Orexo (ORX) investor relations material

Scientific and technological advancements

• Introduced AmorphOX®, a powder-based drug delivery technology enhancing bioavailability, stability, and enabling needle-free delivery for small and large molecules.

• Demonstrated AmorphOX®'s versatility across small molecules, peptides, and biologics, with stability maintained under extreme conditions.

• Early-stage projects showed AmorphOX®-formulated nasal semaglutide powders achieved 7-times higher exposure than oral tablets, with potential to eliminate cold chain requirements.

Pipeline and product development

• Pipeline includes OX640 (epinephrine for anaphylaxis), OX390 (overdose rescue), and Izipry™ (naloxone for synthetic opioid overdose), all leveraging AmorphOX®.

• OX640 showed rapid absorption and sustained epinephrine levels in clinical studies; pivotal trial planned for Q4 2026, with data expected Q1 2027.

• OX390, in preclinical stage, targets adulterated overdoses and is supported by a SEK 75m BARDA award, with human trials expected in just over two years.

• Izipry™ is in the registration phase, with FDA resubmission expected in Q3 2026; commercial-scale manufacturing completed in Q4 2025.

Strategic direction and partnerships

• Focus on global leadership in amorphous powder drug delivery, accelerating R&D and expanding expertise in peptides and proteins.

• Plans to expand academic and industry collaborations, leveraging financial capacity to support proprietary projects until value inflection points.

• Intends to establish and expand partnerships for AmorphOX®, retaining value through royalties and milestones from co-developed projects.