Aura Biosciences (AURA) H.C. Wainwright 4th Annual BioConnect Investor Conference summary

Pipeline and strategic focus

• Lead asset bel-sar targets a range of solid tumors, with initial focus on ocular oncology, specifically choroidal melanoma, metastases to the choroid, and ocular surface cancers.

• Ongoing phase I-B/II trial in non-muscle invasive bladder cancer (NMIBC) with a three-month data readout expected mid-year, exploring both immune ablative and neoadjuvant approaches.

• Recent capital raise enables acceleration of pilot studies and more aggressive advancement of development programs.

• Plans to pursue advanced development and potential sBLA filings for additional ocular indications in close succession.

Mechanistic rationale and clinical paradigm shift

• Bel-sar combines targeted tumor cell killing with immune activation, aiming to reduce metastasis risk and preserve vision.

• Early intervention with bel-sar could allow treatment of choroidal melanoma without the high risk of vision loss associated with radiotherapy.

• Vision preservation is central, with alignment among patients, physicians, and regulators on its importance.

• Regulatory endpoints include time to tumor progression and a composite of tumor progression or vision loss.

Clinical trial design and outcomes

• The CoMpass phase III study is randomized and masked, comparing bel-sar to sham, with primary endpoint of time to tumor progression.

• Phase II data showed 80% tumor control and excellent vision preservation, with minimal vision loss compared to radiation.

• Phase III design closely mirrors phase II, increasing confidence in outcome predictability.