Soleno Therapeutics, Inc. · NASDAQ:SLNO
Soleno Therapeutics — Investor Presentation (January 2020)
26 slides from Soleno Therapeutics's investor presentation, Jan 10, 2020
Slide 1: Corporate Presentation January 2020
Corporate Presentation January 2020 | Soleno Therapeutics Exhibit 99.1
Slide 2: Certain Notices and Disclaimers
| © 2020 Soleno Therapeutics 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
Slide 3: Investment highlights: protected orphan asset in Phase III
Soleno Therapeutics (NASDAQ: SLNO) | © 2020 Soleno Therapeutics Protected by multiple layers of granted and pending patents Provides composition of matter protection, as well as protection of formulations, and method of use Substantial potential for patent term extension IP protection to mid-2030s O
Slide 4: Leadership Team
Leadership Team | © 2020 Soleno Therapeutics Anish Bhatnagar, M.D. Chief Executive Officer Jim Mackaness Chief Financial Officer Neil M. Cowen, Ph.D. Senior VP, Drug Development Revati Shreeniwas, MD VP, Clinical Development Kristen Yen, M.S. VP, Clinical Operations Patricia C. Hirano, M.P.H. VP, Re
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 Birth incidence ~1:15,000 live births Elevated mortality rates; average life expectancy ~30 years Highest unmet needs Hyperphagia Increases in lean
Slide 6: DCCR Once Daily Tablets
DCCR Once Daily Tablets | © 2020 Soleno Therapeutics Tablet formulation of choline salt of diazoxide (diazoxide choline is an NCE) DCCR allows for slow release of diazoxide over 24 hours, and ensures stable levels of free diazoxide Protected by multiple issued patents, including composition of matte
Slide 7: Diazoxide is Not Approved for Use in PWS
| © 2020 Soleno Therapeutics Diazoxide is Not Approved for Use in PWS Use of diazoxide-based dosage forms in PWS blocked by issued Soleno patent claims BID/TID dosing required Rapid absorption → high Cmax Several of the most common adverse events are Cmax-associated Oral KATP channel agonist approve
Slide 8: DCCR Proposed Mechanism of Action
DCCR Proposed Mechanism of Action | © 2020 Soleno Therapeutics Appetite controlled by 2 sets of neurons in the hypothalamus NPY/AgRP: secrete NPY and AgRP, appetite stimulatory neuropeptides POMC: secretes POMC, an appetite suppressive neuropeptide NPY expression is elevated in PWS Loss of SNORD116
Slide 9: Evidence of efficacy in animal models of NPY-associated obesity with hyperphagia
Evidence of efficacy in multiple animal models of NPY-associated obesity with hyperphagia | © 2020 Soleno Therapeutics
Slide 10: DCCR Pilot Study in PWS
DCCR Pilot Study in PWS Randomized, Placebo Withdrawal, Single-Center Study of DCCR in obese, genetically-confirmed PWS patients ages 10 to 22 years Included subjects with mild as well as moderate-to-severe hyperphagia 5 subjects enrolled in a subsequent 6-month open-label extension study | © 2020 S
Slide 11: Hyperphagia Response During Open-Label Treatment
Hyperphagia Response During Open-Label Treatment Greater at Highest Dose and Moderate-Severe Hyperphagia | © 2020 Soleno Therapeutics PLoS One. 2019 Sep 23;14(9):e0221615
Slide 12: Placebo Reverses DCCR Treatment Effect
| © 2020 Soleno Therapeutics Placebo Reverses DCCR Treatment Effect Patients with Moderate-Severe Hyperphagia PLoS One. 2019 Sep 23;14(9):e0221615
Slide 13: DCCR Impacts Body Fat and Lean Body Mass
| © 2020 Soleno Therapeutics DCCR Impacts Body Fat and Lean Body Mass PLoS One. 2019 Sep 23;14(9):e0221615
Slide 14: Waist Circumference
| © 2020 Soleno Therapeutics Waist Circumference Significant Reduction from Baseline-V7 Reduction consistent with a loss of visceral fat. PLoS One. 2019 Sep 23;14(9):e0221615
Slide 15: DCCR Reduces Aggressive Behaviors
| © 2020 Soleno Therapeutics DCCR Reduces Aggressive Behaviors PLoS One. 2019 Sep 23;14(9):e0221615
Slide 16: DCCR Impacts CV Risk Factors
| © 2020 Soleno Therapeutics DCCR Impacts CV Risk Factors PLoS One. 2019 Sep 23;14(9):e0221615
Slide 17: DCCR Safety Consistent with Long History of Safe Use of Diazoxide
| © 2020 Soleno Therapeutics DCCR Safety Consistent with Long History of Safe Use of Diazoxide Safety profile of diazoxide in chronic use is well-known Safety of DCCR consistent with that diazoxide The most common adverse events with DCCR include hyperglycemia and peripheral edema No serious, unexpe
Slide 18: Regulatory Status
Regulatory Status FDA interactions in May 2017 (Type C) and Jan 2018 (EOP2) confirmed key aspects of Phase III development program in PWS Hyperphagia as the primary endpoint HQ-CT as the appropriate tool to assess hyperphagia 3 months as appropriate randomized study duration (safety data in 9 month
Slide 19: Phase III Program Design
| © 2020 Soleno Therapeutics Phase III Program Design Patients randomized in a 2:1 ratio to DCCR or placebo Genetically-confirmed PWS patients who are hyperphagic Study started May 2018, enrollment completed Jan 2020, topline data 1H 2020 Primary endpoint – change in hyperphagia compared to placebo
Slide 20: Phase III Program Update
Phase III Program Update* | © 2020 Soleno Therapeutics DSMB has recommended continuation of C601 study without any change at two pre-defined times during the study 100% PATIENTS ENROLLED >95% 29 ACTIVE SITES PATIENTS EITHER CONTINUING ON STUDY OR HAVE COMPLETED >95% PATIENTS CONTINUING ON STUDY C601
Slide 21: Collaboration with Casimir
Collaboration with Casimir | © 2020 Soleno Therapeutics The FDA’s 21st Century Cures Act defines the importance of individual patient experience to the FDA’s regulatory decision-making process Soleno is collaborating with Casimir, a rare disease research organization, to collect individual patient o
Slide 22: Extensive IP Protection
Extensive IP Protection | © 2020 Soleno Therapeutics Extensive protection of DCCR drug active, drug product, method of manufacture in the treatment of PWS and more generally in syndromic obesity expiring 2025-2035 Composition of matter (potential for extension to 2034 in US and to 2031 in EU) Up to
Slide 23: Pipeline – Other Opportunities for DCCR
Pipeline – Other Opportunities for DCCR | © 2020 Soleno Therapeutics Indication US Population Estimate Prader-Willi syndrome 21,000 – 28,000 Potential Upside Opportunities for DCCR Fragile X-PWS Phenotype 6,700 - 8,500 Prader-Willi Like Syndrome 300 - 500 Smith Magenis Syndrome 21,000 - 28,000 MC4R
Slide 24: Financial Highlights: Financed Through Topline Data
Financial Highlights Financed Through Topline Data Cash Cash balance at end of Q3 2019 $11.2M Additional cash raised through CMPO Oct 2019$14.5M Potential additional cash post Topline Data*$12.0M No Debt Common shares outstanding after CMPO 44.6M Fully Diluted 53.6M | © 2020 Soleno Therapeutics * Po
Slide 25: Investment highlights: protected orphan asset in Phase III
Soleno Therapeutics (NASDAQ: SLNO) | © 2020 Soleno Therapeutics Protected by multiple layers of granted and pending patents Provides composition of matter protection, as well as protection of formulations, and method of use Substantial potential for patent term extension IP protection to mid-2030s O
Slide 26: Soleno Therapeutics
Corporate Presentation January 2020| Soleno Therapeutics
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