Aldeyra Therapeutics, Inc. Q1 FY2022 earnings call

• Clinical progress: Q1 was an exciting quarter with progress in ocular, systemic, and retinal disease programs. Reproxalap is advancing toward a midyear NDA submission for dry eye disease. - TRANQUILITY-2 trial: Completed enrollment, on schedule to report results in Q2. Primary endpoints are Schirmer tests and ocular redness; simulations indicate at least 90% potential positive outcomes. - Systemic and retinal programs: ADX-629 in Phase II trials for multiple indications; ADX-2191 in Phase II clinical trial for retinitis pigmentosa. - R&D Day: Announced topline data from proof-of-concept trials of ADX-629 in psoriasis, asthma, and COVID-19 infection.

No detailed product segment financial performance with revenue contribution percentages provided in the transcript.

• Cash runway: Existing cash, cash equivalents, and marketable securities expected to fund operating expenses through end of 2023. - NDA submission: Expecting midyear NDA submission for reproxalap in dry eye disease. - Trial results: Anticipated results of TRANQUILITY-2 in second quarter.

• COVID-19 impact: Clinical site availability, staffing, and patient recruitment negatively affected, potentially delaying trial timelines. - Clinical trial risks: Results of clinical trials may not predict future trial outcomes. - Regulatory uncertainties: Uncertainties in development, clinical, and regulatory plans for product candidates.

Q: Could you discuss confidence in having a fileable data package on reproxalap trials and motivation for additional trials?

A: Based on agency conversations, confident in NDA package strength. Precedent exists for FDA accepting Schirmer test or redness. Additional trials back up TRANQUILITY-2 in case data is unclear.

Q: Dynamics of dry eye market and confidence in partnering with Bruce?

A: RESTASIS now generic; payers may require step-through, but reproxalap aims to be branded choice. Business development discussions led by commercial lead Kelly Mizer.

Q: Ranking of ADX-629 indications and partnering thoughts?

A: Optimistic about all indications, prioritizing smaller diseases. Partnering an option for mass-market indications like ethanol toxicity and chronic cough.

Q: Handling of endpoints in TRANQUILITY-2 and backup studies?

A: Analyze multiple time points for statistical and clinical relevance. Backup studies will mirror TRANQUILITY-2's statistical approach.

Q: R&D spend, TRANQUILITY data status, and ADX-2191 insights?

A: R&D spend expected to increase. TRANQUILITY data QC nearly complete, database not yet locked. ADX-2191 offers GMP convenience and safety over compounded products for PVR treatment.