Strengthened Clinical and Regulatory Leadership
Team with Key Appointments
Start-up Activities for the Global Phase 3
Trial Ongoing with Release of Drug Product Manufactured with
Commercial Process and First Patient Expected to be Dosed in 2H
2023
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 second quarter ended June 30,
2023, and provided clinical development and operational
highlights.
“As we build momentum across our portfolio, we are happy to
welcome Drs. Bruce Brown and Anthony Daniels as our Therapeutic
Area Heads in Urologic Oncology and Ocular Oncology, respectively,
as well as Dr. Richard Mountfield as our new Senior Vice President
of Regulatory Affairs and Quality. These key appointments are
critical in supporting our corporate growth and expansion of our
clinical programs in two important oncology therapeutic areas with
high unmet medical needs for patients,” said Elisabet de los Pinos,
Ph.D., Chief Executive Officer of Aura.
Dr. de los Pinos added, “We are excited to announce that we have
released our drug product manufactured using the commercial process
to be used in the global Phase 3 trial and remain encouraged by the
progress we have made with the start-up activities, with multiple
sites ready to enroll patients in the United States. We remain
focused on the execution of our clinical studies and plan to share
12- month data from the Phase 2 trial in choroidal melanoma in the
second half of 2023.”
Recent Pipeline Developments
- Global Start up Activities for the Phase 3 trial
ongoing.
- The Phase 3 trial is designed as a superiority trial comparing
belzupacap sarotalocan (bel-sar) versus sham. The trial is a global
Phase 3, randomized, multi-center, masked study, and it is intended
to enroll approximately 100 patients randomized 2:1:2 to receive
high dose regimen of bel-sar, low dose regimen of bel-sar with
suprachoroidal (SC) administration, or a sham control.
- The primary endpoint is time to tumor progression and the first
key secondary endpoint is a composite time to event analysis that
will compare the tumor control and visual acuity of the bel-sar
high dose regimen to sham when the last patient completes their 12
months of follow up.
- Aura released the commercial process material for the global
Phase 3 trial. The majority of sites are qualified globally, and
multiple sites are ready to enroll patients in the United
States.
- The first patient is expected to be dosed in the second half of
2023.
- Enrollment is complete in the Phase 2 trial evaluating SC
administration of bel-sar for the first-line treatment of adult
patients with early-stage choroidal melanoma (CM). Updated
efficacy data with 12 months median follow up of patients treated
with the therapeutic regimen intended to be used in the global
Phase 3 trial is on track to be presented in the second half of
2023.
- The Phase 1 trial of bel-sar for the treatment of non-muscle
invasive bladder cancer (NMIBC) is currently ongoing, and Aura
expects to report data in 2024. This represents an area of high
unmet need with approximately 60,000 patients diagnosed in the
United States every year. Aura received Fast Track Designation from
the Oncology Division of the FDA for this indication in June 2022.
- The Phase 1 multi-center, open-label clinical trial is expected
to enroll approximately 19 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 trial is the incidence and
severity of treatment-related adverse events, serious adverse
events and/or the incidence of dose-limiting toxicities. The trial
will provide histopathological evaluation after the local treatment
to support bel-sar’s biological activity.
- Beyond early-stage CM, Aura continues to build its ocular
oncology franchise. Aura’s goal is to initiate clinical
development in choroidal metastasis, an indication with a high
unmet medical need and no approved therapies, as the second ocular
oncology indication. Aura is on track to initiate the Phase 2 trial
in 2024.
Recent Corporate Events
Strengthened the clinical leadership team with the following
key appointments:
- Dr. Bruce Brown joined Aura as Therapeutic Area Head Urologic
Oncology. Dr. Brown is responsible for leading the bladder cancer
program, including the current ongoing trial, as well as driving
future strategy and development plans. Dr. Brown was previously VP,
Clinical Development at Myovant Sciences. Dr. Brown is a
board-certified urologist and joined the pharmaceutical industry
after practicing urology for 17 years.
- Dr. Anthony Daniels is joining Aura as the Therapeutic Area
Head Ocular Oncology. Dr. Daniels will be responsible for leading
the ocular oncology program and driving future strategy. Dr.
Daniels is a board-certified ophthalmologist who has treated ocular
oncology patients for 15 years, and most recently was Chief of the
Division of Ocular Oncology at Vanderbilt University Medical
Center.
- Dr. Richard Mountfield joined Aura as SVP, Regulatory Affairs
& Quality. Dr. Mountfield is responsible for overseeing
regulatory affairs and quality activities for all programs. Dr.
Mountfield was previously the SVP of Regulatory Affairs &
Quality at Zenas BioPharma.
Second Quarter 2023 Financial Results
- As of June 30, 2023, Aura had cash and cash equivalents and
marketable securities totaling $162.0 million. Aura believes its
current cash and cash equivalents and marketable securities are
sufficient to fund its operations into the second half of
2025.
- Research and development expenses increased to $15.1 million
for the three months ended June 30, 2023 from $9.5 million for the
three months ended June 30, 2022, primarily due to ongoing clinical
costs associated with the progression of our Phase 2 study and CRO
costs associated with the start of our Phase 3 global trial,
manufacturing and development costs for bel-sar, and higher
personnel expenses from growing headcount.
- General and administrative expenses increased to $5.2 million
for the three months ended June 30, 2023 from $4.3 million for the
three months ended June 30, 2022. General and administrative
expenses include $1.2 million and $0.8 million of stock-based
compensation for the three months ended June 30, 2023 and 2022,
respectively. The increase was primarily driven by personnel
expenses, as well as increases in general corporate expenses
related to growth of the Company.
- Net loss for the three months ended June 30, 2023 was $18.3
million compared to $13.5 million for the three months ended June
30, 2022.
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
activities for the global Phase 3 trial evaluating first-line
treatment of early-stage 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. Aura is headquartered in Boston, MA.
For more information, visit aurabiosciences.com, or follow us on
Twitter and LinkedIn.
Forward-Looking Statements
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 metastasis; 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
the Phase 1 trial of bel-sar for non-muscle invasive bladder
cancer; the potential approvability of bel-sar; the Phase 2 trial
of bel-sar for choroidal metastasis; Aura’s expectations regarding
the estimated patient populations and related market opportunities
for bel-sar; and Aura’s expectations regarding cash runway.
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,
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; the risk that governmental
authorities may disagree with Aura’s clinical trial designs;
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; 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 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.
Consolidated Statement of
Operations and Comprehensive Loss
(in thousands, except share
and per share amounts)
Three Months Ended June
30,
Six Months Ended June
30,
2023
2022
2023
2022
Operating Expenses:
Research and development
$
15,120
$
9,510
$
29,524
$
17,786
General and administrative
5,156
$
4,306
10,196
8,841
Total operating expenses
20,276
13,816
39,720
26,627
Total operating loss
(20,276
)
(13,816
)
(39,720
)
(26,627
)
Other income (expense):
Interest income, including amortization
and accretion income
2,009
292
4,000
319
Other income (expense)
(32
)
56
(45
)
5
Total other income
1,977
348
3,955
324
Net loss
(18,299
)
(13,468
)
(35,765
)
(26,303
)
Net loss per common share—basic and
diluted
(0.48
)
(0.46
)
(0.95
)
(0.90
)
Weighted average common stock
outstanding—basic and diluted
37,855,533
29,251,480
37,820,104
29,232,661
Comprehensive loss:
Net loss
$
(18,299
)
$
(13,468
)
$
(35,765
)
$
(26,303
)
Other comprehensive items:
Unrealized loss on marketable
securities
$
(178
)
(123
)
(151
)
(128
)
Total other comprehensive loss
(178
)
(123
)
(151
)
(128
)
Total comprehensive loss
$
(18,477
)
$
(13,591
)
$
(35,916
)
$
(26,431
)
Aura Biosciences, Inc.
Consolidated Balance
Sheets
(in thousands, except share
and per share amounts)
June 30, 2023
December 31, 2022
Assets
Current assets:
Cash and cash equivalents
$
47,732
$
121,582
Marketable securities
114,281
67,229
Restricted cash and deposits
20
20
Prepaid expenses and other current
assets
4,178
7,871
Total current assets
166,211
196,702
Restricted cash and deposits, net of
current portion
768
768
Right of use assets - operating lease
20,003
20,671
Other long-term assets
700
423
Property and equipment, net
5,057
5,371
Total Assets
$
192,739
$
223,935
Liabilities and Stockholders’
Equity
Current liabilities:
Accounts payable
553
2,921
Short-term operating lease liability
3,008
2,963
Accrued expenses and other current
liabilities
5,334
4,573
Total current liabilities
8,895
10,457
Long-term operating lease liability
17,407
17,895
Total Liabilities
26,302
28,352
Commitments and Contingencies
Stockholders’ Equity:
Common stock, $0.00001 par value,
150,000,000 authorized at June 30, 2023 and December 31, 2022, and
38,086,606 and 37,771,918 shares issued and outstanding at June 30,
2023 and December 31, 2022, respectively
—
—
Additional paid-in capital
413,325
406,555
Accumulated deficit
(246,665
)
(210,900
)
Accumulated other comprehensive loss
(223
)
(72
)
Total Stockholders’ Equity
166,437
195,583
Total Liabilities and Stockholders’
Equity
$
192,739
$
223,935
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230809485316/en/
Investor and Media: Alex Dasalla Head of Investor
Relations and Corporate Communications
adasalla@aurabiosciences.com
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