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):

May 8, 2012

 

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 May 8, 2012, BioSante Pharmaceuticals, Inc. publicly announced its financial results for the first quarter of 2012.  For further information, please refer to the news 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

 

News Release issued May 8, 2012

 

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

 

 

Senior Vice President of Finance, Chief Financial Officer and Secretary

 

 

Dated:

May 8, 2012

 

 

3



 

BIOSANTE PHARMACEUTICALS, INC.

 

FORM 8-K

Exhibit Index

 

Exhibit
No.

 

Description

 

Method of Filing

99.1

 

News Release issued May 8, 2012

 

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

First Quarter Financial Results

 

LINCOLNSHIRE, Illinois - (May 8, 2012) --- BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today reported on its financial results for the first quarter of 2012 and cash balance as of March 31, 2012.

 

BioSante’s cash balance as of March 31, 2012 was approximately $49.5 million, compared to a cash balance of approximately $57.3 million on December 31, 2011.

 

BioSante incurred a net loss of approximately $10.3 million or $(0.09) per share for the quarter ended March 31, 2012, compared to a net loss of $17.3 million or $(0.20) per share for the same period in 2011.  The decrease in the net loss was due primarily to lower expenses associated with the clinical development of LibiGel® (testosterone gel).

 

BioSante’s corporate strategy always has included product development of high value medically-needed pharmaceutical products. In light of the top-line results from the two pivotal LibiGel Phase III efficacy trials, which indicated that LibiGel did not meet its co-primary or secondary endpoints, management continues to assess LibiGel’s path forward and potential alternative strategies to utilize the continuing LibiGel Phase III cardiovascular events and breast cancer safety study. Management also has expanded efforts to explore new product development projects through in-licensing and mergers and acquisitions as well as to develop further the GVAX cancer vaccine portfolio.

 

The current projected cash burn rate for 2012 is approximately $2.5 million per month, including expenditures related to the ongoing LibiGel safety study.  If a decision is made to halt the LibiGel safety study, the monthly cash burn rate will decline to approximately $1.5 million per month, pending other product development and corporate activities.

 

About BioSante Pharmaceuticals, Inc.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante´s products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development.  BioSante also is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. Four of these vaccines have been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA). BioSante´s other products include a testosterone gel for male hypogonadism, which is licensed to Teva Pharmaceuticals USA, Inc., and for which a New Drug Application (NDA) was approved by the FDA in February 2012, and the Pill-Plus™, an oral contraceptive in Phase II clinical development by Pantarhei Bioscience B.V. BioSante´s first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, is marketed in the U.S. by Jazz Pharmaceuticals, BioSante´s licensee. 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 future monthly burn rate and other statements identified by words such as “anticipates,” “will,” “continue,” “could,” “believes,” “intends,” “expects,” “projects,” “may,” “potential,” other words of similar meaning, derivations of such words and 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, uncertainties regarding clinical testing, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing and other success of BioSante´s licensees or sublicensees and BioSante´s future revenues, if any, from its licensees and sublicensees; uncertainties relating to the future and costs of BioSante´s product development programs and BioSante´s need for and ability to obtain additional financing if

 



 

needed. 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. All forward-looking statements in this news release speak only as of the date of this news release and are based on BioSante´s current beliefs and expectations. 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:

 

For Investors:

For Media:

The Trout Group LLC

Harris D. McKinney, Inc.

Tricia Swanson

Alan Zachary

(646) 378-2953

312-506-5220

tswanson@troutgroup.com

azachary@harrisdmckinney.com