STIFEL 2026 HEALTHCARE CONFERENCE - AURA BIOSCIENCES INC

Financial Performance:

• Cash on hand stands at $297 million following a recent financing event, providing an operating runway through 2029.
• Funding runway covers the period through top-line efficacy data for the COMPASS pivotal study (H2 2027) and the 24-month follow-up (2028).
• No specific revenue, earnings, or profit margin figures were disclosed as the company is in clinical development with no commercial products yet launched.

Guidance and Future Outlook:

• Awaiting top-line efficacy data from the Phase 3 COMPASS trial in the second half of 2027.
• Pivotal trial enrollment of 108 subjects was completed in May 2026; primary analysis is projected at 15 months post-last patient.
• Scheduled to provide updated epidemiology, market sizing, and earlier-stage program details (choroidal metastases, ocular surface) at an event on December 8, 2026.
• Full data update on earlier-stage programs (metastases and ocular surface) expected in Q1 2027.
• Strategic goal is to become the preeminent ocular oncology company, expanding BELSAR beyond early choroidal melanoma to other solid tumors.

Business Segments and Product Lines:

• Primary focus is BELSAR (belsar) for early choroidal melanoma (uveal melanoma), utilizing a light-activated, locally administered cytotoxic mechanism.
• Deprioritized the NMIBC (bladder cancer) program after encouraging preliminary data to concentrate resources on ocular oncology.
• Ongoing earlier-stage programs include choroidal metastases from other solid tumors (breast, lung) and ocular surface cancers.
• BELSAR utilizes suprachoroidal injection followed by laser activation, designed for in-office administration with a 2-injection, 30-minute interval protocol.

Market and Competitive Landscape:

• Identifies a significant unmet need in early choroidal melanoma, where current treatments (radiotherapy, enucleation) often result in blindness or metastatic risk.
• Claims no direct competition for early-stage treatment; most existing oncology innovation targets metastatic or late-stage disease.
• Market definition is shifting from "indeterminate lesions" to "early choroidal melanoma," potentially expanding the addressable population for treatment.
• Commercial network includes ~90% of US and EU ocular oncologists, facilitating a focused community launch.

Risks and Challenges:

• Enrollment challenges in the COMPASS trial due to strict FDA-negotiated inclusion criteria requiring documented active tumor growth.
• High execution risk associated with drug launches, even in focused communities.
• Uncertainty regarding the long-term durability of tumor control and vision preservation beyond the Phase 3 study timeline.
• Lack of commercial precedents for treating this specific early-stage tumor population without vision loss.

Management Commentary and Tone:

• Tone is confident and visionary, emphasizing the transformative potential of treating early disease to prevent metastasis and preserve vision.
• CEO Natalie Hollis highlighted a strategic pivot to "go all-in" on ocular oncology to maximize execution and value creation.
• Management expressed belief that the market is underappreciated by the investment community due to confusion over patient population sizing.
• Confident in the translational data and safety profile, noting 80% tumor control and 90% vision preservation in Phase 2.

Analyst Questions and Answers:

• Trial Design: Addressed concerns about natural history variability by confirming FDA-validated enrichment criteria (active growth) to ensure statistical power (>99% powered).
• Market Sizing: Explained that slow enrollment in Phase 2 reflected treatment hesitation, not a lack of patients; anticipated market growth once vision-preserving options exist.
• Commercialization: Clarified that in-office administration aligns with existing clinic workflows, requiring minimal practice disruption compared to surgical radiotherapy.
• Balance Sheet: Confirmed $297M cash is sufficient to fund development through top-line data, with no immediate dilution risk anticipated for the next two years.

Other Key Points:

• Preclinical data from NIH (John Schiller lab) demonstrates BELSAR's potency across 140 solid tumor cell lines.
• The mechanism of action is uniquely selective: cytotoxic activity occurs only upon light activation, minimizing off-target toxicity.
• Phase 2 manuscript is currently under submission, expected in 2027.
• Management views the upcoming December 8th event as critical for educating investors on the revised epidemiology and total addressable market.