AURA

EX-99.1

2 aura-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Aura Biosciences Reports First Quarter 2026 Financial Results and Business Highlights

Phase 3 CoMpass trial advancing toward enrollment completion, supporting 2H 2027 topline data

Natalie Holles appointed Chief Executive Officer and President and member of the Board of Directors

Strengthened balance sheet with oversubscribed $299 million equity financing; cash position expected to fund operations into 2H 2028

BOSTON, MA – May 11, 2026 – 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, 2026, and provided recent business highlights.

“We are entering a pivotal period for Aura as we advance our Phase 3 CoMpass trial toward enrollment completion and potential registration,” said Natalie Holles, Chief Executive Officer of Aura Biosciences. “Bel-sar has the potential to become the first frontline, vision-preserving therapy for patients with early choroidal melanoma, and we are on track to deliver topline data from the CoMpass trial in the second half of 2027. Supported by our strengthened balance sheet, we are focused on executing against these priorities and translating this progress into long-term value for patients and shareholders.”

Recent Pipeline Developments

Early Choroidal Melanoma

The ongoing Phase 3 CoMpass trial is the first registration-enabling study in early choroidal melanoma. This global, randomized Phase 3 trial is evaluating bel-sar versus a sham control. The trial is advancing toward enrollment completion, which is expected by mid-2026, with topline data for the 15-month primary endpoint anticipated in the second half of 2027.

Bel-sar has the potential to become the first frontline vision-preserving therapy in this setting. The Company previously received Orphan Drug Designation from the United States Food and Drug Administration (FDA) and the European Medicines Agency and Fast Track designation from the FDA for the treatment of early choroidal melanoma. The CoMpass trial is under a Special Protocol Assessment agreement with the FDA.

Metastases to the Choroid

The ongoing Phase 2 clinical trial of bel-sar in metastases to the choroid continues to enroll patients. The study is designed to include patients with choroidal metastases arising from a range of primary solid tumors and to evaluate early proof-of-concept based on a four-week efficacy endpoint. The Company remains on track to report early data from this trial in 2026.

Cancers of the Ocular Surface

The Company is initiating a Phase 1 proof-of-concept trial in Australia to assess safety, feasibility and tumor response through histopathologic evaluation at a 2–4-week time point. Development activities for this program are ongoing, with early proof-of-concept data expected in 2026.

Bladder Cancer

The ongoing Phase 1b/2 trial evaluating additional doses and cycles of bel-sar across intermediate- and high-risk non-muscle invasive bladder cancer (NMIBC) patients continues to advance, with initial 3-month clinical data expected mid-2026.

The trial is evaluating two approaches: immune ablative and neoadjuvant. In the immune ablative arm, bel-sar is given in two cycles without a transurethral resection of the bladder tumor (TURBT). In the neoadjuvant arm, bel-sar is given in two cycles before TURBT. Patients are monitored for response, recurrence (at 3, 6, 9, and 12 months), and safety.

Corporate Updates

As previously announced on May 4, 2026, the Company’s Board of Directors appointed Natalie Holles as Chief Executive Officer and President and member of the Board of Directors, effective April 30, 2026. Ms. Holles succeeds Elisabet de los Pinos, Ph.D., the Company’s founder, who stepped down from her roles as Chief Executive Officer and President and a member of the Board of Directors, effective on the same date.

First Quarter 2026 Financial Results

• As of March 31, 2026, the Company had cash and cash equivalents and marketable securities totaling $114.7 million. On May 5, 2026, the Company completed an underwritten public offering of common stock and pre-funded warrants, which included the underwriters’ full exercise of their option to purchase additional shares of common stock. After deducting the underwriting discounts and commissions and estimated offering expenses, the Company received approximately $280.8 million in net proceeds from the offering, of which it subsequently used approximately $39.0 million to repurchase all the shares of its common stock held by Matrix Capital Management Master Fund, LP in the previously announced stock repurchase. The Company believes its current cash and cash equivalents and marketable securities, together with the net proceeds of the offering to the Company, are sufficient to fund its operations into the second half of 2028.

• Research and developme

8-K

false 0001501796 0001501796 2026-04-30 2026-04-30

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

Date of Report (Date of earliest event reported): April 30, 2026

Aura Biosciences, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware

001-40971

32-0271970

(State or Other Jurisdiction of Incorporation)

(Commission

File Number)

(IRS Employer Identification No.)

80 Guest Street

Boston, Massachusetts

02135

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: 617 500-8864

Not Applicable

(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:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange

on which registered

Common Stock, $0.00001 par value per share

AURA

The Nasdaq Global Market

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 1.01.

Entry into a Material Definitive Agreement.

On April 30, 2026, Aura Biosciences, Inc. (the “Company”) and Matrix Capital Management Master Fund, LP (“Matrix”) entered into a stock purchase agreement (the “Repurchase Agreement”) pursuant to which the Company has agreed to repurchase, in a privately negotiated transaction, up to 6,922,870 shares of its common stock, which the Company believes represents all shares of its common stock held by Matrix as of the date of this Current Report on Form 8-K (this “Current Report”). Pursuant to the Repurchase Agreement, the Company expects to fund the repurchase using a portion of the net proceeds from the sale of its common stock in the underwritten equity offering that the Company separately announced on May 4, 2026 (the “Equity Offering”), after deducting underwriting discounts and commissions, that are in excess of $200 million, inclusive of any such net proceeds that the Company may receive in connection with the exercise, if any, of the underwriters’ option to purchase additional shares of the Company’s common stock in the Equity Offering. The Company will repurchase the shares from Matrix at a price per share equal to the price per share at which the underwriters will purchase shares from the Company in the Equity Offering (the “Stock Repurchase”), subject to certain conditions. Based on such price per share of the Equity Offering, which the Company separately announced on May 4, 2026 as $5.64, the Company expects to repurchase the 6,922,870 shares of the common stock held by Matrix. The shares being repurchased will become authorized but unissued shares. Prior to giving effect to the Equity Offering and the Stock Repurchase, Matrix held approximately 10.8% of our outstanding common stock based on the number of shares of common stock outstanding as of April 15, 2026.

The closing of the Stock Repurchase is expected to occur no earlier than two business days after the closing of the Equity Offering.

The Stock Repurchase is conditioned upon the closing of the Equity Offering and certain other conditions. We cannot provide any assurance that the Stock Repurchase will occur on the terms described herein, or at all. The description of, and other information in this Current Report regarding, the Stock Repurchase are included for informational purposes only. Nothing in this Current Report should be construed as an offer (i) to sell, or the solicitation of an offer to purchase, any of our common stock that we may repurchase, or (ii) to repurchase, or the solicitation of an offer to sell, any of our common stock.

The Repurchase Agreement and related arrangements and transactions were reviewed and approved by the audit committee (the “Audit Committee”) of the Company’s Board of Directors (the “Board”), which is charged with reviewing related party transactions, and is composed of three independent directors who

EX-99.1

2 aura-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Aura Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights

Accelerated Phase 3 CoMpass Enrollment Supports Mid-2026 Enrollment Completion and 2H 2027 Topline Data Guidance

Phase 1b/2 NMIBC Trial on Track: Initial 3-Month Clinical Data Expected Mid-2026

12-month Stability Completed with New Formulation with Potential Across Non-ocular Solid Tumor Indications, Beginning with Urologic Oncology

BOSTON, MA – March 30, 2026 – 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 fourth quarter and year ended December 31, 2025, and provided recent business highlights.

“2025 has been a year of focused execution across our clinical portfolio, with significant progress in trial enrollment, highlighted by the acceleration of our global Phase 3 CoMpass trial in early choroidal melanoma and continued enrollment in our Phase 1b/2 NMIBC trial,” said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura Biosciences. “Based on strong enrollment momentum, we now expect to complete CoMpass enrollment by mid-2026, with topline data anticipated in the second half of 2027. We believe bel-sar has the potential to become the first frontline, vision-preserving therapy for early choroidal melanoma. Our proof-of-concept trials to expand our ocular franchise also remain on track to deliver data in 2026. In NMIBC, we look forward to reporting initial three-month data mid-year to further define our potential as a frontline approach. We are also encouraged by our new formulation reaching 12-month stability, further expanding our opportunity in non-ocular solid tumors, starting with urologic oncology.”

Recent Pipeline Developments

Early Choroidal Melanoma

Ongoing Phase 3 CoMpass Trial: CoMpass is the first registration-enabling study in early choroidal melanoma. This global, randomized Phase 3 trial is evaluating bel-sar versus a sham control using an enrichment strategy to enroll patients with documented tumor growth. Driven by strong global enrollment momentum, the Company now expects to complete enrollment by mid-2026, with topline data for the 15-month primary endpoint anticipated in the second half of 2027.

Our patient identification tool continues to expand, and we believe this growing pool of patients reflects the unmet need in early choroidal melanoma and the significant need for a vision preserving therapy.

Bel-sar has the potential to become the first frontline vision-preserving therapy in this setting. The Company previously received Orphan Drug Designation from the United States Food and Drug Administration (FDA) and the European Medicines Agency and Fast Track designation from the FDA for the treatment of early choroidal melanoma. The CoMpass trial is under a Special Protocol Assessment agreement with the FDA.

Bladder Cancer

Ongoing Phase 1b/2 Trial: The ongoing trial evaluating additional doses and cycles of bel-sar across intermediate- and high-risk NMIBC patients continues to progress as planned, with initial 3-month clinical data expected in mid-2026.

The trial will evaluate two approaches: an immune ablative design and a neoadjuvant design. In the immune ablative approach, bel-sar is administered in two cycles without the need for a transurethral resection of the bladder tumor, or TURBT. In the neoadjuvant cohorts, bel-sar is administered in two cycles ahead of TURBT. For both approaches, the patients will be monitored for response assessments and reoccurrence at 3, 6, 9, and 12 months. The patients will also be monitored for safety.

Achieved 12-Month Stability of New Formulation for Use in Non-Ocular Solid Tumors, Beginning with Bladder Cancer: The Company has demonstrated 12-month stability for its new formulation designed for use in non-ocular solid tumors, beginning with urologic oncology. We believe this formulation reinforces the opportunity for product differentiation and, with simple refrigeration and no need for cold chain, is intended to support convenient in-office administration for urologists. The Company previously filed a patent application with the U.S. Patent and Trademark Office for this formulation, which, if issued, would be expected to provide patent coverage into 2046.

Metastases to the Choroid

The ongoing Phase 2 clinical trial of bel-sar in metastases to the choroid continues to enroll patients. The study is designed to include patients with choroidal metastases arising from a range of primary solid tumors and to evaluate early proof-of-concept based on a four-week efficacy endpoint. The Company remains on track to report early data from this trial in 2026.

Metastases to the choroid is an indication with high unmet medical need and no approved therapies, with an estimated incidence of approximately 20,000 patients annually acr