Tillkännagivande • Oct 11
Decibel Therapeutics, Inc. Files Form 15 Decibel Therapeutics, Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its Common Stock under the Securities Exchange Act of 1934, as amended. The par value of the company's Common Stock was $0.001 per share. New Risk • Sep 28
New major risk - Revenue and earnings growth Earnings have declined by 20% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (24% average weekly change). Earnings have declined by 20% per year over the past 5 years. Revenue is less than US$1m. Tillkännagivande • Sep 26
Decibel Therapeutics, Inc. Announces Board Changes On August 9, 2023, Decibel Therapeutics, Inc. (the “Company”), entered into an Agreement and Plan of Merger (the “Merger Agreement”), dated as of August 8, 2023, with Regeneron Pharmaceuticals, Inc. (“Parent”), and Symphony Acquisition Sub, Inc. a wholly owned subsidiary of Parent (“Purchaser”). In accordance with the terms of the Merger Agreement, each of William Carson, Alison Finger, Matthew Kapusta, Kevin McLaughlin, Saraswathy Nochur and Laurence Reid resigned from his or her respective positions as a member of the Company’s board of directors and all committees thereof, effective as of the Effective Time and Nouhad Husseini, the sole director of the Purchaser immediately prior to the Effective Time, became the sole director of the Company, in each case, as of the Effective Time. The director resignations were tendered in connection with the Merger and were not a result of any disagreement between the Company and the directors on any matter relating to the Company’s operations, policies or practices. Following the Effective Time, the officers of the Company are as follows: Nouhad Husseini, Managing Director, Robert E. Landry, Chief Financial Officer, Joseph J. LaRosa, Secretary, and Leonard N. Brooks, Treasurer. Tillkännagivande • Aug 27
Decibel Therapeutics, Inc. Announces U.S. Food and Drug Administration Grants Fast Track Designation for DB-OTO On August 25, 2023, Decibel Therapeutics, Inc. announced that the U.S. Food and Drug Administration had granted fast track designation for DB-OTO, the Company’s lead gene therapy product candidate for congenital hearing loss caused by mutations of the otoferlin gene. Tillkännagivande • Aug 11
Regeneron Pharmaceuticals, Inc. (NasdaqGS:REGN) entered into a definitive agreement to acquire remaining unknown majority stake in Decibel Therapeutics, Inc. (NasdaqGS:DBTX) from a group of shareholders for approximately $100 million. Regeneron Pharmaceuticals, Inc. (NasdaqGS:REGN) entered into a definitive agreement to acquire remaining unknown majority stake in Decibel Therapeutics, Inc. (NasdaqGS:DBTX) from a group of shareholders for approximately $100 million on August 8, 2023. Regeneron to initiate a tender offer to acquire all outstanding shares of Decibel at a price of $4.00 per share of Decibel common stock payable in cash at closing plus one CVR. Decibel shareholders will receive a non-tradeable contingent value right (CVR) to receive up to $3.50 per share in cash upon achievement of certain clinical development and regulatory milestones for Decibel’s lead investigational candidate, DB-OTO, within specified time periods. Regeneron currently owns 2,097,314 shares of Common Stock of Decibel. The proposed acquisition values Decibel at a total equity value of approximately $109 million based on the amount payable at closing, and a total equity value of up to approximately $213 million if the CVR milestones are achieved. The Merger Agreement also provides that, in connection with the termination of the Merger Agreement under specified circumstances, Decibel will be required to pay Regeneron a termination fee in the amount of $6,500,000.
The closing of the tender offer will be subject to certain conditions, including the tender of at least a majority of the outstanding shares of Decibel common stock and other customary closing conditions. Upon the successful completion of the tender offer, Regeneron will acquire all shares not acquired in the tender through a second-step merger for the same consideration per share paid in the tender offer. The board of directors of Decibel unanimously approved the merger agreement. The board of directors of Regeneron have also approved the transaction. In connection with execution of the Merger Agreement, Regeneron entered into Tender and Support Agreements with each of (i) OrbiMed Private Investments VIII, LP, OrbiMed Partners Master Fund Limited and OrbiMed Genesis Master Fund, L.P., (ii) Third Rock Ventures III, L.P. and (iii) Laurence Reid, which collectively own approximately 35.7% of the outstanding shares of Common Stock of Decibel, to vote all of such Supporting Stockholder’s shares of Common Stock in favor of the Merger. The transaction is expected to close in the third quarter of 2023.
Andrew R. Brownstein and Victor Goldfeld of Wachtell, Lipton, Rosen & Katz acted as legal advisors to Regeneron. Centerview Partners LLC and Leerink Partners LLC are serving as Decibel’s financial advisors and Stuart M. Falber, Joseph B. Conahan and Scott Lunin of Wilmer Cutler Pickering Hale and Dorr LLP serving as Decibel’s legal advisors. Centerview Partners LLC acted as fairness opinion provider to the board of directors of Decibel. Price Target Changed • Jul 26
Price target increased by 13% to US$15.33 Up from US$13.60, the current price target is an average from 3 analysts. New target price is 420% above last closing price of US$2.95. Stock is down 40% over the past year. The company is forecast to post a net loss per share of US$1.89 next year compared to a net loss per share of US$2.52 last year. Major Estimate Revision • May 22
Consensus EPS estimates upgraded to US$1.89 loss The consensus outlook for fiscal year 2023 has been updated. 2023 losses forecast to reduce from -US$2.20 to -US$1.89 per share. Revenue forecast unchanged from US$15.1m at last update. Biotechs industry in the US expected to see average net income decline 81% next year. Consensus price target of US$12.60 unchanged from last update. Share price rose 17% to US$4.43 over the past week. Tillkännagivande • May 13
Decibel Therapeutics Announces Approval of Clinical Trial Application by the Spanish Agency of Medicines and Medical Devices to Initiate Clinical Development of Lead Gene Therapy Candidate Db-OTO Decibel Therapeutics announced approval of its Clinical Trial Application (CTA) by the Spanish Agency of Medicines and Medical Devices (AEMPS) to initiate a Phase 1/2 clinical trial in pediatric patients of DB-OTO, its lead gene therapy product candidate. DB-OTO is being developed in collaboration with Regeneron Pharmaceuticals, Inc. and is a cell-selective, adeno- associated virus (AAV) gene therapy product candidate designed to provide durable, physiological hearing in individuals with profound, congenital hearing loss caused by mutations of the otoferlin gene. The CTA in Spain is part of an international regulatory strategy for clinical development of DB-OTO, which also includes a regulatory clearance for an Investigational New Drug (IND) application in the United States in October 2022 and a CTA approval by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) in January 2023. Decibel expects that clinical trial participants in the U.K. and Spain will be infants two years of age and younger. The Company anticipates reporting the initial safety and tolerability data and preliminary efficacy data, as measured by ABR, from the first patients in the Phase 1/2 clinical trials in the first quarter of 2024. The Phase 1/2 dose escalation clinical trial, known as CHORD(TM), is designed to evaluate the safety, tolerability and efficacy of DB-OTO in pediatric patients with congenital hearing loss due to an otoferlin deficiency. In addition to safety and tolerability endpoints, the auditory brainstem response (ABR) -- an objective, clinically accepted, physiologic measure of hearing sensitivity -- will be used as an efficacy endpoint in the clinical trial. The ABR, which was used to characterize dose-response of DB-OTO after intra-cochlear delivery in translational studies in animal models, provides an opportunity to rapidly assess hearing functionality and sensitivity. Price Target Changed • Mar 16
Price target decreased by 7.4% to US$12.60 Down from US$13.60, the current price target is an average from 5 analysts. New target price is 238% above last closing price of US$3.73. Stock is up 24% over the past year. The company is forecast to post a net loss per share of US$2.20 next year compared to a net loss per share of US$2.52 last year. Tillkännagivande • Jan 25
PDecibel Therapeutics, Inc. Announces Approval of Clinical Trial Application by the U.K. Medicines and Healthcare Products Regulatory Agency for Lead Gene Therapy Candidate DB-OTO Decibel Therapeutics, Inc. announced authorization of its Clinical Trial Application (CTA) by the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 1/2 clinical trial in pediatric patients of DB-OTO, its lead gene therapy product candidate. DB-OTO is being developed in collaboration with Regeneron Pharmaceuticals, Inc. and is a cell-selective adeno-associated virus (AAV) gene therapy designed to provide durable hearing in individuals with profound, congenital hearing loss caused by mutations of the otoferlin gene. The U.K. CTA is part of an international regulatory strategy for clinical development of DB-OTO, which also includes a regulatory clearance in October 2022 for an Investigational New Drug (IND) application in the United States and a CTA submitted to the Spanish Agency of Medicines and Medical Devices. "This CTA marks the second regulatory clearance for DB-OTO and what they believe to be the first in Europe for any gene therapy targeting otoferlin. Currently, there are no approved pharmacologic treatment options for individuals with otoferlin-related hearing loss. The Phase 1/2 dose escalation clinical trial is designed to evaluate the safety, tolerability and efficacy of DB-OTO in pediatric patients with congenital hearing loss due to an otoferlin deficiency. In addition to safety andtolerability endpoints, the auditory brainstem response (ABR), an objective, clinically accepted, physiologic measure of hearing sensitivity, will be used as an efficacy endpoint in the clinical trial. The ABR, which was used to characterize dose-response of DB-OTO after intra-cochlear delivery in translational studies in animal models, provides an opportunity to rapidly assess hearing functionality and sensitivity. The Company intends to provide an update on the design of the clinical trial in mid-2023. About Decibel TherapeuticsDecibel 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 vision of creatinga world of connection for people with hearing and balance disorders. Major Estimate Revision • Nov 16
Consensus revenue estimates fall by 25% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$13.3m to US$10.0m. Forecast losses increased from -US$1.95 to -US$2.07 per share. Biotechs industry in the US expected to see average net income decline 93% next year. Consensus price target down from US$14.60 to US$14.20. Share price rose 5.8% to US$3.47 over the past week. Board Change • Nov 16
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Director Kevin McLaughlin was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Tillkännagivande • Nov 03
Decibel Therapeutics, Inc. Announces Submission of Clinical Trial Applications for Lead Gene Therapy Candidate Db-Oto Decibel Therapeutics, Inc. announced the submission of Clinical Trial Applications (CTAs) to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom and the Spanish Agency of Medicines and Medical Devices (AEMPS) for a Phase 1/2 clinical trial in pediatric patients of DB-OTO, a gene therapy product candidate designed to provide durable hearing in individuals with profound congenital hearing loss due to an otoferlin deficiency. DB-OTO is being developed in collaboration with Regeneron Pharmaceuticals and is an adeno-associated virus (AAV)-based, dual-vector, gene therapy product candidate. Otoferlin is a protein expressed in cochlear inner hair cells that enables communication between the sensory hair cells of the inner ear and the auditory nerve. Newborns born with mutations in the otoferlin gene have fully developed structures within the inner ear. However, these newborns have profound hearing loss because signaling between the ear and the brain is disrupted. DB-OTO uses a proprietary, cell- selective promoter to express the otoferlin transgene in hair cells, with the goal of enabling the ear to transmit sound to the brain and provide hearing. DB-OTO received Orphan Drug and Rare Pediatric Disease designations from the U.S. FDA in 2021, and on October 17, 2022 Decibel received clearance from the U.S. FDA for its Investigational New Drug (IND) application to initiate a pediatric Phase 1/2 clinical trial in the United States in children and infants. About Decibel TherapeuticsDecibel Therapeutics is a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, one of the 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 vision of creating a world of connection for people with hearing and balance disorders. Board Change • Nov 02
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Director Kevin McLaughlin was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Price Target Changed • Oct 27
Price target decreased to US$14.60 Down from US$16.00, the current price target is an average from 5 analysts. New target price is 254% above last closing price of US$4.12. Stock is down 50% over the past year. The company is forecast to post a net loss per share of US$1.95 next year compared to a net loss per share of US$2.49 last year. Tillkännagivande • Oct 18
Decibel Therapeutics, Inc. Receives Fda Clearance of Ind Application for Db-Oto, A Gene Therapy Product Candidate Designed to Provide Hearing to Individuals with Otoferlin-Related Hearing Loss Decibel Therapeutics, Inc. announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to initiate a Phase 1/2 clinical trial in pediatric patients of DB-OTO, its lead gene therapy product candidate. DB-OTO is designed to provide durable hearing in individuals born with profound congenital hearing loss due to an otoferlin deficiency. DB-OTO is being developed in collaboration with Regeneron Pharmaceuticals and is an adeno-associated virus (AAV)-based, dual-vector, gene therapy product candidate. Otoferlin is a protein expressed in cochlear inner hair cells that enables communication between the sensory hair cells of the inner ear and the auditory nerve. Newborns born with mutations in the otoferlin gene have fully developed structures within the inner ear. However, these newborns have profound hearing loss because signaling between the ear and the brain is disrupted. DB-OTO uses a proprietary, cell-selective promoter to express the otoferlin transgene in hair cells, with the goal of enabling the ear to transmit sound to the brain and provide hearing. DB-OTO received Orphan Drug and Rare Pediatric Disease designations from the FDA in 2021. Currently, there are no approved pharmacologic treatment options for individuals with otoferlin-related hearing loss. In preclinical studies, Decibel observed that delivery of DB-OTO to the inner ear resulted in production of otoferlin protein and durable auditory brainstem responses to sound in a congenitally deaf, rodent otoferlin disease model. Preclinical studies in non-human primates demonstrated that the local delivery procedure for DB-OTO, an intra-cochlear injection using the surgical approach employed by neurotologists and pediatric otolaryngologists during a standard cochlear implantation procedure, resulted in successful distribution and expression of otoferlin protein across the cochlear length. The Phase 1/2 dose escalation clinical trial is designed to evaluate the safety, tolerability and efficacy of DB-OTO in pediatric patients with congenital hearing loss due to an otoferlin deficiency. In addition to safety and tolerability endpoints, established, clinically relevant, objective and behavioral measurements of hearing will be used as efficacy endpoints in the clinical trial. The auditory brainstem response, which was used to characterize dose-response of DB-OTO after intra-cochlear delivery in translational studies, will serve as an early, objective, clinically accepted readout of hearing thresholds in the clinical trial. Tillkännagivande • Oct 13
Decibel Therapeutics Appoints Kevin F. McLaughlin to its Board of Directors Decibel Therapeutics, Inc. announced the appointment of Kevin F. McLaughlin to its Board of Directors. Mr. McLaughlin has more than 40 years of financial and operating management experience spanning the biotech, high-tech and education industries. From 2010 to 2021, he served as Senior Vice President, Chief Financial Officer and Treasurer of Acceleron Pharma until its acquisition by Merck & Co., Inc. in December 2021. Prior to Acceleron, he was SVP and CFO of Qteros, Inc., from 2009 through 2010 and was co-founder, Chief Operating Officer and director of Aptius Education, Inc., from 2007 through 2009. From 1996 through 2007, Mr. McLaughlin held several executive positions with PRAECIS Pharmaceuticals. He joined the company as their first CFO later becoming Chief Operating Officer, and then President and Chief Executive Officer and a member of the Board of Directors. In this capacity he was responsible for negotiating the sale of the company to GSK plc (formerly GlaxoSmithKline). Mr. McLaughlin currently serves on the boards of Stealth Bio Therapeutics and Vericel Corporation. He began his career in senior financial roles at Prime Computer and Computervision Corporation. Mr. McLaughlin received a bachelor’s degree from Northeastern University and an MBA from Babson F.W. Olin Graduate School of Business. Tillkännagivande • Sep 21
Decibel Therapeutics Announces Submission of Investigational New Drug (IND) Application for Lead Gene Therapy Candidate DB-OTO Decibel Therapeutics announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 1/2 clinical trial in pediatric patients of DB-OTO, a gene therapy product candidate designed to provide durable restoration of hearing in individuals with profound congenital hearing loss due to an otoferlin deficiency. DB-OTO is being developed in collaboration with Regeneron Pharmaceuticals and is an adeno-associated virus (AAV)-based dual-vector gene therapy designed to provide durable hearing to individuals with profound congenital hearing loss caused by mutations of the otoferlin gene. The product candidate uses a proprietary, cell-selective promoter to express the otoferlin transgene in hair cells, with the goal of enabling the ear to transmit sound to the brain and provide hearing. In preclinical studies, Decibel observed that local delivery of DB-OTO to the ear resulted in production of otoferlin protein and instatement of auditory brainstem responses to sound in a congenitally deaf rodent disease model. DB-OTO received Orphan Drug and Rare Pediatric Disease designations from the FDA in 2021. Price Target Changed • Aug 12
Price target decreased to US$15.40 Down from US$17.00, the current price target is an average from 4 analysts. New target price is 256% above last closing price of US$4.33. Stock is down 41% over the past year. The company is forecast to post a net loss per share of US$1.79 next year compared to a net loss per share of US$2.49 last year. Tillkännagivande • Jun 29
Decibel Therapeutics Reports Positive Data from Interim Analysis of Ongoing Phase 1b Clinical Trial of DB-020 in Patients Receiving Cisplatin Chemotherapy Decibel Therapeutics reported positive top-line results from an interim analysis of its ongoing Phase 1b clinical trial of DB-020, a novel, proprietary formulation of sodium thiosulfate (STS) designed to protect against hearing loss in cancer patients receiving cisplatin chemotherapy. Cisplatin, one of the most commonly used chemotherapeutic agents, has severe dose-limiting side effects, including ototoxicity, which leads to permanent hearing loss in many patients. There are no approved therapies to prevent or treat cisplatin-induced ototoxicity. 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. 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. The interim analysis includes data collected as of February 4, 2022 from 19 cisplatin-naïve cancer patients being treated with high doses of cisplatin every 21 or 28 days. Of the 19 patients in the interim analysis, 17 patients had evaluable audiograms at baseline and after being dosed with DB-020 in one ear and placebo in the contralateral ear in conjunction with their prescribed infusion of cisplatin chemotherapy. Ototoxicity was defined according to the American Speech-Language-Hearing-Association (ASHA) criteria for significant ototoxic change. Key findings: DB-020 was generally well tolerated, with no significant safety issues observed; DB-020, administered prior to cisplatin, had no apparent effect on systemic cisplatin levels; 13 of 17 (76.5%) patients experienced cisplatin-induced ototoxicity in the placebo ear after the first cycle of cisplatin; 15 of 17 (88.2%) patients experienced cisplatin-induced ototoxicity in the placebo ear by the last evaluable test; Placebo-treated ears lost approximately 30dB on average from baseline in high frequencies, shifting patients from normal or slight hearing loss to moderate hearing loss (two hearing loss categories) on average; In the 15 patients who experienced ototoxicity in the placebo ear by the last evaluable test, DB-020 protected 13 (87%) from ototoxicity in their DB-020-treated ear; 8 of 15 (53.3%) were completely protected, and 5 of 15 (33.3%) were partially protected. (Complete protection was defined as no change in hearing from baseline in the ear that received DB-020 according to the ASHA ototoxicity criteria in the clinically assessed range.); Ears treated with DB-020 lost approximately 8dB on average from baseline; DB-020 reduced cisplatin-induced loss of speech audibility by 80% as measured by the Speech Intelligibility Index, suggesting treatment with DB-020 may reduce the risk of needing assistive hearing devices after receiving cisplatin. Price Target Changed • Jun 28
Price target decreased to US$14.75 Down from US$17.00, the current price target is an average from 4 analysts. New target price is 457% above last closing price of US$2.65. Stock is down 70% over the past year. The company is forecast to post a net loss per share of US$1.74 next year compared to a net loss per share of US$2.49 last year. Major Estimate Revision • May 19
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$23.4m to US$16.3m. EPS estimate increased from -US$1.67 to -US$1.63 per share. Biotechs industry in the US expected to see average net income decline 52% next year. Consensus price target down from US$17.00 to US$16.00. Share price rose 12% to US$2.32 over the past week. Tillkännagivande • May 02
Decibel Therapeutics, Inc., Annual General Meeting, Jun 17, 2022 Decibel Therapeutics, Inc., Annual General Meeting, Jun 17, 2022, at 12:00 Eastern Standard Time. Agenda: To consider the election of one Class I director, Alison Finger, M.B.A., to serve for a three-year term expiring at the 2025 annual meeting of stockholders and until her respective successor has been duly elected and qualified; to consider the ratification of the appointment of Ernst & Young LLP as independent registered public accounting firm for the fiscal year ending December 31, 2022; and to discuss other matters. Price Target Changed • Apr 27
Price target decreased to US$17.00 Down from US$21.60, the current price target is an average from 4 analysts. New target price is 702% above last closing price of US$2.12. Stock is down 78% over the past year. The company is forecast to post a net loss per share of US$1.67 next year compared to a net loss per share of US$2.49 last year. Board Change • Apr 27
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Peter Thompson was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Price Target Changed • Mar 19
Price target decreased to US$21.33 Down from US$23.50, the current price target is an average from 3 analysts. New target price is 588% above last closing price of US$3.10. Stock is down 79% over the past year. The company is forecast to post a net loss per share of US$1.84 next year compared to a net loss per share of US$2.49 last year. Tillkännagivande • Feb 10
Decibel Therapeutics Announces the Presentation of Preclinical Data on Lead Gene Therapy Product Candidate, DB-OTO and Preclinical Data Highlighting the Identification of Proprietary Decibel Therapeutics announced the presentation of preclinical data on its lead gene therapy product candidate, DB-OTO, as well as preclinical data highlighting the identification of proprietary, cell-selective promoters for three of its gene therapy pipeline programs at this year’s virtual 45th Annual MidWinter Meeting of the Association for Research in Otolaryngology (ARO). Decibel presented preclinical data supporting the Company’s lead gene therapy product candidate, DB-OTO, a dual-vector adeno-associated investigational product candidate designed to restore hearing to individuals with profound, congenital hearing loss caused by mutations of the otoferlin gene. DB-OTO uses a proprietary, cell-selective promoter to control otoferlin transgene expression in hair cells, with the goal of enabling the ear to transmit sound to the brain and provide hearing. In previous preclinical studies, administration of DB-OTO resulted in restoration of functional otoferlin protein in mice and dose scaling and distribution in non-human primates (NHPs). New data presented at ARO further characterized expression of otoferlin over time following DB-OTO administration in mice and NHPs, demonstrating that otoferlin expression increased over the first several weeks before plateauing, consistent with the expression previously reported in mice that achieved stable functional recovery. Decibel also shared functional recovery and tolerability data associated with DB-OTO dosing over a 10-fold dose range in mice. Decibel also presented new data at ARO on its preclinical AAV.103 program to treat GJB2-related hearing loss through selective expression of GJB2 in cells that normally express GJB2 and on its preclinical AAV.104 program to treat stereocilin-related hearing loss through selective expression of stereocilin in outer hair cells. These data demonstrated how the Company deploys its platform to develop novel, proprietary, cell-selective promoters and the potential advantages that cell-selective expression may confer to its gene therapy pipeline programs. Decibel is developing DB-OTO, AAV.103 and AAV.104 in collaboration with Regeneron Pharmaceuticals, and Decibel retains global commercial rights in the three programs. Board Change • Dec 10
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Peter Thompson was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Recent Insider Transactions Derivative • Oct 18
Chief People notifies of intention to sell stock Anna Trask intends to sell 10k shares in the next 90 days after lodging an Intent To Sell Form on the 14th of October. If the sale is conducted around the recent share price of US$7.87, it would amount to US$81k. Since March 2021, Anna's direct individual holding has decreased from 18.19k shares to 12.82k. There has only been one transaction (US$76k purchase) from insiders over the last 12 months. Recent Insider Transactions • Sep 20
President recently bought US$76k worth of stock On the 15th of September, Laurence Reid bought around 10k shares on-market at roughly US$7.64 per share. This was the largest purchase by an insider in the last 3 months. This was Laurence's only on-market trade for the last 12 months. Executive Departure • Sep 15
Vice President of Finance & Principal Accounting Officer Ronald Vigliotta has left the company On the 9th of September, Ronald Vigliotta's tenure as Vice President of Finance & Principal Accounting Officer ended. As of June 2021, Ronald still personally held 6.59k shares (US$57k worth at the time). Ronald is the only executive to leave the company over the last 12 months. The current median tenure of the management team is 2.67 years. Valuation Update With 7 Day Price Move • Sep 01
Investor sentiment improved over the past week After last week's 17% share price gain to US$8.64, the stock trades at a trailing P/E ratio of 11.6x. Average forward P/E is 13x in the Biotechs industry in the US. Major Estimate Revision • Aug 17
Consensus revenue estimates fall to US$2.08m The consensus outlook for revenues in 2021 has deteriorated. 2021 revenue forecast decreased from US$6.97m to US$2.08m. Forecast losses increased from -US$1.51 to -US$2.20 per share. Biotechs industry in the US expected to see average net income decline 21% next year. Consensus price target down from US$26.00 to US$24.50. Share price was steady at US$7.37 over the past week. Valuation Update With 7 Day Price Move • Jul 09
Investor sentiment deteriorated over the past week After last week's 18% share price decline to US$7.45, the stock trades at a trailing P/E ratio of 3.1x. Average forward P/E is 13x in the Biotechs industry in the US. Valuation Update With 7 Day Price Move • Jun 11
Investor sentiment improved over the past week After last week's 16% share price gain to US$8.91, the stock trades at a trailing P/E ratio of 3.7x. Average forward P/E is 12x in the Biotechs industry in the US. Valuation Update With 7 Day Price Move • May 21
Investor sentiment improved over the past week After last week's 36% share price gain to US$8.71, the stock trades at a trailing P/E ratio of 3.6x. Average forward P/E is 13x in the Biotechs industry in the US. Tillkännagivande • Feb 26
Decibel Therapeutics, Inc. Presents Promising Preclinical Findings on DB-OTO, Gene Therapy Product Candidate Designed to Provide Hearing to Individuals with Otoferlin Mutations Decibel Therapeutics, Inc. presented preclinical data supporting the company’s gene therapy product candidate, DB-OTO, a potential transformative treatment for individuals with hearing loss due to mutation of the otoferlin gene. These and other data were presented by the company at the 44th Annual MidWinter Meeting of the Association for Research in Otolaryngology (ARO), which was held virtually February 20–24, 2021. Decibel’s DB-OTO product candidate is designed to use dual AAV vectors and a cell-selective promoter to express functional otoferlin in hair cells of the inner ear, with the goal of enabling the ear to transmit sound to the brain and enable hearing. DB-OTO is intended to be delivered to patients using the surgical approach employed by otologists and pediatric otolaryngologists during a standard cochlear implantation procedure. Exploratory studies highlighted in the presentations utilizing the delivery procedure in non-human primates showed successful distribution and expression across the cochlear length. In these studies, DB-OTO and the surgical administration were generally well tolerated. The company presented data which suggest hair cell selective expression of otoferlin may enable greater efficacy and durability and minimize potential toxicity. In addition to these data, Decibel presented preclinical findings demonstrating that DB-OTO restored normal hearing sensitivity in animal models of otoferlin deficiency. Decibel is developing DB-OTO in collaboration with Regeneron Pharmaceuticals and expects to submit an IND or CTA in 2022. Tillkännagivande • Feb 13
Decibel Therapeutics, Inc. has completed an IPO in the amount of $127.116 million. Decibel Therapeutics, Inc. has completed an IPO in the amount of $127.116 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 7,062,000
Price\Range: $18
Transaction Features: Sponsor Backed Offering