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SOLENO THERAPEUTICS Soleno Therapeutics Provides Corporate Update and Reports Third Quarter 2021 Financial Results November 10 , 2021 REDWOOD CITY , Calif . , Nov. 10 , 2021 ( GLOBE NEWSWIRE ) -- Soleno Therapeutics , Inc. ( Soleno ) ( NASDAQ : SLNO ) , a clinical - stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases , today provided a corporate update , and reported financial results for the three and nine months ended September 30 , 2021 . " The recently announced top - line results from Soleno's ongoing open - label extension study evaluating DCCR for the treatment of Prader - Willi syndrome ( PWS ) , and the comparison of these data to matched subjects from the PATH for PWS ( PfPWS ) natural history study , highlight the compelling potential of this promising therapy in addressing the myriad physical and behavioral challenges faced by PWS patients and families , " said Anish Bhatnagar , M.D. , Chief Executive Officer of Soleno Therapeutics . " We have submitted these collective results to the U.S. Food and Drug Administration ( FDA ) as part of an ongoing discussion with the agency regarding the clinical data necessary to support the submission of a New Drug Application ( NDA ) to market DCCR for the treatment of PWS . We remain firmly committed to obtaining regulatory approval for DCCR as a new treatment for people with PWS as quickly as possible . " Third Quarter 2021 and Recent Corporate Highlights • Submitted to the FDA top - line results from the company's ongoing open - label extension study , C602 , evaluating investigational , once - daily DCCR ( Diazoxide Choline ) Extended - Release tablets for patients with PWS and its comparison to data from the PfPWS , an ongoing study sponsored by the Foundation for Prader - Willi Research ( FPWR ) to advance the understanding of the natural history in individuals with PWS . • A total of 115 subjects were enrolled into C602 , the extension study in PWS patients who completed DESTINY PWS , an international , multi - center , randomized , double - blind , placebo - controlled study of DCCR . ■ Key top - line results of Study C602 • • Hyperphagia : There was a progressive improvement in hyperphagia , the primary endpoint in the DESTINY PWS study , represented by a decrease in the HQ - CT total score , which was highly significant ( p < 0.0001 ) after receiving DCCR for 52 weeks . • PWS related behaviors : Behaviors related to PWS were measured using the PWS Profile Questionnaire ( PWS - P ) . After 52 weeks , there were statistically significant improvements in all behavioral domains ( all p < 0.0001 ) . • The safety profile of DCCR remains consistent with the known safety profile of diazoxide and the prior experience with DCCR . No serious , unexpected , related adverse events have occurred with DCCR in the program to date . o Key top - line results of Study C602 compared to matched subjects from PfPWS ■ Hyperphagia : Statistically significant improvement with DCCR was seen compared with PfPWS subjects at 52 weeks ( p < 0.001 ) . ■ PWS related behaviors : As with hyperphagia , statistically significant improvements with DCCR in C602 subjects compared with subjects in the PfPWS study were seen in all behavioral domains of the PWS - P at 52 weeks ( p < 0.003 for all ) . • Presented the above data from C602 and the comparison to PfPWS at the FPWR Annual Scientific Conference . • Presented a DCCR clinical program overview at the FPWR Annual Family Conference , Presentation can be viewed here . • Participated in the Oppenheimer Fall Healthcare Life Sciences and MedTech Summit . • Participated in the 2021 Cantor Virtual Global Healthcare Conference . Financial Results Soleno's current research and development efforts are primarily focused on advancing its lead product candidate , DCCR , for the treatment of PWS , through late - stage clinical development . Financial Results for Three and Nine Months Ended September 30 , 2021 Research and development expenses for the three and nine months ended September 30 , 2021 , were $ 5.0 million and $ 17.7 million , compared to $ 4.8 million and $ 17.6 million for the same periods of 2020 , respectively . The fluctuations in expenses were primarily due to the cadence of activities related to the DCCR development program . General and administrative expenses for the three and nine months ended September 30 , 2021 , were $ 2.8 million and $ 8.2 million , compared to $ 2.3 million and $ 6.5 million for the same periods of 2020 , respectively . The increases were primarily related to increased compensation costs due to headcount growth and increased stock - based compensation expense . The change in the fair value of contingent consideration results from Soleno's obligation to make cash payments to Essentialis stockholders upon the