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Dec 31, 2022
Aldeyra Q4 2022 Earnings Report
Aldeyra reported full-year financial results and corporate highlights.
Key Takeaways
Aldeyra Therapeutics reported its full-year 2022 financial results, highlighting the Priority Review Designation for ADX-2191 and the NDA review for Reproxalap. The company's cash, cash equivalents, and marketable securities totaled $174.3 million as of December 31, 2022, expected to fund operations into the second half of 2024.
NDA for ADX-2191 received Priority Review Designation for primary vitreoretinal lymphoma treatment with a PDUFA date of June 21, 2023.
NDA for Reproxalap accepted for review for treating dry eye disease with a PDUFA date of November 23, 2023.
Positive top-line results were announced from the 12-month safety clinical trial of Reproxalap in dry eye disease.
Phase 2 clinical trials were initiated for ADX-629 in systemic immune-mediated diseases.
Aldeyra
Aldeyra
Forward Guidance
Aldeyra anticipates several clinical and regulatory milestones in the near term. The company believes existing cash, cash equivalents, and marketable securities will be sufficient to fund currently projected operating expenses into the second half of 2024.
Positive Outlook
- Top-line results from the Phase 3 INVIGORATE-2 Trial of Reproxalap in Allergic Conjunctivitis are expected in the first half of 2023.
- Top-line results from the Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa are expected in the first half of 2023.
- Top-line results from the Phase 2 Clinical Trial of ADX-629 in Chronic Cough are expected in the first half of 2023.
- Phase 1 clinical trial of orally administered ADX‑246 for the treatment of systemic immune-mediated diseases is expected to initiate in the second half of 2023 or early 2024.
- Phase 1/2 clinical trial of intravitreally injected ADX‑248 for the treatment of geographic atrophy is expected to initiate in the second half of 2023 or early 2024.
Challenges Ahead
- Clinical trial timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, funding, and other factors.
- Delay in or failure to obtain regulatory approval of Aldeyra's product candidates.
- Uncertainty as to Aldeyra’s ability to commercialize and obtain reimbursement for Aldeyra's product candidates following regulatory approval.
- The rate and degree of market acceptance of any of Aldeyra's product candidates is uncertain.
- The current and potential future impact of the COVID-19 pandemic on Aldeyra’s business, results of operations, and financial position.