– Announced positive data from interim analysis of Phase 1b clinical trial of DB-020 in patients receiving cisplatin chemotherapy; data support continued development of DB-020 as a potential therapy to protect against hearing loss in patients receiving cisplatin chemotherapy for cancer –
– Multiple milestones anticipated across gene therapy pipeline programs for congenital, monogenic hearing loss for remainder of 2022, with IND and/or CTA submission for DB-OTO and candidate selection for AAV.103 –
BOSTON, Aug. 10, 2022 (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, 2022 and provided a corporate update.
“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.
- 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.
- 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.
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.
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 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.
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 potential benefits of cell-selective expression, the expected timeline for submitting investigational new drug applications and clinical trial applications and initiating clinical trials, selecting development candidates and achieving other anticipated milestones, expectations regarding the translation of preclinical findings to human disease 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 fiscal period ended June 30, 2022 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 Sheet Data (Unaudited)|
|June 30,||December 31,|
|Cash, cash equivalents and available-for-sale securities||$||125,649||$||162,294|
|Total stockholders’ equity||$||111,858||$||141,689|
|Condensed Consolidated Statement of Operations (Unaudited)|
|For the three months ended||For the six months ended|
|June 30, 2022||June 30, 2021||June 30, 2022||June 30, 2021|
|Research and development||$||11,241||$||6,827||$||18,707||$||12,847|
|General and administrative||5,862||4,899||12,415||9,782|
|Total Operating expenses||17,103||11,726||31,122||22,629|
|Loss from operations||(17,103||)||(11,726||)||(31,122||)||(22,629||)|
|Other income, net||95||75||158||108|
|Total other income, net||95||75||158||108|
|Income before income tax provision||(17,008||)||(11,651||)||(30,964||)||(22,521||)|
|Provision for income taxes||(38||)||—||(98||)||—|
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