Aldeyra Therapeutics (ALDX) Status Update summary

Investor engagement and communication

• Hosted first investor roundtable to address questions from retail investors and foster direct dialogue.

• Maintains regular calls and presentations focused on clinical data and R&D updates, with institutional investor meetings at major conferences.

• Emphasized transparency while avoiding disclosure of material non-public information.

• Ongoing communication with investors, with further updates expected throughout 2024.

Clinical development and regulatory strategy

• Advanced ADX-629 to pediatric phase II trial for Sjögren-Larsson syndrome after positive adult biomarker results; top-line pediatric data expected in 2025.

• ADX-743, a novel RASP modulator, moved to IND-enabling studies for obesity and hypertriglyceridemia after promising preclinical results; IND submission planned for 2025.

• ADX-248 will enter phase 1/2 clinical testing for atopic dermatitis in the second half of 2024, replacing ADX-246 due to superior preclinical results.

• ADX-631 began preclinical testing for retinal diseases, with an IND application for dry AMD or geographic atrophy targeted for 1H 2025.

• Reproxalap's NDA resubmission for dry eye disease will leverage staggered trial readouts, with the first positive trial prompting submission; NDA review expected to follow a six-month timeline per PDUFA guidelines.

• Achieved FDA agreement on key aspects of dry eye chamber trial design after protocol modifications.

• Late-stage candidates include reproxalap for dry eye disease and allergic conjunctivitis, and ADX-2191 for retinitis pigmentosa.

Commercial partnerships and financial position

• AbbVie holds an option to co-commercialize reproxalap, with a $94 million upfront fee remaining and additional milestones totaling $300 million.

• Commercial preparations with AbbVie are ongoing, including regulatory and pre-launch activities.

• Current cash balance of $133 million funds ongoing trials and preclinical programs.