Aura Biosciences Q1 2024 Financial Results and Highlights

Aura Biosciences, Inc., a clinical-stage biotech company focused on developing precision immunotherapies to treat solid tumors while preserving the function of the affected organ, announced its financial results for the first quarter ending March 31, 2024. The company also provided updates on recent business highlights and developments in its therapeutic pipeline.

The company's CEO, Elisabet de los Pinos, Ph.D., stated that significant progress was made in their ocular and urologic oncology programs during the first quarter of 2024. Enrollment is ongoing in the global Phase 3 CoMpass trial for early-stage choroidal melanoma and indeterminate lesions. This study, which has a target enrollment of around 100 patients, evaluates the efficacy of bel-sar treatment compared to a sham control. The primary endpoint of the trial is the time to tumor progression over a 15-month follow-up period.

Bel-sar is being investigated for additional ocular oncology indications, including choroidal metastasis and cancers of the eye's surface. These conditions collectively affect over 60,000 patients annually in the U.S. and Europe. The company plans to initiate a Phase 2 trial for choroidal metastasis in 2024, addressing a significant unmet medical need as no approved drugs currently exist for this condition. Additionally, bel-sar is being evaluated for cancers of the ocular surface, affecting approximately 35,000 patients annually in these regions. Recent preclinical data presented at the ARVO 2024 Annual Meeting showed promising results, indicating that bel-sar consistently binds to conjunctival melanoma cell lines, both primary and recurrent, and induces immunogenic cell death.

Aura Biosciences is also conducting a Phase 1 trial for bel-sar in the treatment of non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC). This trial is expected to enroll around 21 adult patients and aims to assess the safety and feasibility of bel-sar as a monotherapy. Early data from this trial is anticipated in mid-2024. The company received Fast Track designation from the FDA for NMIBC in June 2022, highlighting the urgent need for effective treatments in this area, which sees approximately 80,000 new cases in the U.S. each year.

In terms of corporate developments, Aura Biosciences strengthened its leadership team by appointing Conor Kilroy as General Counsel and Secretary. Kilroy brings extensive legal experience from his previous roles at Neurogastrx, Inc. and Ironwood Pharmaceuticals, Inc.

Financially, Aura reported cash and cash equivalents and marketable securities totaling $202.9 million as of March 31, 2024. The company expects this cash position to support its operations into the second half of 2026. Research and development expenses for the first quarter of 2024 increased to $17.1 million from $14.4 million in the same period the previous year. This rise was primarily due to ongoing clinical costs related to their Phase 2 study of bel-sar and the Phase 3 trial for early-stage choroidal melanoma, as well as higher personnel expenses.

General and administrative expenses also saw an increase, reaching $5.3 million in the first quarter of 2024, up from $5.0 million in the same period in 2023. This increase was mainly driven by personnel expenses and general corporate growth. Consequently, the net loss for the quarter was $19.7 million, compared to $17.5 million in the first quarter of 2023.

Aura Biosciences remains committed to developing innovative therapies aimed at improving patient outcomes in cancer while preserving the function of affected organs. The company's lead candidate, bel-sar, is in late-stage clinical development for primary choroidal melanoma and is also being explored for other solid cancers, including bladder cancer.