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Aura Biosciences (AURA) investor relations material
Aura Biosciences Evercore ISI 8th Annual HealthCONx Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Evercore ISI 8th Annual HealthCONx Conference summary2 Dec, 2025
Pipeline overview and development strategy
Advancing a novel class of Virus-like Drug Conjugates with direct cytotoxicity and robust immune activation, targeting ocular oncology and bladder cancer as key areas of focus.
Ongoing phase III trial in early-stage choroidal melanoma, aiming for organ preservation and prevention of metastasis, with a unique frontline positioning and minimal competition.
Phase II and proof-of-concept studies in additional ocular indications (metastatic and ocular surface cancers) and bladder cancer, with multiple near-term catalysts expected.
Ocular oncology program details
Phase III trial (CoMpass) in early choroidal melanoma is enrolling patients with growing tumors to ensure a highly powered study and clear differentiation between treatment and sham.
Enrollment bottleneck due to need for tumor progression confirmation, but consistent patient conversion now supports guidance for study completion in 2026 and top-line data in Q4 2027.
Safety profile is favorable, with only Grade 1 local adverse events and no systemic exposure, supporting frontline use.
Secondary composite endpoint includes visual acuity preservation, designed with FDA input to strengthen the value proposition.
Proof-of-concept studies in metastatic and ocular surface cancers expected to support supplemental BLA filings with minimal additional data.
Bladder cancer program and market positioning
Focused on neoadjuvant treatment of early-stage tumors, leveraging the drug's mechanism that requires tumor presence for efficacy and immune activation.
No direct competitors in the neoadjuvant NMIBC space; most others are in adjuvant settings.
Using recurrence-free survival (RFS) as a validated endpoint, aiming to demonstrate improved outcomes with a highly tolerable, urologist-friendly formulation.
Neoadjuvant approach may complement, not replace, adjuvant therapies, with the sequence of therapy being a key differentiator.
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Next Aura Biosciences earnings date
Q4 202520 Mar, 2026
Next Aura Biosciences earnings date
Q4 202520 Mar, 2026
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Frequently asked questions
Aura Biosciences Inc. is a biotechnology company focused on developing therapies for cancer treatment. It specializes in the creation of virus-like drug conjugates (VDC) technology, aiming to address tumors with significant unmet medical needs in ocular and urologic oncology. A key development in their portfolio is AU-011, a VDC candidate targeting primary choroidal melanoma. The company also explores the potential of AU-011 for other ocular oncology indications, including choroidal metastases, and is conducting Phase 2 dose-escalation trials. Aura Biosciences is headquartered in Cambridge, Massachusetts, and its shares are listed on the NASDAQ.
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