UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D. C. 20549
____________
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act Of 1934
Date
of
Report (Date of earliest event reported)
___________________________________________________________
ACURA
PHARMACEUTICALS, INC.
(Exact
Name of Registrant as Specified in Charter)
___________________________________________________________
|
State
of New York
|
1-10113
|
11-0853640
|
|
(State
of Other Jurisdiction
|
(Commission
File Number)
|
(I.R.S.
Employer
|
|
of
Incorporation)
|
|
Identification
Number)
|
616
N. North Court, Suite 120
Palatine,
Illinois 60067
(Address
of principal executive offices) (Zip Code)
(847)
705-7709
(Registrant’s
telephone number, including area code)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d- 2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17CFR
240.13e- 4(c))
Item
2.02 Results
of Operations and Financial Condition
On
November 3, 2006, Acura Pharmaceuticals, Inc. (the "Company") issued a press
release disclosing the financial results for its third quarter ended September
30, 2006. A copy of the Company's press release is attached as Exhibit 99.1
hereto.
Item
9.01 Financial
Statements and Exhibits
| Exhibit Number |
Description
|
| 99.1 | Press Release dated November 3, 2006 Announcing Financial Results for Third Quarter 2006 |
2
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
| ACURA PHARMACEUTICALS, INC. | ||
| |
|
|
| By: | /s/ Peter A. Clemens | |
|
Peter A. Clemens |
||
| Senior Vice President & Chief Financial Officer | ||
| Date: November 3, 2006 | ||
3
Exhibit
Index
| Exhibit Number |
Description
|
| 99.1 | Press Release dated November 3, 2006 Announcing Financial Results for Third Quarter 2006 |
4
CONTACT:
Acura
Pharmaceuticals, Inc.,
Investor
Relations, Peter A. Clemens, SVP & CFO 847-705-7709
FOR
IMMEDIATE RELEASE
ACURA
PHARMACEUTICALS, INC. ANNOUNCES
3RD
QUARTER 2006 FINANCIAL RESULTS AND
CASH
RESERVES UPDATE
Palatine,
IL, November 3, 2006:
Acura
Pharmaceuticals, Inc. (OTC.BB-ACUR) today announced a net loss of $3.1 million
or $0.01 per share for the quarter ending September 30, 2006 compared to a
net
loss of $1.6 million or $0.07 per share for the same period in 2005. Included
in
the 2006 and 2005 quarterly results is a non cash compensation expense of $1.0
million and $0.2 million respectively, primarily pertaining to the Company’s
issued and outstanding stock options and restricted stock units.
For
the
nine months ended September 30, 2006 the Company had a net loss of $9.9 million
or $0.03 per share compared to a net loss of $5.0 million or $0.22 per share
in
2005. Included in the 2006 and 2005 nine month results is a non cash
compensation expense of $5.1 million and $0.8 million respectively, primarily
pertaining to the Company’s issued and outstanding stock options and restricted
stock units.
The
2006
weighted average number of outstanding common shares reflect the conversion
of
all outstanding preferred shares into common shares in the fourth quarter of
2005. Highlights of the Company’s consolidated balance sheets and statements of
operations appear below. Detailed financial statements are included in the
Company’s Form 10-Q for the quarter ended September 30, 2006 filed with the
Securities and Exchange Commission.
Cash
Reserves Update
The
Company estimates that its current cash reserves, including the net proceeds
from the October 2006 Bridge Loan, will fund Aversion® Technology product
development and operating activities through
mid November, 2006.
To
continue operating thereafter, the Company must raise additional financing
or
enter into appropriate agreements with pharmaceutical company partners providing
for cash payments to the Company relating to our Aversion® Technology. No
assurance can be given that the Company will be successful in obtaining any
such
financing or in securing agreements with pharmaceutical company partners on
acceptable terms, if at all, or if secured, that such financing or partner
agreements will provide for payments to the Company sufficient to continue
funding operations. In the absence of such financing or partner agreements,
the
Company will be required to scale back or terminate operations and/or seek
protection under applicable bankruptcy laws.
About
Acura Pharmaceuticals, Inc.
Acura
Pharmaceuticals, Inc., together with its subsidiary, is a specialty
pharmaceutical company primarily engaged in research, development and
manufacture of innovative abuse deterrent, abuse resistant and tamper resistant
formulations ("Aversion® Technology") intended for use in orally administered
opioid-containing pharmaceutical products.
Forward
Looking Statements
This
press release contains "forward-looking statements" as defined in the Private
Securities Litigation Reform Act of 1995. These statements are based on current
expectations of future events. If underlying assumptions prove inaccurate or
unknown risks or uncertainties materialize, actual results could vary materially
from the Company’s expectations and projections. The most significant of such
risks and uncertainties include, but are not limited to, the Company’s ability
to secure additional financing to fund continued product development and
operations, the Company’s ability to enter into contractual arrangements with
qualified pharmaceutical partners to license, develop and commercialize the
Company’s technology and product candidates, the Company’s ability to avoid
infringement of patents, trademarks and other proprietary rights or trade
secrets of third parties, and the Company’s ability to fulfill the FDA’s
requirements for approving the Company’s product candidates for commercial
distribution in the United States, including, without limitation, the adequacy
of the results of the clinical studies completed to date and the results of
other clinical studies, to support FDA approval of the Company’s product
candidates, the adequacy of the development program for the Company’s product
candidates, changes in regulatory requirements, adverse safety findings relating
to the Company’s product candidates, the risk that the FDA may not agree with
the Company’s analysis of its clinical studies and may evaluate the results of
these studies by different methods or conclude that the results of the studies
are not statistically significant, clinically meaningful or that there were
human errors in the conduct of the studies or otherwise, the risk that further
studies of the Company’s product candidates are not positive, and the
uncertainties inherent in scientific research, drug development, clinical trials
and the regulatory approval process. You are encouraged to review other
important risk factors relating to the Company on our web site at www.acurapharm.com
under
the link, “Company Risk Factors” and detailed in Company filings with the
Securities and Exchange Commission. The Company is at development stage and
may
never have any products or technologies that generate revenue. Acura
Pharmaceuticals, Inc. assumes no obligation to update any forward-looking
statements as a result of new information or future events or developments.
All
Acura Pharmaceuticals, Inc. press releases may be reviewed at www.acurapharm.com.
2
|
ACURA
PHARMACEUTICALS, INC.
|
|||||||||||||
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|||||||||||||
|
(in
thousands, except per share data)
|
|||||||||||||
|
(unaudited)
|
(unaudited)
|
||||||||||||
|
Nine
Months Ended
|
Three
Months Ended
|
||||||||||||
|
September
30
|
September
30
|
||||||||||||
|
2006
|
|
2005
|
|
2006
|
|
2005
|
|||||||
|
Operating
Costs
|
|||||||||||||
|
Research
and Development
|
$
|
4,174
|
$
|
2,527
|
$
|
1,630
|
$
|
845
|
|||||
|
Marketing,
General and Administrative
|
4,754
|
2,120
|
1,031
|
628
|
|||||||||
|
Loss
from Operations
|
(8,928
|
)
|
(4,647
|
)
|
(2,661
|
)
|
(1,473
|
)
|
|||||
|
Other
Income (Expense)
|
|||||||||||||
|
Interest
Expense
|
(800
|
)
|
(434
|
)
|
(305
|
)
|
(171
|
)
|
|||||
|
Interest
Income
|
14
|
30
|
4
|
6
|
|||||||||
|
(Loss)
Gain on Asset Disposals
|
(10
|
)
|
85
|
7
|
3
|
||||||||
|
Other
|
(142
|
)
|
1
|
(142
|
)
|
-
|
|||||||
|
Net
Loss
|
$
|
(9,866
|
)
|
$
|
(4,965
|
)
|
$
|
(3,097
|
)
|
$
|
(1,635
|
)
|
|
|
Basic
and Diluted Loss Per Common Share
|
$
|
(0.03
|
)
|
$
|
(0.22
|
)
|
$
|
(0.01
|
)
|
$
|
(0.07
|
)
|
|
|
Weighted
Average Number of Outstanding Common Shares
|
343,947
|
22,906
|
346,835
|
23,169
|
|||||||||
3
|
ACURA
PHARMACEUTICALS, INC.
|
|||||||
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|||||||
|
(in
thousands)
|
|||||||
|
(unaudited)
|
|
(audited)
|
|
||||
|
|
|
At
September 30
|
|
At
December 31
|
|
||
|
|
|
2006
|
|
2005
|
|||
|
Current
Assets
|
$
|
470
|
$
|
444
|
|||
|
Property,
Plant and Equipment, Net
|
1,194
|
1,341
|
|||||
|
Other
Assets
|
7
|
7
|
|||||
|
Total
Assets
|
$
|
1,671
|
$
|
1,792
|
|||
|
Current
Liabilities
|
11,922
|
2,922
|
|||||
|
Long
Term Portion of Capital Lease Obligations and Note Payable
|
13
|
5,032
|
|||||
|
Stockholders'
Deficit
|
(10,264
|
)
|
(6,162
|
)
|
|||
|
Total
Liabilities and Stockholders' Deficit
|
$
|
1,671
|
$
|
1,792
|
|||
4