Viking Therapeutics(VKTX)2025-04-24 20:37Research and Development - The company incurred 40.4 million in research and development expenses, focusing on ongoing clinical trials [118]. - Research and development expenses increased by 71.7% to 24.1 million in the same period of 2024 [129]. - The company expects to incur increased research and development expenses as it advances VK2735, VK2809, and VK0214 programs [128]. - The company expects to initiate Phase 3 clinical studies of VK2735 in the second quarter of 2025 based on FDA feedback [102]. - VK2735's Phase 1 trial was completed in March 2023, leading to the initiation of the Phase 2 VENTURE study in September 2023 [101]. - The Phase 2 VENTURE study of VK2735 demonstrated statistically significant mean body weight reductions of up to 14.7% from baseline after 13 weeks [102]. - VK2809 achieved its primary endpoint in the VOYAGE study, with significant reductions in liver fat content observed from baseline to Week 12 [109]. - In the VOYAGE study, up to 75% of VK2809-treated patients achieved NASH/MASH resolution with no worsening of fibrosis compared to 29% for placebo [110]. - VK0214 demonstrated significant reductions in plasma levels of VLCFAs in a Phase 1b clinical trial, indicating its potential for treating X-ALD [113]. - The company plans to file an investigational new drug application for its new DACRA program in the second half of 2024 [114]. Financial Performance - General and administrative expenses rose by 41.2% to 10.0 million in the same period of 2024 [131]. - Total other income increased by 46.5% to 6.7 million in the same period of 2024 [133]. - Cash used in operating activities was 6.1 million in the same period of 2024 [141]. - Cash provided by investing activities was 851.9 million, sufficient to fund operations through at least June 30, 2026 [134]. - The company anticipates continued losses as it advances drug candidates and seeks regulatory approvals, necessitating additional capital to fund operations and clinical trials [148]. Stock Repurchase and Investments - The company repurchased 729,034 shares under a prior stock repurchase program, which was completed by March 18, 2024 [136]. - A new stock repurchase program was authorized in February 2025, allowing for the purchase of up to 37,940,000, an increase from 813,918,000, down from 851,858,000, compared to 686,000 [154]. - The investment portfolio is primarily composed of U.S. government securities, investment-grade corporate bonds, and money market funds [151]. - The company does not hold any investments for trading purposes, focusing instead on preserving capital and ensuring liquidity [152]. - Interest income from cash and short-term investments will vary with fluctuations in U.S. interest rates [153]. - The company has implemented guidelines to limit the term-to-maturity of its investment instruments to manage interest rate risk [152]. - The fair value of the company's investments is not materially exposed to interest rate risk due to the conservative nature of the instruments held [152]. - The investment policy includes credit quality standards and limits exposure to any single issue or type of instrument [151].