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Dec 31, 2020
Aldeyra Q4 2020 Earnings Report
Aldeyra reported full-year 2020 financial results, highlighted by the completion of enrollment in the Phase 3 INVIGORATE trial and initiation of Phase 2 clinical trials for ADX-629.
Key Takeaways
Aldeyra Therapeutics reported a net loss of $37.6 million for the full year 2020. The company's cash and cash equivalents were $77.9 million as of December 31, 2020, expected to fund operations through 2023.
Patient enrollment completed in Phase 3 INVIGORATE trial, with top-line results expected in the first half of 2021.
Top-line results from Phase 3 TRANQUILITY and TRANQUILITY-2 trials expected in the second half of 2021.
Phase 2 clinical trials of ADX-629 initiated in Q4 2020.
Cash runway projected through 2023, including potential New Drug Application submissions for dry eye disease and allergic conjunctivitis.
Aldeyra
Aldeyra
Forward Guidance
Aldeyra anticipates several key milestones in 2021, including trial results and continued clinical development.
Positive Outlook
- Top-line results from Phase 3 INVIGORATE trial expected in the first half of 2021.
- Initiation of enrollment for Phase 3 TRANQUILITY and TRANQUILITY-2 trials in the first half of 2021.
- Top-line results from Phase 3 TRANQUILITY and TRANQUILITY-2 trials expected in the second half of 2021.
- Top-line results from Phase 2 clinical trials of ADX-629 expected by the end of 2021.
- Completion of enrollment expected in 2021 for Phase 3 GUARD trial of ADX-2191.
Challenges Ahead
- Development timelines may be subject to adjustment depending on recruitment rate.
- Regulatory review may impact development timelines.
- Preclinical and clinical results may delay the initiation or completion of clinical trials.
- Uncertainty as to Aldeyra’s ability to commercialize product candidates following regulatory approval.
- Political, economic, legal, social and health risks, including the recent COVID-19 outbreak and subsequent public health measures, that may affect Aldeyra’s business or the global economy.