Current Report Filing (8-k)
October 09 2015 - 4:48PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT
REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
October 7, 2015
Otonomy, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-36591 |
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26-2590070 |
(State or other jurisdiction
of incorporation) |
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(Commission
File Number) |
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(IRS Employer
Identification No.) |
6275 Nancy Ridge Drive, Suite 100
San Diego, CA 92121
(Address of principal executive offices, including zip code)
(858) 242-5200
(Registrants telephone number, including area code)
Not Applicable
(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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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.
On October 7, 2015, Otonomy, Inc. (the Company) issued a press release in connection with its Investor and Analyst Day, to
review the commercialization plans for OTIPRIO (formerly known as AuriPro) and to provide an update on general corporate activity.
The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
All of the information
furnished in this Item 7.01 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference
in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits
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Exhibit No. |
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Description |
99.1 |
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Press Release dated October 7, 2015. |
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.
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OTONOMY, INC. |
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Date: October 9, 2015 |
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By: |
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/s/ Eric Loumeau |
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Eric Loumeau |
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General Counsel and Chief Compliance Officer |
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EXHIBIT INDEX
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Exhibit No. |
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Description |
99.1 |
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Press Release dated October 7, 2015. |
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Exhibit 99.1
Press Release
Otonomy Holds Investor and Analyst Day and Provides Corporate Update
SAN DIEGO, Oct. 7, 2015 (GLOBE NEWSWIRE) Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the
development and commercialization of innovative therapeutics for diseases and disorders of the ear, today held an investor and analyst day which included a review of the commercialization plans for
OTIPRIO (formerly known as AuriPro) in patients undergoing ear tube surgery, the Phase 3 clinical trial program for OTO-104 in
Ménières disease, an introduction to the OTO-311 program for tinnitus that has been cleared for Phase 1 testing, other pipeline activities as well as a general corporate update. A replay of the event webcast is available online
at www.Otonomy.com in the events and presentations section under the investors tab.
Key Takeaways from the Investor and Analyst Day
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Preparations for OTIPRIOs launch in the U.S. are progressing well. Otonomy expects to launch OTIPRIO in the U.S. in the first quarter of 2016 assuming FDA approval on or before
the December 25, 2015 PDUFA action date. |
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Otonomy will pursue a paced plan for OTIPRIOs label expansion indications including the ongoing Phase 2 clinical trial in patients with acute otitis externa and initiation of a second Phase 2 trial in
patients with acute otitis media and tubes (AOMT) expected in the first quarter of 2016. |
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Design of the OTO-104 Phase 3 clinical trials in Ménières disease has been finalized based on learnings from the Phase 2b study and discussions with the FDA held during an End-of-Phase 2
meeting. The U.S. Phase 3 trial is expected to begin in the fourth quarter of 2015 with the EU Phase 3 trial to start in the first quarter of 2016. Results from both trials are expected in the second half of 2017. |
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FDA clearance has been received for the OTO-311 Investigational New Drug Application (IND), and initiation of a Phase 1 clinical safety trial is expected to begin before the end of 2015. OTO-311 is a single-dose
treatment in development for tinnitus. |
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Through corporate development activities, the company has secured rights to multiple potential product candidates for a fourth program targeting sensorineural hearing loss, the largest market opportunity within the
otology field, and evaluations are ongoing regarding ex-U.S. partnering opportunities for Otonomys current products. |
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Otonomy expects that its strong cash position, together with OTIPRIO revenues, will fund planned operations into 2018. |
About Otonomy
Otonomy is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of
the ear. Otonomys proprietary technology provides sustained exposure of drugs to the ear following a single administration. Otonomy has three product candidates in development. OTIPRIO
is an antibiotic that has completed Phase 3 clinical trials in pediatric patients with middle ear effusion at the time of tympanostomy tube placement surgery, and the FDAhas assigned a PDUFA action date of December 25, 2015 for Otonomys
New Drug Application. OTO-104 is a steroid that has completed a Phase 2b clinical trial in 154 patients with Ménières disease. Based on these results, Otonomy intends to initiate two parallel Phase 3 trials for OTO-104 in
Ménières disease patients with at least one trial initiated by the end of 2015. OTO-311 is an NMDA receptor antagonist in development as a treatment for tinnitus. A Phase 1 clinical safety trial for OTO-311 is expected to begin
before the end of 2015. For additional information please visit www.otonomy.com.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements
generally relate to future events or future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited
to, Otonomys expectations regarding the timing of commercial launch, the timing of its Phase 2 clinical trials for OTIPRIO for the treatment of acute otitis media with tympanostomy tubes (AOMT) and otitis externa, the timing,
duration, design and expectations regarding the two Phase 3 clinical trials for OTO-104, the timing of the initiation of the Phase 2 clinical trials for OTO-311, the market for sensorineural hearing loss, and Otonomys estimated cash
position through 2017. Otonomys expectations regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties. Actual results may differ materially from those indicated by these
forward-looking statements as a result of these risks and uncertainties, including but not limited to: Otonomys limited operating history and its expectation that it will incur significant losses for the foreseeable future;
Otonomys ability to obtain substantial additional financing; Otonomys dependence on the regulatory and commercial success of OTIPRIO and OTO-104 and advancing additional product candidates, such as OTO-311; the
uncertainties inherent in the clinical drug development process, including, without limitation, Otonomys ability to adequately demonstrate the safety and efficacy of its product candidates, the preclinical and clinical results for
its product candidates, which may not support further development of product candidates, and challenges related to patient enrollment in clinical trials; Otonomys ability to obtain regulatory approval for its product candidates; side
effects or adverse events associated with Otonomys product candidates; competition in the biopharmaceutical industry; Otonomys dependence on third parties to conduct preclinical studies and clinical
trials; Otonomys dependence on third parties for the manufacture of products; Otonomys dependence on a small number of suppliers for raw materials; Otonomys ability to protect its intellectual property
related to product candidates in the United States and throughout the world; expectations regarding potential market size, opportunity and growth; Otonomys ability to manage operating expenses; implementation
of Otonomys business model and strategic plans for its business, products and technology; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled Risk Factors
in Otonomys Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the SEC) on August 12, 2015, and Otonomys future reports to be filed with the SEC. The forward-looking
statements in this press release are based on information available to Otonomy as of the date hereof. Otonomy disclaims any obligation to update any forward-looking statements, except as required by law.
Contacts:
Media Inquiries
Canale Communications
Heidi Chokeir, Ph.D.
Vice President
619.849.5377
heidi@canalecomm.com
Investor Inquiries
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com
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