Aura Biosciences Q2 2024 Financial Results and Business Highlights

Aura Biosciences, Inc., a clinical-stage biotechnology firm focused on creating precision therapies for solid tumors while preserving organ function, has disclosed its financial results for the second quarter ending June 30, 2024. The company also shared significant recent advancements in its clinical programs.

Elisabet de los Pinos, Ph.D., CEO of Aura, expressed enthusiasm about the company's progress, particularly in their bladder cancer clinical trial. She highlighted the upcoming virtual event in October, where early data from the Phase 1 trial in non-muscle invasive bladder cancer (NMIBC) will be presented. Pinos emphasized that Aura is well-funded and dedicated to advancing its clinical trials in ocular and urologic oncology, areas in need of novel treatment options that can effectively treat locally while preserving organ function.

In recent pipeline developments, the ongoing Phase 1 trial of bel-sar for bladder cancer is a major focus. Aura plans to host a virtual urologic oncology investor event in October 2024, showcasing early NMIBC data. Bladder cancer affects about 80,000 patients annually in the United States. Bel-sar aims to treat tumors selectively and induce a tumor-specific immune response, potentially allowing in-office treatment by urologists and avoiding surgery. The FDA’s Division of Oncology has granted Fast Track designation to bel-sar for NMIBC treatment. The multi-center, open-label trial will enroll about 21 adult patients to evaluate the safety and feasibility of bel-sar as a monotherapy, including histopathological assessments for biological activity post-treatment.

For primary uveal melanoma, Aura will present Phase 2 end-of-study data at the Retina Society Annual Meeting in September 2024 in Lisbon, Portugal. The global Phase 3 CoMpass trial, targeting small choroidal melanoma and indeterminate lesions, is progressing with site activations and patient enrollments. The trial aims to enroll approximately 100 patients globally and will compare bel-sar treatment to a sham control. The primary endpoint is time to tumor progression at 15 months, per the Special Protocol Assessment (SPA) agreed with the FDA. Early-stage choroidal melanoma impacts around 8,000 patients annually in the U.S. and Europe. The FDA and the European Medicines Agency (EMA) have granted Orphan Drug Designation, and the FDA has granted Fast Track designation for treating primary uveal melanoma.

Aura is also exploring bel-sar for other ocular oncology indications, such as metastases to the choroid and cancers of the ocular surface. Collectively, these conditions affect over 60,000 patients annually in the U.S. and Europe. Clinical development for metastases to the choroid is set to begin in 2024, with the FDA granting Fast Track designation for this indication, which affects about 20,000 patients annually. For cancers of the ocular surface, affecting approximately 35,000 patients annually, Aura continues to advance preclinical work to enable IND filings.

On the corporate front, Aura hosted a virtual KOL event on May 29, 2024, featuring global ocular oncology leaders. The event, "Pioneering a New Standard of Care in Ocular Oncology," is available for replay on Aura’s website.

Financially, Aura reported cash, cash equivalents, and marketable securities totaling $187.4 million as of June 30, 2024. The company anticipates that this strong cash position will fund operations into the second half of 2026. Research and development expenses rose to $16.9 million for Q2 2024, up from $15.1 million in Q2 2023, driven mainly by personnel expenses. General and administrative expenses increased to $5.9 million from $5.2 million in the same period, including higher stock-based compensation costs. The net loss for Q2 2024 was $20.3 million compared to $18.3 million in Q2 2023.

Aura Biosciences, headquartered in Boston, MA, is committed to developing therapies that preserve vision and organ function to improve cancer patient outcomes. The company’s lead candidate, bel-sar, is in late-stage development for primary choroidal melanoma and early-stage development for bladder cancer, among other solid tumors.

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