Soleno Therapeutics (SLNO) investor relations material

Strategic and financial highlights

• VYKAT XR, the first FDA-approved treatment for hyperphagia in Prader-Willi syndrome (PWS), launched in March 2025 and generated over $190M in sales within nine months, achieving profitability and a strong cash position of $506M by year-end 2025.

• The total addressable market in the US is estimated at ~10,000 patients, with geographic expansion underway and EMA validation of the European submission in May 2025.

• Multiple patent families protect VYKAT XR, with potential exclusivity extending into the mid-2030s.

• Announced a $100M stock repurchase in November 2025, reflecting confidence in financial strength.

Disease overview and unmet need

• PWS is a rare, life-threatening genetic disorder characterized by persistent hyperphagia, leading to significant behavioral issues and comorbidities.

• Patients face a high risk of mortality, with an average life expectancy of ~30 years and increased rates of heart failure, diabetes, and respiratory complications.

• Hyperphagia imposes a heavy burden on families and healthcare systems, with high rates of caregiver stress and increased hospitalizations.

• There is a significant unmet need, as VYKAT XR is the only approved treatment addressing hyperphagia in PWS.

Clinical development and efficacy

• The DCCR (VYKAT XR) phase 3 program included randomized, controlled, and open-label extension studies, enrolling patients aged 4+ with PWS.

• Clinical trials demonstrated significant and durable reductions in hyperphagia scores over multiple years.

• Safety profile was consistent with prior experience, with most adverse events being manageable and few serious events.

• VYKAT XR is positioned to become the standard of care for PWS-related hyperphagia.