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SEC Company Response from VALENTIS INC (CIK 0000932352) — Jun 16, 2005

VALENTIS INC (CIK 0000932352)
Date: June 16, 2005 · CIK: 0000932352 · Accession: 0001104659-05-028571

AI Filing Summary & Sentiment

File numbers found in text: 000-22987

Referenced dates: June 2, 2005, November 19, 2001

Date
June 16, 2005
Author
/s/ Joseph Markey
Form
CORRESP
Company
VALENTIS INC (CIK 0000932352)

Letter

VIA EDGAR TRANSMISSION AND FEDERAL EXPRESS United States Securities and Exchange Commission Valentis, Inc. Form 10-K/A for the fiscal year ended June 30, 2004 Filed November 15, 2004 File No. 000-22987

Dear Mr. Rosenberg,

Valentis, Inc. (the “Company”) hereby responds to the letter dated June 2, 2005 that the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) provided in respect of the filing referenced above.

1. Please refer to our comment letter dated November 19, 2001, specifically comment 10. We note your response to this comment on November 21, 2001. Please tell us why you continue to exclude disclosure of the costs incurred to date, the estimated completion date and costs to complete for each of your major research and development projects. We believe this disclosure is important in helping an investor understand your use and expected use of resources in research and development activities. Please refer to the Division of Corporate Finance “Current Issues and Rulemaking Projects Quarterly Update” under section VIII – Industry Specific Issues – Accounting and Disclosure by Companies Engaged in Research and Development Activities.

Response: The Company respectfully advises the Staff that it believes it has provided the requested disclosures. For example, the Company disclosed in its Form 10-K/A filed on November 15, 2004 (“10-K/A”) that it was supporting the Phase II clinical trial of DeltavascTM (see, e.g., 10-K/A, page 38), which was the Company’s lead product under development for the fiscal years ended June 30, 2004, 2003 and 2002, and that its research and development expenses were $10.1 million, $10.0 million and $23.7 million for the fiscal years ended June 30, 2004, 2003 and 2002, respectively. See, e.g., 10-K/A, page 33.

All of the Company’s research and development expenses for the fiscal years ended June 30, 2004 and 2003 were incurred in connection with DeltavascTM. With

respect to the fiscal year ended June 30, 2002, the Company was developing products using two key technology platforms: (i) gene delivery and gene regulation platform and (ii) PEGylation platform. The gene delivery and gene regulation platform accounted for approximately 96% (e.g., $22.8 million of the $23.7 million) of the Company’s research and development expenses; the majority of these expenses were incurred in connection with DeltavascTM. The PEGylation platform accounted for the remaining 4% of the Company’s research and development expenses. The Company no longer develops products using the PEGylation platform. The Company believes that the information with respect to the research and development expenses related to the PEGylation platform for the fiscal year ended June 30, 2002 is not meaningful or material to an investor’s understanding of the Company’s business.

In addition, the Company has provided the requested information with respect to DeltavascTM, which constituted all of the Company’s research and development expenses for the fiscal years ended June 30, 2004 and 2003 and the majority of the Company’s research and development expenses for the fiscal year ended June 30, 2002, as follows: (i) costs incurred to date (see, e.g., 10-K/A, page 33); (ii) estimated completion date, including estimated completion dates for stages of development (see, e.g., 10-K/A, pages 1, 5, 18, 19, 21, 22, 31, 37, 38, 52); and (iii) estimated costs to complete (see, e.g., 10-K/A, page 33).

In connection with our response, the Company acknowledges the following:

• The Company is responsible for the adequacy and accuracy of the disclosure in the filings;

• Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filing; and

• the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.

Should the Staff have any questions or comments on the contents of this letter, please do not hesitate to contact the undersigned at (650) 697-1900, extension 369.

Very truly yours,
/s/ Joseph Markey

Show Raw Text
CORRESP
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[VALENTIS, INC. LETTERHEAD]

VIA EDGAR TRANSMISSION AND FEDERAL EXPRESS

June 16, 2005

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

United States Securities and Exchange Commission

100 F Street, N.E.

Washington, D.C. 20549-0303

  RE:

  Valentis, Inc.

  Form 10-K/A for the fiscal year ended June 30, 2004

  Filed November 15, 2004

  File No. 000-22987

Dear Mr. Rosenberg,

Valentis, Inc.
(the “Company”) hereby responds to the letter dated June 2, 2005 that the staff
(the “Staff”) of the Securities and Exchange Commission (the “Commission”)
provided in respect of the filing referenced above.

1.             Please refer to our
comment letter dated November 19, 2001, specifically comment
10.  We note your response to this
comment on November 21, 2001.  Please tell
us why you continue to exclude disclosure of the costs incurred to date, the
estimated completion date and costs to complete for each of your major research
and development projects.  We believe
this disclosure is important in helping an investor understand your use and
expected use of resources in research and development activities.  Please refer to the Division of Corporate
Finance “Current Issues and Rulemaking Projects Quarterly Update” under section
VIII – Industry Specific Issues – Accounting and Disclosure by Companies
Engaged in Research and Development Activities.

Response:
The Company respectfully advises the Staff that it believes it has
provided the requested disclosures.  For
example, the Company disclosed in its Form 10-K/A filed on November 15, 2004 (“10-K/A”)
that it was supporting the Phase II clinical trial of DeltavascTM (see,
e.g., 10-K/A, page 38), which was the Company’s lead product under
development for the fiscal years ended June 30, 2004, 2003 and 2002, and that its
research and development expenses were $10.1 million, $10.0 million and $23.7
million for the fiscal years ended June 30, 2004, 2003 and 2002,
respectively.  See,
e.g., 10-K/A, page 33.

All of the
Company’s research and development expenses for the fiscal years ended June 30,
2004 and 2003 were incurred in connection with DeltavascTM.  With

respect
to the fiscal year ended June 30, 2002, the Company was developing products
using two key technology platforms: (i) gene delivery and gene regulation
platform and (ii) PEGylation platform.
The gene delivery and gene regulation platform accounted for approximately
96% (e.g., $22.8 million of the $23.7 million) of the Company’s research and
development expenses; the majority of these expenses were incurred in connection
with DeltavascTM.  The
PEGylation platform accounted for the remaining 4% of the Company’s research
and development expenses.  The Company no
longer develops products using the PEGylation platform.  The Company believes that the information
with respect to the research and development expenses related to the PEGylation
platform for the fiscal year ended June 30, 2002 is not meaningful or material
to an investor’s understanding of the Company’s
business.

In addition, the
Company has provided the requested information with respect to DeltavascTM,
which constituted all of the Company’s research and development expenses for
the fiscal years ended June 30, 2004 and 2003 and the majority of the Company’s
research and development expenses for the fiscal year ended June 30, 2002, as
follows: (i) costs incurred to date (see, e.g., 10-K/A, page 33);
(ii) estimated completion date, including estimated completion dates for
stages of development (see, e.g., 10-K/A, pages 1, 5, 18, 19, 21, 22, 31,
37, 38, 52); and (iii) estimated costs to complete (see, e.g.,
10-K/A, page 33).

In connection
with our response, the Company acknowledges the following:

•              The
Company is responsible for the adequacy and accuracy of the disclosure in the
filings;

•              Staff
comments or changes to disclosure in response to Staff comments do not
foreclose the Commission from taking any action with respect to the filing; and

•              the Company may not assert Staff comments
as a defense in any proceeding initiated by the Commission or any person under
the federal securities laws of the United States.

Should the Staff have any questions or comments on the contents of this
letter, please do not hesitate to contact the undersigned at (650) 697-1900,
extension 369.

  Very truly yours,

  /s/ Joseph Markey

  Joseph Markey

  Vice President, Finance and Adminstration

  Valentis, Inc.

cc:           Patrick A. Pohlen,
Esq. (Latham & Watkins LLP)