Core Insights - Soleno Therapeutics, Inc. announced poster presentations for its VYKAT XR clinical development program at the Pediatric Endocrine Society Meeting 2025, focusing on hyperphagia treatment in Prader-Willi syndrome (PWS) [1][2] Group 1: Company Overview - Soleno Therapeutics is a biopharmaceutical company dedicated to developing novel therapeutics for rare diseases [10] - The company's first commercial product, VYKAT XR, is a once-daily oral treatment for hyperphagia in individuals aged 4 years and older with PWS [10] Group 2: Product Information - VYKAT XR (diazoxide choline) was approved by the U.S. FDA on March 26, 2025, and is now available for U.S. patients [4] - The product is indicated for treating hyperphagia associated with PWS [4] Group 3: Clinical Research - Presentations at PES 2025 include studies on long-term administration of VYKAT XR and its effects on lean body mass and behavioral symptoms in PWS [2][3] - The studies highlight significant improvements in hyperphagia and behavioral symptoms upon resuming treatment after a randomized withdrawal period [2]

Title: The Burden of Prader-Willi Syndrome on Patients and the Healthcare System: A Cross-Sectional Examination of Emergency Department Visits and Inpatient Stays in US claims Format: Poster Session: Poster Session 4 Date/Time: May 15, 6:00 - 7:00 PM ET Presenter: Raj Gandhi, PharmD MBA REDWOOD CITY, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that it ...

Core Insights - Soleno Therapeutics, Inc. announced the presentation of data from its VYKAT XR clinical development program for treating hyperphagia associated with Prader-Willi syndrome (PWS) at the upcoming Joint Congress of ESPE and ESE Meeting 2025 [1][2] Company Overview - Soleno Therapeutics is focused on developing and commercializing novel therapeutics for rare diseases, with its first commercial product being VYKAT XR, an oral treatment for hyperphagia in patients aged 4 years and older with PWS [10] Product Information - VYKAT XR (diazoxide choline) was approved by the FDA on March 26, 2025, and is now available to U.S. patients [2] - The product is indicated for the treatment of hyperphagia in adults and pediatric patients with PWS [4] Clinical Presentation Details - The company will present a study titled "The Impact of Prader-Willi Syndrome (PWS) on Caregivers and the Healthcare System: A Burden of Illness Study Design" in a poster format on May 11 and May 12, 2025 [2] - An oral presentation titled "Developmental Behaviour Checklist 2 Response and Relationship to Hyperphagia Reductions" is scheduled for May 13, 2025 [6] Understanding Prader-Willi Syndrome - PWS occurs in approximately 1 in every 15,000 live births, characterized by hyperphagia, which can severely impact the quality of life for affected individuals and their families [3] - Additional symptoms include behavioral problems, cognitive disabilities, low muscle tone, and increased risk of co-morbidities such as diabetes and cardiovascular disease [3]

Financial Data and Key Metrics Changes - The company used $32.8 million in cash for operating activities during Q1 2025, ending the period with $290 million in cash, cash equivalents, and marketable securities, down from $318.6 million as of December 31, 2024 [18] - Research and development expenses for Q1 2025 were $13.5 million, compared to $14.6 million in the same period of 2024 [19] - Selling, general, and administrative expenses for Q1 2025 were $29.3 million, up from $8.5 million in Q1 2024 [19] - The net loss for Q1 2025 was approximately $43.8 million, or $0.95 per share, compared to a net loss of $21.4 million, or $0.59 per share, in Q1 2024 [20] Business Line Data and Key Metrics Changes - The company had not yet commercialized VICAT XR in Q1 2025, resulting in no revenue for the period [19] - As of the end of the reporting period, the company received 268 start forms for VICAT XR in 29 business days since FDA approval [14] Market Data and Key Metrics Changes - The addressable market for VICAT XR in the U.S. is estimated at approximately 10,000 individuals diagnosed with Prader Willi syndrome (PWS) [11] - The company estimates that there are about 9,500 patients with PWS in the EU and the UK, with plans to submit a Marketing Authorization Application (MAA) to the EMA in the first half of the year [22] Company Strategy and Development Direction - The company aims to establish VICAT XR as the standard of care for hyperphagia in PWS and is focused on operational excellence and communicating the drug's value proposition [12] - The company is committed to ensuring that VICAT XR is accessible to all eligible patients and has set up a patient services contact point to assist with payer access [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early response from the PWS community to the availability of VICAT XR in the U.S. but cautioned that revenue generation would take time due to the typical lag in commercial launches [24] - The company anticipates modest revenues for Q2 2025 as they navigate the process of converting start forms into actual sales [28] Other Important Information - The company has secured an additional $75 million under a loan agreement to support operations over the next 18 months following the approval of VICAT XR [18] - The company is actively participating in payer outreach to emphasize the complexity of hyperphagia in PWS patients and the need for new therapeutic options [16] Q&A Session Summary Question: How soon can start forms be converted into revenue? - Management indicated that several steps are involved in converting start forms into revenue, and they expect modest revenues for Q2 [28] Question: What percentage of Phase III program patients are reflected in current start forms? - The majority of the 77 patients from the Phase III program have submitted start forms, with 60 of those in the U.S. [33] Question: How does coverage differ on a state-by-state level? - The company is participating in the Medicaid program, with states varying in their timelines for policy decisions [40] Question: What is the competitive landscape for hyperphagia treatments? - The main competitor is ACADIA with Carbitocin, which has faced regulatory challenges, while another competitor is starting a Phase III study [77] Question: How does the company view the European market opportunity? - The company sees significant potential in Europe, with a similar number of PWS patients as in the U.S. and a strong unmet need for treatment [80]

Financial Data and Key Metrics Changes - The company used $32.8 million in cash for operating activities during Q1 2025, ending the period with $290 million in cash, cash equivalents, and marketable securities, down from $318.6 million as of December 31, 2024 [19] - The net loss for Q1 2025 was approximately $43.8 million, or $0.95 per basic and diluted share, compared to a net loss of $21.4 million, or $0.59 per basic and diluted share for the same period in 2024 [21] Business Line Data and Key Metrics Changes - The company generated no revenue for the period as VICAT XR had not yet been commercialized [20] - Research and development expenses for Q1 2025 were $13.5 million, down from $14.6 million in the same period of 2024 [20] - Selling, general, and administrative expenses for Q1 2025 were $29.3 million, up from $8.5 million in Q1 2024, reflecting ongoing investments in personnel and new programs [20] Market Data and Key Metrics Changes - The company identified approximately 12,000 individuals diagnosed with Prader Willi Syndrome (PWS) in the U.S., with about 10,000 representing the total addressable market for VICAT XR [11] - As of the end of the reporting period, the company received 268 start forms in 29 business days since the approval of VICAT XR [13] Company Strategy and Development Direction - The company aims to establish VICAT XR as the standard of care for hyperphagia in PWS and is focused on operational excellence and communicating the drug's value proposition [12] - The company is also progressing regulatory pathways in other geographies, particularly in the EU, where it plans to submit a Marketing Authorization Application (MAA) in the first half of the year [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early response from the PWS community to the availability of VICAT XR in the U.S. but cautioned that there is typically a lag between receiving start forms and recording revenue [24] - The company expects modest revenues in Q2 as it continues to execute a full commercial launch [28] Other Important Information - The company has established Selena One, a single point of contact for patient services, to support caregivers and healthcare providers in overcoming payer access obstacles [18] - The company is committed to ensuring that VICAT XR is available to all eligible patients and that affordability is not a barrier to treatment [17] Q&A Session Summary Question: How soon can start forms be converted into revenue? - Management indicated that there are several steps to convert start forms into revenue, and they anticipate modest revenues for Q2 [28] Question: What percentage of Phase III program patients are reflected in current start forms? - The majority of the 77 patients from the randomized withdrawal period are expected to have submitted start forms, with a focus on converting them [33] Question: How many days of free drug are patients receiving before reimbursement? - Patients are expected to receive a 28-day prescription as part of the bridge program while waiting for reimbursement [35] Question: How do state-level coverage decisions vary? - Coverage decisions can vary significantly by state, with some states uploading VICAT XR into their systems earlier than others [41] Question: What is the competitive landscape for hyperphagia treatments? - The main competitor is ACADIA with Carbitocin, which has faced regulatory challenges, while another competitor is starting a Phase III study [77] Question: What is the potential for VICAT XR in Europe? - The company sees significant opportunity in Europe, with a similar number of PWS patients as in the U.S. and a high unmet need for treatment [80]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36593 Soleno Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 77-0523891 (State or other jurisd ...

Exhibit 99.1 Soleno Therapeutics Provides Update on U.S. Launch of VYKAT(TM) XR and Reports First Quarter 2025 Financial Results REDWOOD CITY, Calif., May 7, 2025 – Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided an update on the U.S. launch of VYKATTM XR and reported financial results for the first quarter ended March 31, 2025. First Quarter 2025 and Recent Corporate Highlights "During the first ...

REDWOOD CITY, Calif., May 07, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided an update on the U.S. launch of VYKAT XR and reported financial results for the first quarter ended March 31, 2025. First Quarter 2025 and Recent Corporate Highlights "During the first quarter of 2025, we achieved the most significant milestone in the history of our company with FDA approval of V ...

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Core Viewpoint - Soleno Therapeutics, Inc. will report its first quarter 2025 financial results and operational highlights on May 7, 2025, followed by a conference call to discuss the results and business operations [1]. Group 1: Financial and Operational Updates - The financial results and operational highlights will be announced after the close of U.S. financial markets on May 7, 2025 [1]. - A conference call and webcast will take place at 4:30 PM Eastern Time on the same day to discuss the results [1][2]. Group 2: Product Information - Soleno's primary product, VYKAT XR, is indicated for treating hyperphagia in adults and pediatric patients aged 4 years and older with Prader-Willi syndrome [3][9]. - VYKAT XR is a once-daily oral treatment, previously known as DCCR [9]. Group 3: Safety Information - VYKAT XR has contraindications for patients with known hypersensitivity to diazoxide or thiazides [4]. - Warnings include the risk of hyperglycemia and fluid overload, necessitating regular monitoring of fasting plasma glucose and signs of edema [5][6]. - Common adverse reactions reported include hypertrichosis, edema, hyperglycemia, and rash [7].