Core Insights - Soleno Therapeutics is presenting data on its DCCR clinical development program for Prader-Willi syndrome (PWS) at the 62nd Annual European Society for Paediatric Endocrinology Meeting in November 2024 [1] Group 1: Clinical Presentations - The first oral presentation will discuss the relaxation of food control parameters based on improvements in the Food Safe Zone Questionnaire with a reduction of hyperphagia in clinical trials of DCCR in PWS participants, scheduled for November 17, 2024 [2] - The second oral presentation will cover long-term efficacy results of DCCR tablets in PWS participants from completed studies, set for November 18, 2024 [2] Group 2: Prader-Willi Syndrome Overview - PWS occurs in approximately 1 in every 15,000 live births, characterized by hyperphagia, which can severely impact quality of life and lead to significant mortality risks [3] - Other symptoms of PWS include behavioral issues, cognitive disabilities, low muscle tone, and developmental delays, with no approved therapies currently available to address these aspects [3] Group 3: DCCR (Diazoxide Choline) Details - DCCR is a proprietary extended-release formulation of diazoxide choline, administered once daily, and has shown promise in addressing hyperphagia and other symptoms in PWS [4] - The DCCR development program is backed by data from multiple completed Phase 1 and Phase 2 clinical studies, including one specifically in PWS [4] Group 4: Company Overview - Soleno Therapeutics is focused on developing and commercializing novel therapeutics for rare diseases, with an NDA for DCCR currently under FDA review and granted Priority Review status [5]

Financial Performance - Soleno reported a net loss of approximately $76.6 million, or $1.83 per basic and diluted share, for Q3 2024, compared to a net loss of $10.9 million, or $0.95 per share, in Q3 2023[10]. - Total operating expenses for the three months ended September 30, 2024, were $80,212,000, compared to $10,382,000 for the same period in 2023, representing a significant increase[17]. - The net loss for the three months ended September 30, 2024, was $76,616,000, compared to a net loss of $10,861,000 for the same period in 2023[17]. - Total comprehensive loss for the three months ended September 30, 2024, was $75,568,000, compared to $10,862,000 for the same period in 2023[17]. - The net loss per common share for the three months ended September 30, 2024, was $(1.83), compared to $(0.95) for the same period in 2023[17]. Expenses - Research and development expenses for Q3 2024 were $30.1 million, a significant increase from $6.0 million in the same period of 2023, primarily due to hiring and NDA submission costs[6]. - General and administrative expenses rose to $49.2 million in Q3 2024, compared to $3.3 million in Q3 2023, largely driven by increased personnel and professional services costs[7]. - Stock-based compensation expense for research and development in the three months ended September 30, 2024, was $18,516,000, compared to $935,000 in the same period in 2023[18]. - Total stock-based compensation expense for the nine months ended September 30, 2024, was $70,203,000, compared to $4,036,000 for the same period in 2023[18]. Cash Flow and Assets - Soleno used $14.9 million of cash in its operating activities during Q3 2024, with cash, cash equivalents, and marketable securities totaling $284.7 million as of September 30, 2024[5]. - Soleno's total assets increased to $296.7 million as of September 30, 2024, up from $180.7 million at the end of 2023[16]. Other Income - Total other income for Q3 2024 was $3.6 million, compared to total other expense of $0.5 million in Q3 2023, primarily due to increased interest income[9]. - Interest income for the three months ended September 30, 2024, was $3,596,000, compared to $174,000 for the same period in 2023[17]. Regulatory and Market Developments - The NDA for DCCR (diazoxide choline) extended-release tablets was accepted by the FDA and granted Priority Review, with a target action date of December 27, 2024[2]. - Soleno is preparing for a potential U.S. market launch of DCCR, contingent on FDA approval, supported by a strong balance sheet[3]. Leadership Changes - The company appointed Dawn Carter Bir to its Board of Directors, enhancing its leadership with over 30 years of biotechnology experience[2]. Contingent Liabilities - The fair value of the contingent liability for the Essentialis purchase price was estimated at $14.5 million as of September 30, 2024, reflecting a $0.9 million increase from June 30, 2024[8].

Financial Performance - The net loss for Q3 2024 was $76.6 million, compared to a net loss of $10.9 million in Q3 2023, representing a 605% increase[69] - The net loss for the nine months ended September 30, 2024, was $119.9 million, compared to a net loss of $27.7 million in the same period of 2023, representing a 333% increase[75] - The company incurred a net loss of $119.9 million during the nine months ended September 30, 2024, with an accumulated deficit of $396.3 million[81] Operating Expenses - Research and development expenses for Q3 2024 were $30.1 million, a 399% increase from $6.0 million in Q3 2023[71] - General and administrative expenses for Q3 2024 were $49.2 million, a 1383% increase from $3.3 million in Q3 2023[72] - Total operating expenses for Q3 2024 reached $80.2 million, a 673% increase from $10.4 million in Q3 2023[69] - Research and development expenses for the nine months ended September 30, 2024, were $57.1 million, a 246% increase from $16.5 million in the same period of 2023[77] - General and administrative expenses for the nine months ended September 30, 2024, were $68.6 million, a 634% increase from $9.3 million in the same period of 2023[78] - Total operating expenses for the nine months ended September 30, 2024, were $128.6 million, a 368% increase from $27.5 million in the same period of 2023[75] Cash Flow and Financing - Cash used in operating activities was $45.1 million for the nine months ended September 30, 2024, compared to $18.6 million for the same period in 2023[84] - The company used $308.9 million for purchases of marketable securities during the nine months ended September 30, 2024[85] - Financing activities provided $155.9 million in net cash during the nine months ended September 30, 2024, primarily from the sale of common stock[82] - The company had $48.4 million in cash and cash equivalents and $208.4 million in marketable securities as of September 30, 2024[81] - The gross proceeds from a public offering in May 2024 were $158.7 million, with a public offering price of $46.00 per share[81] - The company received $10.0 million from the sale of warrants and $37.7 million from the exercise of certain warrants through September 30, 2024[81] Other Financial Information - Other income for Q3 2024 was approximately $3.6 million, compared to other expense of approximately $479,000 in Q3 2023, primarily due to increased interest income[74] - The fair value of contingent consideration related to DCCR was estimated at $14.5 million as of September 30, 2024, an increase of $2.9 million from December 31, 2023[79] - The company expects to continue incurring losses and may require additional capital for clinical trials and product development[81] - There were no investing activities reported for the nine months ended September 30, 2023[85] - The company does not have any off-balance sheet arrangements[88]

Company Overview - Soleno Therapeutics, Inc. (NASDAQ: SLNO) specializes in rare diseases, particularly focusing on Prader-Willi Syndrome (PWS) hyperphagia, a condition characterized by insatiable hunger that significantly impacts patients' quality of life [1]. Drug Candidate - The company’s leading drug candidate, DCCR, has shown effectiveness in reducing hunger associated with PWS, addressing a critical unmet medical need as there are currently no approved treatments for this condition [1].

Company Overview - Soleno Therapeutics (SLNO) shares increased by 9.1% on Tuesday and an additional 4.1% in after-market trading following a positive regulatory update regarding its new drug application (NDA) for DCCR (diazoxide choline) extended-release tablets aimed at treating Prader-Willi syndrome (PWS) [1] - The FDA's Review Division indicated that an advisory committee meeting is not currently necessary for the DCCR NDA, although the need for one may be reassessed during the review process [2] Product Details - DCCR is a proprietary, once-daily extended-release formulation containing diazoxide choline, which is not yet approved for PWS but is used for treating certain rare diseases [3] - The NDA for DCCR is under the FDA's Priority Review pathway, which shortens the review period to four months, with a final decision expected by December 27, 2024 [3] Market Context - Approximately one in every 15,000 newborns is affected by PWS, with hyperphagia being the most common symptom, leading to serious long-term health issues [5] - There are currently no approved treatments addressing hyperphagia or other aspects of PWS, highlighting a significant unmet medical need [6] Competitive Landscape - Acadia Pharmaceuticals has introduced a new candidate, carbetocin nasal spray, for treating hyperphagia associated with PWS, which was acquired through the purchase of Levo Therapeutics [6] - A previous study indicated that carbetocin showed a statistically significant reduction in hyperphagia-related behaviors, leading to the initiation of a pivotal phase III study by Acadia in late 2023 [7] Regulatory Designations - Soleno has secured extensive patent protection for the use of diazoxide, diazoxide choline, and DCCR in PWS patients, with DCCR receiving Breakthrough, Fast Track, and Orphan Drug designations from the FDA [4]

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Core Insights - Soleno Therapeutics (SLNO) experienced a stock price increase of 9.11%, significantly outperforming the S&P 500 index, which gained less than 1% [1] Regulatory Developments - The FDA announced that it will not require an advisory committee meeting for the New Drug Application (NDA) for diazoxide choline (DCCR) tablets, aimed at treating Prader-Willi Syndrome, indicating a potentially smoother approval process [2] - The FDA's decision regarding the drug is expected by December 27, benefiting from priority review status and breakthrough-therapy designation [2] Financial Analysis - The current stock price of Soleno Therapeutics is $51.97, reflecting recent price appreciation [3] - Despite the positive stock performance, there are warning signs such as insider selling and a low Piotroski F-Score, which typically indicates poor business operations [3] - The company maintains strong financial health with sufficient cash to cover its debt, contributing to a stable financial situation [3] Valuation Insights - Soleno's GF Value cannot be evaluated due to insufficient data [4] - The stock is near its three-year high, and the potential for expedited FDA approval presents a consideration for investors to balance regulatory news against existing financial risks and warning signs [4]

Core Insights - Soleno Therapeutics is nearing FDA approval for its Prader-Willi treatment, leading to a stock price increase of over 9% [1] - The FDA has determined that an advisory committee meeting is not currently needed for Soleno's new drug application for diazoxide choline (DCCR) [2] - The FDA is expected to make a decision on DCCR by December 27, as it has been designated for priority review [3] - DCCR has received breakthrough therapy designation from the FDA, which may expedite the approval process [4]

PDUFA target action date set for December 27, 2024 FDA currently plans to hold an Advisory Committee meeting REDWOOD CITY, Calif., Aug. 27, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. ("Soleno") (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for DCCR for the treatment of Prader-Willi syndrome (PWS) in indi ...

Core Points - Soleno Therapeutics has submitted a New Drug Application (NDA) to the FDA for DCCR (diazoxide choline) extended-release tablets aimed at treating Prader-Willi syndrome (PWS) in individuals aged four years and older who experience hyperphagia [12] - The FDA has 60 days to determine if the NDA will be accepted for review, with Soleno requesting Priority Review, which would target a six-month review period post-acceptance [2] Company Overview - Soleno Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for rare diseases [12] - The company has established extensive patent protection for the therapeutic use of diazoxide, diazoxide choline, and DCCR in individuals with PWS [9] Product Information - DCCR is a proprietary extended-release dosage form of diazoxide choline, administered once daily, and has been used in other rare diseases but is not yet approved for PWS [9] - The development program for DCCR is supported by data from five completed Phase 1 clinical studies and three Phase 2 studies, including one involving individuals with PWS [9] Disease Context - Prader-Willi syndrome is estimated to occur in one in every 15,000 live births, characterized by hyperphagia, behavioral problems, cognitive disabilities, and other serious health issues [5] - There are currently no approved therapies to address the hyperphagia and other symptoms associated with PWS, highlighting the unmet medical need [5]