Orexo (ORX) R&D Day summary

Pipeline overview and program updates

• AmorphOX technology is the foundation for a diversified pipeline in nasal and oral drug delivery, including GLP-1s, vaccines, and overdose countermeasures.

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

• Zubsolv divestment provided $91 million and enabled a strategic shift to a platform- and development-driven business, funding R&D and restructuring.

• Ongoing restructuring includes staff transitions, supplier contract exits, and office downsizing in the U.S.

• Multiple feasibility studies and collaborations are underway with industry and academic partners to expand AmorphOX applications.

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.

• OX640 is preparing for a pivotal nasal allergen challenge study in Q4, with commercial scale-up ongoing and pivotal trial initiation planned for 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 advancing through preclinical proof-of-concept and animal studies, showing improved nasal absorption and thermostability.

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

R&D strategy and innovation priorities

• Focused on three pillars: Explore (early-stage, new modalities), Develop (clinical-stage projects), and Partner (external collaborations).

• Strategic prioritization of GLP-1s and vaccines as high-potential use cases for AmorphOX.

• Emphasis on generating in vivo and human data to de-risk platform and attract partners.

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

• Accelerating R&D in amorphous powder drug delivery and expanding biomolecule research.