Aura Biosciences Q1 2022 Earnings Report
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.