(Mark One) |
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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For the fiscal year ended December 31, 2004 | ||
or | ||
o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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For the transition period from to . |
Delaware | 62-1715807 | |
(State or Jurisdiction of Incorporation or organization) |
(I.R.S. Employer Identification Number) |
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES | ||||||||
SIGNATURES | ||||||||
Exhibit Index | ||||||||
EXHIBIT 24.1 | ||||||||
EXHIBIT 31.1 | ||||||||
EXHIBIT 31.2 |
Number | Description | |||
3.1 | Restated Certificate of Incorporation of GTx, Inc. filed February 6, 2004, as amended
(1) |
|||
3.2 | Amended and Restated Bylaws of GTx, Inc.
(1) |
|||
4.1 | Reference is made to Exhibits 3.1 and 3.2 |
|||
4.2 | Specimen of Common Stock Certificate (1) |
|||
4.3 | Amended and Restated Registration Rights Agreement between Registrant and Oracle Partners, L.P.
dated August 7, 2003
(1)
|
|||
4.4 | Amended and Restated Registration Rights Agreement between Registrant and J. R. Hyde, III dated
August 7, 2003 (1) |
|||
4.5 | Amended and Restated Registration Rights Agreement between Registrant and Memphis Biomed Ventures
dated August 7, 2003 (1) |
|||
10.1 | Genotherapeutics, Inc. 1999 Stock Option Plan (1) |
|||
10.2 | GTx, Inc. 2000 Stock Option Plan (1) |
|||
10.3 | GTx, Inc. 2001 Stock Option Plan (1) |
|||
10.4 | GTx, Inc. 2002 Stock Option Plan (1) |
|||
10.5 | 2004 Equity Incentive Plan and Form of Stock Option Agreement (1) |
|||
10.6 | 2004 Non-Employee Directors Stock Option Plan and Form of Stock Option Agreement (1) |
|||
10.7 | Reserved |
|||
10.8 | Employment Agreement dated October 1, 2003, between Registrant and Mitchell S. Steiner, M.D.
(1) |
|||
10.9 | Employment Agreement dated October 1, 2003, between Registrant and Marc S. Hanover (1) |
|||
10.10 | Employment Agreement dated October 1, 2003, between Registrant and Mark E. Mosteller (1) |
|||
10.11 | Employment Agreement dated October 1, 2003, between Registrant and Henry P. Doggrell (1) |
|||
10.12 | Form of Indemnification Agreement (1) |
|||
10.13 | Lease Agreement, dated March 7, 2001, between The University of Tennessee and TriStar Enterprises,
Inc. (1) |
|||
10.14 | Sublease Agreement dated October 1, 2000, as amended, between Registrant and TriStar Enterprises,
Inc. (1) |
|||
10.15 | Amended and Restated License and Supply Agreement dated October 22, 2001, between Registrant and
Orion Corporation
(1)
|
|||
10.16 | Amendment No. 1 to the License and Supply Agreement dated March 5, 2003, between Registrant and
Orion Corporation (1) |
|||
10.17 | Production and Manufacturing Agreement dated September 9, 2002, between Registrant and ChemSyn
Laboratories (Department of EaglePicher Technologies, LLC) (1) |
|||
10.18 | Amendment No. 1 to the Production and Manufacturing Agreement dated September 30, 2003, between
Registrant and ChemSyn Laboratories (Department of EaglePicher Technologies, LLC) (1) |
|||
10.19 | Quotation Agreement dated August 8, 2003 between Registrant and EaglePicher Pharmaceutical Services
(1) |
|||
10.20 | Amended and Restated Exclusive License Agreement dated June 3, 2002, between Registrant and
University of Tennessee Research Foundation (1) |
|||
10.21 | Amended and Restated Exclusive License Agreement dated June 14, 2003, between Registrant and
University of Tennessee Research Foundation (1) |
|||
10.22 | Amended and Restated Exclusive License Agreement dated August 30, 2003, between Registrant and
University of Tennessee Research Foundation (1) |
|||
10.23 | Amendment No. 2 to the License and Supply Agreement dated December 29, 2003, between Registrant and
Orion
Corporation (1) |
Number | Description | |||
10.24 | Joint Collaboration and License Agreement dated March 16, 2005, between Registrant and Ortho
Biotech, L.P. (3) |
|||
10.25 | Purchase Agreement dated December 13, 2004, between Registrant and Orion Corporation (4) |
|||
10.26 | Amended and Restated License and Supply Agreement effective January 1, 2005, between Registrant and
Orion Corporation
(4) |
|||
14.1 | Code of Ethics (2) |
|||
13.1* | Annual Report to Shareholders |
|||
23.1* | Consent of Ernst & Young LLP |
|||
24.1 | Power
of Attorney |
|||
31.1 | Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|||
31.2 | Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|||
32.1* | Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 |
|||
32.2* | Certification of Chief Financial Officer Pursuant to 18. U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 |
| Confidential treatment requested. The redacted portions have been filed separately with the SEC as required by Rule 406 of Regulation C. | |
* | Previously filed. | |
(1) | Incorporated by reference to the same exhibit filed with GTxs Registration Statement on Form S-1 (File No. 333-109700). | |
(2) | Incorporated by reference to the same exhibit filed with GTxs Annual Report on Form 10-K for the year ended December 31, 2003. | |
(3) | Incorporated by reference to the same exhibit filed with GTxs Form 10-Q for the period ended March 31, 2004, filed on May 7, 2004. | |
(4) | Incorporated by reference to Exhibits 10.1 and 10.2 filed with GTxs Current Report on Form 8-K/A, filed on March 7, 2005. |
GTx, Inc. |
||||
By: | /s/ Mark Mosteller | |||
Mark Mosteller | ||||
Vice President and Chief Financial Officer | ||||
Exhibit Index
Number | Description | |||
3.1 | Restated Certificate of Incorporation of GTx, Inc. filed February 6, 2004, as amended (1) |
|||
3.2 | Amended and Restated Bylaws of GTx, Inc. (1) |
|||
4.1 | Reference is made to Exhibits 3.1 and 3.2 |
|||
4.2 | Specimen of Common Stock Certificate (1) |
|||
4.3 | Amended and Restated Registration Rights Agreement between Registrant and Oracle Partners, L.P.
dated August 7, 2003
(1)
|
|||
4.4 | Amended and Restated Registration Rights Agreement between Registrant and J. R. Hyde, III dated
August 7, 2003 (1) |
|||
4.5 | Amended and Restated Registration Rights Agreement between Registrant and Memphis Biomed Ventures
dated August 7, 2003 (1) |
|||
10.1 | Genotherapeutics, Inc. 1999 Stock Option Plan (1) |
|||
10.2 | GTx, Inc. 2000 Stock Option Plan (1) |
|||
10.3 | GTx, Inc. 2001 Stock Option Plan (1) |
|||
10.4 | GTx, Inc. 2002 Stock Option Plan (1) |
|||
10.5 | 2004 Equity Incentive Plan and Form of Stock Option Agreement (1) |
|||
10.6 | 2004 Non-Employee Directors Stock Option Plan and Form of Stock Option Agreement (1) |
|||
10.7 | Reserved |
|||
10.8 | Employment Agreement dated October 1, 2003, between Registrant and Mitchell S. Steiner, M.D.
(1) |
|||
10.9 | Employment Agreement dated October 1, 2003, between Registrant and Marc S. Hanover (1) |
|||
10.10 | Employment Agreement dated October 1, 2003, between Registrant and Mark E. Mosteller (1) |
|||
10.11 | Employment Agreement dated October 1, 2003, between Registrant and Henry P. Doggrell (1) |
|||
10.12 | Form of Indemnification Agreement (1) |
|||
10.13 | Lease Agreement, dated March 7, 2001, between The University of Tennessee and TriStar Enterprises,
Inc. (1) |
|||
10.14 | Sublease Agreement dated October 1, 2000, as amended, between Registrant and TriStar Enterprises,
Inc. (1) |
|||
10.15 | Amended and Restated License and Supply Agreement dated October 22, 2001, between Registrant and
Orion Corporation
(1)
|
|||
10.16 | Amendment No. 1 to the License and Supply Agreement dated March 5, 2003, between Registrant and
Orion Corporation (1) |
|||
10.17 | Production and Manufacturing Agreement dated September 9, 2002, between Registrant and ChemSyn
Laboratories (Department of EaglePicher Technologies, LLC) (1) |
|||
10.18 | Amendment No. 1 to the Production and Manufacturing Agreement dated September 30, 2003, between
Registrant and ChemSyn Laboratories (Department of EaglePicher Technologies, LLC) (1) |
|||
10.19 | Quotation Agreement dated August 8, 2003 between Registrant and EaglePicher Pharmaceutical Services
(1) |
|||
10.20 | Amended and Restated Exclusive License Agreement dated June 3, 2002, between Registrant and
University of Tennessee Research Foundation (1) |
|||
10.21 | Amended and Restated Exclusive License Agreement dated June 14, 2003, between Registrant and
University of Tennessee Research Foundation (1) |
|||
10.22 | Amended and Restated Exclusive License Agreement dated August 30, 2003, between Registrant and
University of Tennessee Research Foundation (1) |
|||
10.23 | Amendment No. 2 to the License and Supply Agreement dated December 29, 2003, between Registrant and
Orion
Corporation (1) |
|||
10.24 | Joint Collaboration and License Agreement dated March 16, 2005, between Registrant and Ortho
Biotech, L.P. (3) |
|||
Number | Description | |||
10.25 | Purchase Agreement dated December 13, 2004, between Registrant and Orion Corporation (4) |
|||
10.26 | Amended and Restated License and Supply Agreement effective January 1, 2005, between Registrant and
Orion Corporation
(4) |
|||
14.1 | Code of Ethics (2) |
|||
13.1* | Annual Report to Shareholders |
|||
23.1* | Consent of Ernst & Young LLP |
|||
24.1 | Power
of Attorney |
|||
31.1 | Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|||
31.2 | Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|||
32.1* | Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 |
|||
32.2* | Certification of Chief Financial Officer Pursuant to 18. U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 |
| Confidential treatment requested. The redacted portions have been filed separately with the SEC as required by Rule 406 of Regulation C. | |
* | Previously filed. | |
(1) | Incorporated by reference to the same exhibit filed with GTxs Registration Statement on Form S-1 (File No. 333-109700). | |
(2) | Incorporated by reference to the same exhibit filed with GTxs Annual Report on Form 10-K for the year ended December 31, 2003. | |
(3) | Incorporated by reference to the same exhibit filed with GTxs Form 10-Q for the period ended March 31, 2004, filed on May 7, 2004. | |
(4) | Incorporated by reference to Exhibits 10.1 and 10.2 filed with GTxs Current Report on Form 8-K/A, filed on March 7, 2005. |