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Eli Lilly has successfully completed its acquisition of Akouos, enhancing its focus on genetic medicines. The acquisition, valued at $12.50 per share plus contingent value rights, aims to integrate Akouos's innovative gene therapies targeting inner ear conditions, including hearing loss. As of the acquisition date, 81.1% of Akouos's shares were tendered. Post-acquisition, Akouos will be a wholly owned subsidiary of Lilly, and its shares will be delisted. The deal includes potential milestone payments based on the progress of Akouos's clinical trials.
Eli Lilly and Company (NYSE: LLY) and Akouos, Inc. (NASDAQ: AKUS) announced the expiration of a tender offer for Akouos's shares at $12.50 each, plus a contingent value right potentially worth $3.00. The offer expired on November 29, 2022, with 29,992,668 shares (81.1%) validly tendered. All conditions were satisfied, and the acquisition is expected to close on December 1, 2022. Lilly aims to enhance its portfolio in gene therapies for hearing loss through this strategic acquisition.
Akouos received FDA clearance to initiate a Phase 1/2 clinical trial for AK-OTOF, targeting OTOF-mediated hearing loss, and continues to progress towards IND submission for AK-antiVEGF in 2023. A definitive agreement was announced for Eli Lilly to acquire Akouos for approximately $487 million, potentially reaching $610 million, expected to close in Q4 2022. Financially, Akouos reported cash and equivalents of $169.3 million as of September 30, 2022, with a net loss of $19.8 million for Q3 2022, an improvement from $22.9 million in Q3 2021.
Eli Lilly has announced a definitive agreement to acquire Akouos, valued at $487 million with potential additional payouts of up to $610 million. This acquisition aims to enhance Lilly's gene therapy capabilities for treating hearing loss. Akouos specializes in developing innovative adeno-associated viral gene therapies for inner ear conditions, including its lead candidate AK-OTOF for otoferlin gene mutations. The deal, approved by both companies' boards, secures Lilly a premium of 121% over Akouos's stock price before the announcement, with expectations to close in Q4 2022.
Akouos has received FDA clearance for its Investigational New Drug (IND) application to initiate the first pediatric Phase 1/2 clinical trial of AK-OTOF, targeting OTOF-mediated hearing loss. This therapy is groundbreaking as it will be the first gene therapy administered to the inner ear for this condition that affects approximately 20,000 individuals in the U.S. and Europe. The trial aims to assess safety and efficacy, with participants as young as two years old. Preclinical data suggest potential for durable restoration of auditory function.
Akouos, Inc. (Nasdaq: AKUS) reported its Q2 2022 financial results and business highlights. The company submitted an IND for AK-OTOF, targeting otoferlin-mediated hearing loss, marking a first for the FDA in genetic hearing loss treatments. Akouos also made progress toward its AK-antiVEGF IND submission. They presented promising nonclinical data at the ASGCT conference and received a USPTO notice of allowance for AK-OTOF-related patents. Ending Q2 2022, Akouos held $192.9 million in cash, expected to fund operations for over 18 months.
Akouos presented nonclinical data at the ASGCT 25th Annual Meeting, highlighting promising results for AK-OTOF, a gene therapy for OTOF-mediated hearing loss. A single intracochlear administration of an AAVAnc80 vector led to durable auditory restoration in Otof knockout mice and non-human primates. The therapy was well tolerated with no adverse effects. Additionally, the study explored the incorporation of microRNA target sites in AAV vectors to improve gene therapy targeting in the inner ear, supporting future applications.
Akouos, Inc. (Nasdaq: AKUS) reported its Q1 2022 results, highlighting significant advancements in its gene therapy pipeline aimed at addressing hearing loss. The company is on track to submit IND applications for AK-OTOF and AK-antiVEGF this year. As of March 31, 2022, Akouos held $209.1 million in cash, down from $232.5 million at the end of 2021. R&D expenses surged to $20.4 million due to increased IND-enabling activities, contributing to a net loss of $27 million, or $0.78 per share, compared to a loss of $16.1 million, or $0.47 per share in Q1 2021.
Akouos, Inc. (NASDAQ: AKUS) announced that its CEO, Manny Simons, will present at the Bank of America 2022 Healthcare Conference on May 10, 2022, at 10:00 a.m. PDT in Las Vegas, Nevada. The presentation will focus on the company’s dedication to developing gene therapies for disabling hearing loss worldwide. A live webcast will be available through www.akouos.com approximately 15 minutes prior to start time, with an archived replay accessible for 30 days.
Akouos, Inc. (NASDAQ: AKUS), a precision genetic medicine company focused on gene therapies for disabling hearing loss, will present new nonclinical data at the American Society of Gene and Cell Therapy (ASGCT) 25th Annual Meeting in Washington, D.C., from May 16 to 19, 2022. Key presentations include an oral session on AK-OTOF for otoferlin gene-mediated hearing loss and a poster discussing microRNA target sites for gene expression regulation in the inner ear. These findings support the clinical development of innovative therapies aimed at restoring hearing.
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