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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File No.: 001-36593 Soleno Therapeutics, Inc. (Exact name of Registrant as specified in its charter) Delaware 77-0523891 (State or other Jurisdiction ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☐ 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 WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or SOLENO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorp ...

2 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 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 SOLENO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 77-0523891 (State or other juris ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (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, 2023 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 SOLENO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporat ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File No.: 001-36593 Soleno Therapeutics, Inc. (Exact name of Registrant as specified in its charter) Delaware 77-0523891 (State or other Jurisdiction ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 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 SOLENO THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 77-0523891 (State or other ju ...