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SEC Company Response from INTROGEN THERAPEUTICS INC (CIK 0001018710) — Aug 22, 2005

INTROGEN THERAPEUTICS INC (CIK 0001018710)
Date: Aug. 22, 2005 · CIK: 0001018710 · Accession: 0000950134-05-016475

AI Filing Summary & Sentiment

File numbers found in text: 000-21291

Referenced dates: AUGUST 9, 2005, August 9, 2005

Date
August 22, 2005
Author
WILSON SONSINI
Form
CORRESP
Company
INTROGEN THERAPEUTICS INC (CIK 0001018710)

Letter

Via EDGAR and Overnight Delivery Securities and Exchange Commission Introgen Therapeutics, Inc. Annual Report on Form 10-K for the year ended December 31, 2004 Quarterly Report on Form 10-Q for the quarter ended March 31, 2005 File No. 000-21291

Dear Mr. Rosenberg:

On behalf of Introgen Therapeutics, Inc. (“Introgen” or the “Company”), we submit the Company’s Memorandum of Response in response to comments from the Staff of the Securities and Exchange Commission received by letter dated August 9, 2005 relating to Introgen’s Annual Report on Form 10-K for the year ended December 31, 2004 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2005.

If you have any additional questions or comments, please feel free to contact me at (512) 338-5414 or Alan Bickerstaff at (512) 338-5420.

Sincerely,
WILSON SONSINI
GOODRICH & ROSATI,

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CORRESP
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corresp

    8911 Capital of Texas Hwy. North

Westech 360, Suite 3350

Austin, TX 78759-8497

PHONE 512.338.5400

FAX 512.338.5499

www.wsgr.com

August 22, 2005

Via EDGAR and Overnight Delivery

Jim B. Rosenberg

Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

    Re:

    Introgen Therapeutics, Inc.

Annual Report on Form 10-K for the year ended December 31, 2004

Quarterly Report on Form 10-Q for the quarter ended March 31, 2005

File No. 000-21291

Dear Mr. Rosenberg:

     On behalf of Introgen Therapeutics, Inc. (“Introgen” or the “Company”), we
submit the Company’s Memorandum of Response in response to comments from the Staff of the
Securities and Exchange Commission received by letter dated August 9, 2005 relating to Introgen’s
Annual Report on Form 10-K for the year ended December 31, 2004 and Quarterly Report on Form 10-Q
for the quarter ended March 31, 2005.

     If you have any additional questions or comments, please feel free to contact me at (512)
338-5414 or Alan Bickerstaff at (512) 338-5420.

    Sincerely,

WILSON SONSINI
GOODRICH & ROSATI,

Professional Corporation

    /s/ Christopher J. Ozburn

    Christopher J. Ozburn

    cc:

    Amy Bruckner, Securities and Exchange Commission (via Federal Express)

Joel Parker, Securities and Exchange Commission (via Federal Express)

Jim Albrecht, Introgen Therapeutics, Inc. (via facsimile)

Alan Bickerstaff

INTROGEN THERAPEUTICS, INC.

MEMORANDUM OF RESPONSE TO SECURITIES AND EXCHANGE COMMISSION

COMMENTS AS SET FORTH IN THE STAFF’S LETTER DATED AUGUST 9, 2005

          This Memorandum sets forth the response of Introgen Therapeutics, Inc. (“Introgen” or
the “Company”) to comments from the Staff of the Securities and Exchange Commission (the
“Staff”) received by letter dated August 9, 2005 relating to Introgen’s Annual Report on
Form 10-K for the year ended December 31, 2004 and Quarterly Report on Form 10-Q for the quarter
ended March 31, 2005.

          The Company acknowledges the Staff’s comment regarding enhancing its disclosure about research
and development expenses.

          Specifically, the Company acknowledges the Staff’s suggestion that it disclose research and
development costs by project. Introgen recognizes that its MD&A is intended to provide a view of
Introgen through the eyes of its management, but Introgen’s management does not use this kind of
cost breakdown information in its conduct of the Company’s business. Instead, Introgen’s
management tracks and uses the Company’s overall research and development expenses. In fact, if
Introgen were to use the resources and incur the expenses necessary to prepare the cost breakdown
by individual project for disclosure in its Annual and Quarterly Reports, it would be doing so
solely for the purposes of providing such disclosure.

          Introgen understands that this information may be appropriate for those companies that are
engaged in research and development activities and also have significant revenues from the sale of
commercially available products, and therefore that such disclosure might be useful to investors in
such companies. In contrast, Introgen does not currently have products available for commercial
sale and therefore does not produce significant revenues from the sale of its products. Introgen
expects that if and when its products become commercially available and it begins to generate
revenues from the sale of such products, it may begin to track its research and development
expenses in a greater level of detail and will be in a position to disclose a greater level of
detail about such expenses in its Annual and Quarterly Reports.

          In addition, because of the uncertainties associated with its clinical trials and other
requirements and potential requirements of various regulatory agencies from which Introgen must
obtain approval to market its products, Introgen cannot predict with reasonable accuracy, and
therefore cannot provide useful predictions of the nature, timing and estimated costs of the
efforts necessary to complete any of its projects, of the anticipated completion dates of any of
its projects, or of the period in which material cash inflows from these projects are expected to
commence.

          Introgen believes that it appropriately addresses the risks and uncertainties and consequences
associated with the timely completion of development of its projects in the Risk Factors Introgen
discloses in its Annual and Quarterly Reports, particularly the following:

    •

    If we are unable to commercialize ADVEXIN® therapy in various markets for
multiple indications, particularly for the treatment of head and neck cancer, our business
will be harmed.

    •

    If we fail to comply with FDA requirements or encounter delays or difficulties in
clinical trials for our product candidates, we may not obtain regulatory approval of some
or all of our product candidates on a timely basis, if at all.

    •

    If we continue to incur operating losses for a period longer than we anticipate and fail
to obtain the capital necessary to fund our operations, we will be unable to advance our
development program and complete our clinical trials.

          Based on the foregoing, the Company believes that it is not necessary or appropriate for
Introgen to amend its previous filings to provide additional detail about its research and
development expenses. Introgen would be willing, however, to disclose in future Annual and
Quarterly Reports that historically the majority of its research and development expenses are
related to development of its ADVEXIN therapy and the rest are related to its other product
candidates, and that because of the uncertainties associated with regulatory requirements, Introgen
cannot predict with reasonable accuracy the development expenses the Company will incur in the
future, when the development work will be completed, or when the Company will earn significant
revenues from products that might result from the development projects.