Protalix BioTherapeutics, Inc. (de) · AMEX:PLX
Protalix BioTherapeutics, Inc. (de) — Investor Presentation (January 2021)
21 slides from Protalix BioTherapeutics, Inc. (de)'s investor presentation, January 2021
Slide 1: Protalix Biotherapeutics Corporate Presentation January 2021
PROTALIX BIOTHERAPEUTICS CORPORATE PRESENTATION JANUARY 2021
Slide 2: Note Regarding Forward-Looking Statements
Note Regarding Forward-Looking Statements This presentation (the “Presentation”) contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements, including, among others, st
Slide 3: Investment Highlights
Investment Highlights Plant cell expressed recombinant proteins with improved therapeutic profiles Revenue Generating Platform FDA approved, commercially marketed drug for Gaucher Proprietary ProCellEx® platform for recombinant protein expression disease. Elelyso and alfataliglicerase. cGMP manufact
Slide 4: ProCellEx Platform
ProCellEx® Platform First and only company to gain FDA approval of a protein produced through plant cell-based expression system Unique capabilities of tailoring genetic engineering and protein engineering tools for pre/post-production modifications, customized for each individual protein candidate
Slide 5: Advantages of Proprietary Plant Cell-Based Platform (ProCellEx)
Advantages of Proprietary Plant Cell-Based Platform (ProCellEx®) Biologic Optimization Can Handle Complexity Experienced internal interdisciplinary capabilities Ability to express certain proteins that are to improve biologic dynamics (e.g., glycosylation difficult to express in other systems profil
Slide 6: Elelyso for Gaucher Disease
Elelyso® for Gaucher Disease First plant cell derived recombinant protein approved by the FDA Elelyso provides a consistent (and growing) revenue stream for Protalix while validating Validation of the ProCellEx® platform the ProCellEx platform technology and demonstrating the company’s manufacturing
Slide 7: Product Pipeline
Product Pipeline Recombinant proteins with improved therapeutic profiles that target unmet medical needs and established pharmaceutical markets Discovery and Preclinical Phase 1 Phase 2 Phase 3 Marketing Application pegunigalsidase alfa (PRX-102) Fabry Disease tulinercept (OPRX-106) Inflammatory Bow
Slide 8: Fabry Disease
Fabry Disease Fabry disease is primarily treated with Rare Genetic Disease Growing Market enzyme replacement therapy occurs in one of every (ERT) to replace the missing ~$2B+ growing market 40,000 people. alpha-Galactosidase-A enzyme (expected CAGR ~10%) with a recombinant form of the protein via in
Slide 9: Fabry Disease Competitive Landscape
Fabry Disease Competitive Landscape Product Name Fabrazyme® Replagal® Galafold® Parent Company Sanofi Shire Amicus Mechanism ERT ERT Pharmacological chaperone Indication Fabrazyme is indicated for use in patients with Replagal is indicated for long-term enzyme GALAFOLD is an alpha-galactosidase A (a
Slide 10: Potential Advantages of pegunigalsidase alfa (PRX-102)
Potential Advantages of pegunigalsidase alfa (PRX-102) PEGUNIGALSIDASE ALFA • Delivery of active enzyme into the target organs . • Reduction of globotriaosylceramide (Gb3) burden in kidney biopsies which demonstrates potential efficacy based on proven Mechanism of Action. • Clinical improvement meas
Slide 11: Pegunigalsidase alfa (PRX-102) for Fabry Disease
Pegunigalsidase alfa (PRX-102) for Fabry Disease Pegunigalsidase alfa (PRX-102) Chemically modified PEGylated plant recombinant alpha-Galactosidase-A designed to provide active and stable enzyme throughout infusion interval for a potentially improved clinical benefit. Current data have shown Demonst
Slide 12: Pegunigalsidase alfa (PRX-102) Current Clinical Trials
Pegunigalsidase alfa (PRX-102) Current Clinical Trials Design Number of Patients Next Data Read-Out Completed 1mg / kg 2 weeks Interim results follow up Randomized Double Blind 78 expected H1 2021 (basis Head-to-Head vs. 100% Enrolled for EMA MAA Submission) Fabrazyme® 24 mos. 1mg / kg 2 weeks Open
Slide 13: Committed Commercial Partner
Committed Commercial Partner Global Partnership with Chiesi Farmaceutici S.p.A. Up to $1+ billion in potential milestone payments Chiesi’s 6,000 employees and ~$2.5B in revenue (2019) provides Tiered royalties of 15-35% (ex-US); 15- Protalix with the strong Sales & 40% (US) Marketing partner to maxi
Slide 14: Protalix Upcoming Expected Milestones
Protalix Upcoming Expected Milestones Q2 2020 Q4 2020 H1 2021 Top-Line results of Final results (CSR) of Interim results of BRIDGE BRIDGE BALANCE for EMA MAA submission BLA submission under accelerated approval Anticipated launch of pathway for pegunigalsidase alfa pegunigalsidase alfa 2020 TODAY 20
Slide 15: Tulinercept (OPRX-106) for Inflammatory Bowel Disease (IBD)
Tulinercept (OPRX-106) for Inflammatory Bowel Disease (IBD) Tulinercept is a cutting edge development candidate for IBD expressed via ProCellEx® for oral delivery of recombinant proteins whereby the plant cell wall increases resistance and delays to degradation as compared to proteins produced via m
Slide 16: Tulinercept (OPRX-106) for IBD
Tulinercept (OPRX-106) for IBD CLINICAL RESULTS FROM PHASE IIA POSITIONING & UPSIDE • 89% of patients experienced improvements in Mayo Score; 72% • Anti-TNF alfa mechanism – known and established first line treatment improved rectal bleeding; 72% improvement in fecal calprotectin and for steroid ref
Slide 17: Alidornase alfa (PRX-110): Actin Inhibition Resistant DNase
Alidornase alfa (PRX-110): Actin Inhibition Resistant DNase OVERVIEW POSITIONING • Alidornase alfa is a plant cell expressed recombinant human DNase I • Biologically active and safe in humans, alidornase alfa is being chemically modified to resist inhibition by actin, thus enhancing developed for ot
Slide 18: Uricase (PRX-115) for Refractory Gout
Uricase (PRX-115) for Refractory Gout PRX-115 is a PEGylated enzyme expressed via ProCellEx® for intravenous (IV) administration of recombinant Uricase, designed for safe and efficacious treatment of refractory gout. Overview • Gout is the most common form of chronic inflammatory disability, general
Slide 19: Long acting (LA) DNase I (PRX-119) for NETs related diseases
Long acting (LA) DNase I (PRX-119) for NETs related diseases PRX-119 is a cutting edge PEGylated recombinant human DNase I, expressed via ProCellEx®, designed to elongate half-life in the circulation for NETs related diseases. Overview • Neutrophil extracellular traps (NETs) are web-like structures,
Slide 20: Well Capitalized with Strong Institutional & Banking Support
Well Capitalized with Strong Institutional & Banking Support CASH REVENUE $41M (3Q’20) $12M in revenue (3Q’20) FINANCING NET BURN RATE Recent ~$44M financing (March 2020) $6M/Q, declining as patients shift over to extension study UBS O’Connor CASH RUNWAY DEBT LLC Cash Runway to 2Q’22 $58M in debt (C
Slide 21: Experienced Leadership Team
Experienced Leadership Team DROR BASHAN EINAT BRILL ALMON, PH.D. EYAL RUBIN, CPA YARON NAOS YAEL HAYON, PH.D. President & CEO SVP, Chief Development Officer SVP & CFO SVP of Operations VP of R&D Mr. Bashan has served as our Dr. Almon joined Protalix in Dec Mr. Rubin has served as our SVP Mr. Naos jo
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