On Track to Dose the First Patient in the Phase
1 Study Evaluating Belzupacap Sarotalocan (AU‑011) for the
Treatment of Non-Muscle Invasive Bladder Cancer in Q3 2022
On Track to Initiate Pivotal Trial in
Early-Stage Choroidal Melanoma in Q4 2022
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,
2022, and provided clinical development and operational
highlights.
“We have made significant progress in advancing the clinical
development of belzupacap sarotalocan and remain on track to dose
the first patient this quarter in the Phase 1 trial in non-muscle
invasive bladder cancer (NMIBC), which represents our second
indication in the clinic,” said Elisabet de los Pinos, Ph.D., Chief
Executive Officer of Aura. “Current treatments leave patients with
a high risk of recurrence and progression, which in many cases
leads to cystectomy (the entire removal of the bladder and some
surrounding tissues). We look forward to further developing a
potential targeted treatment option for patients with this high
unmet medical need. Notably, we recently received FDA Fast Track
designation in NMIBC, which will further support our development
efforts. Beyond NMIBC, we remain on track to initiate our pivotal
trial of belzupacap sarotalocan in early-stage choroidal melanoma
and file an Investigational New Drug application (IND) for
choroidal metastases, our second ocular oncology indication, in Q4
of this year.”
Recent Pipeline Developments
- Belzupacap sarotalocan (AU-011) is being developed for the
treatment of early-stage choroidal melanoma (CM), a
life-threatening rare disease with no approved therapies. Aura
plans to select the route of administration and treatment regimen
to initiate the pivotal program in Q4 of 2022.
- Multiple clinical studies of belzupacap sarotalocan
were presented at the International Society of Ocular Oncology
(ISOO) 2022 Bi-Annual Meeting, the largest global ocular oncology
meeting. The presentations included updated safety data from
the Phase 2 trial using suprachoroidal (SC) administration, final
safety and efficacy data from the Phase 1b/2 trial using
intravitreal (IVT) administration, as well as top-line data from
the Retrospective Match Case Control study comparing the long-term
visual acuity outcomes following treatment with belzupacap
sarotalocan versus treatment with plaque brachytherapy, the current
standard of care. Collectively, these studies support the value of
a vision-preserving therapy for the treatment of patients with
early-stage choroidal melanoma.
- Aura plans to dose the first patient in a Phase 1 clinical
trial of belzupacap sarotalocan for the treatment of NMIBC in Q3
2022.
- NMIBC is an area of high unmet need with no approved targeted
therapies. The Phase 1 trial will evaluate safety and early proof
of mechanism, exploring distribution, local necrosis and evidence
of immune activation of belzupacap sarotalocan. Aura expects to
report initial Phase 1 data in 2023.
- FDA (Division of Oncology) granted Fast Track designation for
belzupacap sarotalocan for the treatment of NMIBC.
- Beyond early-stage CM, we continue to build our ocular oncology
franchise, with choroidal metastases being the second potential
ocular indication. Aura plans to file an IND for choroidal
metastases, an unmet medical need with no approved therapies, with
the FDA in Q4 of 2022.
- Recent presentations in both choroidal metastases and in
broader oncology indications include:
- Preclinical data highlighting belzupacap sarotalocan’s
anti-tumor activity were presented at the 2022 Association of
Research in Vision and Ophthalmology (ARVO) Annual Meeting.
Preclinical results highlighted belzupacap sarotalocan’s targeted
cytotoxicity in tumor cells derived from the most common cancer
types known to metastasize to the choroid in the eye. Belzupacap
sarotalocan showed dose dependent activity in vivo using cognate
tumor models. These results support further evaluation of
belzupacap sarotalocan as a potential treatment for choroidal
metastases, the most common type of intraocular malignancy in
adults.
- Abstract highlighting belzupacap sarotalocan’s activity as a
single agent and as a combination therapy with checkpoint
inhibitors was selected for publication at the 2022 American
Society of Clinical Oncology (ASCO) Annual Meeting. The
published data showed that belzupacap sarotalocan, in combination
with immune checkpoint inhibition, had anti-tumor activity against
both primary tumors and distant untreated lesions by an abscopal
effect in a preclinical model, demonstrating its clinical potential
for the treatment of both early-stage tumors and also metastatic
cancers.
Second Quarter 2022 Financial Results
- As of June 30, 2022, Aura had cash and cash equivalents and
marketable securities totaling $122.1 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 $9.5 million for
the three months ended June 30, 2022 from $6.6 million for the
three months ended June 30, 2021, primarily due to ongoing
preclinical costs, clinical costs for belzupacap sarotalocan, and
higher personnel expenses from growing headcount.
- General and administrative expenses increased to $4.3 million
for the three months ended June 30, 2022 from $2.2 million for the
three months ended June 30, 2021. General and administrative
expenses include $0.8 million and $0.2 million of stock-based
compensation for the three months ended June 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 June 30, 2022 was $13.5
million compared to $8.9 million for the three months ended June
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 (AU-011),
consists of a virus-like particle conjugated with an anti-cancer
agent. Belzupacap sarotalocan is designed to selectively target and
destroy cancer cells and activate the immune system with the
potential to create long-lasting anti-tumor immunity. Belzupacap
sarotalocan is currently in development for ocular cancers, with an
ongoing Phase 2 dose escalation clinical trial evaluating it as a
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 belzupacap
sarotalocan across its ocular oncology franchise including for the
treatment of patients with choroidal metastases. In addition,
leveraging Aura’s technology platform, Aura is developing
belzupacap sarotalocan more broadly across multiple cancers,
starting with a Phase 1 clinical trial 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 belzupacap sarotalocan (AU-011) for the
treatment of cancers including NMIBC and choroidal melanoma,
expectations with respect to the clinical development of belzupacap
sarotalocan in NMIBC, including expectations regarding the timing
for enrollment of the first patient for the Phase 1 trial and
anticipated initial data, the potential for belzupacap sarotalocan
to provide a therapeutic option for patients with NMIBC, and
potential benefits conferred by Fast Track designation,
expectations with respect to the timing of an anticipated IND
application for choroidal metastases with belzupacap sarotalocan,
and Aura’s anticipated 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; 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, market
uncertainty and inflation on Aura’s business, operations, strategy,
goals and anticipated development and review timelines; Aura’s
ongoing and planned preclinical 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 June
30,
Six Months Ended June
30,
2022
2021
2022
2021
Operating Expenses:
Research and development
$
9,510
$
6,632
$
17,786
$
10,817
General and administrative
4,306
$
2,169
8,841
3,911
Total operating expenses
13,816
8,801
26,627
14,728
Total operating loss
(13,816
)
(8,801
)
(26,627
)
(14,728
)
Other income (expense):
Change in fair value of warrant
liability
61
(3
)
16
1
Change in fair value of derivative
liability
—
(52
)
—
(52
)
Interest income, including amortization
and accretion income
292
4
319
3
Other expense
(5
)
—
(11
)
(3
)
Total other income (expense)
348
(51
)
324
(51
)
Net loss
(13,468
)
(8,852
)
(26,303
)
(14,779
)
Net loss attributable to common
stockholders—basic and diluted
(13,468
)
(12,480
)
(26,303
)
(20,738
)
Net loss per share attributable to common
stockholders—basic and diluted
(0.46
)
(28.53
)
(0.90
)
(49.49
)
Weighted average common stock
outstanding—basic and diluted
29,251,480
437,464
29,232,661
419,059
Comprehensive loss:
Net loss
$
(13,468
)
$
(8,852
)
$
(26,303
)
$
(14,779
)
Other comprehensive items:
Unrealized loss on marketable
securities
(123
)
—
(128
)
—
Total other comprehensive loss
(123
)
—
(128
)
—
Total comprehensive loss
$
(13,591
)
$
(8,852
)
$
(26,431
)
$
(14,779
)
Aura Biosciences, Inc.
Condensed Consolidated Balance
Sheets
(Unaudited)
(in thousands, except share
and per share amounts)
June 30, 2022
December 31, 2021
Assets
Current assets:
Cash and cash equivalents
$
53,849
$
149,063
Marketable securities
68,282
—
Restricted cash and deposits
28
23
Prepaid expenses and other current
assets
5,510
4,618
Total current assets
127,669
153,704
Restricted cash and deposits, net of
current portion
893
125
Right of use assets - operating lease
656
950
Property and equipment, net
5,803
5,251
Total Assets
$
135,021
$
160,030
Liabilities and Stockholders’
Equity
Current liabilities:
Accounts payable
1,198
2,401
Short-term operating lease liability
633
615
Accrued expenses and other current
liabilities
3,981
4,256
Total current liabilities
5,812
7,272
Long-term operating lease liability
51
360
Warrant liability
67
83
Total Liabilities
5,930
7,715
Commitments and Contingencies
Stockholders’ Equity:
Common stock, $0.00001 par value,
150,000,000 authorized at June 30, 2022 and December 31, 2021, and
29,266,848 and 29,211,643 shares issued and outstanding at June 30,
2022 and December 31, 2021, respectively
—
—
Additional paid-in capital
307,659
304,452
Accumulated deficit
(178,440
)
(152,137
)
Accumulated other comprehensive loss
(128
)
—
Total Stockholders’ Equity
129,091
152,315
Total Liabilities and Stockholders’
Equity
$
135,021
$
160,030
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220811005651/en/
Investor and Media Contact: Matthew DeYoung Argot
Partners 212-600-1902 | aura@argotpartners.com
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