Research and Development - The company incurred $345.0 million in research and development expenses for the year ended December 31, 2025, primarily related to the VK2735 Phase 2 VENTURE clinical trial and other ongoing studies [435]. - The VK2735 Phase 2 VENTURE study demonstrated statistically significant reductions in mean body weight after 13 weeks, with reductions up to 14.7% from baseline for patients receiving VK2735 [415]. - The Phase 1 trial of VK2735 was completed in March 2023, leading to the initiation of the Phase 2 VENTURE study in September 2023 [414]. - The company plans to file an Investigational New Drug application for the new Dual Amylin and Calcitonin Receptor Agonist (DACRA) program in the first quarter of 2026 [421]. - The VOYAGE study of VK2809 achieved its primary endpoint, with significant reductions in liver fat content from baseline to Week 12 compared to placebo [427]. - In June 2024, 75% of VK2809-treated patients achieved NASH/MASH resolution with no worsening of fibrosis, compared to 29% for placebo (p=0.0001) [428]. - The Phase 1b clinical trial of VK0214 showed significant reductions in plasma levels of very long chain fatty acids compared to placebo [431]. - The company is dynamically managing its research and development expenses based on scientific data and market potential [436]. - Research and development expenses increased to $344,955,000 in 2025 from $101,644,000 in 2024, representing a 239.4% increase [454]. - The increase in research and development expenses was primarily due to clinical studies costs rising by $202.7 million and manufacturing costs increasing by $32.5 million [454]. - Future research and development expenses will depend on the clinical success of drug candidates and ongoing assessments of their commercial potential [438]. Financial Performance - The company has not generated any revenue to date and does not expect to until regulatory approval and commercialization of its drug candidates [434]. - General and administrative expenses decreased slightly to $48,387,000 in 2025 from $49,277,000 in 2024, a reduction of 1.8% [456]. - Other income, net decreased to $33,703,000 in 2025 from $40,958,000 in 2024, reflecting a decline of 17.7% [458]. - As of December 31, 2025, the company had cash, cash equivalents, and short-term investments totaling $705.7 million, expected to fund operations through at least Q1 2027 [461]. - The company has incurred operating losses since inception and has not generated any revenues to date [462]. - The company expects to continue increasing general and administrative expenses to support research and development activities, including salaries and stock-based compensation [439]. - For the year ended December 31, 2025, net cash used in operating activities was $278.7 million, reflecting net losses adjusted by non-cash charges [470]. - The company anticipates continued losses as it develops drug candidates and seeks regulatory approvals, indicating a need for additional capital [475]. Capital and Financing - The company has entered into an At-The-Market Equity Offering Sales Agreement with a total offering price of up to $125 million, resulting in net proceeds of approximately $13.6 million from shares sold [463]. - A stock repurchase program was authorized in March 2022, allowing the company to repurchase up to $50 million in shares, with 729,034 shares repurchased by March 2024 [464]. - In April 2023, the company completed a public offering of 19,828,300 shares at $14.50 per share, raising gross proceeds of $287.5 million [465]. - In March 2024, the company completed another public offering of 7,441,650 shares at $85.00 per share, resulting in net proceeds of $597.1 million [468]. - The company has a stock repurchase program authorized for up to $250.0 million, effective February 27, 2025 [469]. - From the ATM Offering, the company sold 3,556,911 shares, with remaining gross proceeds of up to $75.7 million available for future sales [467]. - In 2025, net cash provided by financing activities was $76.4 million, primarily from the ATM Offering and option exercises [473]. - The company expects to finance future cash needs through public or private equity or debt offerings, though availability on acceptable terms is uncertain [475]. - A hypothetical 100 basis point change in interest rates would affect interest income on investments by approximately $0.9 million for both 2024 and 2025 [480].
Viking Therapeutics(VKTX) - 2025 Q4 - Annual Report