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Sep 30, 2022
Aura Biosciences Q3 2022 Earnings Report
Aura Biosciences reported financial results and clinical development for the third quarter of 2022.
Key Takeaways
Aura Biosciences reported a net loss of $15.9 million for the third quarter of 2022. The company's cash and cash equivalents totaled $111.5 million as of September 30, 2022, which is expected to fund operations into 2024. The company finalized the global Phase 3 design in alignment with regulatory agencies and selected suprachoroidal route of administration to evaluate the efficacy and safety of bel-sar in early-stage CM. Aura dosed the first patient in a Phase 1 clinical trial of bel-sar for the treatment of non-muscle invasive bladder cancer (NMIBC).
Global Phase 3 trial design with suprachoroidal route of administration of Belzupacap Sarotalocan in early-stage choroidal melanoma was announced.
The first patient was dosed in the Phase 1 study evaluating Belzupacap Sarotalocan for the treatment of non-muscle invasive bladder cancer.
Positive interim Phase 2 data evaluating SC administration of bel-sar for the first-line treatment of patients with early-stage CM were presented at AAO 2022, showing a statistically significant reduction in the tumor growth rate.
Aura plans to file an IND for choroidal metastasis with the FDA in Q4 of 2022.
Aura Biosciences
Aura Biosciences
Forward Guidance
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws.
Positive Outlook
- therapeutic potential of bel-sar for the treatment of cancers including choroidal melanoma, non-muscle invasive bladder cancer and choroidal metastases
- expectations for the Phase 2 and Phase 3 clinical trials of bel-sar for early-stage choroidal melanoma
- expectations regarding the estimated patient populations and related market opportunities for bel-sar
- improved quality of life of patients after treatment with bel-sar
- potential paradigm shift in the approach to the treatment of choroidal melanoma
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
- the risk that interim data from ongoing clinical trials may not be predictive of final data from completed 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