Announcement • Dec 03
Akouos, Inc.(NasdaqGS:AKUS) dropped from NASDAQ Composite Index Akouos, Inc. has been removed from NASDAQ Composite Index . Announcement • Dec 01
Akouos, Inc.(NasdaqGS:AKUS) dropped from NASDAQ Biotechnology Index Akouos, Inc. has been removed from NASDAQ Biotechnology Index . Announcement • Oct 20
Eli Lilly and Company (NYSE:LLY) entered into a definitive agreement to acquire Akouos, Inc. (NasdaqGS:AKUS) from 5AM Venture Management, LLC, New Enterprise Associates, Inc. and others for approximately $460 million. Eli Lilly and Company (NYSE:LLY) entered into a definitive agreement to acquire Akouos, Inc. (NasdaqGS:AKUS) from 5AM Venture Management, LLC, New Enterprise Associates, Inc. and others for approximately $460 million on October 17, 2022. Lilly will commence a tender offer to acquire all outstanding shares of Akouos for $12.50 per share in cash, plus one contingent value right of up to $3.00 per share. In case of termination of the transaction under certain circumstances Akouos will be required to pay a termination fee of $17.5 million.
The deal is subject to receipt of required antitrust clearance, expiration or termination of any applicable waiting period under the HSR Act and the tender of a majority of the outstanding shares of Akouos’s common stock. Following the successful closing of the tender offer, Lilly will acquire any shares of Akouos that are not tendered in the tender offer through a second-step merger at the same consideration as paid in the tender offer. The transaction is not subject to any financing condition. The deal has been approved by the board of directors of Eli Lilly and Company. The board of directors of Akouos unanimously approved the transaction. The transaction is expected to close in the fourth quarter of 2022. For Lilly, Sarkis Jebejian and Keri Schick Norton of Kirkland & Ellis LLP are acting as legal counsel. For Akouos, Rosemary G. Reilly, Joseph B. Conahan and Andrew Bonnes of Wilmer Cutler Pickering Hale & Dorr LLP are acting as legal counsel and Centerview Partners LLC as financial advisor and fairness opinion provider. Announcement • Sep 14
Akouos, Inc. Receives FDA Clearance of Its IND Application for AK-OTOF, A Gene Therapy Intended for the Treatment of OTOF-Mediated Hearing Loss Akouos, 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, first in human, pediatric clinical trial of AK-OTOF, a gene therapy intended for the treatment of patients with otoferlin gene (OTOF)-mediated hearing loss. Currently, there are no approved pharmacologic treatment options for individuals with OTOF-mediated hearing loss, a form of sensorineural hearing loss caused by mutations in the OTOF gene. OTOF-mediated hearing loss is a form of sensorineural hearing loss caused by mutations in the otoferlin gene, which encodes otoferlin, a protein that enables the inner hair cells of the cochlea to release neurotransmitter vesicles in response to stimulation by sound to activate auditory neurons. Individuals with OTOF-mediated hearing loss have bilateral hearing loss that is typically Severe to Profound and congenital, exhibiting absent or highly abnormal auditory brainstem response (ABR) from birth. Approximately 20,000 individuals are affected in the United States and Europe. In April 2021, FDA granted both Orphan Drug Designation and Rare Pediatric Disease Designation for AK-OTOF. AK-OTOF is a dual adeno-associated viral (AAV) vector-based gene therapy intended to treat patients with OTOF-mediated hearing loss by delivering transgenes encoding OTOF to the inner hair cells (IHCs) of the cochlea. A one-time, unilateral intracochlear administration of AK-OTOF is intended to result in the expression of normal full-length functional otoferlin protein in the IHCs, which has the potential to lead to recovery of auditory function. The advancement of AK-OTOF into clinical development is supported by nonclinical data demonstrating administration of AK-OTOF in Otof knockout mice results in durable expression of human otoferlin protein sufficient for sustained restoration of auditory function, as assessed by translationally relevant ABR assessments. In both mice and non-human primates, AK-OTOF was systemically and locally well tolerated, and no adverse effects were observed in clinical pathology, otic pathology, systemic histopathology, or auditory or cochlear function.? The Phase 1/2 clinical trial is designed to evaluate the safety and tolerability of escalating doses of AK-OTOF administered unilaterally to trial participants with OTOF-mediated hearing loss; it is also designed to assess efficacy through clinical measures such as ABR, which is an objective, clinically accepted endpoint. Given both the early onset of serious manifestations, as well as the need for timely intervention due to anatomical considerations and developmental considerations, eligible participants for the clinical trial will be pediatric. Based on interactions with FDA during the 30-day IND review period, the Company expects the first two participants will be as young as seven years of age, and that subsequent participants will be as young as two years of age at the time of administration. The Company plans to provide an update on clinical trial initiation activities for AK-OTOF later this year. Announcement • Jul 28
Akouos, Inc. Announces Resignation of Chris Smith as Member of the Board of Directors, Effective August 15, 2022 On July 21, 2022, Chris Smith notified Akouos, Inc. that he has been appointed as Chief Executive Officer of NeoGenomics, Inc. effective August 15, 2022, and as a result of his new appointment, concurrently notified the Company of his resignation as a member of the Board of Directors of the Company, effective August 15, 2022. With the resignation, Mr. Smith also resigned as a member of the Company’s Nominating and Corporate Governance Committee. Announcement • Jun 26
Akouos, Inc.(NasdaqGS:AKUS) dropped from Russell 2500 Index Akouos, Inc.(NasdaqGS:AKUS) dropped from Russell 2500 Index Announcement • May 20
Akouos, Inc. Presents Nonclinical Data Supporting the Planned Clinical Development of AK-OTOF and Strategies for Regulated Gene Expression in the Inner Ear At the American Society of Gene and Cell Therapy 25Th Annual Meeting Akouos, Inc. presented nonclinical data at the American Society of Gene and Cell Therapy 25th Annual Meeting. The company gave two nonclinical presentations at the meeting: one that supports the planned clinical development of AK-OTOF, a gene therapy intended for the treatment of OTOF-mediated hearing loss; and another that supports the potential use of microRNA target site in adeno-associated viral vectors for regulated gene expression in the inner ear. Nonclinical In Vivo Expression, Durability of Effect, Biodistribution/Shedding, and Safety Evaluations Support Clinical Development of AK-OTOF for OTOF-mediated Hearing Loss. Presenting Author: Ann E. Hickox, Ph.D. Session Title and Room: Ophthalmic and Auditory Diseases; Salon G AK-OTOF is an AAV vector-based gene therapy intended for the treatment of patients with otoferlin gene-mediated hearing loss by delivering transgenes encoding OTOF to inner hair cells. Following intracochlear delivery, and subsequent co-transduction of IHCs by each component vector, the two transgene products recombine to generate a full-length otoferlin mRNA transcript and subsequently a full-length otoferlin protein. Results from this presentation show: Intracochlear administration of AK-OTOF in otoferlin knockout mice, or its tagged version (AAVAnc80-FLAG.hOTOF) in non-human primates (NHPs), leads to full-length human otoferlin protein expression only in the target IHCs; human otoferlin expression in IHCs of Ofof -/- mice restores auditory function as early as two weeks post-administration and restoration was durable through at least six months. AK-OTOF was systemically and locally well tolerated in both mice and NHPs, and no adverse effects were observed in clinical pathology, otic pathology, systemic histopathology, or auditory or cochlear function. Limited systemic exposure of AK-OTOF following intracochlear administration was observed, and no otoferlin protein expression was detected in any non-target tissue types evaluated, including those with detectable levels of vector sequences and otoferlin mRNA expression. Together, these nonclinical studies further support the planned clinical development of AK-OTOF for the treatment of OTOF-mediated hearing loss. In the development of AAV gene therapy vectors, a goal is to generate safe and effective product candidates that deliver targeted transgene expression. Ubiquitous promoters can drive strong widespread expression in the inner ear in mice and NHPs. This expression can be well tolerated across the inner ear, as is the case for Akouos’s first two programs, AK-OTOF and AK-antiVEGF. Addition of selective cis-regulatory elements may be needed for some transgenes, such as GJB2, where expression in a portion of nontarget cells is not well tolerated. This nonclinical study explored the potential use of miR-TS incorporation in AAV vectors for de-targeting transgene expression in different cell types of the cochlea. Using an in vitro model, expression of transgene mRNA and protein in the presence or absence of the target sites was evaluated. Akouos identified multiple microRNA target sites to drive various differential expression patterns demonstrating that a combination of AAVAnc80 and miR-TS can drive expression in supporting cells, while limiting expression in hair cells in cochlear explants. Future work will focus on evaluating miR-TS regulation in vivo and identifying combinations of different miR-TSs to enhance de-targeting in specific cell types where, for example, expression driven by ubiquitous promoters is not well tolerated. Price Target Changed • May 18
Price target decreased to US$23.50 Down from US$29.00, the current price target is an average from 4 analysts. New target price is 691% above last closing price of US$2.97. Stock is down 78% over the past year. The company is forecast to post a net loss per share of US$3.22 next year compared to a net loss per share of US$2.52 last year. Announcement • May 12
Akouos, Inc. Presents Nonclinical Data Supporting Future Clinical Development of Ak-Otof and Ak-Antivegf At the American Society of Gene and Cell Therapy 24Th Annual Meeting Akouos, Inc. presented nonclinical data supporting the future clinical development of both AK-OTOF, a gene therapy intended for the treatment of otoferlin gene (OTOF)-mediated hearing loss, and AK-antiVEGF, a gene therapy intended for the treatment of vestibular schwannoma, in three digital presentation sessions at the virtual American Society of Gene and Cell Therapy (ASGCT) 24th Annual Meeting. Otoferlin plays a critical role in exocytosis of synaptic vesicles at the inner hair cell synapse, and mutations in OTOF, the gene encoding otoferlin, are associated with autosomal recessive sensorineural hearing loss. AK-OTOF is designed to deliver normal OTOF by utilizing a dual vector approach, which encodes the 5’ and the 3’ components of OTOF. Multiple analyses demonstrate in vitro transduction with dual AK-OTOF vector results in full-length human otoferlin (RNA and protein), with no detection of truncated proteins from either AK-OTOF or its component vectors (5’hOTOF and 3’hOTOF). A one-to-one ratio of the AK-OTOF component vectors appears to be optimal for efficient reconstitution of full-length human otoferlin. In cynomolgus macaques, full-length human otoferlin protein expression is detected in inner hair cells of non-human primate (NHP) cochleae by both immunohistochemistry and immunodetection one month following intracochlear administration of AAVAnc80-FLAG.hOTOF. Is New 90 Day High Low • Jan 14
New 90-day low: US$17.45 The company is down 5.0% from its price of US$18.42 on 15 October 2020. The American market is up 12% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 17% over the same period. Announcement • Jan 12
Akouos and Blueprint Genetics Announce the Resonate Program to Improve Access to Genetic Testing for Individuals with Auditory Neuropathy Akouos, Inc. and Blueprint Genetics announced the Resonate program. The program offers genetic testing to eligible individuals with auditory neuropathy at no cost to participants, their insurance, or their healthcare providers. The Resonate program is available in the United States and plans to expand to additional geographic regions throughout 2021. To be eligible for the program, individuals can be any age, and must have a current or prior clinical diagnosis of auditory neuropathy, or a medical history consistent with auditory neuropathy. Auditory neuropathy is a hearing disorder in which the inner ear successfully detects sound, but has a problem with sending sound from the ear to the brain. In many cases, genetic mutations cause auditory neuropathy. The Resonate program provides access to the Blueprint Genetics Comprehensive Hearing Loss and Deafness Panel that includes more than 230 genes associated with genetic forms of hearing loss. To help understand their results, participants in the United States also have access to genetic counseling provided by the program at no cost to participants, their insurance, or their healthcare providers. Is New 90 Day High Low • Oct 08
New 90-day low: US$17.99 The company is down 19% from its price of US$22.30 on 10 July 2020. The American market is up 7.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share.