Akouos Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Highlights – BioSpace

- In 2020, continued to advance genetic medicine pipeline with execution of IND-enabling studies for AK-OTOF and general alignment with FDA on the path to a 2022 IND submission for AK-antiVEGF

- Raised approximately $349 million in gross proceeds, which is expected to fund operations for at least two years

- Due to recent third-party manufacturing delays, IND submission for AK-OTOF program now expected in the first half of 2022; all other IND-enabling activities remain on track

- Establishing internal cGMP manufacturing infrastructure and capabilities in 2021

BOSTON, March 29, 2021 (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 fourth quarter and full year ended December 31, 2020 and provided business highlights.

2020 was a year of tremendous progress for Akouos, marked by continued advancement of our pipeline, expansion of our team, and strengthening of our capital position to further our leadership in the development of precision genetic medicines for inner ear conditions, said Manny Simons, Ph.D., founder, president, and CEO of Akouos. We continue to be excited by the nonclinical data reported to date, which demonstrate the durable recovery of function of AK-OTOF. Due to third-party manufacturing delays, including impacts from the ongoing COVID-19 pandemic, we now expect to submit the IND for AK-OTOF in the first half of 2022. All other IND-enabling activities remain on track. We continue to work with multiple third-party manufacturers to advance cGMP campaigns, for both the AK-OTOF and AK-antiVEGF IND submissions planned for 2022, and we continue to build our internal cGMP manufacturing infrastructure and capabilities.

Business and Pipeline Highlights for 2020, Recent Developments, and Anticipated Milestones

Fourth Quarter and Full Year 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, the timing of our IND submissions for AK-OTOF and AK-antiVEGF, our expectations regarding our manufacturing capabilitiesand timelines, 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 limited operating history; uncertainties inherent in the development of product candidates, including the initiation and completion of nonclinical studies and clinical trials; whether results from nonclinical studies will be predictive of results or success of clinical trials; 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 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 ability to obtain and maintain intellectual property protection for our product candidates; 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; risks related to competitive programs; the potential that our internal manufacturing capabilities and/or external manufacturing supply may experience delays; 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 September 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

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Akouos Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Highlights - BioSpace