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Aura Biosciences Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Clinical Development and Operational Highlights

U.S. Food and Drug Administration (FDA) Grants Fast Track Designation for Belzupacap Sarotalocan (bel-sar) for the Treatment of Choroidal Metastasis, Bel-sar’s Second Ocular Oncology Indication to Receive this Designation

Global Phase 3 Trial in Primary Choroidal Melanoma on Track to Begin Dosing in 1H 2023

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 fourth quarter and year ended December 31, 2022, and provided clinical development and operational highlights.

“2023 is off to a strong start with positive interim Phase 2 safety and efficacy data with suprachoroidal administration in early-stage choroidal melanoma. In February, at the Macula Society’s 46th Annual Meeting, we presented average nine-month interim data which strongly supports the assumptions for the success of the global Phase 3 trial, which is on track to dose the first patient in the first half of this year,” said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. “We are also excited to initiate clinical development in our second ocular oncology indication, choroidal metastasis, and to report early Phase 1 data in our non-muscle invasive bladder cancer program in the second half of this year. Our recently strengthened balance sheet positions us well to execute and advance our pipeline to meaningful clinical milestones across ocular and urologic oncology.”

“We are excited that bel-sar was granted Fast Track Designation for choroidal metastasis. There is an important opportunity to develop a new standard of care as we see a large number of patients with this type of metastasis,” said Dr. Cadmus Rich, Chief Medical Officer of Aura Biosciences. “This is the second Fast Track Designation bel-sar has obtained for an ocular oncology indication, which highlights the need for vision preserving treatment options.”

Recent Pipeline Developments

Recent Corporate Events

Full Year and Fourth 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 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; 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 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)

 

 

 

Year Ended

December 31,

 

 

 

2022

 

 

2021

 

Operating Expenses:

 

 

 

 

 

 

Research and development

 

$

42,238

 

 

$

25,161

 

General and administrative

 

 

18,057

 

 

 

10,089

 

Total operating expenses

 

 

60,295

 

 

 

35,250

 

Total operating loss

 

 

(60,295

)

 

 

(35,250

)

Other income (expense):

 

 

 

 

 

 

Interest income, including amortization and accretion income

 

 

1,864

 

 

 

13

 

Realized loss on marketable securities

 

 

(9

)

 

 

 

Loss on disposal of assets

 

 

(318

)

 

 

(3

)

Other expense

 

 

(5

)

 

 

(11

)

Total other income (expense)

 

 

1,532

 

 

 

(1

)

Net loss

 

 

(58,763

)

 

$

(35,251

)

Net loss attributable to common stockholders—basic and diluted

 

 

(58,763

)

 

 

(46,193

)

Net loss per share attributable to common stockholders—basic and diluted

 

 

(1.96

)

 

 

(8.95

)

Weighted average common stock outstanding—basic and diluted

 

 

29,937,228

 

 

 

5,159,973

 

Comprehensive loss:

 

 

 

 

 

 

Net loss

 

$

(58,763

)

 

$

(35,251

)

Other comprehensive items:

 

 

 

 

 

 

Unrealized loss on marketable securities

 

 

(72

)

 

 

 

Total other comprehensive loss

 

 

(72

)

 

 

 

Total comprehensive loss

 

$

(58,835

)

 

$

(35,251

)

Aura Biosciences, Inc.

Consolidated Balance Sheets

(in thousands, except share and per share amounts)

 

 

 

December 31,

 

 

 

2022

 

 

2021

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

121,582

 

 

$

149,063

 

Marketable securities

 

 

67,229

 

 

 

 

Restricted cash and deposits

 

 

20

 

 

 

23

 

Prepaid expenses and other current assets

 

 

7,871

 

 

 

4,618

 

Total current assets

 

 

196,702

 

 

 

153,704

 

Restricted cash and deposits, net of current portion

 

 

768

 

 

 

125

 

Right of use assets – operating lease

 

 

20,671

 

 

 

950

 

Other long-term assets

 

 

423

 

 

 

 

Property and equipment, net

 

 

5,371

 

 

 

5,251

 

Total Assets

 

$

223,935

 

 

$

160,030

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

 

2,921

 

 

 

2,401

 

Short-term operating lease liability

 

 

2,963

 

 

 

615

 

Accrued expenses and other current liabilities

 

 

4,573

 

 

 

4,339

 

Total current liabilities

 

 

10,457

 

 

 

7,355

 

Long-term operating lease liability

 

 

17,895

 

 

 

360

 

Total Liabilities

 

 

28,352

 

 

 

7,715

 

Commitments and Contingencies

 

 

 

 

 

 

Stockholders’ Equity:

 

 

 

 

 

 

Common stock, $0.00001 par value, 150,000,000 authorized at December 31, 2022 and December 31, 2021, and 37,771,918 and 29,211,643 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively

 

 

 

 

 

 

Additional paid-in capital

 

 

406,555

 

 

 

304,452

 

Accumulated deficit

 

 

(210,900

)

 

 

(152,137

)

Accumulated other comprehensive loss

 

 

(72

)

 

 

 

Total Stockholders’ Equity

 

 

195,583

 

 

 

152,315

 

Total Liabilities and Stockholders’ Equity

 

$

223,935

 

 

$

160,030

 

 

Contacts

Investor and Media:

Alex Dasalla

Head of Investor Relations and Corporate Communications

adasalla@aurabiosciences.com

Argot Partners

Matthew DeYoung

aura@argotpartners.com

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