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Aura Biosciences Reports Second Quarter 2022 Financial Results and Provides Clinical Development and Operational Highlights

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

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 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

Second 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 (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

 

 

Contacts

Investor and Media Contact:
Matthew DeYoung

Argot Partners

212-600-1902 | aura@argotpartners.com

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