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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Akouos Inc | NASDAQ:AKUS | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 13.29 | 16.50 | 14.47 | 0 | 01:00:00 |
“This has been a transformative year for us, and we’ve achieved important milestones that help us advance toward our goal of developing first in class genetic medicines with the potential to address a broad range of inner ear conditions and to create a new standard of care for individuals and families with disabling hearing loss worldwide. We received clearance from FDA for our IND application to initiate a Phase 1/2, first in human, pediatric clinical trial of AK-OTOF for OTOF-mediated hearing loss, a condition where there are currently no approved pharmacologic treatment options,” said Manny Simons, Ph.D., M.B.A., co-founder, president, and chief executive officer of Akouos. “Additionally, we announced a definitive agreement with Eli Lilly and Company to acquire Akouos. We believe joining Lilly will help us accelerate the development of our broad pipeline of inner ear genetic medicines and help us fulfill our mission to make healthy hearing available to all.”
Pipeline and Business Highlights
Third Quarter 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.
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, initiation, plans, and timing of our future clinical trials and our research and development programs, including plans for our expected AK-OTOF Phase 1/2 clinical trial. timing of our IND submission for AK-anti-VEGF, the occurrence of any event, change, or other circumstance that could give rise to the termination of the Agreement and Plan of Merger with Eli Lilly and Company, prospective benefits of the proposed acquisition, the value of potential contingent consideration amounts, and timing of the closing for the transaction. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “might,” “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: risks related to our proposed acquisition by Lilly, 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 and any changes in such 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 Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, filed with the Securities and Exchange Commission on August 15, 2022, 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)
September 30, 2022 | December 31, 2021 | |||||
Cash, cash equivalents and marketable securities | $ | 169,328 | $ | 232,452 | ||
Total assets | 225,509 | 278,755 | ||||
Total liabilities | 44,671 | 45,105 | ||||
Total stockholders’ equity | 180,838 | 233,650 |
Condensed Consolidated Statements of Operations(Unaudited)
(in thousands, except share and per share data)
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 13,937 | $ | 17,399 | $ | 48,643 | $ | 45,776 | |||||||
General and administrative | 6,267 | 5,513 | 19,595 | 16,068 | |||||||||||
Total operating expenses | 20,204 | 22,912 | 68,238 | 61,844 | |||||||||||
Loss from operations | (20,204 | ) | (22,912 | ) | (68,238 | ) | (61,844 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest income | 522 | 483 | 1,074 | 1,546 | |||||||||||
Other expense, net | (157 | ) | (477 | ) | (489 | ) | (1,434 | ) | |||||||
Total other income, net | 365 | 6 | 585 | 112 | |||||||||||
Net loss | $ | (19,839 | ) | $ | (22,906 | ) | $ | (67,653 | ) | $ | (61,732 | ) | |||
Weighted‑average common shares outstanding, basic and diluted | 36,905,818 | 34,436,793 | 35,766,217 | 34,360,274 | |||||||||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.54 | ) | $ | (0.67 | ) | $ | (1.89 | ) | $ | (1.80 | ) |
Contacts
Media:Lee-Ann Murphy Lmurphy@akouos.com
Investors:Courtney Turiano, Stern Investor RelationsCourtney.Turiano@sternir.com
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