Aldeyra Therapeutics (ALDX) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Key clinical achievements and regulatory updates

• Achieved primary endpoint in phase III dry eye chamber trial for Reproxalap, enabling NDA resubmission soon.

• NDA resubmission will include new clinical data, CMC updates, and a safety update for 66 additional patients.

• Label expected to highlight rapid symptom relief within minutes and control of ocular redness, a unique differentiator.

• Positive phase III INVIGORATE-2 trial in allergic conjunctivitis supports potential for dual indications.

• Anticipated NDA resubmission in the coming weeks, with a possible Q1/Q2 PDUFA date.

Market positioning and differentiation

• Reproxalap offers rapid relief for discomfort, redness, and itching, unlike current therapies that take weeks.

• Only chronic therapy in development targeting both dry eye and allergic conjunctivitis.

• Addresses major gaps in current standard of care, including lack of chronic therapies for redness and dual symptom coverage.

• Potential for market differentiation due to broad label and rapid onset of action.

Strategic partnerships and financial outlook

• AbbVie holds an option to co-promote Reproxalap, with a $94M upfront payment and $100M milestone at approval.

• Option expires at the end of April or ten days after approval, whichever comes first.

• Company is well-financed with $120M in cash and runway through 2026, excluding any AbbVie proceeds.

• All discussed pipeline programs are currently funded.