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SOLENO THERAPEUTICS Soleno Therapeutics Provides Corporate Update and Reports Second Quarter 2021 Financial Results July 28 , 2021 REDWOOD CITY , Calif . , July 28 , 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 six months ended June 30 , 2021 . " The Soleno team remains focused on achieving regulatory approval for DCCR for the treatment of Prader - Willi syndrome , or PWS , " said Anish Bhatnagar , M.D. , Chief Executive Officer of Soleno Therapeutics . " We are continuing our dialogue with the U.S. Food and Drug Administration ( FDA ) and , as recently announced , intend to submit the clinical study reports from DESTINY PWS and the C602 extension study , as well as additional data , to the Agency before the end of the third quarter . The FDA has agreed to review these clinical study reports and data to determine if the totality of data generated to date for DCCR are sufficient to support a potential New Drug Application ( NDA ) submission . " Second Quarter 2021 and Recent Corporate Highlights • Continued discussions with FDA and currently evaluating appropriate next steps for DCCR program in PWS o On July 2 , 2021 , the Company received official meeting minutes from the June 11 , 2021 , Type B meeting with the Division of Diabetes , Lipid Disorders and Obesity . The FDA continued to assert that based on the data the Agency has seen to date , an additional clinical trial is necessary for the submission of an NDA . However , the FDA strongly encouraged Soleno to submit the available data and clinical study reports for the Company's Phase 3 trial , DESTINY PWS ( C601 ) , and its long - term , open - label extension study ( C602 ) , to allow FDA to assess if these studies may provide adequate evidence of safety and efficacy to support the submission of an NDA . o As of June 2021 , 97 patients in study C602 have completed one year in the study • Expanded patent protection for DCCR for the treatment of PWS o Received notice of allowance of patents covering the use of diazoxide choline and diazoxide to treat behavioral , metabolic and body composition complications of PWS in New Zealand , Mexico and Canada . Soleno has already successfully prosecuted this patent filing to issuance of three U.S. patents ( 9,757,384 , 10,058,557 , and 10,456,408 ) , and corresponding patents in the EU , Japan , China , Australia , Malaysia , Indonesia and Eurasia . These patents extend protection of DCCR in the treatment of PWS to at least 2035 in all of these regions . • A manuscript titled , " A Qualitative Methodology for Evaluating Novel Treatments for Hyperphagia in People with Prader - Willi Syndrome " published online in the International Journal of Rare Diseases and Disorders o Highlighted collaboration with Casimir Inc. to capture individual patient experience data from participants in the DESTINY PWS study and its long - term extension study . The publication summarizes the methodology utilized to collect these patient experience data that might not otherwise be captured by existing caregiver reported outcome tools . • Subset of interviews conducted from this study were analyzed utilizing natural language processing to better understand the complexities of PWS behaviors and outcomes . Results presented at the Pediatric Academic Societies ( PAS ) 2021 Virtual Annual Meeting . • Hosted webinar highlighting DCCR for the treatment of Prader - Willi syndrome at the European Congress on Endocrinology 202 • Webinar , titled " Results from DESTINY PWS , a Randomized Double - Blind Placebo - Controlled Phase 3 Study in Subjects with Prader - Willi Syndrome , " featured presentations by PWS key opinion leaders from France and the UK . • Participated in the Oppenheimer Rare & Orphan Disease Summit • Received Orphan Drug Designation from the FDA for DCCR for the treatment of Glycogen Storage Disease Type 1a ( GSD 1a ) , or von Gierke disease 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 Six Months Ended June 30 , 2021 Research and development expenses for the three and six months ended June 30 , 2021 , were $ 5.6 million and $ 12.8 million , compared to $ 6.1 million and $ 12.8 million for the same periods of 2020. 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 six months ended June 30 , 2021 , were $ 2.5 million and $ 5.4 million , compared to $ 2.2 million and $ 4.3 million for the same periods of 2020. The increase was primarily related to increased personnel - related costs .