View:
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):
August 14,
2006
BIOSANTE
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
1-31812
|
58-2301143
|
|
(State
or Other Jurisdiction of Incorporation)
|
(Commission
File Number)
|
(I.R.S.
Employer Identification Number)
|
|
111
Barclay Boulevard
Lincolnshire,
Illinois
|
60069
|
|
(Address
of Principal Executive Offices)
|
(Zip
Code)
|
(847)
478-0500
(Registrant’s
Telephone Number, Including Area Code)
N/A
(Former
Name or Former Address, If Changed Since Last Report)
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:
| £ |
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
|
| £ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
| £ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR
240.14d-2(b))
|
| £ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR
240.13e-4(c))
|
Section
2 - Financial Information
Item
2.02. Results of Operations and Financial Condition.
On
August
14, 2006, BioSante Pharmaceuticals, Inc. publicly announced its financial
results for the second quarter and six months ended June 30, 2006. For
further information, please refer to the press release attached hereto as
Exhibit 99.1, which is incorporated by reference herein.
The
information contained in this report and the exhibit hereto shall
not
be deemed to be “filed” for purposes of Section 18 of the Securities Exchange
Act of 1934, as amended, and shall not be incorporated by reference into any
filings made by BioSante Pharmaceuticals, Inc. under the Securities Act of
1933,
as amended, or the Exchange Act, except as may be expressly set forth by
specific reference in such filing.
Section
9 - Financial Statements and Exhibits
Item
9.01. Financial Statements and Exhibits.
(c) Exhibits.
|
Exhibit
No.
|
Description
|
|
99.1
|
Press
Release issued August 14,
2006
|
SIGNATURE
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 hereunto
duly authorized.
BIOSANTE
PHARMACEUTICALS, INC.
By:/s/
Phillip
B.
Donenberg
Chief
Financial Officer, Treasurer and Secretary
Dated: August
14, 2006
BIOSANTE
PHARMACEUTICALS, INC.
FORM
8-K
Exhibit
Index
|
Exhibit
No.
|
Description
|
Method
of Filing
|
|
99.1
|
Press
Release issued August 14, 2006
|
Furnished herewith
|
BioSante
Pharmaceuticals, Inc.
111
Barclay Boulevard
Lincolnshire,
Illinois 60069
www.biosantepharma.com
BioSante
Pharmaceuticals, Inc.
FOR
IMMEDIATE RELEASE
Amex: BPA
BioSante
Pharmaceuticals Reports
Second
Quarter 2006 Financial Results
LINCOLNSHIRE,
Illinois - (August 14, 2006)
---
BioSante Pharmaceuticals, Inc. (AMEX: BPA) today reported its financial
results
for the second quarter and six months ended June 30, 2006.
As
previously announced, BioSante completed a private placement subsequent
to the
end of its second quarter, which resulted in net proceeds to BioSante of
$7.2
million, resulting in a cash balance of approximately $11.0 million on
July 31,
2006. BioSante’s cash burn rate for the first half of 2006 was approximately
$750,000 per month. BioSante’s cash, cash equivalents and short-term investments
as of June 30, 2006 were approximately $4.5 million, as compared to
approximately $9.1 million on December 31, 2005. BioSante remains confident
that
its existing cash resources, including the net proceeds it received from
its
recent private placement, should be sufficient to maintain its current
planned
development activities, including the initiation of LibiGel Phase III clinical
development, and its corresponding level of expenditures through at least
the
next twelve months.
BioSante
incurred a net loss of approximately $2.2 million or ($0.11) per share
for the
quarter ended June 30, 2006, compared to a net loss of $2.6 million or
($0.13)
per share for the same period in 2005. This decrease was due primarily
to a
reduction in research and development expense and an increase in licensing
and
grant revenue. For the six months ended June 30, 2006, BioSante incurred
a net
loss of approximately $5.5 million or ($0.28) per share, compared to a
net loss
of $5.4 million or ($0.28) per share for the same period in 2005. This
increase
was due primarily to the impact of BioSante adopting SFAS No. 123(R)
“Share-Based Payment” and increases in general and administrative expenses,
offset by reductions in research and development expense and an increase
in
licensing and grant revenue.
About
BioSante Pharmaceuticals, Inc.
BioSante
is developing a pipeline of hormone therapy products to treat both men
and
women. These hormone therapy products are gel formulations for transdermal
administration that deliver bioidentical estradiol and testosterone. BioSante's
lead products include Bio-E-Gel®
(transdermal estradiol gel) for the treatment of women with menopausal
symptoms,
and LibiGel®
(transdermal testosterone gel) for the treatment of female sexual dysfunction
(FSD). A Bio-E-Gel new drug application (NDA) was submitted to the FDA
in the
first quarter 2006. The current market in the U.S. for estrogen and testosterone
products is approximately $2.5 billion. The transdermal gel formulations
used in
the women's gel products are licensed by BioSante from Antares Pharma Inc.
The
company also is developing its calcium phosphate nanotechnology (CaP) for
novel
vaccines, including avian flu and biodefense vaccines for toxins such as
anthrax
and ricin, and drug delivery systems. Additional information is available
online
at: www.biosantepharma.com.
This
news release contains forward-looking statements within the meaning of
the
Private Securities Litigation Reform Act of 1995. The statements regarding
BioSante contained in this news release that are not historical in nature,
particularly those that utilize terminology such as "may," "will," "should,"
"likely," "expects," "anticipates," "estimates," "believes", "plans, "hopes",
or
comparable terminology, are forward-looking statements. Forward-looking
statements are based on current expectations and assumptions, and entail
various
risks and uncertainties that could cause actual results to differ materially
from those expressed in such forward-looking statements. Important factors
known
to BioSante that cause actual results to differ materially from those expressed
in such forward-looking statements are the difficulty of developing
pharmaceutical products, obtaining regulatory and other approvals and achieving
market acceptance, and other factors identified and discussed from time
to time
in BioSante's filings with the Securities and Exchange Commission, including
those factors discussed on pages 22 to 34 in BioSante's most recent Form
10-K,
which discussion also is incorporated herein by reference. Additional
risk factors include the risk that BioSante’s cash balances will not be
sufficient to continue its current planned development activities for at
least
the next 12 months and that LibiGel Phase III trials may not begin in 2006.
All
forward-looking statements speak only as of the date of this news release.
BioSante undertakes no obligation to update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise.
For
more information, please contact:
Phillip
Donenberg, BioSante Pharmaceuticals, Inc.; (847) 478-0500;
donenber@biosantepharma.com