Protalix BioTherapeutics Issues 2025 Letter to Stockholders

Core Viewpoint - Protalix BioTherapeutics is making significant progress in its development pipeline and commercial partnerships, particularly with Chiesi Global Rare Diseases, to enhance treatment options for patients with rare diseases like Fabry disease [1][5][10]. Group 1: Company Developments - Protalix has achieved important milestones in 2024, including the validation of a less frequent dosing regimen for pegunigalsidase alfa by the European Medicine Agency [1]. - The company has successfully completed a Phase I First-in-Human clinical trial for PRX-115, demonstrating its potential as a safe and effective treatment for uncontrolled gout, with plans to advance to Phase II trials in the second half of 2025 [10]. - Protalix has repaid all outstanding convertible notes, resulting in a debt-free status, which strengthens its financial position for ongoing operations [12]. Group 2: Product Pipeline - The development pipeline includes proprietary recombinant therapeutic proteins targeting established pharmaceutical markets, such as PRX-115 for gout and PRX-119 for NETs-related diseases [5][11]. - Elfabrio®, the company's second product, received FDA and EMA approval in May 2023, marking a significant achievement in its product portfolio [16]. Group 3: Partnerships and Collaborations - Protalix's collaboration with Chiesi Farmaceutici S.p.A. is crucial for the global development and commercialization of Elfabrio, highlighting the importance of strategic partnerships in the company's growth [5][1]. - The partnership aims to reduce the treatment burden for patients with Fabry disease, showcasing a commitment to patient-centered care [1].