-Efficiently accomplished an oversubscribed Sequence D financing and upsized Preliminary Public Providing elevating roughly $220.1M in gross proceeds-
-Established improvement and manufacturing settlement for otoferlin dual-vector gene remedy with Catalent-
-Launched Amplify™ genetic testing program with Invitae for congenital listening to loss-
-U.S. FDA Quick Observe designation granted for DB-020-
–Introduced 8 podium and poster displays at ARO-
BOSTON, March 29, 2021 (GLOBE NEWSWIRE) — Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology firm devoted to discovering and creating transformative remedies to revive and enhance listening to and stability, at this time reported monetary outcomes for the fourth quarter and full 12 months ended December 31, 2020 and supplied a company replace.
“The previous 9 months have been a powerful interval of execution for Decibel as we completed a number of key milestones. The closing of two upsized financings – our Sequence D and IPO – in addition to an necessary partnership with Catalent targeted on improvement and manufacturing of our lead gene remedy program for listening to loss, DB-OTO, place Decibel in a powerful place operationally and financially to execute on our objectives for 2021,” mentioned Laurence Reid, Ph.D., Chief Government Officer of Decibel. “Throughout our pipeline, we anticipate to announce necessary advances all through this 12 months. We stay up for additional leveraging our proprietary platform of built-in single-cell genomics and bioinformatics analyses utilized to the internal ear, as we advance our precision gene remedy pipeline for listening to and stability problems.”
- Superior DB-OTO for otoferlin (OTOF) -related listening to loss; on monitor for IND submission and Part 1/2 scientific trial initiation in 2022.
- Signed New Improvement and Manufacturing Settlement for Twin-Vector Gene Remedy with Catalent: In February 2021, Decibel introduced a brand new settlement with Catalent to offer Decibel with course of and analytical improvement, in addition to cGMP manufacturing companies for its lead gene remedy product candidate, DB-OTO, being developed for people with listening to loss as a result of mutation of the OTOF gene.
- Introduced Unique Licensing Agreements for Listening to Gene Remedy Know-how with the College of Florida and the College of California, San Francisco: In November 2020, Decibel introduced two unique license agreements for an adeno-associated virus (AAV) gene remedy expertise designed to revive listening to to people with profound, congenital listening to loss brought on by mutations within the otoferlin gene.
- Launched Amplify™ Genetic Testing Program with Invitae: In December 2020, Decibel launched Amplify™, a no-charge genetic testing program to display screen for the genetic explanation for congenital listening to loss in kids recognized with auditory neuropathy with the genetic testing firm, Invitae.
- Introduced New Preclinical Knowledge on the 44th Annual Affiliation for Analysis in Otolaryngology Convention (ARO): In February 2021, Decibel offered preclinical findings supporting the Firm’s lead gene remedy product candidate, DB-OTO. The displays included information from research in non-human primates of the surgical strategy for DB-OTO during which twin vector AAV and Decibel’s cell-selective promoter drove extremely selective expression of GFP in hair cells of non-human primates which demonstrated profitable distribution and expression throughout the cochlear size in non-human primates. Moreover, the Firm offered findings from preclinical research of DB-OTO in mice and non-human primates during which hair cell-selective expression of OTOF enabled efficacy and sturdiness and minimized potential toxicity.
- Acquired U.S. Meals and Drug Administration (FDA) Quick Observe Designation for DB-020: In December 2020, Decibel introduced that its scientific product candidate for the prevention of cisplatin-induced listening to loss, DB-020, was granted Quick Observe designation by the U.S. FDA.
- Closed Upsized Preliminary Public Providing: In February 2021, Decibel accomplished its Preliminary Public Providing of seven,662,000 shares of frequent inventory at a public providing value of $18.00 per share. Internet proceeds from the providing, after deducting underwriting reductions and providing bills, have been roughly $124.8 million.
- Closed $82.2M Sequence D Financing: In November 2020, Decibel introduced the closing of its oversubscribed Sequence D financing, which raised proceeds of $82.2 million. The financing was led by OrbiMed with new investments from BlackRock Well being Sciences, Casdin Capital, Janus Henderson, Samsara BioCapital and Surveyor Capital, together with current investor participation from Foresite Capital, GV, S-Cubed, Sobrato Capital, SR One and Third Rock Ventures.
- Strengthened Board of Administrators with Appointment of Peter A. Thompson, M.D., F.A.C.P.: In November 2020, Decibel introduced the appointment of Peter. A. Thompson, M.D., F.A.C.P., to its board of administrators. Dr. Thompson is presently a associate at OrbiMed.
- Added to Russell 2000 Index: Efficient March 22, 2021, Decibel was added to the Russell 2000® Index as a part of its quarterly IPO additions. The Russell 2000® Index is a subset of the Russell 3000® Index, which measures the efficiency of the small-cap phase of the U.S. fairness market.
Fourth Quarter and Full 12 months 2020 Monetary Outcomes:
- Money Place: As of December 31, 2020, money, money equivalents and available-for-sale securities have been $54.3 million, in comparison with $32.3 million as of December 31, 2019. The rise in money, money equivalents and available-for-sale securities was primarily as a result of closing the preliminary tranche of the Sequence D financing in November 2020.
- Analysis and Improvement Bills: Analysis and improvement bills have been $7.9 million for the fourth quarter of 2020, in comparison with $3.2 million for a similar interval in 2019. Analysis and improvement bills have been $25.3 million for the complete 12 months 2020, in comparison with $29.4 million for the complete 12 months 2019. The lower in analysis and improvement bills for the complete 12 months 2020 was primarily as a result of a lower in bills incurred to advance the Firm’s DB-020 program associated to slower enrollment as a result of COVID-19 and a lower in different oblique analysis and improvement bills.
- Common and Administrative Bills: Common and administrative bills have been $5.1 million for the fourth quarter of 2020, in comparison with $3.3 million for a similar interval in 2019. Common and administrative bills have been $14.2 million for the complete 12 months 2020, in comparison with $14.7 million for the complete 12 months 2019. The lower basically and administrative bills for the complete 12 months 2020 was primarily attributable to a lower in amenities and personnel-related bills as a result of decreased headcount partially offset by a rise in skilled charges.
Based mostly on its present working and improvement plans, Decibel believes that its current money, money equivalents and available-for-sale securities will fund its pipeline packages and working bills into 2024.
About Decibel Therapeutics
Decibel Therapeutics is a clinical-stage biotechnology firm devoted to discovering and creating transformative remedies to revive and enhance listening to and stability, one of many largest areas of unmet want in drugs. Decibel has constructed a proprietary platform that integrates single-cell genomics and bioinformatic analyses, precision gene remedy applied sciences and experience in internal ear biology. Decibel is leveraging its platform to advance gene therapies designed to selectively exchange genes for the therapy of congenital, monogenic listening to loss and to regenerate internal ear hair cells for the therapy of acquired listening to and stability problems. Decibel’s pipeline, together with its lead gene remedy program, DB-OTO, to deal with congenital, monogenic listening to loss, is designed to ship on our imaginative and prescient of a world during which the privileges of listening to and stability can be found to all.
This press launch incorporates forward-looking statements that contain substantial dangers and uncertainties. All statements, aside from statements of historic info, contained on this press launch, together with statements relating to Decibel’s technique, future operations, prospects, plans, aims of administration, the therapeutic potential for Decibel’s product candidates and preclinical packages, the potential advantages of cell-selective expression, the anticipated timeline for submitting investigational new drug functions and attaining different deliberate milestones, expectations relating to the interpretation of preclinical findings to human illness and the sufficiency of Decibel’s current money assets for the interval anticipated, represent forward-looking statements inside the which means of The Non-public Securities Litigation Reform Act of 1995. The phrases “anticipate,” “imagine,” “proceed,” “may,” “estimate,” “anticipate,” “intend,” “could,” “may,” “goal,” “ongoing,” “plan,” “predict,” “challenge,” “potential,” “ought to,” or “would,” or the unfavourable of those phrases, or different comparable terminology are meant to determine forward-looking statements, though not all forward-looking statements comprise these figuring out phrases. Decibel could not truly obtain the plans, intentions or expectations disclosed in these forward-looking statements, and you shouldn’t place undue reliance on these forward-looking statements. Precise outcomes or occasions may differ materially from the plans, intentions and expectations disclosed in these forward-looking statements on account of numerous necessary elements, together with: uncertainties inherent within the identification and improvement of product candidates, together with the conduct of analysis actions and the initiation and completion of preclinical research and scientific trials, the timing of and Decibel’s means to submit and acquire approval to provoke scientific improvement of its program candidates, whether or not outcomes from preclinical research can be predictive of the outcomes of later preclinical research and scientific trials, whether or not Decibel’s money assets are adequate to fund its foreseeable and unforeseeable working bills and capital expenditure necessities, uncertainties associated to the influence of the COVID-19 pandemic on Decibel’s enterprise and operations, in addition to the dangers and uncertainties recognized in Decibel’s filings with the Securities and Trade Fee (SEC), together with these dangers detailed underneath the caption “Threat Elements” within the last prospectus for Decibel’s preliminary public providing filed with the SEC on February 12, 2021. As well as, the forward-looking statements included on this press launch symbolize Decibel’s views as of the date of this press launch. Decibel anticipates that subsequent occasions and developments will trigger its views to alter. Nevertheless, whereas Decibel could elect to replace these forward-looking statements sooner or later sooner or later, it particularly disclaims any obligation to take action. These forward-looking statements shouldn’t be relied upon as representing Decibel’s views as of any date subsequent to the date of this press launch.
|Consolidated Steadiness Sheet|
|Money, money equivalents and available-for-sale securities||$||54,310||$||32,314|
|Convertible most popular inventory||93,091||137,644|
|Complete stockholders’ deficit||(162,689||)||(123,352||)|
|Consolidated Assertion of Operations|
|12 months ended December 31,|
|Analysis and improvement||$||25,322||$||29,405|
|Common and administrative||14,241||14,676|
|Complete Working bills||39,563||44,081|
|Loss from operations||(39,563||)||(44,081||)|
|Different earnings, internet||171||–|
|Complete different earnings, internet||226||1,409|
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