Soleno Therapeutics (SLNO) Guggenheim Inaugural Global Healthcare Innovation Conference summary

Regulatory update and FDA interactions

• Product review by FDA is ongoing, with no current indication of delay for the December 27th PDUFA date, and an Adcom is now considered very unlikely before year-end.

• FDA has gained significant understanding of the disease and the unmet need, aided by recent advisory committees and patient-focused meetings.

• Manufacturing sites are U.S.-based, mainstream, and considered low risk for inspection issues; internal processes ensure high confidence in passing FDA inspections.

• Labeling discussions are expected to begin about four weeks before the PDUFA date.

• No major amendments or new information requests have been made that would trigger a PDUFA delay, but the agency retains discretion.

Clinical and market access insights

• The trial population included patients aged four and up, with no upper age limit; label is expected to reflect this range.

• About 20% of patients have a lifetime prevalence of diabetes, with controlled diabetics included in trials; exclusion for uncontrolled diabetics is possible.

• Estimated U.S. addressable market is around 10,000 patients, with 85-90% above age four.

• Payer discussions are positive, with most payers recognizing the need for coverage; pricing and pre-authorization requirements are key considerations.

• Patient population is split roughly equally among commercial, Medicare, and Medicaid payers.

Commercialization and launch planning

• Company plans to grow from 75 to about 120 employees by launch, with a commercial team of 60+ and 30 sales representatives.

• Geographic field force planning is based on patient and key opinion leader concentrations, with notable populations in Florida and Atlanta.

• Market research indicates strong demand and interest from both families and physicians, especially pediatric endocrinologists.

• Compliance is expected to be high due to patient characteristics and trial retention rates.