Viking Therapeutics(US:VKTX)2024-10-23 21:00Research and Development - The company incurred $70.7 million in research and development expenses during the nine months ended September 30, 2024, primarily for VK2735, VK2809, and VK0214 clinical trials [88]. - VK2735 demonstrated statistically significant mean body weight reductions of up to 14.7% from baseline in the Phase 2 VENTURE study after 13 weeks [78]. - VK2809 achieved a primary endpoint in the VOYAGE study, with significant reductions in liver fat content from baseline to Week 12 compared to placebo [80]. - In the VOYAGE study, up to 75% of VK2809-treated patients achieved MASH/NASH resolution with no worsening of fibrosis, compared to 29% for placebo (p=0.0001) [81]. - VK0214 showed significant reductions in plasma levels of very long-chain fatty acids in a Phase 1b clinical trial, indicating its potential efficacy for X-ALD [85]. - The Phase 2 VENTURE study for VK2735 enrolled adults with obesity or overweight, with a primary endpoint focused on percent change in body weight [78]. - The company plans to advance VK2735 into Phase 3 development based on FDA feedback following positive Phase 2 results [78]. Financial Performance - The company has not generated any revenue to date and does not expect to until drug candidates are approved and commercialized [88]. - Research and development expenses for Q3 2024 increased by 24.0% to $22.8 million compared to $18.4 million in Q3 2023, primarily due to higher manufacturing costs and stock-based compensation [94]. - General and administrative expenses for Q3 2024 rose by 55.0% to $13.8 million from $8.9 million in Q3 2023, mainly driven by increased stock-based compensation and legal services [95]. - Total other income for Q3 2024 was $11.6 million, a significant increase of 145.5% from $4.7 million in Q3 2023, primarily due to interest income [96]. - Research and development expenses for the nine months ended September 30, 2024, totaled $70.7 million, reflecting a 63.2% increase from $43.3 million in the same period of 2023 [97]. - General and administrative expenses for the nine months ended September 30, 2024, were $34.0 million, up 20.5% from $28.2 million in the prior year [98]. - Total other income for the nine months ended September 30, 2024, reached $30.1 million, a 194.0% increase from $10.3 million in the same period of 2023 [99]. Cash and Investments - As of September 30, 2024, the company had cash, cash equivalents, and short-term investments of $930.4 million, expected to fund operations through at least December 31, 2025 [100]. - Cash used in operating activities for the nine months ended September 30, 2024, was $56.6 million, compared to $55.7 million in the same period of 2023 [108][109]. - Cash used in investing activities for the nine months ended September 30, 2024, was $560.0 million, significantly higher than $214.8 million in the same period of 2023 [110]. - Cash provided by financing activities for the nine months ended September 30, 2024, was $611.5 million, compared to $271.2 million in the same period of 2023, primarily from stock offerings [111]. - As of September 30, 2024, cash and cash equivalents totaled $50,347,000, down from $55,516,000 on December 31, 2023 [117]. - Short-term investments available-for-sale increased significantly to $880,093,000 from $306,563,000 [117]. - Total cash and short-term investments reached $930,440,000, compared to $362,079,000 at the end of 2023 [117]. - A 10% increase or decrease in short-term interest rates would result in an annual interest income change of approximately $1.4 million [117]. - The investment portfolio is primarily composed of U.S. government securities, investment-grade corporate bonds, and money market funds [114]. - The company has implemented guidelines to limit the term-to-maturity of its investment instruments to manage interest rate risk [115]. - Interest income from cash and short-term investments will vary with fluctuations in U.S. interest rates [116]. - The company does not believe that the fair value of its investments has a material exposure to interest rate risk due to the conservative nature of the instruments [115]. - The investment portfolio is used to preserve capital, provide liquidity, and earn returns aligned with the company's risk appetite [114]. - The company accounts for its securities as available-for-sale, realizing gains or losses only upon sale or credit loss [115].