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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, 2007
BIOSANTE
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
001-31812
|
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, 2007, BioSante Pharmaceuticals, Inc. publicly announced its financial
results for the second quarter ended June 30, 2007. 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 Item 2.02 and Exhibit 99.1 hereto shall not
be
deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act
of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability
of that section, 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, 2007
|
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
Phillip
B. Donenberg
Chief
Financial Officer, Treasurer and Secretary
Dated: August
14, 2007
BIOSANTE
PHARMACEUTICALS, INC.
FORM
8-K
Exhibit
Index
|
Exhibit
No.
|
Description
|
Method
of Filing
|
|
99.1
|
Press
Release issued August 14, 2007
|
Furnished
herewith
|
BioSante
Pharmaceuticals, Inc.
111
Barclay Boulevard
Lincolnshire,
Illinois 60069
www.biosantepharma.com
FOR
IMMEDIATE
RELEASE
Amex:
BPA
BioSante
Pharmaceuticals Reports
Second
Quarter 2007 Financial Results
LINCOLNSHIRE,
Illinois - (August 14, 2007) ---
BioSante Pharmaceuticals, Inc. (AMEX: BPA) today reported its June 30, 2007
cash
balance and its financial results for the second quarter and six months ended
June 30, 2007.
The
Company’s cash, cash equivalents and short-term investments as of June 30, 2007
were approximately $31.3 million, as compared to approximately $11.5 million
on
December 31, 2006. The increase in cash is due to the private
placement of 3,054,999 shares of common stock at a purchase price of $6.00
per
share. The placement included, for each share purchased, a warrant to
purchase 0.25 shares of common stock at an exercise price of
$8.00. The net proceeds from this placement were approximately $17.3
million. The Company’s cash burn rate is expected to increase in the
second half of 2007 to approximately $850,000 per month as its LibiGel® program
progresses.
BioSante
incurred a net loss of approximately $2.4 million or ($0.10) per share for
the
quarter ended June 30, 2007 and $4.2 million or ($0.18) per share for the six
months ended June 30, 2007, compared to a net loss of $2.2 million or
($0.17) per share and $5.5 million or ($0.28) per share for the same periods
in
2006. This decrease was due primarily to a reduction in business
development and legal expenses and a decrease in non-cash stock-based
compensation expense.
Recent
Product Development Highlights
Hormone
Therapy
In
June
2007, Elestrin™ (estradiol gel) was launched in the U.S. for the treatment of
hot flashes by Bradley Pharmaceuticals, Inc. (NYSE:BDY), BioSante’s U.S.
marketing licensee. Elestrin was approved by the U.S. Food and Drug
Administration (FDA) in December 2006. Upon execution of the
marketing agreement with Bradley in November 2006, BioSante received $3.5
million. The December FDA approval triggered a payment of $10.5
million to BioSante. In March 2007, the Company received $7.0 million
of this payment with the balance to be received by year-end
2007. Sales-based milestone payments could bring payments from Bradley to
BioSante up to an additional $40 million over several years. In addition,
Bradley has agreed to pay to BioSante royalties on sales of
Elestrin.
Also
in
June 2007, the Company announced that it and a subsidiary of Teva Pharmaceutical
Industries Ltd., will reinitiate their development of a male testosterone
therapy product for the U.S. market.
In
May
2007, the Company announced an exclusive license agreement with Pantarhei
Bioscience for the development and marketing of an oral contraceptive in the
United States. In June 2007, the Company announced that it and
Pantarhei have begun a Phase II clinical trial of an oral
contraceptive. The Phase II study, being conducted in the
Netherlands, will include approximately 72 women in a double-blind, placebo
controlled, randomized, comparative 2-way crossover study to determine the
effect of a new patented oral contraceptive on sexual arousability and the
vascular component of the sexual arousal response in women.
Calcium
Phosphate Nanotechnology
In
July
2007, the Company announced new positive results for its calcium phosphate
nanotechnology (CaP) as an adjuvant for a bird flu
vaccine. The data indicate that a significantly lower dose bird flu
vaccine may be possible based on CaP’s adjuvanting ability.
Also
in
July 2007, the Company announced positive pre-clinical results using CaP as
a
potential wrinkle filler in cosmetic medicine. BioSante previously
signed an option and license agreement with Medical Aesthetics Technology
Corporation for use of CaP in aesthetic medicine.
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 bio-identical estradiol and
testosterone. BioSante's lead products include Elestrin™ (estradiol
gel) developed through FDA approval by BioSante indicated for the treatment
of
moderate-to-severe vasomotor symptoms associated with menopause, marketed in
the
U.S. by Bradley Pharmaceuticals, Inc., BioSante's licensee, and
LibiGel®
(transdermal testosterone gel) in Phase III clinical development by BioSante
for
the treatment of female sexual dysfunction (FSD). Also in development
is Bio-T-Gel™, a testosterone gel for male hypogonadism, and an oral
contraceptive in Phase II clinical development using BioSante patented
technology. The current market in the U.S. for estrogen and
testosterone products is approximately $2.5 billion and for oral contraceptives
approximately $3.0 billion. The company also is developing its calcium phosphate
nanotechnology (CaP) for novel vaccines, including hepatitis B, avian flu and
biodefense vaccines for toxins such as anthrax, as well as a system for
delivering drugs via alternative routes of administration and for aesthetic
medicine. 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,” “would,” “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
could cause actual results to differ materially from those expressed in such
forward-looking statements include the difficulty of developing pharmaceutical
products, obtaining regulatory and other approvals and achieving market
acceptance, the success of clinical testing, and other factors identified and
discussed from time to time in BioSante's filings with the Securities and
Exchange Commission, including those factors discussed in BioSante's most recent
annual report on Form 10-K and subsequent quarterly reports on Form 10-Q, which
discussions also are 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