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Mar 31, 2022
Aura Biosciences Q1 2022 Earnings Report
Reported financial results for the first quarter ended March 31, 2022, and provided clinical development and operational highlights.
Key Takeaways
Aura Biosciences reported its first quarter 2022 financial results, highlighting ongoing progress of AU-011 and preparations for pivotal trials in choroidal melanoma, a Phase 1 trial in non-muscle invasive bladder cancer, and submission of an IND for choroidal metastases.
Aura is on track to meet multiple clinical milestones for AU-011 in the second half of 2022, including initiating a pivotal trial in choroidal melanoma.
The company plans to initiate a Phase 1 trial in non-muscle invasive bladder cancer and submit an IND for choroidal metastases in 2H 2022.
Preclinical data presented at ARVO highlighted AU-011's anti-tumor activity and potential as a treatment for choroidal metastases.
Aura had cash, cash equivalents, and marketable securities totaling $133.3 million as of March 31, 2022, expected to fund operations into 2024.
Aura Biosciences
Aura Biosciences
Forward Guidance
Aura Biosciences is focused on advancing the AU-011 development program and meeting clinical milestones in the second half of 2022.
Positive Outlook
- On track to finalize a decision on the route of administration and initiate the pivotal program for AU-011 in choroidal melanoma before the end of the year.
- Building the ocular oncology franchise with choroidal metastases as the second potential ocular indication.
- Abstract highlighting AU-011’s efficacy as a single agent and as a combination therapy with checkpoint inhibitors has been selected for publication at the upcoming 2022 ASCO Annual Meeting.
- Initiating a Phase 1 trial in non-muscle invasive bladder cancer, with multiple clinical sites in the US.
- Investigating additional potential indications for AU-011.
Challenges Ahead
- Uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials.
- The risk that the results of Aura’s clinical trials may not be predictive of future results in connection with future clinical trials.
- Whether Aura will receive regulatory approvals to conduct trials or to market products.
- Whether Aura’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements.
- Risks, assumptions and uncertainties regarding the impact of the continuing COVID-19 pandemic on Aura’s business, operations, strategy, goals and anticipated timelines.