Aldeyra Therapeutics, Inc. Q4 FY2021 earnings call

• 2022 is a catalyst-rich year for Aldeyra, with R&D Day on March 29 to announce topline data from Phase 2 proof-of-concept trials of ADX-629 in psoriasis, asthma, and COVID-19.
• Reproxalap's Phase 3 TRANQUILITY-2 trial results expected mid-year, with plans to submit NDA for dry eye disease pending trial outcome and safety trial enrollment. Also, initiated crossover dry eye disease chamber trial and one-day Schirmer test trial.
• Phase 3 INVIGORATE 2 allergen chamber trial for allergic conjunctivitis initiated in Q1 2022, results expected in 2023.
• Initiation of Phase 2 trial of ADX-2191 in retinitis pigmentosa, a single-center open-label trial to evaluate safety and tolerability. Also, Phase 3 GUARD trial of ADX-2191 in PVR completed enrollment late 2021, results expected in second half of 2022.

No specific product segment financial performance with absolute terms and revenue contribution % detailed in the transcript as it focuses on clinical and R&D aspects rather than product segment financials.

• Midyear expected data announcement for TRANQUILITY-2 trial of reproxalap in dry eye disease.
• R&D Day on March 29 to announce data from ADX-629 Phase 2 trials.
• INVIGORATE 2 results for allergic conjunctivitis expected in 2023.
• Phase 2 trial of ADX-2191 in retinitis pigmentosa results expected in second half of 2022.
• Phase 3 GUARD trial of ADX-2191 in PVR results expected in second half of 2022.

• COVID-19 pandemic negatively affects clinical site availability, staffing, and patient recruitment, potentially delaying clinical trial timelines.
• Risks that clinical trial results may not predict future trial results for the same or different indications.
• Regulatory challenges in obtaining approvals and addressing FDA requirements for NDA submissions, including safety trial and CMC requirements.

Q: On 629, with three diseases (psoriasis, asthma, COVID-19), any sense of best evidence for therapeutic effect?

A: RASP modulation is upstream and has potential to influence various inflammations; optimistic about activity in psoriasis and asthma, and potential effect in COVID-19 though it's different.

Q: Latest thoughts on allergic conjunctivitis and commercial perspective for reproxalap?

A: Overlap between dry eye and allergic conjunctivitis is substantial; whether to file for allergic conjunctivitis depends on dry eye disease data and potential partnerships.

Q: Schirmer’s test result in TRANQUILITY trial, fast onset and MOA explanation?

A: RASP modulation is upstream and rapid; reproxalap binds to RASP rapidly, causing quick changes in signs and symptoms; FDA doesn't require durability evidence for signs but needs to prove physiologic activity beyond anesthesia.

Q: Status of Phase 2 trial optimizing RASP measurement, and crossover/dry eye Schirmer test trials?

A: RASP data will be organized and presented later; crossover dry eye chamber trial eliminates subject variability; Schirmer test trial highlights rapid onset of reproxalap.

Q: Update on safety data, CMC, and timing for dry eye NDA filing; purpose of crossover and Schirmer test trials?

A: CMC progress is good; safety trial ongoing with 100 patients needed for 12-month exposure; crossover and Schirmer test trials serve as backup and expand evidence package.

Q: TRANQUILITY-2 baseline redness scores compared to prior trial?

A: Baseline scores in TRANQUILITY-2 look better/higher than prior Phase 2 trial, but results matter is un-blinding and group differences.

Q: Measurement of redness in INVIGORATE 2 and possibility of referencing INVIGORATE data for DED filing?

A: FDA considers dry disease distinct from allergic conjunctivitis; reduction of redness in allergic conjunctivitis may be considered but not primary for DED NDA; different protocols for dry eye and allergic conjunctivitis trials.

Q: Patient enrollment for TRANQUILITY-2 dry chamber study and follow-up on ADX-2191 PVR indication?

A: Likely near completion of enrollment for TRANQUILITY-2; GUARD trial results in second half of 2022, with potential discussion of next steps including real-world data and literature on methotrexate for PVR.