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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.

EPS
-$0.54
Previous year: -$28.3
-98.1%
Cash and Equivalents
$61.1M
Previous year: $81.8M
-25.3%
Free Cash Flow
-$10.8M
Previous year: -$9.26M
+16.8%
Total Assets
$143M
Previous year: $90.7M
+57.8%

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