Akouos Reports Third Quarter 2021 Financial Results and Provides Business Highlights
12 November 2021 - 11:00PM
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,
2021, and provides business highlights.
“This quarter we advanced our lead programs, AK-OTOF and
AK-antiVEGF, toward planned 2022 IND submissions, and we continue
to apply our genetic medicines platform to the discovery and
research of additional potential therapies for inner ear
conditions,” said Manny Simons, Ph.D., M.B.A., co-founder,
president, and chief executive officer of Akouos. “We also
strengthened our leadership team with the recent appointment of
Stacy Price as our chief technical officer. Her extensive
operations background, including the build of internal
manufacturing capabilities, will be critical as we move our
pipeline toward clinical development and ultimately
commercialization.”
Pipeline and Business Highlights
- AK-OTOF and AK-antiVEGF
advancing toward planned IND submissions – The company
continued to advance its lead product candidate, AK-OTOF, a gene
therapy intended for the treatment of otoferlin gene
(OTOF)-mediated hearing loss. An investigational new drug
application (IND) submission for AK-OTOF is planned for the first
half of 2022. Additionally, Akouos continues to plan for IND
submission in 2022 for AK-antiVEGF, a gene therapy intended for the
treatment of vestibular schwannoma.
- Applying our genetic
medicines platform to a broader range of inner ear conditions
– Akouos is leveraging its multimodal genetic medicine
capabilities to address a range of inner ear conditions, including
those that are monogenic and those of complex etiology. The company
expects to provide updates on additional pipeline programs in early
2022.
- Chief technical officer
joins leadership team – In November 2021, Akouos announced
the appointment of Stacy Price as chief technical officer. Ms.
Price brings more than 25 years of experience managing clinical and
commercial biotechnology manufacturing and technical operations for
a wide range of therapeutic modalities, including gene therapy,
most recently as senior vice president of technical operations at
Ziopharm Oncology. At Akouos, she will be responsible for the
strategy and operations of vector manufacturing and device
development and manufacturing.
- European Commission
designates AK-OTOF as an orphan drug – In August 2021,
Akouos announced that the European Medicines Agency Committee for
Orphan Medicinal Products issued a positive opinion on the
company’s application for orphan drug designation for AK-OTOF for
the treatment of OTOF-mediated hearing loss. Subsequently, the
positive opinion was adopted by the European Commission. AK-OTOF
was previously granted Orphan Drug Designation and Rare Pediatric
Disease Designation by the U.S. Food and Drug Administration for
this same indication.
Third Quarter 2021 Financial Results
- Cash Position – Cash, cash equivalents, and
marketable securities were $249.7 million as of September 30,
2021, as compared to $308.0 million as of December 31, 2020. 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 $17.4 million for the third quarter ended
September 30, 2021, compared to $8.6 million for the same period in
2020. The increase was primarily due to the increased efforts in
IND-enabling studies and increased manufacturing costs for AK-OTOF
and AK-antiVEGF 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 $5.5 million for the third quarter
ended September 30, 2021, compared to $4.5 million for the same
period in 2020. The increase was primarily due to the growth in the
number of G&A employees and other administrative expenses
related to operating as a public company, as well as the expense
allocated to G&A related to Akouos’s leased facilities.
- Net Loss – Net
loss was $22.9 million, or $0.67 per share, for the third quarter
ended September 30, 2021, compared to $13.1 million, or $0.85 per
share, for the same period in 2020.
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, statements relating to the initiation,
plans, and timing of our future clinical trials and our research
and development programs, the timing of our IND submissions for
AK-OTOF and AK-antiVEGF, and the period over which we believe that
our existing cash, cash equivalents and marketable securities will
be sufficient to fund our operating expenses. The words
“anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”
“intend,” “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: 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 three months ended June 30, 2021 filed
with the Securities and Exchange Commission, 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, 2021 |
|
December 31, 2020 |
|
|
|
|
|
|
Cash, cash equivalents and
marketable securities |
|
$ |
249,658 |
|
$ |
308,010 |
Total assets |
|
|
297,454 |
|
|
333,350 |
Total liabilities |
|
|
41,230 |
|
|
22,736 |
Total stockholders’
equity |
|
|
256,224 |
|
|
310,614 |
Condensed Consolidated Statements of
Operations and Comprehensive
Loss(Unaudited)
(in thousands, except share and per share
data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
17,399 |
|
|
$ |
8,641 |
|
|
$ |
45,776 |
|
|
$ |
26,612 |
|
General and administrative |
|
|
5,513 |
|
|
|
4,478 |
|
|
|
16,068 |
|
|
|
9,646 |
|
Total operating expenses |
|
|
22,912 |
|
|
|
13,119 |
|
|
|
61,844 |
|
|
|
36,258 |
|
Loss from operations |
|
|
(22,912 |
) |
|
|
(13,119 |
) |
|
|
(61,844 |
) |
|
|
(36,258 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
483 |
|
|
|
21 |
|
|
|
1,546 |
|
|
|
201 |
|
Other income (expense), net |
|
|
(477 |
) |
|
|
9 |
|
|
|
(1,434 |
) |
|
|
5 |
|
Total other income, net |
|
|
6 |
|
|
|
30 |
|
|
|
112 |
|
|
|
206 |
|
Net loss |
|
$ |
(22,906 |
) |
|
$ |
(13,089 |
) |
|
$ |
(61,732 |
) |
|
$ |
(36,052 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.67 |
) |
|
$ |
(0.85 |
) |
|
$ |
(1.80 |
) |
|
$ |
(3.01 |
) |
Weighted‑average common shares
outstanding, basic and diluted |
|
|
34,436,793 |
|
|
|
15,334,241 |
|
|
|
34,360,274 |
|
|
|
11,991,870 |
|
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on marketable securities |
|
|
(31 |
) |
|
|
8 |
|
|
|
(26 |
) |
|
|
8 |
|
Total other comprehensive income (loss) |
|
|
(31 |
) |
|
|
8 |
|
|
|
(26 |
) |
|
|
8 |
|
Total comprehensive loss |
|
$ |
(22,937 |
) |
|
$ |
(13,081 |
) |
|
$ |
(61,758 |
) |
|
$ |
(36,044 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Contacts
Media:Katie Engleman, 1ABkatie@1abmedia.com
Investors:Courtney Turiano, Stern Investor
RelationsCourtney.Turiano@sternir.com
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