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):

November 9, 2009

 

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:

 

o            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o            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 November 9, 2009, BioSante Pharmaceuticals, Inc. publicly announced its financial results for the third quarter ended September 30, 2009.  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.

 

(d)   Exhibits.

 

Exhibit
No.

 

Description

99.1

 

Press Release issued November 9, 2009

 

2



 

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:   November 9, 2009

 

3



 

BIOSANTE PHARMACEUTICALS, INC.

 

FORM 8-K

Exhibit Index

 

Exhibit
No.

 

Description

 

Method of Filing

99.1

 

Press Release issued November 9, 2009

 

Furnished herewith

 

4


Exhibit 99.1

 

 

BioSante Pharmaceuticals, Inc.

111 Barclay Boulevard

Lincolnshire, Illinois 60069

www.biosantepharma.com

 

 

 

 

FOR IMMEDIATE RELEASE

NASDAQ: BPAX

 

BioSante Pharmaceuticals Reports Third Quarter 2009 Financial Results

 

LINCOLNSHIRE, Illinois - (November 9, 2009) — BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced its third quarter 2009 financial results.

 

BioSante incurred a net loss of approximately $6.4 million or ($0.21) per share for the quarter ended September 30, 2009, compared to a net loss of $6.6 million or ($0.24) per share for the same period in 2008.  This decrease in net loss was due to BioSante’s decision in April 2009 to delay screening of new subjects for its ongoing LibiGel® (testosterone gel) Phase III safety study, partially offset by the recognition of acquisition related costs of approximately $1.5 million related to the Company’s merger with Cell Genesys Inc., which closed October 14, 2009.  Screening of new subjects for the safety study has been reinitiated.

 

“There were three exciting and company-transforming events that occurred during or shortly after the third quarter,” said Stephen M. Simes, BioSante’s president and CEO.  “On August 13th, we closed a $12 million registered direct financing.  On October 14th, we closed our merger with Cell Genesys which together with the $12 million financing gives us enough cash on hand to complete the LibiGel clinical development program to and through submission of a new drug application (NDA) in the first half of 2011. Finally, On October 20th we announced that the independent Data Monitoring Committee (DMC) reviewed unblinded data in the LibiGel Cardiovascular and Breast Cancer Safety Study and based on this review of unblinded data, the DMC unanimously recommended continuation of the study as described in the study protocol, with no modifications.”

 

The Company’s cash and cash equivalents as of September 30, 2009 were approximately $13.2 million, as compared to cash, cash equivalents and short-term investments of approximately $14.8 million on December 31, 2008.  As of the completion of the merger with Cell Genesys on October 14, 2009, BioSante gained $23.2 million in cash, cash equivalents and short-term investments, after deducting anticipated estimated merger-related and other expenses, and assumed $22.0 million in principal amount of 3.125% convertible senior notes issued by Cell Genesys.  In addition to the $23.2 million in cash, the Company obtained, as a result of the merger, a portfolio of cancer immunotherapies (known as GVAX Immunotherapies) and other technologies.  Acquisition of these assets significantly expands the Company’s product portfolio.  Several GVAX Immunotherapies now are in human clinical trials at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, at minimal cost to the Company.

 

About BioSante Pharmaceuticals, Inc.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism. BioSante’s lead products include LibiGel® (transdermal testosterone gel) in Phase III clinical development by BioSante under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction (FSD), and Elestrin™ (estradiol gel) developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, currently marketed in the U.S.  Also in development are 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 billion. The company also is developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook™), as a vaccine adjuvant, including for an H1N1 (swine flu) vaccine, and drug delivery. In addition, BioSante will seek opportunities for its GVAX cancer immunotherapies and other newly acquired technologies.  Additional information is available online at: www.biosantepharma.com.

 

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements often can be identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may” or the negative of these words or other words of similar meaning.  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; BioSante’s need for and ability to obtain additional financing; the effect of general business and economic conditions; and risks arising from BioSante’s merger with Cell Genesys.  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 registration statement on Form S-4 filed in connection with the merger with Cell Genesys and BioSante’s most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q.  The information set forth in this news release speaks only as of the date hereof, and 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:

Alan Zachary, McKinney/Chicago; (312) 944-6784 ext. 316; azachary@mckinneychicago.com;

For information about participating in the LibiGel clinical studies call or visit the following:

877-BLOOM81;  www.bloomstudy.com