PROTALIX BIOTHERAPEUTICS

C O R P O R A T E P R E S E N T A T I O N

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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 Securities Exchange Act of 1934, as amended. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on management's current expectations or plans projections for future operating and financial performance based on assumptions currently believed to be valid. Forward-looking statements can be identified by the use of words such as "anticipate," "believe," "estimate," "expect," "can," "continue," "could," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" and other words or phrases of similar import, as they relate to Protalix, its subsidiaries or its management, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements in this presentation include, among other things, statements regarding our cash runway and the commercialization of our product. Forward-looking statements are subject to many risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, risks related to: the commercialization of ELFABRIO®; ELFABRIO's revenue, expenses and costs may not be as expected; ELFABRIO's market acceptance, competition, reimbursement and regulatory actions, including as a result of the boxed warning contained in the U.S. Food and Drug Administration, or the FDA, approval received for the product; our commercialization partner's ability to obtain and maintain reimbursement for ELFABRIO, and the extent to which patient assistance programs and co-pay programs are utilized; the likelihood that the FDA, European Medicines Agency, or the EMA, or other applicable health regulatory authorities will approve an alternative dosing regimen for ELFABRIO; the regulatory approval and commercial success of our other product and product candidates, if approved; failure or delay in the commencement or completion of our preclinical studies and clinical trials, which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to satisfactorily demonstrate non-inferiority to approved therapies; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; inability to monitor patients adequately during or after treatment; and/or lack of sufficient funding to finance our clinical trials; delays in the approval or potential rejection of any applications we file with the FDA, EMA or other health regulatory authorities for our other product candidates, and other risks relating to the review process; our ability to manage our relationship with our collaborators, distributors or partners, including, but not limited to, Pfizer Inc., or Pfizer, and Chiesi Farmaceutici S.p.A., or Chiesi; risks related to any transactions we may effect in the public or private equity markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; the risk that the results of the clinical trials of our product candidates will not support the applicable claims of safety or efficacy, or that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks related to reforms in the healthcare industry and the risk that uncertainty associated with pharmaceutical pricing, reimbursement and related matters could adversely affect the marketing, pricing and demand for our products, if approved; risks related to our ability to maintain and manage our relationship with our collaborators, distributors or partners; risks relating to our ability to make scheduled payments of the principal of, to pay interest on or to refinance our outstanding notes or any other indebtedness; our dependence on performance by third party providers of services and supplies, including without limitation, clinical trial services; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies and institutions; potential product liability risks, and risks of securing adequate levels of product liability and other necessary insurance coverage; and other factors described in our filings with the U.S. Securities and Exchange Commission. In addition, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Given these uncertainties, investors should not place undue reliance on these forward-looking statements. Except as required by law, we undertake no obligation to update or revise the information contained in this presentation whether as a result of new information, future events or circumstances or otherwise.

Corporate Presentation I May 2023

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Investment Highlights

A Strong Foundation To Further Expand Into The Rare Disease Space

Two Approved Drugs

Elelyso® (alfataliglicerase in Brazil): FDA approved, commercially marketed drug for Gaucher disease.

PRX-102 (pegunigalsidase alfa) has been approved for marketing by the European Commission for Fabry disease and by the FDA (Elfabrio®).

Clinically-Validated Platform

Proprietary ProCellEx® platform for recombinant protein expression cGMP manufacturing facility successfully inspected and audited by multiple regulatory agencies, including the FDA & EMA.

Clinical and Regulatory Expertise

Strong clinical and regulatory expertise for biologics and world-class network of Lysosomal Storage Disorder disease experts

Strong Partnerships

Chiesi Farmaceutici S.p.A.

Pfizer Inc.

Fundação Oswaldo Cruz (Fiocruz)

Development Pipeline

Uricase (PRX-115) for the treatment of severe gout.

Long Acting DNase I (PRX-119) for the treatment of NETs-related diseases, as well as other product candidates, in discovery and preclinical phases.

Revenue-Generating

Multiple revenue streams, including sales to Pfizer, Fiocruz (Brazil) and Chiesi.

Note: cGMP = Current Good Manufacturing Practice.

Corporate Presentation I May 2023

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Product Pipeline

Recombinant proteins designed to have potentially improved therapeutic profiles that target unmet medical needs and established pharmaceutical markets

Discovery and Preclinical

Phase I

Phase II

Phase III

Marketing Application

ELFABRIO®

Fabry Disease

Approved (US and EU)

(pegunigalsidase alfa-iwxj)

Uricase (PRX-115)

Severe Gout

Long Acting (LA) DNase I

NETs-Related

(PRX-119)

Diseases

All of our pipeline candidates are recombinant proteins expressed via our proprietary ProCellEx® system.

Corporate Presentation I May 2023

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ProCellEx®: Protalix's Differentiated Protein Plant Cell Expression Platform

Unique Genetic Engineering Tools

Generates improved tobacco plant cell lines

expressing plant unique expression cassettes designed to produce therapeutic proteins with optimized

pharmacokinetic and pharmacodynamic profiles

Customized Chemical Modifications

Produces complex glycosylated proteins with potentially improved biologic attributes, including

reduced immunogenicity and enhanced protein stability/activity

Intellectual Property Advantages

Proprietary manufacturing processes allow development of 2nd generation PEGylated products providing Composition of Matter protection and other IP protection

Optimized for Complexity

Ability to express proteins that are difficult to express in other cell-based systems

Streamlined Production Process

Simplified maintenance with high batch-to-batch

reproducibility and no risk of viral contamination

Poised for Flexible Scale-Up

GMP-compliant infrastructure with modular capabilities

allows for rapid horizontal scale-upto increase

production volume

Corporate Presentation I May 2023

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Protalix BioTherapeutics Inc. published this content on 21 June 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 21 June 2023 09:38:07 UTC.