Aldeyra Therapeutics (ALDX) Jefferies 2024 Global Healthcare Conference summary

Company overview and technology platform

• Focuses on novel therapeutics for immunology and metabolic diseases, with a pre-commercial lead asset and a partnership with a major pharmaceutical company.

• Pipeline includes multiple clinical-stage assets targeting ocular and systemic diseases, with pivotal and Phase II readouts expected in the coming quarters.

Lead program: Reproxalap for dry eye disease

• Three Phase III symptom trials are underway to address FDA requirements, with the first patient enrolled and data expected in Q3.

• Trials include two identical dry eye chamber studies (Canada and US) and a longer-term field trial, all running in parallel.

• Chamber trials aim to demonstrate rapid symptom relief in minutes, a potential market differentiator.

• NDA resubmission is planned if the first chamber trial is successful, with a potential PDUFA date in Q2 following a six-month review.

• Collaboration with AbbVie includes an option agreement with milestone payments and a 60/40 P&L split upon exercise.

Additional indications and pipeline programs

• Completed two Phase III allergy chamber trials for allergic conjunctivitis, with potential for NDA or sNDA submission pending FDA discussions.

• Retinitis pigmentosa program uses ocular methotrexate, showing promising open-label results in peripheral vision improvement; pivotal trial design agreed with FDA.

• RASP modulation platform underpins pipeline, with ADX-629 as a signal-finding molecule and next-generation candidates advancing in atopic dermatitis, hepatitis, and retinal diseases.

• Orphan designation secured for methotrexate in retinitis pigmentosa, with trial initiation planned for the second half of the year.