PLX 10-K & 10-Q changes, risk factors and insider trading

●We currently depend heavily on the generation of revenues from the sales of ourElfabrio products.and Elelyso.

●There may be safety issues regarding our products that were not known at the time of approval are discovered.

●We may not obtain the necessary U.S., EMAEMA, or other worldwide regulatory approvals to commercialize our drug candidates in a timely manner, if at all.

●We may fail to adequately protect or enforce our intellectual property rights or secure rights to third party patents.patents, and the terms of certain of our patents are limited or have expired.

●Our results may be adversely affected by political,military, economicpolitical and militaryeconomic conditions in Israel.

We currently depend heavily on the generation of revenues from the sales of Elfabrio and Elelyso. Any failure to successfully commercialize Elfabrio will have a material adverse effect on our business, results of operationsoperations, and financial condition.

●Chiesi’s efforts under the Chiesi Agreements and the effectiveness of Chiesi’s commercial strategy and its execution of that strategy, including its pricing strategy, its development and maintenance of successful sales and marketing organizationsorganizations, and the effectiveness of its efforts to obtain adequate third-party reimbursements and, to a lesser extent, Pfizer’s and Fiocruz’s commercial efforts;

●expandingexpansion by Chiesi and Pfizer of the scope of the countries in which our products are approved for marketing;

Any failure to commercializecontinue or expand the commercialization of either Elfabrio or Elelyso globally or the experience of significant delays in doing so willmay have a material adverse effect on our business, results of operationsoperations, and financial condition.

Our product candidates, if approved, may also be subject to certain post-authorization reporting requirements. As an example, the EMA has required that Chiesi submit pharmacovigilance documents intended to provide post-authorization evaluation of Elfabrio’s risk-benefit balance at defined time points after authorization, beginning within six months of authorization, and that an educational program about home administration be agreed upon with the National Competent Authority (as defined by the EMA) prior to the use of Elfabrio in the home setting.

Drug products remain subject to continuing regulatory oversight after they are approved for marketing, including the review of additional safety information. Drugs are more widely used by patients once approved for sale and, therefore, side-effects and other problems may be observed after approval that were not seen or anticipated, or were not as prevalent or severe, during clinical trials or nonclinical studies. The subsequent discovery of previously unknown problems with a product could negatively affect commercial sales of the product, result in restrictions on the product or lead to the withdrawal of the product from the market. The reporting of adverse safety events involving our products or public speculation about such events could cause our stock price to decline or experience periods of volatility and may have a material adverse effect on our business, results of operationsoperations, and financial condition.

If we or the marketing authorization holder, or MAH, of any of our products fail to comply with applicable continuing regulatory requirements, we or such MAH may be subject to fines and/or criminal prosecutions, and the product may become subject to suspension or withdrawal of regulatory approval, product recalls and seizures and operating restrictions. In addition, the manufacturers we or an MAH engage to produce a product and the manufacturing facilities in which the product is made are subject to periodic review and inspection by the FDA and foreign regulatory authorities. If problems are identified during the review or inspection of these manufacturers or manufacturing facilities, it could result in the facility becoming unable to manufacture the product or a determination that inventories are not safe for commercial sale, which may have a material adverse effect on our business, results of operationsoperations, and financial condition.

Coverage and reimbursement may not be available for Elfabrio, ElelysoElelyso, or any other future products in all territories, which could diminish sales of our products or adversely affect the profitably of such sales.

Market acceptance and sales of Elfabrio, Elelyso or any other future products, if any, will depend on coverage and reimbursement policies in the countries in which they are approved for sale. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which drugs they will pay for and establish reimbursement levels. Obtaining reimbursement approval for an approved product from individual governments and other third partythird-party payors is a time consuming (six to 12 months or longer) and costly process that requires our collaborators or us, as the case may be, to provide supporting scientific, clinical and cost-effectiveness data for the use of our products, if and when approved, to every payor. Data sufficient to gain acceptance with respect to coverage and reimbursement might not be available, or post-marketing studies may be required in order to demonstrate the cost-effectiveness of approved products, if any, to such payors’ satisfaction. Such studies might require our collaborators or us to commit a significant amount of management time and financial and other resources.

The pricing of our products in different countries may vary widely, thus creating the potential for third-party trade in our products in an attempt to exploit price differences between countries. This third-party trade of our products could undermine our sales in markets with higher prices which could have a material adverse effect on our business, results of operationsoperations, and financial condition.

We are unable to predict whether we could be subject to actions under any of these or other fraud and abuse laws, or the impact of such actions. Moreover, to the extent that Elfabrio, Elelyso or any other future products, if any, are sold in a foreign country, we and our collaborators may be subject to similar foreign laws and regulations. If we or any of our collaborators are found to be in violation of any of the laws described above and other applicable state and federal fraud and abuse laws, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from government healthcare reimbursement programs and the curtailment or restructuring or our operations, any of which could have a material adverse effect on our business, results of operationsoperations, and financial condition.

Any failure by us to supply drug substance to Chiesi or Pfizer may have a material adverse effect on our business, results of operationsoperations, and financial condition.

We have agreed to sell drug substance to Pfizer and Chiesi for the production of Elelyso and Elfabrio, respectively. With respect to Elelyso, our drug substance supply commitment is foruntil a 15-year period after the execution of the Amended Pfizer Agreement,2030, subject to certain terms and conditions. As part of that obligation, we agreed to substantial financial penalties if we fail to comply with the supply commitments, or are delayed in doing so. The amounts of the penalties depend on when any such failure occurs and for how long it persists, if at all, and other considerations. Any failure to comply with the supply commitments to Pfizer and/or Chiesi may have a material adverse effect on our business, results of operationsoperations, and financial condition.

Our strategy, in certain cases, is to enter into collaboration agreements with third parties to leverage our ProCellEx system to develop product candidates. Failure to enter into such agreements, or non-compliance by us or our collaborators with such agreements, may have a material adverse effect on our business, results of operationsoperations, and financial condition.

Our strategy, in certain cases, is to enter into arrangements with pharmaceutical companies to leverage our ProCellEx system to develop additional product candidates. Our future revenues may depend, in part, on our ability to enter into and maintain arrangements with our existing partners and other companies having sales, marketing and distribution capabilities and the ability of such companies to successfully market and pharmaceutical products on a global scale. Under these arrangements, we may grant to our partners rights to license and commercialize pharmaceutical products developed under the applicable agreements, as we have done with Elfabrio and Elelyso. Commercialization, marketing, distribution and other similar alliances with respect to our products and product candidates will subject us to a number of risks. We may be required to relinquish important rights to our products or product candidates, and the rights of our partners may limit our flexibility in considering alternatives for the commercialization of our products and product candidates. Our partners may control key decisions relating to the development of the products and we may depend on our partners’ expertise and dedication of sufficient time and resources to develop and commercialize our products and product candidates. Our partners may experience financial difficulties which adversely affect their efforts with respect to our product and product candidates. If we or any of our current or future partners breach or terminate the agreements that make up such arrangements, our partners otherwise fail to conduct their obligations under such arrangements in a timely manner, there is a dispute about their obligations or if either party terminates the applicable agreement or elects not to continue the arrangement, we may not enjoy the benefits of the agreements or receive a sufficient amount of royalty or milestone payments from them, if any, which may have a material adverse effect on our business, results of operationsoperations, and financial condition.

A key element of our business strategy is to establish a portfolio of product candidatescandidates, particularly in the rare and orphan disease spaces, as targets for development and eventual commercialization. We seek to do so through our internal research programs and strategic collaborations. Research programs to identify new product candidates require substantial technical, financial and human resources, whether or not any product candidates are ultimately identified. A research program may initially show promise in identifying a potential product candidate, yet fail to immediately yield the product candidate for clinical development for many reasons, including the following:

Any failure or delay in the establishment of a portfolio of product candidates as targets for development and eventual commercialization may have a material adverse effect on our business, results of operationsoperations, and financial condition.

The manufacture of our products is an exacting and complex process, and any manufacturing problems encountered by us or certain of our providers may have a material adverse effect on our business, results of operationsoperations, and financial condition.

The FDA and foreign regulators require manufacturers to register manufacturing facilities. The FDA and foreign regulators also inspect these facilities to confirm compliance with cGMP or similar requirements that the FDA or foreign regulators establish. We or certain of our services and materials providers, including our fill and finish service providers, may face manufacturing or quality control problems causing product production and shipment delays or a situation where we or the provider may not be able to maintain compliance with the FDA’s cGMP requirements, or those of foreign regulators, necessary to continue manufacturing. We or any such third-party manufacturer might be unable to formulate and manufacture our products in the volume and of the quality required to meet our preclinical, clinical and commercial needs. If we engage any contract manufacturers, such manufacturers may not perform as agreed or may not remain in the contract manufacturing business for the time required to supply our preclinical, clinical or commercial needs. In addition, we and contract manufacturers are subject to the rules and regulations of the FDA and comparable foreign regulatory authorities and face the risk that any of those authorities may find that they are not in compliance with applicable regulations. To date, our current facility has passed audits by the FDA and a number of other regulatory authorities but remains subject to audit by other foreign regulatory authorities. There can be no assurance that we or our contract manufacturers will be able to comply, or continue to comply, with FDA or foreign regulatory manufacturing requirements, and the failure to so comply, or continue to comply, may have a material adverse effect on our business, results of operationsoperations, and financial condition.

We rely on third parties for final processing of Elfabrio, ElelysoElelyso, and our other product candidates, which exposes us to a number of risks that may delay development, regulatory approvalapproval, and commercialization of Elfabrio, ElelysoElelyso, or our other product candidates or result in higher product costs.

Any failure to identify and maintain fill and finish service providers could delay our preclinical and clinical trials, the approval, if any, of our potential drug candidates by the FDAFDA, and other regulatory authorities, or the commercialization of our drug candidates, or could result in higher product costs or otherwise deprive us of potential product revenues.

Developments by competitors may render our products or technologies obsolete or non-competitive which would have a material adverse effect on our business, results of operationsoperations, and financial condition.

We compete against fully integrated pharmaceutical companies and smaller companies that are collaborating with larger pharmaceutical companies, academic institutions, government agencies and other public and private research organizations. Our products compete, and our products candidates will have to compete, with existing therapies and therapies under development by our competitors. Our commercial opportunities may be reduced or eliminated if our competitors develop and market products that are less expensive, more effective or safer than our products. Other companies have drug candidates in various stages of preclinical or clinical development to treat diseases for which we are also seeking to develop products. Some of these potential competing drugs are further advanced in development than our drug candidates and may be commercialized earlier. See “Business – Competition.”

These organizations also compete with us to attract qualified personnel, acquisitions and joint ventures candidates and for other collaborations. Activities of our competitors may impose unanticipated costs on our business or adversely affect the market for our products which would have a material adverse effect on our business, results of operationsoperations, and financial condition.

In addition to our own internally developed drug candidates, we proactively seek opportunities to in-license and advance other drug candidates that are strategic and have value-creating potential to take advantage of our development know-how and technology. In-licensing additional drug candidates may significantly increase our capital requirements, and place a strain on the time of our existing personnel, which may delay or otherwise adversely affect the development of our existing drug candidates or cause us to re-prioritize our drug pipeline if we do not have the necessary capital resources to develop all of our drug candidates, which may have a material adverse effect on our business, results of operationsoperations, and financial condition.

If we acquire companies, productsproducts, or technologies, we may face integration risks and costs associated with those acquisitions that could potentially negatively impact our business, results of operations and financial condition.

If we are presented with appropriate opportunities, we may acquire or make investments in complementary companies, products or technologies. If we acquire companies or technologies, we will face risks, uncertaintiesuncertainties, and disruptions associated with the integration process, including difficulties in the integration of the operations of an acquired company, integration of acquired technology with our products, diversion of our management’s attention from other business concerns, the potential loss of key employees or customers of the acquired business and impairment charges if future acquisitions are not as successful as we originally anticipate. In addition, our operating results may suffer because of acquisition-related costs or amortization expenses or charges relating to acquired intangible assets. Any failure to successfully integrate other companies, products or technologies that we may acquire may have a material adverse effect on our business, results of operationsoperations, and financial condition.

We also depend in part on the continued service of our key scientific personnel and our ability to identify, hirehire, and retain additional personnel. We experience intense competition for qualified personnel, and the existence of non-competition agreements between prospective employees and their former employers may prevent us from hiring those individuals or subject us to suit from their former employers. While we attempt to provide competitive compensation packages to attract and retain key personnel, many of our competitors are likely to have greater resources and more experience than we have, making it difficult for us to compete successfully for key personnel.

We have entered into non-competition agreements with substantially all of our employees. These agreements prohibit our employees, if they cease working for us, from competing directly with us or working for our competitors for a limited period. Under current U.S. and Israeli laws, we may be unable to enforce these agreements against most of our employees and it may be difficult for us to restrict our competitors from gaining the expertise our former employees acquired while working for us. If we cannot enforce our employees’ non-compete agreements, we may be unable to prevent our competitors from benefiting from the expertise of our former employees, which may have a material adverse effect on our business, results of operationsoperations, and financial condition.

Further, the global data protection landscape is rapidly evolving, and we are or may become subject to numerous local and foreign laws, requirementsrequirements, and regulations governing the collection, use, disclosure, retention, and security of personal data, such as information that we may collect about individuals worldwide. Implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future, and we cannot yet determine the impact future laws, regulations, standards, or perception of their requirements may have on our business. This evolution may create uncertainty in our business or to collect, store, transfer use and share personal information, necessitate the acceptance of more onerous obligations in our contracts, result in liability or impose additional costs on us. The cost of compliance with these laws, regulations and standards is high and is likely to increase in the future. Any failure or perceived failure by us to comply with local or foreign laws or regulation, our internal policies and procedures or our contracts governing our processing of personal information could result in negative publicity, government investigations and enforcement actions, claims by third parties and damage to our reputation, any of which could have a material adverse effect on our business, results of operationoperations, and financial condition.

Our failure to adhere to or successfully implement processes in response to changing regulatory requirements in this area could result in legal liability or impairment to our reputation in the marketplace, which could have a material adverse effect on our business, financial condition and results of operations.operations, and financial condition.

In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because biotechnology companies have experienced significant stock price volatility in recent years. If we faceAny such litigation, it could result in substantial costs and divert management’s attention and resources, which could have a material adverse effect on our business, results of operationoperations, and financial condition.

The use and marketing of our products and product candidates, including in connection with clinical trials, exposes us to product liability or similar claims if the use or misuse of those products or product candidates cause injury or disease, or results in adverse effects. We presently carry product liability and clinical trial liability insurance with coverages of up to $10.0 million per occurrence and $10.0 million in the aggregate, an amount we consider reasonable and customary. However, this insurance coverage includes various deductibles, limitations and exclusions from coverage, and in any event might not fully cover any potential claims. In the future, we may need to obtain additional product liability and clinical trial liability coverage; however, such insurance is expensive and insurance companies may not issue this type of insurance when we need it. We may not be able to obtain adequate insurance in the future at an acceptable cost. Any product liability claim, even one that was not in excess of our insurance coverage or one that is meritless and/or unsuccessful, may adversely affect the availability of funds for other purposes, such as research and development, which may have a material adverse effect on our business, results of operationsoperations, and financial condition. Product liability claims, even if without merit, may result in reduced demand for our products, if approved, or result in adverse market reactions, which would have a material adverse effect on our business, results of operationsoperations, and financial condition.

Our NOL carryforwards as of December 31, 2024,2025, are equal to approximately $227.2$219.8 million, of which approximately $22.2$20.0 million may be restricted under Section 382 of the Internal Revenue Code, or the IRC. IRC Section 382 applies whenever a corporation with NOLs experiences an ownership change. As a result of IRC Section 382, the taxable income for any post-change year that may be offset by a pre-change NOL may not exceed the fair market value of the pre-change entity multiplied by the IRC long-term tax exempt rate. Significant judgment is required in determining any valuation allowance recorded against deferred tax assets. In assessing the need for a valuation allowance, we considered all available evidence, including past operating results, the most recent projections for taxable income and prudent and feasible tax planning strategies. We reassess our valuation allowance periodically and if future evidence allows for a partial or full release of the valuation allowance, a tax benefit will be recorded accordingly. Any ownership change (including as a result of conversion of our outstanding convertible notes into shares of our common stock),change, or any other limitation on our utilization of NOLs, could have a material adverse effect on our business, results of operationsoperations, and financial condition.

Protalix Ltd. is our wholly-owned subsidiary and thus a controlled foreign corporation of our company for U.S. federal income tax purposes. This organizational structure may create inefficiencies, as certain types of income and investments of Protalix Ltd. that otherwise would not be currently taxable under general U.S. federal income tax principles may become taxable. These inefficiencies may require us to use more of our NOLs than we otherwise might and may result in a tax liability without a corresponding distribution from our subsidiaries which could have a material adverse effect on our business, results of operationsoperations, and financial condition.

We are a holding company with no operations of our own. Accordingly, our ability to conduct our operations, service any current or future debt and pay dividends, if any, is dependent upon the earnings from the business conducted by Protalix Ltd. The distribution of those earnings or advances or other distributions of funds by our subsidiaries to us, as well as our receipt of such funds, are contingent upon the earnings of Protalix Ltd. and are subject to various business considerations and U.S. and Israeli laws. If Protalix Ltd. is unable to make sufficient distributions or advances to us, or if there are limitations on our ability to receive such distributions or advances, we may not have the cash resources necessary to conduct our corporate operations or service our debt which would have a material adverse effect on our business, results of operationsoperations, and financial condition.

The effects of climate change (such as drought, flooding, heat waves, wildfires, increased storm severity, and sea level rise, etc.) could affect our ability to continue our operations and cause delays in the development of our existing drug candidates, manufacturing and shipment, all of which could cause reputational harm or otherwise have an adverse effect on our business, results of operation and financial condition. In addition, the impacts of climate change on the global economy and our industry are rapidly evolving. Changing market dynamics, global policy developments and the increasing frequency and impact of extreme weather events on critical infrastructure across different countries could have the potential to disrupt our business, the business of our third-party suppliers and the business of our customers, and may cause us to experience higher attrition, losseslosses, and additional costs to maintain or resume operations. We also expect to face increasing regulatory requirements and regulatory scrutiny related to climate matters, resulting in higher associated compliance costs. Failure to uphold, meetmeet, or make timely forward progress against our public commitments and goals related to climate action could adversely affect our reputation with suppliers and customers, financial performanceperformance, or the ability to recruit and retain talent.

We may not obtain the necessary U.S., EMA or other worldwide regulatory approvals to commercialize our drug candidates in a timely manner, if at all, which would have a material adverse effect on our business, results of operationsoperations, and financial condition.

To commercialize our drug candidates worldwide, we need FDA approval, EMA approvalapproval, and approvals from other countries’ regulators to commercialize our drug candidates elsewhere, as applicable. Approvals of BLAs, NDAs, MAAs and comparable marketing authorization applications worldwide generally requires that we demonstrate that the subject drug candidate is safe and effective for its intended use which requires significant research, animal or preclinical trials and human or clinical tests trials. Satisfaction of the regulatory requirements of the FDA, EMAEMA, and other countries’ regulatory authorities typically takes many years, depends upon the type, complexity and novelty of the drug candidate and requires substantial resources for research, development and testing. The results of preclinical and clinical trials of our product candidates may fail to demonstrate that the candidates are safe and effective for their intended uses.

Failure to obtain approval of the FDA, EMAEMA, or comparable foreign authorities of any of our product candidates in a timely manner, if at all, will severely undermine our business, results of operationsoperations, and financial condition by decreasing our ability to generate product revenues from the sales of such product candidates. If we or our partners fail to comply with the regulatory requirements in international markets and/or receive applicable marketing approvals, the target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed, which may have a material adverse effect on our prospects, business, results of operations, and financial condition.

Both before and after marketing approval of our drug candidates, if at all, we, our drug candidates, our suppliers, our contract manufacturersmanufacturers, and our contract testing laboratories are subject to extensive regulation by the FDA and comparable foreign regulatory authorities. Failure to comply with applicable requirements of the FDA or comparable foreign regulatory authorities could result in, among other things, any of the following actions:

We also are subject to inspection by the FDA and comparable foreign regulatory authorities, to determine our compliance with regulatory requirements, as are our suppliers, contract manufacturers, and contract testing laboratories, and there can be no assurance that the FDA, or any other comparable foreign regulatory authority, will not identify compliance issues that may disrupt production or distribution, or require substantial resources to correct. We may be required to make modifications to our manufacturing operations in response to these inspections which may require significant resources and may have a material adverse effect upon our business, results of operationsoperations, and financial condition.

The approval process for any drug candidate may also be delayed by changes in government regulation, future legislation or administrative actionaction, or changes in policy of the FDA and comparable foreign authorities that occur prior to or during their respective regulatory reviews of such drug candidate.

Delays in obtaining regulatory approvals with respect to any drug candidate willmay materially and adversely affect our prospects, business, results of operations and financial condition.

Delays in the approval process for any drug candidate may have a material adverse effect upon our prospects, business, results of operationsoperations, and financial condition.

Preclinical and clinical trials are very expensive, time-consumingtime-consuming, and difficult to design and implement and may result in unforeseen costs, which may have a material adverse effect on our business, results of operationsoperations, and financial condition.

WeOur arecorporate committedstrategy to leveraging our track record of success as we progress with theincludes development of treatments for rare and orphan diseases. InTo addition, we continuously workexecute on the further development and enhancement of our ProCellEx technology. Accordingly,strategy, we are turning our focus to new, early-stage product candidates that treat indications for which there are high unmet needs in terms of efficacy and safety, including renal diseases. TreatmentsWe believe our treatments of interest will address both genetic and non-genetic diseases. We currently intend to use our ProCellEx platform and PEGylation capabilities, as well as other modalities such as small molecules and antibodies, to take advantage of highly innovative opportunities. We are also exploring novel platform technologies.

Our first product, Elelyso, an ERT for the treatment of patients with Gaucher disease, was first approved by the FDA in May 2012 and is now approved for marketing in 23more than 40 markets including Brazil, Israel and others. InIt Juneis 2012,not approved for marketing in the CHMP issued a positive opinion regarding the benefit of Elelyso but did not immediately grant marketing authorization because of the ten-year market exclusivity granted to Vpriv in August 2010 for the same condition, which was extended for an additional two years, and expired in August 2022.EU. We have granted the marketing rights to Elelyso globally, excluding Brazil, to Pfizer through an exclusive licensing agreement. We maintain the distribution rights to Elelyso in Brazil, where it is currently marketed as BioManguinhos alfataliglicerase, through the Brazil Agreement. In 2024,2025, we generated $12.6$18.2 million from sales of Elelyso to Pfizer and $11.0$11.1 million from sales of BioManguinhos alfataliglicerase to the Brazilian MoH.

Elfabrio, our second commercial product, an ERT for the treatment of Fabry disease, was approved by the EC for marketing in the EU and by the FDA for marketing in the United States in May 2023 for adult patients. Both approvals cover the 1 mg/kg every two weeksE2W dosage. WeSubsequently, haveit enteredhas intobeen twoapproved exclusivein globalmore licensingthan and10 supplyadditional agreementsmarkets. forCommercialization of Elfabrio withis Chiesi.governed In October 2017 and July 2018, Protalix Ltd., our wholly-owned subsidiary, entered intoby the Chiesi Agreements pursuant to which Chiesi was granted an exclusive license for all markets, both within and outside of the United States to commercialize Elfabrio.Agreements. In 2024,2025, we generated $29.3$22.5 million from sales of Elfabrio to Chiesi.

InWe Marchhave 2023, we initiatedcompleted a phasePhase I1 First-in-Human clinical trial of PRX-115. This study included 64 adult male and female subjects in a dose escalation design with eight sequential dosing cohorts, each composed of eight subjects (six active and two placebo) which is now complete. The results were announced in a poster presentation at the American College of Rheumatology (ACR) Convergence 2024, held November 14-19, 2024 and are summarized in Item 1 of this annual report on Form 10-K. WeCurrently, we are currentlyactively preparingrecruiting forpatients afor, phase II clinical trial of PRX-115 which we expect will commence inand the secondfirst halfpatients ofhave 2025.been randomized in, the RELEASE study.

Under each of the Chiesi Agreements, Chiesi made an upfront payment to Protalix Ltd. of $25.0 million in connection with the execution of each agreement.agreement Inand addition,Protalix Ltd. received additional payments of $25.0 million under the Chiesi Ex-US Agreement, Protalixand Ltd.$20.0 wasmillion entitledunder the Chiesi US Agreement, to additional payments of up to $25.0 million incover pegunigalsidase alfa development costs, and to receive additional paymentsall of upwhich tohave $320.0been million,received in the aggregate, in regulatory and commercial milestone payments. Under the Chiesi US Agreement,full. Protalix Ltd. wascurrently entitledremains to payments of up to a maximum of $20.0 million to cover development costs for pegunigalsidase alfa, and is entitledeligible to receive additional payments of up to a maximum of $760.0$270.0 million, in the aggregate and including the $25.0 million currently payable, subject to the satisfaction of certain regulatory and commercial milestones under the Chiesi Ex-US Agreement. Under the Chiesi US Agreement, Protalix Ltd. currently remains eligible to receive additional payments of up to a maximum of $740.0 million, in the aggregate, insubject to the satisfaction of certain regulatory and commercial milestonemilestones. payments. To date, Protalix Ltd. has received the complete amount of development costs to which it is entitled under the Chiesi Agreements. In addition, followingFollowing the approval of Elfabrio by the FDA, we received a milestone payment equal to $20.0 million.

Under the terms of both of the Chiesi Agreements, Protalix Ltd.Chiesi is requiredsolely responsible for the global commercialization and medical programs of Elfabrio, including patient acquisition and retention, and distribution of Elfabrio to patients. We manufacture all of the Elfabrio drug substance neededand, underafter the agreements,fill\finish subjectprocess tois certaincomplete, exceptions,we andsell Chiesithe will purchase Elfabrioresulting drug product fromto Protalix,Chiesi. subjectOperationally, Chiesi conducts its own internal commercial forecasting to certainguide termsinventory needs. To date, Chiesi has placed bulk orders for Elfabrio. As a result, the orders we receive from Chiesi may not be timed precisely to Chiesi’s pace of patient acquisition and conditions.retention. Accordingly, our sales of Elfabrio to Chiesi may not reflect patient demand for Elfabrio as we sell the fulfilled orders to Chiesi’s inventory. In addition, on a period-to-period basis, there may be variations in the orders placed by Chiesi resulting in variability in our period-to-period results as we, in turn, recognize revenues from sales of Elfabrio upon delivery of the drug product to Chiesi. There may be periods during which no orders are placed by Chiesi, whether as a result of inventory de-stocking or other factors. We do not anticipate that these Chiesi ordering patterns will change until the demand characteristics for Elfabrio stabilize, the launch of Elfabrio matures and Elfabrio’s share of the market for Fabry disease treatment increases globally. The consideration for Protalix Ltd. is based on the drug product supplied to Chiesi and the average selling price of the drug product in theeach relevant territory multiplied by tiered payments as described in the relevant agreement. Under the Chiesi Ex-US Agreement, the price payable to us for drug product supplied is based on a range of 15% to 35% of the average selling price of the drug product in the applicable territory, and, under the Chiesi US Agreement, such price is based on a range of 15% to 40% of the average selling price of the drug product in the United States.

Since its approval by the FDA, Elelyso has been marketed by Pfizer in accordance with the Pfizer Agreement.Pfizer. In October 2015, Protalix Ltd. and Pfizer entered into the Amended Pfizer Agreement, pursuant to which we sold to Pfizer our share in the collaboration created under theour original agreement with Pfizer Agreement for the commercialization of Elelyso. As part of the sale, we agreed to transfer our rights to Elelyso in Israel to Pfizer while gaining full rights to it in Brazil. Under the Amended Pfizer Agreement, Pfizer is entitled to all of the revenues, and is responsible for 100% of expenses globally for Elelyso, excluding Brazil where we are responsible for all expenses and retain all revenues.

On June 18, 2013, we entered into the Brazil Agreement. Fiocruz’s purchases of BioManguinhos alfataliglicerase to date under such agreement have been significantly below certain agreed-upon purchase milestones and, accordingly, we have the right to terminate the Brazil Agreement. Notwithstanding the termination right, we are, at this time, continuing to supply BioManguinhos alfataliglicerase to Fiocruz and patients continue to be treated with BioManguinhos alfataliglicerase in Brazil.

Our primary sources of revenues include our sales of drug product to Chiesi under the Chiesi Agreements, of BioManguinhos alfataliglicerase to Brazil and of drug substance to Pfizer under our Amended Pfizer Agreement. For a discussion of our accounting treatment for revenue recognition, see Note 1(kt) to our consolidated financial statements.

We expect our research and development expense to remain our primary expense in the near future as we continue to develop PRX-115 and our product candidates. Research and development expense consists of:

At this time, due to the inherently unpredictable nature of preclinical and clinical development processes and given the early stage of our preclinical product development programs, we are unable to estimate with any certainty the costs we will incur in the continued development of the product candidates in our pipeline for potential commercialization. Clinical development timelines, the probability of success and development costs can differ materially from expectations. Our future research and development expenses for our product candidates will depend on the preclinical and clinical success of each product candidate, as well as ongoing assessments of each product candidate’s commercial potential. In addition, we cannot forecast with any degree of certainty which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements. See “Risk Factors—We may not obtain the necessary U.S., EMAEMA, or other worldwide regulatory approvals to commercialize our drug candidates in a timely manner, if at all, which would have a material adverse effect on our business, results of operations and financial condition.”

We expect our research and development expenses to continue to be our primary expense in the future as we continue the advancement of our clinical trials and preclinical product development programs for our product candidates.candidates, in particular with respect to the RELEASE study. The lengthy process of completing clinical trials and seeking regulatory approvals for our product candidates requires expenditure of substantial resources. Any failure or delay in completing clinical trials, or in obtaining regulatory approvals, could cause a delay in generating product revenue and cause our research and development expense to increase and, in turn, have a material adverse effect on our operations. Due to the factors set forth above, we are not able to estimate with any certainty when we would recognize any net cash inflows from our projects. See “Risk Factors—Preclinical and clinical trials are very expensive, time-consuming and difficult to design and implement and may result in unforeseen costs, which may have a material adverse effect on our business, results of operationsoperations, and financial condition.”

Our sources of liquidity include our cash balances and bank deposits. At December 31, 2024,2025, we had $34.8$30.3 million in cash and cash equivalents and short termshort-term bank deposits. In September 2024, we satisfied the outstanding principal and accrued interest under the 2024 Notes with a cash payment of approximately $21.2 million which was available primarily from the withdrawal of short termshort-term deposits. We have primarily financed our operations through sales proceeds, equity and debt financings, business collaborations, and grants funding.

During the year ended December 31, 2024,2025, we raisedsold, in the aggregate, 2,775,215 shares of common stock under the 2023 Sales Agreement. We generated gross proceeds equal to approximately $3.8$7.0 million from the sale, in theconnection aggregate,with ofsuch 2,216,692 shares of our common stock under our ATM program.sales. All such sales were completedeffected during the first half of 2025. In addition, during the first quarter of the year ended December 31, 2024. Subsequent to December 31, 2024, we sold, in the aggregate, an additional 1,223,935 shares of common stock under program generating gross proceeds equal to approximately $2.5 million. Such sales completed the ATM program. In addition, since December 31, 2024,2025, we issued 908,000 shares of our common stock in connection with the exercise of warrants issued in 2020 generating proceeds equal to approximately $2.1 million. The warrants expired on March 11, 2025. Accordingly, no warrants remain outstanding.

During the year ended December 31, 2023,2024, we raised gross proceeds equal to approximately $24.9$3.8 million from the salesale, in the aggregate, of 12,560,1502,216,692 shares of our common stock under our ATM program.

ThereExcept as set forth below, there have been no material changes to the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the consolidated financial statements and the related notes included elsewhere in this Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2025. Some of the information contained in this discussion and analysis, particularly with respect to our plans and strategy for our business and related financing, includes forward-looking statements within the meanings 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, or the Exchange Act, including statements regarding expectations, beliefs, intentions or strategies for the future. When used in this report, the terms “anticipate,” “believe,” “estimate,” “expect,” “can,” “continue,” “could,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “wouldwould,” and words or phrases of similar import, as they relate to our company, our subsidiary or our management, are intended to identify forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are only predictions and reflect our views as of the date they are made with respect to future events and financial performance, and we undertake no obligation to update or revise, nor do we have a policy of updating or revising, any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events, except as may be required under applicable law. 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 as a result of several factors, including those set forth in this Quarterly Report on Form 10-Q.

●risks associated with global conditions and developments such as new or increased tariffs, new or changedtreaties, trade restrictions,policies, supply chain challenges, the inflationary environmenttaxes, and tightother laborlimitations market,on andcross-border instability in the banking industry,operations, which may adversely impact our business, results of operations, and abilityfinancial to raise additional financing if and as required and on terms acceptable to uscondition;

●risks relating to our ability to manage our relationship with our collaborators, distributors, and partners, including, but not limited to, Pfizer Inc., or Pfizer, and Chiesi Farmaceutici S.p.A., or Chiesi;

●PRX 115,PRX-115, a recombinant PEGylated uricase (urate oxidase) – a chemically modified enzyme to treat uncontrolled gout; and

●PRX 119,PRX-119, a PEGylated recombinant human DNase I product candidate for long and customized systemic circulation in the bloodstream for NETs-related diseases (neutrophil extracellular traps).

Elfabrio is commercialized worldwide by Chiesi under two exclusive global licensing and supply agreements; the Exclusive License and Supply Agreement dated as of October 17, 2017, by and between Protalix Ltd. and Chiesi, or the Chiesi Ex-US Agreement, and the Exclusive License and Supply Agreement dated as of July 23, 2018, by and between Protalix Ltd. and Chiesi, or the Chiesi US Agreement. The Chiesi Ex-US Agreement and the Chiesi US Agreement are referred to herein collectively as the Chiesi Agreements. Under the Chiesi Ex-US Agreement, we granted to Chiesi an exclusive license for all markets outside of the United States to commercialize pegunigalsidase alfa. At execution of the Chiesi Ex-US Agreement, Chiesi made an upfront, non-refundable, non-creditable payment to Protalix Ltd. of $25.0 million, followed by additional payments of $25.0 million to cover development costs in the aggregate. Following the approval of the E4W dosage by the EMA in 2026, we received a milestone payment equal to $25.0 million. Protalix Ltd. currently remains eligible to receive additional payments of up to a maximum of $270.0 million, in the aggregate and including the $25.0 million currently payable,aggregate, subject to the satisfaction of certain regulatory and commercial milestones. Protalix Ltd. agreed to manufacture all of the pegunigalsidase alfa needed for all purposes under the agreement, subject to certain exceptions, and Chiesi agreed to purchase the pegunigalsidase alfa from Protalix Ltd., subject to certain terms and conditions. Chiesi is required to make payments to Protalix Ltd. ranging from 15% to 35% of its net sales under the Chiesi Ex-US Agreement, depending on the amount of annual sales, subject to certain terms and conditions, as consideration for product supply. The Chiesi Ex-US Agreement shall remain in effect until the later of (i) the expiration of the last enforceable Protalix patent right thereunder or (ii) the 15th anniversary of the launch of sales of pegunigalsidase alfa on a country-by-country basis, subject to certain terms and conditions, unless earlier terminated in accordance with the terms and conditions thereof.

We manufacture Elfabrio drug substance and, after the fill\/finish process is complete, we sell the resulting drug product to Chiesi under both agreements. Operationally, Chiesi conducts its own internal commercial forecasting to guide inventory needs. To date, Chiesi has placed bulk orders for Elfabrio. As a result, the orders we receive from Chiesi may not be timed in relation to Chiesi’s pace of patient acquisition and retention. Accordingly, our sales of Elfabrio to Chiesi may not reflect patient demand for Elfabrio as we sell the fulfilled orders to Chiesi’s inventory. In addition, on a period-to-period basis, there may be variations in the orders placed by Chiesi resulting in variability in our period-to-period results as we, in turn, recognize revenues from sales of Elfabrio upon delivery of the drug product to Chiesi. There may be periods during which no orders are placed by Chiesi, whether as a result of inventory de-stocking or other factors. We do not anticipate that these Chiesi ordering patterns will change until the demand characteristics for Elfabrio stabilize, the launch of Elfabrio matures and Elfabrio’s share of the market for Fabry disease treatment grows both inside the US and outside the US.U.S.

A key element of our overall strategy is to establish a broad portfolio of patents to protect our proprietary technology, proprietary product and product candidates and their methods of use. As of MarchJune 31,30, 2026, we hold a broad portfolio of 15 patent families consisting of approximately 6871 patents in Europe, the United States, Israel, and additional countries worldwide, as well as approximately 3836 pending patent applications.

Three and six months ended MarchJune 31,30, 2026 compared to the three and six months ended MarchJune 31,30, 2025

Revenues from selling goods for the three and six months ended MarchJune 31,30, 2026 reflects aan decreaseincrease of 26%28% and 7% compared to the three and six months ended June 30, 2025, respectively. The total increase in revenues from selling goods for the three and six months ended MarchJune 31,30, 2025.2026 resulted primarily from an increase in sales to Chiesi. The decrease in sales to Pfizer resulted primarily from a timing shift in Pfizer’s purchases for the three months ended March 31, 2026 compared to increased purchases of Elelyso by Pfizer in the three months ended March 31, 2025 to address unexpected manufacturing issues at Pfizer.Pfizer in 2025. The decreaseincrease in sales to Fiocruz (Brazil) areresulted dueprimarily tofrom the timing of deliveries. The total decrease in revenues from selling goods for the period was partially offset by an increase in sales to Chiesi.

The increasedecrease in revenues from license and R&D services for the three months ended MarchJune 31,30, 2026 compared to the three months ended June 30, 2025 resulted from a decrease in the amount of services provided to Chiesi. The increase in revenues from license and R&D services for the threesix months ended MarchJune 31,30, 2026 compared to the six months ended June 30, 2025 resulted from the $25.0 million milestone we received from Chiesi in connection with the approval of the E4W dosage in the EU.EU in the first quarter of 2026. Revenues from license and R&D services are comprised primarily of revenues we recognized in connection with the Chiesi Agreements. WeOther than potential regulatory milestone payments that may become payable, we expect to generate minimal revenues from license and R&D services now that we have completed the clinical development of Elfabrio.

Cost of revenues for the three months ended MarchJune 31,30, 2026 represents an increase of 32% compared to the three months ended June 30, 2025. The increase resulted primarily from an increase in sales to Chiesi and to Fiocruz (Brazil) which was partially offset by a decrease in sales to Pfizer. Cost of revenues for the six months ended June 30, 2026 represents a decrease of 50%15% fromcompared cost of revenues forto the threesix months ended MarchJune 31,30, 2025. The decrease resulted primarily from a decrease in sales to Pfizer and Fiocruz (Brazil) which was partially offset by an increase in sales to Chiesi.Chiesi and to Fiocruz (Brazil).

Selling, general, and administrative expenses for the three months ended MarchJune 31,30, 2026 represents an increase of 17%19% and 18% compared to selling,the general,three and administrative expenses for the threesix months ended MarchJune 31,30, 2025.2025, respectively. The increase resulted primarily from an increase of $0.4$0.3 million and $0.7 million in salary and related expenses.expenses for the three and six months ended June 30, 2026, respectively, and of $0.2 million in selling expenses for the three and six months ended June 30, 2026.

The difference in financial income, net for the three and six months ended June 30, 2026 compared to financial expenses, net for the three monthsand ended March 31, 2026 compared to financial income, net for the threesix months ended MarchJune 31,30, 20252026 resulted primarily from $0.3 million in recorded expenses due to exchange rate fluctuations between the USU.S. Dollar and the New Israel Shekel, and a decrease of $0.1 million in interest income.Shekel.

Income taxes (tax benefit) were as follows:

We recorded tax expenses of approximately $2.8$3.9 million and $1.1 million for the three months ended March 31, 2026six and a tax benefit of approximately $(0.1) million for the three months ended MarchJune 31,30, 2025.2026, respectively. The tax expenses resulted primarily from taxes on income mainly derived from global intangible low-taxed income (GILTI) resulting primarily from limitations under IRC Section 174.174 and from the taxes related to our receipt of the $25 million milestone payment in the first quarter of 2026. On July 4, 2025, tax reform legislation was enacted in the United States through the passage of H.R.1, The One Big Beautiful Bill Act, which includes significant corporate tax changes, including a restoration of the current deductibility of domestic research expenditures beginning in 2025 under Section 174A, with transition options for previously capitalized amounts. Foreign research expenditures continue to require capitalization subject to the mandatory 15-year amortization period under existing IRC Section 174. We implemented the permitted transition options.

Our sources of liquidity include our cash balances and short-term bank deposits. At MarchJune 31,30, 2026, we had $51.1$40.7 million in cash and cash equivalents and short-term bank deposits. We have primarily financed our operations through sales proceeds, equity and debt financings, business collaborations, and grants funding.

On February 27, 2023, we entered into an At The Market Offering Agreement, or the Sales Agreement, with H.C. Wainwright & Co., LLC, as the sales agent, or the Agent, which provided for the sale, from time to time through the Agent, shares of Commoncommon Stockstock having an aggregate offering price of up to $20.0 million. On March 17, 2025, the Sales Agreement was amended to increase the aggregate gross sales price of shares of Commoncommon Stockstock available for offer and sale under the Sales Agreement by $20.0 million. We have no obligation to sell any shares of Commoncommon Stockstock under the Sales Agreement, and may at any time suspend sales under the Sales Agreement or terminate the Sales Agreement in accordance with its terms. The Agent is entitled to a commission of up to 3.0% of the aggregate gross proceeds from the shares of Commoncommon Stockstock sold under the Sales Agreement. During the threesix months ended MarchJune 31,30, 2025, we sold, in the aggregate 1,325,1792,775,215 shares of Commoncommon Stockstock under the Sales Agreement generating gross proceeds equal to approximately $3.0$7.0 million (issuance costs were $0.1$0.2 million). We did not make any sales during the threesix months ended MarchJune 31,30, 2026. As of MarchJune 31,30, 2026, approximately $15.7 million in shares of Commoncommon Stockstock remain available to be sold under the Sales Agreement.

Our cash flows for each of the threesix months ended MarchJune 31,30, 2026 and 2025 were as follows:

Net cash usedprovided inby operations was $5.1$11.6 million for the threesix months ended MarchJune 31,30, 2025.2026. The net lossincome for the threesix months ended MarchJune 31,30, 20252026 of $3.6$22.1 million was increased by a $1.3$4.2 million decreaseincrease in accounts payable and accruals, a$0.9 $2.3million in share-based compensation, $0.7 million in financial expenses, net and $0.8 million in depreciation and partially offset by $8.6 million increase in accounts receivable-trade and other assetsassets, and $0.4$6.6 million in financial income, net and was offset by $0.5 million in share-based compensation, a $1.7 million decreaseincrease in inventories, and $0.3$2.1 million increase in depreciation.R&D grant.

Net cash usedprovided inby investing activities was $0.6 million for the threesix months ended MarchJune 31,30, 2025 was $0.3 million2026 and consisted primarily of $10.0 million short-term deposit withdrawal partially offset by a $8.0 million investment in bank deposits and $1.4 million in the purchase of property and equipment.

Net cash provided by financing activities was $0.2 million for the threesix months ended MarchJune 31,30, 2025 was $5.1 million2026 and consisted of $2.9 million in proceeds from the issuance of Common Stock under the Sales Agreement, net and $2.2 millionresulted from the exercise of warrants and options.

Since our inception, we have incurred significant research and development expenditures which have not been offset by revenues. We have not generated significant revenues from sales of Elelyso or Elfabrio. We have generated operating losses from our continuing operations since our inception althoughexcept the revenues generated infor the years ended December 31, 2023 and 2024, and in the three and six months ended MarchJune 31,30, 2026, exceeded our expenditures for the same periods.2026.

As we increase our research and developments efforts with respect to our current and future product candidates, we expect to continue to incur significant expenditures. We cannot anticipate the costs or the timing of the occurrence of such costs. Although we expect the revenues generated from the sales of Elfabrio and Elelyso will increase, such revenues may not be sufficient to fund the expenditures. To the extent we need to obtain additional financing in excess of such anticipated revenues, it may be difficult for us to do so given the volatility of the price of our Commoncommon Stock.stock. Our material cash needs for the next 24 months will include, among other expenses, (i) costs of preclinical and clinical trials, in particular those of our RELEASE study, (ii) employee salaries, (iii) payments for rent and operation of our manufacturing facilities, (iv) fees to our consultants and legal advisors, patent advisors and fees for service providers in connection with our research and development efforts andefforts, (v) expansion of additional manufacturing space within our current facility and (vi) tax payments. We believe that the funds currently available to us are sufficient to satisfy our capital needs for at least 12 months from the date this report is issued.

Currency fluctuations could affect us through increased or decreased acquisition costs for certain goods and services and salaries expenses. For the threesix months ended MarchJune 31,30, 2026 the currency fluctuations wereresulted immaterial.in expenses of approximately $0.7 million.

We have no off-balance sheet arrangements as of each of MarchJune 31,30, 2026 and December 31, 2025.