Protalix BioTherapeutics, Inc.

Previous wording

●Elfabrio® (pegunigalsidase alfa) for the treatment of adult patients with a confirmed diagnosis of Fabry disease. This product is approved in the United States, the European Union and other jurisdictions with a 1 mg/kg every-two-weeks (E2W) dosage. Additionally, in March 2026, Elfabrio was approved for a 2 mg/kg every-four-weeks (E4W) dosage in the European Union.

Current wording

●Elfabrio® (pegunigalsidase alfa) for the treatment of adult patients with a confirmed diagnosis of Fabry disease. This product is approved in the United States, the European Union, and other jurisdictions with a 1 mg/kg every-two-weeks (E2W) dosage. Additionally, in March 2026, Elfabrio was approved for a 2 mg/kg every-four-weeks (E4W) dosage in the European Union. Subsequently, the E4W dosage was approved in the UK and other jurisdictions.

Previous wording

We licensed to Pfizer the global rights to market and sell Elelyso in all markets, excluding Brazil, pursuant to the Amended Pfizer Agreement. Pursuant to the Amended Pfizer Agreement, we agreed to sell drug substance to Pfizer for the production of Elelyso for a fixed cost, subject to certain terms and conditions, through 2030. Any failure to comply with our supply commitments may subject us to substantial financial penalties. The Amended Pfizer Agreement includes customary provisions regarding cooperation for regulatory matters, patent enforcement, termination, indemnification and insurance requirements. We retain distribution rights to taliglucerase alfa in Brazil.

Current wording

We licensed to Pfizer the global rights to market and sell Elelyso in all markets, excluding Brazil, pursuant to an amended and restated exclusive license and supply agreement, or the Amended Pfizer Agreement. Pursuant to the Amended Pfizer Agreement, we agreed to sell drug substance to Pfizer for the production of Elelyso for a fixed cost, subject to certain terms and conditions, through 2030. Any failure to comply with our supply commitments may subject us to substantial financial penalties. The Amended Pfizer Agreement includes customary provisions regarding cooperation for regulatory matters, patent enforcement, termination, indemnification, and insurance requirements. We retain distribution rights to taliglucerase alfa in Brazil.

Previous wording

Under the Chiesi US Agreement we granted to Chiesi the exclusive license to develop and commercialize pegunigalsidase alfa in the United States. Protalix Ltd. received from Chiesi an upfront, non-refundable, non-creditable payment of $25.0 million from Chiesi and additional payments of $20.0 million to cover development costs. To date, we have received the complete amount of such development costs, and, following the approval of Elfabrio by the FDA, we received a milestone payment equal to $20.0 million. Protalix Ltd. currently remains eligible to receive additional payments of up to a maximum of $740.0 million, in the aggregate, subject to the satisfaction of certain regulatory and commercial milestones. Chiesi is required to make payments to Protalix Ltd. ranging from 15% to 40% of its net sales under the Chiesi US Agreement, depending on the amount of annual sales, subject to certain terms and conditions, as consideration for product supply. The Chiesi 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 in the US, unless earlier terminated in accordance with the terms and conditions thereof.

Current wording

Under the Chiesi US Agreement we granted to Chiesi the exclusive license to develop and commercialize pegunigalsidase alfa in the United States. Protalix Ltd. received from Chiesi an upfront, non-refundable, non-creditable payment of $25.0 million and additional payments of $20.0 million to cover development costs. To date, we have received the complete amount of such development costs, and, following the approval of Elfabrio by the FDA, we received a milestone payment equal to $20.0 million. Protalix Ltd. currently remains eligible to receive additional payments of up to a maximum of $740.0 million, in the aggregate, subject to the satisfaction of certain regulatory and commercial milestones. Chiesi is required to make payments to Protalix Ltd. ranging from 15% to 40% of its net sales under the Chiesi US Agreement, depending on the amount of annual sales, subject to certain terms and conditions, as consideration for product supply. The Chiesi 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 in the U.S., 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-

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-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 U.S. and outside the U.S.

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 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.

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 September 30, 2026, we hold a broad portfolio of 15 patent families consisting of approximately 72 patents in Europe, the United States, Israel, and additional countries worldwide, as well as approximately 35 pending patent applications.

Previous 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.

Current 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.

Previous wording

The Company is eligible to, and intends to, file for grants under the R&D Law (as noted above, the R&D Law includes an option pursuant to which a qualifying company entitled to a tax credit that has not utilized such credit by the tax year ending three years following the year in which the related R&D activity was performed or if the Company choose irrevocably, to receive the full amount of the unused credit as a grant payment instead of the credit).

Current wording

We are eligible to, and intend to, file for grants under the R&D Law (as noted above, the R&D Law includes an option pursuant to which a qualifying company entitled to a tax credit that has not utilized such credit by the tax year ending three years following the year in which the related R&D activity was performed or if we choose irrevocably, to receive the full amount of the unused credit as a grant payment instead of the credit).

Previous 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.

Current wording

Revenues from selling goods for the three and nine months ended September 30, 2026 reflects an increase of 23.5% and 13.9% compared to the three and nine months ended September 30, 2025, respectively. The total increase in revenues from selling goods for the three and nine months ended September 30, 2026 resulted primarily from an increase in sales to Chiesi. The decrease in sales to Pfizer for the nine months ended September 30, 2026 resulted primarily from Pfizer’s purchases to address unexpected manufacturing issues at Pfizer in 2025. The increase in sales to Pfizer and the decrease in sales to Fiocruz (Brazil) for the three months ended September 30, 2026 resulted primarily from the timing of deliveries.

Previous 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

Current wording

The decrease in revenues from license and R&D services for the three months ended September 30, 2026 compared to the three months ended September 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 nine months ended September 30, 2026 compared to the nine months ended September 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 Agreements. Other 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.

Previous 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).

Current wording

Cost of revenues for the three months ended September 30, 2026 represents a decrease of 5.4% compared to the three months ended September 30, 2025. The decrease resulted primarily from a decrease in sales to Fiocruz (Brazil) which was partially offset by an increase in sales to Chiesi and to Pfizer. Cost of revenues for the nine months ended September 30, 2026 represents a decrease of 11.7% compared to the nine months ended September 30, 2025. The decrease resulted primarily from a decrease in sales to Pfizer and to Fiocruz (Brazil) which was partially offset by an increase in sales to Chiesi.

Previous wording

Total decrease in research and development expenses for the three months ended June 30, 2026 represents a decrease of 27% compared to the three months ended June 30, 2025. The decrease in research and development expenses resulted primarily from a $2.1 million grant recorded in accordance with the new R&D law as a reduction of research and development expenses. The increase in research and development expenses for the six months ended June 30, 2026 represents an increase of 3% compared to the six months ended June 30, 2025. The increase resulted primarily from an increase in salary and related expenses, and was partially offset by the $2.1 million grant recorded in accordance with the new Israeli R&D law as a reduction of research and development expenses.

Current wording

Total increase in research and development expenses for the three months ended September 30, 2026 represents an increase of 55.0% compared to the three months ended September 30, 2025. The increase in research and development expenses resulted primarily from a $3.3 million increase in subcontractor-related expenses mainly related to the RELEASE study which was partially offset by a $1.0 million grant recorded in accordance with the new R&D law as a reduction of research and development expenses. The increase in research and development expenses for the nine months ended September 30, 2026 represents an increase of 19.9% compared to the nine months ended September 30, 2025. The increase resulted primarily from an increase in subcontractor-related expenses mainly related to the RELEASE study and in salary and related expenses, and was partially offset by the $3.1 million grant recorded in accordance with the new Israeli R&D law as a reduction of research and development expenses.

Previous 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.

Current wording

Selling, general, and administrative expenses for the three and nine months ended September 30, 2026 represents an increase of 5.1% and 13.3% compared to the three and nine months ended September 30, 2025, respectively. The increase resulted primarily from an increase of $0.7 million in salary and related expenses, $0.2 million in selling expenses, and $0.2 million in other expenses for the nine months ended September 30, 2026, and of $0.1 million in professional fees and $0.1 million in salary and related expenses for the three months ended September 30, 2026.

Previous 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.

Current wording

The increase in financial income, net for the three and nine months ended September 30, 2026 resulted primarily from exchange rate fluctuations between the U.S. dollar and the New Israel Shekel, and higher interest income.

Previous 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.

Current wording

We recorded tax expenses of approximately $0.7 million and $4.6 million for the three and nine months ended September 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 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.

Current wording

Our sources of liquidity include our cash and cash equivalents and short-term bank deposits. At September 30, 2026, we had $48.5 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 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.

Current wording

On February 27, 2023, we entered the Sales Agreement with 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 nine months ended September 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). During the nine months ended September 30, 2026, we sold, in the aggregate 1,613,992 shares of common stock under the Sales Agreement generating gross proceeds equal to approximately $4.3 million (issuance costs were $0.1 million). All such sales occurred in the three months ended September 30, 2026. As of September 30, 2026, approximately $11.3 million in shares of common stock remain available to be sold under the Sales Agreement.

Previous wording

During the six months ended June 30, 2025 and 2026, we issued 198,625 and 145,661 shares of common stock, respectively, in the aggregate, in connection with the exercise of options to purchase 198,625 and 145,661 shares of common stock by certain of our current and former employees. We received cash proceeds equal to $0.3 million and $0.2 million, respectively, in connection with such exercises.

Current wording

During the nine months ended September 30, 2025 and 2026, we issued 248,625 and 453,296 shares of common stock, respectively, in the aggregate, in connection with the exercise of options to purchase 248,625 and 453,296 shares of common stock by certain of our current and former employees. We received cash proceeds equal to $0.3 million and $0.5 million, respectively, in connection with such exercises.

Previous wording

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

Current wording

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

Previous 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.

Current wording

Net cash provided by operations was $15.5 million for the nine months ended September 30, 2026. The net income for the nine months ended September 30, 2026 of $26.1 million was increased by a $3.1 million increase in accounts payable and accruals, $1.5 million in share-based compensation, net and $1.2 million in depreciation and partially offset by $5.4 million increase in accounts receivable-trade and other assets, $8.6 million increase in inventories, and $3.0 million increase in R&D grant.

Previous 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.

Current wording

Net cash used in investing activities was $13.2 million for the nine months ended September 30, 2026 and consisted primarily of $24.1 million investment in bank deposits partially offset by a $13.0 million short-term deposit withdrawal and $2.1 million in the purchase of property and equipment.

Previous 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.

Current wording

Net cash provided by financing activities was $4.7 million for the nine months ended September 30, 2026 and resulted from $4.2 million proceeds from issuance of common stock under the sales agreement, net and $0.5 million from the exercise of stock options.

Previous 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.

Current wording

Net cash used in operations was $14.0 million for thenine months ended September 30, 2025. The net loss for the nine months ended September 30, 2025 of $1.1 million was increased by a $11.8 million increase in accounts receivable-trade and other assets, a $4.0 million decrease in accounts payable and accruals, and was offset by a $1.6 million in share-based compensation and $1.1 million in depreciation.

Previous 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.

Current wording

Net cash used in investing activities for the nine months ended September 30, 2025 was $1.3 million and consisted primarily of the purchase of property and equipment.

Previous 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.

Current wording

Net cash provided by financing activities for the nine months ended September 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 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.

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 reported periods of 2026.

Previous 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.

Current wording

Currency fluctuations could affect us through increased or decreased acquisition costs for certain goods and services and salaries expenses. For the nine months ended September 30, 2026 the currency fluctuations resulted in expenses of approximately $0.4 million.