Akouos Reports Third Quarter 2022 Financial Results and Provides Business Highlights
14 November 2022 - 11:15PM
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.
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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