Protalix issues letter to shareholders

The company said, “As we approach the close of a transitional year for our company, I want to take a moment to reflect on our recent accomplishments…accomplishments that are shaping our path going forward. Elfabrio(R), our second development candidate produced through our proprietary ProCellEx(R) plant cell-based protein expression system, was approved for the treatment of adult patients with Fabry disease by both the U.S. Food and Drug Administration and the European Medicines Agency. Approval of Elfabrio marks a significant milestone for our company and, more importantly, brings a new therapeutic option to patients with unmet needs. This achievement is a testament to the tireless efforts of our talented and professional team, and we take great pride in sharing this success with you, our dedicated stockholders. As Elfabrio has moved from the development stage to being a commercial product, we are taking steps we believe will strengthen our internal operations and improve our production capabilities for two commercial products. We are confident that as the commercialization of Elfabrio continues to develop, it will enable us to improve our capital structure. Our commercial partner, Chiesi Global Rare Diseases, played a pivotal role in our journey, and I extend my gratitude to Giacomo Chiesi and the entire Chiesi team. Their support has been instrumental in our combined success, and we look forward to further strengthening our relationship in the years to come. Since the approval, Chiesi has launched Elfabrio in the United States, the European Union and the United Kingdom, strategically positioning Elfabrio for success in those markets. Protalix is dedicated to being a valuable resource to Chiesi and facilitating Chiesi’s commercial efforts. We are continuing to make progress on our pipeline programs. We have finished the seventh cohort in the phase I clinical trial of PRX-115, our recombinant PEGylated uricase (urate oxidase) under development for the potential treatment of severe gout. At this time, 56 patients have been dosed in this trial and we anticipate completing the trial in the second quarter of 2024. Progress is also being made in the preclinical development of PRX-119, our plant cell-expressed PEGylated recombinant human DNase I product candidate which we are designing to elongate half-life in the circulation for NETs-related diseases. We look forward to updating you as we advance in the development of these and other product candidates, and as we begin to turn our focus to building a sustainable portfolio of treatments for rare diseases. I also want to take a moment to acknowledge the challenges our community continues to face given the current situation in Israel. Our hearts are with all those who have been affected so profoundly, including our colleagues, partners and the broader community. We deeply appreciate the impact of these events on both a personal and professional level, and we continue to extend our support to everyone navigating these difficult times. Looking ahead, the future of Protalix is filled with promise and potential. As we continue to innovate and strengthen our operations, I am confident that our company can deliver impactful solutions for the benefit of patients in need. Our commitment to excellence, coupled with the passion of our team, positions us well for continued growth and success. In closing, I want to express my sincere appreciation for our employees and our Board of Directors for their ongoing dedication to our mission. I also want to thank you, our stockholders, for your continued confidence and trust in our vision. As we navigate the exciting journey ahead, I am optimistic about Protalix’s future and the positive impact we can collectively make in the lives of patients and the broader healthcare community.”