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Viking Therapeutics (NasdaqCM:VKTX) FY Conference Transcript
2026-01-12 23:17
Viking Therapeutics FY Conference Summary Company Overview - **Company**: Viking Therapeutics (NasdaqCM:VKTX) - **Focus**: Development of novel therapeutics for metabolic and endocrine diseases, particularly highlighted by the peptide VK2735, a dual agonist of GLP-1 and GIP receptors [2][28] Key Points on VK2735 and Clinical Programs - **VK2735**: Currently in a Phase III program called the Vanquish program, with two trials in progress for obesity [2][3] - **Oral Formulation**: An oral version of VK2735 has completed Phase II studies, with data submission planned for the European Conference on Obesity in Q2 2026 [3][28] - **Pipeline**: Includes VK2809 (thyroid receptor beta agonist for MASH) and VK0214 (for X-linked adrenal leukodystrophy), both of which have completed early-stage studies [3][28] Clinical Trial Results - **VK2735 Phase I and II Results**: - Phase I showed a dose-dependent reduction in body weight, with up to 8.2% weight loss after 28 days [9][10] - Phase II results indicated a weight loss of up to 12% at the highest dose (120 mg) after 13 weeks, with significant results across all cohorts except the lowest dose [11][23] - Maintenance of weight loss was observed, with 6.7%-10.3% maintained three weeks after the last dose [12][18] Tolerability and Safety - **Tolerability**: VK2735 demonstrated excellent tolerability, with most adverse events being mild to moderate, primarily gastrointestinal [10][21] - **Dosing Strategy**: Future studies may adopt a slower titration approach to mitigate gastrointestinal side effects [17][18] Vanquish Trials - **Trial Design**: The Vanquish program includes two studies, one for obesity and another for obesity with type 2 diabetes, both with a one-year extension for long-term safety and efficacy [25][28] - **Enrollment Status**: Vanquish I has completed enrollment, while Vanquish II is on track to complete enrollment in Q1 2027 [29] Financials - **Cash Position**: Viking Therapeutics reported over $700 million in cash as of the end of Q3 2026, providing a strong financial foundation for ongoing and future projects [28] Future Directions - **Amylin Program**: An IND filing for an amylin program is planned for Q1 2026, with potential for combination therapies with VK2735 [3][44] - **Market Positioning**: The oral formulation of VK2735 is envisioned as a maintenance therapy following injectable treatments, aiming to provide a seamless transition for patients [38][39] Industry Context - **Regulatory Environment**: The FDA's recent developments regarding trial requirements may influence Viking's future clinical strategies, although the company plans to proceed with two Phase III trials for the oral formulation [34][35] - **Competitive Landscape**: The company acknowledges the competitive nature of the obesity treatment market, emphasizing the importance of tolerability and efficacy in their product offerings [30][31] Strategic Interest - **Industry Interest**: There is a growing interest from pharmaceutical companies in the obesity treatment space, with Viking Therapeutics positioned to capitalize on this trend as they advance their programs [47][48]