Soleno Therapeutics, Inc. · NASDAQ:SLNO
Soleno Therapeutics — Capnia — Merger or Acquisition (January 2017)
23 slides from Soleno Therapeutics's merger presentation, Jan 17, 2017
Slide 1: Corporate Presentation January 2017
NASDAQ: CAPN www.capnia.com Corporate Presentation January 2017
Slide 2: Certain Notices and Disclaimers
Certain Notices and Disclaimers Forward-Looking Statements This presentation contains forward-looking statements that are subject to many risks and uncertainties. Forward looking statements appear in a number of places throughout this presentation and include statements regarding our intentions, bel
Slide 3: Highlights
Highlights Capnia and Essentialis to Merge Creating a rare disease therapeutics company Initial focus on PWS, a high unmet need indication with no approved treatments Compelling product profile Addresses hallmark symptoms of PWS, including hyperphagia Phase 2/3 ready Established, decades-long safety
Slide 4: Post Merger Leadership Team
Post Merger Leadership Team Anish Bhatnagar, M.D. Chief Executive Officer David O’Toole Chief Financial Officer Neil Cowen, Ph.D.1 Senior VP of Drug Development Kristen Yen, M.S. VP of Clinical Operations Patricia Hirano, M.P.H. Regulatory Affairs 1 Currently serves as Chief Scientific Officer of Es
Slide 5: Prader-Willi Syndrome (PWS)
Prader-Willi Syndrome (PWS) Complex genetic neurobehavioral/metabolic disorder due to the loss or lack of expression of a set of genes on chromosome 15 Afflicts about 1:15,000-1:25,000 individuals Elevated mortality rates Highest unmet needs hyperphagia aggressive behaviors body composition PWS fami
Slide 6: Diazoxide – Long History of Safe Use; DCCR Data
Diazoxide – Long History of Safe Use DCCR – Extensive Pre-Clinical and Clinical Data Diazoxide I.V., Oral Capsule, and Oral Suspension KATP channel agonist approved in 1976 Previously used as IV treatment for malignant hypertension BID/TID oral suspension for the treatment of hypoglycemia due to hyp
Slide 7: Potential DCCR Modes of Action
Potential DCCR Modes of Action Hypothalamus Restores insulin and leptin sensitivity to POMC and NPY/AgRP neurons normalizing their regulation Blunts central starvation signal Adipocytes Reduces fat mass Down-regulates de-novo fatty acid biosynthesis and upregulates β-oxidation of fat CNS Reduces agg
Slide 8: PC025 Pilot Study in PWS
PC025 Pilot Study in PWS Randomized, Withdrawal, Single Center Trial of DCCR in overweight or obese, genetically-confirmed PWS patients between 10 and 22 years 6 months Open-label extension N=5 Screening Open Label Treatment Phase N=13 Double-Blind, Placebo-Controlled, Randomized Withdrawal Phase N=
Slide 9: DCCR: Significant Hyperphagia Response
DCCR: Significant Hyperphagia Response DCCR Open-Label Treatment Phase 0 p=0.003 ANOVA p=0.08 Mann- Whitney p=0.027 Hyperphagia was measured using a modified Dykens hyperphagia questionnaire, which assesses a range of PWS-specific food-related behaviors Placebo Double-Blind Treatment Phase Presented
Slide 10: DCCR Impacts Fat/Lean Body Mass
DCCR Impacts Fat/Lean Body Mass Fat Mass Lean Body Mass LBM/FM p=0.011 p=0.002 p=0.002 “The impact on fat mass and lean body mass are huge, especially in the context of improvements in hyperphagia” - Dr. Jennifer Miller, University of Florida Presented by Essentialis at the Annual Meeting of the Fou
Slide 11: DCCR Reduces Aggressive Behaviors
DCCR Reduces Aggressive Behaviors “From a family standpoint, the behavioral changes are huge. Aggression takes kids out of the home.” - Dr. Theresa Strong, FPWR “These behavioral changes can be life-changing for the family” - Dr. Jennifer Miller, University of Florida Based on the Behavioral Assessm
Slide 12: DCCR Impacts CV Risk Factors
DCCR Impacts CV Risk Factors Open-Label Treatment Phase TG Tot-C HDL-C LDL-C Non- HDL-C p=0.08 p=0.04 p=0.24 p=0.03 p=0.02 TG Tot-C HDL-C LDL-C Non- HDL-C Double-Blind Treatment Phase DCCR Placebo Further improvement with continued DCCR treatment Presented by Essentialis at the Annual Meeting of the
Slide 13: Safety profile of Proglycem in chronic use is well-known
The safety profile of Proglycem in chronic use is well-known In the development of DCCR, there have been no new safety findings The doses of DCCR that will continue in development are at the low end or below the labeled range for Proglycem More than 120,000 patient years of chronic use “The medicati
Slide 14: DCCR Estimated Development Timeline
DCCR Estimated Development Timeline 2017 2018 2019 2020 Phase 2/3 Study Phase 3 Study CMC, Pharm/Tox, Clin Pharm, Regulatory NDA Submission Open label Extension EOP2 meeting FDA guidance meeting
Slide 15: Extensive IP Protection
Extensive IP Protection Issued/Granted Patents US: 3; EU: 3; JP: 1; Also in China, Canada and Australia Several pending applications Expire in 2026 to 2028 Covers composition of matter, formulations, combinations, method of use and method of manufacture Protection in PWS In addition to the protectio
Slide 16: Pipeline – Multiple Orphan Opportunities
Pipeline – Multiple Orphan Opportunities Product Indication US Patient Population Estimate Timing to NDA DCCR Prader-Willi Syndrome 12,500 - 21,000 2020 Upside opportunities for DCCR DCCR Hypothalamic obesity Hypothalamic Obesity 3,750 – 9,700 2022 DCCR Smith-Magenis syndrome Smith-Magenis Syndrome
Slide 17: Capnia Product Portfolio
Capnia Product Portfolio @ CAPNIA MM264revA 7
Slide 18: Diversified, Revenue Generating Product Portfolio
Diversified, Revenue Generating Product Portfolio
Slide 19: Device and Therapeutic Assets
Device and Therapeutic Assets Product Internal Development Sensalyze™ Technology Platform CoSense® ETCO Monitor (Hemolysis) CoSense ETCO Monitor (Sickle Cell Disease) Nitric Oxide Analyzer (Asthma, BPD) Hydrogen/ Methane Analyzer (Malabsorption/lactose intolerance) ETCO2 monitor for NICU Serenz® All
Slide 20: 2017 Priorities and Milestones
2017 Priorities and Milestones 1Q17 – Close merger transaction with Essentialis; complete concurrent $8M financing Mid-2017 – Complete FDA guidance meeting for DCCR 2H17 – Initiate Phase 2/3 clinical study evaluating DCCR for the treatment of PWS 2017 – Explore strategic alternatives for legacy mark
Slide 21: Financial Highlights
Financial Highlights As of September 30, 2016 Assumes an $8 million equity financing completed at the close of the merger transaction. Additional $2.7 million is possible. Cash runway to value creating milestones (millions) Current1 Post-Merger2 Cash $5.4 $11.0 Debt $0 $0 Shares outstanding: Common
Slide 22: Highlights
Highlights Capnia and Essentialis to Merge Creating a rare disease therapeutics company Initial focus on PWS, a high unmet need indication with no approved treatments Compelling product profile Addresses hallmark symptoms of PWS, including hyperphagia Phase 2/3 ready Established, decades-long safety
Slide 23: Thank you.
NASDAQ: CAPN www.capnia.com Thank you.