Protalix Biotherapeutics, Inc. (de) · AMEX:PLX
Protalix Biotherapeutics, Inc. (de) — Investor Presentation (October 2025)
22 slides from Protalix Biotherapeutics, Inc. (de)'s investor presentation, Oct 17, 2025
Slide 1: Protalix BioTherapeutics Corporate Presentation October 2025
1 PROTALIX BIOTHERAPEUTICS C O R P O R A T E P R E S E N T A T I O N J u n e 2024 PROTALIX BIOTHERAPEUTICS Pioneering solutions to transform the treatment of rare diseases C O R P O R A T E P R E S E N T A T I O N O c t o b e r 2025 Exhibit 99.1
Slide 2: Forward-Looking Statements
2 Forward-Looking Statements This presentation contains forward-looking statements that involve risks and uncertainties within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act. Forward-looking statements are neither hist
Slide 3: Experienced leadership team
3 Experienced leadership team ORI KALID, PH.D. VP of R&D Dr. Kalid brings >20 years of leadership experience in pharmaceutical R&D. Previously he was co-founder and CEO of Silverskate Bio, as well as co-founder and CEO of Pi Therapeutics. He also served at Hotaru Innovation Partners, PREDIX/EPIX Pha
Slide 4: Accomplished Board of Directors
4 Accomplished Board of Directors AMOS BAR SHALEV Director POL F. BOUDES, M.D. Director GWEN A. MELINCOFF Director AHARON SCHWARTZ, PH.D. Director ELIOT FORSTER, PH.D. Chairman DROR BASHAN President & CEO, Director SHMUEL “MULI” BEN ZVI, PH.D. Director Christian Else Director BATM logo
Slide 5: Protalix delivers innovations from concept to market
5 Protalix delivers innovations from concept to market Proven execution of delivering protein products for rare diseases with a pipeline for the future 1: Elfabrio has been approved for marketing in the United States, the European Union, and additional markets. Chiesi Global Rare Diseases, a busines
Slide 6: Two commercial products and a growing pipeline for the future
6 Indication Discovery and Preclinical Phase 1 Phase 2 Phase 3 Marketing Application Status Commercial Portfolio Fabry Disease Approved (US and EU and additional markets) Gaucher Disease Approved in 23 markets, including US PEGylated Uricase (PRX-115) Uncontrolled Gout Phase 2 start expected in 4Q25
Slide 7: Well capitalized to advance Protalix to the next phase
7 Well capitalized to advance Protalix to the next phase CASH STREAMS FROM STRONG PARTNERSHIPS $25.4M in 1H 2025 revenue from selling goods REVENUE $53M in revenue (FY 2024) CASH & CASH RUNWAY $33.4M (June 30, 2025); no debt and no warrants PRX-115 recombinant PEGylated uricase product candidate. Be
Slide 8: Key upcoming milestones and catalysts
8 Key upcoming milestones and catalysts Business development activities in rare renal diseases 3 streams of revenue and projected consistent growth in the medium-term Significant milestone payments expected in mid- and long-term Continued internal R&D pipeline growth Elfabrio® Launch multinational U
Slide 9: Phase ready PRX-115 in development for uncontrolled gout
9 Phase 2 ready PRX-115 in development for uncontrolled gout
Slide 10: Uncontrolled gout: limited options and disadvantages with current therapy
10 Uncontrolled gout: limited options and disadvantages with current therapy An unsatisfied market Gout and uncontrolled gout • Metabolic disorder characterized by elevated blood urate that causes recurrent inflammatory arthritis and joint damage • Rheumatologists report that ~25% of their patients
Slide 11: The US Gout Market
11 11.3M1 5M2 1.2M2 0.3M3 0.18M3 6-8K4 The US Gout Market Treatments The market is poised to expand significantly as newer therapies and competitors enter and further expand disease awareness and reduce clinical inertia A differentiated best-in-class uricase like PRX-115 is poised to increase the ma
Slide 12: PRX-115 Phase 1 single ascending dose study
12 PRX-115 Phase 1 single ascending dose study: encouraging data support Phase 2 Recombinant PEGylated uricase enzyme produced via ProCellEx® 12 Study Scheme Primary Endpoint: Safety and tolerability Secondary Endpoints: PK, PD (uric acid levels) Subjects with elevated uric acid N = 8 per cohort (6
Slide 13: PRX-115 best in class potential for uncontrolled gout
13 PRX-115 best in class potential for uncontrolled gout Addresses an important unmet medical need 13 Next Steps • Phase 2 study in uncontrolled gout patients • Initiation anticipated in 4Q25, IND submitted PRX-115 Phase 1 outcome: • Favorable tolerability profile • Ability to reduce uric acid level
Slide 14: PRX-115 Phase 2 double blind placebo-controlled study design
14 PRX-115 Phase 2 double blind placebo-controlled study design MTX – Methotrexate Patient Population: uncontrolled gout Primary Endpoint: proportion of patients who achieve a reduction in serum uric acid (sUA) to <6.0 mg/dL for at least 80% of the time during Month 6 Secondary Endpoints: additional
Slide 15: Commercial products
15 Commercial products Reliably partnered and delivering revenue
Slide 16: Two commercial products sustaining future growth
16 Rare autosomal recessive disorder (~1/40,000 WW) with systemic visceral and skeletal disease-causing disability and organ dysfunction Rare X-linked disorder (~1/40,000-60,000 males WW) with progressive renal, cardiac, and neurological burden Fabry disease Two commercial products sustaining future
Slide 17: Fabry disease competitive landscape
17 Fabry disease competitive landscape ~$2.1B market (2024) expected to reach over $3.2B (2030), CAGR of 7.4%1 17 1 GlobalData extracted Aug 2025 Product Name Fabrazyme® Replagal® Galafold® Elfabrio® Parent Company Mechanism ERT ERT Pharmacological chaperone ERT longer half-life (pegylated) Approved
Slide 18: Commitment and execution from global partnership with Chiesi
18 Commitment and execution from global partnership with Chiesi Committed Global Partner • International research-focused biopharmaceutical group with sales in excess of €3.4B in 2024 (reflecting 13% growth year-on-year) • Operating in close to 30 countries with over 7,500 employees; invested over 2
Slide 19: Growth strategy
19 Growth strategy
Slide 20: Research strategy - leveraging internal strengths to fuel next stage of growth
20 Research strategy - leveraging internal strengths to fuel next stage of growth Proven ability to drive discovery, development, and registration of new drugs 20 Internal development Protein therapeutics Plant cell-based expression Chemical modification PEGylation, other Drug delivery Exploring new
Slide 21: Protalix delivers innovation from concept to the market
21 Protalix delivers Innovation from concept to the market Revenues USD 53M 2024 Cash USD 33.4M Q2/2025 Debt No Debt / Warrants Growing pipeline for the future • PRX-115 best-in-class potential for uncontrolled gout • Research focus – Renal Rare Diseases Three revenue streams Two commercial products
Slide 22: Protalix BioTherapeutics Corporate Presentation
22 PROTALIX BIOTHERAPEUTICS C O R P O R A T E P R E S E N T A T I O N J u n e 2024 PROTALIX BIOTHERAPEUTICS Pioneering solutions to transform the treatment of rare diseases C O R P O R A T E P R E S E N T A T I O N O c t o b e r 2025
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