Core Insights - Chiesi Global Rare Diseases and Protalix BioTherapeutics received a negative opinion from the CHMP of the EMA regarding the approval of a new dosing regimen for Elfabrio (pegunigalsidase alfa) [1][2] - The proposed regimen of 2 mg/kg every 4 weeks was not deemed to have sufficient efficacy compared to the currently approved regimen of 1 mg/kg every 2 weeks [1][2] Company Overview - Chiesi Global Rare Diseases is a unit of the Chiesi Group focused on innovative therapies for rare diseases [1][16] - Protalix BioTherapeutics specializes in developing recombinant therapeutic proteins using its proprietary ProCellEx® plant cell-based expression system [1][19] - Both companies are committed to reducing the treatment burden for patients with Fabry disease [2][20] Clinical Trial Insights - The CHMP review was based on data from the BRIGHT trial and its extension study, which had a median exposure of almost six years [2] - The data from these studies, along with modeling and exposure-response analyses from prior trials, were insufficient to demonstrate similar efficacy for the new dosing regimen [2] Fabry Disease Context - Fabry disease is a rare lysosomal storage disorder caused by mutations in the GLA gene, leading to serious health complications [11][12] - Early detection and access to treatment are critical for managing symptoms and slowing disease progression [12] Safety Information - Elfabrio is indicated for adults with confirmed Fabry disease and has been associated with hypersensitivity reactions, including anaphylaxis [3][4] - In clinical trials, 14% of patients experienced hypersensitivity reactions, with 3% experiencing anaphylaxis [6][9]

Company Overview - Protalix BioTherapeutics, Inc. is a New Jersey-based biopharmaceutical company specializing in recombinant therapeutic proteins [4] - The company develops innovative plant-based biologics, including products like Elelyso, Elfabrio, PRX-115, and PRX-119 [4] Investment Activity - Goldman Sachs Group Inc. increased its holdings in Protalix BioTherapeutics by 482.3% during the first quarter, acquiring 239,751 shares, bringing its total ownership to 289,461 shares valued at approximately $741,000 [1] Product Development - Protalix is expanding its ProCellEx platform into drug delivery optimization, targeting specific tissue requirements, which is considered a "game-changer" for the company [3] - The ProCellEx platform is noted for its cost efficiency and ability to express complex protein capabilities, positioning it as a leader in future biopharmaceutical developments [3] Market Position - The company is recognized as a hidden penny stock with potential for growth, likened to planting a tree that requires time and patience to flourish [2]

Summary of Protalix BioTherapeutics Conference Call Company Overview - Protalix BioTherapeutics is a publicly traded company listed on NYSE American, with a unique technology for expressing complex human proteins through plant cells rather than mammalian cells [4][3] - The company has been operational for approximately 30 years [4] Core Products - Protalix has two FDA-approved drugs: - **El Eliza** for the treatment of Gaucher disease, licensed to Pfizer [8][10] - **El Fabrio** for the treatment of Fabry disease, licensed to Kiesi [8][18] - Both drugs are sold through partnerships, with annual sales to Pfizer and Brazil estimated at $22 to $24 million [13][12] Financial Performance - The manufacturing agreement with Pfizer for El Eliza expires in October 2030, with hopes to renegotiate for potential return of the drug [15] - The market for El Fabrio is expected to grow from $2.2 billion last year to $3.2 billion by the end of the decade, with Protalix potentially earning $100 to $120 million in royalties from Kiesi [17][20] - Protalix is currently well-capitalized with approximately $34 million in cash and zero debt [46] Pipeline and Future Prospects - The most advanced pipeline asset is **PRX-115**, targeting uncontrolled severe gout, with a significant patient population in the U.S. [9][36] - The company is exploring additional dosing regimens for its drugs, including a once-a-month option for El Fabrio, which is under review by the EMA [29][30] - Protalix aims to leverage its core competencies in rare renal diseases and is open to collaborations in this area [44] Market Dynamics - The competitive landscape includes other enzyme replacement therapies (ERTs) like Fabrazyme and Replagal, which require more frequent infusions compared to El Fabrio [27][41] - The agreement with Kiesi includes royalties of 15-40% on U.S. sales and 15-35% on international sales, along with potential milestone payments [18][20] Key Takeaways - Protalix's unique plant-based technology offers cost advantages and manufacturing flexibility [5][6] - The company is focused on maintaining operational stability while exploring growth opportunities in its pipeline [14][46] - Upcoming catalysts include the EMA's decision on the new dosing regimen and the initiation of Phase 2 trials for PRX-115 [53]

Core Viewpoint - Pluxee has signed an agreement to acquire 100% of ProEves, enhancing its multi-benefit offerings in the Indian market and reinforcing its leadership position in the employee benefits sector [2][8]. Group 1: Acquisition Details - The acquisition of ProEves, a leading corporate childcare benefit player in India, is part of Pluxee's strategic growth plan [2][4]. - ProEves provides a digital platform for parents to select caregivers, addressing preschool and daycare needs, and currently collaborates with over 100 companies [6][4]. - The transaction will be fully funded from existing financial resources, with no material impact on Pluxee's leverage [4][8]. Group 2: Market Position and Impact - Pluxee serves over 3.5 million consumers in India and aims to strengthen its leadership by promoting gender equality and work-life balance through enhanced childcare benefits [3][4]. - The acquisition is expected to be accretive to total revenue organic growth and recurring EBITDA by Fiscal 2026, indicating a positive financial outlook [4][8]. - ProEves partners with over 7,000 childcare centers across India, supporting thousands of working parents each month [6].

Core Viewpoint - Protalix BioTherapeutics, Inc. is set to present its growth strategies and market opportunities at the upcoming Investor Summit Virtual on September 16, 2025, led by former Sr. Vice President and Chief Financial Officer Eyal Rubin [1] Company Overview - Protalix BioTherapeutics focuses on the development, production, and commercialization of recombinant therapeutic proteins [1] - The company utilizes its proprietary ProCellEx® plant cell-based protein expression system for its biopharmaceutical products [1] Event Details - The Q3 Investor Summit presentation is scheduled for September 16, 2025, at 10:30 a.m. [1]

Core Viewpoint - Pluxee has completed the acquisition of 100% of Skipr, enhancing its employee mobility benefits offerings in Belgium and France, and reinforcing its strategic growth plan in Continental Europe [2][3][11] Group 1: Acquisition Details - The acquisition of Skipr, a fast-growing Belgian company specializing in employee mobility solutions, is a strategic move for Pluxee to increase market share and broaden its product portfolio [2][3][4] - Skipr offers a state-of-the-art SaaS solution that allows employees to choose their mobility options while providing HR teams with tools for expense management and carbon footprint tracking [4][8] - The transaction is fully funded from existing financial resources, ensuring limited impact on Pluxee's leverage [6][11] Group 2: Market Position and Growth Potential - By acquiring Skipr, Pluxee is positioned to capture market share in the emerging benefit segment focused on sustainable mobility, which is increasingly important to employers and employees [5][11] - The acquisition is expected to be accretive to Pluxee's Group Organic Growth and Recurring EBITDA starting from Fiscal 2026 [6][11] - This move will expand Pluxee's revenue through an increased client base and create new cross-selling opportunities [5][11] Group 3: Company Background - Pluxee operates in 29 countries and offers a wide range of employee benefits solutions, including Meal & Food, Well-being, Lifestyle, Reward & Recognition, and Public Benefits [7] - The company has over 5,400 team members and serves more than 500,000 clients, impacting over 37 million consumers and 1.7 million merchants [7]

Company Overview - Protalix BioTherapeutics (PLX) is a commercial-stage biotech company focused on recombinant therapeutic proteins [1] - The company utilizes its proprietary plant cell-based ProCellEx technology [1] Product Portfolio - Protalix has two approved enzyme replacement therapies: 1) Elfabrio for Fabry disease 2) Elelyso for Gaucher disease [1]

Financial Data and Key Metrics Changes - The company experienced a 50% increase in revenues from selling goods compared to the same period last year [3] - Revenues from selling goods were $15.4 million for Q2 2025, an increase of $2.1 million or 16% compared to $13.3 million for Q2 2024 [12] - Net income for Q2 2025 was approximately $164,000 or $0 per share, compared to a net loss of approximately $2.2 million or $0.03 per share for the same period in 2024 [16] Business Line Data and Key Metrics Changes - Revenue growth was primarily driven by sales of Elfabrio to Chiesi, with an increase of $8 million in sales to Chiesi, partially offset by a decrease of $4.7 million in sales to Brazil and $1.2 million in sales to Pfizer [12] - Research and development expenses increased by $3 million or 100% to approximately $6 million in Q2 2025, primarily due to preparations for the planned Phase II clinical trial of PRX-115 [14] Market Data and Key Metrics Changes - The global market for Fabry disease is approximately $2.3 billion in 2025 and is forecasted to reach approximately $3.2 billion by 2030 [4] - The company anticipates El Fabryo royalties exceeding $100 million by 2030 based on a projected 15% to 20% market share of the estimated $3.2 billion Fabry total market [6] Company Strategy and Development Direction - The company is focused on building its product development pipeline, particularly in early-stage development assets and therapeutic areas related to renal rare diseases [8] - The company plans to initiate a Phase II study for PRX-115 in 2025 and enroll the first patient in Q4 2025 [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategic plan and the foundation being built for future growth, emphasizing the excitement around the Phase II program for PRX-115 [18] - The management noted that Chiesi has been performing better than expected in the marketplace, with significant growth in patient acquisition [28] Other Important Information - The company had $33.4 million in cash and cash equivalents and short-term bank deposits as of June 30, 2025 [16] - Eyal Rubens, the Chief Financial Officer, is stepping down after six years, and Gilad Mambloc will succeed him [9][10] Q&A Session Summary Question: Comments on Chiesi's planned study called Pagasso - Management confirmed it is part of Chiesi's phase four program to enhance the merits and strengths of the program [22][23] Question: Details on the Phase II trial for PRX-115 - The company plans to operate between 20 to 30 sites for the trial, primarily in the U.S. [24][25] Question: Market share held by Chiesi in Fabry disease - Management stated they do not disclose specific market share numbers but assured that Chiesi is performing well and growing its market share [27][28] Question: Utilization of Gilad's experience in business development - Management clarified that while Gilad has significant experience, the company is currently not planning any mergers or acquisitions and is focusing on growing its pipeline [30][32]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced news journalists who produce independent content across various financial markets [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content includes insights into sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is committed to adopting technology to enhance its content creation and workflow processes [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all published content is edited and authored by humans [5]

```markdown [PART I – FINANCIAL INFORMATION](index=2&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=2&type=section&id=Item%201.%20Financial%20Statements) Presents unaudited condensed consolidated financial statements, including balance sheets, statements of operations, cash flows, and detailed notes [Condensed Consolidated Balance Sheets (Unaudited)](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(Unaudited)) Presents the company's financial position at specific dates, detailing assets, liabilities, and equity Balance Sheet Summary (USD in thousands) | Metric (USD in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------ | :------------ | :------------------ | | Total Assets | 78,486 | 73,417 | | Total Liabilities | 28,583 | 30,206 | | Stockholders' Equity | 49,903 | 43,211 | [Condensed Consolidated Statements of Operations (Unaudited)](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20(Unaudited)) Details the company's revenues, expenses, and net income or loss over specific periods Three Months Ended June 30 (USD in thousands) | Metric (USD in thousands) | 2025 | 2024 | Change | | :------------------------ | :----- | :------ | :------- | | Total Revenue | 15,658 | 13,474 | +16.2% | | Operating Income (Loss) | 1,172 | (2,427) | N/A | | Net Income (Loss) | 164 | (2,203) | N/A | | Basic EPS | 0.00 | (0.03) | N/A | Six Months Ended June 30 (USD in thousands) | Metric (USD in thousands) | 2025 | 2024 | Change | | :------------------------ | :------ | :------ | :------- | | Total Revenue | 25,771 | 17,222 | +49.6% | | Operating Income (Loss) | (2,973) | (7,283) | N/A | | Net Income (Loss) | (3,455) | (6,798) | N/A | | Basic EPS | (0.04) | (0.09) | N/A | [Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(Unaudited)) Outlines changes in equity from net income, stock issuance, and other comprehensive income - Stockholders' equity **increased to** **$49,903 thousand** as of **June 30, 2025**, from **$43,211 thousand** at **January 1, 2025**[16](index=16&type=chunk) - During the **six months** ended **June 30, 2025**, the company issued **2,775,215 shares** of common stock under the Sales Agreement, **generating** **$6,812 thousand**[16](index=16&type=chunk) - Exercise of warrants and options resulted in the issuance of **1,106,625 shares** and **generated** **$2,368 thousand** in proceeds during the **six months** ended **June 30, 2025**[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows (Unaudited)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(Unaudited)) Summarizes cash inflows and outflows from operating, investing, and financing activities Cash Flow Summary (Six Months Ended June 30, USD in thousands) | Activity | 2025 | 2024 | | :------------------------ | :-------- | :------ | | Operating Activities | (10,291) | 578 | | Investing Activities | (750) | (786) | | Financing Activities | 9,180 | — | | Net Decrease in Cash | (1,865) | (235) | | Cash at End of Period | 17,895 | 23,399 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations of significant accounting policies and financial statement items [NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES](index=8&type=section&id=NOTE%201%20-%20SIGNIFICANT%20ACCOUNTING%20POLICIES) Outlines the key accounting principles and methods used in preparing the financial statements [General](index=8&type=section&id=General) Describes the company's business, product portfolio, and financial outlook - **Protalix BioTherapeutics, Inc.** is a biopharmaceutical company focused on developing and commercializing recombinant therapeutic proteins using its proprietary **ProCellEx®** protein expression system[26](index=26&type=chunk) - The company has successfully developed two enzyme replacement therapies (ERTs): **Elfabrio®** for Fabry disease (**approved May 2023**) and **Elelyso®** for Gaucher disease (**approved May 2012**)[26](index=26&type=chunk)[27](index=27&type=chunk) - The product pipeline includes **PRX-115** for uncontrolled gout and **PRX-119** for NETs-related diseases[32](index=32&type=chunk) - The company's cash and cash equivalents and short-term bank deposits as of **June 30, 2025**, are believed to be **sufficient to satisfy capital needs for at least 12 months**[38](index=38&type=chunk) [Basis of presentation](index=11&type=section&id=Basis%20of%20presentation) Explains the framework and principles used for preparing the interim financial statements - The unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP for interim financial information[39](index=39&type=chunk) - There have been **no material changes** in the company's significant accounting policies since **December 31, 2024**[40](index=40&type=chunk) [Net earnings (loss) per share](index=11&type=section&id=Net%20earnings%20(loss)%20per%20share) Defines the calculation methods for basic and diluted earnings per share - Basic earnings (loss) **per share** is calculated by dividing net income (loss) by the weighted average number of common shares outstanding[41](index=41&type=chunk) - Diluted earnings **per share** adjusts basic EPS for potential dilution from stock options, warrants, and convertible notes[42](index=42&type=chunk) [Convertible notes](index=11&type=section&id=Convertible%20notes) Details the accounting treatment and repayment status of the company's convertible debt - The company fully repaid its **7.50%** Senior Secured Convertible Promissory Notes due **2024** in **September 2024** using available cash[43](index=43&type=chunk) - Starting **January 1, 2024**, convertible debt instruments were accounted for as a single liability measured at amortized cost[44](index=44&type=chunk) [New accounting pronouncements](index=11&type=section&id=New%20accounting%20pronouncements) Discusses recently issued accounting standards and their potential impact on financial disclosures - ASU **2023-09** (Income Taxes) is **effective** for fiscal years beginning after **December 15, 2024**[45](index=45&type=chunk) - ASU **2024-03** (Expense Disaggregation) is **effective** for fiscal years beginning after **December 15, 2026**[46](index=46&type=chunk) - The company is currently evaluating the impact of these new ASUs on its consolidated financial statements disclosures[45](index=45&type=chunk)[46](index=46&type=chunk) [NOTE 2 - INVENTORIES](index=12&type=section&id=NOTE%202%20-%20INVENTORIES) Provides a breakdown of inventory components and their valuation Inventories (USD in thousands) | Category | June 30, 2025 | December 31, 2024 | | :--------------- | :------------ | :---------------- | | Raw materials | 4,357 | 4,549 | | Work in progress | 8,144 | 11,245 | | Finished goods | 8,630 | 5,449 | | **Total inventory**| **21,131** | **21,243** | [NOTE 3 – FAIR VALUE MEASUREMENT](index=12&type=section&id=NOTE%203%20%E2%80%93%20FAIR%20VALUE%20MEASUREMENT) Explains the fair value hierarchy and measurement of financial instruments - The company utilizes a fair value hierarchy (Level **1**, **2**, **3**) that prioritizes observable inputs for financial assets and liabilities[48](index=48&type=chunk)[49](index=49&type=chunk) - The fair value of financial instruments included in working capital is identical or close to their carrying value[50](index=50&type=chunk) [NOTE 4 – STOCK TRANSACTIONS](index=12&type=section&id=NOTE%204%20%E2%80%93%20STOCK%20TRANSACTIONS) Details equity-related activities including warrant exercises and stock issuances - During the **three months** ended **March 31, 2025**, the company issued **908,000 shares** from warrant exercises, **generating** **approximately $2.1 million**[51](index=51&type=chunk) - All remaining warrants expired on **March 11, 2025**[51](index=51&type=chunk) - During the **six months** ended **June 30, 2025**, the company sold **2,775,215 shares** under the Sales Agreement, **generating** gross proceeds of **approximately $7.0 million**[51](index=51&type=chunk) - The company issued **198,625 shares** from option exercises, receiving **$0.3 million** in cash proceeds during the **six months** ended **June 30, 2025**[52](index=52&type=chunk) [NOTE 5 – EARNINGS (LOSS) PER SHARE](index=13&type=section&id=NOTE%205%20%E2%80%93%20EARNINGS%20(LOSS)%20PER%20SHARE) Presents the calculation of basic and diluted earnings per share for the periods Earnings (Loss) Per Share (Six Months Ended June 30) | Metric (In thousands, except share data) | 2025 | 2024 | | :--------------------------------------- | :----------- | :----------- | | Net income (loss) | $(3,455) | $(6,798) | | Basic EPS | $(0.04) | $(0.09) | | Diluted EPS | $(0.04) | $(0.09) | | Weighted average shares (Basic) | 77,651,330 | 73,172,980 | | Weighted average shares (Diluted) | 77,651,330 | 73,172,980 | Earnings (Loss) Per Share (Three Months Ended June 30) | Metric (In thousands, except share data) | 2025 | 2024 | | :--------------------------------------- | :----------- | :----------- | | Net income (loss) | $164 | $(2,203) | | Basic EPS | $0.00 | $(0.03) | | Diluted EPS | $0.00 | $(0.03) | | Weighted average shares (Basic) | 78,663,884 | 73,308,281 | | Weighted average shares (Diluted) | 81,271,610 | 73,308,281 | - Diluted EPS for the **six months** ended **June 30, 2025**, did not include **12,936,429 shares** underlying stock options, restricted stock, and warrants because their effect would be anti-dilutive[53](index=53&type=chunk) [NOTE 6 – TAXES ON INCOME (TAX BENEFIT)](index=13&type=section&id=NOTE%206%20%E2%80%93%20TAXES%20ON%20INCOME%20(TAX%20BENEFIT)) Details the company's income tax expense or benefit and effective tax rate Taxes on Income (Tax Benefit) (USD in thousands) | Period | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :----------------------- | :----------------------------- | :----------------------------- | :------------------------------- | :------------------------------- | | Current taxes on income | 266 | - | 266 | - | | Deferred taxes on income | 118 | (207) | 231 | (69) | | **Total taxes on income (tax benefit)** | **384** | **(207)** | **497** | **(69)** | - The effective tax rate for the **six months** ended **June 30, 2025**, was **13%**, compared to **(3)%** for the same period in **2024**, primarily due to **forecasted profits from U.S. taxable GILTI income related to Section 174 of the TCJA**[55](index=55&type=chunk) - Tax reform legislation (H.R.**1**) enacted on **July 4, 2025**, **restores current deductibility for domestic research expenditures beginning in 2025**[56](index=56&type=chunk) [NOTE 7 – SEGMENT INFORMATION](index=14&type=section&id=NOTE%207%20%E2%80%93%20SEGMENT%20INFORMATION) Provides financial data segmented by customer and geographic region - The company operates as a **single operating segment in Israel**[59](index=59&type=chunk) Revenues from Selling Goods by Customer (Six Months Ended June 30, USD in thousands) | Customer | 2025 | 2024 | Change | | :---------------- | :----- | :----- | :------- | | Pfizer (Ireland) | 12,626 | 8,001 | +57.8% | | Fiocruz (Brazil) | 3,016 | 7,266 | -58.5% | | Chiesi (Italy) | 9,793 | 1,714 | +471.4% | | **Total revenues from selling goods** | **25,435** | **16,981** | **+49.8%** | [NOTE 8 – SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION](index=14&type=section&id=NOTE%208%20%E2%80%93%20SUPPLEMENTARY%20FINANCIAL%20STATEMENT%20INFORMATION) Offers additional details on accounts payable and other accrued liabilities Accounts Payable and Accruals – Other (USD in thousands) | Category | June 30, 2025 | December 31, 2024 | | :----------------------------- | :------------ | :---------------- | | Payroll and related expenses | 1,527 | 1,343 | | Provision for vacation | 2,209 | 1,811 | | Accrued expenses | 7,311 | 9,568 | | Royalties payable | 763 | 1,080 | | Income tax payable | 3,742 | 3,476 | | Payable to customer | - | 2,056 | | Property and equipment suppliers | 378 | 254 | | **Total** | **15,930** | **19,588** | [NOTE 9 – SUBSEQUENT EVENTS](index=15&type=section&id=NOTE%209%20%E2%80%93%20SUBSEQUENT%20EVENTS) Discloses significant events that occurred after the reporting period - After **June 30, 2025**, the company **collected approximately $1.4 million from Pfizer and $7.8 million from Chiesi**[60](index=60&type=chunk) - On **July 20, 2025**, **10-year options to purchase 597,990 shares of common stock** were granted to the incoming Sr Vice President and CFO, **Gilad Mamlok**, with an **exercise price of $1.45 per share** and an **estimated fair value of $0.6 million**[61](index=61&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Provides management's perspective on financial condition and operational results, including business overview, pipeline, and liquidity [CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS AND RISK FACTORS SUMMARY](index=16&type=section&id=CAUTIONARY%20STATEMENT%20REGARDING%20FORWARD-LOOKING%20STATEMENTS%20AND%20RISK%20FACTORS%20SUMMARY) Warns about uncertainties and risks that could cause actual results to differ from projections - Forward-looking statements are subject to many risks and uncertainties that could cause actual results to differ materially, including those related to commercialization, regulatory approvals, global conditions, and the ongoing conflict in Israel[63](index=63&type=chunk)[64](index=64&type=chunk) - Companies in the pharmaceutical and biotechnology industries often experience significant setbacks in advanced clinical trials, and regulatory approval is not guaranteed even with promising data[66](index=66&type=chunk) [Recent Company Developments](index=18&type=section&id=Recent%20Company%20Developments) Highlights key corporate events and personnel changes during the reporting period - **Protalix** was added to the **Russell 3000®** and **Russell 2000®** Indexes, **effective June 27, 2025**[67](index=67&type=chunk) - **Gilad Mamlok** was appointed as the new Senior Vice President and Chief Financial Officer, **effective August 24, 2025**, succeeding Eyal Rubin[68](index=68&type=chunk) [Our Business](index=18&type=section&id=Our%20Business) Provides an overview of the company's proprietary technology, marketed products, and pipeline - **Protalix** is a commercial-stage biopharmaceutical company focused on recombinant therapeutic proteins produced via its proprietary **ProCellEx®** plant cell-based protein expression system[69](index=69&type=chunk) - The company has successfully developed two commercial enzyme replacement therapies (ERTs): **Elfabrio®** for Fabry disease and **Elelyso®** for Gaucher disease[70](index=70&type=chunk) - The company's pipeline includes **PEGylated uricase (PRX-115)** for uncontrolled gout and **Long Acting (LA) DNase I (PRX-119)** for NETs-related diseases[76](index=76&type=chunk) [ProCellEx: Our Proprietary Protein Expression System](index=20&type=section&id=ProCellEx%3A%20Our%20Proprietary%20Protein%20Expression%20System) Describes the company's unique plant cell-based protein production platform and its advantages - **ProCellEx** is **Protalix's** proprietary platform for producing recombinant proteins through plant cell-based expression, being the **first and only system to receive FDA approval for such proteins**[80](index=80&type=chunk) - The system offers advantages such as **biologic optimization, handling complex protein expressions, flexible manufacturing, simplified production, and elimination of viral contamination risks**[82](index=82&type=chunk) - **ProCellEx** utilizes advanced genetic engineering and plant cell culture technology (e.g., carrot and tobacco BY-**2** cells) in **cGMP-compliant, clean-room environments**[81](index=81&type=chunk)[84](index=84&type=chunk)[85](index=85&type=chunk) [Our Marketed Products](index=22&type=section&id=Our%20Marketed%20Products) Details the company's approved enzyme replacement therapies for rare genetic disorders - The company markets two enzyme replacement therapies (ERTs): **Elelyso** for Gaucher disease and **Elfabrio** for Fabry disease[92](index=92&type=chunk) - **Elelyso** is **approved** in **23 markets**, including the United States and Brazil, while **Elfabrio** is **approved** in the United States, European Union, and other regions[93](index=93&type=chunk)[97](index=97&type=chunk)[99](index=99&type=chunk) - The **global market for Gaucher disease is forecasted to be approximately $1.7 billion in 2025**, while the **Fabry disease market is projected to grow from $2.3 billion in 2025 to $3.2 billion in 2030**[95](index=95&type=chunk)[102](index=102&type=chunk) [Elelyso for the Treatment of Gaucher Disease](index=22&type=section&id=Elelyso%20for%20the%20Treatment%20of%20Gaucher%20Disease) Focuses on Elelyso's regulatory approvals, market presence, and disease prevalence - **Elelyso** (taliglucerase alfa) was **approved by the FDA** in **2012** for adult patients and in **2014** for children **four years** and older with Type **1** Gaucher disease[93](index=93&type=chunk) - It is the **first plant cell-derived recombinant protein approved by the FDA** for Gaucher disease and is **marketed in 23 countries**[93](index=93&type=chunk) - Gaucher disease is a rare genetic disorder with a **prevalence ranging from 0.70 to 1.75 per 100,000** in the general population[94](index=94&type=chunk) [Elfabrio for the Treatment of Fabry Disease](index=22&type=section&id=Elfabrio%20for%20the%20Treatment%20of%20Fabry%20Disease) Covers Elfabrio's regulatory status, market potential, and disease characteristics - **Elfabrio** was **approved** by the EC and FDA in **May 2023** for adult patients with Fabry disease (**1 mg/kg every two weeks** dosage), with subsequent approvals in other regions[97](index=97&type=chunk)[99](index=99&type=chunk) - The FDA approval included a boxed warning for hypersensitivity reactions/anaphylaxis and warnings/precautions for membranoproliferative glomerulonephritis (MPGN)[104](index=104&type=chunk) - Fabry disease is a serious life-threatening rare genetic disorder affecting **1 in 40,000 to 60,000 males**, leading to Gb**3** accumulation and end-organ failure[100](index=100&type=chunk)[101](index=101&type=chunk) [Regulatory Background of Elfabrio](index=24&type=section&id=Regulatory%20Background%20of%20Elfabrio) Summarizes the regulatory approval process and key milestones for Elfabrio - The **BLA for PRX-102 (Elfabrio) was resubmitted to the FDA in November 2022** after an **initial CRL in April 2021**, which cited the need for a manufacturing facility inspection and addressing updated regulatory circumstances[103](index=103&type=chunk) - The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a **positive opinion** in **February 2023**, leading to **EC approval**[104](index=104&type=chunk) - **Chiesi's Variation Submission to the EMA in December 2024** seeks to **add an additional dose and dosing regimen (2 mg/kg every four weeks)** to the current **Elfabrio** label[105](index=105&type=chunk) [Key Trials and Design](index=25&type=section&id=Key%20Trials%20and%20Design) Outlines the design and primary findings of pivotal clinical trials for Elfabrio - The **PRX-102** clinical development program aimed to demonstrate clinical benefit in adult Fabry patients, analyzing **1 mg/kg every two weeks** and **2 mg/kg every four weeks** dosing regimens[106](index=106&type=chunk)[107](index=107&type=chunk) - Preclinical studies showed **PRX-102** had a **significantly longer half-life, enhanced activity in affected organs, and reduced immunogenicity**[106](index=106&type=chunk) [Phase III BALANCE Study](index=25&type=section&id=Phase%20III%20BALANCE%20Study) Details the comparative efficacy and safety of PRX-102 versus agalsidase beta in Fabry patients - The BALANCE study was a **pivotal 24-month, randomized, double-blind, active-control study** comparing **PRX-102 (1 mg/kg every two weeks)** to **agalsidase beta** in Fabry patients with deteriorating renal function[108](index=108&type=chunk) - **PRX-102** demonstrated a **favorable tolerability profile** with **lower rates of infusion-related reactions (0.5 per 100 infusions for PRX-102 vs. 3.9 for agalsidase beta)** and **less premedication use**[111](index=111&type=chunk)[116](index=116&type=chunk) - A **trend of reduction in anti-drug antibody (ADA) positivity** was observed in the **PRX-102** arm (**from 34.6% to 23.4%**) while remaining stable in the **agalsidase beta** arm[112](index=112&type=chunk) [Phase III BRIDGE Study](index=26&type=section&id=Phase%20III%20BRIDGE%20Study) Evaluates PRX-102's impact on renal function in Fabry patients transitioning from agalsidase alfa - The BRIDGE study was a **12-month open-label study** evaluating **PRX-102 (1 mg/kg every two weeks)** in Fabry patients previously treated with **agalsidase alfa**[117](index=117&type=chunk) - It showed **substantial improvement in renal function**, with the **mean annualized eGFR slope improving from -5.90 mL/min/1.73m2/year on agalsidase alfa to -1.19 mL/min/1.73m2/year on PRX-102**[118](index=118&type=chunk) - **PRX-102** was **well-tolerated**, with the **majority of treatment-emergent adverse events (TEAEs) being mild or moderate in severity**[119](index=119&type=chunk) [Phase III BRIGHT Study](index=26&type=section&id=Phase%20III%20BRIGHT%20Study) Assesses the safety and efficacy of PRX-102 at a 2 mg/kg every four weeks dosage in Fabry patients - The BRIGHT study evaluated **PRX-102 (2 mg/kg every four weeks)** in Fabry patients previously treated with ERT, demonstrating it was **well-tolerated**[120](index=120&type=chunk)[124](index=124&type=chunk) - Study outcomes showed **stable renal function** (**mean eGFR slope -2.92 mL/min/1.73 m2/year**) and **stable plasma lyso-Gb3 concentrations throughout the 52-week treatment period**[126](index=126&type=chunk) - **Patient perception of health remained high and stable**, and **pain severity improved or remained stable**, with **no Fabry clinical events reported**[128](index=128&type=chunk) [Phase I/II Study](index=28&type=section&id=Phase%20I%2FII%20Study) Reports on early-stage clinical findings for PRX-102 in ERT-naïve adult Fabry patients - The phase I/II study in **ERT-naïve adult Fabry patients** demonstrated that **PRX-102 reduced kidney Gb3 inclusions and plasma lyso-Gb3 levels** (**approximately 90% decrease from baseline**)[130](index=130&type=chunk)[132](index=132&type=chunk) - **Renal function remained stable**, and **improvements were noted across gastrointestinal symptoms and overall disease severity (Mainz Severity Score Index, MSSI)**[132](index=132&type=chunk) - **Anti-drug antibodies (ADAs) formed by a minority of patients (<19%) turned negative after 12 months of treatment**, with **no observed impact on safety or efficacy**[133](index=133&type=chunk) [Extension Studies](index=28&type=section&id=Extension%20Studies) Describes the long-term follow-up studies for patients completing initial PRX-102 trials - **Two long-term open-label extension studies** were available for patients completing previous **PRX-102** trials, with **126 patients** initially enrolling[134](index=134&type=chunk) - Following **Elfabrio's** approval, **sponsorship and administration of the extension studies transferred to Chiesi**[136](index=136&type=chunk) - **Most patients have transitioned to commercial or expanded access programs**, leading to the **closure of the 1 mg/kg every two weeks dosage extension study**[136](index=136&type=chunk) [Pediatric FLY Study](index=29&type=section&id=Pediatric%20FLY%20Study) Introduces the ongoing study evaluating pegunigalsidase alfa in pediatric Fabry disease patients - **Chiesi** is sponsoring the **Pediatric FLY Study** to assess pegunigalsidase alfa in **Fabry disease patients aged 2 to less than 18 years**, with recruitment commenced[137](index=137&type=chunk) - The study design is based on the **Initial Pediatric Study Plan (iPSP) agreed with the FDA and the Paediatric Investigation Plan (PIP) accepted by the EMA**[137](index=137&type=chunk) [Japanese RISE Study](index=29&type=section&id=Japanese%20RISE%20Study) Details the clinical trial assessing pegunigalsidase alfa in Japanese Fabry disease patients - **Chiesi** is recruiting patients for the **Japanese RISE study** to evaluate the safety and efficacy of pegunigalsidase alfa (**PRX-102**) in **Japanese Fabry disease patients (adults and adolescents)**[138](index=138&type=chunk) - The study includes both **1 mg/kg every two weeks and 2 mg/kg every four weeks dosages**[138](index=138&type=chunk) [Commercialization of Approved Products](index=29&type=section&id=Commercialization%20of%20Approved%20Products) Explains the company's strategies and partnerships for marketing its approved therapies - **Elelyso is commercialized globally (excluding Brazil) through Pfizer and in Brazil through Fiocruz**[139](index=139&type=chunk)[140](index=140&type=chunk) - **Elfabrio is commercialized globally through Chiesi under two exclusive licensing and supply agreements**[142](index=142&type=chunk) - **Revenue from product sales to partners is recognized upon delivery, which may not directly reflect patient demand and can lead to period-to-period variability in results**[73](index=73&type=chunk)[75](index=75&type=chunk) [Elelyso – Pfizer](index=29&type=section&id=Elelyso%20%E2%80%93%20Pfizer) Describes the licensing agreement with Pfizer for global commercialization of Elelyso (excluding Brazil) - **Protalix has licensed global rights (excluding Brazil) to market and sell Elelyso to Pfizer under the Amended Pfizer Agreement**[139](index=139&type=chunk) - **Protalix supplies drug substance to Pfizer for Elelyso production at a fixed cost, with an initial 10-year supply period and options for extensions**[139](index=139&type=chunk) [Alfataliglicerase – Fundação Oswaldo Cruz (Fiocruz)](index=29&type=section&id=Alfataliglicerase%20%E2%80%93%20Funda%C3%A7%C3%A3o%20Oswaldo%20Cruz%20(Fiocruz)) Details the commercialization agreement for Elelyso in Brazil with Fiocruz - **Elelyso**, marketed as BioManguinhos alfataliglicerase, is commercialized in Brazil through an agreement with **Fiocruz**[140](index=140&type=chunk) - **Despite Fiocruz's purchases being significantly below agreed-upon milestones, Protalix continues to supply the product**[35](index=35&type=chunk)[141](index=141&type=chunk) - BioManguinhos alfataliglicerase is the therapy of choice for newly diagnosed Gaucher patients in Brazil and is used by **approximately 25% of patients**[140](index=140&type=chunk) [Elfabrio (pegunigalsidase alfa/PRX-102) – Chiesi Farmaceutici](index=29&type=section&id=Elfabrio%20(pegunigalsidase%20alfa%2FPRX-102)%20%E2%80%93%20Chiesi%20Farmaceutici) Outlines the exclusive global licensing and supply agreements with Chiesi for Elfabrio - **Under two exclusive global licensing and supply agreements, Protalix received $50.0 million in upfront payments and $45 million in development cost reimbursements from Chiesi**[142](index=142&type=chunk) - **Protalix is eligible for over $1.0 billion in potential milestone payments and tiered payments ranging from 15% to 40% of net sales**[142](index=142&type=chunk)[143](index=143&type=chunk)[145](index=145&type=chunk) - **Chiesi is responsible for global commercialization and medical programs for Elfabrio, while Protalix is responsible for manufacturing the drug substance**[73](index=73&type=chunk)[144](index=144&type=chunk) - **A Fill/Finish Agreement with Chiesi for commercial fill/finish services was amended in November 2024 to have an initial term of 10 years**[147](index=147&type=chunk) [Product Development Pipeline](index=30&type=section&id=Product%20Development%20Pipeline) Presents the company's investigational drug candidates and strategic focus for future development - **Protalix's corporate strategy focuses on developing new, early-stage product candidates for rare and orphan diseases with high unmet needs, including renal diseases**[148](index=148&type=chunk) - The company intends to leverage its **ProCellEx** platform and PEGylation capabilities, as well as other modalities like small molecules and antibodies[148](index=148&type=chunk) - The current pipeline includes **PEGylated uricase (PRX-115)** for uncontrolled gout and **Long Acting (LA) DNase I (PRX-119)** for NETs-related diseases[148](index=148&type=chunk) [PEGylated Uricase (PRX-115)](index=30&type=section&id=PEGylated%20Uricase%20(PRX-115)) Focuses on PRX-115, a candidate for uncontrolled gout, and its clinical trial progress - **PRX-115 is a recombinant PEGylated uricase under development for uncontrolled gout, designed to lower urate levels with low immunogenicity and increased half-life**[149](index=149&type=chunk) - A **completed Phase I clinical trial showed dose-dependent increases in PRX-115 exposure and rapid, dose-dependent reductions in plasma urate levels for up to 12 weeks**[151](index=151&type=chunk)[154](index=154&type=chunk) - **PRX-115 was well-tolerated in the Phase I study, with only 25% of treated subjects reporting mild to moderate study drug-related adverse events**[158](index=158&type=chunk)[160](index=160&type=chunk) - **Preparations for a Phase II clinical trial of PRX-115 have been initiated, with the study expected to commence in the second half of 2025**[163](index=163&type=chunk) [PRX-119](index=33&type=section&id=PRX-119) Describes PRX-119, a DNase I product candidate for NETs-related diseases, and preclinical findings - **PRX-119 is a plant cell-expressed PEGylated recombinant human DNase I product candidate designed for elongated half-life to treat NETs-related diseases**[167](index=167&type=chunk) - **Preclinical studies demonstrated that PRX-119 administration decreased circulating DNA levels and significantly enhanced the survival of mice in sepsis and ARDS models**[168](index=168&type=chunk) [Intellectual Property](index=33&type=section&id=Intellectual%20Property) Summarizes the company's patent portfolio protecting its technology and products - As of **June 30, 2025**, **Protalix** holds a broad portfolio of **16 patent families**, consisting of **approximately 68 patents** and **42 pending patent applications** worldwide[169](index=169&type=chunk) [Research & Development](index=33&type=section&id=Research%20%26%20Development) Details ongoing efforts to enhance the ProCellEx platform and develop new product candidates - The company **continuously works on the further development and enhancement** of its **ProCellEx** plant cell expression technology and bioreactor system[170](index=170&type=chunk) - R&D efforts are focused on new, early-stage product candidates for indications with high unmet needs in efficacy and safety, including renal diseases[171](index=171&type=chunk) - The company intends to use its **ProCellEx** platform, PEGylation capabilities, and other modalities such as small molecules and oligonucleotides, while also exploring novel platform technologies[171](index=171&type=chunk)[172](index=172&type=chunk) [Critical Accounting Policies](index=35&type=section&id=Critical%20Accounting%20Policies) Confirms no material changes to key accounting policies and the use of estimates - **There have been no material changes to the company's critical accounting policies since the Annual Report on Form 10-K for the year ended December 31, 2024**[173](index=173&type=chunk) - The preparation of financial statements requires management to make estimates and assumptions that are evaluated on an ongoing basis[174](index=174&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) Analyzes the company's financial performance for the three and six months ended June 30, 2025 [Three months ended June 30, 2025 compared to the three months ended June 30, 2024](index=35&type=section&id=Three%20months%20ended%20June%2030%2C%202025%20compared%20to%20the%20three%20months%20ended%20June%2030%2C%202024) Compares financial results for the three-month periods, highlighting revenue and expense changes - **Revenues from selling goods increased by $2.1 million (16%) to $15.4 million**, primarily driven by an **$8.0 million increase in sales to Chiesi**, partially offset by decreases in sales to Fiocruz and Pfizer[175](index=175&type=chunk) - **Research and development expenses increased by $3.0 million (100%) to $6.0 million**, mainly due to preparations for the planned Phase II clinical trial of **PRX-115**[178](index=178&type=chunk)[179](index=179&type=chunk) - **Selling, general and administrative expenses decreased by $0.9 million (26%) to $2.6 million**[181](index=181&type=chunk) - **Financial expenses, net, were $0.5 million**, compared to **financial income, net, of $0.2 million** in the prior year, due to exchange rate costs and lower interest income, partially offset by lower notes interest expenses[182](index=182&type=chunk) [Six months ended June 30, 2025 compared to the six months ended June 30, 2024](index=36&type=section&id=Six%20months%20ended%20June%2030%2C%202025%20compared%20to%20the%20six%20months%20ended%20June%2030%2C%202024) Compares financial results for the six-month periods, detailing revenue and expense trends - **Revenues from selling goods increased by $8.4 million (49%) to $25.4 million**, primarily due to increases in sales to Chiesi (**+$8.1 million**) and Pfizer (**+$4.6 million**), partially offset by a decrease in sales to Fiocruz (**-$4.3 million**)[184](index=184&type=chunk) - **Research and development expenses increased by $3.7 million (64%) to $9.5 million**, mainly due to preparations for the planned Phase II clinical trial of **PRX-115**[187](index=187&type=chunk)[188](index=188&type=chunk) - **Selling, general and administrative expenses decreased by $1.4 million (21%) to $5.2 million**[190](index=190&type=chunk) - **Financial expenses, net, were $0.1 million**, compared to **financial income, net, of $0.3 million** in the prior year, due to exchange rate costs and lower interest income, partially offset by lower notes interest expenses[191](index=191&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's cash position, funding sources, and future capital requirements - As of **June 30, 2025**, the company had **$33.4 million in cash and cash equivalents and short-term bank deposits**[193](index=193&type=chunk) - The company repaid its **2024** Notes in **September 2024** with a cash payment of **approximately $21.2 million**[193](index=193&type=chunk) - During the **six months** ended **June 30, 2025**, the company raised **approximately $7.0 million** from common stock issuance under the Sales Agreement, with **approximately $15.7 million remaining available for sale**[194](index=194&type=chunk) - Management believes current funds are **sufficient to satisfy capital needs for at least 12 months** from the report issuance date[195](index=195&type=chunk) [Cash Flows](index=37&type=section&id=Cash%20Flows) Analyzes cash generated or used by operating, investing, and financing activities - **Net cash used in operating activities was $10.3 million** for the **six months** ended **June 30, 2025**, primarily due to net loss and increases in accounts receivable and other assets[196](index=196&type=chunk) - **Net cash provided by financing activities was $9.2 million** for the **six months** ended **June 30, 2025**, from common stock issuance and exercise of warrants and options[196](index=196&type=chunk) - In contrast, **net cash provided by operations was $0.6 million** for the **six months** ended **June 30, 2024**[197](index=197&type=chunk) [Future Funding Requirements](index=38&type=section&id=Future%20Funding%20Requirements) Discusses anticipated capital needs and strategies for securing future financing - The company expects to incur **significant and increasing research and development expenditures** for its product candidates[200](index=200&type=chunk) - Anticipated revenues from **Elfabrio** and **Elelyso** may not be sufficient to fund all future expenditures[200](index=200&type=chunk) - Future cash needs will be financed through product sales, corporate collaborations, licensing arrangements, and public or private equity/debt financings[201](index=201&type=chunk) - The company currently has **no commitments for future external funding**, except for potential milestone payments under the **Chiesi** Agreements[201](index=201&type=chunk) [Effects of Currency Fluctuations](index=38&type=section&id=Effects%20of%20Currency%20Fluctuations) Examines the impact of exchange rate changes on the company's financial results - The company's **functional currency is the U.S. dollar**, but **approximately 44% of its costs are incurred in New Israeli Shekels (NIS)**[205](index=205&type=chunk)[206](index=206&type=chunk) - A decline in the U.S. dollar's value relative to the NIS would **increase the U.S. dollar cost of operations in Israel**[205](index=205&type=chunk)[206](index=206&type=chunk) - Currency fluctuations have **not had a material effect on results** for the **three** and **six months** ended **June 30, 2025**, but the company may engage in hedging transactions in the future[202](index=202&type=chunk)[206](index=206&type=chunk) [Off-Balance Sheet Arrangements](index=38&type=section&id=Off-Balance%20Sheet%20Arrangements) Confirms the absence of any material off-balance sheet financial commitments - The company had **no off-balance sheet arrangements** as of **June 30, 2025**, and **December 31, 2024**[203](index=203&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Details the company's exposure to market risks, primarily focusing on currency exchange risk due to a significant portion of its expenses being denominated in New Israeli Shekels (NIS) while its functional currency is the U.S. dollar [Currency Exchange Risk](index=39&type=section&id=Currency%20Exchange%20Risk) Details the company's exposure to foreign currency fluctuations, particularly with NIS - **Approximately 44% of the company's costs**, including salaries and office expenses, are **incurred in New Israeli Shekels (NIS)**[206](index=206&type=chunk) - A **1% revaluation of the NIS** would affect the company's loss before tax by **less than 1%**[206](index=206&type=chunk) - The company has **not engaged in hedging transactions** to date but may do so in the future to mitigate financial exposure from exchange rate fluctuations[206](index=206&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Outlines the evaluation of the company's disclosure controls and procedures, concluding their effectiveness as of June 30, 2025 [Evaluation of Disclosure Controls and Procedures](index=39&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Assesses the effectiveness of controls ensuring timely and accurate financial reporting - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective as of June 30, 2025**[208](index=208&type=chunk) - These controls are designed to provide **reasonable assurance** that information required for Exchange Act reports is recorded, processed, summarized, and reported timely[207](index=207&type=chunk)[208](index=208&type=chunk) [Inherent Limitations on Effectiveness of Controls](index=39&type=section&id=Inherent%20Limitations%20on%20Effectiveness%20of%20Controls) Acknowledges that control systems provide reasonable, not absolute, assurance against errors - Management acknowledges that disclosure controls and internal control over financial reporting can provide only **reasonable, not absolute, assurance** against all errors and fraud[209](index=209&type=chunk) - The design of a control system must reflect **resource constraints**, and benefits must be considered relative to costs[209](index=209&type=chunk) [Changes in Internal Control over Financial Reporting](index=40&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) Reports on any modifications to internal controls during the reporting period - **No changes in internal control over financial reporting occurred** during the quarter ended **June 30, 2025**, that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[210](index=210&type=chunk) [PART II – OTHER INFORMATION](index=41&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=41&type=section&id=Item%201.%20Legal%20Proceedings) States the company's involvement in any material legal disputes - The company is **not involved in any material legal proceedings**[211](index=211&type=chunk) [Item 1A. Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) Refers to previously disclosed risks and any material changes since the last annual report - **No material changes to the risk factors** previously disclosed in the Annual Report on Form **10-K** for the year ended **December 31, 2024**[212](index=212&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=41&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Reports on any unregistered equity sales or use of proceeds - **None**[213](index=213&type=chunk) [Item 3. Defaults Upon Senior Securities](index=41&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Discloses any defaults on senior debt instruments - **None**[214](index=214&type=chunk) [Item 4. Mine Safety Disclosure](index=41&type=section&id=Item%204.%20Mine%20Safety%20Disclosure) Confirms the non-applicability of mine safety reporting requirements - **Not applicable**[215](index=215&type=chunk) [Item 5. Other Information](index=41&type=section&id=Item%205.%20Other%20Information) Provides details on any other material information not covered elsewhere - **None of the company's directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement** during the quarter ended **June 30, 2025**[216](index=216&type=chunk) [Item 6. Exhibits](index=41&type=section&id=Item%206.%20Exhibits) Lists all supplementary documents filed with the report - Exhibits include **Certificate of Incorporation, Bylaws, Form of Restricted Stock Agreement/Notice, Form of Stock Option Agreement, Employment Agreement, and CEO/CFO Certifications**[217](index=217&type=chunk)[218](index=218&type=chunk) [SIGNATURES](index=43&type=section&id=SIGNATURES) Authenticates the report with official signatures from company executives - The report was signed on **August 14, 2025**, by **Dror Bashan, President and Chief Executive Officer**, and **Eyal Rubin, Senior Vice President and Chief Financial Officer**[223](index=223&type=chunk) ```