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Dec 31, 2021
Aldeyra Q4 2021 Earnings Report
Aldeyra reported full-year financial results and corporate highlights.
Key Takeaways
Aldeyra Therapeutics reported full-year 2021 financial results, with cash and cash equivalents of $229.8 million as of December 31, 2021. The company believes that existing cash will be sufficient to fund operating expenses through the end of 2023. Net loss for the year was $57.8 million, or $1.07 per share.
Top-line data from Phase 2 proof-of-concept trials of ADX-629 in multiple systemic indications are expected by the end of March 2022.
Results from the Phase 3 TRANQUILITY-2 Trial of Reproxalap in Dry Eye Disease are expected mid-2022.
Results from Part 1 of the Phase 3 GUARD Trial of ADX-2191 in Proliferative Vitreoretinopathy are expected in the second half of 2022.
Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa was initiated in the first quarter of 2022; Results Expected in the Second Half of 2022.
Aldeyra
Aldeyra
Forward Guidance
Aldeyra anticipates data milestones for systemic and retinal disease platforms in 2022, alongside the completion of clinical development for reproxalap in dry eye disease.
Positive Outlook
- Top-line data from Phase 2 proof-of-concept trials of ADX-629 in psoriasis, asthma, and COVID-19 are expected by the end of March 2022.
- Results from the Phase 3 TRANQUILITY-2 Trial of reproxalap in dry eye disease are expected mid-2022.
- Results from Part 1 of the Phase 3 GUARD Trial of ADX-2191 in proliferative vitreoretinopathy are expected in the second half of 2022.
- Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa was initiated in the first quarter of 2022; Results Expected in the Second Half of 2022.
- Potential NDA submissions and initial commercialization of reproxalap, if approved, are planned.
Challenges Ahead
- Development timelines may be subject to adjustment depending on recruitment rate, regulatory review, and clinical results.
- Delay in or failure to obtain regulatory approval of Aldeyra's product candidates is possible.
- The risk that prior results observed from preclinical or clinical trials will not be replicated or will not continue in ongoing or future studies.
- Uncertainty as to Aldeyra’s ability to commercialize product candidates following regulatory approval.
- Political, economic, legal, social and health risks, including the COVID-19 pandemic and related public health measures, and war or other military actions, may affect Aldeyra’s business or the global economy.