Protalix BioTherapeutics, Inc.

Previous wording

●the possible disruption of our operations due to the war declared by Israel’s security cabinet against the Hamas terrorist organization located in the Gaza Strip, the military campaign against the Hezbollah and other terrorist activities and armed conflict, including as a result of the disruption of the operations of certain regulatory authorities and of certain of our suppliers, collaborative partners, licensees, clinical trial sites, distributors and customers, and the risk that the current hostilities will result in a greater regional conflict;

Current wording

●the possible disruption of our operations due to military actions conducted by Israel with the Hamas terrorist organization located in the Gaza Strip, Hezbollah and others, including as a result of the disruption of the operations of certain regulatory authorities and of certain of our suppliers, collaborative partners, licensees, clinical trial sites, distributors and customers, and the risk that the current hostilities will result in a greater regional conflict;

Previous wording

●delays in the approval or potential rejection of any applications we file with the FDA, European Medicines Agency, or EMA, or other health regulatory authorities for our other product candidates, and other risks relating to the review process;

Current wording

●delays in the approval or potential rejection of any applications we file with the FDA, European Medicines Agency, or EMA, or other health regulatory authorities for our other product candidates, including the requested a re-examination of the negative opinion issued by the CHMP regarding the proposed dosing regimen of 2 mg/kg body weight infused E4W for Elfabrio, and other risks relating to the review process;

Previous wording

●risks relating to the compliance Fiocruz with its purchase obligations under the Brazil Agreement, which may have a material adverse effect on us and may also result in the termination of such agreement;

Current wording

●risks relating to the compliance by Fiocruz with its purchase obligations under the Brazil Agreement, which may have a material adverse effect on us and may result in the termination of such agreement;

Previous wording

approved by the FDA in May 2012 and is now approved for marketing in 23 markets including Brazil, Israel and others. Elfabrio, which we referred to as PRX-102 during its development stage, has been approved for marketing in the United States, the European Union, Great Britain, Switzerland, Peru, Israel, Russia, Singapore Australia and Taiwan. We have licensed the rights to commercialize Elelyso worldwide (other than Brazil) to Pfizer, and in Brazil to Fiocruz. Elelyso is marketed as BioManguinhos alfataliglicerase in Brazil. We have partnered with Chiesi for the development and commercialization of Elfabrio.

Current wording

To date, we have successfully developed two commercial products, both of which are enzyme replacement therapies (ERTs): Elfabrio® (pegunigalsidase alfa) for the treatment of adult patients with a confirmed diagnosis of Fabry disease and Elelyso® (taliglucerase alfa) for the treatment of adult patients and children four years of age and greater with Gaucher disease. Elelyso was first approved by the FDA in May 2012 and is now approved for marketing in 23 markets including Brazil, Israel and others. Elfabrio, which we referred to as PRX-102 during its development stage, has been approved for marketing in the United States, the European Union, Great Britain, Switzerland, Peru, Israel, Russia, Singapore, Australia and Taiwan. We have licensed the rights to commercialize Elelyso worldwide (other than Brazil) to Pfizer, and in Brazil to Fiocruz. Elelyso is marketed as BioManguinhos alfataliglicerase in Brazil. We have partnered with Chiesi for the development and commercialization of Elfabrio.

Previous wording

In addition to Elelyso and Elfabrio, we are developing PEGylated uricase, or PRX-115, for the treatment of uncontrolled gout, Long Acting (LA) DNase I, or PRX-119, for the treatment of NETs-related diseases, and a number of other technologies and preclinical assets. We have completed a phase I First-in-Human clinical trial of PRX-115 and we are currently in the advance stages of preparations for a phase II clinical trial of PRX-115 which we expect to commence in the second half of 2025.

Current wording

In addition to Elelyso and Elfabrio, we are developing PEGylated uricase, or PRX-115, for the treatment of uncontrolled gout, Long Acting (LA) DNase I, or PRX-119, for the treatment of NETs-related diseases, and a number of other technologies and preclinical assets. We have completed a phase 1 First-in-Human clinical trial of PRX-115 and we are currently in the advance stages of preparations for a phase 2 clinical trial of PRX-115. Wesubmitted an IND to the FDA in connection with the trial and it has become effective following the FDA’s standard 30-day review period. We expect to initiate the trial in the fourth quarter of 2025.

Previous wording

Our ProCellEx technology can be utilized to express complex therapeutic proteins belonging to different drug classes, such as enzymes, hormones, monoclonal antibodies, cytokines and vaccines. The entire protein expression process, from initial nucleotide cloning to large-scale production of the protein product, occurs under Current Good Manufacturing Practice-, or cGMP-, compliant, controlled processes. Our plant cell culture technology uses cells, such as carrot and tobacco (BY-2) cells, which undergo advanced genetic engineering and/or chemical modifications, and are grown on an industrial scale in a disposable, flexible bioreactor system. Our system does not involve mammalian or animal-derived components or transgenic field-grown or whole plants at any point in the production process.

Current wording

Our ProCellEx technology can be utilized to express complex therapeutic proteins belonging to different drug classes, such as enzymes, hormones, monoclonal antibodies, cytokines and vaccines. The entire protein expression process, from initial nucleotide cloning to large-scale production of the protein product, occurs under Current Good Manufacturing Practice-, or cGMP-, compliant, controlled processes. Our plant cell culture technology uses cells, such as carrot and tobacco (BY-2) cells, which undergo advanced

Previous wording

The global market for Gaucher disease, that includes Sanofi’s Cerezyme®, Shire’s (acquired by Takeda Pharmaceutical Company Limited) Vpriv® and Sanofi’s Cerdelga®, among others, was $1.7 billion in 2024, is forecasted to be approximately $1.7 billion in 2025 and is forecasted to grow at a compound annual growth rate (CAGR) of approximately -1.66% from 2024-2030.

Current wording

The global market for Gaucher disease, that includes Sanofi’s Cerezyme®, Shire’s (acquired by Takeda Pharmaceutical Company Limited) Vpriv® and Sanofi’s Cerdelga®, among others, was $1.7 billion in 2024, is forecasted to be approximately $1.7 billion in 2025 and is forecasted to grow at a compound annual growth rate (CAGR) of approximately -1.82% from 2024-2030.

Previous wording

Elfabrio, our second commercial product, 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 with Fabry disease. Both approvals cover the 1 mg/kg every two weeks dosage. According to the EMA, overall, the benefit/risk balance of Elfabrio is positive in the claimed indication (Fabry disease). Similarly, the FDA review team concluded that in the context of Fabry disease as a rare, serious disease with limited therapeutic options that may not be suitable to all individual patients, the benefit-risk of Elfabrio is favorable for the treatment of adults with confirmed Fabry disease. The FDA noted its determination that substantial evidence of effectiveness for Elfabrio in Fabry patients was established with one adequate and well-controlled study, our phase I/II clinical trial of Fabry disease, with confirmatory evidence provided by the

Current wording

Elfabrio, our second commercial product, 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 with Fabry disease. Both approvals cover the 1 mg/kg every two weeks dosage. According to the EMA, overall, the benefit/risk balance of Elfabrio is positive in the claimed indication (Fabry disease). Similarly, the FDA review team concluded that in the context of Fabry disease as a rare, serious disease with limited therapeutic options that may not be suitable to all individual patients, the benefit-risk of Elfabrio is favorable for the treatment of adults with confirmed Fabry disease. The FDA noted its determination that substantial evidence of effectiveness for Elfabrio in Fabry patients was established with one adequate and well-controlled study, our phase 1/2 clinical trial of Fabry disease, with confirmatory evidence provided by theBALANCE study. The FDA review team also concluded that theBALANCE study met its primary efficacy endpoint, which assessed the annualized rate of change in eGFR (estimated glomerular filtration rate) over 104 weeks. However, the FDA also determined that the results from theBALANCE study did not support a non-inferiority claim to the comparator product due to the lack of data to support the non-inferiority margin.

Previous wording

The global market for Fabry disease, that includes agalsidase beta, Sanofi’s Fabrazyme®, agalsidase alfa, Shire’s Replagal® and Amicus Therapeutics’ Galafold®, among others, is forecasted to be approximately $2.3 billion in 2025 and is forecasted to grow at a CAGR of 7.39% from 2024-2030 reaching approximately $3.2 billion in annual sales in 2030.

Current wording

The global market for Fabry disease, that includes agalsidase beta, Sanofi’s Fabrazyme®, agalsidase alfa, Shire’s Replagal® and Amicus Therapeutics’ Galafold®, among others, is forecasted to be approximately $2.2 billion in 2025 and is forecasted to grow at a CAGR of 8.19% from 2024-2030 reaching approximately $3.4 billion in annual sales in 2030.

Previous wording

The PRX-102 MAA was submitted to the EMA in February 2022 after a meeting we held, together with Chiesi, with the Rapporteur and Co-Rapporteur of the EMA regarding PRX-102. In February 2023, we, together with Chiesi, announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion, recommending marketing authorization for PRX-102. As disclosed above, Elfabrio was subsequently approved by the EC for marketing in the EU and in the United States in May 2023 for adult patients with Fabry disease. Both approvals cover the 1 mg/kg every two weeks dosage. Elfabrio was approved by the FDA with a boxed warning for hypersensitivity reactions/anaphylaxis, consistent with ERT class labeling, and warnings/precautions providing guidance on the signs and symptoms of hypersensitivity and infusion-associated reactions seen in the clinical studies as well as treatments to manage such events should they occur. The warnings/precautions for membranoproliferative glomerulonephritis (MPGN) alert prescribers to the possibility of MPGN and provide guidance for appropriate patient management. Overall, the FDA review team concluded that in the context of Fabry disease as a rare, serious disease with limited therapeutic options that may not be suitable to all individual patients, the benefit-risk of Elfabrio is favorable for the treatment of adults with confirmed Fabry disease.

Current wording

The PRX-102 MAA was submitted to the EMA in February 2022 after a meeting we held, together with Chiesi, with the Rapporteur and Co-Rapporteur of the EMA regarding PRX-102. In February 2023, we, together with Chiesi, announced that the CHMP had adopted a positive opinion, recommending marketing authorization for PRX-102. As disclosed above, Elfabrio was subsequently approved by the EC for marketing in the EU and in the United States in May 2023 for adult patients with Fabry disease. Both approvals cover the 1 mg/kg every two weeks dosage. Elfabrio was approved by the FDA with a boxed warning for hypersensitivity reactions/anaphylaxis, consistent with ERT class labeling, and warnings/precautions providing guidance on the signs and symptoms of hypersensitivity and infusion-associated reactions seen in the clinical studies as well as treatments to manage such events should they occur. The warnings/precautions for membranoproliferative glomerulonephritis (MPGN) alert prescribers to the possibility of MPGN and provide guidance for appropriate patient management. Overall, the FDA review team concluded that in the context of Fabry disease as a rare, serious disease with limited therapeutic options that may not be suitable to all individual patients, the benefit-risk of Elfabrio is favorable for the treatment of adults with confirmed Fabry disease.

Previous wording

In December 2024, the EMA validated Chiesi’s Variation Submission for PRX-102. The Variation Submission seeks to add an additional dose and dosing regimen, 2 mg/kg body weight administered every four weeks in adult patients with Fabry disease, to the current Elfabrio label.

Current wording

In December 2024, the EMA validated Chiesi’s Variation Submission for PRX-102. The Variation Submission sought to add an additional dose and dosing regimen, 2 mg/kg body weight administered every four weeks in adult patients with Fabry disease, to the current Elfabrio label. In October 2025, the CHMP issued a negative opinion regarding the submission. In November 2025, Chiesi requested a re-examination of the negative opinion.

Previous wording

The phase III clinical program included three individual studies; theBALANCE study, theBRIDGE study and theBRIGHT study. In the phase III clinical program overall, two potential dosing regimens for PRX-102 were analyzed; 1 mg/kg every two weeks, with the potential for improved efficacy and safety offering a potential alternative to existing enzyme replacement therapies, and 2 mg/kg every four weeks. The phase III program was preceded by the phase I/II clinical trial, a dose range finding study in ERT-naïve adult patients with Fabry disease.

Current wording

The phase 3 clinical program included three individual studies; theBALANCE study, theBRIDGE study and theBRIGHT study. In the phase 3 clinical program overall, two potential dosing regimens for PRX-102 were analyzed; 1 mg/kg every two weeks, with the potential for improved efficacy and safety offering a potential alternative to existing enzyme replacement therapies, and 2 mg/kg every four weeks. The phase 3 program was preceded by the phase 1/2 clinical trial, a dose range finding study in ERT-naïve adult patients with Fabry disease.

Previous wording

Forty-seven (90.4%) patients in the PRX-102 arm experienced at least one treatment-emergent adverse event (TEAE) compared to 24 (96.0%) in the agalsidase beta arm. The number of events adjusted to 100 years of exposure is 572.36 events for the PRX-102 arm and 816.85 events for the agalsidase beta arm.

Current wording

Forty-seven (90.4%) patients in the PRX-102 arm experienced at least one treatment-emergent adverse event (TEAE) compared to 24 (96.0%) in the agalsidase beta arm. The number of events adjusted to 100 years of exposure was 572.36 events for the PRX-102 arm and 816.85 events for the agalsidase beta arm.

Previous wording

Overall, 33 of 183 total TEAEs reported in nine (30.0%) of the patients were considered treatment related; all were mild or moderate in severity and the majority were resolved at the end of the study. There were no serious or severe treatment-related TEAEs and no TEAEs led to death or study withdrawal. Of the treatment-related TEAEs, 27 were infusion-related reactions (IRRs) and the remainder were single events of diarrhea, erythema, fatigue, influenza-like illness, increases urine protein/creatinine ratio, and urine positive for

Current wording

Overall, 33 of 183 total TEAEs reported in nine (30.0%) of the patients were considered treatment related; all were mild or moderate in severity and the majority were resolved at the end of the study. There were no serious or severe treatment-related TEAEs and no TEAEs led to death or study withdrawal. Of the treatment-related TEAEs, 27 were infusion-related reactions (IRRs) and the remainder were single events of diarrhea, erythema, fatigue, influenza-like illness, increases urine protein/creatinine ratio, and urine positive for white blood cells. The 27 IRRs were reported in five (16.7%) patients, all male. All IRRs occurred during the infusion or within two hours post-infusion; no events were recorded between two and 24 hours post-infusion.

Previous wording

The phase I/II clinical trial of PRX-102 (NCT01678898) was a worldwide, multi-center, open-label, dose ranging study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and efficacy parameters of PRX-102 in adult patients with Fabry disease. It was completed in 2015.

Current wording

The phase 1/2 clinical trial of PRX-102 (NCT01678898) was a worldwide, multi-center, open-label, dose ranging study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and efficacy parameters of PRX-102 in adult patients with Fabry disease. It was completed in 2015.

Previous wording

Two long-term open-label extension studies were available for patients who completed theBALANCE,BRIDGE andBRIGHT studies, and the extension of the phase I/II study. Overall, 126 patients who participated in our PRX-102 clinical program initially opted, with the advice of the treating physician, to enroll in one of the extension studies: 97 patients in the 1 mg/kg every two weeks extension study (PB-102-F60, NCT03566017) (10 patients who completed an extension study from the phase I/II study, 18 patients who completed theBRIDGE study; 69 patients who completed theBALANCE study), and 29 patients who completed theBRIGHT study in

Current wording

Two long-term open-label extension studies were available for patients who completed theBALANCE,BRIDGE andBRIGHT studies, and the extension of the phase 1/2 study. Overall, 126 patients who participated in our PRX-102 clinical program initially opted, with the advice of the treating physician, to enroll in one of the extension studies: 97 patients in the 1 mg/kg every two weeks extension study (PB-102-F60, NCT03566017) (10 patients who completed an extension study from the phase 1/2 study, 18 patients who completed theBRIDGE study; 69 patients who completed theBALANCE study), and 29 patients who completed theBRIGHT study in the 2 mg/kg every four weeks extension study (PB-102-F51, NCT03614234). Two of the patients in the 2 mg/kg every four weeks extension study were treated with 1 mg/kg every two weeks.

Previous wording

After the approval of Elfabrio in the US and the EU, sponsorship and administration of the extension studies was transferred to Chiesi. Over time, and as Elfabrio is approved for marketing in different jurisdictions, patients switch-out of the open-label extension studies. Most of them have transferred to a commercial setting; others withdraw for other reasons. Accordingly, the 1 mg/kg every two weeks dosage extension study is now closed as most patients have transferred to commercial or expanded access programs. In addition, most of the patients that enrolled in the 2 mg/kg every four weeks dosage extension study are now being treated with Elfabrio on a commercial basis.

Current wording

After the approval of Elfabrio in the US and the EU, sponsorship and administration of the extension studies was transferred to Chiesi. Over time, and as Elfabrio is approved for marketing in different jurisdictions, patients switch-out of the open-label extension studies. Most of them have transferred to a commercial setting; others withdraw for other reasons. Accordingly, the 1 mg/kg every two weeks dosage extension study is now closed as most patients have transferred to commercial or expanded access programs. In addition, the

Previous wording

Chiesi is currently recruiting patients for its clinical trial entitled “A Multicenter Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Pegunigalsidase Alfa (PRX-102) in Japanese Patients With Fabry Disease,” or theRISE study (NCT05710692). The aim of theRISE study is to evaluate the safety and efficacy of pegunigalsidase alfa in Japanese patients (adults and adolescents) affected by Fabry disease. It is planned that a total of approximately 18-20 male and female Fabry disease patients between the ages of 13 and 60 years will be enrolled in the study which is being conducted in Japan. The study involves both the 1 mg/kg every two weeks and the 2 mg/kg every four weeks dosages.

Current wording

Chiesi is currently recruiting patients for its clinical trial entitled “A Multicenter Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Pegunigalsidase Alfa (PRX-102) in Japanese Patients With Fabry Disease,” or theRISE study (NCT05710692). The aim of theRISE study is to evaluate the safety and efficacy of pegunigalsidase alfa in Japanese patients (adults and adolescents) affected by Fabry disease. It is planned that a total of approximately 18-20 male and female Fabry disease patients between the ages of 13 and 60 years will be enrolled in the study which is being conducted in Japan. The study involves both the 1 mg/kg every two weeks and the 2 mg/kg every four weeks dosage regimens.

Previous wording

Under the Chiesi Agreements, Protalix Ltd. has received $50.0 million in upfront payments and development cost reimbursements of $45 million, and is entitled to more than $1.0 billion in potential milestone payments and tiered payments for drug product purchased

Current wording

Under the Chiesi Agreements, Protalix Ltd. has received $50.0 million in upfront payments and development cost reimbursements of $45 million, and is entitled to more than $1.0 billion in potential milestone payments and tiered payments for drug product purchased from Protalix Ltd. equal to 15% - 35% (ex-US) and 15% - 40% (US), depending on the amount of annual net sales in the applicable territories.

Previous wording

Under the Chiesi Ex-US Agreement, we granted to Chiesi an exclusive license for all markets outside of the United States to commercialize PRX-102. Chiesi made an upfront payment to Protalix Ltd. of $25.0 million in connection with the execution of the agreement, and Protalix Ltd. was entitled to additional payments of up to $25.0 million in development costs in the aggregate, capped at $10.0 million per year. Protalix Ltd. is also eligible to receive additional payments of up to a maximum of $320.0 million, in the aggregate, in regulatory and commercial milestone payments. Protalix Ltd. agreed to manufacture all of the PRX-102 needed for all purposes under the agreement, subject to certain exceptions, and Chiesi will purchase PRX-102 from Protalix Ltd., subject to certain terms and conditions. Chiesi is required to make tiered payments of 15% to 35% of the net sales of the drug product in each applicable territory as consideration for the supply of PRX-102.

Current wording

Under the Chiesi Ex-US Agreement, we granted to Chiesi an exclusive license for all markets outside of the United States to commercialize PRX-102. Chiesi made an upfront payment to Protalix Ltd. of $25.0 million in connection with the execution of the agreement, and Protalix Ltd. was entitled to additional payments of up to $25.0 million in development costs in the aggregate, capped at $10.0 million per year. Protalix Ltd. is also eligible to receive additional payments of up to a maximum of $320.0 million, in the

Previous wording

The exclusive license to develop and commercialize PRX-102 in the United States were granted to Chiesi under the Chiesi US Agreement. Protalix Ltd. received an upfront, non-refundable, non-creditable payment of $25.0 million from Chiesi and was entitled to additional payments of up to a maximum of $20.0 million to cover development costs for PRX-102, capped at $7.5 million per year. Protalix Ltd. is also eligible to receive additional payments of up to a maximum of $760.0 million, in the aggregate, in regulatory and commercial milestone payments. Chiesi agreed to make tiered payments of 15% to 40% of the net sales of the drug product in as consideration for product supply.

Current wording

The exclusive license to develop and commercialize PRX-102 in the United States was granted to Chiesi under the Chiesi US Agreement. Protalix Ltd. received an upfront, non-refundable, non-creditable payment of $25.0 million from Chiesi and was entitled to additional payments of up to a maximum of $20.0 million to cover development costs for PRX-102, capped at $7.5 million per year. Protalix Ltd. is also eligible to receive additional payments of up to a maximum of $760.0 million, in the aggregate, in regulatory and commercial milestone payments. Chiesi agreed to make tiered payments of 15% to 40% of the net sales of the drug product in as consideration for product supply.

Previous wording

We have completed a phase I clinical trial of PRX-115 for the potential treatment of uncontrolled gout entitled “A Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Properties of PRX-115 in Adult Volunteers With Elevated Uric Acid Levels” (NCT05745727), or theFIH study. The study was conducted at New Zealand Clinical Research (NZCR) under the New Zealand Medicines and Medical Devices Safety Authority (MedSafe) and the Health and Disability Ethics Committee (HDEC) guidelines. The completed study included eight sequential dosing cohorts, each composed of eight subjects (six active and two placebo), a 3:1 ratio. Subjects in each cohort, males and females aged 18 through 65, received a single dose of PRX-115 and were analyzed for safety, pharmacokinetics (PK) and pharmacodynamics (PD) (concentrations of plasma urate) for 85 days. Overall, 64 randomized subjects were enrolled across the eight cohorts; 48 subjects were treated with PRX–115 and 16 subjects were treated with placebo.

Current wording

We have completed a phase 1 clinical trial of PRX-115 for the potential treatment of uncontrolled gout entitled “A Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Properties of PRX-115 in Adult Volunteers With Elevated Uric Acid Levels” (NCT05745727), or theFIH study. The study was conducted at New Zealand Clinical Research (NZCR) under the New Zealand Medicines and Medical Devices Safety Authority (MedSafe) and the Health and Disability Ethics Committee (HDEC) guidelines. The completed study included eight sequential dosing cohorts, each composed of eight subjects (six active and two placebo), a 3:1 ratio. Subjects in each cohort, males and females aged 18 through 65, received a single dose of PRX-115 and were analyzed for safety, pharmacokinetics (PK), pharmacodynamics (PD)

Previous wording

Only 25% of the subjects treated with PRX-115 in the study (12/48) having reported study drug-related adverse events. The majority of such adverse events were mild to moderate and transient in nature. One subject experienced an anaphylactic reaction in cohort 2 immediately following the commencement of the infusion (6 minutes) and, accordingly, was exposed to approximately 5% of the applicable PRX-115 dose. The reaction resolved completely and the subject continued in the study for follow-up safety assessments. Premedication with anti-histamines and steroids were administered to all subjects following the anaphylaxis event. No other subjects experienced a similar reaction and no other serious adverse events were reported in the study. No related adverse events were reported for subjects treated in cohorts 6 and 7, and only for one patient per cohort in cohorts 4, 5 and 8.

Current wording

Only 25% of the subjects treated with PRX-115 in the study (12/48) having reported study drug-related adverse events. The majority of such adverse events were mild to moderate and transient in nature. One subject experienced an anaphylactic reaction in cohort 2 immediately following the commencement of the infusion (6 minutes) and, accordingly, was exposed to approximately 5% of the applicable PRX-115 dose. The reaction resolved completely and the subject continued in the study for follow-up safety assessments. Premedication with anti-histamines and steroids were administered to all subjects following the anaphylaxis event. No other subjects experienced a similar reaction and no other serious adverse events were reported in the study. No related adverse events were reported for subjects treated in cohorts 6 and 7, and only for one patient per cohort in cohorts 4, 5 and 8. Approximately 50% of the subjects developed ADAs. The incidence of ADAs showed a negative relationship with the applicable PRX-115 dose, with the highest incidence observed in Cohort 1 and lower incidences in the higher PRX-115 dose cohorts.

Previous wording

We have initiated preparations for a phase II clinical trial of PRX-115, and we expect to commence the study in the second half of 2025.

Current wording

We have initiated preparations for a phase 2 clinical trial of PRX-115, and the IND we submitted in connection with the phase 2 trial has become effective following the FDA’s standard 30-day review period. We expect to commence the study in the fourth quarter of 2025.

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, 2025, we hold a broad portfolio of 16 patent families consisting of approximately 68 patents in Europe, the United States, Israel and additional countries worldwide, as well as approximately 42 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, 2025, we hold a broad portfolio of 16 patent families consisting of approximately 67 patents in Europe, the United States, Israel and additional countries worldwide, as well as approximately 43 pending patent applications.

Previous wording

We recorded revenues from selling goods of $25.4 million during the six months ended June 30, 2025, an increase of $8.4 million, or 49%, compared to revenues of $17.0 million for the six months ended June 30, 2024. The increase resulted primarily from an increase of $8.1 million in sales to Chiesi and of $4.6 million in sales to Pfizer, partially offset by a decrease of $4.3 million in sales to Fiocruz (Brazil).

Current wording

We recorded revenues from selling goods of $17.7 million during the three months ended September 30, 2025, a decrease of $0.1 million, or 1%, compared to revenues of $17.8 million for the three months ended September 30, 2024. The decrease resulted primarily from a decrease of $3.6 million in sales to Chiesi and of $0.6 million in sales to Pfizer, partially offset by an increase of $4.1 million in sales to Fiocruz (Brazil).

Previous wording

We recorded revenues from license and R&D services of $0.2 million for the three months ended June 30, 2025, and June 30, 2024. 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 other than potential regulatory milestone payments.

Current wording

We recorded revenues from license and R&D services of $0.2 million for the three months ended September 30, 2025, an increase of $0.1 million, or 100%, compared to license and R&D services of $0.1 million for the three months ended September 30, 2024. 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 goods sold was $5.9 million for the three months ended June 30, 2025, a decrease of $3.6 million, or 38%, from cost of goods sold of $9.5 million for the three months ended June 30, 2024. The decrease in cost of goods sold was primarily the result of the decrease in sales to Pfizer and Fiocruz (Brazil) partially offset by the increase in sales to Chiesi.

Current wording

Cost of goods sold was $8.3 million for the three months ended September 30, 2025, a decrease of $0.1 million, or 1%, from cost of goods sold of $8.4 million for the three months ended September 30, 2024. The decrease in cost of goods sold was primarily the result of the decrease in sales to Chiesi and Pfizer partially offset by the increase in sales to Fiocruz (Brazil).

Previous wording

For the three months ended June 30, 2025, our total research and development expenses were approximately $6.0 million comprised of approximately $3.0 million in subcontractor-related expenses, approximately $2.0 million of salary and related expenses, approximately $0.2 million of materials-related expenses and approximately $0.8 million of other expenses. For the three months ended June 30, 2024, our total research and development expenses were approximately $3.0 million comprised of approximately $1.6 million of salary and related expenses, approximately $0.5 million in subcontractor-related expenses, approximately $0.2 million of materials-related expenses and approximately $0.7 million of other expenses.

Current wording

For the three months ended September 30, 2025, our total research and development expenses were approximately $4.5 million comprised of approximately $2.6 million of salary and related expenses, approximately $0.5 million in subcontractor-related expenses, approximately $0.5 million of materials-related expenses and approximately $0.9 million of other expenses. For the three months ended September 30, 2024, our total research and development expenses were approximately $3.0 million comprised of approximately $1.6 million of salary and related expenses, approximately $0.6 million in subcontractor-related expenses, approximately $0.2 million of materials-related expenses and approximately $0.6 million of other expenses.

Previous wording

Total increase in research and developments expenses for the three months ended June 30, 2025 was $3.0 million, or 100%, compared to research and developments expenses of $3.0 million for the three months ended June 30, 2024. The increase in research and development expenses resulted primarily from preparations for the planned phase II clinical trial of PRX-115.

Current wording

Total increase in research and developments expenses for the three months ended September 30, 2025 was $1.5 million, or 50%, compared to research and developments expenses of $3.0 million for the three months ended September 30, 2024. The increase in research and development expenses resulted primarily from preparations for the planned phase 2 clinical trial of PRX-115.

Previous wording

Selling, general and administrative expenses were $5.2 million for the six months ended June 30, 2025, a decrease of $1.4 million, or 21%, compared to $6.6 million for the six months ended June 30, 2024. The decrease resulted primarily from a decrease of $0.9 million in salary and related expenses and a decrease of $0.5 million in selling expenses.

Current wording

Selling, general and administrative expenses were $2.9 million for the three months ended September 30, 2025, an increase of $0.3 million, or 12%, compared to $2.6 million for the three months ended September 30, 2024. The increase resulted primarily from an increase of $0.1 million in salary and related expenses and an increase of $0.2 million in selling expenses.

Previous wording

Financial expenses, net was $0.5 million for the three months ended June 30, 2025, compared to financial income, net of $0.2 million for the three months ended June 30, 2024. The increase in financial expenses, net resulted primarily from exchange rate costs and lower interest income on bank deposits partially offset by lower notes interest expenses due to the September 2024 repayment in full of all the outstanding principal and interest payable under the 2024 Notes.

Current wording

Financial income, net was $0.1 million for the three months ended September 30, 2025, compared to financial expenses, net of $0.1 million for the three months ended September 30, 2024. The decrease in financial expenses, net resulted primarily from lower notes interest expenses due to the September 2024 repayment in full of all the outstanding principal and interest payable under the 2024 Notes.

Previous wording

We recorded tax expenses of approximately $0.5 million for the three months ended June 30, 2025, compared to a tax benefit of approximately $(0.1) million for the three months ended June 30, 2024. The tax expenses or benefit resulted primarily from taxes on income mainly derived from GILTI income mainly in respect of Section 174 of the TCJA. Effective in 2022, Section 174 of the TCJA requires all U.S. companies, for tax purposes, to capitalize and subsequently amortize R&D expenses that fall within the scope of Section 174 over five years for research activities conducted in the United States and over 15 years for research activities conducted outside of the United States, rather than deducting such costs in the current year. On July 4, 2025, tax reform legislation was enacted in the United States through the passage of HR1 which includes significant corporate tax changes, including a restoration of the current deductibility for domestic research expenditures beginning in 2025, with transition options for previously capitalized amounts. We continue to evaluate the impact that the new legislation will have on the consolidated financial statements.

Current wording

We recorded tax benefit of approximately $0.1 million for the three months ended September 30, 2025, compared to tax expenses of approximately $0.6 million for the three months ended September 30, 2024. The tax expenses or benefit resulted primarily from taxes on income mainly derived from GILTI income mainly in respect of Section 174 of the TCJA. Effective in 2022, Section 174 of the TCJA requires all U.S. companies, for tax purposes, to capitalize and subsequently amortize R&D expenses that fall within the scope of Section 174 over five years for research activities conducted in the United States and over 15 years for research activities conducted outside of the United States, rather than deducting such costs in the current year. On July 4, 2025, tax reform legislation was enacted in the United States through the passage of HR1 which includes significant corporate tax changes, including a restoration of the current deductibility for domestic research expenditures beginning in 2025, with transition options for previously capitalized amounts.

Previous wording

We recorded revenues from selling goods of $15.4 million during the three months ended June 30, 2025, an increase of $2.1 million, or 16%, compared to revenues of $13.3 million for the three months ended June 30, 2024. The increase resulted primarily from an increase of $8.0 million in sales to Chiesi, partially offset by a decrease of $4.7 million in sales to Fiocruz (Brazil) and of $1.2 million in sales to Pfizer.

Current wording

We recorded revenues from selling goods of $43.1 million during the nine months ended September 30, 2025, an increase of $8.3 million, or 24%, compared to revenues of $34.8 million for the nine months ended September 30, 2024. The increase resulted primarily from an increase of $4.5 million in sales to Chiesi and of $4.0 million in sales to Pfizer, partially offset by a decrease of $0.2 million in sales to Fiocruz (Brazil).

Previous wording

We recorded revenues from license and R&D services of $0.3 million for the six months ended June 30, 2025, an increase of $0.1 million, or 50%, compared to revenues from license and R&D services of $0.2 million for the six months ended June 30, 2024. 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 other than potential regulatory milestone payments.

Current wording

We recorded revenues from license and R&D services of $0.5 million for the nine months ended September 30, 2025, an increase of $0.1 million, or 25%, compared to revenues from license and R&D services of $0.4 million for the nine months ended September 30, 2024. 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 goods sold was $14.1 million for the six months ended June 30, 2025, an increase of $2.0 million, or 17%, from cost of goods sold of $12.1 million for the six months ended June 30, 2024. The increase in cost of goods sold was primarily the result of an increase in sales to Chiesi and Pfizer partially offset by a decrease in sales to Fiocruz (Brazil).

Current wording

Cost of goods sold was $22.4 million for the nine months ended September 30, 2025, an increase of $2.0 million, or 10%, from cost of goods sold of $20.4 million for the nine months ended September 30, 2024. The increase in cost of goods sold was primarily the result of an increase in sales to Chiesi and Pfizer partially offset by a decrease in sales to Fiocruz (Brazil).

Previous wording

For the six months ended June 30, 2025, our total research and development expenses were approximately $9.5 million comprised of approximately $3.9 million of salary and related expenses, approximately $3.8 million in subcontractor-related expenses, approximately $0.4 million of materials-related expenses and approximately $1.4 million of other expenses. For the six months ended June 30, 2024, our total research and development expenses were approximately $5.8 million comprised of approximately $3.2 million of salary and related expenses, approximately $1.0 million of subcontractor-related expenses, approximately $0.3 million of materials-related expenses and approximately $1.3 million of other expenses.

Current wording

For the nine months ended September 30, 2025, our total research and development expenses were approximately $13.9 million comprised of approximately $6.5 million of salary and related expenses, approximately $4.3 million in subcontractor-related expenses, approximately $0.9 million of materials-related expenses and approximately $2.2 million of other expenses. For the nine months ended September 30, 2024, our total research and development expenses were approximately $8.8 million comprised of approximately $4.8 million of salary and related expenses, approximately $1.6 million of subcontractor-related expenses, approximately $0.5 million of materials-related expenses and approximately $1.9 million of other expenses.

Previous wording

Total increase in research and developments expenses for the six months ended June 30, 2025 was $3.7 million, or 64%, compared to research and developments expenses of $5.8 million for the six months ended June 30, 2024. The increase in research and development expenses resulted primarily from preparations for the planned phase II clinical trial of PRX-115.

Current wording

Total increase in research and developments expenses for the nine months ended September 30, 2025 was $5.1 million, or 58%, compared to research and developments expenses of $8.8 million for the nine months ended September 30, 2024. The increase in research and development expenses resulted primarily from preparations for the planned phase 2 clinical trial of PRX-115.

Previous wording

Selling, general and administrative expenses were $2.6 million for the three months ended June 30, 2025, a decrease of $0.9 million, or 26%, compared to $3.5 million for the three months ended June 30, 2024. The decrease resulted primarily from a decrease of $0.6 million in salary and related expenses and a decrease of $0.3 million in selling expenses.

Current wording

Selling, general and administrative expenses were $8.2 million for the nine months ended September 30, 2025, a decrease of $1.0 million, or 11%, compared to $9.2 million for the nine months ended September 30, 2024. The decrease resulted primarily from a decrease of $0.7 million in salary and related expenses and a decrease of $0.3 million in selling expenses.

Previous wording

Financial expenses, net was $0.1 million for the six months ended June 30, 2025, compared to financial income, net of $0.3 million for the six months ended June 30, 2024. The decrease resulted primarily from exchange rate costs and lower interest income on bank deposits partially offset by lower notes interest expenses due to the September 2024 repayment in full of all the outstanding principal and interest payable under the 2024 Notes.

Current wording

Financial income, net was $0.01 million for the nine months ended September 30, 2025, compared to financial income, net of $0.1 million for the nine months ended September 30, 2024. The decrease resulted primarily from exchange rate costs and lower interest income on bank deposits partially offset by lower notes interest expenses due to the September 2024 repayment in full of all the outstanding principal and interest payable under the 2024 Notes.