MedinCell (MEDCL) Status Update summary

Key clinical findings

• No cases of post-injection delirium/sedation syndrome (PDSS) were observed through week 56 in the pivotal Phase 3 SOLARIS trial for olanzapine LAI, supporting a favorable safety profile.

• The long-term systemic safety profile of olanzapine LAI was consistent with other olanzapine formulations, with most common adverse events being weight increase, injection site reactions, and somnolence.

• Serious adverse events occurred in 6% of participants, and 8% discontinued due to treatment-emergent adverse events.

• Long-term effectiveness data showed maintained symptom improvement and stable clinical effectiveness, with improvements in PANSS, CGI-S, and PSP scores.

• Weight and metabolic changes were comparable to existing oral and intramuscular olanzapine formulations, with mean weight gain stabilizing after 32 weeks.

Regulatory and commercial update

• Teva plans to submit a New Drug Application (NDA) for olanzapine LAI in the US in Q4 2025, aiming to address a critical treatment gap in schizophrenia.

• Olanzapine LAI is the second product in the Teva partnership using Medincell's co-polymer technology, following the FDA-approved UZEDY®.

• Medincell is entitled to royalties on net sales and milestone payments upon commercialization.

Technology and innovation

• Olanzapine LAI uses Steady Teq™, a proprietary copolymer technology enabling controlled, steady drug release throughout the dosing interval.

• The formulation is designed to eliminate the risk of PDSS, potentially improving safety and accessibility for patients.