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
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
(Former Name or Former Address, if Changed Since Last Report)
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:
|
|
Trading |
|
|
|
|
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 May 12, 2022, Aura Biosciences Inc, issued a press release announcing its financial results for the quarter ended March 31, 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 |
|
104 |
Cover Page Interactive Data File (embedded within Inline XBRL document) |
|
|
|
|
|
|
|
|
|
|
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.
|
|
|
Aura Biosciences, Inc. |
|
|
|
|
Date: |
May 12, 2022 |
By: |
/s/ Julie Feder |
|
|
|
Julie Feder |
Exhibit 99.1
Aura Biosciences Reports First Quarter 2022 Financial Results and Provides Clinical Development and Operational Highlights
On Track to Meet Multiple Clinical Milestones for AU-011 in 2H 2022: Initiate Pivotal Trial in Choroidal Melanoma, Initiate Phase 1 Trial in Non-Muscle Invasive Bladder Cancer, and Submit IND for Choroidal Metastases
CAMBRIDGE, MA – May 12, 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 first quarter ended March 31, 2022, and provided clinical development and operational highlights.
“We continue to advance the AU-011 overall development program and look forward to several upcoming clinical milestones, in the second half of this year,” said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. “We remain on track with our Phase 2 suprachoroidal study in early stage choroidal melanoma and plan to finalize a decision on the route of administration and initiate our pivotal program before the end of the year. Beyond primary choroidal melanoma, we continue to build our ocular oncology franchise and we are on track to file an Investigational New Drug application for choroidal metastases, with pre-clinical data presented at ARVO last week. Lastly, we will be initiating our Phase 1 trial in non-muscle invasive bladder cancer, with multiple clinical sites in the US. While we remain focused on preparing for our pivotal trial in choroidal melanoma, we are also excited by the prospect of leveraging our VDC therapies across multiple oncology indications and providing new treatment options for patients with life threatening cancers.”
Recent Pipeline Developments
1
First Quarter 2022 Financial Results
2
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, AU-011 (belzupacap sarotalocan), consists of a virus-like particle conjugated with an anti-cancer agent. AU-011 selectively targets and destroys cancer cells and activates the immune system with the potential to create long-lasting anti-tumor immunity. AU-011 is currently in development for ocular cancers, with an ongoing Phase 2 dose escalation clinical trial evaluating first-line treatment of 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 develop AU-011 across its ocular oncology franchise including for the treatment of patients with choroidal metastases. In addition, leveraging Aura’s technology platform, Aura is developing AU-011 more broadly across multiple cancers, starting with a planned Phase 1 clinical trial in patients with non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, 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 AU-011 for the treatment of NMIBC, expectations with respect to the anticipated timing of AU-011’s pivotal trial in CM and Phase 1 clinical trial in NMIBC, pre-clinical data presented at various medical meetings outlined above, and Aura’s anticipated cash runway.
3
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 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 Annual Report on Form 10-K for the year ended December 31, 2021 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
4
Aura Biosciences, Inc.
Condensed Consolidated Statement of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except share and per share amounts)
|
|
Three Months Ended |
|
|||||
|
|
2022 |
|
|
2021 |
|
||
Operating Expenses: |
|
|
|
|
|
|
||
Research and development |
|
$ |
8,276 |
|
|
$ |
4,185 |
|
General and administrative |
|
|
4,535 |
|
|
|
1,742 |
|
Total operating expenses |
|
|
12,811 |
|
|
|
5,927 |
|
Total operating loss |
|
|
(12,811 |
) |
|
|
(5,927 |
) |
Other income (expense): |
|
|
|
|
|
|
||
Change in fair value of warrant liability |
|
|
(44 |
) |
|
|
4 |
|
Interest income (expense), including amortization and accretion income |
|
|
25 |
|
|
|
(1 |
) |
Loss on disposal of assets |
|
|
(5 |
) |
|
|
(3 |
) |
Total other expense |
|
|
(24 |
) |
|
|
— |
|
Net loss |
|
|
(12,835 |
) |
|
|
(5,927 |
) |
Net loss attributable to common stockholders—basic and diluted |
|
|
(12,835 |
) |
|
|
(8,258 |
) |
Net loss per share attributable to common stockholders—basic and diluted |
|
|
(0.44 |
) |
|
|
(20.62 |
) |
Weighted average common stock outstanding—basic and diluted |
|
|
29,213,632 |
|
|
|
400,450 |
|
Comprehensive loss: |
|
|
|
|
|
|
||
Net loss attributable to common stockholders |
|
$ |
(12,835 |
) |
|
$ |
(8,258 |
) |
Other comprehensive items: |
|
|
|
|
|
|
||
Unrealized loss on marketable securities |
|
|
(5 |
) |
|
|
— |
|
Total other comprehensive loss |
|
|
(5 |
) |
|
|
— |
|
Total comprehensive loss |
|
$ |
(12,840 |
) |
|
$ |
(8,258 |
) |
5
Aura Biosciences, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands, except share and per share amounts)
|
|
March 31, 2022 |
|
|
December 31, 2021 |
|
||
Assets |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
108,382 |
|
|
$ |
149,063 |
|
Marketable securities |
|
|
24,899 |
|
|
|
— |
|
Restricted cash and deposits |
|
|
23 |
|
|
|
23 |
|
Prepaid expenses and other current assets |
|
|
6,278 |
|
|
|
4,618 |
|
Total current assets |
|
|
139,582 |
|
|
|
153,704 |
|
Restricted cash and deposits, net of current portion |
|
|
125 |
|
|
|
125 |
|
Right of use assets - operating lease |
|
|
804 |
|
|
|
950 |
|
Property and equipment, net |
|
|
5,911 |
|
|
|
5,251 |
|
Total Assets |
|
$ |
146,422 |
|
|
$ |
160,030 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
|
1,956 |
|
|
|
2,401 |
|
Short-term operating lease liability |
|
|
624 |
|
|
|
615 |
|
Accrued expenses and other current liabilities |
|
|
2,423 |
|
|
|
4,256 |
|
Total current liabilities |
|
|
5,003 |
|
|
|
7,272 |
|
Long-term operating lease liability |
|
|
206 |
|
|
|
360 |
|
Warrant liability |
|
|
127 |
|
|
|
83 |
|
Total Liabilities |
|
|
5,336 |
|
|
|
7,715 |
|
Commitments and Contingencies |
|
|
|
|
|
|
||
Stockholders’ Equity: |
|
|
|
|
|
|
||
Common stock, $0.00001 par value, 150,000,000 authorized at March 31, 2022 and December 31, 2021, and 29,217,236 and 29,211,643 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
306,063 |
|
|
|
304,452 |
|
Accumulated deficit |
|
|
(164,972 |
) |
|
|
(152,137 |
) |
Accumulated other comprehensive loss |
|
|
(5 |
) |
|
|
— |
|
Total Stockholders’ Equity |
|
|
141,086 |
|
|
|
152,315 |
|
Total Liabilities and Stockholders’ Equity |
|
$ |
146,422 |
|
|
$ |
160,030 |
|
6