Accessibility StatementSkip Navigation Then, during Soleno's November 4, 2025 Q3 2025 earnings call, the company revealed that "we did see a disruption in our launch trajectory […] mostly in the form of a lower number of start forms and increase[d] discontinuations for non-serious adverse events." Back on August 15, 2025, short seller Scorpion Capital raised questions about Soleno's disclosures and made several observations regarding VYKATâ"¢ XR. SLNO Investors with Losses Encouraged to Contact Hagens Berma ...

Core Insights - Soleno Therapeutics Inc. (NASDAQ: SLNO) experienced a significant decline of 26.59% in stock price, closing at $46.87, marking the fifth consecutive day of losses as investors anticipated strong earnings for Q3 [1][3] - The company reported a net income of $26 million for the third quarter, a 134% improvement from a net loss of $76.6 million in the same period last year, with revenues reaching $66 million [2][3] Company Performance - The strong Q3 results are attributed to increased awareness of the efficacy and safety of Vykat XR, the first and only FDA-approved drug for hyperphagia, particularly within the Prader-Willi Syndrome (PWS) community [3][4] - Vykat XR is positioned as a critical treatment option for patients aged 4 years and older suffering from hyperphagia, addressing a complex patient population with serious co-morbidities [4]

Core Insights - Soleno Therapeutics has been upgraded to "Overweight" by Wells Fargo, with a revised price target of $106 from $123, while the stock price is currently at $63.85 [1][6] - The company reported a net revenue of $66 million and a net income of $26 million in Q3 2025, primarily driven by VYKAT XR sales [3][6] - Soleno has engaged 494 unique prescribers and has 764 active patients on VYKAT XR since its approval in March 2025 [3][6] Financial Performance - In Q3 2025, Soleno achieved net revenue of $66 million from VYKAT XR sales, resulting in a positive net income of $26 million [3][6] - The stock price has decreased by 2.74% today, with a trading range between $63.81 and $67.43, and a market capitalization of approximately $3.39 billion [4] Strategic Developments - Soleno has appointed Mark W. Hahn to its Board of Directors and Audit Committee to enhance its strategic direction and governance [5] - The company has covered over 132 million lives under its initiatives, indicating an expansion in its reach within the biopharmaceutical industry [5]

U.S. stock futures were lower this morning, with the Dow futures falling more than 50 points on Wednesday.Shares of Super Micro Computer Inc (NASDAQ:SMCI) fell sharply in pre-market trading after the company reported worse-than-expected first-quarter financial results and issued second-quarter EPS guidance below estimates.Super Micro Computer reported quarterly earnings of 35 cents per share, which missed the analyst consensus estimate of 40 cents. Quarterly revenue came in at $5.01 billion, which missed th ...

Core Points - U.S. stock futures are lower, with Dow futures falling over 50 points [1] - Super Micro Computer Inc reported disappointing first-quarter results, with earnings of 35 cents per share, missing the consensus estimate of 40 cents, and revenue of $5.01 billion, below the expected $5.99 billion [2] - Super Micro's revenue decreased from $5.93 billion in the same period last year [2] - The company's shares fell 9.2% to $43.12 in pre-market trading [2] Company-Specific Movements - Biohaven Ltd experienced a significant drop of 46.2% to $7.51 after receiving an FDA Complete Response Letter for VYGLXIA [4] - Trex Company Inc declined 31.9% to $32.02 following worse-than-expected third-quarter results and lowered FY25 sales guidance [4] - Soleno Therapeutics Inc fell 22.2% to $49.65 after reporting third-quarter results [4] - Axon Enterprise Inc's shares dropped 19.6% to $567.50 after mixed third-quarter results and an acquisition announcement [4] - Pinterest Inc dipped 18.8% to $26.69 after posting disappointing third-quarter earnings [4] - SSR Mining Inc fell 17.5% to $17.90 after its third-quarter results [4] - Uniqure NV's shares decreased by 15.8% to $25.61 after a prior gain [4] - Clover Health Investments Corp fell 15.5% to $2.97 after mixed third-quarter results [4] - Upstart Holdings Inc declined 15.3% to $39.15 after mixed results and lowered FY25 guidance [4] - Corsair Gaming Inc fell 12.4% to $6.59 following worse-than-expected third-quarter results [4] - Advanced Micro Devices, Inc. declined 5% to $237.80 despite reporting better-than-expected third-quarter results and projecting fourth-quarter revenue of approximately $9.6 billion [4]

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 ...