Fly Intel: Pre-market Movers » 08:5904/0804/08/21
ORBC, IMMP, GME, AVCT, CAG, APOG, VLO, BOX, OTIC, AMRS, CGC
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Otonomy 6.29M share Spot Secondary priced at $2.25 » 06:1604/0804/08/21
The deal priced below the…
The deal priced below the last closing price of $2.45. Cowen and Piper Sandler are acting as joint book running managers for the offering.
Fly Intel: After-Hours Movers » 18:5604/0704/07/21
RGP, AVCT, LNDC, KDNY, AMRS, OTIC, PRGS
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Otonomy announces common stock offering, no amount given » 16:0804/0704/07/21
Otonomy announced that it…
Otonomy announced that it has commenced an underwritten public offering of its common stock. Cowen and Piper Sandler are acting as joint book-running managers in the offering.
|Over a week ago|
Otonomy initiates phase 2 clinical trial of OTO-313 in Tinnitus » 07:3303/2503/25/21
Otonomy announced the…
Otonomy announced the initiation of a Phase 2 clinical trial of OTO-313 in patients with unilateral tinnitus. The randomized, double-blind, placebo-controlled Phase 2 study will enroll approximately 140 patients with persistent, early onset tinnitus of at least moderate severity. Following the successful Phase 1/2 trial, the primary efficacy endpoint will be a responder analysis based on the proportion of patients reporting a clinically meaningful improvement in TFI from baseline to both Month 1 and Month 2 following treatment. Top-line results are expected in mid-2022. The Phase 2 trial will be conducted at approximately 50 clinical sites in the U.S. and Europe. Following a lead-in period, patients will be randomized to a single intratympanic injection of OTO-313 or placebo and then followed for four months. In order to assess durability of the treatment benefit, patients will be followed for an additional two months. Other measures of efficacy include tinnitus loudness, tinnitus annoyance, and patient global impression of change.
|Over a month ago|
Otonomy price target lowered to $5 from $10 at Piper Sandler » 11:0302/2202/22/21
Piper Sandler analyst…
Piper Sandler analyst Tyler Van Buren lowered the firm's price target on Otonomy to $5 from $10 and keeps an Overweight rating on the shares after the third Otividex Phase III trial missed the primary endpoint. While the intent-to-treat analysis fell short, management noted that the per protocol analysis reached statistics when 12 patients were excluded, so they are continuing to analyze the data to better understand why this occurred, Van Buren tells investors in a research note. The analyst says while not impossible, the precedent of achieving an approval with a non-intent-to-treat patient population is not strong. As such, he decreased the price target to $5 as a result of the "increased uncertainty."
Fly Intel: Pre-market Movers » 09:0402/2202/22/21
CTB, PBCT, KSS, DISCA, GLOP, GLOG, DISH, MGI, OTIC, FAII, RWLK, EBIX, GT, MTB, BA, UAL, RTX
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Otonomy says Phase 3 trial of OTIVIDEX did not meet primary endpoint » 07:0802/2202/22/21
Otonomy announced that…
Otonomy announced that the Phase 3 clinical trial of OTIVIDEX in patients with Meniere's disease did not achieve the primary endpoint, which was the count of definitive vertigo days in Month 3 for OTIVIDEX vs. placebo for the intent-to-treat population using the Negative Binomial Model. This analysis did achieve statistical significance for the per protocol population. These results were similar using the Generalized Poisson model. "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 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 $86.3M as of December 31, 2020, GAAP operating expenses for full year 2020 of $42.6M and non-GAAP operating expenses, which exclude stock-based compensation, for full year 2020 of $36.5M.
Otonomy trading halted, news pending 06:5502/2202/22/21
Otonomy reports Q4 EPS (20c), consensus (22c) » 16:3402/1102/11/21
Cash, cash equivalents,…
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. ."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 Meniere'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."