BioSante Pharmaceuticals Reports Financial
Results for 2010 and Clinical Development and Business Highlights
LINCOLNSHIRE, Illinois (March 16, 2011) –
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced
financial results for the year ended December 31, 2010 and clinical
development and business highlights.
Financial Results for 2010
As of December 31, 2010, BioSante's cash balance was approximately
$38.2 million as compared to $29.9 million at December 31, 2009.
Subsequently, on March 9, 2011, the company completed a registered
direct offering, resulting in net proceeds of approximately $23.8
million. Consequently, on March 10, 2011, BioSante's cash balance
was approximately $54 million. “We are very pleased with our
progress over the last year as well as our current cash balance,”
said Stephen M. Simes, BioSante's president and CEO. "Through
careful cash management and our financing strategy, we believe we
now have removed any near-term financial risk from BioSante, and our
current cash balance is sufficient to finance our operations and
LibiGel clinical development well into 2012, without need for
additional funds."
BioSante's net loss was $46.2 million or $0.70 per share for the
year ended December 31, 2010, compared to a net loss of $47.5
million or $1.40 per share for 2009. This decrease in net loss was
due primarily to transaction and non-cash technology related
expenses in 2009, associated with the company's merger with Cell
Genesys, Inc., offset by increased LibiGel® clinical
development expenses in 2010.
LibiGel® Clinical Highlights
The increased LibiGel clinical development expenses during 2010 was
the result of steady progress in BioSante's LibiGel Phase III
clinical program. LibiGel is in development for the treatment of
female sexual dysfunction (FSD), specifically, hypoactive sexual
desire disorder (HSDD) in menopausal women, for which there is no
FDA-approved product. In February 2011, the company announced
completion of enrollment in the first of two LibiGel Phase III
efficacy trials, and expects enrollment in the second efficacy trial
to be completed in the near future. BioSante continues to expect
data from the two efficacy trials in Fall 2011.
BioSante also is conducting a Phase III safety study of LibiGel
which has enrolled almost 3,000 women resulting in 3,200 women-years
of safety data. A maximum of 4,000 patients will be enrolled in the
study and be followed for a total of five years. However, BioSante
can use the safety study data as part of a New Drug Application
(NDA) submission after an average of 12 months of exposure to
LibiGel or placebo. The study's independent data monitoring
committee (DMC) has met five times and voted unanimously each time
that the study should continue as per FDA-agreed protocol, without
modification.
Pipeline Updates
In addition to the LibiGel clinical program, BioSante has a number
of pipeline candidates in development, including a broad portfolio
of cancer vaccines. Clinical trials of BioSante's Cancer Vaccines
are being conducted to treat leukemia, pancreatic cancer and breast
cancer, among other cancer types. These studies are being conducted
in cooperation with The Johns Hopkins Sidney Kimmel Comprehensive
Cancer Center, and are sponsored or funded at little or no cost to
BioSante. Through March 2011, four of these cancer vaccines, the
Pancreas Cancer Vaccine, Chronic Myeloid Leukemia Cancer Vaccine,
Melanoma Cancer Vaccine, and Acute Myeloid Leukemia Cancer Vaccine,
have received FDA Orphan Drug designations.
BioSante's pipeline also includes Bio-T-Gel™, a testosterone gel
for male hypogonadism, which is licensed to Teva Pharmaceuticals for
development and marketing. BioSante also has a licensing agreement
with Pantarhei Bioscience for the development of the Pill-Plus
triple component oral contraceptive which uses patented technology
from BioSante. Pantarhei is engaged in several Phase II/III clinical
studies with this product.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing
products for female sexual health and oncology. BioSante's lead
products include LibiGel® (transdermal testosterone gel)
for the treatment of female sexual dysfunction (FSD) which is in
Phase III clinical development under a U.S. Food and Drug
Administration (FDA) Special Protocol Assessment. BioSante also is
developing a portfolio of cancer vaccines, four of which have been
granted Orphan Drug designation, and are currently in several Phase
II clinical trials. Other products in development are Bio-T-Gel™, a
testosterone gel for male hypogonadism licensed to Teva
Pharmaceuticals and an oral contraceptive in Phase II clinical
development using BioSante patented technology. The company also is
seeking opportunities for its other technologies. Additional
information is available online at:
www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with
information that is not historical, these are forward-looking
statements under the Private Securities Litigation Reform Act of
1995. Such statements include, but are not limited to, statements
about BioSante’s plans, objectives, expectations and intentions with
respect to future operations and products and other statements
identified by words such as "will," "potential," "could," "can,"
"believe," "intends," "continue," "plans," "expects," "anticipates,"
"estimates," "may," other words of similar meaning or the use of
future dates. Forward-looking statements by their nature address
matters that are, to different degrees, uncertain. Uncertainties and
risks may cause BioSante’s actual results to be materially different
than those expressed in or implied by BioSante’s forward-looking
statements. For BioSante, particular uncertainties and risks
include, among others, the difficulty of developing pharmaceutical
products, obtaining regulatory and other approvals and achieving
market acceptance; the marketing success of BioSante’s licensees or
sublicensees; the success of clinical testing; and BioSante’s need
for and ability to obtain additional financing. More detailed
information on these and additional factors that could affect
BioSante’s actual results are described in BioSante’s filings with
the Securities and Exchange Commission, including its most recent
annual report on Form 10-K and subsequent quarterly reports on Form
10-Q. All forward-looking statements in this news release 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.
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For more information please contact:
For Media:
Alan Zachary
Harris D. McKinney
(312) 506-5220
azachary@harrisdmckinney.com
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com