Otonomy Provides Business Update Related to COVID-19 Pandemic
April 09 2020 - 7:30AM
Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
neurotology, today provided a business update related to the
COVID-19 pandemic.
“Our first priority during this international crisis has been to
ensure the health and safety of our employees, patients enrolled in
our clinical trials, and healthcare professionals at our study
sites in the United States and Europe,” said David A. Weber, Ph.D.,
president and CEO of Otonomy. “We are fortunate that the primary
endpoint for our OTIVIDEX® Phase 3 trial and key exploratory
endpoints in our OTO-313 Phase 2 trial are self-reported by the
patient from home thereby preserving the integrity of data
collection in these trials even in locations with quarantine
restrictions. However, new patient enrollment is being impacted so
we are suspending our guidance for the timing of trial results
until we better understand the timeline for each study. We continue
to carefully manage our spending and believe that our existing
capital can fund operations through our multiple clinical trial
readouts including the OTIVIDEX Phase 3 trial.”
Otonomy Business Updates
Ongoing OperationsOtonomy has taken steps to protect the health
and safety of its employees and community by generally adopting a
work from home policy in line with directives from the State of
California and guidance from the U.S. Centers for Disease Control
and Prevention (CDC). On-site activities have been restricted to
certain essential facility and laboratory support functions and
social distancing policies have been implemented. Other corporate
functions including clinical operations were able to quickly and
effectively transition to remote working.
OTIVIDEX Phase 3 Clinical Trial in Ménière’s DiseaseThis trial
is being conducted at approximately 60 trial sites dispersed across
different regions of the United States and multiple countries in
Europe. We believe there is minimal impact of COVID-19 on the
integrity of data being collected for enrolled patients because
patients report their vertigo episodes via a daily telephone diary
and compliance continues to be high. The enrollment of new patients
is being managed on a country-by-country and site-by-site basis
according to local conditions.
OTO-313 Phase 1/2 Clinical Trial in TinnitusOtonomy has
successfully completed the initial safety cohort of this trial, and
is conducting the exploratory efficacy study at approximately 15
sites located throughout the United States. Several of the efficacy
endpoints are collected by patient-reported daily telephone diary
and we switched to completion of the Tinnitus Functional Index
(TFI) questionnaire at the patient’s home as well to avoid
restrictions on travel or study site visits. The enrollment of new
patients is being managed on a site-by-site basis.
OTO-413 Phase 1/2 Clinical Trial in Hearing LossThis is an
ascending single dose safety and exploratory efficacy study being
conducted at a limited number of trial sites in the United States.
We have successfully completed several dose cohorts but have
temporarily paused new patient enrollment because site visits are
required for extensive hearing assessments to evaluate both safety
and exploratory efficacy. Resumption of enrollment will be
determined on a site-by-site basis.
Financial GuidanceWe finished 2019 with approximately $61
million in cash, cash equivalents and short-term investments and
reiterate that we expect non-GAAP operating expenses for 2020,
which reflect spending, to be in the range of $35-$38 million (with
GAAP operating expenses that include stock-based compensation to
total in the range of $45-$48 million). We believe that this
capital is sufficient to fund company operations into 2021 and are
managing spending to enable this cash runway to extend through
readouts for our three ongoing clinical trials.
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, timing of results, patient recruitment and
enrollment plans and activity for, design and conduct of, data
collection and preservation of data integrity with respect to, and
the risks and impact of COVID-19 to, the Phase 3 clinical trial for
OTIVIDEX, the Phase 1/2 clinical trial for OTO-313 and the Phase
1/2 clinical trial for OTO-413; expectations regarding patient
self-reporting with respect to the Phase 3 clinical trial for
OTIVIDEX and the Phase 1/2 clinical trial for OTO-313; expectations
regarding ongoing operations, including with respect to on-site and
remote working; expectations regarding operating expenses for 2020;
expectations that current capital is sufficient to fund company
operations into 2021; 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 limited operating history and its
expectation that it will incur significant losses for the
foreseeable future; 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; Otonomy’s ability to obtain
regulatory approval for its product candidates; 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; Otonomy’s dependence on third parties for the manufacture
of its product candidates; Otonomy’s dependence on a small number
of suppliers for raw materials; Otonomy’s ability to protect its
intellectual property related to its product candidates 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 Annual Report on Form 10-K filed with
the Securities and Exchange Commission (the "SEC") on February 27,
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 InquiriesSpectrum ScienceChloé-Anne RamseyVice
President404.865.3601 cramsey@spectrumscience.com
Investor InquiriesWestwicke ICRRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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