Protalix BioTherapeutics Reflects on Success and Future Aspirations

Delivering Progress in Biopharmaceutical Innovation

Protalix BioTherapeutics, Inc. (NYSE-American: PLX) has successfully charted a robust course in the biopharmaceutical landscape. This journey is grounded in the development, production, and commercialization of cutting-edge recombinant therapeutic proteins via the proprietary ProCellEx plant cell-based protein expression system. As we move forward, we celebrate the significant milestones we achieved recently.

Evolving Partnerships and Collaborations

One of the key components of our recent success is the strong partnership with Chiesi Global Rare Diseases. This cooperation has been pivotal, especially when it comes to reducing patients' treatment burden with every passing day. Recently, we've witnessed the European Medicine Agency (EMA) validating Chiesi's Variation Submission for pegunigalsidase alfa, allowing for less frequent dosing regimens—an exciting advancement for patients with Fabry disease in the European market.

Clinical Milestones in Gout Treatment

We took great pride in completing a phase I First-in-Human clinical trial for PRX-115, a recombinant PEGylated uricase aimed at treating uncontrolled gout. The promising results showcase PRX-115's potential as a safe and effective treatment, and we were thrilled to share this data at the prominent American College of Rheumatology (ACR) Convergence conference. All signs point to advancing to phase II in the near future, and we are eager to make headway in the second half of 2025.

Driving Innovative Drug Development

As we look ahead, our research and development (R&D) strategy is more refined than ever, particularly focusing on renal rare diseases. Our team is dedicated to exploring plant-based drug delivery systems and the promising avenues they offer for effective and protective treatment modalities. We’re enthusiastic about sharing further developments on our pipeline as the year progresses.

Revenue Growth and Financial Health

Our revenue streams are looking strong, particularly from sales to partners like Chiesi and Pfizer Inc. for our products Elfabrio and Elelyso. The growth in these partnerships positions us well in the market for sustained sales increases in the coming years.

Importantly, we've achieved a significant financial milestone this year by completely repaying all outstanding convertible notes, rendering us a debt-free organization. This success greatly enhances our capacity to support ongoing operations without financial strain.

Community Challenges and Workforce Resilience

We cannot ignore the hardships faced by our community during times of unrest. The effects of military operations on a personal and professional level for many of our colleagues have been profound. Despite the external challenges, we have maintained our operations seamlessly, attributing our strength to the dedicated efforts of our employees. Their resilience is commendable, and we remain hopeful for more tranquil days ahead.

Envisioning the Future of Protalix

As we step into the future, the vision for Protalix is exceptionally bright. Our unwavering commitment to innovation in drug development is matched only by our dedication to enhancing the lives of those in need. I extend my heartfelt gratitude to our employees, Board of Directors, and valued shareholders, whose collective belief in our mission propels us forward.

Thank you for your continued support.

Warm regards,

Dror Bashan, President & Chief Executive Officer

About Protalix BioTherapeutics, Inc.

Protalix specializes in the development of recombinant therapeutic proteins using its innovative ProCellEx system. As pioneers in plant cell-based expression, we prioritize industrial-scale protein production. Notably, we have partnered with Pfizer Inc. for the global rights of taliglucerase alfa and launched Elfabrio, which has garnered FDA approval. Our developmental pipeline is rich with opportunities, including treatments aimed at addressing uncontrolled gout and NETs-related diseases.

Frequently Asked Questions

What is Protalix BioTherapeutics focused on?

Protalix focuses on the development and commercialization of recombinant therapeutic proteins using its proprietary ProCellEx system.

What significant partnership does Protalix have?

Protalix has an important collaboration with Chiesi Global Rare Diseases, enhancing the treatment landscape for rare diseases.

What recent clinical trial did Protalix complete?

The company completed a phase I clinical trial for PRX-115 aimed at treating uncontrolled gout, showing promising results.

How has Protalix performed financially?

Protalix has achieved significant growth, is debt-free, and has seen sales growth through its partnerships with companies like Pfizer.

What is the future outlook for Protalix?

The future is bright for Protalix, with ongoing innovations and a strong commitment to improving patient lives through advanced therapeutics.

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