Soleno Therapeutics (SLNO) investor relations material

Recent product launch and market reception

• FDA approval for the first drug in Prader-Willi syndrome was received at the end of March, with commercial launch following shortly after and exceeding expectations with 646 start forms and 295 prescribers in the first three months.

• High early adoption is attributed to motivated families and a broad prescriber base, including many not previously identified as Prader-Willi treaters.

• The majority of initial patients are between 4 and 26 years old, heavier than the clinical trial population, and often present with more comorbidities.

• Physician enthusiasm is strong, with key opinion leaders comfortable with the drug and its side effect profile, emphasizing the need for appropriate monitoring and titration.

• The company is providing extensive educational materials and support, including specialty pharmacy counseling and a speakers' bureau, to facilitate safe and effective use.

Safety, efficacy, and patient management

• The most common side effects are peripheral edema and hyperglycemia, both of which are trackable and manageable with proper monitoring.

• Discontinuation rates for adverse events are low and consistent with clinical trial data, at about 5.2%.

• Maximal efficacy may take six to nine months to manifest, requiring education for both healthcare professionals and families to set expectations.

• Guidelines for monitoring are evolving, with both company and physician-led efforts underway to standardize care.

• Some patients with severe comorbidities may not be ideal candidates, but these are not absolute contraindications; careful monitoring is emphasized.

Commercial trajectory and financial outlook

• The initial surge in patient starts is not expected to be sustained, with a slow and steady growth trajectory anticipated over the next two to three years.

• The total addressable market in the U.S. is estimated at 10,000 patients, with a similar opportunity in Europe.

• The company is considering both direct commercialization and partnerships in Europe, with regulatory approval expected in about a year.

• Financially, the company is well-capitalized with over $500 million in cash, supporting ongoing launch activities and potential expansion.

• The commercial footprint is considered right-sized, with flexibility for incremental expansion as needed.