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 12,
2005
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
12,
2005, BioSante Pharmaceuticals, Inc. publicly announced its financial results
for the second quarter ended June 30, 2005. 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 12,
2005.
|
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.
| |
|
|
| Date: August 12, 2005 | By: | /s/ Phillip B. Donenberg |
|
|
||
| Chief Financial Officer, Treasurer, and Secretary | ||
BIOSANTE
PHARMACEUTICALS, INC.
FORM
8-K
EXHIBIT
INDEX
Exhibit
No. Description
Method of Filing
99.1 Press
Release issued August 12,
2005 Filed
herewith
BioSante
Pharmaceuticals, Inc.
FOR
IMMEDIATE RELEASE
Amex: BPA
BioSante
Pharmaceuticals Reports Product Development Highlights
and
Second Quarter 2005 Financial Results
LINCOLNSHIRE,
Illinois (August 12, 2005) -
BioSante
Pharmaceuticals
(AMEX:
BPA) today reported on certain product development highlights and announced
financial results for the second quarter ended June 30, 2005.
“Our
positive topline data from the Bio-E-Gel™Phase
III
trial and progress made with our CaP nanotechnology program drove this
successful quarter for BioSante,” said Stephen M. Simes, BioSante’s president
and chief executive officer. “We plan to present full Bio-E-Gel data at a
medical meeting this fall, with publication in a peer-reviewed journal to
follow. Currently, we are preparing a New Drug Application for submission
to the
U.S. Food and Drug Administration for Bio-E-Gel, and anticipate initiating
Phase
III LibiGel™
studies
by year end.”
Product
and Corporate Highlights
| · |
BioSante
announced significant safety and efficacy results of its 12-week,
randomized, double-blind, placebo-controlled Phase III clinical
trial of
Bio-E-Gel (bioidentical estradiol transdermal gel) for the treatment
of
moderate-to-severe hot flashes in menopausal women. The 484-patient
study,
which included three doses of Bio-E-Gel to maximize the safety
profile by
identifying the lowest effective dose, had four co-primary endpoints
of a
significant decrease over placebo in both the number and severity
of hot
flashes at Week 4 and Week 12 of treatment. By Week 4, the mid
and high
doses of Bio-E-Gel showed highly significant decreases in the number
and
severity of hot flashes versus placebo (p<0.0001), a response that was
maintained until Week 12. At Week 5, the low dose showed a highly
significant decrease in the number (p<0.001) and severity (p<0.01)
of hot flashes verses placebo. These significant responses were
maintained
through Week 12 (p<0.0001), therefore suggesting identification of the
lowest effective dose. There were no significant differences in
the safety
profile of any dose of Bio-E-Gel compared to placebo.
|
| · |
The
Company presented a review of progress toward the use of
BioVant™,
BioSante’s patented calcium phosphate (CaP) nanoparticle technology, in
viral and bacterial vaccine candidates at the International Conference
on
Immunopotentiators in Modern Vaccines in Spain. BioSante also presented
BioVant data at the annual World Vaccine Congress in Montreal,
focusing on
the intranasal mucosal surface delivery of an anthrax vaccine,
and
highlighting the simultaneous immune adjuvant effects and non-injected
vaccine delivery potential of
BioVant.
|
| · |
BioSante
announced a new manufacturing agreement with a U.S.-based current
good
manufacturing practices (cGMP) manufacturer for large-scale quantities
of
CaP nanotechnology.
|
| · |
BioSante
was added to the Russell Microcap™
Index, which measures the performance of the microcap segment and
includes
the smallest 1,000 securities in the small-cap Russell 2000 Index
plus the
next 1,000 securities, based on descending market capitalization.
As of
the latest reconstitution, the average market capitalization of
the Index
was approximately $217 million.
|
Second
Quarter 2005 Financial Overview
BioSante
incurred a net loss of approximately $2.58 million, or $(0.13) per basic
and
diluted share for the quarter ended June 30, 2005, compared to a net loss
of
approximately $2.57 million, or $(0.15) per basic and diluted share for the
second quarter of 2004. For the first six months of 2005, the Company’s net loss
totaled approximately $5.35 million, or $(0.28) per basic and diluted share,
compared to a net loss of approximately $5.02 million, or $(0.32) per basic
and
diluted share, for the first six months of 2004. As of June 30, 2005, the
Company’s cash, cash equivalents and short-term investments were approximately
$12.1 million. The Company anticipates a cash burn rate of approximately
$750,000 per month for the remainder of 2005.
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™
(bioidentical estradiol gel) for the treatment of women with menopausal
symptoms, and LibiGel™
(bioidentical testosterone gel) for the treatment of female sexual dysfunction
(FSD). 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. (Amex: AIS).
The
company also is developing its calcium phosphate nanotechnology (CaP) for
novel
vaccines, including 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 press release that are not historical in nature,
particularly those that utilize terminology such as "may," "will," "should,"
"likely," "expects," "anticipates," "estimates," "believes" or "plans," 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 19 to 31 of BioSante's Form 10-KSB, which
discussion also is incorporated herein by reference. 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
Ritu
S.
Baral, The Trout Group LLC; (212) 477-9007 ext 25;
rbaral@troutgroup.com