Aura Biosciences, a clinical-stage biotechnology company, is advancing its lead candidate, bel-sar, through multiple clinical trials targeting solid tumors, including choroidal melanoma and bladder cancer. The company's recent 10-Q report highlights progress in clinical development, regulatory milestones, and strategic initiatives.
Clinical Trial Advancements
The global Phase 3 CoMpass trial is currently evaluating the safety and efficacy of bel-sar as a first-line treatment for adult patients with small choroidal melanoma and indeterminate lesions. The trial design and planned analysis have received written agreement from the FDA under a Special Protocol Assessment (SPA).
Phase 2 end-of-study results for bel-sar in early-stage choroidal melanoma demonstrated an 80% tumor control rate among Phase 3-eligible patients. Notably, responders experienced complete cessation of tumor growth following treatment.
Aura Biosciences has also initiated a Phase 2 clinical trial for metastases to the choroid, with the first sites activated and patient enrollment expected to begin in 2024. Initial data from this trial is anticipated in 2025.
Bel-sar is also under development for bladder cancer, with an ongoing Phase 1 clinical trial evaluating its potential in treating non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC). The FDA has granted Fast Track designation to bel-sar for both early-stage choroidal melanoma and NMIBC.
The company plans to further develop bel-sar in bladder cancer, focusing initially on low-grade, intermediate-risk NMIBC patients through a planned Phase 1b/2 trial expansion. Data from this expansion are expected in 2025.
Financial Overview
The third quarter of 2023 saw Aura Biosciences report total operating expenses of $23.2 million, an increase of $2.7 million compared to the same period in the previous year. This rise is primarily attributed to higher manufacturing development costs and personnel expenses. The net loss for the quarter was $21.0 million, or $0.42 per common share.
For the nine months ended September 30, 2023, total operating expenses amounted to $68.3 million, an increase of $8.1 million. The net loss for the same period was $61.1 million, or $1.23 per common share.
Aura Biosciences raised $92.6 million through an equity offering in November 2023 and $86.7 million in December 2022. The company anticipates that its existing cash, cash equivalents, and marketable securities will fund operations into the second half of 2026.
Strategic Focus
Aura Biosciences is focused on advancing the clinical development of bel-sar across multiple indications. The company has expanded its operational capabilities by entering into an office and laboratory lease in Boston, Massachusetts, with an initial 10-year term.
