MediWound Ltd.

Good morning, everyone, and welcome to the MediWOON's third quarter 2025 earnings call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star and then one using a touch-tone telephone. To withdraw your questions, you may press star and two. Please also note today's event is being recorded. And at this time, I'd like to turn the floor over to Dan Ferry of LifeSci Advisors. Please go ahead.

Thank you, Operator, and welcome, everyone. We're here today, pre-market open, medical initiative press release, announcing financial results for the third quarter ended September 30, 2025. You may access this press release on the company's website under the Investors tab. It would ask you to review the full text of our forward-looking statements within this morning's press release. Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session, relating to anyone's expected future performance, future business prospects, or future events or plans are forward-looking statements, as defined under the Private Securities Litigation Reform Act of 1995. These statements may involve risks and uncertainties that could cause actual results to differ materially from expectations and are described more fully in our filings with the SEC. In addition, all forward-looking statements represent our views only as of today, and MediWound assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise. This conference calls the property of MediWound, and any recording or rebroadcast is expressly prohibited without the written consent of MediWound. With us today are Ofra Godin, Chief Executive Officer of MediWound, and Honey Luxemburg, Chief Financial Officer. Barry Wolfenson, EVP of Strategy and Corporate Development, is also participating on today's call. Following our prepared remarks, we will open up the call for Q&A. Now, I would like to turn the call over to Ofer Gonen, Chief Executive Officer of MediWood. Ofer?

Hi, thank you, Dan, and good morning, everyone. The third quarter was another strong period for MediWood as we executed across our strategic, clinical, and operational objectives. and continue to position the company for its next phase of growth. The three strategic priorities I'd like to emphasize today are our SCRX VLU trial, our next-of-breed manufacturing expansion, and our ability to fund our strategy. We have made meaningful progress on all those fronts. Let's start with an update on Escarex, our late-stage enzymatic debridement therapy for chronic wounds. Enrollment in the VALUE Phase III trial in venous leg ulcers continued to progress, with a target of 216 patients across roughly 40 sites in the United States and Europe. U.S. site activation proceeded as planned, while several EU sites required additional adjustments to meet ancillary-related regulatory requirements. Overall, the majority of sites are now active and enrolling. At this stage, we cannot yet assess whether these EU-related adjustments will impact the overall study timeline. We are actively monitoring enrollment trends and will update our guidance, if needed, as visibility improves. The trial's co-primary endpoints are the incidence of complete debridement and the facilitation of wound closure, both measures on which Escorex demonstrated strong results in previous Phase II studies. A pre-specified interim sample size assessment will be conducted after 65% of patients complete the treatment. We have also made progress on diabetic foot ulcer programs. We have received positive FDA feedback, and we are now awaiting EMA scientific advice. The company plans to initiate the study in the second half of 2026. As our VLU and DFU programs move forward, the market around us is also shifting in ways that highlight SCRx potential. Medicare recently lowered reimbursement rates of skin substitute products, which is expected to put significant pressure on that category and close a long-standing payment loophole. In contrast, escorex is a biologic regulated under BLA pathway and aims to enter the enzymatic debridement segment where a single legacy product generates roughly $370 million annually. Together, these market changes makes Escarex increasingly attractive to potential strategic partners. To quantify this opportunity, we completed and updated U.S. market access and pricing assessment with an independent global consulting firm, incorporating also input from healthcare professionals and payers. The analysis supports a higher potential U.S. price per course of therapy, and estimates annual peak sales of about $831 million. These updated estimates reflect SCRx robust clinical data along with modeled health economic benefits derived from earlier wound closure. With the value of study advancing, a clear regulatory path for DFU, and strong commercial validation, SCRX is positioned to drive MediWound to the next phase of growth. Now let's turn the attention to NexoBread, our innovative enzymatic therapy for severe burns. Most notably, we completed the commissioning of our expanded NexoBread manufacturing facility, a major milestone that strengthens our ability to meet the rising global demand and maintain reliable supply. The process was not simple. We worked through a two-year war, drafted personnel, and import delays on specialized equipment. But the result is transformative. Our production capacity is now six times larger, providing a strong foundation for future growth. We expect to reach full operational capacity by year-end 2025. with regulatory review and approval determining the timing of commercial output. In the United States, our partner VeriCell reported NexoBridge record quarterly revenue since launch, up 38% year-over-year and 26% sequentially. VeriCell noted broad utilization across more than 60 burn centers and plans to pursue a permanent CPT code which would take effect in 2027. Internationally, the TGA in Australia approved NexoBridge for use in both adults and pediatric patients, bringing the total number of approval market to 45 countries worldwide. This approval, together with NexoBridge's prominent presence at the recent European Burn Association Congress, where it was featured in 36 scientific presentations, highlights its expanding clinical recognition and global momentum. Regarding the collaboration with BARDA on an RFP covering stockpiling, development of room temperature stable formulation, and evaluation of an enzymatic debridement product for trauma and blast injury indications, this multi-year program was scheduled to begin on October 1st. As very well noted in the recent earnings call, The government shutdown caused all related activities to pause. Now that the shutdown has ended, we expect BARDA to resume normal operations and move forward with the planned development and procurement activities. The pause also created some uncertainty around the exact timing of BARDA and DoD-related revenue in Q4. We are actively working on these components, but the final outcome will depend on how activities progress through the remainder of the year. Overall, the advancements we have made with NexoBridge position us to a durable and meaningful growth driver for MediWood. From a corporate standpoint, we recently strengthened our balance sheet with a $30 million of equity financing from high-quality healthcare investors. This transaction provides us with the resources and flexibility to execute on our long-term growth strategy with focus and momentum. Given the discussion around the recent financing, this is a perfect point to transition the call to the financials. Hani?