Biosante Pharma (AMEX:BPA)
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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.