Financial Data and Key Metrics Changes - Research and development expenses increased to $60.2 million for Q2 2025 from $23.8 million in Q2 2024, primarily due to clinical study costs and manufacturing expenses [8][9] - General and administrative expenses rose to $14.4 million for Q2 2025 from $10.3 million in Q2 2024, mainly due to stock-based compensation and salaries [9] - The net loss for Q2 2025 was $65.6 million, or $0.58 per share, compared to a net loss of $22.3 million, or $0.20 per share, in Q2 2024 [9] - For the first six months of 2025, research and development expenses totaled $101.5 million, up from $47.9 million in the same period in 2024 [10] - The net loss for the first half of 2025 was $111.2 million, or $0.99 per share, compared to a net loss of $49.6 million, or $0.46 per share, in the first half of 2024 [10][11] - Cash, cash equivalents, and short-term investments decreased to $8 million as of June 30, 2025, from $9 million at the end of 2024 [11] Business Line Data and Key Metrics Changes - The VK2735 program for obesity is advancing with both oral and subcutaneous formulations, with the initiation of the Vanquish Phase III registration program [5][6] - The Phase II trial for the oral tablet formulation of VK2735 completed enrollment, with results expected later in the year [6][21] - The company is also progressing with a new program evaluating novel agonists of the amylin receptor, with an IND filing expected in Q4 2025 [22] Market Data and Key Metrics Changes - The Vanquish Phase III studies will evaluate VK2735 in adults with obesity and those with type 2 diabetes, targeting a total enrollment of approximately 4,500 and 1,100 participants, respectively [15][16] - The primary endpoint of the trials is the percent change in body weight from baseline after 78 weeks of treatment [16] Company Strategy and Development Direction - The company aims to provide both oral and subcutaneous formulations of VK2735 to cater to different patient preferences and mitigate safety challenges [17][18] - Viking Therapeutics is maintaining fiscal discipline and a strong balance sheet to support the advancement of VK2735 through Phase III trials and other key programs [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing studies and the strong demand for new weight loss therapeutics, indicating a positive outlook for the VK2735 program [23] - The company is focused on executing its core clinical strategy and is excited about the progress made in its development programs [5][6] Other Important Information - The company has achieved a comprehensive manufacturing agreement to support the potential commercialization of VK2735 [7] - Viking Therapeutics is preparing for the transition to auto injectors for VK2735 in early 2026, with plans for a bioequivalence study [110] Q&A Session Summary Question: Will the Phase II readout include data from all cohorts? - Yes, it will include all cohorts as it is a parallel cohort study [28] Question: Do you have an oral dose in mind for the monthly dosing study? - No specific dose has been determined yet as Phase II oral data is still pending [34] Question: Can you discuss the rationale for the top dose in the Phase III trial? - The decision to increase the top dose was based on encouraging tolerability and efficacy observed in previous studies [39] Question: What are the expectations for the oral Phase II data? - The company is looking for mid to high single-digit weight loss percentages, ideally around 8% [74] Question: How will placebo patients be motivated to stay in the study? - Regular visits and eligibility for open-label extensions are expected to help maintain participation [104] Question: What does the amylin agonist program need to show in Phase I? - The program should demonstrate impact on body weight and a favorable tolerability profile [124]