Decibel Therapeutics Reports Third Quarter 2022 Financial Results and Corporate Update
November 09 2022 - 3:44PM
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 third quarter ended September
30, 2022 and provided a corporate update.
“Decibel continued to maintain strong momentum throughout 2022
as we achieved the goals we set forth for the year. The FDA
clearance of our IND application and the submission of our CTAs in
the UK and Spain for our lead gene therapy product candidate,
DB-OTO, mark significant milestones for us, and we look forward to
initiating the Phase 1/2 clinical trial in the first half of 2023,”
said Laurence Reid, Ph.D., Chief Executive Officer of Decibel.
“Looking ahead, we plan to continue to strengthen our position as a
leader in the broader hearing loss space and we look forward to the
opportunity to further our goal of developing transformative gene
therapies for the inner ear.” Pipeline Highlights and
Upcoming Milestones:
Gene Therapies for Congenital, Monogenic Hearing
Loss
- Received FDA Clearance of
IND Application for DB-OTO: In October 2022, Decibel
announced that it had received clearance from the U.S. Food and
Drug Administration (FDA) for its Investigational New Drug (IND)
application to initiate a Phase 1/2 clinical trial in pediatric
patients of DB-OTO, its lead gene therapy product candidate. DB-OTO
is being developed in collaboration with Regeneron Pharmaceuticals
and is an adeno-associated virus (AAV)-based dual-vector gene
therapy designed to provide durable hearing to individuals with
profound congenital hearing loss caused by mutations of the
otoferlin gene. DB-OTO uses a proprietary, cell-selective promoter
to express the otoferlin transgene in hair cells, with the goal of
enabling the ear to transmit sound to the brain and provide hearing
to such individuals. DB-OTO received Orphan Drug and Rare Pediatric
Disease designations from the FDA in 2021.
- CTA Applications Filed for
DB-OTO in Europe: In November 2022, Decibel announced
submission of Clinical Trial Applications (CTAs) to the Medicines
and Healthcare Products Regulatory Agency (MHRA) in the United
Kingdom and the Spanish Agency of Medicines and Medical Devices
(AEMPS) for a Phase 1/2 clinical trial of DB-OTO in pediatric
patients.
- Plan to Identify a Product
Candidate for AAV.103 Program in Fourth Quarter of 2022:
Decibel plans to select a product candidate for further development
in its AAV.103 program to restore hearing in individuals with
mutations in the gap junction beta-2 (GJB2) gene, the most common
cause of autosomal recessive, non-syndromic, congenital hearing
loss. Decibel is developing the AAV.103 program in collaboration
with Regeneron Pharmaceuticals and retains global commercial rights
to the AAV.103 program.
Otoprotection Therapeutic
- Intend to Provide Update on
DB-020 in First Half of 2023: Decibel plans to report
additional data from the interim analysis of the Phase 1b clinical
trial of DB-020 at an upcoming conference. The Company continues to
evaluate strategic opportunities to continue development of DB-020,
including seeking feedback from regulatory authorities.
Corporate Update:
- Board of Directors
Update: In October 2022, Decibel announced the appointment
of Kevin F. McLaughlin to its Board of Directors. Kevin brings more
than 40 years of financial and operating management experience
spanning the biotech, high-tech and education industries.
Third Quarter 2022 Financial Results:
- Cash Position: As
of September 30, 2022, cash, cash equivalents and
available-for-sale securities were $111.9 million, compared to
$162.3 million as of December 31, 2021.
- Research and Development
Expenses: Research and development expenses were $10.0
million for the third quarter of 2022, compared to $9.0 million for
the same period in 2021. The increase in research and development
expenses for the third quarter of 2022 was primarily due to
additional costs to advance DB-OTO in support of the Company’s IND
filing, higher research costs related to 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 $6.3
million for the third quarter of 2022, compared to $5.7 million for
the same period in 2021. The increase in general and administrative
expenses for the third quarter of 2022 was primarily due to higher
professional fees including external consulting, advisory, legal
and audit services.
Financial Guidance:
Based on its current operating and development plans, Decibel
believes that its existing cash, cash equivalents and
available-for-sale securities will fund its operating expenses into
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 Quarterly Report on Form
10-Q for the quarterly period ended September 30, 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 Sheet Data (Unaudited) |
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(in
thousands) |
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September
30, |
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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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$ |
111,946 |
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$ |
162,294 |
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Total assets |
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$ |
142,273 |
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$ |
184,477 |
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Total stockholders' equity |
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$ |
96,814 |
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$ |
141,689 |
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Condensed
Consolidated Statement of Operations (Unaudited) |
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(in
thousands) |
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Three Months EndedSeptember 30, |
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Nine Months EndedSeptember 30, |
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2022 |
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2021 |
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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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$ |
10,030 |
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$ |
9,020 |
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$ |
28,737 |
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$ |
21,867 |
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General and administrative |
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6,319 |
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5,680 |
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18,734 |
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15,462 |
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Total Operating expenses |
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16,349 |
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14,700 |
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47,471 |
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37,329 |
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Loss from operations |
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(16,349 |
) |
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(14,700 |
) |
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(47,471 |
) |
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(37,329 |
) |
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Other income: |
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Interest income |
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374 |
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33 |
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532 |
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141 |
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Total other income, net |
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374 |
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33 |
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532 |
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141 |
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Net loss before provision for income taxes |
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(15,975 |
) |
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(14,667 |
) |
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(46,939 |
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(37,188 |
) |
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Provision for income taxes |
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(30 |
) |
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(1,732 |
) |
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(128 |
) |
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(1,732 |
) |
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Net loss |
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$ |
(16,005 |
) |
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$ |
(16,399 |
) |
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$ |
(47,067 |
) |
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$ |
(38,920 |
) |
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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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