Soleno Therapeutics Raises $120 Million After Reporting Positive Prader-Willi Trial Results

Rare Daily Staff

Two days after reporting positive top-line results of its experimental treatment for Prader-Willi syndrome, Soleno Therapeutics, raised $120 million in a public offering and private securities purchase agreement.

In the underwritten public offering Soleno priced 3 million shares of its common stock at a $20.00 per share. The gross proceeds of the public offering are expected to be approximately $60.0 million, before deducting the underwriting discount and other estimated offering expenses. Soleno has also granted the underwriters a 30-day option to purchase up to 450,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

In connection with the public offering, Soleno has entered into a securities purchase agreement with certain investors, including entities affiliated with existing stockholders, for up to approximately $60 million consisting of shares of its common stock and/or pre-funded warrants at a price per share equal to the public offering price. The closing of the public offering and concurrent private placement are expected to occur on or about October 2, 2023, subject to the satisfaction of customary closing conditions.

Soleno’s lead candidate, DCCR Extended-Release tablets, is a once-daily oral tablet for the treatment of Prader-Willi syndrome, that recently completed its phase 3 development program to support a planned New Drug Application submission.

The company’s positive top-line results came from the randomized withdrawal period of Study C602, a long-term treatment study of DCCR, which enrolled 77 patients previously enrolled in Study C602 who had been on open-label treatment with DCCR for between two and four years. Participants were randomized 1:1 to receive either DCCR or placebo for a period of four months. The primary endpoint was change in baseline in hyperphagia-related behaviors, which markedly worsened in the placebo group compared to DCCR.

Secondary endpoints included investigator assessments of participants’ overall severity of illness and change in condition and showed strong trends towards worsening in the placebo group compared to DCCR over the course of the randomized withdrawal period, respectively. DCCR continued to be generally well-tolerated in the randomized withdrawal period with no new or unexpected safety signals, including no serious adverse events or discontinuations due to adverse events occurring in any participants in the DCCR group.

Prader-Willi syndrome (PWS) occurs in an estimated one in every 15,000 live births. The hallmark symptom of this disorder is hyperphagia, a chronic and life-threatening feeling of intense, persistent hunger, food pre-occupation, extreme drive to food seek and consume food that severely diminish the quality of life for patients with PWS and their families. Additional characteristics of PWS include behavioral problems, cognitive disabilities, low muscle tone, short stature (when not treated with growth hormone), the accumulation of excess body fat, developmental delays, and incomplete sexual development. There are currently no approved therapies to treat the hyperphagia/appetite, metabolic, cognitive function, or behavioral aspects of the disorder.