Orexo (ORX) R&D Day summary

Pipeline overview and program updates

• AmorphOX technology is the core focus, supporting nasal and oral drug delivery for peptides, proteins, vaccines, and overdose countermeasures, with both proprietary and partnered projects.

• Key late-stage assets include OX640 (nasal epinephrine), OX390 (atipamezole for opioid/xylazine/medetomidine overdose), and IZIPRY/Izipry (naloxone nasal powder).

• Zubsolv divestment provided $91 million and ongoing earn-outs, enabling a strategic shift to R&D, restructuring, and platform development.

• Multiple feasibility studies and collaborations are ongoing to expand AmorphOX applications and partnerships.

• Three business pillars: Explore (early-stage), Develop (clinical programs), and Partner (feasibility and licensing deals).

Clinical trial data and development milestones

• IZIPRY/Izipry is expected to be refiled with the FDA after summer or in Q3 2026, aiming for approval early next year or approaching key regulatory filings in 2026–2028.

• OX640 is entering pivotal trials in Q4, with a nasal allergen challenge study planned and pivotal trial initiation in Q4 2026.

• OX390 is in in vivo studies, with animal data expected in the summer and first clinical study planned.

• AmorphOX-based GLP-1 and vaccine projects are in preclinical stages, with promising animal data, improved nasal absorption, thermostability, and further studies planned for 2024.

• OX640 demonstrates rapid onset, high stability, and extended absorption in preliminary PK studies.

R&D strategy and innovation priorities

• Focused on transforming injectable drugs to needle-free nasal or oral delivery using AmorphOX, with strategic prioritization of GLP-1s and vaccines.

• Ongoing expansion of AmorphOX applications, including oral peptide delivery and depot formulations in collaboration with partners.

• Emphasis on accelerating R&D in amorphous powder drug delivery and expanding biomolecule research.

• Go/no-go decisions enforced to optimize speed and resource allocation.