Protalix BioTherapeutics, Inc.

Previous wording

●risks associated with global conditions and developments such as new or increased tariffs, new or changed trade restrictions, supply chain challenges, the inflationary environment and tight labor market, and instability in the banking industry, which may adversely impact our business, operations, and ability to raise additional financing if and as required and on terms acceptable to us;

Current wording

●risks associated with other global conditions and developments such as new or changed trade restrictions, supply chain challenges, the inflationary environment, and tight labor market, and instability in the banking industry, which may adversely impact our business, results of operations, and financial condition, and our ability to raise additional financing if and as required and on terms acceptable to us;

Previous wording

●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;

Current wording

●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;

Previous wording

quality, and cost-effective supply of BioManguinhos alfataliglicerase. Fiocruz has not satisfied certain purchase commitments under the Brazil Agreement. We continue to sell BioManguinhos alfataliglicerase for a fixed price through purchase orders and we continue to discuss with Fiocruz potential steps to maximize sales of BioManguinhos alfataliglicerase to the Brazilian MoH.

Current wording

The Brazil Agreement provides for a staged technology transfer that is intended to transfer to Fiocruz the capacity and skills required for the Brazilian government to construct its own manufacturing facility, at its sole expense, and to produce a sustainable, high-quality, and cost-effective supply of BioManguinhos alfataliglicerase. Fiocruz has not satisfied certain purchase commitments under the Brazil Agreement. We continue to sell BioManguinhos alfataliglicerase for a fixed price through purchase orders and we continue to discuss with Fiocruz potential steps to maximize sales of BioManguinhos alfataliglicerase to the Brazilian MoH.

Previous wording

Elfabrio is commercialized worldwide by Chiesi under 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. 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, 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 15 th 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.

Current wording

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, 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 15 th 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.

Previous wording

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.

Current wording

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-

Previous wording

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 March 31, 2026, we hold a broad portfolio of 15 patent families consisting of approximately 68 patents in Europe, the United States, Israel, and additional countries worldwide, as well as approximately 38 pending patent applications.

Current wording

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 June 30, 2026, we hold a broad portfolio of 15 patent families consisting of approximately 71 patents in Europe, the United States, Israel, and additional countries worldwide, as well as approximately 36 pending patent applications.

Previous wording

product candidates that treat indications for which there are high unmet needs in terms of efficacy and safety, including renal diseases. We currently intend that our treatments will address both genetic and non-genetic diseases. We currently intend to use our ProCellEx platform and PEGylation/chemical 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 to expand our pipeline.

Current wording

We are committed to leveraging our track record of success as we develop treatments for rare and orphan diseases. In addition, we are continuously further developing and enhancing our ProCellEx technology. Accordingly, 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. We currently intend that our treatments will address both genetic and non-genetic diseases. We currently intend to use our ProCellEx platform and PEGylation/chemical 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 to expand our pipeline.

Previous wording

Revenues from selling goods for the three months ended March 31, 2026 reflects a decrease of 26% compared to revenues from selling goods for the three months ended March 31, 2025. 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. The decrease in sales to Fiocruz (Brazil) are due to 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.

Current wording

Revenues from selling goods for the three and six months ended June 30, 2026 reflects an increase of 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 June 30, 2026 resulted primarily from an increase in sales to Chiesi. The decrease in sales to Pfizer resulted primarily from Pfizer’s purchases to address unexpected manufacturing issues at Pfizer in 2025. The increase in sales to Fiocruz (Brazil) resulted primarily from the timing of deliveries.

Previous wording

The increase in revenues from license and R&D services for the three months ended March 31, 2026 compared to license and R&D services for the three months ended March 31, 2025 resulted from the $25.0 million milestone we received from Chiesi in connection with the approval of the E4W dosage in the EU. Revenues from license and R&D services are comprised primarily of revenues we recognized in connection with the Chiesi Agreements. We expect to generate minimal revenues from license and R&D services now that we have completed the clinical development of Elfabrio.

Current wording

The decrease in revenues from license and R&D services for the three months ended June 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 six months ended June 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 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

Previous wording

Cost of revenues for the three months ended March 31, 2026 represents a decrease of 50% from cost of revenues for the three months ended March 31, 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.

Current wording

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

Previous wording

Selling, general, and administrative expenses for the three months ended March 31, 2026 represents an increase of 17% compared to selling, general, and administrative expenses for the three months ended March 31, 2025. The increase resulted primarily from an increase of $0.4 million in salary and related expenses.

Current wording

Selling, general, and administrative expenses for the three months ended June 30, 2026 represents an increase of 19% and 18% compared to the three and six months ended June 30, 2025, respectively. The increase resulted primarily from an increase of $0.3 million and $0.7 million in salary and related 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.

Previous wording

The difference in financial expenses, net for the three months ended March 31, 2026 compared to financial income, net for the three months ended March 31, 2025 resulted primarily from $0.3 million in recorded expenses due to exchange rate fluctuations between the US Dollar and the New Israel Shekel, and a decrease of $0.1 million in interest income.

Current wording

The difference in financial income, net for the three and six months ended June 30, 2026 compared to financial expenses, net for the three and six months ended June 30, 2026 resulted primarily from exchange rate fluctuations between the U.S. Dollar and the New Israel Shekel.

Previous wording

We recorded tax expenses of approximately $2.8 million for the three months ended March 31, 2026 and a tax benefit of approximately $(0.1) million for the three months ended March 31, 2025. 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. 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.

Current wording

We recorded tax expenses of approximately $3.9 million and $1.1 million for the six and three months ended June 30, 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 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.

Previous wording

Our sources of liquidity include our cash balances and short-term bank deposits. At March 31, 2026, we had $51.1 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.

Current wording

Our sources of liquidity include our cash balances and short-term bank deposits. At June 30, 2026, we had $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.

Previous wording

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 Common Stock 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 Common Stock available for offer and sale under the Sales Agreement by $20.0 million. We have no obligation to sell any shares of Common Stock 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 Common Stock sold under the Sales Agreement. During the three months ended March 31, 2025, we sold, in the aggregate 1,325,179 shares of Common Stock under the Sales Agreement generating gross proceeds equal to approximately $3.0 million (issuance costs were $0.1 million). We did not make any sales during the three months ended March 31, 2026. As of March 31, 2026, approximately $15.7 million in shares of Common Stock remain available to be sold under the Sales Agreement.

Current wording

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 common stock 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 common stock available for offer and sale under the Sales Agreement by $20.0 million. We have no obligation to sell any shares of common stock 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 common stock sold under the Sales Agreement. During the six months ended June 30, 2025, we sold, in the aggregate 2,775,215 shares of common stock under the Sales Agreement generating gross proceeds equal to approximately $7.0 million (issuance costs were $0.2 million). We did not make any sales during the six months ended June 30, 2026. As of June 30, 2026, approximately $15.7 million in shares of common stock remain available to be sold under the Sales Agreement.

Previous wording

Our cash flows for each of the three months ended March 31, 2026 and 2025 were as follows:

Current wording

Our cash flows for each of the six months ended June 30, 2026 and 2025 were as follows:

Previous wording

Net cash provided by operations was $22.0 million for the three months ended March 31, 2026. The net income for the three months ended March 31, 2026 of $18.3 million was increased by a $6.4 million decrease in accounts receivable-trade and other assets, $0.5 million in share-based compensation, $0.2 million in financial expenses, net, $0.4 million in depreciation and a $0.8 million increase in accounts payable and accruals, and was offset a $4.7 million increase in inventories.

Current wording

Net cash provided by operations was $11.6 million for the six months ended June 30, 2026. The net income for the six months ended June 30, 2026 of $22.1 million was increased by a $4.2 million increase in accounts payable and accruals, $0.9 million 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 assets, $6.6 million increase in inventories, and $2.1 million increase in R&D grant.

Previous wording

Net cash provided by investing activities was $4.2 million for the three months ended March 31, 2026 and consisted primarily of $10.0 million short-term deposit withdrawal partially offset by a $5.0 million investment in bank deposits and $0.8 million in the purchase of property and equipment.

Current wording

Net cash provided by investing activities was $0.6 million for the six months ended June 30, 2026 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.

Previous wording

Net cash provided by financing activities was $0.2 million for the three months ended March 31, 2026 and resulted from the exercise of options.

Current wording

Net cash provided by financing activities was $0.2 million for the six months ended June 30, 2026 and resulted from the exercise of options.

Previous wording

Net cash used in operations was $5.1 million for the three months ended March 31, 2025. The net loss for the three months ended March 31, 2025 of $3.6 million was increased by a $1.3 million decrease in accounts payable and accruals, a $2.3 million increase in accounts receivable-trade and other assets and $0.4 million in financial income, net and was offset by $0.5 million in share-based compensation, a $1.7 million decrease in inventories, and $0.3 million in depreciation.

Current wording

Net cash used in operations was $10.3 million for the six months ended June 30, 2025. The net loss for the six months ended June 30, 2025 of $3.5 million was increased by a $6.9 million increase in accounts receivable-trade and other assets, a $1.9 million decrease in accounts payable and accruals, and was offset by a $1.0 million in share-based compensation and $0.7 million in depreciation.

Previous wording

Net cash used in investing activities for the three months ended March 31, 2025 was $0.3 million and consisted primarily of the purchase of property and equipment.

Current wording

Net cash used in investing activities for the six months ended June 30, 2025 was $0.8 million and consisted primarily of the purchase of property and equipment.

Previous wording

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

Current wording

Net cash provided by financing activities for the six months ended June 30, 2025 was $9.2 million and consisted of $6.8 million proceeds from issuance of common stock under the Sales Agreement, net and $2.4 million from the exercise of warrants and options.

Previous wording

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 although the revenues generated in the years ended December 31, 2023 and 2024, and in the three months ended March 31, 2026, exceeded our expenditures for the same periods.

Current wording

Since our inception, we have incurred significant research and development expenditures which have not been offset by revenues. We have generated operating losses from our continuing operations since our inception except for the years ended December 31, 2023 and 2024, andthe three andsix months ended June 30, 2026.

Previous wording

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 Common 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 and (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.

Current wording

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 common 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, (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.

Previous wording

Currency fluctuations could affect us through increased or decreased acquisition costs for certain goods and services and salaries expenses. For the three months ended March 31, 2026 the currency fluctuations were immaterial.

Current wording

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