Numinus Wellness (NUMI) Maxim Group’s 2024 Healthcare Virtual Summit summary

Business overview and industry positioning

• Focuses on delivering both traditional and novel psychiatric therapies, with leadership in ketamine-assisted therapy and clinical trial site management for major psychedelic studies.

• Built infrastructure for reimbursement, operating SOPs, and multidisciplinary integration to support mental health offerings.

• Actively involved in industry-wide clinical trials, collaborating with leading drug developers and supporting robust trial execution.

• Emphasizes the importance of qualified practitioner training and infrastructure for safe and effective therapy delivery.

• Developed a licensing platform to help other clinics integrate novel therapies using their operational expertise.

Regulatory landscape and clinical trial insights

• Recent FDA decisions, such as the Lykos ruling, highlighted the need for clear protocols and more data, especially regarding therapy versus drug regulation.

• Therapist training and consistent delivery standards were key discussion points in regulatory panels.

• Functional unblinding remains a challenge in psychiatric drug trials, but psychedelic studies are considered among the most robust in the field.

• Enrollment and sample size are significant hurdles, but strong infrastructure has enabled high trial participation.

Financial performance and growth strategy

• Ketamine therapy remains a core, profitable service, with U.S. clinics showing quarter-over-quarter improvement.

• Clinical trial business is thriving, benefiting from the initiation of larger studies and contributing to increased profitability.

• Reduced burn rate and ongoing exploration of M&A opportunities to support growth and operational efficiency.

• Shifted focus from Canadian to U.S. operations due to better reimbursement and lower operational costs.