AURA 8-K
Aura Biosciences, Inc. (AURA)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
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 May 15, 2025, Aura Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 2.02, 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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Appointment of Chief Financial and Business Officer
Effective as of May 13, 2025 (the “Effective Date”), the Board of Directors of the Company appointed Anthony Gibney as the Company’s Chief Financial and Business Officer. Beginning on the Effective Date, Amy Elazzouzi, the Company’s Senior Vice President, Finance, will cease serving as the Company’s principal financial officer and continue as the Company’s principal accounting officer and Mr. Gibney will serve as the Company’s principal financial officer.
Anthony Gibney, age 54, is an experienced biotechnology leader and former investment banker who brings over 30 years of experience dedicated to advising and leading biotechnology companies across their businesses, including corporate strategy, business development, finance and investor relations, among many others. Mr. Gibney advised the Company as a senior finance and strategy advisor from March 2025 to May 2025. From May 2024 to May 2025, Mr. Gibney provided strategic and financing consulting services for biotechnology clients. Previously, Mr. Gibney served as the Executive Vice President, Chief Business & Strategy Officer of IVERIC Bio, Inc. from December 2021 until its acquisition by Astellas Pharma Inc. in July 2023. Prior to that, Mr. Gibney served as Chief Financial Officer and Chief Business Officer at Fog Pharmaceuticals, Inc. from May 2020 to December 2021, and as Executive Vice President and Chief Business Officer at Achillion Pharmaceuticals, Inc. from August 2018 until its sale to Alexion Pharmaceuticals, Inc. in May 2020. Before Achillion, Mr. Gibney was a Managing Director and Co-head of Biotechnology Investment Banking at Leerink Partners LLC and Managing Director of Merrill Lynch’s Healthcare Group. Mr. Gibney has served on the board of directors of Clearside Biomedical, Inc. since April 2024, InflaRx, N.V. since June 2021 and LAPIX Therapeutics, Inc. since January 2024. Mr. Gibney received a B.A. in Economics and History from Yale University.
In connection with his appointment as Chief Financial and Business Officer, Mr. Gibney entered into an offer letter (the “Employment Offer Letter”), setting forth the amended and restated terms of his employment with the Company. Pursuant to the Employment Offer Letter, Mr. Gibney will be paid an annual base salary of $525,000. Following the end of each calendar year, Mr. Gibney will be eligible to receive a discretionary annual performance bonus with a target of 45% of his then annual base salary based upon the Board’s assessment of the Company’s achievement of its performance goals and Mr. Gibney’s continued employment with the Company. Mr. Gibney is also eligible to participate in the Company’s Executive Severance Plan (the “Severance Plan”) as a Tier Two Executive (as defined in the Severance Plan), which provides for severance payments and benefits to Mr. Gibney in the event that the Company terminates his employment without Cause or if Mr. Gibney resigns with Good Reason (each as defined in the Severance Plan). The foregoing description of the Severance Plan does not purport to be complete and is qualified in its entirety by the full text of the Severance Plan, a copy of which was filed with the Securities and Exchange Commission (the “SEC”) as Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 (File No. 001-40971) as filed with the SEC on November 12, 2024.
In connection with his appointment as the Company’s Chief Financial and Business Officer, the Company will grant Mr. Gibney an option to purchase 250,000 shares of the Company’s common stock at the fair market value based on the closing price of the Company’s common stock on The Nasdaq Global Market on the date of grant. The stock options will vest as follows: 25% shall vest and become exercisable on the first anniversary of the Effective Date, and 2.0834% shall vest and become exercisable on a monthly basis thereafter over the following 36 months, subject to Mr. Gibney’s continued service as of each vesting date. The Company will also grant Mr. Gibney 150,000 restricted stock units, which will vest as follows: 25% shall vest on the 15th of the month following the first anniversary of the Effective Date (the “First Vesting Date”), and 25% shall vest on each of the first year anniversary, second year anniversary, and third year anniversary of the First Vesting Date, subject to Mr. Gibney’s continued service as of each vesting date. The stock options and restricted stock units will be granted pursuant to the Company’s 2021 Stock Option and Incentive Plan (the “2021 Plan”) and will be subject to a stock option agreement and a restricted stock award agreement, respectively.
In addition, Mr. Gibney will enter into an indemnification agreement with the Company, the form of which was filed with the SEC as Exhibit 10.7 to the Company’s Registration Statement on Form S-1 (File No. 333-260156) as initially filed with the SEC on October 8, 2021 and declared effective on October 28, 2021, pursuant to which the Company may be required, among other things, to indemnify Mr. Gibney for certain expenses (including reasonable attorneys’ fees), judgments, fines, penalties, excise taxes and settlement amounts actually and reasonably incurred by him in any action or proceeding arising out of his service as an officer of the Company. Mr. Gibney has also entered into an agreement with the Company that contains non-solicitation and non-competition provisions that apply during and for one year following his employment with us, an invention assignment provision, and a non-disclosure provision that applies during and following his employment with us.
There are currently no arrangements or understandings between Mr. Gibney and any other person pursuant to which Mr. Gibney was appointed as Chief Financial and Business Officer of the Company and there are no family relationships between Mr. Gibney and any of the Company’s directors or executive officers. There are currently no transactions in which Mr. Gibney has an interest requiring disclosure under Item 404(a) of Regulation S-K.
The foregoing description of the Employment Offer Letter does not purport to be complete and is qualified in its entirety by the full text of the Employment Offer Letter, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025.
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 the 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 hereunto duly authorized.
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Aura Biosciences, Inc. |
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Date: |
May 15, 2025 |
By: |
/s/ Elisabet de los Pinos |
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Elisabet de los Pinos (Principal Executive Officer) |
Exhibit 99.1
Aura Biosciences Reports First Quarter 2025 Financial Results and Business Highlights
First Patient Enrolled in Multi-Dose Phase 1b/2 Trial of Bel-sar in Non-Muscle-Invasive Bladder Cancer (NMIBC); Initial Data at 3 Months Expected by Year-End 2025
Strengthened Leadership Team with the Appointment of Tony Gibney as Chief Financial and Business Officer
BOSTON, MA – May 15, 2025 – Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, today reported financial results for the first quarter ended March 31, 2025, and provided recent business highlights.
“Aura has started 2025 with strong momentum, making meaningful strides across both our ocular and urologic oncology programs,” said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. “Our global Phase 3 CoMpass trial in early-stage choroidal melanoma continues to advance, and we enrolled the first patient in our multi-dose Phase 1b/2 trial in NMIBC. At Aura, we remain deeply focused on transforming the treatment landscape in ocular and urologic cancers—two areas where patients urgently need innovative therapies.”
Recent Pipeline Developments
Early-Stage Choroidal Melanoma
Update on Ongoing Phase 3 CoMpass Trial: CoMpass is the first registration-enabling study in early-stage choroidal melanoma. The study is a global, Phase 3, randomized trial evaluating bel-sar treatment against a sham control arm and includes an enrichment strategy to enroll approximately 100 patients with documented tumor growth.
The CoMpass trial is actively enrolling globally. To identify appropriate patients to meet the enrichment strategy of documented growth, the Company has enabled a pre-screening ‘run in’ period. Globally, since June 2024, investigators have registered over 220 patients in a pre-screening tool as having met initial enrollment criteria for the study, highlighting the global need for a frontline vision-preserving therapy. Given the momentum in the study globally, the Company believes study enrollment may be completed as early as the end of 2025.
The Company previously received Orphan Drug Designation from the FDA and the European Medicines Agency and Fast Track designation from the FDA for the treatment of early-stage choroidal melanoma. The CoMpass trial is under a Special Protocol Assessment agreement with the FDA.
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Additional Ocular Oncology Indications
In addition to early-stage choroidal melanoma, bel-sar is being explored for metastases to the choroid and cancers of the ocular surface. These three ocular oncology indications have a collective incidence of greater than 60,000 patients annually in the United States and Europe.
Metastases to the Choroid
Metastases to the choroid is an indication with high unmet medical need and no approved therapies. Bel-sar has the potential to treat a wide variety of tumor types that metastasize from several primary tumors. The Company has initiated a Phase 2 clinical trial in metastases to the choroid from breast and lung cancer and have activated sites with patients in prescreening in the United States. The Company is currently implementing a protocol amendment for the Phase 2 trial to broaden the inclusion criteria beyond breast and lung cancer to include all metastases from different solid tumors as a basket study approach. The Company believes that this approach, in addition to advancing bel-sar in metastases to the choroid, can provide clinical insights into multiple tumor types that could be impacted by bel-sar. The Company expects initial data from this trial in 2025.
Metastases to the choroid represents the second potential ocular oncology indication for bel-sar, affecting approximately 20,000 patients annually in the United States and Europe. The Company previously received FDA Fast Track designation for bel-sar in this indication.
Cancers of the Ocular Surface
The Company’s third potential ocular oncology indication is cancers of the ocular surface, which affects approximately 35,000 patients in the United States and Europe annually and has no approved therapies. We continue to advance pre-clinical activities in cancers of the ocular surface, and we plan to initiate a Phase 1 trial in 2025.
Bladder Cancer
Patent Application Filed for New Formulation of Bel-sar for Use in Bladder Cancer: The Company has filed a patent application for a new formulation of bel-sar for use in urologic oncology. This new formulation is designed to enable convenient in-office urologist procedures with enhanced storage and handling at refrigerator temperatures, as well as an adjusted volume and concentration.
Positive Data from Completed Phase 1 Window-of-Opportunity Trial: In the completed Phase 1 window-of-opportunity trial for NMIBC, the administration of a single, low dose of the ocular formulation of bel-sar resulted in multiple clinical complete responses among patients with intermediate and high-risk NMIBC. These histopathologic outcomes highlight robust cell-mediated immunity and a urothelial field effect. Additionally, the study demonstrated a favorable safety profile, with only grade 1 drug-related adverse events occurring in less than 10% of patients. Detailed data can be accessed here: link. Based on these findings, the Company believes bel-sar has the potential to transform treatment of patients with intermediate and high-risk NMIBC with its immune-ablative, front-line approach.
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Ongoing Phase 1b/2 Trial: Based on the positive data from the Phase 1 window of opportunity trial, the Company is advancing the development of bel-sar in NMIBC. The ongoing Phase 1b/2 trial will evaluate additional doses and cycles of bel-sar in approximately 26 intermediate and high-risk patients. The trial will evaluate two approaches: an immune ablative design and a multimodal neoadjuvant design. In the immune ablative approach, bel-sar will be administered in two cycles without the need for a transurethral resection of the bladder tumor (TURBT). In the multimodal neoadjuvant cohorts, bel-sar will be administered in two cycles ahead of TURBT. For both approaches, patients will be monitored for response assessments and recurrence at 3, 6, 9, and 12 months.
Endpoints of this trial include multiple efficacy assessments, such as complete response rate at 3 months and durability of response up to 12 months in the immune ablative cohorts and recurrence-free survival in the neoadjuvant cohorts. Patients will also be monitored for safety. The Company expects initial efficacy data at 3 months by year-end 2025.
The Company has filed a patent application with the U.S. Patent and Trademark Office covering the new formulation, which if issued, would provide patent coverage for this formulation into 2046.
Corporate Updates
First Quarter 2025 Financial Results
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About Aura Biosciences
Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors that aim to preserve organ function. Our lead candidate, bel-sar (AU-011), is currently in late-stage development for primary choroidal melanoma and in early-stage development in other ocular oncology indications and bladder cancer. Aura Biosciences is headquartered in Boston, MA. Our mission is to grow as an innovative global oncology company that positively transforms the lives of patients.
For more information, visit aurabiosciences.com. Follow us on X (formerly Twitter) @AuraBiosciences and visit us 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 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 multiple cancers; statements regarding Aura’s plans and expectations for its ongoing and future clinical trials of bel-sar in multiple oncology indications, including with respect to clinical trial initiations; statements regarding the timing and plans to present initial data with respect to its Phase 2 clinical trial of bel-sar for the treatment of metastases to the choroid and Phase 1b/2 clinical trial of bel-sar for the treatment of NMIBC; statements regarding Aura’s expectations for an improved quality of life of patients after treatment with bel-sar and changes to the treatment paradigm for patients; statements regarding Aura’s expectations for the estimated patient populations and related market opportunities for bel-sar; and statements regarding the Company’s expected cash runway.
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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 preclinical and clinical trials may not be predictive of future results in connection with future clinical trials; the risk that early or 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 special protocol assessment agreement with the U.S. Food and Drug Administration; 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 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 United States 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 Relations Contact:
Alex Dasalla
Head of Investor Relations and Corporate Communications
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Aura Biosciences, Inc.
Condensed Consolidated Statements 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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2025 |
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2024 |
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Operating Expenses: |
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Research and development |
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$ |
23,343 |
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$ |
17,052 |
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General and administrative |
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5,692 |
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5,261 |
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Total operating expenses |
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29,035 |
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22,313 |
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Total operating loss |
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(29,035 |
) |
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(22,313 |
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Other income (expense): |
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Interest income, including amortization and accretion income |
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1,594 |
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2,685 |
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Other expense |
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(24 |
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(32 |
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Total other income |
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1,570 |
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2,653 |
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Loss before income taxes |
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(27,465 |
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(19,660 |
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Income tax provision, net |
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(18 |
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(46 |
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Net loss |
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$ |
(27,483 |
) |
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$ |
(19,706 |
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Net loss per common share—basic and diluted |
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$ |
(0.55 |
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$ |
(0.40 |
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Weighted average common stock outstanding—basic and diluted |
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50,126,148 |
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49,451,943 |
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Comprehensive loss: |
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Net loss |
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$ |
(27,483 |
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$ |
(19,706 |
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Other comprehensive items: |
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Unrealized loss on marketable securities |
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(137 |
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(521 |
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Currency translation adjustment |
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(21 |
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— |
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Total other comprehensive loss |
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(158 |
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(521 |
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Total comprehensive loss |
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$ |
(27,641 |
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$ |
(20,227 |
) |
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Aura Biosciences, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands, except share and per share amounts)
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March 31, 2025 |
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December 31, 2024 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
38,226 |
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$ |
31,693 |
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Marketable securities |
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89,765 |
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119,401 |
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Prepaid expenses and other current assets |
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6,526 |
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9,529 |
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Total current assets |
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134,517 |
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160,623 |
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Restricted cash and deposits |
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768 |
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768 |
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Right-of-use assets - operating lease |
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17,005 |
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17,379 |
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Other long-term assets |
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— |
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518 |
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Property and equipment, net |
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3,111 |
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3,215 |
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Total Assets |
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$ |
155,401 |
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$ |
182,503 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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2,006 |
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2,304 |
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Short-term operating lease liability |
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3,172 |
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3,149 |
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Accrued expenses and other current liabilities |
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6,985 |
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9,460 |
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Total current liabilities |
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12,163 |
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14,913 |
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Long-term operating lease liability |
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15,272 |
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15,620 |
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Total Liabilities |
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27,435 |
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30,533 |
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Commitments and Contingencies |
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Stockholders’ Equity: |
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Common stock, $0.00001 par value, 150,000,000 authorized at March 31, 2025 and December 31, 2024, and 50,225,312 and 49,998,279 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively |
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— |
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— |
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Additional paid-in capital |
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529,571 |
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525,934 |
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Accumulated deficit |
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(401,710 |
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(374,227 |
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Accumulated other comprehensive income |
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105 |
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263 |
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Total Stockholders’ Equity |
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127,966 |
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151,970 |
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Total Liabilities and Stockholders’ Equity |
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$ |
155,401 |
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$ |
182,503 |
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