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Soleno Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full-Year 2022 Financial Results
REDWOOD CITY, Calif., March 21, 2023 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company
About this update from Soleno Therapeutics, Inc.
[{"type":"text","content":"REDWOOD CITY, Calif., March 21, 2023 (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 fourth quarter and full-year ended December 31, 2022. Fourth Quarter 2022 and Recent Corporate Highlights Enrollment is nearing completion in the randomized withdrawal period of Study C602, a long-term treatment study of DCCR (Diazoxide Choline) Extended-Release tablets for the treatment of Prader-Willi syndrome (PWS): 58/63 (>90% of U.S. participants) have been randomized.15/83 (18%) participants are in the U.K., where enrollment is expected to start imminently following recent approval of the protocol from the MHRA.5 of 83 total participants in the study (6%) declined to participate, in line with our expectation of non-participation.Top-line data continue to be expected in third quarter 2023. Entered into Securities Purchase Agreement with leading healthcare investors, Nantahala Capital Management, Abingworth, and Vivo Capital for up to $60 million in gross proceeds to Soleno. The first $10 million is contingent upon announcing last patient enrolled in the randomized withdrawal trial; $15 million upon announcement of positive top-line data; and the potential of up to an additional $35 million following U.S. Food and Drug Administration (FDA) approval of DCCR for the treatment of PWS.Published two peer-reviewed papers featuring results from the previously completed Phase 3 DESTINY PWS (C601) trial of DCCR for PWS: “Chromosomal Microarray Study in Prader-Willi Syndrome,” published in the International Journal of Molecular Sciences, reports microarray analysis performed on chromosomes from 154 individuals enrolled in the trial and can be found here.“Diazoxide Choline Extended-Release Tablet in People with Prader-Willi Syndrome: A Double-Blind Placebo-Controlled Trial,” published in The Journal of Clinical Endocrinology and Metabolism (JCEM), presents comprehensive results from the trial and can be found here. “We are excited that enrollment in the randomized withdrawal phase of Study 602 is nearing completion,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “Importantly, reaching this milestone enables the Company t...