On March 29, 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 fourth quarter and full year ended December 31, 2020 and provided a corporate update (Press release, Decibel Therapeutics, MAR 29, 2021, View Source [SID1234577265]).

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"The past nine months have been a strong period of execution for Decibel as we accomplished several key milestones. The closing of two upsized financings – our Series D and IPO – as well as an important partnership with Catalent focused on development and manufacturing of our lead gene therapy program for hearing loss, DB-OTO, place Decibel in a strong position operationally and financially to execute on our goals for 2021," said Laurence Reid, Ph.D., Chief Executive Officer of Decibel. "Across our pipeline, we expect to announce important advances throughout this year. We look forward to further leveraging our proprietary platform of integrated single-cell genomics and bioinformatics analyses applied to the inner ear, as we advance our precision gene therapy pipeline for hearing and balance disorders."

Company Highlights:

Advanced DB-OTO for otoferlin (OTOF) -related hearing loss; on track for IND submission and Phase 1/2 clinical trial initiation in 2022.

Signed New Development and Manufacturing Agreement for Dual-Vector Gene Therapy with Catalent: In February 2021, Decibel announced a new agreement with Catalent to provide Decibel with process and analytical development, as well as cGMP manufacturing services for its lead gene therapy product candidate, DB-OTO, being developed for individuals with hearing loss due to mutation of the OTOF gene.

Announced Exclusive Licensing Agreements for Hearing Gene Therapy Technology with the University of Florida and the University of California, San Francisco: In November 2020, Decibel announced two exclusive license agreements for an adeno-associated virus (AAV) gene therapy technology designed to restore hearing to individuals with profound, congenital hearing loss caused by mutations in the otoferlin gene.

Launched Amplify Genetic Testing Program with Invitae: In December 2020, Decibel launched Amplify, a no-charge genetic testing program to screen for the genetic cause of congenital hearing loss in children diagnosed with auditory neuropathy with the genetic testing company, Invitae.

Presented New Preclinical Data at the 44th Annual Association for Research in Otolaryngology Conference (ARO): In February 2021, Decibel presented preclinical findings supporting the Company’s lead gene therapy product candidate, DB-OTO. The presentations included data from studies in non-human primates of the surgical approach for DB-OTO in which dual vector AAV and Decibel’s cell-selective promoter drove highly selective expression of GFP in hair cells of non-human primates which demonstrated successful distribution and expression across the cochlear length in non-human primates. Additionally, the Company presented findings from preclinical studies of DB-OTO in mice and non-human primates in which hair cell-selective expression of OTOF enabled efficacy and durability and minimized potential toxicity.

Received U.S. Food and Drug Administration (FDA) Fast Track Designation for DB-020: In December 2020, Decibel announced that its clinical product candidate for the prevention of cisplatin-induced hearing loss, DB-020, was granted Fast Track designation by the U.S. FDA.
Corporate Highlights:

Closed Upsized Initial Public Offering: In February 2021, Decibel completed its Initial Public Offering of 7,662,000 shares of common stock at a public offering price of $18.00 per share. Net proceeds from the offering, after deducting underwriting discounts and offering expenses, were approximately $124.8 million.

Closed $82.2M Series D Financing: In November 2020, Decibel announced the closing of its oversubscribed Series D financing, which raised proceeds of $82.2 million. The financing was led by OrbiMed with new investments from BlackRock Health Sciences, Casdin Capital, Janus Henderson, Samsara BioCapital and Surveyor Capital, along with existing investor participation from Foresite Capital, GV, S-Cubed, Sobrato Capital, SR One and Third Rock Ventures.

Strengthened Board of Directors with Appointment of Peter A. Thompson, M.D., F.A.C.P.: In November 2020, Decibel announced the appointment of Peter. A. Thompson, M.D., F.A.C.P., to its board of directors. Dr. Thompson is currently a partner at OrbiMed.

Added to Russell 2000 Index: Effective March 22, 2021, Decibel was added to the Russell 2000 Index as part of its quarterly IPO additions. The Russell 2000 Index is a subset of the Russell 3000 Index, which measures the performance of the small-cap segment of the U.S. equity market.
Fourth Quarter and Full Year 2020 Financial Results:

Cash Position: As of December 31, 2020, cash, cash equivalents and available-for-sale securities were $54.3 million, compared to $32.3 million as of December 31, 2019. The increase in cash, cash equivalents and available-for-sale securities was primarily due to closing the initial tranche of the Series D financing in November 2020.

Research and Development Expenses: Research and development expenses were $7.9 million for the fourth quarter of 2020, compared to $3.2 million for the same period in 2019. Research and development expenses were $25.3 million for the full year 2020, compared to $29.4 million for the full year 2019. The decrease in research and development expenses for the full year 2020 was primarily due to a decrease in expenses incurred to advance the Company’s DB-020 program related to slower enrollment due to COVID-19 and a decrease in other indirect research and development expenses.

General and Administrative Expenses: General and administrative expenses were $5.1 million for the fourth quarter of 2020, compared to $3.3 million for the same period in 2019. General and administrative expenses were $14.2 million for the full year 2020, compared to $14.7 million for the full year 2019. The decrease in general and administrative expenses for the full year 2020 was primarily attributable to a decrease in facilities and personnel-related expenses due to reduced headcount partially offset by an increase in professional fees.
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.