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): August 12, 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 2.02 |
Results of Operations and Financial Condition. |
On August 12, 2015, Otonomy, Inc.
(the Company) issued a press release announcing its financial results for the second quarter ended June 30, 2015. The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
All of the information furnished in this Item 2.02 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. |
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Exhibit No. |
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Description |
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99.1 |
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Press Release dated August 12, 2015. |
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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: August 12, 2015 |
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By: |
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/s/ Paul E. Cayer |
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Paul E. Cayer Chief Financial and Business
Officer |
-3-
EXHIBIT INDEX
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Exhibit No. |
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Description |
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99.1 |
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Press Release dated August 12, 2015. |
-4-
Exhibit 99.1
FOR IMMEDIATE RELEASE
Otonomy Reports Second Quarter 2015 Financial Results and Provides Corporate Update
SAN DIEGO, August 12, 2015 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 reported financial results for the quarter ended June 30, 2015 and provided an update on its corporate activities and product pipeline.
Second Quarter 2015 and Subsequent Highlights
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Filed New Drug Application (NDA) for AuriProTM: In April 2015, Otonomy announced that the U.S. Food and Drug Administration (FDA) accepted its NDA submission
for the approval of AuriPro as a treatment of middle ear effusion in pediatric patients undergoing tympanostomy tube placement (TTP) surgery. The FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of December 25, 2015. If
approved by or on the PDUFA date, Otonomy expects to launch the product in the United States during the first quarter of 2016. Results of the AuriPro Phase 3 clinical trials were presented at the American Society of Pediatric Otolaryngology (ASPO)
meeting in April 2015 and at the International Society for Otitis Media (ISOM) symposium in June 2015. |
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Demonstrated AuriPro Feasibility in First Label Expansion Indication: In May 2015, Otonomy announced the completion of enrollment in a Phase 2 clinical trial evaluating AuriPro for the treatment of pediatric
patients with acute otitis media with tympanostomy tubes (AOMT). The one-month, prospective, multicenter, open-label trial enrolled a total of 39 pediatric patients in the United States. This initial feasibility study demonstrated the practicality
of administering AuriPro in a physicians office to fully alert children with AOMT, and the clinical activity of AuriPro for cessation of otorrhea. |
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Initiated Enrollment in Phase 2 Clinical Trial for AuriPro in Second Label Expansion Indication: In July 2015, Otonomy announced the enrollment of the first patients in a Phase 2 clinical trial evaluating AuriPro
for the treatment of patients with otitis externa, also known as swimmers ear. The one-month, prospective, multi center, open-label trial is expected to enroll approximately 75 patients in order to assess the feasibility of AuriPro as a
single-dose treatment for patients with otitis externa. |
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Reported Topline Data for OTO-104 Phase 2b Trial in Ménières Disease: In May 2015, Otonomy announced topline results from
its Phase 2b trial evaluating OTO-104 in patients with unilateral Ménières disease. The primary endpoint of the trial was reduction in vertigo frequency during Month 3 following treatment, compared to a one month
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baseline period. In the topline analysis, OTO-104 demonstrated a 61% reduction from baseline in vertigo frequency in Month 3 vs. 43% for placebo which narrowly missed achieving statistical
significance with a p-value of 0.067. A similar positive trend was also observed during Month 2 following treatment. The trial achieved statistical significance (p < 0.05) for multiple prospectively defined secondary endpoints at multiple time
points. Otonomy has scheduled an End-of-Phase 2 meeting with the FDA and expects to initiate two parallel Phase 3 trials for OTO-104 in Ménières patients, with the first trial expected to begin by the end of 2015 and the second
trial expected to begin during the first quarter of 2016. |
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Completed Enrollment of OTO-104 Multiple-dose Safety Study in Ménières Disease: In April 2015, Otonomy completed enrollment in a multiple-dose safety study of OTO-104 in patients with
Ménières disease. This prospective, randomized, placebo-controlled study is designed to evaluate the safety of quarterly dosing of OTO-104. A total of 128 Ménières patients were enrolled in the study across
multiple trial sites in the United Kingdom. |
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Appointed Chief Medical Officer and Chief Compliance Officer to Support AuriPro Commercial Launch: Otonomy announced the appointment of Dean Hakanson, M.D., as its chief medical officer in April 2015, and the
appointment of Eric Loumeau as general counsel and chief compliance officer in May 2015. Both additions to the executive management team are important to support the commercial launch of AuriPro in the U.S. market. |
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Appointed George J. Morrow as Director: In April 2015, Otonomy appointed George J. Morrow to the Board of Directors. Mr. Morrow has extensive experience in pharmaceutical sales and marketing. He led global
commercial operations at Amgen for nearly a decade, held senior level commercial roles for nearly 10 years at GlaxoSmithKline and its subsidiaries, and served in various sales and marketing positions of increasing responsibility during 11 years at
Merck. |
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Request for Patent Interference Accepted by USPTO: In April 2015, Otonomy filed a Suggestion of Interference with the United States Patent and Trademark Office (USPTO) related to one of Otonomys patent
applications and a patent issued to Auris Medical Holding AG, and in July 2015 the USPTO issued a Declaration of Interference. In the Declaration of Interference, Otonomy has been designated as the Senior Party and Auris as the
Junior Party. Under U.S. Patent law, the Junior Party has the burden of showing that they, and not the Senior Party, were the first inventors. This action does not involve issued U.S. patents covering Otonomys product
candidates but is intended to support Otonomys strategy to broadly protect sustained-exposure drug delivery to the ear. |
Our
strong momentum continued in the second quarter as we made significant progress on both the regulatory and clinical development fronts, said David A. Weber, Ph.D., president and CEO of Otonomy. We expect the remainder of 2015 to be
equally productive with AuriPros PDUFA action date set for December 25, 2015, a near-term End-of-Phase 2 meeting scheduled with FDA to
review the Phase 2b results in Ménières disease and discuss plans for the Phase 3 program which we expect to initiate by the end of 2015, and continued clinical development
for AuriPro in label expansion indications. In addition, we expect to broaden our clinical pipeline with the submission of an investigational new drug (IND) application to the FDA and initiation of a Phase 1 clinical trial for OTO-311, a potential
treatment for tinnitus, by the end of 2015.
Anticipated Upcoming Milestones
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AuriPros PDUFA action date is December 25, 2015. Contingent on FDA approval on or before this date, Otonomy expects to launch AuriPro in the U.S. in the first quarter of 2016. |
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Hold End-of-Phase 2 meeting with the FDA to review the OTO-104 Phase 2b results in Ménières disease and discuss plans for Phase 3. Otonomy expects to initiate two parallel Phase 3 trials for OTO-104
in Ménières patients, with the first trial expected to begin by the end of 2015 and the second trial expected to begin during the first quarter of 2016. |
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File IND for OTO-311 as a potential treatment for tinnitus and initiate a Phase 1 clinical trial in the fourth quarter of 2015. |
Second Quarter Financial Highlights
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Cash, cash equivalents, and short-term investments totaled $211.9 million as of June 30, 2015, compared with $223.6 million as of March 31, 2015. |
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Operating expenses totaled $12.6 million for the second quarter of 2015 versus operating expenses of $9.8 million for the second quarter of 2014. |
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Research and development expenses for the second quarter of 2015 were $7.3 million, compared with $8.3 million for the second quarter of 2014. The decrease was primarily a result of lower clinical trial-related expenses
for AuriPro following the completion of two Phase 3 clinical trials during the second half of 2014 and lower clinical trial-related expenses for OTO-104 following the completion of enrollment in the Phase 2b study during December 2014. These
decreases were partially offset by increased personnel costs, increased preclinical development expenses for OTO-311 and costs for label expansion indication studies for AuriPro that began during 2015. |
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General and administrative expenses in the second quarter of 2015 were $5.3 million, compared to $1.5 million for the same period a year earlier. The increase was primarily attributable to expanded operating activities,
costs associated with becoming a publicly traded company and costs related to our commercial preparation activities. |
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Net loss for the second quarter of 2015 was $12.5 million, compared with a net loss of $10.2 million for the second quarter of 2014. |
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Management reaffirms its expectation for 2015 operating expenses in the range of $70-$75 million. |
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. AuriPro 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 FDA has assigned a PDUFA action date of December 25, 2015 for the companys New Drug Application. OTO-104 is a steroid that
has recently 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. 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 Otonomys future financial or operating performance. Forward-looking statements in this press release include, but are not limited to, Otonomys expectations regarding the commercial launch of AuriPro
in the United States, the Phase 2 clinical trial for AuriPro for the treatment of patients with otitis externa, the initiation of two Phase 3 trials for OTO-104, the timing of the submission of an IND filing to the FDA and initiation of a Phase 1
clinical trial for OTO-311, continued clinical development for AuriPro in label expansion indications, estimated operating expenses for 2015 and Otonomys chief executive officers statement regarding the second half of 2015.
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 AuriPro 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.
Otonomy, Inc.
Condensed Statements of Operations
(in thousands, except share and per share data)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2015 |
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2014 |
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2015 |
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2014 |
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(unaudited) |
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Operating expenses: |
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Research and development |
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$ |
7,289 |
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$ |
8,264 |
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$ |
15,896 |
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$ |
17,255 |
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General and administrative |
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5,352 |
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1,564 |
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8,853 |
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3,129 |
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Total operating expenses |
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12,641 |
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9,828 |
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24,749 |
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20,384 |
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Loss from operations |
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(12,641 |
) |
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(9,828 |
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(24,749 |
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(20,384 |
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Other income (expense) |
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97 |
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(403 |
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188 |
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(668 |
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Net loss |
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(12,544 |
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(10,231 |
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(24,561 |
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(21,052 |
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Accretion to redemption value of convertible preferred stock |
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(15 |
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(28 |
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Net loss attributable to common stockholders |
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$ |
(12,544 |
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$ |
(10,246 |
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$ |
(24,561 |
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$ |
(21,080 |
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Net loss per share attributable to common stockholders, basic and diluted |
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$ |
(0.52 |
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$ |
(109.07 |
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$ |
(1.04 |
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$ |
(237.33 |
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Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted |
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24,139,791 |
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93,938 |
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23,670,508 |
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88,822 |
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Otonomy, Inc.
Condensed Balance Sheet Data
(in thousands)
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As of June 30, 2015 |
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As of December 31, 2014 |
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(unaudited) |
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Cash and cash equivalents |
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$ |
190,294 |
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$ |
139,810 |
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Short-term investments |
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21,598 |
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16,223 |
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Total assets |
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219,165 |
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159,164 |
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Total liabilities |
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6,418 |
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5,551 |
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Accumulated deficit |
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(127,030 |
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(102,469 |
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Total stockholders equity |
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212,747 |
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153,613 |
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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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