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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 | |
---|---|---|---|---|---|---|---|---|---|---|
-0.15 | -2.11% | 6.95 | 6.67 | 7.98 | 7.09 | 6.64 | 7.07 | 180,408 | 21:00:10 |
Received FDA Agreement Under Special Protocol Assessment (SPA) for the CoMpass Phase 3 Clinical Trial
Positive Clinical Efficacy Updates of Bel-sar for Early-Stage Choroidal Melanoma from the Ongoing Phase 2 Clinical Trial with Suprachoroidal Administration Presented at AAO 2023
Preliminary Data from Phase 1 Trial in Bladder Cancer – First Patient Utilizing a Single Dose of Bel-sar with Light Activation Demonstrated a Clinical Complete Response
Raised Gross Proceeds of $99.0 Million in an Underwritten Public Offering
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, 2023, and provided clinical development and operational highlights.
“In the third quarter we made meaningful progress across our portfolio,” said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. “We are encouraged by the agreement with the FDA under the SPA, as it reinforces the plan for our CoMpass trial and further supports our goal of having the first approved vision-preserving therapy for patients with early-stage choroidal melanoma. The Phase 2 data presented at AAO, with 90% of patients at twelve months follow-up, show results that are highly consistent with, and strongly support, the assumptions for the design of the CoMpass Phase 3 trial.”
Dr. de los Pinos added, “We are pleased with the preliminary data from our ongoing Phase 1 trial in bladder cancer, where the first patient who received a single dose of bel-sar with light activation demonstrated a clinical complete response evidenced by absence of cancer cells on histopathology, and we look forward to additional data from the program in mid-2024. With a strong balance sheet from our recent financing, we are well-positioned to execute our pipeline to meaningful clinical milestones.”
Recent Pipeline Developments
Positive updated Phase 2 data evaluating SC administration of bel-sar for the first-line treatment of adult patients with early-stage CM was presented at AAO 2023.
Recent Corporate Events
Third Quarter 2023 Financial Results
About Aura Biosciences
Aura Biosciences, Inc. is a clinical-stage biotechnology company developing 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 the standard of care with radiotherapy leaves patients with severe comorbidities, including significant 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 and 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, MIBC, NMIBC, 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 MIBC and NMIBC; the potential approvability of bel-sar; the Phase 2 trial of bel-sar for choroidal metastasis; and the Company’s 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, even where Aura has obtained agreement with governmental authorities on the design of such trials, such as the Phase 3 SPA agreement with FDA; 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 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. Consolidated Statement of Operations and Comprehensive Loss (in thousands, except share and per share amounts)
Three Months Ended September 30,
Nine Months Ended September 30,
2023
2022
2023
2022
Operating Expenses:
Research and development
$
15,428
$
11,293
$
44,952
$
29,079
General and administrative
5,060
$
4,762
15,256
13,603
Total operating expenses
20,488
16,055
60,208
42,682
Total operating loss
(20,488
)
(16,055
)
(60,208
)
(42,682
)
Other income (expense):
Interest income, including amortization and accretion income
1,981
483
5,981
802
Other income (expense)
(5
)
(329
)
(50
)
(324
)
Total other income
1,976
154
5,931
478
Net loss
(18,512
)
(15,901
)
(54,277
)
(42,204
)
Net loss per common share—basic and diluted
(0.48
)
(0.54
)
(1.43
)
(1.44
)
Weighted average common stock outstanding—basic and diluted
38,185,197
29,273,577
37,943,139
29,246,449
Comprehensive loss:
Net loss
$
(18,512
)
$
(15,901
)
$
(54,277
)
$
(42,204
)
Other comprehensive items:
Unrealized gain (loss) on marketable securities
$
89
(19
)
(62
)
(147
)
Total other comprehensive income (loss)
89
(19
)
(62
)
(147
)
Total comprehensive loss
$
(18,423
)
$
(15,920
)
$
(54,339
)
$
(42,351
)
Aura Biosciences, Inc. Consolidated Balance Sheets (in thousands, except share and per share amounts)
September 30, 2023
December 31, 2022
Assets
Current assets:
Cash and cash equivalents
$
55,584
$
121,582
Marketable securities
93,472
67,229
Restricted cash and deposits
20
20
Prepaid expenses and other current assets
4,812
7,871
Total current assets
153,888
196,702
Restricted cash and deposits, net of current portion
768
768
Right of use assets - operating lease
19,569
20,671
Other long-term assets
685
423
Property and equipment, net
4,856
5,371
Total Assets
$
179,766
$
223,935
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
1,490
2,921
Short-term operating lease liability
3,035
2,963
Accrued expenses and other current liabilities
6,369
4,573
Total current liabilities
10,894
10,457
Long-term operating lease liability
17,154
17,895
Total Liabilities
28,048
28,352
Commitments and Contingencies
Stockholders’ Equity:
Common stock, $0.00001 par value, 150,000,000 authorized at September 30, 2023 and December 31, 2022, and 38,216,717 and 37,771,918 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively
—
—
Additional paid-in capital
417,029
406,555
Accumulated deficit
(265,177
)
(210,900
)
Accumulated other comprehensive loss
(134
)
(72
)
Total Stockholders’ Equity
151,718
195,583
Total Liabilities and Stockholders’ Equity
$
179,766
$
223,935
View source version on businesswire.com: https://www.businesswire.com/news/home/20231109599988/en/
Investor and Media: Alex Dasalla Head of Investor Relations and Corporate Communications adasalla@aurabiosciences.com
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