Summary of Definium Therapeutics Inc FY Conference Call Company Overview - **Company**: Definium Therapeutics Inc (NasdaqGS:DFTX) - **Focus**: Development of treatments for psychiatric disorders, specifically targeting generalized anxiety disorder (GAD) and major depressive disorder (MDD) with their lead program DT120, a proprietary form of LSD [1][2] Industry Context - **Market Opportunity**: There are tens of millions of people suffering from anxiety and depression in the U.S., with the prevalence growing at mid-single-digit rates annually [2][3] - **Current Treatments**: Existing drugs have not significantly changed in efficacy for over 30 years, leading to a high unmet need in the market [3][4] Core Findings and Data - **Clinical Trials**: - Three pivotal studies for DT120 are expected to read out in 2026, building on promising Phase 2 data [2][4] - Phase 2 data showed a Cohen's d of 0.81, significantly higher than the less than 0.4 seen in current approved drug classes [6] - A 21.9 point improvement on the Hamilton Anxiety Rating Scale was observed 12 weeks after a single administration, with a 48% remission rate [7][10] - The response pattern showed durability, with no reversion to baseline symptoms observed at the 12-week mark [10][11] - **Comparative Efficacy**: Current approved therapies show marginal efficacy changes of under 4 points, while DT120 demonstrated a 7.7 unit change on the Hamilton Anxiety Scale [8][9] Development Strategy - **Phase 3 Studies**: - The studies will include a head-to-head comparison in MDD and will follow patients for 12 weeks with additional open-label retreatment options [21][25] - The FDA has granted Breakthrough Therapy designation, facilitating a quicker development timeline [25][26] - **Commercial Framework**: - There is a growing enthusiasm for psychedelic treatments among healthcare providers, with 70% of surveyed healthcare professionals indicating intent to prescribe DT120 for GAD if approved [31] - The potential market includes approximately 50 million patients with GAD and MDD, with 27 million currently receiving treatment [36] Regulatory and Reimbursement Considerations - **Payer Engagement**: Positive feedback from payers regarding the drug's profile and intent to find reimbursement pathways has been noted [34][48] - **CPT Codes**: Discussions are ongoing regarding the development of unique CPT codes for longer treatment sessions, which could streamline reimbursement processes [47][48] Additional Insights - **Autism Spectrum Disorder**: Definium is also exploring DT402, an R enantiomer of MDMA, for autism spectrum disorder, focusing on improving core functional domains rather than just suppressive effects [5][43][44] - **Patient Engagement**: Qualitative research indicates significant patient satisfaction with the changes experienced after treatment with DT120, highlighting the drug's potential impact on quality of life [12][32] Conclusion - Definium Therapeutics is positioned to address significant unmet needs in psychiatric treatment with innovative approaches and promising clinical data, while actively engaging with stakeholders to ensure successful market entry and adoption of their therapies.

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January 2026 Corporate Presentation Disclaimer This presentation (the "Presentation") has been prepared by Definium Therapeutics, Inc. (" Definium ", the "Company", "we", "our" or "us") solely for informational purposes. This Presentation does not constitute an offering o f, or a solicitation of an offer to purchase, securities of Definium and under no circumstances is it to be construed as a prospectus or advertisement or public offering of securities. Any trade ma rks included herein are the property of t ...