Decibel Therapeutics Reports Second Quarter 2023 Financial Results and Corporate Update
11 Agosto 2023 - 8:45AM
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 second quarter ended June 30,
2023 and provided a corporate update.
“This week we announced a definitive agreement with Regeneron
Pharmaceuticals to acquire Decibel, which we believe reflects the
tremendous promise of gene therapy for hearing loss,” said Laurence
Reid, Ph.D., Chief Executive Officer of Decibel. “We remain highly
focused on executing on the CHORD clinical trial and excited by the
potential benefit that DB-OTO may provide to people with
otoferlin-related hearing loss. With six active clinical trial
sites at prestigious institutions across three countries, we
continue to work towards our goal of addressing this unmet medical
need.”
Pipeline Highlights and Upcoming
Milestones:
Gene Therapies for Congenital, Monogenic Hearing
Loss
- Phase 1/2
CHORDTM Dose Escalation Clinical
Trial of DB-OTO in Pediatric Patients:
- 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 has been developing DB-OTO in collaboration with Regeneron
Pharmaceuticals.
- In May 2023,
Decibel announced the initiation of CHORD, a global Phase 1/2 dose
escalation clinical trial of DB-OTO in pediatric patients. Decibel
has opened clinical trial sites in the U.S., the U.K. and Spain and
has commenced patient screening activities. DB-OTO received Orphan
Drug Designation from the European Medicines Agency (EMA) Committee
on Orphan Medicinal Products (COMP) in May 2023, adding to its
Orphan Drug and Rare Pediatric Disease Designations from the U.S.
Food and Drug Administration (FDA).
- Continued Progress with
IND-Enabling Activities to Support the Advancement of AAV.103 for
GJB2-Related Hearing Loss Program:
- In March 2023, Decibel achieved a
pre-investigational new drug (IND) milestone under its
collaboration agreement with Regeneron Pharmaceuticals related to
the initiation of manufacturing of AAV.103, Decibel’s gene therapy
product candidate 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.
Otoprotection Therapeutic
- Received FDA Breakthrough
Therapy Designation for DB-020:
- In July 2023, Decibel received FDA
Breakthrough Therapy Designation for DB-020, a novel, proprietary
formulation of sodium thiosulfate (STS), designed to protect
against hearing loss in cancer patients receiving cisplatin
chemotherapy. This was supported by Decibel’s Phase 1b clinical
trial in which 87% of treated patients experiencing ototoxicity in
their placebo-treated ear were partially or completely protected
from ototoxicity. Breakthrough Therapy Designation is intended to
expedite the development and review of medicines intended to treat
serious or life-threatening conditions that have preliminary
clinical evidence indicating that the drug may demonstrate
substantial improvement over available treatments. A Breakthrough
Therapy Designation conveys all the fast-track program features,
more intensive FDA guidance on the drug development program, an
organizational commitment involving senior FDA managers and
eligibility for rolling review and priority review.
Corporate Update:
- Announced definitive
agreement for Regeneron Pharmaceuticals to acquire
Decibel:
- On August 9, 2023, Decibel and
Regeneron announced the entry into an agreement for Regeneron to
acquire Decibel to build on the existing collaboration, and
accelerate and further resource key gene therapy programs for
hearing loss. The proposed acquisition values Decibel at a total
equity value of approximately $109 million based on the amount
payable at closing, and a total equity value of up to approximately
$213 million if the contingent value right (CVR) milestones
are achieved.
Second Quarter 2023 Financial Results:
- Cash Position: As
of June 30, 2023, cash, cash equivalents and available-for-sale
securities were $78.3 million, compared to $104.6 million as of
December 31, 2022.
- Research and Development
Expenses: Research and development expenses were $12.8
million for the second quarter of 2023, compared to $11.2 million
for the same period in 2022. The increase in research and
development expenses for the second quarter 2023 was primarily due
to higher clinical development and related costs for the Company’s
Phase 1/2 clinical trial of DB-OTO, additional regulatory and
clinical costs for DB-020, and higher personnel-related costs due
to increased headcount, wages and stock-based compensation.
- General and Administrative
Expenses: General and administrative expenses were $6.2
million for the second quarter of 2023, compared to $5.9 million
for the same period in 2022. The increase in general and
administrative expenses for the second quarter 2023 was primarily
due to increased facility-related costs due to decreased sublease
income and higher personnel-related costs due to increased
headcount, wages and stock-based compensation, partially offset by
decreased professional fees year over year.
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 Statements
This 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 and gene therapy for the inner ear, 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,
the sufficiency of Decibel’s existing cash resources for the period
anticipated, the occurrence of any event, change, or other
circumstance that could give rise to the termination of the
Agreement and Plan of Merger with Regeneron Pharmaceuticals, Inc.,
the prospective benefits of the proposed acquisition, the value of
potential contingent consideration amounts and timing of the
closing for the transaction, 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: risks related to our proposed acquisition by
Regeneron, 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,, 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 June 30, 2023
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.
|
Condensed
Consolidated Balance Sheet Data
(Unaudited) |
|
(in
thousands) |
|
|
|
|
|
|
|
|
|
|
|
June
30, |
|
December
31, |
|
|
|
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
Cash, cash
equivalents and available-for-sale securities |
$ |
78,300 |
|
|
$ |
104,561 |
|
|
|
|
|
|
Total
assets |
$ |
94,387 |
|
|
$ |
123,373 |
|
|
|
|
|
|
Total
stockholders' equity |
$ |
53,312 |
|
|
$ |
81,793 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Statement of Operations (Unaudited) |
|
(in
thousands) |
|
|
|
|
|
|
|
|
|
|
|
For the three months ended |
|
For the six months ended |
|
|
June 30, 2023 |
|
June 30, 2022 |
|
June 30, 2023 |
|
June 30, 2022 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
$ |
12,828 |
|
|
$ |
11,241 |
|
|
$ |
20,762 |
|
|
$ |
18,707 |
|
|
General and administrative |
|
6,213 |
|
|
|
5,862 |
|
|
|
12,400 |
|
|
|
12,415 |
|
|
Total Operating expenses |
|
19,041 |
|
|
|
17,103 |
|
|
|
33,162 |
|
|
|
31,122 |
|
|
Loss from
operations |
|
(19,041 |
) |
|
|
(17,103 |
) |
|
|
(33,162 |
) |
|
|
(31,122 |
) |
|
Other
income: |
|
|
|
|
|
|
|
|
Other income, net |
|
976 |
|
|
|
95 |
|
|
|
1,854 |
|
|
|
158 |
|
|
Total other income, net |
|
976 |
|
|
|
95 |
|
|
|
1,854 |
|
|
|
158 |
|
|
Income
before income tax provision |
|
(18,065 |
) |
|
|
(17,008 |
) |
|
|
(31,308 |
) |
|
|
(30,964 |
) |
|
Provision for income taxes |
|
(80 |
) |
|
|
(38 |
) |
|
|
(141 |
) |
|
|
(98 |
) |
|
Net
loss |
$ |
(18,145 |
) |
|
$ |
(17,046 |
) |
|
$ |
(31,449 |
) |
|
$ |
(31,062 |
) |
|
|
|
|
|
|
|
|
|
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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