Protalix Bio Therapeutics, Inc. (PLX) stock soared 46.67% in the pre-market trading session at the price of $1.54 after reporting topline data from the BALANCE clinical trial evaluating PRX–102.
PLX is a biopharmaceutical firm that develops and commercializes therapeutic proteins using its plant cell-based ProCellEx technology. The company’s novel expression system introduces a unique method to produce recombinant proteins industrially.
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BALANCE Phase-3 Clinical Trial Results
On 4th April 2022, PLX published topline results from its BALANCE clinical trial. The pivotal Phase-3 clinical trial evaluates the safety and efficacy of pegunigalsidase alfa compared with agalsidase beta to treat Fabry disease. PRX–102 is an underdeveloped PEGylated enzyme replacement therapy for Fabry patients.
The Phase-3 trial is an active control, double-blind, two years, randomized study of PRX–102 in patients with worsening renal function. The study registered 78 patients previously treated with agalsidase beta for one year with an eGFR slope less than –2 mL/min/1.73 m2/year. The company has completed the BALANCE clinical trial and published topline outcomes from the final analysis.
PLX Fiscal 2021 Financial Results
Earlier on 31st March 2022, PLX announced its financial results for the fiscal year ended 31st December 2021. Protalix has also delivered corporate updates on current clinical developments. Cash and cash equivalents were roughly US$39.0M on 31st December 2021. The company reported a net loss of US$27.6M, or per share of US$0.62, for fiscal 2021. Net loss totaled US$6.5M, or per share of US$0.22, last year.
PLX recorded revenues of US$16.7M from sales for the year 2021. It represents a surge of 3 percent, or US$0.5M, from US$16.2M for 2020. The cost of selling goods totaled US$16.3M for the year 2021. It represents a growth of 50 percent, or US$5.4M, from US$10.9M the previous year. For 2021, R&D expenses totaled US$29.7M, representing a drop of 22 percent, or US$8.5M. The company has US$38.2M in R&D costs for fiscal 2020.