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Sep 30, 2020
Aldeyra Q3 2020 Earnings Report
Announced financial results for the third quarter of 2020 and provided a corporate update.
Key Takeaways
Aldeyra Therapeutics reported a net loss of $8.9 million for Q3 2020, compared to a net loss of $18.7 million for the same period in 2019. The company's cash, cash equivalents, and marketable securities totaled $86.2 million as of September 30, 2020, which is expected to fund operations through 2022.
Phase 3 Objective Sign Trial in Dry Eye Disease planned for Q4 2020.
Phase 2 Clinical Trials of ADX-629 in COVID-19, Atopic Asthma, and Psoriasis expected to start in Q4 2020.
Top-line results from the Phase 3 INVIGORATE Clinical Trial in Allergic Conjunctivitis expected in the first half of 2021.
Cash, cash equivalents, and marketable securities of $86.2 million as of September 30, 2020, expected to support operations through 2022.
Aldeyra
Aldeyra
Forward Guidance
Aldeyra expects its cash, cash equivalents, and marketable securities as of September 30, 2020, to be sufficient to fund operations through the end of 2022.
Positive Outlook
- NDA submissions for reproxalap in dry eye disease and allergic conjunctivitis, assuming positive clinical trial results and regulatory review.
- Continuation of Part 1 of the Phase 3 GUARD Trial in PVR.
- Phase 2 clinical testing of ADX-629.
- Initiation of Phase 3 Objective Sign Trial in Dry Eye Disease Planned for the Fourth Quarter 2020
- Phase 2 Clinical Trials of ADX-629 in COVID-19, Atopic Asthma, and Psoriasis Expected to Initiate in the Fourth Quarter of 2020
Challenges Ahead
- All of Aldeyra’s development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials.
- As a result of the COVID-19 pandemic, clinical site availability, staffing, and patient recruitment have been negatively affected and the timelines to complete Aldeyra’s clinical trials may be delayed.
- Delay in or failure to obtain regulatory approval of Aldeyra’s product candidates
- Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue.
- Risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or trials involving Aldeyra’s product candidates