Amylyx Pharmaceuticals Reports $41.4 Million Net Loss in Q2 2025, Focuses on Clinical Pipeline

Amylyx Pharmaceuticals, Inc. reported a net loss of $41.4 million for the second quarter of 2025, a significant improvement compared to a net loss of $72.7 million in the same period last year. The company did not generate any product revenue during this quarter, reflecting the discontinuation of its product RELYVRIO/ALBRIOZA for ALS, which had previously contributed $87.6 million in revenue for the first half of 2024. Total operating expenses for the quarter decreased by 43% to $42.9 million, down from $75.3 million in the prior year, primarily due to reduced selling, general, and administrative expenses following a restructuring plan that cut the workforce by approximately 70%.

In terms of operational developments, Amylyx is advancing its clinical pipeline, focusing on three investigational therapies: avexitide for post-bariatric hypoglycemia (PBH), AMX0035 for Wolfram syndrome and progressive supranuclear palsy (PSP), and AMX0114 for amyotrophic lateral sclerosis (ALS). The company initiated the pivotal Phase 3 LUCIDITY trial for avexitide in April 2025, with the first participant dosed. Additionally, AMX0035 is undergoing a Phase 2b/3 trial for PSP, with interim results expected in the third quarter of 2025. The company’s total cash, cash equivalents, and marketable securities stood at $180.8 million as of June 30, 2025, which management believes will be sufficient to fund operations through 2026.

The filing also highlighted a strategic shift following the discontinuation of RELYVRIO/ALBRIOZA, which has led to a focus on avexitide and AMX0035. The company is actively seeking collaborations to support the development and commercialization of its product candidates. However, it faces challenges in securing additional funding, as it anticipates significant expenses related to ongoing clinical trials and potential commercialization efforts. The company’s accumulated deficit increased to $684 million, reflecting the ongoing investment in research and development.

Looking ahead, Amylyx remains optimistic about its pipeline, particularly avexitide, which has received Breakthrough Therapy Designation from the FDA. The company is also exploring additional indications for AMX0035 and plans to continue its research and development efforts. However, it acknowledges the inherent risks and uncertainties in the biotechnology sector, including regulatory approval processes and market acceptance challenges. The company’s ability to achieve profitability will depend on the successful commercialization of its product candidates, which remains uncertain given the competitive landscape and the complexities of drug development.