-----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, LR6y1MXE/W2KCaMZbnv0mS1Ree5hBFVtyI9208B+V+nJZATKi/0ff1AlXN2rnzE7 0/lrq2kVKenKo0+ZQ9RHhg== 0001193125-06-229425.txt : 20061109 0001193125-06-229425.hdr.sgml : 20061109 20061109085417 ACCESSION NUMBER: 0001193125-06-229425 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20061109 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20061109 DATE AS OF CHANGE: 20061109 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: 061199597 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): November 9, 2006

 


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 November 9, 2006, we issued a press release announcing our results for the quarter ended September 30, 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 November 9, 2006


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: November 9, 2006   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 THIRD QUARTER 2006 RESULTS AND HIGHLIGHTS

RECENT ACCOMPLISHMENTS

— Highlights Include Strong Financial Position and Emerging Phase I Clinical Data for IPI-504, Infinity’s Lead Hsp90 Drug Candidate —

CAMBRIDGE, Mass. – November 09, 2006 – Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), an innovative cancer drug discovery and development company, today announced results for the third quarter of 2006.

Key third quarter highlights include:

 

  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

 

  Completion of 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 corporate development opportunities or financings

 

  Key additions to the leadership team including Gerald Quirk, General Counsel; Steven Kafka, Vice President, Strategic Product Planning and Finance; and John Evans, Manager of Investor Relations and Business Development

“Infinity had a standout third quarter. We are well-positioned to create substantial value for patients and stockholders in the coming years,” said Steven. H. Holtzman, Chief Executive Officer of Infinity.

“The success of our partnership and financing initiatives this year, and the resultant strength of our balance sheet, positions us well to execute on the potential of our product candidates” said Adelene Perkins, Executive Vice President and Chief Business Officer of Infinity. “We are highly encouraged by the evidence of biological activity of IPI-504, our lead anticancer agent targeting Hsp90, and look forward to continuing development of this and other promising agents in our pipeline,” added Julian Adams, President and Chief Scientific Officer of Infinity.

Clinical Development Update

On November 7, 2006, Infinity announced preliminary results of its Phase I clinical trial evaluating IPI-504 in Gleevec®-resistant metastatic gastrointestinal stromal tumors (GIST). IPI-504 has been well-tolerated to date at doses up to 400 mg/m2. In seven of 17 evaluated patients, IPI-504 also demonstrated evidence of biological activity using positron emission tomography imaging, or PET, as a biomarker, including a pattern of response to administration of IPI-504 that suggests the presence of a drug-dependent effect. In addition to the observed PET responses, six of 15 patients received five or more cycles of therapy of

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IPI-504. These results support the further exploration of IPI-504 in refractory GIST as well as in other types of cancer that rely on a single oncogenic client protein of Hsp90 for proliferation and survival.

IPI-504 has also been well-tolerated in its ongoing Phase I clinical trial in patients with relapsed, refractory multiple myeloma. The multiple myeloma trial has added significantly to Infinity’s understanding of IPI-504’s safety and tolerability, a key component of any eventual application for approval of IPI-504. To date, Infinity has not observed the necessary biological activity to move forward into a single agent Phase II trial in this indication. Nevertheless, multiple myeloma remains a potential setting for IPI-504, but more likely as combination therapy.

In the near term, Infinity will focus its resources on GIST as well as on additional indications in which it believes IPI-504 will have a higher likelihood of success as single agent therapy, in order to accelerate the path to potential registration. An update on the Phase I trial in multiple myeloma will be provided at the American Society of Hematology (ASH) Annual Meeting in December.

Business Update

In August 2006, Infinity entered into an agreement with MedImmune, Inc. to jointly develop and commercialize novel small molecule cancer drugs targeting Hsp90 and the Hedgehog cell-signaling pathway. Under the terms of the agreement, Infinity receives a total up-front fee of $70 million and is entitled to receive up to $430 million in potential clinical and commercial milestone payments. In September 2006, Infinity received the first $35 million of the $70 million up-front fee and will receive the remaining $35 million in early January 2007. MedImmune and Infinity will share equally all costs of and worldwide profits from the development and commercialization of any future products in the two programs. For each of the programs, Infinity has primary responsibility for discovery, preclinical development and translational clinical development of products through proof-of-concept in humans. MedImmune will have primary responsibility for obtaining worldwide regulatory approval and for commercializing any resultant products. Infinity also shares co-promotion rights with MedImmune in the United States.

On September 12, 2006, Infinity announced the completion of its reverse merger with Discovery Partners International, Inc. The merger provided Infinity with approximately $78 million in net cash as well as a public listing. The combined company now operates as Infinity Pharmaceuticals, Inc., having retained no employees, operations, or programs from Discovery Partners. Infinity began trading on the NASDAQ Global Market under the ticker symbol “INFI” on September 13, 2006.

Third Quarter Financial Information

The Discovery Partners 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.


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At September 30, 2006, Infinity had total cash, cash equivalents, and available-for-sale securities of approximately $125 million. In addition, Infinity will receive $35 million in early January 2007 representing the second half of MedImmune’s up-front payment to Infinity. Infinity’s current cash position, together with the additional payment from MedImmune, is expected to be sufficient to support Infinity’s current operating plan through at least the end of 2009, in the absence of any additional financings or business development activities.

Infinity’s net loss for the quarter ended September 30, 2006 was $4.7 million, compared to a net loss of $9.5 million for the third quarter of 2005. The improvement in net loss was primarily driven by an increase in strategic alliance revenue.

Total revenue was $6.0 million for the quarter ended September 30, 2006. Infinity’s revenue was derived from its strategic alliances, including license fees received upon the amendment of Infinity’s license agreement with Amgen in July 2006, the amortization of up-front license fees for product-based alliances with MedImmune and Novartis, reimbursable research and development services performed under the Novartis Bcl product discovery and development collaboration, and revenue related to the delivery of proprietary small molecule compounds to Johnson & Johnson under the companies’ technology access alliance agreement. Infinity did not record revenue in the third quarter of 2005.

Research and development expense was $8.3 million for the quarter ended September 30, 2006. Any amounts Infinity is reimbursed by MedImmune by operation of the cost-sharing provisions of the MedImmune agreement are offset against Infinity’s research and development expense. Infinity’s recorded research and development expense of $8.3 million for the quarter ended September 30, 2006 reflects total R&D expenditures of $9.3 million less MedImmune’s reimbursement of approximately $1.0 million during the quarter. Research and development expense was $8.2 million in the third quarter of 2005. The expansion of clinical trials for IPI-504 and higher preclinical development expenses for IPI-504 and Hedgehog pathway inhibitors are expected to be the principal drivers of research and development expense going forward.

General and administrative expense was $2.5 million for the quarter ended September 30, 2006. This includes expenses associated with Infinity’s compliance with the Sarbanes-Oxley Act as well as one-time costs associated with the collaboration agreement with MedImmune. General and administrative expense was $1.4 million in the third quarter of 2005.

Conference Call on Tuesday, November 14, 2006 at 8:30 a.m. Eastern Time

Infinity management will host a conference call on Tuesday, November 14, 2006 at 8:30 a.m. EST. Management will discuss the clinical data released on November 7 and being presented at the EORTC conference in Prague on Friday, November 10, as well as the company’s third quarter 2006 financial results. A live webcast of the conference call can be accessed in the Investor section of Infinity’s website at www.ipi.com. Callers may participate in the call by dialing 800-565-5442 (domestic) and 1-913-312-1298 (international) five minutes prior to the start time. An archived version of the webcast will be available on Infinity’s website for 30 days.


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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 the expectation that Infinty is well-positioned to drive forward its pipeline of anti-cancer agents and create substantial value for patients and stockholders; the efficacy, safety, and intended utilization of Infinity’s product candidates; the results of discovery efforts and clinical trials; plans regarding regulatory filings, future research and clinical trials; future presentations of clinical data; the drivers of future research and development expense; 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 combined 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; 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; decisions made by the ASH regarding the presentation of multiple myeloma data; 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” that was filed as Exhibit 99.2 to Infinity’s current report on Form 8-K, as filed with the Securities and Exchange Commission on September 18, 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.

Contacts:

 

Investors:    John Evans    Media:    Monique Allaire
   617.453.1254       617.453.1105
   John.Evans@ipi.com       Monique.Allaire@ipi.com


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INFINITY PHARMACEUTICALS, INC.

Condensed Consolidated Balance Sheets

(unaudited)

 

     September 30, 2006    December 31, 2005

Cash, cash equivalents and available-for-sale securities, current

   $ 122,992,724    $ 10,945,928

Other current assets

     40,309,956      1,589,515

Available for sale securities, long-term

     2,416,730      —  

Property and equipment, net

     8,186,453      9,899,657

Other long-term assets

     1,927,518      2,016,011
             

Total assets

   $ 175,833,381    $ 24,451,111
             

Current liabilities

   $ 28,163,344    $ 11,760,785

Deferred revenue, less current portion

     68,229,167      —  

Debt and other long-term liabilities

     12,737,026      2,516,348

Total stockholders’ equity

     66,703,844      10,173,978
             

Total liabilities and stockholders’ equity

   $ 175,833,381    $ 24,451,111
             

INFINITY PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Operations

(unaudited)

 

    

Three Months Ended

September 30,

   

Nine Months Ended

September 30,

 
     2006     2005     2006     2005  

Collaborative research and development revenue

   $ 5,997,358     $ —       $ 9,534,803     $ —    

Operating expenses:

        

Research and development

     8,267,227       8,169,668       26,770,193       22,534,858  

General and administrative

     2,453,456       1,407,836       5,811,807       4,107,488  
                                

Total operating expenses

     10,720,683       9,577,504       32,582,000       26,642,346  
                                

Loss from operations

     (4,723,325 )     (9,577,504 )     (23,047,197 )     (26,642,346 )

Other (expense)/income:

        

Interest expense

     (551,094 )     (186,835 )     (905,148 )     (617,718 )

Interest and investment income

     525,771       218,365       928,421       715,657  
                                

Net other (expense)/income

     (25,323 )     31,530       23,273       97,939  
                                

Net loss

   ($ 4,748,648 )   ($ 9,545,974 )   ($ 23,023,924 )   ($ 26,544,407 )
                                

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