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]

Core Viewpoint - The submission of the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets to the FDA represents a significant advancement for Soleno Therapeutics and individuals with Prader-Willi syndrome (PWS) [1][6]. Group 1: Company Overview - Soleno Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for rare diseases [10]. - The company has submitted an NDA for DCCR, which is a once-daily oral tablet aimed at treating PWS [10]. Group 2: Product Information - DCCR is designed to treat hyperphagia, a life-threatening symptom of PWS, and has received Breakthrough and Fast Track Designations in the U.S., as well as Orphan Drug Designation for PWS in both the U.S. and E.U. [7][9]. - The development program for DCCR is supported by data from five completed Phase 1 clinical studies and three completed Phase 2 clinical studies, including one involving individuals with PWS [9]. Group 3: Market Context - PWS occurs in approximately 1 in every 15,000 live births, with hyperphagia being the hallmark symptom that severely impacts the quality of life for affected individuals and their families [8]. - There are currently no approved therapies to address the hyperphagia, metabolic, cognitive, or behavioral aspects of PWS [8].

The independent members of the Board of Directors of Soleno approved the grant of non-qualified stock options to purchase 247,200 shares of common stock to eight employees as an inducement for them entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company's lead candidate, DCCR (diazoxide choline) extended-release tablets, a once-daily oral table ...

Core Points - Soleno Therapeutics, Inc. is set to join the Russell 3000® Index effective July 1, 2024, marking a significant milestone for the company [1][2] - The inclusion in the Russell indexes reflects the progress made in advancing its lead candidate DCCR (diazoxide choline) extended-release tablets through clinical development [2] - The Russell US Indexes reconstitution captures the 4,000 largest US stocks ranked by total market capitalization, with membership in the Russell 3000® Index providing automatic inclusion in the Russell 1000® or Russell 2000® Indexes [2] Company Overview - Soleno Therapeutics focuses on developing and commercializing novel therapeutics for rare diseases, with its lead candidate DCCR aimed at treating Prader-Willi syndrome (PWS) [4] - DCCR has recently completed its Phase 3 development program to support a planned NDA submission [4] Industry Context - Russell indexes are widely utilized by investment managers and institutional investors for index funds and as benchmarks for active investment strategies, with approximately $10.5 trillion in assets benchmarked against these indexes as of December 2023 [3]

Core Insights - Soleno Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for rare diseases [2] - The company's lead candidate, DCCR extended-release tablets, has recently completed its Phase 3 development program and is preparing for a New Drug Application (NDA) submission [2] Upcoming Events - Anish Bhatnagar, M.D., CEO of Soleno, will participate in the Jefferies Global Healthcare Conference on June 5, 2024, at 11:30 AM ET [1] - The CEO will also attend the Goldman Sachs 45th Annual Global Healthcare Conference on June 11, 2024, at 4:00 PM ET [1] - Live audio webcasts of these events will be available on the company's website [1]

[Soleno Therapeutics Q1 2024 Corporate and Financial Update](index=1&type=section&id=Soleno%20Therapeutics%20Q1%202024%20Corporate%20and%20Financial%20Update) [Corporate Highlights and Strategic Priorities](index=1&type=section&id=Corporate%20Highlights%20and%20Strategic%20Priorities) The company is focused on its mid-2024 DCCR NDA submission, supported by a recent financing and team expansion - The company's top priority is the **New Drug Application (NDA) submission for DCCR** in Prader-Willi syndrome (PWS), on track for mid-2024[3](index=3&type=chunk)[4](index=4&type=chunk) - DCCR was granted **Breakthrough Therapy Designation** by the U.S. FDA for the treatment of PWS in adults and children ages four and older[3](index=3&type=chunk)[4](index=4&type=chunk) - Successfully closed an underwritten public offering of approximately **$158.7 million**, strengthening the company's financial position[4](index=4&type=chunk) - Strengthened the leadership team with key appointments to prepare for **potential commercialization**[4](index=4&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) The Q1 2024 net loss widened to $21.4 million due to higher expenses, while a public offering boosted cash reserves [Key Financial Metrics](index=2&type=section&id=Key%20Financial%20Metrics) Q1 2024 saw operating expenses triple to $23.5 million, widening the net loss to $21.4 million year-over-year Q1 2024 vs Q1 2023 Financial Performance (in millions) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Research and Development Expense | $14.6 | $5.3 | | General and Administrative Expense | $8.5 | $2.9 | | Total Operating Expenses | $23.5 | $8.5 | | Net Loss | $21.4 | $8.4 | | Net Loss per Share | $0.59 | $0.88 | - The increase in R&D expense was primarily due to increased headcount and expenditures supporting the **NDA submission and commercial launch preparation**[7](index=7&type=chunk) - The rise in G&A expense was mainly related to higher **stock-based compensation**, increased headcount, and higher professional expenses[8](index=8&type=chunk) [Balance Sheet and Cash Position](index=2&type=section&id=Balance%20Sheet%20and%20Cash%20Position) The company held $158.4 million in cash and investments, with a May offering boosting pro forma reserves to $307.2 million Cash and Investments Position (as of March 31, 2024) | Item | Amount (in millions) | | :--- | :--- | | Cash and cash equivalents | $42.8 | | Short-term investments | $106.8 | | Long-term investments | $8.8 | | **Total Cash & Investments** | **$158.4** | - In May 2024, the company received **$148.8 million in net proceeds** from a public offering, bringing pro forma cash reserves to **$307.2 million**[6](index=6&type=chunk) - The company has a contingent liability with a fair value of **$12.0 million** as of March 31, 2024, related to future commercial sales milestones for DCCR[9](index=9&type=chunk) [Business and Product Overview](index=2&type=section&id=Business%20and%20Product%20Overview) The company is a clinical-stage biopharma developing its lead candidate, DCCR, for the rare disease Prader-Willi Syndrome [About Prader-Willi Syndrome (PWS)](index=2&type=section&id=About%20Prader-Willi%20Syndrome%20(PWS)) PWS is a rare genetic disorder defined by life-threatening hyperphagia for which there are no approved therapies - PWS occurs in one in every **15,000 live births** and is characterized by hyperphagia, a chronic and life-threatening feeling of intense hunger[12](index=12&type=chunk) - A global survey showed that **96.5% of parents and caregivers** rated hyperphagia as the most important symptom to be relieved by a new medicine[13](index=13&type=chunk) - There are currently **no approved therapies** to treat the hyperphagia, metabolic, cognitive function, or behavioral aspects of PWS[13](index=13&type=chunk) [About DCCR (Diazoxide Choline) Extended-Release Tablets](index=3&type=section&id=About%20DCCR%20(Diazoxide%20Choline)%20Extended-Release%20Tablets) DCCR is a proprietary, once-daily tablet for PWS that has completed Phase 3 and received multiple FDA designations - DCCR is a novel, proprietary **once-daily extended-release tablet** form of diazoxide choline[14](index=14&type=chunk) - The **Phase 3 clinical program** showed DCCR was promising in addressing hyperphagia and other symptoms like aggressive/destructive behaviors and fat mass[14](index=14&type=chunk) - DCCR has received **Orphan Drug, Fast Track, and Breakthrough Designations** in the U.S. for the treatment of PWS[14](index=14&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) The statements detail the company's financial position, with total assets of $168.8 million and a Q1 net loss of $21.4 million [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets were $168.8 million as of March 31, 2024, with total liabilities of $25.5 million Condensed Balance Sheet Data (in thousands) | Balance Sheet Item | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $42,847 | $169,681 | | Total current assets | $151,223 | $171,358 | | Total assets | $168,837 | $180,691 | | Total liabilities | $25,451 | $23,184 | | Total stockholders' equity | $143,386 | $157,507 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a Q1 2024 net loss of $21.4 million, a significant increase from $8.4 million in Q1 2023 Condensed Statement of Operations Data (in thousands) | Statement of Operations Item | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Research and development | $14,602 | $5,316 | | General and administrative | $8,472 | $2,854 | | Operating loss | $(23,475) | $(8,469) | | Net loss | $(21,398) | $(8,356) | | Net loss per share, basic and diluted | $(0.59) | $(0.88) |

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (State or other jurisdiction of incorporation or organization) Delaware 77-0523891 (I.R.S. Employer Identification No.) (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36593 SOL ...

Exhibit 99.1 Soleno Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full-Year 2023 Financial Results REDWOOD CITY, Calif., March 6, 2024 – Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update, and reported financial results for the fourth quarter and full-year ended December 31, 2023. Full Year 2023 and Recent Corporate Highlights • Announced posi ...