EXAS » Topics » 3.1 Organization.

This excerpt taken from the EXAS 8-K filed Jun 12, 2009.
3.1    Organization.  The Company is duly incorporated and validly existing in good standing under the laws of the State of Delaware.  The Company has full power and authority to own, operate and occupy its properties and to conduct its business as currently conducted and is registered or qualified to do business and in good standing in each jurisdiction in which it owns property or transacts business and where the failure to be so qualified would have a material adverse effect upon the Company and its subsidiaries as a whole or the business, financial condition, properties, operations or assets of the Company and its subsidiaries as a whole or the Company’s ability to perform its obligations under the Agreements in all material respects (“Material Adverse Effect”), and no proceeding has been instituted in any such

 

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jurisdiction revoking, limiting or curtailing, or seeking to revoke, limit or curtail, such power and authority or qualification.  Except as set forth in the SEC Reports, the Company does not currently own, directly or indirectly, a majority of the stock or other equity interests in any entity (each, a “Subsidiary”).  Each Subsidiary of the Company has been duly incorporated, formed, or organized, and is validly existing, in good standing under the laws of the jurisdiction of its incorporation, formation, or organization, with full power and authority to own its properties and conduct its business as currently conducted.  All of the issued and outstanding capital stock of each Subsidiary of the Company has been duly authorized and validly issued and is fully paid and non-assessable and except as disclosed in the SEC Reports, is owned of record by the Company, or a Subsidiary of the Company.

 

This excerpt taken from the EXAS 10-Q filed May 15, 2009.

Organization

 

EXACT Sciences Corporation (the “Company”) was incorporated in February 1995.  The Company’s purpose is to improve quality of life through the development of innovative diagnostics.  The mission of the company is to save lives by launching an FDA-cleared, patient friendly colon cancer test that detects both pre-cancer and cancer.  Effective April 2, 2009 the Company’s board of directors appointed Kevin T. Conroy as president and chief executive, and Maneesh K. Arora as senior vice president and chief financial officer. Both Conroy and Arora bring significant experience with molecular diagnostics and managing complex clinical trials to their new roles at the Company. They were most recently president and chief executive, and chief financial officer, respectively, of Third Wave Technologies Inc. Third Wave, a NASDAQ-traded molecular diagnostics company which was acquired last year by Hologic Inc. for $582 million.

 

The American Cancer Society estimates that 80-90 million people in the United States are eligible for colorectal cancer screening.  The company will approach this market opportunity by remaining focused on key priorities.  The company’s priorities for 2009 are: 1) product development, 2) clinical trial planning and 3) creating a performance culture at Exact.

 

As more fully described in Note 3 below, the Company entered into a strategic transaction with Genzyme Corporation (the “Genzyme Strategic Transaction”) on January 27, 2009, pursuant to which Genzyme acquired certain intellectual property assets related to the fields of prenatal and reproductive health and licensed certain intellectual property outside the fields of colorectal cancer screening and stool-based DNA detection. Genzyme also purchased 3.0 million shares of the Company’s common stock.  Pursuant to the strategic transaction, EXACT retained worldwide rights to its colorectal cancer screening and stool-based DNA testing intellectual property, and will receive a share of Genzyme’s sublicensing income derived from the purchased intellectual property outside the fields of prenatal and reproductive health.

 

The Genzyme Strategic Transaction provides for the Company to receive up to $24.5 million in cash in total.  On January 27, 2009, the Company received $16.65 million, with an additional $1.85 million to be received over the next 18 months, contingent upon the non-occurrence of certain events, in exchange for the sale and license of certain of the Company’s intellectual property assets, including those relating to reproductive and prenatal health.  In addition, at closing, Genzyme purchased 3.0 million shares of EXACT common stock at $2.00 per share for an aggregate purchase price of $6.0 million.

 

The Company has licensed certain of its technologies, including improvements to such technologies, on an exclusive basis through December 2010 to Laboratory Corporation of America® Holdings (“LabCorp®”) for use in a commercial testing service for the detection of colorectal cancer developed by LabCorp.  The Company has devoted the majority of its efforts to date on research and development and commercialization support of its colorectal cancer detection technologies.

 

The Company expects that cash, cash equivalents and marketable securities on hand at March 31, 2009 will be sufficient to fund its current operations for at least the next twelve months, based on current operating plans.  The projection is based on the Company’s currently anticipated cost structure and operating assumptions and does not provide for the full funding of the development of the Company’s stool-based DNA technology and related FDA submission and commercialization efforts or other programs and initiatives. The Company does not expect that product royalty payments or milestone payments from LabCorp will materially supplement its liquidity position in the next twelve months, if at all.  Since the Company has no current sources of material ongoing revenue, it believes that it will need to raise additional capital to complete the development, FDA submission for clearance or approval, and commercialization of its technologies, including an FDA-approved in vitro diagnostic test for stool-based DNA colorectal cancer screening.  If the Company is unable to obtain sufficient additional funds to enable it to fund its operations through the completion of the development of such a test, the submission to the FDA for clearance or approval of the test, and commercialization of the test, the Company’s results of operations and financial condition would be materially adversely affected and it may be required to delay such efforts and otherwise scale back operations.  Even if the Company successfully raises sufficient funds to continue its operations to fund the development, FDA submission, and commercialization of its technology, including an FDA-approved in vitro diagnostic test for stool-based DNA colorectal cancer screening, the Company cannot assure you that its business will ever generate sufficient cash flow from operations to become profitable.

 

These excerpts taken from the EXAS 10-K filed Mar 31, 2009.

Organization

        EXACT Sciences Corporation (the "Company") was incorporated in February 1995. The Company has developed proprietary DNA-based technologies for use in the detection of cancer. The Company has selected colorectal cancer as the first application of its technologies. The Company has licensed certain of its technologies, including improvements to such technologies, on an exclusive basis through December 2010 to Laboratory Corporation of America® Holdings ("LabCorp®") for use in a commercial testing service for the detection of colorectal cancer developed by LabCorp. LabCorp's first generation testing service, "PreGen-Plus™," was a non-invasive stool-based DNA testing service for the detection of colorectal cancer in the average-risk population and was marketed by LabCorp from August 2003 through June 1, 2008. In July 2008, LabCorp began offering "ColoSure™", its new non-invasive laboratory developed stool- based DNA testing service for the detection of colorectal cancer in the average-risk population, which is based on the Vimentin gene, a methylated DNA marker that in published studies was shown to be associated with colorectal cancer. The Company has devoted the majority of its efforts to date on research and development and commercialization support of its colorectal cancer detection technologies.

        As fully described in Note 15 below, the Company entered into a strategic transaction with Genzyme Corporation (the "Genzyme Strategic Transaction") on January 27, 2009, pursuant to which Genzyme acquired certain intellectual property assets related to the fields of prenatal and reproductive health and licensed certain intellectual property outside the fields of colorectal cancer screening and stool-based DNA detection. Genzyme also purchased 3.0 million shares of the Company's common stock. Pursuant to the strategic transaction, EXACT retained worldwide rights to its colorectal cancer screening and stool-based DNA testing intellectual property, and will receive a share of Genzyme's sublicensing income derived from the purchased intellectual property outside the fields of prenatal and reproductive health.

        The Genzyme Strategic Transaction provides for the Company to receive up to $24.5 million in cash in total. On January 27, 2009, the Company received $16.65 million, with an additional $1.85 million to be received over the next 18 months, contingent upon the non-occurrence of certain events, in exchange for the sale and license of certain of the Company's intellectual property assets, including those relating to reproductive and prenatal health. In addition, at closing, Genzyme purchased 3.0 million shares of EXACT common stock at $2.00 per share for an aggregate purchase price of $6.0 million.

        The Company expects that cash and cash equivalents on hand at December 31, 2008, together with the receipt of $22.65 million in January 2009 in connection with the Genzyme transaction, will be sufficient to fund its current operations for at least the next twelve months, based on current operating plans. The projection is based on the Company's currently anticipated cost structure and operating assumptions, which include allocations related to collection of stool samples for study purposes which would likely be used to support an FDA submission for clearance or approval of the Company's stool-based DNA technology for colorectal cancer screening. Such allocations do not provide for the full funding of the commercial development of the Company's stool-based DNA technology and related FDA submission and commercialization efforts or other programs and initiatives. We do not expect that product royalty payments or milestone payments from LabCorp will materially supplement the Company's liquidity position in the next twelve months, if at all. Since the Company has no current

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EXACT SCIENCES CORPORATION

Notes to Consolidated Financial Statements December 31, 2008 (Continued)

(Amounts in thousands, except share and per share data)

(1) ORGANIZATION AND BASIS OF PRESENTATION (Continued)


sources of material ongoing revenue, it believes that it will need to raise additional capital to complete the development, FDA submission for clearance or approval, and commercialization of its technologies, including an FDA-approved in vitro diagnostic test for stool-based DNA colorectal cancer screening. If the Company is unable to obtain sufficient additional funds to enable us to fund its operations through the completion of the development of such a test, the submission to the FDA for clearance or approval of the test, and commercialization of the test, the Company's results of operations and financial condition would be materially adversely affected and it may be required to delay such efforts and otherwise scale back operations. Even if the Company successfully raises sufficient funds to continue our operations to fund the development, FDA submission, and commercialization of its technology, including an FDA-approved in vitro diagnostic test for stool-based DNA colorectal cancer screening, the Company cannot assure you that its business will ever generate sufficient cash flow from operations to become profitable.

Organization

        EXACT Sciences Corporation (the "Company") was incorporated in February 1995. The Company has developed proprietary DNA-based technologies for use in the detection of cancer. The Company has selected colorectal cancer as the first application of its technologies. The Company has licensed certain of its technologies, including improvements to such technologies, on an exclusive basis through December 2010 to Laboratory Corporation of America® Holdings ("LabCorp®") for use in a commercial testing service for the detection of colorectal cancer developed by LabCorp. LabCorp's first generation testing service, "PreGen-Plus™," was a non-invasive stool-based DNA testing service for the detection of colorectal cancer in the average-risk population and was marketed by LabCorp from August 2003 through June 1, 2008. In July 2008, LabCorp began offering "ColoSure™", its new non-invasive laboratory developed stool- based DNA testing service for the detection of colorectal cancer in the average-risk population, which is based on the Vimentin gene, a methylated DNA marker that in published studies was shown to be associated with colorectal cancer. The Company has devoted the majority of its efforts to date on research and development and commercialization support of its colorectal cancer detection technologies.

        As fully described in Note 15 below, the Company entered into a strategic transaction with Genzyme Corporation (the "Genzyme Strategic Transaction") on January 27, 2009, pursuant to which Genzyme acquired certain intellectual property assets related to the fields of prenatal and reproductive health and licensed certain intellectual property outside the fields of colorectal cancer screening and stool-based DNA detection. Genzyme also purchased 3.0 million shares of the Company's common stock. Pursuant to the strategic transaction, EXACT retained worldwide rights to its colorectal cancer screening and stool-based DNA testing intellectual property, and will receive a share of Genzyme's sublicensing income derived from the purchased intellectual property outside the fields of prenatal and reproductive health.

        The Genzyme Strategic Transaction provides for the Company to receive up to $24.5 million in cash in total. On January 27, 2009, the Company received $16.65 million, with an additional $1.85 million to be received over the next 18 months, contingent upon the non-occurrence of certain events, in exchange for the sale and license of certain of the Company's intellectual property assets, including those relating to reproductive and prenatal health. In addition, at closing, Genzyme purchased 3.0 million shares of EXACT common stock at $2.00 per share for an aggregate purchase price of $6.0 million.

        The Company expects that cash and cash equivalents on hand at December 31, 2008, together with the receipt of $22.65 million in January 2009 in connection with the Genzyme transaction, will be sufficient to fund its current operations for at least the next twelve months, based on current operating plans. The projection is based on the Company's currently anticipated cost structure and operating assumptions, which include allocations related to collection of stool samples for study purposes which would likely be used to support an FDA submission for clearance or approval of the Company's stool-based DNA technology for colorectal cancer screening. Such allocations do not provide for the full funding of the commercial development of the Company's stool-based DNA technology and related FDA submission and commercialization efforts or other programs and initiatives. We do not expect that product royalty payments or milestone payments from LabCorp will materially supplement the Company's liquidity position in the next twelve months, if at all. Since the Company has no current

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EXACT SCIENCES CORPORATION

Notes to Consolidated Financial Statements December 31, 2008 (Continued)

(Amounts in thousands, except share and per share data)

(1) ORGANIZATION AND BASIS OF PRESENTATION (Continued)


sources of material ongoing revenue, it believes that it will need to raise additional capital to complete the development, FDA submission for clearance or approval, and commercialization of its technologies, including an FDA-approved in vitro diagnostic test for stool-based DNA colorectal cancer screening. If the Company is unable to obtain sufficient additional funds to enable us to fund its operations through the completion of the development of such a test, the submission to the FDA for clearance or approval of the test, and commercialization of the test, the Company's results of operations and financial condition would be materially adversely affected and it may be required to delay such efforts and otherwise scale back operations. Even if the Company successfully raises sufficient funds to continue our operations to fund the development, FDA submission, and commercialization of its technology, including an FDA-approved in vitro diagnostic test for stool-based DNA colorectal cancer screening, the Company cannot assure you that its business will ever generate sufficient cash flow from operations to become profitable.

Organization



        EXACT Sciences Corporation (the "Company") was incorporated in February 1995. The Company has developed proprietary
DNA-based technologies for use in the detection of cancer. The Company has selected colorectal cancer as the first application of its technologies. The Company has licensed certain of its
technologies, including improvements to such technologies, on an exclusive basis through December 2010 to Laboratory Corporation of America® Holdings ("LabCorp®") for use in a
commercial testing service for the detection of colorectal cancer developed by LabCorp. LabCorp's first generation testing service, "PreGen-Plus™," was a
non-invasive stool-based DNA testing service for the detection of colorectal cancer in the average-risk population and was marketed by LabCorp from August 2003 through
June 1, 2008. In July 2008, LabCorp began offering "ColoSure™", its new non-invasive laboratory developed stool-
based DNA testing service for the detection of colorectal cancer in the average-risk population, which is based on the Vimentin gene, a methylated DNA marker that in published studies was
shown to be associated with colorectal cancer. The Company has devoted the majority of its efforts to date on research and development and commercialization support of its colorectal cancer detection
technologies.



        As
fully described in Note 15 below, the Company entered into a strategic transaction with Genzyme Corporation (the "Genzyme Strategic Transaction") on January 27, 2009,
pursuant to which Genzyme acquired certain intellectual property assets related to the fields of prenatal and reproductive health and licensed certain intellectual property outside the fields of
colorectal cancer screening and stool-based DNA detection. Genzyme also purchased 3.0 million shares of the Company's common stock. Pursuant to the strategic transaction, EXACT retained
worldwide rights to its colorectal cancer screening and stool-based DNA testing intellectual property, and will receive a share of Genzyme's sublicensing income derived from the purchased intellectual
property outside the fields of prenatal and reproductive health.



        The
Genzyme Strategic Transaction provides for the Company to receive up to $24.5 million in cash in total. On January 27, 2009, the Company received $16.65 million,
with an additional $1.85 million to be received over the next 18 months, contingent upon the non-occurrence of certain events, in exchange for the sale and license of certain
of the Company's intellectual property assets, including those relating to reproductive and prenatal health. In addition, at closing, Genzyme purchased 3.0 million shares of EXACT common stock
at $2.00 per share for an aggregate purchase price of $6.0 million.



        The
Company expects that cash and cash equivalents on hand at December 31, 2008, together with the receipt of $22.65 million in January 2009 in connection with the Genzyme
transaction, will be sufficient to fund its current operations for at least the next twelve months, based on current operating plans. The projection is based on the Company's currently anticipated
cost structure and operating assumptions, which include allocations related to collection of stool samples for study purposes which would likely be used to support an FDA submission for clearance or
approval of the Company's stool-based DNA technology for colorectal cancer screening. Such allocations do not provide for the full funding of the commercial development of the Company's stool-based
DNA technology and related FDA submission and commercialization efforts or other programs and initiatives. We do not expect that product royalty payments or milestone payments from LabCorp will
materially supplement the Company's liquidity position in the next twelve months, if at all. Since the Company has no current



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EXACT SCIENCES CORPORATION



Notes to Consolidated Financial Statements December 31, 2008 (Continued)



(Amounts in thousands, except share and per share data)



(1) ORGANIZATION AND BASIS OF PRESENTATION (Continued)






sources
of material ongoing revenue, it believes that it will need to raise additional capital to complete the development, FDA submission for clearance or approval, and commercialization of its
technologies, including an FDA-approved in vitro diagnostic test for stool-based DNA colorectal cancer screening. If the Company is unable to obtain sufficient additional funds to enable
us to fund its operations through the completion of the development of such a test, the submission to the FDA for clearance or approval of the test, and commercialization of the test, the Company's
results of operations and financial condition would be materially adversely affected and it may be required to delay such efforts and otherwise scale back operations. Even if the Company successfully
raises
sufficient funds to continue our operations to fund the development, FDA submission, and commercialization of its technology, including an FDA-approved in vitro diagnostic test for
stool-based DNA colorectal cancer screening, the Company cannot assure you that its business will ever generate sufficient cash flow from operations to become profitable.



Organization



        EXACT Sciences Corporation (the "Company") was incorporated in February 1995. The Company has developed proprietary
DNA-based technologies for use in the detection of cancer. The Company has selected colorectal cancer as the first application of its technologies. The Company has licensed certain of its
technologies, including improvements to such technologies, on an exclusive basis through December 2010 to Laboratory Corporation of America® Holdings ("LabCorp®") for use in a
commercial testing service for the detection of colorectal cancer developed by LabCorp. LabCorp's first generation testing service, "PreGen-Plus™," was a
non-invasive stool-based DNA testing service for the detection of colorectal cancer in the average-risk population and was marketed by LabCorp from August 2003 through
June 1, 2008. In July 2008, LabCorp began offering "ColoSure™", its new non-invasive laboratory developed stool-
based DNA testing service for the detection of colorectal cancer in the average-risk population, which is based on the Vimentin gene, a methylated DNA marker that in published studies was
shown to be associated with colorectal cancer. The Company has devoted the majority of its efforts to date on research and development and commercialization support of its colorectal cancer detection
technologies.



        As
fully described in Note 15 below, the Company entered into a strategic transaction with Genzyme Corporation (the "Genzyme Strategic Transaction") on January 27, 2009,
pursuant to which Genzyme acquired certain intellectual property assets related to the fields of prenatal and reproductive health and licensed certain intellectual property outside the fields of
colorectal cancer screening and stool-based DNA detection. Genzyme also purchased 3.0 million shares of the Company's common stock. Pursuant to the strategic transaction, EXACT retained
worldwide rights to its colorectal cancer screening and stool-based DNA testing intellectual property, and will receive a share of Genzyme's sublicensing income derived from the purchased intellectual
property outside the fields of prenatal and reproductive health.



        The
Genzyme Strategic Transaction provides for the Company to receive up to $24.5 million in cash in total. On January 27, 2009, the Company received $16.65 million,
with an additional $1.85 million to be received over the next 18 months, contingent upon the non-occurrence of certain events, in exchange for the sale and license of certain
of the Company's intellectual property assets, including those relating to reproductive and prenatal health. In addition, at closing, Genzyme purchased 3.0 million shares of EXACT common stock
at $2.00 per share for an aggregate purchase price of $6.0 million.



        The
Company expects that cash and cash equivalents on hand at December 31, 2008, together with the receipt of $22.65 million in January 2009 in connection with the Genzyme
transaction, will be sufficient to fund its current operations for at least the next twelve months, based on current operating plans. The projection is based on the Company's currently anticipated
cost structure and operating assumptions, which include allocations related to collection of stool samples for study purposes which would likely be used to support an FDA submission for clearance or
approval of the Company's stool-based DNA technology for colorectal cancer screening. Such allocations do not provide for the full funding of the commercial development of the Company's stool-based
DNA technology and related FDA submission and commercialization efforts or other programs and initiatives. We do not expect that product royalty payments or milestone payments from LabCorp will
materially supplement the Company's liquidity position in the next twelve months, if at all. Since the Company has no current



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EXACT SCIENCES CORPORATION



Notes to Consolidated Financial Statements December 31, 2008 (Continued)



(Amounts in thousands, except share and per share data)



(1) ORGANIZATION AND BASIS OF PRESENTATION (Continued)






sources
of material ongoing revenue, it believes that it will need to raise additional capital to complete the development, FDA submission for clearance or approval, and commercialization of its
technologies, including an FDA-approved in vitro diagnostic test for stool-based DNA colorectal cancer screening. If the Company is unable to obtain sufficient additional funds to enable
us to fund its operations through the completion of the development of such a test, the submission to the FDA for clearance or approval of the test, and commercialization of the test, the Company's
results of operations and financial condition would be materially adversely affected and it may be required to delay such efforts and otherwise scale back operations. Even if the Company successfully
raises
sufficient funds to continue our operations to fund the development, FDA submission, and commercialization of its technology, including an FDA-approved in vitro diagnostic test for
stool-based DNA colorectal cancer screening, the Company cannot assure you that its business will ever generate sufficient cash flow from operations to become profitable.



This excerpt taken from the EXAS 10-Q filed Nov 7, 2008.

Organization

 

EXACT Sciences Corporation (the “Company”) was incorporated in February 1995.  The Company has developed proprietary DNA-based technologies for use in the detection of cancer.  The Company has selected colorectal cancer as the first application of its technologies.  The Company has licensed certain of its technologies, including improvements to such technologies, on an exclusive basis through December 2010 to Laboratory Corporation of America® Holdings (“LabCorp®”) for use in a commercial testing service for the detection of colorectal cancer developed by LabCorp.  LabCorp’s first generation testing service, “PreGen-Plus™,” was a non-invasive stool-based DNA testing service for the detection of colorectal cancer in the average-risk population and was marketed by LabCorp from August 2003 through June 1, 2008.  In July 2008, LabCorp began offering “ColoSure™”, its new non-invasive laboratory developed stool-based DNA testing service for the detection of colorectal cancer in the average-risk population, which is based on the Vimentin gene, a methylated DNA marker that in published studies was shown to be associated with colorectal cancer.  The Company has devoted the majority of its efforts to date on research and development and commercialization support of its colorectal cancer detection technologies.

 

This excerpt taken from the EXAS 10-Q filed Aug 8, 2008.

Organization

 

EXACT Sciences Corporation (the “Company”) was incorporated in February 1995.  The Company has developed proprietary DNA-based technologies for use in the detection of cancer.  The Company has selected colorectal cancer as the first application of its technologies.  The Company has licensed certain of its technologies, including improvements to such technologies, on an exclusive basis through December 2010 to Laboratory Corporation of America® Holdings (“LabCorp®”) for use in a commercial testing service for the detection of colorectal cancer developed by LabCorp.  LabCorp’s first generation testing service, “PreGen-Plus™,” was a non-invasive stool-based DNA testing service for the detection of colorectal cancer in the average-risk population and was marketed by LabCorp from August 2003 through June 1, 2008.  In July 2008, LabCorp began offering “ColoSure™”, its new non-invasive laboratory developed stool-based DNA testing service for the detection of colorectal cancer in the average-risk population, which is based on the Vimentin gene, a methylated DNA marker that in published studies was shown to be associated with colorectal cancer.  The Company has devoted the majority of its efforts to date on research and development and commercialization support of its colorectal cancer detection technologies.

 

This excerpt taken from the EXAS 10-Q filed May 9, 2008.

Organization

 

EXACT Sciences Corporation (the “Company”) was incorporated in February 1995.  The Company develops proprietary DNA-based technologies for use in the detection of cancer.  The Company has selected colorectal cancer as the first application of its technologies.  The Company has licensed certain of its technologies, including improvements to such technologies, on an exclusive basis through December 2010 to Laboratory Corporation of America® Holdings (“LabCorp®”) for use in a commercial testing service developed by LabCorp and marketed under the name “PreGen-Plus™.”  PreGen-Plus is a non-invasive stool-based DNA testing service for the detection of colorectal cancer in the average-risk population.  The Company has devoted the majority of its efforts to date on research and development and commercialization support of PreGen-Plus.

 

These excerpts taken from the EXAS 10-K filed Mar 17, 2008.

Organization

        EXACT Sciences Corporation (the "Company") was incorporated in February 1995. The Company develops proprietary DNA-based technologies for use in the detection of cancer. The Company has selected colorectal cancer as the first application of its technologies. The Company has licensed certain of its technologies, including improvements to such technologies, on an exclusive basis through December 2010 to Laboratory Corporation of America® Holdings ("LabCorp®") for use in a commercial testing service developed by LabCorp and marketed under the name "PreGen-Plus™." PreGen-Plus is a non-invasive stool-based DNA testing service for the detection of colorectal cancer in the average-risk population. The Company has devoted the majority of its efforts to date on research and development and commercialization support of PreGen-Plus.

Organization



        EXACT Sciences Corporation (the "Company") was incorporated in February 1995. The Company develops proprietary DNA-based technologies for use in the
detection of cancer. The Company has selected colorectal cancer as the first application of its technologies. The Company has licensed certain of its technologies, including improvements to such
technologies, on an exclusive basis through December 2010 to Laboratory Corporation of America® Holdings ("LabCorp®") for use in a commercial testing service developed by
LabCorp and marketed under the name "PreGen-Plus™." PreGen-Plus is a non-invasive stool-based DNA testing service for the detection of colorectal cancer
in the average-risk population. The Company has devoted the majority of its efforts to date on research and development and commercialization support of PreGen-Plus.



This excerpt taken from the EXAS 10-Q filed Nov 6, 2007.

(1) ORGANIZATION

 

        EXACT Sciences Corporation (the “Company”) was incorporated in February 1995.  The Company develops proprietary DNA-based technologies for use in the detection of cancer.  The Company has selected colorectal cancer as the first application of its technologies.  The Company has licensed certain of its technologies, including improvements to such technologies, on an exclusive basis through December 2010 to Laboratory Corporation of America® Holdings (“LabCorp®”) for use in a commercial testing service developed by LabCorp and marketed under the name “PreGen-Plus™.”  PreGen-Plus is a non-invasive stool-based DNA testing service for the detection of colorectal cancer in the average-risk population.  The Company has devoted the majority of its efforts to date on research and development and commercialization support of PreGen-Plus.

 

        The Company has generated limited operating revenues since its inception and, as of September 30, 2007, had an accumulated deficit of approximately $158.7 million.  The Company’s losses have historically resulted from costs incurred in conjunction with  research, development, and clinical study initiatives, salaries and benefits associated with the hiring of personnel, the initiation of marketing programs and, prior to August 31, 2007, costs related to its sales function to support the commercialization of its stool-based DNA screening technology.

 

        The Company expects that its cash, cash equivalents and marketable securities balances at September 30, 2007 will be sufficient to fund its operations through 2008, based upon the Company’s current cost structure and current assumptions regarding the studies and other requirements that it believes may be necessary to obtain U.S. Food and Drug Administration (“FDA”) regulatory clearance for the DNA-based colorectal cancer screening technology described in the October 11, 2007 warning letter from the FDA to the Company (the “Warning Letter”).  See Note 7 for a description of the Warning Letter.  The Company has no current sources of material ongoing revenue and, accordingly, it will likely need to raise additional capital in the next twelve months or further reduce the scale of the Company’s operations, or both.  There can be no assurance that the Company will be successful in any future capital raising efforts, or that it would be able to raise additional funds at an acceptable price level.  An inability to fund the Company’s operations would have a material adverse effect on its business, financial condition and results of operations.

 

This excerpt taken from the EXAS 10-Q filed May 8, 2007.

(1) ORGANIZATION

EXACT Sciences Corporation (the “Company”) was incorporated in February 1995.  The Company develops proprietary DNA-based technologies for use in the detection of cancer.  The Company has selected colorectal cancer as the first application of its technologies.  The Company has licensed certain of its technologies, including improvements to such technologies, on an exclusive basis through August 2008 to Laboratory Corporation of America® Holdings (“LabCorp®”) for use in a commercial testing service developed by LabCorp and marketed under the name “PreGen-Plus™.”  PreGen-Plus is a non-invasive stool-based DNA testing service for the detection of colorectal cancer in the average-risk population.  The Company has devoted the majority of its efforts to date on research and development and commercialization support of PreGen-Plus.

This excerpt taken from the EXAS 10-K filed Mar 15, 2007.

(1)   ORGANIZATION

EXACT Sciences Corporation (the “Company”) was incorporated in February 1995. The Company develops proprietary DNA-based technologies for use in the detection of cancer. The Company has selected colorectal cancer as the first application of its technologies. The Company has licensed certain of its technologies, including improvements to such technologies, on an exclusive basis through August 2008 to Laboratory Corporation of America® Holdings (“LabCorp®”) for use in a commercial testing service developed by LabCorp and marketed under the name “PreGen-Plus™.”  PreGen-Plus is a non-invasive stool-based DNA testing service for the detection of colorectal cancer in the average-risk population. The Company has devoted the majority of its efforts to date on research and development and commercialization support of PreGen-Plus.

This excerpt taken from the EXAS 10-Q filed Nov 9, 2006.

(1) ORGANIZATION

EXACT Sciences Corporation (the “Company”) was incorporated in February 1995.  The Company develops proprietary DNA-based technologies for use in the detection of cancer.  The Company has selected colorectal cancer as the first application of its technologies.  The Company has licensed certain of its technologies, including improvements to such technologies, on an exclusive basis through August 2008 to Laboratory Corporation of America® Holdings (“LabCorp®”) for use in a commercial testing service developed by LabCorp and marketed under the name “PreGen-Plus™.”  PreGen-Plus is a non-invasive stool-based DNA testing service for the detection of colorectal cancer in the average-risk population.  The Company has devoted the majority of its efforts to date on research and development and commercialization support of PreGen-Plus.

This excerpt taken from the EXAS 10-Q filed Aug 4, 2006.

(1)   ORGANIZATION

EXACT Sciences Corporation (the “Company”) was incorporated in February 1995. The Company is an applied genomics company that develops proprietary DNA-based technologies for use in the detection of cancer. The Company has selected colorectal cancer as the first application of its technologies. The Company has licensed certain of its technologies, including improvements to such technologies, on an exclusive basis through August 2008, to Laboratory Corporation of America® Holdings (“LabCorp®”) for use in a commercial testing service developed by LabCorp and marketed under the name “PreGen-Plus™.” PreGen-Plus is a non-invasive stool-based DNA testing service for the detection of colorectal cancer in the average-risk population. The Company has devoted the majority of its efforts to date on research and development and commercialization support of PreGen-Plus.

This excerpt taken from the EXAS 10-Q filed Apr 27, 2006.

(1) ORGANIZATION

 

EXACT Sciences Corporation (the “Company”) was incorporated in February 1995. The Company is an applied genomics company that develops proprietary DNA-based technologies for use in the detection of cancer. The Company has selected colorectal cancer as the first application of its technologies. The Company has licensed certain of its technologies, on an exclusive basis through August 2008, to Laboratory Corporation of America® Holdings (“LabCorp®”) for use in a commercial testing service developed by LabCorp and marketed under the name “PreGen-Plus™.”  PreGen-Plus is a non-invasive stool-based DNA testing service for the detection of colorectal cancer in the average-risk population. The Company has devoted the majority of its efforts to date on research and development and commercialization support of PreGen-Plus.

 

This excerpt taken from the EXAS 10-K filed Mar 15, 2006.
(1)   ORGANIZATION

EXACT Sciences Corporation (the “Company”) was incorporated in February 1995. The Company is an applied genomics company that develops proprietary DNA-based technologies for use in the detection of cancer. The Company has selected colorectal cancer as the first application of its technologies. The Company has licensed certain of its technologies, on an exclusive basis through August 2008, to Laboratory Corporation of America® Holdings (“LabCorp®”) for use in a commercial testing service developed by LabCorp and marketed under the name “PreGen-Plus™.”  PreGen-Plus is a non-invasive stool-based DNA testing service for the detection of colorectal cancer in the average-risk population. The Company has devoted the majority of its efforts to date on research and development and commercialization support of PreGen-Plus.

This excerpt taken from the EXAS 10-Q filed Oct 28, 2005.

(1) ORGANIZATION

 

        EXACT Sciences Corporation (the “Company”) was incorporated in February 1995.  The Company is an applied genomics company that develops proprietary DNA-based technologies for use in the detection of cancer.  The Company has selected colorectal cancer as the first application of its technologies.  The Company has licensed certain of its technologies, on an exclusive basis through August 2008, to Laboratory Corporation of America® Holdings (“LabCorp®”) for use in a commercial testing service developed by LabCorp and marketed under the name “PreGen-Plus™.”  PreGen-Plus is a non-invasive stool-based DNA testing service for the detection of colorectal cancer in the average-risk population.  The Company has devoted the majority of its efforts to date on research and development and commercialization support of PreGen-Plus.

 

This excerpt taken from the EXAS 10-Q filed Aug 2, 2005.

(1) ORGANIZATION

 

                EXACT Sciences Corporation (the “Company”) was incorporated on February 10, 1995.  The Company is an applied genomics company that develops proprietary DNA-based technologies for use in the detection of cancer.  The Company has selected colorectal cancer as the first application of its technologies. The Company has licensed certain of its technologies, on an exclusive basis through August 2008, to Laboratory Corporation of America® Holdings (“LabCorp®”) for use in a commercial testing service developed by LabCorp and marketed under the name “PreGen-Plus™.”  PreGen-Plus is a non-invasive DNA-based testing service for the detection of colorectal cancer in the average-risk population.  The Company has devoted the majority of its efforts to date on research and development and commercialization support of PreGen-Plus.

 

This excerpt taken from the EXAS 10-Q filed May 6, 2005.

(1) ORGANIZATION

 

EXACT Sciences Corporation (the “Company”) was incorporated on February 10, 1995.  The Company is an applied genomics company that develops and commercializes proprietary DNA-based tests for the early detection of cancer.  The Company has selected colorectal cancer as the first application of its technology platform.  The Company has devoted the majority of its efforts to date on the research, development and commercialization of PreGen-Plus™, the Company’s proprietary, non-invasive DNA-based technology for the early detection of colorectal cancer in the average-risk population, which is offered commercially through a license agreement with Laboratory Corporation of America® Holdings (“LabCorp®”).

 

 

This excerpt taken from the EXAS 10-K filed Mar 14, 2005.

(1) ORGANIZATION

        EXACT Sciences Corporation (the "Company") was incorporated on February 10, 1995. The Company is an applied genomics company that develops and commercializes proprietary DNA-based tests for the early detection of cancer. The Company has selected colorectal cancer as the first application of its technology platform. The Company has devoted a majority of its efforts on research and development activities related to its PreGen™ technologies, including several large multi-center clinical studies. More recently, the Company has also been focused on the marketing of PreGen-Plus™, the Company's proprietary, non-invasive DNA-based technology for the early detection of colorectal cancer in the average-risk population being offered commercially through a license agreement with Laboratory Corporation of America® Holdings ("LabCorp®").

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