Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - SMX (Security Matters) Public Limited Company (SMX) increased by 52% to $2.24 [3] - Entravision Communications Corporation (EVC) rose by 33% to $2.66 [3] - Babcock & Wilcox Enterprises, Inc. (BW) saw a 28% increase to $4.79 [3] - NeuroPace, Inc. (NPCE) gained 24% reaching $11.71 [3] - Kennedy-Wilson Holdings, Inc. (KW) also increased by 24% to $9.30 [3] - Rigel Pharmaceuticals, Inc. (RIGL) rose by 22% to $34.72 [3] - Digital Turbine, Inc. (APPS) increased by 21% to $7.20 [3] - Lumentum Holdings Inc. (LITE) saw a 15% increase to $218.06 [3] - AsiaStrategy (SORA) rose by 14% to $3.63 [3] - Marine Petroleum Trust (MARPS) increased by 7% to $5.05 [3] Premarket Losers - Biohaven Ltd. (BHVN) decreased by 42% to $7.96 [4] - Trex Company, Inc. (TREX) fell by 34% to $30.65 [4] - Soleno Therapeutics, Inc. (SLNO) saw a 23% decline to $49.00 [4] - Axon Enterprise, Inc. (AXON) decreased by 19% to $572.00 [4] - Clover Health Investments, Corp. (CLOV) fell by 19% to $2.82 [4] - Pinterest, Inc. (PINS) decreased by 18% to $26.91 [4] - SSR Mining Inc. (SSRM) saw a 17% decline to $17.91 [4] - Upstart Holdings, Inc. (UPST) decreased by 16% to $38.81 [4] - WF International Limited (WXM) fell by 12% to $2.25 [4] - Corsair Gaming, Inc. (CRSR) decreased by 11% to $6.66 [4]

来源：ESG评级中心 点击查看更多企业ESG评级。 据新浪财经ESG评级中心，2025年11月04日，Soleno Therapeutics Inc.（SLNO.US）MSCI（明晟）ESG 评级由BBB调降至B。 ...

Financial Data and Key Metrics Changes - Total net revenue for Q3 2025 was $66 million, more than doubling from $32.7 million in Q2 2025 [3][16] - The company achieved profitability with a net income of $26 million for the quarter, compared to a net loss of $76.6 million in the same period of 2024 [20] - Cash generated from operating activities was $43.5 million, and the company had $556.1 million in cash, cash equivalents, and marketable securities at the end of Q3 [16][20] Business Line Data and Key Metrics Changes - ViCAD XR, the company's leading product, had 764 active patients at the end of Q3, with 1,043 cumulative patient start forms since launch [12][16] - The number of unique prescribers increased to 494, with 199 new prescribers added in Q3 [12][16] - Over 50% of the top 300 providers submitted start forms, indicating strong adoption [13] Market Data and Key Metrics Changes - Coverage policies for ViCAD XR reached approximately 132 million lives by the end of Q3, with significant access across commercial, Medicaid, and Medicare channels [14] - The company is actively pursuing regulatory approval for DCCR in Europe, with a potential market of 9,500 individuals living with PWS in key European countries [10] Company Strategy and Development Direction - The company aims to establish ViCAD XR as the standard of care for hyperphagia in individuals with PWS, focusing on education and engagement with the PWS community [9][10] - Continued investment in stakeholder awareness, education, and access resources is planned to support the treatment journey for patients [15] Management's Comments on Operating Environment and Future Outlook - Management acknowledged a disruption in launch momentum due to a short seller report but noted efforts to re-engage patients and educate stakeholders [7][32] - The company remains optimistic about the long-term growth potential, with a focus on expanding prescriber education and patient access [9][10] Other Important Information - The discontinuation rate for ViCAD XR related to adverse events was approximately 8%, with total discontinuation at about 10% [7] - The company is preparing responses to EMA's day 120 questions regarding DCCR's marketing authorization application in Europe [10] Q&A Session Summary Question: Can you comment on the restart rate regarding discontinuations? - Management indicated that it is early to provide meaningful numbers on restarts, but some patients have already started again [22][23] Question: What is the lag time between start forms and insurance coverage? - The fill rate for prescriptions is approximately 30 days, with a backlog of about one month for start forms [28] Question: How did the short report impact discontinuations and patient start forms? - Management noted a decrease in start forms and an increase in discontinuations during August and September, attributing it to the short report and summer factors [32][60] Question: What is the average dose across all patients currently on the drug? - The average dosing is still evolving, with most patients coming in between four and 26 years of age [39][40] Question: What is the profile of adverse events leading to discontinuations? - Most reported adverse events are non-serious and on-label, such as low levels of peripheral edema and hyperglycemia [44][56] Question: Is there a need for additional efforts to find new patients? - The company has identified approximately 12,000 claims for individuals with PWS and is confident in targeting these patients effectively [76]

Revenue and Sales Performance - Product revenue, net was $66.0 million for the three months ended September 30, 2025, due to sales of VYKAT XR after FDA approval, compared to zero for the same period in 2024 [121] - Product revenue, net for the nine months ended September 30, 2025, was $98.7 million, attributed to VYKAT XR sales post-FDA approval, compared to zero for the same period in 2024 [129] - Cost of goods sold was $1.1 million for the three months ended September 30, 2025, due to VYKAT XR sales, compared to zero for the same period in 2024 [122] - Cost of goods sold for the nine months ended September 30, 2025, was $1.8 million, compared to zero for the same period in 2024, following FDA approval of VYKAT XR in March 2025 [130] Operating Income and Expenses - Operating income for the three months ended September 30, 2025, was $22.1 million, a significant increase of $102.3 million compared to an operating loss of $80.2 million in the same period of 2024 [120] - Total operating expenses for the nine months ended September 30, 2025, were $128.8 million, a slight increase of 0% compared to $128.6 million in the same period of 2024 [128] - Research and development expenses decreased by 72% to $8.4 million for the three months ended September 30, 2025, compared to $30.1 million in the same period of 2024 [123] - Research and development expenses decreased to $31.1 million for the nine months ended September 30, 2025, from $57.1 million in the same period of 2024, with a notable reduction in costs related to NDA submission and clinical activities [131] - Selling, general and administrative expenses were $33.8 million for the three months ended September 30, 2025, down 31% from $49.2 million in the same period of 2024 [124] - Selling, general and administrative expenses increased to $91.3 million for the nine months ended September 30, 2025, from $68.6 million in the same period of 2024, driven by hiring for commercial launch and increased marketing activities [132] Net Loss and Financial Position - Net loss for the nine months ended September 30, 2025, was $22.5 million, a reduction of $97.4 million compared to a net loss of $119.9 million in the same period of 2024 [128] - The company reported a net loss of $22.5 million for the nine months ended September 30, 2025, with an accumulated deficit of $474.7 million [136] Cash and Securities - Cash and cash equivalents totaled $246.7 million, with marketable securities at $309.4 million, as of September 30, 2025 [136] - The company raised $230.0 million in a public offering of common stock in July 2025, with gross proceeds before expenses [138] - Net cash used in operating activities was $1.9 million for the nine months ended September 30, 2025, a significant decrease from $45.1 million in the same period of 2024 [141] - The company used $267.9 million for purchases of marketable securities during the nine months ended September 30, 2025, compared to $308.9 million in the same period of 2024 [145] - The company believes existing cash and marketable securities will be sufficient to meet working capital needs for the next twelve months, depending on the success of VYKAT XR commercialization [140] Fair Value of Contingent Consideration - The fair value of contingent consideration payable was estimated at $19.5 million as of September 30, 2025, reflecting a $0.6 million increase from the previous quarter [125] - The fair value of contingent consideration related to VYKAT XR sales milestones increased to $19.5 million as of September 30, 2025, up $4.7 million from December 31, 2024, due to the product's FDA approval [133] Interest Income - Interest income increased by 36% to $11.8 million for the nine months ended September 30, 2025, compared to $8.7 million in the same period of 2024 [128]

Exhibit 99.1 Soleno Therapeutics Reports Third Quarter 2025 Financial Results and Provides Update on U.S. Launch of VYKAT(TM) XR REDWOOD CITY, Calif., November 4, 2025 – Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today reported financial results for the third quarter ended September 30, 2025 and provided an update on the U.S. launch of VYKATTM XR. Third Quarter 2025 and Recent Corporate Highlights "Our stro ...

Core Insights - Soleno Therapeutics reported strong financial results for Q3 2025, driven by the launch of VYKAT XR, the first FDA-approved therapy for hyperphagia in Prader-Willi syndrome (PWS) patients aged 4 and older [3][4][5] Financial Performance - The company generated $66.0 million in product revenue for Q3 2025, marking a more than 100% increase from $32.7 million in Q2 2025 [5] - Operating cash flow for the quarter was $43.5 million, with total cash, cash equivalents, and marketable securities amounting to $556.1 million at the end of Q3 2025 [4] - Net income for Q3 2025 was approximately $26.0 million, or $0.47 per diluted share, a significant recovery from a net loss of $(76.6) million, or $(1.83) per diluted share, in Q3 2024 [11][25] Product and Market Update - VYKAT XR has shown a favorable efficacy and safety profile, with over 100 patients treated for more than one year and some for over six years [3] - As of September 30, 2025, Soleno received 1,043 patient start forms and had 764 active patients on the drug, indicating strong market uptake [8] Research and Development - Research and development expenses decreased to $8.4 million in Q3 2025 from $30.1 million in Q3 2024, reflecting reduced costs associated with regulatory submissions and clinical activities [7] - The company anticipates fluctuations in R&D expenditures based on the status of clinical programs and regulatory activities [7] Selling, General and Administrative Expenses - Selling, general and administrative expenses were $33.8 million for Q3 2025, down from $49.2 million in the same period of 2024, primarily due to reduced stock-based compensation [8] - The company expects SG&A expenses to continue increasing as it supports the commercialization of VYKAT XR [9] Contingent Liabilities - Soleno has a contingent liability of up to $21.2 million related to former stockholders of Essentialis, with a fair value of $19.5 million as of September 30, 2025, reflecting increasing sales of VYKAT XR [10]

Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Soleno Therapeutics, Inc. due to allegations of materially misleading business information issued by the company [1] Group 1 - The investigation is focused on the potential impact of misleading information on the investing public [1] - Shareholders who purchased Soleno Therapeutics securities may be entitled to compensation without any out-of-pocket fees or costs [1]

Core Insights - Soleno Therapeutics, Inc. is participating in multiple investor conferences in November 2025, showcasing its commitment to engaging with the investment community [1] - The company focuses on developing novel therapeutics for rare diseases, with its first commercial product being VYKAT XR™, an oral treatment for hyperphagia associated with Prader-Willi syndrome [2] Group 1: Upcoming Investor Conferences - Soleno will present at the Guggenheim Securities Healthcare Innovation Conference on November 11, 2025, at 9:00 AM ET in a fireside chat format [1] - The company will also participate in the Stifel 2025 Healthcare Conference on November 12, 2025, at 8:40 AM ET, again in a fireside chat format [1] - Additionally, Soleno is scheduled to present at the Jefferies London Healthcare Conference on November 18, 2025, at 5:00 PM GMT [1] Group 2: Company Overview - Soleno Therapeutics is dedicated to the development and commercialization of therapeutics aimed at treating rare diseases [2] - The company's first product, VYKAT XR™ (diazoxide choline) extended-release tablets, is designed for once-daily oral administration for patients aged 4 years and older with Prader-Willi syndrome [2]

Core Thesis - Soleno Therapeutics, Inc. (SLNO) is positioned for significant growth due to its FDA-approved therapy VYKAT XR for hyperphagia in Prader-Willi Syndrome (PWS) patients, with a strong early commercial performance and substantial market potential [2][3][4] Company Overview - Soleno Therapeutics is a single-asset company focused on VYKAT XR, the first and only FDA-approved treatment for hyperphagia in PWS patients aged four and older, a rare genetic disorder affecting approximately 8,000–12,500 individuals in the U.S. and about 20,000 in Europe [2] - VYKAT XR is an extended-release formulation of diazoxide choline that acts as a potassium channel activator to reduce hyperphagia by modulating neuronal activity [2] Financial Performance - The drug is priced at around $500,000 annually for adults, with Q2 revenue reaching $32.7 million, surpassing expectations [3] - By the end of Q2, there were 295 unique prescribers and 646 patient start forms, with an additional ~500 in Q3, totaling around 1,000 treatments [3] - SLNO estimates peak sales potential between $1.8 billion and $2.6 billion, indicating significant valuation upside [3] Market Position and Competition - The company faces limited competition, with peers like ACADIA having failed, and Aardvark's upcoming readout being the only near-term competitive threat [3] - Safety concerns raised by Scorpion Capital appear overstated, with no major new safety updates since September and positive real-world patient feedback [4] Future Outlook - Expectations for Q3 2025 revenue are projected to exceed $60–65 million, compared to consensus estimates of $46 million, indicating a strong launch trajectory [4] - The manageable safety profile and limited competition position SLNO for a potential rerating toward $100+ within 12–18 months [4]

Core Points - Soleno Therapeutics, Inc. will report its third quarter 2025 financial results and operational highlights on November 4, 2025, after U.S. market close [1] - A conference call and webcast will be held at 4:30 PM Eastern Time to discuss the results and provide business updates [1][2] Company Overview - Soleno Therapeutics focuses on developing and commercializing novel therapeutics for rare diseases [3] - The company's first commercial product is VYKAT XR (diazoxide choline) extended-release tablets, designed for treating hyperphagia in individuals with Prader-Willi syndrome aged 4 years and older [3]