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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Aura Biosciences Inc | NASDAQ:AURA | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.12 | 1.54% | 7.89 | 7.57 | 8.24 | 8.11 | 7.86 | 8.01 | 100,857 | 01:00:00 |
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
Recent Event
Third Quarter 2022 Financial Results
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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