Decibel Therapeutics Reports Second Quarter 2022 Financial Results and Corporate Update

On August 10, 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 second quarter ended June 30, 2022 and provided a corporate update (Press release, Decibel Therapeutics, AUG 10, 2022, View Source [SID1234618051]).

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"We are very pleased to report substantial progress made thus far in 2022, notably the announcement of positive top-line results from the interim analysis of our ongoing Phase 1b clinical trial of DB-020 for patients with cisplatin-induced hearing loss. We believe these positive data showcase the integrated capabilities that Decibel has implemented to develop innovative therapeutics for conditions of the inner ear. As we continue to advance our gene therapy pipeline, we believe this achievement strengthens our position as leaders in the hearing loss and balance disorder space. We are further poised to submit one or more regulatory filings for our lead gene therapy product candidate, DB-OTO and to announce a product candidate for our AAV.103 program in the second half of 2022," said Laurence Reid, Ph.D., Chief Executive Officer of Decibel.

Pipeline Highlights and Upcoming Milestones:

Gene Therapies for Congenital, Monogenic Hearing Loss

Anticipated IND/CTA Filing for DB-OTO Product Candidate: Decibel is continuing to prepare for submission of 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 the second half of 2022. Decibel has commenced trial site startup activities and, subject to the clearance of its IND or CTA, expects to initiate a Phase 1/2 clinical trial of DB-OTO for pediatric patients with congenital hearing loss due to an otoferlin deficiency in the first half of 2023. Decibel is developing DB-OTO in collaboration with Regeneron Pharmaceuticals and retains global commercial rights to the product candidate.
Product Candidate Selection for AAV.103 Program: In 2022, Decibel also plans to select a product candidate for further development in its 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. Decibel is developing the AAV.103 program in collaboration with Regeneron Pharmaceuticals and retains global commercial rights to the AAV.103 program.
Otoprotection Therapeutic

Reported Positive Data from Interim Analysis of Ongoing Phase 1b Clinical Trial of DB-020 in Patients Receiving Cisplatin Chemotherapy: In June 2022, Decibel reported positive top-line results from the interim analysis of its ongoing Phase 1b clinical trial of DB-020, a novel, proprietary formulation of sodium thiosulfate, designed to protect against hearing loss in cancer patients receiving cisplatin chemotherapy. Patients enrolled in the Phase 1b clinical trial were randomized to receive one of two doses of DB-020 in one ear while the contralateral ear received placebo, enabling each patient to serve as their own control. Patients were administered DB-020 and placebo up to three hours prior to each cisplatin infusion. Consistent with the results of a Phase 1 clinical trial of DB-020 previously completed by the Company in healthy volunteers, data from the interim analysis demonstrated that DB-020 was well tolerated, with adverse events generally mild to moderate and no significant safety issues observed. In the data from the interim analysis, 88% of patients experienced ototoxicity in their placebo-treated ear, and of these patients, 87% were partially or completely protected from ototoxicity in their DB-020-treated ears.
Board Update:

Announced planned change to the Board of Directors: In June 2022, Matthew Foy, a partner at SR One, departed Decibel’s Board of Directors due to the expiry of his three-year term. "We thank Matt for his service and are appreciative of key contributions he has made to the evolution of Decibel’s strategy," said Laurence Reid.
Second Quarter 2022 Financial Results:

Cash Position: As of June 30, 2022, cash, cash equivalents and available-for-sale securities were $125.6 million, compared to $162.3 million as of December 31, 2021.
Research and Development Expenses: Research and development expenses were $11.2 million for the second quarter of 2022, compared to $6.8 million for the same period in 2021. The increase in research and development expenses for the second quarter of 2022 was primarily due to higher development costs incurred to advance our DB-OTO product candidate, higher research costs related to our other pre-clinical 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 $5.9 million for the second quarter of 2022, compared to $4.9 million for the same period in 2021. The increase in general and administrative expenses for the second quarter of 2022 was primarily due to higher professional fees including external consulting, advisory, legal 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 enable it to fund its pipeline programs and operating expenses into 2024.