Decibel Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Corporate Update
March 14 2023 - 3:05PM
Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology
company dedicated to discovering and developing transformative
treatments to restore and improve hearing and balance, today
reported financial results for the fourth quarter and full year
ended December 31, 2022 and provided a corporate update.
“I am incredibly pleased with the progress Decibel made
throughout 2022. We believe the clearance of our IND and CTA for
DB-OTO supports our belief that AAV gene therapy is an ideal
modality for the inner ear. We remain on track to initiate CHORD™,
the global Phase 1/2 clinical trial of DB-OTO in the first half of
the year, evaluating DB-OTO in pediatric patients of diverse ages,
including infants two years of age and younger. Beyond our clinical
stage product candidates, we are making encouraging progress on our
other programs and platform and were pleased to present data
supporting the selection of a product candidate for our GJB2
program. GJB2-related hearing loss is the leading cause of
autosomal recessive, non-syndromic, congenital hearing loss
worldwide. We believe cell-selective expression of GJB2 will be
critical for future success of any gene therapy targeting
GJB2-related hearing loss, and the identification of gene
regulatory elements to confer this precise expression showcases the
strength of our platform,” said Laurence Reid, Ph.D., Chief
Executive Officer of Decibel. “In June 2022, we reported positive
data from an interim analysis of our Phase 1b clinical trial of
DB-020, supporting both its potential benefit and the integrated
capabilities Decibel has implemented to develop innovative
therapeutics for conditions of the inner ear. As we look ahead, we
remain deeply committed to our mission of restoring and improving
hearing and balance for those in need.”
Pipeline Highlights and Upcoming
Milestones:
Gene Therapies for Congenital, Monogenic Hearing
Loss
- Received Investigational
New Drug (IND) Application and Clinical Trial Application (CTA)
Clearance and On Track for Phase 1/2 Trial Initiation:
- DB-OTO is an AAV-based dual-vector
gene therapy product candidate designed to be delivered one time to
selectively express functional otoferlin (OTOF) in the inner hair
cells of individuals with OTOF deficiency with the goal of enabling
the ear to transmit sound to the brain and enable durable,
physiological hearing. Decibel is developing DB-OTO in
collaboration with Regeneron Pharmaceuticals and retains global
commercial rights to the product candidate.
- In October 2022, Decibel received
clearance from the FDA for its IND application to initiate CHORD™,
a Phase 1/2 clinical trial in pediatric patients of DB-OTO.
Additionally, in January 2023, Decibel announced authorization of
its CTA by the United Kingdom Medicines and Healthcare products
Regulatory Agency (MHRA) for its CTA for the trial. Decibel plans
to initiate the CHORD™ clinical trial of DB-OTO in pediatric
patients in the first half of 2023.
- Decibel expects that the first two
patients in the U.S. will be as young as seven years of age and
that participants in the U.K. will be infants two years of age and
younger.
- CTA Application Filed for
DB-OTO in Spain: In November 2022, Decibel announced the
submission of its CTA to the Spanish Agency of Medicines and
Medical Devices (AEMPS) to open sites in Spain for CHORD™.
- Presented New Non-Clinical
Data of DB-OTO at the 46th Annual
Association for Research in Otolaryngology (ARO) MidWinter
Meeting: In February 2023, Decibel presented new
non-clinical data supporting the strong safety profile of DB-OTO,
Decibel’s lead gene therapy product candidate. In Good Laboratory
Practices (“GLP”) studies, Decibel did not observe any adverse
DB-OTO-related findings in otic or non-otic tissues across any
evaluation of OTOF-deficient mice or non-human primates.
- Identified Product Candidate
for AAV.103 GJB2-Related Hearing Loss Program: In February
2023, Decibel presented preclinical data at ARO on its AAV.103 gene
therapy program designed to restore hearing in individuals with
mutations in the gap junction beta-2 (GJB2) gene, the leading cause
of autosomal recessive, non-syndromic, congenital hearing loss
worldwide. In the data presented, selective targeting of
GJB2-expressing cells resulted in robust and durable hearing
restoration in a mouse model of GJB2 deficiency. Decibel is
developing the AAV.103 program in collaboration with Regeneron
Pharmaceuticals and retains global commercial rights to the
program.
Otoprotection Therapeutic
- Provided Interim Analysis
Update on DB-020 Phase 1b Clinical Trial: In February
2023, Decibel presented additional data from the interim analysis
of the Phase 1b clinical trial of DB-020 in patients receiving
cisplatin chemotherapy. The Company continues to explore strategic
opportunities to advance development of DB-020 and expects to
consult with regulatory authorities in 2023 regarding its clinical
development plan.
Corporate Update:
- Board of Directors
Update: In October 2022, Decibel announced the appointment
of Kevin F. McLaughlin to its Board of Directors.
Fourth Quarter and Full Year 2022 Financial
Results:
- Cash Position: As
of December 31, 2022, cash, cash equivalents and available-for-sale
securities were $104.6 million, compared to $162.3 million as of
December 31, 2021.
- Research and Development
Expenses: Research and development expenses were $11.6
million for the fourth quarter of 2022, compared to $8.0 million
for the same period in 2021. Research and development expenses were
$40.3 million for the full year 2022, compared to $29.8 million for
the full year 2021. The increase in research and development
expenses for the fourth quarter and full year 2022 were primarily
due to additional costs to advance DB-OTO in support of the
Company’s IND and CTA filings, higher clinical development costs to
support its upcoming Phase 1/2 clinical trial of DB-OTO, higher
research costs related to its other preclinical gene therapy
programs and higher personnel-related costs due to increased
headcount, wages and stock-based compensation.
- General and Administrative
Expenses: General and administrative expenses were $4.9
million for the fourth quarter of 2022, compared to $4.9 million
for the same period in 2021. General and administrative expenses
were $23.6 million for the full year 2022, compared to $20.4
million for the full year 2021. The increase in general and
administrative expenses for the full year 2022 was primarily due to
higher professional fees including external consulting, advisory,
legal and audit services, as well as higher personnel-related costs
due to increased headcount, wages and stock-based
compensation.
Financial Guidance:
Based on its current operating and development plans, Decibel
believes that its cash, cash equivalents and available-for-sale
securities as of December 31, 2022 will fund its operating expenses
into the first half of 2024.
About Decibel Therapeutics
Decibel Therapeutics is a clinical-stage biotechnology company
dedicated to discovering and developing transformative treatments
to restore and improve hearing and balance, one of the largest
areas of unmet need in medicine. Decibel has built a proprietary
platform that integrates single-cell genomics and bioinformatic
analyses, precision gene therapy technologies and expertise in
inner ear biology. Decibel is leveraging its platform to advance
gene therapies designed to selectively replace genes for the
treatment of congenital, monogenic hearing loss and to regenerate
inner ear hair cells for the treatment of acquired hearing and
balance disorders. Decibel’s pipeline, including its lead gene
therapy product candidate, DB-OTO, to treat congenital, monogenic
hearing loss, is designed to deliver on our vision of a world in
which the privileges of hearing and balance are available to all.
For more information about Decibel Therapeutics, please visit
www.decibeltx.com or follow us on Twitter.
Forward-Looking StatementsThis press release
contains forward-looking statements that involve substantial risks
and uncertainties. All statements, other than statements of
historical facts, contained in this press release, including
statements regarding Decibel’s strategy, future operations,
prospects, plans, objectives of management, the therapeutic
potential for Decibel’s product candidates and preclinical
programs, the potential benefits of cell-selective expression, the
expected timeline for initiating clinical trials, reporting
clinical trial results and achieving other anticipated milestones,
expectations regarding the translation of preclinical findings to
human disease and the sufficiency of Decibel’s existing cash
resources for the period anticipated, constitute forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. The words “anticipate,” “believe,” “continue,”
“could,” “estimate,” “expect,” “intend,” “may,” “might,”
“objective,” “ongoing,” “plan,” “predict,” “project,” “potential,”
“should,” or “would,” or the negative of these terms, or other
comparable terminology are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Decibel may not actually achieve the
plans, intentions or expectations disclosed in these
forward-looking statements, and you should not place undue reliance
on these forward-looking statements. Actual results or events could
differ materially from the plans, intentions and expectations
disclosed in these forward-looking statements as a result of
various important factors, including: uncertainties inherent in the
identification and development of product candidates, including the
conduct of research activities and the initiation and completion of
preclinical studies and clinical trials, the timing of and
Decibel’s ability to submit and obtain approval to initiate
clinical development of its program candidates, whether results
from preclinical studies will be predictive of the results of later
preclinical studies and clinical trials, whether Decibel’s cash
resources are sufficient to fund its foreseeable and unforeseeable
operating expenses and capital expenditure requirements,
uncertainties related to the impact of the COVID-19 pandemic on
Decibel’s business and operations, as well as the risks and
uncertainties identified in Decibel’s filings with the Securities
and Exchange Commission (SEC), including those risks detailed under
the caption “Risk Factors” in Decibel’s Annual Report
on Form 10-K for the fiscal year ended December 31, 2022 and in
other filings Decibel may make with the SEC. In addition, the
forward-looking statements included in this press release represent
Decibel’s views as of the date of this press release. Decibel
anticipates that subsequent events and developments will cause its
views to change. However, while Decibel may elect to update these
forward-looking statements at some point in the future, it
specifically disclaims any obligation to do so. These
forward-looking statements should not be relied upon as
representing Decibel’s views as of any date subsequent to the date
of this press release.
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Condensed
Consolidated Balance Sheets |
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(in
thousands) |
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December 31, |
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2022 |
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2021 |
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Cash, cash equivalents and available-for-sale securities |
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$ |
104,561 |
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$ |
162,294 |
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Total assets |
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$ |
123,373 |
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$ |
184,477 |
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Total stockholders' equity |
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$ |
81,793 |
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$ |
141,689 |
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Condensed
Consolidated Statement of Operations |
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(in
thousands) |
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Year ended December 31, |
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2022 |
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2021 |
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Operating expenses: |
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Research and development |
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$ |
40,330 |
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$ |
29,847 |
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General and administrative |
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23,627 |
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20,384 |
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Total
Operating expenses |
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63,957 |
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50,231 |
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Loss from operations |
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(63,957 |
) |
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(50,231 |
) |
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Other income: |
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Interest income |
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1,192 |
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|
193 |
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Other income, net |
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- |
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12 |
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Total other
income, net |
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1,192 |
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|
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205 |
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Net loss before provision for income taxes |
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|
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(62,765 |
) |
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(50,026 |
) |
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Provision for income taxes |
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(240 |
) |
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(1,797 |
) |
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Net loss |
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$ |
(63,005 |
) |
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$ |
(51,823 |
) |
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Investor Contact:Julie SeidelStern IR,
Inc.julie.seidel@sternir.com212-362-1200
Media Contact:Chris RaileyTen Bridge
Communicationschris@tenbridgecommunications.com
617-834-0936
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