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Aura Biosciences Reports First Quarter 2023 Financial Results and Provides Clinical Development and Operational Highlights

U.S. Food and Drug Administration (FDA) Guidance in Type C Meeting Supports Global Phase 3 Trial in Early-stage Choroidal Melanoma

Enrollment Complete in Phase 2 Trial in Choroidal Melanoma Using Suprachoroidal Route of Administration

BOSTON–(BUSINESS WIRE)–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 first quarter ended March 31, 2023, and provided clinical development and operational highlights.

“We are encouraged by our recent interactions with the FDA in support of our global Phase 3 trial designed to enable us to develop the first vision preserving targeted therapy for the treatment of patients with early-stage choroidal melanoma, a disease with a high unmet medical need and no approved therapies,” said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. “With a strong balance sheet, we are well-positioned to execute and advance our pipeline to meaningful clinical milestones.”

Recent Pipeline Developments

Recent Corporate Events

First Quarter 2023 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 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, even after governmental authorities have reviewed and commented on such 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; risks, assumptions and uncertainties regarding the impact of the 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 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

(in thousands, except share and per share amounts)

 

 

 

Three Months Ended

March 31,

 

 

2023

 

2022

Operating Expenses:

 

 

 

 

Research and development

 

$

14,405

 

 

$

8,276

 

General and administrative

 

 

5,039

 

 

$

4,535

 

Total operating expenses

 

 

19,444

 

 

 

12,811

 

Total operating loss

 

 

(19,444

)

 

 

(12,811

)

Other income (expense):

 

 

 

 

Interest income, including amortization and accretion income

 

 

1,991

 

 

 

25

 

Loss on disposal of assets

 

 

0

 

 

 

(5

)

Other income (expense)

 

 

(13

)

 

 

(44

)

Total other income (expense)

 

 

1,978

 

 

 

(24

)

Net loss

 

 

(17,466

)

 

 

(12,835

)

Net loss per common share—basic and diluted

 

 

(0.46

)

 

 

(0.44

)

Weighted average common stock outstanding—basic and diluted

 

 

37,784,282

 

 

 

29,213,632

 

Comprehensive loss:

 

 

 

 

Net loss

 

$

(17,466

)

 

$

(12,835

)

Other comprehensive items:

 

 

 

 

Unrealized gain (loss) on marketable securities

 

$

27

 

 

$

(5

)

Total other comprehensive gain (loss)

 

 

27

 

 

 

(5

)

Total comprehensive loss

 

$

(17,439

)

 

$

(12,840

)

Aura Biosciences, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share amounts)

 

 

 

March 31, 2023

 

December 31, 2022

Assets

 

 

 

 

Current assets:

 

 

 

 

Cash and cash equivalents

 

$

38,492

 

$

121,582

Marketable securities

 

 

135,030

 

 

67,229

Restricted cash and deposits

 

 

20

 

 

20

Prepaid expenses and other current assets

 

 

5,579

 

 

7,871

Total current assets

 

 

179,121

 

 

196,702

Restricted cash and deposits, net of current portion

 

 

768

 

 

768

Right of use assets – operating lease

 

 

20,340

 

 

20,671

Other long-term assets

 

 

623

 

 

423

Property and equipment, net

 

 

5,167

 

 

5,371

Total Assets

 

$

206,019

 

$

223,935

Liabilities and Stockholders’ Equity

 

 

 

 

Current liabilities:

 

 

 

 

Accounts payable

 

 

1,055

 

 

2,921

Short-term operating lease liability

 

 

2,985

 

 

2,963

Accrued expenses and other current liabilities

 

 

4,067

 

 

4,573

Total current liabilities

 

 

8,107

 

 

10,457

Long-term operating lease liability

 

 

17,654

 

 

17,895

Total Liabilities

 

 

25,761

 

 

28,352

Commitments and Contingencies

 

 

 

 

Stockholders’ Equity:

 

 

 

 

Common stock, $0.00001 par value, 150,000,000 authorized at March 31, 2023 and December 31, 2022, and 37,800,102 and 37,771,918 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively

 

 

 

 

Additional paid-in capital

 

 

408,669

 

 

406,555

Accumulated deficit

 

 

(228,366)

 

 

(210,900)

Accumulated other comprehensive loss

 

 

(45)

 

 

(72)

Total Stockholders’ Equity

 

 

180,258

 

 

195,583

Total Liabilities and Stockholders’ Equity

 

$

206,019

 

$

223,935

 

Contacts

Investor and Media Contact:

Alex Dasalla

Head of Investor Relations and Corporate Communications

adasalla@aurabiosciences.com

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