Soleno Therapeutics (SLNO) Piper Sandler 36th Annual Healthcare Conference summary

Regulatory update and FDA review

• FDA extended the PDUFA date from December 27 to March 27 due to major amendments requiring more review time, with robust back-and-forth and timely responses to FDA queries.

• No 483s were issued during inspections, and the company distances itself from recent industry warning letters.

• Label negotiations typically occur just before the PDUFA date; expectations are for a label reflecting PWS patients aged four and above with hyperphagia.

• The 120-day safety update was submitted on time; ongoing FDA information requests contributed to the review extension.

• No advisory committee (Adcom) is currently expected before the new PDUFA date.

Market opportunity and patient population

• Claims data and academic research estimate about 10,000 diagnosed PWS patients in the U.S., with 85%-90% over age four and eligible for treatment.

• Most undiagnosed patients are likely older, as 85%-90% of U.S. cases are diagnosed at birth.

• PWS patients are geographically distributed across the U.S., with concentrations in areas like Florida, Texas, and New York due to centers of excellence.

• Primary prescribers are pediatric endocrinologists, with about 300 providers influencing 40% of prescriptions; adult endocrinologists, psychiatrists, and geneticists are secondary targets.

Commercialization and launch strategy

• Sales force will consist of about 30 people, with leadership already hired and key geography reps being onboarded ahead of approval.

• Patient and physician awareness of DCCR is high among advocacy-engaged families, estimated in the few thousands.

• Strong interest exists among both families and physicians, but the initial uptake will depend on provider capacity to onboard patients.

• U.S. launch plans are complemented by European regulatory filings targeted for the first half of next year, with EU4 and U.K. markets seen as significant.