Company: ARWR
Filing Date: 2025-02-10
Form Type: 10-Q
Source: 0001628280-25-004634
Chunk: 93

Company: ARROWHEAD PHARMACEUTICALS, INC.
Filing Date: 2025-02-10
Form: 10-Q
Item: Part I, Item 2
Chunk 93
---
 Food and Drug Administration (FDA) on November 16, 2024, which was accepted for filing on January 17, 2025. The FDA provided a Prescription Drug User Fee Act (PDUFA) action date of November 18, 2025, and indicated it is not currently planning to hold an advisory committee meeting;

•Entered into a global and collaboration agreement with Sarepta Therapeutics, Inc. The Company received $325.0 million as an equity investment on February 7, 2025 and will receive $500.0 million as an upfront payment during the second quarter of fiscal 2025. The Company will also receive $250.0 million to be paid in equal installments over five years and is eligible to receive an additional $300.0 million in near-term payments. Additionally, the Company is eligible to receive royalties on commercial sales and up to approximately $10.0 billion in future potential milestone payments;

•GSK dosed the fifth patient in a Phase 2 trial in December 2024, triggering a $2.5 million milestone payment to the Company which was paid in the second quarter of fiscal 2025;

•Announced that the Company has dosed the first subjects in a Phase 1/2a clinical trial of ARO-INHBE;

•Presented interim results from a Phase 1/2a clinical study of ARO-CFB at the 8th Complement-Based Drug Development Summit. The study resulted in multiple promising findings including: (1) ARO-CFO led to dose dependent reductions in circulating CFB protein by up to 90% with greater than 3 months duration, (2) single and multiple doses of ARO-CFB led to near complete inhibition of alternative pathway activity based on Wieslab AP, and (3) single and multiple doses of ARO-CFB led to near complete inhibition of alternative pathway hemolytic activity, measured by AH50; and

•Filed a request for regulatory clearance to initiate Phase 1/2a clinical trial of ARO-ALK7, which is being developed as a potential treatment for obesity.

Net loss attributable to Arrowhead Pharmaceuticals, Inc. was $173.1 million and $132.9 million for the three months ended December 31, 2024 and 2023, respectively. Net loss per share – diluted was $1.39 and $1.24 for the three months ended December 31, 2024 and 2023, respectively. The change