On May 11, 2026 Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, reported financial results for the first quarter ended March 31, 2026, and provided recent business highlights.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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 development expenses increased to $28.0 million for the three months ended March 31, 2026 from $23.3 million for the three months ended March 31, 2025, primarily due to ongoing clinical and clinical research organization (CRO) costs associated with the progression of our global Phase 3 trial of bel-sar in early choroidal melanoma and manufacturing and development costs for bel-sar.

•
General and administrative expenses increased to $6.9 million for the three months ended March 31, 2026 from $5.7 million for the three months ended March 31, 2025. General and administrative expenses include $1.6 million of stock-based compensation for each of the three months ended March 31, 2026 and 2025. The increase in general and administrative expenses was primarily driven by higher personnel expenses related to growth of the Company and increased professional fees.

•
Net loss for the three months ended March 31, 2026, was $33.7 million, compared to $27.5 million for the three months ended March 31, 2025.

(Press release, Aura Biosciences, MAY 11, 2026, View Source [SID1234665451])