Group 1 - Soleno Therapeutics, Inc. will participate in two upcoming investor conferences in June 2025, including the Jefferies Global Healthcare Conference and the Goldman Sachs 46 Healthcare Conference [1] - The Jefferies Global Healthcare Conference presentation is scheduled for June 4, 2025, at 10:30 AM ET, while the Goldman Sachs conference presentation will take place on June 10, 2025, at 8:40 AM ET [1] - Both presentations will be available for replay in the Investors section on the company's website [1] Group 2 - Soleno Therapeutics focuses on developing and commercializing novel therapeutics for rare diseases [2] - The company's first commercial product, VYKAT™ XR (diazoxide choline) extended-release tablets, is designed for treating hyperphagia in individuals with Prader-Willi syndrome aged four years and older [2]

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]

Core Insights - Soleno Therapeutics, Inc. is presenting data on Prader-Willi syndrome (PWS) and its clinical program for VYKAT™ XR at the ISPOR Meeting 2025 [1][2] - VYKAT XR is approved for treating hyperphagia in patients with PWS aged 4 years and older [4][9] Group 1: Presentation Details - The first presentation focuses on mortality rates from a Phase 3 clinical trial of patients with hyperphagia and PWS treated with VYKAT XR, scheduled for May 14 [2] - The second presentation examines the burden of PWS on patients and the healthcare system, highlighting emergency department visits and inpatient stays, scheduled for May 15 [2] Group 2: About Prader-Willi Syndrome - PWS occurs in approximately 1 in 15,000 live births, characterized by hyperphagia, which can severely impact quality of life [3] - Additional symptoms include behavioral issues, cognitive disabilities, low muscle tone, and increased risk of serious health complications [3] Group 3: About VYKAT XR - VYKAT XR was approved by the FDA on March 26, 2025, and is now available for U.S. patients [4] - It is a once-daily oral treatment specifically for hyperphagia in individuals with PWS [9]

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 ...

Core Insights - Soleno Therapeutics achieved FDA approval for VYKAT XR, a treatment for hyperphagia in patients with Prader-Willi syndrome, marking a significant milestone for the company [3][7] - The company reported a net loss of approximately $43.8 million for Q1 2025, compared to a net loss of $21.4 million in the same period of 2024 [11][27] - Soleno is focused on a robust commercial launch of VYKAT XR, with initial interest indicated by 268 patient start forms and 131 unique prescribers [3][7] Financial Results - For the first quarter ended March 31, 2025, Soleno used $32.8 million in cash for operating activities and had $290.0 million in cash, cash equivalents, and marketable securities [5] - Research and development expenses were $13.5 million, a decrease from $14.6 million in Q1 2024, while selling, general, and administrative expenses rose to $29.3 million from $8.5 million in the same period last year [6][8] - The company incurred a contingent liability of $17.8 million related to potential cash payments to former Essentialis stockholders upon achieving certain sales milestones for VYKAT XR [9] Product Launch and Market Engagement - VYKAT XR was launched on April 14, 2025, following FDA approval on March 26, 2025, and the company is actively engaging with payers to establish broad access for patients [4][7] - The Marketing Authorization Application (MAA) for VYKAT XR is on track for submission to the European Medicines Agency (EMA) in Q2 2025 [7] Stock-Based Compensation - The company recognized $14.7 million in stock-based compensation expenses for Q1 2025, compared to $6.4 million in Q1 2024, with a significant portion attributed to performance-based RSU grants [6][29]

Core Viewpoint - The article emphasizes the importance of identifying and maintaining trends in short-term investing, highlighting that sound fundamentals and positive earnings estimates are crucial for sustaining momentum in stocks [1]. Group 1: Stock Screening and Selection - The "Recent Price Strength" screen is a unique short-term trading strategy that helps identify stocks with strong fundamentals capable of maintaining an uptrend [2]. - Stocks that pass this screen are typically trading in the upper portion of their 52-week high-low range, indicating bullish sentiment [2]. Group 2: Soleno Therapeutics, Inc. (SLNO) - Soleno Therapeutics has shown a significant price increase of 52.3% over the past 12 weeks, indicating strong investor interest [3]. - The stock has also increased by 9.8% over the last four weeks, suggesting that the upward trend is still intact [4]. - SLNO is currently trading at 99.7% of its 52-week high-low range, indicating a potential breakout [4]. Group 3: Fundamental Strength - SLNO holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises [5]. - The Zacks Rank system has a strong track record, with Zacks Rank 1 stocks averaging a +25% annual return since 1988 [6]. - The Average Broker Recommendation for SLNO is 1 (Strong Buy), reflecting high optimism from the brokerage community regarding its near-term price performance [6]. Group 4: Additional Investment Opportunities - Besides SLNO, there are other stocks that meet the criteria of the "Recent Price Strength" screen, suggesting further investment opportunities [7]. - The article encourages exploring over 45 Zacks Premium Screens tailored to different investing styles for potential stock picks [7].