-----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, JHguTSk7Q4TW1unkoKqhfblbJL32DUStC5rJtMI2fIsuhJcbFfSRDPcWUPnYvJml +cryxX1Nvu3BztTXV4Za8A== 0001104659-04-029566.txt : 20041005 0001104659-04-029566.hdr.sgml : 20041005 20041004203554 ACCESSION NUMBER: 0001104659-04-029566 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20041003 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041005 DATE AS OF CHANGE: 20041004 FILER: COMPANY DATA: COMPANY CONFORMED NAME: EXACT SCIENCES CORP CENTRAL INDEX KEY: 0001124140 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 204782291 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-32179 FILM NUMBER: 041064153 BUSINESS ADDRESS: STREET 1: 100 CAMPUS DRIVE CITY: MARLBOROUGH STATE: MA ZIP: 01752 BUSINESS PHONE: 5086831200 MAIL ADDRESS: STREET 1: 100 CAMPUS DRIVE CITY: MARLBOROUGH STATE: MA ZIP: 01752 FORMER COMPANY: FORMER CONFORMED NAME: EXACT CORP DATE OF NAME CHANGE: 20000919 8-K 1 a04-11035_38k.htm 8-K

 

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):  October 3, 2004

 

EXACT SCIENCES CORPORATION

(Exact Name of Registrant as Specified in its Charter)

 

Delaware

(State or Other Jurisdiction of Incorporation)

 

000-32179

 

02-0478229

(Commission File Number)

 

(IRS Employer Identification No.)

 

 

 

100 Campus Drive, Marlborough, Massachusetts

 

01752

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code:  (508) 683-1200

 

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 (see General Instruction A.2. below):

 

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))

 

 



 

Item 7.01

 

Regulation FD Disclosure.

 

On October 3, 2004, Exact Sciences Corporation issued a press release, a copy of which is being furnished as Exhibit 99.1 to this Report on Form 8-K.

 

The information in this Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and 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 filing.

 

Item 9.01

 

Financial Statements and Exhibits.

 

 

 

(c)

 

Exhibits:

 

 

 

 

 

99.1

 

Press Release issued by the Company on October 3, 2004, furnished herewith.

 

2



 

SIGNATURES

 

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.

 

 

 

 

EXACT Sciences Corporation

 

 

 

 

 

 

October 4, 2004

 

By:

/s/ Jeffrey R. Luber

 

 

 

 

Jeffrey R. Luber

 

 

 

General Counsel and Secretary

 

3



 

EXHIBIT INDEX

 

Exhibit Number

 

Description

 

 

 

99.1

 

Press Release issued by the Company on October 3, 2004, furnished herewith.

 

4


EX-99.1 2 a04-11035_3ex99d1.htm EX-99.1

Exhibit 99.1

 

 

Press Release

FOR IMMEDIATE RELEASE

 

 

For further information:

 

Investor Relations and

 

Media:

 

Corporate Communications:

 

Kerry Beth Daly

 

Amy Hedison

 

Fleishman-Hillard

 

EXACT Sciences

 

P: (617) 267-8223

 

P: (508) 683-1252

 

E: dalyk@fleishman.com

 

E: ahedison@exactsciences.com

 

EXACT SCIENCES PRESENTS RESEARCH ON NEW DNA
STABILIZATION TECHNIQUES, SCANNING METHODS AND
GENETIC MARKERS

 

Marlborough, Mass. October 3, 2004 – EXACT Sciences Corporation (NASDAQ: EXAS) announced today that its Chief Technology Officer, Anthony P. Shuber, will present information on the Company’s latest applied research efforts on Sunday, October 3, 2004 at 8:00 am (EDT).  The presentation will take place at the Conference on Colon Cancer in Murine Models and the Human, hosted by Jackson Laboratory, in Bar Harbor, Maine.

 

The presentation by Mr. Shuber, entitled “Technical Challenges and the Development of a Stool DNA Assay for Colorectal Cancer Screening,” focuses both on the Company’s accomplishments to date in developing its commercially available, DNA-based assay, PreGen-Plus™, and on the ongoing efforts of the Company’s applied research group to further improve the assay.  These improvements include minimizing DNA degradation in stool and developing a novel DNA sequence scanning technique, both of which, the Company believes, will further improve assay sensitivity over time.

 

Mr. Shuber will present data demonstrating the benefit of maximizing DNA stability during sample handling, as well as the substantially increased ability to identify colorectal cancer associated mutations in tissues by utilizing the recently developed scanning technique.  Mr. Shuber will also describe additional efforts to increase the assay’s performance by reconfiguring the assay’s current marker panel with the addition of novel markers.  The Company intends to further investigate and then validate these results in stool samples.

 



 

“The beauty of working with DNA lies not only in its challenges but in the belief that these challenges can be overcome,” commented Mr. Shuber.  “The concept of a DNA-based fecal assay for the detection of colorectal cancer has been in the scientific literature for well over a decade, but the technical challenges seemed unsolvable.  In fact, the applied research team at EXACT Sciences was able to address the issues and was the first group to develop robust technologies, which are now commercially available in PreGen-Plus.  Moreover, we knew that we could continue to improve the performance of an assay that is DNA-based by meeting other technical and biological challenges going forward.  I believe that the data to be presented at this conference supports the development of a next-generation assay with even greater sensitivity.  Our research efforts now will be focused on the validation of these new technologies, with the hope that we will be able to create commercially viable technologies that further optimize and enhance the performance of PreGen-Plus.”

 

About EXACT Sciences Corporation

EXACT Sciences Corporation is a leader in rapidly applying genomics knowledge to develop effective, patient-friendly screening methods to detect cancer early, to assist physicians in saving patients’ lives.  Its first commercial test, PreGen-Plus™, is used for screening colorectal cancer in the average-risk population.  Colorectal cancer, which is the most deadly cancer among non-smokers, is curable if detected early.  Despite the availability of colorectal cancer screening and diagnostic tests for more than 20 years, however, the rate of early detection of colorectal cancer remains low, and deaths from colorectal cancer remain high.  EXACT Sciences believes its genomics-based technologies will enable early detection of colorectal cancer so that more people can be effectively treated.  Founded in 1995, EXACT Sciences is based in Marlborough, Mass.  Detailed information on EXACT Sciences and PreGen-Plus can be found on the World Wide Web at www.exactsciences.com and www.pregenplus.com.

 

Certain statements made in this press release that are not based on historical information are express or implied forward-looking statements relating to, among other things, EXACT Sciences’ expectations concerning, among other things, the Company’s research and development strategies and programs and their likely future success, the development of new technologies to enhance the sensitivity of its products in the detection of cancer, and the effectiveness and market acceptance of its technologies. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond EXACT Sciences’ control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements.  In particular, the risks and uncertainties include, among other things, the ability of EXACT Sciences to become profitable; the success of its strategic relationship with LabCorp; its ability to license certain technologies or obtain raw materials for its technologies; the ability to convince Medicare and other third-party payors to provide adequate reimbursement for EXACT Sciences’ products and services; the ability to convince medical practitioners to order tests using EXACT Sciences’ technologies; the ability to increase the performance of the PreGen-Plus test; the ability of EXACT Sciences or LabCorp to lower costs through automating and simplifying key operational processes; the inclusion of PreGen-Plus in cancer screening guidelines; the number of people who decide to be screened for colorectal cancer using EXACT Sciences’ technologies; competition; the ability to comply with federal and state statutes and regulations relating to EXACT Sciences’ products and services, including FDA requirements, the U.S. Department of Transportation and the Clinical Laboratory Improvement Amendments; the ability to protect EXACT Sciences’ intellectual property and the cost of enforcing or defending EXACT Sciences in litigation relating to intellectual property rights; the possibility that other companies will develop and market novel or improved methods for detecting colorectal cancer; and the ability to raise additional capital on acceptable terms.  Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.  EXACT Sciences undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.  For additional disclosure regarding these and other risks faced by EXACT Sciences, see the disclosure contained in EXACT Sciences’ public filings with the Securities and Exchange Commission including, without limitation, its most recent Annual Report on Form 10-K and subsequent SEC filings.

 

-####-

 

2


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