Aldeyra Therapeutics, Inc. Q3 FY2021 earnings call

• Anterior segment ocular programs: Expect top-line results from TRANQUILITY and TRANQUILITY-2 trials of reproxalap in dry eye disease. Enrollment complete in Phase II reproxalap trial for dry eye. Expect to file NDA for dry eye early next year and provide NDA update for allergic conjunctivitis by end of 2021.
• Retina programs: ADX-2191 granted orphan drug designation for retinitis pigmentosa, PVR, and primary vitreoretinal lymphoma. On track to initiate Phase II trial for retinitis pigmentosa by end of 2021; Part 1 of Phase III GUARD trial in PVR to conclude enrollment by end of 2021 with results expected next year.
• Systemic disease program: On track to report Phase II proof-of-concept results from ADX-629 in asthma, psoriasis, and COVID-19 in Q4 2021 or Q1 2022.
• Financials: Cash and cash equivalents as of September 30, 2021, were $241.4 million, sufficient to fund operating expenses through end of 2023.

Research and development expenses for the third quarter of 2021 were $12.9 million, compared to $6.1 million in the same period of 2020. General and administrative expenses were $2.5 million in Q3 2021 versus $2.3 million in Q3 2020. The net loss for Q3 2021 was $15.8 million, or $0.27 per share, compared to a net loss of $8.9 million, or $0.23 per share, in Q3 2020.

Anticipate filing a new drug application for dry eye disease early next year. Expect to provide an NDA update for reproxalap in allergic conjunctivitis by the end of 2021. On track to initiate Phase II clinical trial of ADX-2191 in retinitis pigmentosa by end of 2021. Expect results from Phase III GUARD trial in PVR next year. On track to report Phase II proof-of-concept clinical results from ADX-629 in Q4 2021 or Q1 2022.

COVID-19 pandemic impact on clinical site availability, staffing, and patient recruitment, potentially delaying clinical trial timelines. Uncertainty that clinical trial results may not accurately predict future trial outcomes. Regulatory uncertainties related to NDA submissions and meeting FDA requirements.

Q: On the commercialization front, is setting up a short-term commercial alliance easy to do and have they thought about it?

A: Joshua Reed mentioned they have lots of options, including using a different organization to commercialize, and reproxalap's commercial potential gives them various options.

Q: On the Schirmer test and reproxalap's label, how important is Schirmer?

A: Todd Brady stated patients care about ocular redness more than Schirmer's test, and ocular redness is a significant commercial advantage.

Q: About the Phase II reproxalap trial for dry eye, why was it done and how does it relate to TRANQUILITY trials?

A: Todd Brady explained the Phase II trial was to optimize tear RASP level measurement, and the results could inform powering of TRANQUILITY trials.

Q: On TRANQUILITY-1 and 2 trials, what's left before NDA filing?

A: Todd Brady said remaining boxes include sign requirements (ocular redness), safety trial completion, and CMC requirements.

Q: On ADX-2191 retinitis pigmentosa trial, details of design and expected data?

A: Todd Brady mentioned it's an open-label trial, primary endpoint is safety, secondary endpoints include visual acuity, etc., and data expected next year.

Q: On allergic conjunctivitis NDA update, status and efficacy data?

A: Todd Brady said discussions with FDA are about efficacy requirements, with two completed Phase III trials but different designs.

Q: On early stage pipeline for RASP inhibitors, any updates?

A: Todd Brady said they're developing new RASP inhibitor analogues and expect updates next year.

Q: On findings in the reproxalap vs lifitegrast publication and physician feedback?

A: Todd Brady mentioned positive feedback on reproxalap's quick action and better tolerability vs lifitegrast.

Q: On TRANQUILITY study size and powering for redness?

A: Todd Brady explained powering considerations, both Phase II and III trials are powered for ocular redness.