Announcement • Aug 24

Arrowhead Pharmaceuticals Presents New Clinical Data and Product Updates At European Society of Cardiology Congress

Arrowhead Pharmaceuticals, Inc. announced that it will present important new data at the European Society of Cardiology Congress (ESC) in Munich, Germany. Detailed results from the Phase 3 SHASTA-3 and SHASTA-4 Studies of Plozasiran in Patients with Severe Hypertriglyceridemia will be presented as a HOT LINE Late-Breaking Science Session on August 30, 2026. Arrowhead will host a webcast to review ESC data and Q&A on August 31, 2026. ESC 2026 Presentation Details: Date & Time: Sunday, August 30, 2026, 17:30 CEST. Session Title: HOT LINE 9 Late-breaking Science Session. Location: Munich Auditorium-Hall B3. Title: Plozasiran in patients with severe hypertriglyceridemia: the SHASTA-3 and SHASTA-4 pivotal trial 12-month results. Presenter: Gerald Watts, University of Western Australia, Perth, Australia. Discussant review: Borge G. Nordestgaard, Copenhagen University Hospital, Copenhagen, Denmark. Panel discussion. Date & Time: Monday, August 31, 2026, 9:00 am CEST. Session Title: Late-breaking science: Beyond statins: the next wave of lipid-lowering therapies. Location: Tripoli Auditorium-Hall B1. Title: A phase 3 clinical trial to evaluate the efficacy and safety of vsa003 (zodasiran) injection in Chinese adolescents and adults with homozygous familial hypercholesterolemia (HOFH). Presenter: Zhuang Tian, Peking Union Medical College Hospital, Beijing, China. Arrowhead Investor Webcast: Date & Time: Monday, August 31, 2026, 14:00 CEST/8:00 am EDT/5:00 am PDT. Topic: Review SHASTA-3 and SHASTA-4 pivotal trial 12-month results, Q&A. Participants: Gerald Watts, Borde Nordestgaard, and Arrowhead management. The recorded webcast will be made available on the Events and Presentations page under the Investors section of the Arrowhead website approximately two hours after the event. Severe hypertriglyceridemia (sHTG) is characterized by triglyceride (TG) levels greater than 500 mg/dL, with the most severe form being familial chylomicronemia syndrome (FCS) where TGs typically exceed 880 mg/dL. SHTG significantly increases the risk of acute pancreatitis (AP), which can often include recurrent attacks requiring repeat hospital admissions and worsening outcomes. AP risk is proportional to the number, characteristics, and concentration of triglyceride rich lipoproteins (TRLs), particularly chylomicrons, and increases as TGs rise. Elevated TGs can also increase the risk of atherosclerotic cardiovascular disease (ASCVD). Limited treatment options exist to sustainably reduce TGs below guideline-directed risk thresholds. SHASTA-3 (NCT06347003) and SHASTA-4 (NCT06347016) are global double-blind, placebo-controlled, Phase 3 studies to evaluate the efficacy and safety of plozasiran in adults with severe hypertriglyceridemia. Between the two studies, approximately 750 participants were randomized to receive 4 doses (once every 3 months) of 25 mg plozasiran or placebo. The primary endpoint is percent change in fasting serum triglyceride levels from baseline to Month 12 compared to placebo. After Month 12, eligible participants are offered an opportunity to continue in an optional open-label extension. REDEMPLO (plozasiran) is currently approved by the U.S. Food and Drug Administration, Health Canada, China’s National Medical Products Administration, the Australian Therapeutic Goods Administration, and by the European Commission as an adjunct to diet to reduce triglycerides for adults with FCS. REDEMPLO is the first and only siRNA treatment approved in these countries to be studied in both clinically diagnosed and genetically confirmed patients living with FCS. REDEMPLO is designed to suppress the production of apolipoprotein C-III (APOC3), a protein produced in the liver that raises triglyceride levels by slowing their breakdown and clearance. By targeting APOC3 with sustained silencing, REDEMPLO delivers significant reductions in triglyceride levels. REDEMPLO is self-administered via subcutaneous injection once every three months. REDEMPLO has been granted Orphan Medicinal Product Designation by the EMA for the treatment of patients with FCS, and Breakthrough Therapy Designation, Fast Track Designation, and Orphan Drug Designation by the U.S. FDA for the treatment of patients with FCS and was also granted Breakthrough Therapy designation by the U.S. FDA in severe hypertriglyceridemia. Sanofi acquired the rights to develop and commercialize REDEMPLO in Greater China, with Arrowhead retaining rights to REDEMPLO in all geographies, outside of Greater China. Homozygous Familial Hypercholesterolemia is an ultra-rare treatment-resistant genetic condition characterized by elevated LDL-C and early-onset cardiovascular disease. Most cases of HoFH are due to mutations in the gene that encodes the LDL receptor (LDLR). HoFH represents a unique disease where LDL-C lowering therapies not requiring functional LDL receptors may have benefit. If left untreated, individuals with HoFH can have median LDL-C levels above 400 mg/dL (over 10 mmol/L), leading to early clinical manifestations of coronary artery disease. Patients with HoFH may also have cholesterol deposits under the skin (xanthomas), around the eyes (xanthelasmas), or around the cornea (corneal arcus), but physical signs are not always present, particularly in children. HoFH remains challenging to treat and currently only patients with the more severe HoFH phenotypes get diagnosed and treated early. The estimated prevalence of HoFH globally is between 1:360,000 and 1:250,000. Zodasiran, previously called ARO-ANG3, is a first-in-class investigational RNA interference (RNAi) therapeutic designed to reduce production of angiopoietin-like protein (ANGPTL3), which is a hepatocyte expressed regulator of lipid and lipoprotein metabolism with multiple potential modes of action, including inhibition of lipoprotein lipase (LPL) and endothelial lipase (EL). ANGPTL3 is an emerging therapeutic target with relevance to hypercholesterolemia, hypertriglyceridemia, and mixed hyperlipidemia. Genetic studies suggest that individuals with ANGPTL3 loss-of-function variants have enhanced lipoprotein lipase and endothelial lipase activity, resulting in lower levels of atherogenic lipoproteins and a reduced risk of ASCVD. Zodasiran has received Orphan Drug Designation for the treatment of HoFH from the U.S. Food and Drug Administration. In prior clinical studies, investigational zodasiran was associated with dose-dependent reductions in triglycerides, triglyceride rich lipoprotein remnants, and total atherogenic lipoproteins, including LDL-C, in patients with homozygous (HoFH) and heterozygous (HeFH) familial hypercholesterolemia and mixed hyperlipidemia. Zodasiran also showed a favorable safety profile. In the Phase 2 GATEWAY study in patients with HoFH, there were no drug discontinuations, drug-related serious adverse events, or deaths. The most frequent adverse events were COVID-19, nasopharyngitis, upper respiratory tract infection, and dizziness.

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