Soleno Therapeutics(SLNO) - 2024 Q2 - Quarterly Results

Corporate Highlights Soleno Therapeutics achieved significant Q2 2024 milestones, including DCCR's NDA submission, a successful public offering, and key FDA designations - Submitted a New Drug Application (NDA) to the U.S. FDA for Diazoxide Choline Extended-Release (DCCR) for the treatment of Prader-Willi Syndrome (PWS) in individuals four years and older[2] - Closed an underwritten public offering of 3,450,000 shares at $46.00 per share, raising approximately $158.7 million[2] - Received Breakthrough Therapy Designation from the FDA for DCCR for treating genetically confirmed PWS with hyperphagia in adults and children aged four and older[2] - Joined the broad-market Russell 3000® Index effective July 1, 2024[2] Financial Results Soleno reported a higher net loss in Q2 2024 due to increased R&D and G&A expenses, while maintaining a strong cash position Key Financial Metrics (Q2 2024) Q2 2024 saw increased R&D and G&A expenses leading to a higher net loss, despite a robust cash position Q2 & H1 2024 vs 2023 Financial Performance (in millions) | Metric | Q2 2024 | Q2 2023 | H1 2024 | H1 2023 | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $12.3 | $5.1 | $26.9 | $10.5 | | General & Administrative | $10.9 | $3.2 | $19.4 | $6.0 | | Net Loss | $21.9 | $8.5 | $43.3 | $16.8 | | Net Loss Per Share | $0.57 | $0.81 | $1.16 | $1.69 | Balance Sheet Highlights (as of June 30, 2024) | Account | Amount (in millions) | | :--- | :--- | | Cash, cash equivalents and marketable securities | $294.6 | | Total Assets | $304.1 | | Total Liabilities | $23.4 | - The fair value of the contingent consideration liability for commercial sales milestones of DCCR increased by $2.0 million to $13.6 million as of June 30, 2024[5] Stock-based Compensation Expense (in thousands) | Category | Q2 2024 | Q2 2023 | H1 2024 | H1 2023 | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $2,705 | $470 | $5,166 | $652 | | General & Administrative | $4,455 | $734 | $8,439 | $1,183 | | Total | $7,160 | $1,204 | $13,605 | $1,835 | Financial Statements This section provides unaudited condensed consolidated balance sheets and statements of operations for specified periods Condensed Consolidated Balance Sheets (in thousands) | | June 30, 2024 (Unaudited) | December 31, 2023 | | :--- | :--- | :--- | | Total current assets | $267,502 | $171,358 | | Total assets | $304,131 | $180,691 | | Total current liabilities | $9,150 | $11,505 | | Total liabilities | $23,374 | $23,184 | | Total stockholders' equity | $280,757 | $157,507 | Condensed Consolidated Statements of Operations (in thousands) | | Three Months Ended June 30 | Six Months Ended June 30 | | :--- | :--- | :--- | | | 2024 | 2023 | 2024 | 2023 | | Total operating expenses | $24,868 | $8,623 | $48,343 | $17,092 | | Operating loss | $(24,868) | $(8,623) | $(48,343) | $(17,092) | | Net loss | $(21,854) | $(8,475) | $(43,252) | $(16,831) | Business and Pipeline Overview Soleno Therapeutics focuses on rare disease treatments, with DCCR for PWS showing promise and multiple FDA designations About Prader-Willi Syndrome (PWS) PWS is a rare genetic disorder characterized by severe hyperphagia, for which no approved therapies currently exist - PWS occurs in approximately one in every 15,000 live births[7] - The hallmark symptom is hyperphagia, a chronic and life-threatening feeling of intense, persistent hunger[7] - There are currently no approved therapies to treat the hyperphagia/appetite, metabolic, cognitive function, or behavioral aspects of the disorder[8] About DCCR (Diazoxide Choline) Extended-Release Tablets DCCR is Soleno's proprietary once-daily extended-release tablet for PWS, showing promise and holding FDA designations - DCCR is a novel, proprietary extended-release dosage form of diazoxide choline administered once-daily[9] - The DCCR development program is supported by data from five Phase 1 studies and three Phase 2 studies[9] - Diazoxide choline has received Orphan Drug Designation in the U.S. and E.U., and Fast Track and Breakthrough Designations in the U.S.[9]