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 (naloxone nasal powder).

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

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

• Three business pillars: Explore (early-stage), Develop (clinical-stage), and Partner (feasibility/service agreements).

Clinical trial data and development milestones

• IZIPRY is expected to be refiled with the FDA after summer or in Q3 2026, aiming for approval early next year.

• OX640 will enter its first human study with the final commercial dose in Q4, with pivotal trial initiation planned for Q4 2026.

• OX390 is undergoing in vivo studies, with results expected in the summer and a first clinical study planned.

• AmorphOX-based GLP-1 and vaccine projects are in preclinical proof-of-concept stages, showing improved nasal absorption, thermostability, and supporting animal/stability data.

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

R&D strategy and innovation priorities

• Focused on de-risking AmorphOX by generating in vivo and human data to attract partners and maximize value.

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

• Iterative, data-driven approach to project selection and advancement, leveraging external expert input and enforcing go/no-go decisions.

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