Core Insights - Protalix BioTherapeutics reported total revenues of $43.6 million for the first nine months of 2025, a 24% increase compared to the same period in 2024, while third-quarter revenues were $17.9 million, reflecting a 1% decrease year-over-year [2][13] - The company is advancing its recombinant PEGylated uricase candidate, PRX-115, for uncontrolled gout, with plans to initiate a phase 2 clinical trial later this year based on promising phase 1 data [2][5] - Protalix's financial results indicate a net income of approximately $2.4 million for the third quarter of 2025, down from $3.2 million in the same quarter of 2024 [6] Financial Highlights - Total revenues for the nine months ended September 30, 2025, were $43.1 million, up from $34.8 million in 2024, with significant contributions from sales of Elfabrio, Elelyso, and alfataliglicerase [13] - Cost of goods sold increased by 10% to $22.4 million for the nine months ended September 30, 2025, primarily due to increased sales to Chiesi and Pfizer [13] - Research and development expenses rose by 58% to approximately $13.9 million for the nine months ended September 30, 2025, driven by preparations for the phase 2 clinical trial of PRX-115 [13][18] Operational Updates - The company submitted an Investigational New Drug (IND) application to the FDA for PRX-115, which became effective after the standard 30-day review period [5] - Protalix is collaborating with Chiesi Global Rare Diseases to address a negative opinion from the EMA regarding Elfabrio's dosing regimen, while the currently approved regimen remains unaffected [5] - As of September 30, 2025, Protalix had $29.4 million in cash and cash equivalents, sufficient to meet capital needs for at least the next 12 months [8]