Announced the Global Phase 3 Trial Design with
Suprachoroidal Route of Administration of Belzupacap Sarotalocan in
Early-Stage Choroidal Melanoma
First Patient Dosed in the Phase 1 Study
Evaluating Belzupacap Sarotalocan for the Treatment of Non-Muscle
Invasive Bladder Cancer
Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage
biotechnology company developing a novel class of virus-like drug
conjugate (VDC) therapies for multiple oncology indications, today
reported financial results for the third quarter ended September
30, 2022 and provided clinical development and operational
highlights.
“We are encouraged by the meaningful clinical advances that we
have made in both our ocular and urologic oncology programs in the
third quarter,” said Elisabet de los Pinos, Ph.D., Chief Executive
Officer of Aura. “Aligning with regulatory agencies on the global
Phase 3 trial design with suprachoroidal administration following
positive Phase 2 data are key milestones supporting our goal of
having the first approved vision preserving therapy for patients
with early-stage choroidal melanoma. In addition, successfully
dosing a first patient in non-muscle invasive bladder cancer is a
meaningful achievement as we expand our platform into broad
oncology indications.”
Recent Pipeline Developments
- Belzupacap Sarotalocan (bel-sar) is being developed for the
first-line treatment of early-stage choroidal melanoma (CM), a
life-threatening rare disease with no approved therapies.
- Aura finalized the global Phase 3 design in alignment with
regulatory agencies and selected suprachoroidal (SC) route of
administration to evaluate the efficacy and safety of bel-sar in
early-stage CM. The Phase 3 trial is randomized and masked and
will include three arms, where the primary analysis will compare
bel-sar to sham. Aura is planning to enroll approximately 75 adult
patients with early-stage CM, including patients with indeterminate
lesions and small choroidal melanoma. Patients will be enrolled
with documented growth as an enrichment strategy intended to
increase the efficiency of the trial and which will include an
adaptive design to further increase the probability of
success.
- Positive interim Phase 2 data evaluating SC administration
of bel-sar for the first-line treatment of patients with
early-stage CM were presented at AAO 2022. The results, with an
average of six-months follow up in patients that received three
cycles of therapy in Cohorts 5 and 6, showed a statistically
significant reduction in the tumor growth rate (-0.296 mm/yr, p =
0.0007) compared to each patient’s documented growth rate at study
entry, and an 88.9% (8/9) tumor control rate. In addition, the
visual acuity preservation rate was 88.9% (8/9) in these cohorts,
with the majority of patients being at high risk for vision loss
with tumors close to fovea or optic disk. The overall safety
profile of bel-sar was favorable, with no dose-limiting toxicities
or treatment-related serious adverse advents reported as of August
19, 2022. There was no posterior inflammation and only mild
anterior inflammation (Grade 1) in 20% of the patients.
Treatment-related adverse events (AEs) were predominantly mild and
resolved quickly without sequalae.
- Aura dosed the first patient in a Phase 1 clinical trial of
bel-sar for the treatment of non-muscle invasive bladder cancer
(NMIBC) an area of high unmet need with approximately 80,000
patients diagnosed in the U.S. every year. Aura received Fast Track
Designation from the U.S. Food and Drug Administration in Q2.
- The Phase 1 multi-center, open-label clinical trial is expected
to enroll approximately 23 adult patients. The trial is designed to
assess the safety and tolerability of bel-sar as a single agent.
The primary endpoint of the Phase 1 clinical trial is the incidence
and severity of treatment-related AEs and serious adverse events
and the incidence of dose-limiting toxicities. Aura expects to
report initial Phase 1 data in 2023.
- Beyond early-stage CM, the Company continues to build its
ocular oncology franchise, with the goal of having choroidal
metastasis, an unmet medical need with no approved therapies, as
the second ocular indication. Aura plans to file an IND for
choroidal metastasis with the FDA in Q4 of 2022.
- Preclinical data supporting bel-sar’s broad tumor targeting
potential and immune mediated mechanism of action was presented at
the 22nd EURETINA Congress. Preclinical results highlighted
bel-sar’s targeted cytotoxicity towards tumor cells derived from
the most common cancer types known to metastasize to the choroid,
supporting its potential use for the treatment of choroidal
metastases, a key second ocular oncology indication. The
presentation also included preclinical data that supported the
activity of bel-sar as a single agent as well as in combination
with checkpoint inhibitors, highlighting the possibility to treat
not only primary tumors in the eye but also potentially distant
metastases by an abscopal effect.
Recent Event
- Aura hosted a virtual Investor Day on October 3, 2022.
The program included preclinical data on bel-sar as a single agent
and in combination with checkpoint inhibitors, two-year visual
acuity data from the retrospective matched case control study of
bel-sar vs. plaque radiotherapy, and interim data from the ongoing
Phase 2 trial evaluating SC administration in early-stage choroidal
melanoma. Aura’s executive management team was joined by ocular
oncology leaders Dr. Carol Shields, Chief of the Ocular Oncology
Service at Wills Eye Hospital and Professor of Ophthalmology at
Thomas Jefferson University; Dr. Martine Jager, Professor of
Ophthalmology, Leiden University, and Past President of the
International Society of Ocular Oncology and the Association for
Research in Vision and Ophthalmology; and Dr. Ivana Kim, Director
of the Ocular Melanoma Center, Massachusetts Eye and Ear and
Associate Professor of Ophthalmology, Harvard Medical School. The
webcast is available here.
Third Quarter 2022 Financial Results
- As of September 30, 2022, Aura had cash and cash equivalents
and marketable securities totaling $111.5 million. Aura believes
its current cash and cash equivalents and marketable securities are
sufficient to fund its operations into 2024.
- Research and development expenses increased to $11.3 million
for the three months ended September 30, 2022 from $6.4 million for
the three months ended September 30, 2021, primarily due to ongoing
preclinical costs, manufacturing and development costs for bel-sar,
and higher personnel expenses from growing headcount.
- General and administrative expenses increased to $4.8 million
for the three months ended September 30, 2022 from $2.5 million for
the three months ended September 30, 2021. General and
administrative expenses include $1.1 million and $0.4 million of
stock-based compensation for the three months ended September 30,
2022 and 2021, respectively. The increase was primarily driven by
personnel expenses, as well as increases in general corporate
expenses related to operating as a public company.
- Net loss for the three months ended September 30, 2022 was
$15.9 million compared to $8.8 million for the three months ended
September 30, 2021.
About Aura Biosciences
Aura Biosciences, Inc. is a clinical-stage biotechnology company
developing virus-like drug conjugates (VDCs), a novel class of
therapies, for the treatment of multiple oncology indications.
Aura’s lead VDC candidate, belzupacap sarotalocan (bel-sar;
AU-011), consists of a virus-like particle conjugated with an
anti-cancer agent. Bel-sar is designed to selectively target and
destroy cancer cells and activate the immune system with the
potential to create long-lasting anti-tumor immunity. Bel-sar is
currently in development for ocular cancers, and Aura has initiated
a global Phase 3 trial evaluating first-line treatment of choroidal
melanoma, a vision- and life-threatening form of eye cancer where
standard of care with radiotherapy leaves patients with severe
comorbidities, including major vision loss. Aura plans to pursue
development of bel-sar across its ocular oncology franchise
including for the treatment of patients with choroidal metastasis.
In addition, leveraging Aura’s technology platform, Aura is
developing bel-sar more broadly across multiple cancers, including
in patients with non-muscle invasive bladder cancer (NMIBC). Aura
is headquartered in Boston, MA.
For more information, visit aurabiosciences.com, or follow us on Twitter and
LinkedIn.
Forward Looking Statement
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, and other federal securities laws. Any statements
that are not statements of historical fact may be deemed to be
forward looking statements. Words such as “may,” “will,” “could”,
“should,” “expects,” “intends,” “plans,” “anticipates,” “believes,”
“estimates,” “predicts,” “projects,” “seeks,” “endeavor,”
“potential,” “continue” or the negative of such words or other
similar expressions that can be used to identify forward-looking
statements. These forward looking statements include express or
implied statements regarding Aura’s future expectations, plans and
prospects, including, without limitation, statements regarding the
therapeutic potential of bel-sar for the treatment of cancers
including choroidal melanoma, non-muscle invasive bladder cancer
and choroidal metastases; any express or implied statements
regarding the Company’s expectations for the Phase 2 and Phase 3
clinical trials of bel-sar for early-stage choroidal melanoma; and
Aura’s expectations regarding the estimated patient populations and
related market opportunities for bel-sar.
The forward-looking statements in this press release are neither
promises nor guarantees, and investors should not place undue
reliance on these forward-looking statements because they involve
known and unknown risks, uncertainties, and other factors, many of
which are beyond Aura’s control and which could cause actual
results to differ materially from those expressed or implied by
these forward-looking statements, including, without limitation, an
improved quality of life of patients after treatment with bel-sar;
a potential paradigm shift in the approach to the treatment of
choroidal melanoma; the urgent need for a vision preserving
targeted therapy; the potential of bel-sar compared to the existing
standard of care for patients with choroidal melanoma;
uncertainties inherent in clinical trials and in the availability
and timing of data from ongoing clinical trials; the expected
timing for submissions for regulatory approval or review by
governmental authorities; the risk that the results of Aura’s
clinical trials may not be predictive of future results in
connection with future clinical trials; the risk that interim data
from ongoing clinical trials may not be predictive of final data
from completed clinical trials; whether Aura will receive
regulatory approvals to conduct trials or to market products;
whether Aura’s cash resources will be sufficient to fund its
foreseeable and unforeseeable operating expenses and capital
expenditure requirements; risks, assumptions and uncertainties
regarding the impact of the continuing COVID-19 pandemic on Aura’s
business, operations, strategy, goals and anticipated timelines;
Aura’s ongoing and planned pre-clinical activities; and Aura’s
ability to initiate, enroll, conduct or complete ongoing and
planned clinical trials. These risks, uncertainties, and other
factors include those risks and uncertainties described under the
heading “Risk Factors” in Aura’s most recent Annual Report on Form
10-K and Quarterly Report on Form 10-Q filed with the U.S.
Securities and Exchange Commission (SEC) and in subsequent filings
made by Aura with the SEC, which are available on the SEC’s website
at www.sec.gov. Except as required by law, Aura disclaims any
intention or responsibility for updating or revising any
forward-looking statements contained in this press release in the
event of new information, future developments or otherwise. These
forward-looking statements are based on Aura’s current expectations
and speak only as of the date hereof and no representations or
warranties (express or implied) are made about the accuracy of any
such forward-looking statements.
Aura Biosciences, Inc.
Condensed Consolidated
Statement of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except share
and per share amounts)
Three Months Ended September
30,
Nine Months Ended September
30,
2022
2021
2022
2021
Operating Expenses:
Research and development
$
11,293
$
6,365
$
29,079
$
17,182
General and administrative
4,762
$
2,530
13,603
6,441
Total operating expenses
16,055
8,895
42,682
23,623
Total operating loss
(16,055
)
(8,895
)
(42,682
)
(23,623
)
Other income (expense):
Interest income, including amortization
and accretion income
483
5
802
8
Realized loss on marketable securities
(9
)
—
(9
)
—
Loss on disposal of assets
(313
)
—
(318
)
(3
)
Other income (expense)
(7
)
52
3
1
Total other income (expense)
154
57
478
6
Net loss
(15,901
)
(8,838
)
(42,204
)
(23,617
)
Net loss attributable to common
stockholders—basic and diluted
(15,901
)
(12,506
)
(42,204
)
(33,244
)
Net loss per share attributable to common
stockholders—basic and diluted
(0.54
)
(28.33
)
(1.44
)
(77.93
)
Weighted average common stock
outstanding—basic and diluted
29,273,577
441,448
29,246,449
426,604
Comprehensive loss:
Net loss
$
(15,901
)
$
(8,838
)
$
(42,204
)
$
(23,617
)
Other comprehensive items:
Unrealized loss on marketable
securities
(19
)
—
(147
)
—
Total other comprehensive loss
(19
)
—
(147
)
—
Total comprehensive loss
$
(15,920
)
$
(8,838
)
$
(42,351
)
$
(23,617
)
Aura Biosciences, Inc.
Condensed Consolidated Balance
Sheets
(Unaudited)
(in thousands, except share
and per share amounts)
September 30, 2022
December 31, 2021
Assets
Current assets:
Cash and cash equivalents
$
61,110
$
149,063
Marketable securities
50,409
—
Restricted cash and deposits
182
23
Prepaid expenses and other current
assets
4,207
4,618
Total current assets
115,908
153,704
Restricted cash and deposits, net of
current portion
768
125
Right of use assets - operating lease
20,996
950
Property and equipment, net
5,475
5,251
Total Assets
$
143,147
$
160,030
Liabilities and Stockholders’
Equity
Current liabilities:
Accounts payable
1,724
2,401
Short-term operating lease liability
2,942
615
Accrued expenses and other current
liabilities
5,298
4,339
Total current liabilities
9,964
7,355
Long-term operating lease liability
18,129
360
Total Liabilities
28,093
7,715
Commitments and Contingencies
Stockholders’ Equity:
Common stock, $0.00001 par value,
150,000,000 authorized at September 30, 2022 and December 31, 2021,
and 29,283,285 and 29,211,643 shares issued and outstanding at
September 30, 2022 and December 31, 2021, respectively
—
—
Additional paid-in capital
309,542
304,452
Accumulated deficit
(194,341
)
(152,137
)
Accumulated other comprehensive loss
(147
)
—
Total Stockholders’ Equity
115,054
152,315
Total Liabilities and Stockholders’
Equity
$
143,147
$
160,030
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221110005370/en/
Investor and Media Contact:
Alex Dasalla Head of Investor Relations and Corporate
Communications adasalla@aurabiosciences.com
Argot Partners Matthew DeYoung aura@argotpartners.com
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