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Mar 31
Aura Biosciences Q1 2025 Earnings Report
Aura Biosciences reported its first quarter 2025 financial results, highlighting progress in ocular and urologic oncology programs, including the first patient enrollment in a multi-dose Phase 1b/2 trial for NMIBC and continued advancement of the global Phase 3 CoMpass trial for choroidal melanoma.
Key Takeaways
Aura Biosciences started 2025 with strong momentum, advancing both its ocular and urologic oncology programs. The company enrolled the first patient in its multi-dose Phase 1b/2 trial for NMIBC and expects initial data by year-end 2025. The global Phase 3 CoMpass trial for early-stage choroidal melanoma continues to advance, with enrollment potentially completing by the end of 2025. The company reported a net loss of $27.483 million for the quarter.
First patient enrolled in multi-dose Phase 1b/2 trial of bel-sar in Non-Muscle-Invasive Bladder Cancer (NMIBC), with initial data expected by year-end 2025.
Global Phase 3 CoMpass trial for early-stage choroidal melanoma is actively enrolling, with potential completion by year-end 2025.
Strengthened leadership team with the appointment of Tony Gibney as Chief Financial and Business Officer.
Cash and cash equivalents and marketable securities totaled $128.0 million as of March 31, 2025, sufficient to fund operations into the second half of 2026.
Aura Biosciences
Aura Biosciences
Forward Guidance
Aura Biosciences expects initial efficacy data from its Phase 1b/2 clinical trial for NMIBC by year-end 2025 and anticipates completing enrollment for the global Phase 3 CoMpass trial for choroidal melanoma as early as the end of 2025. The company believes its current cash and cash equivalents are sufficient to fund operations into the second half of 2026.
Positive Outlook
- Initial efficacy data from the Phase 1b/2 clinical trial of bel-sar for NMIBC is expected by year-end 2025.
- Enrollment for the global Phase 3 CoMpass trial for early-stage choroidal melanoma may be completed as early as the end of 2025.
- The company's cash resources are projected to fund operations into the second half of 2026.
- The company plans to initiate a Phase 1 trial in cancers of the ocular surface in 2025.
- The company expects initial data from the Phase 2 trial in metastases to the choroid in 2025.
Challenges Ahead
- Uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials.
- The risk that results from preclinical and clinical trials may not be predictive of future results.
- The risk that governmental authorities may disagree with clinical trial designs.
- Uncertainty regarding regulatory approvals to conduct trials or market products.
- The risk that Aura's cash resources may not be sufficient to fund unforeseen operating expenses and capital expenditure requirements.