þ | Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
|
|
For the quarterly period ended March 31, 2005. |
o | Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. | |
For the transition period from to . |
Delaware (State or other jurisdiction of incorporation or organization) |
62-1715807 (I.R.S. Employer Identification No.) |
PART II OTHER INFORMATION | ||||||||
ITEM 6. EXHIBITS | ||||||||
SIGNATURES | ||||||||
EXHIBIT INDEX | ||||||||
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) | |
10.24
|
Joint Collaboration and License Agreement dated March 16, 2005, between Registrant and Ortho Biotech, L.P. (2) | |
10.25
|
Purchase Agreement dated December 13, 2004, between Registrant and Orion Corporation (3) | |
10.26
|
Amended and Restated License and Supply Agreement effective January 1, 2005, between Registrant and Orion Corporation (3) | |
31.1
|
Certification required by Rule 13a-14(a) or Rule 15d-14(a). | |
31.2
|
Certification required by Rule 13a-14(a) or Rule 15d-14(a). | |
32.1*
|
Certification of Chief Executive Officer of 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 of 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 Form 10-Q for the period ended March 31, 2004 filed May 7, 2004. | |
(3) | Incorporated by reference to GTxs Form 8-K filed March 7, 2005. |
2.
GTx, Inc. | ||||
July 27, 2005
|
By: | /s/ Mitchell S. Steiner | ||
Mitchell S. Steiner, Chief Executive Officer | ||||
July 27, 2005
|
By: | /s/ Mark. E. Mosteller | ||
Mark E. Mosteller, Chief Financial Officer | ||||
(Principal Financial and Accounting Officer) |
3.
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. (2) | |
10.25
|
Purchase Agreement dated December 13, 2004, between Registrant and Orion Corporation (3) | |
10.26
|
Amended and Restated License and Supply Agreement effective January 1, 2005, between Registrant and Orion Corporation (3) | |
31.1
|
Certification required by Rule 13a-14(a) or Rule 15d-14(a). | |
31.2
|
Certification required by Rule 13a-14(a) or Rule 15d-14(a). | |
32.1*
|
Certification of Chief Executive Officer of 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 of 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 Form 10-Q for the period ended March 31, 2004 filed May 7, 2004. | |
(3) | Incorporated by reference to GTxs Form 8-K filed March 7, 2005. |
1. | I have reviewed this Quarterly Report on Form 10-Q of GTx, Inc.; | |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; | |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; | |
4. | The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | ||
(b) | Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | ||
(c) | Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. | The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and | ||
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. |
Date: July 27, 2005 |
||
/s/ Mitchell S. Steiner | ||
Mitchell S. Steiner, M.D., F.A.C.S. | ||
Chief Executive Officer and Vice-Chairman of the Board of Directors |
5. | I have reviewed this Quarterly Report on Form 10-Q of GTx, Inc.; | |
6. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; | |
7. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; | |
8. | The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | ||
(b) | Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | ||
(c) | Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. | The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and | ||
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. |
Date: July 27, 2005 |
||
/s/ Mark E. Mosteller | ||
Mark E. Mosteller, CPA | ||
Vice President and Chief Financial Officer |