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].

Shares of Soleno Therapeutics (SLNO) jumped 9.1% on Tuesday and continued to gain another 4.1% during the after-market hours following a positive regulatory update on its new drug application (NDA) seeking approval for DCCR (diazoxide choline) extended-release tablets to treat Prader-Willi syndrome (PWS). Per SLNO, the Review Division of the FDA has stated that there is no need for an advisory committee meeting for the DCCR NDA at present. However, the regulatory body will continue to consider the potential ...

Most of us have heard the dictum "the trend is your friend." And this is undeniably the key to success when it comes to short-term investing or trading. But it isn't easy to ensure the sustainability of a trend and profit from it. The trend often reverses before exiting the trade, leading to a short-term capital loss for investors. So, for a profitable trade, one should confirm factors such as sound fundamentals, positive earnings estimate revisions, etc. that could keep the momentum in the stock alive. Inv ...

Soleno Therapeutics (SLNO, Financial) experienced a notable stock price increase of 9.11% following positive developments in its regulatory process. This performance far exceeded that of the S&P 500 index, which saw gains of less than 1%. The catalyst behind this surge is the announcement that the FDA will not require an advisory committee meeting for its New Drug Application (NDA) for diazoxide choline (DCCR) tablets, which are designed to treat Prader-Willi Syndrome. This move suggests a potentially smoot ...

The company's Prader-Willi treatment inched closer to FDA approval. Soleno Therapeutics (SLNO 9.11%) had some good news to report on the regulatory front on Tuesday. Investors were cheered by this as evidenced by their sending the biotech's stock more than 9% higher in price on the day. This performance was much better than that of the closely watched S&P 500 index, which closed up by less than 1%. Skipping ahead in the review process? Before market open that day, Soleno reported that the U.S. Food and Drug ...

Soleno Therapeutics (SLNO) gained 6.3% on Aug. 27 after the FDA accepted the new drug application (NDA) seeking approval for its lead candidate, DCCR (diazoxide choline) extended-release tablets, to treat Prader-Willi syndrome (PWS) in patients aged four years and older who have hyperphagia, under the Priority Review pathway. A filing designated as a Priority Review reduces the review period to four months. A final decision from the FDA is expected on Dec. 27, 2024. The regulatory body in the United States ...

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 ...