SEC Company Response from INTROGEN THERAPEUTICS INC (CIK 0001018710) — Oct 13, 2005
INTROGEN THERAPEUTICS INC (CIK 0001018710)
Date: Oct. 13, 2005 · CIK: 0001018710 · Accession: 0000950134-05-019144
AI Filing Summary & Sentiment
File numbers found in text: 000-21291
Referenced dates: AUGUST 9, 2005, August 9, 2005
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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
October 13, 2005
Via EDGAR and U.S. Mail
Amy Bruckner
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 Ms. Bruckner:
On behalf of Introgen Therapeutics, Inc. (“Introgen” or the “Company”), we
submit the Company’s attached Memorandum of Response in response to your comments via telephone on
October 12, 2005 relating to the disclosures concerning research and development expenses in
Introgen’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q.
If you have any additional questions or comments, please feel free to contact me at (512)
338-5420.
Sincerely,
WILSON SONSINI GOODRICH & ROSATI,
Professional Corporation
/s/ Alan Bickerstaff
Alan D. Bickerstaff
cc:
Jim B. Rosenberg, Securities and Exchange Commission (via EDGAR)
Joel Parker, Securities and Exchange Commission (via EDGAR)
Jim Albrecht, Introgen Therapeutics, Inc. (via email)
INTROGEN THERAPEUTICS, INC.
MEMORANDUM OF RESPONSE TO SECURITIES AND EXCHANGE COMMISSION
COMMENTS AS SET FORTH IN THE STAFF’S LETTER DATED AUGUST 9, 2005
AND AS DISCUSSED IN TELEPHONE CONFERENCES OF SEPTEMBER 21, 2005
AND OCTOBER 12, 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, and to further comments provided by the
Staff in telephone conferences of September 21, 2005 and October 12, 2005.
As discussed, Introgen proposes to enhance its disclosure about its research and development
expenses by including the following disclosure in the “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” in its future Annual Reports on Form 10-K and
Quarterly Reports on Form 10-Q, beginning with the Quarterly Report on Form 10-Q for the quarter
ending September 30, 2005. The disclosure below is identical to the disclosure proposed in our
Memorandum of Response delivered to you on October 5, 2005, except as follows: (i) a new sentence
was added in the first paragraph set forth below in response to Staff comments; and (ii) the table
set forth below discloses expenses for the six months ended June 30, 2005 and the years ended
December 31, 2004 and 2003, rather than for the three- and nine-month periods ended September 30,
2005 and 2004, respectively. Introgen will of course provide the numerical data for the three- and
nine-month periods ended September 30, 2005 and 2004, respectively, in its Quarterly Report on Form
10-Q for the quarter ending September 30, 2005. Introgen proposes to add the following disclosure
after the first paragraph captioned “Costs and Expenses—Research and Development” for the periods
discussed under “Management’s Discussion and Analysis of Financial Condition and Results of
Operations — Results of Operations” in each such Annual Report or Quarterly Report:
Our research and
development expenses include, but are not limited to, expenses related to personnel,
facilities and equipment, pre-clinical research, clinical trials, manufacturing of materials
for use in clinical trials, conducting data analysis and conducting regulatory documentation
submissions to the FDA. Our research and development expenses can be divided between
programs in the pre-clinical stage and programs in the clinical stage, both as noted in the
table under “Business—Product Development Programs”, and general research and development
expenses attributable to all programs. We manage our business by tracking research and
development expenses in these categories in lieu of tracking research and development
expenses on a project-by-project basis. Research and development expense consists of the
following:
Six Months
Year Ended
Ended June 30,
December 31,
2005
2004
2003
Pre-clinical stage programs expense
$
972
$
1,638
$
1,641
Clinical stage programs expense
9,060
16,986
11,740
General research and development expense
907
1,850
1,592
Total research and development expense
$
10,939
$
20,474
$
14,973
To commercialize our product candidates, we must obtain certain regulatory approvals.
Satisfaction of regulatory requirements typically takes many years and involves compliance
with requirements covering pre-clinical research, clinical trials, manufacturing, quality
control, labeling and promotion of drugs for human use. To obtain regulatory approvals, we
must, among other requirements, complete clinical trials and other work demonstrating our
product candidates are safe and effective for a particular cancer type or other disease. The
FDA and other similar agencies throughout the world have substantial discretion over the
work we must perform to obtain regulatory approval.
The likelihood that a product candidate will be commercially successful may be affected
by a variety of factors, including, among others, the quality of the product candidate, the
validity of the target and disease indication, early clinical data, competition,
manufacturing capability and commercial viability. Because of the discretion of the FDA and
similar agencies throughout the world, as well as the foregoing factors, we cannot predict
with reasonable accuracy (1) the future expenses we will incur developing these product
candidates, (2) when we will complete our work in developing these product candidates or (3)
when, if ever, we will earn significant revenues from approved products that might result
from these product development programs.
For a discussion of the risks and uncertainties associated with developing our
products, as well as the risks and uncertainties associated with potential commercialization
of our product candidates, see the “—Risk Factors” section of this Management’s Discussion
and Analysis of Financial Condition and Results of Operations, particularly the risk factors
entitled:
•
“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”;
•
“Even if our products are approved by regulatory authorities, if we fail to comply
with ongoing regulatory requirements, or if we experience unanticipated problems with
our products, these products could be subject to restrictions or withdrawal from the
market”;
•
“Failure to comply with foreign regulatory requirements governing human clinical
trials and marketing approval for drugs could prevent us from selling our products in
foreign markets, which may adversely affect our operating results and financial
conditions”;
•
“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”;
•
“If we cannot maintain our existing corporate and academic arrangements and enter
into new arrangements, we may be unable to develop products effectively, or at all”;
•
“If we are not able to create effective collaborative marketing relationships, we
may be unable to market ADVEXIN therapy successfully or in a cost-effective manner”
•
“Even if we receive regulatory approval to market our ADVEXIN therapy, INGN 241,
INGN 225 or other product candidates, we may not be able to commercialize them
profitably.”