Aldeyra Therapeutics, Inc. Q4 FY2022 earnings call

• Achieved two FDA accepted new drug applications: Reproxalap for dry eye disease and ADX-2191 (priority review for primary vitreoretinal lymphoma). • Focused on advancing next-generation RASP modulation platform: ADX-629, ADX-246, and ADX-248 in 2023. • ADX-629 in Phase 2 trials for indications like idiopathic nephrotic syndrome, Sjogren-Larsson syndrome, and atopic dermatitis; top-line results expected in second half of 2023. • Planned Phase 2 trial in moderate alcohol-associated hepatitis; top-line results expected for refractory/chronic cough trial in first half of 2023. • ADX-2191 NDA priority review for ocular lymphoma (PDUFA June 21, 2023); PDUFA for Reproxalap is November 23, 2023; ongoing partnering discussions for Reproxalap; Reproxalap showed superior visual acuity in dry eye safety trial. • Commercial preparations for Reproxalap and ADX-2191, with ADX-2191 targeting retinal surgeons and Reproxalap targeting optometrists.

• Cash, cash equivalents, and marketable securities as of December 31, 2022 were $174.3 million, sufficient to fund operating expenses into the second half of 2024. • PDUFA dates: Reproxalap on November 23, 2023; ADX-2191 on June 21, 2023. • Top-line results expected for ADX-629 trials (Sjogren-Larsson syndrome, atopic dermatitis, idiopathic nephrotic syndrome), INVIGORATE-2 trial, and Phase 2 trial of ADX-2191 in retinitis pigmentosa in 2023.

• Risks that clinical trial results may not predict future trial outcomes accurately. • Regulatory risks associated with FDA review and approval processes for NDAs. • Uncertainties in partnering discussions and commercialization of products like Reproxalap.

Q: Marc Goodman asks about the side effect profile of oral products.

A: Todd Brady discusses RASP modulation's safety, noting ADX-629 has very few side effects and that RASP modulation avoids toxicity by influencing a family of mediators, not individual proteins.

Q: Yigal Nochomovitz inquires about Reproxalap partnering discussions and the AC trial.

A: Todd Brady mentions robust partnering conversations for Reproxalap, highlights Reproxalap's differentiators in dry eye, and discusses the AC trial's overlap with dry eye and potential impact on partnering decisions.

Q: Justin Kim asks about ADX-246 differentiation.

A: Todd Brady talks about ADX-246's potency and potential once-daily dosing, distinguishing it from ADX-629 which is administered twice daily.

Q: Sung asks about ADX-2191 priority review impact and visual acuity strategy.

A: Todd Brady explains regulatory strategy of submitting NDA for ocular lymphoma first, and discusses how visual acuity data from Reproxalap's safety trial will be highlighted in label negotiations.

Q: Catherine Novack asks about visual acuity change in Reproxalap's safety trial and RASP modulators in geographic atrophy.

A: Todd Brady notes Reproxalap's visual acuity improvement was statistically significant vs. vehicle, and discusses RASP modulation's dual mechanism in geographic atrophy (anti-inflammatory and preventing metabolite accumulation).

Q: Yale Jen asks about INVIGORATE-2 study status and retinitis pigmentosa data.

A: Todd Brady discusses INVIGORATE-2 enrollment nearing completion and the significance of retinitis pigmentosa trial as a milestone for ADX-2191