Protalix BioTherapeutics' Q3 2025: Contradictions Emerge on PRX-115 Trial Timelines, Chiesi Expansion, Elfabrio Dosing, and Cash Runway

Business Commentary:

* Revenue Performance: - Protalix BioTherapeutics reported total revenues of $43.6 million for the first 9 months of 2025, representing a 24% increase compared to the same period last year. - This growth was supported by the commercial success of its enzyme replacement therapies and the continued demand from its partners, Chiesi, Pfizer, and Fiocruz in Brazil.

• Regulatory and Pipeline Developments:
• The company is pursuing a reexamination of the negative opinion regarding the proposed every 4 weeks dose regimen for Elfabrio in Europe, with an expected answer in Q1 of 2026.

• Protalix is advancing PRX-115, its recombinant PEGylated uricase candidate for potential treatment of uncontrolled gout, with an IND filed and plans to initiate a Phase II clinical trial later this year.

• Research and Development Investments:

• Research and development expenses for the 9 months ended September 30, 2025, totaled $13.9 million, an increase of $5.1 million or 58% compared to the prior year period.

• The increase was mainly due to preparations for the planned Phase II clinical trial of PRX-115, which is considered a strategic investment in the company's pipeline and long-term growth.

• Financial Stability:

• Protalix had $29.4 million in cash and cash equivalents and short-term bank deposits as of September 30, 2025, which is considered sufficient to satisfy its capital needs for at least 12 months.
• The company's financial stability is supported by its strong cash position and positive quarterly net income, enabling it to execute its strategic priorities.

Contradiction Point 1

PRX-115 Phase II Trial Timeline

It directly impacts expectations regarding the timeline for the start and completion of a crucial clinical trial, which could influence the company's development pipeline and investor expectations.

Are you still on track to begin the PRX-115 trial by year-end, and what is the timeline for top-line readout and enrollment? - John Vandermosten (Zacks Small-Cap Research)

2025Q3: We plan to start screening patients in a few weeks. - Gilad Mamlok(CFO)

Can you provide details on the PRX-115 Phase II trial, including site count and enrollment plans? - John D. Vandermosten (Zacks Small-Cap Research)

2025Q2: We plan to have 20-30 sites in total, the majority in the U.S., with a couple outside. Recruitment will start soon, and enrollment is expected by the end of the year. - Dror Bashan(CEO)

Contradiction Point 2

Chiesi's Market Expansion Plans

It involves changes in strategic partnerships and market expansion plans, which are crucial for the company's growth and revenue projections.

Have there been any recent approvals for Chiesi? - John Vandermosten (Zacks Small-Cap Research)

2025Q3: There is a long list of markets Chiesi is under submission or planning to submit, so we are not concerned on this front. This is part of the further expansion of Elfabrio globally. - Gilad Mamlok(CFO)

Could you share Chiesi's plans and objectives for the PEGASO study? - John D. Vandermosten (Zacks Small-Cap Research)

2025Q2: This is part of their Phase IV program aimed at enhancing the merits and strengths of the Elfabrio program. Outcomes will be updated accordingly. - Dror Bashan(CEO)

Contradiction Point 3

Elfabrio Dosing Regimen and Market Opportunity

It involves the company's stance on the dosing regimen for Elfabrio and its potential impact on the market opportunity, which are crucial for strategic planning and investor expectations.

What is the timeline for the anticipated reexamination of the CHMP opinion on Elfabrio's every 4-week dosing regimen? What is the competitive landscape in treatment refractory gout and its impact on PRX-115's commercial potential? Is there any volatility in Elfabrio's sales revenue? - Raghuram Selvaraju (H.C. Wainwright & Co, LLC, Research Division)

2025Q3: An answer to the reexamination request is expected in Q1 2026. Regarding gout, there are multiple developments, but we foresee a significant market growth in the next 5-6 years. If our Phase II trial is successful, PRX-115 could take a significant share of the increased market. - Dror Bashan(President,CEO&Director)

Are there any updates on Elfabrio's milestone and plans for similar dosing in the U.S.? - John Vandermosten (Zacks)

2025Q1: Chiesi's sales efforts and outcomes are strong, with a good pace of commercial patient recruitment. Protalix sales are from Chiesi's inventory, not directly to the market. The application submitted by Chiesi for a dosing frequency change in the EU is ongoing, and we are encouraged. - Dror Bashan(President and CEO)

Contradiction Point 4

Cash Runway and Revenue Recognition

It involves the company's cash runway and revenue recognition strategy, which are critical for financial planning and investor confidence.

Is the cash runway guidance based solely on operating expenditures, or does it include ongoing royalty-based revenue from Elfabrio? - Raghuram Selvaraju (H.C. Wainwright & Co, LLC, Research Division)

2025Q3: It is based on both operating expenditures and receipt of royalty-based revenue. We have good predictability on the royalty stream. - Gilad Mamlok(Senior VP&CFO)

Are there any upcoming Elfabrio milestones or efforts to secure similar dosing in the U.S.? - John Vandermosten (Zacks)

2025Q1: Chiesi's sales efforts and outcomes are strong, with a good pace of commercial patient recruitment. Protalix sales are from Chiesi's inventory, not directly to the market. The application submitted by Chiesi for a dosing frequency change in the EU is ongoing, and we are encouraged. - Dror Bashan(President and CEO)

Contradiction Point 5

PRX-115 Trial Timeline and Costs

It involves discrepancies in the timeline for the start of the PRX-115 trial and the associated costs, which are critical for understanding the company's spending and development priorities.

Is the PRX-115 trial still on track to start before year-end? What is the timeline for top-line readout and enrollment? - John Vandermosten (Zacks Small-Cap Research)

2025Q3: We plan to start screening patients in a few weeks. - Gilad Mamlok(CFO)

What is the cost of the Phase 2 study for PRX-115, and when can we expect top-line data and development plans if results are positive? - John Vandermosten (Zach's SCR)

2024Q4: Top-line data is expected in two years. Assuming positive outcomes, Protalix would likely pursue a commercial partner. - Dror Bashan(CEO)