1. SAN DIEGO, Feb. 25, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that management will participate in three upcoming virtual conferences:

    • A fireside chat at the Cowen 41st Annual Health Care Conference on March 4, 2021 at 12:50 p.m. ET / 9:50 a.m. PT;
    • A pre-recorded presentation at the H.C. Wainwright Global Life Sciences Conference available on-demand starting at 7 a.m. ET / 4 a.m. PT on March 9, 2021; and
    • A presentation at the Oppenheimer 31st Annual Healthcare Conference on March 16, 2021 at 11:20 a.m. ET / 8:20 a.m. PT.

    Live audio webcasts will be available through the Events page of the company's website (www.otonomy.com

    SAN DIEGO, Feb. 25, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that management will participate in three upcoming virtual conferences:

    • A fireside chat at the Cowen 41st Annual Health Care Conference on March 4, 2021 at 12:50 p.m. ET / 9:50 a.m. PT;

    • A pre-recorded presentation at the H.C. Wainwright Global Life Sciences Conference available on-demand starting at 7 a.m. ET / 4 a.m. PT on March 9, 2021; and

    • A presentation at the Oppenheimer 31st Annual Healthcare Conference on March 16, 2021 at 11:20 a.m. ET / 8:20 a.m. PT.

    Live audio webcasts will be available through the Events page of the company's website (www.otonomy.com).

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and tinnitus. For additional information, please visit www.otonomy.com.

    Contacts:

    Media Inquiries

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932



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  2. SAN DIEGO, Feb. 22, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that the Phase 3 clinical trial of OTIVIDEX in patients with Ménière's disease did not achieve the primary endpoint, which was the count of definitive vertigo days (DVD) in Month 3 for OTIVIDEX vs. placebo for the intent-to-treat (ITT) population (n = 148; p value = 0.312) using the Negative Binomial Model. This analysis did achieve statistical significance for the per protocol (PP) population (n = 136; p value = 0.031). These results were similar using the Generalized Poisson model (p value = 0.340 for ITT and p value = 0.030 for PP).

    "We are disappointed…

    SAN DIEGO, Feb. 22, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that the Phase 3 clinical trial of OTIVIDEX in patients with Ménière's disease did not achieve the primary endpoint, which was the count of definitive vertigo days (DVD) in Month 3 for OTIVIDEX vs. placebo for the intent-to-treat (ITT) population (n = 148; p value = 0.312) using the Negative Binomial Model. This analysis did achieve statistical significance for the per protocol (PP) population (n = 136; p value = 0.031). These results were similar using the Generalized Poisson model (p value = 0.340 for ITT and p value = 0.030 for PP).

    "We are disappointed by the top-line results for the primary intent-to-treat population and are undertaking an assessment to understand the difference observed with the per protocol analysis. We thank the many patients, clinical investigators and study site staff who supported this effort," said David A. Weber, Ph.D., president and CEO of Otonomy. "Our focus turns to the strong pipeline we have built as recently highlighted by the successful clinical trial results for OTO-313 in tinnitus and OTO-413 in hearing loss. OTO-313 and OTO-413 each address a large patient population with significant unmet need and no approved drug therapy. These programs provide an attractive opportunity for the company with clinical readouts anticipated in mid-2022. We expect that our existing cash balance will permit us to achieve these clinical readouts as well as advance our preclinical hearing loss programs including OTO-825, a gene therapy for congenital hearing loss."

    The company previously reported a cash balance including cash, cash equivalents, and short-term investments totaling $86.3 million as of December 31, 2020, GAAP operating expenses for full year 2020 of $42.6 million and non-GAAP operating expenses, which exclude stock-based compensation, for full year 2020 of $36.5 million.

    About OTIVIDEX Phase 3 Trial

    The OTIVIDEX Phase 3 trial was a four month, prospective, randomized, double-blind, placebo-controlled trial of patients with unilateral Ménière's disease conducted in the United States and Europe. Following an initial one month lead-in period, eligible subjects were randomized 1:1 to a single intratympanic injection of OTIVIDEX or placebo and then followed for three months. A total of 149 patients were randomized into the study. The primary endpoint was the count of definitive vertigo days in Month 3 for OTIVIDEX vs. placebo assessed using the Negative Binomial model.

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, statements related to plans and expectations regarding OTO-313, OTO-413 and OTO-825, and Otonomy's other preclinical programs, including with respect to patient populations; anticipated timing of clinical readouts for OTO-313 and OTO-413; Otonomy's expectation that its existing cash balance will permit the company to achieve such clinical readouts as well as advance its preclinical hearing loss programs; expectations regarding Otonomy's ability to advance its pipeline; and statements by Otonomy's president and CEO.

    Otonomy's 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: delays and disruption resulting from the COVID-19 pandemic and governmental and site responses to the pandemic, including current and future impacts to Otonomy's operations, the manufacturing of its product candidates, the progression of its current clinical trials, and patient conduct and compliance; Otonomy's ability to accurately forecast financial results; Otonomy's ability to obtain additional financing; risks and uncertainties related to the impact of this announcement on the Company's business, financial condition and the price of the Company's securities; Otonomy's dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment, conduct and compliance in clinical trials; the integrity of patient-reported outcomes in its current and future clinical trials; the risks of the occurrence of any event, change or other circumstance that could impact the performance under or give rise to the termination of Otonomy's collaboration, co-promotion or license agreements, or that could impact Otonomy's ability to repay or comply with the terms of the loan provided by Oxford Finance LLC; side effects or adverse events associated with Otonomy's product candidates; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials, and for the manufacture of its product candidates; Otonomy's ability to protect its intellectual property in the United States and throughout the world and to ensure compliance with various laws and regulations in countries in which it conducts clinical trials; expectations regarding potential therapy benefits, market size, opportunity and growth; Otonomy's ability to manage operating expenses; implementation of Otonomy's business model and strategic plans for its business, products and technology; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 11, 2021, and Otonomy's 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

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932



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    • Presentation of positive top-line clinical results for OTO-313 in tinnitus and OTO-413 in hearing loss
    • Supportive preclinical data to be presented for OTO-825 gene therapy and OTO-510 otoprotection program

    SAN DIEGO, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced multiple presentations at the upcoming Association for Research in Otolaryngology (ARO) 44th Annual MidWinter Meeting, to be held virtually February 20-24, 2021. These include participation in an invited symposium, presentation of the previously disclosed positive top-line clinical results for OTO-313 in tinnitus and OTO-413 in hearing loss, and multiple…

    • Presentation of positive top-line clinical results for OTO-313 in tinnitus and OTO-413 in hearing loss

    • Supportive preclinical data to be presented for OTO-825 gene therapy and OTO-510 otoprotection program

    SAN DIEGO, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced multiple presentations at the upcoming Association for Research in Otolaryngology (ARO) 44th Annual MidWinter Meeting, to be held virtually February 20-24, 2021. These include participation in an invited symposium, presentation of the previously disclosed positive top-line clinical results for OTO-313 in tinnitus and OTO-413 in hearing loss, and multiple presentations related to Otonomy's preclinical programs.

    "We are pleased to have the opportunity to present clinical results for OTO-313 and OTO-413 during ARO, which is the premier meeting of research scientists in the neurotology field," said Alan Foster, Ph.D., Vice President, Research of Otonomy. "Additionally, our multiple presentations this year highlight the breadth of our pipeline and provide supportive data for our preclinical programs including OTO-825, a gene therapy for congenital hearing loss, and OTO-510, an otoprotectant for cisplatin-induced hearing loss."

    Otonomy is participating in a symposium entitled "From bench to bedside – translational oto-therapeutic approaches" that will be held from 12:30 to 2:30 p.m. EST on February 24. The Otonomy presentation topic and presenter are as follows:

    • "From research to preclinical development: translating in vitro/ex vivo research into clinically relevant in vivo studies for hearing loss" by Bonnie Jacques, Ph.D.

    All other Otonomy presentations are during poster sessions occurring from 3 to 5 p.m. EST on the days indicated below.

    Presentations related to Otonomy's clinical programs for tinnitus and hearing loss:

    • "A Phase 1/2 study of OTO-313 given as a single intratympanic injection in patients with moderate to severe, persistent tinnitus" by Maxwell et al., on February 23.
    • "A first-in-human study of OTO-413, an intratympanic sustained-exposure formulation of BDNF, for the treatment of speech-in-noise hearing impairment" by Anderson et al., on February 23.

    Additional presentations related to Otonomy's preclinical hearing loss programs:

    • "Characterization of novel AAV capsid variants for delivery of GJB2 gene therapy for congenital hearing loss" a joint presentation from Otonomy and Applied Genetics Technology Corporation (AGTC) by Uribe et al., on February 24.
    • "Identification and characterization of a novel therapeutic class for protection against cisplatin-induced hearing loss" by Tsivkovskaia et al., on February 21.
    • "Characterization of a TrkB mAb agonist for the treatment of speech-in-noise hearing difficulties (cochlear synaptopathy)" by Tsivkovskaia et al., on February 22.
    • "Novel tools to probe neurotrophic signaling in cochlear neurons: fab fragments derived from Trk-selective agonist monoclonal antibodies are potent and selective antagonists of the TrkB and TrkC receptors" by Siegel et al., on February 22.

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and tinnitus. For additional information please visit www.otonomy.com.

    Contacts:

    Media Inquiries:

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries:

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932



    Primary Logo

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    • OTIVIDEX® Phase 3 trial results in Ménière's disease expected by end of February
    • OTO-313 Phase 2 trial in tinnitus planned to start in first quarter of 2021 with top-line results expected in mid-2022
    • OTO-413 Phase 1/2 trial expansion in hearing loss expected to start in second quarter of 2021 with results anticipated in mid-2022

    Conference call and webcast today at 4:30 p.m. ET

    SAN DIEGO, Feb. 11, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today reported financial results for the quarter and year ended December 31, 2020 and provided an update on its product pipeline and corporate activities. The company will host a conference call…

    • OTIVIDEX® Phase 3 trial results in Ménière's disease expected by end of February

    • OTO-313 Phase 2 trial in tinnitus planned to start in first quarter of 2021 with top-line results expected in mid-2022
    • OTO-413 Phase 1/2 trial expansion in hearing loss expected to start in second quarter of 2021 with results anticipated in mid-2022

    Conference call and webcast today at 4:30 p.m. ET

    SAN DIEGO, Feb. 11, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today reported financial results for the quarter and year ended December 31, 2020 and provided an update on its product pipeline and corporate activities. The company will host a conference call and webcast today at 4:30 p.m. ET to discuss recent highlights and financial results.

    "We made great progress in advancing our product pipeline and achieving our corporate objectives during 2020 including positive clinical results for OTO-313 in tinnitus, positive clinical results for OTO-413 in hearing loss, and completion of enrollment for our Phase 3 trial of OTIVIDEX in Ménière's disease," said David A. Weber, Ph.D., president and CEO of Otonomy. "We also selected a product candidate, OTO-825, for our GJB2 gene therapy program, demonstrated preclinical proof-of-concept for our otoprotection program, and licensed a novel compound for our OTO-6XX hair cell repair and regeneration program. We are looking forward to important catalysts this year beginning with the OTIVIDEX Phase 3 results later this month."

    Otonomy Program Updates

    • OTIVIDEX: results for Phase 3 trial in Ménière's disease expected by end of February. This trial enrolled a total of 149 patients from the United States and Europe, exceeding the target of 142 patients. In November 2020, Otonomy announced that a review of the revised statistical analysis plan by the U.S. Food and Drug Administration (FDA) confirmed use of the Negative Binomial model for analysis of the primary endpoint in this trial. The last patient last visit was completed at the end of December 2020 and results are expected by the end of this month. Assuming positive results, we plan to submit a New Drug Application to the FDA in the third quarter of 2021.



    • OTO-313: Phase 2 trial in tinnitus planned to start in the first quarter of 2021 with top-line results expected in mid-2022. In July 2020, Otonomy reported positive top-line results from the Phase 1/2 trial of OTO-313 in patients with unilateral tinnitus of at least moderate severity. This trial demonstrated a positive clinical response for a single intratympanic injection of OTO-313 using the Tinnitus Functional Index (TFI) that was correlated with tinnitus loudness, tinnitus annoyance and patient global impression of change measures. Based on these results, Otonomy plans to conduct a Phase 2 trial that will enroll approximately 140 patients with unilateral tinnitus. To enrich the study population, the trial will exclude patients with severe hearing loss and increase the minimum TFI score required for entry. The company will also expand the unilateral patient population eligible for enrollment by increasing the time from tinnitus onset from six months to one year, and will extend the observation period to assess durability of the treatment effect.



    • OTO-413: Phase 1/2 trial expansion planned to start in second quarter of 2021 with top-line results expected in mid-2022. In December 2020, Otonomy announced positive top-line results from an ascending single dose safety and exploratory efficacy study for OTO-413 in patients with hearing loss. This trial demonstrated that a single intratympanic injection of OTO-413 was well-tolerated across all dose cohorts. Furthermore, the therapeutic activity of OTO-413 versus placebo was demonstrated across multiple clinically-validated speech-in-noise hearing tests at consecutive time points (Days 57 and 85). Beginning in the second quarter of 2021, Otonomy plans to enroll additional hearing loss patients in an expansion of the Phase 1/2 trial to evaluate a refined study protocol in preparation for Phase 2. This expansion will randomize subjects to a single treatment with OTO-413 or placebo and evaluate a reduced number of endpoints focusing on the phrase, word and digit speech-in-noise hearing tests assessed in the initial patient cohorts. Enrollment criteria will continue to target a broad hearing loss population to support design of a Phase 2 trial.



    • OTO-825: GJB2 gene therapy product candidate selected. Otonomy and Applied Genetic Technologies Corporation (AGTC) are collaborating to co-develop and co-commercialize an AAV-based gene therapy to restore hearing in patients with hearing loss caused by a mutation in the gap junction beta-2 (GJB2) gene -- the most common cause of congenital hearing loss. Preclinical results presented at conferences during 2020 demonstrated that a gene of interest can be expressed in support cells of the cochlea, which are the relevant target cells for treating GJB2 deficiency, using novel and proprietary AAV capsids. Also, consistent gene expression was observed for at least 12 weeks in non-human primates following a single local administration. These results supported selection of OTO-825 for advancement into IND enabling studies.



    • OTO-510: preclinical development ongoing for novel and proprietary otoprotection molecule. Cisplatin is a potent chemotherapeutic agent that is widely used to treat a variety of cancers in adults and children, however, it is commonly associated with severe adverse effects including cisplatin-induced hearing loss (CIHL). Otonomy has identified a novel series of molecules with improved otoprotection in preclinical CIHL studies compared to other agents in development. Preclinical development continues for a small molecule from this class formulated to provide sustained exposure from a single intratympanic injection.



    • OTO-6XX: preclinical development ongoing for hair cell repair and regeneration program. In July 2020, Otonomy entered into an exclusive license agreement with KYORIN Pharmaceutical Co., Ltd. (Kyorin) that provides Otonomy with exclusive worldwide rights to develop, manufacture and commercialize a novel compound for the treatment of sensorineural hearing loss. Otonomy is formulating the patent-protected compound utilizing the company's proprietary technology to provide sustained drug exposure in the inner ear following a single local administration. The OTO-6XX program targets hair cell repair and regeneration for the treatment of severe hearing loss.



    • OTIPRIO®: co-promotion partnership initiated and expanded with ALK-Abelló, Inc. (ALK). In June 2020, Otonomy entered a co-promotion agreement that provided ALK with an exclusive right to promote OTIPRIO for acute otitis externa (AOE). This agreement was expanded in October 2020 to include OTIPRIO's other FDA-approved indication, use during ear tube surgery. During the multi-year agreement, Otonomy will receive co-promotion fees and reimbursement of a proportion of product support costs while also retaining a share of adjusted gross profits from the sale of OTIPRIO by ALK.

    Fourth Quarter and Full Year 2020 Financial Highlights

    • Cash Position: Cash, cash equivalents, and short-term investments totaled $86.3 million as of December 31, 2020, compared to $60.7 million as of December 31, 2019. In July 2020, Otonomy completed an underwritten public offering of 17,275,000 shares of its common stock, which includes the underwriters' full exercise of their option to purchase additional shares, and the Company sold pre-funded warrants to purchase up to 4,000,000 shares of its common stock, for total gross proceeds of approximately $69.1 million, before deducting underwriting discounts and commissions and other offering expenses payable by Otonomy. All of the securities were sold by Otonomy.



    • Long-term Debt: Otonomy obtained a $15.0 million term loan from Oxford Finance LLC in December 2018. In July 2020, the terms of the loan were amended to extend the interest-only repayment period from 24 months to 36 months, followed by 23 months of amortization.



    • Operating Expenses: GAAP operating expenses were $10.1 million for the fourth quarter of 2020, compared to $10.7 million for the fourth quarter of 2019. For the full year 2020, GAAP operating expenses were $42.6 million compared to $44.5 million for 2019. Non-GAAP operating expenses, which exclude stock-based compensation, were $8.5 million for the fourth quarter of 2020, compared to $10.2 million for the fourth quarter of 2019. For the full year 2020, non-GAAP operating expenses were $36.5 million compared to $39.6 million for 2019.



    • Research and Development Expenses: GAAP research and development (R&D) expenses for the fourth quarter of 2020 were $6.4 million, compared to $7.0 million for the fourth quarter of 2019. The decrease for the quarter was primarily due to reduced third-party development costs that were partially offset by increased compensation expense. For the full year 2020, GAAP R&D expenses were $28.0 million compared to $32.8 million for 2019.



    • Selling, General and Administrative Expenses: GAAP selling, general and administrative (SG&A) expenses in the fourth quarter of 2020 were $3.7 million, compared to $3.6 million for the fourth quarter of 2019. For the full year 2020, GAAP SG&A expenses were $14.6 million compared to $11.7 million for 2019.

    Webcast and Conference Call

    Otonomy management will host a webcast and conference call regarding these program updates at 4:30 p.m. ET / 1:30 p.m. PT today. The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 3372182. A live webcast of the call will be available online in the investor relations section of Otonomy's website at www.otonomy.com and will be archived there for 30 days.

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, statements related to the design and conduct of, activity, enrollment plans and patient population for, and timing of initiation and results for current and planned clinical trials; statements relating to the use of and expectations regarding the Negative Binomial model for the Phase 3 clinical trial of OTIVIDEX; statements regarding plans to submit a New Drug Application for OTIVIDEX; the potential benefits and opportunities of, and activities under the collaboration agreement between Otonomy and AGTC, including but not limited to plans to advance into IND enabling studies, the co-promotion agreement between Otonomy and ALK, and the license agreement between Otonomy and Kyorin; expectations regarding preclinical programs, including the potential benefits and development activities; expectations regarding Otonomy's ability to advance its pipeline and regarding upcoming catalysts; and statements by Otonomy's president and CEO. Otonomy's 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: delays and disruption resulting from the COVID-19 pandemic and governmental and site responses to the pandemic, including current and future impacts to Otonomy's operations, the manufacturing of its product candidates, the progression of its current clinical trials, and patient conduct and compliance; Otonomy's ability to accurately forecast financial results; Otonomy's ability to obtain additional financing; Otonomy's dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment, conduct and compliance in clinical trials; the integrity of patient-reported outcomes in its current and future clinical trials; the risks of the occurrence of any event, change or other circumstance that could impact the performance under or give rise to the termination of the collaboration agreement between Otonomy and AGTC, the co-promotion agreement between Otonomy and ALK, or the license agreement between Otonomy and Kyorin, or that could impact Otonomy's ability to repay or comply with the terms of the loan provided by Oxford Finance LLC; side effects or adverse events associated with Otonomy's product candidates; Otonomy's ability to successfully commercialize its product candidates, if approved; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials, and for the manufacture of its product candidates; Otonomy's ability to protect its intellectual property in the United States and throughout the world and to ensure compliance with various laws and regulations in countries in which it conducts clinical trials; expectations regarding potential therapy benefits, market size, opportunity and growth; Otonomy's ability to manage operating expenses; implementation of Otonomy's business model and strategic plans for its business, products and technology; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 11, 2021, and Otonomy's 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

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

     

    Investor Inquiries

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932

    ke.com 

     
     
    Otonomy, Inc.
    Condensed Balance Sheet Data
    (in thousands)
        
     As of December 31, As of December 31,
      2020   2019 
        
    Cash and cash equivalents$30,767  $25,194 
            
    Short-term investments 55,576   35,476 
            
    Right-of-use assets 14,082   15,465 
            
    Total assets 106,265   83,018 
            
    Long-term debt, net 15,158   14,967 
            
    Leases, net of current 13,847   15,320 
            
    Total liabilities 39,999   42,785 
            
    Accumulated deficit (504,624)  (459,893)
            
    Total stockholders' equity 66,266   40,233 
            



    Otonomy, Inc.
    Condensed Statements of Operations
    (in thousands, except share and per share data)
             
      Three Months Ended Years Ended
      December 31, December 31,
       2020   2019   2020   2019 
             
      (unaudited)    
    Product sales, net$53  $93  $273  $600 
    Costs and operating expenses:       
     Cost of product sales 274   276   1,188   912 
     Research and development 6,374   7,034   27,997   32,805 
     Selling, general and administrative 3,692   3,625   14,575   11,690 
    Total costs and operating expenses 10,340   10,935   43,760   45,407 
    Loss from operations (10,287)  (10,842)  (43,487)  (44,807)
             
    Other (expense) income, net (360)  (83)  (1,244)  132 
    Net loss$(10,647) $(10,925) $(44,731) $(44,675)
             
    Net loss per share, basic and diluted$(0.20) $(0.36) $(1.10) $(1.45)
             
    Weighted-average shares used to compute net loss per share,      
     basic and diluted 52,257,321   30,768,174   40,845,844   30,726,786 
             



    Otonomy, Inc.
    Reconciliation of GAAP to Non-GAAP Operating Expenses
    (in thousands)
             
      Three Months Ended Years Ended
      December 31, December 31,
       2020   2019   2020   2019 
                     
      (unaudited)
    GAAP operating expenses       
     Research and development$6,374  $7,034  $27,997  $32,805 
     Selling, general and administrative 3,692   3,625   14,575   11,690 
    Total GAAP operating expenses 10,066   10,659   42,572   44,495 
    Non-GAAP adjustments       
     R&D stock-based compensation expense (632)  183   (2,456)  (2,085)
     SG&A stock-based compensation expense (950)  (628)  (3,642)  (2,793)
    Total non-GAAP adjustments (1,582)  (445)  (6,098)  (4,878)
    Non-GAAP operating expenses$8,484  $10,214  $36,474  $39,617 
             


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  3. SAN DIEGO, Feb. 04, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced it will report financial results for the fourth quarter and full year 2020 and provide a corporate update at 4:30 p.m. ET on February 11, 2021.

    The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 3372182. A live webcast of the call will be available online in the investor relations section of Otonomy's website at www.otonomy.com and will be archived there for 30 days.

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of…

    SAN DIEGO, Feb. 04, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced it will report financial results for the fourth quarter and full year 2020 and provide a corporate update at 4:30 p.m. ET on February 11, 2021.

    The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 3372182. A live webcast of the call will be available online in the investor relations section of Otonomy's website at www.otonomy.com and will be archived there for 30 days.

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and tinnitus. For additional information, please visit www.otonomy.com.

    Contacts:

    Media Inquiries:

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries:

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932



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  4. SAN DIEGO, Jan. 05, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that management is scheduled to participate in a fireside chat at the virtual H.C. Wainwright BioConnect 2021 Conference to be held January 11-14, 2021.

    The fireside chat will be available on-demand through the H.C. Wainwright conference portal, starting at 6 a.m. EST on Monday, January 11, 2021. An archived webcast will also be accessible through the Events page of the company's website (www.otonomy.com).

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered…

    SAN DIEGO, Jan. 05, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that management is scheduled to participate in a fireside chat at the virtual H.C. Wainwright BioConnect 2021 Conference to be held January 11-14, 2021.

    The fireside chat will be available on-demand through the H.C. Wainwright conference portal, starting at 6 a.m. EST on Monday, January 11, 2021. An archived webcast will also be accessible through the Events page of the company's website (www.otonomy.com).

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and tinnitus. For additional information, please visit www.otonomy.com.

    Contacts:

    Media Inquiries

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932



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    • OTO-413 demonstrated a higher proportion of responders than placebo based on multiple speech-in-noise hearing tests
    • A single intratympanic injection of OTO-413 was well-tolerated
    • Otonomy intends to continue clinical development of OTO-413
    • Management will review results during a conference call today at 8 a.m. ET

    SAN DIEGO, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced positive top-line results from the Phase 1/2 clinical trial of OTO-413 in subjects with speech-in-noise hearing difficulty. The randomized, double-blind, placebo-controlled trial demonstrated that a single intratympanic injection of OTO-413, a sustained…

    • OTO-413 demonstrated a higher proportion of responders than placebo based on multiple speech-in-noise hearing tests

    • A single intratympanic injection of OTO-413 was well-tolerated
    • Otonomy intends to continue clinical development of OTO-413
    • Management will review results during a conference call today at 8 a.m. ET

    SAN DIEGO, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced positive top-line results from the Phase 1/2 clinical trial of OTO-413 in subjects with speech-in-noise hearing difficulty. The randomized, double-blind, placebo-controlled trial demonstrated that a single intratympanic injection of OTO-413, a sustained exposure formulation of brain-derived neurotrophic factor (BDNF), was well-tolerated across all dose cohorts. Furthermore, there was demonstration of therapeutic activity of OTO-413 versus placebo across multiple clinically-validated speech-in-noise hearing tests at consecutive time points (Days 57 and 85). Based on these results, the company plans to continue development of OTO-413 for the treatment of hearing loss.

    Assessment of OTO-413 Therapeutic Activity

    All subjects enrolled in this trial self-reported hearing difficulty in a noisy environment that was confirmed by speech-in-noise (SIN) testing. Subjects could also have up to moderately-severe hearing loss by standard testing in a quiet background. Multiple clinically-validated SIN hearing tests including Digits-in-Noise (DIN), Words-in-Noise (WIN), and American English Matrix test were administered at baseline and following treatment at Day 15, 29, 57, and 85. The assessment of therapeutic activity is based on demonstration of a clinically meaningful improvement from baseline according to the thresholds utilized for each of the SIN tests. The top-line results below include the 9 subjects from the OTO-413 high dose (0.3 mg) cohort with test results on both Day 57 and Day 85 and 8 placebo subjects pooled from the last 3 dose cohorts.

    • 6 out of 9 (67%) OTO-413 subjects demonstrated a clinically-meaningful improvement on at least one of the three SIN tests at both Days 57 and 85 versus 0 out of 8 (0%) for placebo.



    • 3 out of 9 (33%) OTO-413 subjects demonstrated a clinically-meaningful improvement by two or more different SIN tests at both Days 57 and 85 versus 0 out of 8 (0%) for placebo.



    • Considering the American English Matrix test that mimics a real world setting by using short sentences in background noise, 4 out of 9 (44%) OTO-413 subjects showed a clinically-meaningful improvement at both Days 57 and 85 compared to 0 out of 7 (0%) placebo subjects showing a clinically-meaningful improvement at any single time point.



    • Most of the patients enrolled in this trial also had moderately-severe hearing loss by standard testing in a quiet background. The responder rate for OTO-413 was equally favorable in this subset with 5 out of 7 (71%) OTO-413 subjects demonstrating a clinically-meaningful improvement in at least one SIN test and 3 out of 7 (43%) responding by two or more tests at both Days 57 and 85 compared to 0 out of 6 (0%) placebo subjects.



    • Improvements from baseline were also observed for multiple other exploratory endpoints and for OTO-413 treated subjects in the lower dose cohorts.

    In summary, Otonomy believes that these higher responder rates for OTO-413 compared to placebo at two consecutive time points across multiple SIN tests demonstrates therapeutic activity and supports continued development of OTO-413 for the treatment of hearing loss.

    OTO-413 Safety Evaluation

    A total of 29 subjects were treated with OTO-413 across four ascending dose cohorts (0.01 mg, 0.03 mg, 0.10 mg and 0.30 mg) with a similar frequency of adverse events (AEs) reported as for placebo subjects. There was no apparent impact of OTO-413 dose on AE incidence, no serious AEs reported and no patients who discontinued the trial due to an AE. Otonomy believes these results demonstrate that a single intratympanic injection of OTO-413 was well-tolerated.



    "Difficulty hearing a conversation with noise in the background is a common complaint by patients presenting for hearing loss treatment and this is only expected to grow as the population ages and noise exposure in our society continues to increase," said Barbara Shinn-Cunningham, Ph.D., Director, Carnegie Mellon Neuroscience Institute and Cowan Professor of Auditory Neuroscience, Biomedical Engineering, Psychology, and Electrical & Computer Engineering at Carnegie Mellon University. "Extensive research conducted over the last decade suggests that damage to cochlear synapses plays a role in this speech-in-noise hearing difficulty. Treatment with a neurotrophic factor such as BDNF offers potential for repair. I am encouraged by these initial results for OTO-413 across multiple speech-in-noise hearing tests and look forward to its continued development as an option for patients to regain functional hearing."

    "We are excited to announce these positive top-line clinical results for OTO-413 that support its continued development for patients with hearing loss," said David A. Weber, Ph.D., president and CEO of Otonomy. "It is also a great way to build on the successful clinical trial results we announced this summer for OTO-313 in tinnitus, and further affirms our leading position in the emerging neurotology field. We continue to look forward to our third clinical catalyst with results from the Phase 3 trial of OTIVIDEX® in Ménière's disease still expected in the first quarter of 2021."

    Webcast and Conference Call

    Otonomy management will host a webcast and conference call regarding these clinical results at 8 a.m. ET today. The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 9882298. A live webcast of the call will be available online in the investor relations section of Otonomy's website at www.otonomy.com and will be archived there for 30 days.

    About Speech-in-Noise Hearing Difficulty

    Recent scientific advances have shown that the loss of synaptic connections between inner ear hair cells and auditory nerve fibers contributes to hearing impairment. This cochlear synaptopathy is proposed as an underlying pathology in age-related and noise-induced hearing loss and is believed to contribute to the common difficulty of hearing speech in the presence of background noise. Overall, there are more than 50 million people in the U.S. with acquired hearing loss including a significant proportion experiencing speech-in-noise hearing difficulty, which can lead to social isolation, depression and early cognitive decline.

    About the Phase 1/2 Trial

    The Phase 1/2 trial was primarily intended to evaluate the safety of ascending doses of OTO-413 administered by a single intratympanic injection and secondarily to assess a clinical signal for OTO-413 across multiple speech-in-noise (SIN) hearing tests and other exploratory efficacy endpoints. The first three dose cohorts (0.01 mg, 0.03 mg, and 0.10 mg) each enrolled 8 subjects with a fourth dose cohort (0.30 mg) expanded to enroll 15 subjects. All cohorts were randomized 3:1 for OTO-413 or placebo. Subjects were evaluated at screening and baseline (pre-dose) and then again at Day 15, Day 29, Day 57 and Day 85 following treatment. The SIN tests included the Digits-in-Noise (DIN) test, Words-in-Noise (WIN) test, and American English Matrix test that uses sentences in background noise. Each of these SIN tests has been clinically-validated with a threshold level of improvement considered clinically meaningful. All 29 subjects treated with OTO-413 and 10 placebo subjects were included in the safety assessment. The top-line assessment of therapeutic activity was conducted in 9 evaluable OTO-413 subjects from the high dose cohort compared to 8 placebo subjects pooled from the last three dose cohorts.

    About OTO-413

    OTO-413 is a proprietary, sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), which is a naturally occurring protein involved in neuron growth and repair. Nonclinical studies have demonstrated that local administration of BDNF repairs the connections between inner hair cells and auditory nerve fibers in the cochlea that are damaged due to noise trauma or exposure to ototoxic chemicals. Furthermore, Otonomy has demonstrated in preclinical studies that repair of synaptic connections is associated with a restoration of hearing function. The initial indication for OTO-413 is speech-in-noise hearing difficulty, a type of hearing loss believed to be caused by cochlear synaptopathy.

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, expectations regarding the potential benefits, patient population, development activity and advancement of Otonomy's clinical programs; statements relating to the timing of results of ongoing clinical trials; statements relating to potential treatment for patients suffering from hearing loss; statements by Barbara Shinn-Cunningham, Ph.D.; and statements by Otonomy's president and CEO. Otonomy's 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: delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic, including current and future impacts to Otonomy's operations, the manufacturing of its product candidates, the progression of its current clinical trials, enrollment in its current and future clinical trials and patient conduct and compliance; Otonomy's ability to obtain additional financing; Otonomy's dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, and the nonclinical and clinical results for its product candidates, which may not support further development; the integrity of patient-reported outcomes in its current and future clinical trials; side effects or adverse events associated with Otonomy's product candidates; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials; Otonomy's ability to protect its intellectual property in the United States and throughout the world; expectations regarding potential therapy benefits, market size, opportunity and growth; Otonomy's ability to manage operating expenses; implementation of Otonomy's business model and strategic plans for its business, products and technology; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on November 4, 2020, and Otonomy's 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

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932

     



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    • FDA's review confirms use of Negative Binomial model for analysis of primary endpoint in ongoing OTIVIDEX Phase 3 trial in Ménière's disease; results still expected in first quarter of 2021
    • Company finalizing design of Phase 2 trial for OTO-313 in tinnitus and expects to start study in the first quarter of 2021

    SAN DIEGO, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today provided updates regarding the statistical analysis plan for the ongoing Phase 3 trial of OTIVIDEX in Ménière's disease, and outlined plans for a Phase 2 trial of OTO-313 in tinnitus.

    • OTIVIDEX: FDA's review of the OTIVIDEX statistical analysis plan confirms
    • FDA's review confirms use of Negative Binomial model for analysis of primary endpoint in ongoing OTIVIDEX Phase 3 trial in Ménière's disease; results still expected in first quarter of 2021

    • Company finalizing design of Phase 2 trial for OTO-313 in tinnitus and expects to start study in the first quarter of 2021

    SAN DIEGO, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today provided updates regarding the statistical analysis plan for the ongoing Phase 3 trial of OTIVIDEX in Ménière's disease, and outlined plans for a Phase 2 trial of OTO-313 in tinnitus.

    • OTIVIDEX: FDA's review of the OTIVIDEX statistical analysis plan confirms use of the Negative Binomial model for analysis of the primary endpoint in the ongoing Phase 3 clinical trial in Ménière's disease. In July 2020, Otonomy submitted a revised statistical analysis plan for the ongoing trial to the U.S. Food and Drug Administration (FDA) that proposed use of the Negative Binomial model for primary analysis of the daily vertigo count data reported by patients. Otonomy believes that this statistical test provides the best fit of the OTIVIDEX clinical data based on the Phase 2b trial, the AVERTS-2 Phase 3 trial, and the integrated dataset from both trials. As previously reported, the ongoing Phase 3 clinical trial has completed enrollment and results are expected in the first quarter of 2021. Assuming positive results, submission of a New Drug Application to the FDA is planned for the third quarter of 2021.



    • OTO-313: Phase 2 trial design to be based on the successful Phase 1/2 trial, and initiation is expected in the first quarter of 2021. In July 2020, Otonomy reported positive top-line results from a Phase 1/2 trial of OTO-313 in patients with unilateral tinnitus of at least moderate severity. This trial demonstrated a positive clinical response for a single intratympanic injection of OTO-313 using the Tinnitus Functional Index (TFI) that was correlated with tinnitus loudness, tinnitus annoyance and patient global impression of change measures. Based on continued analysis of this data, input from key opinion leaders, and feedback from the FDA in a Type C meeting, Otonomy intends to evaluate the same dose for OTO-313 in a Phase 2 trial that will enroll an enriched unilateral tinnitus patient population. To enrich the study population, Otonomy intends to exclude patients with severe hearing loss and increase the minimum TFI score required for entry. The company will also expand the unilateral patient population eligible for enrollment by increasing the time from tinnitus onset, and will extend the observation period to assess durability of the treatment effect.

    "We appreciate the timely feedback from the FDA that supports our plan to analyze the OTIVIDEX Phase 3 trial results and, together with input from tinnitus clinical experts, will help us finalize the OTO-313 Phase 2 trial design," said David A. Weber, Ph.D., president and CEO of Otonomy. "We are looking forward to having the OTIVIDEX results and initiating the OTO-313 Phase 2 trial in the first quarter of 2021. In the meantime, we are working to complete the OTO-413 Phase 1/2 trial in patients with speech-in-noise hearing deficit, and expect to announce results in December."

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, statements relating to the design of (including without limitation regarding dose and patient population), initiation of, development activity for, and advancement of clinical trials; statements relating to the timing of results, activity for, and conduct of ongoing clinical trials; statements relating to the updated statistical analysis plan for the ongoing Phase 3 clinical trial of OTIVIDEX and expectations regarding the Negative Binomial model; statements regarding plans to submit a New Drug Application for OTIVIDEX; and statements by Otonomy's president and CEO. Otonomy's 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: delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic, including current and future impacts to Otonomy's operations, the manufacturing of its product candidates, the progression of its current clinical trials, enrollment in its current and future clinical trials and patient conduct and compliance; Otonomy's ability to accurately forecast financial results; Otonomy's ability to obtain additional financing; Otonomy's dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; the integrity of patient-reported outcomes in its current and future clinical trials; the risks of the occurrence of any event, change or other circumstance that could impact Otonomy's ability to repay or comply with the terms of the loan provided by Oxford Finance LLC; side effects or adverse events associated with Otonomy's product candidates; Otonomy's ability to successfully commercialize its product candidates, if approved; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials, and for the manufacture of its product candidates; Otonomy's ability to protect its intellectual property in the United States and throughout the world; Otonomy's ability to manage operating expenses; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on November 4, 2020, and Otonomy's 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

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932



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  5. SAN DIEGO, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that management is scheduled to participate in two upcoming virtual investor conferences.

    • Evercore ISI 3rd Annual HealthCONx Conference: presentation on December 1, 2020 at 3:05 p.m. ET / 12:05 p.m. PT. A live audio webcast of the presentation will be available through the Events page of the company's website at www.otonomy.com and an archived replay will be available shortly after the event.

    • Piper Sandler 32nd Annual Healthcare Conference: 1 on 1 investor meetings on December 2, 2020. A pre-recorded fireside chat will be accessible from November 23 to…

    SAN DIEGO, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that management is scheduled to participate in two upcoming virtual investor conferences.

    • Evercore ISI 3rd Annual HealthCONx Conference: presentation on December 1, 2020 at 3:05 p.m. ET / 12:05 p.m. PT. A live audio webcast of the presentation will be available through the Events page of the company's website at www.otonomy.com and an archived replay will be available shortly after the event.



    • Piper Sandler 32nd Annual Healthcare Conference: 1 on 1 investor meetings on December 2, 2020. A pre-recorded fireside chat will be accessible from November 23 to December 3, 2020 through the Events page of the company's website at www.otonomy.com.

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and tinnitus. For additional information please visit www.otonomy.com.

    Contacts:

    Media Inquiries

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932

      



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    • Enrollment completed in Phase 3 clinical trial of OTIVIDEX®in Ménière's disease with results expected in the first quarter of 2021
    • Positive results reported for Phase 1/2 clinical trial of OTO-313 in tinnitus patients
    • Enrollment completed in Phase 1/2 clinical trial of OTO-413 in hearing loss with results expected by end of year
    • Public offering completed for total gross proceeds of $69.1 million

    Conference call and webcast today at 4:30 p.m. ET

    SAN DIEGO, Nov. 04, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today reported financial results for the quarter ended September 30, 2020 and provided an update on its product pipeline and corporate…

    • Enrollment completed in Phase 3 clinical trial of OTIVIDEX® in Ménière's disease with results expected in the first quarter of 2021

    • Positive results reported for Phase 1/2 clinical trial of OTO-313 in tinnitus patients
    • Enrollment completed in Phase 1/2 clinical trial of OTO-413 in hearing loss with results expected by end of year
    • Public offering completed for total gross proceeds of $69.1 million

    Conference call and webcast today at 4:30 p.m. ET

    SAN DIEGO, Nov. 04, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today reported financial results for the quarter ended September 30, 2020 and provided an update on its product pipeline and corporate activities. The company will host a conference call and webcast today at 4:30 p.m. ET to discuss recent highlights and financial results.

    "We have continued to successfully execute our business plan by completing patient enrollment in the OTIVIDEX Phase 3 trial in Ménière's disease and the OTO-413 Phase 1/2 trial in hearing loss, as well as announcing positive results from the OTO-313 Phase 1/2 trial in tinnitus. Completion of enrollment keeps us on track for announcing the hearing loss trial results by end of year and results for our Phase 3 Ménière's trial in the first quarter," said David A. Weber, Ph.D., president and CEO of Otonomy. "I am also pleased with the progress we are making in our preclinical programs that extend our efforts across additional hearing loss pathologies and patient populations. When combined with our clinical-stage programs, we have the broadest pipeline in the neurotology field. And thanks to the over-subscribed financing we completed in the third quarter, we are well-capitalized to advance our pipeline through upcoming milestones."

    Otonomy Program Updates

    • OTIVIDEX Phase 3 clinical trial in Ménière's disease: patient enrollment completed at the beginning of October with results expected in the first quarter of 2021. This trial enrolled a total of 149 patients from the United States and Europe, exceeding the target of 142 patients. After randomization to treatment with a single intratympanic injection of OTIVIDEX or placebo, patients are followed for three months. In July 2020, Otonomy provided an update on the statistical analysis plan for the ongoing trial. In response to questions received from the U.S. Food and Drug Administration (FDA), Otonomy submitted a revised plan that uses the Negative Binomial model for primary analysis of the daily vertigo count data reported by patients. We believe that the Negative Binomial model provides the best fit of the OTIVIDEX clinical data based on the Phase 2b trial, the AVERTS-2 Phase 3 trial, and the integrated dataset from both trials. Assuming positive results in this additional Phase 3 trial, we plan to submit a New Drug Application to the FDA in the third quarter of 2021.



    • OTO-313: positive results reported from Phase 1/2 clinical trial in tinnitus. In July 2020, Otonomy reported positive top-line results from the Phase 1/2 trial of OTO-313 in patients with persistent tinnitus of at least moderate severity. Patients reported the severity of their tinnitus symptoms using the Tinnitus Functional Index (TFI), a clinically-validated instrument, and by daily reporting of their tinnitus loudness and annoyance. The trial achieved its objectives by demonstrating a positive clinical signal for a single intratympanic injection of OTO-313 using a TFI responder analysis, with a favorable safety profile. In particular, 43% of OTO-313 patients were responders on the TFI at both Day 29 and Day 57 compared to 13% of placebo patients (p-value < 0.05). Furthermore, OTO-313 patients who were TFI responders also reported improvements in tinnitus loudness and annoyance levels using daily diaries and improvement in the Patient Global Impression of Change (PGIC). Based on these results, Otonomy has submitted a Type C meeting request to review aspects of the Phase 2 clinical plan with the FDA.



    • OTO-413 Phase 1/2 clinical trial in hearing loss: patient enrollment completed with results expected by end of year. This ascending single dose safety and exploratory efficacy study for OTO-413, a sustained exposure formulation of brain-derived neurotrophic factor (BDNF), enrolled a total of 39 patients including 15 patients in the high dose cohort. Patients were randomized 3:1 for a single intratympanic injection of OTO-413 or placebo and then followed for 3 months. All patients have a speech-in-noise hearing deficit measured at baseline and can have normal up to moderately-severe hearing loss by conventional testing. In this first clinical evaluation of BDNF delivered via intratympanic injection, the primary objective is the assessment of safety and tolerability with multiple assessments of hearing function also conducted at baseline and during follow-up to evaluate signs of clinical activity. The Company expects to announce top-line results from this trial by end of year.



    • GJB2 gene therapy program: product candidate selected. Otonomy and Applied Genetic Technologies Corporation (AGTC) are collaborating to co-develop and co-commercialize an AAV-based gene therapy to restore hearing in patients with hearing loss caused by a mutation in the gap junction beta-2 (GJB2) gene -- the most common cause of congenital hearing loss. Preclinical results presented at conferences earlier this year demonstrated that a gene of interest can be expressed in support cells of the cochlea, which are the relevant target cells for treating GJB2 deficiency, using novel and proprietary AAV capsids. Also, consistent gene expression was observed for at least 12 weeks following a single local administration. These results supported selection of the product candidate for further development.



    • OTO-510 otoprotection program: preclinical development ongoing for novel and proprietary molecule. Cisplatin is a potent chemotherapeutic agent that is widely used to treat a variety of cancers in adults and children, however, it is commonly associated with severe adverse effects including cisplatin-induced hearing loss (CIHL). Otonomy has identified a novel series of molecules with improved otoprotectant activity in preclinical CIHL studies compared to other agents in development. Preclinical development continues for a small molecule from this class formulated to provide sustained exposure from a single intratympanic injection.



    • OTO-6XX program for severe hearing loss: exclusive license completed for novel compound. In July 2020, Otonomy entered into an exclusive license agreement with KYORIN Pharmaceutical Co., Ltd. (Kyorin) that provides Otonomy with exclusive worldwide rights to develop, manufacture and commercialize a novel compound for the treatment of sensorineural hearing loss. Under the terms of the agreement, Otonomy made an upfront payment to Kyorin and will make success-based milestone payments and pay a royalty on worldwide net sales. Otonomy is formulating the patent-protected compound utilizing the company's proprietary technology to provide sustained drug exposure in the inner ear following a single local administration. The OTO-6XX program is targeting hair cell regeneration for the treatment of severe hearing loss.



    • OTIPRIO®: co-promotion partnership initiated and expanded with ALK-Abelló, Inc. (ALK). In June 2020, Otonomy entered a co-promotion agreement that provided ALK with an exclusive right to promote OTIPRIO for acute otitis externa (AOE) to office-based health care professionals in the United States including ear, nose and throat (ENT) physicians, pediatricians and primary care physicians. In October 2020, this agreement was expanded to enable ALK to also promote OTIPRIO for its second FDA-approved indication, use during ear tube surgery, in all provider facilities including hospitals and ambulatory surgery centers. During the multi-year agreement, Otonomy will receive co-promotion fees and reimbursement of a proportion of product support costs while also retaining a share of adjusted gross profits from the sale of OTIPRIO.



    Third Quarter Financial Highlights

    • Cash Position: Cash, cash equivalents, and short-term investments totaled $94.5 million as of September 30, 2020, compared to $60.7 million as of December 31, 2019. In July 2020, Otonomy completed an underwritten public offering of 17,275,000 shares of its common stock, which includes the underwriters' full exercise of their option to purchase additional shares, and the Company sold pre-funded warrants to purchase up to 4,000,000 shares of its common stock, for total gross proceeds of approximately $69.1 million, before deducting underwriting discounts and commissions and other offering expenses payable by Otonomy. All of the securities were sold by Otonomy.



    • Long-term Debt: Otonomy obtained a $15.0 million term loan from Oxford Finance LLC in December 2018. In July 2020, the terms of the loan were amended to extend the interest-only repayment period from 24 months to 36 months, followed by 23 months of amortization.



    • Operating Expenses: GAAP operating expenses were $10.4 million for the third quarter of 2020, compared to $10.0 million for the third quarter of 2019. Non-GAAP operating expenses, which exclude stock-based compensation, were $8.8 million for the third quarter of 2020, compared to $8.3 million for the third quarter of 2019.



    • Research and Development Expenses: GAAP research and development (R&D) expenses for the third quarter of 2020 were $7.0 million, compared to $8.1 million for the third quarter of 2019. The decrease for the quarter was primarily due to reduced third-party development costs that were partially offset by increased compensation expense.



    • Selling, General and Administrative Expenses: GAAP selling, general and administrative (SG&A) expenses in the third quarter of 2020 were $3.4 million, compared to $1.9 million for the third quarter of 2019. The increase this quarter was primarily the result of discontinued cost reimbursement received from OTIPRIO co-promotion partners.



    • Financial Update and Guidance:

      °  2020 Operating Expenses: Otonomy continues to expect that non-GAAP operating expenses will be in the range of $35-$38 million, and GAAP operating expenses will be in the range of $45-$48 million.

      °  Cash Runway: Otonomy expects that its current cash, cash equivalents, and short-term investments will be sufficient to fund the company's operations for at least two years.

    Webcast and Conference Call

    Otonomy management will host a webcast and conference call regarding these program updates at 4:30 p.m. ET / 1:30 p.m. PT today. The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 5179918. A live webcast of the call will be available online in the investor relations section of Otonomy's website at www.otonomy.com and will be archived there for 30 days.

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, statements relating to the potential benefits, development activity and advancement of clinical trials; statements relating to the timing of results, activity for, and conduct of, ongoing clinical trials; statements relating to the updated statistical analysis plan for the ongoing Phase 3 clinical trial of OTIVIDEX and expectations regarding the Negative Binomial model; statements regarding plans to submit a New Drug Application for OTIVIDEX; the potential benefits and opportunities of, and activities under the collaboration agreement between Otonomy and AGTC, the co-promotion agreement between Otonomy and ALK, and the license agreement between Otonomy and Kyorin; expectations regarding preclinical programs, including the potential benefits and development activities; expectations regarding operating expenses for 2020, cash runway, and Otonomy's ability to advance its pipeline; and statements by Otonomy's president and CEO. Otonomy's 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: delays and disruption resulting from the COVID-19 pandemic and governmental and site responses to the pandemic, including current and future impacts to Otonomy's operations, the manufacturing of its product candidates, the progression of its current clinical trials, and patient conduct and compliance; Otonomy's ability to accurately forecast financial results; Otonomy's ability to obtain additional financing; Otonomy's dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment, conduct and compliance in clinical trials; the integrity of patient-reported outcomes in its current and future clinical trials; the risks of the occurrence of any event, change or other circumstance that could give rise to the termination of the collaboration agreement between Otonomy and AGTC, the co-promotion agreement between Otonomy and ALK, or the license agreement between Otonomy and Kyorin, or that could impact Otonomy's ability to repay or comply with the terms of the loan provided by Oxford Finance LLC; side effects or adverse events associated with Otonomy's product candidates; Otonomy's ability to successfully commercialize its product candidates, if approved; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials, and for the manufacture of its product candidates; Otonomy's ability to protect its intellectual property in the United States and throughout the world and to ensure compliance with various laws and regulations in countries in which it conducts clinical trials; expectations regarding potential therapy benefits, market size, opportunity and growth; Otonomy's ability to manage operating expenses; implementation of Otonomy's business model and strategic plans for its business, products and technology; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 4, 2020, and Otonomy's 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

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932





    Otonomy, Inc.
    Condensed Balance Sheet Data
    (in thousands)
        
     As of September 30, As of December 31,
     2020 2019
     (unaudited)  
    Cash and cash equivalents$54,235  $25,194 
        
    Short-term investments 40,250   35,476 
        
    Right-of-use assets 14,434   15,465 
        
    Total assets 115,312   83,018 
        
    Long-term debt, net 15,114   14,967 
        
    Leases, net of current 14,229   15,320 
        
    Total liabilities 40,187   42,785 
        
    Accumulated deficit (493,977)  (459,893)
        
    Total stockholders' equity 75,125   40,233 
        



    Otonomy, Inc.
    Condensed Statements of Operations
    (in thousands, except share and per share data)
            
     Three Months Ended Nine Months Ended
     September 30, September 30,
     2020 2019 2020 2019
      
     (unaudited)
    Product sales, net$50  $125  $220  $507 
    Costs and operating expenses:       
    Cost of product sales 189   220   914   636 
    Research and development 7,016   8,057   21,623   25,771 
    Selling, general and administrative 3,363   1,903   10,883   8,065 
    Total costs and operating expenses 10,568   10,180   33,420   34,472 
    Loss from operations (10,518)  (10,055)  (33,200)  (33,965)
            
    Other (expense) income, net (349)  16   (884)  215 
    Net loss$(10,867) $(10,039) $(34,084) $(33,750)
            
    Net loss per share, basic and diluted$(0.22) $(0.33) $(0.92) $(1.10)
            
    Weighted-average shares used to compute net loss per share, basic and diluted 49,220,921   30,748,995   37,014,253   30,712,839 
            



    Otonomy, Inc.
    Reconciliation of GAAP to Non-GAAP Operating Expenses
    (in thousands)
            
     Three Months Ended Nine Months Ended
     September 30, September 30,
     2020 2019 2020 2019
      
     (unaudited)
    GAAP operating expenses       
    Research and development$7,016  $8,057  $21,623  $25,771 
    Selling, general and administrative 3,363   1,903   10,883   8,065 
    Total GAAP operating expenses 10,379   9,960   32,506   33,836 
    Non-GAAP adjustments       
    R&D stock-based compensation expense (628)  (1,037)  (1,824)  (2,268)
    SG&A stock-based compensation expense (945)  (651)  (2,692)  (2,165)
    Total non-GAAP adjustments (1,573)  (1,688)  (4,516)  (4,433)
    Non-GAAP operating expenses$8,806  $8,272  $27,990  $29,403 
            



    Otonomy, Inc.
    Reconciliation of 2020 GAAP to Non-GAAP Operating Expense Guidance
    (in millions)
      
      
    GAAP operating expenses$45 - $48
    Non-GAAP adjustments 
    Stock-based compensation expense$10
    Non-GAAP operating expenses$35 - $38

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  6. SAN DIEGO, Oct. 28, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced it will report financial results for the third quarter of 2020 and provide a corporate update at 4:30 p.m. ET on November 4, 2020.

    The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 5179918. A live webcast of the call will be available online in the investor relations section of Otonomy's website at www.otonomy.com and will be archived there for 30 days.

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative…

    SAN DIEGO, Oct. 28, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced it will report financial results for the third quarter of 2020 and provide a corporate update at 4:30 p.m. ET on November 4, 2020.

    The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 5179918. A live webcast of the call will be available online in the investor relations section of Otonomy's website at www.otonomy.com and will be archived there for 30 days.

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and tinnitus. For additional information please visit www.otonomy.com.

    Contacts:

    Media Inquiries:

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries:

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932

    Primary Logo

    View Full Article Hide Full Article
  7. SAN DIEGO, Oct. 02, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced the completion of patient enrollment in the Phase 3 clinical trial of OTIVIDEX in Ménière's disease. A total of 149 patients have been enrolled in the trial, exceeding the target of 142 patients. Following randomization to treatment with a single intratympanic injection of OTIVIDEX or placebo, patients are followed for three months.

    "Completion of enrollment is an important milestone for the OTIVIDEX program and keeps us on track for announcing results in the first quarter of 2021. With positive results from this trial and the positive AVERTS-2 trial…

    SAN DIEGO, Oct. 02, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced the completion of patient enrollment in the Phase 3 clinical trial of OTIVIDEX in Ménière's disease. A total of 149 patients have been enrolled in the trial, exceeding the target of 142 patients. Following randomization to treatment with a single intratympanic injection of OTIVIDEX or placebo, patients are followed for three months.

    "Completion of enrollment is an important milestone for the OTIVIDEX program and keeps us on track for announcing results in the first quarter of 2021. With positive results from this trial and the positive AVERTS-2 trial results already in-hand, we would expect to submit a New Drug Application in the third quarter of 2021," said David A. Weber, Ph.D., president and CEO of Otonomy. "We are grateful to the patients and investigators participating in this trial. We also appreciate the high compliance that continues to be demonstrated by patients in reporting their daily vertigo episodes, which we believe reflects the high disease burden and unmet medical need of Ménière's disease patients."

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to statements relating to the timing and announcement of results and conduct of, and activity for the ongoing Phase 3 clinical trial of OTIVIDEX in Ménière's disease; expectations regarding submission of a New Drug Application; and statements by Otonomy's president and CEO. Otonomy's 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: delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic, including current and future impacts to Otonomy's operations, the manufacturing of its product candidates, the progression of its current clinical trials, and patient conduct and compliance; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, and challenges related to patient enrollment, conduct and compliance in clinical trials; the integrity of patient-reported outcomes in clinical trials; side effects or adverse events associated with Otonomy's product candidates; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials; expectations regarding potential therapy benefits; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on August 4, 2020, and Otonomy's 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

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932

    Primary Logo

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  8. SAN DIEGO, Sept. 02, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that management is scheduled to participate in four upcoming virtual investor conferences.

    • Citi's 15th Annual BioPharma Virtual Conference on September 9-10, 2020: 1 on 1 investor meetings.
       
    • H.C. Wainwright 22nd Annual Global Investment Conference: presentation on September 14, 2020 at 12 p.m. ET (9 a.m. PT).
       
    • Cantor Virtual Global Healthcare Conference: presentation on September 16, 2020 at 9:20 a.m. ET (6:20 a.m. PT).
       
    • Oppenheimer Fall Healthcare Life Sciences & MedTech Summit: presentation on September 23, 2020 at 10 a.m. ET (7 a.m. PT).

    A live audio…

    SAN DIEGO, Sept. 02, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that management is scheduled to participate in four upcoming virtual investor conferences.

    • Citi's 15th Annual BioPharma Virtual Conference on September 9-10, 2020: 1 on 1 investor meetings.

       
    • H.C. Wainwright 22nd Annual Global Investment Conference: presentation on September 14, 2020 at 12 p.m. ET (9 a.m. PT).

       
    • Cantor Virtual Global Healthcare Conference: presentation on September 16, 2020 at 9:20 a.m. ET (6:20 a.m. PT).

       
    • Oppenheimer Fall Healthcare Life Sciences & MedTech Summit: presentation on September 23, 2020 at 10 a.m. ET (7 a.m. PT).

    A live audio webcast of the presentations will be available through the Events page of the company's website (www.otonomy.com). 

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and tinnitus. For additional information please visit www.otonomy.com.

    Contacts:

    Media Inquiries:

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries:

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932

    Primary Logo

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    • Positive top-line results reported for Phase 1/2 trial of OTO-313 in tinnitus patients
    • Public offering completed for total gross proceeds of $69.1 million
    • Results from Phase 3 trial of OTIVIDEX® in Ménière's disease expected in first quarter of 2021
    • Results from Phase 1/2 trial of OTO-413 in hearing loss expected in fourth quarter of 2020

    Conference call and webcast today at 5 p.m. ET

    SAN DIEGO, Aug. 04, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today reported financial results for the quarter ended June 30, 2020 and provided an update on its product pipeline and corporate activities. The company will host a conference call and webcast…

    • Positive top-line results reported for Phase 1/2 trial of OTO-313 in tinnitus patients

    • Public offering completed for total gross proceeds of $69.1 million
    • Results from Phase 3 trial of OTIVIDEX® in Ménière's disease expected in first quarter of 2021
    • Results from Phase 1/2 trial of OTO-413 in hearing loss expected in fourth quarter of 2020

    Conference call and webcast today at 5 p.m. ET

    SAN DIEGO, Aug. 04, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today reported financial results for the quarter ended June 30, 2020 and provided an update on its product pipeline and corporate activities. The company will host a conference call and webcast today at 5 p.m. ET to discuss recent highlights and financial results.

    "We have made great strides in advancing our product pipeline and achieving our corporate objectives during the past several months despite the challenges presented by the COVID-19 pandemic," said David A. Weber, Ph.D., president and CEO of Otonomy. "For our clinical programs, we announced positive results for OTO-313 in tinnitus, continued to progress enrollment of our ongoing OTIVIDEX Phase 3 trial in Ménière's disease while strengthening its statistical analysis plan, and have nearly completed enrollment of the OTO-413 trial in hearing loss. We also selected a product candidate for our GJB2 gene therapy program, licensed a novel compound for our OTO-6XX hair cell regeneration program, and demonstrated preclinical proof-of-concept for our otoprotection program. To support this broad and rich pipeline, we completed an oversubscribed financing that extends our cash runway and bolsters our shareholder base."

    Otonomy Program Updates

    • OTO-313: positive top-line results reported from Phase 1/2 clinical trial in tinnitus. In July 2020, Otonomy reported positive top-line results from the Phase 1/2 trial of OTO-313 in patients with persistent tinnitus of at least moderate severity. The exploratory efficacy cohort of the trial included 31 evaluable patients randomized to a single intratympanic injection of OTO-313 or placebo (1:1 randomization) and then followed for eight weeks. Patients reported the severity of their tinnitus symptoms using the Tinnitus Functional Index (TFI), a clinically-validated instrument, and by the daily reporting of their tinnitus loudness and annoyance. The trial achieved its objectives by demonstrating a positive clinical signal for OTO-313 based on a TFI responder analysis, with a favorable safety profile. In particular, 43% of OTO-313 patients were responders based on the TFI at both Day 29 and Day 57 compared to 13% of placebo patients (p-value < 0.05). Furthermore, OTO-313 patients who were TFI responders on both Day 29 and Day 57 also reported improvements in tinnitus loudness and annoyance levels based on daily diaries and reported improvement in the Patient Global Impression of Change (PGIC), a general assessment of tinnitus status. Given these results, Otonomy is advancing OTO-313 into full Phase 2 development which may include evaluation of a higher dose and/or retreatment.

       
    • OTIVIDEX Phase 3 clinical trial in Ménière's disease: patient enrollment is ongoing with results expected in the first quarter of 2021. This trial is being conducted at approximately 60 trial sites dispersed across different regions of the United States and multiple countries in Europe. In July 2020, Otonomy provided an update on the statistical analysis plan for the ongoing trial. In response to questions received from the U.S. Food and Drug Administration (FDA), Otonomy submitted a revised plan that uses the Negative Binomial model for primary analysis of the daily vertigo count data reported by patients. We believe that the Negative Binomial model provides the best fit of the OTIVIDEX clinical data based on the Phase 2b trial, AVERTS-2 Phase 3 trial, and integrated dataset from both trials. The Negative Binomial model also provides increased power to detect a treatment benefit enabling us to reduce the target enrollment to 142 patients while maintaining more than 90% power. We expect to complete patient enrollment during the third quarter of 2020 and announce results in the first quarter of 2021.

       
    • OTO-413 Phase 1/2 clinical trial in hearing loss: patient enrollment is ongoing with results expected in the fourth quarter of 2020. This is an ascending single dose safety and exploratory efficacy study for OTO-413, a sustained exposure formulation of brain-derived neurotrophic factor (BDNF). We have successfully escalated through three dose levels totaling 24 patients and have nearly completed enrollment of patients in the high dose cohort. We expect to enroll approximately 16 patients in this cohort, randomized 3:1 for a single intratympanic injection of OTO-413 or placebo. Patients enrolled in this trial have a speech-in-noise hearing deficit measured at baseline and can have normal up to moderately-severe hearing loss by conventional testing. Following treatment, patients undergo repeated testing for safety and exploratory efficacy over 3 months. We expect to announce results from this trial in the fourth quarter of 2020.

       
    • GJB2 gene therapy program: preclinical results support selection of product candidate. Otonomy and Applied Genetic Technologies Corporation (AGTC) are collaborating to co-develop and co-commercialize an AAV-based gene therapy to restore hearing in patients with hearing loss caused by a mutation in the gap junction beta-2 (GJB2) gene -- the most common cause of congenital hearing loss. Preclinical results presented at the American Society of Gene & Cell Therapy (ASGCT) meeting in May 2020 demonstrated that a gene of interest can be expressed in support cells of the cochlea, which are the relevant target cells for treating GJB2 deficiency, using novel and proprietary AAV capsids. Also, consistent gene expression was observed for at least 12 weeks following a single local administration. These results supported selection of the product candidate for further development.

       
    • OTO-510: preclinical data presented for a novel and proprietary class of otoprotectant agents. Cisplatin is a potent chemotherapeutic agent that is widely used to treat a variety of cancers in adults and children, however, it is commonly associated with severe adverse effects including cisplatin-induced hearing loss (CIHL). Otonomy has presented preclinical results demonstrating varying degrees of otoprotection against CIHL for several classes of therapeutic agents. In particular, a novel class of agents that potently binds to cisplatin demonstrated greater otoprotection than anti-oxidant and anti-apoptotic molecules, and increased potency relative to other molecules currently in development.

       
    • OTO-6XX: exclusive license completed for novel hearing loss compound. In July 2020, Otonomy entered into an exclusive license agreement with KYORIN Pharmaceutical Co., Ltd. ("Kyorin") that provides Otonomy with exclusive worldwide rights to develop, manufacture and commercialize a novel compound for the treatment of sensorineural hearing loss. Under the terms of the agreement, Otonomy will make an upfront payment to Kyorin as well as success-based milestone payments and pay a royalty on worldwide net sales. Otonomy is formulating the patent-protected compound utilizing the company's proprietary technology to provide sustained drug exposure in the inner ear following a single local administration. The OTO-6XX program is targeting hair cell regeneration for the treatment of severe hearing loss.

       
    • OTIPRIO®: co-promotion partnership initiated with ALK-Abelló, Inc. (ALK). In June 2020, Otonomy entered a co-promotion agreement that provides ALK with an exclusive right to promote OTIPRIO for acute otitis externa (AOE) to office-based health care professionals in the United States including ear, nose and throat (ENT) physicians, pediatricians and primary care physicians. During the multi-year agreement, Otonomy will receive co-promotion fees and reimbursement of a proportion of product support costs while also retaining a share of adjusted gross profits from the sale of OTIPRIO for use in AOE.

    Second Quarter Financial Highlights

    • Cash Position: Cash, cash equivalents, and short-term investments totaled $41.1 million as of June 30, 2020, compared to $60.7 million as of December 31, 2019. In July 2020, Otonomy completed an underwritten public offering of 17,275,000 shares of its common stock, which includes the underwriters' full exercise of their option to purchase additional shares and pre-funded warrants to purchase up to 4,000,000 shares of its common stock, for total gross proceeds of approximately $69.1 million, before deducting underwriting discounts and commissions and other offering expenses payable by Otonomy. All of the securities were sold by Otonomy.

       
    • Long-term Debt: Otonomy obtained a $15 million term loan from Oxford Finance LLC in December 2018. In July 2020, the terms of the loan were amended to extend the interest-only repayment period from 24 months to 36 months, followed by 23 months of amortization.

       
    • Operating Expenses: GAAP operating expenses were $10.6 million for the second quarter of 2020, compared to $11.8 million for the second quarter of 2019. Non-GAAP operating expenses, which exclude stock-based compensation, were $9.1 million for the second quarter of 2020, compared to $10.6 million for the second quarter of 2019.

       
    • Research and Development Expenses: GAAP research and development (R&D) expenses for the second quarter of 2020 were $6.9 million, compared to $8.9 million for the second quarter of 2019. The decrease for the quarter was primarily due to reduced third-party development costs that were partially offset by increased compensation expense.

       
    • Selling, General and Administrative Expenses: GAAP selling, general and administrative (SG&A) expenses in the second quarter of 2020 were $3.7 million, compared to $2.9 million for the second quarter of 2019. The increase this quarter was primarily the result of discontinued cost reimbursement received from OTIPRIO co-promotion partners.

       
    • Financial Update and Guidance:

      -  2020 Operating Expenses: Otonomy continues to expect that non-GAAP operating expenses will be in the range of $35-$38 million, and GAAP operating expenses will be in the range of $45-$48 million.

      -  Cash Runway: Otonomy expects that its current cash, cash equivalents, and short-term investments will be sufficient to fund the company's operations for at least two years.

    Webcast and Conference Call

    Otonomy management will host a webcast and conference call regarding these program updates at 5 p.m. ET / 2 p.m. PT today. The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 3489668. A live webcast of the call will be available online in the investor relations section of Otonomy's website at www.otonomy.com and will be archived there for 30 days.

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, statements relating to the potential benefits, development activity and advancement of clinical trials; statements relating to the timing of results, patient enrollment activity for, and conduct of, ongoing clinical trials; statements relating to the updated statistical analysis plan for the ongoing Phase 3 clinical trial of OTIVIDEX; expectations regarding the Negative Binomial model; the potential benefits and opportunities of, and activities under the collaboration agreement between Otonomy and AGTC, the co-promotion agreement between Otonomy and ALK, and the license agreement between Otonomy and Kyorin; expectations regarding preclinical programs, including the potential benefits and development activities; expectations regarding operating expenses for 2020 and cash runway; and statements by Otonomy's president and CEO. Otonomy's 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: delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic, including current and future impacts to Otonomy's operations, the manufacturing of its product candidates, the progression of its current clinical trials, enrollment in its current and future clinical trials and patient conduct and compliance; Otonomy's ability to accurately forecast financial results; Otonomy's ability to obtain additional financing; Otonomy's dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; the integrity of patient-reported outcomes in its current and future clinical trials; the risks of the occurrence of any event, change or other circumstance that could give rise to the termination of the collaboration agreement between Otonomy and AGTC, the co-promotion agreement between Otonomy and ALK, or the license agreement between Otonomy and Kyorin, or that could impact Otonomy's ability to repay or comply with the terms of the loan provided by Oxford Finance LLC; side effects or adverse events associated with Otonomy's product candidates; Otonomy's ability to successfully commercialize its product candidates, if approved; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials, and for the manufacture of its product candidates; Otonomy's ability to protect its intellectual property in the United States and throughout the world and to ensure compliance with various laws and regulations in countries in which it conducts clinical trials; expectations regarding potential therapy benefits, market size, opportunity and growth; Otonomy's ability to manage operating expenses; implementation of Otonomy's business model and strategic plans for its business, products and technology; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on August 4, 2020, and Otonomy's 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

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932

     
    Otonomy, Inc.
    Condensed Balance Sheet Data
    (in thousands)
        
     As of June 30, As of December 31,
      2020   2019 
     (unaudited)  
    Cash and cash equivalents$32,045  $25,194 
        
    Short-term investments 9,021   35,476 
        
    Right-of-use assets 14,787   15,465 
        
    Total assets 61,228   83,018 
        
    Long-term debt, net 15,069   14,967 
        
    Leases, net of current 14,594   15,320 
        
    Total liabilities 40,979   42,785 
        
    Accumulated deficit (483,110)  (459,893)
        
    Total stockholders' equity 20,249   40,233 
        



    Otonomy, Inc.
    Condensed Statements of Operations
    (in thousands, except share and per share data)
            
     Three Months Ended Six Months Ended
     June 30, June 30,
      2020   2019   2020   2019 
            
     (unaudited)
    Product sales, net$10  $190  $170  $382 
    Costs and operating expenses:       
    Cost of product sales 511   203   725   416 
    Research and development 6,935   8,919   14,607   17,714 
    Selling, general and administrative 3,684   2,884   7,520   6,162 
    Total costs and operating expenses 11,130   12,006   22,852   24,292 
    Loss from operations (11,120)  (11,816)  (22,682)  (23,910)
            
    Other (expense) income, net (334)  89   (535)  199 
    Net loss$(11,454) $(11,727) $(23,217) $(23,711)
            
    Net loss per share, basic and diluted$(0.37) $(0.38) $(0.75) $(0.77)
            
    Weighted-average shares used to compute net loss per share,       
    basic and diluted 30,873,488   30,703,411   30,843,850   30,694,461 
            



    Otonomy, Inc.
    Reconciliation of GAAP to Non-GAAP Operating Expenses
    (in thousands)
            
     Three Months Ended Six Months Ended
     June 30, June 30,
      2020   2019   2020   2019 
                    
     (unaudited)
    GAAP operating expenses       
    Research and development$6,935  $8,919  $14,607  $17,714 
    Selling, general and administrative 3,684   2,884   7,520   6,162 
    Total GAAP operating expenses 10,619   11,803   22,127   23,876 
    Non-GAAP adjustments       
    R&D stock-based compensation expense (628)  (572)  (1,196)  (1,231)
    SG&A stock-based compensation expense (906)  (680)  (1,747)  (1,514)
    Total non-GAAP adjustments (1,534)  (1,252)  (2,943)  (2,745)
    Non-GAAP operating expenses$9,085  $10,551  $19,184  $21,131 



    Otonomy, Inc.
    Reconciliation of 2020 GAAP to Non-GAAP Operating Expense Guidance
    (in millions)
      
      
    GAAP operating expenses $45 - $48
    Non-GAAP adjustments 
    Stock-based compensation expense$10
    Non-GAAP operating expenses $35 - $38
      

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  9. SAN DIEGO, Aug. 03, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced an exclusive license agreement with KYORIN Pharmaceutical Co., Ltd. ("Kyorin") that provides Otonomy with exclusive worldwide rights to develop, manufacture and commercialize a novel compound for the treatment of sensorineural hearing loss. Under the terms of the agreement, Otonomy will make an upfront payment to Kyorin as well as success-based milestone payments and royalties on worldwide net sales of a product containing the patent-protected compound. Otonomy is formulating the compound utilizing the company's proprietary technology to provide sustained…

    SAN DIEGO, Aug. 03, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced an exclusive license agreement with KYORIN Pharmaceutical Co., Ltd. ("Kyorin") that provides Otonomy with exclusive worldwide rights to develop, manufacture and commercialize a novel compound for the treatment of sensorineural hearing loss. Under the terms of the agreement, Otonomy will make an upfront payment to Kyorin as well as success-based milestone payments and royalties on worldwide net sales of a product containing the patent-protected compound. Otonomy is formulating the compound utilizing the company's proprietary technology to provide sustained drug exposure in the inner ear following a single local administration.

    "We are pleased to complete this license agreement that stems from a successful research collaboration with Kyorin focused on identifying a novel treatment for hearing loss," said David A. Weber, Ph.D., president and CEO of Otonomy. "We have demonstrated that this compound is active in preclinical models of cochlear hair cell regeneration, and has potential for the treatment of severe hearing loss. The OTO-6XX hair cell regeneration program is complementary to our OTO-413 hearing loss program that repairs damaged connections between hair cells and auditory nerve fibers, giving us the opportunity to address a broad population of hearing loss patients. We look forward to advancing the OTO-6XX program while also working to complete the ongoing Phase 1/2 trial of OTO-413 in patients with speech-in-noise hearing difficulty, with results from this trial expected in the fourth quarter of 2020."

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, expectations regarding the potential benefits and opportunities of, and activities under the license agreement between Kyorin and Otonomy;  expectations regarding preclinical programs, including potential benefits, development activity,  and advancement; expectations regarding potential benefits of, and timing of results for ongoing clinical trials; and statements by Otonomy's president and CEO. Otonomy's 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: delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic, including current and future impacts to Otonomy's operations, the manufacturing of its product candidates, the progression of its current clinical trials, enrollment in its current and future clinical trials and patient conduct and compliance; the risks of the occurrence of any event, change or other circumstance that could give rise to the termination of the license agreement between Kyorin and Otonomy; Otonomy's ability to obtain additional financing; Otonomy's dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; side effects or adverse events associated with Otonomy's product candidates; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials; expectations regarding potential therapy benefits; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" attached as Exhibit 99.2 to Otonomy's 8-K filed with the Securities and Exchange Commission (the "SEC") on July 9, 2020, and Otonomy's 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

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932

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  10. SAN DIEGO, July 28, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced it will report financial results for the second quarter of 2020 and provide a corporate update at 5 p.m. EDT on August 4, 2020.

    The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 3489668. A live webcast of the call will be available online in the investor relations section of Otonomy's website at www.otonomy.com and will be archived there for 30 days.

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics…

    SAN DIEGO, July 28, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced it will report financial results for the second quarter of 2020 and provide a corporate update at 5 p.m. EDT on August 4, 2020.

    The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 3489668. A live webcast of the call will be available online in the investor relations section of Otonomy's website at www.otonomy.com and will be archived there for 30 days.

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and tinnitus. For additional information please visit www.otonomy.com.

    Contacts:

    Media Inquiries:

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries:

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932

    ro

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  11. SAN DIEGO, July 13, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced the closing of its previously announced underwritten public offering of 17,275,000 shares of its common stock, which includes the underwriters' full exercise of their option to purchase additional shares and pre-funded warrants to purchase up to 4,000,000 shares of its common stock, for total gross proceeds of approximately $69.1 million, before deducting the underwriting discounts and commissions and other offering expenses payable by Otonomy. All of the securities were sold by Otonomy.

    Cowen and Piper Sandler acted as active joint book-running managers…

    SAN DIEGO, July 13, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced the closing of its previously announced underwritten public offering of 17,275,000 shares of its common stock, which includes the underwriters' full exercise of their option to purchase additional shares and pre-funded warrants to purchase up to 4,000,000 shares of its common stock, for total gross proceeds of approximately $69.1 million, before deducting the underwriting discounts and commissions and other offering expenses payable by Otonomy. All of the securities were sold by Otonomy.

    Cowen and Piper Sandler acted as active joint book-running managers for the offering. Cantor Fitzgerald & Co. acted as bookrunner and H.C. Wainwright & Co. acted as lead manager for the offering.

    A shelf registration statement (File No. 333-227269) was previously filed with the Securities and Exchange Commission (SEC) on September 10, 2018 and became effective on September 21, 2018. The final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting one of the following: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at ; or Piper Sandler & Co., by mail at 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attn: Prospectus Department, or by telephone at  (800) 747-3924, or by email at .  

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

    Contacts:

    Media Inquiries

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    408.865.3601

    Investor Inquiries

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932

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  12. SAN DIEGO, July 09, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced the pricing of an underwritten public offering of 14,500,000 shares of its common stock at a price to the public of $3.25 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase up to an aggregate of 4,000,000 shares of its common stock at a purchase price of $3.249 per each pre-funded warrant, which represents the per share public offering price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant. The aggregate gross proceeds from this offering are expected to be approximately…

    SAN DIEGO, July 09, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced the pricing of an underwritten public offering of 14,500,000 shares of its common stock at a price to the public of $3.25 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase up to an aggregate of 4,000,000 shares of its common stock at a purchase price of $3.249 per each pre-funded warrant, which represents the per share public offering price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant. The aggregate gross proceeds from this offering are expected to be approximately $60.1 million, before deducting underwriting discounts and commissions and other offering expenses payable by Otonomy. In addition, Otonomy has granted the underwriters a 30-day option to purchase up to an additional 2,775,000 shares of its common stock in connection with the public offering at the public offering price per share, less underwriting discounts and commissions.  All of the shares of common stock and pre-funded warrants are being sold by Otonomy. The offering is expected to close on or about July 13, 2020, subject to customary closing conditions. 

    Cowen and Piper Sandler are acting as joint book-running managers in the offering. Cantor Fitzgerald & Co. is acting as a bookrunner and H.C. Wainwright & Co. is acting as lead manager for this offering.

    A shelf registration statement (File No. 333-227269) was previously filed with the Securities and Exchange Commission (SEC) on September 10, 2018 and became effective on September 21, 2018. A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC on July 9, 2020. The final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to these securities may also be obtained by contacting one of the following: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at ; or Piper Sandler & Co., by mail at 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attn: Prospectus Department, or by telephone at  (800) 747-3924, or by email at .  

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the federal securities laws. These statements involve risks and uncertainties that could cause actual results to differ materially, including, but not limited to, whether or not Otonomy will be able to consummate the offering, the satisfaction of customary closing conditions, prevailing market conditions, the anticipated use of the proceeds of the offering which could change as a result of market conditions or for other reasons, and the impact of general economic, industry or political conditions in the United States or internationally. Additional risks and uncertainties relating to the offering, Otonomy and its business can be found under the heading "Risk Factors" in Otonomy's most recent current, quarterly and annual reports filed with the SEC and in the preliminary prospectus supplement and accompanying prospectus relating to the offering to be filed with the SEC.  Otonomy assumes no duty or obligation to update or revise any forward-looking statements for any reason.

    Contacts:

    Media Inquiries

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    408.865.3601

    Investor Inquiries

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932

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  13. SAN DIEGO, July 08, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that it has commenced an underwritten public offering of its common stock. All shares of common stock to be sold in the offering will be offered by Otonomy and, in lieu of common stock, to offer and sell to certain investors pre-funded warrants to purchase shares of its common stock in an underwritten public offering. In addition, Otonomy expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in this public offering. The offering is subject to market and other conditions, and there can…

    SAN DIEGO, July 08, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that it has commenced an underwritten public offering of its common stock. All shares of common stock to be sold in the offering will be offered by Otonomy and, in lieu of common stock, to offer and sell to certain investors pre-funded warrants to purchase shares of its common stock in an underwritten public offering. In addition, Otonomy expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in this public offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    Cowen and Piper Sandler are acting as joint book-running managers in the offering. Cantor Fitzgerald & Co. is acting as a passive bookrunner.

    A shelf registration statement (File No. 333-227269) was previously filed with the Securities and Exchange Commission (SEC) on September 9, 2018 and became effective on September 21, 2018. A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may also be obtained by contacting one of the following: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at ; or Piper Sandler & Co., by mail at 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attn: Prospectus Department, or by telephone at  (800) 747-3924, or by email at . The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the federal securities laws, including, but not limited to, statements Otonomy makes regarding its intention to conduct an offering and sale of securities, the grant of the option to purchase additional shares and the ability to complete this offering. These statements involve risks and uncertainties that could cause actual results to differ materially, including, but not limited to, whether or not Otonomy will be able to raise capital through the sale of shares of common stock or consummate the offering, the final terms of the offering, the satisfaction of customary closing conditions, prevailing market conditions, the anticipated use of the proceeds of the offering which could change as a result of market conditions or for other reasons, and the impact of general economic, industry or political conditions in the United States or internationally. Additional risks and uncertainties relating to the offering, Otonomy and its business can be found under the heading "Risk Factors" in Otonomy's most recent current, quarterly and annual reports filed with the SEC and in the preliminary prospectus supplement and accompanying prospectus relating to the offering to be filed with the SEC. Otonomy assumes no duty or obligation to update or revise any forward-looking statements for any reason.

    Contacts:

    Media Inquiries

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    408.865.3601

    Investor Inquiries

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932

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    • OTO-313 demonstrated a higher proportion of responders than placebo
    • Given clear signal in this proof of concept study, Otonomy plans to advance OTO-313 to full Phase 2 development in tinnitus
    • OTO-313 was well-tolerated with lower incidence of adverse events than placebo group
    • Management will review results during conference call today at 4:30 p.m. ET

    SAN DIEGO, July 06, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced positive top-line results from the Phase 1/2 clinical trial of OTO-313 in patients with persistent tinnitus of at least moderate severity. The exploratory efficacy cohort of the trial included 31 evaluable patients…

    • OTO-313 demonstrated a higher proportion of responders than placebo

    • Given clear signal in this proof of concept study, Otonomy plans to advance OTO-313 to full Phase 2 development in tinnitus
    • OTO-313 was well-tolerated with lower incidence of adverse events than placebo group
    • Management will review results during conference call today at 4:30 p.m. ET

    SAN DIEGO, July 06, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced positive top-line results from the Phase 1/2 clinical trial of OTO-313 in patients with persistent tinnitus of at least moderate severity. The exploratory efficacy cohort of the trial included 31 evaluable patients randomized to a single intratympanic injection of OTO-313 or placebo (1:1 randomization) and then followed for eight weeks. Patients reported the severity of their tinnitus symptoms using the Tinnitus Functional Index (TFI), a clinically-validated instrument, and by the daily reporting of their tinnitus loudness and annoyance. The trial achieved its objectives by demonstrating a positive clinical signal for OTO-313 based on a TFI responder analysis, with a favorable safety profile. Given these results, Otonomy intends to advance OTO-313 into full Phase 2 development which may include evaluation of a higher dose and/or retreatment with OTO-313.

    Top-line results for the Phase 1/2 trial were as follows:

    • 43% of OTO-313 patients were responders at both Day 29 and Day 57 compared to 13% of placebo patients. A responder is a patient whose TFI score decreases by 13-points or more from their baseline score, a change considered clinically meaningful based on the TFI instrument validation.

       
    • For patients who were responders at both Day 29 and Day 57, OTO-313 demonstrated a higher responder rate than placebo at all TFI improvement levels considered clinically meaningful (TFI reduction ≥ 13, 15, 20, 25, and 30 points). The difference in responder rate between OTO-313 and placebo was statistically significant on post hoc analysis (p-value < 0.05) for TFI reductions ≥ 13, 15, and 20 points.

       
    • OTO-313 patients who were responders at both Day 29 and Day 57 reported improvements in both tinnitus loudness and annoyance levels based on daily diaries and also reported improvement in the Patient Global Impression of Change (PGIC), a general assessment of tinnitus status. There was a very strong relationship demonstrated between the improvement in TFI score reported by these OTO-313 responders and their improvement in tinnitus loudness and annoyance levels as well as PGIC based on the calculated correlation coefficients of ≥ 0.8 for these endpoints.

       
    • A single intratympanic injection of OTO-313 was well-tolerated with lower incidence of adverse events than the placebo group.

    "We are excited to announce these positive clinical results for OTO-313 and to advance this potential treatment for patients suffering from the high burden of persistent tinnitus," said David A. Weber, Ph.D., president and CEO of Otonomy. "This is also a great start to our three planned clinical trial readouts with results for our OTO-413 Phase 1/2 trial expected in the fourth quarter of 2020 and results from the Phase 3 trial of OTIVIDEX® in Ménière's disease expected in the first quarter of 2021."

    "Tinnitus is a common problem that affects millions of people around the world. A significant proportion of patients experience moderate to severe tinnitus, which can negatively impact sleep and relaxation, disrupt the ability to focus at work and at home, create feelings of distress and anxiety, and lower overall quality of life," said Kenneth Maxwell, M.D., a Neurotologist at Piedmont Ear Nose & Throat Associates in Winston-Salem, North Carolina and an investigator in the OTO-313 Phase 1/2 trial. "Unfortunately, there are no FDA approved drug treatments for tinnitus and existing approaches rely on coping strategies. Therefore, I am very encouraged by the treatment response observed with OTO-313 in this trial as well as the consistency of the improvement for OTO-313 responders across all four tinnitus endpoints examined in this trial, and I look forward to participating in future clinical studies."

    Webcast and Conference Call

    Otonomy management will host a webcast and conference call regarding these program updates at 4:30 p.m. ET / 1:30 p.m. PT today. The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 4273643. A live webcast of the call will be available online in the investor relations section of Otonomy's website at www.otonomy.com and will be archived there for 30 days.

    About Tinnitus

    Tinnitus is the medical term for the perception of noise when there is no sound. It is often described as a ringing in the ear but can also sound like roaring, clicking, hissing or buzzing. Tinnitus is often caused by cochlear injury due to excessive noise, physical trauma, persistent ear infection or exposure to ototoxic agent, leading to over-activation of auditory nerve fibers and the perception of noise in the absence of an external stimulus. Approximately 10 percent of U.S. adults suffer from the condition, which can severely impact daily activities and result in anxiety and depression. Tinnitus also accounts for the most prevalent service-connected disability among veterans with an estimated cost exceeding $2 billion. There are currently no FDA approved drug treatments for tinnitus.

    About OTO-313

    OTO-313 is a sustained-exposure formulation of the potent and selective N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine providing localized drug administration to the inner ear. We believe that gacyclidine can reduce the severity of tinnitus symptoms following cochlear injury by decreasing the over-activation of damaged auditory nerve fibers in the cochlea and their connections. The therapeutic potential of gacyclidine for tinnitus has been demonstrated in preclinical models and several pilot clinical studies. OTO-313 utilizes a novel, patent-protected formulation technology to provide several weeks of gacyclidine drug exposure in the inner ear compartment following a single intratympanic injection.

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, expectations regarding the potential benefits, development activity and advancement of clinical trials; statements relating to the timing of results, patient recruitment and activity for, conduct of, ongoing clinical trials; statements relating to potential treatment for patients suffering from the high burden of persistent tinnitus; statements by an investigator in the OTO-313 Phase 1/2; statements by Otonomy's president and CEO; and estimated costs of tinnitus. Otonomy's 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: delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic, including current and future impacts to Otonomy's operations, the manufacturing of its product candidates, the progression of its current clinical trials, enrollment in its current and future clinical trials and patient conduct and compliance; Otonomy's ability to obtain additional financing; Otonomy's dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; the integrity of patient-reported outcomes in its current and future clinical trials; side effects or adverse events associated with Otonomy's product candidates; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials; Otonomy's ability to protect its intellectual property in the United States and throughout the world; expectations regarding potential therapy benefits, market size, opportunity and growth; Otonomy's ability to manage operating expenses; implementation of Otonomy's business model and strategic plans for its business, products and technology; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on May 7, 2020, and Otonomy's 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

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932

    Primary Logo

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  14. SAN DIEGO, July 06, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today provided an update on the statistical analysis plan related to the ongoing Phase 3 clinical trial of OTIVIDEX in Ménière's disease. In response to questions received from the U.S. Food and Drug Administration (FDA) regarding use of the Generalized Poisson model to analyze the daily vertigo count data reported by patients, Otonomy submitted a revised statistical analysis plan that uses a statistical test called the Negative Binomial model for the primary analysis of the ongoing trial.

    Otonomy selected the Negative Binomial model to address the FDA's questions because…

    SAN DIEGO, July 06, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today provided an update on the statistical analysis plan related to the ongoing Phase 3 clinical trial of OTIVIDEX in Ménière's disease. In response to questions received from the U.S. Food and Drug Administration (FDA) regarding use of the Generalized Poisson model to analyze the daily vertigo count data reported by patients, Otonomy submitted a revised statistical analysis plan that uses a statistical test called the Negative Binomial model for the primary analysis of the ongoing trial.

    Otonomy selected the Negative Binomial model to address the FDA's questions because it believes it provides the best fit of the OTIVIDEX clinical data based on the Phase 2b trial (for patients with vertigo enrollment criteria matching the Phase 3 clinical trials), the AVERTS-2 Phase 3 clinical trial, and the integrated dataset from both trials. As the table below indicates, the ad hoc analysis of the Definitive Vertigo Day (DVD) count data reported by patients for Month 3 is statistically significant (p value < 0.05) using the Negative Binomial model for each of these prior trial populations as well as the integrated summary.

    p value for Analysis of

    DVD Count in Month 3
    Phase 2b*

    (n = 97)
    AVERTS-2**

    (n = 111)
    Integrated Dataset
    Generalized Poisson Model0.0020.013< 0.001
    Negative Binomial Model0.0160.008< 0.001

    *Patients with baseline DVD count of 4-22 days during the one-month baseline period

    **Patients who completed 3-month follow-up period (of which 105 completed daily diaries)

    "We have recently completed an extensive review of the statistical analysis model that we believe best fits the OTIVIDEX clinical data, which is characterized by approximately 40% of OTIVIDEX-treated patients having no DVD's in Month 3," said David A. Weber, Ph.D., president and CEO of Otonomy. "Based on this review, we determined that the Negative Binomial model provides an improved fit and reduced Type 1 error compared to the Generalized Poisson model. The Negative Binomial model also gives us additional power to detect a treatment benefit enabling us to comfortably reduce the target patient enrollment in the ongoing trial from 160 to 142 patients while maintaining more than 90% power. We look forward to completing the enrollment of this trial during the third quarter of 2020 and announcing results in the first quarter of 2021."

    Webcast and Conference Call

    Otonomy management will review this update for the OTIVIDEX program together with a review of the OTO-313 Phase 1/2 trial results (announced under a separate release) during a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today. The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 4273643. A live webcast of the call will be available online in the investor relations section of Otonomy's website at www.otonomy.com and will be archived there for 30 days.

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, expectations regarding the potential benefits, development activity and advancement of clinical trials; statements relating to the timing and announcement of results, patient recruitment and enrollment and activity for, conduct of, the ongoing Phase 3 clinical trial of OTIVIDEX in Ménière's disease; statements relating to updated statistical analysis plan related to the ongoing Phase 3 clinical trial of OTIVIDEX; expectations regarding the Negative Binomial model; and statements by Otonomy's president and CEO. Otonomy's 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: delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic, including current and future impacts to Otonomy's operations, the manufacturing of its product candidates, the progression of its current clinical trials, enrollment in its current and future clinical trials and patient conduct and compliance; Otonomy's ability to obtain additional financing; Otonomy's dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; the integrity of patient-reported outcomes in its current and future clinical trials; side effects or adverse events associated with Otonomy's product candidates; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials; expectations regarding potential therapy benefits; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on May 7, 2020, and Otonomy's 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

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932

     

    Primary Logo

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    • Results from Phase 3 trial of OTIVIDEX® in Ménière's disease expected in first quarter of 2021
    • Results from Phase 1/2 trial of OTO-313 in tinnitus expected in July 2020
    • Results from Phase 1/2 trial of OTO-413 in hearing loss expected in fourth quarter of 2020
    • Current capital funds operations through all clinical trial readouts

    Conference call and webcast today at 4:30 p.m. ET

    SAN DIEGO, June 15, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today provided an update on its product pipeline and the timeline to results for the company's three ongoing clinical trials, including the Phase 3 trial of OTIVIDEX in Ménière's disease. The company…

    • Results from Phase 3 trial of OTIVIDEX® in Ménière's disease expected in first quarter of 2021

    • Results from Phase 1/2 trial of OTO-313 in tinnitus expected in July 2020
    • Results from Phase 1/2 trial of OTO-413 in hearing loss expected in fourth quarter of 2020
    • Current capital funds operations through all clinical trial readouts

    Conference call and webcast today at 4:30 p.m. ET

    SAN DIEGO, June 15, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today provided an update on its product pipeline and the timeline to results for the company's three ongoing clinical trials, including the Phase 3 trial of OTIVIDEX in Ménière's disease. The company will host a conference call and webcast today at 4:30 p.m. ET to review these updates.

    "We have been able to mitigate the impact of the COVID-19 pandemic on our clinical trials by taking steps to ensure the integrity of data collection from enrolled patients and supporting the increasing number of sites able to reinitiate recruitment of new patients," said David A. Weber, Ph.D., president and CEO of Otonomy. "While the timing of our trial results has been adjusted due to the pandemic, what remains the same is that we have clinical trial catalysts in the coming months for three novel product candidates that each address significant unmet medical needs in neurotology for which there are no FDA-approved drug treatments. We are excited about the transformational opportunity these multiple readouts provide beginning with the announcement of our Phase 2 tinnitus results next month."

    Otonomy Program Updates

    • OTIVIDEX Phase 3 clinical trial in Ménière's disease: patient enrollment is ongoing with results expected in the first quarter of 2021. This trial is being conducted at approximately 60 trial sites dispersed across different regions of the United States and multiple countries in Europe. We believe there is minimal impact of COVID-19 on the integrity of efficacy data being collected because patients report their vertigo episodes via a daily telephone diary and compliance remains high. New patient enrollment was impacted beginning in March due to quarantine restrictions but we are now seeing renewed activity across numerous sites in multiple countries. We expect to complete patient enrollment during the third quarter of 2020 and announce results in the first quarter of 2021.

       
    • OTO-313 Phase 1/2 clinical trial in tinnitus: results from exploratory efficacy cohort expected in July 2020. We have completed enrollment in the exploratory efficacy cohort of this randomized, double-blind, placebo-controlled trial and are currently conducting study completion activities. This cohort enrolled 35 patients with at least moderate tinnitus severity assessed during a two-week lead-in period using the Tinnitus Functional Index (TFI), a clinically-validated tinnitus questionnaire. Patients were randomized 1:1 to a single intratympanic injection of OTO-313 (sustained exposure formulation of the NMDA receptor antagonist gacyclidine) or placebo, and followed for eight weeks. In addition to scoring the severity of their tinnitus at regular intervals using the TFI, patients also reported their tinnitus loudness and annoyance using a daily telephone diary during the follow-up period. While not powered for statistical significance, we believe this patient number and study design will be sufficient to assess a clinical signal with OTO-313 treatment and inform next steps for the program. We expect to announce study results in July.

       
    • OTO-413 Phase 1/2 clinical trial in hearing loss: patient enrollment is ongoing with results expected in the fourth quarter of 2020. This is an ascending single dose safety and exploratory efficacy study for OTO-413, a sustained exposure formulation of brain-derived neurotrophic factor (BDNF). We have successfully escalated through three dose levels totaling 24 patients and recently initiated enrollment for the high dose cohort. We expect to enroll approximately 16 patients in this cohort, randomized 3:1 for a single intratympanic injection of OTO-413 or placebo. Patients enrolled in this trial have a speech-in-noise hearing deficit measured at baseline and can have normal up to moderately-severe hearing loss by conventional testing. Following treatment, patients undergo repeated testing for safety and exploratory efficacy over 3 months. We expect to announce results from this trial in the fourth quarter of 2020.

       
    • GJB2 gene therapy program: preclinical results support selection of product candidate. Otonomy and Applied Genetic Technologies Corporation (AGTC) are collaborating to co-develop and co-commercialize an AAV-based gene therapy to restore hearing in patients with hearing loss caused by a mutation in the gap junction beta-2 (GJB2) gene -- the most common cause of congenital hearing loss. Preclinical results presented at the American Society of Gene & Cell Therapy (ASGCT) meeting in May 2020 demonstrated that a gene of interest can be expressed in support cells of the cochlea, which are the relevant target cells for treating GJB2 deficiency, using novel and proprietary AAV capsids. Also, consistent gene expression can be observed in these cells for at least 12 weeks following a single local administration. These results support the selection of a product candidate for further development.

       
    • OTO-510: preclinical data presented for novel and proprietary class of otoprotectant agents. Cisplatin is a potent chemotherapeutic agent that is widely used to treat a variety of cancers in adults and children, however, it is commonly associated with severe adverse effects including cisplatin-induced hearing loss (CIHL). Otonomy has presented preclinical results demonstrating varying degrees of otoprotection against CIHL for several classes of therapeutic agents. In particular, a novel class of agents that potently binds to cisplatin demonstrated greater otoprotection than anti-oxidant and anti-apoptotic molecules, and increased potency relative to other cisplatin-binding molecules currently in development.

       
    • OTO-6XX: preclinical development ongoing for regenerative hearing loss program. Otonomy has demonstrated regeneration of hair cells in a preclinical proof-of-concept model using a class of small molecules formulated for sustained-exposure local delivery, and has selected a lead compound for development. The OTO-6XX program is targeting hair cell regeneration for the treatment of severe hearing loss.

       
    • OTIPRIO® Co-Promotion Agreement completed with ALK-Abelló, Inc. (ALK). Otonomy recently entered a co-promotion agreement that provides ALK with an exclusive right to promote OTIPRIO for acute otitis externa (AOE) to office-based health care professionals in the United States including ear, nose and throat (ENT) physicians, pediatricians and primary care physicians. During the multi-year agreement, Otonomy will receive co-promotion fees and reimbursement of a proportion of product support costs while also retaining a share of adjusted gross profits from the sale of OTIPRIO for use in AOE.

       
    • Financial Guidance:
      • 2020 Operating Expenses: Otonomy continues to expect that non-GAAP operating expenses will be in the range of $35-$38 million, and GAAP operating expenses will be in the range of $45-$48 million.
      • Cash Runway: Otonomy expects that its current cash, cash equivalents, and short-term investments will be sufficient to fund company operations to mid-2021, through readouts for our three ongoing clinical trials.

    Webcast and Conference Call

    Otonomy management will host a webcast and conference call regarding these program updates at 4:30 p.m. ET / 1:30 p.m. PT today. The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 3655435. A live webcast of the call will be available online in the investor relations section of Otonomy's website at www.otonomy.com and will be archived there for 30 days.

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, statements relating to the timing of results, patient recruitment and activity for, conduct of, and the impact of COVID-19 on, ongoing clinical trials; the potential benefits and opportunities of, and activities under the collaboration agreement between Otonomy and AGTC and the co-promotion agreement between Otonomy and ALK; expectations regarding preclinical programs, including development activities; expectations regarding operating expenses for 2020 and cash runway; and statements by Otonomy's president and CEO. Otonomy's 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: delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic, including current and future impacts to Otonomy's operations, the manufacturing of its product candidates, the progression of its current clinical trials, enrollment in its current and future clinical trials and patient conduct and compliance; Otonomy's ability to accurately forecast financial results; Otonomy's ability to obtain additional financing; Otonomy's dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; the integrity of patient-reported outcomes in its current and future clinical trials; the risks of the occurrence of any event, change or other circumstance that could give rise to the termination of the collaboration agreement between AGTC and Otonomy or the co-promotion agreement between ALK and Otonomy, or that could impact Otonomy's ability to repay or comply with the terms of the loan provided by Oxford Finance LLC; side effects or adverse events associated with Otonomy's product candidates; Otonomy's ability to successfully commercialize its product candidates, if approved; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials, and for the manufacture of its product candidates; Otonomy's ability to protect its intellectual property in the United States and throughout the world; expectations regarding potential therapy benefits, market size, opportunity and growth; Otonomy's ability to manage operating expenses; implementation of Otonomy's business model and strategic plans for its business, products and technology; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on May 7, 2020, and Otonomy's 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

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932

    Primary Logo

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  15. SAN DIEGO, June 11, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that David A. Weber, Ph.D., president and chief executive officer, is scheduled to present a company overview at the Raymond James 2020 Human Health Innovation Conference (Virtual) on Thursday June 18, 2020 at 2:20 p.m. ET (11:20 a.m. PT).

    A live audio webcast of the presentations will be available through the Events page of the company's website (www.otonomy.com). 

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology…

    SAN DIEGO, June 11, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that David A. Weber, Ph.D., president and chief executive officer, is scheduled to present a company overview at the Raymond James 2020 Human Health Innovation Conference (Virtual) on Thursday June 18, 2020 at 2:20 p.m. ET (11:20 a.m. PT).

    A live audio webcast of the presentations will be available through the Events page of the company's website (www.otonomy.com). 

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and tinnitus. For additional information please visit www.otonomy.com.

    Contacts:

    Media Inquiries:

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries:

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932

    Primary Logo

    View Full Article Hide Full Article
  16. SAN DIEGO, June 10, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that due to the health, safety and travel concerns of stockholders and federal, state and local government recommendations and restrictions imposed in response to the novel coronavirus (COVID-19) pandemic, the location of its 2020 Annual Meeting of Stockholders has changed. The Annual Meeting of Stockholders will be held virtually, by webcast, and stockholders will not be able to attend in person. The meeting will be held on the same date and time as originally scheduled, Tuesday, June 23, 2020 at 8 a.m. PDT. 

    As described in the company's proxy materials…

    SAN DIEGO, June 10, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that due to the health, safety and travel concerns of stockholders and federal, state and local government recommendations and restrictions imposed in response to the novel coronavirus (COVID-19) pandemic, the location of its 2020 Annual Meeting of Stockholders has changed. The Annual Meeting of Stockholders will be held virtually, by webcast, and stockholders will not be able to attend in person. The meeting will be held on the same date and time as originally scheduled, Tuesday, June 23, 2020 at 8 a.m. PDT. 

    As described in the company's proxy materials previously distributed for the Annual Meeting, Otonomy stockholders as of the close of business on April 24, 2020 are entitled to attend and vote, and ask questions at the Annual Meeting. 

    Otonomy stockholders can access the meeting at www.virtualshareholdermeeting.com/OTIC2020 and entering the 16-digit control number found on the proxy card, voting instruction form, or other notices previously received by stockholders. Stockholders may vote and ask questions during the Annual Meeting by following the instructions available on the meeting website.

    All stockholders are encouraged to vote and submit their proxies in advance of the meeting by one of the methods described in the proxy materials. The proxy card that was previously distributed will not be updated to reflect the change in meeting format and may be used to vote shares in connection with the Annual Meeting. Stockholders who have previously sent in proxies, or voted via telephone or by internet, do not need to take any further action.

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and tinnitus. For additional information, please visit www.otonomy.com.

    Contacts:

    Media Inquiries:

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries:

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932

    Primary Logo

    View Full Article Hide Full Article
  17. SAN DIEGO, June 08, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced it will host a conference call and webcast to review the status and timeline to results for the company's three ongoing clinical trials including the Phase 3 trial of OTIVIDEX® in Ménière's disease at 4:30 p.m. EDT / 1:30 p.m. PDT on June 15, 2020. This call is consistent with Otonomy's previously announced plan to provide an update on the timing guidance, which had been pulled in April as a result of the COVID-19 pandemic. 

    The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference…

    SAN DIEGO, June 08, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced it will host a conference call and webcast to review the status and timeline to results for the company's three ongoing clinical trials including the Phase 3 trial of OTIVIDEX® in Ménière's disease at 4:30 p.m. EDT / 1:30 p.m. PDT on June 15, 2020. This call is consistent with Otonomy's previously announced plan to provide an update on the timing guidance, which had been pulled in April as a result of the COVID-19 pandemic. 

    The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 3655435. A live webcast of the call will be available online in the investor relations section of Otonomy's website at www.otonomy.com and will be archived there for 30 days.

    About Otonomy



    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and tinnitus. For additional information please visit www.otonomy.com.

    Contacts:

    Media Inquiries:

    Spectrum Science

    Chloé-Anne Ramsey

    Vice President

    404.865.3601

    Investor Inquiries:

    Westwicke ICR

    Robert H. Uhl

    Managing Director

    858.356.5932

    Primary Logo

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  18. Silverback Therapeutics ("Silverback"), a biopharmaceutical company advancing a pipeline of therapies that are systemically delivered, but locally active, today announced the appointment of Vickie L. Capps as director and audit committee chair.

    "Vickie has had a distinguished career in finance and executive leadership, and I was fortunate to have her guidance on the board of Synthorx," said Laura Shawver, Ph.D., president, chief executive officer and director of Silverback Therapeutics. "Her exceptionally strong skill set as a senior finance and audit professional, in addition to strategic business development and corporate governance acumen, will be critical as Silverback advances to a clinical stage company later this year."

    In addition…

    Silverback Therapeutics ("Silverback"), a biopharmaceutical company advancing a pipeline of therapies that are systemically delivered, but locally active, today announced the appointment of Vickie L. Capps as director and audit committee chair.

    "Vickie has had a distinguished career in finance and executive leadership, and I was fortunate to have her guidance on the board of Synthorx," said Laura Shawver, Ph.D., president, chief executive officer and director of Silverback Therapeutics. "Her exceptionally strong skill set as a senior finance and audit professional, in addition to strategic business development and corporate governance acumen, will be critical as Silverback advances to a clinical stage company later this year."

    In addition to Silverback, Ms. Capps is a member of the board of directors and the audit committee chair of each of NuVasive, Inc., a public medical device company (NASDAQ:NUVA) and Otonomy, Inc., a public biopharmaceutical company (NASDAQ:OTIC). She is a member of the board of directors of Amedisys, Inc., a public home health and hospice company (NASDAQ:AMED), and a member of its audit and compensation committees. Ms. Capps is also a member of the boards of directors of OmniGuide, Inc., a private medical device company, and the San Diego State University Research Foundation. Ms. Capps is a member of the Senior Advisory Board of Consonance Capital Partners, a healthcare focused private equity firm. She previously served as a member of the boards of directors of several other public and private companies, most recently, Synthorx, Inc. (Nasdaq), prior to its sale to Sanofi in January 2020, and Enclara Pharmacia (private) prior to its sale to Humana in January 2020. Ms. Capps is a Certified Public Accountant and she received her Bachelor of Science degree in business administration and accounting from San Diego State University.

    About Silverback Therapeutics™

    Silverback Therapeutics is a privately held biopharmaceutical company advancing a pipeline of therapies that are systemically delivered, but locally active and target fundamental disease pathways. Silverback's ImmunoTAC™ technology is a targeted therapy platform designed to promote local modulation of important biologic pathways which enables innovative therapeutic approaches for oncology, virology, and fibrosis. Silverback's lead candidate, SBT6050, is a novel immuno-oncology therapeutic comprised of a TLR8 specific agonist (a potent activator of myeloid cells) conjugated to a HER2-directed monoclonal antibody. Solid tumors, including those resistant to T cell targeted immunotherapy, are replete with myeloid cells. Activation and reprogramming of myeloid cells drives an innate immune response resulting in direct tumor killing and can also nucleate a T cell response. Successful activation of myeloid cells can lead to anti-tumor immunity, even in tumors that are resistant to immune checkpoint blockade. Clinical investigation of SBT6050 is expected to begin in 2H 2020. Silverback Therapeutics is located in Seattle, Washington. To learn more, visit www.silverbacktx.com.

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  19. SAN DIEGO, May 12, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced preclinical results from the company's gene therapy collaboration with Applied Genetic Technologies Corporation (NASDAQ:AGTC) that support the selection of a product candidate for development as a treatment for gap junction beta-2 (GJB2) deficiency, the most common cause of congenital hearing loss. These results are being presented during the American Society of Gene & Cell Therapy (ASGCT) 23rd Annual Meeting being held virtually May 12-15, 2020.

    "Working with AGTC, we have identified novel and proprietary capsids that are capable of transducing support…

    SAN DIEGO, May 12, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced preclinical results from the company's gene therapy collaboration with Applied Genetic Technologies Corporation (NASDAQ:AGTC) that support the selection of a product candidate for development as a treatment for gap junction beta-2 (GJB2) deficiency, the most common cause of congenital hearing loss. These results are being presented during the American Society of Gene & Cell Therapy (ASGCT) 23rd Annual Meeting being held virtually May 12-15, 2020.

    "Working with AGTC, we have identified novel and proprietary capsids that are capable of transducing support cells of the cochlea, which are the relevant target cells for treating GJB2 deficiency," said David A. Weber, Ph.D., president and chief executive officer of Otonomy. "The selection of a lead capsid and other components for continued development of a GJB2 gene therapy candidate is supported by cochlea explant studies in multiple rodent species as well as in vivo studies in non-human primates that are summarized in today's ASGCT presentation."

    The joint poster presentation by Otonomy and AGTC demonstrate the following:

    • A gene of interest can be expressed in cochlear cells relevant to GJB2 rescue, including support cells of the organ of Corti and spiral limbus, and fibrocytes of the spiral ligament.
    • The tropism and gene expression level in support cells is higher for these novel capsids than for previously reported capsids used in the otic field.
    • Consistent gene expression can be observed in support cells throughout the cochlea for at least 12 weeks following a single local injection.
    • None of the novel AAV capsids evaluated for further development exhibited signs of cellular toxicity.

    In October 2019, Otonomy and AGTC announced a strategic collaboration to co-develop and co-commercialize an AAV-based gene therapy to restore hearing in patients with sensorineural hearing loss caused by a mutation in the GJB2 gene.

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to expectations regarding the potential benefits, development activity and advancement of preclinical programs; the potential benefits of and activity under the collaboration agreement between AGTC and Otonomy, including but not limited to development activity; and statements by Otonomy's president and CEO. Otonomy's 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: the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates and the nonclinical and clinical results for its product candidates, which may not support further development; Otonomy's ability to obtain regulatory approval for its product candidates; the risks of the occurrence of any event, change or other circumstance that could give rise to the termination of the collaboration agreement between AGTC and Otonomy; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials; Otonomy's dependence on third parties for the manufacture of its product candidates; Otonomy's ability to protect its intellectual property related to its product candidates in the United States and throughout the world; expectations regarding potential therapy benefits, market size, opportunity and growth; Otonomy's ability to manage operating expenses; implementation of Otonomy's 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 Otonomy's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on May 7, 2020, and Otonomy's 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:
    Spectrum Science
    Chloé-Anne Ramsey
    Vice President
    404.865.3601

    Investor Inquiries:
    Westwicke ICR
    Robert H. Uhl
    Managing Director
    858.356.5932

    Primary Logo

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  20. SAN DIEGO, May 07, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today reported financial results for the quarter ended March 31, 2020 and provided an update on its product pipeline and corporate activities. In lieu of a conference call today, the company plans to host a program update call in June to review the status and timeline to results for the three ongoing clinical trials including the Phase 3 trial of OTIVIDEX® in Ménière's disease.

    "As we announced several weeks ago, we have taken steps to ensure the health and safety of our employees, patients, and study site healthcare professionals during the COVID-19 pandemic while also…

    SAN DIEGO, May 07, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today reported financial results for the quarter ended March 31, 2020 and provided an update on its product pipeline and corporate activities. In lieu of a conference call today, the company plans to host a program update call in June to review the status and timeline to results for the three ongoing clinical trials including the Phase 3 trial of OTIVIDEX® in Ménière's disease.

    "As we announced several weeks ago, we have taken steps to ensure the health and safety of our employees, patients, and study site healthcare professionals during the COVID-19 pandemic while also working diligently to mitigate the impact to our ongoing clinical trials," said David A. Weber, Ph.D., president and CEO of Otonomy. "Collection of patient-reported symptom data continues to be very good supporting the integrity of these trials. However, quarantine restrictions have slowed new patient enrollment in the OTIVIDEX trial and required us to pause enrollment in the OTO-413 trial, which has now resumed. Regarding the OTO-313 trial, we have enrolled a sufficient number of patients to inform our next steps in the program and have discontinued further enrollment. We look forward to reviewing the status of these trials as well as timing to results during a program update call in June."

    Otonomy Business Updates

    • COVID-19 Pandemic: update provided in April 2020. Otonomy has taken steps to protect the health and safety of its employees and community by generally adopting a work from home policy in line with directives from the State of California and guidance from the U.S. Centers for Disease Control and Prevention (CDC). On-site activities have been restricted to certain essential facility and laboratory support functions and social distancing policies have been implemented. We are also assessing our eligibility for programs under the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
       
    • OTIVIDEX Phase 3 clinical trial in Ménière's disease: patient compliance for reporting vertigo episodes is high and new patient enrollment is ongoing. This trial is being conducted at approximately 60 trial sites dispersed across different regions of the United States and multiple countries in Europe. We believe there is minimal impact of COVID-19 on the integrity of efficacy data being collected because patients report their vertigo episodes via a daily telephone diary and compliance continues to be high. Quarantine restrictions are impacting the rate of new patient enrollment, which is being managed on a country-by-country and site-by-site basis according to local conditions.
       
    • OTO-313 Phase 1/2 clinical trial in tinnitus: patient enrollment in exploratory efficacy cohort has been completed. An initial safety cohort of this randomized, double-blind, placebo-controlled trial was successfully completed and a second cohort designed to evaluate the activity of OTO-313 across multiple exploratory efficacy endpoints including the Tinnitus Functional Index (TFI) questionnaire is ongoing. This second cohort has enrolled a total of 35 patients, which Otonomy believes is sufficient to inform next steps for the OTO-313 program. As a result, new patient enrollment has been discontinued and the company will initiate study completion activities following final patient visits. Timing to study results will be provided during the program review call in June.
       
    • OTO-413 Phase 1/2 clinical trial in hearing loss: new patient enrollment has resumed. This is an ascending single dose safety and exploratory efficacy study being conducted at a limited number of trial sites in the United States. As previously announced, we have successfully completed several dose cohorts but temporarily paused new patient enrollment because site visits are required for extensive hearing assessments to evaluate both safety and exploratory efficacy. We have resumed new patient enrollment, which is being managed on a site-by-site basis.
       
    • GJB2 gene therapy program: preclinical data presented for novel and proprietary AAV capsids. Otonomy and Applied Genetic Technologies Corporation (AGTC) are collaborating to co-develop and co-commercialize an AAV-based gene therapy to restore hearing in patients with hearing loss caused by a mutation in the gap junction beta 2 gene (GJB2) -- the most common cause of congenital hearing loss. Preclinical results presented at the Association for Research in Otolaryngology (ARO) meeting in January demonstrated that a gene of interest can be expressed in support cells of the cochlea, which are the relevant target cells for treating GJB2 deficiency, using novel and proprietary AAV capsids.
       
    • OTO-510: preclinical data presented for novel and proprietary class of otoprotectant agents. Cisplatin is a potent chemotherapeutic agent that is widely used to treat a variety of cancers in adults and children, however it is commonly associated with severe adverse effects including cisplatin-induced hearing loss (CIHL). At ARO, Otonomy presented preclinical results demonstrating varying degrees of otoprotection against CIHL for several classes of therapeutic agents. In particular, a novel class of agents that potently binds to cisplatin demonstrated greater otoprotection than anti-oxidant and anti-apoptotic molecules, and increased potency relative to other cisplatin-binding molecules currently in development.
       
    • OTO-6XX: preclinical development ongoing for regenerative hearing loss program. Otonomy has demonstrated regeneration of hair cells in a preclinical proof-of-concept model using a class of small molecules formulated for sustained-exposure local delivery, and has selected a lead compound for development. The OTO-6XX program is targeting hair cell regeneration for the treatment of severe hearing loss.

    First Quarter Financial Highlights

    • Cash Position: Cash, cash equivalents, and short-term investments totaled $48.6 million as of March 31, 2020, compared to $60.7 million as of December 31, 2019.
       
    • Long-term Debt: Otonomy obtained a $15 million term loan from Oxford Finance LLC in December 2018. The loan provides for a 24 month interest-only repayment period, followed by 35 months of amortization.
       
    • Operating Expenses: GAAP operating expenses were $11.5 million for the first quarter of 2020, compared to $12.1 million for the first quarter of 2019. Non-GAAP operating expenses, which exclude stock-based compensation, were $10.1 million for the first quarter of 2020, compared to $10.6 million for the first quarter of 2019.
       
    • Research and Development Expenses: GAAP research and development (R&D) expenses for the first quarter of 2020 were $7.7 million, compared to $8.8 million for the first quarter of 2019. The decrease for the quarter was primarily due to reduced third-party development costs that were partially offset by increased compensation expense.
       
    • Selling, General and Administrative Expenses: GAAP selling, general and administrative (SG&A) expenses in the first quarter of 2020 were $3.8 million, compared to $3.3 million for the first quarter of 2019. The increase this quarter was primarily the result of discontinued cost reimbursement received from OTIPRIO co-promotion partners.
       
    • Financial Guidance:
      • 2020 Operating Expenses: Otonomy expects that GAAP operating expenses will be in the range of $45-$48 million, and that non-GAAP operating expenses will be in the range of $35-$38 million.
      • Cash Runway: Otonomy expects that its current cash, cash equivalents, and short-term investments will be sufficient to fund company operations into 2021 and we are managing spending to enable this cash runway to extend through readouts for our three ongoing clinical trials.

    Non-GAAP Operating Expenses

    In this press release, Otonomy's operating expenses are provided in accordance with generally accepted accounting principles (GAAP) in the United States and also on a non-GAAP basis. Non-GAAP operating expenses exclude stock-based compensation. Non-GAAP operating expenses are provided as a complement to operating expenses provided in accordance with GAAP because management believes non-GAAP operating expenses help indicate underlying trends in the company's business, are important in comparing current results with prior period results and provide additional information regarding the company's financial position. Management also uses non-GAAP operating expenses to establish budgets and operational goals that are communicated internally and externally and to manage the company's business and to evaluate its performance. The attached financial information includes a reconciliation of the GAAP operating expenses to non-GAAP operating expenses and a reconciliation of GAAP operating expense guidance to non-GAAP operating expense guidance.

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, statements relating to the timing of results, patient recruitment and activity for, conduct of, and the impact of COVID-19 on, ongoing clinical trials; expectations regarding operating expenses for 2020 and cash runway; and statements by Otonomy's president and CEO. Otonomy's 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: delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic, including current and future impacts to Otonomy's operations, the manufacturing of its product candidates, the progression of its current clinical trials, enrollment in its current and future clinical trials and patient conduct and compliance; Otonomy's ability to accurately forecast financial results; Otonomy's ability to obtain additional financing; Otonomy's dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; the integrity of patient-reported outcomes in its current and future clinical trials; the risks of the occurrence of any event, change or other circumstance that could impact Otonomy's ability to repay or comply with the terms of the loan provided by Oxford Finance LLC; side effects or adverse events associated with Otonomy's product candidates; Otonomy's ability to successfully commercialize its product candidates, if approved; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials, and for the manufacture of its product candidates; Otonomy's ability to protect its intellectual property in the United States and throughout the world; expectations regarding potential therapy benefits, market size, opportunity and growth; Otonomy's ability to manage operating expenses; implementation of Otonomy's business model and strategic plans for its business, products and technology; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on May 7, 2020, and Otonomy's 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
    Spectrum Science
    Chloé-Anne Ramsey
    Vice President
    404.865.3601

    Investor Inquiries
    Westwicke ICR
    Robert H. Uhl
    Managing Director
    858.356.5932

      Otonomy, Inc.
      Condensed Balance Sheet Data
      (in thousands)
             
        As of March 31,   As of December 31,
          2020       2019  
        (unaudited)    
      Cash and cash equivalents $ 31,038     $ 25,194  
             
      Short-term investments   17,568       35,476  
             
      Right-of-use assets   15,131       15,465  
             
      Total assets   70,051       83,018  
             
      Long-term debt, current   1,286        
             
      Long-term debt, net of current   13,731       14,967  
             
      Leases, net of current   14,951       15,320  
             
      Total liabilities   40,114       42,785  
             
      Accumulated deficit   (471,656 )     (459,893 )
             
      Total stockholders' equity   29,937       40,233  
             
             
     


    Otonomy, Inc.
    Condensed Statements of Operations
    (in thousands, except share and per share data)
             
        Three Months Ended
        March 31,
          2020       2019  
             
        (unaudited)
    Product sales, net $ 160     $ 192  
    Costs and operating expenses:      
      Cost of product sales   214       213  
      Research and development   7,672       8,795  
      Selling, general and administrative   3,836       3,278  
    Total costs and operating expenses   11,722       12,286  
    Loss from operations   (11,562 )     (12,094 )
             
    Other (expense) income, net   (201 )     110  
    Net loss $ (11,763 )   $ (11,984 )
             
    Net loss per share, basic and diluted $ (0.38 )   $ (0.39 )
             
    Weighted-average shares used to compute net loss per share,    
      basic and diluted   30,814,211       30,658,412  
             
     



    Otonomy, Inc.
    Reconciliation of GAAP to Non-GAAP Operating Expenses
    (in thousands)
             
        Three Months Ended
        March 31,
          2020       2019  
         
    GAAP operating expenses      
      Research and development $ 7,672     $ 8,795  
      Selling, general and administrative   3,836       3,278  
    Total GAAP operating expenses   11,508       12,073  
    Non-GAAP adjustments      
      R&D stock-based compensation expense   (568 )     (659 )
      SG&A stock-based compensation expense   (841 )     (834 )
    Total non-GAAP adjustments   (1,409 )     (1,493 )
    Non-GAAP operating expenses $ 10,099     $ 10,580  
             



    Otonomy, Inc.
    Reconciliation of 2020 GAAP to Non-GAAP Operating Expense Guidance
    (in millions)
         
         
    GAAP operating expenses $45 - $48
    Non-GAAP adjustments  
      Stock-based compensation expense $10
    Non-GAAP operating expenses $35 - $38
         

      

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  21. SAN DIEGO, April 09, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today provided a business update related to the COVID-19 pandemic.

    "Our first priority during this international crisis has been to ensure the health and safety of our employees, patients enrolled in our clinical trials, and healthcare professionals at our study sites in the United States and Europe," said David A. Weber, Ph.D., president and CEO of Otonomy. "We are fortunate that the primary endpoint for our OTIVIDEX® Phase 3 trial and key exploratory endpoints in our OTO-313 Phase 2 trial are self-reported by the patient from home thereby preserving the integrity…

    SAN DIEGO, April 09, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today provided a business update related to the COVID-19 pandemic.

    "Our first priority during this international crisis has been to ensure the health and safety of our employees, patients enrolled in our clinical trials, and healthcare professionals at our study sites in the United States and Europe," said David A. Weber, Ph.D., president and CEO of Otonomy. "We are fortunate that the primary endpoint for our OTIVIDEX® Phase 3 trial and key exploratory endpoints in our OTO-313 Phase 2 trial are self-reported by the patient from home thereby preserving the integrity of data collection in these trials even in locations with quarantine restrictions. However, new patient enrollment is being impacted so we are suspending our guidance for the timing of trial results until we better understand the timeline for each study. We continue to carefully manage our spending and believe that our existing capital can fund operations through our multiple clinical trial readouts including the OTIVIDEX Phase 3 trial."

    Otonomy Business Updates

    Ongoing Operations
    Otonomy has taken steps to protect the health and safety of its employees and community by generally adopting a work from home policy in line with directives from the State of California and guidance from the U.S. Centers for Disease Control and Prevention (CDC). On-site activities have been restricted to certain essential facility and laboratory support functions and social distancing policies have been implemented. Other corporate functions including clinical operations were able to quickly and effectively transition to remote working.

    OTIVIDEX Phase 3 Clinical Trial in Ménière's Disease
    This trial is being conducted at approximately 60 trial sites dispersed across different regions of the United States and multiple countries in Europe. We believe there is minimal impact of COVID-19 on the integrity of data being collected for enrolled patients because patients report their vertigo episodes via a daily telephone diary and compliance continues to be high. The enrollment of new patients is being managed on a country-by-country and site-by-site basis according to local conditions.

    OTO-313 Phase 1/2 Clinical Trial in Tinnitus
    Otonomy has successfully completed the initial safety cohort of this trial, and is conducting the exploratory efficacy study at approximately 15 sites located throughout the United States. Several of the efficacy endpoints are collected by patient-reported daily telephone diary and we switched to completion of the Tinnitus Functional Index (TFI) questionnaire at the patient's home as well to avoid restrictions on travel or study site visits. The enrollment of new patients is being managed on a site-by-site basis.

    OTO-413 Phase 1/2 Clinical Trial in Hearing Loss
    This is an ascending single dose safety and exploratory efficacy study being conducted at a limited number of trial sites in the United States. We have successfully completed several dose cohorts but have temporarily paused new patient enrollment because site visits are required for extensive hearing assessments to evaluate both safety and exploratory efficacy. Resumption of enrollment will be determined on a site-by-site basis.

    Financial Guidance
    We finished 2019 with approximately $61 million in cash, cash equivalents and short-term investments and reiterate that we expect non-GAAP operating expenses for 2020, which reflect spending, to be in the range of $35-$38 million (with GAAP operating expenses that include stock-based compensation to total in the range of $45-$48 million). We believe that this capital is sufficient to fund company operations into 2021 and are managing spending to enable this cash runway to extend through readouts for our three ongoing clinical trials.

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, timing of results, patient recruitment and enrollment plans and activity for, design and conduct of, data collection and preservation of data integrity with respect to, and the risks and impact of COVID-19 to, the Phase 3 clinical trial for OTIVIDEX, the Phase 1/2 clinical trial for OTO-313 and the Phase 1/2 clinical trial for OTO-413; expectations regarding patient self-reporting with respect to the Phase 3 clinical trial for OTIVIDEX and the Phase 1/2 clinical trial for OTO-313; expectations regarding ongoing operations, including with respect to on-site and remote working; expectations regarding operating expenses for 2020; expectations that current capital is sufficient to fund company operations into 2021; and statements by Otonomy's president and CEO. Otonomy's 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: delays and disruption resulting from the COVID-19  pandemic and governmental responses to the pandemic, including current and future impacts to Otonomy's operations, the manufacturing of its product candidates, the progression of its current clinical trials, enrollment in its current and future clinical trials and patient conduct and compliance; Otonomy's limited operating history and its expectation that it will incur significant losses for the foreseeable future; Otonomy's ability to accurately forecast financial results; Otonomy's ability to obtain additional financing; Otonomy's dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; the integrity of patient-reported outcomes in its current and future clinical trials; Otonomy's ability to obtain regulatory approval for its product candidates; the risks of the occurrence of any event, change or other circumstance that could impact Otonomy's ability to repay or comply with the terms of the loan provided by Oxford Finance LLC; side effects or adverse events associated with Otonomy's product candidates; Otonomy's ability to successfully commercialize its product candidates, if approved; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials; Otonomy's dependence on third parties for the manufacture of its product candidates; Otonomy's dependence on a small number of suppliers for raw materials; Otonomy's ability to protect its intellectual property related to its product candidates in the United States and throughout the world; expectations regarding potential therapy benefits, market size, opportunity and growth; Otonomy's ability to manage operating expenses; implementation of Otonomy's business model and strategic plans for its business, products and technology; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on February 27, 2020, and Otonomy's 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
    Spectrum Science
    Chloé-Anne Ramsey
    Vice President
    404.865.3601

    Investor Inquiries
    Westwicke ICR
    Robert H. Uhl
    Managing Director
    858.356.5932

     

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    • Results from three clinical trials expected in 2020 including the Phase 3 trial of OTIVIDEX™ in Ménière's disease
    • Current capital funds operations into 2021

    Conference call and webcast today at 4:30 p.m. ET

    SAN DIEGO, Feb. 27, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today reported financial results for the fourth quarter and year ended December 31, 2019 and provided an update on its product pipeline and corporate activities. The company will host a conference call and webcast today at 4:30 p.m. ET to discuss recent highlights and financial results.

    "We have positioned Otonomy for a transformational year in 2020 with three clinical…

    • Results from three clinical trials expected in 2020 including the Phase 3 trial of OTIVIDEX™ in Ménière's disease
    • Current capital funds operations into 2021

    Conference call and webcast today at 4:30 p.m. ET

    SAN DIEGO, Feb. 27, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today reported financial results for the fourth quarter and year ended December 31, 2019 and provided an update on its product pipeline and corporate activities. The company will host a conference call and webcast today at 4:30 p.m. ET to discuss recent highlights and financial results.

    "We have positioned Otonomy for a transformational year in 2020 with three clinical trial readouts including the Phase 3 trial of OTIVIDEX in Ménière's disease, Phase 2 trial of OTO-313 in tinnitus, and Phase 1/2 trial of OTO-413 in hearing loss," said David A. Weber, Ph.D., president and CEO of Otonomy. "In addition to these clinical-stage programs that address significant patient populations with high disease burden and no FDA-approved drug treatments, we are also advancing multiple preclinical programs including a gene therapy collaboration targeting congenital hearing loss. I am proud of the progress we have made across our pipeline, which is the broadest in the emerging neurotology field, and look forward to sharing updates during this catalyst rich year."

    Product Pipeline Update

    • OTIVIDEX: Enrollment in Phase 3 Clinical Trial in Ménière's Disease is Ongoing with Results Expected by the End of the Third Quarter of 2020. Otonomy has completed one successful Phase 3 trial and is conducting this additional pivotal trial to support a submission for U.S. registration of OTIVIDEX in Ménière's disease. The company plans to enroll approximately 160 patients in the United States and Europe, with the design and conduct of this trial based on the successful AVERTS-2 trial. Responder rate results from the AVERTS-2 trial and comparable patient population from the Phase 2b trial have recently been provided. These results show good agreement between the trials with almost 75% of patients experiencing at least a 50% reduction in definitive vertigo days from baseline to Month 3 following a single treatment with OTIVIDEX. Also, roughly 60% of patients had at least a 75% reduction from baseline, and approximately 40% of patients had no definitive vertigo days in Month 3. Furthermore, OTIVIDEX consistently demonstrated clear separation from placebo that was comparable across the two studies.

    • OTO-313: Enrollment in Phase 1/2 Clinical Trial in Tinnitus is Ongoing with Results Expected by the End of the Second Quarter of 2020. OTO-313 is a sustained-exposure formulation of the potent and selective NMDA receptor antagonist gacyclidine. Otonomy has successfully completed the initial safety cohort of this randomized, double-blind, placebo-controlled trial, and is now enrolling patients in the exploratory efficacy part of the study. For this cohort, we expect to enroll up to 50 tinnitus patients who meet a narrow set of entry criteria including that the tinnitus be persistent and at least a moderate level of severity. A number of exploratory efficacy endpoints will be assessed including the Tinnitus Functional Index, which is a validated clinical instrument that measures tinnitus severity and its impact on patients.

    • OTO-413: Enrollment in Phase 1/2 Clinical Trial in Hearing Loss is Ongoing with Results Expected in the Second Half of 2020. Otonomy is enrolling hearing loss patients in a Phase 1/2 clinical trial of OTO-413, which is a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF). The Phase 1/2 trial is a randomized, double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety and exploratory efficacy of OTO-413 in up to 40 patients with speech-in-noise hearing difficulty. Patients will receive a single intratympanic injection of OTO-413 or placebo and be followed for three months. A number of efficacy endpoints will be evaluated including electro-physiological measurements of hearing function and speech-in-noise hearing tests.

    • GJB2 Gene Therapy Program: Preclinical Data Presented for Novel and Proprietary AAV Capsids. Otonomy and Applied Genetic Technologies Corporation (AGTC) are collaborating to co-develop and co-commercialize an AAV-based gene therapy to restore hearing in patients with hearing loss caused by a mutation in the gap junction beta 2 gene (GJB2) -- the most common cause of congenital hearing loss. Preclinical results presented at the Association for Research in Otolaryngology (ARO) meeting in January demonstrated that a gene of interest can be expressed in support cells of the cochlea, which are the relevant target cells for treating GJB2 deficiency, using novel and proprietary AAV capsids.

    • OTO-510: Preclinical Data Presented for Novel and Proprietary Class of Otoprotectant Agents. Cisplatin is a potent chemotherapeutic agent that is widely used to treat a variety of cancers in adults and children, however it is commonly associated with severe adverse effects including cisplatin-induced hearing loss (CIHL). At ARO, Otonomy presented preclinical results demonstrating varying degrees of otoprotection against CIHL for several classes of therapeutic agents. In particular, a novel class of agents that potently binds to cisplatin demonstrated greater otoprotection than anti-oxidant and anti-apoptotic molecules, and increased potency relative to other cisplatin-binding molecules currently in development.

    • OTO-6XX: Preclinical Development Ongoing for Regenerative Hearing Loss Program. Otonomy has demonstrated regeneration of hair cells in a preclinical proof-of-concept model using a class of small molecules formulated for sustained-exposure local delivery, and has selected a lead compound for development. The OTO-6XX program is targeting hair cell regeneration for the treatment of severe hearing loss.

    Anticipated Upcoming Milestones

    • Report results from the OTO-313 Phase 2 tinnitus trial by the end of the second quarter of 2020.
       
    • Report results from the OTIVIDEX Phase 3 Ménière's disease trial by the end of the third quarter of 2020.
       
    • Report results from the OTO-413 Phase 1/2 hearing loss trial in the second half of 2020.

    Board of Directors Updates

    • Appointment of Ciara Kennedy, Ph.D. to Board of Directors: Otonomy appointed Ciara Kennedy to the board of directors and to the corporate governance and nominating committee effective as of March 1, 2020. Dr. Kennedy currently serves as president, chief executive officer, and a member of the board of directors of Amplyx Pharmaceuticals, a clinical-stage company developing innovative drug therapies for debilitating and life-threatening diseases in patients with compromised immune systems. Prior to Amplyx, she served as chief operating officer at Lumena Pharmaceuticals, until the company's acquisition by Shire Pharmaceuticals, and then continued as vice president, head of cholestatic liver disease at Shire post acquisition. Previously, Dr. Kennedy held several positions at Cypress Bioscience where she played a key role in the company's FDA approval and launch of Savella® for fibromyalgia, and also held several positions in program and alliance management at Biogen Idec where she managed multiple development projects spanning the drug discovery and development continuum. She is a founder of Reneo Pharmaceuticals and Mirum Pharmaceuticals, and also serves as a member of the board of directors of privately held Aristea Therapeutics. Dr. Kennedy received her doctorate at the Queen's University of Belfast, Northern Ireland, her Master of Business Administration from the Rady School of Management at UCSD, and Bachelor of Science from University of Cork, Ireland.
       
    • Resignation of Heather Preston, M.D. from Board of Directors: Dr. Heather Preston has notified the company of her intention to resign from Otonomy's board of directors and from her position on the corporate governance and nominating committee effective as of February 28, 2020 in order to devote additional attention to her responsibilities as a managing partner at Pivotal bioVenture Partners. The decision of Dr. Preston to resign is not the result of any disagreement with the company on any matter relating to its operations, policies or practices.

    "I am delighted to welcome Ciara to the board and believe that Otonomy will benefit greatly from her experience in drug development, operations, patient advocacy management and corporate development for biopharmaceutical companies across multiple therapeutic areas," added Dr. Weber. "I would also like to take this opportunity to express my sincere gratitude and appreciation for the long term service and significant contributions made by Heather. Since joining the board with our first syndicated venture financing, Heather's active participation and thoughtful guidance to the company and its board throughout have been greatly appreciated."

    Fourth Quarter and Full Year 2019 Financial Highlights

    • Cash Position: Cash, cash equivalents, and short-term investments totaled $60.7 million as of December 31, 2019, compared to $97.3 million as of December 31, 2018. The cash balance includes proceeds from a $15.0 million term loan provided by Oxford Finance LLC that was completed in December 2018.
       
    • Operating Expenses: GAAP operating expenses were $10.7 million for the fourth quarter of 2019, compared to $13.2 million for the fourth quarter of 2018. For the full year 2019, GAAP operating expenses were $44.5 million compared to $51.9 million for 2018. Non-GAAP operating expenses, which exclude stock-based compensation, were $10.2 million for the fourth quarter of 2019, compared to $10.8 million for the fourth quarter of 2018. For the full year 2019, non-GAAP operating expenses were $39.6 million compared to $39.5 million for 2018.
       
    • Research and Development Expenses: GAAP research and development (R&D) expenses for the fourth quarter of 2019 were $7.0 million, compared to $9.7 million for the fourth quarter of 2018. The decrease was primarily due to reduced spending for nonclinical and manufacturing activities to support initiation of clinical trials for OTO-313 and OTO-413 and decreased stock-based compensation expense. For the full year 2019, GAAP R&D expenses were $32.8 million compared to $31.8 million for 2018.
       
    • Selling, General and Administrative Expenses: GAAP selling, general and administrative (SG&A) expenses in the fourth quarter of 2019 were $3.6 million, compared to $3.6 million for the fourth quarter of 2018. For the full year 2019, GAAP SG&A expenses were $11.7 million compared to $20.0 million for 2018. The year-to-year decrease was primarily a result of lower stock-based compensation expense and reduced OTIPRIO® selling expenses as a result of payments from co-promotion partners.
       
    • Financial Guidance:
      • Operating Expenses: Otonomy expects that non-GAAP operating expenses for 2020 will be in the range of $35-$38 million, and that GAAP operating expenses will be in the range of $45-$48 million.
      • Cash Runway: Otonomy expects that its current cash, cash equivalents, and short term investments will be sufficient to fund the company through completion of the OTIVIDEX Phase 3 trial, OTO-313 Phase 1/2 trial, and OTO-413 Phase 1/2 trial in 2020, and will support company operations into 2021.

    Webcast and Conference Call

    Otonomy management will host a webcast and conference call regarding this announcement at 4:30 p.m. ET/1:30 p.m. PT today. The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 2048824. A live webcast of the call will be available online in the investor relations section of Otonomy's website at www.otonomy.com and will be archived there for 30 days.

    Non-GAAP Operating Expenses

    In this press release, Otonomy's operating expenses are provided in accordance with generally accepted accounting principles (GAAP) in the United States and also on a non-GAAP basis. Non-GAAP operating expenses exclude stock-based compensation. Non-GAAP operating expenses are provided as a complement to operating expenses provided in accordance with GAAP because management believes non-GAAP operating expenses help indicate underlying trends in the company's business, are important in comparing current results with prior period results and provide additional information regarding the company's financial position. Management also uses non-GAAP operating expenses to establish budgets and operational goals that are communicated internally and externally and to manage the company's business and to evaluate its performance. The attached financial information includes a reconciliation of the GAAP operating expenses to non-GAAP operating expenses and a reconciliation of GAAP operating expense guidance to non-GAAP operating expense guidance.

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, timing of results, patient recruitment and enrollment plans for, and design and conduct of, the Phase 3 clinical trial for OTIVIDEX, and expectations regarding submission for U.S. registration; timing of results, patient recruitment and enrollment plans for, and design and conduct of, the Phase 1/2 clinical trial for OTO-313; timing of results, patient recruitment and enrollment plans for, and design and conduct of, the Phase 1/2 clinical trial for OTO-413; expectations regarding the status, timing and nature of upcoming milestones; expectations regarding advancement of preclinical programs; the potential benefits of and activity under the collaboration agreement between AGTC and Otonomy, including but not limited to development and commercialization activity; expectations regarding operating expenses for 2020; expectations that current capital is sufficient to fund the company through completion of the OTIVIDEX Phase 3 trial, OTO-313 Phase 1/2 trial, and OTO-413 Phase 1/2 trial, and will support company operations into 2021; and statements by Otonomy's president and CEO. Otonomy's 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: Otonomy's limited operating history and its expectation that it will incur significant losses for the foreseeable future; Otonomy's ability to accurately forecast financial results; Otonomy's ability to obtain additional financing; Otonomy's dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; Otonomy's ability to obtain regulatory approval for its product candidates; the risks of the occurrence of any event, change or other circumstance that could give rise to the termination of the collaboration agreement between AGTC and Otonomy; the risks of the occurrence of any event, change or other circumstance that could impact Otonomy's ability to repay or comply with the terms of the loan provided by Oxford Finance LLC; side effects or adverse events associated with Otonomy's product candidates; Otonomy's ability to successfully commercialize its product candidates, if approved; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials; Otonomy's dependence on third parties for the manufacture of its product candidates; Otonomy's dependence on a small number of suppliers for raw materials; Otonomy's ability to protect its intellectual property related to its product candidates in the United States and throughout the world; expectations regarding potential therapy benefits, market size, opportunity and growth; Otonomy's ability to manage operating expenses; implementation of Otonomy's 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 Otonomy's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on February 27, 2020, and Otonomy's 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
    Spectrum Science
    Chloé-Anne Ramsey
    Vice President
    404.865.3601

    Investor Inquiries
    Westwicke ICR
    Robert H. Uhl
    Managing Director
    858.356.5932

    Otonomy, Inc.
    Condensed Balance Sheet Data
    (in thousands)
           
      As of December 31,   As of December 31,
        2019       2018  
           
    Cash and cash equivalents $ 25,194     $ 33,633  
           
    Short-term investments   35,476       63,651  
           
    Right-of-use assets   15,465        
           
    Total assets   83,018       104,992  
           
    Long-term debt, net   14,967       14,764  
           
    Leases, net of current   15,320        
           
    Total liabilities   42,785       25,255  
           
    Accumulated deficit   (459,893 )     (415,218 )
           
    Total stockholders' equity   40,233       79,737  
           


    Otonomy, Inc.
    Condensed Statements of Operations
    (in thousands, except share and per share data)
                   
      Three Months Ended   Years Ended
      December 31,   December 31,
        2019       2018       2019       2018  
                   
      (unaudited)        
    Product sales, net $ 93     $ 208     $ 600     $ 745  
    Costs and operating expenses:              
    Cost of product sales   276       271       912       946  
    Research and development   7,034       9,669       32,805       31,844  
    Selling, general and administrative   3,625       3,580       11,690       20,008  
    Total costs and operating expenses   10,935       13,520       45,407       52,798  
    Loss from operations   (10,842 )     (13,312 )     (44,807 )     (52,053 )
                   
    Other (expense) income, net   (83 )     467       132       1,685  
    Net loss $ (10,925 )   $ (12,845 )   $ (44,675 )   $ (50,368 )
                   
    Net loss per share, basic and diluted $ (0.36 )   $ (0.42 )   $ (1.45 )   $ (1.65 )
                   
    Weighted-average shares used to compute net loss per share, basic and diluted   30,768,174       30,646,951       30,726,786       30,610,244  
                   


    Otonomy, Inc.
    Reconciliation of GAAP to Non-GAAP Operating Expenses
    (in thousands)
                   
      Three Months Ended   Years Ended
      December 31,   December 31,
        2019       2018       2019       2018  
                                   
    GAAP operating expenses              
    Research and development $ 7,034     $ 9,669     $ 32,805     $ 31,844  
    Selling, general and administrative   3,625       3,580       11,690       20,008  
    Total GAAP operating expenses   10,659       13,249       44,495       51,852  
    Non-GAAP adjustments              
    R&D stock-based compensation expense   183       (1,075 )     (2,085 )     (4,447 )
    SG&A stock-based compensation expense   (628 )     (1,375 )     (2,793 )     (7,955 )
    Total non-GAAP adjustments   (445 )     (2,450 )     (4,878 )     (12,402 )
    Non-GAAP operating expenses $ 10,214     $ 10,799     $ 39,617     $ 39,450  
                   


    Otonomy, Inc.
    Reconciliation of 2020 GAAP to Non-GAAP Operating Expense Guidance
    (in millions)
       
    GAAP operating expenses $45 - $48
    Non-GAAP adjustments  
    Stock-based compensation expense $10
    Non-GAAP operating expenses $35 - $38
       

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  22. SAN DIEGO, Feb. 24, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that David A. Weber, Ph.D., president and chief executive officer, is scheduled to present at two upcoming investor conferences:

    • Cowen 40th Annual Health Care Conference in Boston on March 2, 2020 at 12 p.m. ET (9 a.m. PT)
       
    • Oppenheimer 30th Annual Healthcare Conference in New York on March 17, 2020 at 1 p.m. ET (10 a.m. PT)

    A live audio webcast of the presentations will be available through the Events page of the company's website (www.otonomy.com). 

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics…

    SAN DIEGO, Feb. 24, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that David A. Weber, Ph.D., president and chief executive officer, is scheduled to present at two upcoming investor conferences:

    • Cowen 40th Annual Health Care Conference in Boston on March 2, 2020 at 12 p.m. ET (9 a.m. PT)
       
    • Oppenheimer 30th Annual Healthcare Conference in New York on March 17, 2020 at 1 p.m. ET (10 a.m. PT)

    A live audio webcast of the presentations will be available through the Events page of the company's website (www.otonomy.com). 

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and tinnitus. For additional information please visit www.otonomy.com.

    Contacts:

    Media Inquiries:
    Spectrum Science
    Chloé-Anne Ramsey
    Vice President
    404.865.3601

    Investor Inquiries:
    Westwicke ICR
    Robert H. Uhl
    Managing Director
    858.356.5932

    Primary Logo

    View Full Article Hide Full Article
  23. SAN DIEGO, Feb. 20, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced it will report financial results for the fourth quarter and full year 2019 as well as provide a corporate update at 4:30 p.m. EST on February 27, 2020.

    The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 2048824. A live webcast of the call will be available online in the investor relations section of Otonomy's website at www.otonomy.com and will be archived there for 30 days.

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development…

    SAN DIEGO, Feb. 20, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced it will report financial results for the fourth quarter and full year 2019 as well as provide a corporate update at 4:30 p.m. EST on February 27, 2020.

    The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 2048824. A live webcast of the call will be available online in the investor relations section of Otonomy's website at www.otonomy.com and will be archived there for 30 days.

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and tinnitus. For additional information please visit www.otonomy.com.

    Contacts:

    Media Inquiries:
    Spectrum Science
    Chloé-Anne Ramsey
    Vice President
    404.865.3601

    Investor Inquiries:
    Westwicke ICR
    Robert H. Uhl
    Managing Director
    858.356.5932

    Primary Logo

    View Full Article Hide Full Article
  24. SAN DIEGO, Jan. 28, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced preclinical results from the company's gene therapy collaboration with Applied Genetic Technologies Corporation (NASDAQ:AGTC) focused initially on treating GJB2 deficiency for congenital hearing loss, and preclinical results demonstrating the therapeutic potential of a class of compounds being evaluated for otoprotection against cisplatin-induced hearing loss (CIHL). These results were presented during the ongoing Association for Research in Otolaryngology (ARO) 43rd Annual MidWinter Meeting being held in San Jose, California.

    "Together with our strategic…

    SAN DIEGO, Jan. 28, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced preclinical results from the company's gene therapy collaboration with Applied Genetic Technologies Corporation (NASDAQ:AGTC) focused initially on treating GJB2 deficiency for congenital hearing loss, and preclinical results demonstrating the therapeutic potential of a class of compounds being evaluated for otoprotection against cisplatin-induced hearing loss (CIHL). These results were presented during the ongoing Association for Research in Otolaryngology (ARO) 43rd Annual MidWinter Meeting being held in San Jose, California.

    "Together with our strategic partner, AGTC, we are encouraged by these initial preclinical results that demonstrate our ability to express a gene of interest in the target cells relevant to the treatment of congenital hearing loss due to GJB2 deficiency," said David A. Weber, Ph.D., president and chief executive officer of Otonomy. "Also, the preclinical results presented for our OTO-510 program highlight the therapeutic potential of a novel class of cisplatin-binding molecules for protection against CIHL and the higher potency of these agents versus other molecules currently in clinical development."

    Preclinical Results for GJB2 Gene Therapy Collaboration

    In October 2019, Otonomy and AGTC announced a strategic collaboration to co-develop and co-commercialize an AAV-based gene therapy to restore hearing in patients with sensorineural hearing loss caused by a mutation in the gap junction protein beta 2 gene (GJB2) -- the most common cause of congenital hearing loss. The joint presentation by Otonomy and AGTC at ARO provided initial demonstration that a gene of interest can be expressed in support cells of the cochlea, which are the relevant target cells for treating GJB2 deficiency, using novel and proprietary AAV capsids. Furthermore, these studies identified several capsids with favorable tropism and gene expression level in support cells compared to previously reported capsids used in the field. Importantly, none of the novel AAV capsids evaluated for further development exhibited signs of cellular toxicity.

    Preclinical Results for OTO-510 Otoprotection Program

    Cisplatin is a potent chemotherapeutic agent that is widely used to treat a variety of cancers in adults and children. Unfortunately, the administration of cisplatin is commonly associated with severe adverse effects including CIHL that is progressive, bilateral and irreversible. At ARO, Otonomy presented preclinical results demonstrating varying degrees of otoprotection against CIHL for several different classes of therapeutic agents. In particular, a novel proprietary class of agents that potently bind to cisplatin demonstrated greater otoprotection than anti-oxidant and anti-apoptotic molecules, and increased potency relative to other cisplatin-binding molecules currently in clinical development. These results highlight the therapeutic potential of Otonomy's novel otoprotectant agents as the basis for the OTO-510 program for CIHL.

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to expectations regarding the potential benefits, development activity and advancement of preclinical programs; the potential benefits of and activity under the collaboration agreement between AGTC and Otonomy, including but not limited to development activity; and statements by Otonomy's president and CEO. Otonomy's 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: Otonomy's limited operating history and its expectation that it will incur significant losses for the foreseeable future; Otonomy's ability to accurately forecast financial results; Otonomy's ability to obtain additional financing; Otonomy's dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; Otonomy's ability to obtain regulatory approval for its product candidates; the risks of the occurrence of any event, change or other circumstance that could give rise to the termination of the collaboration agreement between AGTC and Otonomy; the risks of the occurrence of any event, change or other circumstance that could impact Otonomy's ability to repay or comply with the terms of the loan provided by Oxford Finance LLC; side effects or adverse events associated with Otonomy's product candidates; Otonomy's ability to successfully commercialize its product candidates, if approved; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials; Otonomy's dependence on third parties for the manufacture of its product candidates; Otonomy's dependence on a small number of suppliers for raw materials; Otonomy's ability to protect its intellectual property related to its product candidates in the United States and throughout the world; expectations regarding potential therapy benefits, market size, opportunity and growth; Otonomy's ability to manage operating expenses; implementation of Otonomy's 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 Otonomy's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on November 5, 2019, and Otonomy's 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:
    Spectrum Science
    Chloé-Anne Ramsey
    Vice President
    404.865.3601

    Investor Inquiries:
    Westwicke ICR
    Robert H. Uhl
    Managing Director
    858.356.5932

    Primary Logo

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  25. SAN DIEGO, Jan. 23, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced multiple presentations at the upcoming Association for Research in Otolaryngology (ARO) 43rd Annual MidWinter Meeting, to be held January 25-29, in San Jose, California. These presentations include initial preclinical results from the company's gene therapy collaboration with Applied Genetic Technologies Corporation (NASDAQ:AGTC) focused on GJB2 deficiency, the most common cause of congenital hearing loss, and demonstration of otoprotection for a class of compounds Otonomy is evaluating in preclinical studies for cisplatin-induced hearing loss (CIHL…

    SAN DIEGO, Jan. 23, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced multiple presentations at the upcoming Association for Research in Otolaryngology (ARO) 43rd Annual MidWinter Meeting, to be held January 25-29, in San Jose, California. These presentations include initial preclinical results from the company's gene therapy collaboration with Applied Genetic Technologies Corporation (NASDAQ:AGTC) focused on GJB2 deficiency, the most common cause of congenital hearing loss, and demonstration of otoprotection for a class of compounds Otonomy is evaluating in preclinical studies for cisplatin-induced hearing loss (CIHL).

    "Our multiple presentations at ARO again this year highlight our broad pipeline in neurotology, with data to be presented in support of our programs addressing the treatment of both inherited and acquired forms of hearing loss as well as protection against cisplatin ototoxicity," said David A. Weber, Ph.D., president and chief executive officer of Otonomy. "While our highest priority during 2020 is the successful completion of our three ongoing clinical trials, including the Phase 3 trial of OTIVIDEX™ in Ménière's disease, we remain committed to the advancement of our multiple preclinical programs that address important unmet needs in neurotology."

    All Otonomy presentations are during poster sessions occurring from 1 to 4 p.m. PST on the days indicated below.

    Joint presentation with AGTC related to the GJB2 gene therapy program:

    • "Ex vivo assessment of AAV capsid variant tropism and safety in rat cochlea" by Uribe et al., on January 27.

    Presentations related to Otonomy's OTO-510 program for CIHL:

    • "Ex vivo evaluation of the therapeutic potential of several drug classes to prevent cisplatin mediated ototoxicity in the rat cochlea" by Mathur et al., on January 26.
    • "Evaluations of various therapeutic classes in protection against cisplatin-induced hearing loss (preclinical models)" by Tsivkovskaia et al., on January 26.

    Presentations related to Otonomy's other clinical and preclinical hearing loss programs:

    • "Characterization of OTO-413, an intratympanic sustained-exposure formulation of the neurotrophic factor BDNF, in preclinical models of cochlear synaptopathy" by Tsivkovskaia et al., on January 26.
    • "Comparisons of single versus combinatorial strategies for hair cell regeneration in cochlear explants" by Uribe et al., on January 27.

    Joint presentation of data with research collaborators at the University of Washington related to preclinical evaluations of an age-related hearing loss model:

    • "Age-related hearing loss in zebrafish: surprising senescence in an animal with continuous hair cell turnover" by Coffin et al., on January 28.

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, timing of results of ongoing clinical trials, including  the Phase 3 clinical trial for OTIVIDEX; expectations regarding advancement of preclinical programs; the potential benefits of and activity under the collaboration agreement between AGTC and Otonomy, including but not limited to development activity; and statements by Otonomy's president and CEO. Otonomy's 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: Otonomy's limited operating history and its expectation that it will incur significant losses for the foreseeable future; Otonomy's ability to accurately forecast financial results; Otonomy's ability to obtain additional financing; Otonomy's dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; Otonomy's ability to obtain regulatory approval for its product candidates; the risks of the occurrence of any event, change or other circumstance that could give rise to the termination of the collaboration agreement between AGTC and Otonomy; the risks of the occurrence of any event, change or other circumstance that could impact Otonomy's ability to repay or comply with the terms of the loan provided by Oxford Finance LLC; side effects or adverse events associated with Otonomy's product candidates; Otonomy's ability to successfully commercialize its product candidates, if approved; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials; Otonomy's dependence on third parties for the manufacture of its product candidates; Otonomy's dependence on a small number of suppliers for raw materials; Otonomy's ability to protect its intellectual property related to its product candidates in the United States and throughout the world; expectations regarding potential therapy benefits, market size, opportunity and growth; Otonomy's ability to manage operating expenses; implementation of Otonomy's 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 Otonomy's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on November 5, 2019, and Otonomy's 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:
    Spectrum Science
    Chloé-Anne Ramsey
    Vice President
    404.865.3601

    Investor Inquiries:
    Westwicke ICR
    Robert H. Uhl
    Managing Director
    858.356.5932

    Primary Logo

    View Full Article Hide Full Article
  26. Three programs with clinical trial results in 2020 including OTIVIDEX™ Phase 3 trial in Ménière's disease

    Current capital funds operations into 2021

    SAN DIEGO, Jan. 09, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today provided an update on its product pipeline and financial guidance. Consistent with previously stated timing, the company expects to have results for the Phase 3 trial of OTIVIDEX in Ménière's disease in the third quarter of 2020, the Phase 1/2 trial of OTO-313 in tinnitus patients in the second quarter of 2020, and the Phase 1/2 trial of OTO-413 in patients with hearing loss in the second half of 2020.

    The company finished…

    Three programs with clinical trial results in 2020 including OTIVIDEX™ Phase 3 trial in Ménière's disease

    Current capital funds operations into 2021

    SAN DIEGO, Jan. 09, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today provided an update on its product pipeline and financial guidance. Consistent with previously stated timing, the company expects to have results for the Phase 3 trial of OTIVIDEX in Ménière's disease in the third quarter of 2020, the Phase 1/2 trial of OTO-313 in tinnitus patients in the second quarter of 2020, and the Phase 1/2 trial of OTO-413 in patients with hearing loss in the second half of 2020.

    The company finished 2019 with approximately $61 million in cash, cash equivalents and short term investments and expects that its current capital is sufficient to fund operations through the three clinical trials and into 2021.

    "We are excited to begin 2020, a potentially transformational year for Otonomy driven by our three clinical trial readouts, each of which is a meaningful milestone given the significant patient population, high disease burden, and lack of approved drug treatments," said David A. Weber, Ph.D., president and CEO of Otonomy. "While successful completion of these clinical trials is our highest priority, we also continue to advance multiple preclinical programs including our gene therapy collaboration targeting congenital hearing loss."

    Product Pipeline Update

    • OTIVIDEX: Enrollment in Phase 3 Clinical Trial in Ménière's Disease is Ongoing with Results Expected in the Third Quarter of 2020. Otonomy has completed one successful Phase 3 trial and is conducting this additional pivotal trial to support a submission for U.S. registration of OTIVIDEX in Ménière's disease. The company plans to enroll approximately 160 patients in the United States and Europe.

    • OTO-313: Enrollment in Phase 1/2 Clinical Trial in Tinnitus is Ongoing with Results Expected in the Second Quarter of 2020. Otonomy has successfully completed the initial safety cohort of this randomized, double-blind, placebo-controlled trial, and is enrolling approximately 50 patients with persistent tinnitus in the exploratory efficacy study cohort. OTO-313 is a sustained-exposure formulation of the potent and selective NMDA receptor antagonist gacyclidine.

    • OTO-413: Enrollment in Phase 1/2 Clinical Trial in Hearing Loss is Ongoing with Results Expected in the Second Half of 2020. Otonomy is enrolling hearing loss patients in a Phase 1/2 clinical trial of OTO-413, which is a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF). The Phase 1/2 trial is a randomized, double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety and exploratory efficacy of OTO-413 in patients with speech-in-noise hearing difficulty.

    • Advancing multiple preclinical programs for treatment and prevention of hearing loss.
      • GJB2 gene therapy program: Otonomy and Applied Genetic Technologies Corporation (AGTC) are collaborating to co-develop and co-commercialize an AAV-based gene therapy to restore hearing in patients with hearing loss caused by a mutation in the gap junction protein beta 2 gene (GJB2) -- the most common cause of congenital hearing loss.
      • OTO-6XX: development program targeting hair cell regeneration for severe hearing loss.
      • OTO-510: otoprotection program for patients at risk for cisplatin-induced hearing loss.

    Financial Updates and Guidance

    • Cash Position: Cash, cash equivalents, and short-term investments totaled approximately $61 million as of December 31, 2019. This balance includes proceeds from a $15 million term loan completed in December 2018.

    • Operating Expenses: Otonomy expects that non-GAAP operating expenses for 2020 will be in the range of $35-$38 million, and that GAAP operating expenses will be in the range of $45-$48 million.

    • Cash Runway: Otonomy expects that its current cash, cash equivalents, and short term investments will be sufficient to fund the company through completion of the OTIVIDEX Phase 3 trial, OTO-313 Phase 1/2 trial, and OTO-413 Phase 1/2 trial in 2020, and will support company operations into 2021.

    Non-GAAP Operating Expenses

    In this press release, Otonomy's operating expenses are provided in accordance with generally accepted accounting principles (GAAP) in the United States and also on a non-GAAP basis. Non-GAAP operating expenses exclude stock-based compensation. Non-GAAP operating expenses are provided as a complement to operating expenses provided in accordance with GAAP because management believes non-GAAP operating expenses help indicate underlying trends in the company's business, are important in comparing current results with prior period results and provide additional information regarding the company's financial position. Management also uses non-GAAP operating expenses to establish budgets and operational goals that are communicated internally and externally and to manage the company's business and to evaluate its performance.

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, timing of results, patient recruitment and enrollment plans for, and design and conduct of, the Phase 3 clinical trial for OTIVIDEX, and expectations regarding submission for U.S. registration; timing of results, patient recruitment and enrollment plans for, and design and conduct of, the Phase 1/2 clinical trial for OTO-313; timing of results, patient recruitment and enrollment plans for, and design and conduct of, the Phase 1/2 clinical trial for OTO-413; expectations regarding the status, timing and nature of upcoming milestones; expectations regarding advancement of preclinical programs; the potential benefits of and activity under the collaboration agreement between AGTC and Otonomy, including but not limited to development and commercialization activity; expectations regarding operating expenses for 2020; expectations that current capital is sufficient to fund the company through completion of the OTIVIDEX Phase 3 trial, OTO-313 Phase 1/2 trial, and OTO-413 Phase 1/2 trial, and will support company operations into 2021; and statements by Otonomy's president and CEO. Otonomy's 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: Otonomy's limited operating history and its expectation that it will incur significant losses for the foreseeable future; Otonomy's ability to accurately forecast financial results; Otonomy's ability to obtain additional financing; Otonomy's dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; Otonomy's ability to obtain regulatory approval for its product candidates; the risks of the occurrence of any event, change or other circumstance that could give rise to the termination of the collaboration agreement between AGTC and Otonomy; the risks of the occurrence of any event, change or other circumstance that could impact Otonomy's ability to repay or comply with the terms of the loan provided by Oxford Finance LLC; side effects or adverse events associated with Otonomy's product candidates; Otonomy's ability to successfully commercialize its product candidates, if approved; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials; Otonomy's dependence on third parties for the manufacture of its product candidates; Otonomy's dependence on a small number of suppliers for raw materials; Otonomy's ability to protect its intellectual property related to its product candidates in the United States and throughout the world; expectations regarding potential therapy benefits, market size, opportunity and growth; Otonomy's ability to manage operating expenses; implementation of Otonomy's 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 Otonomy's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on November 5, 2019, and Otonomy's 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
    Spectrum Science
    Leticia Diaz
    Vice President
    202.587.2517

    Investor Inquiries
    Westwicke ICR
    Robert H. Uhl
    Managing Director
    858.356.5932

    Primary Logo

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  27. SAN DIEGO, Nov. 26, 2019 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that David A. Weber, Ph.D., president and chief executive officer, is scheduled to participate in two upcoming investor conferences:

    • A fireside chat at the 31st Annual Piper Jaffray Healthcare Conference in New York on December 3, 2019 at 2:30 p.m. ET (11:30 a.m. PT)

    • A hearing loss panel at the Evercore ISI 2nd Annual HealthCONx Conference in Boston on December 4, 2019 at 12:30 p.m. ET (9:30 a.m. PT)

    A live audio webcast of the fireside chat and panel discussion will be available through the Events page of the company's website (www.otonomy.com). 

    About

    SAN DIEGO, Nov. 26, 2019 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that David A. Weber, Ph.D., president and chief executive officer, is scheduled to participate in two upcoming investor conferences:

    • A fireside chat at the 31st Annual Piper Jaffray Healthcare Conference in New York on December 3, 2019 at 2:30 p.m. ET (11:30 a.m. PT)

    • A hearing loss panel at the Evercore ISI 2nd Annual HealthCONx Conference in Boston on December 4, 2019 at 12:30 p.m. ET (9:30 a.m. PT)

    A live audio webcast of the fireside chat and panel discussion will be available through the Events page of the company's website (www.otonomy.com). 

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and tinnitus. For additional information please visit www.otonomy.com.

    Contacts:

    Media Inquiries
    Spectrum
    Leticia Diaz
    Vice President 
    202.587.2517

    Investor Inquiries
    Westwicke ICR
    Robert H. Uhl
    Managing Director
    858.356.5932

    Primary Logo

    View Full Article Hide Full Article
    • Results from three clinical trials expected in 2020 including the Phase 3 trial of OTIVIDEX™ in Ménière's disease
    • Broadest pipeline in neurotology field expanded to include gene therapy collaboration targeting most common cause of congenital hearing loss
    • Current capital funds operations into 2021

    Conference call and webcast today at 4:30 p.m. ET

    SAN DIEGO, Nov. 05, 2019 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today reported financial results for the quarter ended September 30, 2019 and provided an update on its product pipeline and corporate activities. The company will host a conference call and webcast today at 4:30 p.m. ET to discuss…

    • Results from three clinical trials expected in 2020 including the Phase 3 trial of OTIVIDEX™ in Ménière's disease
    • Broadest pipeline in neurotology field expanded to include gene therapy collaboration targeting most common cause of congenital hearing loss
    • Current capital funds operations into 2021

    Conference call and webcast today at 4:30 p.m. ET

    SAN DIEGO, Nov. 05, 2019 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today reported financial results for the quarter ended September 30, 2019 and provided an update on its product pipeline and corporate activities. The company will host a conference call and webcast today at 4:30 p.m. ET to discuss recent highlights and financial results.

    "We made significant progress in the third quarter toward our goal of reporting results from three clinical trials in 2020: we advanced enrollment in the Phase 3 trial of OTIVIDEX in Ménière's disease; we successfully completed the initial safety cohort and initiated enrollment in the exploratory efficacy cohort in the Phase 1/2 trial of OTO-313 in tinnitus patients; and we received FDA clearance to initiate the Phase 1/2 trial of OTO-413 in patients with hearing loss, an important milestone for this innovative program," said David A. Weber, Ph.D., president and CEO of Otonomy. "While successful completion of these clinical trials is our highest priority, we also continue to advance multiple preclinical programs including the recently announced gene therapy collaboration targeting congenital hearing loss. Importantly, we are effectively managing our spending in order to enable our existing capital to fund operations through the three clinical trial readouts next year and into 2021. To this point, we are reducing our operating expense estimate for 2019."

    Product Pipeline Update

    • OTIVIDEX: Enrollment in Phase 3 Clinical Trial in Ménière's Disease is Ongoing with Results Expected in the Third Quarter of 2020. Otonomy has completed one successful Phase 3 trial and is conducting this additional pivotal trial to support a submission for U.S. registration of OTIVIDEX in Ménière's disease. The company plans to enroll approximately 160 patients in the United States and Europe.

    • OTO-313: Enrollment in Phase 1/2 Clinical Trial in Tinnitus is Ongoing with Results Expected in the Second Quarter of 2020. Otonomy has successfully completed the initial safety cohort of this randomized, double-blind, placebo-controlled trial, and has initiated enrollment of approximately 50 patients with persistent tinnitus in the exploratory efficacy study cohort. OTO-313 is a sustained-exposure formulation of the potent and selective NMDA receptor antagonist gacyclidine.

    • OTO-413: Enrollment in Phase 1/2 Clinical Trial in Hearing Loss is Ongoing with Results Expected in the Second Half of 2020. Otonomy has initiated a Phase 1/2 clinical trial of OTO-413, which is a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF) in development for hearing loss. The Phase 1/2 trial is a randomized, double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety and exploratory efficacy of OTO-413 in patients with speech-in-noise hearing difficulty.

    • Announced Strategic Collaboration to Develop and Commercialize Gene Therapy for Congenital Hearing Loss: In October, Otonomy and Applied Genetic Technologies Corporation (AGTC) announced that they had entered into a strategic collaboration to co-develop and co-commercialize an AAV-based gene therapy to restore hearing in patients with sensorineural hearing loss caused by a mutation in the gap junction protein beta 2 gene (GJB2) -- the most common cause of congenital hearing loss.

    Anticipated Upcoming Milestones

    • Report results from the OTO-313 Phase 1/2 tinnitus trial in the second quarter of 2020.
       
    • Report results from the OTIVIDEX Phase 3 Ménière's disease trial in the third quarter of 2020.
       
    • Report results from the OTO-413 Phase 1/2 hearing loss trial in the second half of 2020.

    Third Quarter Financial Highlights

    • Cash Position: Cash, cash equivalents, and short-term investments totaled $68.2 million as of September 30, 2019, compared to $97.3 million as of December 31, 2018.
       
    • Operating Expenses: GAAP operating expenses were $10.0 million for the third quarter of 2019, compared to $13.0 million for the third quarter of 2018. Non-GAAP operating expenses, which exclude stock-based compensation, were $8.3 million for the third quarter of 2019, compared to $10.1 million for the third quarter of 2018.
       
    • Research and Development Expenses: GAAP research and development (R&D) expenses for the third quarter of 2019 were $8.1 million, compared to $8.3 million for the third quarter of 2018. A slight net decrease in expenses for this quarter compared to a year ago resulted from a decrease in OTO-413 nonclinical and manufacturing activities partially offset by an increase in expenses for the OTO-313 and OTO-413 clinical trials.
       
    • Selling, General and Administrative Expenses: GAAP selling, general and administrative (SG&A) expenses in the third quarter of 2019 were $1.9 million, compared to $4.7 million for the third quarter of 2018. The decrease this quarter was primarily a result of reduced stock-based compensation expense together with OTIPRIO cost reimbursement received from our OTIPRIO co-promotion partners.
       
    • Financial Guidance:
      • 2019 Operating Expenses: Otonomy is revising its financial guidance for 2019 to reflect reduced operating expenses for the year. GAAP operating expenses are expected to be in the range of $50-$55 million, a decrease from previous guidance of $55-$60 million. Non-GAAP operating expenses are expected to be in the range of $40-$45 million, compared to the previous estimate of $45-$50 million.
      • 2020 Operating Expenses: Otonomy expects that operating expenses will be lower than 2019 as multiple clinical trials are completed.
      • Cash Runway: Otonomy expects that its current cash, cash equivalents, and short term investments will be sufficient to fund the company through completion of the OTIVIDEX Phase 3 trial, OTO-313 Phase 1/2 trial, and OTO-413 Phase 1/2 trial in 2020, and will support company operations into 2021.             

    Webcast and Conference Call

    Otonomy management will host a webcast and conference call regarding this announcement at 4:30 p.m. ET/1:30 p.m. PT today. The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 6045449. A live webcast of the call will be available online in the investor relations section of Otonomy's website at www.otonomy.com and will be archived there for 30 days.

    Non-GAAP Operating Expenses

    In this press release, Otonomy's operating expenses are provided in accordance with generally accepted accounting principles (GAAP) in the United States and also on a non-GAAP basis. Non-GAAP operating expenses exclude stock-based compensation. Non-GAAP operating expenses are provided as a complement to operating expenses provided in accordance with GAAP because management believes non-GAAP operating expenses help indicate underlying trends in the company's business, are important in comparing current results with prior period results and provide additional information regarding the company's financial position. Management also uses non-GAAP operating expenses to establish budgets and operational goals that are communicated internally and externally and to manage the company's business and to evaluate its performance. The attached financial information includes a reconciliation of the GAAP operating expenses to non-GAAP operating expenses and a reconciliation of GAAP operating expense guidance to non-GAAP operating expense guidance.

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, timing of results, patient recruitment and enrollment plans for, and design and conduct of, the Phase 3 clinical trial for OTIVIDEX, and expectations regarding submission for U.S. registration; timing of results, patient recruitment and enrollment plans for, and design and conduct of, the Phase 1/2 clinical trial for OTO-313; timing of results, patient recruitment and enrollment plans for, and design and conduct of, the Phase 1/2 clinical trial for OTO-413; expectations regarding the status, timing and nature of upcoming milestones; expectations regarding advancement of preclinical programs; the potential benefits of and activity under the collaboration agreement between AGTC and Otonomy, including but not limited to development and commercialization activity; expectations regarding operating expenses for 2019 and 2020; expectations that current capital is sufficient to fund the company through completion of the OTIVIDEX Phase 3 trial, OTO-313 Phase 1/2 trial, and OTO-413 Phase 1/2 trial, and will support company operations into 2021; and statements by Otonomy's president and CEO. Otonomy's 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: Otonomy's limited operating history and its expectation that it will incur significant losses for the foreseeable future; Otonomy's ability to accurately forecast financial results; Otonomy's ability to obtain additional financing; Otonomy's dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; Otonomy's ability to obtain regulatory approval for its product candidates; the risks of the occurrence of any event, change or other circumstance that could give rise to the termination of the collaboration agreement between AGTC and Otonomy; the risks of the occurrence of any event, change or other circumstance that could impact Otonomy's ability to repay or comply with the terms of the loan provided by Oxford Finance LLC; side effects or adverse events associated with Otonomy's product candidates; Otonomy's ability to successfully commercialize its product candidates, if approved; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials; Otonomy's dependence on third parties for the manufacture of its product candidates; Otonomy's dependence on a small number of suppliers for raw materials; Otonomy's ability to protect its intellectual property related to its product candidates in the United States and throughout the world; expectations regarding potential therapy benefits, market size, opportunity and growth; Otonomy's ability to manage operating expenses; implementation of Otonomy's 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 Otonomy's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on November 5, 2019, and Otonomy's 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
    Spectrum Science
    Leticia Diaz
    Vice President
    202.587.2517

    Investor Inquiries
    Westwicke ICR
    Robert H. Uhl
    Managing Director
    858.356.5932


     
    Otonomy, Inc.
    Condensed Balance Sheet Data
    (in thousands)
               
      As of September 30,     As of December 31,  
      2019     2018  
      (unaudited)        
    Cash and cash equivalents $ 16,257     $ 33,633  
    Short-term investments 51,897     63,651  
    Right-of-use assets 15,792      
    Total assets 92,008     104,992  
    Long-term debt, net 14,917     14,764  
    Leases, net of current 15,673      
    Total liabilities 41,388     25,255  
    Accumulated deficit (448,968 )   (415,218 )
    Total stockholders' equity 50,620     79,737  
               


     
    Otonomy, Inc.
    Condensed Statements of Operations 
    (in thousands, except share and per share data)
     
      Three Months Ended
        Nine Months Ended
     
      September 30,
        September 30,
     
      2019     2018     2019     2018  
      (unaudited)
    Product sales, net $ 125     $ 113     $ 507     $ 537  
    Costs and operating expenses:                      
    Cost of product sales 220     162     636     675  
    Research and development 8,057     8,300     25,771     22,175  
    Selling, general and administrative 1,903     4,652     8,065     16,428  
    Total costs and operating expenses 10,180     13,114     34,472     39,278  
    Loss from operations (10,055 )   (13,001 )   (33,965 )   (38,741 )
    Other income, net 16     455     215     1,218  
    Net loss $ (10,039 )   $ (12,546 )   $ (33,750 )   $ (37,523 )
    Net loss per share, basic and diluted $ (0.33 )   $ (0.41 )   $ (1.10 )   $ (1.23 )
    Weighted-average shares used to compute net loss per share,                      
    basic and diluted 30,748,995     30,630,125     30,712,839     30,597,874  
                           


     
    Otonomy, Inc.
    Reconciliation of GAAP to Non-GAAP Operating Expenses
    (in thousands)
     
      Three Months Ended
        Nine Months Ended
     
      September 30,
        September 30,
     
      2019     2018     2019     2018  
      (unaudited)
    GAAP operating expenses                      
    Research and development $   8,057     $   8,300     $   25,771     $   22,175  
    Selling, general and administrative 1,903     4,652     8,065     16,428  
    Total GAAP operating expenses 9,960     12,952     33,836     38,603  
    Non-GAAP adjustments                      
    R&D stock-based compensation expense (1,037 )   (1,037 )   (2,268 )   (3,372 )
    SG&A stock-based compensation expense (651 )   (1,770 )   (2,165 )   (6,580 )
    Total non-GAAP adjustments (1,688 )   (2,807 )   (4,433 )   (9,952 )
    Non-GAAP operating expenses $   8,272     $   10,145     $   29,403     $   28,651  
                           

     

     
    Otonomy, Inc.
    Reconciliation of 2019 GAAP to Non-GAAP Operating Expense Guidance
    (in millions)
       
       
    GAAP operating expenses $50 - $55
    Non-GAAP adjustments  
    Stock-based compensation expense $10
    Non-GAAP operating expenses $40 - $45
       

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  28. SAN DIEGO, Oct. 29, 2019 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced it will report financial results for the third quarter 2019 as well as provide a corporate update at 4:30 p.m. EST on November 5, 2019.

    The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 6045449. A live webcast of the call will be available online in the investor relations section of Otonomy's website at www.otonomy.com and will be archived there for 30 days.

    About Otonomy
    Otonomy is a biopharmaceutical company dedicated to the development of innovative…

    SAN DIEGO, Oct. 29, 2019 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced it will report financial results for the third quarter 2019 as well as provide a corporate update at 4:30 p.m. EST on November 5, 2019.

    The live call may be accessed by dialing (877) 305-6769 for domestic callers and (678) 562-4239 for international callers with conference ID code number: 6045449. A live webcast of the call will be available online in the investor relations section of Otonomy's website at www.otonomy.com and will be archived there for 30 days.

    About Otonomy
    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and tinnitus. For additional information please visit www.otonomy.com.

    Contacts:

    Media Inquiries
    Spectrum Science
    Leticia Diaz
    Vice President
    202.587.2517


    Investor Inquiries
    Westwicke ICR
    Robert H. Uhl
    Managing Director
    858.356.5932

     

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  29. GAINESVILLE, Fla. and CAMBRIDGE, Mass. and SAN DIEGO, Oct. 01, 2019 (GLOBE NEWSWIRE) -- Applied Genetic Technologies Corporation (NASDAQ:AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, and Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that they have entered into a strategic collaboration to co-develop and co-commercialize an AAV-based gene therapy to restore hearing in patients with sensorineural hearing loss caused by a mutation in the gap junction protein beta 2 gene (GJB2)— the most common cause of congenital hearing loss. 

    Mutations in…

    GAINESVILLE, Fla. and CAMBRIDGE, Mass. and SAN DIEGO, Oct. 01, 2019 (GLOBE NEWSWIRE) -- Applied Genetic Technologies Corporation (NASDAQ:AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, and Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that they have entered into a strategic collaboration to co-develop and co-commercialize an AAV-based gene therapy to restore hearing in patients with sensorineural hearing loss caused by a mutation in the gap junction protein beta 2 gene (GJB2)— the most common cause of congenital hearing loss. 

    Mutations in GJB2 account for approximately 30% of all genetic hearing loss cases. Patients with this mutation can have severe-to-profound deafness in both ears that is identified in screening tests routinely performed in newborns. Under the collaboration agreement, the parties will equally share the program costs and proceeds, and can include additional genetic hearing loss targets in the future. 

    "There is a tremendous unmet need for effective drug therapies to treat sensorineural hearing loss and this is especially true in children born with severe or progressive hearing loss due to genetic mutations," said Lawrence R. Lustig, M.D., Chair, Department of Otolaryngology – Head & Neck Surgery, Columbia University College of Physicians and Surgeons. "Gene therapy holds great promise to restore functional and lasting hearing in these cases, with early intervention providing significant benefits in the development of language skills, socialization and overall quality of life for patients and their families."

    "We are excited to initiate this collaboration which combines our deep capabilities, technology and expertise in gene therapy development and manufacturing with Otonomy's extensive experience in otic drug delivery and existing infrastructure for preclinical and clinical development in neurotology," said Sue Washer, president and CEO of AGTC. "In addition to the positive data that we recently released supporting our XLRP and achromatopsia clinical trials, advancing this program in neurotology further demonstrates the versatility of our gene therapy platform and its applicability to treat a broad range of indications." 

    "As leaders in neurotology, we are pleased to add our expertise to that of the highly experienced AGTC team, leveraging what each of us does best and sharing the cost and effort to bring a novel therapeutic to patients with profound need," said David A. Weber, Ph.D., president and CEO of Otonomy. "The addition of this gene therapy program further extends our broad, innovative pipeline across the largest market opportunities in neurotology including acquired and genetic forms of hearing loss, tinnitus, and balance disorders such as Ménière's disease." 

    About Genetic Hearing Loss
    Hearing loss is the most common inherited sensory disorder. In developed countries such as the United States, genetic mutations are responsible for the vast majority of hearing loss in young children, which is estimated to affect 1 out of 500 children before speech develops. Because congenital hearing loss is one of the most prevalent chronic conditions in children, neonatal screening is routinely performed. This is typically followed by genetic testing in those cases where a deficit has been detected. Mutations have been identified in over 100 genes including the gap junction protein beta 2 gene (GBJ2), which is the most frequent cause of severe-to-profound congenital hearing loss. The GJB2 gene encodes connexin-26 which is expressed in cochlear support cells, forming gap junctions that control potassium homeostasis which is critical for the survival and function of hair cells and normal hearing. Mutations in GJB2 impair gap junctions and cochlear homeostasis leading to hair cell dysfunction and hearing loss. The goal of GJB2 gene therapy is to restore functional gap junctions and preserve hair cells to improve hearing.

    About AGTC
    AGTC is a clinical-stage biotechnology company that uses a proprietary gene therapy platform to develop transformational genetic therapies for patients suffering from rare and debilitating diseases. Its initial focus is in the field of ophthalmology, where it has active clinical trials in X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM CNGB3 & ACHM CNGA3). In addition to its clinical trials, AGTC has preclinical programs in optogenetics, adrenoleukodystrophy (ALD), which is a disease of the central nervous system (CNS) and other ophthalmology and otology indications. The optogenetics program is being developed in collaboration with Bionic Sight. AGTC has a significant intellectual property portfolio and extensive expertise in the design of gene therapy products including capsids, promoters and expression cassettes, as well as expertise in the formulation, manufacture and physical delivery of gene therapy products. For additional information please visit www.agtc.com

    About Otonomy
    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and 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 the future financial or operating performance of AGTC and/or Otonomy. Forward-looking statements in this press release include, but are not limited to, the potential benefits of and activity under the collaboration agreement between AGTC and Otonomy, including but not limited to development and commercialization activity, and cost and proceeds sharing, the potential benefits of the therapy, the strategy and development activities of AGTC and Otonomy, and statements by the president and CEO of AGTC and the president and CEO of Otonomy. AGTC's and Otonomy's 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: the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of the collaboration agreement between AGTC and Otonomy; uncertainties inherent in the clinical drug development process; competition in the biopharmaceutical industry; expectations regarding either company's expertise and capabilities; AGTC's and Otonomy's ability to protect its intellectual property; expectations regarding potential therapy benefits, market size and opportunity; the ability to obtain regulatory approval for such therapies; AGTC's and Otonomy's ability to manage operating expenses; implementation of their respective  business models and strategic plans for their business, products and technology; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in AGTC's Annual Report on Form 10-K for the fiscal year ended June 30, 2019, filed with the Securities and Exchange Commission (the "SEC") and in Otonomy's Quarterly Report on Form 10-Q filed with the SEC on August 1, 2019, and AGTC's and Otonomy's future reports to be filed with the SEC. The forward-looking statements in this press release are based on information available to AGTC and Otonomy as of the date hereof. AGTC and Otonomy each disclaim any obligation to update any forward-looking statements, except as required by law.

    AGTC Contacts:
    IR/PR Contacts:
    David Carey (IR) or Tom Vickery (PR)
    Lazar Partners Ltd.
    T: (212) 867-1768 or (646) 871-8485
     or 

    Otonomy Contacts:
    Media Inquiries
    Spectrum
    Leticia Diaz
    Vice President 
    202.587.2517

    Investor Inquiries
    Westwicke Partners
    Robert H. Uhl
    Managing Director
    858.356.5932

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  30. SAN DIEGO, Sept. 26, 2019 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that David A. Weber, Ph.D., president and chief executive officer, will present at the 2019 Cantor Global Healthcare Conference on Friday, October 4, 2019 at 12:35 p.m. ET (9:35 a.m. PT) at the InterContinental New York Barclay Hotel in New York City.

    A live audio webcast and replay of the presentation will be available through the Events and Presentations page of the company's website (www.otonomy.com).  

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered…

    SAN DIEGO, Sept. 26, 2019 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that David A. Weber, Ph.D., president and chief executive officer, will present at the 2019 Cantor Global Healthcare Conference on Friday, October 4, 2019 at 12:35 p.m. ET (9:35 a.m. PT) at the InterContinental New York Barclay Hotel in New York City.

    A live audio webcast and replay of the presentation will be available through the Events and Presentations page of the company's website (www.otonomy.com).  

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and tinnitus. For additional information please visit www.otonomy.com.

    Contacts:

    Media Inquiries
    Spectrum
    Leticia Diaz
    Vice President 
    202.587.2517

    Investor Inquiries
    Westwicke Partners
    Robert H. Uhl
    Managing Director
    858.356.5932

     

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  31. SAN DIEGO, Sept. 17, 2019 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced the initiation of a Phase 1/2 clinical trial of OTO-413, a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), in patients with hearing loss. The Phase 1/2 trial is a randomized, double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety and exploratory efficacy of OTO-413 in patients with speech-in-noise hearing difficulty.

    "Recent scientific research in the neurotology field has demonstrated that damage or loss of synaptic connections between inner ear hair cells and spiral ganglion neurons…

    SAN DIEGO, Sept. 17, 2019 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced the initiation of a Phase 1/2 clinical trial of OTO-413, a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), in patients with hearing loss. The Phase 1/2 trial is a randomized, double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety and exploratory efficacy of OTO-413 in patients with speech-in-noise hearing difficulty.

    "Recent scientific research in the neurotology field has demonstrated that damage or loss of synaptic connections between inner ear hair cells and spiral ganglion neurons, known as cochlear synaptopathy, is involved in the hearing difficulty that many people experience in a loud environment, and that this pathology may also play a role in age-related and noise-induced hearing loss," said Andrea Vambutas, M.D., Director for the Center of Hearing & Balance at the New York Head & Neck Institute. "Repair of the synaptic connection through local administration of a neurotrophic factor such as BDNF holds promise for patients with speech-in-noise hearing difficulty, and this Phase 1/2 clinical trial provides an exciting first opportunity to evaluate this therapeutic approach."

    "Initiating this clinical trial as planned keeps us on track to have results for three clinical programs in 2020 – the OTIVIDEX™ Phase 3 trial in Ménière's disease in the first half of 2020, the OTO-313 Phase 1/2 trial in tinnitus patients in the first half of 2020, and this OTO-413 Phase 1/2 trial in the second half of 2020," said David A. Weber, Ph.D., president and CEO of Otonomy. "Furthermore, advancing this program into clinical development also highlights our leadership in neurotology with clinical-stage programs addressing hearing loss, tinnitus, and balance disorders, the largest indications and market opportunities in this emerging field."

    About OTO-413

    OTO-413 is a proprietary, sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), which is a naturally occurring protein involved in neuron growth and repair. Nonclinical studies have demonstrated that local administration of BDNF repairs ribbon synapses damaged due to noise trauma or exposure to ototoxic chemicals, and restores hearing function. The initial indication for OTO-413 is speech-in-noise hearing difficulty, a type of hearing loss believed to be caused by cochlear synaptopathy that affects an estimated 9 million people in the United States. A Phase 1/2 clinical trial evaluating the safety and exploratory efficacy of OTO-413 in patients with speech-in-noise hearing difficulty is expected to have results in the second half of 2020.

    About Otonomy

    Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière's disease, hearing loss, and 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 the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, timing of results, patient recruitment and enrollment plans, and trial design and conduct for the Phase 1/2 clinical trial for OTO-413, timing of results for the OTIVIDEX Phase 3 trial in Ménière's disease and the OTO-313 Phase 1/2 trial in tinnitus patients, and statements by Otonomy's president and CEO. Otonomy's 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: Otonomy's limited operating history and its expectation that it will incur significant losses for the foreseeable future; Otonomy's ability to accurately forecast financial results;  Otonomy's ability to obtain additional financing; Otonomy's dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; Otonomy's ability to obtain regulatory approval for its product candidates; side effects or adverse events associated with Otonomy's product candidates; Otonomy's ability to successfully commercialize its product candidates, if approved; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct nonclinical studies and clinical trials; Otonomy's dependence on third parties for the manufacture of its product candidates; Otonomy's dependence on a small number of suppliers for raw materials; Otonomy's ability to protect its intellectual property related to its product candidates in the United States and throughout the world; expectations regarding potential therapy benefits, market size, opportunity and growth; Otonomy's ability to manage operating expenses; implementation of Otonomy's 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 Otonomy's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on August 1, 2019, and Otonomy's 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
    Spectrum Science
    Leticia Diaz
    Vice President
    202.587.2517

    Investor Inquiries
    Westwicke Partners
    Robert H. Uhl
    Managing Director
    858.356.5932

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