On May 12, 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 first quarter ended March 31, 2022 and provided a corporate update (Press release, Decibel Therapeutics, MAY 12, 2022, View Source [SID1234614387]).
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"2022 is slated to be a year of important growth and execution for Decibel as we have multiple catalysts expected throughout the remainder of the year. We have built a strong foundation both operationally and scientifically and are looking forward to these significant milestones, which potentially can further validate Decibel’s inner ear expertise and commitment to further exploiting our proprietary gene therapy platform," said Laurence Reid, Ph.D., Chief Executive Officer of Decibel. "Notably, we plan to share data from an interim analysis of our Phase 1b trial of DB-020 for cisplatin-induced hearing loss in the second quarter of 2022, and we intend to initiate a Phase 1/2 clinical trial of DB-OTO later this year, subject to regulatory clearance."
Pipeline Highlights and Upcoming Milestones:
Gene Therapies for Congenital, Monogenic Hearing Loss
DB-OTO Program Remains On Track For 2022 Milestones: Decibel remains on track to submit an investigational new drug application (IND) to the U.S. Food and Drug Administration and/or a Clinical Trial Application (CTA) in Europe for DB-OTO in 2022. Decibel also anticipates the initiation of a Phase 1/2 clinical trial of DB-OTO for pediatric patients with congenital hearing loss due to an otoferlin deficiency in 2022, subject to regulatory clearance.
Presented New Preclinical Data from Four Gene Therapy Programs at the 45th Annual Association for Research in Otolaryngology Conference (ARO): In February 2022, Decibel presented preclinical data highlighting the identification of proprietary, cell-selective promoters for three of its gene therapy pipeline programs deployed from its platform, in addition to new DB-OTO data, which further characterized expression of otoferlin over time following DB-OTO administration in mice and non-human primates. These findings are consistent with the expression previously reported in mice that achieved stable functional recovery. Additionally, functional recovery and tolerability data associated with DB-OTO dosing over a 10-fold dose range in mice was observed. Decibel is developing DB-OTO in collaboration with Regeneron Pharmaceuticals and retains global commercial rights to DB-OTO.
On Track to Identify a Product Candidate for AAV.103 Program in 2022: Product candidate selection for the AAV.103 program to restore hearing to individuals with a gap junction beta-2 (GJB2) deficiency, the most common cause of autosomal recessive, non-syndromic, congenital hearing loss, is expected in 2022. Decibel is developing AAV.103 in collaboration with Regeneron Pharmaceuticals and retains global commercial rights to the AAV.103 program.
Otoprotection Therapeutic
Phase 1b Proof-of-Concept Trial of DB-020 for the Treatment of Cisplatin-Induced Hearing Loss Interim Results Anticipated in the Second Quarter of 2022: Results of the interim analysis from the ongoing Phase 1b clinical trial of DB-020 in patients with cisplatin-induced hearing loss, a serious and debilitating condition for which there are no approved therapies, are expected in the second quarter of 2022. Cisplatin, a commonly used chemotherapy agent, is known to cause hearing loss, tinnitus and speech recognition difficulty. DB-020 is comprised of a proprietary formulation of sodium thiosulfate that has been optimized for delivery to the ear. DB-020 is designed to protect hearing without interfering with cisplatin’s anti-cancer activity by locally disabling cisplatin in the cochlea.
First Quarter 2022 Financial Results:
Cash Position: As of March 31, 2022, cash, cash equivalents and available-for-sale securities were $139.4 million, compared to $162.3 million as of December 31, 2021.
Research and Development Expenses: Research and development expenses were $7.5 million for the first quarter of 2022, compared to $6.0 million for the same period in 2021. The increase in research and development expenses for the first quarter of 2022 was primarily due to higher development costs incurred to advance the DB-OTO and DB-020 programs, as well as higher personnel-related costs due to increased headcount, wages and stock-based compensation.
General and Administrative Expenses: General and administrative expenses were $6.6 million for the first quarter of 2022, compared to $4.9 million for the same period in 2021. The increase in general and administrative expenses for the first quarter of 2022 was primarily due to higher professional fees including external consulting, advisory 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 existing cash, cash equivalents and available-for-sale securities will fund its pipeline programs and operating expenses into 2024.