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SOLENO THERAPEUTICS Soleno Therapeutics Provides Corporate Update and Reports First Quarter 2021 Financial Results May 5 , 2021 REDWOOD CITY , Calif . , May 05 , 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 months ended March 31 , 2021 . " We are continuing our dialogue with the U.S. Food and Drug Administration ( FDA ) to evaluate the appropriate next steps in our DCCR program for the treatment of Prader - Willi Syndrome ( PWS ) and work towards obtaining regulatory approval as expeditiously as possible , " said Anish Bhatnagar , M.D. , Chief Executive Officer of Soleno Therapeutics . “ The Soleno team remains committed to the development of DCCR and building an appropriate data set to support its development . To this end , we were excited to recently present behavioral outcomes data from caregiver interviews that summarized individual patient experiences during treatment with DCCR . We were also pleased to speak to the PWS community directly during the recent PWS DCCR Town Hall meeting where we reiterated our continued focus on DCCR and outlined the proposed necessary steps for submitting a marketing application to the FDA in the U.S. More importantly , we were able to listen to the stories about the individual study participants ' experiences during our completed Phase III clinical trial of DCCR , DESTINY PWS , and the ongoing long - term safety extension study . " Dr. Bhatnagar continued , " We are grateful for the work completed by the Foundation for Prader - Willi Research and Prader - Willi Syndrome Association | USA in collecting the experiences of PWS patients and caregivers treated with DCCR . This petition , which was submitted to the FDA , was signed by more than 26,000 individuals in support of DCCR . " First Quarter 2021 and Recent Corporate Highlights • Continued discussions with FDA and currently evaluating appropriate next steps for DCCR program in PWS • Presented behavioral outcomes data from the Company's ongoing open - label extension study ( C602 ) of DCCR in PWS at the Pediatric Academic Societies ( PAS ) 2021 Virtual Annual Meeting ( poster available here ) o A majority of patients ( 83 % ) reported positive changes in multiple behavioral outcome domains , including food - seeking behaviors , mealtime behaviors and daily life behaviors in a preliminary analysis of data from interviews of caregivers of participants in C602 • Presented assessment of baseline renal function in PWS patients enrolled in clinical study C601 at the Endocrinology Society ( ENDO ) 2021 Virtual Annual Meeting ( poster available here ) • With researchers from the U.S. National Institutes of Health , presented resting energy expenditure data for a limited number of subjects enrolled in clinical studies C601 and C602 at the Pediatric Academic Societies ( PAS ) 2021 Virtual Annual Meeting ( poster available here ) • DCCR treated subjects showed progressive increases in resting energy expenditure • Presented a post - hoc analysis of C601 taking into account data prior to the ' COVID impact ' ( defined as the PES 2021 Virtual Annual Meeting ( poster available here ) 1 March 2020 ) at • The primary endpoint , change in hyperphagia using HQ - CT , and all key secondary endpoints showed significant improvements in DCCR treated subjects compared with placebo • There were significant improvements in a number of behavioral and cardiometabolic endpoints in DCCR treated subjects compared with placebo • Participated in PWS DCCR Town Hall • • Highlighted the proposed necessary steps to submit a marketing application for DCCR in the U.S. and reaffirmed the Company's commitment to this process • Listened to individual patient and caregiver experiences with DCCR Participated in a fireside chat at the 31st Annual Oppenheimer 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 . First Quarter Ended March 31 , 2021 Financial Results Research and development expenses were $ 7.2 million for the quarter ended March 31 , 2021 , compared to $ 6.7 million in the same period of 2020 . The increase was primarily due to increased activities related to the DCCR development program . General and administrative expense was $ 3.0 million for the quarter ended March 31 , 2021 , compared to $ 2.0 million in the same period of 2020 . The change in the fair value of contingent consideration results from Soleno's obligation to make cash payments to Essentialis stockholders upon the achievement of certain future commercial milestones associated with the sale of DCCR in accordance with the terms of the Essentialis merger agreement . The fair value was estimated to be approximately $ 9.3 million at March 31 , 2021 , resulting in a decrease in expense of approximately $ 1.0 million from the estimate at December 31 , 2020 .