Core Viewpoint - Soleno Therapeutics, Inc. has announced a public offering of 2,352,941 shares of common stock priced at $85.00 per share, aiming to raise approximately $200 million before expenses [1][3]. Group 1: Offering Details - The public offering consists of 2,352,941 shares, with an additional 30-day option for underwriters to purchase up to 352,941 more shares at the same price [1]. - The offering is expected to close on or about July 11, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds will primarily fund the commercialization of VYKAT XR, the first approved therapy for hyperphagia in Prader-Willi syndrome, which received FDA approval on March 26, 2025 [3]. - Additional proceeds will support regulatory and market development activities in the EU, further R&D efforts, and general corporate purposes, including working capital and potential acquisitions [3]. Group 3: Underwriters - Goldman Sachs & Co. LLC, Guggenheim Securities, TD Cowen, Cantor, and Oppenheimer & Co. are serving as joint book-running managers for the offering [2]. Group 4: Company Overview - Soleno Therapeutics focuses on developing novel therapeutics for rare diseases, with VYKAT XR being its first commercial product aimed at treating hyperphagia in individuals aged 4 and older with Prader-Willi syndrome [6].

Core Viewpoint - Soleno Therapeutics, Inc. plans to offer and sell $200 million of its common stock in an underwritten public offering, with an additional option for underwriters to purchase up to $30 million more [1][2]. Group 1: Offering Details - The public offering is subject to market conditions, and there is no assurance regarding the completion or terms of the offering [1]. - Goldman Sachs & Co. LLC and Guggenheim Securities are acting as the joint book-running managers for the offering [2]. - The shares will be offered under a registration statement previously filed with the SEC, and a preliminary prospectus will be made available [4]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to fund the commercialization of VYKAT™ XR, the first approved therapy for hyperphagia in Prader-Willi syndrome, which received FDA approval on March 26, 2025 [3]. - Proceeds will also support regulatory and market development activities in the EU, further R&D efforts, and general corporate purposes, including working capital and potential acquisitions [3][6].

Core Insights - Soleno Therapeutics, Inc. announced preliminary unaudited financial and operational results for the three months ended June 30, 2025, indicating ongoing financial review processes that may alter the reported figures [1][5] Financial Performance - Estimated net revenue from sales of VYKATTM XR for the three months ended June 30, 2025, is projected to be between $31.0 million and $33.0 million, based on specific assumptions regarding Medicare/Medicaid rebates and other factors [5] - As of June 30, 2025, Soleno reported approximately $293.8 million in cash, cash equivalents, and marketable securities [5] - The company had approximately $50.0 million of debt outstanding under its loan and security agreement with Oxford Financing LLC and its affiliates as of June 30, 2025 [5] Product Development - Soleno's first commercial product, VYKATTM XR, is a once-daily oral treatment for hyperphagia in individuals with Prader-Willi syndrome, approved on March 26, 2025 [2] - The company received approximately 646 patient start forms from about 295 unique prescribers between the product's approval date and June 30, 2025 [5]

Core Insights - Soleno Therapeutics, Inc. announced the selection of two abstracts for presentation at the Annual Meeting of the Endocrine Society (ENDO 2025) regarding VYKAT™ XR (diazoxide choline) extended-release tablets, aimed at treating hyperphagia in individuals with Prader-Willi syndrome [1][2] Company Overview - Soleno Therapeutics is focused on developing and commercializing novel therapeutics for rare diseases, with VYKAT XR being its first commercial product [10] - VYKAT XR was approved by the U.S. FDA on March 26, 2025, and is now available for patients in the U.S. [3] Product Information - VYKAT XR is indicated for treating hyperphagia in adults and pediatric patients aged 4 years and older with Prader-Willi syndrome [3] - The product's safety information includes contraindications for patients with known hypersensitivity to diazoxide or thiazides [4] Presentation Details - The first presentation at ENDO 2025 will focus on the glycemic outcomes of VYKAT XR in treating hyperphagia over four years [2] - The second presentation will characterize peripheral edema in individuals with Prader-Willi syndrome during long-term administration of VYKAT XR over 4.5 years [6] Health Implications - Prader-Willi syndrome is a rare genetic disorder affecting approximately 1 in 15,000 live births, characterized by hyperphagia, which can lead to severe health complications [2] - The treatment with VYKAT XR aims to address the life-threatening aspects of hyperphagia and improve the quality of life for affected individuals [2]

Core Insights - Soleno Therapeutics presented new data on VYKAT XR (diazoxide choline) extended-release tablets at the 2025 International Prader-Willi Syndrome Conference, highlighting its potential benefits for individuals with Prader-Willi Syndrome (PWS) [1][2] Group 1: Efficacy of VYKAT XR - VYKAT XR significantly reduces hyperphagia symptoms in PWS patients managed with strict food controls, showing statistically significant reductions in HQ-CT Total scores (p ≤ 0.0001) [5] - Participants in highly food-restricted environments benefited from VYKAT XR treatment similarly to those in less restricted environments, indicating broad applicability of the treatment [5] Group 2: Safety and Efficacy in Co-Morbid Conditions - 60% of study participants had evidence of pre-diabetes or diabetes (PD/DM) at baseline, with efficacy outcomes at Week 156 showing similar results for both PD/DM and normoglycemic groups (p<0.0001) [7] - Although a higher proportion of hyperglycemia-related adverse events were reported in the PD/DM group (42.7% vs 24.0%), these events were generally manageable, and treatment discontinuation rates were low (4.0% in PD/DM vs 6.0% in normoglycemic) [8][9] Group 3: Background on Prader-Willi Syndrome - Prader-Willi Syndrome is a rare genetic neurodevelopmental disorder affecting approximately 1 in every 15,000 live births, characterized by hyperphagia, which can lead to severe health complications [10][11] - Hyperphagia in PWS can result in significant mortality and long-term co-morbidities such as diabetes, obesity, and cardiovascular disease [12] Group 4: Product Information - VYKAT XR was approved by the FDA on March 26, 2025, and is indicated for the treatment of hyperphagia in adults and pediatric patients aged 4 years and older with PWS [13][18]

Core Viewpoint - Soleno Therapeutics, Inc. is actively participating in the 2025 United In Hope: International Prader-Willi Syndrome Conference, showcasing its commitment to advancing research and improving the lives of individuals affected by Prader-Willi syndrome (PWS) through multiple presentations [1][3]. Company Overview - Soleno Therapeutics focuses on developing novel therapeutics for rare diseases, with its first commercial product, VYKAT™ XR (diazoxide choline) extended-release tablets, recently approved by the FDA on March 26, 2025 [11]. Conference Participation - The conference, anticipated to be the largest focused on PWS, is a collaboration between the Prader-Willi Syndrome Association | USA, the Foundation for Prader-Willi Research, and the International Prader-Willi Syndrome Organisation [2]. - Soleno will present one oral and six poster presentations, highlighting the significance of data and advocacy in addressing the needs of the PWS community [1][3]. Presentation Details - Key presentations include: - "Swallowability and Dosing Compliance of Diazoxide Choline Extended-Release (DCCR) Tablets in Patients with Prader-Willi Syndrome" [4]. - "Diazoxide Choline Extended-Release (DCCR) Tablets Significantly Reduce Hyperphagia in Patients with PWS Who Are Managed with Strict Food Controls" [4]. - "Long-term Efficacy Results of Diazoxide Choline Extended-Release (DCCR) Tablets in Participants with Prader-Willi Syndrome" [7]. - Presenters include experts from Queen Mary University of London and the University of Florida, indicating a strong academic collaboration [4][7][8]. About Prader-Willi Syndrome - PWS is a rare genetic neurodevelopmental disorder affecting approximately one in every 15,000 live births, characterized by hyperphagia, which can lead to severe health complications [9][10].

Group 1: Conference Overview - The 2025 United In Hope: International Prader-Willi Syndrome Conference is the first-ever international meeting jointly hosted by the Prader-Willi Syndrome Association | USA, the Foundation for Prader-Willi Research, and the International Prader-Willi Syndrome Organisation [1][2] - The conference is expected to be the largest focused on Prader-Willi syndrome (PWS) ever held, taking place from June 24-28, 2025, in Phoenix, AZ [2] Group 2: Company Involvement - Soleno Therapeutics, Inc. announced one oral and six poster presentations at the conference, highlighting its commitment to advancing research and improving the lives of those impacted by PWS [1][3] - The company's first commercial product, VYKAT™ XR (diazoxide choline) extended-release tablets, was approved by the U.S. FDA on March 26, 2025, for the treatment of hyperphagia in individuals with PWS [8] Group 3: Presentation Details - The oral presentation will cover long-term efficacy results of diazoxide choline extended-release tablets in participants with PWS from completed studies, presented by Evelien Gevers [4] - Multiple poster presentations will address various aspects of diazoxide choline extended-release tablets, including swallowability, dosing compliance, and the emotional impact of hyperphagia [4][5] Group 4: About Prader-Willi Syndrome - Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in gene expression on chromosome 15, occurring in approximately one in every 15,000 live births [6][7] - The defining symptom of PWS is hyperphagia, which can lead to severe health issues and significantly diminish the quality of life for affected individuals and their families [7]

Summary of Celeno Therapeutics Conference Call Company Overview - Celeno Therapeutics is based in Redwood Shores, San Francisco Bay Area, with approximately 140 employees and rapid growth [1] - The company has a single asset, DCCR (Dizoxidicholine Extended Release Tablets), now known as VICAT XR, approved by the FDA for treating hyperphagia in patients with Prader Willi syndrome (PWS) aged four years and older [1][6] Industry Context - Prader Willi syndrome (PWS) is a rare genetic neurobehavioral metabolic disorder occurring in about 1 in 15,000 births [3] - The hallmark symptom of PWS is hyperphagia, characterized by an insatiable desire to eat, leading to severe health risks and caregiver burdens [4][5][6] Clinical Development and Efficacy - VICAT XR is the first treatment approved for hyperphagia in PWS, with a clinical program demonstrating significant reduction in hyperphagia [7] - The clinical trials began in 2018, with the primary endpoint readout in June 2020 showing no statistical significance, attributed to COVID-19 impacts [8][9] - A subsequent randomized withdrawal phase in September 2023 yielded statistically significant results, indicating the drug's effectiveness [9][10] Safety Profile - The safety profile of DCCR is consistent with its parent molecule, diazoxide, with common adverse events including hypertrichosis, edema, and hyperglycemia, typically self-limiting [12] - Only two severe adverse events reported during the clinical program [12] Commercial Opportunity - The estimated market opportunity for VICAT XR in the US is over $2 billion, with approximately 12,000 individuals living with PWS in the US and an addressable market of about 10,000 patients [13][14] - A concentrated group of 300 healthcare providers (HCPs) primarily treats 2,100 PWS patients, providing a focused commercial strategy [15] Launch Strategy - The launch strategy for VICAT XR includes a robust clinical program, a strong commercial team, and deep engagement with payers and the PWS community [15][16] - The company has established a field force team with experience in rare disease launches and is working closely with payers to ensure coverage [16][20] Payer Engagement - Payers are receptive to the value proposition of VICAT XR, recognizing the urgent need for hyperphagia treatment and the drug's efficacy [20] - The company offers SILONO-one for end-to-end patient support, ensuring access to the drug and educational resources [21] European Market Potential - PWS is a global condition, with an estimated 9,500 individuals living with PWS in the EU, presenting a strong opportunity for VICAT XR [23] - The company has submitted a Marketing Authorization Application (MAA) to the EMA, with validation announced in May 2025 [24] Financial Highlights - Celeno Therapeutics reported a strong balance sheet with $290 million in cash at the end of Q1, allowing for the execution of its commercial strategy [2][25] - The company has 55 million shares outstanding and minimal debt [25]

Soleno Therapeutics (SLNO) FY 2025 Annual General Meeting June 05, 2025 11:00 AM ET Speaker0 Hello and welcome to the Soleno Therapeutics Inc. Twenty twenty five Annual Meeting of Stockholders. Please note that this meeting is being recorded. Questions may be submitted via the message icon at the top left of your screen by typing your message, then clicking the send icon to the right of the message box. The meeting is about to begin. Good morning, ladies and gentlemen. I am Jim MacInnes, Chief Financial Off ...

Summary of Soleno Therapeutics (SLNO) Conference Call Company Overview - **Company Name**: Soleno Therapeutics - **Location**: Redwood City, California, San Francisco Bay Area - **Employee Count**: Approximately 40, up from 20 in the past 18 months [1] Industry and Product Information - **Industry**: Biotechnology, specifically focused on rare genetic diseases - **Product**: VICAT XR - **Indication**: Treatment of hyperphagia in patients with Prader Willi Syndrome (PWS) aged four years and older - **Market Opportunity**: Estimated commercial opportunity greater than $2 billion in the U.S. and significant potential outside the U.S. [2] Disease Background - **Prader Willi Syndrome (PWS)**: - Genetic, neurobehavioral, and metabolic disorder occurring in 1 in 15,000 live births - Characterized by low muscle tone at birth, leading to severe hyperphagia and behavioral issues as patients grow older [3][4][6] - Patients often require significant family support, leading to high divorce rates and PTSD in unaffected siblings [10] Clinical Development and Approval - **Approval Process**: - Based on a long phase three program with breakthrough and fast track designations - First drug approved for PWS since the disease was described in 1956 [11][12] - **Clinical Trials**: - Initial study (c six zero one) did not meet primary endpoints but subsequent analysis excluding COVID-affected data showed significant efficacy [15][17] - Randomized withdrawal study demonstrated significant worsening in placebo patients, supporting FDA submission [17][33] Safety and Efficacy - **Efficacy**: - Hyperphagia scores improved from a median baseline of 23 to 9 after treatment [16][18] - Strong evidence of efficacy with a significant p-value of 0.002 in randomized withdrawal data [17] - **Safety Profile**: - Generally consistent with the parent molecule, with common adverse events being mild and self-limiting [20] - Notable adverse events include erythema multiforme and diabetic ketoacidosis [21] Market Dynamics - **Patient Population**: - Estimated 12,000 patients in the U.S. with a total addressable market (TAM) of about 10,000 [23][24] - High diagnosis rates (85-90%) in the Western world [25] - **Commercial Strategy**: - Strong analytics and field force teams with rare disease experience - Early engagement with payers and advocacy groups to facilitate understanding and acceptance of the drug [27][28] Competitive Landscape - **Competitors**: - ACADIA's carbitosin and Aardvark's bitter taste receptor drug are in late-stage development [40][42] - ACADIA's previous attempts faced regulatory challenges, while Aardvark's data is considered less interpretable [41][43] Financial Position - **Balance Sheet**: - Approximately $290 million in cash at the end of the last quarter, including $50 million in debt [3][39] Regulatory and Intellectual Property - **IP Protection**: - Significant intellectual property protection expected to last into the late 2030s [38] Conclusion - **Launch Strategy**: - Positioned to become the standard of care for PWS with no exclusions for severity of hyperphagia and no contraindications [35] - Initial launch metrics indicate a broad-based prescription paradigm, which is promising for future growth [36][37]