- Bolstered Board of Directors and Scientific Advisory Board with key appointments -
- On track for anticipated 2022 milestones including submission of IND and/or CTA for DB-OTO and interim analysis of DB-020 Phase 1b trial for cisplatin-induced hearing loss -
BOSTON, Aug. 10, 2021 (GLOBE NEWSWIRE) -- Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today reported financial results for the second quarter ended June 30, 2021 and provided a corporate update.
“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.”
- 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.
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.
- 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.
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.
About Decibel Therapeutics
Decibel Therapeutics is a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, one of the largest areas of unmet need in medicine. Decibel has built a proprietary platform that integrates single-cell genomics and bioinformatic analyses, precision gene therapy technologies and expertise in inner ear biology. Decibel is leveraging its platform to advance gene therapies designed to selectively replace genes for the treatment of congenital, monogenic hearing loss and to regenerate inner ear hair cells for the treatment of acquired hearing and balance disorders. Decibel’s pipeline, including its lead gene therapy product candidate, DB-OTO, to treat congenital, monogenic hearing loss, is designed to deliver on our vision of a world in which the privileges of hearing and balance are available to all. For more information about Decibel Therapeutics, please visit www.decibeltx.com or follow us on Twitter.
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Decibel’s strategy, future operations, prospects, plans, objectives of management, the therapeutic potential for Decibel’s product candidates and preclinical programs, the expected timeline for submitting investigational new drug applications and achieving other planned milestones and the sufficiency of Decibel’s existing cash resources for the period anticipated, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Decibel may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the conduct of research activities and the initiation and completion of preclinical studies and clinical trials, the timing of and Decibel’s ability to submit and obtain approval to initiate clinical development of its program candidates, whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials, whether Decibel’s cash resources are sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements, uncertainties related to the impact of the COVID-19 pandemic on Decibel’s business and operations, as well as the risks and uncertainties identified in Decibel’s filings with the Securities and Exchange Commission (SEC), including those risks detailed under the caption “Risk Factors” in Decibel’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021 and in other filings Decibel may make with the SEC. In addition, the forward-looking statements included in this press release represent Decibel’s views as of the date of this press release. Decibel anticipates that subsequent events and developments will cause its views to change. However, while Decibel may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Decibel’s views as of any date subsequent to the date of this press release.
|Condensed Consolidated Balance Sheets|
|June 30, 2021||December 31, 2020|
|Cash, cash equivalents and available-for-sale securities||$||184,600||$||54,310|
|Convertible preferred stock||—||93,091|
|Total stockholders' deficit||(185,210||)||(162,689||)|
|Condensed Consolidated Statement of Operations|
|(in thousands)||For the three months ended||For the six months ended|
|June 30, 2021||June 30, 2020||June 30, 2021||June 30, 2020|
|Research and development||$||6,827||$||5,299||$||12,847||$||12,735|
|General and administrative||4,899||2,555||9,782||6,733|
|Total Operating expenses||11,726||7,854||22,629||19,468|
|Loss from operations||(11,726||)||(7,854||)||(22,629||)||(19,468||)|
|Total other income, net||75||47||108||126|
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