Akouos Reports Third Quarter 2020 Financial Results and Provides Business Highlights

11/12/20

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

  • Appointed Sachiyo Minegishi as chief financial officer – In October 2020, Sachiyo Minegishi joined Akouos as chief financial officer. Ms. Minegishi has 20 years of experience in the biotechnology and pharmaceutical industry, serving in various roles at global companies, as well as in investment banking, most recently leading the gene therapy program for sickle cell disease at bluebird bio.
  • Promoted Jennifer Wellman to chief operating officer – In October 2020, Akouos announced the promotion of Jennifer Wellman to chief operating officer, from her prior role as senior vice president of regulatory and quality. Ms. Wellman brings to Akouos over 20 years of experience in adeno-associated viral (AAV) vector gene therapy research and development, and was previously co-founder and head of product development strategy at Spark Therapeutics, Inc.
  • Continued progress towards IND filing in 2021 to enable a Phase 1/2 clinical trial for AK-OTOF, a gene therapy intended for the treatment of hearing loss due to mutations in the OTOF gene – Through a targeted delivery of a proprietary ancestral AAV, known as AAVAnc80, containing the OTOF gene, Akouos aims to restore otoferlin expression, potentially restoring physiologic hearing and providing long-lasting benefits to individuals with OTOF-mediated hearing loss. Akouos plans to submit an IND application to the FDA in 2021 to conduct a Phase 1/2 clinical trial. The planned Phase 1/2 clinical trial consists of two parts. The first part is a dose escalation phase designed to assess the safety, tolerability and bioactivity of AK-OTOF, administered to trial participants through a single unilateral intracochlear injection. The second part is a cohort expansion phase designed to assess safety and efficacy.
  • Execution on build of internal manufacturing capabilities to support future research and clinical activities is on track – Akouos is leveraging its expertise in gene therapy to develop internal, scalable manufacturing capabilities to support research, including IND-enabling studies, and current Good Manufacturing Practice activities for clinical trials. The plans to internalize manufacturing will enable more influence on the manufacturing process, associated analytics, and supporting quality systems, as well as increase the ability to control timelines, costs, and intellectual property.

Third Quarter 2020 Financial Results

  • Cash Position – Cash, cash equivalents and marketable securities were $320.1 million as of September 30, 2020, as compared to $25.1 million as of December 31, 2019. Akouos expects the cash balance to fund operations for at least the next two years.
  • Research and Development (R&D) Expenses – R&D expenses were $8.6 million for the third quarter ended September 30, 2020, compared to $4.4 million for the same period in 2019. The increase was primarily due to the increased efforts in preclinical IND-enabling studies for AK-OTOF and the growth in the number of R&D employees and their related activities, as well as the expense allocated to R&D related to Akouos’s leased facilities.
  • General and Administrative (G&A) Expenses – G&A expenses were $4.5 million for the third quarter ended September 30, 2020, compared to $0.9 million for the same period in 2019. The increase was primarily due to the growth in the number of G&A employees and other administrative expenses, as well as the expense allocated to G&A related to Akouos’s leased facilities.
  • Net Loss – Net loss was $13.1 million, or $0.85 loss per share, for the third quarter ended September 30, 2020, compared to $8.2 million, or $13.21 loss per share, for the same period in 2019.

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.