On November 9, 2022 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported financial results for the third quarter ended September 30, 2022 and provided a corporate update (Press release, Decibel Therapeutics, NOV 9, 2022, View Source [SID1234623654]).

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"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.