-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, NVN8XUMhX0R2cVBcXOhP9mITtUTWRWNo/mistLqwQUkth2sVwl4QSkG+OlCPH1jp z3oLtjUVp2VZok+u2YIAnA== 0001193125-07-022838.txt : 20070208 0001193125-07-022838.hdr.sgml : 20070208 20070207192605 ACCESSION NUMBER: 0001193125-07-022838 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20070207 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070208 DATE AS OF CHANGE: 20070207 FILER: COMPANY DATA: COMPANY CONFORMED NAME: INFINITY PHARMACEUTICALS, INC. CENTRAL INDEX KEY: 0001113148 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330655706 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-31141 FILM NUMBER: 07589565 BUSINESS ADDRESS: STREET 1: 780 MEMORIAL DRIVE CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6174531000 MAIL ADDRESS: STREET 1: 780 MEMORIAL DRIVE CITY: CAMBRIDGE STATE: MA ZIP: 02139 FORMER COMPANY: FORMER CONFORMED NAME: INFINITY PHARMACEUTICALS, INC./NEW/ DATE OF NAME CHANGE: 20060913 FORMER COMPANY: FORMER CONFORMED NAME: DISCOVERY PARTNERS INTERNATIONAL INC DATE OF NAME CHANGE: 20000428 8-K 1 d8k.htm FORM 8-K Form 8-K

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): February 7, 2007

 


Infinity Pharmaceuticals, Inc.

(Exact name of registrant as specified in charter)

 


 

Delaware   000-31141   33-0655706

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

780 Memorial Drive, Cambridge, MA   02139
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (617) 453-1000

 


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:

 

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

 

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

 

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

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 



Item 2.02. Results of Operations and Financial Condition

On February 7, 2007, we issued a press release announcing our results for the quarter and year ended December 31, 2006 and will conduct a previously-announced, publicly-available conference call to discuss those results. A copy of this press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information contained in this Form 8-K and Exhibit 99.1 hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) The following exhibits are included in this report:

 

Exhibit No.

  

Description

99.1

   Press release dated February 7, 2007

 


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.

INFINITY PHARMACEUTICALS, INC.

Date: February 7, 2007

By:  /s/  Adelene Q. Perkins                        

        Adelene Q. Perkins

        Chief Financial Officer and Treasurer

EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

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FOR IMMEDIATE RELEASE

INFINITY ANNOUNCES FOURTH QUARTER AND YEAR END 2006 RESULTS

— Company Forecasts Strong Financial Position and Broad Clinical Trial Expansion of IPI-504, Infinity’s Lead Drug Candidate —

CAMBRIDGE, Mass. – February 07, 2007 – Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), an innovative cancer drug discovery and development company, today announced results for the quarter and year ended December 31, 2006, company highlights, and goals for 2007.

Key 2006 highlights included:

 

   

Evidence of biological activity of IPI-504, Infinity’s lead anticancer agent, in a Phase I clinical trial in patients with gastrointestinal stromal tumors (GIST)

 

   

Establishment of a worldwide collaboration with MedImmune, Inc. around Infinity’s two lead programs, inhibitors of heat shock protein 90 (Hsp90) and the Hedgehog cell-signaling pathway

 

   

Establishment of a worldwide collaboration with Novartis on Infinity’s Bcl-2 inhibitor program

 

   

Extension of a license agreement by Amgen for non-exclusive access to Infinity’s collection of diverse, natural product-like compounds

 

   

Completion of a reverse merger with Discovery Partners International, Inc., providing Infinity with approximately $78 million in net cash and a public listing on NASDAQ under the ticker symbol “INFI”

 

   

Cash balance sufficient to support Infinity’s current operating plan at least through December 31, 2009 in the absence of any new business development opportunities or financings

 

 

 

Julian Adams, Ph.D. appointed President of Infinity and awarded the 25th Annual American Association for Cancer Research (AACR)-Bruce F. Cain Memorial Award

“Infinity made great progress in 2006, having evolved into a clinical-stage company with promising evidence of biological activity with our lead anticancer agent, established a strong financial profile, and entered global alliances with MedImmune and Novartis,” said Steven H. Holtzman, Chief Executive Officer of Infinity. “As is evident in the goals we have set for ourselves, we anticipate substantial progress in our product pipeline and continued financial strength, which we hope will create long-term value for both patients and shareholders of Infinity.”

In November 2006, Infinity and MedImmune announced promising preliminary data from an open-label Phase I study of IPI-504, a small molecule inhibitor of Hsp90, in patients with Gleevec®-resistant metastatic GIST. Based on the observed evidence of biological activity and IPI-504’s observed tolerability to date, Infinity and MedImmune have expanded this study to add a second schedule of administration. The first patient on the second dose administration schedule was enrolled in December 2006. Infinity has also announced plans to initiate a Phase I/II trial of IPI-504 as a single agent in patients with advanced non-small cell lung cancer (NSCLC) in the first half of 2007.

“The evidence of biological activity for IPI-504 in the Phase I trial in patients with GIST was a significant milestone for Infinity and encourages us to advance IPI-504 into a broad range of Phase I and II clinical trials this year,” added Julian Adams, Ph.D., President and Chief Scientific Officer of Infinity. “Infinity will continue to focus on moving compounds rapidly into and through the clinic in an effort to develop novel therapies for patients.”

Infinity recently announced the following 2007 goals relating to its product pipeline:

 

   

Initiate a Phase I/II trial of IPI-504 in patients with NSCLC

 

   

Complete the Phase I trial of IPI-504 in patients with GIST

 

   

Progress IPI-504 to one or more Phase II trials

 

   

Initiate one or more studies of IPI-504 in combination with other agents

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Enter clinical development with an oral formulation of IPI-504

 

   

Select a clinical candidate for its Hedgehog pathway program

 

   

Continue to progress on its Bcl-2 program

 

   

Advance its early discovery programs

2006 Financial Results

On September 12, 2006, Infinity completed its reverse merger with Discovery Partners International, Inc. This transaction is treated for accounting purposes as a reverse asset acquisition and recapitalization. Therefore, the financial information described below reflects the historical results of the pre-merger Infinity and that of the combined company following the merger. This information does not include the historical financial results of Discovery Partners.

On December 31, 2006, Infinity had total cash, cash equivalents, and available-for-sale securities of $101.7 million, after prepayment of approximately $15.9 million to extinguish its outstanding indebtedness to Oxford Finance Corporation and Horizon Technology Funding Company LLC in December 2006. In January 2007, Infinity received $35 million from MedImmune, representing the second tranche of the up-front payment associated with the strategic alliance entered into in August 2006. Infinity is able to spend aggressively toward its research and development programs while managing cash flow by virtue of its cost-sharing agreement with MedImmune on the Hsp90 and Hedgehog programs and the funding of the Bcl-2 program by Novartis. In the absence of any additional financings or business development activities, Infinity anticipates ending 2007 with at least $100 million in cash, cash equivalents, and available-for-sale securities, which is expected to be sufficient to support its current projected operating plan through at least the end of 2009.

Infinity’s net loss for the fourth quarter of 2006 was $5.4 million as compared to a net loss of $9.8 million for the fourth quarter of 2005. For the year ended December 31, 2006, Infinity reported a net loss of $28.4 million as compared to a net loss of $36.4 million for the comparable period in 2005. The improvement in net loss in both periods was primarily driven by an increase in strategic alliance revenue.

Total revenue for the fourth quarter of 2006 was $9.0 million as compared to $0.5 million for the fourth quarter of 2005. For the year ended December 31, 2006, revenue was $18.5 million as compared to $0.5 million for 2005. The increase in revenue for both the quarter and the full year was primarily derived from Infinity’s strategic product alliances with MedImmune and Novartis and the extension of the technology access agreement by Amgen.

Research and development (R&D expense was $9.0 million for the fourth quarter of 2006 as compared to $8.9 million for the fourth quarter of 2005. The year-over-year quarterly comparison reflects an increase in R&D expense associated with personnel-related expenses and an increase in depreciation and asset impairment charges, most of which was offset by MedImmune’s reimbursement of R&D expense. Any amounts Infinity is reimbursed by MedImmune under the cost-sharing provisions of the MedImmune agreement are offset against Infinity’s R&D expense. Infinity’s R&D expense of $9.0 million for the fourth quarter of 2006 reflects total R&D expenditures of $12.0 million less MedImmune’s reimbursement of approximately $3.0 million during the quarter. For the year ended December 31, 2006, Infinity’s R&D expense was $35.8 million as compared to $31.5 million for the previous year. Infinity’s R&D expense of $35.8 million for the full year of 2006 reflects total R&D expenditures of $39.8 million less MedImmune’s reimbursement of approximately $4.0 million during the year. The primary drivers of the increase in R&D expense for the full year of 2006 were an increase in personnel-related expenses and an increase in preclinical and clinical development expenses associated with IPI-504 and the Hedgehog pathway program.

General and administrative expense was $3.7 million for the fourth quarter of 2006 as compared to $1.4 million in the fourth quarter of 2005. For the year ended December 31, 2006, Infinity’s general and administrative expense was $9.5 million as compared to $5.5 million for the previous year. The increase in expenses for both the quarter and the full year reflect higher personnel-related expenses as well as increased expenses related to Infinity’s transition into a public company, including compliance with the Sarbanes-Oxley Act.

 


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Conference Call on Thursday, February 8, 2007 at 8:30 a.m. Eastern Time

Infinity management will host a conference call on Thursday, February 8, 2007 at 8:30 a.m. EST to provide a business update and discuss the quarter and year end results. A live webcast of the conference call can be accessed in the Investor section of Infinity’s website at http://www.ipi.com. Callers may participate in the call by dialing 800-289-0533 (domestic) and 1-913-981-5525 (international) five minutes prior to the start time. An archived version of the webcast will be available on Infinity’s website for 30 days.

About Infinity Pharmaceuticals, Inc.

Infinity is an innovative cancer drug discovery and development company that is seeking to leverage its strength in small molecule drug technologies to discover, develop, and deliver to patients best-in-class medicines for the treatment of cancer and related conditions. For more information on Infinity, please refer to the company’s website at http://www.ipi.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding future clinical trial activity for IPI-504 in both intravenous and oral form; the collection of additional clinical information on IPI-504; the intended utilization and commercial potential of IPI-504; the ability to name clinical candidates in the company’s research programs; estimates of 2007 financial performance and year-end cash balance; and the expectation that Infinity will have cash to support its current operating plan through at least December 31, 2009. Such statements are subject to numerous factors, risks and uncertainties that may cause actual events or results to differ materially from the company’s current expectations. For example, there can be no guarantee that any product candidate Infinity is developing will successfully complete necessary preclinical and clinical development phases, be approved for sale in any market or that, if approved, revenue from sales of such product will reach any specific level. In particular, management’s expectations could be affected by risks and uncertainties relating to: results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities and investigational review boards at clinical trial sites; Infinity’s ability to enroll patients in its clinical trials; Infinity’s dependence on its collaborations with MedImmune and Novartis; Infinity’s ability to obtain additional funding required to conduct its research, development and commercialization activities; unplanned cash requirements and expenditures; and Infinity’s ability to obtain, maintain and enforce patent and other intellectual property protection for any products it is developing. These and other risks which may impact management’s expectations are described in greater detail under the caption “Risk Factors” included Infinity’s quarterly report on Form 10-Q for the quarter ended September 30, 2006, as filed with the Securities and Exchange Commission on November 9, 2006. Further, any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Gleevec® is a registered trademark of Novartis Pharmaceuticals Corporation.

INFI-G

 

Contacts:  

Investors: John Evans

617.453.1254

John.Evans@ipi.com

 

Media: Monique Allaire

617.453.1105

Monique.Allaire@ipi.com

 

 


LOGO

 

INFINITY PHARMACEUTICALS, INC.

Condensed Consolidated Balance Sheets

(unaudited)

 

     December 31, 2006    December 31, 2005

Cash, cash equivalents and available-for-sale securities

   $ 101,696,784    $ 10,945,928

Other current assets

     44,401,769      1,589,515

Property and equipment, net

     6,539,930      9,899,657

Other long-term assets

     2,009,399      2,016,011
             

Total assets

   $ 154,647,882    $ 24,451,111
             

Current liabilities

   $ 24,834,320    $ 11,760,785

Deferred revenue, less current portion

     64,791,667      —  

Debt and other long-term liabilities

     2,596,940      2,516,348

Total stockholders’ equity

     62,424,955      10,173,978
             

Total liabilities and stockholders’ equity

   $ 154,647,882    $ 24,451,111
             

INFINITY PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Operations

(unaudited)

 

    

Three Months Ended

December 31,

   

Twelve Months Ended

December 31,

 
     2006     2005     2006     2005  

Collaborative research and development revenue

   $ 8,959,755     $ 521,750     $ 18,494,558     $ 521,750  

Operating expenses:

        

Research and development

     9,022,085       8,924,738       35,792,278       31,459,596  

General and administrative

     3,652,476       1,422,558       9,464,283       5,530,046  
                                

Total operating expenses

     12,674,561       10,347,296       45,256,561       36,989,642  
                                

Loss from operations

     (3,714,806 )     (9,825,546 )     (26,762,003 )     (36,467,892 )

Other (expense)/income:

        

Interest expense

     (601,954 )     (166,572 )     (1,507,102 )     (784,290 )

Debt extinguishment charge

     (1,550,860 )     —         (1,550,860 )     —    

Interest and investment income

     1,531,531       167,297       2,459,952       882,954  
                                

Total other (expense)/income

     (621,283 )     725       (598,010 )     98,664  
                                

Loss before income taxes

     (4,336,089 )     (9,824,821 )     (27,360,013 )     (36,369,228 )

Income taxes

     (1,087,960 )     —         (1,087,960 )     —    
                                

Net loss

   ($ 5,424,049 )   ($ 9,824,821 )   ($ 28,447,973 )   ($ 36,369,228 )
                                

# # #

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