OTIC Otonomy Inc.

4.7
-0.16  -3%
Previous Close 4.86
Open 4.9
52 Week Low 1.53
52 Week High 6.983
Market Cap $226,670,214
Shares 48,227,705
Float 45,811,662
Enterprise Value $187,951,511
Volume 469,586
Av. Daily Volume 477,500
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Upcoming Catalysts

Drug Stage Catalyst Date
OTIVIDEX
Ménière's disease
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
OTO-413
Hidden hearing loss
Phase 1/2
Phase 1/2
Phase 1/2 data released December 17, 2020. 6 out of 9 (67%) patients 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.
OTO-313
Tinnitus
Phase 1/2
Phase 1/2
Phase 2 trial to commence 1Q 2021.
OTIPRIO
Acute otitis externa
Approved
Approved
Approval announced March 2, 2018.
OTO-104 AVERTS-1
Meniere's disease
Phase 3
Phase 3
Phase 3 data released August 30 failed to meet primary and key secondary endpoints.
OTIPRIO (ciprofloxacin otic suspension)
Ear Tube Placement Surgery
Approved
Approved
Approved December 11, 2015

Latest News

  1. 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



    Primary Logo

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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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  2. 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

      



    Primary Logo

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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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