Aldeyra Q2 2020 Earnings Report
Key Takeaways
Aldeyra Therapeutics reported a net loss of $7.5 million for the quarter ended June 30, 2020, compared to a net loss of $13.3 million for the same period in 2019. The company is advancing clinical-stage programs focused on the development of reproxalap and ADX-629. They expect to fund operations through 2022, including potential approvals for reproxalap in dry eye disease and allergic conjunctivitis.
FDA agreed that RASP is an objective sign of dry eye disease; assessment of tear RASP levels in dry eye disease patients expected to begin in the fourth quarter of 2020.
New Drug Application (NDA) submission for Reproxalap in Dry Eye Disease Expected by the End of 2021.
Current cash is expected to support operations through 2022, including potential approvals for Dry Eye Disease and Allergic Conjunctivitis.
Initiate clinical trials assessing levels of RASP, a pro-inflammatory mediator, in the tears of patients with dry eye disease.
Aldeyra
Aldeyra
Forward Guidance
Aldeyra expects cash, cash equivalents, and marketable securities as of June 30, 2020, plus the additional at-the-market offering program proceeds, are expected to be sufficient to fund operations through the end of 2022, including potential NDA approvals for reproxalap in dry eye disease and allergic conjunctivitis, assuming positive clinical trial results, and planned NDA submissions, acceptances, and approvals.
Positive Outlook
- Potential NDA approvals for reproxalap in dry eye disease.
- Potential NDA approvals for reproxalap in allergic conjunctivitis.
- Sufficient to fund operations through the end of 2022.
- Continuation of Part 1 of the Phase 3 GUARD Trial in PVR.
- Phase 2 clinical testing of ADX-629, an orally administered RASP inhibitor, in inflammatory diseases.
Challenges Ahead
- Clinical trial results assumption.
- Planned NDA submissions assumption.
- Planned NDA acceptances assumption.
- Planned NDA approvals assumption.
- The current and potential future impact of the COVID-19 pandemic on our business, results of operations and financial position.