UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On August 11, 2022, Aura Biosciences Inc, issued a press release announcing its financial results for the quarter ended June 30, 2022. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Form 8-K, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
d) Exhibits.
Exhibit No. |
Description |
99.1 |
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104 |
Cover Page Interactive Data File (embedded within Inline XBRL document) |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Aura Biosciences, Inc. |
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Date: |
August 11, 2022 |
By: |
/s/ Julie Feder |
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Julie Feder |
Exhibit 99.1
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, MA – August 11, 2022 – 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.
Investor and Media Contact:
Matthew DeYoung
Argot Partners
212-600-1902 | aura@argotpartners.com
Aura Biosciences, Inc.
Condensed Consolidated Statement of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except share and per share amounts)
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Three Months Ended |
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Six Months Ended |
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2022 |
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2021 |
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2022 |
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2021 |
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Operating Expenses: |
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Research and development |
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$ |
9,510 |
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$ |
6,632 |
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$ |
17,786 |
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$ |
10,817 |
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General and administrative |
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4,306 |
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$ |
2,169 |
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8,841 |
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3,911 |
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Total operating expenses |
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13,816 |
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8,801 |
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26,627 |
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14,728 |
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Total operating loss |
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(13,816 |
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(8,801 |
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(26,627 |
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(14,728 |
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Other income (expense): |
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Change in fair value of warrant liability |
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61 |
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(3 |
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16 |
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1 |
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Change in fair value of derivative liability |
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— |
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(52 |
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— |
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(52 |
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Interest income, including amortization and accretion income |
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292 |
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4 |
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319 |
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3 |
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Other expense |
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(5 |
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— |
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(11 |
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(3 |
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Total other income (expense) |
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348 |
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(51 |
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324 |
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(51 |
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Net loss |
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(13,468 |
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(8,852 |
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(26,303 |
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(14,779 |
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Net loss attributable to common stockholders—basic and diluted |
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(13,468 |
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(12,480 |
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(26,303 |
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(20,738 |
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Net loss per share attributable to common stockholders—basic and diluted |
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(0.46 |
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(28.53 |
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(0.90 |
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(49.49 |
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Weighted average common stock outstanding—basic and diluted |
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29,251,480 |
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437,464 |
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29,232,661 |
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419,059 |
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Comprehensive loss: |
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Net loss |
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$ |
(13,468 |
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$ |
(8,852 |
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$ |
(26,303 |
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$ |
(14,779 |
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Other comprehensive items: |
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Unrealized loss on marketable securities |
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(123 |
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— |
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(128 |
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— |
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Total other comprehensive loss |
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(123 |
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— |
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(128 |
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— |
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Total comprehensive loss |
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$ |
(13,591 |
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$ |
(8,852 |
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$ |
(26,431 |
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$ |
(14,779 |
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Aura Biosciences, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands, except share and per share amounts)
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June 30, 2022 |
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December 31, 2021 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
53,849 |
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$ |
149,063 |
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Marketable securities |
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68,282 |
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— |
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Restricted cash and deposits |
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28 |
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23 |
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Prepaid expenses and other current assets |
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5,510 |
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4,618 |
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Total current assets |
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127,669 |
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153,704 |
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Restricted cash and deposits, net of current portion |
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893 |
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125 |
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Right of use assets - operating lease |
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656 |
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950 |
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Property and equipment, net |
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5,803 |
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5,251 |
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Total Assets |
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$ |
135,021 |
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$ |
160,030 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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1,198 |
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2,401 |
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Short-term operating lease liability |
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633 |
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615 |
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Accrued expenses and other current liabilities |
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3,981 |
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4,256 |
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Total current liabilities |
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5,812 |
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7,272 |
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Long-term operating lease liability |
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51 |
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360 |
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Warrant liability |
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67 |
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83 |
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Total Liabilities |
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5,930 |
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7,715 |
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Commitments and Contingencies |
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Stockholders’ Equity: |
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Common stock, $0.00001 par value, 150,000,000 authorized at June 30, 2022 and December 31, 2021, and 29,266,848 and 29,211,643 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively |
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— |
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— |
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Additional paid-in capital |
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307,659 |
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304,452 |
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Accumulated deficit |
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(178,440 |
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(152,137 |
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Accumulated other comprehensive loss |
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(128 |
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— |
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Total Stockholders’ Equity |
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129,091 |
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152,315 |
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Total Liabilities and Stockholders’ Equity |
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$ |
135,021 |
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$ |
160,030 |
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