PLX

EX-99.1

2 plx-20260513xex99d1.htm

EX-99.1

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Exhibit 99.1

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Protalix BioTherapeutics Reports First Quarter 2026 Financial and Business Results

Company to host conference call and webcast today at 8:00 a.m. EDT

●Elfabrio commercial execution continues following European Commission approval of the 2 mg/kg every-4-weeks (E4W) dosing regimen; $25 million milestone received from Chiesi

●PRX-115 Phase 2 study continues to advance as planned with top-line results anticipated in the second half of 2027

●The Company reaffirms its previously stated 2026 revenue guidance of $78.0-$83.0 million including the $25.0 million milestone received from Chiesi

●Cash, cash equivalents, and short-term bank deposits were $51 million as of March 31, 2026, providing sufficient capital to fund ongoing operations including the Phase 2 RELEASE clinical trial of PRX-115

CARMIEL, Israel, May 13, 2026 -- Protalix BioTherapeutics, Inc. (NYSE American:PLX), a biopharmaceutical company focused on the discovery, development, production, and commercialization of innovative therapeutics for rare diseases with significant unmet needs, today reported financial results for the first quarter ended March 31, 2026, and provided a business and clinical update.

During the first quarter, the Company continued to execute against its commercial partnerships, advance its clinical and preclinical development programs, and reaffirm its strategic priorities and financial outlook for 2026.

“Protalix entered 2026 with positive momentum,” said Dror Bashan, President and Chief Executive Officer of Protalix BioTherapeutics. “With the recent regulatory progress for Elfabrio in Europe, which triggered the $25 million milestone payment, the continued enrollment of our PRX-115 Phase 2 RELEASE study, and a growing focus on rare renal diseases, we believe the company is entering a pivotal period of growth and clinical advancement. We are confident in our strategy and reaffirm our guidance for 2026. We believe our business model positions us well to generate long-term value while advancing therapies that meaningfully address unmet needs.”

First Quarter 2026 Operational Update

Elfabrio® for Fabry Disease

●Protalix and its partner, Chiesi Farmaceutici, continue to support the launch and expansion of Elfabrio across approved markets.

●Following the previously announced European Commission approval of the 2 mg/kg every-4-weeks (E4W) dosing regimen, Protalix believes Elfabrio is well-positioned to reduce treatment burden for patients with Fabry disease in the European Union without compromising efficacy.

●The E4W option enhances Elfabrio’s competitive positioning in the European Union and supports broader adoption by providing increased dosing flexibility.

●The FDA-approved dosing regimen for Elfabrio in the United States remains 1 mg/kg every 2 weeks.

●With the global Fabry market projected to reach approximately $3 billion by 2031, Elfabrio® is positioned as a leading therapy with the potential to achieve a meaningful 15% to 20% global market share, supported by strong execution through Protalix’s partnership with Chiesi.

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PRX-115 for Uncontrolled Gout – RELEASE Phase 2 continues enrollment

●The RELEASE Phase 2 clinical trial (NCT07280156) of PRX-115, a recombinant PEGylated uricase, for the treatment of uncontrolled gout continues to enroll patients.

●The Company continues to anticipate top-line results in the second half of 2027.

●PRX-115 is designed as a potential best-in-class, long-acting uricase therapy, which is supported by favorable Phase 1 data, with a possible E4W dosing schedule with or without an immunomodulator, or less frequent dosing with an immunomodulator, aiming to improve adherence and durability of response for patients with uncontrolled gout.

●By addressing immunogenicity challenges and enabling more flexible dosing intervals, the Company believes PRX-115 is well-positioned to capture a meaningful share of the uncontrolled gout segment, where even modest penetration represents significant commercial opportunity.

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Focus on Rare Renal Indications (Preclinical Programs)

●The Company continues to advance PRX-119, its long-acting DNase I program, as part of a broader strategic focus on rare renal indications.

●The Company also continues to collaborate with Secarna to identify RNA-based therapeutic candidates that may complement its proprietary ProCellEx® platform.

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Financial Outlook: Building Durable Growth and Long–Term Value

The Company operates a profitable growing commercial business through its partnerships, and a focused pipeline aligned to areas of high unmet need. The Company has a strong balance sheet, with no outstanding debt or warrants. The Company believes that its current business model limits downside risk while preserving significant upside potential as the Company progresses its clinical and preclinical programs, expands its commercial footprint, and pursues strategic partnerships to accelerate im

EX-99.1

2 plx-20260318xex99d1.htm

EX-99.1

Exhibit 99.1

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Protalix BioTherapeutics Reports Fiscal Year 2025 Financial and Business Results

Company to host conference call and webcast today at 8:00 a.m. EDT

●The European Commission (EC) approved the 2mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio® in adults living with Fabry disease providing a meaningful reduction in treatment burden without compromising efficacy

●The EC approval triggered the Company’s entitlement to a $25.0 million milestone payment from Chiesi, strengthening the Company’s cash position and supporting an expected cash balance of approximately $50.0 million by April 2026

●Based on current estimates, management expects total revenues in 2026 to range from approximately $78.0 million to $83.0 million including the $25.0 million payment referenced above

●The Phase 2 clinical trial of PRX‑115 is actively enrolling; the Company believes PRX-115 has the potential to be a best-in-class therapy, improving uncontrolled gout patients’ compliance and outcomes

●Continued strategic focus on rare renal diseases to build a pipeline through innovation and partnerships

CARMIEL, Israel, March 18, 2026 -- Protalix BioTherapeutics, Inc. (NYSE American:PLX), a biopharmaceutical company focused on the discovery, development, production and commercialization of innovative therapeutics for rare diseases with significant unmet needs, today reported financial results for the fiscal year ended December 31, 2025, and provided a business and clinical update.

“2025 was a year of meaningful progress for Protalix, marked by strong commercial execution with our partners and important advances and strategic direction across our clinical and preclinical pipeline,” said Dror Bashan, President and Chief Executive Officer, Protalix BioTherapeutics. “The EC approval of the E4W dosing regimen for Elfabrio in the European Union represents an advancement for patients by reducing treatment burden without compromising efficacy. This milestone strengthens the long‑term value of our Fabry franchise. In parallel, we believe the ongoing development of PRX‑115 positions us to address the substantial unmet need in uncontrolled gout with a potential best‑in‑class therapy. We are also sharpening our focus on rare renal diseases with PRX‑119 and our RNA‑based discovery collaboration with Secarna, leveraging the capabilities of our ProCellEx® platform. As we enter 2026, we remain committed to driving profitable growth, expanding opportunities across our portfolio, and delivering innovative therapies that meaningfully improve the lives of patients with rare diseases.”

Recent Business Highlights

Elfabrio for Fabry Disease - E4W regimen provides meaningful reduction in treatment burden

in EU

●In March 2026, the European Commission (EC) approved a novel 2mg/kg every-4-weeks (E4W) dosing regimen for Elfabrio in adults with Fabry disease who are stable on an enzyme replacement therapy (ERT).

●This decision followed the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending this additional dosing regimen.

●The E4W regimen provides a potentially meaningful reduction in treatment burden without comprising efficacy, one of the more common unmet needs in Fabry disease, and the 50%

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infusion frequency reduction represents a quality of life improvement for Fabry patients in the EU.

●This approval was supported by the BRIGHT study and long--term extension data, which demonstrated that the E4W dosing regimen maintained clinical and renal outcomes in stable patients.

●Further support came from an updated Population Pharmacokinetics (PopPK) model and exposure–response analysis, which leveraged data from multiple clinical studies.

●Elfabrio is now the only ERT approved for E4W dosing to treat Fabry in the EU – strengthening its competitive positioning and potential market share expansion.

●The FDA-approved dosing regimen for Elfabrio in the United States remains 1mg/kg every 2 weeks.

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PRX-115 for Uncontrolled Gout – Phase 2 trial actively enrolling

●Actively enrolling, and the first patients have been randomized, in the RELEASE Phase 2 clinical trial of PRX‑115 (NCT07280156), a recombinant PEGylated uricase.

●The RELEASE study builds on favorable Phase 1 clinical trial results, where PRX‑115 was generally well-tolerated and demonstrated rapid, durable serum urate reduction below target levels across all cohorts.

●PRX‑115 is designed as a potential best‑in‑class, long‑acting therapy, with a possible E4W dosing schedule with or without an immunomodulator, or less frequent dosing with an immunomodulator, aiming to improve adherence and durability of response for patients with uncontrolled gout.

●By addressing immunogenicity challenges and enabling more flexible dosing intervals, the Company believes PRX‑115 is well-positioned to capture a meaningful share in the uncontrolled gout segment, where even modest penetration represents signi

Protalix BioTherapeutics, Inc._November 13, 2025 0001006281false00010062812025-11-132025-11-13 ​ ​

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of Earliest Event Reported): November 13, 2025

Protalix BioTherapeutics, Inc. (Exact name of registrant as specified in its charter)

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Delaware

001-33357

65-0643773

(State or other jurisdiction of incorporation) ​ (Commission File Number) ​ (IRS Employer Identification No.)

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2 University Plaza ​ ​ ​ ​

Suite 100 ​ ​ ​ ​

Hackensack, NJ ​ ​ ​ 07601

(Address of principal executive offices) ​ ​ ​ (Zip Code)

​ Registrant’s telephone number, including area code 201-696-9345 (Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below): ☐    Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) ​ Securities registered pursuant to Section 12(b) of the Act: ​

Title of each class Trading Symbol(s) Name of each exchange on which registered

Common stock, $0.001 par value PLX NYSE American

​ Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ◻ ​ ​ ​ ​

Item 2.02         Results of Operations and Financial Condition On November 13, 2025, Protalix BioTherapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended September 30, 2025 and provided a business and clinical update. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing. Item 9.01         Financial Statements and Exhibits

Exhibit No.

Description

99.1 ​ Press Release dated November 13, 2025

104 ​ Cover Page Interactive Data File (embedded within the Inline XBRL document)

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: November 13, 2025

PROTALIX BIOTHERAPEUTICS, INC.

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By: /s/ Dror Bashan

Name: Dror Bashan

Title: President and Chief Executive Officer

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