Arrowhead Pharmaceuticals Announces Q3 Fiscal 2024 Results

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported its financial outcomes for the third quarter of fiscal 2024, which ended on June 30, 2024. The company also scheduled a conference call on August 8, 2024, at 4:30 p.m. ET to deliberate over the results.

Christopher Anzalone, Ph.D., President and CEO of Arrowhead, expressed satisfaction with the quarter's progress. The company had several notable presentations at medical and scientific conferences and publications in high-impact journals, reflecting strong clinical results. Arrowhead is advancing well in its late-stage clinical studies and is nearing the commercialization of both its wholly-owned and partnered RNA interference (RNAi) therapeutics. On the financial side, the company bolstered its balance sheet with two significant inflows, focusing its resources on plozasiran, its most promising commercial opportunity, anticipated to launch in 2025 upon regulatory approval for familial chylomicronemia syndrome.

The company strengthened its financial position through a strategic financing agreement with Sixth Street, securing a $500 million senior secured credit facility. This includes $400 million available immediately and an additional $100 million subject to mutual agreement over a seven-year term. Furthermore, Arrowhead received a $50 million milestone payment from Royalty Pharma plc after completing the enrollment of the Phase 3 OCEAN(a) - Outcomes Trial of olpasiran, being conducted by Amgen. Olpasiran, originally developed by Arrowhead, aims to lower lipoprotein(a) levels, a genetic risk factor for cardiovascular disease.

Arrowhead also reported successful topline results from the Phase 3 PALISADE study of plozasiran in patients with familial chylomicronemia syndrome (FCS). The study showed plozasiran achieved significant reductions in triglycerides and APOC3 levels, met all key secondary endpoints, and demonstrated a favorable safety profile. Additional data will be presented at the European Society of Cardiology (ESC) Congress 2024.

The company initiated pivotal Phase 3 SHASTA-3 and SHASTA-4 studies of plozasiran in severe hypertriglyceridemia patients and announced plans for a Phase 3 cardiovascular outcomes trial called CAPITAN. Arrowhead presented new Phase 2 data from the MUIR study of plozasiran in mixed hyperlipidemia patients and from the ARCHES-2 study of investigational zodasiran at the European Atherosclerosis Society Congress.

In the MUIR study, plozasiran significantly reduced triglycerides, atherogenic lipoproteins, and increased HDL at varying doses. The ARCHES-2 study showed zodasiran decreased triglycerides, remnant cholesterol, LDL-C, ApoB, and non-HDL-C in mixed hyperlipidemia patients. Both therapies demonstrated favorable safety profiles.

Arrowhead also presented final Phase 2 SHASTA-2 data for plozasiran in severe hypertriglyceridemia patients, showing significant reductions in triglycerides and APOC3. In preclinical studies, ARO-INHBE showed promising results in obesity and metabolic disease treatments, and ARO-RAGE showed potential for treating inflammatory lung diseases like asthma.

The company launched the 2024 Summer Series of R&D webinars, focusing on different therapeutic areas in its pipeline. The schedule includes completed sessions on muscular, cardiometabolic, pulmonary areas, and upcoming sessions on obesity/metabolic and central nervous system.

Financially, Arrowhead reported a decrease in quarterly revenue from $15.8 million in 2023 to zero in 2024, with operating expenses rising significantly. The net loss for the quarter was $170.8 million, up from $102.9 million the previous year. The company’s cash resources stood at $436.7 million as of June 30, 2024.

Arrowhead Pharmaceuticals develops RNAi-based medicines targeting intractable diseases by silencing specific genes. This approach leverages the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. The company’s innovative therapies hold promise for revolutionizing treatments for various severe diseases.