Protalix BioTherapeutics Announces Q1 2024 Financial and Business Results

Protalix BioTherapeutics, Inc., a biopharmaceutical company based in Carmiel, Israel, has disclosed its financial results for the first quarter ended March 31, 2024, along with updates on its clinical and business activities. The company, which specializes in the development and commercialization of recombinant therapeutic proteins using its proprietary ProCellEx® plant cell-based expression system, is set to discuss these results in a conference call and webcast scheduled for May 10, 2024, at 8:30 a.m. EDT.

Dror Bashan, Protalix's President and CEO, revealed positive initial outcomes from the first seven cohorts of their phase I clinical trial for PRX-115, a recombinant uricase candidate aimed at treating uncontrolled gout. Encouraged by these results, the company plans to add an eighth cohort and prepare for a phase II trial. Full results from the expanded trial will be analyzed and announced upon completion.

The phase I trial, a double-blind, placebo-controlled, single ascending dose study, enrolled 56 participants divided into seven cohorts. Among them, 42 received PRX-115, while 14 were given a placebo. Key preliminary findings indicated that PRX-115 showed a dose-dependent increase in exposure, effectively reducing plasma uric acid concentrations to below 6.0 mg/dL in a rapid manner. The treatment was generally well-tolerated, with 26% of participants reporting mild to moderate adverse events, except for one case of anaphylactic reaction that was quickly resolved.

Protalix is also working on PRX-119, a PEGylated recombinant human DNase I product candidate designed to prolong half-life for NETs-related diseases. The company continues to invest in early-stage development assets to expand its product pipeline.

From a financial perspective, Protalix reported a reduction in revenues for the first quarter of 2024. Sales of goods amounted to $3.7 million, a 27% decrease from the $5.1 million recorded in the same period in 2023. This decline was attributed mainly to reduced sales to Pfizer and Brazil. Additionally, revenues from licensing and R&D services dropped significantly to $0.1 million, down from $4.5 million in the previous year, primarily due to the completion of obligations under the Chiesi Agreements and regulatory approvals for Elfabrio in 2023.

The company's cost of goods sold for the quarter was $2.6 million, reflecting a 16% decrease from the previous year's $3.1 million. Research and development expenses also saw a substantial decline, amounting to $2.9 million compared to $5.8 million in the first quarter of 2023, largely due to the completion of the Fabry clinical program and related regulatory processes.

Selling, general, and administrative expenses remained steady at $3.1 million for both comparative periods. Financial income improved to $0.1 million, in contrast to financial expenses of $0.5 million in the first quarter of 2023, primarily due to higher interest income and reduced note interest expenses from conversions executed in 2023.

Protalix reported a net loss of $4.6 million for the first quarter of 2024, slightly higher than the $3.1 million net loss in the same period of 2023. The company’s cash, cash equivalents, and short-term bank deposits stood at approximately $48.5 million as of March 31, 2024.

Protalix's development pipeline includes proprietary versions of recombinant therapeutic proteins targeting established pharmaceutical markets. In collaboration with Chiesi Farmaceutici S.p.A., Protalix is advancing the global development and commercialization of Elfabrio. The company's proprietary ProCellEx system remains a cornerstone of its innovative approach to producing recombinant proteins at an industrial scale.