- Enrollment accomplished in Part three scientific trial of OTIVIDEX®in Ménière’s illness with outcomes anticipated in the first quarter of 2021
- Constructive outcomes reported for Part 1/2 scientific trial of OTO-313 in tinnitus sufferers
- Enrollment accomplished in Part 1/2 scientific trial of OTO-413 in listening to loss with outcomes anticipated by finish of 12 months
- Public providing accomplished for whole gross proceeds of $69.1 million
Convention name and webcast at present at four:30 p.m. ET
SAN DIEGO, Nov. 04, 2020 (GLOBE NEWSWIRE) — Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical firm devoted to the event of modern therapeutics for neurotology, at present reported monetary outcomes for the quarter ended September 30, 2020 and offered an replace on its product pipeline and company actions. The corporate will host a convention name and webcast at present at four:30 p.m. ET to debate current highlights and monetary outcomes.
“We’ve got continued to efficiently execute our marketing strategy by finishing affected person enrollment within the OTIVIDEX Part three trial in Ménière’s illness and the OTO-413 Part 1/2 trial in listening to loss, in addition to saying constructive outcomes from the OTO-313 Part 1/2 trial in tinnitus. Completion of enrollment retains us on monitor for saying the listening to loss trial outcomes by finish of 12 months and outcomes for our Part three Ménière’s trial within the first quarter,” stated David A. Weber, Ph.D., president and CEO of Otonomy. “I’m additionally happy with the progress we’re making in our preclinical packages that reach our efforts throughout further listening to loss pathologies and affected person populations. When mixed with our clinical-stage packages, we’ve got the broadest pipeline within the neurotology subject. And because of the over-subscribed financing we accomplished within the third quarter, we’re well-capitalized to advance our pipeline via upcoming milestones.”
Otonomy Program Updates
- OTIVIDEX Part three scientific trial in Ménière’s illness: affected person enrollment accomplished initially of October with outcomes anticipated within the first quarter of 2021. This trial enrolled a complete of 149 sufferers from the USA and Europe, exceeding the goal of 142 sufferers. After randomization to remedy with a single intratympanic injection of OTIVIDEX or placebo, sufferers are adopted for 3 months. In July 2020, Otonomy offered an replace on the statistical evaluation plan for the continuing trial. In response to questions obtained from the U.S. Meals and Drug Administration (FDA), Otonomy submitted a revised plan that makes use of the Destructive Binomial mannequin for major evaluation of the each day vertigo depend knowledge reported by sufferers. We imagine that the Destructive Binomial mannequin offers one of the best match of the OTIVIDEX scientific knowledge primarily based on the Part 2b trial, the AVERTS-2 Part three trial, and the built-in dataset from each trials. Assuming constructive outcomes on this further Part three trial, we plan to submit a New Drug Software to the FDA within the third quarter of 2021.
- OTO-313: positive outcomes reported from Part 1/2 scientific trial in tinnitus. In July 2020, Otonomy reported constructive top-line outcomes from the Part 1/2 trial of OTO-313 in sufferers with persistent tinnitus of no less than reasonable severity. Sufferers reported the severity of their tinnitus signs utilizing the Tinnitus Useful Index (TFI), a clinically-validated instrument, and by each day reporting of their tinnitus loudness and annoyance. The trial achieved its aims by demonstrating a constructive scientific sign for a single intratympanic injection of OTO-313 utilizing a TFI responder evaluation, with a good security profile. Specifically, 43% of OTO-313 sufferers have been responders on the TFI at each Day 29 and Day 57 in comparison with 13% of placebo sufferers (p-value < zero.05). Moreover, OTO-313 sufferers who have been TFI responders additionally reported enhancements in tinnitus loudness and annoyance ranges utilizing each day diaries and enchancment within the Affected person World Impression of Change (PGIC). Primarily based on these outcomes, Otonomy has submitted a Sort C assembly request to evaluate facets of the Part 2 scientific plan with the FDA.
- OTO-413 Part 1/2 clinical trial in hearing loss: affected person enrollment accomplished with outcomes anticipated by finish of 12 months. This ascending single dose security and exploratory efficacy examine for OTO-413, a sustained publicity formulation of brain-derived neurotrophic issue (BDNF), enrolled a complete of 39 sufferers together with 15 sufferers within the excessive dose cohort. Sufferers have been randomized three:1 for a single intratympanic injection of OTO-413 or placebo after which adopted for three months. All sufferers have a speech-in-noise listening to deficit measured at baseline and might have regular as much as moderately-severe listening to loss by typical testing. On this first scientific analysis of BDNF delivered through intratympanic injection, the first goal is the evaluation of security and tolerability with a number of assessments of listening to operate additionally carried out at baseline and through follow-up to judge indicators of scientific exercise. The Firm expects to announce top-line outcomes from this trial by finish of 12 months.
- GJB2 gene remedy program: product candidate chosen. Otonomy and Utilized Genetic Applied sciences Company (AGTC) are collaborating to co-develop and co-commercialize an AAV-based gene remedy to revive listening to in sufferers with listening to loss attributable to a mutation within the hole junction beta-2 (GJB2) gene — the commonest reason for congenital listening to loss. Preclinical outcomes introduced at conferences earlier this 12 months demonstrated that a gene of curiosity might be expressed in assist cells of the cochlea, that are the related goal cells for treating GJB2 deficiency, utilizing novel and proprietary AAV capsids. Additionally, constant gene expression was noticed for no less than 12 weeks following a single native administration. These outcomes supported collection of the product candidate for additional improvement.
- OTO-510 otoprotection program: preclinical improvement ongoing for novel and proprietary molecule. Cisplatin is a potent chemotherapeutic agent that’s extensively used to deal with quite a lot of cancers in adults and kids, nonetheless, it’s generally related to extreme antagonistic results together with cisplatin-induced listening to loss (CIHL). Otonomy has recognized a novel sequence of molecules with improved otoprotectant exercise in preclinical CIHL research in comparison with different brokers in improvement. Preclinical improvement continues for a small molecule from this class formulated to offer sustained publicity from a single intratympanic injection.
- OTO-6XX program for extreme listening to loss: unique license accomplished for novel compound. In July 2020, Otonomy entered into an unique license settlement with KYORIN Pharmaceutical Co., Ltd. (Kyorin) that gives Otonomy with unique worldwide rights to develop, manufacture and commercialize a novel compound for the remedy of sensorineural listening to loss. Beneath the phrases of the settlement, Otonomy made an upfront cost to Kyorin and can make success-based milestone funds and pay a royalty on worldwide internet gross sales. Otonomy is formulating the patent-protected compound using the corporate’s proprietary expertise to offer sustained drug publicity within the inside ear following a single native administration. The OTO-6XX program is concentrating on hair cell regeneration for the remedy of extreme listening to loss.
- OTIPRIO®: co-promotion partnership initiated and expanded with ALK-Abelló, Inc. (ALK). In June 2020, Otonomy entered a co-promotion settlement that offered ALK with an unique proper to advertise OTIPRIO for acute otitis externa (AOE) to office-based well being care professionals in the USA together with ear, nostril and throat (ENT) physicians, pediatricians and first care physicians. In October 2020, this settlement was expanded to allow ALK to additionally promote OTIPRIO for its second FDA-approved indication, use throughout ear tube surgical procedure, in all supplier services together with hospitals and ambulatory surgical procedure facilities. In the course of the multi-year settlement, Otonomy will obtain co-promotion charges and reimbursement of a proportion of product assist prices whereas additionally retaining a share of adjusted gross earnings from the sale of OTIPRIO.
Third Quarter Monetary Highlights
- Money Place: Money, money equivalents, and short-term investments totaled $94.5 million as of September 30, 2020, in comparison with $60.7 million as of December 31, 2019. In July 2020, Otonomy accomplished an underwritten public providing of 17,275,000 shares of its frequent inventory, which incorporates the underwriters’ full train of their choice to buy further shares, and the Firm offered pre-funded warrants to buy as much as four,000,000 shares of its frequent inventory, for whole gross proceeds of roughly $69.1 million, earlier than deducting underwriting reductions and commissions and different providing bills payable by Otonomy. All the securities have been offered by Otonomy.
- Lengthy-term Debt: Otonomy obtained a $15.zero million time period mortgage from Oxford Finance LLC in December 2018. In July 2020, the phrases of the mortgage have been amended to increase the interest-only reimbursement interval from 24 months to 36 months, adopted by 23 months of amortization.
- Working Bills: GAAP working bills have been $10.four million for the third quarter of 2020, in comparison with $10.zero million for the third quarter of 2019. Non-GAAP working bills, which exclude stock-based compensation, have been $eight.eight million for the third quarter of 2020, in comparison with $eight.three million for the third quarter of 2019.
- Analysis and Improvement Bills: GAAP analysis and improvement (R&D) bills for the third quarter of 2020 have been $7.zero million, in comparison with $eight.1 million for the third quarter of 2019. The lower for the quarter was primarily on account of lowered third-party improvement prices that have been partially offset by elevated compensation expense.
- Promoting, Normal and Administrative Bills: GAAP promoting, normal and administrative (SG&A) bills within the third quarter of 2020 have been $three.four million, in comparison with $1.9 million for the third quarter of 2019. The rise this quarter was primarily the results of discontinued price reimbursement obtained from OTIPRIO co-promotion companions.
- Monetary Replace and Steerage:
° 2020 Working Bills: Otonomy continues to anticipate that non-GAAP working bills might be within the vary of $35-$38 million, and GAAP working bills might be within the vary of $45-$48 million.
° Money Runway: Otonomy expects that its present money, money equivalents, and short-term investments might be adequate to fund the corporate’s operations for no less than two years.
Webcast and Convention Name
Otonomy administration will host a webcast and convention name concerning these program updates at four:30 p.m. ET / 1:30 p.m. PT at present. The dwell name could also be accessed by dialing (877) 305-6769 for home callers and (678) 562-4239 for worldwide callers with convention ID code quantity: 5179918. A dwell webcast of the decision might be accessible on-line within the investor relations part of Otonomy’s web site at www.otonomy.com and might be archived there for 30 days.
Otonomy is a biopharmaceutical firm devoted to the event of modern therapeutics for neurotology. The corporate pioneered the applying of drug supply expertise to the ear with a view to develop merchandise that obtain sustained drug publicity from a single native administration. This method is roofed by a broad patent property and is being utilized to develop a pipeline of merchandise addressing necessary unmet medical wants together with Ménière’s illness, listening to loss, and tinnitus. For extra info please go to www.otonomy.com.
Cautionary Observe Concerning Ahead Wanting Statements
This press launch incorporates forward-looking statements throughout the which means of the Non-public Securities Litigation Reform Act of 1995. Ahead-looking statements usually relate to future occasions or the longer term monetary or working efficiency of Otonomy. Ahead-looking statements on this press launch embrace, however should not restricted to, statements referring to the potential advantages, improvement exercise and development of scientific trials; statements referring to the timing of outcomes, exercise for, and conduct of, ongoing scientific trials; statements referring to the up to date statistical evaluation plan for the continuing Part three scientific trial of OTIVIDEX and expectations concerning the Destructive Binomial mannequin; statements concerning plans to submit a New Drug Software for OTIVIDEX; the potential advantages and alternatives of, and actions beneath the collaboration settlement between Otonomy and AGTC, the co-promotion settlement between Otonomy and ALK, and the license settlement between Otonomy and Kyorin; expectations concerning preclinical packages, together with the potential advantages and improvement actions; expectations concerning working bills for 2020, money runway, and Otonomy’s skill to advance its pipeline; and statements by Otonomy’s president and CEO. Otonomy’s expectations concerning these issues could not materialize, and precise leads to future intervals are topic to dangers and uncertainties. Precise outcomes could differ materially from these indicated by these forward-looking statements on account of these dangers and uncertainties, together with however not restricted to: delays and disruption ensuing from the COVID-19 pandemic and governmental and website responses to the pandemic, together with present and future impacts to Otonomy’s operations, the manufacturing of its product candidates, the development of its present scientific trials, and affected person conduct and compliance; Otonomy’s skill to precisely forecast monetary outcomes; Otonomy’s skill to acquire further financing; Otonomy’s dependence on the regulatory success and development of its product candidates; the uncertainties inherent within the scientific drug improvement course of, together with, with out limitation, Otonomy’s skill to adequately reveal the security and efficacy of its product candidates, the nonclinical and scientific outcomes for its product candidates, which can not assist additional improvement, and challenges associated to affected person enrollment, conduct and compliance in scientific trials; the integrity of patient-reported outcomes in its present and future scientific trials; the dangers of the prevalence of any occasion, change or different circumstance that might give rise to the termination of the collaboration settlement between Otonomy and AGTC, the co-promotion settlement between Otonomy and ALK, or the license settlement between Otonomy and Kyorin, or that might impression Otonomy’s skill to repay or adjust to the phrases of the mortgage offered by Oxford Finance LLC; unintended effects or antagonistic occasions related to Otonomy’s product candidates; Otonomy’s skill to efficiently commercialize its product candidates, if accepted; competitors within the biopharmaceutical business; Otonomy’s dependence on third events to conduct nonclinical research and scientific trials, and for the manufacture of its product candidates; Otonomy’s skill to guard its mental property in the USA and all through the world and to make sure compliance with varied legal guidelines and laws in international locations through which it conducts scientific trials; expectations concerning potential remedy advantages, market dimension, alternative and progress; Otonomy’s skill to handle working bills; implementation of Otonomy’s enterprise mannequin and strategic plans for its enterprise, merchandise and expertise; normal financial and market situations; and different dangers. Data concerning the foregoing and extra dangers could also be discovered within the part entitled “Threat Elements” in Otonomy’s Quarterly Report on Type 10-Q filed with the Securities and Trade Fee (SEC) on November four, 2020, and Otonomy’s future reviews to be filed with the SEC. The forward-looking statements on this press launch are primarily based on info accessible to Otonomy as of the date hereof. Otonomy disclaims any obligation to replace any forward-looking statements, besides as required by regulation.
Robert H. Uhl
|Condensed Stability Sheet Information|
|As of September 30,||As of December 31,|
|Money and money equivalents||$||54,235||$||25,194|
|Lengthy-term debt, internet||15,114||14,967|
|Leases, internet of present||14,229||15,320|
|Whole stockholders’ fairness||75,125||40,233|
|Condensed Statements of Operations|
|(in 1000’s, besides share and per share knowledge)|
|Three Months Ended||9 Months Ended|
|September 30,||September 30,|
|Product gross sales, internet||$||50||$||125||$||220||$||507|
|Prices and working bills:|
|Value of product gross sales||189||220||914||636|
|Analysis and improvement||7,zero16||eight,057||21,623||25,771|
|Promoting, normal and administrative||three,363||1,903||10,883||eight,065|
|Whole prices and working bills||10,568||10,180||33,420||34,472|
|Loss from operations||(10,518||)||(10,055||)||(33,200||)||(33,965||)|
|Different (expense) earnings, internet||(349||)||16||(884||)||215|
|Web loss per share, primary and diluted||$||(zero.22||)||$||(zero.33||)||$||(zero.92||)||$||(1.10||)|
|Weighted-average shares used to compute internet loss per share, primary and diluted||49,220,921||30,748,995||37,zero14,253||30,712,839|
|Reconciliation of GAAP to Non-GAAP Working Bills|
|Three Months Ended||9 Months Ended|
|September 30,||September 30,|
|GAAP working bills|
|Analysis and improvement||$||7,zero16||$||eight,057||$||21,623||$||25,771|
|Promoting, normal and administrative||three,363||1,903||10,883||eight,065|
|Whole GAAP working bills||10,379||9,960||32,506||33,836|
|R&D stock-based compensation expense||(628||)||(1,zero37||)||(1,824||)||(2,268||)|
|SG&A stock-based compensation expense||(945||)||(651||)||(2,692||)||(2,165||)|
|Whole non-GAAP changes||(1,573||)||(1,688||)||(four,516||)||(four,433||)|
|Non-GAAP working bills||$||eight,806||$||eight,272||$||27,990||$||29,403|
|Reconciliation of 2020 GAAP to Non-GAAP Working Expense Steerage|
|(in hundreds of thousands)|
|GAAP working bills||$45 – $48|
|Inventory-based compensation expense||$10|
|Non-GAAP working bills||$35 – $38|