Soleno Therapeutics, Inc. · NASDAQ:SLNO
Soleno Therapeutics — Investor Presentation (August 2025)
21 slides from Soleno Therapeutics's investor presentation, Aug 18, 2025
Slide 1: Corporate Presentation August 2025
Corporate Presentation August 2025 | Soleno Therapeutics Exhibit 99.1
Slide 2: Certain Notices and Disclaimers
| © 2025 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: Strategic Highlights
Soleno Therapeutics (NASDAQ: SLNO) | © 2025 Soleno Therapeutics Strategic Highlights Protected by multiple layers of granted and pending patents Provides composition of matter protection, as well as protection of formulations and method of use Potential for substantial patent term extension to mid-
Slide 4: Prader-Willi Syndrome: A Complex Rare, Genetic Neurobehavioral, Metabolic Disorder
Soleno proprietary quant research Butler MG, et al., Genet Med. 2017 Jun;19(6):635-642. Kayadjanian N et al., PLoS One 2018 Mar 26; 12(3): e0194655 Global survey conducted by the Foundation for Prader-Willi Research Mazaheri MM, et al., J Intellect Disabil Res. 2013 Sep;57(9):861-73. Prader-Willi Sy
Slide 5: FDA Approved March 26, 2025
| © 2025 Soleno Therapeutics FDA APPROVED MARCH 26, 2025 Indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS) Not for Product Promotional Use
Slide 6: Changing What it Means to Live with PWS
Changing What it Means to Live with PWS | © 2025 Soleno Therapeutics VYKAT XR is the first-to-market treatment for hyperphagia in patients with PWS 4 yrs and older Clinical program demonstrated ability to significantly reduce hyperphagia and impact other PWS-related comorbidities VYKAT XR can become
Slide 7: DCCR Phase 3 Clinical Program
DCCR Phase 3 Clinical Program | © 2025 Soleno Therapeutics C601 13-Week Double-Blind Treatment C601 13-Week Double-blind Treatment C602 C602 C614 Open-Label Extension Open-Label Extension Period 16-week Randomized Withdrawal Period 2:1 Randomization N = 127 DCCR N = 85 Placebo N = 42 Completed n = 1
Slide 8: HQ-CT Total Scores Over Time
HQ-CT Total Scores Over Time1, 2 Studies C601, C602-OLE, C602-RWP, and C614 HQ-CT, Hyperphagia Questionnaire for Clinical Trials; OLE, open-label extension; RWP, randomized withdrawal period 1. Gevers E. Long term efficacy of Diazoxide Choline in participants with PWS from the completed C601 (Destin
Slide 9: DCCR Safety Profile
DCCR Safety Profile* Extensive clinical trial safety database with >100 PWS patients treated >1 year >440 total person-years of experience overall Includes patients with >6 years of continuous exposure Safety profile generally consistent with prior experience with DCCR and the known profile of diazo
Slide 10: Scientific Outreach & Community Engagement
Scientific Outreach & Community Engagement | © 2025 Soleno Therapeutics Continued engagement with PWS community, HCPs and PAOs Growing body evidence presented at medical and scientific conferences by key opinion leaders and study physicians Engage and support the PWS community by attending local, st
Slide 11: VYKAT XR Indication Presents a Significant Commercial Opportunity
VYKAT XR Indication Presents a Significant Commercial Opportunity | © 2025 Soleno Therapeutics U.S. PWS Birth Incidence Verified in Claims: Treated People Living With PWS Total Addressable Market (TAM) Diagnosis Rate ~85% of diagnoses are made within the first year of life1 Total On-label Addressabl
Slide 12: Pathway to Successful US Launch of VYKAT XR
Pathway to Successful US Launch of VYKAT XR | © 2025 Soleno Therapeutics Comprehensive Access Strategy Rare Disease & Launch Capabilities Differentiated formulation Efficacy observed in multiple aspects of the disease in clinical trials ~5 years of response in clinical trial data Well characterized
Slide 13: Launch Strategy Requires Specific Considerations for Different Age Groups
Soleno proprietary quant research ICD10 claims data Launch Strategy Requires Specific Considerations for Different Age Groups | © 2025 Soleno Therapeutics Onset of hyperphagia and increasing disruptive PWS-related behaviors Caregivers and families are actively engaged in care (~4 visits/year)1 Major
Slide 14: Broad Reimbursement Supported by Clear Clinical Value Proposition
Broad Reimbursement Supported by Clear Clinical Value Proposition for VYKAT XR | © 2025 Soleno Therapeutics Communicate compelling value proposition to gain payer coverage Urgent need for hyperphagia treatment: severe burden and high mortality rate Rare disease with small patient numbers leading to
Slide 15: Soleno One Provides End-to-End Patient Support
Soleno OneTM Provides End-to-End Patient Support | © 2025 Soleno Therapeutics Limited Distribution Model Soleno OneTM live Day 1 of Launch First prescription sent by April 14th 1-833-SOLENO-1 Access. Education. Resources. Not for Product Promotional Use
Slide 16: First and only approved treatment for hyperphagia in PWS
| © 2025 Soleno Therapeutics First and only approved treatment for hyperphagia in individuals 4 years of age and older with PWS Approval based on comprehensive clinical trial program Key elements of VYKAT XR label No exclusions for severity of hyperphagia No Boxed Warning No Risk Evaluation and Miti
Slide 17: Launch to End of Q2 2025 Performance Metrics
Received 646 start forms Number of new prescribers: 295 ~100 million Lives Covered 1 2 3 Launch to End of Q2 2025 Performance Metrics Not for Product Promotional Use Launch Metrics as of End of Day June 30, 2025 | © 2025 Soleno Therapeutics 5.2 % adverse event related discontinuations as of August 1
Slide 18: Significant Opportunity in Europe
Significant Opportunity in Europe Confirmed high unmet need Strong thought leader support Concentrated market driven by centers of excellence Estimated ~9,500 people living with PWS in EU4 and UK1 In May 2025, we announced submission and EMA validation of MAA | © 2025 Soleno Therapeutics United King
Slide 19: Extensive IP Protection
Extensive IP Protection | © 2025 Soleno Therapeutics Three families of patents prosecuted in major pharma markets – primary cases in all three issued Uses of pharmaceutical formulations of KATP channel activators PWS relevant claims: treatment of hyperphagia in PWS with diazoxide 20-Year Expiration
Slide 20: Financial Highlights
Financial Highlights Fully Diluted Share Count June 30, 2025 Cash in millions Pro forma cash1 $509.5 Debt $50.0 Cash, cash equivalents and investments 1 Includes marketable securities and $215.7m from July 2025 public offering June 30, 2025 In millions Common stock 50.4 Pre-funded warrants 0.3 March
Slide 21: Soleno Therapeutics
Corporate Presentation August 2025| Soleno Therapeutics
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