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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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 March 27, 2024, Aura Biosciences, Inc., issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2023. 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: |
March 27, 2024 |
By: |
/s/ Julie Feder |
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Julie Feder |
Exhibit 99.1
Aura Biosciences Reports Fourth Quarter and Full Year 2023 Financial Results and Business Highlights
Enrolling Patients in Global Phase 3 CoMpass Trial in Small Choroidal Melanoma and Indeterminate Lesions; Granted SPA Agreement by FDA
Data Expected Mid-2024 from Ongoing Phase 1 Trial in Bladder Cancer
(Non-Muscle Invasive Bladder Cancer and Muscle Invasive Bladder Cancer)
Strong Cash Position into Second Half of 2026
BOSTON, MA – March 27, 2024 – Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision immunotherapies to treat solid tumors to preserve the function of the afflicted organ with cancer, today reported financial results for the fourth quarter and year ended December 31, 2023, and provided recent business highlights.
“We’re excited to expand bel-sar into bladder cancer, as we leverage our therapy‘s unique mechanism of action in additional solid cancer indications with major unmet medical need,” said Elisabet de los Pinos, Ph.D., CEO of Aura Biosciences. “Bel-sar is a potential vision-and-organ sparing therapy that we believe will change the standard of care in ocular oncology, in particular choroidal melanoma, where there are no treatment options except radiotherapy which leads to vision loss, or surgical removal of the eye. There is an urgent need to develop vision-sparing therapies, as all eye cancers represent an estimated 60,000 patients annually in the US and EU. This is a multi-billion dollar market, which includes choroidal melanoma, choroidal metastases, and ocular surface cancers. Our financial strength allows us to fund multiple clinical programs through major inflection points while enabling the flexibility to expand bel-sar into additional indications, starting with bladder cancer.”
Recent Pipeline Developments
Global Phase 3 CoMpass trial actively enrolling patients for the treatment of small choroidal melanoma (CM) and indeterminate lesions (ILs).
Positive Phase 2 data evaluating SC administration of bel-sar for patients with small CM and ILs was presented at the American Academy of Ophthalmology (AAO) 2023 Annual Meeting.
Results:
Bel-sar is being evaluated in additional ocular oncology indications with a collective incidence of approximately 60,000 patients/year in the US/EU per year. The Company’s plan is to initiate clinical development in choroidal metastasis (Cmets), an indication with a high unmet medical need where bel-sar has the potential to be the first approved therapy that is vision and organ sparing. Cmets is the second potential ocular oncology indication for bel-sar affecting over 20,000 patients in the US/EU annually. The Company is on track to initiate a Phase 2 trial in 2024.
The Phase 1 trial of bel-sar for the treatment of non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC) is currently ongoing, and the Company expects to report data in mid-2024. This represents an area of high unmet need with approximately 80,000 patients diagnosed in the U.S. every year where we have the possibility to selectively treat and induce a tissue and tumor specific immune response to prevent progression and recurrence of the disease. The Company received Fast Track Designation from the Oncology Division of the FDA for NMIBC in June 2022.
Recent Corporate Events
Full Year and Fourth Quarter 2023 Financial Results
About Aura Biosciences
Aura Biosciences is a clinical-stage biotechnology company developing precision immunotherapies to treat solid tumors designed to preserve the function of the afflicted organ with cancer. Our lead candidate bel-sar is in late-stage clinical development for the treatment of patients with primary choroidal melanoma, and other ocular oncology indications as well as in early-stage clinical development in bladder cancer. We are evaluating the safety and efficacy of bel-sar as a potential vision-sparing therapy in an ongoing global Phase 3 CoMpass trial for the first-line treatment of adult patients with early-stage choroidal melanoma. Bel-sar is also being evaluated in additional solid cancers, including bladder cancer. Our mission is to develop vision and organ-sparing therapies to improve patient outcomes in cancer. Aura is headquartered in Boston, MA. For more information, visit aurabiosciences.com. Visit us @AuraBiosciences and on 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, 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 choroidal melanoma and indeterminate legions and the Phase 1 trial of bel-sar for non-muscle invasive bladder cancer and 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; the risk that governmental authorities may disagree with Aura’s clinical trial designs, even where Aura has obtained agreement with governmental authorities on the design of such trials, such as the Phase 3 SPA agreement with FDA; 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; 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 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:
Alex Dasalla
Head of Investor Relations and Corporate Communications
IR@aurabiosciences.com
Aura Biosciences, Inc.
Consolidated Statement of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
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Year Ended |
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2023 |
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2022 |
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Operating Expenses: |
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Research and development |
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$ |
65,232 |
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$ |
42,238 |
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General and administrative |
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19,759 |
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18,057 |
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Total operating expenses |
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84,991 |
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60,295 |
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Total operating loss |
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(84,991 |
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(60,295 |
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Other income (expense): |
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Interest income, including amortization and accretion income |
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8,588 |
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1,864 |
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Gain (loss) from disposal of assets |
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208 |
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(318 |
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Other income (expense) |
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(76 |
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(14 |
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Total other income |
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8,720 |
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1,532 |
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Loss before income taxes |
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(76,271 |
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(58,763 |
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Income tax benefit (provision), net |
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(137 |
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— |
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Net loss |
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(76,408 |
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(58,763 |
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Net loss per common share—basic and diluted |
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(1.93 |
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(1.96 |
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Weighted average common stock outstanding—basic and diluted |
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39,620,036 |
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29,937,228 |
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Comprehensive loss: |
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Net loss |
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$ |
(76,408 |
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$ |
(58,763 |
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Other comprehensive items: |
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Unrealized gain (loss) on marketable securities |
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611 |
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(72 |
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Total other comprehensive income (loss) |
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611 |
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(72 |
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Total comprehensive loss |
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$ |
(75,797 |
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$ |
(58,835 |
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Aura Biosciences, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
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December 31, 2023 |
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December 31, 2022 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
41,063 |
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$ |
121,582 |
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Marketable securities |
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185,087 |
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67,229 |
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Restricted cash and deposits |
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19 |
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20 |
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Prepaid expenses and other current assets |
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5,625 |
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7,871 |
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Total current assets |
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231,794 |
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196,702 |
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Restricted cash and deposits, net of current portion |
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768 |
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768 |
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Right of use assets - operating lease |
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18,854 |
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20,671 |
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Other long-term assets |
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509 |
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423 |
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Property and equipment, net |
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3,150 |
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5,371 |
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Total Assets |
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$ |
255,075 |
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$ |
223,935 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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1,787 |
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2,921 |
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Short-term operating lease liability |
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2,687 |
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2,963 |
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Accrued expenses and other current liabilities |
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7,883 |
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4,573 |
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Total current liabilities |
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12,357 |
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10,457 |
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Long-term operating lease liability |
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16,870 |
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17,895 |
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Total Liabilities |
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29,227 |
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28,352 |
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Commitments and Contingencies |
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Stockholders’ Equity: |
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Common stock, $0.00001 par value, 150,000,000 authorized at December 31, 2023 and December 31, 2022, and 49,350,788 and 37,771,918 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively |
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— |
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— |
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Additional paid-in capital |
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512,617 |
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406,555 |
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Accumulated deficit |
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(287,308 |
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(210,900 |
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Accumulated other comprehensive loss |
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539 |
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(72 |
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Total Stockholders’ Equity |
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225,848 |
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195,583 |
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Total Liabilities and Stockholders’ Equity |
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$ |
255,075 |
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$ |
223,935 |
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