BOSTON, Nov. 14, 2022 (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 reports financial results for the third quarter ended September 30, 2022 and provides business highlights.
“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
- Received Clearance from FDA for IND application for AK-OTOF to initiate a Phase 1/2, first in human, pediatric clinical trial – AK-OTOF is a dual adeno-associated viral (AAV) vector-based gene therapy intended to treat patients with OTOF-mediated hearing loss. A one-time, unilateral intracochlear administration of AK-OTOF may lead to recovery of auditory function. The Company plans to initiate a pediatric Phase 1/2 clinical trial, designed to assess both safety and efficacy. The first two participants in the clinical trial will be as young as seven years of age, subsequent participants will be as young as two years of age. The second part of the trial will be a cohort expansion phase to assess both continued safety and efficacy in participants and is expected to include children younger than two years of age. The planned Phase 1/2 clinical trial is expected to be global and will initially be activated in the U.S. followed by activation in other countries.
- Announced definitive agreement for Eli Lilly and Company to acquire Akouos – The Company and Lilly announced on October 18 the entry into an agreement for Lilly to acquire Akouos to accelerate development of gene therapies that aim to restore, improve, and preserve hearing for patients living with disabling hearing loss worldwide. The transaction is valued at approximately $487 million plus a contingent value right for an aggregate amount up to approximately $610 million. The merger is expected to close in the fourth quarter of 2022, subject to customary closing conditions, including receipt of required antitrust clearance and the tender of a majority of the outstanding shares of Akouos’s common stock. Additional details can be found in the announcement press release as well as the Company’s recent SEC filings.
- Continued progress toward planned IND submission for AK-antiVEGF for vestibular schwannoma – The Company continues to prepare for submission of a planned second IND for AK-antiVEGF, a gene therapy intended for the treatment of patients with vestibular schwannoma. The Company remains on track to submit an IND in 2023 for AK-antiVEGF.
Third Quarter Financial Results
- Cash Position – Cash, cash equivalents, and marketable securities were $169.3 million as of September 30, 2022, compared to $249.7 million as of September 30, 2021. Akouos expects its cash, cash equivalents, and marketable securities to fund operations beyond the next eighteen months.
- Research and Development (R&D) Expenses – R&D expenses were $13.9 million for the third quarter ended September 30, 2022, compared to $17.4 million for the same period in 2021. The decrease was due to timing of manufacturing activities conducted by existing third-party manufacturers, in addition to the substantial completion of activities with one of our third-party manufacturers related to our AK-OTOF program, partially offset by increased expenses due to the growth in the number of R&D employees and their related activities.
- General and Administrative (G&A) Expenses – G&A expenses were $6.3 million for the third quarter ended September 30, 2022, compared to $5.5 million for the same period in 2021. The increase was primarily due to the growth in the number of G&A employees and their related activities.
- Net Loss – Net loss was $19.8 million, or $0.54 per share, for the third quarter ended September 30, 2022, compared to $22.9 million, or $0.67 per share, for the same period in 2021.
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.
