Belzupacap sarotalocan (AU-011)

May 11, 2026: Aura Biosciences, Inc. (NASDAQ: AURA) reported Q1 2026 financial results and provided pipeline updates for bel-sar (AU-011).

• Early choroidal melanoma: The global randomized Phase 3 CoMpass registration-enabling trial (bel-sar vs sham) is advancing toward enrollment completion expected by mid-2026; topline data for the 15-month primary endpoint are anticipated in 2H 2027. The program has FDA and EMA Orphan Drug Designation, FDA Fast Track, and the trial is under an FDA Special Protocol Assessment.
• Metastases to the choroid: Ongoing Phase 2 trial continues enrolling; early proof-of-concept is based on a four-week efficacy endpoint, with early data expected in 2026.
• Cancers of the ocular surface: Initiating a Phase 1 proof-of-concept trial in Australia evaluating safety/feasibility and histopathologic tumor response at 2–4 weeks; early proof-of-concept data expected in 2026.
• Bladder cancer (NMIBC): Ongoing Phase 1b/2 dose/cycle study in intermediate- and high-risk NMIBC; initial 3-month clinical data expected mid-2026 (immune ablative and neoadjuvant approaches).

Corporate/financing: Natalie Holles was appointed CEO/President and Board member effective April 30, 2026. The company completed a May 5, 2026 equity offering with ~$280.8M net proceeds (and repurchased ~$39.0M of shares from Matrix Capital), extending expected cash runway into 2H 2028.