REDWOOD CITY, Calif., April 23, 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 will report its first quarter 2025 financial results, as well as operational highlights, after the close of the U.S. financial markets on Wednesday, May 7, 2025. The Company will host a conference call and webcast at 4:30 PM Eastern Time to discuss the results and provide an update o ...

REDWOOD CITY, Calif., April 14, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ:SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced the U.S. commercial availability of VYKAT™ XR (diazoxide choline) extended-release tablets, the company's treatment for hyperphagia in patients four years of age and older with Prader-Willi syndrome (PWS), which was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2025. Pres ...

Shares of Soleno Therapeutics (SLNO) have rallied 37% in the premarket hours today following the FDA approval of Vykat XR (diazoxide choline) extended-release tablets for treating hyperphagia in adults and children aged four years and older with Prader-Willi syndrome (PWS). The company expects to launch the drug in the United States in April 2025.Soleno’s Vykat XR, previously referred to as DCCR, is an innovative, once-daily, proprietary extended-release dosage form that contains diazoxide choline, the crys ...

First approved therapy to address hyperphagia in individuals with Prader-Willi syndrome Management to host conference call and webcast today, March 26th, at 5:30pm ET REDWOOD CITY, Calif., March 26, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved VYKAT XR (diazoxide choline) extended-release tablets, previously referred ...

Financial Performance - Soleno reported a net loss of approximately $(175.9) million, or $(4.38) per basic and diluted share, for the year ended December 31, 2024, compared to a net loss of $(39.0) million, or $(2.36) per share, in 2023[17]. - Net loss for Q4 2024 was $55,982,000, compared to a net loss of $11,296,000 in Q4 2023, indicating a 397% increase in losses[27]. - Total comprehensive loss for the year ended December 31, 2024, was $175,489,000, compared to $38,988,000 in 2023, representing a 350% increase[27]. - Total operating loss for the year ended December 31, 2024, was $187,671,000, compared to $41,384,000 in 2023, indicating a 353% increase[27]. - Net loss per common share for Q4 2024 was $1.27, up from $0.33 in Q4 2023, reflecting a 284% increase[27]. Expenses - Research and development expenses for the full year 2024 were $78.6 million, including $33.7 million of non-cash stock-based compensation, compared to $25.2 million in 2023[9]. - General and administrative expenses for the year ended December 31, 2024, totaled $105.9 million, which includes $66.2 million of non-cash stock-based compensation, compared to $13.5 million in 2023[13]. - Total operating expenses for Q4 2024 were $59,116,000, a significant increase from $13,910,000 in Q4 2023, representing a 324% rise[27]. - General and administrative expenses for Q4 2024 were $37,303,000, a substantial rise from $4,410,000 in Q4 2023, which is an increase of 746%[27]. - Stock-based compensation expense for the year ended December 31, 2024, totaled $99,958,000, compared to $5,945,000 in 2023, reflecting a 1,580% increase[29]. Income and Assets - Total other income for the year was $11.8 million, up from $2.4 million in 2023, primarily due to increased interest income[16]. - Interest income for the year ended December 31, 2024, was $12,052,000, compared to $2,578,000 in 2023, showing a 367% increase[27]. - Soleno had $318.6 million in cash, cash equivalents, and marketable securities as of December 31, 2024[8]. - Soleno's total assets grew to $330.972 million as of December 31, 2024, compared to $180.691 million in 2023[25]. Personnel and Operations - Personnel costs increased by $10.7 million in 2024 as the company hired additional employees for research and commercialization activities[14]. - Research and development expenses for the year ended December 31, 2024, reached $78,568,000, compared to $25,189,000 in 2023, marking a 212% increase[27]. - Weighted-average common shares outstanding for calculating basic and diluted net loss per common share increased to 43,924,831 in Q4 2024 from 34,441,721 in Q4 2023, a growth of 28%[27]. Regulatory and Financial Agreements - The company entered into a loan agreement for up to $200 million, with $50 million available upfront, contingent on FDA approval of DCCR for PWS[11]. - Soleno's NDA for DCCR was accepted by the FDA and granted Priority Review, with a target action date of March 27, 2025[4]. - The fair value of contingent liabilities related to the Essentialis merger increased to $14.8 million as of December 31, 2024, reflecting a $3.2 million increase from the previous year[15].

Drug Development and Regulatory Approval - The company has submitted a new drug application (NDA) for diazoxide choline extended-release tablets (DCCR) for the treatment of Prader-Willi syndrome (PWS), with a PDUFA target action date set for March 27, 2025[20]. - DCCR has received Breakthrough Therapy and Fast-Track designations in the U.S. and Orphan Drug designations in both the U.S. and European Union[20]. - The Phase 3 study (DESTINY PWS) enrolled 127 participants and, while it did not meet its primary endpoint, significant improvements were observed in two of three key secondary endpoints[34]. - The company announced positive statistically significant results for the primary endpoint from the randomized withdrawal period of Study C602 on September 26, 2023[37]. - The FDA may require additional studies or post-marketing requirements (PMRs) to further characterize the safety or efficacy of drug candidates if approved[71]. - The FDA can withdraw product approval if ongoing regulatory requirements are not met or if safety problems are identified post-market[73]. - Drugs for serious or life-threatening diseases may be designated as fast track or breakthrough candidates, eligible for accelerated review[74]. - Orphan drugs, developed for rare diseases, can receive up to 7 years of market exclusivity in the U.S.[75]. - Regulatory approval for DCCR is uncertain, and any delays could materially affect revenue generation and business operations[135]. Clinical Trials and Efficacy - A Phase 2 clinical trial showed significant reductions in mean hyperphagia score, body fat mass, LDL cholesterol, and non-HDL cholesterol, along with increases in lean body mass[30][32]. - 98.4% of participants in the combined studies reported treatment emergent adverse events (TEAEs), with the most common being hypertrichosis (68.8%) and peripheral edema (34.4%)[38]. - The company must conduct extensive clinical trials to demonstrate DCCR's safety and effectiveness, which are expensive and time-consuming[155]. - Regulatory authorities may require additional clinical trials or impose restrictions on DCCR's marketing, impacting its commercial viability[157]. Market and Commercialization Strategy - The company aims to address unmet medical needs in PWS, with 96.5% of survey respondents indicating reducing hunger as a very important symptom to relieve[28][29]. - The company is focused on improving metabolic health, with 92.9% of survey respondents indicating it as a very important symptom to address[28]. - The company anticipates that DCCR will be the first treatment for hyperphagia in PWS patients to reach the U.S. market if approved by the current PDUFA date[44]. - The commercial team is building out its organization in anticipation of FDA approval, including hiring approximately 30 field force individuals and industry veterans with rare disease experience[46]. - Approximately 300 healthcare providers are influencing prescriptions for about 40% of the PWS patient population in the U.S., indicating a concentrated market for DCCR[45]. - The company is conducting a formal pricing analysis for DCCR, with launch pricing expected to be influenced by the product label negotiated with the FDA[49]. - The company is positioned to launch DCCR efficiently in the U.S. market through its commercial organization following FDA approval[45]. Financial Performance and Projections - The company reported a net loss of $175.9 million for the year ended December 31, 2024, including non-cash stock-based compensation of $100.0 million, with an accumulated deficit of $452.3 million[119]. - As of December 31, 2024, the company had $318.6 million in cash, cash equivalents, and marketable securities, having used $69.1 million in operating activities during the year[119]. - The company is a clinical-stage entity with no approved products, making future viability assessments challenging[108]. - The company is heavily reliant on the success of DCCR, its sole therapeutic product candidate, for future revenue generation[112]. - The company anticipates continuing to incur substantial losses for the foreseeable future due to ongoing research and development expenses[119]. - The company has not commenced commercialization of DCCR and has generated no revenue from operations through December 31, 2024[119]. - The company may need to raise additional capital to support operations and potential commercialization efforts, which may not be available on acceptable terms[120]. - The market opportunity for DCCR may be smaller than estimated, impacting revenue potential and business viability[138]. Operational Risks and Challenges - The company faces significant risks related to obtaining regulatory approval for DCCR, which could delay or prevent commercialization[118]. - The company faces significant debt obligations that could restrict operations and future financing, with covenants limiting various business activities[127]. - The timing of DCCR's commercial launch is dependent on FDA approval, which introduces uncertainty in revenue recognition[128]. - The company has a limited sales and marketing infrastructure and lacks experience in selling therapeutic products, which may hinder commercialization efforts for DCCR[143]. - Establishing a robust sales and marketing organization is crucial for DCCR's success, with significant costs associated with recruiting and training personnel[143]. - The company may face challenges in forming strategic partnerships, which could alter development and commercialization plans for DCCR[147]. - Delays in clinical trials or regulatory approvals could significantly harm the commercial prospects of DCCR and increase development costs[160]. - The company may encounter difficulties in managing growth due to limited financial resources and management experience, which could disrupt operations[181]. Compliance and Regulatory Environment - The company must comply with HIPAA and other privacy laws, which protect the privacy and security of health information[82]. - Violations of federal and state antifraud laws can result in substantial penalties, including exclusion from federal healthcare programs[85]. - The federal Anti-Kickback Statute prohibits remuneration to induce referrals for services reimbursed by federal healthcare programs, with severe penalties for violations[92]. - The FDA and EMA impose extensive ongoing regulations on approved pharmaceutical products, including recordkeeping and periodic reporting[77]. - Noncompliance with FDA regulations can lead to severe penalties, including product recalls and fines[81]. - The company has identified material weaknesses in its internal control over financial reporting, necessitating remediation efforts[198]. - The company may face increased costs and operational challenges due to compliance with various regulatory requirements as it transitions to a larger reporting company[194]. Intellectual Property and Competition - The company faces competition from at least nine other current or proposed clinical trials evaluating therapies for PWS, indicating a crowded market[168]. - The company faces risks related to intellectual property, including potential infringement claims that could materially affect business success[209]. - A finding of infringement could prevent the company from commercializing products or force cessation of business operations, leading to significant financial liabilities[212]. - The ability to obtain and maintain effective intellectual property rights is crucial for the company's success in commercializing planned products[215]. Supply Chain and Manufacturing - The company is highly dependent on sole source suppliers for raw materials and active pharmaceutical ingredients (APIs) for DCCR, which poses a risk of supply interruptions that could adversely affect commercialization efforts[200]. - Manufacturing or quality assurance difficulties at contractors and suppliers could lead to delays and disruptions in the manufacturing and sale of DCCR, potentially resulting in lost revenue or reduced market opportunities[202]. - The qualification process for new suppliers could take months or years, and any delays could significantly harm the company's business[203]. - The company plans to rely on specialty pharmacies for the distribution of DCCR in the United States, making sales highly dependent on their performance[204]. - If specialty pharmacy partners fail to meet contractual obligations, it could harm product sales and expose the company to legal liabilities[205]. - The company relies on third parties for clinical trials, and any failure to meet deadlines or regulatory requirements could delay regulatory approvals for planned products[206].

Corporate Update - Soleno Therapeutics is preparing for the anticipated U.S. launch of its drug DCCR for Prader-Willi syndrome (PWS) and has strengthened its commercial organization [3][6] - The New Drug Application (NDA) for DCCR was accepted by the FDA and granted Priority Review, with a new PDUFA target action date set for March 27, 2025 [7] - The company has made strategic investments in commercial and medical affairs programs, including education and data analytics [3][6] Financial Results - For the year ended December 31, 2024, Soleno reported a net loss of approximately $175.9 million, or $4.38 per share, compared to a net loss of $39.0 million, or $2.36 per share, in 2023 [16][27] - Operating expenses for the year totaled $187.7 million, with research and development expenses at $78.6 million and general and administrative expenses at $105.9 million [10][12][27] - The company had $318.6 million in cash, cash equivalents, and marketable securities as of December 31, 2024 [9] Research and Development - Research and development expenses increased significantly, with a total of $78.6 million for 2024, compared to $25.2 million in 2023 [10][11] - The increase in expenses was attributed to hiring additional employees and consulting costs related to NDA submissions [11][13] - DCCR has shown promise in clinical trials for addressing hyperphagia and other symptoms associated with PWS [19] Corporate Governance - Dawn Carter Bir was appointed to Soleno's Board of Directors, bringing over 30 years of biotechnology executive leadership experience [8] - The company has also made changes in its board structure, with Matthew Pauls assuming the role of Lead Independent Director [8] Market Position - PWS is a rare genetic disorder affecting approximately 1 in 15,000 live births, characterized by hyperphagia and other significant health challenges [17][18] - There are currently no approved therapies for the treatment of hyperphagia and other symptoms associated with PWS, highlighting the potential market opportunity for DCCR [18][19]

Core Insights - Soleno Therapeutics has secured a financing agreement for up to $200 million, which includes an initial draw of $50 million [1][3] - The financing is aimed at strengthening the company's financial position and supporting anticipated commercial launch activities for its lead candidate, DCCR [2][5] - The loan agreement includes conditions for additional funding based on FDA approval and commercial milestones related to DCCR [3] Financial Details - The initial draw of $50 million increases Soleno's pro-forma cash, cash equivalents, and marketable securities to $334.7 million as of September 30, 2024 [4] - The loan has an interest-only period of 48 months and a total term of 60 months, with potential extensions based on milestone achievements [3] Company Overview - Soleno Therapeutics focuses on developing novel therapeutics for rare diseases, with its lead candidate DCCR currently under FDA review and granted Priority Review status [5] - Oxford Finance LLC, the financing partner, specializes in providing senior secured loans to life sciences and healthcare companies [6]

Core Viewpoint - Soleno Therapeutics, Inc. is actively engaged in the development of novel therapeutics for rare diseases, with a focus on its lead candidate DCCR for Prader-Willi syndrome, which is currently under FDA review [1][3]. Company Participation - Management of Soleno Therapeutics will participate in a fireside chat at the Piper Sandler 36th Annual Healthcare Conference on December 5, 2024, at 9:00 AM Eastern Time [1]. Product Development - The company’s lead candidate, DCCR (diazoxide choline) extended-release tablets, is a once-daily oral treatment for Prader-Willi syndrome and has been granted Priority Review by the FDA [3]. Investor Engagement - A live audio webcast and replay of the fireside chat will be accessible in the Investors section on the company's website [2].

Core Summary - The FDA has extended the review period for Soleno Therapeutics' NDA for DCCR (diazoxide choline) extended-release tablets, with the new PDUFA target action date set for March 27, 2025 [1] - The extension was due to the FDA's determination that responses to recent information requests constituted a major amendment to the NDA, requiring additional review time [2] - Soleno submitted the NDA on June 27, 2024, and it was granted Priority Review in August 2024 [3] - DCCR has received Breakthrough, Fast Track, and Orphan Drug Designations in the U S and E U for the treatment of Prader-Willi syndrome (PWS) [3] About PWS - PWS occurs in approximately 1 in 15,000 live births and is characterized by hyperphagia, a chronic and life-threatening condition [4] - Hyperphagia leads to severe quality of life issues and can cause significant mortality and long-term comorbidities such as diabetes, obesity, and cardiovascular disease [4] - 96 5% of respondents in a global survey rated hyperphagia as the most important or very important symptom to be relieved by a new medicine [4] - There are currently no approved therapies to treat hyperphagia, metabolic, cognitive function, or behavioral aspects of PWS [4] About DCCR - DCCR is a novel, proprietary extended-release dosage form of diazoxide choline, administered once daily [5] - The parent molecule, diazoxide, has been used for decades in other rare diseases but is not approved for PWS [5] - Soleno has established extensive patent protection for the therapeutic use of diazoxide, diazoxide choline, and DCCR in PWS [5] - The DCCR development program is supported by data from five Phase 1 and three Phase 2 clinical studies, including one in PWS patients [5] - In Phase 3 trials, DCCR showed promise in addressing hyperphagia and other symptoms such as aggressive behaviors and metabolic parameters [5] About Soleno Therapeutics - Soleno is focused on developing and commercializing novel therapeutics for rare diseases [6] - The company's lead candidate, DCCR, is currently under FDA review for the treatment of PWS and has been granted Priority Review [6]