Patients must choose between their life and their vision.

Choroidal melanoma is the most common intraocular cancer in adults, with an incidence of approximately 11,000 patients per year in the United States and Europe. This comprises approximately 90% of all cases of uveal melanoma, consisting of melanomas in the choroid, ciliary body and iris, which are collectively referred to as the uvea. It is estimated that 96% of patients are diagnosed early without clinical evidence of metastatic disease. There are approximately 2,000 new cases treated each year in the United States and 1,600 new cases treated each year in Europe. However, despite the current treatments with radiotherapy, the long-term prognosis is poor with death occurring in more than 50% of cases. There are no FDA-approved therapies for choroidal melanoma. We intend to develop AU-011, our first VDC, as a first line therapy to treat early -stage disease which includes small melanomas and indeterminate lesions representing approximately 9,000 patients in the United States and Europe.

We believe that earlier diagnosis and early treatment intervention of lesions in the eye before the onset of metastatic disease may dramatically change outcomes for patients.

AU-011 is injected into the eye and it selectively binds to the surface of choroidal melanoma cells. Once the VDC is bound to the tumor cell membrane it delivers a potent cytotoxic, photosensitizing drug that is then activated with infrared light. As a result of the VDC’s targeted binding to the tumor cell, the generation of singlet oxygen in very close proximity to the tumor cell membrane causes a physical disruption of the cell membrane leading to acute cellular necrosis. This process also triggers natural anti-tumor immunity which recruits the patient’s innate immune system to identify and destroy further cancer cells.

AU-011 FOR THE TREATMENT OF CHOROIDAL MELANOMA

AU-011, our first VDC Candidate, is a VLP conjugated with a novel laser activated cytotoxin that is being developed for the first-line treatment of primary choroidal melanoma. We have completed a Phase 1b/2 trial that has demonstrated a statistically significant tumor growth rate reduction in patients with prior active growth and high levels of tumor control with visual acuity preservation in a majority of patients, as assessed using clinical endpoints in alignment with the feedback from U.S. Food and Drug Administration, or the FDA. We believe these data support further advancement into late-stage clinical development.