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Otonomy, Inc. (Nasdaq: OTIC) has announced a public offering of 14,500,000 shares of common stock at $3.25 per share, alongside pre-funded warrants for 4,000,000 shares at $3.249 each. The total gross proceeds are estimated at $60.1 million, excluding underwriting and offering expenses. The offering is set to close around July 13, 2020. Cowen and Piper Sandler are leading the offering, with an option for underwriters to purchase an additional 2,775,000 shares. The company's registration statement with the SEC became effective in September 2018.
Otonomy, Inc. (Nasdaq: OTIC) has announced an underwritten public offering of its common stock, including pre-funded warrants. The offering includes a 30-day option for underwriters to purchase up to an additional 15% of the shares sold. Market conditions may affect the offering's completion and terms. Cowen and Piper Sandler are leading the offering, with Cantor Fitzgerald as a passive bookrunner. A preliminary prospectus supplement will be filed with the SEC to outline the offering details. This announcement is subject to various risks and uncertainties regarding capital raising.
Otonomy, Inc. (Nasdaq: OTIC) announced positive results from its Phase 1/2 clinical trial of OTO-313 for treating persistent tinnitus. In the trial, 43% of patients receiving OTO-313 were responders, significantly higher than the 13% of placebo patients. The treatment exhibited a favorable safety profile, with fewer adverse events compared to the placebo group. These outcomes justify advancing OTO-313 to full Phase 2 development. Management will discuss the results in a conference call today at 4:30 p.m. ET.
Otonomy, Inc. (OTIC) has updated its statistical analysis plan for the ongoing Phase 3 trial of OTIVIDEX in treating Ménière’s disease. In response to FDA inquiries, the company is transitioning to a Negative Binomial model, which it believes better fits the clinical data compared to the Generalized Poisson model. This adjustment allows Otonomy to reduce the target enrollment from 160 to 142 patients while maintaining over 90% statistical power. Results from the trial are expected to be announced in Q1 2021.
Otonomy (Nasdaq: OTIC) provided a clinical update on its product pipeline, highlighting three ongoing trials. Key timelines include Phase 3 results for OTIVIDEX in Ménière’s disease expected in Q1 2021, Phase 1/2 results for OTO-313 in tinnitus expected in July 2020, and Phase 1/2 results for OTO-413 in hearing loss anticipated in Q4 2020. The company believes it can manage COVID-19 impacts on trial integrity. Financial guidance indicates operating expenses of $35-$38 million for 2020, with sufficient funds to support operations through mid-2021.
Otonomy, a biopharmaceutical company, announced that its CEO, David A. Weber, Ph.D., will present a company overview at the Raymond James 2020 Human Health Innovation Conference on June 18, 2020, at 2:20 p.m. ET. The presentation will be available via a live audio webcast on Otonomy’s website. The company focuses on developing innovative therapeutics for neurotology, leveraging drug delivery technology to address conditions like Ménière’s disease, hearing loss, and tinnitus.
Otonomy, Inc. (Nasdaq: OTIC) has announced a change in the format of its 2020 Annual Meeting of Stockholders, which will now be held virtually due to COVID-19 safety measures. The meeting is scheduled for June 23, 2020, at 8 a.m. PDT, and only stockholders who held shares as of April 24, 2020, can participate. Access to the meeting will be through a webcast, with instructions for voting and asking questions provided on the meeting's website.
Otonomy, Inc. (Nasdaq: OTIC) will host a conference call and webcast on June 15, 2020, at 4:30 p.m. EDT to discuss the status of its ongoing clinical trials, including the Phase 3 trial of OTIVIDEX® for Ménière’s disease. This update follows a delay in April due to COVID-19. Interested parties can access the call by dialing (877) 305-6769 domestically or (678) 562-4239 internationally, using conference ID 3655435. The call will also be available via webcast on Otonomy’s website, archived for 30 days.
Otonomy, Inc. (OTIC) reported its Q1 2020 financial results and provided updates on its clinical trials. As of March 31, 2020, Otonomy had $48.6 million in cash, down from $60.7 million in Q4 2019. GAAP operating expenses decreased to $11.5 million from $12.1 million year-over-year. The company is managing the impact of COVID-19 on clinical trials, with patient enrollment in OTIVIDEX halted but expected to resume. Future updates on trial statuses will occur during a June program call. Otonomy anticipates sufficient cash to fund operations into 2021.
