Arrowhead Pharmaceuticals (NasdaqGS:ARWR) Conference Transcript

Summary of Arrowhead Pharmaceuticals Conference Call Company Overview - Company: Arrowhead Pharmaceuticals (NasdaqGS:ARWR) - Event: Conference at TD Cowen's 2025 Treatment Advances in Obesity Summit - Date: November 24, 2025 Key Points Recent Progress and Upcoming Expectations - Arrowhead recently received the first approval for Redemplo in FCS (Familial Chylomicronemia Syndrome) and plans to provide updates on its launch progress in the upcoming quarterly call [2][28] - The company is set to release data from its INHBE and ALK-7 programs in early January 2026, following the holiday season [2][5] - Initiation of the dimer phase one study for ApoC3 PCSK9 is expected early next year [3] Obesity Treatment Focus - Arrowhead identifies a significant unmet need in obesity treatment, particularly in achieving greater fat mass loss while sparing lean tissue [5] - There is potential for therapeutics that induce moderate weight loss (7-10%) with better tolerability profiles compared to GLP-1s [5][6] - The company is exploring gene targets in adipocytes and hepatocytes to silence genes related to fat storage and metabolism [6] INHBE Program Insights - INHBE encodes Activin E, a protein involved in fat storage regulation, primarily expressed in the liver [8] - Dysregulation of Activin E signaling can lead to increased fat storage, particularly in individuals with excessive caloric intake or type 2 diabetes [9] - Preclinical studies in diet-induced obesity mouse models showed a 20% reduction in weight gain with INHBE siRNA treatment compared to controls [10] - Combination studies with GLP-1s demonstrated additive weight loss effects while preserving lean mass [11] Clinical Trial Updates - The ongoing phase one study includes single and multiple ascending dose cohorts in healthy obese volunteers and type 2 diabetic patients [13][14] - The study is nearly fully enrolled, with a focus on safety and biomarker knockdown, particularly measuring Activin E levels [15] - Initial data release is expected in early 2026, with a critical mass of data needed to make decisions on moving forward with candidates [27] ALK-7 Program Comparison - ALK-7 targets a receptor on adipocytes, utilizing a novel delivery platform, while INHBE targets the liver signaling pathway [20][21] - Preclinical data for ALK-7 showed a 40% reduction in fat mass in treated animals, suggesting it may be a more potent approach than INHBE [21][22] - Both programs are designed to address obesity but through different mechanisms, with ongoing studies to determine their relative efficacy [23] Redemplo Launch Expectations - Initial launch expectations for Redemplo are positive, with significant interest from investigators and potential patients [28] - The company is cautious about pricing strategies and will provide updates in the upcoming earnings call [28] Future Outlook - Arrowhead anticipates a robust data release in early 2026, which will inform decisions on the progression of its obesity programs and potential partnerships [27] - The company is also monitoring the competitive landscape, particularly in relation to other siRNA approaches targeting similar pathways [18] Additional Considerations - The company is focused on differentiating its products based on efficacy, tolerability, and the quality of weight loss achieved [16] - Ongoing studies will help clarify the impact of treatments on liver fat content and overall metabolic health [30][31]