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 third quarter ended September 30, 2021 and provided a corporate update.
“Decibel continues to work towards bringing transformative treatments to patients with hearing and balance disorders as we move to the end of a successful 2021 and look forward to 2022. We remain on track to initiate a Phase 1/2 clinical trial of DB-OTO in pediatric patients in 2022 and report the results of an interim analysis of our Phase 1b clinical trial of DB-020 in patients receiving cisplatin chemotherapy in the first half of 2022,” said Laurence Reid, Ph.D., Chief Executive Officer of Decibel. “We are incredibly pleased to have received Orphan Drug and Rare Pediatric Disease designations for DB-OTO, reiterating the importance of our approach to gene therapies for congenital, monogenic hearing loss. Beyond DB-OTO, we have continued to leverage our precision gene therapy platform to advance our GJB2, stereocilin and regeneration gene therapy programs.”
Gene Therapies for Congenital, Monogenic Hearing Loss
Gene Therapies for Hair Cell Regeneration
Otoprotection Therapeutic
Research Highlights:
Third Quarter 2021 Financial Results:
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.
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 program, DB-OTO, to treat congenital, monogenic hearing loss, is designed to deliver on our vision of creating a world of connection for people with hearing and balance disorders. For more information about Decibel Therapeutics, please visit www.decibeltx.com or follow us on Twitter.
Forward-Looking Statements
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 product 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 September 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 | ||||||||||||||||||
(unaudited) | ||||||||||||||||||
(in thousands) | ||||||||||||||||||
September 30, 2021 | December 31, 2020 | |||||||||||||||||
Cash, cash equivalents and available-for-sale securities | $ | 172,384 | $ | 54,310 | ||||||||||||||
Total assets | 185,287 | 67,285 | ||||||||||||||||
Convertible preferred stock | — | 93,091 | ||||||||||||||||
Total stockholders' deficit | (201,609 | ) | (162,689 | ) | ||||||||||||||
Condensed Consolidated Statement of Operations | ||||||||||||||||||
(unaudited) | ||||||||||||||||||
(in thousands) | For the three months ended | For the nine months ended | ||||||||||||||||
September 30, 2021 | September 30, 2020 | September 30, 2021 | September 30, 2020 | |||||||||||||||
Operating expenses: | ||||||||||||||||||
Research and development | $ | 9,020 | $ | 4,691 | $ | 21,867 | $ | 17,426 | ||||||||||
General and administrative | 5,680 | 2,397 | 15,462 | 9,130 | ||||||||||||||
Total Operating expenses | 14,700 | 7,088 | 37,329 | 26,556 | ||||||||||||||
Loss from operations | (14,700 | ) | (7,088 | ) | (37,329 | ) | (26,556 | ) | ||||||||||
Other income: | ||||||||||||||||||
Interest income | 33 | 2 | 141 | 103 | ||||||||||||||
Other income | — | (25 | ) | — | — | |||||||||||||
Total other income, net | 33 | (23 | ) | 141 | 103 | |||||||||||||
Income before income tax provision | (14,667 | ) | (7,111 | ) | (37,188 | ) | (26,453 | ) | ||||||||||
Provision for income taxes | (1,732 | ) | — | (1,732 | ) | — | ||||||||||||
Net loss | $ | (16,399 | ) | $ | (7,111 | ) | $ | (38,920 | ) | $ | (26,453 | ) | ||||||
Investor Contact:
Julie Seidel
Stern IR, Inc.
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212-362-1200
Media Contact:
Chris Railey
Ten Bridge Communications
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617-834-0936
Last Trade: | US$4.91 |
Daily Volume: | 0 |
Market Cap: | US$123.390M |
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