On August 10, 2021 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, 2021 and provided a corporate update (Press release, Decibel Therapeutics, AUG 10, 2021, View Source [SID1234586248]).
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"The second quarter of 2021 has been a time of continued progress across the business as we gear up for meaningful milestones expected in 2022. We have several 2022 catalysts slated for our pipeline programs, including advancing our DB-OTO program into clinical development and the planned interim analysis from our human Phase 1b clinical trial of DB-020 for cisplatin-induced hearing loss," said Laurence Reid, Ph.D., Chief Executive Officer of Decibel. "We were pleased to welcome Dr. William H. Carson as Chairman of the Board of Directors and also announced several significant appointments to our Scientific Advisory Board, further bolstering our team of academic and industry experts. We look forward to working with these world-class experts as we work to pursue our goal of delivering novel therapies to patients with hearing loss and balance disorders."
Company Highlights:
Appointed New Chairman of Board of Directors: In June 2021, Decibel announced the appointment of William H. Carson, M.D., as Chairman of the Board of Directors.
Expanded Scientific Advisory Board: In May 2021, Decibel announced the appointment of several leading experts in gene therapy, cochlear development and molecular genetics to its Scientific Advisory Board (SAB). Appointees included Connie Cepko, Ph.D., Guangping Gao, Ph.D., Matthew Kelley, Ph.D., Glenn Pierce, M.D., Ph.D. and Dinah Sah, Ph.D.
Pipeline Progress
Gene Therapies for Congenital, Monogenic Hearing Loss
On Track to Achieve DB-OTO Key Milestones in 2022: Decibel expects to submit an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) and/or a Clinical Trial Application (CTA) in Europe for DB-OTO and initiate a Phase 1/2 clinical trial of DB-OTO for pediatric patients with congenital hearing loss due to an otoferlin deficiency in 2022.
Preclinical Pipeline Continues to Progress: Decibel expects to announce the program target for its AAV.104 discovery program in patients with autosomal recessive hearing disorders in 2021.
Gene Therapies for Hair Cell Regeneration
On Track to Announce AAV.201 Program Target: Decibel continues to advance AAV.201, its gene therapy program for regeneration of hair cells in the vestibule for the treatment of bilateral vestibulopathy (BVP). Decibel plans to announce the program target for AAV.201 in 2022.
Otoprotection Therapeutic
On Track to Report Interim Results from Phase 1b Proof-of-Concept Trial of DB-020 for the Treatment of Cisplatin-Induced Hearing Loss: Decibel expects to report interim results from the ongoing Phase 1b clinical trial of DB-020 in patients with cisplatin-induced hearing loss in the first half of 2022.
Second Quarter 2021 Financial Results:
Cash Position: As of June 30, 2021, cash, cash equivalents and available-for-sale securities were $184.6 million, compared to $54.3 million as of December 31, 2020. The increase in cash, cash equivalents and available-for-sale securities was due to receipt of the proceeds from the issuance and sale of our Series D convertible preferred stock and from our initial public offering (IPO) in the first quarter of 2021.
Research and Development Expenses: Research and development expenses were $6.8 million for the second quarter of 2021, compared to $5.3 million for the second quarter of 2020. The increase in research and development expenses for the second quarter of 2021 was driven primarily by an increase in manufacturing costs related to toxicology studies of DB-OTO.
General and Administrative Expenses: General and administrative expenses were $4.9 million for the second quarter of 2021, compared to $2.6 million for the same period in 2020. The increase in general and administrative expenses for the second quarter of 2021 was primarily attributable to increases in professional fees, personnel costs and directors’ and officers’ insurance costs incurred as a result of becoming a public company.
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.