Soleno used $12.6 million of cash in its operating activities during the three months ended June 30, 2025, and had $293.8 million of cash, cash equivalents and marketable securities as of the end of the quarter. Cash as of the end of the second quarter excludes $230 million of gross proceeds that the company raised in July through an underwritten offering of common stock. Product revenue, net was $32.7 million for the three months ended June 30, 2025. VYKAT XR had not been approved or commercially launched ...

| Date: | Wednesday, August 6, 2025 | | --- | --- | | Time: | 4:30 PM Eastern Time | | United States: | 1-800-717-1738 | | International: | 1-646-307-1865 | | Conference ID: | 96180 | | Webcast: | Link | The conference call will be broadcast live and will be available for replay for 30 days on the Company's website, www.soleno.life. INDICATION REDWOOD CITY, Calif., July 28, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. ("Soleno") (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics ...

Company Overview - Soleno Therapeutics, Inc. (SLNO) currently holds a Momentum Style Score of A, indicating strong potential for momentum investing [3][12] - The company has a Zacks Rank of 2 (Buy), suggesting favorable market performance [4][12] Price Performance - SLNO shares have increased by 6.91% over the past week, while the Zacks Medical - Drugs industry has decreased by 0.38% during the same period [6] - Over the past quarter, SLNO shares have risen by 17.34%, and they have gained 87.5% over the last year, outperforming the S&P 500's increases of 16.43% and 18.63%, respectively [7] Trading Volume - The average 20-day trading volume for SLNO is 1,461,273 shares, which is a useful indicator of market interest and price movement [8] Earnings Outlook - In the past two months, three earnings estimates for SLNO have been revised upwards, while none have been revised downwards, leading to an increase in the consensus estimate from -$3.09 to -$2.33 [10] - For the next fiscal year, two estimates have moved upwards with no downward revisions, indicating positive sentiment regarding future earnings [10]

Group 1 - Soleno Therapeutics, Inc. (SLNO) shares have increased by 2.2% over the past four weeks, closing at $86.02, with a mean price target of $114.5 indicating a potential upside of 33.1% [1] - The average price targets from analysts range from a low of $97.00 to a high of $145.00, with a standard deviation of $15.46, suggesting a variability in estimates [2] - Analysts show strong agreement on SLNO's ability to report better earnings than previously predicted, which supports the potential for stock upside [4][11] Group 2 - The Zacks Consensus Estimate for SLNO's current year earnings has increased by 25.8% over the past month, with three estimates revised higher and no negative revisions [12] - SLNO holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13] - While consensus price targets may not be reliable for predicting the extent of gains, they can provide a directional guide for price movement [14]

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].

[Form 8-K Current Report](index=1&type=section&id=Form%208-K%20Current%20Report) [Item 2.02 Results of Operations and Financial Conditions](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Conditions) Soleno Therapeutics, Inc. announced preliminary Q2 2025 results via a press release, furnished as Exhibit 99.1, not "filed" under Section 18 - The company issued a press release on **July 10, 2025**, announcing preliminary financial results and operating metrics for the **three months ended June 30, 2025**[4](index=4&type=chunk) - Information furnished under Item 2.02, including Exhibit 99.1, is not deemed "filed" for Section 18 of the Exchange Act, nor incorporated by reference unless explicitly stated[5](index=5&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=2&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists the exhibits filed with the Form 8-K, including the press release and interactive data file Exhibits Filed | Exhibit No. | Description | | :--- | :--- | | 99.1 | Press Release issued by Soleno Therapeutics, Inc., dated July 10, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | [Signatures](index=3&type=section&id=Signatures) The report was officially signed on **July 10, 2025**, by Anish Bhatnagar, Chief Executive Officer - The report was signed on **July 10, 2025**, by **Anish Bhatnagar**, Chief Executive Officer[11](index=11&type=chunk)

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]