Otonomy Provides Corporate and Product Pipeline Update
January 09 2020 - 7:30AM
Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
neurotology, today provided an update on its product pipeline and
financial guidance. Consistent with previously stated timing, the
company expects to have results for the Phase 3 trial of OTIVIDEX
in Ménière’s disease in the third quarter of 2020, the Phase 1/2
trial of OTO-313 in tinnitus patients in the second quarter of
2020, and the Phase 1/2 trial of OTO-413 in patients with hearing
loss in the second half of 2020.
The company finished 2019 with approximately $61 million in
cash, cash equivalents and short term investments and expects that
its current capital is sufficient to fund operations through the
three clinical trials and into 2021.
“We are excited to begin 2020, a potentially transformational
year for Otonomy driven by our three clinical trial readouts, each
of which is a meaningful milestone given the significant patient
population, high disease burden, and lack of approved drug
treatments,” said David A. Weber, Ph.D., president and CEO of
Otonomy. “While successful completion of these clinical trials is
our highest priority, we also continue to advance multiple
preclinical programs including our gene therapy collaboration
targeting congenital hearing loss.”
Product Pipeline Update
- OTIVIDEX: Enrollment in Phase 3 Clinical Trial
in Ménière’s Disease is Ongoing with Results Expected in
the Third Quarter of 2020. Otonomy has completed one
successful Phase 3 trial and is conducting this additional pivotal
trial to support a submission for U.S. registration of OTIVIDEX in
Ménière’s disease. The company plans to enroll approximately 160
patients in the United States and Europe.
- OTO-313: Enrollment in Phase 1/2 Clinical Trial in
Tinnitus is Ongoing with Results Expected in the Second Quarter of
2020. Otonomy has successfully completed
the initial safety cohort of this randomized, double-blind,
placebo-controlled trial, and is enrolling approximately 50
patients with persistent tinnitus in the exploratory efficacy study
cohort. OTO-313 is a sustained-exposure formulation of the potent
and selective NMDA receptor antagonist gacyclidine.
- OTO-413: Enrollment in Phase 1/2 Clinical
Trial in Hearing Loss is Ongoing with Results
Expected in the Second Half of 2020. Otonomy is enrolling
hearing loss patients in a Phase 1/2 clinical trial of OTO-413,
which is a sustained-exposure formulation of brain-derived
neurotrophic factor (BDNF). The Phase 1/2 trial is a randomized,
double-blind, placebo-controlled, single ascending dose study
designed to evaluate the safety and exploratory efficacy of OTO-413
in patients with speech-in-noise hearing difficulty.
- Advancing multiple preclinical programs for treatment
and prevention of hearing loss.
- GJB2 gene therapy program: Otonomy and Applied
Genetic Technologies Corporation (AGTC) are collaborating to
co-develop and co-commercialize an AAV-based gene therapy to
restore hearing in patients with hearing loss caused by a mutation
in the gap junction protein beta 2 gene (GJB2) -- the most common
cause of congenital hearing loss.
- OTO-6XX: development program targeting hair
cell regeneration for severe hearing loss.
- OTO-510: otoprotection program for patients at
risk for cisplatin-induced hearing loss.
Financial Updates and Guidance
- Cash Position: Cash, cash equivalents, and
short-term investments totaled approximately $61 million as of
December 31, 2019. This balance includes proceeds from a $15
million term loan completed in December 2018.
- Operating Expenses: Otonomy expects that
non-GAAP operating expenses for 2020 will be in the range of
$35-$38 million, and that GAAP operating expenses will be in the
range of $45-$48 million.
- Cash Runway: Otonomy expects that its current
cash, cash equivalents, and short term investments will be
sufficient to fund the company through completion of the OTIVIDEX
Phase 3 trial, OTO-313 Phase 1/2 trial, and OTO-413 Phase 1/2 trial
in 2020, and will support company operations into 2021.
Non-GAAP Operating Expenses
In this press release, Otonomy’s operating expenses are provided
in accordance with generally accepted accounting principles (GAAP)
in the United States and also on a non-GAAP basis. Non-GAAP
operating expenses exclude stock-based compensation. Non-GAAP
operating expenses are provided as a complement to operating
expenses provided in accordance with GAAP because management
believes non-GAAP operating expenses help indicate underlying
trends in the company’s business, are important in comparing
current results with prior period results and provide additional
information regarding the company’s financial position. Management
also uses non-GAAP operating expenses to establish budgets and
operational goals that are communicated internally and externally
and to manage the company’s business and to evaluate its
performance.
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 for, and design and conduct of, the Phase 3
clinical trial for OTIVIDEX, and expectations regarding submission
for U.S. registration; timing of results, patient recruitment and
enrollment plans for, and design and conduct of, the Phase 1/2
clinical trial for OTO-313; timing of results, patient recruitment
and enrollment plans for, and design and conduct of, the Phase 1/2
clinical trial for OTO-413; expectations regarding the status,
timing and nature of upcoming milestones; expectations regarding
advancement of preclinical programs; the potential benefits of and
activity under the collaboration agreement between AGTC and
Otonomy, including but not limited to development and
commercialization activity; expectations regarding operating
expenses for 2020; expectations that current capital is sufficient
to fund the company through completion of the OTIVIDEX Phase 3
trial, OTO-313 Phase 1/2 trial, and OTO-413 Phase 1/2 trial, and
will support 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: 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;
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 give rise to the termination of the
collaboration agreement between AGTC and Otonomy; 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; and other risks. Information regarding the
foregoing and additional risks may be found in the section entitled
"Risk Factors" in Otonomy’s Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission (the "SEC") on November
5, 2019, 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 ScienceLeticia DiazVice President
202.587.2517ldiaz@spectrumscience.com
Investor InquiriesWestwicke ICRRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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