Attached files
file | filename |
---|---|
EX-99.1 - EX-99.1 - Pernix Sleep, Inc. | a55050exv99w1.htm |
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 8, 2010
SOMAXON PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware | 000-51665 | 20-0161599 | ||
(State or Other Jurisdiction | (Commission | (IRS Employer | ||
of Incorporation) | File Number) | Identification No.) |
420 Stevens Avenue, Suite 210, Solana Beach, California | 92075 | |
(Address of Principal Executive Offices) | (Zip Code) |
Registrants telephone number, including area code: (858) 480-0400
(Former Name or Former Address, if Changed Since Last Report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01. Regulation FD Disclosure
Richard W. Pascoe, President and Chief Executive Officer of Somaxon Pharmaceuticals, Inc., and
other executive officers will be presenting the information attached as Exhibit 99.1 to this report
at various investor and analyst meetings, including at the 12th Annual BIO CEO & Investor
Conference in New York City on February 8, 2010.
The information in this Current Report on Form 8-K, including the slides attached hereto as
Exhibit 99.1, is being furnished pursuant to this Item 7.01 and shall not be deemed filed for
purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or
otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by
reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act,
whether made before or after the date hereof, except as expressly set forth by specific reference
in such filing to this Current Report on Form 8-K.
By filing this Current Report on Form 8-K and furnishing this information, Somaxon makes no
admission as to the materiality of any information in this report. The information contained in the
slides is summary information that is intended to be considered in the context of Somaxons filings
with the SEC and other public announcements that Somaxon makes, by press release or otherwise, from
time to time. Somaxon undertakes no duty or obligation to publicly update or revise the information
contained in this report, although it may do so from time to time as its management believes is
appropriate. Any such updating may be made through the filing of other reports or documents with
the SEC, through press releases or through other public disclosure.
Somaxon cautions you that statements included in this report that are not a description of
historical facts are forward-looking statements. The inclusion of forward-looking statements
should not be regarded as a representation by Somaxon that any of its plans will be achieved.
Actual results may differ materially from those set forth in this report due to the risks and
uncertainties inherent in Somaxons business including, without limitation, Somaxons
interpretations of its communications and interactions with the FDA relating to the regulatory
review process and requirements for approval of the NDA for Silenor, and the FDAs agreement with
such interpretations; Somaxons interpretation of the results of its clinical trials for Silenor,
the timing of the interpretation of such results and the FDAs agreement with such interpretation;
the potential for Silenor to receive regulatory approval for one or more indications on a timely
basis or at all; Somaxons ability to raise sufficient capital to meet FDA requirements and
otherwise fund its operations, and to meet its obligations to parties with whom it contracts
relating to financing activity, and the impact of any such financing activity on the level of
Somaxons stock price; the impact of any inability to raise sufficient capital to fund ongoing
operations, including the potential to be required to restructure the company or to be unable to
continue as a going concern; the potential for the FDA to impose non-clinical, clinical or other
requirements to be completed before or after regulatory approval of Silenor; Somaxons ability to
demonstrate to the satisfaction of the FDA that potential NDA approval of Silenor is appropriate
prior to the submission of the results of standard, long-term carcinogenicity studies, given the
context of completed trials and pending studies; the timing and results of non-clinical studies for
Silenor, and the FDAs agreement with Somaxons interpretation of such results; Somaxons ability
to successfully commercialize Silenor, if it is approved by the FDA; the potential to enter into
and the terms of any commercial partnership or other strategic transaction relating to Silenor; the
scope, validity and duration of patent protection and other intellectual property rights for
Silenor; whether any approved label for Silenor is sufficiently consistent with such patent
protection to provide exclusivity for Silenor; Somaxons ability to operate its business without
infringing the intellectual property rights of others; inadequate therapeutic efficacy or
unexpected adverse side effects relating to Silenor that could delay or prevent regulatory approval
or commercialization, or that could result in recalls or product liability claims; other
difficulties or delays in development, testing, manufacturing and marketing of and obtaining
regulatory approval for Silenor; the market potential for insomnia treatments, and Somaxons
ability to compete within that market; and other risks detailed in Somaxons prior press releases
as well as in its periodic filings with the Securities and Exchange Commission. You are cautioned
not to place undue reliance on these forward-looking statements, which speak only as of the date
hereof. All forward-looking statements are qualified in their entirety by this cautionary
statement, and Somaxon undertakes no obligation to revise or update this report to reflect events
or circumstances after the date hereof. This caution is made under the safe harbor provisions of
Section 21E of the Exchange Act.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits.
Exhibit No. | Description | |
99.1
|
Company Update Slides dated February 8, 2010. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
SOMAXON PHARMACEUTICALS, INC. | ||||||
Date: February 8, 2010 |
||||||
By: Name: |
/s/ Matthew W. Onaitis
|
|||||
Title: | Vice President and General Counsel |
EXHIBIT INDEX
Exhibit No. | Description | |
99.1
|
Company Update Slides dated February 8, 2010. |