Decibel Therapeutics Reports First Quarter 2023 Financial Results and Corporate Update
15 Maio 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 first quarter ended March 31,
2023 and provided a corporate update.
“2023 is a very important year for Decibel as we work to advance
the CHORD global Phase 1/2 trial for DB-OTO, our gene therapy
pipeline and DB-020. The initiation of our first gene therapy
clinical study is the first of several important inflection points
that we expect to occur in 2023, including dosing the initial
patients and early clinical readouts from the CHORD clinical trial.
We believe DB-OTO has the potential to be a best-in-class gene
therapy for individuals with otoferlin-related hearing loss,” said
Laurence Reid, Ph.D., Chief Executive Officer of Decibel. “The
multiple challenges of severe hearing loss continue to drive our
vision. Congenital hearing loss is recognized as a potential
neurodevelopmental emergency and with our product candidates we are
aiming to provide durable, physiological hearing to address
this.”
Pipeline Highlights and Upcoming
Milestones:
Gene Therapies for Congenital, Monogenic Hearing
Loss
- Initiated CHORD
Phase 1/2 Clinical Trial of DB-OTO; Received European
Orphan Drug Designation for DB-OTO:
- DB-OTO is an AAV-based, dual-vector, gene therapy product
candidate designed to be administered a single 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 Decibel retains global commercial
rights to the product candidate.
- In May 2023,
Decibel announced approval from the Spanish Agency of Medicines and
Medical Devices (AEMPS) and in January 2023, Decibel announced
approval from the U.K. Medicines and Healthcare Products Regulatory
Agency (MHRA) for its Clinical Trial Applications (CTAs) for its
CHORD clinical trial of DB-OTO. The Company has previously
announced clearance from the U.S. Food and Drug Administration
(FDA) for its Investigational New Drug (IND) application for CHORD.
Decibel expects that the first two patients in CHORD in the U.S.
will be as young as seven years of age and that participants in the
U.K. and Spain will be infants two years of age and younger.
- In March 2023, the
European Medicines Agency (EMA) Committee on Orphan Medicinal
Products (COMP) and European Commission (EC) issued orphan drug
designation for DB-OTO. Orphan drug designation is granted by the
EC for medicines in development to treat rare conditions affecting
no more than five in 10,000 people in the European Union, provided
there is no other satisfactory treatment option or the medicine can
be of significant benefit to those affected by a specific
condition. Medicines that are granted orphan drug designation by
the EC qualify for financial and regulatory incentives including
protocol assistance, possible exemptions or reductions in certain
regulatory fees, and, if approved for marketing, ten years of
market exclusivity in the European Union.
- Announced Presentations
Related to DB-OTO and AAV.103 at the American Society of Gene and
Cell Therapy (ASGCT) 26th Annual Meeting; Presented New
Non-Clinical Safety Data from DB-OTO at the 46th Annual Association
for Research in Otolaryngology (ARO) MidWinter Meeting:
- In May 2023, Decibel announced it
will deliver podium presentations related to DB-OTO and AAV.103 at
ASGCT. Decibel will also present posters related to its preclinical
pipeline and its platform.
- In February 2023, Decibel presented
new non-clinical data supporting the clinical development of
DB-OTO. In Good Laboratory Practices 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.
- Selected a Product
Candidate for AAV.103 GJB2-Related Hearing Loss Program and
Initiated Manufacturing Activities to Support IND-Enabling
Studies: In February 2023, Decibel presented preclinical
data at ARO on its AAV.103 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.
Results demonstrated that selective expression of GJB2 in
non-sensory cells that normally express GJB2 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 has achieved a pre-IND milestone in
April 2023 related to initiation of manufacturing under the
collaboration agreement. Decibel retains global commercial rights
to the product candidate.
Otoprotection Therapeutic
- DB-020 Phase 1b Clinical
Trial Data to Be Presented at the American Society of Clinical
Oncology (ASCO) 2023 Annual Meeting: Decibel will present
data from the Phase 1b clinical trial of DB-020, its product
candidate for prevention of cisplatin-induced hearing loss in
patients receiving cisplatin chemotherapy. In the interim results
from the trial, DB-020 demonstrated reduced ototoxicity, a
favorable safety and tolerability profile and no observed effect on
systemic cisplatin pharmacokinetics (PK) in such patients. The
Company is seeking advice from regulatory agencies concerning the
future development of DB-020.
Corporate Update:
- Board of Directors
Update: In March 2023, Decibel announced the appointment
of Matthew Kapusta, MBA, to its Board of Directors. Mr. Kapusta
serves as the CEO of uniQure, a gene therapy company.
First Quarter 2023 Financial Results:
- Cash Position: As
of March 31, 2023, cash, cash equivalents and available-for-sale
securities were $87.9 million, compared to $104.6 million as of
December 31, 2022.
- Research and Development
Expenses: Research and development expenses were $7.9
million for the first quarter of 2023, compared to $7.5 million for
the same period in 2022. The increase in research and development
expenses for the first quarter of 2023 was primarily due to costs
to prepare for the Company’s 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 and wages.
- General and Administrative
Expenses: General and administrative expenses were $6.2
million for the first quarter of 2023, compared to $6.6 million for
the same period in 2022. The decrease in general and administrative
expenses for the first quarter of 2023 was primarily due to lower
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 planned 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 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, 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 March 31, 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) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
|
|
|
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
Cash, cash equivalents and available-for-sale securities |
|
|
|
|
|
$ |
87,941 |
|
|
$ |
104,561 |
|
|
|
Total assets |
|
|
|
$ |
110,454 |
|
|
$ |
123,373 |
|
|
|
Total stockholders' equity |
|
|
|
$ |
69,844 |
|
|
$ |
81,793 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Statement of Operations
(Unaudited) |
|
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
|
$ |
7,934 |
|
|
$ |
7,466 |
|
|
|
General and administrative |
|
|
|
|
6,187 |
|
|
|
6,553 |
|
|
|
Total Operating expenses |
|
|
|
|
14,121 |
|
|
|
14,019 |
|
|
|
Loss from operations |
|
|
|
|
(14,121 |
) |
|
|
(14,019 |
) |
|
|
Other income: |
|
|
|
|
|
|
|
|
Interest income |
|
|
|
|
878 |
|
|
|
63 |
|
|
|
Total other income, net |
|
|
|
|
878 |
|
|
|
63 |
|
|
|
Net loss before provision for income taxes |
|
|
|
(13,243 |
) |
|
|
(13,956 |
) |
|
|
Provision for income taxes |
|
|
|
|
(61 |
) |
|
|
(60 |
) |
|
|
Net loss |
|
|
|
$ |
(13,304 |
) |
|
$ |
(14,016 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Investor Contact:Julie SeidelStern IR,
Inc.julie.seidel@sternir.com212-362-1200
Media Contact:Chris RaileyTen Bridge
Communicationschris@tenbridgecommunications.com 617-834-0936
Decibel Therapeutics (NASDAQ:DBTX)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Decibel Therapeutics (NASDAQ:DBTX)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024