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Protalix BioTherapeutics, Inc. filings document a commercial-stage biopharmaceutical issuer with NYSE American-listed common stock and a business built around recombinant therapeutic proteins produced through ProCellEx®. The company’s Form 8-K reports cover operating results, financial condition, business and clinical updates, corporate presentations, stockholder communications and regulatory events involving Elfabrio®.
Protalix’s proxy materials describe board governance, executive compensation, equity awards and shareholder voting matters. Its regulatory disclosures also identify material event reporting around European regulatory actions for Elfabrio, collaboration-related communications with commercialization partners, and the capital-market status of its common stock.
Protalix BioTherapeutics, Inc. filed a current report stating that on May 21, 2026 it posted a new corporate presentation on its website. The presentation is furnished as Exhibit 99.1 and, under the cited Exchange Act instructions, is treated as furnished rather than filed for liability purposes.
Protalix BioTherapeutics reported a strong turnaround for the quarter ended March 31, 2026. Total revenue rose to $33.8M from $10.1M a year earlier, driven mainly by $26.3M of license and R&D revenue that included a $25.0M milestone from Chiesi following EU approval of the every‑four‑weeks Elfabrio dosing regimen.
The company generated net income of $18.3M, versus a net loss of $3.6M in the prior‑year quarter, with basic EPS improving to $0.23. Product sales were $7.4M, down from $10.0M, reflecting lower Elelyso volumes to Pfizer and Fiocruz, partly offset by growing Elfabrio sales to Chiesi.
Operating cash flow was $22.0M, boosting cash and cash equivalents to $41.0M and total cash plus short‑term deposits to $51.1M. Total assets reached $102.3M and stockholders’ equity $67.2M. Management believes current cash resources and deposits can fund operations for at least 12 months as R&D spending increases, including the RELEASE study and early‑stage pipeline work.
Protalix BioTherapeutics reported sharply improved first quarter 2026 results. Total revenue rose to $33.8M for the quarter ended March 31, 2026, up from $10.1M a year earlier, driven mainly by $26.3M of license and R&D service revenue, including a milestone tied to Elfabrio’s European progress.
The company generated net income of $18.3M versus a net loss of $3.6M in the prior-year period, with diluted EPS at $0.22. Cash and cash equivalents increased to $41.0M, supporting a debt-free balance sheet. Management reaffirmed its 2026 revenue outlook and highlighted ongoing enrollment in the PRX-115 Phase 2 RELEASE gout study and continued focus on rare renal disease programs.
Protalix BioTherapeutics, Inc. will hold its 2026 annual stockholder meeting on June 25, 2026 in Tel Aviv. Holders of the 80,571,642 shares of common stock outstanding as of April 30, 2026 may vote.
Stockholders are asked to elect eight directors for one-year terms, approve on a non-binding advisory basis the compensation of named executive officers, and approve an amended and restated 2006 Stock Incentive Plan that raises the share reserve from 17,475,171 to 20,975,171 shares. They will also vote on ratifying Kesselman & Kesselman as independent auditor for 2026 and any other proper business.
The proxy details board and committee composition, independence, ownership and extensive executive pay information. In 2025, CEO Dror Bashan received total compensation of $1.17 million, while all directors and executive officers collectively beneficially owned about 5,576,142 shares, or 6.7% of the common stock.
Protalix BioTherapeutics, Inc. senior vice president and CFO Gilad Mamlok reports his equity holdings in an amended Form 3. He holds 3,631 shares of common stock directly. He also holds stock options covering 597,990 shares of common stock at an exercise price of $1.45 per share, expiring on July 20, 2035. These options vest in 12 equal quarterly installments from the grant date and can vest faster if there is a corporate transaction or change in control under the company’s Amended and Restated 2006 Stock Incentive Plan.
Protalix BioTherapeutics schedules a disclosure that MAK Capital Fund LP, MAK Capital One L.L.C. and Michael A. Kaufman beneficially own 3,616,289 shares of Common Stock, equal to 4.5% of the class.
The filing states the ownership figure is as of 03/30/2026 and cites 80,421,181 shares outstanding as of November 1, 2025 per the issuer's Form 10-Q.
Protalix BioTherapeutics is a commercial-stage biopharmaceutical company focused on rare diseases using its proprietary plant cell-based protein expression platform, ProCellEx. The company markets two enzyme replacement therapies: Elelyso for Gaucher disease and Elfabrio for Fabry disease, both manufactured on this platform.
Elelyso is supplied to Pfizer globally (excluding Brazil) and to Fiocruz in Brazil, with revenues recognized on drug substance deliveries that may be uneven due to bulk ordering patterns. Elfabrio is commercialized worldwide by Chiesi, which purchases finished product from Protalix and manages all patient-facing commercial activities.
The filing highlights 2025 developments, including inclusion in the Russell 3000 and 2000 Indexes, a CFO transition, and the European Commission approval of a 2 mg/kg every-four-weeks Elfabrio dosing regimen for stable adult Fabry patients after a successful appeal. Protalix is advancing its pipeline with PRX-115, a PEGylated uricase for uncontrolled gout now in a Phase 2 RELEASE study after a completed Phase 1 trial, and PRX-119, a long-acting DNase I for NETs-related diseases in preclinical development.
Protalix BioTherapeutics reported fiscal year 2025 results showing total revenue of $52,744 thousand, slightly below 2024’s $53,399 thousand, and a net loss of $6,604 thousand compared with net income of $2,932 thousand in 2024. Basic loss per share was $(0.08).
Operating income swung from a $3,917 thousand profit in 2024 to a $5,500 thousand operating loss in 2025, driven by higher cost of goods sold and increased research and development spending. Total assets rose to $82,346 thousand, with stockholders’ equity increasing to $48,230 thousand as of December 31, 2025.
The company highlighted European Commission approval of the every‑four‑weeks dosing regimen for Elfabrio for Fabry disease, continued Phase 2 enrollment for PRX‑115 in uncontrolled gout, and a strategic focus on rare renal indications, noting a profitable commercial base, no outstanding debt or warrants, and an upcoming conference call to discuss the results.
Protalix BioTherapeutics reported that the European Commission approved a 2 mg/kg every‑4‑weeks dosing regimen for Elfabrio (pegunigalsidase alfa) in adults with Fabry disease who are stable on enzyme replacement therapy. The decision adds an alternative to the existing every‑two‑weeks schedule in the European Union.
Based on this approval, Protalix is entitled to receive a $25 million regulatory milestone payment from its partner Chiesi Global Rare Diseases. The company notes that the new regimen is not approved in the United States, where the FDA‑approved dose remains 1 mg/kg every two weeks.