Pegunigalsidase alfa

-- Chiesi’s abstract presentations highlight clinical insights and patient-reported outcomes in Fabry disease and alpha-mannosidosis -- -- Rooted in patient voice and scientific rigor, this research reflects Chiesi’s long-standing role in advancing science for the lysosomal storage disorders community -- PARMA, Italy, Aug. 28, 2026 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, today announced presentations at the Society of Inborn Errors of Metabolism (SSIEM) 2026 Annual Symposium, held August 25-28, 2026, in Helsinki, Finland. The company is proud to support 13 scientific abstracts across Fabry disease and alpha-mannosidosis, including 6 Chiesi-led presentations and 7 independent studies supported by Chiesi through scientific research grants and educational projects. These abstracts reflect the scope of the Company's scientific engagement with the lysosomal storage disorders (LSDs) and rare disease communities. These abstracts highlight the breadth of research advancing the understanding of Fabry disease and alpha-mannosidosis. Chiesi-led presentations include long-term Phase 3 data from the F60/BRILLIANCE trial, patient-reported outcomes from a cross-sectional survey in untreated Fabry disease, and research exploring earlier diagnosis and genotype–phenotype relationships in alpha-mannosidosis. Independent studies supported by Chiesi examine real-world clinical experience, disease biology, biomarkers and newborn screening. Together, this research contributes to a growing body of evidence to advance understanding of disease burden, diagnosis and long-term management in rare diseases. “Rare disease care demands patience, precision, and an unwavering focus on the people we're ultimately trying to help. The data presented at this year's SSIEM Annual Symposium reflects years of collaboration with investigators, clinicians, and the Fabry disease and alpha-mannosidosis communities,” said Enrico Piccinini, Senior Vice President, Europe and International, Chiesi Global Rare Diseases . “From new tools that could help identify diagnosis earlier to long-term data on treatment outcomes, this research is united by a single goal: better understanding the experiences of people living with rare diseases and using those insights to help inform care. We're proud to have shared these findings with the broader scientific community and remain devoted to advancing solutions that make a meaningful difference.” “This body of evidence spans long-term clinical trial data, real-world outcomes, and new biomarker research, contributing to a more comprehensive understanding of disease progression and unmet needs across the care journey,” said Alessio Amadasi, Vice President, Medical Affairs EU & International, Chiesi Global Rare Diseases . “That kind of understanding informs better care today while helping to shape the future of rare disease management.” Beyond the data presented at this year's Congress, Chiesi Global Rare Diseases recognizes that advancing care for people living with lysosomal storage disorders requires continued learning, collaboration, and investment in research. While the findings shared at SSIEM contribute to a growing body of knowledge, important questions remain across diagnosis, disease understanding, and long-term care. That is why Chiesi develops initiatives such as Find For Rare, now in its second edition, an independently assessed, expert-led research grant initiative designed to enable innovative research in lysosomal storage disorders. By providing funding opportunities through an independent selection process, Find For Rare helps advance knowledge in areas that matter most to the rare disease community and reflects Chiesi's long-term commitment to supporting progress for people living with these conditions today and for those who come next. Details of Chiesi-led presentations are as follows: Fabry disease Title: The reality of untreated Fabry disease: patient-reported challenges from a 238-participant cross-sectional survey Format : Poster Presentation (Poster #87) Presenter: Dawn Laney, M.S., Emory University School of Medicine Date/Time: Wednesday, August 26, 5:30-7:30 pm EEST Title: Long-term safety and efficacy of pegunigalsidase alfa in treatment-naive Fabry disease patients in F60/BRILLIANCE trial Format : Poster Presentation (Poster #539) Presenter: Ozlem Goker-Alpan​, M.D., Lysosomal and Rare Disorders Research and Treatment Center Date/Time: Wednesday, August 26, 5:30-7:30 pm EEST Title: Long-term safety and efficacy of pegunigalsidase alfa in patients who switched from agalsidase alfa Format : Poster Presentation (#739) Presenter: Robert Hopkin, M.D., Cincinnati Children's Hospital Medical Center Date/Time: Wednesday, August 26, 5:30-7:30 pm EEST Title: Tolerability of 1-Hour Infusions of Pegunigalsidase Alfa in Fabry Disease: Data from the F60/BRILLIANCE Trial. Format : Poster Presentation (#529) Presenter: Robert Hopkin, M.D., Cincinnati Children's Hospital Medical Center Date/Time: Wednesday, August 26, 5:30-7:30 pm EEST Alpha-mannosidosis Title: Detection of alpha-mannosidosis: a phenotypic similarity approach powered by natural language processing Format : Poster Presentation (#284) Presenter: Nathalie Guffon, M.D., Femme Mère Enfant Hospital Date/Time: Wednesday, August 26, 5:30-7:30 pm EEST Title: Clinical impact of the MAN2B1 c.2248C>T variant in patients with alpha-mannosidosis: genotype–phenotype insights from the SPARKLE registry Format : Poster Presentation (#314) Presenter: Nicole Muschol, M.D., University Medical Center Hamburg-Eppendorf Date/Time: Wednesday, August 26, 5:30-7:30 pm EEST Details of independent presentations supported by Chiesi are as follows: Fabry disease Title: Pegunigalsidase alfa improves exercise tolerance and skeletal muscle bioenergetics in a Fabry disease mouse model Format: Poster Presentation Presenter: Jessica Gambardella, Ph.D. Federico II University of Naples, Naples, Italy Title: Real-world experience with the new four-week dosing regimen of pegunigalsidase alfa in Fabry disease: a multicenter study Format: Poster Presentation Presenter: Alicia Ugena, MD, Hospital Universitario de Cuenca, Cuenca, Spain Alpha-mannosidosis Title: Integrating α-mannosidosis into the differential diagnostic algorithm for suspected MPS: A 30-month update Format : Poster Presentation Presenter: Berthold Streubel, M.D., Medical University of Vienna Title: Alpha-Mannosidosis: Biomarker-based Treatment Monitoring Format : Poster Presentation Presenter: Dominik Dörfel, University Medical Center Hamburg-Eppendorf Title: Secondary Mitochondrial Dysfunction in Alpha-Mannosidosis: Implications for Disease Pathophysiology and Therapeutic Targeting Format : Oral Platform Presentation Presenter: Mollie Dewsbury, Liverpool John Moores University Title: Integrated Clinical, Biochemical, and Genetic Characterization of α-Mannosidosis in a Spanish Cohort: The α-REVEAL Study Format : Oral Platform Presentation Presenter: Belén Pérez, Ph.D., Autonomous University of Madrid (Center for the Diagnosis of Molecular Diseases) Title: Newborn screening for alpha-mannosidosis: quantitative assessment of a novel biomarker in dried blood spots Format : Oral Platform Presentation Presenter: Dominik Dörfel, University Medical Center Hamburg-Eppendorf Important Safety Information and Indication Elfabrio ® (pegunigalsidase alfa-iwxj) is a prescription infusion medicine used to treat adults with confirmed Fabry disease. Important Safety Information What is the most important information I should know about Elfabrio? Severe allergic reactions (hypersensitivity reactions), including anaphylaxis, may occur during and after Elfabrio treatment. If severe allergic reactions or anaphylaxis occurs during treatment, your healthcare provider will immediately stop the infusion and provide appropriate medical care. If these reactions should occur after treatment, seek immediate medical care. What should I know about Elfabrio infusions? Your healthcare provider may give you other medications prior to your Elfabrio infusions to help manage allergic reactions and infusion-related side effects. They will explain how to recognize the signs and symptoms of these allergic reactions and infusion-related side effects. If these signs and symptoms occur, it’s important for you to seek immediate medical care. If the reaction is mild to moderate, your healthcare provider may choose to slow the infusion rate or withhold the dose. In clinical trials, 41 patients (29%) experienced an infusion-related side effect. The most common signs and symptoms of an infusion-related reaction with Elfabrio were hypersensitivity, nausea, chills, itchy skin, rash, chest pain, dizziness, vomiting, feelings of weakness, pain, sneezing, shortness of breath, nasal congestion, throat irritation, abdominal pain, skin redness, diarrhea, burning sensation, nerve pain, headache, tingling or numbness, shaking movements, agitation, increased body temperature, flushing, slow heart rate, muscle pain, high blood pressure, and low blood pressure. Your healthcare provider will do blood and urine tests to check your kidney function during treatment with Elfabrio. The most common side effects of Elfabrio include infusion-related side effects, common cold, headache, diarrhea, fatigue, nausea, back pain, pain in the limbs, and sinus infection. Please see Full Prescribing Information for Elfabrio. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Important Safety Information and Indication Lamzede ® (velmanase alfa-tycv) is intended for the treatment of non-central nervous system symptoms of alpha-mannosidosis in adult and pediatric patients. Important Safety Information What is the most important information I should know about Lamzede? Severe allergic reactions (hypersensitivity reactions) including anaphylaxis, may occur during and after Lamzede treatment. If severe allergic reactions or anaphylaxis occur during treatment, your healthcare provider will immediately stop the infusion and provide appropriate medical care. If these reactions should occur after treatment, seek immediate medical care. What should I know about infusions? Your healthcare provider may give you other medications prior to your next infusion to help manage allergic reactions and infusion-related side effects. They will explain how to recognize the signs and symptoms of these allergic reactions and infusion-related side effects. If these signs and symptoms occur, it’s important for you to seek immediate medical care. What are the common signs and symptoms of an allergic reaction or infusion-related side effects with Lamzede? In clinical trials, some patients experienced signs and symptoms of an allergic reaction, which included bluish skin discoloration, low blood pressure, vomiting, hives, skin redness, facial swelling, fever, and involuntary movements. In clinical trials, when patients experienced an infusion-related side effect, the most common signs were fever, chills, skin redness, vomiting, cough, itching, rash, and pink eye. Are there certain people who should or should not take Lamzede? Lamzede may cause harm to your unborn baby. For females who are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with Lamzede. Tell your healthcare provider right away if you become pregnant or think you may be pregnant. You should use effective birth control during treatment with Lamzede and for at least 14 days after the last dose. What are the most common side effects of Lamzede? Lamzede can cause side effects including severe allergic reactions and anaphylaxis, common cold, fever, headache, and joint pain or stiffness. Please see Full Prescribing Information for Lamzede. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. About Fabry Disease Fabry disease is a rare, inherited lysosomal storage disorder caused by mutations in the GLA gene, which leads to a deficiency of the enzyme alpha-galactosidase A. This deficiency results in an accumulation of a fatty substance called globotriaosylceramide (GL-3) in the body’s cells, affecting the heart, kidneys, skin, nervous system, and other organs. Fabry disease can cause a range of serious signs and symptoms, including fatigue, chronic pain, gastrointestinal issues, decreased ability to sweat, progressive kidney failure, heart complications, and increased risk of stroke. The condition affects both males and females and can present from childhood through adulthood, often with delayed diagnosis or misdiagnosis. While Fabry disease is rare, early detection and access to appropriate treatment — such as enzyme replacement therapy or pharmacological chaperone therapy — are critical in managing symptoms and slowing disease progression. About Alpha-mannosidosis Alpha-mannosidosis is an ultra-rare, inherited lysosomal storage disorder caused by mutations in the MAN2B1 gene, which results in a deficiency of the enzyme alpha-mannosidase. This deficiency leads to the accumulation of oligosaccharides, within the body’s cells, causing progressive damage to multiple organs and tissues. Alpha-mannosidosis can affect the musculoskeletal system, hearing, immune system, nervous system, and other organs, and is associated with a wide range of signs and symptoms, including skeletal abnormalities, impaired mobility, hearing loss, cognitive impairment, immune dysfunction, and behavioral or mental health challenges. The condition affects both children and adults and may present with few or mild symptoms early in life, progressing over time as oligosaccharides accumulate. While alpha-mannosidosis is rare, timely diagnosis and appropriate disease management are important to help address symptoms and support long-term outcomes for affected individuals. About Chiesi Group Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The Company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By changing its legal status to a Benefit Corporation in Italy, the US, France and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet high standards of social and environmental impact. The Company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,500 employees. The Group’s research and development center in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. For more information visit . About Chiesi Global Rare Diseases Chiesi Global Rare Diseases is a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases. As a family business, Chiesi Group strives to create a world where it is common to have therapy for all diseases and acts as a force for good, for society and the planet. The goal of the Global Rare Diseases unit is to ensure equal access so as many people as possible can experience their most fulfilling life. The unit collaborates with the rare disease community around the globe to bring voice to underserved people in the health care system. For more information visit . Follow @ChiesiGlobalRareDiseases on LinkedIn , Facebook , Instagram , X and YouTube . Chiesi Global Rare Diseases Media Contact Sky Striar LifeSci Communications Email: sstriar@lifescicomms.com PP-RA-02343 V1.0

Company to host conference call and webcast today at 8:00 a.m. EDT Revenues from selling goods increased to $19.8 million in the second quarter of 2026, up $4.4 million from the second quarter of 2025, driven primarily by sales of Elfabrio® Total revenue climbed to $53.6 million, year to date, from $25.8 million for the same period in 2025, which includes the previously reported $25.0 million Chiesi milestone payment Year-to-date, the Company achieved profitability with a net income of $22.1 million The Company reiterates full-year 2026 guidance of $78.0 million to $83.0 million in total revenue PRX-115 Phase 2 study continues to advance as planned, with top-line results anticipated in the second half of 2027 Cash, cash equivalents, and short-term bank deposits were $40.7 million as of June 30, 2026, providing sufficient capital to fund ongoing operations including the Phase 2 RELEASE clinical trial of PRX-115 CARMIEL, Israel, Aug. 12, 2026 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the discovery, development, production, and commercialization of innovative therapeutics for rare diseases with significant unmet needs, today reported financial results for the second quarter ended June 30, 2026, and provided a business and clinical update. During the second quarter, Protalix grew revenues from selling goods, driven primarily by continued penetration of Elfabrio® globally, advanced enrollment in the PRX-115 Phase 2 RELEASE clinical trial, and reaffirmed its strategic priorities and financial outlook for 2026. "We enter the second half of 2026 in a position of strength, driven by the continued penetration and growth of Elfabrio® through our partnership with Chiesi, a trend toward achieving our financial goals for 2026," said Dror Bashan, President and Chief Executive Officer of Protalix BioTherapeutics. "Total revenue climbed to $53.6 million from $25.8 million for the same period in 2025. With $40.7 million in cash and short-term deposits, we are well-positioned to fund execution across our operations. We remain focused on continued enrollment in our PRX-115 Phase 2 RELEASE study and our pipeline addressing rare renal indications." Second Quarter 2026 Operational Update Elfabrio® for Fabry Disease On May 4, 2026, the U.S. Patent and Trademark Office (USPTO) issued a Patent Term Extension certificate for U.S. Patent No. 9,194,011, covering Elfabrio® (pegunigalsidase alfa–iwxj). The extension adds five years to the patent term, moving the U.S. expiration date to November 17, 2035. Elfabrio® received orphan drug designation and Marketing Authorization in South Korea in May 2026, with Kwangdong Pharmaceutical Co., Ltd. as the local marketing authorization holder. PRX-115 for Uncontrolled Gout – RELEASE Phase 2 continues enrollment On July 7, 2026, the USPTO issued U.S. Patent No. 12,674,146, "Modified Uricase and Uses Thereof," to Protalix Ltd., strengthening the Company's intellectual property position around PRX-115. Patient enrollment continues in the Company's RELEASE Phase 2 clinical trial (NCT07280156) of PRX–115, a recombinant PEGylated uricase, for the treatment of uncontrolled gout. The Company continues to anticipate top–line results in the second half of 2027. Focus on Rare Renal Indications (Preclinical Programs) The Company continues to advance PRX–119, its long–acting DNase I program, as part of a broader strategic focus on rare renal indications, as well as other research collaborations. Financial Outlook: Building Durable Growth and Long–Term Value The Company operates a profitable growing commercial business through its partnerships, and a focused pipeline aligned to areas of high unmet need. The Company has a strong balance sheet, with no outstanding debt or warrants. The Company believes that its current business model limits downside risk while preserving significant upside potential as the Company progresses its clinical and preclinical programs, expands its commercial footprint, and pursues strategic partnerships to accelerate impact and scale. Priorities remain consistent: Support our commercial partners through the manufacture and supply of our products Advance PRX–115 as a potential best–in–class therapy for patients with uncontrolled gout Advance rare renal programs leveraging the Company's R&D strengths The Company reaffirms its previously stated 2026 revenue expectations: Total revenue in 2026 to range from approximately $78.0 million to $83.0 million including the $25.0 million milestone which the Company has received from Chiesi. Full–year 2026 revenues from sales of Elfabrio® without milestones to range from approximately $33.0 million to $35.0 million. Full–year 2026 revenues from sales of Elelyso® to range from approximately $20.0 million to $23.0 million. This outlook is not a guarantee of future performance, and stockholders should not rely on such forward-looking statements. These estimates are based on management's current estimates, which are subject to change and may be updated accordingly. See "Forward-Looking Statements" for additional information. Second Quarter and Year-to-Date 2026 Financials highlights Revenues from selling goods were $19.8 and $27.2 million for the three and six months ended June 30, 2026, respectively compared to $15.4 and $25.4 million for the same periods in 2025, respectively, an increase of $4.4 and $1.8 million, respectively. The increase was driven primarily by higher sales to Chiesi and Fiocruz (Brazil), partially offset by lower Pfizer purchases mainly due to Pfizer's manufacturing issues in the previous year. Revenues from license and R&D services were $0.1 and $26.4 million for the three and six months ended June 30, 2026, respectively, compared to $0.2 and $0.3 million for the same periods in 2025, the decrease in the second quarter was due to a lower amount of services provided to Chiesi in the second quarter of 2026. The increase in the first half of 2026 resulted from the $25.0 million milestone payment received from Chiesi in connection with the E4W dosage approval in the EU in the first quarter of 2026. Other than potential regulatory milestone payments, the Company expects to generate minimal revenues from license and R&D services going forward, having completed the clinical development of Elfabrio®. Cost of revenues were $7.8 and $11.9 million for the three and six months ended June 30, 2026, respectively, an increase of $1.9 million (32%) and a decrease of $2.2 million (15%) compared to $5.9 and $14.1 million for the same periods in 2025. The increase in the second quarter was driven primarily by higher sales to Chiesi and Fiocruz (Brazil), partially offset by lower sales to Pfizer. The decrease in the first half of 2026 resulted primarily from a decrease in sales to Pfizer which was partially offset by an increase in sales to Chiesi and to Fiocruz (Brazil). Research and development (R&D) expenses were $4.4 and $9.8 million for the three and six months ended June 30, 2026, respectively, a decrease of $1.6 million and an increase of $0.3 million compared to $6.0 and $9.5 million for the same periods in 2025. Both periods reflect a $2.1 million grant receivable recorded under the new R&D law as a reduction of R&D expenses. The Company expects to continue to incur R&D expenses as the RELEASE study progresses and additional preclinical and clinical programs advance. Selling, general, and administrative (SG&A) expenses were $3.1 and $6.2 million for the three and six months ended June 30, 2026, respectively, an increase of $0.5 and $1.0 million, respectively, compared to $2.6 and $5.2 million for the prior-year periods, driven primarily by $0.3 and $0.7 million in higher salary and related expenses, respectively, and of $0.2 million higher selling expenses for the three and six months ended June 30, 2026. Financial income, net was $0.2 million for the three and six months ended June 30,2026, compared to financial expenses, net of $0.5 and $0.1 million for the same periods in 2025. The change resulted primarily from exchange rate fluctuations between the U.S. dollar and the New Israeli Shekel. Taxes on income were $1.1 and $3.9 million for the three and six months ended June 30, 2026, respectively, compared to $0.5 and $0.4 million for the same periods in 2025 an increase of $0.6 and $3.5 million, respectively. The increase resulted primarily from taxes on income derived from global intangible low-taxed income (GILTI) resulting from limitations under IRC Section 174 and from taxes related to the Company's receipt of the $25 million milestone payment in the first quarter of 2026. Cash, cash equivalents, and short–term bank deposits were $40.7 million at June 30, 2026. Net income for the three months ended June 30, 2026 was $3.8 million or $0.05 per share, basic and diluted, compared to net income of $164,000 or $0.00 per share, basic and diluted, for the same period in 2025. Net income for the six months ended June 30, 2026 was $22.1 million, or $0.28 per share, basic, and $0.27 per share, diluted, compared to a net loss of $3.5 million, or $0.04 per share, basic and diluted, for the same period in 2025. Conference Call and Webcast Information The Company will host a conference call today, August 12, at 8:00 am EDT, to review the financial results and provide a business update. To participate in the conference call, please dial the following numbers prior to the start of the call: Conference Call Details: Date: August 12, 2026 Time: 8:00 a.m. Eastern Daylight Time (EDT) Toll Free: 1-877-423-9813 International: 1-201-689-8573 Israeli Toll Free: 1-809-406-247 Conference ID: 13761985 Call me™: The Call me™ feature allows you to avoid the wait for an operator; you enter your phone number on the platform and the system calls you right away. Webcast Details: The conference will be webcast live from the Protalix website and will be available via the following links: Company Link: Webcast Link: Conference ID: 13761985 Participants are requested to access the websites at least 15 minutes ahead of the conference to register, download, and install any necessary audio software. A replay of the call will be available for two weeks on the Events Calendar of the Investors section of the Protalix website, at the above link. About Protalix BioTherapeutics, Inc. Protalix is a biopharmaceutical company focused on the discovery, development, production, and commercialization of innovative therapeutics for rare diseases. Protalix has researched, developed, and currently manufactures two enzyme replacement therapies that are currently available in multiple markets. These therapies are recombinant therapeutic proteins expressed through Protalix's proprietary plant cell-based expression system, ProCellEx®. ProCellEx is a unique plant cell-based system that enables Protalix to produce recombinant proteins in an industrial-scale manner with no exposure to mammalian cells. Protalix is the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa, Elelyso®, for the treatment of Gaucher disease, excluding in Brazil where Protalix retains full rights. Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio® which was approved by both the FDA and the European Medicines Agency (EMA) in May 2023. Protalix's development pipeline includes, among others, two proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of uncontrolled gout; and PRX–119, a plant cell-expressed long-acting DNase I for the treatment of NETs-related diseases. To learn more, please visit . Forward-Looking Statements To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements generally relate to future events or the Company's future financial or operating performance, including the 2026 financial outlook described above. Actual outcomes and results may differ materially from what is expressed or forecast in such forward-looking statements. The terms "anticipate," "believe," "estimate," "expect," "can," "continue," "could," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would," and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings of the clinical trial. Factors that might cause material differences include, among others: risks related to the commercialization of Elfabrio® (pegunigalsidase alfa-iwxj), our approved product for the treatment of adult patients with Fabry disease; risks relating to Elfabrio's market acceptance, competition, reimbursement, and regulatory actions, including as a result of the boxed warning contained in the FDA approval received for the product; risks related to the regulatory approval and commercial success of our other product and product candidates, if approved; risks related to our expectations with respect to the projected market of our products and product candidates; failure or delay in the commencement or completion of our preclinical studies and clinical trials, which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to satisfactorily demonstrate non-inferiority to approved therapies; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; and/or inability to monitor patients adequately during or after treatment; the risk that the results of our clinical trials of our product candidates will not support the applicable claims of safety or efficacy and that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; the possible disruption of our operations due to the regional conflict in Iran and the military actions between Israel and Iran, the Hamas terrorist organization located in the Gaza Strip, Hezbollah, the Houthis terrorist group that controls parts of Yemen, 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 increased regional conflict; delays in the approval or potential rejection of any applications we file with the FDA, European Medicines Agency or other health regulatory authorities for our other product candidates and other risks relating to the review process; risks associated with global conditions and developments such as new or increased tariffs, treaties, trade policies, taxes, and other limitations on cross-border operations, which may adversely impact our business, results of operations, and financial condition; risks associated with 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; risks related to any transactions we may effect in the public or private equity or debt markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; risks relating to our evaluation and pursuit of strategic partnerships; risks relating to our ability to manage our relationship with our collaborators, distributors, and partners, including, but not limited to, Pfizer Inc. and Chiesi Farmaceutici S.p.A.; risks related to the amount and sufficiency of our cash and cash equivalents and short-term bank deposits; risks relating to changes to interim, top-line or preliminary data from clinical trials that we announce or publish; risks relating to the compliance by Fundação Oswaldo Cruz, or Fiocruz, an arm of the Brazilian Ministry of Health with its purchase obligations under our supply and technology transfer agreement that we entered into with Fiocruz in June 2013, which may have a material adverse effect on us and may result in our terminating such agreement; risk of significant lawsuits, including stockholder litigation, which is common in the life sciences sector; our dependence on performance by third-party providers of services and supplies, including without limitation, clinical trial services; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies; risks related to our supply of drug products to Pfizer; potential product liability risks, and risks of securing adequate levels of related insurance coverage; the possibility of infringing a third-party's patents or other intellectual property rights and the uncertainty of obtaining patents covering our products and processes and successfully enforcing our intellectual property rights against third-parties; risks relating to changes in healthcare laws, rules and regulations in the United States or elsewhere; and other factors described in our filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law. You are cautioned not to place undue reliance on these forward-looking statements. Investor Contact Mike Moyer, Managing Director LifeSci Advisors +1-617-308-4306 [email protected] SOURCE Protalix BioTherapeutics, Inc. 21% more press release views with Request a Demo