Annonce • Feb 18
Otonomy, Inc. Announces Executive Changes On February 15, 2023, the board of directors of the Otonomy, Inc. appointed H. Michael Hogan, a representative of Armanino LLP (Armanino), a consultant to the Company, to the Board. In connection and simultaneously with Mr. Hogan’s appointment to the Board, the size of the Board was reduced to one and Jay Lichter, Ph.D., James B. Breitmeyer, M.D., Ph.D., Jill Broadfoot, Vickie Capps, Ciara Kennedy, Ph.D., Iain McGill, Theodore R. Schroeder and David A. Weber, Ph.D. resigned from the Board. The directors did not resign because of any disagreement with the Company relating to its operations, policies or practices. Mr. Hogan will serve as a director pursuant to the Company’s engagement of Armanino, but will not receive any compensation for his service as the Company’s sole director. Annonce • Oct 14
Otonomy, Inc Reports Results from Clinical Evaluation of OTO-413 Higher Doses in Patients with Hearing Loss Otonomy, Inc. announced that the clinical evaluation of higher doses for OTO-413 (0.75 mg and 1.50 mg) in patients with hearing loss demonstrated no clinically meaningful improvement for patients from baseline across multiple speech-in-noise (SIN) hearing tests. These results are in contrast to the positive clinical signal observed with 0.3 mg OTO-413 versus placebo in the previous Phase 1/2 and Phase 2a trial cohorts using the same study design and endpoints. The randomized, double-blind, placebo-controlled higher dose cohorts enrolled patients who self-reported difficulty hearing in a noisy environment that was confirmed with a SIN hearing test. In each dose cohort, nineteen patients were randomized 2:1 to a single intratympanic injection of OTO-413 (0.75 mg or 1.50 mg) or placebo. Patients were assessed with the same SIN tests utilized in prior cohorts including the Words-in-Noise (WIN) test, with the assessment of treatment benefit based on demonstration of a clinically meaningful improvement from baseline versus placebo at both Days 57 and 85. Annonce • Sep 17
Otonomy Receives Non-Compliance Letter from Nasdaq On September 14, 2022, Otonomy, Inc. (the Company) received a written notice from the Listing Qualifications Staff of The Nasdaq Stock Market (Nasdaq) notifying the Company that it has not been in compliance with theminimum bid price requirement set forth in Nasdaq Listing Rule 5450(a)(1) for a period of 30 consecutive business days (the Notice). This Notice has no immediate effect on the listing of the Company's stock on The Nasdaq Global Select Market. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company is provided a compliance period of 180 calendar days from the date of the Notice to regain compliance with the minimum closing bid price requirement. If the Company does not regain compliance during the compliance period, the Company may be afforded a second 180 calendar day period to regain compliance. To qualify, the Company must meet the continued listing requirement for market value of publicly-held shares and all other initial listing standards for the Nasdaq Capital Market (with the exception of the minimum bid price requirement) and notify Nasdaq of its intent to cure the deficiency by effecting a reverse stock split if necessary. If the Company does not regain compliance within the allotted compliance periods, including any extensions that may be granted by Nasdaq, the Company's stock will be subject to delisting. The Company can achieve compliance with the minimum bid price requirement if, during either compliance period, the closing bid price per share of the Company's stock is at least $1.00 for a minimum of ten consecutive business days. The Company intends to monitor the closing bid price of its stock and assess potential actions to regain compliance, but there can be no assurance that the Company will regain compliance with the minimum bid price requirement during the 180-day compliance period, secure a second 180-day period to regain compliance, or maintain compliance with the other Nasdaq listing requirements. Annonce • Aug 11
Otonomy, Inc. Announces Departure of Robert Michael Savel II, as Chief Technical Officer Effective August 15, 2022 Otonomy, Inc. announced that Robert Michael Savel II, the Company’s Chief Technical Officer, will depart the Company, effective August 15, 2022. Mr. Savel is eligible to receive severance benefits under his Employment Agreement with the Company, dated April 16, 2021. Annonce • Aug 02
Otonomy Reports Results from Phase 2 Clinical Trial of Oto-313 in Patients with Tinnitus Otonomy, Inc. announced that the OTO-313 Phase 2 trial in tinnitus demonstrated no clinically meaningful benefit versus placebo for primary and secondary endpoints across all timepoints. The randomized, double-blind, placebo-controlled Phase 2 trial enrolled 153 patients with persistent, unilateral tinnitus of at least moderate severity. Patients were randomized 1:1 to a single intratympanic injection of OTO-313 (n=77) or placebo (n=76) and followed for 4 months. The primary endpoint was a responder analysis based on the proportion of patients who reported a clinically meaningful improvement, defined as a reduction of 13 points or more in the Tinnitus Functional Index (TFI), from baseline to both Months 1 and 2 following treatment. The trial failed to meet this primary endpoint as well as secondary endpoints for the total study population. Although OTO-313 did show a higher response rate than placebo in a prospectively defined patient subgroup with tinnitus duration of less than 6 months (population studied in Phase 1/2 trial), the overall results do not support further development of OTO-313. The company’s clinical focus shifts to OTO-413 for the treatment of hearing loss. Positive Phase 2a results for OTO-413 were announced in April 2022, which corroborated findings from an earlier Phase 1/2 study. In addition, enrollment is complete for evaluation of higher dosing with top-line results expected in the fourth quarter of 2022. Annonce • Jul 19
Otonomy, Inc. to Report Q2, 2022 Results on Jul 25, 2022 Otonomy, Inc. announced that they will report Q2, 2022 results at 4:00 PM, US Eastern Standard Time on Jul 25, 2022 Reported Earnings • May 11
First quarter 2022 earnings released: US$0.20 loss per share (vs US$0.23 loss in 1Q 2021) First quarter 2022 results: US$0.20 loss per share. Net loss: US$13.6m (loss widened 11% from 1Q 2021). Over the next year, revenue is expected to shrink by 100% compared to a 6.1% growth forecast for the industry in Germany. Annonce • May 03
Otonomy, Inc. to Report Q1, 2022 Results on May 09, 2022 Otonomy, Inc. announced that they will report Q1, 2022 results on May 09, 2022 Annonce • Apr 21
Otonomy, Inc. Reports Positive Top-Line Results from Phase 2a Clinical Trial of OTO-413 in Patients with Hearing Loss Otonomy, Inc. announced positive top-line results from the Phase 2a clinical trial of OTO-413 in subjects with hearing loss. The randomized, double-blind, placebo-controlled trial demonstrated that a single intratympanic injection of 0.3 mg OTO-413, a sustained exposure formulation of brain-derived neurotrophic factor (BDNF), provided clinically meaningful treatment benefit versus placebo across multiple speech-in-noise (SIN) hearing tests as well as the Patient Global Impression of Change (PGIC) at consecutive time points (Days 57 and 85). These results support the clinical activity of OTO-413 observed in the prior Phase 1/2 trial and provide a second, independent demonstration of the treatment potential of OTO-413 for patients over a broad range of hearing loss levels. The design of the Phase 2a trial was the same as the previous Phase 1/2 trial. All subjects self-reported hearing difficulty in a noisy environment that was confirmed by SIN testing. Subjects could also have up to moderately-severe hearing loss by standard audiometric testing. As in the Phase 1/2 trial, multiple clinically-validated SIN hearing tests including Digits-in-Noise, Words-in-Noise, and the American English Matrix test were administered at baseline and following treatment. The assessment of treatment benefit was based on demonstration of a clinically-meaningful improvement from baseline versus placebo at both Days 57 and 85. The results below are for the 30 evaluable subjects (out of 33 total enrolled), which includes 20 treated with OTO-413 and 10 who received placebo. 40% (8 of 20) OTO-413 subjects demonstrated a clinically-meaningful improvement on at least one of the three SIN tests at both Days 57 and 85 versus 20% (2 out of 10) for placebo. 15% (3 of 20) OTO-413 subjects demonstrated a clinically-meaningful improvement by two or more different SIN tests at both Days 57 and 85 versus 0% (0 of 10) for placebo. For the Words-in-Noise test that has been well-established and validated in hearing loss patients, 40% (6 of 15 with evaluable tests) OTO-413 subjects demonstrated a clinically-meaningful improvement at both Days 57 and 85 versus 0% (0 of 9 with evaluable tests) for placebo. Most of the patients enrolled in this trial also had moderate-to-severe high-frequency hearing loss measured with standard audiometric testing. The responder rate for OTO-413 was favorable in this subset as well with 41% (7 of 17) OTO-413 subjects demonstrating a clinically-meaningful improvement in at least one SIN test at both Days 57 and 85 compared to 13% (1 of 8) placebo subjects. The PGIC demonstrated a treatment benefit with 50% (10 of 20) OTO-413 subjects reporting an improvement from baseline at both Days 57 and 85 compared to only 10% (1 of 10) for placebo. Treatment with OTO-413 was well tolerated. There were no serious adverse events and no discontinued patients due to an adverse event (AE). 32% of OTO-413 and 46% of placebo subjects reported an AE, most of which were mild. Based on these positive results, Otonomy intends to initiate a full dose-ranging Phase 2 trial in hearing loss patients by the end of 2022. This trial will also incorporate learnings from the ongoing higher dose evaluations that are assessing the tolerability and treatment activity of two higher doses of OTO-413: 0.75 mg and 1.50 mg, which is five times the dose evaluated in the Phase 2a trial. Results from the higher dose evaluation are expected in the second half of 2022. Reported Earnings • Mar 02
Full year 2021 earnings: Revenues and EPS in line with analyst expectations Full year 2021 results: US$0.81 loss per share (up from US$1.10 loss in FY 2020). Net loss: US$51.2m (loss widened 14% from FY 2020). Revenue was in line with analyst estimates. Over the next year, revenue is expected to shrink by 100% compared to a 7.8% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 26% per year but the company’s share price has fallen by 6% per year, which means it is significantly lagging earnings. Annonce • Feb 24
Otonomy, Inc. Completes Enrollment in Phase 2 Clinical Trial of OTO-313 in Tinnitus Otonomy, Inc. announced the completion of patient enrollment in the Phase 2 clinical trial of OTO-313 in tinnitus. The randomized, double-blind, placebo-controlled trial enrolled 153 patients with persistent, unilateral tinnitus of at least moderate severity (target enrollment was 140 patients). Patients were randomized 1:1 to a single intratympanic injection of OTO-313 (0.32 mg) or placebo and are being followed for 4 months. The primary endpoint is the same as reported for the successful Phase 1/2 trial: a responder analysis based on the proportion of patients who report a clinically meaningful improvement in the Tinnitus Functional Index (TFI) from baseline to Months 1 and 2 following treatment. Top-line results for all timepoints are expected to be available in mid-2022. Annonce • Feb 18
Otonomy, Inc. to Report Q4, 2021 Results on Feb 28, 2022 Otonomy, Inc. announced that they will report Q4, 2021 results on Feb 28, 2022 Annonce • Jan 07
Otonomy Reports Corporate and Product Pipeline Update Otonomy, Inc. provided an update on its product pipeline and financial guidance. Consistent with previously stated timing, the company expects to report results for the Phase 2a cohort of OTO-413 in hearing loss patients early in the second quarter of 2022 and the Phase 2 trial of OTO-313 in tinnitus patients in mid-2022. The company also plans to initiate a clinical safety evaluation of higher unilateral as well as bilateral dosing of OTO-313 and, as previously announced, has initiated clinical evaluation of higher dosing of OTO-413. Results of these multiple studies are expected to inform initiation of a full dose-ranging Phase 2 trial for OTO-413 by the end of 2022 and start of the Phase 3 clinical program for OTO-313 in the first half of 2023. The company finished 2021 with approximately $77 million in cash, cash equivalents and short term investments and expects that its current capital is sufficient to fund operations into the second half of 2023. Product Pipeline Update: OTO-313: Phase 2 trial in tinnitus is ongoing with top-line results expected in mid-2022; initiating safety evaluation of higher and bilateral dosing. Otonomy is conducting a Phase 2 trial of OTO-313 that will enroll approximately 140 patients with persistent, unilateral tinnitus of at least moderate severity. Patients are being randomized 1:1 to a single intratympanic injection of OTO-313 (0.32 mg) or placebo. The primary endpoint is the same as reported for the successful Phase 1/2 trial: a responder analysis based on the proportion of patients who report a clinically meaningful improvement in the Tinnitus Functional Index (TFI) from baseline to Months 1 and 2 following treatment. To assess durability of the OTO-313 treatment effect, the follow-up period has been extended out to four months. Following the positive Phase 1/2 trial, Otonomy conducted additional nonclinical testing and successfully completed a Type C meeting with the U.S. Food and Drug Administration (FDA) in December supporting initiation of a 1-month safety study for bilateral and higher (0.64 mg) dosing of OTO-313. Additional efficacy results from the Phase 2 extended observation period and safety data from the bilateral and higher unilateral dose study are anticipated in the second half of 2022. Altogether, these multiple clinical data readouts for OTO-313 are expected to support an End-of-Phase 2 meeting with the FDA and inform the design of the Phase 3 clinical program planned to start in the first half of 2023. OTO-413: Phase 2a cohort in hearing loss is fully enrolled with top-line results expected early in the second quarter of 2022; clinical evaluation of higher dosing initiated.Otonomy has completed enrollment in the Phase 2a cohort for the higher OTO-413 dose (0.3 mg) evaluated in the initial Phase 1/2 trial cohorts. A total of 33 patients with hearing loss were randomized 2:1 to receive a single intratympanic injection of OTO-413 or placebo. Patients are being followed for three months and assessed using multiple clinically-validated speech-in-noise hearing tests. Otonomy has also initiated enrollment to evaluate safety of at least one higher dose of OTO-413 (starting with 0.75 mg). Each dose cohort will enroll approximately 12 hearing loss patients randomized 2:1 to OTO-413 or placebo and patients will be assessed as in the Phase 2a. Based on results from the Phase 2a cohort and higher-dose safety evaluation, Otonomy expects to initiate a full dose-ranging Phase 2 efficacy trial by the end of 2022. OTO-825:preclinical studies validate therapeutic potential ofGJB2 gene therapy for congenital hearing loss with Investigational New Drug (IND) filing expected in first half of 2023. OTO-825 is an AAV-based gene therapy to restore hearing in patients with a mutation in the gap junction beta-2 (GJB2) gene, the most common cause of congenital hearing loss. Preclinical proof-of-concept results for OTO-825 demonstrate that a single administration of OTO-825 rescues hearing loss and cochlear damage in two preclinical models representing a range of hearing loss severity caused by GJB2 deficiency. A Pre-IND meeting has been completed with the FDA and IND-enabling activities are ongoing. 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. The goal of the OTO-510 program is otoprotection without tumor protection. OTO-6XX: preclinical development ongoing for severe hearing loss program. Otonomy is evaluating therapeutic approaches to repair or regenerate cochlear hair cells that are damaged due to noise, aging or exposure to ototoxic chemicals. This mechanism is expected to be complementary to repair of cochlear synapses, which is addressed by OTO-413. Reported Earnings • Nov 11
Third quarter 2021 earnings released: US$0.19 loss per share (vs US$0.22 loss in 3Q 2020) Third quarter 2021 results: Net loss: US$12.9m (loss widened 19% from 3Q 2020). Over the last 3 years on average, earnings per share has increased by 24% per year but the company’s share price has fallen by 4% per year, which means it is significantly lagging earnings. Reported Earnings • Aug 06
Second quarter 2021 earnings released: US$0.19 loss per share (vs US$0.37 loss in 2Q 2020) Second quarter 2021 results: Net loss: US$12.5m (loss widened 9.2% from 2Q 2020). Over the last 3 years on average, earnings per share has increased by 24% per year but the company’s share price has fallen by 23% per year, which means it is significantly lagging earnings. Annonce • Jun 16
Otonomy Initiates Expansion of Phase 1/2 Clinical Trial for Oto-413 in Hearing Loss Otonomy, Inc. announced the initiation of an expansion study for the Phase 1/2 clinical trial of OTO-413 in patients with speech-in-noise hearing difficulty. The randomized, double-blind, placebo-controlled study cohort will enroll approximately 30 hearing loss patients of which 20 will be treated with a single intratympanic injection of OTO-413 and 10 will receive placebo. Patients will be followed for 3 months and therapeutic activity will be assessed using the same three clinically-validated speech-in-noise hearing tests utilized in the prior cohorts: the American English Matrix phrase test, the Words-in-Noise test and the Digits-in-Noise test. Top-line results are expected in mid-2022. The Phase 1/2 expansion study will be conducted at multiple clinical sites in the U.S. and will enroll approximately 30 patients with self-reported hearing loss confirmed by a speech-in-noise hearing test. The primary assessment of treatment benefit will be based on the proportion of responders in the OTO-413 group versus placebo who demonstrate a clinically-meaningful level of improvement in speech-in-noise hearing from baseline to Months 2 and 3 following treatment. Recent research has shown that the loss of synaptic connections between inner ear hair cells and auditory nerve fibers contributes to hearing impairment and may occur earlier than the loss of cochlear hair cells. 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. 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. An initial dose ascending clinical trial demonstrated that a single intratympanic injection of OTO-413 was well-tolerated, and the proportion of subjects with a clinically-meaningful improvement in speech-in-noise hearing was higher in the OTO-413 treated group than placebo. Annonce • Jun 05
ALK-Abelló A/S (CPSE:ALK B) acquired OTIPRIO from Otonomy, Inc. (NasdaqGS:OTIC). ALK-Abelló A/S (CPSE:ALK B) acquired OTIPRIO from Otonomy, Inc. (NasdaqGS:OTIC) on May 28, 2021. The transaction includes intellectual property and other material assets with respect to OTIPRIO.
ALK-Abelló A/S (CPSE:ALK B) completed the acquisition of OTIPRIO from Otonomy, Inc. (NasdaqGS:OTIC) on May 28, 2021. Reported Earnings • May 12
First quarter 2021 earnings released: US$0.23 loss per share (vs US$0.38 loss in 1Q 2020) First quarter 2021 results: Net loss: US$12.2m (loss widened 3.8% from 1Q 2020). Over the last 3 years on average, earnings per share has increased by 24% per year but the company’s share price has fallen by 23% per year, which means it is significantly lagging earnings. Annonce • Apr 29
Otonomy, Inc. Announces to Present Preclinical Proof-of-Concept Results for OTO-825 Gene Therapy at ASGCT Annual Meeting Otonomy, Inc. announced the upcoming presentation of preclinical proof-of-concept data for OTO-825 at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting on May 13, 2021. OTO-825 is the clinical candidate targeting the gap junction beta-2 (GJB2) gene developed under the company’s collaboration with Applied Genetic Technologies Corporation. Mutations in the GJB2 gene are the most common cause of congenital hearing loss and typically result in moderate to severe hearing impairment. The oral presentation entitled “AAV-mediated GJB2 gene therapy rescues hearing loss and cochlear damage in a mouse model of congenital hearing loss caused by conditional Connexin26 knockout” by Mathur et al., will be presented on May 13 at 6:30 p.m. EDT. Is New 90 Day High Low • Feb 24
New 90-day low: €2.33 The company is down 35% from its price of €3.60 on 25 November 2020. The German market is up 9.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 8.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €93.22 per share. Annonce • Feb 23
Otonomy Announces Top-Line Results for the Phase 3 Clinical Trial of OTIVIDEX® in Patients with Ménière's Disease Otonomy, Inc. 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). 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. Reported Earnings • Feb 13
Full year 2020 earnings released: US$1.10 loss per share (vs US$1.45 loss in FY 2019) Full year 2020 results: Net loss: US$44.7m (flat on FY 2019). Over the last 3 years on average, earnings per share has increased by 27% per year but the company’s share price has fallen by 1% per year, which means it is significantly lagging earnings. Analyst Estimate Surprise Post Earnings • Feb 13
Revenue misses expectations Revenue missed analyst estimates by 48%. Over the next year, revenue is forecast to grow 2,669%, compared to a 2.5% growth forecast for the Pharmaceuticals industry in Germany. Annonce • Feb 05
Otonomy, Inc. to Report Q4, 2020 Results on Feb 11, 2021 Otonomy, Inc. announced that they will report Q4, 2020 results at 4:30 PM, US Eastern Standard Time on Feb 11, 2021 Is New 90 Day High Low • Jan 07
New 90-day high: €5.29 The company is up 49% from its price of €3.54 on 09 October 2020. The German market is up 8.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 10.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €132 per share. Annonce • Dec 19
Otonomy, Inc. Reports Positive Top-Line Results from Phase 1/2 Clinical Trial of OTO-413 in Patients with Hearing Loss Otonomy, Inc. 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. 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. 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. Is New 90 Day High Low • Dec 11
New 90-day high: €4.37 The company is up 37% from its price of €3.18 on 11 September 2020. The German market is up 2.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is down 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €140 per share. Annonce • Dec 02
Otonomy, Inc. Provides Update on Otividex® and Oto-313 Programs Otonomy, Inc. 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 planconfirms use of the Negative Binomial model for analysis of the primary endpoint in the ongoing Phase 3 clinical trial in Ménière’sdisease. 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. Analyst Estimate Surprise Post Earnings • Nov 07
Revenue misses expectations Revenue missed analyst estimates by 9.1%. Over the next year, revenue is forecast to grow 1,756%, compared to a 3.2% growth forecast for the Pharmaceuticals industry in Germany. Reported Earnings • Nov 07
Third quarter 2020 earnings released: US$0.22 loss per share Third quarter 2020 results: Net loss: US$10.9m (loss widened 8.2% from 3Q 2019). Over the last 3 years on average, earnings per share has increased by 30% per year but the company’s share price has fallen by 11% per year, which means it is significantly lagging earnings. Annonce • Oct 29
Otonomy, Inc. to Report Q3, 2020 Results on Nov 04, 2020 Otonomy, Inc. announced that they will report Q3, 2020 results at 4:30 PM, US Eastern Standard Time on Nov 04, 2020 Is New 90 Day High Low • Oct 07
New 90-day high: €4.02 The company is up 19% from its price of €3.37 on 09 July 2020. The German market is up 3.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is down 7.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €115 per share. Annonce • Jul 31
Otonomy, Inc. to Report Q2, 2020 Results on Aug 04, 2020 Otonomy, Inc. announced that they will report Q2, 2020 results at 9:12 PM, GMT Standard Time on Aug 04, 2020 Annonce • Jul 10
Otonomy, Inc. has completed a Follow-on Equity Offering in the amount of $60.121 million. Otonomy, Inc. has completed a Follow-on Equity Offering in the amount of $60.121 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 14,500,000
Price\Range: $3.25
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 4,000,000
Price\Range: $3.249 Annonce • Jul 03
Otonomy, Inc.(NasdaqGS:OTIC) dropped from Russell Microcap Value Index Otonomy, Inc.(NasdaqGS:OTIC) dropped from Russell Microcap Value Index