#Israel #Protalix BioTherapeutics #Chiesi Global Rare Diseases #Elfabrio #Carmiel

Protalix BioTherapeutics: 2025 Letter to Stockholders

On December 23, 2024, Protalix BioTherapeutics, Inc. (NYSE-American: PLX) penned a letter to its stockholders from President and CEO Dror Bashan, outlining significant progress made during the year and a forward-looking perspective towards 2025.

Achievements of 2024

Protalix, a biopharmaceutical firm specializing in the development and commercialization of recombinant therapeutic proteins, reported crucial advancements. The company's collaboration with Chiesi Global Rare Diseases has been instrumental in their journey, particularly the European Medicines Agency's recent validation of a variation submission for pegunigalsidase alfa, a medication for Fabry disease. This validation allows for a less frequent dosing schedule, showcasing Protalix's commitment to alleviating the treatment burden faced by patients.

In 2024, significant strides were made in the clinical pipeline with the completion of a Phase I trial for PRX-115, a recombinant PEGylated uricase intended to treat uncontrolled gout. Initial findings indicate the compound's safety and potential as an effective uric acid-lowering therapy, which was presented at the American College of Rheumatology's Convergence 2024 conference. The team is now set to advance PRX-115 into a Phase II trial by late 2025.

The firm’s refined research and development strategy, particularly concerning renal rare diseases, highlights the focus of their dedicated R&D team. Protalix aims to explore plant-based delivery systems that could enhance therapeutic efficacy and patient outcomes. Exciting developments in these areas are anticipated for 2025.

Financial Health

Building on recent successes, Protalix reported strong revenue streams from its existing partnership with Chiesi, alongside collaborations with other companies including Pfizer and Uplyso in Brazil. This approach has enabled a stable financial footing, allowing the company to eliminate all outstanding convertible notes, achieving a debt-free status. This impressive feat provides Protalix with the flexibility to support ongoing operations and prioritize future growth.

Challenges and Resilience

Despite facing challenges amid ongoing military tensions in Israel, Protalix has successfully maintained operational continuity. The dedication of the workforce has been commendable, and the company remains focused on its mission to supply innovative treatments. CEO Dror Bashan expressed profound gratitude to the employees and stakeholders for their unwavering support during these trying times.

Looking Forward

With an optimistic outlook, Protalix is poised to introduce novel therapeutic solutions aimed at improving patients' lives in the coming years. The company’s focus on innovation, patient-centered care, and a robust pipeline reinforces confidence in their trajectory towards success.

Conclusion

The 2025 letter to stockholders from Protalix BioTherapeutics highlights a year of notable achievements while detailing a clear strategy for future growth. With innovative therapies in development and a solid financial foundation, Protalix is set to continue advancing in the biopharmaceutical sector, driven by the collective efforts of its dedicated team and supportive partners.