Protalix Biother SEC Filings

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.

Protalix BioTherapeutics disclosed that MAK Fund, MAK Capital and Michael A. Kaufman reported beneficial ownership of 4,649,599 shares of Common Stock, representing 5.8% of the class.

The filing states the 4,649,599 shares are beneficially owned as of 03/04/2026, using an outstanding share base of 80,421,181 Common Stock as of November 1, 2025, per the company’s Form 10-Q filed November 13, 2025. The reporting persons disclose shared voting and dispositive power over these shares.

Protalix BioTherapeutics, Inc. furnished a new corporate presentation as part of a current report. On February 11, 2026, the company posted this corporate presentation to its website and made it available to investors as Exhibit 99.1 to a Form 8-K.

The company notes that this presentation, included under Item 7.01, is being provided for informational purposes and is not deemed “filed” under the Exchange Act, which limits potential liability and controls how it can be incorporated into other SEC filings.

Protalix BioTherapeutics reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of a new dosing regimen for Elfabrio for Fabry disease. The proposed regimen is 2 mg/kg given every four weeks for adult patients who are stable on enzyme replacement therapy.

The announcement was made together with Protalix’s development and commercialization partner, Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici S.p.A., highlighting their collaboration on Elfabrio in the rare disease space.

Protalix BioTherapeutics, Inc. reported that on January 5, 2026 it issued a press release that included a letter the company released to its stockholders. This information is being made available to investors through a current report on Form 8-K.

The press release and stockholder letter are furnished as Exhibit 99.1, meaning they are provided for informational purposes and are not treated as “filed” for liability purposes under Section 18 of the Exchange Act or automatically incorporated into other SEC filings. Protalix’s common stock trades on the NYSE American under the symbol PLX.

Protalix BioTherapeutics, Inc. insider transaction: the company’s President and CEO, who also serves as a director, reported buying 56,000 shares of common stock of Protalix BioTherapeutics, Inc. on 12/19/2025 at a price of $1.81 per share. After this purchase, the insider directly owns 188,516 common shares and indirectly holds an additional 2,344,418 shares through a trust. The filing notes that, to qualify for certain tax benefits under Section 102 of the Israeli Tax Ordinance, securities issued to an employee in connection with the company’s plan must be registered in the name of a trustee.

Protalix BioTherapeutics, Inc. (PLX) reported an insider transaction by a director on a Form 4. On 11/18/2025, the director sold 168 shares of common stock at $1.87 per share, coded as a sale. Following this transaction, the director reported 0 shares held directly and 7,500 shares held indirectly through a trust.

The filing notes that, to qualify for certain tax benefits under Section 102 of the Israeli Tax Ordinance, securities issued under the company’s 2006 Stock Incentive Plan must be registered in the name of a trustee.