolio by filing additional patent applications covering the use and
manufacture of onapristone and/or a companion diagnostic product. If the pending patent application issues, the issued patent would
be scheduled to expire in 2031.
We made a one-time cash payment of $500,000
to Invivis upon execution of the license agreement on February 13, 2012. Additionally, Invivis will receive performance-based cash
payments of up to an aggregate of $15.1 million upon successful completion of clinical and regulatory milestones relating to onapristone,
which milestones include the marketing approval of onapristone in multiple indications in the United States or the European Union
as well as Japan. We will make the first milestone payment to Invivis upon the dosing of the first subject in the first Company-sponsored
Phase I clinical trial of onapristone, which is anticipated to occur in the second half of 2013. In addition, we will pay Invivis
low single digit sales royalties based on net sales of onapristone by us or any of our sublicensees. Pursuant to a separate services
agreement, Invivis will provide us with certain clinical development support services, which includes the assignment of up to two
full-time employees to perform such services, in exchange for a monthly cash payment.
Under the license agreement with Invivis,
we also agreed to indemnify and hold Invivis and its affiliates harmless from any and all claims arising out of or in connection
with the production, manufacture, sale, use, lease, consumption or advertisement of onapristone, provided, however, that we shall
have no obligation to indemnify Invivis for claims that (a) any patent rights infringe third party intellectual property, (b) arise
out of the gross negligence or willful misconduct of Invivis, or (c) result from a breach of any representation, warranty confidentiality
obligation of Invivis under the license agreement. The license agreement will terminate upon the later of (i) the last to expire
valid claim contained in the patent rights, and (ii) February 13, 2032. In general, Invivis may terminate the license agreement
at any time upon a material breach by us to the extent we fail to cure any such breach within 90 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 AR-12 and AR-42 are governed
by separate license agreements with The Ohio State University Research Foundation, or Ohio State, entered into in January 2008.
Pursuant to each of these agreements, we have exclusive, worldwide, royalty-bearing licenses for the rights to commercialize technologies
embodied by certain issued patents, patent applications, know-how and improvements relating to AR-12 and AR-42 for all therapeutic
uses.
Under our license agreement for AR-12,
we have exclusive, worldwide rights to one issued U.S. patent and four pending U.S. patent applications that relate to AR-12 and
particular uses of AR-12 according to our business plan. The issued patent includes composition of matter claims. The issued patent
is currently scheduled to expire in 2024. If the pending patent applications issue, the latest of the issued patent or patents
would be scheduled to expire in 2028.
Under our license agreement for AR-42,
we have exclusive, worldwide rights to two pending U.S. patent applications that relate to AR-42 and particular uses of AR-42 according
to our business plan. If either or both of the pending patent applications issue, the issued patent or patents would both be scheduled
to expire in 2024. In addition, in 2010, we filed one U.S. provisional patent application directed primarily to particular methods
of using AR-42. If any U.S. patent claiming priority to the provisional patent applications issues, such a patent would be scheduled
to expire in 2031.
In 2008, 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. 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 license agreements for AR-12 and AR-42 provide
for aggregate potential milestone payments of up to $6.1 million for AR-12, of which $5.0 million is due only after marketing approval
in the United States, Europe and Japan, and $5.1 million for AR-42, of which $4.0 million is due only after marketing approval
in the United States, Europe and Japan. In September 2009, we paid Ohio State a milestone payment upon the commencement
of the Phase I clinical study of AR-12. The first milestone payment for AR-42 will be due when the first patient is dosed
in the first Company-sponsored Phase I clinical trial, which is not expected to occur in 2013. Pursuant to the license agreements
for AR-12 and AR-42, we must pay Ohio State royalties on net sales of licensed products at rates in the low-single digits. To
the extent we enter into a sublicensing agreement relating to either or both of AR-12 or AR-42, we will be required to pay Ohio
State a portion of all non-royalty income received from such sublicensee.
The license agreements with Ohio State
further provide that we will indemnify Ohio State from any and all claims arising out of the death of or injury to any person or
persons or out of any damage to property, or resulting from the production, manufacture, sale, use, lease, consumption or advertisement
of either AR-12 or AR-42, except to the extent that any such claim arises out of the gross negligence or willful misconduct of
Ohio State. The license agreements for AR-12 and AR-42, respectively, expire on the later of (i) the expiration of the last valid
claim contained in any licensed patent and (ii) 20 years after the effective date of the license. Ohio State will generally be
able to terminate either license upon our breach of the terms of the license 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.
AR-67 License Agreement
We formerly held exclusive rights to develop
and commercialize an oncology therapeutic drug candidate known as AR-67 pursuant to an October 2006 license agreement with the
University of Pittsburgh (“Pitt”). In the first quarter of 2012, we determined to cease development of AR-67 and agreed
with Pitt to terminate the license agreement. As a result, we no longer have rights in AR-67; however, we retain ownership
of all data accumulated during our development of AR-67.
On January 12, 2012, we received a notice
from Pitt, demanding payment of $250,000 in satisfaction of an annual license fee owed under the license agreement and providing
us with 60 days’ notice to remedy the default.. As of December 31, 2012, we had accrued for the outstanding annual license
fee of $250,000. On March 28, 2013, we and Pitt agreed to a settlement of Pitt’s outstanding claim against us for the $250,000
annual license fee in exchange for our payment of $235,000 in full satisfaction of all remaining obligations under the license
agreement, which payment was made April 2, 2013.
Off -Balance Sheet Arrangements
There were no off-balance sheet arrangements
as of June 30, 2013.
Critical Accounting Policies and Estimates
Our financial statements are prepared in
accordance with generally accepted accounting principles. The preparation of these 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, including research and development and clinical trial accruals, and stock-based
compensation estimates. 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 the following critical accounting policies
reflect the more significant judgments and estimates used in the preparation of our financial statements and accompanying notes.
Research and Development Expenses and Accruals
R&D expenses consist primarily of salaries
and related personnel costs, fees paid to consultants and outside service providers for pre-clinical, clinical, and manufacturing
development, legal expenses resulting from intellectual property prosecution, costs related to obtaining and maintaining our product
licenses, contractual review, and other expenses relating to the design, development, testing, and enhancement of our product candidates.
Amounts due under such arrangements may be either fixed fee or fee for service, and may include upfront payments, monthly payments,
and payments upon the completion of milestones or receipt of deliverables.
Our cost accruals for clinical trials and
other R&D activities are based on estimates of the services received and efforts expended pursuant to contracts with numerous
clinical trial centers and clinical research organizations, or CROs, clinical study sites, laboratories, consultants, or other
clinical trial vendors that perform the activities. Related contracts vary significantly in length, and may be for a fixed amount,
a variable amount based on actual costs incurred, capped at a certain limit, or for a combination of these elements. Activity levels
are monitored through close communication with the CROs and other clinical trial vendors, including detailed invoice and task completion
review, analysis of expenses against budgeted amounts, analysis of work performed against approved contract budgets and payment
schedules, and recognition of any changes in scope of the services to be performed. Certain CROs and significant clinical trial
vendors provide an estimate of costs incurred but not invoiced at the end of each quarter for each individual trial. The estimates
are reviewed and discussed with the CRO or vendor as necessary, and are included in R&D expenses for the related period. For
clinical study sites, which are paid periodically on a per-subject basis to the institutions performing the clinical study, we
accrue an estimated amount based on subject screening and enrollment in each quarter. All estimates may differ significantly from
the actual amount subsequently invoiced, which may occur several months after the related services were performed.
In the normal course of business we contract
with third parties to perform various R&D activities in the on-going development of our product candidates. The financial terms
of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows. Payments
under the contracts depend on factors such as the achievement of certain events, the successful enrollment of patients, and the
completion of portions of the clinical trial or similar conditions. The objective of our accrual policy is to match the recording
of expenses in our financial statements to the actual services received and efforts expended. As such, expense accruals related
to clinical trials and other R&D activities are recognized based on our estimate of the degree of completion of the event or
events specified in the specific contract.
No adjustments for material changes in estimates
have been recognized in any period presented.
Stock-Based Compensation
Our results include non-cash compensation
expense as a result of the issuance of stock, stock options and warrants. We have issued stock options to employees, directors,
consultants and Scientific Advisory Board members under our 2005 Stock Option Plan, as amended.
We expense the fair value of employee stock-based
compensation over the vesting period. When more precise pricing data is unavailable, 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.
Stock options or other equity instruments
to non-employees (including consultants and all members of our Scientific Advisory Board) issued as consideration for goods or
services received by us are accounted for 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.
During the period in which our common stock
was registered under the Securities Exchange Act and publicly traded (October 3, 2008 through May 5, 2009), our management used
the following assumptions: On the option grant date, the current available quoted market price for determining the fair value of
our common stock, an expected volatility based on the average expected volatilities of a sampling of five companies with similar
attributes to us, including industry, stage of life cycle, size and financial leverage, an expected dividend rate of 0% based on
management plan of operations, a risk free interest rate based on the current U.S. Treasury 5-year Treasury Bill and an expected
forfeiture rate of 0%.
Subsequent to the deregistration of our common
stock in May 2009, for all options granted in 2009, management estimated the fair value of our common stock to be $1.00 based on
the following factors. The stock was publicly trading at $1.00 per share prior to being deregistered. Subsequent to the deregistration,
we did not experience any significant events including clinical trial results, new product acquisitions or discoveries which management
believes would influence a material change in share price following the deregistration. In addition, our management used the following
assumptions for options granted during this period: An expected volatility based on the average expected volatilities of a sampling
of five companies with similar attributes to us, including industry, stage of life cycle, size and financial leverage, an expected
dividend rate of 0% based on management plan of operations, a risk free interest rate based on the current U.S. Treasury 5-year
Treasury Bill and an expected forfeiture rate of 0%.
On February 9, 2011, the effective date
of the registration statement filed in connection with our September 2010 private placement of Series A Preferred Stock, we again
became subject to the reporting requirements of the Exchange Act. Due to the lack of an active public market for our common stock,
management estimated the fair value of our common stock using a Monte Carlo simulation model and, in doing so, utilized a third-party
valuation report. The Monte Carlo simulation is a generally accepted statistical method used to generate a defined number of stock
price paths in order to develop a reasonable estimate of the range of our future expected stock prices and minimizes standard error.
Management used this valuation for options granted in 2011 and during the six months ended June 30, 2013 (no stock options were
granted during the year ended December 31, 2012). In addition, our management used the following assumptions for options granted
during this period: An expected volatility based on the average expected volatilities of a sampling of five companies with similar
attributes to us, including industry, stage of life cycle, size and financial leverage, an expected dividend rate of 0% based on
management plan of operations, a risk free interest rate based on the current U.S. Treasury 5-year Treasury Bill and an expected
forfeiture rate of 0%.
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.
Convertible Debentures and Warrant Liability
The Company accounts for the convertible
debentures and warrants issued in connection with the 2012 Purchase Agreement and for the warrants issued in connection with the
2010 Purchase Agreement in accordance with the guidance on Accounting for Certain Financial Instruments with Characteristics of
both Liabilities and Equity, which provides that the Company classify the warrant instrument as a liability at its fair value and
adjusts the instrument to fair value at each reporting period. This liability is subject to re-measurement at each balance sheet
date until exercised, and any change in fair value is recognized as a component of other income or expense. The fair value of warrants
issued by the Company, in connection with private placements of securities, has been estimated using a Monte Carlo simulation model.
The Monte Carlo simulation is a generally accepted statistical method used to generate a defined number of stock price paths in
order to develop a reasonable estimate of the range of the Company’s future expected stock prices and minimizes standard
error.
|
Item 3.
|
Quantitative and Qualitative Disclosures About Market
Risk.
|
Not applicable.
|
Item 4.
|
Controls and Procedures.
|
We maintain disclosure controls and procedures
that are designed to ensure that information required to be disclosed in our reports under the Exchange Act is recorded, processed,
summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms and
that such information is accumulated and communicated to our management, including our Principal Executive Officer and Principal
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 Commission Rule 13a-15(b),
we carried out an evaluation, under the supervision and with the participation of our management, including our Principal Executive
Officer and Principal Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures
as of the end of the quarter covered by this report. Based on the foregoing, our Principal Executive Officer and Principal Financial
Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
There has been no change in our internal
control over financial reporting during the most recent fiscal quarter that has materially affected, or is reasonably likely to
materially affect, our internal control over financial reporting.