Aldeyra Therapeutics (ALDX) Oppenheimer 36th Annual Healthcare Life Sciences Conference summary

Regulatory and clinical development updates

• Lead candidate Reproxalap is approaching an extended PDUFA date of March 16 for dry eye disease after multiple FDA review cycles and amendments, with a quiet review process underway.

• Two positive phase III trials for allergic conjunctivitis have been completed, with plans for a supplemental NDA submission following potential dry eye approval.

• ADX-2191, an orphan drug for primary vitreoretinal lymphoma, is in a pivotal trial comparing injection frequencies, with data expected by end of this year or early next year.

• ADX-248, an oral RASP modulator for atopic dermatitis, is in phase I with phase II planned for later this year and data anticipated next year.

Market positioning and differentiation

• Reproxalap aims to be the only chronic-use dry eye drug with redness on the label and rapid onset of action, differentiating it from existing therapies.

• Potential to be the only approved drug for both dry eye and allergic conjunctivitis, offering unique value for patients with overlapping conditions.

• The dry eye market is expanding with new agents, but none offer immediate relief or address both symptoms and appearance as Reproxalap proposes.

Strategic partnerships and financial outlook

• AbbVie holds an option to commercialize Reproxalap, exercisable within 10 business days post-approval, with up to $200 million in upfront and milestone payments.

• Profit-sharing agreement with AbbVie is structured as a 60/40 split, with Aldeyra responsible for 40% of costs and profits, and an annual cap on Aldeyra's costs.

• $75 million in cash as of Q3 provides approximately two years of runway, supporting ongoing and planned trials; AbbVie exercise would further strengthen financial position.