- Expanded leadership team with appointment of Sachiyo Minegishi as CFO and promotion of Jennifer Wellman to COO -
- Continued progress towards 2021 IND submission for AK-OTOF, a gene therapy intended for the treatment of hearing loss due to mutations in the OTOF gene -
- Execution on build of internal manufacturing capabilities and infrastructure to support future research and clinical trials is on track -
BOSTON, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Akouos,Inc. (Nasdaq: AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today reported financial results for the third quarter ended September 30, 2020 and provided updated business highlights.
We continue to advance AK-OTOF, a gene therapy intended for the treatment of hearing loss due to mutations in the OTOF (otoferlin) gene, towards a 2021 IND filing. Today, individuals with OTOF-mediated hearing loss have no therapeutic options. Our novel gene therapy candidate has the potential to restore hearing for these individuals, who typically have no functional hearing at birth, said Manny Simons, Ph.D., founder, president and CEO of Akouos. Also, despite the challenging environment around us, the team is executing on our plan to establish internal manufacturing capabilities and infrastructure to support IND-enabling studies and clinical trials. Our progress towards our long-term mission, making healthy hearing available to all, is a testament to our deeply committed, experienced team and our strategic partners.
Business and Pipeline Highlights
Third Quarter 2020 Financial Results
About Akouos
Akouos is a precision genetic medicine company dedicated to developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals living with disabling hearing loss worldwide. Leveraging its precision genetic medicine platform that incorporates a proprietary adeno-associated viral (AAV) vector library and a novel delivery approach, Akouos is focused on developing precision therapies for forms of sensorineural hearing loss. Headquartered in Boston, Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the initiation, plans, and timing of our future clinical trials and our research and development programs, our expectations regarding our manufacturing capabilities, and the period over which we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses. The words anticipate, believe, continue, could, estimate, expect, intend, may, plan, potential, predict, project, should, target, will, would and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: our plans to develop and, if approved, subsequently commercialize our product candidates; the timing of and our ability to submit applications for, and obtain and maintain regulatory approvals for, our product candidates; our expectations regarding our regulatory strategy; our expectations regarding our ability to fund our operating expenses and capital expenditure requirements with our cash, cash equivalents and marketable securities; the potential advantages of our product candidates; the rate and degree of market acceptance and clinical utility of our product candidates; our estimates regarding the potential addressable patient population for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates; our intellectual property position; our ability to identify additional products, product candidates, or technologies with significant commercial potential that are consistent with our commercial objectives; the impact of government laws and regulations; our competitive position and expectations regarding developments and projections relating to our competitors and any competing therapies that are or become available; developments and expectations regarding developments and projections relating to our competitors and our industry; the impact of the COVID-19 pandemic on our business, results of operations, and financial condition; our ability to maintain and establish collaborations or obtain additional funding; and other factors discussed in the Risk Factors included in the Companys Quarterly Report on Form 10-Q for the three months ended June 30, 2020 filed with the Securities and Exchange Commission, and in other filings that the Company makes with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Condensed Consolidated Balance Sheet Data(Unaudited)
(in thousands)
Condensed Consolidated Statements of Operations and Comprehensive Loss(Unaudited)
(in thousands, except share and per share data)
Contacts
Media:
Katie Engleman, 1ABkatie@1abmedia.com
Investors:
Courtney Turiano, Stern Investor RelationsCourtney.Turiano@sternir.com
See the article here:
Akouos Reports Third Quarter 2020 Financial Results and Provides Business Highlights - GlobeNewswire
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