October 23, 2017 11:19 AM ET

Biotechnology

Company Overview of Soleno Therapeutics, Inc.

Company Overview

Soleno Therapeutics, Inc. focuses on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company’s lead candidate, diazoxide choline controlled-release (DCCR), a once-daily oral tablet for the treatment of Prader-Willi Syndrome (PWS), is entering into Phase II/III clinical development. It also markets medical devices, including the CoSense End-Tidal Carbon Monoxide (ETCO) monitor, which measures ETCO and is used by hospitals to detect hemolysis in newborns; and NeoPip T-piece resuscitator and related consumables, which deliver consistent pre-set inspiratory pressure and positive end-expiratory pressures, as well as temperature probes, scales, s...

1235 Radio Road

Suite 110

Redwood City, CA 94065

United States

Founded in 1999

20 Employees

Phone:

650-213-8444

Fax:

650-213-8383

Key Executives for Soleno Therapeutics, Inc.

President, CEO, Interim Principal Financial & Accounting Officer and Director
Age: 47
Total Annual Compensation: $460.0K
Senior Vice President of Research and Development
Age: 55
Total Annual Compensation: $266.5K
Consultant
Age: 58
Total Annual Compensation: $300.0K
Compensation as of Fiscal Year 2016.

Soleno Therapeutics, Inc. Key Developments

Soleno Therapeutics Announces Updated Safety and Efficacy Data from Clinical Trial of DCCR for Treatment of Prader-Willi Syndrome

Soleno Therapeutics, Inc. announced that updated safety and efficacy data from the pilot clinical trial of Diazoxide Choline Controlled Release Tablet (DCCR) for the treatment of Prader-Willi syndrome (PWS) were the subject of a poster presentation at the 10th International Meeting of Pediatric Endocrinology, being held September 14-17 in Washington, D.C. The data were presented by Virginia Kimonis, M.D., Division of Genetics and Metabolism, School of Medicine, University of California, Irvine, and Principal Investigator of the trial. The purpose of the study was to assess the safety and efficacy of multiple dose levels of DCCR in subjects ages 10-22 years with genetically-confirmed PWS. The study consisted of a 10-week open-label treatment phase, during which subjects were escalated from 1.5 mg/kg to a maximum of 5.1 mg/kg of DCCR and then treated stably for the remainder of the phase. Subjects with an improvement in hyperphagia and/or an increase in resting energy expenditure during the open-label phase were classified as responders and were eligible to enter a 4-week double-blind placebo-controlled withdrawal treatment phase, in which they were randomized to DCCR or placebo. Thirteen subjects were enrolled; 11 subjects completed the open-label phase, were classified as responders and randomized into the double-blind phase. Key efficacy results included a significant improvement from baseline in hyperphagia (mean baseline score = 15 out of possible scores of 0-34) starting within two weeks of DCCR treatment. As previously reported, a highly statistically significant reduction (-4.32, p=0.0055) was seen in hyperphagia from baseline to the end of the open-label treatment phase. In addition, greater improvement in hyperphagia from baseline was observed in those subjects with moderate to severe hyperphagia who received DCCR doses ≥ 4.2 mg/kg (the planned population and target dose for the Phase III study) with a reduction of -7.83 (n =3). A significant improvement in the number of subjects reporting one or more aggressive and destructive behaviors was seen (p=0.006). During the open-label treatment phase, a mean decrease in body fat mass (p=0.02) and increases in lean body mass (p=0.003) and lean body mass /fat mass ratio (p=0.004) were seen. These changes were associated with a statistically significant reduction in waist circumference (-3.45 cm, p=0.006), consistent with the loss of visceral fat. Leptin levels were significantly decreased (p=0.007) from baseline, while ghrelin levels remained unchanged (p=0.93). The safety profile of DCCR in this study was consistent with the known profile of diazoxide. The most commonly reported treatment-emergent adverse events observed are also common in PWS patients, including glycemic impacts, peripheral edema, upper respiratory tract infections, constipation, and somnolence. Insulin sensitivity as measured by reduction HOMA-IR was improved. DCCR has Orphan Designation for the treatment of PWS in the U.S.

Soleno Therapeutics, Inc. Announces Executive Changes

On August 29, 2017, David O’Toole, Senior Vice President, Chief Financial Officer of Soleno Therapeutics, Inc. notified the company of his decision to resign from employment with the company, effective September 11, 2017. Mr. O'Toole will serve as a consultant to the company to provide support during the transition period. Mr. O'Toole and the company intend to enter into a consulting agreement in connection with Mr. O'Toole's transition. Under the terms of the O'Toole Agreement, Mr. O'Toole agreed to provide limited transition services as reasonably requested by the Company. The foregoing description of the O'Toole Agreement is qualified in its entirety by reference to the full text of the agreement, which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ending December 31, 2017. Mr. Jonathan Wolter, a partner at FLG Partners LLC will serve as the company’s interim Chief Financial Officer. Mr. Wolter will provide financial consulting services until the Company completes its search for a new Chief Financial Officer. Since January 2016, Mr. Wolter has acted as consulting CFO for DigiSight Technologies, Inc. and from July 2011 through December 2015, acted as Vice President, Chief Financial Officer for Palo Alto Research Center.

Soleno Therapeutics, Inc. Announces Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2017

Soleno Therapeutics, Inc. announced unaudited consolidated earnings results for the second quarter and six months ended June 30, 2017. For the quarter, the company reported product revenue of $0.001 million compared to $0.002 million a year ago. Operating loss was $3.210 million compared to $2.295 million a year ago. Net loss from continues operation attributable to the shareholders was $3.239 million or $0.06 per basic and diluted share compared to $2.367 million or $0.15 per basic and diluted share a year ago. Net loss was $3,966 million or $0.07 per basic and diluted share compared to $3,513 million or $0.22 per basic and diluted share a year ago. For the six months, the company reported product revenue of $0.004 million compared to $0.002 million a year ago. Operating loss was $4.785 million compared to $5.323 million a year ago. Net loss from continues operation attributable to the shareholders was $5.486 million or $0.14 per basic and diluted share compared to $4.340 million or $0.29 per basic and diluted share a year ago. Net loss was $6,856 million or $0.17 per basic and diluted share compared to $6,702 million or $0.45 per basic and diluted share a year ago.

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