Biosante Pharma (AMEX:BPA)
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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(TM) 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(TM) 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 less than
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 less than 0.001) and severity (p less than 0.01) of
hot flashes verses placebo. These significant responses were
maintained through Week 12 (p less than 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(TM), 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(TM) 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(TM) (bioidentical estradiol gel) for the treatment of women
with menopausal symptoms, and LibiGel(TM) (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.